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: 1381386
Sex: F
Age:
State:

Vax Date: 06/01/2021
Onset Date: 06/02/2021
Rec V Date: 06/08/2021
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: Woke up feeling a bit nauseous/ Experiencing nausea "on and off"; This is a spontaneous report received from a contactable consumer. A 14-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 01Jun2021 15:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient woke up feeling a bit nauseous. experiencing nausea "on and off" throughout the morning on 02Jun2021. Event took place after use of product. 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: 1381387
Sex: F
Age:
State:

Vax Date: 12/02/2020
Onset Date: 04/01/2021
Rec V Date: 06/08/2021
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: Nodules (implant site nodule) in the perioral area; mild redness (Implant site erythema) and elevation; The physician believed it was more a Foreign body reaction (Foreign body reaction); This is a spontaneous report from a non-contactable consumer (patient). A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in 2021 as unknown single dose for covid-19 immunisation and hyaluronic acid (RESTYLANE) Defyne, via an unspecified route of administration from 02Dec2020 (Batch/Lot number was not reported). The patient's medical history and concomitant medications were not reported. On an unknown date in Apr2021 the patient experienced NODULES (Implant site nodule) in the perioral area from Defyne. There was mild Redness (Implant site erythema) and elevation, and the HCP could feel fairly large subcutaneous nodules, which were not fluctuant or tender. the physician believed it was more a foreign Body type reaction (foreign body reaction) than a biofilm or an infection. Action taken for hyaluronic acid was unknown. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1381388
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 06/08/2021
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: Intermittent dizziness; Tinnitus and pressure in her right ear; Tinnitus and pressure in her right ear; This is a spontaneous report from a contactable consumer (patient's sister). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, consumer was prepared for this because patient who happens to be a nurse has had some intermittent dizziness. The tinnitus and pressure in her right ear are what's concerning her because she was a musician. She contacted her doctor and had a tele-visit/video visit with the doctor on 30May2021. When she had an appointment with her doctor on 30May2021 the doctor did not know what to tell her really; if these effects were anticipated to subside with time; patient questioned if she should go back for the second shot of Pfizer COVID Vaccine which she won't do if the events do not improve. The doctor told her it could happen again or not at all, that there was no way to know until she got the second shot of Pfizer COVID Vaccine. The outcome of the events was unknown. Information about batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1381389
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/08/2021
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: ear infection; achy body; This is a spontaneous report received from a contactable consumer, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient stated she had an ear infection when she received her shot with an achy body and all that. The outcome of the events was unknown. Information on batch/Lot number requested.

Other Meds:

Current Illness:

ID: 1381390
Sex: F
Age:
State:

Vax Date: 04/03/2021
Onset Date: 04/03/2021
Rec V Date: 06/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Bumps and dark spots under the eyes; Bumps and dark spots under the eyes; Swelling under the eyes; This is a spontaneous report from a contactable other healthcare professional. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date in 2021 (2-3 months ago) as an unknown, single dose for COVID-19 immunization, hyaluronic acid (RESTYLANE, Formulation: Unknown), via an unspecified route of administration from 03Apr2021 at an unspecified dose and frequency for an unknown indication. The patient's medical history and concomitant medications were not reported. Patient received Pfizer COVID vaccines 2-3 months ago. Patient injected with Restylane Silk on 03Apr2021 under eyes. Reported swelling under the eyes same day (03Apr2021). On 04Apr2021 reported bumps and dark spots under eyes. Massage only. The action taken in response to the events for hyaluronic acid was unknown. The outcome of the events was not resolved. Follow-up needed, Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1381391
Sex: F
Age:
State:

Vax Date: 05/11/2021
Onset Date: 05/14/2021
Rec V Date: 06/08/2021
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:

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

Symptoms: Diagnosed with Covid; This is a spontaneous report from a non-contactable consumer reported for a female patient. A female patient of an unspecified age received the first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: unknown), via an unspecified route of administration on 11May2021, as first dose single dose for covid-19 immunisation. The patient medical history was not reported. The patient did not receive any concomitant medications. On 14May2021, the patient was diagnosed with covid. It was reported that the patient was scheduled for her second dose on an unspecified date. The patient later stated that she received the Pfizer vaccine, not the Moderna vaccine (mRNA-1273). The event was reported as non-serious. The outcome of the event was unknown. The reporter was asking whether the patient should get her second dose or not. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1381392
Sex: U
Age:
State:

Vax Date: 03/02/2021
Onset Date:
Rec V Date: 06/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: having a problem since I got the vaccine with keeping my balance; I kept loosing my balance; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and Expiration date were not reported), dose 2 via an unspecified route of administration on 02Mar2021, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccine included bnt162b2 dose 1 bnt162b2 for covid-19 immunisation. The patient had a problem since got the vaccine with keeping patient balance. When patient had the second shot, March 02nd which was exactly three months from today and it had not gone away. It started about an hour after when patient got the second shot patient kept loosing my balance now it seems like it was getting worse. The outcome of the events was not recovered. Follow up attempts are needed, Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1381393
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 06/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Allergic reaction; threw up in the first 5 minute; he was not feeling well; This is a spontaneous report from a contactable consumer (patient's mother). A male patient (reporter's son) of an unspecified age (13 unspecified units) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0186), via an unspecified route of administration on an unspecified date in 2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated, so patient got his first vaccination here in (withheld) and he threw up within the first 5 minute on an unspecified date in 2021 and the doctor that administered it said he had an allergic reaction on an unspecified date in 2021 so reporter just she was concerned and want to know what to watch for or if anything like this happened to another young child you know between 12 and she guess 15. Just you know see what if there was any concern here that's a normal thing or you know. The patient was not feeling well on an unspecified date in 2021. When confirmed the vaccine as Pfizer COVID 19 Vaccine, reporter stated, yes, it was, and he was 13. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1381394
Sex: F
Age:
State: PA

Vax Date: 05/15/2021
Onset Date: 05/01/2021
Rec V Date: 06/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: I felt the nausea; everything was so bright you know, I had the same effect but mine went away; This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0182), via an unspecified route of administration on 15May2021 at 04:00 PM, as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received list of any other medications within 2 weeks of vaccination. She stated that she stayed at hospital like half hours for her daughter because the doctor said to stay there and then she felt the nausea, and everything was so bright on an unspecified date, in May2021 and she had the same effect but went away. She stated that she did not have too many reactions. The patient did not receive any allergy medication Prior to vaccination and was not diagnosed with COVID-19. The patient was not tested for COVID-19 since the vaccination. On an unspecified date in 2021, the patient was resolved from the events. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1381395
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 06/08/2021
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: some aches/aching all over; aching all over and in her back; Sciatica pain; This is a spontaneous report from a contactable consumer (patient herself). A 74-years-old female patient received both first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date in Mar2021 single dose for COVID-19 immunization. Medical history and concomitant medication was not reported. In 2021, caller reports she received two doses of Pfizer covid vaccine in March and had some aches. Then three weeks later she is experiencing aching all over and in her back. She stated that she has always had Sciatica pain. She was taking Tylenol. She recently saw her HCP but was feeling good then, she will make an appointment to see HCP about current aching. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1381396
Sex: M
Age:
State: OH

Vax Date: 05/13/2021
Onset Date: 05/15/2021
Rec V Date: 06/08/2021
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: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: sore arm muscle pain/forearm pain; sore arm muscle pain; This is a spontaneous report from a contactable pharmacist (patient). A 66-year-old male patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0167, Expiry Date, UPC, NDC number of Pfizer BioNTech COVID-19 Vaccine: Unknown), via an unspecified route of administration, administered in upper left arm on 13May2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history included as was in hit and run car accident a while ago few 5 years ago and so I have pain in my face my trigeminal nerve associated with that but I am taking medication for that. Concomitant medication included oxycodone at 10 mg taken for an unspecified indication, start and stop date were not reported. At pharmacy where COVID-19 vaccine was administered. The patient stated as, the patient had first Pfizer vaccine three weeks ago and patient supposed to get second one tomorrow, but patient have been having for the last 3 weeks really, on 15May2021, sore arm muscle pain / forearm pain, pain prohibits him from lifting glass or door knob and thought it would just meant to go away but it hasn't gotten any less so patient wondering if patient should get the second one and what to do you know I don't. Due date of second shot was confirmed as 03Jun2021. The patient think doesn't have it in any other part of his body and haven't injured himself or fallen or knocked it against the door knob or it's patient forearm where he experiencing extreme muscle pain for the last 3 weeks. The patient took Ibuprofen or Aleve but, don't know sometimes patient stomach was sensitive to that but patient tried to take Ibuprofen, one day it didn't seem to do or do much but maybe he should take in successive days I don't know the events were just persisting it's not getting better or worse. Outcome of the events not recovered. Follow-up actions are needed. Further information is requested.

Other Meds: OXYCODONE

Current Illness:

ID: 1381397
Sex: U
Age:
State:

Vax Date: 03/17/2021
Onset Date:
Rec V Date: 06/08/2021
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: My hip joints are so bad since I got the shot I can barely walk; its's so painful in my joint; Pain all the time; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received an unspecified dose of BNT162B2 via an unspecified route of administration on 17Mar2021 (Expiration date: Unknown) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On unspecified date, the patient not been able to walk without much pain since got Pfizer COVID vaccine and have been telling to the doctor and they have been telling to patient, they don't wanna report it and the patient's joints are so bad since got the shot, the patient can barely walk and in so much pain all the time. The patient was not success with go away and it's been since march it has not gone away. The patient stated that will sue and want to talk to the person in charge not the Pharmacist. The patient further stated, "I want to report the side effects, I'm not the only one that is having joint problem, I live in an older community and other people are having the same side effects (further clarification unknown), mine are so painful I can even hardly walk its's so painful in my joint. Everyday it's horrible and I thought it will go away. My last COVID shot was 17March and this is 02June now and my problem has not gone away is getting worse and I need help. I would like you guys to pay for it, you gave it to me." The outcome of events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1381398
Sex: M
Age:
State:

Vax Date:
Onset Date: 06/03/2021
Rec V Date: 06/08/2021
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: Woke up this morning with top lip swollen; woke up this morning with fingertips swollen; This is a spontaneous report from a non-contactable consumer or other non hcp (patient) via Pfizer sponsored prgram. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 03Jun2021, the patient woke up in morning with top lip swollen, with fingertips swollen. The patient was due for his second dose Pfizer Covid 19 Vaccine on 03Jun2021 (today). Patient wanted to know if he should get the second dose Pfizer Covid Vaccine today, 03Jun2021 or not. Reporter seriousness was unspecified. The outcome of the events was reported as unknown at the time of report. No follow-up attempts are possible. No information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1381399
Sex: M
Age:
State:

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 06/08/2021
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: have facial tingling on right side of face form cheek bone to jaw bone; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the first dose of BNT162B2 via an unspecified route of administration on Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, shortly after dose, the patient started to have facial tingling on right side of face from cheek bone to jaw bone. Tingling was still intermittently ongoing. The patient would like to know if this something that has been experienced or reported by others and would also like to know if he should get second dose of vaccine or not. The outcome of event was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1381400
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/08/2021
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: tinnitus worsened; This is a spontaneous report from contactable consumer (patient). A female patient of an unspecified age received received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. Medical history included tinnitus. Concomitant medications were not reported. Patient stated that She had tinnitus, and after the shot her tinnitus got worse. She was wondering if the Covid vaccine affects the neurological system. She had an appointment to get her second dose of the vaccine and is not sure if she should get it. She wanted to know if she doesn't get the second dose how it will effect the first dose. It was reported that She probably won't answer the phone unless it comes up as a contact. She was getting bombarded by telemarketers. If Pfizer wanted to call they could send a text with a number that she can call. She really doesn't like to get too much mail. She lives on a busy street and is trying to eliminate how much mail she gets. She declined to give her mailing address. She has put this off. She thought that maybe it would fade away, but it's not. If she has to be in some sort of study because of this she would probably cooperate. She asked if the second dose of the vaccine is the same as the first dose. She needs to make a decision quick because her appointment for the second dose is in 30 minutes. She would rather be transferred to Medical Information now. Patient was unwilling to complete the report The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1381401
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 06/08/2021
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: Sore; This is a spontaneous report from a Pfizer sponsored program. A 102-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9265), via an unspecified route of administration in the upper left arm, on 01Feb2021, as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (Lot Number: EK9231), via unspecified route of administration in the upper left arm, on 11Jan2021 in the morning, as a 1st dose, 0.3 ml, single dose for COVID-19 immunisation. She did not receive any other vaccines outside of the Pfizer Covid 19 vaccine within 4 weeks. The patient reported, she received both doses of the Pfizer BioNTech vaccine. She tested her immunity and found out she doesn't have immunity. She had questions about the lack of efficacy. She was a little bit sore on the same date as the injection. It went away in a few hours. The patient was treated with some ice. The outcome of the sore was recovered.

Other Meds:

Current Illness:

ID: 1381402
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/08/2021
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: arm really sore/ arm hurt all night; "uncomfort" in his arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number was not reported as patient did not card with him), via an unspecified route of administration, on an unspecified date (at age of 58-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration, on an unspecified date as single dose for covid-19 immunization. On an unspecified date, the patient stated that he woke up in the morning with a sore arm after receiving the second dose of the Pfizer COVID vaccine yesterday. He said that he did not have any issues with the first dose. The patient said that he talked to three people as wanted to know if this side effect was normal or if he should seek emergency care from a doctor. The patient had "uncomfort" in his arm and arm was sore. His arm was hurting all night and was uncomfortable. The patient was concerned because he had never experienced this before, and he did not know if he needed to see a doctor for the arm pain. The patient was informed about the role of Pfizer. When probed, patient stated that he was not at his home and did not have vaccination card with him. Product details (ndc# upc# and treatment) and pharmacy details could not be probed as he was unwilling to share further information. Hence, further probing could not be done and limited information available over the call. The outcome of the events was unknown. Follow-up attempts are needed. Further information is expected.

Other Meds:

Current Illness:

ID: 1381403
Sex: F
Age:
State: NM

Vax Date: 05/16/2021
Onset Date: 05/28/2021
Rec V Date: 06/08/2021
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: ALT was really high/A couple days ago had blood work and ALT was like super high; This is spontaneous report from contactable female consumer (patient). A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in arm left on 16May2021 15:00 (at the age of 21-year-old) at a 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was taking unspecified thyroid medications. No family history was reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took flu shot and thought she had adverse reaction because the patient like passed out or something. The patient experienced alt was really high/a couple days ago had blood work and alt was like super high on 28May2021. Patient asking for advise following her first Pfizer vaccine she is scheduled this Sunday for the 2nd one. Patient stated, On Friday, she got blood work, went to see my primary care physician, ALT was really high. Patient was not taking anything other than thyroid medication, thinking maybe it is the vaccine. They were going to repeat the blood work in 6 weeks. Had tests done 4 or 5 months ago and were fine. The patient was a consumer reporting she had not received the second dose Pfizer Covid Vaccine and was scheduled to receive the second dose Pfizer Covid Vaccine on Sunday, 06JUN2021. The patient stated she received the first dose Pfizer Covid Vaccine. A couple days ago had blood work done and ALT was like super high: A couple days ago the patient had blood work done and the patient's ALT was like super high. The patient stated this was her liver she guessed. The patient went to her primary care and the primary care stated maybe the vaccine caused the ALT to go up so high. The patient stated she was not taking any medications or anything or doing anything differently. The patient was wondering if she should still receive the second dose Pfizer Covid Vaccine. The patient underwent lab tests and procedures which included ALT was like really high on 28May2021. Therapeutic measures (unspecified) were taken as a result of alt was really high/a couple days ago had blood work and alt was like super high. Outcome of the event was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1381404
Sex: F
Age:
State: FL

Vax Date: 05/21/2021
Onset Date: 05/22/2021
Rec V Date: 06/08/2021
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: Headache; Runny nose; Cough; Back pain; Cold; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer (patient) reported for herself that she received first dose of BNT162B2 (bnt162b2, formulation: Solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration on 21May2021 at 10:30 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 22May2021 the patient experienced headache, runny nose, cough, back pain and cold. Patient had undergone unspecified lab tests a month ago before the shot on an unspecified date and not recently. Patient had mentioned the second dose will be taken on 09Jun2021. Patient didn't receive any other vaccinations with in 4weeks of vaccination. The outcome of the events headache, back pain was recovering whereas outcome of other events was unknown.

Other Meds:

Current Illness:

ID: 1381405
Sex: F
Age:
State: CA

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 06/08/2021
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: Very little reaction the next day; feeling sickening; feels helpless; feels like her heart is heavy and in the middle of all over the face and on her forehead and then she just can not do anything; Very little reaction the next day; feeling sickening; feels helpless; feels like her heart is heavy and in the middle of all over the face and on her forehead and then she just can not do anything; Very little reaction the next day; feeling sickening; feels helpless; feels like her heart is heavy and in the middle of all over the face and on her forehead and then she just can not do anything; This is a spontaneous report from a contactable consumer. A female patient (reporter's daughter) received second dose of BNT162B2 (COVID Vaccine, Solution for injection, Batch/lot number: Unknown (reported as did not know whether EW0178), Expiry date: Unknown, NDC/UPC number: Unknown) via an unspecified route of administration in May2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of Covid-19 vaccine as single dose for Covid-19 immunization. On an unspecified date, the patient experienced very little reaction the next day; feeling sickening; felt helpless; felt like her heart was heavy and in the middle of all over the face and on her forehead and then she just could not do anything: Reporter stated, "the patient got her second shot, last Friday. She was 17 years old. She had very little reaction the next day but then she was saying she was feeling sickening feeling you know she feels helpless. She was here so did not know if that was expected or what she was to do. She felt like her heart was very heavy and in the middle of all over the face and on her forehead and then she just could not do anything". Reporter was informed about the Medical Information Department for the concern and was provided with the contact number for Pfizer Medical Information, Option 3, and was informed that the department opens from Monday to Friday, from 8 am to 8 pm and 9 am to 3 pm on Saturday and Sunday as per EST. Reporter hung up abruptly. Hence, limited information available. Reporter seriousness for the event was unspecified. Outcome of the events was unknown. Follow-up attempts are needed; information about lot/batch number requested.

Other Meds:

Current Illness:

ID: 1381406
Sex: F
Age:
State: NE

Vax Date: 05/27/2021
Onset Date: 06/01/2021
Rec V Date: 06/08/2021
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: severe dizziness; vertigo; This is a spontaneous report received from a contactable female consumer (patient). A 31-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of ad-ministration, administered in arm right on 27May2021 15:00 (at the age of 31-year-old) as a 2nd dose, single dose for COVID-19 immunization. The patient 's medical history was not reported. The patient had no known allergies. The patient's concomitant medication included doxycycline monohydrate 100 mg. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 06May2021 (at the age of 31-year-old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe dizziness and vertigo on 01Jun2021 10:00 PM. Patient was not diagnosed for COVID-19 prior to vaccination. The patient had not tested COVID-19 post vaccination. The patient did not receive any treatment medication for the events. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds: DOXYCYCLINE MONOHYDRATE

Current Illness:

ID: 1381407
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/08/2021
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: felt tired in the evening; pain in her side; had pain in her side where her ribs are; This is a spontaneous report from Medical information team. A contactable consumer (patient) reported that a 70-year-old female (same age during vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had Tetanus shot on an unspecified date. As per reported, the caller stated she already called this morning. She had the first covid shot yesterday at 11:00 am. She felt tired in the evening, but it says you can get tiredness. She woke up around 5:30 am and had a pain in her side. It started suddenly, abruptly, and severely. She expected pain in her arm, and she has had tetanus shots and she was expecting muscle pain in her arm. But she had pain in her side where her ribs are, and it says you can get muscle pain. She had to take acetaminophen, an over-the-counter pain medication to take the edge off and it is not as bad now, but she still feels it and she will probably have to take another. She stated it may not be from the vaccine, she probably slept on her side wrong or something, but she doesn't normally have this. Outcome of events was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1381409
Sex: M
Age:
State: CA

Vax Date: 04/22/2021
Onset Date: 05/01/2021
Rec V Date: 06/08/2021
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: arm sore; got a little warm; got a little headache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration in arm left, on 22Apr2021 (Lot Number: EW0171) and on 14May2021 (Lot Number: EW0182), (at the age of 28-years-old) respectively, both as single doses for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that his second shot was scheduled at the location where he got his first dose, but he could not go to that location, so he rescheduled the second dose at different location. Further he added that, the guy at the second location did not know he was going to get the second shot hence, the patient was afraid if he might get the first shot twice and wanted to know if he should be concerned about this. On an unspecified date in May2021, the patient had arm sore, got a little warm and headache. The patient experienced the same side effects as he did with the first dose and stated that the symptoms started the next day after each dose and lasted about two days (exact dates were unknown). The outcome of the events was unknown. Additional information is requested.

Other Meds:

Current Illness:

ID: 1381410
Sex: M
Age:
State: OK

Vax Date:
Onset Date:
Rec V Date: 06/08/2021
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: he was still feeling sick; he was still feeling sick; lethargic; cant sleep night; has a sense of feeling of a warm oil running through his veins; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at unknown, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, he got the Pfizer vaccine 3 weeks ago tomorrow and he was still feeling sick, lethargic, could not sleep night, and has a sense of feeling of a warm oil running through his veins. Reporter explained the vaccine was for COVID. Also reported that his cousin had a severe side effect, Cousin was sick with it for 2 days. Declined to complete a report for his cousin. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1381411
Sex: F
Age:
State: OK

Vax Date: 05/14/2021
Onset Date: 05/01/2021
Rec V Date: 06/08/2021
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: Lethargic; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0177, Expiration date and NDC number: unknown), via an unspecified route of administration on 14May2021 (3 weeks ago) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date of May2021, patient was just lethargic for 2 days and after 48 hours she was fine. Patient's husband stated that vaccine shot did not bother her. Patient's husband declined to complete a report for the patient. The event recovered on May2021. Investigation Assessment: Not Provided.

Other Meds:

Current Illness:

ID: 1381412
Sex: F
Age:
State: IA

Vax Date: 03/16/2021
Onset Date: 03/17/2021
Rec V Date: 06/08/2021
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: Nausea; Loose stools; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE, lot/batch number unknown) intramuscularly in left deltoid on 16Mar2021 09:15AM at the age of 65-years-old at 2nd dose single dose for COVID-19 immunization. Medical history included fractures at wrist from 23Jan2021, and hematuria/nephrolith from 01Jan2021 and ongoing. The historic vaccine was bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE, lot/batch number unknown) intramuscularly in left deltoid on 23Feb2021 03:15 PM at the age of 65-years-old at 1st dose single dose for COVID-19 immunization and experienced sore arm, queasiness in stomach 18 hours later, and loose stool. Concomitant medications were none. The patient did not take any relevant test. Prior vaccinations within 4 weeks were reported as none. The patient experienced nausea on 17Mar2021 15:00, and loose stools on 17Mar2021. The Seriousness criteria was reported as not serious. No treatment received. The outcome of events was recovered. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness: Hematuria; Nephrolithiasis

ID: 1381413
Sex: F
Age:
State:

Vax Date: 05/14/2021
Onset Date: 05/18/2021
Rec V Date: 06/08/2021
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: chills; cough; shortness of breath; body aching; loss of taste; lots of nasal congestion and mucus; lots of nasal congestion and mucus; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration on 14May2021, as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 18May2021, 4 days after receiving the vaccine, patient experienced chills, cough, shortness of breath, body aching, loss of taste, lots of nasal congestion and mucus, did not have a fever. Therapeutic measure taken for the events included unspecified antibiotics. The patient underwent lab test and procedure on 24May2021 which included for COVID-19 virus test and tested negative. Patient wanted to know if she could receive the second dose of the vaccine on Friday if they are still taking antibiotics. It was reported that no contraindications for patients with infections taking antibiotics. The patient stated that she prefers to make a written report and accepted to get contacted back. The patient was referred to her physician for treatment recommendations. The outcome of the events was unknown. Information about Lot Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021651028 Same reporter/drug/event, different patient.;US-PFIZER INC-2021651029 Same reporter/drug/event, different patient.

Other Meds:

Current Illness:

ID: 1381414
Sex: F
Age:
State:

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 06/08/2021
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: dizziness; did not allow me to have my eyes open; blood pressure was high; felt my body very cold; arm was very swollen; pain, a sharp pain, especially on the right side of the brain and the part of my head; tiredness; heaviness in the head; anxious; felt a lot of heat in my body; One hour later in her right arm she had a lot of pain; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported), via an unspecified route of administration on 01Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had first dose of the Pfizer COVID 19 vaccine on 01Jun2021 and ten minutes after that she started feeling dizzy and could not keep her eyes open and since she was still at the vaccination facility, they took her blood pressure, and it was high. One hour later in her right arm she had a lot of pain and it was swollen she felt the pain was a sharp pain that was on her right arm which was the arm she had the injection. Caller also felt pain in her brain and part of the head. Caller also reported being tired and had dizziness. Caller stated the headache and dizziness was constant, but she felt it mostly on the right side of her body which was the side she received the injection. Caller had to close her eyes so the dizziness would stop. Caller stated this happened on 01Jun2021 and 02Jun2021 and it was making her feel very anxious and she felt really really hot and when she had her blood pressure high, she felt her body cold. The clinical outcome of the events were unknown. Follow-up 2 (PRD 03Jun2021): This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: dizziness, did not allow me to have my eyes open, blood pressure was high, felt my body very cold, arm was very swollen, pain, a sharp pain, especially on the right side of the brain and the part of my head, tiredness, heaviness in the head, anxious, felt a lot of heat in my body, one hour later in her right arm she had a lot of pain. Information on the lot/batch number has been requested. further information has been request-ed.

Other Meds:

Current Illness:

ID: 1381415
Sex: F
Age:
State: MI

Vax Date: 03/18/2021
Onset Date: 05/01/2021
Rec V Date: 06/08/2021
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: Experiencing swelling of her soft tissue palate at the back of her throat/swelling where her soft tissue palate gets swollen; She can't swallow; The roof of mouth also feels dry and sticky and achy; The roof of mouth also feels dry and sticky and achy; The roof of mouth also feels dry and sticky and achy; She is muscle pain at the left back side of her mouth; The nerves start getting crazy; back of her tongue feels like it swells; Feels like she's gagging; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration in Arm Left on 18Mar2021 at 11:30(at the age of 39 years old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included , ankylosing spondylitis from 2020 and ongoing, ongoing autoimmune thyroiditis(Hashimoto) diagnosed after her second baby, she was 6 so maybe 5 years ago , cardiac disorder from an unknown date and states her mom has a heart condition and they tested her and her heart's good. The patient concomitant medications were not reported. The historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration in Arm Left on 26Feb2021 at 14:00 as single dose for COVID-19 immunization (she reported as, she knows it was close to the expiration because she got in at the last minute. It was probably the same day, the expiration. the first one was the same day expiration by 1700), flu vaccine (FLU VACCINE VII) 6.5 to 7 years ago(she would have been 34 year old) and she get Guillain-Barre and she just felt numbness, and she cut her hand open by accident a week after the first shot and got tetatnus shot (TETANUS VACCINE) on right arm on 04Mar2021 for immunization. The patient experienced as, experiencing swelling of her soft tissue palate at the back of her throat/swelling where her soft tissue palate gets swollen, she can't swallow, the roof of mouth also feels dry and sticky and achy, she is muscle pain at the left back side of her mouth, the nerves start getting crazy, back of her tongue feels like it swells, feels like she's gagging on an unspecified date on May2021. Reporter reported as, she has been experiencing swelling of her soft tissue palate at the back of her throat which started 3 weeks ago. She said that she feels like she can't swallow, it comes and goes and has been in the ER multiple times because of this. The roof of mouth also feels dry and sticky and achy. She has muscle pain at the left back side of her mouth. She enquired regarding reports on this and as to how long she will be experiencing this. She was taking Pfizer COVID vaccine as she got very paranoid, they instilled a lot of fear, she has a lot of autoimmune diseases too. She is just wondering if Pfizer has had any other people with similar symptoms to what she had after the second vaccine in March. She just started getting some insane symptoms in her mouth. she's been to the hospital 3 times with swelling where her soft tissue palate gets swollen and the nerves start getting crazy. She wasn't sure in the beginning if it could be tied to the vaccine, but from her last three hospital visits they are kind of questioning it, its kind of an unexplained reaction. It started where she felt like she couldn't swallow so they ran tests, they thought maybe it was strep throat and everything got cleared. It was nothing viral, nothing medically they could find. They could see the swelling, but theres no reason for it. The back of her tongue feels like it swells feels like she's gagging. It swells then it goes down. It gets worse then it's go back down. It's not getting better, but progressively gets worse then stabilizes then worse again. It just won't go away. She was a little skeptical of the Covid shot as she had flu shot which she did get Guillain-Barre. She was told it was safe. She was tested for strep probably 5 days after her symptoms started. She also got a Covid swab too because they didn't know what it was. They tested her for everything, viral, bacterial, Covid, strep, and everything came back negative. They are kind of puzzled, she's having symptoms, they come and go and it drives her to the emergency room because of the swelling in the soft tissue in her throat. She did read online there is some people with the vaccine have had swelling so she thought and wondered if its related.she went to the emergency room three times and she has been to an ENT, neurology, her family doctor, she has been everywhere. They discharged her every time she went to the hospital. they see the inflammation almost like it's spasming, as it gets spasms and goes down then goes up, it's very spontaneous. She went to a gastroenterologist and they did a scope and they said it was red and inflamed all the way from the back of her throat to her soft palate and all the way to her stomach, it's swollen and inflamed. She states that's why she's on steriods. They thought it could be a viral infection and the biopsy came back and it's not so they are questioning the vaccine. She states Rheumatology, they also did a test to see if her inflammation marks are high and they weren't so it shows it's not her autoimmune, it's something else. The patient underwent lab tests and procedures which included bacterial test: negative on an unspecified date, endoscopy: red and inflammed all the way from back to throat on an unspecified date , sars-cov-2 test: negative on an unspecified date on May2021, streptococcus test: negative on an unspecified date on May2021, viral test: negative on an unspecified date. Therapeutic measures were taken as a result of experiencing swelling of her soft tissue palate at the back of her throat/swelling where her soft tissue palate gets swollen. Adverse event resulted in visit to emergency room and physician office. Outcome of all the events were not recovered. Information on batch/Lot number was obtained. Further information has been requested.

Other Meds:

Current Illness: Ankylosing spondylitis (Verbatim: Ankylosing spondylitis); Hashimoto's disease (diagnosed after her second baby, she is 6 so maybe 5 years ago.)

ID: 1381416
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 06/08/2021
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: high blood pressure; This is a spontaneous report from a non-contactable pharmacist. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on Feb2021 as 1ST DOSE, SINGLE DOSE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced high blood pressure. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1381417
Sex: F
Age:
State:

Vax Date: 05/27/2021
Onset Date: 05/27/2021
Rec V Date: 06/08/2021
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: she was given the second dose of the Pfizer Covid vaccine subcutaneously rather than IM; redness to her arm around the injection site; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program COVAX US Support via medical information team. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), subcutaneously on 27May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), dose 1 on unspecified date for covid-19 immunisation. The patient stated that she was given the second dose of the Pfizer Covid vaccine subcutaneously rather than IM (intramuscular). She stated that she had the second dose of the Pfizer Covid vaccine on the 27May2021. She noticed redness to her arm around the injection site but not on it which was resolving. The patient queried that "Can I go get a Antibody test to determine if I am protected" and the response was as follows: CDC states that antibody testing is not recommended to assess for immunity to SARS-CoV-2 [the virus that causes COVID-19] following COVID-19. In addition, antibody tests currently authorized under an Emergency Use Authorization (EUA) are not authorized for the review of an immune response in vaccinated people. The patient also queried that "If I was given the vaccine subcutaneously rather than in the muscle, I'm I protected fully? I spoke to the pharmacist where I had the vaccine and they said it would be alright. Outcome of the event redness to her arm around the injection site was reported as resolving. Information about lot/batch number is requested.

Other Meds:

Current Illness:

ID: 1381418
Sex: M
Age:
State: CA

Vax Date: 05/25/2021
Onset Date:
Rec V Date: 06/08/2021
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: shooting pain down both arms; shooting pain down both arms; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 25May2021 (Batch/Lot Number: EW0185) as single dose for COVID-19 immunisation. Medical history included 8 years ago he threw his back out at work and his left leg died almost overnight, lost all the muscle, it was just bone, caller was tearful, 4 years ago he had a viral infection and abscess on L4, L5, vertebrae. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/lot number: EW0171), administered in right arm on an unspecified date for COVID-19 immunisation. It was reported that the patient got second shot on 25May2021 and his arms were killing him. Got shot in right arm and it was his left arm that was having a constant shooting pain that goes all the way down his arm. The patient stated that he will just be relaxing and then all of a sudden the arm would feel like he was having a shot in his arm, he could feel the veins popping out of his wrist, and felt like they were stretching. Patient called his doctor but they will not call him back. The patient was encouraged to reach out to a HCP or urgent care for any medical advice. There was no investigation assessment. Outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1381419
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/08/2021
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: sore arm; tired; This is a spontaneous report from a contactable consumer reported for her father (a male consumer age not provided) that: A male patient of an unspecified age received unknown dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient relevant family medical history include: she says her parents and sister all were vaccinated and were fine but her dad and sister have heart conditions but have been fine, no one had any effects other than like sore arm and tired. The patients concomitant medications were not reported. On an unknown date the patient experienced sore arm and tired. No other products provided and Investigations not provided. The outcome of events was Communication: Report 2 of 3. AE identified after the caller unable to clarify with the caller the specific product received by her father. No further information provided. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1381420
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/08/2021
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: Arm was hurting after first dose; Was getting itching in his hands; Finger tips had swelling; This is a spontaneous report from a Pfizer-sponsored program . This is a spontaneous report from a non-contactable male consumer reported for himself that: A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. Medical history included Herniated disc and Back pain from an unknown date and unknown if ongoing. Concomitant medication(s) included hydrocodone (HYDROCODONE) taken for Herniated disc and Back pain, start and stop date were not reported. On an unspecified date, the patient experienced his arm was hurting, added that about a week ago, he was getting to itch in his hands; his fingertips would swell up, not on the nail side. It started on one hand and the other day was on the other hand. Yesterday swelling was on right hand and today it was on the left hand. The itching had gone away. The patient was taking 5mg for about 2 years for a herniated disc and back pain. He wanted to know if it was safe to take the second shot with the medication. Caller clarified pain medication as Hydrocodone 5mg, one every 8 hours. The outcome of the events Arm was hurting after first dose and Fingertips had swelling was unknown and for was getting to itch in his hands it was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: HYDROCODONE

Current Illness:

ID: 1381421
Sex: U
Age:
State:

Vax Date: 05/14/2021
Onset Date: 05/01/2021
Rec V Date: 06/08/2021
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: Chills; Cough; Shortness of breath; Body aching; Loss of taste; Lots of nasal congestion and mucus; Lots of nasal congestion and mucus; This is a spontaneous report from a contactable consumer (parent). A 15-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/batch no. was not reported) via unspecified route, as 1st dose, single dose on 14May2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that on an unspecified date in May2021, a day later one of her children experienced chills, cough, shortness of breath, body aching, loss of taste, lots of nasal congestion and mucus, did not have a fever, then she presented the symptoms 4 days after receiving the vaccine and her other son presented it a week later. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24May2021. Therapeutic measures were taken as a result of events with antibiotics. The report was non-serious. Outcome of the events was unknown. Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021650327 Same reporter/drug/event, different patient.;US-PFIZER INC-2021651029 Same reporter/drug/event, different patient.

Other Meds:

Current Illness:

ID: 1381422
Sex: M
Age:
State: IA

Vax Date: 05/05/2021
Onset Date: 05/01/2021
Rec V Date: 06/08/2021
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: Puked all over the work; Feel sick alittle; This is a spontaneous report from a contactable consumer (patient). A 39-years-old male consumer reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 05May2021 at 21:15 in left arm as a single dose for covid-19 immunization. Medical history and concurrent conditions were reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine or any other medications within two weeks of vaccination. Concomitant medications and relevant past drug history were not reported. The patient received first dose of vaccine on 05May2021 at 21:15 and felt fine that night. On an unknown date in May2021, he went to work and felt sick a little, puked all over the work van and he felt fine after two days. The events were assessed as non-serious. Patient was not hospitalized for the events. The outcome of the events was resolved in May2021. Information about batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1381423
Sex: F
Age:
State: WI

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 06/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: fever; arm got itchy and sore; arm got itchy and sore; felt dizzy and woozy; tasted a metal-ish taste; This is a spontaneous report from a contactable consumer (patient herself). A 66-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0172, Expiry date: Unknown) via an unspecified route of administration on 07Apr2021 on left arm as 1st dose, single dose for COVID-19 immunization. The patient's medical history included systemic lupus erythematosus, diagnosed in 2010 and is under control and COVID-19 as caller did not want to get COVID again bad. There were no concomitant medications. On 07Apr2021, the same day of vaccination, the patient experienced felt dizzy and woozy, tasted a metalish taste, on 08Apr2021, experienced fever, arm got itchy and sore. After the caller left the vaccination site, she drove about a block and then she tasted a metalish taste and felt dizzy but it went away. A couple of days after receiving the first dose, the caller's arm got itchy and sore. The caller got a fever of 99.2 which lasted about 2 days. After about 2 weeks, the fever and arm soreness flared back up, right before it was time for her second shot. The caller's arm was sore in that area and around the shoulder a little bit. Then the caller was feeling okay. The patient underwent lab tests and procedures include fever of 99.2 and shoulder x-ray which was negative on 27May2021. The outcome of the events felt dizzy and woozy and tasted a metalish taste recovered on 07Apr2021, fever recovered on 10Apr2021 and arm got itchy and sore was recovered on an unspecified date in 2021.

Other Meds:

Current Illness:

ID: 1381424
Sex: F
Age:
State: WI

Vax Date: 04/29/2021
Onset Date: 04/01/2021
Rec V Date: 06/08/2021
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: fever; hurt arm; Felt sick; All of the sudden the injection area flared up and was hurting bad in the injection spot again; Then the patient's shoulder got bad in that area and under it and she couldn't lift it up, it felt like a blockage, it was stuck; it sounded like bursitis in this area; This is spontaneous report received from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (Solution for injection, Lot number: FWDI50, NDC number/Expiry date: Unknown) via an unspecified route of administration on 29Apr2021 (at age of 66-year-old) as single dose for Covid-19 immunization. The patient's medical history included lupus (diagnosed in 2010, it was under control). The patient previously took first dose of BNT162B2 (at the age of 66-year-old) (Lot number: EW0172, NDC number/Expiry date: Unknown) to her left arm on 07Apr2021 for Covid-19 immunization and experienced tasted a metallish taste 07Apr2021 to 07Apr2021, fever from 08Apr2021 to 10Apr2021, felt dizzy and woozy 07Apr2021 to 07Apr2021 and arm got itchy and sore from 08Apr2021. On an unspecified date, the patient felt sick; hurt arm on 29Apr2021; and fever on 30Apr2021. The caller did not want to get covid again bad. The caller was calling about the Pfizer Covid vaccine. The caller's nurse felt that the caller should report her side effects that she had after her injection. Her first injection was on 07Apr2021 and on 29Apr2021 she got her second dose. PCP declined address and email. First Dose: felt dizzy and woozy. After the caller left the vaccination site, she drove about a block and then she tasted a metallish taste and felt dizzy but it went away. A couple of days after receiving the first dose, the her arm got itchy and sore. The caller got a fever of 99.2 which lasted about 2 days. After about 2 weeks, the fever and arm soreness flared back up, right before it was time for her second shot. The caller's arm was sore in that area and around the shoulder a little bit. Then the caller was feeling okay. When the caller got her second shot, the guy pinched the meat and then she felt something like the tip of the needle inside and said "ouch" and laughed. The caller usually did not feel it but that time she did. The caller was sick and had a fever a little longer and a little worse. The caller's fever went to 100.2 but then it went down to 99. For about 4-5 days the caller felt sick. Then the caller's shoulder got bad in that area and under it and she could not lift it up, it felt like a blockage, it was stuck. The caller went to the doctor the doctor ordered therapy for her arm. Then the caller had an appointment with the bone doctor and did an X-ray. They did not see anything but the doctor said it sounded like bursitis in this area. The caller did not hit, pull, or hurt her shoulder before the vaccine. The doctor prescribed meloxicam and that helped around the shoulder area. All of the sudden the injection area flared up and was hurting bad in the injection spot again. When the caller was laying down it feels like her arm is pulling and heavy. The caller had been off and on feeling sick, the caller would take ibuprofen or aspirin and that would help. Outcome of the events hurt arm was not recovered; fever was recovered on 05May2021; whereas other events was unknown. Follow-up attempts needed. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1381425
Sex: F
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 06/08/2021
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: increased blood pressure and never had it before; This is a spontaneous report from a contactable physician. A 101-year-old female patient received bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The caller's cousin got the vaccine and after that she developed increased blood pressure and never had it before. Outcome of the event was unknown. Follow-up attempts are needed . Further information has been requested.

Other Meds:

Current Illness:

ID: 1381426
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/08/2021
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: sore arm; tired; This is a spontaneous report from a contactable female consumer. A female patient with unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as unknown dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient's family medical history includes heart conditions, caller stated about her parents and sister. On an unspecified date, after the vaccination, the patient experienced sore arm and fatigue. Patient also stated that, her dad and sister have heart conditions but have been fine, no one had any effects other than like sore arm and tired. The reporter assessed all events as non-serious. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021650887 Same reporter/drug/events, different patients

Other Meds:

Current Illness:

ID: 1381427
Sex: F
Age:
State: OH

Vax Date: 05/06/2021
Onset Date: 05/06/2021
Rec V Date: 06/08/2021
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: First dose: Swelling at the injection site; The first dose was annoying and she slept for a day; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection) via an unspecified route of administration, in arm right on 06May2021 (at the age of 57-year-old) (Lot Number: EW976) as 1st dose, single dose for covid-19 immunization. The patient medical history included ulcer (Diagnosed in 2020 and patient could not take Ibuprofen because of this). The patient concomitant medications were not reported. On 06May2021 (reported as after 6 hours of first dose of vaccine), the patient experienced swelling at the injection site. The patient reported that the first time she had a swelling the size of her hand at the injection site. The first dose was annoying, and she slept for a day on an unknown date in 2021. The patient was prone to swelling, she never progressed after the second round of allergies shots because of the swelling. The swelling happened after every allergy shot, she ever had this was 20 years ago. The swelling would start about a day later. The patient would get one allergy shot on a Monday (date unspecified) and then one shot on a Friday (date unspecified). The outcome of the event was swelling at the injection site was recovered on 10May2021and for hypersomnia was recovered on 2021. No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness:

ID: 1381428
Sex: F
Age: 0
State: OK

Vax Date: 12/10/2020
Onset Date: 12/10/2020
Rec V Date: 06/08/2021
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: patient was given the Dtap/IPV portion of PENTACEL and did not get the ActHIB part, no AE; Upon Internal review a signification amendment was performed on 04-Jun-2021, to change the product code of Pentacel from 242 to 520. Initial information received on 14-Dec-2020 regarding an unsolicited valid non-serious case from a physician. This case involves a 2 months old female patient who was given the first dose of DTAP/IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Lot number UJ336AAA and expiration date 05-Jul-2021) and did not get the ACT-HIB part, via intramuscular route in the right thigh for prophylactic vaccination on 10-Dec-2020 (Product preparation issue). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE for prophylactic vaccination. It was a case of actual medication error due to inappropriate reconstitution technique (same day latency). Physician stated that an employee gave the DTAP/IPV portion of PENTACEL. She wanted to know how to proceed, to give them just an ActHIB or another Pentacel. The physician stated that an employee at the office gave the DTaP/IPV portion of Pentacel on 10-Dec-2020. At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: HEPATITIS B VACCINE; ROTAVIRUS VACCINE; PNEUMOCOCCAL VACCINE

Current Illness:

ID: 1381431
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Injection site reaction; Initial information was received on 27-May-2021 regarding an unsolicited valid non-serious case from a consumer/non-hcp (healthcare professional). This case involves a 29 years old female patient who experienced injection site reaction while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC]. The patient's past medical treatments, past vaccinations, concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (Suspension for injection, lot number and expiration date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious injection site reaction (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Laboratory data was not reported. It is unknown if the patient experienced any additional symptoms/events. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. There will be no information on the batch number for this case.

Other Meds:

Current Illness:

ID: 1381432
Sex: M
Age: 1
State: MN

Vax Date: 05/17/2021
Onset Date: 05/17/2021
Rec V Date: 06/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: patient was administered a 0.5ml dose of the diluent of the Pentacel vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Medical Information inbound (reference number- 00608210) and transmitted to Sanofi on 19-May-2021. This case involves 16 month old male patient who was administered a 0.5ml dose of only the diluent of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: U6842BA; expiry date: 05-JUL-2021) via unknown route in the right thigh for prophylactic vaccination on 17-MAY-2021(product preparation error). Medical history, medical treatment(s), past vaccination(s), and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for prophylactic vaccination on 17-MAY-2021. It was a case of an actual medication error due to active ingredient not added to diluent (latency same day). The reporter stated that a nurse administered the diluent only regarding the Pentacel. The reporter wanted to know what if a vaccination with just a stand alone vaccine for the components not given by just administering the diluent. Also, the reporter wanted to know if the powder component be given if diluted with something else. At the time of report no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: MMR VACCIN

Current Illness:

ID: 1381433
Sex: F
Age:
State: MI

Vax Date: 05/19/2021
Onset Date:
Rec V Date: 06/08/2021
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: Ipol that had undergone temperature excursion on 16MAY2021, and was recommended that it not be used, had been given to patient with no adverse event; Initial information was received on 20-May-2021 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 20 months old female patient who was administered 0.5 ml third dose of suspect IPV (VERO) [IPOL] (lot R1D972M, expiry date: 17-JUL-2021) via intramuscular route in the left thigh for prophylactic vaccination on 19-May-2021 (Product storage error) Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); HEPATITIS A VACCINE and PNEUMOCOCCAL VACCINE 13V for prophylactic vaccination. It was a case of an actual medication error due to Incorrect product storage. At the time of report, no adverse event was reported. Caller stated that she called to get stability for IPOL because it was puncture and she was advised to discard. Caller stated before she could take it out of the fridge it was administered to a child. She would like to know what should be done from here. Ipol that had undergone temperature excursion on 16MAY2021, and was recommended not be used This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: DTAP; HEPATITIS A; PNEUMOCOCCAL VACCINE 13V

Current Illness:

ID: 1381434
Sex: M
Age:
State: MA

Vax Date: 05/20/2021
Onset Date: 05/20/2021
Rec V Date: 06/08/2021
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: patient erroneously received reconstituted HIB portion of the PENTACEL vaccine after diluting with sterile water/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a physician and other healthcare professional via Medical Information via call-center (Reference number- 00609908) and transmitted to Sanofi on 20-May-2021. This case involves a 2-months-old male patient (unknown demographics) to whom nurse administered the first dose of 0.5 mL HIB portion DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (frequency: once, strength: standard, batch number: UJ415AA and expiry date not reported via intramuscular route at an left thigh administration site) after diluting with sterile water then administered the DTaP-IPV portion of PENTACEL in the right thigh (product preparation error) on 20-May-2021 for prophylactic vaccination. The patient's medical history, past medical treatment, vaccination, and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS B VACCINE for prophylactic vaccination. It was an actual medication error case due to wrong solution used in drug reconstitution (latency: same day). Nurse requests escalation for question: Did the patient receive any protection from the erroneously reconstituted HIB portion of the PENTACEL vaccine. She asks why it is not valid and requests information regarding why specific diluent; 0.4 percentage NaCl must be used. At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: PREVNAR 13; HEPATITIS B VACCINE

Current Illness:

ID: 1381435
Sex: M
Age: 0
State: TX

Vax Date: 05/20/2021
Onset Date: 05/20/2021
Rec V Date: 06/08/2021
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: An expired dose of Pentacel was given to a patient, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Global Medical Information (GMI) (Reference number- 00611112) and transmitted to Sanofi on 21-May-2021. This case involves a 6 months old male patient who was administered 0.5 ml second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ259AAA, expiry date: 14-May-2021, powder vial- Lot: UJ259AA and liquid vial-lot: UJ331AA, expiry date: 14-May-2021) once via intramuscular route in the left vastus lateralis for prophylactic vaccination on 20-May-2021 (Expired product administered). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE 13V, HEPATITIS B VACCINE and ROTAVIRUS VACCINE for prophylactic vaccination. It was a case of an actual medication error due to Expired vaccine used (latency same day) The reporter stated that yesterday (20-May-2021) an expired Pentacel was given to a patient and wanted to know what needs to be done now. The reporter asked whether another dose can be given to the patient. The Pentacel had expired 1 week ago. It was reported that they will call the patient's parents At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: PNEUMOCOCCAL VACCINE 13V; HEPATITIS B VACCINE; ROTAVIRUS VACCINE

Current Illness:

ID: 1381436
Sex: F
Age: 12
State: MI

Vax Date: 05/24/2021
Onset Date: 05/24/2021
Rec V Date: 06/08/2021
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: 12 year old patient was administered an expired Menactra, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Medical Information inbound (reference number-00613470) and transmitted to Sanofi on 24-May-2021. This case involves a 12 year old female patient who was administered an expired 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6576AB; expiry date: 04-APR-2021) via intramuscular route in the left arm for prophylactic vaccination on 24-MAY-2021 (expired product administered). Medical history, medical treatment(s), past vaccination(s), and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency same day). The reporter was asking for appropriate follow up. At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: BOOSTRIX

Current Illness:

ID: 1381437
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 06/08/2021
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: Vaccine refrigerator experienced an unreported temperature excursion greater than 72 hours/no AE; stability data of product was not provided.

Other Meds:

Current Illness:

ID: 1381438
Sex: M
Age: 0
State: VA

Vax Date: 05/26/2021
Onset Date: 05/26/2021
Rec V Date: 06/08/2021
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: an expired Pentacel dose was given to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious was received from a Physician via Medical Information (Reference number- 00616586) and transmitted to Sanofi on 26-May-2021. This case involves a 7 months old male patient who received a 0.5 mL expired dose (second dose) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot UJ162ABA and expiry date: 24-Apr-2021) via intramuscular route in the right thigh (expired product administered) for prophylactic vaccination on 26-May-2021. The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided. The reporter wanted to know wanted to know if it should be counted as a valid dose or if patient needs revaccination. It was an actual medication error case due to expired vaccine used (latency: same day). At the time of reporting, the patient experienced no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm