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: 1326054
Sex: F
Age:
State: FL

Vax Date: 01/21/2021
Onset Date: 02/23/2021
Rec V Date: 05/18/2021
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: Horrible pains in both shoulders/ a friend in (State name) that hers lasted a month-Eben Pain spreaded to other joints; This is a spontaneous report from a contactable consumer. This contactable consumer reported for female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EL9267), via an unspecified route of administration administered in arm left on 18Feb2021 at single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EL9263), via an unspecified route of administration, administered in arm right on 21Jan2021 10:00 at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included arthritis, HBP and chronic boreliosis, all from an unknown date and unknown if ongoing. The patient previously took NSAIDs, LEVAQUIN, latex and experienced hypersensitivity. Concomitant medications included Oxycodone 7.5 mg; Carvedilol 20 mg; Gabapentin 300. was reported that the No adverse effects first 4 days. The patient experienced horrible pain in both shoulders, samnitska m up dcery houf on 23Feb2021 06:00. Could not lift a cup of water, pull her pants up or shirt on. Because patient heard from a friend in a different state that hers lasted a month I was waiting. After three weeks, Eben Pain spreaded to other joints patient visited her family doctor. He prescribed Medrol- steroid pack and to stop Simvastatin. Pain subsided after 24 hours. The outcome of patient was recovered. No follow-up attempts are possible; no further information are expected.

Other Meds: OXYCODONE; CARVEDILOL; GABAPENTIN

Current Illness:

ID: 1326055
Sex: M
Age:
State: MD

Vax Date: 03/04/2021
Onset Date: 03/01/2021
Rec V Date: 05/18/2021
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: Shingles; he couldn't sleep; breaking out in a rash on his scalp, chest and neck/ starting to itch/ it was looking less red/ rash felt like a sunburn or if like he was hit with a cactus/ did sting some; breaking out in a rash on his scalp, chest and neck/ starting to itch/ it was looking less red/ rash felt like a sunburn or if like he was hit with a cactus/ did sting some; felt like he had a scratch on his scalp; felt like he had a scratch on his scalp and his wife told him that it looked a little swollen; This is a spontaneous report from a contactable consumer (patient) and pharmacist. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered on the left arm on 04Mar2021 09:45 (also reported as 12:00) (Batch/Lot Number: EN6199) at the age of 32 years old as 1st dose, single for COVID-19 immunisation. Medical history included seasonal allergies (had it his whole life), sore arm and a family history of shingles (he's had an uncle or something that had shingles before but nothing with his parents). The patient had no allergies to medications, food or other products. Concomitant medication included loratadine (CLARITINE) from Feb2021 for seasonal allergies. The patient wanted to know on what he should expect after receiving the second dose of the vaccine and if he was eligible to receive the vaccine. The patient reported side effects on v-safe. He heard from other doctors that shingles had been reported from the first dose of the vaccine. He wanted to know if shingles would impact the antibodies that he may develop post vaccination. The patient stated that the fact sheet indicated that the second dose should be administered 3 weeks after the first dose, he was scheduled to receive the second dose 4 weeks later and wanted to know if it was safe to receive the vaccine outside the of the recommended time frame. The patient stated that he should be trying to take loratadine everyday (usually takes at night before bed) 1 since he does get kind of bad allergies sometimes. On 12Mar2021 (8 days later after the vaccination), the patient was diagnosed with shingles after breaking out in a rash on his scalp, chest and neck. The patient met his doctor and was recommended to report the adverse event. The patient went through CDC V safe and was provided with an information sheet that from Walgreens that listed the number for Pfizer to call if he needed further information. The patient reported that the noticed the rash (present on his scalp, chin, neck and up around his neck on his right side) on 06Mar2021 or 07Mar2021. The patient stated that the rash onset was "two fold". He noticed it when the back of his head on the right side started to become agitated in Mar2021. He stated that he sleeps with an eye mask on due to block out the lights from the baby monitor for his 6-month-old and originally thought that it was the sleep mask that was bothering him. He mentioned that on 06Mar2021 or 07Mar2021, he felt like he had a scratch on his scalp and his wife told him that it looked a little swollen. He then reported that the rash on his scalp started to get more and more uncomfortable. When the patient came home on 10Mar2021 around 17:00 or 17:30, he removed his shirt and his wife looked at him and asked what it was. He then reported that the rash appeared on his neck and chin and showed up overnight or that morning. He then stated that the rash on his chin and neck was not painful or anything. The patient then stated that the rash on his head was getting pretty agitated as of 10Mar2021. The patient thought that the rash on his chin, neck, and chest was eczema or heat rash, but thought it was odd because heat rash is normally flat. When he woke up on Wednesday (10Mar2021), the rash was looking worse but was still not bothering him except for the rash on his head. He considered going to urgent care on Thursday (11Mar2021) but didn't follow through. On Thursday night to Friday night (11Mar2021 to 12Mar2021), he couldn't sleep. His rash felt like a sunburn or if like he was hit with a cactus, and the rash on his neck started to bother him. The patient went to urgent care on 12Mar2021, and when the nurse practitioner walked in, looked at him and said that it was shingles. The patient saw 3 people at the urgent care, a nurse, nurse practitioner and a resident doctor as a doctor was needed to confirm the diagnosis. All three of the staff members said that the rash was shingles where the rash was following a nerve pattern. The patient used a cream to treat the rash, he mentioned that he tried diphenhydramine HCl 2%, zinc acetate 0.1% (Benadryl Extra Strength Itch Stopping Cream, Topical Analgesic Skin Protectant; Lot 1790LZ/3, Exp: May2022) briefly on the back of his scalp for 1 night as it was starting to itch and feel weird. He mentioned that it did sting some but didn't think anything of it as sometimes the cream will sting when put over a scab. He also used Aquaphor Healing Ointment Baby Advanced Therapy (Exp: Aug2022, UPC: 0 7214063386 8; NART number 63386), taking slabs of it and putting it over the rash. He then stated that neither did anything. After going to the urgent care, he was put on antibiotics (late described as an antiviral that should clear up in 7 to 10 days since he was young and healthy) that day and essentially said there was not much he could do. The staff also recommended that because he had 6-month-old he should call his son's pediatrician but that his infant son should be okay. He followed up with his son's pediatrician and his doctor, who stated that it should be fine, just to minimize contact with his son. The rash was still visible on his chin, neck and chest. On his scalp was harder to see because of his hair. He stated that going on feel, outside of one spot it felt significantly better. He can now wash his hair and lay on that side of his head without pain. The rash on his neck looks like some are starting to scab over. He reported that not one patch has disappeared yet, but his wife said that it was looking less red and inflamed. His doctor scheduled a routine blood draw for 08Mar2021 during his physical and stated that he was willing to go through test results as he was unsure what would be helpful, but there were numerous results for each lab test (CBC with auto differential, Lipid panel with reflex to direct LDL, Comprehensive metabolic panel, PSA, total, Urinalysis, and Vitamin D (25-hydroxy) total). He reported that his doctor had sent him a message in the evening on 08Mar2021 that said "results all normal". The patient didn't require a visit to the emergency room but required a visit to physician office. The patient had no prior vaccinations (within 4 weeks). He stated that there was no history of his parents experiencing an adverse event with vaccines, just the usual sore arm, stuff like that. On 19Mar2021, the pharmacist reported that the events were non-serious. The pharmacist reported that the treatment used for the event was famciclovir. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events pruritic rash and erythematous rash was recovering, for shingles was recovered, while unknown for the other events. Follow-up attempts are completed. No further information is expected.

Other Meds: CLARITINE

Current Illness:

ID: 1326056
Sex: F
Age:
State: NY

Vax Date: 03/17/2021
Onset Date: 03/18/2021
Rec V Date: 05/18/2021
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: Sore arm; feeling tired; This is a spontaneous report from a contactable consumer (parent). A 20-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on 17Mar2021 at 17:15 (at the age of 20-year-old) as 1st DOSE, SINGLE in left arm for COVID-19 immunisation. The patient's medical history included known allergies from amoxicillin. Patient was not pregnant at the time of vaccination. Concomitant medications included Tri Femynor 28 Tablet and doxycycline hyclate 100 mg. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 09:00 AM, the patient experienced sore arm and feeling tired. Therapeutic measures included ibuprofen taken for sore arm. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The clinical outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds: TRI FEMYNOR; DOXYCYCLINE HYCLATE

Current Illness:

ID: 1326057
Sex: M
Age:
State: PA

Vax Date: 03/17/2021
Onset Date: 03/19/2021
Rec V Date: 05/18/2021
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: Stiff neck; sore arm at injection site; This is a spontaneous report from a contactable consumer (patient's wife). The 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP6955 expiry date: unknown) via an unspecified route of administration in right arm on 17Mar2021 01:15 PM, as a single dose for Covid-19 immunisation. Medical history included high cholesterol. The patient has no known allergies medications, food, or other products. Concomitant medications in two weeks included fexofenadine hydrochloride (ALLEGRA); atorvastatin (LIPITOR [ATORVASTATIN]). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Facility where COVID-19 vaccine was administered was at a clinic. Patient not tested for COVID-19 prior to vaccination. On 19Mar2021, the patient experienced stiff neck and sore arm at injection site. He did not receive treatment for events. Patient not tested for COVID-19 after the vaccination. The outcome of the events of stiff neck and sore arm at injection site was reported as recovering. No follow-up attempts were needed. No further information was expected.

Other Meds: ALLEGRA; LIPITOR [ATORVASTATIN]

Current Illness:

ID: 1326058
Sex: M
Age: 27
State:

Vax Date: 05/15/2021
Onset Date: 05/15/2021
Rec V Date: 05/18/2021
Hospital:

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

Lab Data:

Allergies: amoxicillin

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

Symptoms: dry cough, runny nose, migraine, dizziness, trouble sleeping, stiffness, weakness in left arm, sore throat,...

Other Meds: No

Current Illness: No

ID: 1326059
Sex: F
Age: 30
State: CT

Vax Date: 05/14/2021
Onset Date: 05/14/2021
Rec V Date: 05/18/2021
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: One antibiotic (don't remember name), nitrous oxide

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

Symptoms: Remained in waiting room for 15 minutes as per instructions from medical staff. Within approximately 10 minutes of administration, I experienced a wave of warmth that led to a feeling that I would pass out. Called out to nursing staff that I was feeling "dizzy" (didn't know what else to call it). It was not like normal dizziness. Remained seated with legs stretched out to try to combat the feeling I would pass out. Nurses checked my blood pressure and it was in the low 70's. Along with low blood pressure, I experienced temporary hearing loss in left ear, nausea (feeling I could throw up), feeling I could diarrhea/defecate immediately (but held it in for obvious reasons), mental confusion. Nurses called the Emergency Department at my local hospital and told me I should (based on symptoms) be admitted to the hospital. Nurse said my blood pressure wasn't stabilizing at a normal rate of a typical vasovagal reaction. Nurse withheld administering Epipen and monitored the course of my symptoms. EMTs arrived and checked my vitals again in the Ambulance. In the Ambulance, I recall the technician saying my blood pressure was somewhere around 140. This reading is abnormally high for me (my typical blood pressure is around 110). I declined admission to the hospital due to my horrible medical insurance and worry about exorbitant costs. Symptoms did not resolve until approximately 50 minutes after the start of the incident (approx. 9:22 AM).

Other Meds: Multi-vitamin supplement

Current Illness: None. No illnesses in the past year.

ID: 1326060
Sex: F
Age: 60
State: CO

Vax Date: 04/01/2021
Onset Date: 04/05/2021
Rec V Date: 05/18/2021
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: Flagyl, peremythrin

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Dark urine 5 days Tinitus ongoing Low grade fever hot feeling inside ears resolved 3 days Lymph node swollen R armpit and both sides of throat resolved 5 days Pain overall intense off the charts body pain I had to take medication resolved 3 days

Other Meds: No

Current Illness: Chronic ibs, hepc, arthritis

ID: 1326061
Sex: F
Age: 23
State: WA

Vax Date: 04/30/2021
Onset Date: 05/03/2021
Rec V Date: 05/18/2021
Hospital:

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

Lab Data:

Allergies: Coconut

Symptom List: Pharyngeal swelling

Symptoms: Skipped historically regular period for the first time ever, with multiple negative pregnancy tests

Other Meds: Vitamin D, Magnesium, Daily multivitamin

Current Illness: None

ID: 1326062
Sex: M
Age: 37
State: FL

Vax Date: 05/17/2021
Onset Date: 05/17/2021
Rec V Date: 05/18/2021
Hospital:

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

Lab Data:

Allergies: nka

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: 37 year old male arrived to observation area. Pt. stated feeling nauseated, weakness. Observed to be sweating. Two episodes of emitus with clear fluid vomitus. Denies any other pain. Fire Rescue arrived at scene. Vital signs rendered. Pt. declined hospitalization at this time. Patient recovered from adverse reaction. PO fluids given as tolerated. Pt denied any pain or discomfort. Pt. left observation area at 12:05pm.

Other Meds: no

Current Illness: no

Date Died: 02/12/2021

ID: 1326063
Sex: M
Age: 78
State: FL

Vax Date: 01/08/2021
Onset Date: 02/12/2021
Rec V Date: 05/18/2021
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:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Died February 12, 2021

Other Meds:

Current Illness: none

ID: 1326064
Sex: F
Age: 21
State: FL

Vax Date: 05/17/2021
Onset Date: 05/17/2021
Rec V Date: 05/18/2021
Hospital:

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

Lab Data:

Allergies: n/a

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

Symptoms: Upon arrival to observation 21 year old female stated she felt nauseous and light headed. Fire Rescue took vitals and after 10 minutes pt. felt better and refused more treatment and was driven home with instructions to call 911 if symptoms worsen.

Other Meds: n/a

Current Illness: n/a

ID: 1326065
Sex: F
Age:
State: PA

Vax Date: 03/08/2021
Onset Date: 03/09/2021
Rec V Date: 05/18/2021
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: Upper arm muscle sore & achy; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non-pregnant female patient received first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206) via an unspecified route of administration, administered in Left Arm on 08Mar2021 02:00 as single dose for covid-19 immunization; tozinameran (PFIZER BIONTECH COVID 19 VACCINE, Solution for injection, Lot Number: #EN6206), via an unspecified route of administration on 08Mar2021 as single dose for covid-19 immunization. Medical history included diabetes mellitus, chronic kidney disease, thyroid, rheumatoid arthritis from an unknown date and unknown if ongoing , osteoarthritis and high blood pressure. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid. No known allergies were reported for the patient. On 09Mar2021 the patient experienced upper arm muscle sore & achy. No treatment was received for the event. The outcome of event was not recovered. Location of injection information is available for all vaccines received on the same date. Information on Lot/Batch number was available. Additional information has been requested. Follow-up (12May2021): This follow-up is being submitted to notify that the lot/batch number was not available despite the follow-up attempts made.

Other Meds:

Current Illness:

ID: 1326066
Sex: M
Age:
State: OH

Vax Date: 02/15/2021
Onset Date: 03/15/2021
Rec V Date: 05/18/2021
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: swollen lymph nodes in the area of the clavicle post 2nd dose; This is a spontaneous report from a contactable reporter reporting for a 33-year-old male patient who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration into the right arm on 15Feb2021 (at the age of 33-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Unknown if any allergies presented. On 15Mar2021, the patient experiencing swollen lymph nodes in the area of the clavicle post second dose. Prior to vaccination, the patient was not diagnosed with COVID-19 and unknown if tested post vaccination. No treatments received. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. Unknown if since the vaccination, the patient had been tested for COVID-19 and also allergies to medications, food or other products. Reporter learned of the adverse event that reporter reported on behalf of someone on 26Mar2021, the same day it was reported. Outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1326067
Sex: F
Age:
State: MT

Vax Date: 03/03/2021
Onset Date: 03/09/2021
Rec V Date: 05/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I got Covid 19 a few days after my first shot. Test positive on 09Mar; This is a spontaneous report received from a contactable consumer (patient). A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6203 and Expiration date not reported) via an unspecified route of administration, in Arm left, on 03Mar2021 (at the age of 60 years) as a 1st dose, single for covid-19 immunization. The patient medical history included diabetes, hypertension and UTI (Urinary tract infection). Concomitant medications included acyclovir [ACICLOVIR] taken for an unspecified indication and ambroxol hydrochloride (ABX) taken for urinary tract infection, for both start and stop date were not reported. Other medications the patient received within 2 weeks of vaccination includes Abx for UTI. The patient received some other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. On 09Mar2021, she got COVID-19 a few days after her first shot. The adverse event result in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the event. The patient underwent lab tests and procedures which included Nasal Swab sars-cov-2 test: positive on 09Mar2021. Outcome of the event was reported as recovering. No follow-up attempts are needed. No further information is expected.

Other Meds: ACYCLOVIR [ACICLOVIR]; ABX

Current Illness:

ID: 1326068
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/18/2021
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: she thought she was going to die; This is a spontaneous report from a contactable consumer (patient's sister). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced that she thought she was going to die on an unspecified date. She stated she was not sure if she is going to get the second dose. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1326069
Sex: U
Age:
State:

Vax Date: 03/25/2021
Onset Date: 03/01/2021
Rec V Date: 05/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fever; Splitting headache; Heart was racing like 100 beat per second and I kept waking with nightmare and just these deep breathing to try and slow my heart down; Average beats per minute all night long was 86 which is normally like 50/Hope that didn't damage my heart by having this racing heartbeat all night long and it's high now; Exhausted; This is a spontaneous report received from a contactable consumer (patient). An unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 25Mar2021 at 2nd dose, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 on 04Mar2021 for COVID-19 immunization. Patient lab data included heart beat results were reported as heart was racing a 100 beat per second all night long/beats per minute all night long was 86 which is normally like 50. On an unspecified date in Mar2021 consumer stated that I had my second Pfizer (captured as Unspecified medication) yesterday morning, my first one was on 04Mar2021 and didn't had any problems or any reactions at all. But the second one I had a fever, splitting headache and my heart was racing a 100 beat per second all night long and I kept waking up with these nightmare and waking up and just these deep breathing to try and slow my heart down. And it was just this thing because I have a fit bit that I was wearing and the average beats per minute all night long was 86 which is normally like 50. So something weird was going on and I was exhausted right now. And I just hope that didn't damage my heart by having this racing heartbeat all night long and it's high now, it's high still, much higher than normal. I normally am a very fit person so I normally have a very low heart rate. I am kind of little worried about it but I wanted to let you guys know and also see if there is a way to just make sure that I don't need to go to the doctor". Outcome of the events was reported as unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1326070
Sex: M
Age:
State: FL

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 05/18/2021
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: two days after his first dose of the vaccine He tested positive with the Covid-19; His Doctor advised him to get the second dose only after 60 days before getting his second dose; This is a spontaneous report from a Pfizer sponsored Program. A contactable male consumer reported that; a male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 20Jan2021at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced two days after his first dose of the vaccine he tested positive with the COVID-19 and his doctor advised him to get the second dose only after 60 days before getting his second dose on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 antibody test was positive on 22Jan2021. The outcome of the event was unknown. No follow-up attempts are possible. No information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1326071
Sex: F
Age:
State: NY

Vax Date: 03/25/2021
Onset Date: 03/06/2021
Rec V Date: 05/18/2021
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: I had a routine COVID test at work about 2 pm on Friday, This test came back with positive results; This is a spontaneous report from a contactable consumer. A 23-years-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8727), dose 2 via an unspecified route of administration, administered in right arm on 25Mar2021 at 02:45 as second dose, single for covid-19 immunisation. Medical history included drug hypersensitivity. Allergies to medications, food, or other products included Zythromax. Concomitant medication included estrogens conjugated (estrin [estrogens conjugated]) birth control. On 04Mar2021 at 03:45 pm, the patient received first dose of bnt162b2 (Batch/Lot Number: FN6205) administered in right arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 06Mar2021 friday, she had a routine COVID test at work about 2 pm. This test came back with positive results which was very strange considering she had not changed her routine or the people she interacted with for the last month and everyone she had interacted with also tested negative on the same day. She had no reason to test positive between this and the fact that she strictly went from home to work and back daily. For the second dose: About 2 am on 26Mar2021, she woke up with a fever of 100.9. She called out of work and spent entire next day in bed with horrific chills and an off and on fever eventually peaking at 102.8 around 5pm. Sometime after that, she fell asleep and slept until around 7 the next morning and by then her fever had broken. The whole day that she was feverish she had such bad body aches it hurt to walk across her apartment to the bathroom even and she spent the day off and on sleeping. The event assessed as non-serious with outcome of recovered. No follow up attempts needed; information about batch/lot no. cannot be obtained. No further information is expected.

Other Meds: ESTRIN [ESTROGENS CONJUGATED]

Current Illness:

ID: 1326072
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: sore arm; mild headache.; This is a spontaneous report received from a contactable consumer. A female patient of unknown age, received adalimumab (HUMIRA, solution for injection in pre-filled syringe and pen) from unknown date, subcutaneous for Psoriatic Arthritis. Covid-19 vaccine was also considered suspect. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number unknown), via an unspecified route of administration on unknown date at single dose for COVID-19 immunization. Patient experienced headache and sore arm. Outcome of events was unknown. No follow up attempts are possible. Information related to batch/lot number could not be requested

Other Meds:

Current Illness:

ID: 1326073
Sex: M
Age:
State: MI

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 05/18/2021
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: experiencing rather strong flu-like symptoms; This is a spontaneous report from a contactable consumer. A adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection),via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was not known if patient receive any other vaccines within 4 weeks prior to the COVID vaccine and if there was list of any other medications the patient received within 2 weeks of vaccination. It was unknown if patient was diagnosed with COVID-19, prior to vaccination and if patient has been tested for COVID-19, Since the vaccination. It was not known if patient had allergies to medications, food, or other products. On 02Apr2021, the patient experienced rather strong flu-like symptoms. It was unknown if treatment received for the event. The outcome of event was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1326074
Sex: M
Age:
State: WI

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 05/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: rash/on chest bilaterally; This is spontaneous report received from contactable other-HCP on behalf of the patient. A 72 -year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264), via an Intramuscular route of administration, administered in left arm on 11Feb2021 (at the age of 72-years) as a single dose for COVID-19 immunization. The patient medical history included GERD, hyperlipidaemia, CLL, DJD. The patient had no known allergies. Patient did not receive any other vaccine four weeks prior vaccination. Patient not had COVID prior vaccination. Concomitant medications included amlodipine, celebrex, lipitor, omeprazole. On 11Feb2021 (same day after vaccination), patient experienced rash on chest bilaterally. Patient visited dermatologist as a result of event. Patient was treated with triamcinolone. Patient was not tested for COVID post vaccination. The outcome of the event rash was recovering. No Follow-up attempts are needed. No further information is expected.

Other Meds: AMLODIPINE; CELEBREX; LIPITOR ORIFARM; OMEPRAZOLE

Current Illness:

ID: 1326075
Sex: F
Age:
State: CA

Vax Date: 03/28/2021
Onset Date: 04/03/2021
Rec V Date: 05/18/2021
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: I got covid six days after my vaccination and I'd like to understand what if any are the effects of receiving the second dose. What is the protocol exactly?; This is a spontaneous report from contactable consumer reported for herself. This 31-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8732, expiry date: unknown) in left arm via unknown route of administration on 28Mar2021 at 14:45 as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or no other medications received within 2 weeks of vaccination. Medical history and concomitant medications were not reported. She got COVID six days after her vaccination on 03Apr2021 at 09:00 AM and would like to understand what if any are the effects of receiving the second dose. It was also reported that, started having symptoms for COVID-19 on 03Apr2021 and then tested positive for COVID-19. She underwent lab test: SARS- CoV-2-NAT with positive result on 07Apr2021. She did not receive any treatment. She has fully recovered d from COVID-19, has no symptoms and she has completed her required isolation period. Outcome of event was recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1326076
Sex: M
Age:
State:

Vax Date: 03/28/2021
Onset Date: 03/31/2021
Rec V Date: 05/18/2021
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: Sick; very weak; had a GI condition I had been dealing with return/ 3 days after getting his first vaccine dose the condition he had came back; had a GI condition I had been dealing with return/ 3 days after getting his first vaccine dose the condition he had came back; This is a spontaneous report from a contactable consumer (patient) from Medical Information Team. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 28Mar2021 at single dose for COVID-19 immunization. Medical history included gastrointestinal disorder from Oct2020. The patient's concomitant medications were not reported. The patient had a regular reaction for a couple of days after receiving the shot but on day three, on 31Mar2021, he had a gastrointestinal condition he had been dealing with return. The patient reports that he has had a gastrointestinal issue since last October and his gastrointestinal physician has been trying to schedule a scope test. Three days after getting his first vaccine dose the condition he had come back, and he was not able to get the scope test until 29Apr2021. The patient was sick on an unspecified date. He reported that he was very weak (unspecified date) and, at the time of the report, he was just trying to stay out of the hospital. Outcome of all events was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1326077
Sex: F
Age:
State: WA

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 05/18/2021
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: Headache; soreness at injection site; extreme muscle and joint pain; extreme muscle and joint pain; mild fatigue; This is a spontaneous report received from a contactable consumer (patient). This non-pregnant 18-year-old female patient received the second dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME; lot number EW0153) via an unspecified route of administration in the right arm on 15Apr2021 at 08:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient had not been diagnosed with COVID-19. Concomitant medications included sulfamethoxazole, methylphenidate hydrochloride, and sertraline, all from unknown dates for unknown indications. The patient previously received the first dose of COVID-19 vaccine (lot number EP6955) on 25Mar2021 at 08:15 (at the age of 18-years-old) for COVID-19 immunisation. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. On 15Apr2021 at 16:00 the patient experienced headache, soreness at injection site, extreme muscle and joint pain, and mild fatigue. No treatment was received for the events. The clinical outcomes of headache, soreness at injection site, extreme muscle and joint pain, and mild fatigue were unknown. It was also reported that since vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Other Meds: SULFAMETHOXAZOLE; METHYLPHENIDATE HYDROCHLORIDE; SERTRALINE

Current Illness:

ID: 1326078
Sex: M
Age:
State:

Vax Date: 03/03/2021
Onset Date: 03/01/2021
Rec V Date: 05/18/2021
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: diarrhea; This is a spontaneous report from a contactable consumer (patient). This 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 03Mar2021, and the second dose of BNT162B2 (lot number unknown) via an unspecified route of administration on 01Apr2021, as single doses for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported he received the first dose on 03Mar2021 and about 10 days to 2 weeks later he experienced diarrhea. It was reported the diarrhea had continued to "this day," as of (16Apr2021) and had still not gotten better two weeks after he received his second dose on 01Apr2021. He reported he was aware that it could be a side effect that may last for one to two days but was wondering if there had been any reports of diarrhea lasting this long of a period. The clinical outcome of diarrhea was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1326079
Sex: F
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 05/18/2021
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: she had a fever of 101F (her normal body temp is 96.8F); rash on her forehead; little pustules; headache; little trouble breathing; This is a spontaneous report received from a Pfizer sponsored program via a contactable consumer (patient) reported for herself. A 60-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown, Expiry date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was 60 years) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included she had an anaphylactic reaction twice in her life, once to macadamia nuts, and once to "an allergy shot with dust stuff in it". She had a complicated allergy history. Also reported allergies to corn and Benadryl and allergic to an ingredient in benadryl, originally reported as "polypropylene glycol", but later corrected to "polyethylene glycol". The patient was allergic to corn and poly-something in BENADRYL so she couldn't take it anymore. Co-suspect medication included diphenhydramine hydrochloride (BENADRYL). She stated that after the first dose, she had fever of 101F (her normal body temp is 96.8F), a rash on her forehead, and a headache, and noted that on the second day she 'had a little trouble breathing' but said it might be from seasonal allergies. Pretty normal reactions- her normal body temperature was 96.8F had a fever of 101F that's one of the regular side effects and a little bit of a problem breathing- on the second day. Rash on forehead right away, headache too. kept a cold compress and kept switching it every couple of minutes b/c of the fever little pustules. When she put the cloth on regularly it soaked her skin. Rash went away after she had 2 anaphylactic rxn - macadamia nut & allergen shot that had dust stuff in it. She treated the fever and forehead rash with cool compresses and kept switching it every couple of minutes, putting the cloth on regularly it soaked in skin and noted that the rash had what appeared to be 'little pustules" and thought the rash may have been caused by the fever because they resolved at the same time. She had a side effect after the first dose of the vaccine. She asked whether she could receive the second dose and whether she should get the second dose. The nurse that gave her husband his shot said that the reactions to the second dose were more severe. She received the response stating that provided contraindications and discussed potential signs and symptoms of severe allergic reaction as listed in 'CONS-what are the risks of the vaccine (v5.0)' and when they would expect them to occur. Confirmed that fever was commonly reported and that common AEs were more frequently reported after dose 2 in clinical trials (Tables 1-4). Referred caller to her HCP or vaccination site for additional guidance and monitoring. Confirmed that polyethylene glycol is an ingredient in the Pfizer Covid19 vaccine. She should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They referred her to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Her healthcare provider knew her health situation and had access to information that can better help inform that decision. The caller was unsure if she should take 2nd dose of COVID vaccine. Bendadryl no longer Pfizer but unclear when she developed allergy to it. The outcome of events she had a fever of 101F (her normal body temp is 96.8F), rash and little pustules was recovered on an unknown date. The outcome of the events headache and little trouble breathing was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Follow-up (16Apr2021): New information received from a Pfizer-sponsored program via a contactable consumer (patient) reported for herself included: Added Benadryl as co-suspect medication.

Other Meds:

Current Illness:

ID: 1326080
Sex: F
Age:
State:

Vax Date: 03/24/2021
Onset Date: 03/25/2021
Rec V Date: 05/18/2021
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: stated patient reported on 8Apr2021 she developed pimples where she was red.; warm to the touch; that her chest, decolletage to her sternal notch, was bright red.; This is a spontaneous report from a contactable physician. A 60-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 25Mar2021 the patient experienced her chest, d?colletage to her sternal notch was bright red. The area was red and warm to the touch. On 08Apr2021 she developed pimples where she was red. She only had about 10 pimples "now" between her breast and her sternal bone. The physician wanted to know if the patient could receive dose 2 of BNT162B2. The outcomes of chest bright red, warm to touch, and pimples were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1326081
Sex: F
Age:
State:

Vax Date: 04/09/2021
Onset Date: 04/01/2021
Rec V Date: 05/18/2021
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: a mild sore arm; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 09Apr2021 as a single dose for COVID-19 immunization. Medical history included allergic to shellfish, clams, and mussels, Raynaud's and a heart murmur. The patient's concomitant medications were not reported. In Apr2021, the patient did not have any reaction other than a mild sore arm. The patient was scheduled to take the second dose on 30Apr2021 which would have been 3 weeks after the first dose. She asked if she could postpone receiving her second vaccine. She did not have any reaction other than a mild sore arm. The outcome of a mild sore arm was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1326082
Sex: M
Age:
State: NY

Vax Date: 04/12/2021
Onset Date: 04/12/2021
Rec V Date: 05/18/2021
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: Fever; chills; malaise; vomiting; This is a spontaneous report from a contactable consumer (patient) via company representative. A 43-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Apr2021 at the age of 43 years old (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for covid-19 immunisation. It was reported that after Second dose of BNT162b2 vaccine (week of 12Apr2021), patient experienced fever, chills, malaise and vomiting on 12Apr2021 for 24 hours and symptoms resolved. Events took place after use of product. The outcome of the events was recovered in Apr2021. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1326083
Sex: F
Age:
State: CT

Vax Date:
Onset Date:
Rec V Date: 05/18/2021
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: Bad swelling; This is a spontaneous report from Pfizer Sponsored Program. A contactable consumer (patient) reported for herself. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered on an unspecified date as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history included Mammogram. The patient concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered on an unspecified date as 1ST DOSE, SINGLE for COVID-19 immunization. On an unspecified date the patient experienced bad swelling from second vaccine. Had to reschedule Mammogram. She did not get swelling from first vaccine. She Inquired if that was a common side effect. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1326084
Sex: F
Age:
State: CT

Vax Date: 04/15/2021
Onset Date: 04/01/2021
Rec V Date: 05/18/2021
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: Lymph node swelling/ having lymph nodes on the left side of the back of her neck that were swollen; Fever; She felt really hot and sweaty for 2 days.; She felt really hot and sweaty for 2 days.; Muscle pain; She felt the pain in knees, hips, wrist, and elbows with second dose/Joint pain; She felt disabled like she can't move; Crazy fatigue; Joint pain had increased; Arm pain; Feeling like someone had punched her 10 times/ felt like someone punched her ten times at injection site; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 15Apr2021 13:30 (Batch/Lot Number: EL9262) as 2nd dose, single for covid-19 immunisation. Medical history included autoimmune disorder (ongoing), psoriatic arthropathy (ongoing), rheumatoid arthritis (ongoing), abdominal operation (appendix removed), Joint pain, anxiety, vitamin D deficiency, palpations, arrhythmias, hysterectomy and hypersensitivity (she has lots of allergies. anaphylaxis was a concern for her). Family history included her two sisters and mom had GI symptoms after the Covid19 vaccine. One of the two sisters works in healthcare. Concomitant medications included paracetamol (ACETAMINOPHEN) ongoing since unknown years at a dose of one 500 mg, ranges from 2 to 3 a day, liquid gel for arthralgia, hypersensitivity (she took it as she had to); atenolol tablet ongoing since at least 20 years at a dose of 100 mg oral, two times daily for palpitations, arrhythmia (she had lots of allergies and when she finds something that works, she leaves it alone); levothyroxine tablet ongoing since 10-15 years at a dose of 0.05 mg oral once daily for thyroid hormone replacement therapy; alprazolam tablet ongoing since at least 20 years at a dose of 1 mg oral 3-4 times a day for anxiety; vitamin D Nos ongoing since an unknown date at a dose of 50 mcg, softgel, once a day for vitamin d deficiency (If the deficiency goes lower her doctor would have her take two but right now she takes one). No other vaccine in four weeks. The patient previously took first dose of bnt162b2 in left arm (Lot number:ER8732) on 25Mar2021 at 14:30 for covid-19 immunisation and had experienced dizziness, vaccination site pain, hyperpyrexia, fatigue, pyrexia, myalgia, condition aggravated, pain in extremity, hyperhidrosis, feeling hot and took flu shot made her unconscious. It was reported that, patient was reporting on herself and had a question. She got the first vaccine on 25MAR2021. She had the second dose on 15APR2021. She asked the doctor about it because she does have several autoimmune issues. She mentioned she had gotten a flu shot in the past but the flu shot made her unconscious. It had no after effect, and it did not do anything. She had not received the flu shot in the last 20 years and had not gotten the flu either. For the flu shot she didn't have the Lot, NDC or EXP. At that time, she was working in healthcare and made everyone do it. It was a fluke and no after-effects. She also mentioned she had lots of allergies. Anaphylaxis was a concern for her. With the first shot, she couldn't describe it, but first 10 to 15 seconds less than a minute started feeling dizzy but not really, states it was like when you first wake up from surgery where you are confused. It was an odd sensation. Then it went away. She didn't think much about it. She didn't even feel the needle prick then half hour later it felt like someone punched her 10 times, which lasted for two or three days. She decided to sit extra time in the waiting room area. She later confirmed later that this was regarding the Pfizer Covid Vaccine. She mentioned that she takes Tylenol on a daily basis but did not take it the day she got the vaccine. She went on to explain that she had a list of what to expect but the first dose it wasn't that bad. Within 8 hours of both vaccines experienced crazy fatigue and was so tired. She has joint pain normally and was in a flare due to psoriatic and rheumatoid arthritis but after the vaccines the joint pain had increased. After a couple of days, it went back to how her pain normally was. Her main issue was with the second vaccine. The second shot on 15APR2021 did expect it to be worst. Dizzy: It went away. It was less than a minute and then it was gone. It happened while she was sitting in the seat. It was so strong and then it went away in a minute, it was gone. She felt like someone punched her ten times at the injection site: occurred with both doses, the first time it occurred starting 25MAR2021 She didn't even feel the needle prick, the injection itself did not hurt, then it felt like someone punched her hard 10 times. This started 20 to 30 minutes after getting the vaccine. When she got home no redness or really even swelling. Later confirmed no swelling. She had arm pain that lasted for 2-3 days and then it went away. The same thing occurred with the second dose on 15APR2021. Then it resolved on its own. She used icepack as a treatment. it did not kill the pain but made it more tolerable. She was just more sensitive. She confirmed that she recovered completely from the feeling like someone had punched her 10 times from both the first and second dose. Fatigue: It started 8 hours after vaccine on both 25Mar2021 and 15Apr2021. She thought she was home free. It was weird. She also mentioned with fatigue she started having a fever, muscle pain, and horrible joint pain all at the same time. They lasted 2-3 days and then she recovered completely. Fever: Started 25MAR2021 after the first vaccine and then started again on 15 APR 2021 after the second vaccine. She felt really hot and sweaty for 2 days. She said she does not feel get fevers very often. She had it 8 hours after both injections she wasn't sure why it took 8 hours. The first-time highest temperature about 101. Both times she took Tylenol every 6 hours for two days and as soon as the Tylenol wore off the fever would come back but the temperature would be lower. She confirmed she recovered completely after both occurrences. Caller initially stated she was taking Tylenol and then later clarified she was taking CVS brand acetaminophen. She mentioned she takes this one because she had a lot of allergies and cannot take the regular Tylenol brand due to the fillers in it, Tylenol bothers her. Caller referred to CVS acetaminophen as Tylenol throughout the report and then clarified at the end. Tylenol clarified as CVS brand acetaminophen. Did not had lot number, expiration, NDC. The lot number and expiration date are rubbed off the bottle and she cannot read them, there is a black smear where it says lot/exp. Muscle pain: Hit all at once and lasted 2 days for both vaccine doses. She recovered completely from both occurrences. and started within 8 hours for both doses. Joint pain: It started within the same time. Within 8 hours of both doses. She had joint pain every day but it amplified after vaccine doses. She felt disabled like she can't move. There was a difference. First time mostly was in her knees and hips. The second time it seemed to last longer, it aggravated the flare already there. She felt the pain in knees, hips, wrist, and elbows with second dose. States the wrist joint pain was really bad and she sometimes gets that with her rheumatoid arthritis but she was not having pain in arms, in her wrists and elbows before the injection. She has pain now but its the normal pain that she had felt prior to the injection. Lymph Node swelling: on saturday the 17APR2021 noticed her lymph nodes were swelling. She had a mammogram appointment. It was located under her left armpit. She called your doctor next day on the 18th because it was getting more painful. She was also having lymph nodes on the left side of the back of her neck that were swollen. That was part of the reason that she was calling because she wanted to see if that was normal. The lymph nodes swelling are all still there and they hurt. When probed for outcome caller did not clearly provide. She just mentioned that she was aware that it cou

Other Meds: ACETAMINOPHEN; ATENOLOL; LEVOTHYROXINE; ALPRAZOLAM; VITAMIN D NOS

Current Illness: Autoimmune disorder (Verbatim: autoimmune issues); Psoriatic arthritis (Verbatim: Psoriatic arthritis); Rheumatoid arthritis (Verbatim: Rheumatoid arthritis)

ID: 1326085
Sex: F
Age:
State: FL

Vax Date: 04/14/2021
Onset Date: 04/16/2021
Rec V Date: 05/18/2021
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: I have been running on fever now from 100-102 was reported as worsened; I have been running on fever now from 100-102 was reported as worsened; This is a spontaneous report from a contactable consumer (patient herself). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0158, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in left arm on 14Apr2021 (at the age of 53-year-old) as 1ST dose, single for covid-19 immunization. The patient medical history included to stabilize my thyroid. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken 0.05 mg, 1x/day (One tablet daily before breakfast) for to stabilize her thyroid with ongoing; liothyronine sodium (CYTOMEL) taken 5 ug, 2x/day(2 tablets orally daily in the morning before breakfast) orally for to stabilize her thyroid with ongoing. Consumer stated that she was reported the first reaction to the vaccine. She has been running on fever now from 100-102 since Friday afternoon. She was received the vaccine last Wednesday and she just did not think that was normal. Consumer further stated, she did not know if she was going to take second shot if she feels like that. The second shot is rescheduled for 05May2021. Consumer wanted to know if that was normal. On 16Apr2021, the patient reported, I have been running on fever now from 100-102 was reported as worsened. Reported seriousness for the event was unspecified. The patient underwent lab tests and procedures which included body temperature: 100-102 on 16Apr2021. Therapeutic measures were taken as a result of the event a treatment included with, she took 2 tablets of Tylenol Extra Strength 500 mg and orally when her fever was high. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: SYNTHROID; CYTOMEL

Current Illness:

ID: 1326086
Sex: F
Age:
State: CA

Vax Date: 04/21/2021
Onset Date: 04/23/2021
Rec V Date: 05/18/2021
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: Severe inflammation and pain in left axillary lymphs; Severe inflammation and pain in left axillary lymphs; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: unknown, via unspecified route, in left arm on 21Apr2021 15:30 (at 47-years age) 1ST DOSE SINGLE for covid-19 immunisation. The patient's medical history included Migraines, past drug advil. The patient's concomitant medications included vitamin D, zinc, magnesio in within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications in 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021 the patient had experienced severe inflammation and pain in left axillary lymphs. The outcome of the event was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: ZINC; MAGNESIUM; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1326087
Sex: F
Age:
State: CA

Vax Date: 03/27/2021
Onset Date: 04/14/2021
Rec V Date: 05/18/2021
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: She was unable to work due to the pain; Pain in thigh, calf, hamstring of both the legs. It comes and goes away. It improves when I sleep but worsen when I sit and work. It started as thigh pain during my periods and then became calf and hamstring pain.; This is a spontaneous report from a contactable consumer. A 30-years-old female, non-pregnant, patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 27Mar2021 15:00 (Batch/Lot Number: ER8730) as single dose for COVID-19 immunization. Medical history included arthritis from an unknown date and unknown if ongoing, hip pain in Jan2021, resolved by taking vitamin D3 tablets by "NatureMade" 2000IU and milk. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19, since the vaccination the patient has not been tested for COVID-19. On 14Apr2021 13:00 the patient started experiencing pain in thigh, calf, hamstring of both the legs. It comes and goes away. It improves during sleep but worsen when the patient sits and works. It started as thigh pain during the patient's periods and then became calf and hamstring pain. The patient reported that it surely has altered something in her body. She is a software engineer and most of the time she needs to work on her laptop. She took Pfizer vaccine to save herself from COVID-19 instead this vaccine is crippling her and she was unable to work due to the pain. As a result of the event the patient scheduled an appointment with orthopedic. It was also reported that the patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, at Pharmacy or Drug Store, on 24Apr2021 at 2:30 pm (Batch/lot number: EW0170). At the time of the report the event had not resolved yet. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1326088
Sex: M
Age:
State:

Vax Date: 04/22/2021
Onset Date: 04/26/2021
Rec V Date: 05/18/2021
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: I did a rapid test it came back positive. I did a PCR test also, but I am waiting for the result.; chills; muscle pain; mostly fatigue; This is a spontaneous report received from Medical Information and a contactable male consumer (patient). A 40-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiration date not reported), via an unspecified route of administration on 22Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Monday, 26Apr2021 the patient started feeling symptoms included fatigue, muscle Soreness, that were pretty light. On 27Apr2021, they got worst, the patient had muscle pain and mostly fatigue and in the night, the patient started having chills that are persisting on 28Apr2021. The patient underwent lab tests and diagnosis which include a rapid covid test that came back positive and also got a PCR test but results will not be back for about 48 hours. The outcome of all the events was reported as unknown. Information about lot/batch number has been requested. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1326089
Sex: F
Age:
State: MA

Vax Date: 04/28/2021
Onset Date: 04/28/2021
Rec V Date: 05/18/2021
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: hives on her mucous membranes/got a few hives on shoulder; bumps; then itching inside nostril and other mucous membranes/whole mucous membrane area down there still feels sensitive or irritated or something/burning feeling in mucous membranes, itching and stinging; then itching inside nostril; hives/red flushy skin/itching; touches something like the remote, patient felt very cold; itching on forehead and on back and on shoulder and in other places/itching; flushing; At first had a funny taste in mouth right away; did have diarrhea a lot when first got home; By evening face was flush red; face was probably a little bit puffy; even today every so often where hair touches face is sensitive/All openings to body are sensitive; mucous membrane area down there still feels sensitive or irritated; got goosebumps right away; burning feeling in mucous membranes; stinging; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: ER8736), via an unspecified route of administration in right arm on 28Apr2021 08:15 (at the age of 61-years-old) as 1 st dose, single for covid-19 immunisation. No prior vaccinations (within 4 weeks). No family medical history relevant to the events. No additional vaccines administered on same date of bnt162b2. Medical history included strong reaction to bee stings, allergies/some nuts, allergies/shellfish, allergies to a sulfa drug, allergies, hives, red flushy skin and itching (noted from all allergies that never had anaphylaxis before but gets hives or red flushy skin and itching from some or all of these). There were no concomitant medications. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies. The patient received the first dose of bnt162b2 yesterday (on 28Apr2021 at 08:15) and had a reaction to it. The site of the injection for first dose was fine, nothing around the site. On 28Apr2021, the patient experienced at first had a funny taste in mouth right away (vaccination facility said they had never heard that before; gone momentarily after first dose/went away completely); then itching inside nostril and other mucous membranes (within five minutes of receiving the first dose); by evening face was flush red (coloring part was completely gone away); face was probably a little bit puffy; even today every so often where hair touches face is sensitive and will get itchy again; did have diarrhea a lot when first got home (lasted 15-20 minutes and then it was over); right away had itching on forehead and on back and on shoulder and in other places; whole mucous membrane area down there still feels sensitive or irritated or something. All openings to body are sensitive; continued to have burning feeling in mucous membranes, itching and stinging. Skin was really sensitive, when patient felt warm if pushed up sleeves, arm got a little cool and got goosebumps right away. If the patient touches something like the remote, patient felt very cold, skin seemed very sensitive all over. The patient took temperature to see if had a fever, temperature was 98.6, exactly normal, usually runs lower than that but definitely wasn't a fever. The patient left the vaccination facility after half an hour, nothing seemed life threatening. On 29Apr2021, the patient experienced that even today overnight got a few hives on shoulder, back up by shoulder area on one side and noticed the bumps, felt where the bumps were but they are not as big and they were itchy occasionally but not very itchy. (were better now). The events did not require emergency room or physician office visit. The patient stated that it wasn't anaphylactic reaction. The patient have read online that if have a reaction in less than four hours, it was considered severe. The patient was a little concerned when got the shot and was reassured at the vaccination facility that they had not seen anaphylaxis. The patient was wondering if it was okay to get the second dose or should the caller hold off. The patient asked if her symptoms were categorized as a severe allergic reaction (in 2021) and thereby contraindicate her from getting her second dose. The outcome was recovered from taste disorder and diarrhoea on 28Apr2021, from flushing and swelling face on 29Apr2021, from erythema in 2021; recovering from pruritus, piloerection, skin disorder and sensitive skin; not recovered from mucosal pain, burning sensation mucosal, pain, mucosal disorder and nasal pruritus while unknown for the remaining events.

Other Meds:

Current Illness:

ID: 1326096
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 03/17/2021
Rec V Date: 05/18/2021
Hospital: Y

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: STROKE; FELL DOWN; This spontaneous report received from a health care professional (patient's wife) concerned a 54 year old male of Hispanic or Latino other race. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes, and high cholesterol. The patient had no known allergies and was non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, administered on 16-MAR-2021 at 16:00 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. After vaccination, later on that evening her husband mentioned that he did not feel too good. He took a Tylenol and then went to bed. At around 3:00 that evening his wife woke up to go to the bathroom and noticed her husband was awake. When she asked he responded that he thought he might have suffered a stroke. On unspecified date he experienced fell down and unable to move the right side of his body. On 17-MAR-2021 at around 5:00 that morning, she took him to the emergency room (ER). There the ER department performed a computerized tomography (CAT) scan and confirmed that he indeed had a stroke and decided to transfer him to another hospital. On 22-MAR-2021, he was then discharged. He was hospitalized for 5 days. A few days later on 24 or 25-MAR-2021 she took him to her Doctor Of Medicine (MD.) where they had him do rehab which consisted of daily walking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and the outcome of fell down was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210515350-Covid-19 vaccine ad26.cov2.s- A 54- year- old male of Hispanic or Latino other race presents with Stroke. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY

Other Meds:

Current Illness: Diabetes; High cholesterol; Hypertension; Non-smoker

ID: 1326097
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 05/18/2021
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: DIZZY; MASSIVE HEADACHE/WORST HEADACHE ONLY ON RIGHT SIDE OF THE HEAD; This spontaneous report received from a consumer by a Business partner was received on 07-MAY-2021 and concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced dizzy. On 2021, the subject experienced massive headache/worst headache only on right side of the head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the massive headache/worst headache only on right side of the head and dizzy was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.

Other Meds:

Current Illness:

ID: 1326098
Sex: M
Age:
State: CT

Vax Date:
Onset Date: 05/12/2021
Rec V Date: 05/18/2021
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: SUSPECTED COVID-19 INFECTION; LARYNGITIS; STUFFY NOSE; MINOR BODY ACHES; FEELING CLAMMY AND COLD SWEATS; REALLY THIRSTY; MINOR HEADACHE; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the patient experienced other symptoms like suspected clinical vaccination failure, laryngitis, stuffy nose, minor body aches, feeling of clammy and cold sweats, really thirsty and minor headache. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-MAY-2021, the subject experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure, laryngitis, minor headache, stuffy nose, minor body aches, feeling clammy and cold sweats and really thirsty was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210523526-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1326099
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/18/2021
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: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 14-MAY-2021. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced confirmed immunological vaccine failure. On MAY-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) Negative with a level of 5.87 when <12 is considered negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179590.; Sender's Comments: V0: 20210523786-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1326100
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 05/13/2021
Rec V Date: 05/18/2021
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: DIZZINESS; LEG CRAMPS/BAD CHARLEY HORSE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A,and expiry: 23-JUN-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced dizziness. On 13-MAY-2021, the subject experienced leg cramps/bad charley horse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leg cramps/bad charley horse, and had not recovered from dizziness. This report was non-serious.

Other Meds:

Current Illness:

ID: 1326101
Sex: F
Age:
State: OK

Vax Date:
Onset Date: 04/20/2021
Rec V Date: 05/18/2021
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: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 60-year-old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry date : Unknown) dose was not reported, 1 total administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-APR-2021, the patient had negative quantitative antibody test (spike protein test) (confirmed immunological vaccine failure). Laboratory data included: Semi Quantitative spike protein Antibody test (NR: not provided) as Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. . The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210457869.; Sender's Comments: V0:20210525044 covid-19 vaccine ad26.cov2.s - Confirmed immunological vaccine failure.This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically:SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1326102
Sex: M
Age:
State: MI

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/18/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: DIARRHEA; CHILLS; UNBREAKABLE FEVER OF 104F; CARDIOGENIC SHOCK; KIDNEY FAILURE; IMPAIRED LIVER FUNCTION; HIGH BLOOD PRESSURE (200/100); ABNORMAL WHITE BLOOD CELL COUNT (16000); BLISTERS ON CONJUNCTIVA OF BOTH EYES; This spontaneous report received from a physician concerned a 63 year old white male. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The physician reported that one day after receiving vaccine, on 08-MAY-2021, the patient experienced nausea, vomiting, shortness of breath, diarrhea, fever, chills, sweats, and severe chest pain. The patient was admitted to hospital for suspicion of heart attack. He was checked and no blockages were found. Laboratory data included: Scan (NR: not provided) No blockages were found. On 10-MAY-2021, he was transferred to another hospital where he was currently on a ventilator. The doctor reported that he had had fever of 104 f that was unbreakable. His blood pressure was 200/100 mmHg and his pulse oxygen was not good. His white blood cell count was 16000 and he was tested negative for covid-19. The doctor also reported that patient was in cardiogenic shock and was in kidney failure. He reported that the patient's liver function was getting better and patient's face and chest was very red. The patient also had blisters on conjunctiva of both eyes. It was unknown where patient received the vaccine as of this time. No further information was available since doctor had patients to see. Laboratory data included: Blood pressure (NR: not provided) 200/100 mmHg, Covid-19 virus test (NR: not provided) Negative, Body temperature increased (NR: not provided) 104 f, Pulse Oxygen (NR: not provided) Not good, and White blood cell count (NR: not provided) 16000. The patient was admitted to the hospital on 08-MAY-2021 and the duration of hospitalization was 6 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from impaired liver function, had not recovered from blisters on conjunctiva of both eyes, kidney failure, abnormal white blood cell count (16000), high blood pressure (200/100), cardiogenic shock, and unbreakable fever of 104f, and the outcome of diarrhea and chills was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening).; Sender's Comments: V0: 20210525538-covid-19 vaccine ad26.cov2.s-cardiogenic shock, kidney failure, impaired liver function, high blood pressure (200/100), abnormal white blood cell count (16000), blisters on conjunctiva of both eyes, diarrhea, chills, unbreakable fever of 104f. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1326103
Sex: M
Age:
State: CO

Vax Date:
Onset Date:
Rec V Date: 05/18/2021
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: BLACKED OUT; DIDN'T FEEL RIGHT; This spontaneous report received from a social media from patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23-MAY-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, after receiving the vaccine, the patient reported before he could pull over knowing he did not feel right he blacked out in an instant on the highway going 75 mph and woke up to a medic in his face. .The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blacked out and didn't feel right was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210526963-Covid-19 vaccine ad26.cov2.s-Blacked out. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1326104
Sex: M
Age:
State: MT

Vax Date:
Onset Date: 05/03/2021
Rec V Date: 05/18/2021
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: ABDOMINAL PAIN; SORENESS; TIREDNESS; This spontaneous report received from a patient concerned a 36 year old male. The patient's weight was 190 pounds, and height was 175 centimeters. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no pertinent medical history. the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Pain scale (NR: not provided) 4/10 (unit not reported). On 03-MAY-2021, the subject experienced abdominal pain. On 03-MAY-2021, the subject experienced soreness. On 03-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness, and tiredness on 06-MAY-2021, and had not recovered from abdominal pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness: Alcohol use (Moderate); Non-smoker

ID: 1326105
Sex: M
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 05/18/2021
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: SHAKING; FELT LIKE WHEN HE HAD COVID BACK IN OCTOBER WHERE HE WAS HOPITALIZED; VERY LOW ENERGY LEVEL; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced shaking, felt like when he had covid back in october where he was hopitalized, very low energy level, nausea, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shaking, nausea, fever, headache, very low energy level and felt like when he had covid back in october where he was hopitalized was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1326106
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 05/15/2021
Rec V Date: 05/18/2021
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: DIZZINESS; COUGH; SNEEZING; SORE THROAT; SOME HOARSEN; This spontaneous report received from a patient concerned an 83 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced sore throat. On 15-MAY-2021, the subject experienced some hoarsen. On an unspecified date, the subject experienced dizziness, cough, and sneezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat, and the outcome of dizziness, cough, sneezing and some hoarsen was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1326107
Sex: F
Age:
State:

Vax Date:
Onset Date: 05/11/2021
Rec V Date: 05/18/2021
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: DIZZINESS; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAY-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness. This report was non-serious.

Other Meds:

Current Illness:

ID: 1326108
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/18/2021
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: STOMACH CRAMPING; NAUSEA; VERY SLEEPY; ACHY EVERYWHERE; SORE ARM; CHILLS; DIZZINESS; HEART RACING; FEVER; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced dizziness. On MAY-2021, the subject experienced heart racing. On MAY-2021, the subject experienced fever. On 11-MAY-2021, the subject experienced very sleepy. On 11-MAY-2021, the subject experienced achy everywhere. On 11-MAY-2021, the subject experienced sore arm. On 11-MAY-2021, the subject experienced chills. On 14-MAY-2021, the subject experienced stomach cramping. On 14-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sleepy on 15-MAY-2021, and dizziness, heart racing, nausea, and fever on MAY-2021, and had not recovered from achy everywhere, chills, stomach cramping, and sore arm. This report was non-serious.

Other Meds:

Current Illness:

ID: 1326109
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/18/2021
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: DIZZINESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizziness was not reported. This report was non-serious.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm