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: 1113708
Sex: F
Age: 58
State: GA

Vax Date: 03/17/2021
Onset Date: 03/18/2021
Rec V Date: 03/19/2021
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: OxyContin, Bandaids adhesive

Symptom List: Dysphagia, Epiglottitis

Symptoms: The next day after vaccine chills, vomiting and swollen lymph nodes of left armpit

Other Meds: Armour thyroid,Potassium,Trazodone,,Bupropion,Amlodpine,Benazepril,Hydrochlorothiazide,Omega3,Zinc,Women one day vitamin,Vitamin Collagen,Probiotic for women,Vitamin D3

Current Illness: Hypertension, Hypothyroidism, Hypokalemia

ID: 1113709
Sex: F
Age: 37
State:

Vax Date: 02/10/2021
Onset Date: 02/16/2021
Rec V Date: 03/19/2021
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: 6 days after felt light flu like symptom. On day 7 my armpit hit and I couldn?t lift my arm past my shoulder without pain. My armpit still hurts today when I workout and when I press under my armpit. The pain to lift my arm only lasted 24 hours and day 7 was also the day I felt the most exhausted.

Other Meds: None

Current Illness: None

ID: 1113710
Sex: F
Age: 26
State:

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 03/19/2021
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: Pain/slight swelling on the left eye later that night of the injection.

Other Meds: None

Current Illness: None

ID: 1113711
Sex: F
Age: 62
State: OK

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 03/19/2021
Hospital:

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

Lab Data:

Allergies: Cortisones Codeine Sulfa Drugs Illosone Azelastine Detergents Iceberg lettuce Beef Milk

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: First DaY immediately after the shot: Strong itching around mouth; 40 minutes later: runny nose; strong sense of back of throat and esophagus burning; sensation in lungs like...pulsing slight burn--If you can imagines a sparkler (yep, the kind from the 4th of July) being in your lungs that is only a little painful, more like a wiggle, than a painful sensation, that would describe it. 2nd day: really tired by 4PM, feeling feverish. Very tired . Tired enough that I accidentally left the house for a job interview wearing one white sock and one black sock. Which isn't normal for me. 3rd day: muscle aches. 4th days feels like a really mild virus. This is not me but another person from my former job said she had spontaneous canker sores from the Pfizer shot.

Other Meds: None

Current Illness: None

Date Died: 03/17/2021

ID: 1113713
Sex: F
Age: 84
State: FL

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 03/19/2021
Hospital: Y

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

Symptoms: My mother called me when she was going to get her second vaccination. She was alive and well and living independently at her home. She could walk, talk, make her own food, wash and dry her own clothes and take her own baths. After taking the second vaccination she went down hill. She became sicker and sicker and eventually she started coughing up blood. She decided to go to the hospital, another Hospital of facility. I don't know what the treatment was at that hospital but she was soon transferred to facility and that is where I was notified she was in the hospital and visited her there. After arriving they intubated her and said she had blood clots in her brain and heart. When I saw her after she transferred from Hospital to the Hospital I noticed one arm was swollen. Her legs were as they have been for the last 20 years and looked okay to me--no discoloration other than her regular discoloring at one right ankle and the same old same old slight swelling in the left ankle. The doctors and nurses were putting the blame on her legs but you could tell things were happening else where. But as she got worse and worse at the hospital her right arm become more and more swollen with dark bruises appearing--the hospital staff took pictures. The left arm continued to swell and did not look normal at all. She apparently had bleeding in her left lung from a blood clot. She had three areas of her brain that add clots and some bleeding. She was constipated and gaseous when they cleaned her. They didn't treat her constipation which made being intubated worse because I feel that caused her intestines to swell, thus she also had bleeding in her intestines. My mother died on March 17, 2021 at hospital in ICU. I was told they could not treat the blood clots because of the bleeding in her lung, intestines and brain.

Other Meds:

Current Illness:

ID: 1113714
Sex: F
Age: 40
State: IL

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 03/19/2021
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: Shellfish

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

Symptoms: Facial swelling in area of filler

Other Meds: Brio, pro air in hailer

Current Illness:

ID: 1113715
Sex: M
Age: 42
State: PA

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 03/19/2021
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: NONE

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: PATIENT WAS AT AT COVID-19 VACCINATION OFFSITE EVENT ON 3/18/2021 TO RECEIVE SECOND DOSE OF COVID VACCINE. PATIENT WAS SCREENED BY PHARMACIST VIA VACCINE AGENCY AND INFORMED CONSENT FORM FOR ACCURACY. PATIENT RECEIVED FIRST DOSE OF VACCINE WITH NO ISSUES, BUT HAD AN OUTBREAK OF HIVES 20 MINUTES AFTER THE SECOND DOSE ADMINISTRATION. PATIENT WAS ATTENDED TO BY PROVIDERS WHO WERE ONSITE AND ADMINISTERED 50MG OF DIPHENHYDRAMINE LIQUID, AND WITHIN 20-25 MINUTES OF ADMINISTRATION OF DIPHENHYDRAMINE THE HIVES WENT DOWN. FOLLOW UP CALL WAS MADE BY PPROVIDER 810PM ON 3/18/2021, TO MAKE SURE PATIENT WAS DOING WELL, WHICH HE STATED EVERYTHING WAS FINE AND REACTION STOPPED COMPLETELY.

Other Meds:

Current Illness:

ID: 1113716
Sex: F
Age: 29
State: CA

Vax Date: 03/10/2021
Onset Date: 03/17/2021
Rec V Date: 03/19/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Pharyngeal swelling

Symptoms: Redness, swelling and itchiness at injection site.

Other Meds: None

Current Illness: None

ID: 1113717
Sex: F
Age: 23
State: OH

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 03/19/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: Major tenderness in arm. Cant raise arm without feeling really tight

Other Meds:

Current Illness:

ID: 1113718
Sex: F
Age: 53
State: WI

Vax Date: 03/10/2021
Onset Date: 03/11/2021
Rec V Date: 03/19/2021
Hospital:

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

Lab Data:

Allergies: Amoxicillin. Sensitivity to niacin vit B3

Symptom List: Diarrhoea, Nasal congestion

Symptoms: In First 24 hours itching swelling redness upper arm around injection site with superficial loss of feeling outside arm. Area. Approx 5? in diameter. No weakness. Concerned about second vaccine and a worse reaction if condition has not resolved by that time.

Other Meds: Vitamin D. Multi vitamin

Current Illness:

ID: 1113719
Sex: F
Age: 34
State: DE

Vax Date: 03/11/2021
Onset Date: 03/19/2021
Rec V Date: 03/19/2021
Hospital:

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

Lab Data:

Allergies: Gluten

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

Symptoms: Red itchy rash at injection site, with lump at injection point.

Other Meds: Prozac, 30mg Vitamin D Allergy medication

Current Illness: N/a

ID: 1113720
Sex: M
Age: 38
State: OK

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 03/19/2021
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: ?Pfizer-BioNTech COVID-19 Vaccine EUA? Injection site pain Muscle pain Chills Joint pain Fever

Other Meds: None

Current Illness: None

ID: 1113722
Sex: F
Age: 27
State:

Vax Date: 03/13/2021
Onset Date: 03/13/2021
Rec V Date: 03/19/2021
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: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Nausea , fatigue, weakness, headache , back and Neck pain, pressure behind eyes, headache, fever, intermittent hot then chills, rapid heart rate 110s, and shortness of breath at rest & w/ exertion. Vaccine @ 9:00am 3/13 ?> symptoms progressing at 4:00pm and lasting until next day 3/14 3:00pm

Other Meds: - Wellbutrin XL - Junel FE ( birth control)

Current Illness: None

ID: 1113723
Sex: F
Age: 26
State: AZ

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 03/19/2021
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: Vancomycin

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

Symptoms: 30 minutes after leaving the site, got a mild reaction where my face got tingly and red but then it subsided but then 4 hours after receiving the vaccine I began getting a low grade fever (100.6) by 5pm that same day, I began having flu like symptoms, body aches, headaches, fatigued, chills, sweating and fever had risen to 101.7. Took ibuprofen to help with the symptoms but fever kept rising. By 8pm., fever was at 102.9, headache worsen, sweats throughout the night and felt dizzy. Next morning 3/18, fever was low grade by 7am (100.4) by 9AM, fever was gone, felt tired, with mild body aches and moderate headache and felt exhausted the rest of the day. Symptoms are getting better with rest.

Other Meds: None

Current Illness: None

ID: 1113724
Sex: F
Age: 47
State: OH

Vax Date: 02/26/2021
Onset Date: 03/19/2021
Rec V Date: 03/19/2021
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: sulfa, pcn, narcotics, levoquin, gluten, jaurdiance

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

Symptoms: swelling of tongue, metallic taste in mouth, instant frontal lobe headache and rash that appeared on my back 48 hours later- I took a benedryl and had my husband monitor me. I was watched for 30 minutes at the site with my symptoms being manageable there and they got worse within the hour. I am allergic to sulfa with mild reactions to it in small doses. The tongue swelling, headache and metallic taste in my mouth were gone in 12 hours.

Other Meds: lisinopril, armour thyroid, omprezil

Current Illness: none

ID: 1113725
Sex: M
Age: 60
State: FL

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 03/19/2021
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: n/a

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

Symptoms: Patient felt nausea and started dry heaving. He was sweating profusely and had tremors. BP 140/60, HR54, O2 sat 98. He stated that he had not had a meal today and it could be his sugar. His glucose was evaluated and was normal. Pt. was taken to NWMC and was accompanied by his wife.

Other Meds: Aspirin, Statin, Lisinapril

Current Illness: n/a

ID: 1113869
Sex: F
Age:
State: PR

Vax Date: 01/13/2021
Onset Date: 01/18/2021
Rec V Date: 03/19/2021
Hospital: Y

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: Cerebrovascular Hemorrhage (Stroke), left occipital zone; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK4176) at single dose, in the left arm, on 13Jan2021, at 15:00, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. Relevant medical history included Sulfa allergy (Sulfonamide allergy) and drug hypersensitivity due to pethidine hydrochloride (DEMEROL) was reported as past drug event. On 03Feb2021, received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN5318) at single dose, in the left arm, for COVID-19 immunisation. Concomitant medications included levothyroxine sodium (SYNTHROID) and estrogens conjugated, medroxyprogesterone acetate (PREMPRO). On 18Jan2021, at 12:30 PM, the patient experienced cerebrovascular hemorrhage (stroke), left occipital zone. Hospitalization and treatment (stroke Center ICU care) were required (duration of hospitalization 4 days). Clinical outcome of the adverse event was recovering at time of this report. Post the vaccination, the patient has been tested for COVID-19 (Nasal Swab) on 18Jan2021 and resulted negative.

Other Meds: SYNTHROID; PREMPRO

Current Illness:

ID: 1113909
Sex: U
Age:
State: GA

Vax Date: 11/11/2015
Onset Date:
Rec V Date: 03/19/2021
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: stroke events; demyelinating disease of the central nervous system; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 11-NOV-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route, and lot # not provided). Shortly after receiving zoster vaccine live (ZOSTAVAX) the patient suffered dizziness, nausea, vomiting, vertigo, facial weakness/numbness, sensorineural hearing loss and memory loss, and was diagnosed with multiple stroke events and demyelinating disease of the central nervous system. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, symptoms had resulted in physical limitations not present prior to using the product. Further, as a tragic consequence, the patient suffered 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. The outcome of the events was not recovered. Causality assessment was related. The reporter considered stroke events and demyelinating disease of the central nervous system to be disabling events. Upon internal review stroke events and demyelinating disease of the central nervous system were detemined to be medically significant events.

Other Meds:

Current Illness:

ID: 1113915
Sex: F
Age: 77
State: LA

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 03/19/2021
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: A-fib; difficulty breathing; sleeping on and off; dry heaving, feeling nauseated, not hungry; weak; chills; mild headache; Tired/fatigue; muscle pain on the arm; joint pain; Feeling nauseated; A spontaneous report was received from a consumer concerning a 77-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain. The patient's medical history, as provided by the reporter, included prior COVID-19 infection. It is not clear if the patient had prior A-Fib. No relevant concomitant medications were reported. On 25-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On 25-Jan-2021, patient was feeling fine right after first dose of the Moderna vaccine. On 26-Jan-2021, the patient felt difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain. Lab details was not provided by the reporter. Treatment for the events included rubbing gel. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tired, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1113916
Sex: M
Age: 85
State: NY

Vax Date: 02/01/2021
Onset Date: 02/27/2021
Rec V Date: 03/19/2021
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: ACUTE LIVER FAILURE; Hepatic enzymes increased; A spontaneous report was received from a health care professional concerning a 85-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed Acute liver failure and hepatic enzymes increased The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported. On unknown date in Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot unknown) intramuscularly for prophylaxis of COVID-19 infection. On 27 Feb 2021, the patient was hospitalized for 2-3 days (approximate date of admission on 27 February 2021 and date of discharge on 1 March 2021) . Reason for hospitalization is secondary to acute liver dysfunction with laboratory evidence of elevated liver enzymes. Treatment for the event was not reported. Action taken with mRNA-1273 in response to the event was not applicable The outcome of the event's, reported were considered unknown. .; 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: 1113917
Sex: F
Age: 87
State: FL

Vax Date: 01/13/2021
Onset Date: 02/25/2021
Rec V Date: 03/19/2021
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: throat closure three weeks after second dose; has lost the ability to swallow.; hernia; A spontaneous report was received from a consumer concerning an 88-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat closure three weeks after second dose/obstruction, hernia, and lost ability to swallow/dyphagia. The patient's medical history included an aortic valve replacement. Concomitant medications were not provided by the reporter. On 13 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 01120A) intramuscularly for prophylaxis of COVID-19 infection. On 10 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection On an unknown date, the patient had lost the ability to swallow. Patient was taken to the ER and ER doctors thought it was a hernia and suggested a surgery. This was three weeks post dose of the vaccine. The reporter reported that the patient was taken to the hospital on 4 Mar 2021. The doctor diagnosed hernia, but they didn't explain the throat closing. They told him to take the patient to a GI doctor. The GI didn't think it was necessary to do a surgery and scheduled a colonoscopy. The reporter disagreed with the colonoscopy because it didn't address the throat swelling. The hospital had put the patient on IV fluids but didn't have a lot of answers. On 8 Mar 2021, the hospital prescribed antibiotics and speech therapy. Treatment activities reported by the reporter included IV fluids, antibiotics, and speech therapy . Action taken with mRNA-1273 in response to the events was not applicable. The outcome of events, obstruction, hernia, and dysphagia were considered unknown.; Reporter's Comments: The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.

Other Meds:

Current Illness:

ID: 1113918
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 03/19/2021
Hospital: Y

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: Hiatal hernia; Doesn't have the ability to swallow; A spontaneous report was received from a consumer concerning a 87-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced that doesn't have the ability to swallow (dysphagia) and hiatal hernia. . The patient's medical history was not provided. Concomitant medications was not reported. On an undisclosed date, approximately three weeks prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On an undisclosed date approximately three weeks after receiving mRNA-1273, the patient did not have the ability to swallow. Her doctors blamed hiatal hernia. The patient was hospitalized. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable because the patient received her second dose. The outcome of events was unknown.; Reporter's Comments: The events were consistent with anatomical anomaly of gastrointestinal tract. Company assessed the events to be unlikely related to company product.

Other Meds:

Current Illness:

ID: 1113919
Sex: F
Age:
State: PA

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 03/19/2021
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: Fever; Muscle ache; Fatigue; Lymph node in left armpit swollen to the size of a small; laryngitus; lips are also now swollen; earache; lingering cold symptoms/feels like a head cold; sore throat; slight cough; tongue significantly swollen; Less than 19 days between dose 1 and dose 2; Less than 19 days between dose 1 and dose 2; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself. A 52-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation . Medical history included psoriasis , blood cholesterol increased . Concomitant medication(s) included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced hypersensitivity and swollen tongue. The patient received the first dose of bnt162b2 vaccine on 04Feb2021. The patient experienced tongue significantly swollen on 23Feb2021 07:00 with outcome of recovering , fever on 23Feb2021 07:00 with outcome of recovering , muscle ache on 23Feb2021 07:00 with outcome of recovering , fatigue on 23Feb2021 07:00 with outcome of recovering , lymph node in left armpit swollen to the size of a small grapefruit on 23Feb2021 07:00 with outcome of recovering , laryngitus on 23Feb2021 07:00 with outcome of recovering , lips are also now swollen on 23Feb2021 07:00 with outcome of recovering , feels like a head cold on 23Feb2021 07:00 with outcome of recovering , earache on 23Feb2021 07:00 with outcome of recovering , lingering cold symptoms on 23Feb2021 07:00 with outcome of recovering , sore throat on 23Feb2021 07:00 with outcome of recovering , slight cough on 23Feb2021 07:00 with outcome of recovering. Swollen tongue was considered an Important Medical Event. The patient received the second dose 18 days after the first dose and this is considered an off label use. Follow up information has been requested.

Other Meds: CITALOPRAM; ATORVASTATIN; VITAMIN D [ERGOCALCIFEROL]; PROBIOTICS

Current Illness:

ID: 1113920
Sex: F
Age:
State: PA

Vax Date: 02/09/2021
Onset Date:
Rec V Date: 03/19/2021
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:

Symptom List: Injection site pain, Pain

Symptoms: positive COVID-19 test with no symptoms; Asymptomatic COVID-19; Eventually develop arrhythmia; valley fever; chills; night sweats for 1 and half week; rash looked like confetti; low grade temp; I had an irritation in my upper nose; Platelet count was found to be 90/platelet count dropped corrected with in one week; This is a spontaneous report from a contactable consumer, the patient A 83-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on 09Feb2021 (at the age of 83-years-old) as a single dose, for COVID-19 vaccination. The patient medical history includes Atrial Fibrillation. Concomitant medication include Eliquis, Synthroid, Pravastatin, Diltiazem and Dofetilide The patient experienced arrhythmia, valley fever, chills , night sweats, rash looked like confetti, low grade temp, asymptomatic covid-19, had an irritation in my upper nose, platelet count was found to be 90/platelet count dropped corrected with in one week. The clinical course was reported as follows On '04Mar2020' traveled and had an irritation in my upper nose which I later came to understand was caused my asymptomatic COVID-19. Was treated for valley fever with Antifungal med, Eventually developed arrhythmia. Sought treatment at Clinic. Initial diagnosis made at urgent care where platelet count was found to be 90 '1st week in April' 2020 also reported as an event. Treatment was give for Valley Fever. No Treatment was given for Asymptomatic COVID-19 and Platelet count was found to be 90. No hospitalization was involved The patient underwent lab tests that included Platelet count drop/found to be 90 '1st week in April' , Sars-cov-2 test: tested positive on 'last week in March 2020' 'Tested positive for covid 19 in the first quarter of 2020' . The clinical outcome of the event Asymptomatic COVID-19, Drug ineffective, Arrhythmia, chills, night sweats, rash, fever, nasal discomfort were unknown, while Valley fever and Platelet count low was recovered. Consumer inquired if the vaccine might trigger another platelet drop. Did not seem to but second shot next Tuesday 02Mar2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: ELIQUIS; SYNTHROID; PRAVASTATIN; DILTIAZEM; DOFETILIDE

Current Illness:

ID: 1113921
Sex: M
Age:
State: UT

Vax Date: 02/27/2021
Onset Date: 03/02/2021
Rec V Date: 03/19/2021
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: 3 days after vaccination severe nerve pain and neuropathy; 3 days after vaccination severe nerve pain and neuropathy; Low grade fever, under 100; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 27Feb2021 at 12:00 PM (at age of 45 years old) at a single dose for COVID-19 immunization. Medical history included hereditary spastic paraplegia. No known allergies. The patient did not have COVID prior vaccination, also not tested COVID post vaccination. No other vaccine in four weeks. Concomitant medications included dextromethorphan hydrobromide, quinidine sulfate (NUEDEXTA), pregabalin (LYRICA), cetirizine hydrochloride (ZYRTEC), venlafaxine. On 02Mar2021 at 09:15 AM (3 days after vaccination), severe nerve pain and neuropathy occurred. Sensation common with my disorder, but never this severe. Affected arms and legs. Lasted about 18 after onset. Typical incident will last no more than an hour. Low grade fever, under 100. No treatment received. The outcome of the events was recovering.

Other Meds: NUEDEXTA [DEXTROMETHORPHAN HYDROBROMIDE;QUINIDINE SULFATE]; LYRICA; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VENLAFAXINE

Current Illness:

ID: 1113922
Sex: F
Age:
State: NY

Vax Date: 02/23/2021
Onset Date: 02/24/2021
Rec V Date: 03/19/2021
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: Fainted; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Feb2021 10:00 (lot number: EN6201) at the age of 77 years old, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously took codeine and experienced allergies. The patient previously received first dose of bnt162b2 on 04Feb2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, lot number: EL9264, administration time: 09:45 AM, vaccine location: left arm). Next morning after vaccination (occurred on 24Feb2021 08:00), the patient felt lightheaded while bending over to empty dishwasher. The patient sat down on chair; and the patient's husband found the patient on floor, as she had fainted. The patient had no recall of fainting. No treatment was given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. The patient did not receive other vaccines four weeks prior to COVID vaccine. The patient recovered from the events on unspecified date.

Other Meds:

Current Illness:

ID: 1113923
Sex: F
Age:
State:

Vax Date: 12/16/2020
Onset Date: 12/16/2020
Rec V Date: 03/19/2021
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: severe biopsy proven perniosis of bilateral hands; headaches; fatigue; left sided facial numbness; This is a spontaneous report from a contactable physician. A 36-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), intramuscular on left arm on 16Dec2020 at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient has no known allergies and was not pregnant. She was not diagnosed with COVID prior to vaccination and has no other vaccine in four weeks. The patient received her vaccine at a clinic. On 16Dec2020, the patient developed severe biopsy proven perniosis of bilateral hands, right after the vaccine which was still lasting. She also had headaches, fatigue for 2 weeks post vaccination (as reported) and left sided facial numbness for hours post vaccination. She had pain and swelling of the fingers which inhibits her from working as an nurse. She has been on disability leave from work. All lupus and other autoimmune work up have been negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/ department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with amlodipine, prednisone course, topical steroids and pentoxifylline. The patient underwent lab test and procedure which included nasal swab which was negative post vaccination on an unspecified date. The outcome of the events was not recovered. The events were assessed as serious causing disability or permanent damage. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the perniosis of bilateral hands and other reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. 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: 1113924
Sex: F
Age:
State: AZ

Vax Date: 02/28/2021
Onset Date: 03/01/2021
Rec V Date: 03/19/2021
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: Bell's palsy left side of face; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202) at the age of 71-years-old, intramuscular on left arm on 28Feb2021 at 13:30 at single dose for COVID-19 immunization. Medical history included asthma, allergies, blood cholesterol abnormal (reported as cholesterol), and allergies to penicillin which were all ongoing. The patient was not pregnant. She has no COVID prior to vaccination and has no prior vaccination and other vaccines in four weeks. Ongoing concomitant medications included zileuton (ZYFLO CR) and budesonide, formoterol fumarate (SYMBICORT) for asthma; levocetirizine and azelastine hydrochloride, fluticasone propionate (DYMISTA) for allergies; immunoglobulin human normal (HIZENTRA); and atorvastatin (LIPITOR) for cholesterol. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264) at the age of 71-years-old, intramuscular on left arm on 02Feb2021 at 14:30 at single dose for COVID-19 immunization. The patient previously took aspirin and experienced allergy. The allergy was reported to be ongoing. The facility type where the vaccine was administered as reported to be other and mega-site. The patient experienced Bell's palsy left side of face on 01Mar2021 which required physician office visit. The patient was not tested for COVID post vaccination. Therapeutic measures were taken as a result of the event and included treatment with valacyclovir 1g, 3x/day. The outcome of the event was not recovered. The event was assessed as non-serious by the reporter.

Other Meds: ZYFLO CR; SYMBICORT; LEVOCETIRIZINE; DYMISTA; HIZENTRA; LIPITOR [ATORVASTATIN]

Current Illness: Allergy; Asthma; Blood cholesterol abnormal; Penicillin allergy

ID: 1113926
Sex: F
Age:
State:

Vax Date: 02/15/2021
Onset Date:
Rec V Date: 03/19/2021
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: Covid Pneumonia; covid virus/tested positive for the covid virus; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 15Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received, 1st dose Pfizer covid vaccine 15Feb2021, and in between 1st and 2nd dose, she got covid virus. The patient tested positive for the covid virus on 22Feb2021, went to ER on that Friday, found covid in her lungs, Diagnosed with Covid Pneumonia. The patient is scheduled on 08Mar2020, the patient wants some advice on pushing it back, and if and when she should get it. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1113927
Sex: M
Age:
State: PA

Vax Date: 02/16/2021
Onset Date: 02/23/2021
Rec V Date: 03/19/2021
Hospital: Y

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: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 16Feb2021 (lot number reported as EN9581 and EL1282; pending clarification) at the age of 79 years old, as single dose for COVID-19 immunisation. There were no relevant medical history and concomitant medications. On 23Feb2021, seven days after the vaccine shot, the patient experienced diarrhea and it was just resistant (diarrhea won't stop). The patient had been in the hospital (was admitted) from Friday morning (26Feb2021) to 01Mar2021 due to the event; and yesterday morning (02Mar2021) the patient underwent endoscopy and colonoscopy with unknown results. The adverse event required a visit to the emergency room. The patient did not receive any vaccinations 4 weeks prior to the administration of first COVID vaccine. There were no additional vaccines administered on same date as Pfizer COVID vaccine. The patient has not recovered from diarrhea as of this report. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1113928
Sex: M
Age:
State: AL

Vax Date: 02/23/2021
Onset Date: 02/25/2021
Rec V Date: 03/19/2021
Hospital: Y

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: hallucinations; headache; hearing disturbing noises; nausea; stomach pain; diarrhea; vision became worse; This is a spontaneous report from a contactable consumer (patient himself). A 91-year-old male patient received the second (2nd) dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6200, expiration date was not reported), via an unspecified route of administration, administered in the right arm on 23Feb2021 at 12:30 PM as a single dose for COVID-19 immunization. Relevant medical history included high blood pressure, severe anemia, diabetes, vision problems/poor vision, and spinal stenosis; all from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included bimatoprost (LUMIGAN) and insulin aspart (NOVOLOG) with "Bd Nano," and hydrochlorothiazid; all taken for an unspecified indication, start and stop date were not reported. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient had other vaccine in four weeks, but not specified. Following the 2nd dose on 25Feb2021 at 01:00 AM, the patient suffered headache, hallucinations, hearing disturbing noises, nausea, stomach pain, and diarrhea. Additionally, he has had poor vision, but following the shot, his vision became worse. The adverse events (AE) resulted in hospitalization for 3 days on an unspecified date. It was unknown if the patient received any treatment for the events. The patient was not recovered from all the events.

Other Meds: LUMIGAN; NOVOLOG; HYDROCHLOROTHIAZID

Current Illness:

ID: 1113929
Sex: F
Age:
State: AZ

Vax Date: 02/27/2021
Onset Date: 02/01/2021
Rec V Date: 03/19/2021
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: diarrhea; color of the diarrhea looked red and looked like it had blood on it; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea/she has hemorrhoids from having babies years ago; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea/she has hemorrhoids from having babies years ago; shaking/trembling out of control; hurting from her neck down to her toes; joints were achy, hurt, and stiff; joints were achy, hurt, and stiff; her teeth were chattering and cant stop, and when she tried to stop that it made it worse; she had hard time walking/Her gait was off and she was kind of jerking; fell in the bathroom; she was too weak; hard time rolling and trying to get out of bed; Her gait was off and she was kind of jerking; little nausea; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea; she was kind of wiped out for a couple of days (in 2021) and it was all over now; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6203), via an unspecified route of administration in left arm on 27Feb2021 (at the age of 76years) as single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia diagnosed in 1999; Covid-19 from 23Nov2020 to Dec2020 (went to the hospital because of pain in her side at night. Was told she had pneumonia and pleurisy, she got it 2 days after her husband did, but hers was a mild case); her husband had Covid in Nov2020 and died in Dec2020 and hemorrhoids (from having babies years ago). Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN). The patient had no investigation assessment. The patient scheduled her first dose for 27Dec2021. The patient had questions about it, but the person administering it did not speak English and she said that initially she did not have any reactions while she was there. The patient received the first dose of the vaccine on 27Feb2021 and has a lot of adverse events. After the getting the shot, she woke up at 0400 and experienced shaking (whole body was shaking), trembling out of control, hurting from her neck down to her toes, her joints were achy, hurt, and stiff, her teeth were chattering and couldn't stop, and when she tried to stop that it made it worse, when she got up she had hard time walking, so much that when she had diarrhea, she had diarrhea on the floor, she also noticed that the color of the diarrhea looked red and looked like it had blood on it but she was not sure. After that, she sat down in a chair and noticed that it had blood when she got up and suspected that she had hemorrhoids and bleeding because of the diarrhea. She thought it was a result of the reaction to the shot. She noted that that she had COVID on 23Nov2020 and that she heard that people who had COVID might not need to get the second shot but it was only speculation so she was asking if this was true. She mentioned that she waited 90 days before getting the vaccine as per CDC guidelines and knew that the 2nd dose can be given for 42 days after the first dose. The patient's daughter in law who was an occupational therapist volunteered to fly in and take care of her after the second shot on 27Mar2021 but her 2nd shot was due on 20Mar2021 so she wouldn't be there until then. The patient was having a hard time rescheduling her appointment so asked if there was anything can be done. The patient would prefer not to take the second dose due to the side effects. The patient also reported that it looked like someone who had a stroke trying to walk again, her gait was off and she was kind of jerking. As she would take a step her foot would go down on a slant like it was skidding. She said that this happened one other time to her. It was like she was leaning forward and could not stop herself. When she was able to get up, she went into the living room and sat in her husband's chair and fell asleep until 15:00. When she got up, she noticed a lot of blood in the chair. The patient asked if this was allowed. She went home and took a couple of acetylsalicylic acid, caffeine, paracetamol because she did not have paracetamol (Tylenol), and she went to sleep. She had a hard time rolling and trying to get out of bed. She turned on her electric blankety and her heat. She said that by 0600 most of the shaking had gone away. She felt a little nausea, but got some dry toast. She said that she wanted to take a shower, but she started getting diarrhea from the injection. She fell in the bathroom and could not get herself up for over an hour because she was too weak. When she fell on the floor, she tried to get on a rug because she was still having the diarrhea on the floor. She said that it was everywhere. The next day she called her son and his wife they said that she could be alone for her second shot. She was scheduled for 20Mar2021 for her second dose. The patient had a hard time changing the appointment and her son could not come to stay with her until 27Mar2021. A friend told the patient that on the news it said that a second shot may not be necessary for people who have had Covid-19 already and she wanted to know if Pfizer has heard of this. The patient said that she was kind of wiped out for a couple of days (in 2021) and it was all over now. The doctor's office was aware of what happened and she was told to take extra strength Tylenol before and after the second injection to address these symptoms. The consumer considered the case as non-serious. The outcome of the event fatigue was recovered in 2021 while for the remaining events was unknown.

Other Meds: EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]

Current Illness: Fibromyalgia (diagnosed)

ID: 1113930
Sex: M
Age:
State: KY

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 03/19/2021
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:

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

Symptoms: blood loss; hemoglobin dropped to about 10; accident; This is a spontaneous report from a contactable consumer (patient himself). A 44-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included tetanus vaccine taken for immunization. On 25Feb2021, patient received his first Pfizer Coronavirus vaccine. The next day, the 26Feb2021, he had an accident and suffered some blood loss. He did not have a transfusion but his hemoglobin dropped to about 10. He was also given a tetanus shot. Will his vaccine still be effective and should he keep his appointment to get his 2nd vaccine on 24Mar2021 or redo them later? Outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds: TETANUS VACCINE

Current Illness:

ID: 1113931
Sex: F
Age:
State: OH

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 03/19/2021
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: Tremor

Symptoms: Seizure; Headache; Couldn't feel lower legs; Extreme chest pains and chills; Extreme chest pains and chills; Arm swelling; Pain; Itching; This is a spontaneous report from a contactable healthcare professional (patient). A 23-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration (left arm) on 02Mar2021, 16:15, as single dose for COVID-19 immunisation. Medical history included ongoing epilepsy, covid back in Dec2020, known allergies to flu vaccine and TB test and seizure (have history). Concomitant medications included levetiracetam (KEPPRA), lamotrigine (LAMICTAL), cenobamate (XCOPRI) and magnesium. The patient had no other vaccine in 4 weeks. On 02Mar2021 16:15, the patient experienced arm swelling, pain, itching, couldn't feel lower legs, extreme chest pains and chills. On 02Mar2021, at 17:15, the patient experienced headache an hour later. On 03Mar2021 01:00, the patient experienced seizure at the middle of the night around 01:00. The events resulted in emergency room/department or urgent care. The patient had Covid prior vaccination; and was not Covid tested post vaccination. Outcome of event seizure was not recovered; outcome of the rest of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The patient had underlying epilepsy. However, based on the close temporal association, a possible contributory role of bnt162b2 to the development of seizure cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: KEPPRA; LAMICTAL; XCOPRI; MAGNESIUM

Current Illness: Epilepsy

ID: 1113932
Sex: M
Age:
State: WA

Vax Date: 02/24/2021
Onset Date: 02/25/2021
Rec V Date: 03/19/2021
Hospital: Y

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: hip fracture; atrial fib; could not communicate; everything the patient's wife touched he said "ouch"; rigors or chills; he was limp; loss the use of his legs; convulsion; Still not eating and confused; Still not eating and confused; This is a spontaneous report from a contactable consumer (patient's wife) medical information team. A male patient of an unspecified age (reported as 90, no units provided) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 24Feb2021 at a single dose for COVID-19 immunisation. Medical history included dialysis receiving dialysis 3x/week; and walker (walking aid user). Concomitant medications were not reported. The patient received his second Pfizer vaccine dose on 24Feb2021. When the patient came home Thursday morning (25Feb2021) from dialysis, he was limp, loss the use of his legs, could not communicate, everything the patient's wife touched he said "ouch". They had to push the patient around on his walker. Her son was helping the patient in the bathroom and he called out and thought the patient was having a convulsion, although she thought it may be rigors or chills. The patient was brought back to the recliner and took his vital signs and he was in atrial fib. The MD was called and medicated him. On Friday (26Feb2021), he was not doing so well, his nephrologist was called and was told to watch him for another day. The patient was admitted to the hospital on Saturday (27Feb2021). The patient was still not eating and confused and he has been diagnosed with a hip fracture. The patient's wife wanted to know if other people had these kinds of side effects. The patient has not recovered from "still not eating and confused". The outcome of the remaining events was unknown.

Other Meds:

Current Illness:

ID: 1113933
Sex: F
Age:
State: FL

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 03/19/2021
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: Loss of upper field of vision Right eye; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 03Mar2021 16:15 (Lot Number: EN6198) as single dose for covid-19 immunization (age at vaccination: 66 years). Medical history included fibromyalgia, hypothyroid, hyper cholesterol, arthritis, depression, and allergies: Mango, penicillin, sulfa drugs, all from an unknown date. The patient is not pregnant. No Covid prior to vaccination and not tested for Covid post vaccination. Concomitant medications included thyroid (ARMOUR THYROID); fluoxetine hydrochloride (PROZAC); atorvastatin (LIPITOR); celecoxib (CELEBREX); zolpidem; all taken for an unspecified indication, start and stop date were not reported. The patient previously took floxacin and experienced drug allergy. The patient experienced loss of upper field of vision right eye on 03Mar2021 18:30. No treatment given for event. Outcome of the event was unknown.; Sender's Comments: Based on the information provided, and on a close temporal association, the Company assessed that a reasonable possibility could not be completely excluded that the reported event Loss of upper field of vision right eye was related to the PFIZER-BIONTECH COVID-19 VACCINE..

Other Meds: ARMOUR THYROID; PROZAC; LIPITOR [ATORVASTATIN]; CELEBREX; ZOLPIDEM

Current Illness:

ID: 1113935
Sex: F
Age:
State: PA

Vax Date: 02/24/2021
Onset Date: 03/03/2021
Rec V Date: 03/19/2021
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: some hearing loss in left ear; Ear ringing; This is a spontaneous report from a contactable other health professional (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at the age of 39-years-old on 24Feb2021 18:00 (Lot Number: EL8982) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Feb2021 6:00 PM (Lot Number: unknown) as a single dose for COVID-19 immunization. The patient experienced some hearing loss in left ear (medically significant) and ear ringing on 03Mar2021 19:00. Unknown if patient received treatment. The outcome of the events was not recovered. The patient was not pregnant. Facility type vaccine was Hospital. No other vaccine in four weeks. No COVID prior vaccination. Not COVID tested post vaccination.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1113936
Sex: F
Age:
State: IN

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 03/19/2021
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: Asthenia, Chills, Headache, Myalgia

Symptoms: Losing her mind/ mental fog; No appetite and went 32 hours without eating/He stated she's lost her appetite; heard in the background stating the COVID-19 Vaccine screwed up her mind; Headache; Eyes hurt/Her eyes felt like they were going to pop out; Feels tired and weak; Feels tired and weak; can't think straight; pain in head and stomach; change of mood; altered mental status and nightmares; altered mental status and nightmares; she is so mean to everybody / not acting normal; her eyes felt like they were going to pop out; Suicidal thoughts/thinking of committing suicide; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL267, expiry date 31May2021) via an unspecified route of administration, at the age of 67-year-old, on 24Feb2021, as SINGLE DOSE (0.3mi as reported) for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and ongoing allergy to penicillin. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9265, expiry date 31May2021) via an unspecified route of administration, on 03Feb2021, single dose for covid-19 immunisation wherein the patient had to got to Emergency room and it was found that her magnesium and potassium were low. The patient had a super bad reaction to the Pfizer vaccine. Patient's mind has not been normal ever since and she is so mean to everybody. The patient was fine until she got the vaccine. The reporter has had the ambulance and police up there to try and help but the caller wouldn't go out to the hospital. The patient had a normal mind before she got the shot. The patient has a bad headache that will not go away (8 days) and her eyes are hurting really bad/eye pain/ eyes hurt. She feels so tired and weak. The second COVID-19 Vaccine messed the patient up. She had the same symptoms for both first and second dose (unspecified symptoms), but the second dose has really messed up her mind. Patient probably won't have a mind. It was reported that the patient's mind was alright, but the second COVID-19 Vaccine did her in. Now patient is saying she won't get her mind back. It has messed up her mind. Clarified when caller states it messed up her mind, he is referring to the patient being mean. Stated patient did have a headache, but wasn't hateful. Stated patient's mind is so bad, she is just mean. If patient doesn't get help soon she is going to tell herself good night. Patient stated in background "If I don't get my mind back I'm going to end up killing myself because he made me." At 11PM last Wednesday (24Feb2021), patient starting losing her mind. Confirmed with caller that patient is currently having suicidal thoughts. Patient used to be a real nice lady and blames this on the COVID-19 Vaccine. Patient is afraid she is not going to get her mind back. Advised caller to seek emergent medical attention for the patient. Patient is against everybody now because of the crazy COVID-19 Vaccine. Patient heard in the background stating the COVID-19 Vaccine screwed up her mind. Caller stated patient is quite upset with everybody. Patient is not acting normal. Patient doesn't think her mind will ever get straightened. The medicine was too much for her body. After getting the second dose, the patient lost her mind, she's lost her appetite/ No appetite and went 32 hours without eating, can't think straight, altered state of mental, mental fog, pain in head and stomach, change of mood, nightmares, her eyes felt like they were going to pop out. Her doctor said it was probably an overdose. The patient was not like this prior to second dose. Outcome of the event was unknown. The reporter believes her mental fog is due to second dose of vaccine.

Other Meds:

Current Illness: Penicillin allergy

ID: 1113937
Sex: F
Age:
State: MI

Vax Date: 01/28/2021
Onset Date: 02/04/2021
Rec V Date: 03/19/2021
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: First dose received 28Jan2021 approx. 1 week after 1st dose, presented with a nose infection (left nostril, suspected MRSA) prescribed Doxycycline for 7 days. Infection reduced (but not completely; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunisation. Medical history included panic disorder. Concomitant medications included sertraline hydrochloride (ZOLOFT); trazodone; doxycycline (DOXYCYCLINE); sulfamethoxazole, trimethoprim (BACTRIM); all taken for unspecified indications, start and stop dates were not reported. First dose received 28Jan2021 approx. 1 week after 1st dose, presented with a nose infection (left nostril, suspected MRSA) prescribed Doxycycline for 7 days. Infection reduced (but not completely resolved). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Feb2021, sars-cov-2 test: negative on 02Mar2021. Therapeutic measures were taken as a result of first dose received 28jan2021 approx. 1 week after 1st dose, presented with a nose infection (left nostril, suspected mrsa) prescribed doxycycline for 7 days. infection reduced (but not completely (staphylococcal infection). The outcome of the event was recovering.

Other Meds: ZOLOFT; TRAZODONE; DOXYCYCLINE; BACTRIM

Current Illness:

ID: 1113938
Sex: F
Age:
State: AZ

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 03/19/2021
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: woke wet from sweat; Nausea; neuropathy was elevated to an unbearable level /neuropathy flared up; body aches; severe muscle ache; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's daughter-in-law). An 82-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date) at 82-year-old vaccination age via an unspecified route of administration in the right arm on 11Feb2021 15:30 as a single dose for covid protection (covid-19 immunisation). Medical history included transient ischaemic attack (TIA) which she has had this happen twice, thyroid removal in 1970, stroke (last doctor screwed up her medications and could have caused a stroke), has been losing a lot of weight (prior to vaccination) and neuropathy. Concomitant medications included influenza vaccine (FLU) on an unspecified date for an unspecified indication, blood pressure medicine, and hormone medication since she had her thyroid removed in 1970. The patient did not receive vaccinations within 4 weeks prior. The reporter mentioned that the patient has experienced body aches on 12Feb2021, nausea on 13Feb2021 and she woke wet from sweat on 16Feb2021. It was mentioned that her neuropathy was elevated to an unbearable level on 12Feb2021. She didn't feel it the first day. When talking about the neuropathy, the reporter stated that it was like something stabbing her from the knees to the toes. She has to lay in bed. Her legs hurt so bad she is unable to stand and can't sit for long. She woke wet with sweat twice. The first time was on 16Feb2021 and again on 19 or 20Feb2021. She had a flu shot on an unspecified date when they came out. The events did not require emergency room or physician's office visit. The reporter mentioned that her mother in law who was due tomorrow for the second dose and wanted to cancel because their doctor advised them to wait for at least a month to receive the second dose. According to her, her mother in law was sick for almost 3 weeks after the first dose, her mother in law experienced severe muscle ache and her neuropathy flared up on an unspecified date in 2021. The outcome of the events sweaty was recovered on an unspecified date in 2021, as for the event nausea was recovered on 01Mar2021 while muscle ache was unknown. The outcome of the other events was recovering. The following information on the batch/lot number has been requested.

Other Meds: FLU

Current Illness:

ID: 1113939
Sex: F
Age:
State: TX

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 03/19/2021
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: lost the hearing in her left ear; became light headed; This is a spontaneous report from a contactable consumer (patient herself). An 82-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9269, expiration date was unknown), via an unspecified route of administration, administered in the left arm on 03Feb2021 at 15:45 as a single dose for COVID-19 immunization. The vaccine facility type was reported as "other." Relevant medical history included hydrocephalus condition, which was corrected with surgery and for which the patient was also wearing hearing aides; all from an unknown date and unknown if ongoing. The patient had no known allergies; however, she had seasonal allergies on occasion from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (PROTONIX) and simvastatin (ZOCOR); both taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. Right after the patient received her first vaccine dose (while at the clinic) on 03Feb2021 at 15:45, she became light headed. The next day, on 04Feb2021, she lost the hearing in her left ear. The adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The patient was not recovered from the events.

Other Meds: PROTONIX [OMEPRAZOLE]; ZOCOR

Current Illness:

ID: 1113940
Sex: F
Age:
State: TN

Vax Date: 02/28/2021
Onset Date: 02/28/2021
Rec V Date: 03/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Bleeding started really heavy/ Soaking up a bunch of different pads; Really bad pain in stomach as well as right pelvic area; Really bad pain in stomach as well as right pelvic area; Pain in right chest area; bunch of pain; Headache; Diarrhea; Nausea; Pain where I got the shot; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6200) via an unspecified route of administration in the left arm on 28Feb2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient mentioned that the only medication she was taking was birth control. The patient got the COVID-19 vaccine on Sunday and had the normal side effects like headache, diarrhea, nausea and pain where she got the shot. The patient took Excedrin extra strength on Sunday night. Then on Monday night (01Mar2021) when she went to sleep there was pain in her chest, her right chest area there was in a bunch of pain. When the patient woke up on Tuesday morning (02Mar2021), she had bleeding, and that bleeding started really, really heavy. She just came off of her period a week ago. She had a full blown period for an entire week and then on Tuesday the patient started bleeding very, very heavily. She was soaking up a bunch of different pads. She was not sure what it was, she had pain, really bad pain in stomach as well as like pain in her pelvic area, right pelvic area. Patient weight was 135 (units unknown). The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1113941
Sex: F
Age:
State: NV

Vax Date: 02/27/2021
Onset Date: 02/27/2021
Rec V Date: 03/19/2021
Hospital: Y

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: Seizures; throat swelled up; Troponin level increased; Mild heart attack; arm was hurting; breathing issues; Dry heaves; Mucus to come out; Nauseous; Dizzy; Headache; Ears became hypersensitive; Senses heightened; Throwed up; This is a spontaneous report from a contactable other health professional (patient). A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 27Feb2021 (lot# EN6205), as 0.3 ml single, for COVID-19 immunisation. Medical history included seizure from 2017 (she hasn't had a seizure in 8 months), allergy (to a lot of things). Concomitant medications were not reported. The patient did not have other vaccinations in 4 weeks prior. Within 15 minutes from having the vaccination at the center the patient experienced the first seizure that lasted about an hour. The seizure was really bad, she had breathing issues, dry heaving like she was trying to throw up, mucus to come out. The paramedics checked her out, they stayed around until she came out of the seizure. The patient went home and then at 07:50 PM she started heavy shallow breathing, was nauseous, dizzy, had a headache, which also happened at the center. Ears became hypersensitive, it was so noisy like loud, but her husband and the paramedics said it wasn't loud but she could hear it, all of her senses were heightened. She had a second seizure and didn't known how long it lasted. Patient had another seizure at 08:25 PM, at 08:40 PM she had another one, at 09:00 PM patient was coming back around and had another seizure and her throat closed up and that's when she went to the hospital, when her throat started to close up. While the patient was in the emergency room (ER) she had another seizure, she had 6 total seizures, she has never had this many before so she knows it was an adverse event to this vaccination. The seizures also increased the patient's heart enzymes- troponin levels. The patient has an EEG, was given 4 baby chewable Aspirin, as she had a mild heart attack. She thought the seizure increased her troponin. The patient mentioned that during the first event at the center, she was so into the seizures, she remembers grabbing her left shoulder, her arm was hurting. She was so into the seizure and trying to throwing up that it didn't dawn on her. The hospital didn't tell her she had a mild heart attack, it just dawned on her because her troponin levels were up mildly and she thought the seizures were triggering something in her heart, not just her seizures. The patient got another headache and was dizzy and had shallowing breathing. Seizures recovered on 28Feb2021. The patient underwent lab tests and procedures which included chest x-ray: normal, it didn't show pneumonia or fluid on the lungs on 27Feb2021, electrocardiogram (EKG): normal on unspecified date, electroencephalogram (EEG): normal on 27Feb2021, troponin: increased on 27Feb2021. Follow-up attempts are completed. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1113942
Sex: F
Age:
State:

Vax Date: 02/20/2021
Onset Date: 02/20/2021
Rec V Date: 03/19/2021
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: miscarriage; pregnant patient received BNT162B2; pregnant patient received BNT162B2; This is a spontaneous report from a non-contactable consumer. This consumer (patient) that a 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6201) at the age of 34-years, via an unspecified route of administration on 20Feb2021 at single dose for COVID-19 immunisation. Medical history was not reported. Patient was pregnant at time of vaccination, last menstrual date was 21Jan2021. No other vaccine in four weeks, no COVID-19 prior vaccination. Concomitant medication included ustekinumab (STELARA). The patient experienced miscarriage on an unspecified date (on 03Feb2021, as reported). The pregnant patient received BNT162B2 on 20Feb2021. No COVID-19 tested post vaccination. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021238716 Same product and AE , different patient

Other Meds: STELARA

Current Illness:

ID: 1113943
Sex: F
Age:
State: SC

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 03/19/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: TIA; I felt really lousy; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), dose 2 at the age of 73-year-old, via an unspecified route of administration on 26Feb2021 as single dose for COVID-19 immunisation. Medical history included high blood pressure (don't have really high blood pressure but the doctor has her on blood pressure medicine, have no diabetes or whatever, and had allergies. Concomitant medication included amlodipine besylate 5 mg, taken every morning. She takes most of her medicines in the morning and had taken that stuff at about 5 o'clock or so early in the morning. The patient was previously vaccinated with the first dose of BNT162B2 on 05Feb2021 at the age of 73-year-old and hand no problem. The patient stated that when she had the first COVID vaccination she had no problem and then Friday she went to get the second one, it was 3 weeks later, when she had first one she stated that she had allergies, so they had her wait 15 minutes, no problem. When she went for the second one, thankfully someone drove her that was outside the 'game court' location. When they gave it they said, she pull up and will let her know after she pull up and will decide if she has to wait 15 minutes or 30 minutes and they asked her if she had allergies, and she said yes, they said pull over here and she has to wait 30 minutes and all she know was, it's probably 2 minutes from the time she got the vaccine until she got to the place to wait. She would say 15 minutes after she got it on 26Feb2021, she felt really lousy and told her friend, they 'said' she was having a Trans Ischemic Attack (TIA), and took me to the hospital and everything. An ambulance was called on 26Feb2021 at around 8 o'clock that morning, right after she had the vaccine and carried her straight in the hospital. She was discharged the next day 27Feb2021 at about 7 PM. The patient had a CT scan of her brain, MRI of her brain, and then cardial, something with reference to her heart, she forgot, all with unknown results. The body weight right now was about 150 pounds. The outcome of the events was unknown.

Other Meds: AMLODIPINE BESYLATE

Current Illness:

ID: 1113944
Sex: F
Age:
State: GA

Vax Date: 03/02/2021
Onset Date: 03/04/2021
Rec V Date: 03/19/2021
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: Orbital edema; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown) via intramuscular in the left arm on 02Mar2021 09:00 AM at age of 51 years old at single dose for COVID-19 immunisation. Medical history included goiter, allergies to Sulfa. There was no covid prior vaccination. Patient was not pregnant. Concomitant medication included other vaccine in two weeks estradiol, norethisterone acetate (COMBIPATCH). Patient experienced adverse event included orbital edema on 04Mar2021 02:00 AM. Patient had doctor or other healthcare professional office/clinic visit. Patient received treatment with prednisone for event. There was no covid tested post vaccination. Outcome of event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported orbital edema cannot be excluded based on temporal association. 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: COMBIPATCH

Current Illness:

ID: 1113945
Sex: F
Age:
State: TN

Vax Date: 02/23/2021
Onset Date: 02/24/2021
Rec V Date: 03/19/2021
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: left arm aching from the site of the injection; aching from back of her arm to the back part of her elbow, then it comes to the far outer part of her forearm down to the wrist and ring finger and pinky finger.; numbness down left arm/partially numb, she has feeling because it's aching; itchy torso from armpits to hips/itchy back and stomach; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6201), intramuscular, administered in left arm on 23Feb2021, 14:00 as single dose for COVID-19 immunisation. Medical history included neuropathy in feet, cholesterol (abnormal), 2 vertebra in her back that are starting to fuse, shrinking as she's getting older, allergic to NSAIDS, she clarifies Advil, Tylenol and the medications reverses on her and gives her a headache, and she gets itchy; was in the hospital for surgery, for lady stuff and needs glasses. She doesn't have a heart problem she doesn't have any other medical issues. She's not diabetic the neuropathy was idiopathic. Concomitant medications included atorvastatin for cholesterol (abnormal), acetylsalicylic acid (BABY ASPIRIN), and duloxetine hydrochloride (CYMBALTA). The patient previously took morphine and was allergic, and hallucinating as she was told by the nurse, she said there were monkeys on the ceiling and her husband was trying to kill her and gets itchy with morphine. This is the same reaction she had when found out she had the reaction to NSAIDs, for example, she could take Advil or Tylenol for one night but it she took it two nights, that was when she woke up itching all over. She reports no rash, just itch. It just lasted that one night and it was gone. She could take some Advil and get that itchy feeling. On 01Mar2021, the patient experienced left arm aching from the site of the injection back down under the back of her arm to the back part of her elbow, then it comes to the far outer part of her forearm down to the wrist and ring finger and pinky finger; numbness down left arm/it was also partially numb, she has feeling because it's aching and she was describing it as an ache, not sharp just an ache. She can feel it, but its not all there. She knows all this stuff was new to all of us. She's following up and doesn't keep her up at night it's just not normal; and on 24Feb2021, her torso, the night after injection, from her armpits to her hips was itchy. She woke up and she went to the bathroom scratching her back and stomach. Her Covid 19 vaccine card was handwritten she sees 23Feb2021 and that's the date she got the shot. She's been isolating since Feb2020. She was only going out for necessity. She took a risk and had family at her home for Christmas. She hasn't been to church in almost a year, so she was taking this very seriously. Before they even started telling you to wear a mask she was listening to the news in December and January. She states, alright she's isolating, it's the safest thing she can do she's not ready to leave this world yet even knowing she's past her golden years. Her doctor put her on Atorvastatin it because of her age, she had blood drawn but she wasn't given any counts on an unspecified date. Her first thought was she had a chest problem but it's not a heart attack, the ache doesn't go any farther than what she told. It's not stopping her from being productive, from doing things. The events did not require a visit to the emergency room, physician office and was not hospitalized. The patient had no prior vaccinations within 4 weeks and no events following prior vaccinations. Outcome of event itchy torso from armpits to hips/itchy back and stomach was unknown; and outcome of the rest of events was not recovered.

Other Meds: ATORVASTATIN; BABY ASPIRIN; CYMBALTA

Current Illness:

ID: 1113946
Sex: M
Age:
State: CA

Vax Date: 03/02/2021
Onset Date: 03/03/2021
Rec V Date: 03/19/2021
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:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: found blood in his stool; This is a spontaneous report from a contactable consumer (patient). This 46-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN 6205), via an unspecified route of administration in the right arm on 02Mar2021 at 06:30 PM at single dose for COVID-19 immunization. Medical history included allergy to beef (was informed may have an allergy to beef but not be fully tested due to covid restrictions). Concomitant medications were none. The patient had no other vaccine in four weeks, no other medications in two weeks. The following day the patient found blood in his stool on 03Mar2021 at 09:30 AM. It was unsure if this was related to the vaccine but never had an issue prior to the vaccination. No treatment was received for the event. Outcome of the event was not recovered. The patient had no covid prior vaccination, no covid tested post vaccination.

Other Meds:

Current Illness:

ID: 1113947
Sex: F
Age:
State: IN

Vax Date: 03/03/2021
Onset Date: 03/04/2021
Rec V Date: 03/19/2021
Hospital: Y

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: Chills; stomach pain joints; vomit; weak blood pressure; stomach pain joints; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm at 63-year-old (not pregnant at the time of vaccination) on 03Mar2021 at 16:00 (lot number: EN6198, expiration date unknown) at single dose for COVID-19 immunization. Medical history included diverticulitis. No known allergies were reported. The patient was not diagnosed with COVID prior vaccination. Concomitant medications were reported as unspecified other medications in two weeks. No other vaccine in four weeks. On 04Mar2021 at 06:00 AM the patient experienced chills stomach pain joints vomit weak blood pressure (as reported). The events resulted in hospitalization. The patient underwent lab tests and procedures which included nasal swab: negative on 04Mar2021. No COVID tested post vaccination. It was unknown whether treatment was received. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1113948
Sex: M
Age:
State: NC

Vax Date: 02/16/2021
Onset Date: 02/21/2021
Rec V Date: 03/19/2021
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: Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 55-year-old, via an unspecified route of administration, administered in left arm on 16Feb2021 08:30 (Lot Number: EN6200) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. On 20Feb2021, the patient started developing some tingling and the right side of his face doesn't work anymore. The next day (21Feb2021) he went to the doctor and he was diagnosed with Bell's Palsy. He has got full blown, right side of his face was flop, bell's palsy. He went to the doctor and they put him on Prednisone, which he was still treating. The event required a visit to the physician office. The outcome of the event was unknown.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm