VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1058040
Sex: F
Age: 81
State: MI

Vax Date: 02/15/2021
Onset Date: 02/22/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: Lactose intolerant Milk alergy

Symptom List: Dysphagia, Epiglottitis

Symptoms: Extreme itching at the site of vaccine. Few days later was swelling, warm to the touch, redness and hard muscle at the site. Itching continued. Symptoms are subsiding 5 days after initial itching started.

Other Meds: Diltiazem Pantoprozole Furosemide Levothyroxine Aspirin Primidone Metoprol Vitamin D Potassium Vitamin B Complex Calcium Centrum Silver Atorvastatian Prolia Optive Eye Miralax

Current Illness: None

ID: 1058041
Sex: M
Age: 72
State: IL

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies: none

Symptom List: Anxiety, Dyspnoea

Symptoms: none

Other Meds: none

Current Illness: none

ID: 1058042
Sex: F
Age: 55
State: CA

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Numbness in left upper extremity, especially hand. BP 142/83, pulse 59.

Other Meds:

Current Illness:

ID: 1058043
Sex: F
Age: 64
State: MO

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies: pcn

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: RASH, DYSPNEA, CHEST PAIN, FEVER JOINT PAIN, CHILLS, FEVER. TREATMENT: KENALOG, BENADRYL, PEPCID.

Other Meds:

Current Illness:

ID: 1058044
Sex: F
Age: 39
State: AL

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: pt reports scratchy throat; wheezing noted bilaterally up wob us 147/90 rr22 hr97 o2 99% ra observed pt 5 min. pt requests to go to emergency department via personal vehicle instead of ambulance. pt transported to ed via own vehicle with escort from tsco. report called to ed; received im epi in er

Other Meds:

Current Illness:

ID: 1058045
Sex: F
Age: 57
State: TN

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies: DOXYCYCLINE PO SULFA PO BOTH CAUSES RASH

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: PATIENT COMPLAINED OF ITCHING FROM HEAD TO NECK AND THEN "HER LIPS FELT TINGLY" APPROXIMATELY 30 MINS AFTER RECEIVING INJECTIONS. EPI AND BENADRYL WAS ADMINISTERED IM AND EMT ARRIVED TO EVALUATE. SHE REFUSED TRANSPORT BUT REPORTED SYMPTOMS WERE GETTING BETTER AND SHE WAITING FOR MONITORING FOR ANOTHER 30 MINUTES. SHE AGREED TO GO TO ER AND THE EMT AGREED TO FOLLOW HER TO BE SURE SHE WAS OK ALONG THE WAY.

Other Meds:

Current Illness:

ID: 1058046
Sex: M
Age: 73
State: KS

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: unknown

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Patient stated he was extremely tired. Spouse stated he was not responding normally. Has a pituitary glad issue and has emergency steroids, but did not have with him or use in advance. Spouse was uncomfortable with how he was not acting normal. EMS was called at 12:00 pm due to history and at request of spouse. EMS arrived at 12:10 pm and transported at 12:26 pm. Vitals: 164/90 HR 40 blood glucose 137 170/92 HR 42 Ox sat 97%

Other Meds: meds for pituitary disorder, emergency steroids others unknown

Current Illness: unknown

ID: 1058047
Sex: F
Age: 17
State: VA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: unknown

Symptom List: Pharyngeal swelling

Symptoms: Patient received first dose of Moderna vaccine 1.5 months prior to turning 18 months of age.

Other Meds: unknown

Current Illness: unknown

ID: 1058048
Sex: F
Age: 86
State: CO

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: Celiac sprue alergic to wheat, rye, barley and oats

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Stomach, no treatment

Other Meds: Preservision, Tramadol, vitamin d, cognium, elavil 10mg, amlodipine 5mg, calcium carponate-vitamin-d3, donepezil 5mg, fenofibrate 150mg,multivitamin, protonix 25mg, potassium chloride, sacrafate 1 g, levothyroxine 25mg, bentyl

Current Illness: none

ID: 1058049
Sex: F
Age: 48
State: OH

Vax Date: 02/23/2021
Onset Date: 02/24/2021
Rec V Date: 02/26/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: shellfish, vancomycin, azithromycin, codeine, egg, gluten, meperidine, metoclopramide, pencillin, sulfa

Symptom List: Diarrhoea, Nasal congestion

Symptoms: She developed new onset acute psychosis. Was admitted to hospital for management and monitored overnight with head imaging, labs and an EEG that did not show any seizure activity. Psychosis appears to have resolved over past 24 h (several days after injection) - d/c from hospital last night 2/25.

Other Meds: keppra, vimpat, trental, zonegran, protonix, compazine, zofran, norco, ativan, metoprolol, celebrex, zoloft

Current Illness: metastatic lung CA with mets to brain and radiation necrosis causing seizures

ID: 1058050
Sex: M
Age: 78
State: IN

Vax Date: 02/20/2021
Onset Date: 02/21/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies: None

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Fever over 100 degrees with muscle aches. Took tylenol to treat the fever and aches. Both fever and aches persisted for 1 day. Next day I had no problems.

Other Meds:

Current Illness: None

ID: 1058051
Sex: F
Age: 55
State: AZ

Vax Date: 02/09/2021
Onset Date: 02/12/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies: None

Symptom List: Rash, Urticaria

Symptoms: Both arms, hands and lower legs appear with red dots in the third day I got the second COVID-19 vaccine. I didn't report before thinking that will disappear in the follow days. I didn't develop any symptoms like fiver or any of the symptoms that are in V-Safe text. Two weeks passed and not get better I have to seek for medical attention and see my primary Dr. 02/25/2021. She send me to get laboratory work and now I'm waiting for the results . Hope in God this vaccine do not affect my health and my life.

Other Meds: None

Current Illness: None

ID: 1058052
Sex: F
Age: 19
State: NM

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: Steroids (unspecified, unknown reaction), fish

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: 1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands. Patient stated she did have a Depo-Provera Injection after 1st vaccine approximately 3 weeks ago. Pt did state she pre-medicated herself with Benadryl 50mg orally at approximately 1300hrs today. Mom was present with patient while covering physicians and EMS on duty assessed patient. VS:112/82-B/P, 123-HR, 18-RR, SaO2 98% on RA. Allergies: Steroids, fish FMHx: Sports induced asthma and gallstones. 1550: Patient had notable facial swelling eye redness and flushing. 0.15 Epinephrine IM via home Epi-Pen self delivered by patient's mother for increase SOB, and tightness in chest. EMS transport called to transport patient to location. VS:118/86-B/P, 100-HR, 18-RR, Sa02 96% on RA. 1600:Transfer of care to EMS staff assisting in transfer of the patient.

Other Meds: Unknown

Current Illness: Unknown

ID: 1058139
Sex: M
Age:
State: AR

Vax Date: 09/26/2017
Onset Date:
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: developed painful outbreak of shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (Pt) of unknown age. Pt's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On or around 26-SEP-2017, the Pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) as recommended by his primary physician for routine adult health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequently, on an unspecified date in 2017 (reported as within a week after vaccination), the Pt developed a painful outbreak of shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the Pt's symptoms had resulted in physical limitations not presenting prior to the use of the vaccine. As a result, Pt sustained severe, serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome of herpes zoster was considered as not recovered. The reporters considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX). The reporters considered the event of herpes zoster to be disabling.

Other Meds:

Current Illness: Routine health maintenance

ID: 1058140
Sex: U
Age:
State: LA

Vax Date: 08/01/2014
Onset Date:
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: the patient developed the first of many painful outbreaks of shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (Pt) of unknown age and gender. Pt's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On or around August 2014, the Pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) as recommended for routine adult health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequently, on an unspecified date in early 2015, the Pt developed the first of many painful outbreaks of shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the Pt's symptoms had resulted in physical limitations not presenting prior to the use of the vaccine. As a result, Pt sustained severe, serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome of herpes zoster was considered as not recovered. The reporters considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX). The reporters considered the event of herpes zoster to be disabling.

Other Meds:

Current Illness: Routine health maintenance

ID: 1058142
Sex: F
Age: 79
State: CA

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: 2 episodes in which she wanted to pass out; Ache; Flu like symptoms; Fever; A spontaneous report was received from a consumer, concerning herself, a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, aches, flu like symptoms and 2 episodes in which she wanted to pass out. The patient's medical history was not provided. Concomitant product use was not provided. On 08 Feb 2021, the patient received their first of two planned doses of mRNA-1273 ([LOT# 007M20A]) intramuscularly for prophylaxis of COVID-19 infection. On 08-Feb-2021, the patient reported that about 1 to 2 hours after receiving the vaccine, the patient reported that she "wanted to pass out" when she went grocery shopping. The patient also had fever, aches and flu-like symptoms. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events of fever, aches, flu like symptoms and "2 episodes in which she wanted to pass out", were considered resolved on an unspecified date in Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1058143
Sex: M
Age: 63
State: FL

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Blood stain streaks bright red in feces; Nausea; fatigue; Headache; Diarrhoea; Feeling gassy; Fever; Vomiting yellow bile; A spontaneous report was received from a consumer regarding a 63-year-old male patient who received Moderna covid-19 vaccine and have experienced blood stain in faeces, vomiting, nausea, headache, flatulence, fatigue and fever. The patient's medical history was not provided. His concomitants include Baby aspirin (blood thinner),Potassium(for low potassium),Gabapentin(for pain),VitB12(for nerves),Duloxetine Hcl (Neuropathy),Doxazosin Mesylate ( for prostrate),Lisinopril(for hypertension),Simvastatin(for cholesterol) and Alprazolam(anti-anxiety).No information on allergies. On 10-FEB-2021, prior to the onset of events, the patient received his first of two planned doses of covid-19 vaccine intramuscularly for the prophylaxis of covid-19 infection (Lot#015M20A). On 11-FEB-2021, he vomited yellow bile looking stuff, had diarrhea, fever and felt gassy. On 12-FEB-2021, he no longer felt vomiting, but felt nauseous, slight fever, fatigue and headache. On 13-FEB-2021, he felt nauseous and had blood stained faeces (bright red). Caller was informed to consult physician for treatment and her question regarding second dose for her husband. Action taken with 2nd dose of Moderna Covid-19 vaccine was not reported. The outcome of the event vomiting is recovered, but other events are not recovered at the time of report.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Other Meds: BABY ASPIRIN; POTASSIUM; GABAPENTIN; VITAMIN B12 [CYANOCOBALAMIN]; DULOXETINE HCL; DOXAZOSIN [DOXAZOSIN MESILATE]; LISINOPRIL; SIMVASTATIN; ALPRAZOLAM

Current Illness:

ID: 1058144
Sex: F
Age:
State: NJ

Vax Date: 02/04/2021
Onset Date: 02/06/2021
Rec V Date: 02/26/2021
Hospital: Y

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: vasculitis; coughing up blood; really bad head cold; dizzy; Started gettting sick; A spontaneous report received from a Consumer concerning, 79-year-old, female patient who received dose of Moderna COVID-19 vaccine experienced Vasculitis. The patient's medical history included Afib. Patient's concomitant included Eliquis. On 04FEB2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in left arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Patient daughter reports her mother who is 79-year-old female with no underlining health issues other than Afib, which she takes blood thinners for has been in ICU since 10FEB2021. Patient daughter stated that she was told her mother has vasculitis as a result of the Moderna Covid-19 vaccine. Patient daughter stated that her mother started getting sick on 06Feb2021. She stated her mother started coughing up blood on Sunday 07FEB2021. She stated her mother also had a bad head cold and was dizzy. Patient daughter stated that her mother has some genetic predisposition and the Moderna COVID-19 vaccine triggered it. Patient daughter stated that her mother doctor advised her not to receive the 2nd dose of the Moderna COVID-19 vaccine. Patient treatment included Chemotherapy Infusion (Rituxan) and Blood Transfusion. Action taken with mRNA-1273 in response to the event was withdrawn. The outcome of the event was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: ELIQUIS

Current Illness: AFib

ID: 1058145
Sex: F
Age: 52
State: TX

Vax Date: 12/24/2020
Onset Date: 12/25/2020
Rec V Date: 02/26/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: fever; fainting spell; fatigue; cough; headache; myalgias; Case reference number MOD-2021-013971 is a spontaneous case report sent by a Physician on 25-JAN-2021 00:00:00 , which refers to a Female aged 52 Years . On 24-Dec-2020 the patient took Moderna COVID-19 vaccination. Some 2 days later, the patient developed fainting. The next day of vaccination the patient also developed cough,headache,myalgia,fever,fatigue. The patient experienced the following serious criteria: Medically Significant. The eventual diagnosis made on was Syncope . The Physician did not declare any relatedness between fainting and Moderna COVID-19 Vaccine. The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons ? (probably due to pre existing disease); there is no plausible mechanism to implicate the drug. . Terse Narrative (for narratives and signal review) Brief 3 line summary of above for Regulatory Authority listing: Report Source- Physician, Age- 52 Years, Sex- Female, Suspect Drug- Moderna COVID-19 Vaccine, Treatment- Diagnosis\Outcome- fatigue - Recovered/Resolved,fainting - Recovered/Resolved,fever - Recovered/Resolved,myalgias - Recovered/Resolved,headache - Recovered/Resolved,cough - Recovered/Resolved.; Reporter's Comments: Patient ID: Investigator Site: Case reference number MOD-2021-013971 is a clinical trial case report which refers to a 52 Years old Female patient. The patient experienced fainting which resulted in medically significant . . The patients started Moderna COVID-19 Vaccine on . Some 2 days later, the patient developed fainting.' Relevant laboratory results included and relevant physical signs were . The patient experienced the following serious criteria: -Medically Significant The eventual diagnosis made was Syncope .The event(s) were: fatigue - Recovered/Resolved,fainting - Recovered/Resolved,fever - Recovered/Resolved,myalgias - Recovered/Resolved,headache - Recovered/Resolved,cough - Recovered/Resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1058146
Sex: M
Age: 72
State:

Vax Date: 01/18/2021
Onset Date: 02/12/2021
Rec V Date: 02/26/2021
Hospital: Y

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Slurry speech; Swollen tongue; Sore arm; A spontaneous report was received from a consumer concerning a male patient of 72 year old, who was received Moderna's COVID-19 vaccine(Mrna-1273) and experienced sore arm,slurry speech and swollen tongue. The patients medical history,as provided by the reporter, included chemotherapy.No Concomitant medications were reported. On 12 feb 2021,prior to the onset of events, the Patient received their second of two planned dose of Mrna-1273(Lot number:026L20A) vaccine intramuscularly for prophylaxis of COVID-19 infection. On 12 feb 2021,after taking vaccine patient experienced soreness in arm.On the second day he woke up with slurry speech and swollen tongue. Patient was Admitted emergency room where he was kept overnight for observation and treatment. Treatment for the event included hospitalization. The outcome for the event sore arm,blurred speech and swollen tongue was not mentioned.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness: Chemotherapy

ID: 1058147
Sex: M
Age:
State: FL

Vax Date: 02/06/2021
Onset Date: 02/10/2021
Rec V Date: 02/26/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Two complex seizures; An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: UNKNOWN) via an unspecified route of administration on 06Feb2021 (at the age of 88-years-old) as a single dose for COVID-19 immunization. Medical history included atrial flutter from an unspecified date and unspecified if ongoing. It was reported that the patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (within two weeks) included warfarin sodium (COUMADIN). It was reported that the patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccination. The patient experienced two complex seizures, serious for hospitalization, on 10Feb2021. The clinical course was reported as follows: "Two complex seizures confirmed by ED (emergency department) physician. No history of seizures. Negative CT head and labs. Unclear if seizure was related to COVID vaccine 5 days prior." It was reported that treatment was not received for the event. The clinical outcome of the event two complex seizures was recovered/resolved on an unspecified date. It was also reported that the patient had not tested positive for COVID-19 post vaccination. No follow-up attempts are possible; information about lot number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Seizures cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: COUMADIN

Current Illness:

ID: 1058148
Sex: M
Age:
State: VA

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Severe Tinnitus; Slight soreness at injection site on 06Feb2021; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261), via an unspecified route of administration in the left arm on 06Feb2021 at 13:45 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), and simvastatin (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took oxycodone hydrochloride/paracetamol (PERCOCET) on unknown dates for an unknown indication and experienced drug allergy. The patient experienced slight soreness at injection site on 06Feb2021 and severe tinnitus on 08Feb2021 at 05:00; both reported as serious for disability. The tinnitus was further described as intermittent and constant buzzing and vibrations in right ear only. No other issues or symptoms. The patient did not receive any treatment for the events. The clinical outcomes of the tinnitus and slight soreness at injection site were not recovered.

Other Meds: LEVOTHYROXINE; LISINOPRIL; SIMVASTATIN

Current Illness:

ID: 1058149
Sex: F
Age:
State: DE

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: had been having more ear pain / had not had ear pain in awhile /right ear had been hurting her; had been having more ear pain / had not had ear pain in awhile /right ear had been hurting her; Itching on the left side of her tongue; She had a little bit of swelling on the left side of her tongue; Other autoimmune type things going on; This is a spontaneous report from a contactable nurse reporting for herself. This 62 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3246) on 19Jan2021 at 14:30 (at the age of 62 years old), in left arm, for COVID-19 immunisation. Prior vaccinations (within 4 weeks) or on the same day: none. Medical history included ongoing trigeminal neuralgia (she had nerve issues, clarifying she was diagnosed about 6-1/2 years ago with trigeminal neuralgia that caused right-sided pain in her head and in her right ear), Raynaud's in her hands and feet since she was a kid. The patient previously took a 7-day course of levofloxacin (LEVAQUIN) and after that she had a diagnosis of ongoing erythromelalgia in her hands and feet and permanent ringing in ears, both since 2014, after she took, saying she functioned fine with the permanent ringing in her ears, she had gotten used it. She also felt horrible and had a muscle tear in her right arm a week after taking Levaquin. Concomitant medication included nortriptyline 20 mg capsule once daily (at night), ongoing since about 6-1/2 years ago, for trigeminal neuralgia. On 19Jan2021, 3 hours after vaccination, the patient experienced itching on the left side of her tongue. On the same day she had a little bit of swelling on the left side of her tongue. She took 1 generic 25 mg tablet of diphenhydramine (BENADRYL) at 19:30 and was okay and slept fine. The next day it felt different but it wasn't itching. She had other autoimmune type things going on. Since an unspecified date in Feb2021 the patient had been having more ear pain and usually took medicine for this but had not had ear pain in awhile. The patient said the left side of her tongue itching and swelling was enough to make her concerned. She also said she was concerned that there may be something in the COVID-19 vaccine that will activate her nerve issue since her right ear had been hurting her since Feb2021. She said she thought that maybe the cold weather was causing her right ear pain, but she had been on medication for over 6 years now that had been taking care of her right ear pain. She said she did not want to have the second COVID-19 vaccine injection if it was going to set off her nerve issue. She stated the doctors were thinking that she should get it but staying there and be monitored and not get it on her day off. She would be getting it at the student health center where she worked so she could be monitored and would have access to medical treatment if needed. Relevant tests: none. The events did not require ER visit or physician office visit. Itching on the left side of her tongue resolved on 19Feb2021. Swelling of tongue resolved on 20Feb2021. The other events outcome was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of autoimmune disorder and other events due to temporal relationship. However, the reported events may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including autoimmune panel, ANA and ESR, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: NORTRIPTYLINE

Current Illness: Trigeminal neuralgia (diagnosed about 6-1/2 years ago, caused right-sided pain in her head and in her right ear)

ID: 1058150
Sex: F
Age:
State: OH

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 02/26/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: convulsing uncontrollably; stroke; rash; chest felt really heavy like someone was sitting on it; her throat felt like it was on fire; shaking uncontrollably/ arms and legs were shaking; Her speech was slurred, she could not communicate; Stuttering; dysphagia; tongue was falling to the side/mile was droopy on the right side/right arm- she would try to move it but it would not go/right leg was almost paralyzed; This is a spontaneous report from a contactable consumer (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 09Feb2021 18:10 at a single dose for COVID-19 immunization. The patient had no relevant medical history. She was healthy and takes no medications. The patient got the vaccine Tuesday night at 6:10 PM. She waited in the parking lot where she got it, which was through (School Name). She had a severe reaction and had to receive an Epi Pen. This reaction occurred maybe 10 minutes after she got it. She had not left the parking lot yet, so it was prior to the 15 minutes. She broke out in a rash, her chest felt really heavy like someone was sitting on it, like an elephant, and her throat felt like it was on fire which is what is started as, then it went to her ears. From there, it escalated. She had gotten out of her car and took her sweatshirt off, she thought she was just hot. As soon as she got back in the car and as soon as she got in she started convulsing uncontrollably and shaking uncontrollably. Two ladies she works with had parked next two her on both sides and they noticed this and went to get the emergency squad. She did not lose consciousness. She could still hear everything but her arms and legs were shaking, and her right leg was shaking and stuck. The emergency squad had to help her out of the car. The ambulance gave her an Epi Pen injection and the squad took her to the hospital. Her speech was slurred, she could not communicate. She was stuttering the same thing over and over. She had a CAT scan with contrast and the stroke team decided she needed TPA - the stoke medication. They administered that and admitted her to the hospital Tuesday night. Wednesday she had an MRI, echocardiogram and another CAT scan and they released her to come home last night. She is still having lingering effects. Her speech is back. Her arm movement is back. The reason they treated her as a stroke patient, they said, is because when they told her to stick her tongue out, she had dysphagia - her tongue was falling to the side, and her smile was droopy on the right side. Her right arm- she would try to move it but it would not go. And her right leg too. She could do everything on her left side and nothing on her right side. She was conscious and could hear but could not get anything to work. After receiving the TPA, Wednesday when she woke up, she was being checked on every 30 minutes throughout the night, she was able to speak and communicate. She will still stutter and have slow words but it is way better and she can communicate. Her right arm is able to move and she can use it but her fine motor is hard. Like writing stuff is a challenge. She also has a walker. Her right leg is almost paralyzed, it drags beside her as she walks. She can move but has to really concentrate to get going. She has not reached out to her doctor yet. She was admitted to the hospital and had a bunch of tests done. The Epi Pen gave her stroke like symptoms. They were not sure in the hospital if it was actually a stroke based on her 2 MRI's and CAT scans. It did not look like a stroke from those but they think that the Epi Pen and the stress it puts into your body made her body shut down. Which the Epi Pen they said can cause stroke like symptoms. They were unsure as they have seen multiple things with the vaccine come in over the last few weeks. They told her she would need to work on the therapies out-patient. She will have to have PT/OT for lingering effects she was suffering from. Outcome of events was recovered with sequelae.

Other Meds:

Current Illness:

ID: 1058151
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: thrombocytopenia; This is a spontaneous report from a non-contactable consumer (the patient daughter). A non-pregnant elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient diagnosed with COVID-19. It is unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On an unspecified date the patient experienced thrombocytopenia. The patient had lab tests and procedures performed which included platelet count: thrombocytopenia on an unknown date. It was unknown if treatment was received for the event. The clinical outcome of thrombocytopenia was not recovered. If was unknown if since the vaccination, the patient had been tested for COVID-19. Information on the lot number has been requested.

Other Meds:

Current Illness:

ID: 1058152
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/05/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: stroke; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, Lot unknown, first dose) intramuscular on 01Feb2021 (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 05Feb2021, four days after vaccination, the patient had a stroke. The outcome of the event stroke was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1058153
Sex: M
Age:
State: TX

Vax Date: 01/22/2021
Onset Date: 01/27/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Bell's Palsy - L facial droop; This is a spontaneous report from a contactable physician. A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK4176), intramuscularly on 22Jan2021 at 08:00 am on the left arm at single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM 2), hypertension (HTN), hypersensitivity lung disease (HLD), and hepatitis C (Hep C) s/p treatment, all from an unknown date. Patient had no known allergies. Concomitant medication included acetylsalicylic acid (ASA), gabapentin, lisinopril, and an unspecified statin from unknown dates and indication. No other vaccines were received in four weeks. On 27Jan2021, it was reported that the patent experienced Bell's palsy - L facial droop which resulted in emergency room visit and required treatment of "Pred". The patient had no COVID prior to vaccination and was tested post vaccination on 27Jan2021 via nasal swab which had a negative result. The patient received the vaccine in a hospital. The outcome of the event was reported as recovering.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of event Bell's palsy cannot be excluded, due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: ASA; GABAPENTIN; LISINOPRIL

Current Illness:

ID: 1058154
Sex: F
Age:
State: AK

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 02/26/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: I woke up severely dizzy; I couldn't walk; vomiting; tongue swelled; having an allergic reaction to the Covid vaccine; coughing up mucus; severe body aches; This is a spontaneous report from a contactable consumer (patient). Information were received also from Pfizer-sponsored program COVAX US Support. A 44-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#EL9267), via an unspecified route of administration in the left arm on 09Feb2021 17:30 at single dose for COVID-19 immunisation. Medical history included asthma, iodine allergy. The patient previously took atropine and sulfur and experienced drug hypersensitivity. The patient was not pregnant. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast (MONTELUKAST), ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT), colecalciferol (VITAMIN D). The patient experienced dizziness, couldn't walk, vomiting, tongue swelled, allergic reaction to the covid vaccine, coughing up mucus and severe body aches on 10Feb2021 at 00:00 with outcome of recovering. The patient reported that about six hours after the vaccine, she woke up severely dizzy, she couldn't walk and was vomiting. Her husband called the paramedics and She was taken to the hospital. She was at the hospital for 6 hours. Her tongue swelled while she was at the hospital (as reported). The attending physician said that she was having an allergic reaction to the Covid vaccine. She was not been able to go to work this week. She had been coughing up mucus and had had severe body aches. The patient would like to have help paying for the medical bills she had incurred. Events resulted in Emergency room/department or urgent care. The patient received medications as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.

Other Meds: ADVAIR; MONTELUKAST; MULTI VIT; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1058155
Sex: M
Age: 69
State: CO

Vax Date: 02/09/2021
Onset Date: 02/11/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Since my vaccination I have been having pain in my left leg muscles. The pain is worse if I bend my leg very much. It has been over two weeks since the vaccination and the pain is not getting better. I contacted my doctor and he suggested that I report the incident.

Other Meds: multi day vitamin, fish oil, vitamin D, turmeric

Current Illness:

ID: 1058156
Sex: F
Age: 55
State: ID

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Broke out in hives on my back and blood pressure was very high

Other Meds: Synthroid, Lipitor, Chlorthalidone, Bupropion

Current Illness:

ID: 1058157
Sex: F
Age: 66
State: NY

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: lyrica, trasadone,cymbalta, codeine, honey

Symptom List: Injection site pain

Symptoms: itching and aching in muscle of left arm followed by redness spreading towards elbow

Other Meds: gabapentin 33mg, buspirone hcl 15mg, tizanidine hcl 4mg

Current Illness: fibromyalgia

ID: 1058158
Sex: F
Age: 76
State: MA

Vax Date: 02/06/2021
Onset Date: 02/15/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: sulfamethoxazole, clarithromycin, cefuroxime, doxycycline, erythromycin, penicillin

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: On February 14, I had used the handlebar rotation exercise of a stationery bike for 5 minutes. The next day I noticed a large swelling about the size of half a pear on the muscle where my Moderna injection was done. It was as hard as a nut, red, and warm and itchy with a red rash around it. I saw an urgent care medical person and was told it was probably a reaction to the exercise and that sometimes that happens after an injection. I was told to use cold compresses, hydrocortison cream, and rest it. I did this, for 5 days, but though the swelling subsided, the rash continued to move around and down my arm. I went back to urgent care on February 19 and was told that it looked better. I was offered prednazone for it, but declined since I was still on Budesonide . I was told it would probably clear up over the weekend. On February 22 it hadn't cleared up so I saw a PC. She noted the rash had spread, but swelling had gone down. She checked my lymph node under my left arm and noticed it was swollen. She said it was most likely due to a mild infection in the arm where I had received the vaccination. She prescribed a Zpack and after 2 days, all symptoms were gone and I felt so much better. This event happened 10 days after my vaccination.

Other Meds: 1 Centrum Silver, two 600 mg calcium & vitamin D3, one 81 mg aspirin, one 5mg amlodipine besylate, on 20 mg omeprazole, 3 mg budesonide

Current Illness: recovering from infectious colitis diagnosed on 11/2/20

Date Died: 02/25/2021

ID: 1058160
Sex: M
Age: 97
State: NE

Vax Date: 02/11/2021
Onset Date: 02/25/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies: NKDA

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Resident expired on 2-25-21

Other Meds: Acetaminophen, Aspirin, Atorvastatin, Carvedilol, Fiber-lax, Furosemide, Levetiraceta, Levothyroxin, Lorazepam, Quitiapine, Terazosin, VitD, Antidiarrheal tabs PRN,Tramadol PRN

Current Illness: None

ID: 1058161
Sex: F
Age: 63
State: KS

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: Megace, Amoxicillin, Diltiazam

Symptom List: Tremor

Symptoms: Throat swelling and tongue felt raw was given Benedryl (2) by Dr. in attendance and observed for around 45 minutes. Later that evening (about 4 hours later) heart had a series of strong, short, contractions. Continued for the next few day but less each day. Followed up with cardiologist and was in regular rhythm but show him my left arm where I had a red circle (3 inches or so) around injection site. Referred to PCP and they suggested no 2nd vaccination. If deemed in need of another Covid vaccination allergist should be consulted first.

Other Meds: Eliquis, Sotalol, Latanaprost Eye Drops

Current Illness: None

ID: 1058162
Sex: F
Age: 62
State: NY

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Cos tongue tingling and possible rash. was taken to ED by RRT. She stated having flushing neck and cheeks, elevated blood pressure 138/115 to 140/73

Other Meds:

Current Illness:

ID: 1058163
Sex: F
Age: 71
State: MO

Vax Date: 02/17/2021
Onset Date: 02/25/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: patient received vaccination on 2/17, noticed redness and swelling on 2/25. it is painful

Other Meds: Redness, swelling and pain below injection site

Current Illness:

ID: 1058164
Sex: U
Age: 72
State:

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Difficulty breathing, possible anxiety per patient, evaluated by EMS-cleared

Other Meds:

Current Illness:

ID: 1058165
Sex: M
Age: 86
State: CA

Vax Date: 02/24/2021
Onset Date: 02/25/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: none

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: extreme chills, fatigue, nausea, vomiting, diarrhea. chills started morning of the day following vaccination. Hours later extreme fatigue followed by nausea, vomiting and diarrhea. Today, 48 hours later feeling much better with slight nausea which appears to be better.

Other Meds: finesteride,lisinopril, simvastatin, entyvio multiple vtamins

Current Illness: colitis

ID: 1058166
Sex: F
Age: 71
State: ME

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies: NKA

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Acute ischemic stroke

Other Meds:

Current Illness: No Known illnesses

ID: 1058167
Sex: F
Age: 77
State: IN

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: n/a

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: The patient received the Pfizer vaccine for the second dose instead of the Moderna vaccine.

Other Meds: n/a

Current Illness: n/a

ID: 1058168
Sex: F
Age: 69
State:

Vax Date: 01/19/2021
Onset Date: 01/21/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: 2 days after vaccine started with rash, body aches, joint pain. Treated but continues

Other Meds:

Current Illness:

ID: 1058169
Sex: F
Age:
State: OH

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 02/26/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: Diagnosed with May-thurner syndrome; Deep vein thrombosis; Both of her feet were only slightly swollen; Dull minor headache; Off-label use; Inappropriate schedule of vaccine administered; Localized discomfort where injection of second dose of Pfizer COVID-19 Vaccine was given; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (weight: 77.56 kg, height: 157 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the upper left arm, on 23Jan2021, for COVID-19 immunisation. Relevant medical history included thyroid condition from an unspecified date (over 25-30 years before this report) and ongoing, controlled with levothyroxine sodium (SYNTHROID); and breast cancer from an unspecified date, in 2019 (treatment and surgery on an unspecified date, in 2019. Presumed resolved with radiation treatment, but no treatment within a year prior to getting Pfizer COVID-19 vaccine). The patient previously, on 05Jan2021 (18 days before the second dose), received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) for COVID-19 immunisation. After the first dose, the patient experienced localized discomfort at the injection site and swelling of feet. Concomitant medication included levothyroxine sodium (SYNTHROID) from an unspecified date and ongoing, 0.88 mg, daily, for thyroid condition. On 23Jan2021, the patient experienced injection site discomfort described as "localized discomfort where injection of second dose of Pfizer COVID-19 Vaccine was given". On 24Jan2021, she had dull minor headache. On an unspecified date, the patient was hospitalized after the second dose and was diagnosed with May-thurner syndrome. She clarified that May-Thurner syndrome was where the iliac artery collapses and crushed the iliac vein in the upper abdomen; from that point down it started creating a blood clot. She developed a deep vein thrombosis (DVT) from her left ankle up to her right rib cage area; it was a monster. On 10Feb2021, the patient experienced deep vein thrombosis and thrombectomy was performed on the same day (outpatient thrombectomy surgery, performed 10Feb2021. It was a great surgery, very corrective. She never did have any pain or discomfort which confused everyone. She felt fine this whole time, no issues). On an unspecified date, both of her feet were only slightly swollen. Relevant laboratory test, performed on an unspecified date, in 2021, included computerised tomogram (CT scan with contrast of her abdomen and chest) that showed deep vein thrombosis: left ankle-right ribcage area. The adverse events May-Thurner syndrome and deep vein thrombosis were assessed as serious, hospitalization required from 02Feb2021 to 10Feb2021. The patient recovered from deep vein thrombosis on 10Feb2021, recovered from headache on 26Jan2021, recovered from swelling of feet and vaccination site discomfort on an unspecified date, while clinical outcome of the other events was unknown. Her vascular surgeon said he did not believe these events were vaccine related but cannot rule it out; her Primary Care Physician absolutely believed the events were vaccine related. The information on the lot number has been requested.

Other Meds: SYNTHROID

Current Illness: Thyroid disorder (controlled with levothyroxine sodium (SYNTHROID))

ID: 1058170
Sex: M
Age: 78
State: FL

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: The patient received his first dose of the Moderna vaccine. He reports that approximately 2 hours after the injection he began to have right sided tongue swelling. He was assessed in the ED. He had no facial swelling but there was right sided tongue swelling present. Oral airway was patent. Tachycardia was present (HR 116) and BP 197/96. He was given Benadryl, Solu-Medrol, and IV fluids. He was later considered stable and was dicharged 3 hours later.

Other Meds: Aspirin 81 mg Pravastatin 40 mg Ezetimibe 10 mg Metoprolol succinate 50 mg

Current Illness:

Date Died: 02/07/2021

ID: 1058171
Sex: M
Age: 89
State: IN

Vax Date: 01/22/2021
Onset Date: 02/07/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Death

Other Meds:

Current Illness:

ID: 1058172
Sex: M
Age: 65
State: MN

Vax Date: 02/01/2021
Onset Date: 02/15/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies: raw carrots, melons, general anesthesia, morphine

Symptom List: Vomiting

Symptoms: vomit, diarrhea, chills, lost consciousness, BP drop. Paramedics brought to ER. Given fluids, EKG, and lab tests to make sure it wasn't heart related. Tests came back normal.

Other Meds: Lipitor, Lisinopril, Vit D, baby aspirin

Current Illness: none

ID: 1058173
Sex: M
Age: 81
State: OH

Vax Date: 01/23/2021
Onset Date: 02/26/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Shingles,prescribed: Valacyclovir, rash along radial nerve

Other Meds: Amlodipine, Ziac,Plavix,Isosorbide Mono,AZO Cranberry Gummies, Ferrous sulfate 325mg, fluticasone nasal, levothyroxine 100 mcg, Mutivitamin, PreserVision, Fish Oil, Rosuvastin 20mg, CoQ10 400Mg.

Current Illness:

ID: 1058174
Sex: F
Age: 69
State: IA

Vax Date: 02/24/2021
Onset Date: 02/26/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies: Peanuts, eggs

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: 36 hours later, (approximately), I woke up with a rash. Under the both arms it looked like a sunburn. Across the chest an sides, it was spotty. The right side had more rash than the right, and both sides wrapped around to the back, about 2 inches, on both sides. Less going down the rest of the torso. Took Benadryl, 2-25 mg, 4 hours apart, for a total of 100 mg. 1:00PM, Feb. 26, rash faded significantly. Also had a dry mouth and a bit of a racing heart, right after being given the vaccination & again when the rashes appeared. However, this could have been anxiety. Both times it went away after walking & deep breathing. Lasted for about 15 minutes each time.

Other Meds: No

Current Illness: None

ID: 1058175
Sex: F
Age: 39
State: NC

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: Peanut

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Very hot, flushed immediately after injection. She felt panicky, lips, fingers/feet were tingling. She cooled down and was back to normal within 20 minutes of vaccination. No other events reported thereafter.

Other Meds:

Current Illness:

ID: 1058176
Sex: F
Age: 44
State: NC

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening and reported to RN that she was feeling lightheaded and dizzy after about 20 minutes of observation. States she is feeling slightly anxious. BP 160/96 pulse 108 sat 98%. Patient is not reporting any other symptoms. Patient reports a History of HTN and anxiety States she does not normally feel lightheaded/dizzy. States this BP is elevated for her. Patient given water and crackers, with slight relief of dizziness. EMS called and at pt side for evaluation. At 1212p, Bp 173/91, hr 94, sat 97% given cracker and water, which patient stated made her feel slightly better. EMS evaluating patient Emotional support provided. At 1220, BP 182/98, pulse down to 85, with sats at 95%. Patient feeling better. EMS transported patient to a quite space and continued to monitor. Patient speaking with husband as well. At 1242, EMS released stating patient feeling better and BP down to 160/90. Patient encouraged to discuss with PCP events. She was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening and reported to RN that she was feeling lightheaded and dizzy after about 20 minutes of observation. States she is feeling slightly anxious. BP 160/96 pulse 108 sat 98%. Patient is not reporting any other symptoms. Patient reports a History of HTN and anxiety States she does not normally feel lightheaded/dizzy. States this BP is elevated for her. Patient given water and crackers, with slight relief of dizziness. EMS called and at pt side for evaluation. At 1212p, Bp 173/91, hr 94, sat 97% given cracker and water, which patient stated made her feel slightly better. EMS evaluating patient Emotional support provided. At 1220, BP 182/98, pulse down to 85, with sats at 95%. Patient feeling better. EMS transported patient to a quite space and continued to monitor. Patient speaking with husband as well. At 1242, EMS released stating patient feeling better and BP down to 160/90. Patient encouraged to discuss with PCP events.

Other Meds:

Current Illness:

ID: 1058177
Sex: F
Age: 45
State: IL

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 02/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies: none

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: undiluted 0.3ml vial was given to patient, the patient did not have any adverse affects reported

Other Meds: none

Current Illness: none

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm