VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
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: 1017023
Sex: F
Age: 41
State: IL

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/09/2021
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: Bactrim, adhesives, devils claw

Symptom List: Dysphagia, Epiglottitis

Symptoms: Red rash over face and neck. Off and on for 3 days. Got better with Benadryl.

Other Meds: None

Current Illness: None

ID: 1017026
Sex: F
Age: 72
State: VA

Vax Date: 02/06/2021
Onset Date: 02/08/2021
Rec V Date: 02/09/2021
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: No Known Drug Allergies (NKDA)

Symptom List: Anxiety, Dyspnoea

Symptoms: Vaccine administered in left deltoid by RN. Swollen left arm noticed by RN on 2/8/2021 in AM (~0800). Patient did not notice swelling or complain of ADR.

Other Meds: Citalopram, Enoxaparin, Famotidine, Lisinopril, Pantoprazole, Sucralfate (routine) PRN meds include APAP, Maalox, Zofran, and Trazodone.

Current Illness: Failure to thrive, Malnutrition, Anorexia with nausea/vomiting, Abdominal Pain.

ID: 1017029
Sex: M
Age: 36
State: TN

Vax Date: 02/05/2021
Onset Date: 02/06/2021
Rec V Date: 02/09/2021
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: None

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

Symptoms: Severe left arm soreness and fatigue - bedridden x 3 days

Other Meds: None

Current Illness: None

ID: 1017031
Sex: F
Age: 53
State: SC

Vax Date: 01/25/2021
Onset Date: 02/03/2021
Rec V Date: 02/09/2021
Hospital:

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

Lab Data:

Allergies: No known allergies

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: 2/5/2021 S/O: Patient endorses 2-day history of rash of trunk, lower extremities, feet. Rash is pruritic. Started on torso and then spread peripherally to involve back, legs. Spares face. Itching improved with Benadryl. She is 10 days status post second dose of COVID-19 vaccine. She denies lip/tongue swelling, fever, chills, cough, wheezing, dyspnea. Patient denies any history of allergies or adverse vaccine reactions. A/P: 1. Chilblain-like lesions of multiple toes R23.8 -Rash concerning for pseudochilblains associated with COVID-19 infection. -Patient otherwise with no signs of Covid infection. -Suspect adverse drug reaction to vaccine. -We will send patient for PCR testing to rule out active infection. 2. Pruritic rash L28.2 -Suspect drug reaction. Recommend continue antihistamine twice BID. -Rx Medrol Dosepak 2/6/2021 COVID Test Negative 2/8/2021 Patient states her rash is gone, toes are improving, and Medrol Dosepak is working well.

Other Meds: Baclofen 10mg TID Vivelle 0.05mg/24hr - 1 patch topically 2x/week Topiramate 25mg BID Tramadol 50mg q4h PRN pain Docusate 100mg BID PRN constipation Multivitamin daily Ibuprofen 800mg PRN

Current Illness: No acute illnesses or issues at time of vaccination and up to 1 month prior

ID: 1017035
Sex: F
Age: 88
State: OH

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 02/09/2021
Hospital:

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

Lab Data:

Allergies: no known

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

Symptoms: A long term care facility patient was given three COVID-19 vaccines each 21 days apart. No adverse reaction reported but the patient should not have received a third vaccine.

Other Meds: unknown

Current Illness: no known

ID: 1017038
Sex: F
Age: 68
State: PA

Vax Date: 01/29/2021
Onset Date: 02/04/2021
Rec V Date: 02/09/2021
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: Adhesive tape, Polymixin B, Neosporin bacitracin

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

Symptoms: patient with redness, pain,swelling aprox 1 week after vaccine, resolved with tylenol, ice benadryl

Other Meds: zoledronic acid , vit D, tylenol

Current Illness:

ID: 1017041
Sex: M
Age: 79
State: RI

Vax Date: 01/30/2021
Onset Date: 02/08/2021
Rec V Date: 02/09/2021
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: NKDA

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: large area of induration, redness, and warmth of entire arm --area approx 10 by 8 inches

Other Meds: Lyrica, vitamin B

Current Illness:

ID: 1017044
Sex: F
Age: 57
State: TX

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Patient was given COVID19 (Pfizer-BioNTech) dose #1 on 1/22/2021 and COVID19 (Pfizer-BioNTech) dose #2 on 2/4/2021, 13 days after first dose. On 2/5/21, patient denies any side effects from vaccine

Other Meds:

Current Illness:

ID: 1017047
Sex: F
Age: 82
State: TX

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 02/09/2021
Hospital:

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

Lab Data:

Allergies: lactose intolerance

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: 12 hours after receiving vaccine I woke with severe stabbing pain in stomach, moving up left side went to ER about 48 hours later, diagnosed Shingles, slight rash on left side above breast around to left back shoulder I continue to have shingles

Other Meds: Metoprolol Succinate Er; Synthroid; Valsartan; Colon Health probiotic; magnesium Oxide; CoQ10; calcium citrate; Vitamin D; Biotin; Vitamin B-12; Preservision AREDS; Allegra; Indomethacin; Zolpidem Tartrate.

Current Illness: N/A

Date Died: 02/07/2021

ID: 1017051
Sex: M
Age: 77
State:

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 02/09/2021
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:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: pt received vaccine on 2/3. early on 2/4 developed chest pain, dyspnea, and was seen in ED and diagnosed with acute exacerbation of CHF and NSTEMI type 2, and anemia. on 2/5 transfusion was started and pt developed worsening dyspnea and then PEA arrest. Pt achieved ROSC and was transferred to the cardiac intensive care unit where he required vasopressor support. he subsequently declined and died on 2/7

Other Meds:

Current Illness:

ID: 1017053
Sex: M
Age: 77
State: NC

Vax Date: 01/19/2021
Onset Date: 02/01/2021
Rec V Date: 02/09/2021
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: Extreme fatigue then a break out of shingles right upper back and around and under arm

Other Meds: Lisinopril 10 MG, Crestor 20 mg, Allopurinol 300 mg, Vitamin D3 10, 000 U, 81 mg aspirin

Current Illness: None

ID: 1017056
Sex: F
Age: 69
State: TX

Vax Date: 01/27/2021
Onset Date: 02/04/2021
Rec V Date: 02/09/2021
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:

Symptom List: Rash, Urticaria

Symptoms: Day after injection, tired, arm sore & redness, all went away. On Day 8 2"x2" raised red patch on skin, Day 14 patch is larger with welts and itches. No medicine taken or applied.

Other Meds: Metropolol 25mg Rovustatin 10mg Aspirin 81 mg CoQ10 200 mg Olopatadine HCL 2% Restasis .05% Rhinocort 32 mcg Azithromycin 5 day

Current Illness: Sinus drainage, sore throat

ID: 1017059
Sex: F
Age: 79
State: TN

Vax Date: 01/22/2021
Onset Date: 01/29/2021
Rec V Date: 02/09/2021
Hospital:

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

Lab Data:

Allergies: Cipro, Avelox, Codine, Lidocrane with epi,

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

Symptoms: one week after vaccine noted red spot 2 inches below injection site sl itch note. Two weeks after vaccine was red to elbow and was not feeling well, itching was worse, went to Urgent Care saw Doctor who order Preisone and K-flex

Other Meds: Metoprolol 25 mg bid, Triamterne/HTCZ 37.5/25 one a day, Premine .625mg one a day, One- A-Day Vitamin, vitamin E,

Current Illness: none

ID: 1017060
Sex: F
Age: 33
State:

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 02/09/2021
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: symptoms included: body aches, chills, possible fever, vomiting, and fatigue Treatment included: Tylenol (as directed) and rest Time course: Body aches, chills, fever, and vomiting only lasted about 2 hours. Fatigue persisted for about 15 hours.

Other Meds:

Current Illness:

ID: 1017061
Sex: F
Age: 74
State: CA

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 02/09/2021
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: Lactose, sulfa, tramadol, some antibiotics

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

Symptoms: Weakness, slight swelling of upper lip and construction of throat. Weakness after 15 minutes, swelling and construction after 40 minutes, on drive home. Went to ER but swelling and construction better by the time I saw doctor. Monitored for about an hour and released. Weakness on and off for several days after. Followed up with primary care doctor and referred to an allergist. Waiting for appointment.

Other Meds: Yuvafem, D-mannose, fish oil, Allegra, Astragalus, Eyebright, Pepcid AC, vitamins

Current Illness: None

ID: 1017064
Sex: F
Age: 71
State: MI

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/09/2021
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: Stated fingers and palm were tingling/numb when she went to go home. Vitals taken, juice given, stable, decided she was ok to go home.

Other Meds:

Current Illness:

ID: 1017066
Sex: M
Age: 67
State: PA

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 02/09/2021
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: NONE

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

Symptoms: Patient called on Monday 2/8 complaining of flu like symptoms, Advised to take acetaminophen, drink plenty of fluids and rest. Called him back Tues 2/9 said he spoke to his nurse and was going to the hospital. Didn't describe symptoms before he hung up.

Other Meds: NONE THAT WE KNOW OF

Current Illness: NONE

ID: 1017068
Sex: F
Age: 30
State:

Vax Date: 02/05/2021
Onset Date: 02/07/2021
Rec V Date: 02/09/2021
Hospital:

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: 5 hours later after the 2nd dose of vaccine. I had aching pain at the injection site and throughout my left arm, radiating to my chest (like squeezing or feels heavy) as well as nausea. On Sunday morning around 330 am, I had bad chills and temperature of 100.5 and had taken Tylenol prior to having chills. Later in the day, I had severe headache and fatigue.

Other Meds:

Current Illness:

ID: 1017070
Sex: U
Age:
State: CA

Vax Date: 01/25/2013
Onset Date:
Rec V Date: 02/09/2021
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: pulmonary edema; congestive heart failure; Undifferentiated spondyloarthritis.; herpes zoster; post herpetic neuralgia; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 54-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided. On or about 25-JAN-2013, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to the patient vaccination, the patient presented multiple outbreaks of herpes zoster, post herpetic neuralgia, congestive heart failure, pulmonary edema and undifferentiated spondylarthritis. As a direct and proximate result, the patient had been treated by provider. At the reporting time, the outcome for all the events was unknown. The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX). Upon internal review the events of pulmonary edema and congestive heart failure were considered as medically significant.

Other Meds:

Current Illness:

ID: 1017071
Sex: F
Age: 33
State: VA

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

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

Lab Data:

Allergies: Flagyl

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

Symptoms: Patient was received her Covid vaccination in her right arm approximately 9:15am. With about 5 minutes she became shaky, sweaty, flushed, and stated she had a ?medication taste in mouth?. She had eaten breakfast, but was given a snack & juice. Nurse reported slightly elevated BP (exact numbers not given). Patient was taken to ER for care.

Other Meds: Unknown

Current Illness: Unknown

ID: 1017072
Sex: U
Age:
State: CA

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

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: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unspecified age and gender. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On an unspecified date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster, postherpetic neuralgia, encephalitis, right eye vision loss (blindness unilateral), headaches and balance issues (balance disorder). As a result of these symptoms, the pt was seen and treated by medical providers and is still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using this product. The pt sustained serious, severe, permanent, progressive and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, mental and emotional distress, loss of enjoyment of life, physical impairment and injury due to resulting physical limitations and seriousness of the condition. The pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered and causality was related to zoster vaccine live (ZOSTAVAX). The reporter considered the events to be disabling. Upon internal review, the pt's encephalitis and blindness unilateral were determined to be medically significant events.

Other Meds:

Current Illness:

ID: 1017073
Sex: F
Age: 62
State: AR

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 02/09/2021
Hospital:

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

Lab Data:

Allergies: none

Symptom List: Unevaluable event

Symptoms: Pfizer-BioNTech COVID-19 vaccine EUA---- 2/4/21 0430am woke up with numbness in left leg which progressed to entire left side of body. 02/05/21 03:30 PM presented to ER for evaluation of left side body numbness. Numerous test & blood work performed. D/C home with diagnosis of transient cerebral ischemia & instructed to follow up with neurologist.

Other Meds: Aspirin 81mg, Lipitor 40mg, Humalog 100u/ml sliding scale

Current Illness: none

ID: 1017074
Sex: M
Age: 87
State: TN

Vax Date: 01/02/2021
Onset Date: 01/06/2021
Rec V Date: 02/09/2021
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: Pneumonia on both lungs; A report was received from a consumer who was an 87 year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the serious adverse event pneumonia on both lungs. The patient's medical history was not provided. Concomitant medications reported included carvedilol, digoxin, furosemide, lisinopril, simvastatin, codeine phosphate hemihydrate/paracetamol, testosterone, acetylsalicylic acid, and multivitamins. On 02 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported receiving the first dose of Moderna Covid-19 vaccine on 02 Jan 2021. On 04 Jan 2021, he was having a very difficult time breathing. He went to the doctor on 06 Jan 2021 and found out he had pneumonia on both lungs and was positive for COVID-19. He was treated by the doctor. Treatment for the event included antibiotics, 1 week of steroids, and a bamlanivimab injection on 11 Jan 2021. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, pneumonia on both lungs, was unknown/not reported.; Reporter's Comments: This spontaneous report concerns an 87-year-old male patient serious adverse event pneumonia on both lungs. The event occurred 5 days after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: 025L20A, expiration date-unknown). Treatment administered included antibiotics, steroids and bamlanivimab injection, and outcome was unknown. Although a temporal association exist, there is not enough information to adequately assess the causal association between the reported event and mRNA-1273 vaccine administration. Critical details such as diagnostic test for COVID infection prior to vaccination was not established or ascertained. Causality is also confounded by the patient's advanced age. Main field defaults to ?possibly related'

Other Meds: CARVEDILOL; DIGOXIN; FUROSEMIDE; LISINOPRIL; SIMVASTATIN; ALTERMOL; TESTOSTERONE; ASPIRIN [ACETYLSALICYLIC ACID]; MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1017075
Sex: F
Age: 33
State: CA

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 02/09/2021
Hospital:

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

Lab Data:

Allergies: No known allergies

Symptom List: Injection site pain, Pain

Symptoms: Systemic: Other- patient had blueness in one hand, states she had problems breathing, and vomiting, epipen was given and paramedics were called, she was taken to the hospital, not believed to be anaphylaxis

Other Meds:

Current Illness:

ID: 1017076
Sex: F
Age: 25
State: NC

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/09/2021
Hospital: Y

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: Paralyzed on the right side down to her foot; Numbness in her hands and feet; Slurred speech; Felt really heavy in her face area, hurt really bad; Shooting pain; Feels tingly; Felt really heavy in her neck, hurt really bad; unable to walk; A spontaneous report was received from a consumer who was also a 25-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly, unable to walk and shooting pain feelings. The patient's medical history was not provided. Concomitant product use was not provided. On 21 Jan 2021, approximately two hours prior to the start of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. Approximately two hours after receiving the vaccine at 12:30 pm, the patient experienced heavy feeling in her neck and face area that hurt really bad. Later, she noticed numbness in her hands and feet. Slurred speech was reported from a bystander. By 3:30pm, the patient was completely paralyzed on her right side. She was taken to the hospital, and a code stroke was initiated; however, all labs were normal. On 26 Jan 2021, the patient was still paralyzed on her right side, unable to walk, had shooting pain feeling, and two fingers on her right hand were able to move but still felt tingly. The doctors planned to discharge her on the next day to a rehab center because she could not function alone. Treatment for the event included pain medication and hospitalization. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, developed heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly, unable to walk and shooting pain feelings were considered unknown.; Reporter's Comments: A spontaneous report concerns a 25-year-old, female, patient, who experienced heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly and shooting pain feelings. The events of heavy feeling in her neck and face area, numbness in her hands and feet, slurred speech, completely paralyzed on her right side occurred on the same day after the administration of the first dose of mRNA-1273 (Lot number 032L20A, expiration date unknown). The events of inability to walk, had shooting pain feeling and two fingers on her right hand were able to move but still felt tingly occurred the following day after the vaccine administration. Treatment included pain medication and outcome is unknown. Based on the information provided, which indicates a strong temporal association between the reported events and administration of mRNA-1273 vaccine (onset latency of 2 hours), a causal association cannot be excluded.

Other Meds:

Current Illness:

ID: 1017077
Sex: F
Age: 35
State: CO

Vax Date: 01/22/2021
Onset Date: 01/01/2021
Rec V Date: 02/09/2021
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: Severe arm rash the size of a baseball welt; Muscle pain; Had a fever for five days; Severe leukopenia; Could not walk; A spontaneous report was received from a pharmacist who was a 35-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe leukopenia, had a fever for five days, muscle pain, could not walk, and severe arm rash the size of a baseball welt. The patient's medical history was not provided. No concomitant medication use was reported. On 22 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date in Jan 2021, the patient's white blood cell count decreased which was considered severe leukopenia. Additionally, she experienced a fever for five days that would not decrease with paracetamol or ibuprofen, had muscle pain, and could not walk. On 25 Jan 2021, the patient had a severe arm rash the size of a baseball welt. Treatment for the arm rash included diphenhydramine. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events, severe leukopenia, had a fever for five days, muscle pain, could not walk, and severe arm rash the size of a baseball welt, was unknown.; Reporter's Comments: This case concerns a 35-years-old female patient, who experienced a serious unexpected event of leukopenia, a non-serious unexpected event of gait disturbance, rash and non-serious expected event of myalgia, and pyrexia. The event of rash occurred on day 4 after first dose of mRNA-1273, lot # unknown. Remaining events occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Laboratory tests revealed severe leukopenia (details not provided). Treatment included Tylenol, Ibuprofen and Benadryl. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1017078
Sex: F
Age: 49
State: TX

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 02/09/2021
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: clindamycin cream, erythromycin cream, lasis, latex, levaquin, morphine, penicillin, silicone, tramadol

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: full body itching

Other Meds: symbicort asthma puff, oneprazole, diazepam, multi vitamin, stool softener, hydrocodone 10mg, benefiber, restatis

Current Illness:

ID: 1017079
Sex: U
Age:
State: CA

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 02/09/2021
Hospital:

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: Fainted; Had a seizure; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted and had a seizure. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, after vaccine administration, the patient fainted and had a seizure. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, fainted and seizure, were unknown.; Reporter's Comments: This case concerns a patient, who experienced events of fainted and seizure. The events occurred the same day after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.

Other Meds:

Current Illness:

ID: 1017080
Sex: F
Age:
State:

Vax Date: 01/26/2021
Onset Date: 01/01/2021
Rec V Date: 02/09/2021
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: fainted; body aches; fever; Chills; A spontaneous report was received from a consumer who is a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fainting, body aches, fever and chills. The patient's medical history was not provided. Concomitant medications were not reported. On 26 Jan 2021, the patient received their second dose of two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient experienced body aches, fever and chills and she got up in the middle of the night and fainted. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events fainting, body aches, fever and chills, were considered not resolved.~; Reporter's Comments: This case concerns a female patient, who experienced events of fainting, body aches, fever and chills. The events occurred the same day after the second and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.

Other Meds:

Current Illness:

ID: 1017081
Sex: M
Age:
State:

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 02/09/2021
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: Difficulty breathing/ shortness of breath; Tested positive for COVID-19; Pain; Not feeling well / very sick; Vaccine is defective; Bad headache; Fever; A spontaneous report was received from a consumer concerning a 65-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced bad headache, pain, fever, not feeling well, difficulty breathing/ shortness of breath, and tested positive for COVID-19. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 14 Jan 2021, approximately two to three days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 04L20) intramuscularly for COVID-19 infection. On unknown date, the patient experienced a bad headache, pain, fever and was still not feeling well. Patient went to emergency room and had difficulty breathing, shortness of breath and ended up receiving an infusion of casirivimab imdevimab. Patient tested positive for COVID-19 as well. Treatment for the event included casirivimab/ imdevimab. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, bad headache, pain, fever, not feeling well, difficulty breathing/ shortness of breath, and tested positive for COVID-19, was unknown.; Reporter's Comments: A spontaneous report concerns a 65-years-old, male patient who experienced the unexpected serious event difficulty breathing/ shortness of breath bad and non-serious events of headache, pain, fever, not feeling well and tested positive for COVID-19. The events occurred approximately two to three days after administration of mRNA-1273 vaccine (Lot number 04L20). Treatment provided included casirivimab/imdevimab and outcome of the events is unknown. Based on the known information about COVID and duration to diagnosis, it is very unlikely to be associated with the vaccine administration. The other events are temporally associated with the administration of mRNA-1273, a causal relationship cannot be excluded. Headache and fever are consistent with the known safety profile of the vaccine

Other Meds:

Current Illness:

ID: 1017083
Sex: M
Age: 71
State:

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Pneumonia; coughing up blood; A spontaneous report was received from a consumer who was also a 71-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pneumonia and coughing up blood. The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported. On 19 Jan 2021, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient began to cough up blood and was seen and treated by a healthcare professional. A chest x-ray was done and revealed pneumonia. Treatment for the event included doxycycline, prednisone and an inhaler. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, pneumonia and coughing up blood, were unknown.; Reporter's Comments: This case concerns a 71-year-old male subject, who experienced a serious unexpected event of Pneumonia, and non-serious unexpected event of Hemoptysis. The events occurred one day after the first dose of the mRNA-1273 administration. Treatment for the event included doxycycline, prednisone and an inhaler. Since Pneumonia has insidious onset rather than acute onset, the event was possibly related to underlying condition confounded by elderly age of patient. Very limited information regarding these events have been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event of Pneumonia and Hemoptysis, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1017084
Sex: F
Age: 50
State: NY

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/09/2021
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 induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Moderna COVID-19 Vaccine EUA Fever starting night of shot lasting 4 days fever as high as 103.2 Chills, fatigue,body aches, sores in mouth and one outside of bottom lip, ringing in ears Felt just like I had Covid-19 all over again!!!!! Called Doctor and was told I was probably having a allergic reaction to the shot and should feel better in a couple days. It took 4. Also asked if I should get the 2nd shot and was told yes, and I probably would have adverse side effects from that one as well. I am supposed to receive that on March 4th 2021. I cant wait LOL

Other Meds:

Current Illness:

ID: 1017085
Sex: F
Age: 40
State: AZ

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 02/09/2021
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: Latex - Contact Septra - Nausea Vomiting Lactose intolerant

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

Symptoms: Client was observed for 15 min. after vaccination with no issues and left Clinic. Client returned to Clinic approx. 5 min. later. She complained of feeling her lips swollen and a little tingling. Client observed in Clinic. Benadryl 50 mg was given. Vitals remained stable. Client reported no tingling to lips and less swollen 1/2 hour after Benadryl. Client remained in Clinic for 1 hr. and 40 min. after Benadryl given as she was waiting for husband to pick her up. Upon leaving Clinic Client stated felt better, Lips feeling normal.

Other Meds: N/A

Current Illness: None

ID: 1017086
Sex: F
Age: 41
State: NC

Vax Date: 01/28/2021
Onset Date: 02/08/2021
Rec V Date: 02/09/2021
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 known

Symptom List: Tremor

Symptoms: Trigeminal neuralgia - ongoing for last two days

Other Meds: Adderall, Lysine, birth control

Current Illness: None

ID: 1017087
Sex: F
Age:
State: TN

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/09/2021
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: lips became numb; throat started to sound very scratchy and itchy; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 22Jan2021 at 16:15 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, hypertension, morbid obesity, anemia, arthritis, allergic to fish (shell & fin) and all nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, but it was reported that the patient took other medications within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 22Jan2021, at 16:15 (also reported as after 15 minutes), the patient's lips became numb and the throat started to sound very scratchy and itchy. This resulted in a doctor or other healthcare professional visit. Treatment for the events included the patient taking her own diphenhydramine (BENADRYL), epinephrine (EPIPEN) and albuterol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of lips became numb and the throat started to sound very scratchy and itchy was resolved with sequel on Jan2021. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1017088
Sex: F
Age: 41
State: ID

Vax Date: 01/12/2021
Onset Date: 01/27/2021
Rec V Date: 02/09/2021
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: None

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

Symptoms: Developed a large hive around the injection site 2 weeks after the first dose

Other Meds: Bupropion XL 150 Vitamin D3 5,000

Current Illness: None

ID: 1017089
Sex: M
Age:
State: NY

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/09/2021
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: walking is still very bad; lower back pain; he reported lower back pain, that has migrated more to the right hip and into the glute; he reported lower back pain, that has migrated more to the right hip and into the glute; it might be kidney pain; arm pain; This is a spontaneous report from a contactable other Health Professional (HCP). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3302), intramuscular on 22Jan2021 15:10 at 0.3 mL, single (0.3ml by intramuscular injection left shoulder) for COVID-19 prophylaxis. Medical history included ongoing high blood pressure (diagnosed about 21 years ago), ongoing gout (Diagnosed about 2 years ag), ongoing ankle spur right foot, ongoing diminished cartilage both knees, joint pain. The concomitant medications included torsemide. The patient reported adverse event (AE) after his first Pfizer-Biontech covid19 vaccine at 15:10 on 22Jan2021. He reported arm pain starting 3 hours after vaccination until noon the next day (23Jan2021). When he woke up on 23Jan2021 he reported lower back pain, that has migrated more to the right hip and into the glute. The pain inhibits walking, standing, etc. He did note that he is >300lbs and has had joint pain in the past, but the hip pain is new. He also thought it might be kidney pain, as he takes a daily diuretic. He stated he has been treating with Aleve twice a day, but that walking is still very bad. The patient is an optometrist that was calling about the Covid-19 vaccine and said that he did not know if the Lot number written on the vaccination card is EL3302, E13302, or EI3302. He got the vaccine on 22Jan2021 and reported that he got a sore arm about 3 hours after receiving the injection. He woke up with a sore lower back pain. He is 5ft 9.5 and 310 lbs and he is on Torsemide, a pretty strong diuretic. He woke up with the back pain and stated that it moved right and middle to his buttocks, a little lower than the end of his spine and to the right. He did not think it was his kidneys. He said that Torsemide can make kidneys work overtime. His knees were pretty shot, the left worse than the right. No further details provided. He was upset to know that he has shrunk a 1.5 inches over the years. He has been taking 2 Aleve a day since Saturday, this morning was his 4th pill. He said that it is really odd when he stands equally on both feet his lower back hurts. He has to sleep on his right side and that it hurts more when he sleeps on his back and on his left side. He was fearful doing eye exams next to his patient and how the lower back pain would affect him. Reporter considered seriousness for Lower back pain was Medically significant. The outcome of event lower back pain was not recovered; of event arm pain was recovered on 23Jan2021; of other events was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect vaccine BNT162B2 to the event low back pain cannot be excluded. The ongoing gout and concomitant drug torsemide may also play contributory roles to the event. 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: TORSEMIDE

Current Illness: Blood pressure high (diagnosed about 21 years ago); Cartilage damage (Diminished cartilage both knees); Gout (Diagnosed about 2 years ago); Heel spur syndrome (Ankle spur right foot)

ID: 1017090
Sex: F
Age: 24
State: VA

Vax Date: 01/21/2021
Onset Date: 02/01/2021
Rec V Date: 02/09/2021
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: penicillin, omnisef, cinnamon, avocados, celery, lettuce, mold

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: started with headache and sore throat, then high fever (103) a few hours after first symptoms. body aches, chills and vomiting.

Other Meds: Zyrtec, lo loestrin fe

Current Illness:

ID: 1017091
Sex: M
Age:
State: FL

Vax Date: 01/22/2021
Onset Date: 01/24/2021
Rec V Date: 02/09/2021
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:

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

Symptoms: severe shaking convulsive; chills; nausea; leg cramps; difficulty breathing; vomitting; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received single dose of BNT162B2 (PFIZER, Solution for injection, batch/lot number and exp date not reported ), via an unspecified route of administration (vaccine location: left arm) on 22Jan2021 10:45 for COVID-19 immunization. Medical history included diabetes and high cholesterol. The patient did not have Covid prior vaccination. The patient had no known allergies. Concomitant medication/other medications within two weeks included rosuvastatin calcium (CRESTOR), telmisartan, empagliflozin, metformin hydrochloride (SYNJARDY), and atenolol. There was no other vaccine within four weeks. On 24Jan2021 02:00, the patient experienced severe shaking convulsive, chills, nausea, leg cramps, difficulty breathing, and vomiting. No treatment was received for the events. The patient was not Covid tested post vaccination. The patient recovered from the events on an unspecified date in Jan2021. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.

Other Meds: TELMISARTAN; SYNJARDY; ATENOLOL; CRESTOR

Current Illness:

ID: 1017092
Sex: F
Age:
State: GA

Vax Date: 01/09/2021
Onset Date: 01/11/2021
Rec V Date: 02/09/2021
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:

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

Symptoms: little depressed; not feeling like herself; weak; tired; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140 and expiry date unknown), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient received the first dose on the left arm on 19Dec2020 10:30 (lot number: EL0140). Medical history included hypertension. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no side effects after the first vaccine except for a little tenderness which went away. On 11Jan2021, after receiving the second dose, she felt really tired but which went away. On 20Jan2021 (last Wednesday), she started to feel tired, weak, and not feeling like herself. On 22Jan2021, the patient was a little depressed. She did not have a headache. Her blood pressure was fine and she never had a fever. She had an X-ray back in Sep2020. Her vision is good. She is not hurting anywhere. She doesn't feel as strong. She doesn't understand the tiredness, weakness, and depression. Outcome of the event tired was recovered on 11Jan2021, of the events doesn't feel like herself and weak was not recovered, and of the event depression was recovering. The reporter assessed all the events as related to the bnt162b2. The events depression and doesn't feel like herself were reported as serious: medically significant while the other events were reported as non-serious.; Sender's Comments: A possible contributory role of bnt162b2 in triggering the onset depression and doesn't feel like herself cannot be excluded, considering the plausible temporal relationship. 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:

Current Illness:

ID: 1017093
Sex: F
Age:
State: WV

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 02/09/2021
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: swollen eyes; a rash on her forehead , around her eyes and both cheeks; very itchy eyes; This is a spontaneous report from a contactable Nurse (patient's mother). A 22-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 06Jan2021 17:30 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Nurse stated her daughter received her first Pfizer vaccine on 06Jan2021 around 5:30 pm. The patient's signs and symptoms began shortly after receiving the shot. That evening at 19:00, she had very itchy eyes, the next morning (07Jan2021) she woke up with swollen eyes, a rash on her forehead, around her eyes and both cheeks. She took benedryl and zyrtec on 07Jan2021. The symptoms clear up by 10Jan2021, following a visit to her HCP, on 08Jan2021. She received a steroid shot, a prednisone dose pack her HCP. Her HCP recommended she not take dose 2 and instructed her mother to call Pfizer for recommendations. The outcome of the events was recovered on 10Jan2021. The reporting nurse considered the case as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: The reported events of swollen eyes, itching eyes and rash on face were likely related to first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), due to plausible temporal relationship. 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:

Current Illness:

ID: 1017094
Sex: F
Age: 38
State: MD

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

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

Lab Data:

Allergies: Iodine Midodrine

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

Symptoms: patient became sweaty and flushed

Other Meds:

Current Illness:

ID: 1017095
Sex: F
Age:
State: OR

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/09/2021
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: tingling with pins and needles feeling all through arms, legs, face; nausea; dizziness sight; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on the left arm on 21Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included "Celtics disease", allergies to gluten and negative COVID-19 test nasal swab on 10Oct2020. Concomitant medication included birth control and prenatal vitamin. Patient did not have COVID prior to vaccination and was not pregnant. Vaccination was received in the hospital and no other vaccine was received four weeks prior. On 21Jan2021 16:00, the patient reported nausea, dizziness sight and chills were normal then she had tingling with pins and needles feeling all through arms, legs, face. She still had prickling feeling in arms and her left foot was tingling and it had been four days later. The adverse events pins and needles reportedly resulted in disability or permanent damage. Patient has been tested for COVID post-vaccination on an unspecified date with unknown results. Treatment was received for the events. Outcome of the events was not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of prickling feeling in arms and her left foot tingling cannot be excluded, considering the plausible temporal relationship. 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:

Current Illness:

ID: 1017096
Sex: F
Age:
State: CA

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/09/2021
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: pain in my chest/stomach; pain in my chest/stomach; she couldn't sleep last night at all she was awake all night; had strange visions flashing in my head while trying to sleep; acid reflux/burping up acid; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: TL9261, expiration date not provided), via an unspecified route of administration on 25Jan2021 16:30 at a single dose for COVID-19 immunization. The patient has no medical history and there were no concomitant medications. On 25Jan2021, the patient experienced having acid reflux, pain in her chest/stomach that lasted all night last night and was worse when lying down. When she burped, it relieved some pressure. She had strange visions flashing in her head while trying to sleep on 25Jan2021. The patient was wondering if she was having a reaction from the vaccine. On 25Jan2021, after over an hour after the vaccine, she started having severe pain in the chest and stomach area and she couldn't sleep last night at all. She was awake all night, burping up acid. She was wondering if those were reaction to the vaccine, should she go see her doctor or what should she do about that. She got her first dose on 25Jan2021 and she started having chest and stomach pain the same day at about 6 PM. She was burping acid all night and early in the morning of 26Jan2021 and she was having these strange things like pictures going to her head that were weird. She was not sleeping but they were strange images, they were strange, they weren't normal. She says with that added in it sounds crazy. She has her vaccine card that says she should get the next one 15Feb2021. She wanted to avoid catching the corona. She had drank acid yesterday and she was wondering if that was causing her to have acid reflux. She clarified that she drank a lot of acidic liquids on 25Jan2021 and she was wondering if that might have had something to do with it, like orange juice and cranberry juice so she is wondering did that have anything to do with it, the acidity maybe made her stomach have acid reflux because she has had that in the past. She asked if she should go to the doctor. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1017097
Sex: F
Age: 53
State: IN

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/09/2021
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: None

Symptom List: Vomiting

Symptoms: Very sore and swollen upper left arm I could barely raise my arm half way up for two days. There was stiffness in the back of my neck,. I also had a headache, runny nose and was very tired and sleepy the next day. Additionally, I could taste the vaccine which was coming from the back of my throat and my menstrual cycle started one day late.

Other Meds: Vitamin C, Eldeberry, liquid zinc, Olive leaf, Sea Moss Gel, Alive Multivitamins, 5 mgs of blood pressure medicine.

Current Illness: None

ID: 1017098
Sex: M
Age:
State: FL

Vax Date: 01/23/2021
Onset Date: 01/24/2021
Rec V Date: 02/09/2021
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: Edema of glottis; General malaise / indisposition; nausea; dizziness; body pain; pain in the joints; swelling of the throat; high pressure; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: El9263) solution for injection, via an unspecified route of administration in left arm on 23Jan2021 09:15 at a single dose for Covid-19 immunization. Medical history included high blood pressure, and diabetes. Concomitant medications included losartan, metformin, and simvastatin. The patient experienced edema of glottis, general malaise, nausea, dizziness, body pain, pain in the joints, indisposition, swelling of the throat, and high pressure; all on 24Jan2021 21:00. Patient visited the physician and received treatment for the adverse events (general examination). The patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 since the vaccination. Outcome of the events was recovering. No follow-up activities are needed. Information regarding the batch/lot number has been obtained. No further information is expected.

Other Meds: LOSARTAN; METFORMIN; SIMVASTATIN

Current Illness:

ID: 1017099
Sex: M
Age:
State: IL

Vax Date: 01/05/2021
Onset Date: 01/07/2021
Rec V Date: 02/09/2021
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: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Diplopia due to left 6th (abducen) cranial nerve palsy; Diplopia due to left 6th (abducen) cranial nerve palsy; This is a spontaneous report from a contactable physician. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), intramuscular, in the left arm, on 05Jan2021 07:30 at a single dose for covid-19 immunization. Medical history included type 2 diabetes. Concomitant medications were unspecified. The patient took unspecified medications in two weeks. The patient did not have any other vaccine in four weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. The patient had no known allergies. On 07Jan2021, the patient experienced diplopia due to left 6th (abducen) cranial nerve palsy. The event resulted in doctor office/clinic visit, and emergency room visit. Therapeutic measure was taken as a result of the event which included fresnel prism on current glasses to alleviate diplopia. Outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported diplopia due to left 6th (abducen) cranial nerve palsy and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. 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 RA, IEC, as appropriate.

Other Meds:

Current Illness:

ID: 1017100
Sex: F
Age: 72
State: MO

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/09/2021
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: none

Symptom List: Injection site swelling, Limb discomfort

Symptoms: 02/04 - chills and headache all day; 02/05 - headache, fatigue, nausea; 02/06 - headache (partial day), nausea (am); fatigue all day; 02/07 - minor fatigue most of day

Other Meds: carvedilol 6.25 mg; cetirizine 10 mg; furosemide 40mg; lisinopril 5mg; mirabegron 25mg; multivitamin; spironolactone 25mg; vitamin D3; zinc; vitamin C.

Current Illness: none

ID: 1017101
Sex: F
Age:
State: GA

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/09/2021
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: Tip of tongue feels slightly enlarged; Salty taste in mouth; Tingle sensation on tip tongue; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3302), via an unspecified route of administration on 22Jan2021 08:00 at single dose on the right arm for COVID-19 immunization. Medical history included high blood pressure and COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications included amlodipine and ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) received within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 12:00, the patient experienced salty taste in mouth for over 2days. Tingle sensation on tip tongue. Tip of tongue feels slightly enlarged. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No treatment received for the adverse event. Outcome of the events was not recovered.

Other Meds: AMLODIPINE; LO LOESTRIN FE

Current Illness:

ID: 1017102
Sex: M
Age:
State: FL

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 02/09/2021
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:

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

Symptoms: eye infection; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (wife) reported that a male patient of an unspecified age received the first dose of bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller reported that her husband received the 1st dose of the Pfizer vaccine 2 weeks ago (Jan2021) and he had an eye infection unrelated to the vaccine. Caller was asking if he can take antibiotics and asking if that would be contraindicated with the vaccine that he got. Caller also mentioned that her husband was afraid to take antibiotics and wanted to know if it was okay to take antibiotics which was prescribed by his Doctor. Her husband was also an healthcare professional but he was an Orthopedic Surgeon and it's not his field. The reported wanted to know if that would reduce the immunity that he got from the vaccine. The patient developed the eye infection a week ago (Jan2021). He had not taken the antibiotic before. Second dose would be on 01Feb2021. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The eye infection is most likely an intercurrent condition and unrelated to suspect vaccine BNT162B2.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm