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: 0925588
Sex: F
Age: 33
State: CO

Vax Date: 12/23/2020
Onset Date: 12/28/2020
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies: pineapple which pt admits to eating a little of the day before

Symptom List: Dysphagia, Epiglottitis

Symptoms: Localized reaction near injection site 5 days post vaccination. Red/defined/raised/itchy. Improved on day 6, still some itching which pt took antihistamines for.

Other Meds: acyclovir, sertraline

Current Illness: n/a

ID: 0925589
Sex: F
Age: 62
State: AK

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/07/2021
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: Anaphylaxis to Tylenol Sinus Severe Congestion Daytime formula Hives to Iodine, Aleve, Nexporium Multiple seasonal allergies. H/o severe reaction to an epidural, specific unknown. H/o mild reaction to influenza vaccine but has had since without problem.

Symptom List: Anxiety, Dyspnoea

Symptoms: Approximately 25-30 minutes after administration of vaccine, patient complained of a soreness of her right throat and felt a sensation of swelling. Clinical exam revealed a small area of erythema on right side of posterior pharynx. No edema was noted. No skin rash or changes. No soft tissue and no facial/throat swelling. Lungs were CTA bilaterally. VS remained stable. Treated with Benadryl 25mg capsule PO x1. Symptoms resolved within 20 minutes. Patient remained in observation for an additional hour. Discharged home in stable condition, symptoms completely resolved. Given PO Benadryl to take home use prn.

Other Meds: Onglyza 5mg Metformin ER 500mg Losartan 50mg/HCTZ 12.5mg Jardiance 25mg Gabapentin 300mg Fluticasone 250mcg/salmeterol 50mcg INH Albuterol INH Epipen 0.3mg/0.3mL autoinjector

Current Illness: No known illness.

ID: 0925590
Sex: F
Age: 50
State: NC

Vax Date: 12/16/2020
Onset Date: 12/16/2020
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pfizer EK5730) receipt 16 DEC 2020. She reports no immediate reaction except experienced a dry throat which she noted after her 30 minute wait, but no urticaria, SOB, wheezing, oral/face/throat/tongue edema, flushing, pruritic, CP n/v/d. She states about 3 hours later she developed a dermatitis initially to her legs. The lesions were raised, pink, initially nonpruritic, fixed but no vesicles, pustules or bruising. She took a shower which exacerbated the symptoms with erythematous patches and severe burning sensation. She reports she was seen in ER and her spouse noted lesions to her neck and ears. Her eyes felt swollen. She left ER due to the wait and obtained Benadryl OTC. She saw her PCP in the morning. She received IM dexamethasone and oral prednisone dose pack. She continued to not feel well. She experienced heart palpitations, feeling hot and flushed, fatigue and headache which she treated with Tylenol. She treated the dermatitis with Zyrtec 10-20 mgs q1-2 x daily, but sometimes took Benadryl. Last dose was Benadryl at midnight, Zyrtec 10 at 0600 and has one day of prednisone left. She also experienced bilat tingling in her feet starting day 5. which the left resolved but her right foot continued. She has no paresis, paralysis, altered gait, tripping or fall, difficulty emptying her bladder. She saw PCP on 05 January. ESR was normal . Overall symptoms improved but continued r foot numbness, pain to her legs. She reports PCP ordered CXR and abdominal series which were normal.

Other Meds:

Current Illness:

ID: 0925591
Sex: F
Age: 50
State: OH

Vax Date: 12/30/2020
Onset Date: 01/07/2021
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies: Milk, Keflex

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Patient woke up on 1/7/2021 (8 days after vaccination) with a large red dot at the injection site. The area itches.

Other Meds: Zoloft, Synthroid, lisinopril, omeprazole, Zocor, elderberry, zinc, Vitamin C, Vitamin D3

Current Illness: None

ID: 0925592
Sex: F
Age: 67
State: KY

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies: Epinephrin for dental work

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

Symptoms: At 8:30 pm , sudden increase in Blood pressure 192/90 , pulse rate at 108 Palpitation Lasted for 30-45 min then gradual decline to normal at 130/80 Laid in bed & drinking water

Other Meds: Lipitor 10 mg once a day Multivitamin Vit C 500 mg once a day

Current Illness: None

ID: 0925593
Sex: M
Age: 45
State: GA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/07/2021
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: NKDA

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

Symptoms: I am an anesthesiologist reporting my own event: injection received 0900. At 1400 I began low grade fever and not feeling well. By 1600 I had extreme fatigue and severe mental fogginess. This fogginess lasted approximately 24 hours. Other reactions included chills, fever, myalgia, arthralgia, headache as expected. I feel the mental effects could put patients in danger if healthcare practitioners are not aware of the possibility of this and receive the vaccine while on duty. I did not experience this with the first dose.

Other Meds: Advair, albuterol, omeprazole, singulair

Current Illness: none

ID: 0925594
Sex: F
Age: 56
State: NY

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/07/2021
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: Pyrexia, White blood cell count decreased

Symptoms: Reports Itchy throat, difficulty breathing. Has a history of multiple allergies. Transferred to ED. Symptoms resolved.

Other Meds:

Current Illness:

ID: 0925595
Sex: F
Age: 32
State: MO

Vax Date: 12/28/2020
Onset Date: 01/01/2021
Rec V Date: 01/07/2021
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: I had a COVID vaccine on Dec 28th. My arm hurt a little but nothing bad. I felt like shot was given sub q at the time but didn?t worry about it. It was little red, but as the week has gone by it have gotten red, larger, firm.

Other Meds:

Current Illness:

ID: 0925596
Sex: F
Age: 32
State: NJ

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Soreness in arms and nausea.

Other Meds: Aurovela 24 FE, Valacyclovir

Current Illness: None

ID: 0925597
Sex: F
Age: 31
State: ND

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/07/2021
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: N/A

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Muscle aches, headache, nausea, 1 episode of passing out

Other Meds: Multivitamin

Current Illness: N/A

ID: 0925598
Sex: F
Age: 44
State: UT

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies: Morphine

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

Symptoms: Patient has history of anaphaylyxsis, she pre medicated at home this morning with Zyrtec 20 mg and Famotadine 40 mg prior to going to F13 clinic for her covid vaccination. Patient stayed an hour after vaccine administration to be monitored. She came to ER for further monitoring and allergic reaction concerns and received 2 doses of 25 mg diphenhydramine. She was reporting itching of her trunk and arms, itchy throat, and hot flashes. She was monitored in ER, she maintained airway and stayed on RA the entire visit.

Other Meds:

Current Illness:

ID: 0925599
Sex: M
Age: 39
State: NJ

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/07/2021
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: no

Symptom List: Rash, Urticaria

Symptoms: Pt felt fine until 24 hrs later when he experienced chills lasting though the night and now he has severe headache.

Other Meds: Cinthroid

Current Illness: no

ID: 0925600
Sex: F
Age: 53
State: PA

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies: Chlorhexidine

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

Symptoms: - approximately 1 hour after receiving the vaccination, the injection site was hard, swollen, red circle approximately size of a half dollar, and sore to touch. now, 48 hours after ae currently on going. - later in the evening, same date of vaccination, I felt itchy all over, itchiness resolved approximately 3 hours after itching began.

Other Meds: Synthroid 50mg

Current Illness: none

ID: 0925601
Sex: F
Age: 61
State: OH

Vax Date: 12/29/2020
Onset Date: 12/31/2020
Rec V Date: 01/07/2021
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: sulfa

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

Symptoms: Day 2 diahrea and vomited for 1 hr. (thought food poisoning) on day 8 right arm swelled up size approximately 2" x 3". On day 9, 2/3 of right arm swollen, firm and warm to touch. Showed 2 physicians, advised to apply topical benadryl and oral benadryl taken.

Other Meds: multi vitamin, Vit D3, VitC, zinc

Current Illness: none

ID: 0925602
Sex: M
Age: 24
State: MS

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/07/2021
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: Chills, fever, aches

Other Meds:

Current Illness:

ID: 0925603
Sex: F
Age: 29
State: MI

Vax Date: 12/29/2020
Onset Date: 01/05/2021
Rec V Date: 01/07/2021
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: Augmentin

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

Symptoms: Pt received vaccine on 12/29/2020. On 01/05/2021, she noted large, approximately 11cm, red, swollen, warm and painful area at the site of the injection.

Other Meds: None

Current Illness: None

ID: 0925604
Sex: F
Age: 30
State: WI

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/07/2021
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: Biaxin- rash, flagyl-rash

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

Symptoms: Shortly after receiving the vaccine: lightheadedness lasting a few hours. The day after sore arm at the injection site. 3 days after until present: major fatigue.

Other Meds: Norethindrone birth control

Current Illness:

ID: 0925605
Sex: F
Age: 35
State: MO

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Moderate tingling to arms, itching throat, and flushing. Vital Signs 1315 - HR 91, RR 24, SPO2 99% Vital Signs 1320 - BP 125/88, HR 86, RR 20, SPO2 100% Vital Signs 1335 - BP 109/80, HR 84, RR 16, SPO2 98% Vital Signs 1345 - BP 123/90, HR 89, RR 16, SPO2 100%

Other Meds:

Current Illness:

ID: 0925606
Sex: F
Age: 53
State: MT

Vax Date: 12/29/2020
Onset Date: 01/07/2021
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies: Latex

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Cellulitis - redness, swelling, painful lump at injection site aprox 4 inch diameter

Other Meds: None

Current Illness:

ID: 0925607
Sex: F
Age: 50
State: NV

Vax Date: 12/29/2020
Onset Date: 01/06/2021
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies: Benzoperoxide

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

Symptoms: Injection site redness or pain

Other Meds: Levothyroxine, Progesterone, Aleve, Culturelle

Current Illness: none

ID: 0925608
Sex: F
Age: 25
State: FL

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies: Latex

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

Symptoms: Hives, full body rash

Other Meds: Lexapro

Current Illness: No

ID: 0925623
Sex: F
Age:
State: OR

Vax Date: 05/14/2009
Onset Date: 05/14/2009
Rec V Date: 01/07/2021
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: had hives from the Pneumovax vaccine; This spontaneous report was received from a medical assistant via Pfizer (Mfr. Control No. 2020498664) and refers to a female patient of unknown age. Her concurrent condition included diabetes mellitus type 2. The patient had severe allergies to shellfish causing lips and throat swelling, penicillin and iodine allergy, an egg allergy (it was noted on the patient's medical chart that she was able to eat small amounts of egg). The reporter stated the patient also has the allergy to the flu vaccine. On 04-MAY-2009, the patient was vaccinated with the flu vaccine. On the same date, the patient experienced severe reaction to an old flu shot because the flu shot was grown in egg. It was further clarified that the patient experienced hives, shortness of breath and had to have an electrocardiogram (EKG; results not provided), because her heart did funny things (not further clarified). On 14-MAY-2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, route of administration, lot number and expiry date were not reported) for prophylaxis. On 14-MAY-2009, the patient experienced hives. The outcome of the event was reported as recovered/resolved on an unspecified date. The reporter considered the event to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).

Other Meds: influenza virus vaccine (unspecified)

Current Illness: Allergy to vaccine; Egg allergy (the patient is able to eat small amounts of egg); Iodine allergy; Penicillin allergy; Type 2 diabetes mellitus

ID: 0925624
Sex: U
Age:
State: TX

Vax Date: 12/17/2020
Onset Date: 12/17/2020
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No additional AE reported; A vaccine specialist reported ROTATEQ was improperly stored and administered; This spontaneous report has been received from a consumer concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported. On 17-DEC-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) Lot # 1661000 expiration date 13-MAY-2021 for prophylaxis(dosage regimen and anatomical location were not reported). The temperature was reported to had been at 46.8?Fahrenheit (F) for 10 minutes. No additional adverse events were reported. There was digital data logger involved and no previous temperature excursion was reported.

Other Meds:

Current Illness:

ID: 0925625
Sex: U
Age:
State: CA

Vax Date: 12/16/2020
Onset Date: 12/16/2020
Rec V Date: 01/07/2021
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: No additional AE/PQC reported.; improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 16-DEC-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # T015598, expiration date 02-NOV-2021, (exact dose, injection site and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 20.5 degrees Fahrenheit for 1 hour and 54 minutes. The digital data logger was involved in recording the temperature excursion details. Administered dose of vaccine experienced the previous temperature excursion of 6 to 14 (12.3) degrees Fahrenheit for 23 hours. There was no additional adverse events reported.

Other Meds:

Current Illness:

ID: 0925626
Sex: U
Age:
State: IL

Vax Date: 02/07/2017
Onset Date:
Rec V Date: 01/07/2021
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: herpes zoster; post herpetic neuralgia; vision problems; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided. On or about 07-FEB-2017, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to the patient vaccination, the patient presented herpes zoster, post herpetic neuralgia and vision problems. As a direct and proximate result, the patient had been treated by a medical provided. Additionally, the symptoms had been resulted in physical limitation not present prior vaccination. The patient sustained severe and permanent injuries; the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. As a direct and proximate result, the patient suffered severe and permanent physical injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reporter considered the event of herpes zoster, post herpetic neuralgia and vision problems to be related to zoster vaccine live (ZOSTAVAX).

Other Meds:

Current Illness:

ID: 0925627
Sex: U
Age:
State: AK

Vax Date:
Onset Date:
Rec V Date: 01/07/2021
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: outbreaks of herpes zoster; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided. On an unspecified date, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to the patient vaccination, the patient presented multiple outbreaks of herpes zoster. As a direct and proximate result, the patient had been treated by a medical provided. Additionally, the symptoms had been resulted in physical limitation not presented prior vaccination. The patient sustained severe and permanent injuries; the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. As a direct and proximate result, the patient suffered severe and permanent physical injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reporter considered the event multiple outbreaks of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).

Other Meds:

Current Illness:

ID: 0925628
Sex: F
Age: 78
State: NC

Vax Date: 07/09/2019
Onset Date: 07/09/2019
Rec V Date: 01/07/2021
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: pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included herpes zoster (first experienced when she was 21 years old and it developed 2 to 3 times a year since then). On 9th July 2019, the patient received the 1st dose of Shingrix. On 9th July 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On 9th July 2019, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional information was provided as follows: The patient reported pain at the injection site during administration of Shingrix in the left deltoid and said it lasted a few seconds and then resolved. For tolerance of 2nd dose, refer case US2020245637. The reporter consented to follow up. ; Sender's Comments: US-GLAXOSMITHKLINE-US2020245637:same patient

Other Meds:

Current Illness:

ID: 0925629
Sex: M
Age: 74
State: GA

Vax Date: 12/07/2020
Onset Date: 12/01/2020
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: rash spread on his face to his cheeks/rash spread to cheeks on face; This case was reported by a consumer via call center representative and described the occurrence of rash aggravated in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of rash (On 10th September 2020, the patient received 1st dose, please refer the case US2020248551.). Concurrent medical conditions included rash. On 7th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix, the patient experienced rash aggravated. On an unknown date, the outcome of the rash aggravated was not recovered/not resolved. It was unknown if the reporter considered the rash aggravated to be related to Shingrix. Additional details were provided as follows: After the first Shingrix, the patient experienced rash on his forehead. The rash was unresolved when he received his second vaccine. After the second vaccine, he reported, the rash spread on his face to his cheeks. The patient permission to contact HCP; Sender's Comments: US-GLAXOSMITHKLINE-US2020248551:same patient

Other Meds:

Current Illness: Rash

ID: 0925630
Sex: F
Age:
State: MN

Vax Date: 10/19/2020
Onset Date: 10/01/2020
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: performs a lot of activity with the arm the pain worsens at night / unable to move the arm due to the pain; had pain and some swelling at site of injection / pain did not diminish but worsened; swelling at site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 7TB74, expiry date unknown) for prophylaxis. On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, injection site swelling and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site swelling and injected limb mobility decreased to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported, however it could be 74 or 75 years. The patient experienced pain and some swelling at site of injection, first 4 to 5 days after the vaccination. Over the weeks, pain did not diminish but worsened and if the patient performs a lot of activity with the arm the pain worsens at night. Recently during the time of reporting, the patient was unable to move the arm due to the pain. The reporter consented to follow-up. This case had been linked with US2020231855, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020231855:same reporter

Other Meds:

Current Illness:

ID: 0925631
Sex: F
Age:
State: FL

Vax Date: 11/19/2020
Onset Date:
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Face swelled / with eyes almost shut; eye almost shut; This case was reported by a nurse via call center representative and described the occurrence of facial swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included multiple allergies (unspecified allergies). On 19th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced facial swelling and swelling of eyelid. On an unknown date, the outcome of the facial swelling and swelling of eyelid were unknown. The reporter considered the facial swelling and swelling of eyelid to be related to Shingrix. Additional details were provided as follows: The patient was reporter's mother. The patient had a medical history or unspecified allergies The age at vaccination was not reported. The patient was vaccinated with Shingrix and her face swelled. The reporter showed the GSK representative pictures of patient's face which was swollen and her eyes looked, in the picture, to be almost shut. The nurse was asking the sales representative if her mother should get the 2nd Shingrix shot or not. The reporter consent to follow up. No further information was provided.

Other Meds:

Current Illness: Multiple allergies (unspecified allergies)

ID: 0925632
Sex: F
Age:
State: WI

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/07/2021
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: worry; frustration; regrets/wishing she would have never taken it; phlegm; can't talk; taking her voice, she felt like she was losing her voice; scary/"scaring" her; coughing/cough; difficult for her to catch her breath/lost her breath, couldn't catch her breath/couldn't breath; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date 30Apr2021) intramuscular on 29Dec2020 09:16 at 0.3 mL, single for Covid-19 immunization in a hospital. Medical history included diabetic, allergy reactions, blood pressure (abnormal), cholesterol (abnormal); all ongoing, and reaction to dust. Concomitant medications included ongoing amlodipine;hydrochlorothiazide;valsartan for blood pressure, ongoing potassium for unspecified indication, BP pills (unspecified) and has cholesterol medications. The patient informed that yesterday (29Dec2020), she got the COVID vaccine shot at work, received it at 9:16 am and was monitored for 30 minutes post administration. The patient went to work and was holding the babies. The patient worked in transport in the NICU at a hospital. Few hours after the injection, while working in the NICU, she experienced coughing to the point where it was difficult for her to catch her breath. The patient started coughing so bad, she had no control. She mentioned trying to drink water and continued coughing more. The patient lost her breath, couldn't catch her breath, she had to call for the charge nurse (manager), as she couldn't breath and they took her to the ER and consulted at the ER of her facility. The patient informed that she kept coughing and couldn't catch her breath. They made her drink water. The patient has allergies, so she always has an epi pen with her. The patient felt like she had an allergic reaction to the vaccine. The doctor there explained that her symptoms were not related the Covid-19 vaccine she received earlier. The patient specified that the last time she had a similar reaction was at work and was due to dust. The patient explained that she was perfectly fine before receiving the vaccine, laughing, and so what can her symptoms be related to, if it was not the vaccine. The patient was coughing all night, can't get rid of the cough. She has called her doctor. The nurse said just to watch herself for now. The patient informed that she was supposed to go back to work tomorrow and she was afraid to go around the babies. The patient informed that today (30Dec2020), she gargled apple cider vinegar and salt water, and phlegm came out. The patient continued saying that she has still been coughing, can't talk and that it was scary. The patient informed that she was taking her voice, she felt like she was losing her voice. It was "scaring" her. She was unsure if it was the Pfizer vaccine. The patient attempted to reach her HCP and that she cannot be seeing at her clinic due to her cough. The patient mentioned that she won't have access to a respiratory clinic until Tuesday. The patient expressed her concerned about returning to work with babies and asked if she should return to work tomorrow. The patient pursued verbalizing her worry and frustration. The patient asked if she can decide not to get the second dose. The patient voiced her regrets on receiving the first dose of the COVID-19 vaccine. She stated wishing she would have never taken it and that all who have an EpiPen should not receive it. The outcome of the event cough was not recovered, Dyspnoea, Allergy to vaccine, Productive cough, Speech disorder, Aphonia, Nervousness, Anxiety, Frustration tolerance, Depressed mood was unknown.

Other Meds: ;

Current Illness: Allergic reaction (carries epi pen at all times); Blood cholesterol abnormal; Blood pressure abnormal; Diabetic (10 to 13 years)

ID: 0925633
Sex: F
Age:
State: TN

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/07/2021
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: her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her left side, a cold spike feeling up her shoulder and neck and up to her face; upper esophageal sphincter got tight and felt funny like she was going to throw up; her whole body was shaking- her head, hands, and legs; feeling giddy; blood pressure was up; being stressed; was going to throw up/transient nausea; felt a little funny; This is a spontaneous report from a contactable Nurse(patient). A 54-year-old female patient received BNT162B2 (lot number EL0140), via an unspecified route of administration at left deltoid on 30Dec2020 14:28 at the 54 years old at 0.3 mL single for where she works she was exposed to patients who need rehab that were exposed and getting COVID. The patient medical history included Primary Essential Tremors and ongoing (had these for about 10-11 years. Her mother and grandmother also had them. Normally they were very fine, small tremors that people didn't notice. She can hold and turn her head and hide it) and Sulfa drug allergy (would get shortness of breath). The concomitant product was none. The patient previously took flu vaccine and experienced preservative made neck twitch and joint sores. Yesterday the patient got the COVID Vaccine and had a pretty significant adverse event. She was calling to report it and to see if she should get the second dose of the vaccine. The patient was also a licensed speech pathologist. She received the vaccine yesterday at 2:28 PM. She was allergic to Sulfa drugs and would get shortness of breath, so they wanted her to wait 30 minutes for monitoring. She was feeling giddy on 30Dec2020, but she ran into a friend that she had not seen before quarantine, so they were talking. It was exciting. After her 30 minutes she went to her car and felt a little funny. She thought she was hungry so she ate half a banana and had some water. She had an appointment to get to so she started to drive off, and by the time she got to the interstate she was feeling funny. She got on her left side, a cold spike feeling up her shoulder and neck and up to her face on 30Dec2020. This was like the precursor. Then on 30Dec2020 her face started to go numb. It felt like a dental block you would get with Lidocaine. It went from her temple area, below her eye all the way to her lips. It was midline on the left side. She was breathing fine. She was trying to figure out if she should pull over or call(Number), but her airway did not close up. Her upper esophageal sphincter got tight and felt funny like she was going to throw up. She drove to the hospital close to her house which is affiliated with where she got the vaccine. She normally had primary tremors, small to where people do not notice. But her whole body was shaking- her head, hands, and legs on 30Dec2020. She looked like a bobble head. But she could still breath. They took her right in and they did an EKG to make sure it was not her heart. Her blood pressure was up on 30Dec2020, she assumes for being stressed. They monitored her. They gave her Pepcid and Benadryl. She did not want any nausea medications. She stayed for about 2 hours and slept some from the Benadryl. Her face slowly became less numb. The numbness went away started from her lips and outward to her check and temple area. Then it just felt funny. When she touched it, which she never lost sensation, it was like, whose face is this? It was strange. She is not numb anymore. It took a while for it to go away, and it still felt weird. When she woke up this morning it was completely gone. She had recovered completely from all of these things. The only thing she has now was some transient nausea. It was very mild. It comes and goes. It had improved. She had not taken anything for it. The events Feeling funny, her face started to go numb, upper esophageal sphincter got tight, a cold spike feeling up her shoulder and neck and up to her face, Her whole body was shaking- her head, hands, and legs, were all assessed as Medically significant. The outcome of the event Nausea was recovering, the events Felt giddy, blood pressure was up, Stress was recovered on 31Dec2020, the other events were recovered on 30Dec2020. The reporter considered there was a reasonable possibility that the events Feeling funny, a cold spike feeling up her shoulder and neck and up to her face, Face started to go numb from her temple area, below her eye all the way to her lips, upper esophageal sphincter got tight , whole body was shaking- her head, hands, and legs, Nausea, were related to the product BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impacts of this report on the benefit/risk profile of the 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: Essential tremor (had these for about 10-11 years)

ID: 0925634
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/07/2021
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: DVT; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The nurse asked if there is any DVT cases reported following the administration of Pfizer-BioNTech COVID-19 Vaccine. E-transmitting duplicate AE caller already reported a DVT case post vaccination. Caller also asked "Why is there's a statement indicating that individuals with a history of bleeding disorder or taking anti-coagulant should contact their vaccination provider? How did they prove 95 % efficacy? Why aren't antibodies produced after the 1st dose of Covid-19 vaccine?" The outcome of the event DVT was unknown. Information on Lot/batch number has been requested.; Sender's Comments: Very limited information was provided for this individual patient, such as pre-existing medical history, suspect administration details, clinical course and relevant supportive lab data for the reported Deep vein thrombosis (DVT). Pending further details, the Company would handle this reported DVT related to the administration of BNT162B2, COVID-19 immunization, for reporting purpose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Other Meds:

Current Illness:

ID: 0925635
Sex: F
Age:
State: PA

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: throat swelling; Initially had headache; dizziness; irritability; Throat tingling; difficulty swallowing; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EJ1685) as the first dose via an unspecified route of administration in the left arm on 29Dec2020 06:00 for COVID-19 immunization. Medical history included fibromyalgia, asthma, prediabetes, and carpal tunnel syndrome. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no previous allergies to vaccines. The patient allergies to medications which included: doxycycline, medroxyprogesterone acetate (DEPO-PROVERA), metoclopramide (REGLAN), gluten. The patient initially had headache, dizziness and irritability, throat tingling, throat swelling, and difficulty swallowing started around 12 hours after injection, event onset date reported as 29Dec2020 18:00. The events resulted in emergency room/ department or urgent care. The events were reported as non-serious by HCP. Treatment received for the events included diphenhydramine and hydroxyzine embonate (HYDROXYZINE PAMOATE). The outcome of the events was recovering.; Sender's Comments: The reported pharyngeal swelling together with other symptoms was likely related to the single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0925636
Sex: F
Age:
State: MI

Vax Date: 12/22/2020
Onset Date: 12/23/2020
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection; Moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection; This is a spontaneous report from a contactable physician (patient). A 37-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 17:15 at single dose on her left arm for covid-19 immunization. Medical history included known allergies to penicillin. The patient had no other medical history. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient was not received list of any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection on 23Dec2020. These events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient had received prednisone to treat the events. The outcome of the events was not recovered.; Sender's Comments: A possible contribution role of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of sensorineural hearing loss in left ear and headache cannot be excluded due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0925637
Sex: F
Age:
State: CA

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around her mouth went numb; heart palpitations; I had hives on my chest; a wave of heat rush up her back; This is a spontaneous report from a contactable nurse (patient). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 22Dec2020 10:30 at first single dose for COVID-19 immunization. Medical history included ectopic pregnancy, hay fever. Concomitant medication received within 2 weeks included: loratadine, colecalciferol (vitamin D), olly womens multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. About 15 minutes after the vaccine the patient experienced jaw tightening and muscle spasms. The patient was given oral Benadryl 50 mg. About 5 minutes after taking the Benadryl, her entire face and around her mouth went numb. The patient began having heart palpitations and felt a wave of heat rush up her back. She had hives on her chest. The patient received 1 dose of epinephrine from an Epi-Pen and transported to the emergency room for further treatment. Adverse event start date: 22Dec2020 11:00 AM. Events were considered as non-serious. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event included: Benadryl, Epinephrine, Solumedrol, Pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Test Name: SARS-CoV-2 by PCR (Nasal Swab) on 30Dec2020: Negative. Outcome of the events was not recovered.; Sender's Comments: The temporal relationship is suggestive of an acute anaphylactic reaction. Based on the temporal relationship and the known pattern of response, the vaccination with BNT162B2 might play 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: ; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 0925638
Sex: F
Age:
State:

Vax Date: 12/22/2020
Onset Date: 12/27/2020
Rec V Date: 01/07/2021
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: Joint pain; loss of balance; increased drowsiness; Headaches induced by allergies; Limited neck mobility/lessened neck pain but still limited mobility; Scalp tenderness and sensitivity; Significant migraines/debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness); Sharp pains in neck/Neck pain; Sharp pains in neck, ear, head pain (similar to an ear infection pain); head pain/sharp pains in lower head/covers whole head, pulsating, sharp pain/Increase in headaches but no longer centralized to back of head/ headaches induced by allergies; Nausea; Neck stiffness; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number was unknown, via an unspecified route of administration in the right arm on 22Dec2020 07:30 at a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received vaccine in Tuesday (22Dec2020). The following Sunday (27Dec2020) at 12:00, she had nausea and neck stiffness. On Monday (28Dec2020), she had sharp pains in neck, ear, head pain (similar to an ear infection pain), and nausea. She used teledmed appt and got antibiotics (unspecified). On Tuesday (29Dec2020), she had significant migraines, limited neck mobility, sharp pains in neck and lower head, scalp tenderness and sensitivity which felt like whiplash when she moved her head w/ her head feeling "swimmy". She tried to see urgent care but was to go to ER. On Wednesday (30Dec2020), there was lessened neck pain but still limited mobility, increased in headaches but no longer centralized to back of head. She went to ER and they said that she had headaches induced by allergies. She mentioned that she never had migraines or allergies in her life. They also reported no ear infection. She did complete CT Scan with no concerning results on 30Dec2020. On Thursday (31Dec2020) & Friday, she no longer has neck pain but with continued nausea, joint pain, debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness). The events were reported as non-serious. The treatment received for the adverse events included fluids, pain & nausea meds. The patient was not diagnosed with Covid prior to vaccination. She was tested for covid post vaccination on 30Dec2020 through a nasal swab with negative result. The outcome of the events neck stiffness, ear pain, scalp tenderness and sensitivity, and 'Headaches induced by allergies' was unknown; while neck pain was recovered on 31Dec2020. The outcome of the events 'significant migraines/debilitating migraines', nausea, limited neck mobility, head pain/Headache, joint pain, loss of balance, and increased drowsiness was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the event migraine cannot be excluded based on a compatible temporal relation between vaccination and onset of event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0925639
Sex: F
Age:
State: ID

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/07/2021
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: Miscarriage; patient was pregnant while taking BNT162B2; patient was pregnant while taking BNT162B2; This is a spontaneous report from a contactable Other Health Professional. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly on 22Dec2020 06:00 AM at single dose at Arm Right at Hospital for COVID. Medical history included ongoing sleep apnoea. There were no concomitant medications. There were no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced miscarriage on 29Dec2020 13:00. The patient was pregnant while taking BNT162B2. The patient was 4 Weeks pregnant at the onset of the event. Patient last menstrual period date was 24Nov2020. The Pregnancy due to deliver was on 07Sep2021. The pregnancy resulted in spontaneous abortion. Since the vaccination, the patient has been tested for COVID-19 on an unknown date with unknown results. Nasal Swab on 28Dec2020 was Negative. There was no treatment received for the adverse event. The outcome of event was recovering.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further 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 agency, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness: Sleep apnoea

ID: 0925640
Sex: M
Age:
State: NJ

Vax Date: 12/20/2020
Onset Date: 12/27/2020
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: DVT left calf; This is a spontaneous report from a contactable Physician (patient). A 60-year-old male patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular on 20Dec2020 08:00 at single dose on right arm for COVID-19 immunization. Medical history included Gastric reflux. The patient had no known allergies. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medications included omeprazole (PRILOSEC) and ergocalciferol (VIT D). The patient had not received other vaccine in four weeks. The patient experienced deep vein thrombosis (DVT) left calf on 27Dec2020 09:00 which resulted emergency room visit. Treatment received for the event included Xarelto. The outcome of the event was not resolved. Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further 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: PRILOSEC [OMEPRAZOLE]; VIT D

Current Illness:

ID: 0925641
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/07/2021
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: reaction to excipient; kidneys tried to shut down; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. A female patient of an unspecified age received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), and potassium (MANUFACTURER UNKNOWN); both via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history included ongoing kidney issues from an unknown date, allergic to antibiotics and pain pills from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, the patient experienced: kidneys tried to shut down and reaction to excipient; which were assessed as medically significant. The consumer stated, "I looked at the ingredient list: potassium is listed. I have kidney issues and potassium is really bad, my kidneys tried to shut down on me. I'm allergic to "antibiotics and pain pills." The clinical outcome of the events, renal failure and reaction to excipient, was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.

Other Meds:

Current Illness: Kidney disorder

ID: 0925642
Sex: F
Age:
State: TN

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mental impairment cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: LEXAPRO; ; IBUPROFAN

Current Illness:

ID: 0925643
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: reported increased hand stiffness after vaccination; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation. Medical history included psoriasis and psoriatic arthritis. The patient's concomitant medications were not reported. The patient previously took adalimumab (HUMIRA) and non compliant with Humira. The patient had psoriasis and psoriatic arthritis, reported increased hand stiffness after vaccination on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "psoriasis and psoriatic arthritis with increased hand stiffness after vaccination" and the administration of BNT162B2, based on the reasonable temporal association. The patient's pre-existing medical condition of psoriasis and psoriatic arthritis might have provided alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Other Meds:

Current Illness:

ID: 0925644
Sex: F
Age:
State: NY

Vax Date: 12/23/2020
Onset Date: 12/26/2020
Rec V Date: 01/07/2021
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: Confirmed DVT in the left leg; COVID test (PCR swab): positive on 26Dec2020; COVID test (PCR swab): positive on 26Dec2020; This is a spontaneous report from a contactable other healthcare professional. An 85-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# ELO140, expiration date: Mar2021), via an unspecified route of administration in arm (deltoid; unknown side) on 23Dec2020 at single dose for Covid-19 immunisation. Medical history included type 2 diabetes mellitus from 2017 and ongoing, high blood pressure from 2017 and ongoing, atrial fibrillation (A-Fib) from 2019 and ongoing. The patient's concomitant medications were not reported. The patient was administered first dose of the COVID vaccine on 23Dec2020 and then was swabbed for COVID on 26Dec2020, and then on 28Dec2020 her PCR swab was positive for COVID. She was asymptomatic until she started complaining of leg pain. She ordered an ultrasound for the patient on 30Dec2020, and it confirmed a deep vein thrombosis (DVT) in left leg. The patient was being treated with anticoagulant apixaban (ELIQUIS) currently. Caller stated that this could be that it (DVT) is from COVID, but her real question was, could it be from the vaccine? In Pfizer's information packet for patients, there is section on what to tell your provider prior to getting vaccinated. One of the things on there is if you have a bleeding disorder or are on an anticoagulant. There is no explanation as to why it was in the packet of information. Caller has looked everywhere and can not figure out why that is on the FAQ/packet information. The patient was due for the second dose on 13Jan2020, but she was worried and hesitant to approve it. The patient underwent lab tests and procedures which included COVID test (PCR swab): positive on 26Dec2020, ultrasound of the left leg: confirmed DVT on 30Dec2020. The outcome of events was not recovered.; Sender's Comments: There is not a reasonable possibility that event "COVID test (PCR swab): positive" is related to BNT162B2 vaccine. The event occurred 3 days after vaccination, when vaccine was not expected to achieve the effect. The event DVT of legs is not considered related to BNT162B2 vaccine. The patient had underlying diabetes and cardiovascular disorders, which are considered as risk factors for DVT. 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: Atrial fibrillation (Verbatim: A-Fib); Blood pressure high (Verbatim: High Blood pressure); Type 2 diabetes mellitus (Verbatim: Type 2 diabetes mellitus)

ID: 0925645
Sex: M
Age:
State: PA

Vax Date: 12/18/2020
Onset Date: 12/24/2020
Rec V Date: 01/07/2021
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: Patient was poorly responsive to her inhalers that she used for asthma; Persistent shortness of breath and chest tightness starting within a few days after vaccine; Persistent shortness of breath and chest tightness starting within a few days after vaccine; This is a spontaneous report from a contactable physician (patient). A 40-year-old male patient received the first single dose of BNT162B2 (Solution for injection, lot number: EK5730, exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 18Dec2020 04:15 for COVID-19 immunization. Medical history included allergy induced asthma, allergies to cats and dust, and occasional seasonal allergies. Concomitant medication included other vaccine/s received within 4 weeks prior to the COVID vaccine: first dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX, GlaxoSmithKline) administered as single dose via unspecified route of administration (vaccine location: left arm) on 08Dec2020. There were no other medications the patient received within 2 weeks of vaccination. The patient experienced persistent shortness of breath and chest tightness starting within a few days after vaccine (24Dec2020). Patient was poorly responsive to her inhalers that she used for asthma (onset date not reported). She rarely needed the, used about once or twice a year). It was constant, but with periods of improvement followed regression. Will likely seek medical evaluation as it's been over a week now and rather concerning. The patient did not consider the events shortness of breath and chest tightness as serious. Treatment for the adverse events shortness of breath and chest tightness included fluticasone propionate, almeterol (ADVAIR), albuterol, and unspecified anti-allergy medications. Patient did not have covid prior vaccination. Patient was tested for COVID post vaccination wherein patient tested negative for COVID via Covid test rapid on 30Dec2020. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of shortness of breath and chest tightness was not recovered and unknown for the other event.; Sender's Comments: Based on the time association, the possible contribution of BNT162B2 to the events shortness of breath , chest tightness and asthma aggravated 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: 0925646
Sex: U
Age:
State:

Vax Date: 12/18/2020
Onset Date: 12/01/2020
Rec V Date: 01/07/2021
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: diabetes was high; seeing double vision; Headache on the right side; This is a spontaneous report from a contactable nurse. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) dose number 1, via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had the vaccine in a hospital on a Friday (18Dec2020). No side effect was noted over the weekend. On 21Dec2020, when the patient woke up, s/he was seeing double vision, so s/he went to the doctor; they ran some test (unknown result). Because the patient was having headache on the right side in Dec2020, s/he went back to the doctor on 23Dec2020; the patient was sent to the eye doctor and they ran all kind of test. On 24Dec2020, the only thing they could find was that the patient's diabetes was high, so they kind of felt that what that could have been was kind of coincidental. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The mentioned "diabetes was high" is likely an intercurrent disease, unlikely related to the administration of BNT162B2, the COVID-19 immunization. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Other Meds:

Current Illness:

ID: 0925647
Sex: M
Age:
State: MD

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/07/2021
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: joint pain; it doesn't seem to be feeling well; sweating; Fever; chills; night sweats, that he will randomly start sweating; headache; muscle pain/mild muscle aches; gastric upset; Fatigue; he had mild arm soreness right after he got the vaccine; This is a spontaneous report from a contactable Other-HCP (patient). This 45-year-old male Other-HCP received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, NDC number: 59267-1000-1) on 22Dec2020 at single dose in his right arm for COVID-19 immunization. Medical history and concomitant drug were not reported. It was reported that patient experienced Fever on 27Dec2020 with outcome was recovered on 29Dec2020, chills and night sweats on 27Dec2020 with outcome was not recovered, Headache on 27Dec2020 with outcome was not recovered, muscle pain 27Dec2020 with outcome was not recovered, gastric upset on 27Dec2020 with outcome was Recovering, Fatigue on 27Dec2020 with outcome was unknown, arm soreness on 22Dec2020 with outcome was not recovered, joint pain with outcome was unknown, it doesn't seem to be feeling well with outcome was unknown, sweating with outcome was unknown. All events were serious (medical significant). Caller stated that he thought having a reaction to the vaccination, spoken with Occupational Health at his job and with a doctor, stated everyone is a bit stumped. Caller stated he has had for over a week now, fever, chills, night sweats, that he will randomly start sweating, headache, joint pain, gastric upset, and it doesn't seem to be feeling well. Stated the joint pain is actually more muscle pain. Stated he got the vaccination on Tuesday 22Dec2020, stated he has been having these symptoms for over 5 days now. Stated he does not think this is something infectious, that no one in his family is getting sick, his wife or child are not catching it from him. Stated he tried to do research online for data about delayed side effects, would like to know if we have any information on delayed side effects. Stated he considers these events medically significant because he cannot be cleared to go back to work. Stated he had mild arm soreness right after he got the vaccine, states he had mild muscle aches Wednesday and Thursday, then they went away and came back all on Saturday night and Sunday. Stated he is worried about getting a second vaccine. Stated he tested negative for the COVID on 29Dec2020. Stated he has a CBC and other blood work scheduled for today, results unknown at this time. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the 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: 0925648
Sex: F
Age:
State: MI

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/07/2021
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: Tachycardia; Palpitations; had a strong, whole body heat, and flushing; had a strong, whole body heat, and flushing; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 4th of 6 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said her friend is a registered nurse, and received the COVID-19 Vaccine on Monday, 28Dec2020. She said her friend stated she, and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. She had no other symptoms after receiving the COVID-19 Vaccine. There is unknown whether the patient received the treatment or not. The outcome of the events was recovered on 28Dec2020. Information on lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events flushing, feeling hot, tachycardia and palpitations. 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.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.

Other Meds:

Current Illness:

ID: 0925649
Sex: F
Age:
State:

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 01/07/2021
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: It sounds like to be an allergic reaction; She passed out; Tachycardia; Nausea; Lightheadedness; This is a spontaneous report from a non-contactable physician. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 at single dose to be vaccinated for her protection. Medical history was none. The patient's concomitant medications were not reported. Patient took the Pfizer COVID-19 vaccine and next day she had a very serious reaction. She did not know that if it was due to the vaccine. But she had tachycardia requiring her to go to the emergency room and she passed out and she had nausea and lightheadedness as well. It sounds like to be an allergic reaction. Given the seriousness of tachycardia and passing out as well as the lightheadedness and nausea it sounds too severe just to be a mild immune response. So, it was sort of rare immune response or it was unrelated it was unknown at this time. Outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the compatible time association, the contribution of suspect BNT162B2 to the 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: 0925650
Sex: F
Age:
State: MI

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/07/2021
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: strong, whole body heat, and flushing; strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable Nurse. This Nurse reported for similar events for 6 patients. This is 2nd of 6 reports. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said her friend was a registered nurse, and received the COVID-19 Vaccine on Monday, 28Dec2020. She said her friend stated she, and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient said she became tachycardia and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. She had no other symptoms after receiving the COVID-19 Vaccine. It was unknown whether the patient received the treatment or not. The outcome of the events was recovered on 28Dec2020. Information on lot/batch number has been requested.; Sender's Comments: The reported transient events of whole body heat, flushing, tachycardia and palpitations were likely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship and clinic course. 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.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patients.

Other Meds:

Current Illness:

ID: 0925651
Sex: U
Age:
State: MI

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/07/2021
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: Serious, weird reaction/had a strong, whole body heat, and flushing; Serious, weird reaction/had a strong, whole body heat, and flushing; Serious, weird reaction/tachycardic; Serious, weird reaction/had palpitations; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is 5th of 6 reports. A patient of unspecified gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter did not know if the patient had received any other vaccines at the same time as the COVID-19 Vaccine, and if the patient had received any other vaccines within the last 4 weeks. It was reporter that the reporter's friend texted her last night, on 30Dec2020, at around midnight. The reporter, and 5 other registered nurses she works with in a hospital, received the COVID-19 vaccine at the same time and had the same exact symptoms she experienced. They had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a weird reaction right after being injected with the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient became tachycardic and had palpitations that lasted a few minutes. The tachycardia and palpitations then slowly resolved in less than 5 minutes. The patient had no other symptoms after receiving the COVID-19 Vaccine. The registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. For treatment information, the reporter didn't believe the patient received any medical attention. Reporter believed that the patient just waited symptoms out, and within 5 minutes the symptoms had gone away. The outcome of the events was recovered on 28Dec2020. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events flushing, feeling hot, tachycardia and palpitations. 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.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm