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: 0955757
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: hive like rash that went up her arm and neck; swelling in throat; This case was reported by a nurse vi and described the occurrence of rash urticaria-like in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced rash urticaria-like and throat swelling. On an unknown date, the outcome of the rash urticaria-like and throat swelling were unknown. It was unknown if the reporter considered the rash urticaria-like and throat swelling to be related to Shingrix. Additional information was provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced a hive like rash that went up her arm and neck and swelling in throat. No further information was provided.

Other Meds:

Current Illness:

ID: 0955758
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: right sided weakness with numbness from her face down her entire body; right sided weakness with numbness from her face down her entire body; right sided weakness with numbness from her face down her entire body; bad headache; pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 41 unknown unit) received the first dose of bnt162b2 (BNT162B2) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know how long side effects last after receiving the first dose of the Covid vaccine. The patient received first dose of Covid vaccine on Thursday (unspecified date) and reported side effects. She reported side effects of right sided weakness with numbness from her face down her entire body. She describes the feeling as if she's been "shot up with novocaine on the right side of her body." She was also experiencing a really bad headache and pain at the injection site. She reported that the side effects do not seem to be wearing off. She wanted to know if this has been reported as a common side effect. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0955759
Sex: F
Age:
State:

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe malaise; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; loss of appetite; Transient dysgeusia; Mild nausea; Pleuritic chest pain; This is a spontaneous report from a non-contactable physician. This 27-year-old female physician (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=E15249), via unspecified route at left arm on 08Jan2021 07:30 AM at single dose for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization. Facility type of vaccine was hospital. No other vaccine in four weeks. No Covid prior vaccination. No covid tested post vaccination. On 08Jan2021 06:00 PM, patient experienced severe headache from 12-36h post administration (as reported), impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia (nearly meningeal signs); mild nausea; pleuritic chest pain; severe malaise; transient dysgeusia; loss of appetite. Treatment for events included initially NSAIDs until had difficulty tolerating was received. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the time association, the possible 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: 0955760
Sex: F
Age:
State:

Vax Date: 12/31/2020
Onset Date: 01/04/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: tachycardia; shortness of breath; elevated blood pressure 165/90; tired; stomach upset; felt unwell; This is a spontaneous report from a contactable other health professional (patient). A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced on 04Jan2021 felt unwell, tired, stomach upset (it continued all week) and on 07Jan2021 tachycardia and shortness of breath. Clinical course: she was feeling very like short of breath and her heart racing, had elevated blood pressure 165/90, usually it was normal. The patient was sent to the emergency room (ER) and got worked up, she had a complete blood panel, everything came back normal; she had a chest X-Ray and 2 bags of fluid, then the patient was discharged. The patient outcome of the events was recovered. The information on the batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0955761
Sex: F
Age:
State: PA

Vax Date: 12/24/2020
Onset Date: 01/02/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: started having a lot of left eye pain/he diagnosed her with Scleritis; This is a spontaneous report from a contactable other healthcare professional (HCP) a Nurse Practitioner, who reported for herself. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EJ1685 also reported as ES1685), intramuscular in left deltoid on 24Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing anxiety diagnosed years ago, maybe when she was 23. Concomitant medication included ongoing celecoxib (CELEXA) for anxiety started about a year, or year and a half ago. She did not take other vaccines on the same day as the COVID vaccine. She had no recent labs. On 02Jan2021 the patient experienced scleritis. Event was described as follows: patient got her first COVID vaccine on 24Dec2020 and on 02Jan2021 she started having a lot of left eye pain. She went to her Ophthalmologist and he diagnosed her with Scleritis. She had no history of anything with her eyes or any vascular or autoimmune issues; no eye disorder history or rheumatology history. Patient is due to get her second dose of the vaccine on 14Jan2021, and she spoke with her primary care doctor and her ophthalmologist, and neither of them have any answer on if she should get the second dose or not, they did not have much guidance for her as this was such a new product. Patient reported that scleritis was persisting, but it has improved and she was on Prednisone eye drops. Event scleritis was considered serious as Medically significant because of what it is and what it can do, but this was not a severe case (as reported). Final outcome of scleritis was recovering.; Sender's Comments: The reported scleritis was more likely an intercurrent disease, and less likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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: CELEXA [CELECOXIB]

Current Illness: Anxiety (diagnosed years ago, maybe when she was 23)

ID: 0955762
Sex: F
Age:
State: MI

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/19/2021
Hospital: Y

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:

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

Symptoms: Appendicitis; Vomiting; Nausea; Chills; This is a spontaneous report from a contactable consumer. A consumer reported that her 65-year-old mother received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number Unknown), into the arm at single dose on 31Dec2020 for COVID-19 immunization. The patient did not have any medical history and did not receive any concomitant products. On 31Dec2020 the same evening of vaccination, the patient experienced vomiting, nausea and chills that were considered flu like. On 03Jan2021 or 04Jan2021 her appendix ruptured. She entered emergency room on 07Jan2021 and was diagnosed with appendicitis. She was admitted to hospital on 07Jan2021. She has been given hospital care for past four days. She will have surgery in 6 weeks to repair and right now they are cleaning ruptured area. Her care team is wondering if she should get second dosage. The patient is currently hospitalized. The patient recovered from the event vomiting on 31Dec2020, recovered from the events Nausea and Chills on 07Jan2021 and was Recovering from the appendicitis. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0955782
Sex: F
Age: 23
State: MA

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies: Latex

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: c/o temp 100.6, chills, sore throat, & muscle aches 12 hours after receiving vaccine. Symptoms resolved in 48 hours

Other Meds: Unknown

Current Illness: Unknown

ID: 0955783
Sex: F
Age: 30
State: MA

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Pharyngeal swelling

Symptoms: Chills, Bodyaches, Nausea & Back Discomfort developed 12 hours after receiving vaccine - resolved after 48hrs.

Other Meds: None

Current Illness: Unknown

ID: 0955784
Sex: F
Age: 51
State: MA

Vax Date: 01/11/2021
Onset Date: 01/13/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies: Unknown

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Headache, chills, low grade fever developed 24 hours after receiving vaccine - resolved in 2 days.

Other Meds: Unknown

Current Illness: Unknown

ID: 0955785
Sex: F
Age: 23
State: RI

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies: Penicillin

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Headache, weakness & dizziness starting afternoon after receiving vaccine and lasting 6 hours. Afterwards c/o weakness & dizziness lasting for 2-3 days.

Other Meds: Unknown

Current Illness: COVID (+) 12/5/20

ID: 0955816
Sex: F
Age: 21
State: KY

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

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

Lab Data:

Allergies: CODEINE,PCN,MORPHINE

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

Symptoms: PATIENT RECEIVED VACCINE AT 9 AM AND WHEN HER 15 MINUTE MONITOR PERIOD WAS UP SHE REPORTED DIZZINESS AND TREMORS. THE TREMORS WERE VISIBLE IN HER HANDS AND LEGS. HER V/S WERE TAKEN AND HER B/P WAS 140/100, HR WAS 103. NO HX OF HTN. RESPIRATIONS AND O2 SAT WERE NORMAL. SHE WAS KEPT AND MONITORED FOR A TOTAL OF 45 MINUTES AND SYMTOMS WERE STILL PRESENT WITH HER B/P 140/103 AND PULSE AT 110. SHE WAS ESCORTED TO ER FOR EVALUATION. NO TREATMENT WAS WARRENTED , HER B/P CAME DOWN TO 122/87 AND THE TREMORS RESOLVED. SHE WAS DISCHARGED HOME AT 1130 AM. FOLLOWED UP WITH

Other Meds: none

Current Illness: NONE

ID: 0955849
Sex: F
Age: 15
State: NY

Vax Date: 01/17/2021
Onset Date: 01/19/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Patient was 15 when vaccine was administered (authorized for 18 and older). No known adverse reactions.

Other Meds:

Current Illness:

ID: 0955851
Sex: M
Age: 84
State: MO

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

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

Lab Data:

Allergies:

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

Symptoms: Felt like a bloody nose, like blood running down his throat. Got up to go to restroom and spit out blood into the toilet.

Other Meds:

Current Illness:

ID: 0955852
Sex: F
Age: 35
State: MN

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

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

Lab Data:

Allergies: none known

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

Symptoms: Wrong Dose of Vaccine - Too High

Other Meds:

Current Illness:

ID: 0955853
Sex: F
Age: 25
State: WV

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

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

Lab Data:

Allergies:

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

Symptoms: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Systemic: Nausea-Mild, Systemic: Swollen Lymph nodes in armpit-Medium; symptoms lasted 6 days

Other Meds:

Current Illness:

ID: 0955854
Sex: M
Age: 50
State: NE

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

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

Lab Data:

Allergies: None known

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

Symptoms: Serious flu like sypmtons (aka Covid sypmtons) started 6 hours after vaccination. Severe body ache, headache, slight fever and chills.

Other Meds: Lozartan

Current Illness: None. Covie-19 Positive July 30, 2020.

ID: 0955856
Sex: F
Age: 60
State: KY

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 01/19/2021
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: Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and foggy. Unable to fully concentrate on tasks. Flushed in face and unsteady lasting approximately 1 hour. Developed headache lasting remainder of shift. Developed body aches/chills in evening

Other Meds:

Current Illness:

ID: 0955857
Sex: F
Age: 50
State: TX

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

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

Lab Data:

Allergies: Penicillin

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Chills and shaking from chills. Pounding headache that has not gone away. Sweating and body aches

Other Meds: Tylenol

Current Illness:

ID: 0955858
Sex: M
Age: 60
State: CA

Vax Date: 01/17/2021
Onset Date: 01/18/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies: statin medications, erythromycin

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Low grade fever (99...typical is 96-97 for me), intense lower back pain and headache. Also, lethargy and a heaviness to my breathing when exercising.

Other Meds: Xarelto 20mg, Pantoprazole 20mg, Gas-X extra strength, Zyrtec

Current Illness: superficial blood clot to upper right leg

ID: 0955859
Sex: F
Age:
State: VA

Vax Date: 08/01/2020
Onset Date: 08/01/2020
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: no adverse event; stored at an improper temperature; the shingles shot (manufacturer unknown) at the same time as PNEUMOVAX 23); This spontaneous report was received from a the patients mother, and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. In August 2020 (exact date unknown) the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), at a dose of 0.5 milliliter (lot #, expiration date and route of administration were unknown) for prophylaxis. The reporter stated that the patient had the shingles shot (manufacturer unknown) at the same time as pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) had been stored at an improper temperature, No additional adverse events or product quality complaints were reported.

Other Meds:

Current Illness:

ID: 0955861
Sex: F
Age: 46
State: KY

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/19/2021
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: Crestor Paxil potassium pills sudafed sulfa Bactrim

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

Symptoms: On my second does the same night on 1/13/2021 I started feeling nauseas. The next morning on 1/14/2021 I felt horrible, my stomach was hurting, my left arm was swollen, felt really weak & tired, I had a lot of fatigue & I felt very nauseas. It last 24 hrs.

Other Meds: blood pressure medication cholesterol medication

Current Illness: strep throat carpal tunnel surgery on 1/8/2021

ID: 0955864
Sex: F
Age:
State:

Vax Date: 12/05/2020
Onset Date: 12/05/2020
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Has a knot on her hand; Knot on her hand and it was swollen; This case was reported by a other health professional and described the occurrence of induration in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 5th December 2020, the patient received Shingrix. On 5th December 2020, less than a day after receiving Shingrix, the patient experienced induration and hand swelling. On an unknown date, the outcome of the induration and hand swelling were unknown. It was unknown if the reporter considered the induration and hand swelling to be related to Shingrix. Additional details were provided as follows: The reporter gave Shingrix this afternoon on the day of reporting and patient called back 2.5 hours later and had a knot on her hand and it was swollen. No reaction at the injection site but the hand was on the arm of the injection.

Other Meds:

Current Illness:

ID: 0955865
Sex: F
Age: 17
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: Patient was 17 when vaccine was administered No known adverse reactions.

Other Meds:

Current Illness:

ID: 0955866
Sex: F
Age: 62
State: NY

Vax Date: 09/18/2020
Onset Date: 09/01/2020
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: itchy rash with bumps; rash; bumps; This case was reported by a nurse via call center representative and described the occurrence of itchy rash in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number P9733, expiry date 12th March 2022) for prophylaxis. On 18th September 2020, the patient received the 1st dose of Shingrix. In September 2020, 24 hrs after receiving Shingrix, the patient experienced itchy rash, rash and papular rash. On an unknown date, the outcome of the itchy rash and rash were not recovered/not resolved and the outcome of the papular rash was unknown. It was unknown if the reporter considered the itchy rash, rash and papular rash to be related to Shingrix. Additional details were reported as follows: The patient received the dose of Shingrix in her left deltoid and 24 hours later experienced an itchy rash with bumps from her left deltoid until her elbow. The symptoms were still going on two months later. Consented to follow up.

Other Meds:

Current Illness:

ID: 0955867
Sex: F
Age: 58
State: WA

Vax Date: 10/31/2020
Onset Date: 11/04/2020
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Shingles around her eye; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number ZJ432, expiry date 27th May 2022) for prophylaxis. On 31st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th November 2020, 4 days after receiving Shingrix, the patient experienced shingles. Shingrix was discontinued. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The patient developed shingles around her eye. The patient's doctor suggested to the patient not to receive a second Shingrix shot. The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 0955868
Sex: F
Age: 53
State: NH

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Cellulitis; the injection site became red; the injection site became swollen; the injection site became hot; it was itchy; hives at the injection site; The PA felt like a contaminated injection needle caused the reaction; Raised hives across the whole injection area; A spontaneous report was received from a 53-year-old female healthcare professional, who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, the injection site became red, the injection site became swollen, the injection site became hot, it was itchy, hives at the injection site, the PA felt like a contaminated injection needle caused the reaction, and raised hives across the whole injection area. The patient's medical history was not provided. No concomitant medications were reported. On 23 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left bicep for prophylaxis of COVID-19 infection. On 24 Dec 2020, one day after vaccination, the injection site of the patient became swollen, red, and hot. On 28 Dec 2020, the symptoms started to fade. On 29 Dec 2020, the patient was itchy and experienced hives at the injection site. On 31 Dec 2020, the patient went to urgent care with raised hives across the whole injection area. The Physician's Assistant at the urgent care felt that it was cellulitis caused by a contaminated injection needle and treated the patient with cefalexin. Within 24 hours of treatment, the event resolved. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events cellulitis, the injection site became red, the injection site became swollen, the injection site became hot, it was itchy, hives at the injection site, the PA felt like a contaminated injection needle caused the reaction, and raised hives across the whole injection area was considered resolved on 01 Jan 2021.; Reporter's Comments: Company comment: This case concerns a 53-year-old female patient, who experienced a serious event of Cellulitis and non-serious events of Injection site erythema, Injection site swelling, Injection site warmth, Injection site pruritus, Injection site urticaria (onset date of 29DEC2020), Exposure via contaminated device, Injection site reaction, and Injection site urticaria (onset date of 31DEC2020). The events of Injection site erythema, Injection site swelling, and Injection site warmth occurred on the next day of administration of their first of two planned doses of mRNA-1273 (Lot number: 039K20A). The events of Injection site pruritus, Injection site urticaria (onset 29DEC2020), and Cellulitis occurred 6 days after mRNA-1273 administration. The event of Injection site urticaria (onset 31DEC2020) occurred 8 days after mRNA-1273 administration. Treatment with antibiotics was performed with positive therapeutic response. The events of Exposure via contaminated device and Injection site reaction were considered to occur on the same day of mRNA-1273 administration by the healthcare worker. Based on the current available information and temporal association between the use of the product and the start date of the events of Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Injection site pruritus, Injection site urticaria (onset date of 29DEC2020), Injection site reaction, and Injection site urticaria (onset date of 31DEC2020), a causal relationship cannot be excluded. Causality of the event of Exposure via contaminated device is assessed as Not applicable, because the event is a procedural issue.

Other Meds:

Current Illness:

ID: 0955869
Sex: F
Age:
State: NC

Vax Date: 01/04/2021
Onset Date: 01/09/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Bell's Palsy; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: ELD14D, via an unspecified route of administration, in left side of arm, on 04Jan2021 at single dose for COVID-19 immunization. Medical history included early breast cancer from 2017 and ongoing. Concomitant medication included tamoxifen citrate 20 mg tablet by mouth once daily from 2017 and ongoing for breast cancer (cancer pill, she has to be on it for 5 years). The patient received the vaccine as she is "with fire department, thought she needed to take it, she had early breast cancer, is around lots of people". On 09Jan2021 the patient was diagnosed with Bell's palsy, assessed as medically significant and in Jan2021 she experienced earache (she thought it was an earache, but it was more than that, but it made her ear hurt, and she has no infection), her mouth was drawled a little, further detailed as numbness and "the eye, it is messing with it, when she is trying to see out of it, she can see, but it's blurry like" and, "where the ear thing is", on the back of the lymph node was real sore and her face was kind of puffy, which is the reason she went to the doctor. The patient had to go to her doctor, he told her she had a reaction to the shot, he called it Bell's Palsy, and said to let Pfizer know. Her doctor gave her something to take for mouth drawled/numbness, which is supposed to help, and she has to go back in a week. The event Bell's palsy outcome was unknown at the time of the report.

Other Meds:

Current Illness: Breast cancer (Early breast cancer)

ID: 0955870
Sex: F
Age: 68
State: FL

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

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

Lab Data:

Allergies: none

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Approx. 10 hrs after injection I developer soreness at the injection site and upper Left arm. The injection site was tender to touch and a dull ache went down my left arm to the fingers. The symptoms persist into the day after the vaccination.

Other Meds: HCTZ 12.5 mg qd, multivit 1 qd, areds 2, 2 Tabs qd, Vit D 2000IU qg

Current Illness: none

ID: 0955871
Sex: F
Age:
State: WI

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Doesn't feel like eating; Fever; Chills/ Chilled; Nausea; Severe Headache/Dull headache/Frontal headache; Fatigue; Body aches; This is a spontaneous report from a contactable Nurse (patient). This 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1686), via intramuscular, on 06Jan2021 (at 14:30) at single dose at left deltoid for COVID-19 immunisation, administered at hospital. Age at vaccination is 61-year-old. Historical vaccine included Diphtheria and Tetanus vaccine (intramuscular, at single dose) on 15Dec2020 for immunization; and Shingles vaccine (intramuscular, at single dose) on 15Dec2020 for varicella immunization. Relevant medical history included usual tenderness. No relevant concomitant medications were provided. On 07Jan2021, she woke up at 2:00 in the morning, she had a high temperature, she was chilled, she had a severe headache, nausea, fatigue, and body aches. She got up and took ibuprofen (ADVIL). She was basically in bed, she had to cancel all her appointments in the morning, she just laid in bed and the following afternoon her fever broke at about 4:30 in the afternoon then she just had a low grade temperature and a dull headache, nausea through the next day, Friday the 08Jan2021. She still has a very dull headache and just not right, kind of like a flu bug. She had no fever; she had not had any fever after Friday afternoon or Saturday. Fever started at 2 in the morning 07Jan2021 and she experienced the chills until after fever broke. Fever went above 102 degrees. She still had a little of the nausea, she just didn't feel like eating. She still had the dull headache. The nausea and headache have improved when compared to how it was on the 07Jan2021. She was back to work now she just has a dull frontal headache. The reporting nurse assessed all the events, except of 'Doesn't feel like eating', serious for disability. She stated she may have had usual tenderness but nothing like this. The patient had recovered from the event fever on 08Jan2021 and from the event 'chills/chilled' on 07Jan2021; the patient was recovering from 'nausea' and 'severe Headache/Dull headache/Frontal headache', while the outcome of the remaining events was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded due to temporal relationship. It is worth noting that patient had other vaccines not far ago, including Diphtheria and Tetanus vaccine and Shingles vaccine on 15Dec2020 for immunization. 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: 0955872
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/19/2021
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: throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow. The patient condition was life threatening. The patient described the events as follows: 40 min after injection my throat and tongue started to feel weird and tight. Pharmacy at my work hospital gave me 25 mg Benadryl and 650mg Tylenol. At about 1 hr 45 min after injection my throat got to the point of so swollen and itchy I couldn't swallow. I went to nearest emergency room hospital they administered Decadron orally, Pepcid P.O. (orally), and Toradol via IM (Intramuscular). The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0955873
Sex: M
Age: 57
State:

Vax Date: 01/08/2021
Onset Date: 01/17/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies: nkda

Symptom List: Injection site pain

Symptoms: itching and swelling at injection site ongoing x 3 days, swelling reduced

Other Meds: Talz, Vitamin D, multi-vitamin

Current Illness: none

ID: 0955874
Sex: M
Age:
State: FL

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Have a cut in my leg which is very unusual; Saw a big cut in my feet; I was bleeding from somewhere; It was quite a lot of blood drawing out of my body; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient started to receive single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 23Dec2020 09:00 for COVID-19 immunization; and adalimumab (HUMIRA), via an unspecified route of administration from an unspecified date at unspecified dose (injection every other month) for arthritis. Medical history included arthritis, blood pressure (abnormal), and blood cholesterol (abnormal). Concomitant medication included rosuvastatin for blood cholesterol, olmesartan medoxomil, metoprolol succinate (TOPROL XL), and vitamins: ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride. Patient stated, "The reason I am calling, I have just a concern that something happened to me. I did not pay much attention but now I have read the news one doctor died after getting this COVID Vaccine (Further details were not available over the call) I have a small incident happened to me the day after I received my first dose of the COVID Vaccine. I just wanted to get some information. You know what happened the next day night, in the evening I was taking a shower and all of sudden I was bleeding from somewhere. Lot of blood was coming out while I was toweling my body out. I couldn't find out where the blood is coming from. I checked, it's not from my urine, not from my rectum but it was quite a lot of blood drawing out of my body. Immediately, I called my wife into bathroom, then I squeezed my body then the bleeding stops. It was on 24Dec2020. You know my kids were at home. I don't want them to find it. The bleeding stopped and everything went away. Then I thought maybe it is something related to my GI. I went to my GI doctor yesterday to have a checkup, they don't know anything either but I am due for my second dose for next week Wednesday. Now I had this news about thrombocytopenia on this doctor died (Clarification unknown). So I am just afraid if there is anything related this. Do you have any explanation on how I bleed and where it bleed? It was lot of bleeding even my towel was full of blood." Patient wanted to see if anybody else had similar experience or if he get the second dose and he get the complication again. Patient was a medical technologist. He was doing ultrasounds. He was working in a pediatric hospital. Patient was not prescribed/recommended vaccination. "Nobody recommended it. During my hospital. I am healthcare professional. So everybody in my hospital. I just went there and get it. I didn't ask my doctor." Patient added, "You know everything I read about this case and then you know, I have a cut in my leg which is very unusual. I have never seen that. I don't know how it happened. You know all of sudden oneday I wake up and I saw a big cut in my feet also. So, I am just afraid (onset date not reported)." The action taken in response to the events for adalimumab was unknown. The outcome of the events was unknown. Information about Lot/Batch number is requested.

Other Meds: ; ; TOPROL XL; VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] HUMIRA

Current Illness:

ID: 0955875
Sex: M
Age: 50
State: PR

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

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

Lab Data:

Allergies: lettuce, coffee, chocolate, grass

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

Symptoms: facial and eye flushing, hot breath

Other Meds: vitamins

Current Illness: none

ID: 0955876
Sex: F
Age:
State: PA

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Possible Bells Palsy; Arm/neck soreness; Arm/neck soreness/ neck are painful; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; Feel numb; Sore-all on same side as injection; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, lot number: EL3246) , via an unspecified route of administration on 13Jan2021 17:00 at single dose on left arm for covid-19 immunisation . The patient medical history was not reported. Concomitant medication included fluticasone propionate (FLONASE), pantoprazole. The patient experienced arm/neck soreness, travel up neck to side of face/around temple; side of head/face/cheeks/jaw, neck are painful, feel numb, and sore-all on same side as injection; and possible Bells Palsy on 14Jan2021 02:00. 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 has not been tested for COVID-19. No allergies to medications, food, or other products. No treatment was received for the events. The outcome of the events was not recovered.

Other Meds: FLONASE [FLUTICASONE PROPIONATE];

Current Illness:

ID: 0955877
Sex: F
Age: 45
State: KS

Vax Date: 01/04/2021
Onset Date: 01/16/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies: Iodine, e-myacin, lupron, medrol dose pack, augmentin, Bactrim, sulfa based antibiotics, thymerisol, gluten, corn, levaquin,

Symptom List: Erythema, Pruritus

Symptoms: Initially had sore arm starting 12 hours after receiving shot and lasting about 48 hours. Slight redness at injection site. 12 days after injection injection site became hard, red, hot and small red dots appeared, some which bled minimally. This condition has continued for the past two days. Additionally have experienced nausea, Diarrhea, headache and fatigue.

Other Meds: Levothyroxine, plaquenil, Claritin, probiotic, vitamin D, zinc, Vitamin C, Lutein, omega 3.

Current Illness: None

Date Died:

ID: 0955879
Sex: U
Age:
State: OH

Vax Date: 12/22/2020
Onset Date:
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar death events for 8 patients. This report is for 5th of 8 patients. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. The patient died on an unspecified date. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case. The event death with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available.,Linked Report(s) : US-PFIZER INC-2021034595 same drug, reporter and event but different patient; Reported Cause(s) of Death: expired before receiving the second dose

Other Meds:

Current Illness:

Date Died:

ID: 0955880
Sex: U
Age:
State: OH

Vax Date: 12/22/2020
Onset Date:
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: passed unexpectedly; This is a spontaneous report from a contactable nurse communicated to a Pfizer colleague. This nurse reported similar death events for 8 patients. This report is for 8th of 8 patients. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient passed unexpectedly on an unspecified date. The patient died on an unspecified date. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case. The event death with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available. 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.,Linked Report(s) : US-PFIZER INC-2021034595 same drug, reporter and event but different patient; Reported Cause(s) of Death: passed unexpectedly

Other Meds:

Current Illness:

ID: 0955881
Sex: F
Age: 41
State: MO

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: :hills, Systemic: Headache, Systemic: Hypertensive, tachycardic, tremors, severe anxiety

Other Meds:

Current Illness:

ID: 0955882
Sex: F
Age:
State: ID

Vax Date: 12/31/2020
Onset Date: 01/04/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: allergy; Short of breath; Tachycardia/my heartrate was like 140 - 150; Blood pressure was like 165 over 114/my blood pressure just like skyrocketed; Upset stomach; Tired; Started to feel not very good/not feeling like wonderful/overall sickness; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL014 (can't really tell), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. Medical history included allergy and heartburn. Concomitant medication included omeprazole for heartburn, cetirizine hydrochloride (off-brand for Zyrtec) as allergy medicine and a birth control medicine. Consumer stated, she just was calling this number because she didn't necessarily know if she had an adverse reaction or a symptom. She just wanted to report it and see if maybe you had any insight if this has happened to anybody else. Consumer further stated, she had an adverse reaction where she had to go to the emergency room. So, she didn't know if it was from the Vaccine or not because her reaction was very delayed. She got her vaccine on 31Dec2020, New Year's Eve and then starting on Monday after the vaccine on 04Jan2021. She started to feel not very good, it was mostly just like overall sickness, just as muscle aches, tired, having upset stomach so that was after 4 days. Patient had allergy from an unspecified date. And then on 07Jan2021, a week after she got the vaccine, she had signs of tachycardia and her blood pressure just like skyrocketed, her blood pressure was like 165 over a 114 and her heartrate was like 140 - 150. And she worked in healthcare, which was why she was one of the first ones to get the vaccine and she went to the ER and got worked up and they couldn't find, nothing was abnormal with her labs or blood work. She even had a chest X-ray and they couldn't find anything and they just gave her fluids and sent her home. And she was home now and still not feeling like wonderful, she felt better though but she just wanted to report that and see if there was any correlation. She didn't really know because it was so delayed, a week later. So she just wanted to report it. Consumer further stated, she forget to tell one thing, she was also short of breath on 07Jan2021. So that was why they had sent her to ER because of Tachycardia, shortness of breath and her blood pressure was really high. They didn't give her any medicine they just gave two big bags of fluid and then they discharged her. Consumer stated, she was scheduled to have her second one, she thought it was 14Jan2021. She wanted to know if she should get the second one. Consumer stated, when she went into the ER she had a lot of lab work. She didn't even know what all they did but a lot like, blood panels, she checked everything was there, that was on Thursday, last week, 07Jan2021. Consumer stated no treatment was received for the events. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: ; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 0955883
Sex: F
Age: 55
State:

Vax Date: 10/28/2020
Onset Date: 10/30/2020
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Shoulder pain; Trouble sleeping due to the pain; Still in pain when she lays down or does motion exercises. It hurts when she is taking her shirt off; Arm pain; This spontaneous case was received on 22-Dec-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-05910) and concerned a 55-year-old, female patient. The patient's medical history was not reported. The patient's concomitant medications included levothyroxine, used for an unreported indication. On 28-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis. The batch number reported was P100267084. On 30-Oct-2020, 48 hours after receiving Afluria Quadrivalent, the patient felt shoulder pain, arm pain and had trouble sleeping due to the pain. She was in pain when she was laying down or did motion exercises and it hurt when she was taking her shirt off. On an unspecified date in 2020, the patient visited physician's office three times and was treated with muscle relaxants tizanidine and hydrocodone. At the time of initial reporting, on 22-Dec-2020, the patient had not recovered from all events. The patient was still on muscle relaxant. The reporter did not provide a causality assessment. This case was assessed as non-serious. This case is linked to case 202008405 (due to same reporter). Company comment: A 55-year-old patient was vaccinated with Afluria Quadrivalent. Two days after receiving Afluria Quadrivalent, the patient arthralgia, pain in extremity, pain upon movement and had trouble sleeping due to the pain. Sleeping disorder is assessed as not related to the suspect vaccine. Causal role of the suspect vaccine is assessed as possibly related for arthralgia, pain in extremity and pain upon movement.; Sender's Comments: A 55-year-old patient was vaccinated with Afluria Quadrivalent. Two days after receiving Afluria Quadrivalent, the patient arthralgia, pain in extremity, pain upon movement and had trouble sleeping due to the pain. Sleeping disorder is assessed as not related to the suspect vaccine. Causal role of the suspect vaccine is assessed as possibly related for arthralgia, pain in extremity and pain upon movement.

Other Meds: LEVOTHYROXIN

Current Illness:

ID: 0955884
Sex: F
Age: 32
State: CA

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

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

Lab Data:

Allergies: pcn

Symptom List: Pain in extremity

Symptoms: Red bumps/spot on face and neck

Other Meds: none

Current Illness:

ID: 0955887
Sex: F
Age: 39
State: AK

Vax Date: 01/09/2021
Onset Date: 01/10/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: 1 day following administration of 2nd COVID vaccine in series, patient began to experience voices, delusions and hallucinations. Jesus visiting her. Poor eating. Poor sleeping. Denied fevers, chills, muscle aches.

Other Meds: None

Current Illness: None

ID: 0955889
Sex: F
Age: 54
State:

Vax Date: 12/26/2020
Onset Date: 01/04/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies: none

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

Symptoms: From Dec 26-29, 2020, I had injection site pain. On Jan 4, 2021, I had ear pain and it went away in two days. On Jan 7, 2021, I had mild pain on my armpit and left shoulder (Note: my left shoulder had an injury ~ 3 years ago. However, it only has pain now and then when the weather is cold or on rainy days). The pain on my armpit went away on Jan 15, 2021. The mild pain in my left shoulder is still there. On Jan 9, 2021, I got a ~8 cm in diameter BCG-like rash with induration on the edges. I took Claritin one time a day for six days, and alternate Tylenol and Motrin every 12 hours for six days. It got better on Jan 12, 2021. Now the rash is almost gone.

Other Meds: none

Current Illness: none

ID: 0955891
Sex: M
Age: 60
State: RI

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies: No medications

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

Symptoms: Systemic: Cardiac Disorder (diagnosed by MD)-Medium; symptoms lasted 1 day

Other Meds:

Current Illness:

ID: 0955893
Sex: F
Age: 37
State:

Vax Date: 01/11/2021
Onset Date: 01/13/2021
Rec V Date: 01/19/2021
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: Minor rash and swelling in arm where vaccine injection occurred

Other Meds:

Current Illness:

ID: 0955894
Sex: F
Age: 28
State: MO

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: OT (9/6/92) came into OPE from Employee Health. Her Covid vaccine was given in the wrong location of her arm. She has swelling, itchiness and pain at the injection site.

Other Meds:

Current Illness:

ID: 0955895
Sex: F
Age: 54
State: AL

Vax Date: 01/07/2021
Onset Date: 01/09/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies: Latex - cross sensitivity to foods Shellfish Bactrim Levaquin

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

Symptoms: Day one - fever, general unwell feeling. Worked Day two-,fever, joint pain, unwell. At home Day three - no fever, increase in fatigue, aching joints Day four- better but unwell feeling. Worked Day five- thirteen- felt very fatigued / headache Day 14 on, better each day.

Other Meds: Macrodantin

Current Illness: Seasonal

ID: 0955896
Sex: F
Age: 37
State: AZ

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies: gentian violet-topical medication

Symptom List: Injection site swelling, Limb discomfort

Symptoms: fatigue, headache, dizziness, swollen glands, body aches ( 5+ days all symptoms)

Other Meds: levothyroxine

Current Illness:

ID: 0955897
Sex: F
Age: 55
State: CA

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 01/19/2021
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: Symptoms started 12 hours after receiving vaccine. Pain at injection site, headache, body aches, swollen lymph nodes, stiff neck

Other Meds:

Current Illness:

ID: 0955898
Sex: M
Age: 17
State: NY

Vax Date: 01/12/2021
Onset Date: 01/19/2021
Rec V Date: 01/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient was 17 when vaccine was administered (authorized for 18 and older). No known adverse events.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm