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: 1047823
Sex: F
Age: 19
State: NM

Vax Date: 01/13/2021
Onset Date: 01/22/2021
Rec V Date: 02/23/2021
Hospital: Y

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

Lab Data:

Allergies: Penecilin

Symptom List: Dysphagia, Epiglottitis

Symptoms: Localized super infection occurred 11 days after first receiving vaccine. Diagnosed with asthma soon after and hospitalized for the first time on 2/13 for severe respiratory complications. Prescribed nebulizer treatment at home with albuteral, montekulast, prednisone, and qvar inhaler. Went to urgent care today in hopes to avoid hospital bills. Chest xray showed some fluid. Prescribed iputropium for my nebulizer treatment and also azithromyacin to stall any infection. Lets hope no more hospital visits. Waiting to hear back from pulmonologist to schedule appt.

Other Meds: BuproprionXL and Sertaline

Current Illness:

ID: 1047824
Sex: F
Age: 20
State: IA

Vax Date: 02/17/2021
Onset Date: 02/23/2021
Rec V Date: 02/23/2021
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: sulfa (hives)

Symptom List: Anxiety, Dyspnoea

Symptoms: After first dose, got hives around injection site on left arm about 12 days later. Went away over night, but reappeared briefly a couple days later. After second dose, got same hives around injection site a couple days after vaccination. Comes and goes. On 2/22 got hives on left and right arms, back, and chest.

Other Meds: n/a

Current Illness: n/a

ID: 1047825
Sex: F
Age: 70
State: CT

Vax Date: 02/15/2021
Onset Date: 02/22/2021
Rec V Date: 02/23/2021
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: Rash at the injection site, COVID arm, appearing one week after injection

Other Meds: None

Current Illness: None

ID: 1047826
Sex: F
Age: 27
State: NV

Vax Date: 02/14/2021
Onset Date: 02/22/2021
Rec V Date: 02/23/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Approximately 12 days post vaccination, vaccination spot became swollen, red, and firm, slightly bothersome and itchy

Other Meds: Sertraline, buspirone, lisnopril

Current Illness: None

ID: 1047827
Sex: F
Age: 41
State: OR

Vax Date: 02/20/2021
Onset Date: 02/22/2021
Rec V Date: 02/23/2021
Hospital:

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

Lab Data:

Allergies: Latex

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

Symptoms: Left arm/shoulder. Large red itchy rash at injection site.

Other Meds: None

Current Illness: None

ID: 1047828
Sex: M
Age: 41
State: MD

Vax Date: 02/20/2021
Onset Date: 02/21/2021
Rec V Date: 02/23/2021
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: Tahini Oil

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

Symptoms: Nausea, vomiting, cramping, fever, chills, lethargy, headaches, and body aches

Other Meds: Paxil 30 mg Astorovstatin 40 mg Lisinopril 10 mg Multivitamin and vitamin b supplement

Current Illness: None

ID: 1047830
Sex: F
Age: 35
State: OR

Vax Date: 02/20/2021
Onset Date: 02/21/2021
Rec V Date: 02/23/2021
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: Mild fever (no higher than 99.5F), fatigue, muscle aches, injection site pain all started about 15 hours after vaccination and lasted about 12 hours.

Other Meds: None

Current Illness: None

ID: 1047831
Sex: F
Age: 65
State: WA

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 02/23/2021
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: acute flu lasting 3 days followed by 1 day with lighter symptoms. The 3 days included acute pain,fatigues,sleepiness,chills, body aches . On day 2 about 28 hours after taking the vaccine I walked to the bathroom and fainted. I am 65 and have never fainted.

Other Meds:

Current Illness: DIABETE HEART DISEASE

ID: 1047832
Sex: F
Age: 60
State: VA

Vax Date: 02/20/2021
Onset Date: 02/22/2021
Rec V Date: 02/23/2021
Hospital:

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

Lab Data:

Allergies: Cymbalta Topomax Velocous antibiotic

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Round rash the size of a 50 cents coin. Itchy and red. The area turns white when I lift my arm.

Other Meds: High blood pressure medicine Vitamin supplements D3, B12, B-complex, Multi vitamin, C, garlic

Current Illness: Sinus allergy

ID: 1047833
Sex: F
Age: 42
State: VA

Vax Date: 02/10/2021
Onset Date: 02/13/2021
Rec V Date: 02/23/2021
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: Milk

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Within 3-5 days of receiving first vaccine, I developed lymphadenopathy in the axillary of the arm used for injection. I then also began to notice that my (previously diagnosed, treated, and under control) eczema began to manifest. It has persisted and is only marginally under control with previous prescription steroid ointment.

Other Meds: Lexapro 20mg Lamictal 100mg Seroquel 50mg

Current Illness: none

ID: 1047924
Sex: F
Age: 37
State: WI

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 02/23/2021
Hospital:

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

Lab Data:

Allergies: Shellfish, eggs

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

Symptoms: Severe deep throbbing headache that Tylenol did not work on. Lasted 8 hrs caused nausea and eye pressure.

Other Meds: Eliquis, Biotin, ferrous sulfate

Current Illness: low iron

ID: 1047925
Sex: F
Age: 78
State: TX

Vax Date: 02/22/2021
Onset Date: 02/23/2021
Rec V Date: 02/23/2021
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: Morphine, codeine-based

Symptom List: Rash, Urticaria

Symptoms: At location, she felt fine during 15min wait At 3:30-4:30 Zoom call, she looked good, but said she wasn?t feeling great & was concerned due to chills & 4days headaches after 1st dose At 8:30pm she called with chills, 3 layers of clothes & bedwarmer on... said her teeth chattered & was trying to drink warm water to heat from the inside (hydration w/o cold water; said no more coffee) At 11:00pm she texted chills were over, she was expecting aches ?but would be asleep during them?... good attitude at the time At 2:19am she called, had fallen & couldn?t get up, said she called a friend to come help her ... said she?d tried to get up, but legs were numb... said she was dizzy when she fell, total dry mouth & had reached for water, but it spilled when she knocked into things when she fell. She wondered if she should call Fire Dept (but wasn?t making total sense). Her friend came, tried to help, but I think she decided to call 911 for help getting her up & wants EMTs to check her out. **She had fallen during Covid, went to ER & they gave fluids & she was ?good? for a week, but then dizzy & severe lethargy, same friend took her to ER & she was admitted (negative covid test at that point), but very large PE, thus heparin & then Eliquis (Dec 2020).

Other Meds: Eliquis due to Covid Pulmonary Embolisms + many others (I?m daughter ... Mom got dizzy, fell & couldn?t get up, said legs felt numb & her friend is calling 911 to help now)

Current Illness: Eliquis after heparin in ICU for Covid PE in December 2020

ID: 1047926
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/23/2021
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: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: An hour after shot I began experiencing numbness, tingling, dizziness, and redness on the left side of my face in the cheek area. I took ibuprofen and with the advice if an online doctor I went to ER 5 dsys after the shot to have CT scan.

Other Meds:

Current Illness:

ID: 1048182
Sex: F
Age:
State: UT

Vax Date: 10/16/2020
Onset Date: 11/16/2020
Rec V Date: 02/23/2021
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: pain at the injection site / patient is still sore / gets a sharp pain which is worse at night; This case was reported by a other health professional and described the occurrence of injection site pain in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number Z392F, expiry date 30th June 2021) for prophylaxis. Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 16th October 2020, the patient received the 1st dose of FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 16th November 2020, 31 days after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: This case was reported by office manager. The age at vaccination was not reported. The reporter stated that the patient called the office on 16th November 2020 stating where the shot was given on the right deltoid there was pain at the injection site. There was no lump, redness, swelling or rash. On 20th November 2020, the patient was evaluated by the doctor and stated that patient was still sore and got a sharp pain which was worse at night. This case was linked wiith US2021AMR005709 and US2020AMR252174 reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR252174:same reporter US-GLAXOSMITHKLINE-US2021AMR005709:same reporter

Other Meds:

Current Illness:

ID: 1048191
Sex: F
Age: 36
State: MA

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: It leaked and she is concerned she missed some of the dose; A spontaneous report was received from a nurse concerning a 36-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and it leaked and she is concerned that she missed some of the dose. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection, but there was an issue with the needle and syringe. It leaked and she is concerned that she missed some of the dose. Treatment information was not provided. The outcome of the even was considered resolved on 05 Feb 2021.; Reporter's Comments: Based on current information the causality of this event was assessed as not applicable.

Other Meds:

Current Illness:

ID: 1048192
Sex: M
Age: 65
State: FL

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 02/23/2021
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: the injection went too low on his deltoid; got a bruise, a fairly good size of bruise; A spontaneous report was received from a healthcare professional concerning a 65-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fairly good size of bruise. The medical history was not provided. Concomitant product use was not provided. On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 07 Jan 2021, the injection went too low on his deltoid, and he suspected that it did not hit the deltoid muscle but the muscle below that, and that was why he got a bruise. He got a fairly good size of bruise. He also stated that he didn't have a lot of muscle mass. On 04 Feb 2021, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection and he had no issue. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event vaccine administered at inappropriate site was considered resolved on 07 Jan 2021. The outcome of the event fairly good size of bruise was unknown.; Reporter's Comments: This report refers to a case of vaccine administered at inappropriate site for mRNA-1273 (lot # unknown) with reported non-serious unlisted event of contusion. Based on the current available information and temporal association between the use of the product and the start date of the event of contusion, a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1048193
Sex: F
Age: 90
State: MI

Vax Date: 02/05/2021
Onset Date: 02/06/2021
Rec V Date: 02/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Hallucinating, seeing things; Was in overdrive; Couldn't sleep, she was awake for 24 hours; A spontaneous report was received from a consumer calling in regards to her 90 year old mother who "started hallucinating, seeing things, she was talking to people who weren't there". "She was awake for 24 hours", "she was in overdrive". The patient's medical history included, Dementia, High blood pressure and Low blood pressure. On 05-Feb-2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 vaccine, Lot # 038K20A, intramuscularly into her left upper arm for prophylaxis of Covid-19 infection. On the night of 06-Feb-2021, the patient started hallucinating, "She was seeing things", "she was talking to people who weren't there". She "couldn't sleep, she was awake for 24 hours. "She was in overdrive". She was reaching for things that weren't there,"hearing babies crying", "people knocking at the door", " stay couldn't stay still, she was arranging things". "Things that didn't bother her before were now a big problem". She was , "out of her mind". The reporter further stated, she was stronger, "didn't need her walker anymore". Finally yesterday (07-Feb-2021) she slept for 24 hours straight. She stated her mother is now back to her "dementia" self. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the events, Hallucinating, seeing things,talking to people who weren't there, Couldn't sleep, Awake for 24 hours, in overdrive, reaching for things that weren't there, hearing babies crying, people knocking at the door, couldn't stay still, arranging things. Things that didn't bother her before were now a big problem, out of her mind. stronger, didn't need her walker anymore", were considered recovered/resolved. Company comment: the reported events Hallucinations, Abnormal Behavior, and Sleep disorder" were considered possibly related to mRNA-1273.; Reporter's Comments: This report concerns a 90--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # 038K2A and started hallucinating, seeing things, she was talking to people who weren't there". "She was awake for 24 hours", "she was in overdrive". 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: CARVEDILOL; DONEPEZIL; LEVOTHYROXINE; LOSARTAN; Methotrexate; OMEPRAZOLE; PAROXETINE; PREDNISONE; SIMVASTATIN; CALCIUM; FISH OIL; MEMANTINE

Current Illness:

ID: 1048194
Sex: M
Age: 59
State: MA

Vax Date: 12/22/2020
Onset Date: 01/22/2021
Rec V Date: 02/23/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Cellulitis infection; Right ankle pain; Body pain; Joint pain; A spontaneous report was received from healthcare professional concerning a 59-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis infection, joint pain and right ankle pain, and body pain. The patient's medical history included hypertension, cirrhosis of the liver, splenomegaly, sarcoidosis of the lung, diabetes, and having varicose veins in the stomach. No relevant concomitant medications were reported. On 22 Dec 2020, the patient received his first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the right upper arm. On 19-Jan-2021, prior to the onset of the events, the patient received his second of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in the left upper arm for prophylaxis of Covid-19 infection. On 22 Jan 2021, the patient experienced a joint pain and body pain. On 25 Jan 2021, the patient experienced right ankle pain. On 28 Jan 2021, the patient experienced a severe cellulitis infection in his arm and was hospitalized from 28 Jan 2021. The patient was discharged from hospital on 08 Jan 2021. Treatment for the events included Cetaphil (reported as IV) and cephalexin (antibiotic). Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events joint pain and body pain were resolved on 25 Jan 2021. The outcome of the event right ankle pain was resolved on 28 Jan 2021. The outcome for the event of cellulitis infection was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness: Cirrhosis of liver; Diabetes (Diabetes pump); Gastric varices; Hypertension; Pulmonary sarcoidosis; Splenomegaly

ID: 1048195
Sex: M
Age:
State: CO

Vax Date: 01/11/2021
Onset Date: 01/26/2021
Rec V Date: 02/23/2021
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: Seizures; Seizure; A spontaneous report was received from a physician assistant concerning a patient of unknown age who experienced seizures. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 11JAN2021, approximately 16 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 26JAN2021 and 29JAN2021, the patient experienced seizures. The patient does not have history of seizures. The patient was transported to the ER for treatment and they had a consult with a neurologist on 08FEB2021. The neurologist advised the patient that it would be ok to get the second dose of the vaccine. The events seizures, was considered resolved on 26 Jan 2021 and 29 Jan 2021.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of seizure (twice) after receiving first dose of mRNA-1273 (Lot# unknown). Very limited information has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1048196
Sex: F
Age: 48
State: FL

Vax Date: 12/24/2020
Onset Date: 12/24/2020
Rec V Date: 02/23/2021
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: Passed out/ Status post syncopal episode; Double vision; Diagnosis of static vision; Hypothyroid; Diarrhea; Injection site pain; Headache; A spontaneous report was received from a healthcare professional concerning a 48-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypothyroidism, passed out/status post syncopal episode, diarrhea, injection site pain, headache, static vision/double vision. The patient's medical history was not provided. Concomitant medication history was not provided. The patient received their first of two planned doses of mRNA-1273 (batch number: unknown) on 24 DEC 2020. On 21 JAN 2021, the patient received their second of two planned doses of mRNA-1273 (batch number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. The patient developed injection site pain and diarrhea after the second dose. She continued to have the headache from the first dose that was administered. On 03 FEB 2021, the patient experienced double vision and dizziness while driving to work. The patient passed out at work and was admitted to the hospital. A CT of the brain showed no acute findings and her CT angiography was normal. The patient was discharged in less than 24 hours with the diagnosis of static vision, hypothyroid and status post syncopal episode. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event passed out/status post syncopal episode and static vision/double vision were resolved. The outcome of the events hypothyroidism, diarrhea, injection site pain, and headache were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: MOD21-024368:Crosslinked: Same reporter MOD21-024340:Crosslinked: Same reporter MOD21-024343:Crosslinked: Same reporter MOD210-24360:Crosslinked: Same reporter MOD21-024387:Crosslinked: Same reporter MOD21-024396:Crosslinked: Same reporter MOD21-024411:Crosslinked: Same reporter

Other Meds:

Current Illness:

ID: 1048197
Sex: M
Age: 78
State: FL

Vax Date: 01/18/2021
Onset Date: 02/08/2021
Rec V Date: 02/23/2021
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: Oxygen level was down; Tested positive for COVID; A spontaneous report was received from a consumer, concerning a 78-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced oxygen level was down and tested positive for COVID-19. The patient's medical history included heart disease and atrial fibrillation. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 18 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 012120A] intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced low oxygen levels. On 08 Feb 2021, the patient tested positive for COVID-19. Treatment for the event included hospitalization. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events oxygen level was down and tested positive for COVID were 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: Atrial fibrillation; Heart disease, unspecified

ID: 1048198
Sex: F
Age:
State:

Vax Date: 02/09/2021
Onset Date: 02/09/2020
Rec V Date: 02/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Was like hallucinating; A spontaneous report was received from a consumer, a 90 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced was like hallucinating/hallucination. The patient's medical history was not provided. Concomitant product use was not provided. On 09 Feb 2021, the same day of the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A) in the left arm for prophylaxis of COVID-19 infection. After getting the vaccine, the patient had lunch and went home. The patient arrived home two hours after receiving the vaccine and fell asleep. When the patient opened her eyes after the nap, she saw her phone in front of her and reported the letters were moving as if she was writing; however, the patient reported that she was not even holding the phone and that the phone was still plugged in. The patient stated, "I was like hallucinating". Treatment for the event included was not reported. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event was 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 event, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1048199
Sex: F
Age:
State: AZ

Vax Date: 12/17/2020
Onset Date: 12/17/2020
Rec V Date: 02/23/2021
Hospital: Y

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: hives; facial swelling; throat swelling; throat itching; nausea; anaphylactic reaction/ Anaphylaxis; This is a spontaneous report from a contactable physician via FDA. A 49-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in the arm on 17Dec2020 at 13:30 at 0.3 ml, single dose for covid-19 immunization. Medical history included ongoing essential hypertension, ongoing protein c deficiency, ongoing lumbosacral radiculopathy, ongoing type 2 diabetes mellitus, ongoing pulmonary embolism, Strep pharyngitis from 29Nov2020 and resolved at the time of vaccination, serious allergic reaction, allergy to iodonated contrast media and Cardiac Arrest after IV contrast. Concomitant medication included apixaban (unknown manufacturer) for Protein C Deficiency, metformin hydrochloride (unknown manufacturer) for Type 2 Diabetes, chlorthalidone (unknown manufacturer) for hypertension, metoprolol (unknown manufacturer), clonidine hydrochloride (unknown manufacturer) for hypertension, atorvastatin (unknown manufacturer), magnesium oxide heavy;tocopheryl acetate (unknown manufacturer), tramadol hydrochloride (unknown manufacturer), diphenhydramine hcl (unknown manufacturer), epinephrine bitartrate (unknown manufacturer) for serious allergic reaction and anaphylaxis. On 17Dec2020 at 13:48, approximately 13min after vaccination while in observation the patient experienced hives, facial swelling, throat swelling/itching, and nausea. Patient was immediately taken to Emergency Department where epinephrine was given 1M in the left thigh followed by 125mg IV solumedrol, 50mg IV benadryl, 1000mL NS, and 20mg IV famotidine. Hemodynamically stable throughout ED course. The events were considered serious as per hospitalization. Medical Tests and Laboratory results related to the adverse event included: CRP: 11.0, Glucose-182, BRN-29, INR-1.1, Remained of CMP and CBC were WNL. The physician stated that anaphylactic reaction onset 6min after vaccination symptoms improved - 20min after epipen administration, Resolved 60 min later. The signs and symptoms of anaphylactic reaction included Diffuse rash, Itching, throat/lip swelling, shortness of breath, cough, BP 128/72, Spon-97% HR-71. The patient rushed to ED from vaccination PoD. Received EpiPen approximately 8 min post vaccination. Then received steroid, antihistamines, IVF. Sx improved in 20 min resolved 60 min. The patient was not hospitalized and not admitted to an intensive care unit for anaphylactic reaction. The physician stated that multiorgan involvement included respiratory, dermatological/mucosal. Also reported as Respiratory: Yes; Upper airway swelling: Yes; Respiratory distress: Yes; Tachypnoea: Yes; Dry cough: Yes; Difficulty breathing (without wheeze or stridor):Yes; Dermatological/Mucosal: Yes; Generalized urticarial: Yes; Angioedema (not hereditary): Yes; Generalized pruritus with skin rash: Yes. The following laboratory tests or diagnostic studies performed included Hematology on 17Dec2020 showed: results with units, if applicable: 8/13/299/41; Clinical chemistry on 17Dec2020 showed: results with units, if applicable: 137,103,29/36,22,07 (Less than sign) 182; CRP on 17Dec2020 showed: results with units, if applicable: 11.0. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient had not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient had anaphylaxis on 17Dec2020 at 13:36. The patient was not deceased and received treatment. Treated in emergency room/ epinephrine IM IV steroids, antihistamines, IV fluids. The physician considered the Pfizer product had a causal effect to the adverse event. The outcome of the event anaphylactic reaction/ anaphylaxis was recovered on 17Dec2020, while other events were recovered on 17Dec2020 at 13:48. Information on the lot/batch number has been requested. Follow-up (08Feb2021): New information received from the contactable Physician included: additional medical history and lab data, concomitant medications details, suspect drug information (lot number, dosage regimen details), event information (new event "anaphylactic reaction/ Anaphylaxis") and other clinical courses.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events anaphylactic reaction/Anaphylaxis urticaria, swelling face, pharyngeal swelling, throat irritation and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: APIXABAN; METFORMIN [METFORMIN HYDROCHLORIDE]; CHLORTHIAZIDE; METOPROLOL; CLONIDINE [CLONIDINE HYDROCHLORIDE]; ATORVASTATIN; MAGNESIUM OXIDE HEAVY;TOCOPHERYL ACETATE; TRAMADOL [TRAMADOL HYDROCHLORIDE]; DIPHENHYDRAMINE HCL; EPINEPHRINE [EPIN

Current Illness: Essential hypertension; Lumbosacral radiculopathy; Protein C deficiency; Pulmonary embolism; Type 2 diabetes mellitus

ID: 1048200
Sex: F
Age:
State: NJ

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/23/2021
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: Trigeminal Neuralgia; Nausea; Chills; Body aches; Lightheadedness; Trigeminal nerve disorder; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot: EL1284/expiration date not provided) via intramuscular route of administration, in left arm, on 19Jan2021 (at the age of 63 years old) as a single dose for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included losartan, amlodipine, metoprolol, esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL0140/expiration date not provided) on 29Dec2020 (at the age of 63 years old) as a single dose in the left arm for COVID-19 immunization. On 20Jan2021, the patient experienced nausea, chills, body aches, lightheadedness, trigeminal nerve disorder. On 22Jan2021, the patient was diagnosed with trigeminal neuralgia. The events resulted in a physician office visit and Emergency Room visit. The seriousness criteria was disabling/incapacitating. The facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been not been tested for COVID-19. Treatment received for the events included steroids, anti-convulsant and pain relievers. The outcome of the events was not recovered. Follow-up (08Feb2021): New information from a contactable nurse (patient) includes: new event (trigeminal neuralgia), event details, seriousness criteria, treatment received and events outcome.; Sender's Comments: Based on the plausible temporal association and considering lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported events, nausea, chills, body aches, lightheadedness, trigeminal nerve disorder, Trigeminal Neuralgia and the administration of the COVID-19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Other Meds: LOSARTAN; AMLODIPINE; METOPROLOL; NEXIUM [ESOMEPRAZOLE MAGNESIUM]

Current Illness:

ID: 1048201
Sex: F
Age:
State: CA

Vax Date: 01/19/2021
Onset Date: 01/24/2021
Rec V Date: 02/23/2021
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: Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Scarring; This is a spontaneous report from a contactable nurse (patient herself). A 66-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EK4176), via an unspecified route of administration in the left arm on 19Jan2021 at 10:00 as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not have any other vaccine in four weeks, did not have other medications in two weeks, did not have COVID prior to vaccination, has no known allergies, and was not pregnant. There were no concomitant medications. On 24Jan2021 at 08:00, the patient experienced pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on the vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm erupted after 4 more days. Scarring and itching up for two weeks. The patient was not tested for COVID after vaccination. As treatment, Permethrin cream was used to see if it was scabies to "no eff". The adverse events resulted in a doctor or other healthcare professional office/clinic visit and disability or permanent damage. Outcome of the events was recovering.; Sender's Comments: Based on temporal association and/or known drug profile a contributory role of BNT162B2 to the reported events cannot be totally excluded. Case will be reassessed if additional information is received. 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: 1048202
Sex: F
Age:
State: NC

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/23/2021
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: passed out / fell; passed out / fell; developed a nose bleed that would not stop; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. Medical history included high blood pressure, diabetic, stage 3 kidney disease, known allergies to penicillin. The patient's concomitant medications were not reported. It was reported that patient got the shot on Thursday morning (04Feb2021) and later that evening reported as at 10:00pm, the patient developed a nose bleed that would not stop. By 10:30pm she passed out/fell, site car management was called and she was sent to the ER where she stayed for evaluations for 2 days. The reporter does not think the Covid shot was connected to the event. No treatment was given to the patient. The patient had no covid prior to vaccination and was not tested for covid post vaccination. The patient was recovering from the events at the time of the report. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1048203
Sex: F
Age:
State: PA

Vax Date: 02/06/2021
Onset Date: 02/07/2021
Rec V Date: 02/23/2021
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: I had passed out hitting a table bumped head and back.; very dry mouth; felt very light headed; Thought maybe I may have been dehydrated; 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: EL3249), via an unspecified route of administration at Left arm on 06Feb2021 07:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included High blood pressure. Concomitant medications included losartan, atorvastatin calcium (LIPITOR) and vitamins. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient woke up 1:30 am 07Feb2021very dry mouth, used restroom, felt very lightheaded, went back to room, next thing she heard was glass breaking. She had passed out hitting a table bumped head and back. Her boyfriend was with she helped she up. Said her legs went out from under her. Thought maybe she may have been dehydrated though she had drunk water throughout the day and before bedtime. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Feb2021.

Other Meds: LOSARTAN; LIPITOR [ATORVASTATIN CALCIUM]

Current Illness:

ID: 1048204
Sex: F
Age:
State: NC

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/23/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure was out of control; dizziness does not allow her to go to work; lingering dizziness; Get a tightening in her chest; Fatigue; Left side of temple toward the crown of head she has pressure on the left side of the body; Left side of temple toward the crown of head she has pressure on the left side of the body; lightheadedness; troponin kept increasing; Inflammation around heart; This is a spontaneous report from two contactable consumers or other non health professional (including patient self, a healthcare worker works with patients with lymphomas, a licensed massage/lymphatic therapist). This 53-years-old female received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, Expiry Date: 30Apr2021) at 0.3 ml single dose intramuscular injection in left arm on 22Jan2021 10:28 (also reported as 10:38) for Covid-19 vaccination. Medical history was none (also reported as no patient history). Concomitant drug was none (reported as no other products). Family Medical History Relevant to AE(s) was none. Historical vaccine included flu shot in Nov2020 for immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No other vaccines given the same day or 4 weeks prior. AE(s) following prior vaccinations was none. Patient never had a reaction to any vaccine or shot before. Patent experienced anaphylactic reaction on 22Jan2021, heart enzymes elevated on 22Jan2021, blood pressure was out of control on 22Jan2021, get a tightening in her chest on an unknown date, lingering dizziness on an unknown date, dizziness did not allow her to go to work on an unknown date, inflammation around heart on 22Jan2021, troponin kept increasing on 22Jan2021, fatigue on an unknown date, lightheadedness on an unknown date, left side of temple toward the crown of head she has pressure on the left side of the body on an unknown date. Seriousness for heart enzymes elevated and anaphylactic reaction was hospitalization from 22Jan2021 to 23Jan2021. The events anaphylactic reaction required a visit to Emergency Room, but not Physician Office. The event clinical course was as follows: patient received her 1st dose of the Pfizer vaccine she had an anaphylactic reaction. She was given 3-4 Epis on site (on 22Jan2021) before being transferred to the ER. In the ambulance, she was administered a 4th EpiPen (on 22Jan2021) before getting to the ER, and then admitted to the cardiac unit on 22Jan2021 for observation. Patient also reported Given 3-4 EpiPens on 22Jan2021 and EpiPen auto-injector was Lack of Effect. No Return Sample Received. When she first started having symptoms, her blood pressure was 128/73. When the symptoms got worse her blood pressure started increasing. Her blood pressure was 220/116, they had to admit her to the cardiac unit because her heart enzymes were elevated and her blood pressure was out of control. Her troponin kept increasing and had inflammation around her heart. Her symptoms of anaphylactic reaction went away that same day, 22Jan2021, at the vaccination from her anaphylactic reaction. Patient was discharged and released from the cardiac unit on that Saturday (23Jan2021 ) around 7:30pm. No one could tell her anything about this since she was still having lingering effects and was getting ready to locate a cardiologist and still has tightness in the chest. She mentioned the dizziness did not allow her to go to work. She experiences it on and off, not consistent but less severe than initially. She still had lingering dizziness and she had to drive for a majority of her day and that was concerning. She said that on the left side she will get a tightening in her chest. She said that no one knows what this means moving forward. Patient was concerned about the severity of the reaction and was still not back to normal. She had never had a reaction to any vaccine or shot before and has been in the military. She needed help, direction since she was still not at the full potential to work. She was still fatigued and has tightness of her chest and those are concerns for her. Patient mentioned a part of the symptoms she also had were lightheadedness and dizziness and that started after the vaccine and it's not as severe, but she still had it. On left side of her temple toward the crown of her head she had pressure on the left side of the body and that was the same side where she received the injection, on that left side. Outcome of anaphylactic reaction was resolved with sequel on 22Jan2021. Outcome of heart enzymes elevated was resolved on 23Jan2021. Outcome of blood pressure was out of control was resolved with sequel on 23Jan2021. Outcome of lingering dizziness was resolving. Outcome of left side of temple toward the crown of head she had pressure on the left side of the body, lightheadedness was not resolved. Outcome of tightness in the chest and fatigue was not resolved. Outcome of inflammation around heart and troponin kept increasing was resolved with sequel on an unknown date. Outcome of the other event was unknown.

Other Meds:

Current Illness:

ID: 1048205
Sex: M
Age:
State:

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

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: he has chronic myeloid leukemia - white blood cell count is higher; His oxygen is low; Blood clot in his legs; first dose on 19Jan2021 and second dose on 02Feb2021; first dose on 19Jan2021 and second dose on 02Feb2021; This is a spontaneous report from a contactable nurse reported for her father that an 82-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Feb2021 at single dose for covid-19 immunisation. Medical history included chronic myeloid leukemia (CML). Concomitant medications were not reported. Patient previously received first dose of BNT162B2 on 19Jan2021 at single dose for covid-19 immunisation. Patient received Pfizer-BioNTech COVID-19 Vaccine first dose on 19Jan2021 and second dose on 02Feb2021. Two days after second dose (04Feb2021) he had to go to the hospital - he had chronic myeloid leukemia - white blood cell count was higher (Feb2021), he had been in the hospital for the last 3 days as of 08Feb2021, his oxygen was low, had a blood clot in his legs, had a bone marrow biopsy, all on an unspecified date in Feb2021. The nurse is taking its related to this vaccine and assessed this case as not serious. Outcome of the events was unknown. Information on the lot/batch number has been requested.; 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: 1048206
Sex: M
Age:
State: NY

Vax Date: 01/22/2021
Onset Date: 01/28/2021
Rec V Date: 02/23/2021
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: Immune system was destroying red blood cells that caused Hemoiytic Anemia; This is a spontaneous report from a contactable consumer (patient) reported that a 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 35235643), via an unspecified route of administration on the left arm on 22Jan2021 13:00 at a single dose for covid-19 immunization. The vaccine was administered at the hospital. Medical history included Type 2 diabetic, high blood pressure, and high cholesterol; all from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin, clopidogrel, metformin, pravastatin, and metoprolol; all were taken from an unspecified date for an unspecified indication. The patient experienced immune system was destroying red blood cells that caused hemolytic anemia on 28Jan2021 with outcome of recovering. The reported event led to patient's hospitalization for 8 days. The treatment received for the event was prednisone. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-1 test (nasal swab): negative on 31Jan2021.

Other Meds: GABAPENTIN; CLOPIDOGREL; METFORMIN; PRAVASTATIN; METOPROLOL

Current Illness:

ID: 1048207
Sex: F
Age:
State: NY

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 02/23/2021
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: numbness of face; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; menstral cycle thrown off by 10 days; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: not available/provided to reporter at the time of report completion), intramuscular, Left arm on 06Jan2021 13:45 at single dose for covid-19 immunization. Age at vaccination was 43 years. Patient was not pregnant at the time of vaccination. Medical history included Hoshimotos and Acid reflux. Allergies to medications, food, or other products included sulfa allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications received within 2 weeks of vaccination included omeprazole 40mg, paroxetine 20mg. On 06Jan2021 14:00, the patient experienced swelling and itching of tongue and lips within 15 min, numbness of face the next day (on 07Jan2021) continuing for several weeks. Menstral cycle thrown off by 10 days. The events resulted in emergency room/department or urgent care. Recovered with lasting effects. Benadryl, pepcid and prednisone treatment was received for the events. Events outcome was recovered with sequelae. Information on the lot/batch number has been requested.; Sender's Comments: Based on the strong temporal relationship, the association between the vaccine and the events swollen tongue, lip swelling, tongue pruritus, lip pruritus, hypoaesthesia cannot be completely excluded. Delayed menstruation is probably an intercurrent condition for which the patient's age is also a contributing factor. 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: OMEPRAZOLE; PAROXETINE

Current Illness:

ID: 1048208
Sex: M
Age:
State: VA

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/23/2021
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: passed out; felt lightheaded; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the right arm on 25Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included hypertension, hypothyroidism, high cholesterol. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. On 25Jan2021, the patient felt lightheaded since vaccine. On 02Feb2021, the patient passed out. The patient has never passed out before. He went to the cardiologist on 04Feb2021 and had EKG and review of BP readings and HR readings etc., all checked out ok. Today was 08Feb2021 and still lightheaded. The cardiologist suggested we call you but cannot get through. We were extremely concerned about getting the 2nd vaccine because of reports of worse symptoms with that one. We cannot get through to you and do not know what to do. The 2nd vaccine was scheduled for 15Feb2021.The events resulted in doctor or other healthcare professional office/clinic visit. The patient has not recovered from the events. Treatment was received for the event passed out and ordered Exam-EKG-Holter Monitor. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1048209
Sex: M
Age:
State: IN

Vax Date: 02/01/2021
Onset Date: 02/06/2021
Rec V Date: 02/23/2021
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: Bleeding from right kidney; Bleeding from right kidney; Left kidney is shrunken and function at about 10%; Left kidney is shrunken and function at about 10%; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL8982), via an unspecified route of administration on an unspecified date in Feb2021 (19:00) at single dose (at the age of 89-year-old on Left arm) for COVID-19 immunization. Medical history included arthritic knees and shoulder, prostate cancer, macro degeneration, hearing loss, congestive heart failure, Last right kidney bleed one a year ago (2020 to 2020). The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered:Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient had no known allergies to medications, food, or other products. Patient had Bleeding from right kidney into nephoscimy bag. No noticeable bold from bladder. Left kidney is shrunken and function at about 10%. All events from 06Feb2021 04:00. No treatment was received in response to the events. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1048210
Sex: M
Age:
State: WI

Vax Date: 01/30/2021
Onset Date: 02/01/2021
Rec V Date: 02/23/2021
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: Tremor

Symptoms: Bleeding out of ileostomy; Did not sleep; no appetite; Feeling unwell; achy; tired; weaker; This is a spontaneous report from a contactable consumer (patient's daughter). An 88-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), intramuscular on 30Jan2021 09:45 at SINGLE DOSE in left arm for Prevention. Medical history included Type 2 diabetes diagnosed 10 years ago, Quadruple Bypass surgery in 2003, High blood pressure. He was Diabetic, was a heart patient. Before he had his ostomy, he had colitis that causes the patient to bleed when pooping and his guts were ravaged. His stomach might be weakened from having it for years and years in his 30's, 40's to early 50's. Family medical history included Grandfather died at 42 of bleeding ulcer in his stomach. There were no concomitant medications. Prior Vaccinations within 4 weeks was none. He has allergies to pills but was not taking any. He does not have a fever. She has the names of the pills he is allergic to as follows: Simvastatin, Lisinopril, Losartan, Aggrenox cap. They are listed on his report from (institution name withheld) that he has allergies to. He received his first dose of the Pfizer COVID-19 vaccine on 30Jan2021. There was no prescriber on 30Jan2021 through 01Feb2021, everything was good. On 02Feb2021, that is when his ostomy shot out blood like a faucet when he was taking a shower. He was changing the bandage that day, he was changing his right sided ileostomy bag and he told her that blood shot out of it "like a faucet." On 3Feb2021 was nerve wracking, but there was no blood. He was changing his ostomy pad again on 04Feb2021 and it started bleeding so much that he went to the hospital. He was discharged within a few hours because "they couldn't find anything wrong." He has had colitis for years and has an ileostomy, where they take out a bunch of his colon. This week he has had some funny bleeding in his ileostomy. It was spurting out blood. He had to go to the ER on 4Feb2021 night because it was bleeding and then it stops. People in ER did not know what the bleeding was from. He was bleeding in the ileostomy on 04Feb2021 and 05Feb2021. On 05Feb2021 his ostomy bled a little bit more but it has not bled again since 06Feb2021. She also reports that he feels, " icky, tired, no appetite and achy." The feeling unwell began on 7Feb2021. That worsened since loss of blood made him weaker and worried. When he got back from the hospital/ER, he said they were rude. There was a blizzard. He checked in around 8pm and they discharged him around 11pm that same night. ER visit at the institution on 04Feb2021, 8pm to 11pm and released. They performed CT scan abdomen and Pelvis and IV. Results are unknown. Now he was good. The achiness and tiredness was between persistent and worsened. He was worrying now. She took his forehead temperature and it was good on 7Feb2021. She took everybody's and they were all good. He just feels icky and the blood thing is nerve wracking. He is convinced it is coming back. He was not on a blood thinner or anything listed on the vaccine fact sheet. The patient experienced Feeling unwell on 6Feb2021 with outcome of Not Recovered (Feeling unwell was reported as worsened), achy and tired on 5Feb2021 with outcome of unknown, No appetite on 7Feb202108:30 with outcome of Not Recovered, Bleeding out of ileostomy on 2Feb2021 09:45 with outcome of Recovering, Did not sleep on 7Feb2021 21:30 with outcome of Not Recovered. He has a lot of the risk factors; He is Diabetic, is a heart patient, and has high blood pressure, but he really wanted to get the shot. The patient's primary care provider's nurse do not believe the bleeding had anything to do with the Pfizer COVID-19 vaccine.

Other Meds:

Current Illness:

ID: 1048211
Sex: M
Age:
State: NY

Vax Date: 01/16/2021
Onset Date: 01/24/2021
Rec V Date: 02/23/2021
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: a genitourinary infection (UTI)/diagnosed with a gram negative urinary tract infection; iron level was low at 21. He said a normal iron level for a male is 35; couldn't walk afterwards; Tiredness; another soft tissue injury; Headache; left eye was totally blurry/ one eye blurriness; has severe eye dryness; Injection site pain; Injection site redness; injection site puffiness; stated he noticed at around 2:30PM-3:00PM he had a rash on his hip and back; shingles/ shingles pain; a fever of 100.4 Degree F/Fever; This is a spontaneous report from a contactable pharmacist (patient) reported similar events for two patients. This is the first of two reports. A 64-year-old male patient receive first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), at same age intramuscular in arm left on 16Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included fallen at work and landed on his left side, hitting his head and left knee, a knot on the left side of his head, bleeding from above his left eyebrow, had a left black eye, all on Nov2020, subarachnoid hemorrhage, cataract surgery, using crutches when he walks, in the hospital from Nov2020 to 17Nov2020, pacemaker implanted while he was in the hospital on Nov2020, he couldn't walk on 19Nov2020, 6 stents, 3 cardiac stents on Oct2020, and chicken pox as a young adult. Concomitant medication included aspirin [acetylsalicylic acid], clopidogrel bisulfate (PLAVIX) from unspecified date to 27Jan2021 for 6 stents, paracetamol (TYLENOL, 500 mg, caplets, NDC Number: 5058044936, Lot Number: SJA066 and Expiration Date: Jul2024). The patient said he received his first COVID-19 Vaccine dose on 16Jan2021. He said at the time he pre-medicated with 2 paracetamol. He said he had read afterwards that it is not recommended to pre-medicate with Tylenol before receiving the COVID-19 Vaccine. On 24Jan2021 he developed a fever of 100.4 Degree F (body temperature). He stated his fever was 8 days after receiving his first COVID-19 Vaccine dose. On 27Jan2021, he was urinating blood/blood clots and was admitted to the hospital and treated for a UTI. He was diagnosed with a genitourinary infection (UTI). He clarified on the morning of 27Jan2021 his urine looked darker than normal. He said he went to physical therapy (PT) on 27Jan2021. He said when he came back from PT, and went to the bathroom, there was blood and blood clots in his urine. He said he called his urologist, and his urologist saw him on 27Jan2021. He said his urologist took a urine sample, and his urine sample was clear and negative for nitrites. He clarified his urologist did a digital prostate exam, and his prostate was fine. He said his urologist wanted him to make an appointment for a cystoscopy, and a CAT scan of his abdomen and pelvis. He said after he got home from the urologist, he went to the bathroom, and again had blood and blood clots in his urine. He went to emergency room. While he was in the Emergency Room, he was set-up on CBI (Continuous Bladder Irrigation). He said the urologist did not seem concerned about the amount of blood in his urine. He clarified he was admitted to the hospital, and had in place for approximately 16 hours. Next day (28Jan2021) he was diagnosed with a gram negative urinary tract infection. He said he was given a daily dose of IV Ceftriaxone 1gram on 29Jan2021 and 30Jan2021. He said he was also given a daily dose on 29Jan2021 and 30Jan2021 of IV Ferrlecit 125mg because his iron level was low at 21. He said a normal iron level for a male is 35. On 31Jan2021 he had injection site pain in his left arm, he said the COVID-19 Vaccine injection site was red and puffy. He said the COVID-19 Vaccine injection site pain, redness, and puffiness resolved on the same day, 31Jan2021. He said his second COVID-19 Vaccine dose was given in the same arm (left) on 06 Feb2021. He stated he asked that the second COVID-19 Vaccine dose be given in the same arm (left) because his left arm is his non-dominant arm. He was discharged from the hospital on 30Jan2021, and was given a prescription to take 1 Levaquin 250mg orally for 3 days starting on 31Jan2021. He said the Levaquin 250mg was dispensed in a pharmacy bottle, and did not have the NDC, Lot, and Expiration Date. He said he was also prescribed oral Feosol 325mg, twice a day, starting on 31Jan2021. He provided the Feosol 325mg, NDC Number: 12451-10-17 (unsure if he provided the correct NDC), Lot Number: 201167, and Expiration Date: Jul2022. At around 2:30-3:00PM on 31Jan2021, he developed a rash on his hip and back, saying the hip and back rash were along the same pathway. He said he spoke to a PA (physician assistant) about his rash. He said on 31Jan2021 he had taken 1 oral dose of the Levaquin 250mg. He said the PA discontinued the oral Levaquin 250mg, and changed his prescription to Macrobid 100mg, twice a day, for 5 days. He said he started the Macrobid 100mg, twice a day, on Monday, 01Feb2021. He said he completed the Macrobid 100mg prescription on Sunday, 07Feb2021, and did not have the Macrobid 100mg NDC, Lot and Expiration Date. He clarified his rash was raised, oozy, and looked weird, like a pimple that came to head. He said he spoke to his dermatologist on a video call Sunday, 31Jan2021. He said his dermatologist told him he had shingles and prescribed Valtrex 1gram, three times a day, for 7-10 days. He stated the Valtrex 1gram was dispensed in a pharmacy bottle. He said he took his first Valtrex 1gram dose on Sunday evening, 31Jan2021, and was still taking the Valtrex 1gram as of today (08Feb2021). He had an appointment to see his dermatologist in person on Wednesday, 03Feb2021, but woke up with a wicked headache that morning, so he took paracetamol and went back to sleep. He said when he woke, he still had headache, and his left eye was totally blurry. He said back in Nov2020 he had fallen at work and landed on his left side, hitting his head and left knee. He said his fall left him with a knot on the left side of his head, and he had bleeding from above his left eyebrow, and had a left black eye. He said he also had a subarachnoid hemorrhage. He said he had a CT scan of his head that showed the subarachnoid hemorrhage was contained, so the doctors wanted to just monitor him. He said he was on Effient at the time and the doctors changed him to Plavix. He said he also was taking Aspirin 81mg. He said he was taken off of Plavix on 27Jan2021 when he was admitted to the hospital for having blood and blood clots in his urine. He said he continues to take the Aspirin 81mg daily. He clarified he has been on compensation since his fall in Nov2020. He said he also had cataract surgery 2 years ago. He said he immediately called his eye doctor, and then went to the hospital Emergency Room because he thought he had a stroke. He said the Emergency room did a CAT scan and CTA of his head, which were both normal. He said a neurologist saw him in the Emergency Room, and said since it was a headache with one eye blurriness, he should see his eye doctor. He said the neurologist told him if he had a headache and both eyes were blurry, it would more likely have been a stroke. He stated when he was discharged from the Emergency Room on 03Feb2020, he went directly to his eye doctor. He said his eye doctor did several tests: field of vision, a sonogram, pictures of his left eye, and a dilation of his eyes. He said he had an eye test where he looked at a half circle and clicked a counter when he saw dots, and another eye test where he stared at something that looked like a hot air balloon, while the eye doctor took measurements. He said the eye doctor also measured his eye pressure, which was normal. He said he was at his eye doctor's office for a good couple of hours. He said his eye doctor told him that he has little white dots on the background area of his eyes that indicates he has severe eye dryness. He said his left eye is much worse than right eye. He said his eye doctor asked him if he took Crack, or Cocaine, or any kind of opioids in the last few weeks. He said he told his doctor he took 1 dose of an opioid on 31Jan2021 because of the shingles pai

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; PLAVIX; TYLENOL

Current Illness:

ID: 1048212
Sex: F
Age:
State:

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/23/2021
Hospital: Y

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: lightheaded; experience funny feeling in face; HA; Vaccine Related Anxiety; This is spontaneous report from a Non-contactable Other Health Professional. An 87-year-old female patient received first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME, lot# EM9809), intramuscularly in right arm on 04Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minutes waiting period after the injection, the patient experienced funny feeling in face, lightheaded and HA (headache) on an unspecified date with outcome of unknown. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. Treatment included: no therapy. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine Related Anxiety (include misc mental health). Patient left at 15:40pm accompanied by husband. Follow up with PMP regarding blood pressure. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. 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: 1048213
Sex: F
Age:
State: OH

Vax Date: 02/05/2021
Onset Date: 02/01/2021
Rec V Date: 02/23/2021
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: Site is painful to touch; looks like cellulitis/possible cellulitis; body aches; swollen at injection site; red at injection site; warm at injection site; armpit lymph node still swollen; This is a spontaneous report from a contactable nurse (patient). A female patient not pregnant of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in right arm on 05Feb2021 18:00 at single dose for COVID-19 immunization. Medical history included Allergies: sulfa. Other medical history: none. Concomitant medication in two weeks included trazodone, omeprazole and BCP. The patient previously took oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and experienced Allergies, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Intramuscular 18Jan2021 12:00 PM in right arm for COVID-19 immunization. Facility type vaccine: Workplace clinic. If other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: No. After second injection, right arm became red, warm and swollen at injection site 6 hrs later. After 12 hours, increased redness, warmth, swelling and total body aches. After 24 hours, same as above. After 42 hours, injection site right arm very red, swollen. looks like cellulitis. 72 hours later saw PCp for possible cellulitis vs site reaction. Site is painful to touch, very red, hot, swollen. armpit lymph node still swollen but only pink in color. Script for Keflex sent to pharmacy. Event treatment: cefalexin (KEFLEX) Po. All the events were not recovered. AE resulted in Doctor or other healthcare professional office/clinic visit.; Sender's Comments: The reported event of suspected cellulitis with injection site reactions was possibly related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), considering the temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: TRAZODONE; OMEPRAZOLE

Current Illness:

ID: 1048214
Sex: F
Age:
State: MD

Vax Date: 01/23/2021
Onset Date: 01/01/2021
Rec V Date: 02/23/2021
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: angina; angina; Fever; Chills; Cough; Sore throat; runny nose; Nausea; Diarrhea; Headache; arm heavy; muscle aches and heaviness; muscle aches and heaviness; she just woke up feeling sick; fevers may come like a hot flash; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown), via an unspecified route of administration on 23Jan2021 at a single dose, in left arm for COVID-19 immunization. Medical history included fibromyalgia diagnosed years ago, angina (some stents). There were no concomitant medications. On Jan2021, the patient experienced angina, fever, chills, cough, sore throat, runny nose, nausea, diarrhea, headache, arm heavy, muscle aches and heaviness, and she just woke up feeling sick. The patient experienced multiple AEs after 1st dose of vaccine (received on 23Jan2021). The patient experienced angina later last week. Clinical course: The patient has misplaced card, states her second appointment for the second dose is this Saturday. Caller stated she started having these experiences the day after she was vaccinated with her first dose, received first dose of 23Jan2021. She had fevers, chills, cough- not an aggressive cough, a funny kind of sore throat- like something wrapped around her throat like the muscles of her throat, no congestion but does have a runny nose, states she has some nausea, no vomiting but feeling like she needed to vomit and diarrhea, and headache. The symptoms started about the third day after the vaccine, started with the fevers, stated the fevers may come like a hot flash, lasts seconds even, states you know it is a fever because your bones get hot. These symptom's did not attack her body at one time. Her whole arm stayed heavy, the whole arm not just the injection site, for almost 10 whole days. She previously had fibromyalgia and thought maybe that made the symptoms worse. She had muscle aches and feeling heavy. Her symptoms were spread out over time, no two were at the same time, sore throat was one of the last things. Diarrhea was ongoing, not a runny diarrhea but it was enough to empty stomach and was soft. She was a medic in the military, worked as a Nurse, clarifies she was an LPN and took all the underlying courses to be a PA. One of the issues she found, she thought it may be deadly, as a prior healthcare person and in tune to her body, the people who are in the nursing homes may not be mobile, states so one of the things she felt was just feeling really really sick, that she couldn't put a pin point on it, states she just woke up feeling sick, states she had the urge to get out of bed and got up and after she got up the feeling left her, states a person in the nursing home may just feel really bad and cannot get up, thinks a protocol should be that the people that are immobile should be required to move or if they can't get up they need to move their muscles, people with these symptoms need to get up and get moving. She also has history of angina and a stent, has not had angina in a while and had 3 days where she thought she may need to go talk to her doctor. It was on Wednesday, Thursday and Friday this week. States one of her friends, 92 years old, said she got high after the vaccine and didn't want to talk to anybody, states it was her first dose, she was kind of leery about the 2nd shot, feels like this was kind of aggressive. She had both doses and had no symptoms, but 92-year-old female had no symptoms right away, other than normal body aches and pains, but the next day was high as a kite. Her son has heart disease and she advised him not to take it right now. They were losing a lot of people to the vaccine in nursing homes, no further information provided. This could be affecting good hearts more than damaged hearts, read that this virus likes to work in parts of the body that are already damaged. The outcome of event diarrhea was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, a causal association between the reported angina and BNT162B2 cannot be completely excluded. Note however, that the patient has underlying angina with some stents that may also have contributed to the event. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1048215
Sex: F
Age:
State: CA

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 02/23/2021
Hospital: Y

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: Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), at same age, via an unspecified route of administration in left arm on 05Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included metoprolol. The patient previously took ampicillin and experienced drug allergy. The patient experienced dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side. Right side weakness. Only one eye blinks right eye droopy, all on 05Jan2021 10:00. Events resulted in emergency room visit. The patient was hospitalized for 1 days for all events. It was unknown whether treatment was received for all events. Patient is 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. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 08Feb2021. The outcomes of events were not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side, right side weakness, only one eye blinks right eye droopy, and the administration of the COVID 19 vaccine, BNT162B2, administration, based on the reasonable 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 RA, IEC, as appropriate.

Other Meds: METOPROLOL

Current Illness:

ID: 1048216
Sex: F
Age: 49
State:

Vax Date: 11/17/2020
Onset Date: 11/01/2020
Rec V Date: 02/23/2021
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: Throat felt it would close up; Bell's palsy/my face appeared droopy/water spilled down my face when I tried to drink/face was worse/couldn't close eyes/can not blow or whistle; Heart racing; I felt kind of off, not my normal self/didn't feel right; Could not swallow/needs to drink with a straw; Could not breathe; Pain was up to her ear; Pain was up to her ear; This spontaneous case was received on 10-Feb-2021 from other non-health professional (consumer) via Agency (reference number: SEQW21-00450) and concerned a 49-year-old, female patient. The patient's concurrent conditions included asthma, acid reflux, vitamin K deficiency and fibromyalgia. The patient's concomitant medications included unspecified Nexium (esomeprazole), Cartia XT (diltiazem hydrochloride), Zyrtec (cetirizine hydrochloride) and unspecified multivitamin, all used for an unreported indication. On 17-Nov-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location, route of administration: not reported) as flu prophylaxis. The batch number was not reported. On 18-Nov-2020, next day after receiving Flucelvax Quadrivalent, the patient felt kind of off and not normal self. The patient's heart was racing. On 19-Nov-2020, two days after receiving Flucelvax Quadrivalent, the patient did not feel right and when she went to take her medicine, the water spilled down her face when she tried to drink. The patient's face appeared droopy. On 20-Nov-2020, three day after receiving Flucelvax Quadrivalent, the patient went to emergency room (ER) as her face was worse. The patient could not close her eye and throat felt it would close up. It was reported that the patient had Bell's palsy. On an unspecified date in Nov-2020 (since as reported), the patient went to the doctor and asked if this would be permanent and the doctor told her that they did not know and that they would need to wait and see. There was nothing that could be done. The patient reported that she had disabled son who liked blowing bubbles and when he asked her to blow bubbles for him, she remembered that she could not blow or whistle. The patient needed to drink with a straw and was afraid that this would last for the rest of her life. The patient also could not breathe, she could not swallow, and the pain was up to her ear. At the time of initial reporting on 10-Feb-2021, the patient was recovering from all events since that was not as bad as it was before. The reporter did not provide causality assessment. The event of 'Bell's palsy' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department. Company comment: A 49-year-old patient was administered Flucelvax Quadrivalent. Next day after receiving Flucelvax Quadrivalent, the patient developed palpitations and felt kind off and not normal self. Two days after receiving Flucelvax Quadrivalent, the patient did not feel right and when she went to take her medicine, the water spilled down her face when she tried to drink. The patient's face appeared droopy. Three day after receiving Flucelvax Quadrivalent, the patient went to emergency room (ER) as her face was worse. The patient could not close her eye and throat felt it would close up. It was reported that the patient had Bell's palsy. The patient also could not breathe, she could not swallow, and the pain was up to her ear. Causal role of the suspect vaccine was confounded for dyspnoea and throat tightness, since the patient's concurrent conditions included asthma. However, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for all events. Per Brighton collaboration criteria, presented information correspond to level 1 diagnostic certainty for Facial paralysis.; Sender's Comments: A 49-year-old patient was administered Flucelvax Quadrivalent. Next day after receiving Flucelvax Quadrivalent, the patient developed palpitations and felt kind off and not normal self. Two days after receiving Flucelvax Quadrivalent, the patient did not feel right and when she went to take her medicine, the water spilled down her face when she tried to drink. The patient's face appeared droopy. Three day after receiving Flucelvax Quadrivalent, the patient went to emergency room (ER) as her face was worse. The patient could not close her eye and throat felt it would close up. It was reported that the patient had Bell's palsy. The patient also could not breathe, she could not swallow, and the pain was up to her ear. Causal role of the suspect vaccine was confounded for dyspnoea and throat tightness, since the patient's concurrent conditions included asthma. However, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for all events. Per Brighton collaboration criteria, presented information correspond to level 1 diagnostic certainty for Facial paralysis.

Other Meds: CARTIA XT; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; MULTIVITAMIN [VITAMINS NOS]

Current Illness: Acid reflux (oesophageal); Asthma; Fibromyalgia; Vitamin K deficiency

Date Died:

ID: 1048399
Sex: F
Age: 102
State: PA

Vax Date: 02/01/2021
Onset Date: 02/10/2021
Rec V Date: 02/23/2021
Hospital:

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

Lab Data:

Allergies: Penicillin

Symptom List: Pain in extremity

Symptoms: Stopped eating and drinking and died

Other Meds: Prilosec 10 mg/daily,Synthroid .110, daily multivitamin

Current Illness: Covid-19 (Pos. antibody 12/20/2020), Dementia

ID: 1048400
Sex: F
Age: 40
State:

Vax Date: 02/22/2021
Onset Date: 02/23/2021
Rec V Date: 02/23/2021
Hospital:

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

Lab Data:

Allergies: No

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

Symptoms: Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminophen, I felt very dizzy, nauseous, stay up, couldn't talk, after I drank cold water, I started with profuse sweating followed by chills, also had lower abdominal pain and pain on the left side of the chest. I went to the bathroom and did not have diarrhea. I was finally able to get up with help from my wife. Slow walking. The event lasted about 15 minutes. Since then I've take acetaminophen every 4 hrs.

Other Meds: No

Current Illness: Sinusitis

ID: 1048641
Sex: M
Age: 1
State: DC

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: the consumer developed a "measles-like reaction" following MMR-11 administration; This spontaneous report was received from a nurse practitioner referring to a 12 months old male patient. There were none concomitant medication, pertinent medical history and drug reactions and allergies. On 04-FEB-2021, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: rHA) (strength was not provided, lot# was T001211 and expiration date was 20-NOV-2021), 0.5 ml with sterile diluent (manufacturer unknown) (strength, lot# and expiration date was not provided) 0.5 (unit not provided) subcutaneously for immunization. On the same day, the patient developed a measles-like reaction following measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administration. Medical attention was sought. Ibuprofen was given as treatment. The outcome of the event was not recovered. The causality between the event and both therapies was not provided. Upon internal review, the event of measles was determined to be medically significant.

Other Meds:

Current Illness:

ID: 1048642
Sex: U
Age: 27
State: NC

Vax Date: 12/23/2019
Onset Date: 12/26/2019
Rec V Date: 02/23/2021
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: Did not take the fourth dose of Vivotif; Took third dose of Vivotif on day 4; Spontaneous report received on 06JAN2020. A pharmacist reported that a consumer "took third dose of Vivotif on day 4" (PT: Inappropriate schedule of product administration) and "did not take the fourth dose of Vivotif" (PT: Incomplete course of vaccination) while being on Vivotif for immunisation. The consumer took first, second and third dose of Vivotif on 23DEC2019, 25DEC2019 and 26DEC2019 respectively. It was reported that the consumer did not take the fourth dose. Action taken with Vivotif with respect to the reported events was not applicable. The outcome of the reported events was unknown. Company Comment: A consumer took third dose of Vivotif on day 4" (Inappropriate schedule of product administration) and also did not take the fourth dose of Vivotif (Incomplete course of vaccination). Considering the nature of the events, the causality of both the events is not applicable to Vivotif.; Sender's Comments: A consumer took third dose of Vivotif on day 4" (Inappropriate schedule of product administration) and also did not take the fourth dose of Vivotif (Incomplete course of vaccination). Considering the nature of the events, the causality of both the events is not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 1048643
Sex: F
Age:
State: OR

Vax Date:
Onset Date:
Rec V Date: 02/23/2021
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:

Symptom List: Vomiting

Symptoms: Took her last dose of Vivotif a day early; Spontaneous report received on 07JAN2020. A female consumer "took her last dose of Vivotif a day early" (PT: Inappropriate schedule of product administration) after staring Vivotif course for immunization. It was reported that the consumer took her last dose of Vivotif a day early. Action taken with Vivotif with respect to event was not applicable. The clinical outcome of the reported event was unknown. Company Comment: A consumer took her last dose of Vivotif a day early (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not applicable.; Sender's Comments: A consumer took her last dose of Vivotif a day early (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not applicable.

Other Meds:

Current Illness:

ID: 1048644
Sex: M
Age:
State:

Vax Date: 01/04/2020
Onset Date:
Rec V Date: 02/23/2021
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: Missed second dose of Vivotif; Spontaneous report received on 07JAN2020. A male consumer reported he had "missed second dose of Vivotif" (PT: Product dose omission). He was receiving Vivotif for immunisation. The consumer took his first dose of Vivotif on 04JAN2020 and then missed second dose of Vivotif. 48 hours had passed after his second dose was due at the time of the report. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer missed taking second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is not applicable to Vivotif.; Sender's Comments: A consumer missed taking second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 1048645
Sex: F
Age:
State: MI

Vax Date: 01/06/2020
Onset Date: 01/06/2020
Rec V Date: 02/23/2021
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: Took one dose of Vivotif while taking minocycline daily; Spontaneous report received on 07JAN2020. A nurse reported that an adult female (age in between 20-30 years) consumer "took one dose of Vivotif while taking minocycline daily" (PT: Labelled drug-drug interaction medication error). He was receiving Vivotif for immunisation and minocycline for acne. The consumer took first dose of Vivotif on 06JAN2020. She was also taking minocycline daily before starting Vivotif for acne. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer who was taking minocycline daily for acne took one dose of Vivotif (Labelled drug-drug interaction medication error). Vaccination with Vivotif should be postponed during and for at least three days before and after antibiotic treatment. Considering the nature of the event, the causality of Labelled drug-drug interaction medication error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer who was taking minocycline daily for acne took one dose of Vivotif (Labelled drug-drug interaction medication error). Vaccination with Vivotif should be postponed during and for at least three days before and after antibiotic treatment. Considering the nature of the event, the causality of Labelled drug-drug interaction medication error is assessed as not applicable to Vivotif

Other Meds:

Current Illness:

ID: 1048646
Sex: U
Age: 64
State: AR

Vax Date: 01/06/2020
Onset Date: 01/12/2020
Rec V Date: 02/23/2021
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: Missed last dose of Vivotif; Spontaneous report received on 13JAN2020. A pharmacist reported that a 64-year-old consumer "missed last dose of Vivotif" (PT: Product dose omission). The consumer was receiving Vivotif for immunisation. The consumer started Vivotif on 06JAN2020 and took three doses as per schedule but forgot to take the last dose, which was due on 12JAN2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer forgot to take the last dose and missed last dose of Vivotif (missed dose). The causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer forgot to take the last dose and missed last dose of Vivotif (missed dose). The causality of missed dose is assessed as not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 1048647
Sex: U
Age:
State: CA

Vax Date: 01/12/2020
Onset Date: 01/13/2020
Rec V Date: 02/23/2021
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: Took Vivotif two days in a row; Spontaneous report received on 13JAN2020. A pharmacist reported that a consumer "took Vivotif two days in a row" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunisation. The consumer took first and second dose of Vivotif on 12JAN2020 and 13JAN2020 respectively. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer took first dose of Vivotif and the very next day, took the second dose (Inappropriate schedule of product administration). Vivotif doses should be taken every alternate day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first dose of Vivotif and the very next day, took the second dose (Inappropriate schedule of product administration). Vivotif doses should be taken every alternate day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 1048648
Sex: U
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 02/23/2021
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: Took unrefrigerated Vivotif; Spontaneous report received on 14JAN2020. A pharmacist reported that a 50-year-old consumer who "took unrefrigerated Vivotif" (PT: Product storage error). The consumer was receiving Vivotif for immunisation. The consumer completed the course of unrefrigerated Vivotif. The pharmacist assumed that the consumer had started Vivotif approximately 8 days ago. She could not confirm the lot number of Vivotif and stated that the vaccine was likely left unrefrigerated since 17DEC2019. Moreover, she confirmed that the consumer took Vivotif every other day. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer took unrefrigerated Vivotif (Incorrect product storage). Considering the nature of the event, the causality of incorrect product storage is assessed as not applicable to Vivotf.; Sender's Comments: A consumer took unrefrigerated Vivotif (Incorrect product storage). Considering the nature of the event, the causality of incorrect product storage is assessed as not applicable to Vivotf.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm