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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 565 out of 10,317

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VAERS ID: 1925873 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030A21A / 1 RA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021B21A / 2 AR / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013F21A / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Aphasia, Catatonia, Cognitive disorder, Computerised tomogram normal, Dysstasia
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: rosuvastatin, kepra, plavix, levothyroxine, omeprazole, methotrexate, prolia, calcium,
Current Illness: no
Preexisting Conditions: tia
Allergies: no
Diagnostic Lab Data: CT scans revealed no new neurological activity.
CDC Split Type:

Write-up: Mom does fine in the afternoon of shot. Goes to bed just fine....In the morning she''s catatonic. Cannot stand, no comprehension of anything we''re asking of her or telling her. She cannot speak. Cannot put 2 words together! She has had a history of Tia''s and seizures that affect her ability to speak. Her previous seizures only last up to an hour. The reaction to the shots seem to cause a seizure that lasts 24 hours almost. 2 out of the 2 doses we called EMS.


VAERS ID: 1925875 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Celebrex; Levothyroxine; Latanaprost & Brimonidine Eye Drops; Multi-Vitamin
Current Illness: N.A.
Preexisting Conditions: Hypo thyroidism; Raynaud Syndrome
Allergies: Penicillin; Cipro; Oral Decongestants
Diagnostic Lab Data: N. A.
CDC Split Type:

Write-up: Not sure if coincidental or causal. Booster shot was painless. That evening started developing soreness in arm injected. Over the following days left shoulder/arm (length of shoulder down arm to bicep/tricep and occasionally elbow/top of forearm) became increasingly sore and painful with a very limited range of motion. Condition has not improved. I have had previous issues with that shoulder and am currently experiencing similar but less serious issues with my right shoulder resulting from a strain weightlifting. However, there was no obvious trigger for the left shoulder issue other than the booster shot. I had assumed the problem was a coincidence but was told by my massage therapist last week that she has two other clients experiencing a similar problem after receiving the booster shot.


VAERS ID: 1925886 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-02-19
Onset:2021-11-17
   Days after vaccination:271
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6200 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram, Asthenia, Blood creatine phosphokinase, Blood lactate dehydrogenase, C-reactive protein, COVID-19, Chest X-ray, Chills, Computerised tomogram thorax, Cough, Decreased appetite, Dizziness, Electrocardiogram, Fatigue, Fibrin D dimer, Full blood count, Headache, Metabolic function test, Pain, Procalcitonin, Scan with contrast, Serum ferritin, Troponin
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Guillain-Barre 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? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: albuterol prn for wheezing amitriptyline 10mg HS aspirin 81mg daily atorvastatin 10mg daily Flecainide 50mg BID hydroxyurea 1000mg BID levothyroxine 50mcg daily metoprolol tartrate 100mg BID multivitamin daily omeprazole 20mg daily sucralfa
Current Illness: None documented
Preexisting Conditions: migraines, hypercholesterolemia, polyarticular osteoarthritis, vertigo, hypothyroidism, diverticular disease, carotid artery stenosis, mitral valve regurgitation, tricuspid valve regurgitation, aortic valve regurgitation, vitamin d deficiency, thrombocytosis, iron deficiency anemia, increased glucose levels, arthritis, adenomatous polyp of colon, hiatal hernia, anxiety and depression, syncope
Allergies: bee stings - throat swelling iodine - throat swelling morphine - hives shellfish - throat swelling
Diagnostic Lab Data: CMP, Lactate Dehydrogenase, CBC, D Dimer, Ferritin, Creatine Kinase, Troponin, C-Reactive Protein Inflammation, Procalcitonin. CT Angiography chest with contrast, chest xray, and EKG
CDC Split Type:

Write-up: Patient contracted COVID after being fully vaccinated. No booster. chills, headache, dizziness, weakness, cough, body aches, fatigue, anorexia.


VAERS ID: 1927783 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Accidental underdose
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: Medical History/Concurrent Conditions: Stem cell transplant (Took after Moderna second dose.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Received half dose booster instead of a full dose repeat; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Received half dose booster instead of a full dose repeat) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Stem cell transplant (Took after Moderna second dose.) on 01-Apr-2021. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received half dose booster instead of a full dose repeat). On 17-Nov-2021, ACCIDENTAL UNDERDOSE (Received half dose booster instead of a full dose repeat) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant information was not provided. It was reported that patient was instructed by MD to repeat the doses after stem cell transplant but HCP gave her a half dose booster instead of repeating full dose. Treatment information was not provided. This case was linked to MOD-2021-403091 (Patient Link).


VAERS ID: 1927877 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-11-06
Onset:2021-11-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 071F21A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypertension, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Hypertension (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: LEVOTHYROXINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Patient has high blood pressure because of the hives; Patient broke up in bad hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Patient broke up in bad hives) and HYPERTENSION (Patient has high blood pressure because of the hives) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE for an unknown indication. On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced URTICARIA (Patient broke up in bad hives). On an unknown date, the patient experienced HYPERTENSION (Patient has high blood pressure because of the hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and PEPSIN at an unspecified dose and frequency. At the time of the report, URTICARIA (Patient broke up in bad hives) and HYPERTENSION (Patient has high blood pressure because of the hives) outcome was unknown. concomitant medication included levothyroxine used for thyroids


VAERS ID: 1928066 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 EW0196 / 3 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101685465

Write-up: rash that has become increasingly worse, spreading all over her body/rash feels like poison ivy and looks very prickly and itchy; rash feels like poison ivy and looks very prickly and itchy; rash is like poison ivy all over her body and it is very uncomfortable; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101689900 (Pfizer). A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: EW0196) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, LOT: EN6203, Route, Anatomical Location: left arm), administration date: 02Mar2021, when the patient was 72 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, LOT: EP6955, around 3:00pm, Route, Anatomical Location: left arm), administration date: 27Mar2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 19Nov2021, outcome "not recovered", described as "rash that has become increasingly worse, spreading all over her body/rash feels like poison ivy and looks very prickly and itchy"; RASH PRURITIC (non-serious) with onset 19Nov2021, outcome "not recovered", described as "rash feels like poison ivy and looks very prickly and itchy"; DISCOMFORT (non-serious) with onset 19Nov2021, outcome "not recovered", described as "rash is like poison ivy all over her body and it is very uncomfortable"; IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster". Therapeutic measures were taken as a result of rash, rash pruritic, discomfort. Additional information: The caller stated that the rash had gotten worse with a mighty force and states that it feels like poison ivy and looks very prickly and itchy. It started on the inside of the right arm, which was the opposite of the left arm, which she got the shot it. The rash started on the left arm and was spreading everywhere, all over her body, with a vengeance. It was like poison ivy all over her body and it was very uncomfortable. She has tried Cortisone cream and tried taking Benadryl. Because Benadryl was an antihistamine, she thought it should calm things down. It did for a little bit but, not enough to stop it. She was having to take it every 3 or 4 hours.


VAERS ID: 1928814 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1855194 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations: pt stated he has had reaction to the flu vaccine which landed him in the hospital
Other Medications: cosentics
Current Illness:
Preexisting Conditions: autoimmune disorder
Allergies:
Diagnostic Lab Data: yes, echocardiogram, sonogram of arteries
CDC Split Type:

Write-up: Dizziness and passed out, became extremely confused and couldn''t remember anything. Went to ER.


VAERS ID: 1928858 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 9399909 / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Body temperature increased, Chills, Condition aggravated, Dizziness, Dyspnoea, Fatigue, Feeling hot, Flushing, Headache, Hyperhidrosis, Immediate post-injection reaction, Lymphadenopathy, Respiratory tract congestion, Tachycardia, Tremor
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Klonopin, Iron, Fludocortisone, Neurotin, Topiramate, Omeprazole, Naproxen, Potassium
Current Illness:
Preexisting Conditions: Fibromyalgia, Spondylopathy, IBS
Allergies: Tetracyclines, macrolides, sulfa anitbiotics, cephalosporins, penicillins
Diagnostic Lab Data: none
CDC Split Type:

Write-up: right away: dizzy, sweaty, flushing 4pm head started throbbing 630pm: headache started in the back and spread to left side, tachycardia 8pm: chills 830:chills and shaking 130am: shaking chills 99.4 temp 5am: 101.5 temp, headache worse 730am: 98.6, headache 11am 97.9, head hot and throbbing 2pm: 98.2 temp 6:50: 99 temp and chills friday 11/19 9am: 96.3 temp bad headache -chronic disease has worsened due to this, trouble breathing 10am: glands swollen 11/20 temp 97.2, fatigued, congested 11/21 fatigued, couldn''t shower 96.4


VAERS ID: 1929072 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Asthenia, Balance disorder, Dizziness, Fatigue, Headache, Loss of personal independence in daily activities, Urinary incontinence, Vertigo
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole 40mg, Aspirin 82mg, and 4 others.
Current Illness: None
Preexisting Conditions: Diabetic
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Symptoms: Weak, tired, Vertigo/loss of balance for entire day (Day after receiving Moderna booster shot). Retired, so spent day on couch, but didn''t want to move or get up. Lost bladder control. Spells of dizziness and headache. Didn''t seek medical attention. Slept better second night and returned to normal activities the following day. Approximately 18 hours of not being able to function normally and having combination of the above symptoms.


VAERS ID: 1929074 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-26
Onset:2021-11-17
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014F21A / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Photopsia, Vitreous detachment
SMQs:, Accidents and injuries (broad), Retinal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: redness, itching, swelling
Other Medications: Synthroid, ezetimibe, pravastatin, vitamin b12, folate, vitamin c, vitamin D, CoQ10, estrace cream, systane ultra, Zadiator eye drops prn
Current Illness: none
Preexisting Conditions: osteoarthritis, hypercholesterolemia,
Allergies: sulfa, latex, nickle, steroid creams, adhesive tape
Diagnostic Lab Data: Retinal exam, eye pressures, visual acuity
CDC Split Type:

Write-up: Flashing lightening bolt, left peripheral vision. Referred to retinologist. No retinal tear. Detaching vitreous humour


VAERS ID: 1929385 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 FF2590 / 3 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Syringe issue
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: NA
Current Illness: NA
Preexisting Conditions: NA
Allergies: NA
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Equipment failure-leaked at the hub


VAERS ID: 1929618 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-11-10
Onset:2021-11-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822811 / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Malaise
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Colchicine, Lisinopril, nifedipine, testosterone, sildenafil
Current Illness: None known.
Preexisting Conditions: Pseudogout; hypogonadimsm; hypertension; dyslipidemia
Allergies: Mushroom-angioedema
Diagnostic Lab Data: Pt declines labs on 12.7.21
CDC Split Type:

Write-up: Pt reports generalized polyarthralgia, fatigue and malaise onset 1 week after J&J vaccine. Pt feels like these symptoms are directly related to his post-vaccine status and he reports the symptoms are more severe than he has felt in the past with any pseudogout flare.


VAERS ID: 1929654 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-11-16
Onset:2021-11-17
   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 FG3527 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: 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: Loratadine, Vitamin D3, Magnesium, Vitamin C, Ibuprofen
Current Illness: Headaches
Preexisting Conditions: Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Ringing in ears.


VAERS ID: 1931259 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 211D21A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Blood pressure; Non-smoker (quit smoking in the 1980s).
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211142267

Write-up: HEADACHE; This spontaneous report received from a patient concerned a 74 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included: fibromyalgia, and concurrent conditions included: non-alcohol user, non-smoker, and blood pressure. The patient was previously treated with covid-19 vaccine ad26.cov2.s for prophylactic vaccination (unspecified manufacturer) (Dose Number In Series 1) and experienced drug allergy when treated with hydrocodone (for fibromyalgia), duloxetine hydrochloride, fluconazole, diltiazem, doxycycline (received only for 7 days), famotidine, fluticasone, irbesartan, gabapentin, carisoprodol, budesonide/formoterol fumarate and topiramate. The patient received booster dose of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, administered on 16-NOV-2021 for prophylactic vaccination (Dose Number In Series 2). No concomitant medications were reported. On 17-NOV-2021, the patient experienced headache. Treatment medications (dates unspecified) included: hydrocodone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 18-NOV-2021. This report was non-serious. This case, from the same reporter is linked to 20211142554.


VAERS ID: 1931260 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maine  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 2 - / -

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? 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: USJNJFOC20211142309

Write-up: This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. On an Unspecified date the patient was previously treated with covid-19 vaccine ad26. cov2.s from unspecified manufacturer (Dose Number in Series: 1) for prophylactic vaccination and did not report any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, (Dose Number in Series: 2) 1 total administered on 17-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s booster dose the patient experienced expired vaccine used. (Dose Number in Series: 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.


VAERS ID: 1931261 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 211D21A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRAVASTATIN; FAMOTIDINE; LOSARTAN; METFORMIN; LATANOPROST; TOPROL XL; SIMBRINZA
Current Illness: Abstains from alcohol; Ex-smoker (quit smoking in the 1980s); Glaucoma
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211142554

Write-up: VERY BAD HEADACHE; This spontaneous report received from a consumer concerned an 86 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s past medical history was not reported. Concurrent conditions are non-alcohol user, quit smoking (patient quit smoking in 1980''s) and glaucoma. The patient was previously treated with covid-19 vaccine ad26. cov2. s. (manufacturer not specified) (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 in total, for prophylactic vaccination (dose series 1). The patient received additional covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: UNKNOWN) dose was not reported, 1 in total, on right arm administered on 16-NOV-2021 for prophylactic vaccination. (dose series 2). Concomitant medications included brimonidine tartrate/brinzolamide and latanoprost for glaucoma; and famotidine, losartan, metformin, metoprolol succinate, and pravastatin for unknown indications. On 17-NOV-2021, the patient experienced very bad headache after he woke up (dose series 2). The headache lasted all day. Tylenol (Paracetamol) did not help to reduce the headache. Patient did not experience the headache on the night of 17-NOV-2021, and it went away during sleep. Headache was gone on 18-NOV-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very bad headache on 18-NOV-2021. This report was non-serious. This case, from the same reporter is linked to 20211142267.


VAERS ID: 1932274 (history)  
Form: Version 2.0  
Age: 9.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 RA / SYR

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

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

Write-up: Ringing, whooshing sound in ears for 7+ hours. Progressively became lighter and after a couple of days, the ringing stopped.


VAERS ID: 1932420 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-11-09
Onset:2021-11-17
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822811 / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: levothyroxine 75 mcg po daily Labatelol 200 mg po bid
Current Illness: recent pregnancy, c-section on 10/17/2021
Preexisting Conditions: hypothyroidism
Allergies: PCN
Diagnostic Lab Data: 11/17/21 Venous Ultrasound detected
CDC Split Type:

Write-up: DVT- Left lower leg


VAERS ID: 1932566 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dehydration, Diarrhoea, Dizziness, Extra dose administered, Gastrointestinal disorder, Impaired work ability, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: Pertussis
Other Medications: Metformin 1000mg Twice daily. Levothyroxine 25mcg, daily Prenatal vitamin.
Current Illness: none
Preexisting Conditions: PCOS
Allergies: Flexeril
Diagnostic Lab Data:
CDC Split Type:

Write-up: About 15 minutes after receiving my Covid-19 Moderna booster shot, I violently and uncontrollably vomited. Soon after, I developed a fever of 103F. I continued to vomit and experience uncontrollable diarrhea. Since I could not hold down motrin, (etc) to manage the fever, I became dehydrated and very dizzy. An IV therapy company came to my house, and administered 3 saline bags as well as IV drugs to the fever and nausea. After 48 hrs, with cold baths and liquid (childrens) motrin and tylenol my fever reduced to 101F, but sever GI symptoms were persistent for 6 days I could not return to the office/work until Tuesday of the following week. Still, weeks later, I have not produced a solid bowel movement. Please note that I had zero affects from my first or second Moderna shot. This only happened with the booster.


VAERS ID: 1932825 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 AR / IM

Administered by: Public       Purchased by: ?
Symptoms: No adverse event, 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: Na
Current Illness: Na
Preexisting Conditions: Na
Allergies: Na
Diagnostic Lab Data: Na
CDC Split Type:

Write-up: Patient was administered pediatric dose of Pfizer vaccine at age of 12 by RN. Patient should have received 12+ dose at this time. Patient and parent state no observable adverse effects from pediatric dose. Patient given correct 12+ dose today (12/8/21). Patient observed with no adverse events after doseage as per protocol.


VAERS ID: 1932888 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-11-16
Onset:2021-11-17
   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 - / 3 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Acute kidney injury, Decreased appetite, Fatigue, Metabolic function test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (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), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: BMP 12/6/21 and 12/1/21
CDC Split Type:

Write-up: pt had fatigue for 10 days, poor appetite, and acute kidney injury


VAERS ID: 1933104 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-10-28
Onset:2021-11-17
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC31A3 / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chills, Eye disorder, Eye swelling, Laboratory test abnormal, Ophthalmological examination, Rhinorrhoea, Upper-airway cough syndrome
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin; Zyrtec; Ozempic; irbesartan; multivitamin over 50; vitamin C; vitamin D; melatonin; Crestor
Current Illness: None
Preexisting Conditions: Diabetes
Allergies: Erythromycin (rash); codeine; oxycodone (all); tetracycline; seasonal allergies
Diagnostic Lab Data: Eye exam
CDC Split Type: vsafe

Write-up: The night after vaccine I had the chills and I went to bed. The next morning I had a temperature of 99.9 and I called work to see if I could go to work and I could. I had no other symptoms at that time and that night my nose started running and dropping constantly and the next day was Saturday and into Sunday everything was done and I didn''t have any temperature on Sunday. I didn''t notice any eye issues until 11/17 and I read the chart and seen something was wrong with my eye. I didn''t notice it when I was working on the computer but on the single eye reading I could tell and that''s when he did an extra test and found my eye was swollen and so he gave me an injection in my eye and I need to have 4 more done and get a picture of it again in January. I''ve worn glasses all my life but I''ve never had any trouble with my eyes like that before.


VAERS ID: 1933115 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1855194 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Gait disturbance
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Hypoglycaemia (broad)

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

Write-up: Went to bed and woke up after midnight with terrible joint pain. Shoulder joints hurt, knee joints hurt (I could barely walk), and the most serious issue was with my left wrist. I could barely move my fingers and when I was able to move my fingers, it felt like something in my wrist kept popping. I had to use my other hand to rotate my wrist around until it made a loud pop noise and then I was able to move my hand without it continuously popping and hurting. I went back to bed and woke up about 2 hours later with the same issue. The rest of my joints are better now, but I''m still having issues with my left wrist/hand. I can''t always fully stretch my thumb, my wrist continues to pop randomly throughout the day and it''s painful, sometimes my hand seizes up and I can''t move it, and I have to wear a wrist brace during work because I work on a computer all day and it will randomly seize up without a brace on. I never had an issue with my wrist before until that night.


VAERS ID: 1934836 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Exposure to COVID-19
Preexisting Conditions: Comments: Patient''s husband has covid
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211142958

Write-up: COVID POSITIVE; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: covid-19 exposure (from husband). On an unspecified date, the patient was treated to received covid-19 vaccine ad26.cov2.s from unspecified manufacturer (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported, 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. On 17-NOV-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 17-NOV-2021, the patient reported that, she had covid (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid positive was not reported. This report was non-serious.


VAERS ID: 1935007 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental underdose
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: a patient accidentally received a booster dose at a local pharmacy for his first dose of the Moderna COVID-19 Primary Series; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (a patient accidentally received a booster dose at a local pharmacy for his first dose of the Moderna COVID-19 Primary Series) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 17-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (a patient accidentally received a booster dose at a local pharmacy for his first dose of the Moderna COVID-19 Primary Series). On 17-Nov-2021, ACCIDENTAL UNDERDOSE (a patient accidentally received a booster dose at a local pharmacy for his first dose of the Moderna COVID-19 Primary Series) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.


VAERS ID: 1935100 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30135BA / 3 LA / -

Administered by: Public       Purchased by: ?
Symptoms: Body temperature, Chills, Fatigue, Immunisation, Joint swelling, Musculoskeletal stiffness, Myalgia, Nausea, Pain, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NAPROXEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; Psychiatric disorder NOS (Post-traumatic stress disorder)
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Fever; Result Unstructured Data: Test Result:102
CDC Split Type: USPFIZER INC202101627674

Write-up: Fever of 102; Severe nausea; Vomiting; Extreme chills every time I stand up; Muscle aches; Fatigue; Extreme stiffness pain; Extreme stiffness pain; Swelling in joints especially my knees; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 15:45 (Lot number: 30135ba) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis in knees and back" (unspecified if ongoing); "Military related PTSD" (unspecified if ongoing), notes: Post-traumatic stress disorder. Concomitant medication(s) included: NAPROXEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Rw0172, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 10May2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0170, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 19Apr2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Fever of 102"; NAUSEA (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Severe nausea"; VOMITING (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Vomiting"; CHILLS (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Extreme chills every time I stand up"; MYALGIA (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Muscle aches"; FATIGUE (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Fatigue"; MUSCULOSKELETAL STIFFNESS (non-serious), PAIN (non-serious) all with onset 18Nov2021 08:30, outcome "recovering" and all described as "Extreme stiffness pain"; JOINT SWELLING (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Swelling in joints especially my knees". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, nausea, vomiting, chills, myalgia, fatigue, musculoskeletal stiffness, pain, joint swelling. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1935163 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2593 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Diarrhoea, Fatigue, Headache, Pain, Pyrexia, SARS-CoV-2 test, Skin discolouration
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis
Allergies:
Diagnostic Lab Data: Test Date: 20211101; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC202101723404

Write-up: Fever; Extreme body aches; Extreme headache; Diarrhea; Chest pain; Blue palms; Fatigue; This is a spontaneous report received from a non-contactable reporter (consumer or other non HCP). The reporter is the patient. A 27-year-old female patient (not pregnant) received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 17Nov2021 at 10:00 (Lot number: FF2593) at the age of 27 years, as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: FH8027, Administration site: Left arm, Administration Time: 09:45), administration date: 27Oct2021, when the patient was 27 years old, for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Fever"; PAIN (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Extreme body aches"; HEADACHE (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Extreme headache"; DIARRHOEA (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Diarrhea"; CHEST PAIN (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Chest pain"; SKIN DISCOLOURATION (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Blue palms"; FATIGUE (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Fatigue". Therapeutic measures were not taken as a result of pyrexia, pain, headache, diarrhoea, chest pain, skin discolouration and fatigue. Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient had no known allergies. 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 patient underwent the following laboratory tests and procedures: Nasal swab (01Nov2021) negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1935220 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: New York  
Vaccinated:2021-11-15
Onset:2021-11-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Bell's palsy, Eyelid function disorder, Facial paralysis, Speech disorder
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)

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

Write-up: the vaccine caused me to get bells palsy the right side of my face sagging and difficult speech right eye not closing very well


VAERS ID: 1935315 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA FC-014C21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Dysgeusia, Feeling abnormal, Gait disturbance, Headache, Palpitations
SMQs:, Peripheral neuropathy (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

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

Write-up: Diarrhea; Metallic taste in my mouth; I stagger when I walk. Walking is difficult. I feel like I am losing balance; My heart was racing right after I got the vaccine, My heart speeds up and then settles down; Headaches; I do not feel the same since I received the Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I do not feel the same since I received the Moderna Covid-19 vaccine.), DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste in my mouth), GAIT DISTURBANCE (I stagger when I walk. Walking is difficult. I feel like I am losing balance) and PALPITATIONS (My heart was racing right after I got the vaccine, My heart speeds up and then settles down) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FC-014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced FEELING ABNORMAL (I do not feel the same since I received the Moderna Covid-19 vaccine.). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste in my mouth), GAIT DISTURBANCE (I stagger when I walk. Walking is difficult. I feel like I am losing balance), PALPITATIONS (My heart was racing right after I got the vaccine, My heart speeds up and then settles down) and HEADACHE (Headaches). At the time of the report, FEELING ABNORMAL (I do not feel the same since I received the Moderna Covid-19 vaccine.) had not resolved and DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste in my mouth), GAIT DISTURBANCE (I stagger when I walk. Walking is difficult. I feel like I am losing balance), PALPITATIONS (My heart was racing right after I got the vaccine, My heart speeds up and then settles down) and HEADACHE (Headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient received the vaccine in her left arm shoulder deltoid muscle. No concomitant medication was provided. No treatment medication was provided.


VAERS ID: 1935725 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Unknown  
Location: Michigan  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
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-19 Vaccine 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: 1935875 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Unknown  
Location: Michigan  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
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-19 Vaccine 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: 1935879 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
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-19 Vaccine 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: 1935938 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
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-19 Vaccine 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: 1935955 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
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-19 Vaccine 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: 1936031 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
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-19 Vaccine 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: 1936076 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
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-19 Vaccine 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: 1936107 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-10-29
Onset:2021-11-17
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017E21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Blood test, Culture urine, Flatulence
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Generic Flonase
Current Illness: Just a crud cold about two weeks prior
Preexisting Conditions: Post nasal drip
Allergies: No
Diagnostic Lab Data: Bloodwork at the ER 11/29/2021 nothing abnormal. Urine sample 11/29/2021 normal
CDC Split Type: vsafe

Write-up: On 11/17/2021 I had a stabbing type pain in the stomach are thru the whole night and a lot of gas, under the right rib cage. On 11/29/2021 same symptoms but not as bad. Pain is still going on but subsided.


VAERS ID: 1936124 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 066F21A / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
Current Illness:
Preexisting Conditions: High blood pressure
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: I experienced hives, rash and abdominal pain


VAERS ID: 1936169 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-11-03
Onset:2021-11-17
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 071F21A / 3 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atorvastatin, Amoldopine, Carbamazepine, Alphagan, Xalatan
Current Illness: None
Preexisting Conditions: Epilepsy, Elevated intraocular pressure,pre-hypertension
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe acute urticaria from groin to neck. Initial treatment at Urgent Care - Cortisone injection and 6 day Prednisolone. Daily Zyrtec. Benadryl as needed apply Sarna Anti-itch cream to affected areas to relieve itch. Apply diphehydramine gel if needed Primary Care physician added daily Pepcid tablet and advised to continue topical treatment as required. Referred to Allegy specialist. Allergy specialist recommended increasing Zyrtec to 2 tablets in morning and Pepcid 1 tablet at night with guidance to increase as high as 4 or each if required. As symptoms subside gradually wean off of Zyrtec and Pepcid. Follow up appointment on February 16, 2022


VAERS ID: 1936186 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: New York  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8027 / 1 LA / IM

Administered by: Pharmacy       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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Allergies: Nkda
Diagnostic Lab Data:
CDC Split Type:

Write-up: Broke out in hives all over opposite arm.


VAERS ID: 1936209 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
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-19 Vaccine 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: 1936246 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Immunisation, No adverse event, Wrong technique in product usage process
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 received a dose of Pfizer COVID-19 Vaccine 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: 1936358 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-03-27
Onset:2021-11-17
   Days after vaccination:235
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 031M20A / 1 - / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 007B21A / 2 - / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Pneumonia, SARS-CoV-2 RNA increased
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: COPD, Type 2 Diabetes Mellitus, HTN, Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 11/18/2021 2019 Novel Corona virus RNA detected Hospitalized 11/21/21 DX with Pneumonia


VAERS ID: 1936972 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-10-01
Onset:2021-11-17
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperhidrosis, Paraesthesia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Adhesive bandaids (slight rash for a day located at the bandaid sight)
Diagnostic Lab Data: My pcp ran his nail down my arm and we saw the histamine reaction
CDC Split Type:

Write-up: Exactly two weeks after my moderna booster shot I developed a histamine outbreak with hives on my groin area, arms, chest, thighs, and lower neck. The come for about 30 minutes and then go away and come back. I can run my finger nail across my skin and swelled line will appear for a while. My hands can sometimes feel a little swollen and tingle. After my shower I have fed lines and dots on my arms and shoulders. Goes away after a few minutes. This has been going on for about three weeks.


VAERS ID: 1936994 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6200 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8727 / 2 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8030 / 3 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site discolouration, Injection site inflammation, Injection site pain, Injection site swelling, Vaccine positive rechallenge
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none except psoriasis diagnosed at age 20; no treatments and no problems
Allergies: marijuana (headaches), none known
Diagnostic Lab Data: none
CDC Split Type:

Write-up: #1: no soreness, no redness in left arm #2: Mild soreness in arm if pressure applied to injection site in evening of day of shot; all gone by morning #3: Moderate soreness in right arm if pressure applied to injection site; perception of mild swelling in muscle at injection site; soreness gone by morning of subsequent day. moderate inflammation about the size of a coin at injection site with roughness on a medium pink inflammation at injection site still observed 7 days later when bandaid first removed. Smooth medium pink discoloration the size of a coin observed 15 days later. Light pink discoloration the size greater than a quarter coin ovserved 19 days later. Slight pink after 23 days quarter sized.


VAERS ID: 1936998 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6200 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8727 / 2 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8030 / 3 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Condition aggravated, Dry skin, Injection site erythema, Injection site inflammation, Injection site pain, Injection site reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none except psoriasis diagnosed at age 20; no treatments and no problems
Allergies: marijuana (headaches), none known
Diagnostic Lab Data: none
CDC Split Type:

Write-up: #1: no soreness, no redness in left arm #2: Mild soreness in arm if pressure applied to injection site in evening of day of shot; all gone by morning #3: Moderate soreness in right arm if pressure applied to injection site; perception of mild swelling in muscle at injection site; soreness gone by morning of subsequent day. moderate inflammation about the size of a 50� coin at injection site with roughness on a medium pink inflammation at injection site still observed 7 days later when bandaid first removed. Smooth medium pink discoloration the size of a 50� coin observed 15 days later. Light pink discoloration the size greater than a quarter coin ovserved 19 days later. Slight pink after 23 days quarter sized.


VAERS ID: 1937232 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-08-14
Onset:2021-11-17
   Days after vaccination:95
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 034C21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Chest pain, Herpes zoster, Pruritus, Rash, Rash vesicular, Scab
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Vitamin D 1000mcg, B12, Calcium + magnesium
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data:
CDC Split Type:

Write-up: Started to get a rash on my left side. It initially itched and there was no rash, a couple days later there was a rash, a couple days later there were blisters. At this point I thought it was poison oak from a hike I had been on a week prior. A couple days later they started to crust over and it started feeling more painful than itching. Another couple days they started turning into black scabs and all the while it continued to get more painful and I began having stabbing pain in my chest. At this point (after nearly 3 weeks) I searched online to see if there is an correlation between poison oak and nerve pain. That lead me to images of shingles and I KNEW that''s what it was. The next day I called urgent care, wno came out and diagnosed me with shingles and prescribed me the antiviral medication Valacyclovir 1gm tablet Q12 hrs x 10 days. I am currently half way through. I am still experiencing the pain of the rash, however the stabbing chest pain seems to have subsided. My blood pressure was 138/86 mm[Hg]. 02 Saturation 97% Room Air at Rest, Temperature 97.9 degrees ear, HR = 76 on 12/4 when I was seen by urgent care.


VAERS ID: 1938439 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: New York  
Vaccinated:2021-02-14
Onset:2021-11-17
   Days after vaccination:276
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002B / 1 - / OT

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

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

Write-up: Tired after their booster dose; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Tired after their booster dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 007M20A and 002B) for COVID-19 vaccination. No Medical History information was reported. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Tired after their booster dose). At the time of the report, FATIGUE (Tired after their booster dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported by the reporter. No treatment was reported by the reporter. This case was linked to MOD-2021-406064 (Patient Link).


VAERS ID: 1938559 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-11-12
Onset:2021-11-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Diarrhoea, Malaise, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

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

Write-up: Received first Covid vaccine on 11/12/2021. On 11/17/2021 he had to stay home from school sick with nausea, stomach pains, nausea, vomiting, and diarrhea. The same thing happened again today, 12/9/2021 and his second dose was 12/3/2021. I?ll report separately for the incident related to his second vaccine dose.


VAERS ID: 1938664 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8841 / 3 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID; KEFLEX [CEFALEXIN MONOHYDRATE]
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: Hashimoto''''s thyroid disease
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Fever; Result Unstructured Data: Test Result:99.5 Fahrenheit; Comments: low grade fever
CDC Split Type: USPFIZER INC202101619835

Write-up: Very sore arm (injection arm); low grade fever; chills; body aches (especially back, neck and legs); headache; fatigue; dose_received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 09:00 (Lot number: FF8841) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto''''s thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; KEFLEX [CEFALEXIN MONOHYDRATE]. Vaccination history included: Bnt162b2 (dose- 2, lot number=EL3247, route=Intramuscular, location=left arm), administration date: 17Feb2021, when the patient was 45 years old, for Covid-19 immunization; Bnt162b2 (dose-1, lot number=EL3247, route=Other, location=left arm), administration date: 27Jan2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "dose_received: 3"; PAIN IN EXTREMITY (non-serious) with onset 18Nov2021, outcome "unknown", described as "Very sore arm (injection arm)"; PYREXIA (non-serious) with onset 18Nov2021, outcome "unknown", described as "low grade fever"; CHILLS (non-serious) with onset 18Nov2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset 18Nov2021, outcome "unknown", described as "body aches (especially back, neck and legs)"; HEADACHE (non-serious) with onset 18Nov2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 18Nov2021, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, pyrexia, chills, pain, headache, fatigue. Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received Synthorid, Keflex any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected


VAERS ID: 1938667 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: New York  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW1096 / 3 LA / OT

Administered by: Work       Purchased by: ?
Symptoms: Chills, Fatigue, Immunisation, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101620677

Write-up: arm soreness; chills; fatigue; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 11:00 (Lot number: EW1096) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 53 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Route of Administration: Intramuscular), administration date: 25Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 11:00, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021 19:00, outcome "recovering", described as "arm soreness"; CHILLS (non-serious) with onset 17Nov2021 19:00, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 17Nov2021 19:00, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of pain in extremity, chills, fatigue. additional information: the patient had no known allergies. other medical history none. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not receive any other medication within 2 weeks of COVID vaccination. The patient did not diagnose with covid-19 prior to the vaccination. The patient did not test for Covid post vaccination. facility type vaccine: Workplace clinic. Follow-up attempts are completed. No further information


VAERS ID: 1938672 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH 8030 OR FM / 3 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Body temperature, Body temperature decreased, Feeling cold, Immunisation, Somnolence, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DILTIAZEM [DILTIAZEM HYDROCHLORIDE]; FUROSEMIDE; POTASSIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; COVID-19; Diabetes; Interstitial lung disease; Latex allergy; Penicillin allergy; Pulmonary fibrosis
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:sudden drop
CDC Split Type: USPFIZER INC202101629529

Write-up: Sudden body temperature drop.; Uncontrollable shaking; body felt cold; woke up groggy but ok; Dose number 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Nov2021 10:00 (Lot number: FH 8030 or FM) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pulmonary Fibrosis" (unspecified if ongoing), notes: Pulmonary Fibrosis; "penicillin" (unspecified if ongoing); "Afib" (unspecified if ongoing); "Diabetes Interstitial lung disease" (unspecified if ongoing); "Diabetes Interstitial lung disease" (unspecified if ongoing); "latex" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM [DILTIAZEM HYDROCHLORIDE]; FUROSEMIDE; POTASSIUM; FLU VACCINE VII, administration date Oct2021. Past drug history included: Iodine, reaction(s): "Known Allergy: Iodine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER 8729, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 02May2021, when the patient was 78 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 04Apr2021, when the patient was 78 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 10:00, outcome "unknown", described as "Dose number 3"; BODY TEMPERATURE DECREASED (non-serious) with onset 17Nov2021 16:30, outcome "recovering", described as "Sudden body temperature drop."; TREMOR (non-serious) with onset 17Nov2021 16:30, outcome "recovering", described as "Uncontrollable shaking"; FEELING COLD (non-serious) with onset 17Nov2021 16:30, outcome "recovering", described as "body felt cold"; SOMNOLENCE (non-serious) with onset 17Nov2021 16:30, outcome "recovering", described as "woke up groggy but ok". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of body temperature decreased, tremor, somnolence. Therapeutic measures were taken as a result of feeling cold. Additional information: Sudden body temperature drop. Uncontrollable shaking, body felt cold as tho suddenly in sub zero temp. Inside entire time added more clothing not enough then added heating pad direct to body and fell asleep. Woke up groggy but OK. AE resulted in: None of the above. If covid tested post vaccination: No, Location of injection for vaccine received within 4 weeks PRIOR: Flu shot - Left arm, Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store, List of any other medications the patient received within 2 weeks of vaccination: Diltiazem 240mg, Furosemide 40mg, Potassium 10meq, Follow-up attempts are completed. No further information is expected.


VAERS ID: 1938673 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (Relevant past drug history Name of Drug as Reported: no Reaction: Allergy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101629531

Write-up: swollen lymph nodes in left arm pit and left jaw/neck area.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 13:00 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Relevant past drug history, Name of Drug as Reported: no, Reaction: Allergy. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 01:45 PM, Route of Administration: Intramuscular), administration date: 12Apr2021, when the patient was 30 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM, Route of Administration: Intramuscular), administration date: 22Mar2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 13:00, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021 20:00, outcome "not recovered", described as "swollen lymph nodes in left arm pit and left jaw/neck area.". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Did not receive any other medications within 2 weeks of vaccination. patient was not diagnosed with covid-19 prior to vaccination. since the vaccination patient was not tested for covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1938695 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Immunisation, Malaise, Pain, Pyrexia, Vaccination site mass, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: body temperatures; Result Unstructured Data: Test Result: elevated; Comments: 03:30 am.
CDC Split Type: USPFIZER INC202101641492

Write-up: COVID-19 vaccine booster; soreness on the arm became the size of an egg; elevated body temperatures; Malaise; body aches; first side effects of soreness and pain on the injection site.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 17Nov2021 10:00 (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. The following information was reported IMMUNISATION (non-serious), outcome unknown; PAIN (non-serious) with onset 18Nov2021, outcome recovering; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021, outcome unknown; MALAISE (non-serious) with onset 18Nov2021, outcome recovering; PYREXIA (non-serious) with onset 18Nov2021 03:30, outcome unknown; VACCINATION SITE MASS (non-serious) with onset 18Nov2021 07:00, outcome recovering. Relevant laboratory tests and procedures are available in the appropriate section. Patient reported that Vaccine shot at around 10 am on 17Nov2021. Around noon first side effects of soreness and pain on the injection site. At 3:30am elevated body temperatures woke up patient on 18Nov. Malaise and body aches in the morning, resolving as time goes by. The soreness on the arm became the size of an egg around 7am this morning (18Nov). Also diminishing the size as the hours go by. COVID-19 vaccine booster. Event took place after use of product. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1938696 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLU
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Other medical history: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101646752

Write-up: Sever hives starting about 36 hours after dose.; Current age: 10 years, Dose recieved 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Nov2021 15:15 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 17Nov2021 15:15, outcome "unknown", described as "Current age: 10 years, Dose recieved 1"; URTICARIA (non-serious) with onset 19Nov2021 06:00, outcome "not recovered", described as "Sever hives starting about 36 hours after dose.". The events "current age: 10 years, dose recieved 1" and "sever hives starting about 36 hours after dose." were evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria. Additional information: Other vaccine 4 weeks product included Flu. No other medications in two weeks. Sever hives starting about 36 hours after dose. Ongoing now pt say 6. Not had covid prior vaccination. Not tested covid post vaccination. No known allergies. Follow-Up (29Nov2021): Follow-up attempts are completed. No further information is expected.


VAERS ID: 1938714 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 320308D / 3 LA / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Cough, Fatigue, Immunisation, Influenza like illness, Pyrexia, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Type II diabetes mellitus (Verbatim: Type II Diabetic)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101651986

Write-up: Flu like symptoms; horrific cough; Feverish; I was so fatigue I could not get out of it; runny nose; I am blowing a lot, it is nothing but a clear mucous; armpit very bad soreness under the ''''shot arm'''' and it actually traced over to my right arm, which was not the ''''shot arm''''; soreness really bad on to my left armpit; got the Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 60-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: 320308D, Expiration Date: 28Feb2022) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation; dulaglutide (TRULICITY), subcutaneous (Batch/Lot number: unknown) as 1.5 mg, weekly. Relevant medical history included: "Type II Diabetic" (unspecified if ongoing), notes: Verbatim: Type II Diabetic. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Mar2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "I had no issue"; Bnt162b2 (Dose: 2), administration date: Mar2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "I had no issue"; Flu shot (I got the Flu shot (Unspecified Flu shot) yeah in Oct2021.), administration date: Oct2021, when the patient was 60 years old, for Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "got the Pfizer booster"; AXILLARY PAIN (non-serious) with onset 18Nov2021, outcome "recovering", described as "armpit very bad soreness under the ''''shot arm'''' and it actually traced over to my right arm, which was not the ''''shot arm''''; soreness really bad on to my left armpit"; INFLUENZA LIKE ILLNESS (non-serious) with onset 19Nov2021, outcome "recovering", described as "Flu like symptoms"; COUGH (non-serious) with onset 19Nov2021, outcome "recovering", described as "horrific cough"; PYREXIA (non-serious) with onset 19Nov2021, outcome "recovering", described as "Feverish"; FATIGUE (non-serious) with onset 19Nov2021, outcome "recovering", described as "I was so fatigue I could not get out of it"; RHINORRHOEA (non-serious) with onset 19Nov2021, outcome "recovering", described as "runny nose; I am blowing a lot, it is nothing but a clear mucous". Therapeutic measures were taken as a result of axillary pain, influenza like illness, cough, pyrexia, fatigue, rhinorrhoea. Additional information: Patient had received Robitussin cough syrup as treatment for the cough. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1939425 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-11-06
Onset:2021-11-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: CSF test abnormal, Culture positive, Eye pain, Headache, Human herpesvirus 6 infection, Laboratory test normal, Lethargy, Magnetic resonance imaging, Magnetic resonance imaging head normal, Meningitis viral, Nucleated red cells, Photosensitivity reaction, Pyrexia, SARS-CoV-2 test negative, Sleep disorder, Streptococcus test negative, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: HHV6 detected in meningitis/encephalitis panel 831 nucleated cells in CSF MRI of brain showed normal parenchymal signal and morphology with a single 4 mm subcortical nonenhancing FLAIR hyperintensity in the right postcentral gyrus
CDC Split Type:

Write-up: On the 11th day post-vax, 11/17/21, Patient woke and complained of eye pain. Was later sent home from school due to fever. Was lethargic, displayed photosensitivity, headache and fever worsened. Had a routine (tested weekly at school) COVID test on 11/16, was negative. Tested for strep on 11/19, negative. Taken to ER on 11/22, labs looked ok, perked up with fluids, sent home. 11/23 Tylenol and Motrin no longer able to control headache. He wanted to lay down in dark bedroom. Threw up in the afternoon, then again the next morning after being unable to sleep due to head pain. Admitted to hospital on day 10, 11/24 awaiting results of LP. Started on antibiotics, regular fluids. HHV6 was found in culture, diagnosed with viral meningitis.


VAERS ID: 1939646 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-22
Onset:2021-11-17
   Days after vaccination:87
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 AR / SYR

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Condition aggravated, Fatigue, Lung disorder, Nasopharyngitis, Pain, Pyrexia, SARS-CoV-2 test positive, Sinusitis, Sneezing
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: cinnamon supplement, 5 different antihistamines, valsartan, lipitor, multi vitamin
Current Illness:
Preexisting Conditions: High Blood pressure, type 2 diabetes, high cholesterol , autoimmune disease, asthma, tachardcardia
Allergies: every antibiotic except for a dental one and vivox,
Diagnostic Lab Data: Covid 19 positive
CDC Split Type: vsafe

Write-up: each vaccine I had a fever and exhaustion for 3 days, when I got Covid I started sneezing then it started feeling like I had bad head cold, body aches, fatigue and then week after I ended up with a nasty sinus infection. I treated with Mucinex and Ibuprofen I have residual lung stuff. my exhaustion and headaches have eased.


VAERS ID: 1939650 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-06-04
Onset:2021-11-17
   Days after vaccination:166
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetaminophen (TYLENOL EXTRA STRENGTH) 500 MG tablet albuterol (VENTOLIN HFA) 108 (90 BASE) MCG/ACT HFA inhaler asenapine (SAPHRIS) 10 MG sl tablet busPIRone (BUSPAR) 10 MG tablet diphenhydrAMINE (BENADRYL) 25 MG capsule gabapentin (NEURONT
Current Illness:
Preexisting Conditions: Diabetes mellitus, anemia, anxiety, asthma, depression, GERD, hypertension, hyperlipidemia, IBS, migraine, neuropathy, PCOS, pulmonary embolism, pulmonary hypertension
Allergies:
Diagnostic Lab Data: COVID-19 test positive on 11/17/2021.
CDC Split Type:

Write-up: Patient presented to emergency department on 11/17/2021 for worsening shortness of breath, cough, fever, chills, and body aches. She was found to be COVID-19 positive and admitted for further management. She was treated with supplemental oxygen and dexamethasone. Patient was discharged home on 11/20/2021.


VAERS ID: 1939700 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Incorrect dose administered, No adverse event, Wrong 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: none
Current Illness: none known
Preexisting Conditions: none known
Allergies: nkda
Diagnostic Lab Data: none
CDC Split Type:

Write-up: no adverse reaction noted, wrong vaccine given, pfizer peds given instead of pfizer.


VAERS ID: 1939773 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
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-19 Vaccine 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: 1939841 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
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-19 Vaccine 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: 1939887 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
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-19 Vaccine 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: 1939914 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Balance disorder, Burning sensation, Exercise tolerance decreased, Gait disturbance, Hypoaesthesia, Muscle spasms, Muscular weakness, Neurological examination, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

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

Write-up: History of CMT (Charcot-Marie-Tooth disease). Neurology visit on 12/07/2021. Last visit was in 12/11/2018. Weakness & numbness of her hands and feet have gotten worse especially after the COVID Pfizer vaccine first dose (Nov 17/2021). Since then, she started to have burning sensation on both upper (circumfrential) and lowr extremities (posterior side) which lasted a couple of days. She also felt pins and needles in hands and hamstrings muscles. She reports increased weakness (she used to do wt lifting easily of a 25 bounds that she is not able to do anymore). She also been tripping over feet. She noticed worsening of her balance while walking. Cramps are mostly on arms, hamstring and middle back.


VAERS ID: 1940075 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Vermont  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Feeling hot, Laboratory test, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Gabapentin, atorvastatin
Current Illness: None
Preexisting Conditions: None
Allergies: cosmetics, SLS, nickel
Diagnostic Lab Data: My doctor ordered a lab panel 12/6/2021
CDC Split Type:

Write-up: Intense itching, mostly on the palms of my hands and soles of my feet. Sometimes on my forearms and my legs and to of my feet. Almost always symmetrical affecting both feet at once or both hands. Comes on super quickly and feels like I am on fire, goes away almost as suddenly. Feels as if it is most active in the morning and in the evening but it comes and goes other times as well. Most intense at night.


VAERS ID: 1940126 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013F21N / 3 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Chills, Diarrhoea, Dizziness postural, Fatigue, Headache, Pain, Painful respiration, Palpitations, Pyrexia, Yawning
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Evoxac, Tri Sprintec (birth control)
Current Illness: None
Preexisting Conditions: Sjogren''s syndrome
Allergies: No
Diagnostic Lab Data: My primary care physician sold her practice, retired and the office has not replaced physicians, so I did not go to the doctor.
CDC Split Type:

Write-up: he day after the vaccine, I ran a fever, had chills, body aches, headache, fatigue and diahrrea and arthralgia. I also had heart palpatations on lying down or reclining. The third day after the vaccine, I woke up with sharp chest pain on my left side. It felt like when you have gas or a stitch in your side, but it was up too high. I felt no crushing pressure, so I knew it wasn''t a heart attack. I tried to breathe in deeply to see if it was gas, but the pain was worse the deeper I breathed. I had the urge to yawn all day to try to alleviate the pain. I also had headache, diziness upon standing, heart palpatations upon reclining or lyning down, and diarrhea. The fourth day after the vaccine, the chest pain was still there upon deep breathing. Heart palpatations upon lying down or reclining and headache continued through the fourth and fifth day. I started taking NSAIDS the 3rd day and 4th day after reading about paracarditis and myocarditis, hoping that the asprin, ibuprofen and acetaminophen would bring down the swelling. By about 1:00 pm on the 5th day, the chest pain subsided. I still have heart palpatations upon lying down, but less frequently and not as strong when the beat returns.


VAERS ID: 1940129 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 067F21A / 3 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Chills, Interchange of vaccine products, Pain, Product administered to patient of inappropriate age, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prescription oral birth control, Larife
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Patient was administered Moderna booster shot (0.25 mL dose). Had previously received Pfizer series COVID vaccine. Patient is not 18 years old and is not authorized to receive any Moderna vaccines. Patient had fever 102.0 F., chills and body aches the day after vaccine and symptoms ended the same day.


VAERS ID: 1940722 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-11-13
Onset:2021-11-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939905 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Disturbance in attention, Injection site pain, Interchange of vaccine products, Joint swelling, Lymph node pain, Pain, Pain in extremity, Peripheral swelling, Sleep disorder, Ultrasound scan normal
SMQs:, Cardiac failure (broad), Angioedema (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Extremely high fever and injection site reaction that lasted over a week - was in the hospital for a seizure when vaccine was gi
Other Medications: Multivitamin, Elderberry Gummies, Turmeric & Ginger Gummies, spironolactone 50 mg, Montelukast 10 mg, mefenamic acid 250 mg (during periods), amphetamine-dextroamphetamine 20 mg in the morning & 10 mg in the afternoon, propranolol 10 mg, am
Current Illness: None
Preexisting Conditions: Migraine Double vision due to damaged optic nerves Ovarian cysts Painful periods Low back pain
Allergies: -Codeine -Pneumovax
Diagnostic Lab Data: 11/19/2021 - No DVTs detected **I may have further tests when I see my doctor for a follow up this Monday, 12/13/2021.
CDC Split Type:

Write-up: I received my regular COVID-19 vaccine on 4/29/2021 which was the Johnson & Johnson/Janssen vaccine. I did not have any known long term side effects; the only side effects I had were short-term - fatigue, body aches, low grade fever, and injection site pain. On 11/13/2021, I received the Moderna booster shot; within 12 hours, I had similar short-term side effects to the Johnson & Johnson vaccine, but the injection site pain lasted almost two weeks with severe lymph node pain. Four days after the shot, on 11/17/2021, my left ankle and foot became extremely swollen. The swelling kept coming and going over the next 24-32 hours, so I saw my primary care doctor the morning of 11/19/2021. My leg was swollen and hurting a lot in my calf and behind my left knee; my doctor was concerned about a blood clot, so she sent me the same day for an ultrasound at our local hospital. No major blood clots/DVTs were detected. The doctor told me to follow up in a few weeks if the pain and swelling continue and to take ibuprofen and wear compression socks. The pain has gotten worse, and ibuprofen doesn''t help and the compression socks make the pain worse. I have a follow up appointment with my doctor this Monday, 12/13. The pain is so bad that I can''t sleep and have difficulty focusing.


VAERS ID: 1941855 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8027 / 3 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Immunisation, Swelling face
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: OZEMPIC; ZYRTEC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Diabetes (Verbatim: Diabetes)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101620424

Write-up: Booster; painful knots on my temple and it is like its still here. It feels like my, back side of my face is like so huge; back side of my face is like so huge.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FH8027) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 21Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "Allergy" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC taken for diabetes mellitus; ZYRTEC taken for hypersensitivity. Past drug history included: Tylenol, reaction(s): "headaches", notes: (Dose: 400mg) twice and only 2 tablets each time. . Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization; Bnt162b2 (Dose: 02), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 17Nov2021, outcome "unknown", described as "painful knots on my temple and it is like its still here. It feels like my, back side of my face is like so huge"; SWELLING FACE (non-serious) with onset 17Nov2021, outcome "unknown", described as "back side of my face is like so huge.". Therapeutic measures were taken as a result of swelling face. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1941856 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8841 / 3 LA / OT
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / -

Administered by: Work       Purchased by: ?
Symptoms: Immunisation, Off label use, Pain, Pain in extremity, Product use issue
SMQs:, Tendinopathies and ligament disorders (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101620454

Write-up: patient received pfizer covid-19 dose 3 on 17Nov2021 and FLU vaccine also on 17Nov2021; patient received pfizer covid-19 dose 3 on 17Nov2021 and FLU vaccine also on 17Nov2021; dose number 3; Very sore arm; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 (Lot number: FF8841) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 17Nov2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose details:, Previous dose Product: COVID 19,, Previous dose brand=Pfizer,, Previous dose brand unknown: False,, Previous dose lot number: EP-6955,, Previous dose lot unknown: False,, Previous dose administrator route: Intramuscular, Previous dose administration date: 01Apr2021, Previous dose number: 2, Previous dose Vaccine location: Left arm), administration date: 01Apr2021, when the patient was 41 years old, for Covid-19 immunization; Bnt162b2 (Previous dose details:, Previous dose Product: COVID 19,, Previous dose brand=Pfizer,, Previous dose brand unknown: False,, Previous dose lot number: EL3247,, Previous dose lot unknown: False,, Previous dose administrator route: Intramuscular, Previous dose administration date: 11Mar2021, Previous dose number: 1, Previous dose Vaccine location: Left arm), administration date: 11Mar2021, when the patient was 41 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "dose number 3"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021, outcome "recovered", described as "Very sore arm"; PAIN (non-serious) with onset 17Nov2021, outcome "recovered", described as "Body aches"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 17Nov2021, outcome "unknown" and all described as "patient received pfizer covid-19 dose 3 on 17Nov2021 and FLU vaccine also on 17Nov2021". Therapeutic measures were not taken as a result of pain in extremity, pain. Additional information: Facility type vaccine: Workplace clinic. Other vaccine in four weeks: No. It was reported that patient had no COVID prior vaccination nor been tested for COVID post vaccination. Known allergies, other medical history: NA. Follow-Up (24Nov2021): Follow-up attempts are completed. No further information is expected.


VAERS ID: 1941906 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Cough, Diarrhoea, Gastrointestinal disorder, Headache, Immunisation, Myalgia, Pyrexia, Respiratory tract congestion
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: ENBREL
Current Illness: Rheumatoid arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Body temperature; Result Unstructured Data: Test Result: low grade in the 90s but also gets up into the; Comments: 100s.
CDC Split Type: USPFIZER INC202101676929

Write-up: diarrhea; bowel issues; fever runs low; headache; chills; muscles are sore; cough; congestion; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. A 75-year-old female patient received bnt162b2 (BNT162B2), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 75 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis. Vaccination history included: Covid-19 vaccine (dose 1 , Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (dose 2 , Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "fever runs low"; HEADACHE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 18Nov2021, outcome "not recovered", described as "chills"; MYALGIA (non-serious) with onset 18Nov2021, outcome "unknown", described as "muscles are sore"; COUGH (non-serious) with onset 18Nov2021, outcome "unknown", described as "cough"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 18Nov2021, outcome "unknown", described as "congestion"; DIARRHOEA (non-serious) with onset 21Nov2021, outcome "unknown", described as "diarrhea"; GASTROINTESTINAL DISORDER (non-serious) with onset 21Nov2021, outcome "unknown", described as "bowel issues". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, headache. Additional information: The patient took Tylenol (paracetamol) for her headache and fever which helps it subside for a while but then it comes back. The patient reported that she took her Enbrel weekly on Wednesdays. The patient had bowel issues but this came out of the blue. The fever runs low grade in the 90s but also get up into the 100s. Patient reported that having the diarrhea today made her pretty nervous and concerned. She may try to get into a walk in clinic to see a doctor. Her Rheumatologist told her that she had a lesser chance of getting COVID since she was on Enbrel. The causal relationship between the events gastrointestinal disorder, chills, respiratory tract congestion, cough, diarrhoea, headache, pyrexia, myalgia and Enbrel, Single Dose Prefilled Syringe was not provided by the consumer. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1942094 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Wyoming  
Vaccinated:2021-11-15
Onset:2021-11-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN JANSSEN 213D21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood creatine phosphokinase normal, Blood magnesium normal, Burning sensation, Fatigue, Feeling abnormal, Headache, Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Limb discomfort, Metabolic function test, Muscle tightness, Neck pain, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: back issues
Allergies: none
Diagnostic Lab Data: normal labs for CMP, CK, Magnesium. pending nerve conduction test.
CDC Split Type:

Write-up: Began as extreme heaviness, pain in the injection arm immediately. 11-17-2021: numbness, tingling and pain down left arm into hand/fingers. So painful couldn''t use that hand. 11-26-2021 pain, numbness moved to the right arm, hand/fingers. Rt arm pain, burning sensation, heaviness. Lt neck weird tightness/pain, headache. Lt arm still painful, numbness, tingling, unable to use. 11-28-2021 went to both feet. Feels like walking on nails, feet on fire. Since injection have been extremely fatigued, brain fog is ridiculous. All symptoms continue...


VAERS ID: 1942120 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213D21A / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Blood test normal, Muscle spasms, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Dystonia (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? No
Previous Vaccinations: Moderna COVID-19 Vaccine. Almost identical issues.
Other Medications: Zyrtek, Allergy Immunotherapy, multivitamins
Current Illness: Sinus infection in October, 2021
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Hematology ran a number of blood tests. All came back in the normal range.
CDC Split Type:

Write-up: Vaginal bleeding for about 20 days, following the COVID vaccine. I received the vaccine at 10:30 a.m., and started bleeding around 8 p.m. The bleeding last about 10 days, stopped for 2 days, and started again for another 7 days. It was accompanied by cramping and abdominal pain.


VAERS ID: 1942260 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013F21A / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Joint swelling, Pain, Peripheral swelling, Pyrexia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations: Moderna - swelling in arm, reported by patients spouse at time of this report
Other Medications: Eliquis, levothyroxine, levocetirizine
Current Illness: N/A
Preexisting Conditions: Hypothyroid, Heart disease
Allergies: doxycycline, azithromycin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever of 105, swelling in entire arm, wrist and finger, bodily pain , all culminating in hospitalization


VAERS ID: 1942333 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain, Arthralgia
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

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

Write-up: Abdominal pain, joint pain. Joint pain lasted 24 hrs or so. Abdominal pain has slowly subsided but still feeling it. Planning to make a Dr?s visit but delayed due to looking for a new provider.


VAERS ID: 1942439 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Migraine with aura, Seizure, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Trileptal 300mg
Current Illness:
Preexisting Conditions: Epilepsy
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: November 17, 2021 (day after vaccination) Migraines and visual auras (3:30pm - 7:00pm) Stomach cramps and vomiting (6:00pm - 7:30pm) Cluster seizures (7:30pm, 8:22pm, 9:05pm, 10:45pm) Valtoco 10mg administered


VAERS ID: 1942442 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-11-08
Onset:2021-11-17
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301258A / UNK - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Condition aggravated, Extra dose administered, Obsessive-compulsive disorder
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: previous J&J covid vaccine
Other Medications: multi vitamin, pro-biotic, glucosamine with msm
Current Illness:
Preexisting Conditions: Celiac Disease IBS (possibly IBD) OCD, previously severe, now pretty well managed
Allergies: mildly allergic to vicodin and percoset
Diagnostic Lab Data:
CDC Split Type:

Write-up: with in 2 weeks of this booster shot, my OCD again spiked unexpectedly and significantly, as it did when I got the J&J shot in the spring. I had forgot that even happened in the spring until I was emailing my therapist for a second appointment in the year (not normal for me in a number of years). The therapist suggested that I might very well be right about there being a connection since we know that OCD has a connection to the immune system/inflammatory response. Seemed worth reporting since it happened both times, with 2 different shots.


VAERS ID: 1943443 (history)  
Form: Version 2.0  
Age: 9.0  
Sex: Unknown  
Location: Michigan  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-13
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-19 Vaccine 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: 1943474 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-13
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-19 Vaccine 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: 1943485 (history)  
Form: Version 2.0  
Age: 9.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-13
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-19 Vaccine 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: 1943498 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-13
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: 1943620 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-11-12
Onset:2021-11-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8030 / 1 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Anosmia, Blood creatinine increased, COVID-19, Chest X-ray abnormal, Diarrhoea, Dyspnoea, Electrocardiogram abnormal, Fibrin D dimer increased, Headache, Pneumonia, SARS-CoV-2 test positive, Sinus tachycardia, Troponin
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Taste and smell disorders (narrow), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amLODIPine (NORVASC) 10 MG PO Tab take 10 mg by mouth once daily. 11/26/2021 Unknown time lisinopril (PRINIVIL, ZESTRIL) 40 MG PO Tab
Current Illness: Diabetes mellitus (CMS/HCC) ? Hypertension
Preexisting Conditions: ? Diabetes mellitus (CMS/HCC) ? Hypertension
Allergies: none
Diagnostic Lab Data: Currently still in the hospital
CDC Split Type:

Write-up: Shortness of Breath Per pt, "I''ve tested positive for covid 9 days ago. I feel a lot better but my wife made me come in." HPI: This is a 43y.o. male with significant past medical history of HTN, T2DM, and morbid obesity that presented to the hospital with chief complaint of COVID-19 infection. He reports he became symptomatic on 11/17 and tested positive on 11/22. He has since had worsening headache, loss of smell, and diarrhea. He developed shortness of breath yesterday prompting him to seek ED evaluation. He denies any fever, chills, chest pain, palpitations, cough, abdominal pain, nausea, vomiting, constipation, or urinary complaints. In the ED, patient normotensive, afebrile, stable SPO2 on room air. Cr 1.78, troponin 0.05, d-dimer 755. EKG with sinus tachycardia. CXR with multifocal pneumonia. He has been admitted for further evaluation and management with ID consultation. Patient seen and examined only by the attending physician; NP only responsible for chart review in an effort to limit exposure given the patient''s COVID positive status.


VAERS ID: 1943891 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-13
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: 1944057 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-13
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: 1944062 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-13
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: 1944070 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-11-04
Onset:2021-11-17
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2593 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menometrorrhagia, Menstrual disorder
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: n/a
Current Illness: menorrhagia
Preexisting Conditions: menorrhagia
Allergies: n/a
Diagnostic Lab Data: Evaluated on 11/17/21 by OB/GYN and told to wait 3 months for re-eval
CDC Split Type:

Write-up: Had an uterine ablation on 10/14/21.Had First dose Pfizer on 10/8/21.Had the ablation 10/14/21 and the second vaccine on 11/4/21. Pt had very heavy bleeding/clotting beginning on 11/14/21 -was seen by doctor on 11/17/21 and diagnosed with Menometrorrhagia and continues to have worse menstrual cycles than prior to uterine ablation.


VAERS ID: 1944113 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-13
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-19 Vaccine 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: 1944135 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-13
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-19 Vaccine 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: 1944165 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-05-06
Onset:2021-11-17
   Days after vaccination:195
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNK / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNK / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: hospitalized due to COVID


VAERS ID: 1944194 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Immunisation, No adverse event, Wrong technique in product usage process
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 received a dose of Pfizer COVID-19 Vaccine 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: 1944683 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Alaska  
Vaccinated:2021-10-17
Onset:2021-11-17
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK1127 / 1 RA / IM
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / N/A LA / IM

Administered by: Other       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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 0.2 mL Pediatric formulation Pfizer dose erroneously administered to 12-year-old who should have received 0.3 mL of Adult/Adolescent formulation Pfizer.


VAERS ID: 1945315 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-11-04
Onset:2021-11-17
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033F21A / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Burning sensation, Pruritus, Skin warm, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Very Itchy hives in random places of my body. Hives have burning sensation, hot to the touch and unbearably itchy. Hives appear for 15 minutes in a random spot of my body like arm or neck or leg and then disappear. They appear on some other spot randomly. Gets worse at night. Affects my sleep badly. Claritin helps for 24 hours but then the hives come back.


VAERS ID: 1946877 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 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: LEVOTHYROXINE; ROSUVASTIN; VALSARTAN
Current Illness: Hyperlipidemia; Hypertension; Hypothyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism since 08-Jun-2015, Hypertension since 05-Nov-2015 and Hyperlipidemia since 05-Nov-2015. Concomitant products included ROSUVASTATIN CALCIUM (ROSUVASTIN) from 05-Nov-2015 to an unknown date for Hyperlipidemia, VALSARTAN from 05-Nov-2015 to an unknown date for Hypertension, LEVOTHYROXINE from 05-Nov-2015 to an unknown date for Hypothyroidism. On 17-Nov-2021 at 8:25 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was reported that patient was tested positive for COVID-19 in past. No treatment were reported. This case was linked to MOD-2021-389253, MOD-2021-407640, MOD-2021-407615, MOD-2021-407628 (Patient Link).


VAERS ID: 1946880 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 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: ATORVASTATIN; LEVOTHYROXINE; IBANDRONATE; MELOXICAM; SERTRALINE; TRAZODONE
Current Illness: Hypothyroidism; Malignant hypertension; Mixed hyperlipidemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism since 21-Aug-2017, Malignant hypertension since 18-Oct-2013 and Mixed hyperlipidemia since 18-Oct-2021. Concomitant products included SERTRALINE from 18-Sep-2013 to an unknown date for Depression, ATORVASTATIN from 15-Jan-2014 to an unknown date for Hyperlipidemia, LEVOTHYROXINE from 21-Jun-2017 to an unknown date for Hypothyroidism, TRAZODONE from 18-Sep-2013 to an unknown date for Insomnia, MELOXICAM from 18-Sep-2013 to an unknown date for Joint pain, IBANDRONATE SODIUM (IBANDRONATE) from 08-Aug-2016 to an unknown date for Osteopenia. On 17-Nov-2021 at 9:53 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 17-Nov-2021 at 9:53 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-Nov-2021 at 9:53 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. This case was linked to MOD-2021-407640 (Patient Link).


VAERS ID: 1946882 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 3 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTAN; OMEPRAZOLE; LIPITOR
Current Illness: GERD; Hypercholesterolemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201130; Test Name: SARS-CoV-2 test positive; Test Result: Positive ; Result Unstructured Data: PCR test
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Hypercholesterolemia and GERD. Concomitant products included OMEPRAZOLE for GERD, ATORVASTATIN CALCIUM (LIPITOR) for Hypercholesterolemia, LOSARTAN for Hypertension. On 17-Nov-2021 at 10:13 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2020, SARS-CoV-2 test positive: positive (Positive) PCR test. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-389253, MOD-2021-407570, MOD-2021-407615, MOD-2021-407628 (Patient Link).


VAERS ID: 1947064 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 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: LEVOTHYROXINE; ROSUVASTATIN
Current Illness: Hyperlipidemia; Hypothyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. Concurrent medical conditions included Hyperlipidemia since 07-May-2021 and Hypothyroidism since 07-May-2021. Concomitant products included ROSUVASTATIN from 07-May-2021 to an unknown date for Hyperlipidemia, LEVOTHYROXINE from 07-May-2021 to an unknown date for Hypothyroidism. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications are provided. Patient reported allergic to Humira. This case was linked to MOD-2021-407640, MOD-2021-407570 (Patient Link).


VAERS ID: 1947077 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-15
Onset:2021-11-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Mass, Rash, Vaccination site 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No, Comment: other medical history: No known_allergies No
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101605505

Write-up: Rashes around area of the shot. Neck has severe rash and small bumps around body. Raised bumps on back; Rashes around area of the shot. Neck has severe rash and small bumps around body. Raised bumps on back; Raised bumps on back; This is a spontaneous report received from contactable Consumer or other non-HCP. The reporter is the patient. A 11-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 10:00 (Batch/Lot number: unknown) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: other medical history: No, known_allergies No. Concomitant medication(s) included: TYLENOL. The following information was reported: VACCINATION SITE RASH (non-serious), RASH (non-serious) all with onset 17Nov2021 17:00, outcome "not recovered" and all described as "Rashes around area of the shot. Neck has severe rash and small bumps around body. Raised bumps on back"; MASS (non-serious) with onset 17Nov2021 17:00, outcome "not recovered", described as "Raised bumps on back". Therapeutic measures were not taken as a result of vaccination site rash, rash, mass. Additional information: The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and post vaccination, patient had tested with covid 19. No known allergies and other medical history reported for the patient. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1947083 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF 8841 / 3 LA / -

Administered by: Work       Purchased by: ?
Symptoms: Arthralgia, Immunisation, Lethargy, Lymphadenopathy, Vaccination site pain
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101619744

Write-up: dose_received: 3; injection site soreness; joint pains; minor swollen axillary lymph node (unilateral to injection site side); lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 10:15 (Lot number: FF 8841) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma & severe allergies" (unspecified if ongoing); "severe allergies" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN 5318, Location of injection: Arm Left), administration date: 17Feb2021, when the patient was 32 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN 5318, Location of injection: Arm Left), administration date: 27Jan2021, when the patient was 32 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 18:00, outcome "unknown", described as "dose received: 3"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021 18:00, outcome "recovering", described as "injection site soreness"; ARTHRALGIA (non-serious) with onset 17Nov2021 18:00, outcome "recovering", described as "joint pains"; LYMPHADENOPATHY (non-serious) with onset 17Nov2021 18:00, outcome "recovering", described as "minor swollen axillary lymph node (unilateral to injection site side)"; LETHARGY (non-serious) with onset 17Nov2021 18:00, outcome "recovering", described as "lethargy". Therapeutic measures were not taken as a result of vaccination site pain, arthralgia, lymphadenopathy, lethargy. Additional Information: Facility type vaccine was workplace clinic. No other vaccines were given within 4 weeks. Other medications were given within 2 weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Patient had no known allergies. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1947559 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
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: 1947564 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
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.


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