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: 1278397
Sex: F
Age: 33
State: PA

Vax Date: 04/30/2021
Onset Date: 05/01/2021
Rec V Date: 05/01/2021
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: None

Symptom List: Dysphagia, Epiglottitis

Symptoms: I had all the normal symptoms to be expected with a vaccine, slight fever, headache and body pain. That's not my concerning part. My left arm is all red and swollen around the injection site: 1?-inch wide by 1-inch long and getting bigger. I have taken pictures of it (if you'd like them).

Other Meds: None

Current Illness: No

ID: 1278398
Sex: F
Age: 29
State: CA

Vax Date: 12/31/2020
Onset Date: 02/03/2021
Rec V Date: 05/01/2021
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: None

Symptom List: Anxiety, Dyspnoea

Symptoms: Moderna COVID?19 Vaccine EUA After receiving the second dose of the Moderna COVID-19 vaccine on 2/3/2021 I noticed a bump at the injection site that has not gone away as of today (5/1/2021). At times the bump is itchy.

Other Meds: None

Current Illness: None

ID: 1278399
Sex: M
Age: 36
State: IN

Vax Date: 04/28/2021
Onset Date: 04/28/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: Chills and general achy feelings

Other Meds: None

Current Illness: None

ID: 1278400
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: hurt himself; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient hurt himself on an unspecified date and was treated with a tetanus shot and antibiotics (unspecified). The patient was reportedly scheduled for his second dose on 16Apr2021; the patient's wife was inquiring if this would affect the vaccine. Outcome of event was unknown. Information about lot/batch has been requested.

Other Meds:

Current Illness:

ID: 1278401
Sex: F
Age:
State: PA

Vax Date: 03/30/2021
Onset Date: 03/31/2021
Rec V Date: 05/01/2021
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: Genital swelling; hand swelling; Feet swelling; Chills; Headache; This is a spontaneous report from a contactable consumer (patient, self-reported). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7533 and expiration date was not reported), via an unspecified route of administration on 30Mar2021 14:50, as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6208), via an unspecified route of administration on 09Mar2021, as single dose for COVID-19 immunization and experienced same event (chills, headache, swollen hands, feet and genital). It reported that on 31Mar2021 patient experienced chills and headaches that went away after a day. And next day on 01Apr2021 experienced Feet swelling and on 05Apr2021, hand and genital swelling. Patient mentioned that the swelling on her hands and feet went away but her genitals are still a little swollen. She mentioned that genital swelling gets a little less day by day. She will be seeing her doctor and would like to know what to tell him before getting treatment. Caller stated the first day she took Tylenol for her headache just one Tylenol and it went away. Caller stated she had all these symptoms after the first dose as well. Adverse events does not require a visit to emergency room and no physician office. No prior vaccinations within 4 weeks and no adverse event following prior vaccinations. The outcome of the event chills and headache were recovered on 01Apr2021, feet swelling was recovered on 02Apr2021 and hand swelling was recovered on 06Apr2021 and the outcome of the event genital swelling was recovering. Follow-up (15Apr2021): This is a spontaneous report from a contactable consumer. Patient demographic, event details, corrective treatment information's were updated and Caller stated she had all these symptoms after the first dose as well. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1278402
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: aches; slight fever; This is a spontaneous report from a non-contactable consumer (patient's father). A 25-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. It was reported that the patient was out with friends had dinner. The patient received his first dose of the Pfizer covid vaccine Monday morning and got a call Monday night one of his friends tested positive. The patient got shot Monday and had a slight fever, aches, and woke up this morning and is fine. It was reported that they were concerned if he needs to get a test or anything. The outcome of the events was recovering/resolving. No follow-up attempts were possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278403
Sex: M
Age:
State: VA

Vax Date: 03/24/2021
Onset Date: 03/25/2021
Rec V Date: 05/01/2021
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: he had an allergic reaction to the vaccine; This is a spontaneous report received from medical information team. A contactable consumer (patient) reported that a 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: ER8732) via an unspecified route of administration in left arm (at the age of 58-year-old) on 24Mar2021 at 13:30 at single dose for COVID-19 immunisation. Medical history included diabetes, diagnosed about four years ago, he believes; blood pressure diagnosed about the same time, about 4 years ago; cholesterol levels were diagnosed about 15 years ago, probably more than that, all ongoing. Concomitant medications included ongoing metformin orally at 500 mg once a day for diabetes; ongoing lisinopril orally at 5 mg once a day for blood pressure; ongoing gemfibrozil orally at 600 mg twice a day for high cholesterol. The patient previously received acetylsalicylic acid (ASPIRIN) in 1994 and that's the last time he took it and was allergic to it. He took it once. The first time he took it, he got a very severe allergic reaction, his whole face was swollen. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. After he took the first dose of the vaccine, he developed swelling to the left side of face near to his lips that night, and it was gone the next morning. He just had a little swelling on his lips up into the face. He got vaccine on 24Mar2021 at 13:30, the swelling, he got that at 00:00 on 25Mar2021 at night and the next morning, he still saw it and by noon it was gone. The 2nd dose was supposedly on 14Apr2021 but no available schedule so he booked today (15Apr2021). When he went to get the second dose of the vaccine, there refused to vaccinate him because they said he had an allergic reaction to the vaccine. Nurses and the doctors at the facility refused to give him the 2nd dose, instead advised him to report it to Pfizer. He already talked to his primary care physician and said that he can take at his own risk. A visit to Emergency Room or Physician Office was not required. The outcome of event was recovered on 25Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds: METFORMIN; LISINOPRIL; GEMFIBROZIL

Current Illness: Blood pressure abnormal; Diabetes; High cholesterol

ID: 1278404
Sex: F
Age:
State: FL

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 05/01/2021
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: Fever; Chills; Malaise; Fatigue; Arm Pain; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0161, expiration date not reported) via unspecified route of administration in Arm Left on 14Apr2021 10:30 (age at vaccination 50-years-old) as single dose for covid-19 immunisation. Facility where most recent COVID-19 vaccine was administered was other. Medical history included chronic diverticulitis, drug hypersensitivity to penicillin, augmentin, erythromycin and lactose intolerance. Concomitant medications in two weeks included loratadine, pseudoephedrine sulfate (CLARITIN-D) taken for hypersensitivity from an unknown date. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 24Mar2021 at 09:00 AM, (at the age of 50-years-old) as a single dose for COVID-19 immunization. Patient did not have or was diagnosed for COVID prior to vaccination. Patient was not tested for COVID post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Apr2021 20:30 the patient experienced fever, chills, malaise, fatigue and arm pain. The patient received acetaminophen as treatment for the adverse events. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: CLARITIN-D

Current Illness:

ID: 1278405
Sex: F
Age:
State:

Vax Date: 04/14/2021
Onset Date: 04/01/2021
Rec V Date: 05/01/2021
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: developed high fever; Chills; Headache; This is a spontaneous report from a contactable consumer via Medical information team. A female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via an unspecified route of administration on 14Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Daughter, calling on behalf of mother reported that the patient received her first dose on 14Apr2021 (yesterday) and now developed high fever, chills and headache on an unspecified date in Apr2021. She wanted to know whether she can take any medicine and was waiting for doctor to call her back. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278406
Sex: F
Age:
State: TX

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 05/01/2021
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: sleepy; tired; tested positive for covid-19 after receiving the first dose of the covid-19 vaccine; tested positive for covid-19 after receiving the first dose of the covid-19 vaccine; body ache; runny nose; left eye was throbbing; she couldn't swallow like her body forgot how to do it; feeling she had something in her throat; severe headache; tension on her neck that felt like a neck injury; neck pain; jaw was paralyzed; pain in arm; This is a spontaneous report from a contactable lactation registered nurse (patient). A 37-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number and expiration date unknown) via an unspecified route of administration on 06Jan2021 around 5 pm (at 37-year-old) at single dose for COVID-19 immunization. Medical history included migraine. Concomitant medication included amitriptyline since 2018 at 10 mg nightly, 20 mg and 30 mg for migraine and stopped after COVID, and she was feeling tired/ sleepy and that made it worse; riboflavin sodium phosphate (VITAMIN B), and magnesium. The next day on 07Jan2021 about 7:59 am (around 13 hours after receiving the vaccine), all of a sudden she was driving and her jaw was paralyzed, it's became hard, she couldn't move it and it was very painful. she never had that and she was driving with her two little kids and it freaked her out and she tried to park and she finally parked being it lasted for a couple of minutes. When she looked at the time again it was 8:03 am, it was gone. She needed to get her kids to safety because she was driving but then it went away. On 09Jan2021, she started to have all of a sudden this tension on her neck that felt like a neck injury, it was hard to move her neck to a certain side and started while she was working. It was progressing and she thought she hurt herself. The pain began to lead to a severe headache. The neck pain felt like an injury lasted for a couple of days, but headache persisted and was intense, it lasted for 2 weeks and her coworkers thought she had COVID. She worked on 09Jan2021 and 10Jan2021 and then called out after that. On 12Jan2021 and 13Jan2021 the pain was not just in her head but in the left eye, it was throbbing and severe pain deep inside. It lasted for a couple of days lasted for over a week, it was not as bad as the first couple of days, the pain was the most severe on the 12Jan2021 and 13Jan2021 and couldn't do anything and stayed in bed. It felt like it was nerve pain and she never had that before, it was definitely different. She took daily anti migraine medicine and as long as she took it she doesn't have migraine headaches. For her Sumatriptan 50 mg, she took it twice on 12Jan2021, but because of the side effects it makes her nauseous and she couldn't take it anymore, she just has the prescription. She was only allowed to have 10 a month. It is sumatriptan and it didn't work either and she was supposed to take it to reverse the headache and it didn't work. For the amitriptyline, its 10 mg and had to triple to 30 mg. She took it at nighttime, but one of the side effects is that it made her sleepy but she didn't sleep. She has a 3 month supply and had plenty, if she needed to adjust but that was her first time she was taking that much, her doctor said she could up her dose to 20 mg, her gave her permission before because it can be used at higher doses if needed, she did try the 20 mg but that did not work so she had to triple to 30 mg. Once she realized that was not helping she just said forget it. She had to triple the dose of her migraine medicine and she was taking 3000-4000 mg of paracetamol (TYLENOL) even that couldn't take it down and even did cold compresses. The headaches lasted for a couple of weeks and then she finally got COVID. The headache after that was different, not as intense, and even taking paracetamol a couple times per day was dealing with this headache, the fever the body aches. It is not like the headache she got from the vaccine. It lasted for another week with COVID and was different and managing the headache. So currently she was good. She stopped taking amitriptyline, she was taking it for 3 years and was switched to Vitamin B2 and magnesium in the last month and had no headaches. She had to switch after getting COVID because she felt more tired and sleepy and felt that the amitriptyline would make it worse so she had to find something else. She was good with the new medications. She was cleared to go back to work on 03Feb2021. She was pretty much good by 03Feb2021. She was told by her MD not to get a second dose but her employer stated she could be terminated if she was not fully vaccinated. She was concerned and scared of having this reaction again. Her arm pain hurt for a few hours but because she has other pain she thought it was her left arm but she really couldn't recall. she did have pain in her arm, it was normal pain nothing significant. It started at 11 pm on 06Jan2021 and lasted until Saturday 09Jan2021 and remembered that she had a hard time helping at work because she has to used the arm but the arm soreness was just like with any other vaccine, nothing abnormal. From 10Jan2021 to 13Jan2021 she kept feeling she like had something in her throat in the morning, and when she would start drinking she couldn't swallow like her body forgot how to do it. She would hold it in her mouth and then 30 seconds later she would start swallowing and then it went away. It was just in the morning for like 4 days. It cleared by 14Jan2021, clarifies it ended then. Caller stated her husband took a test on 11Jan2021 and didn't get his results until 14Jan2021 and showed he was positive and he was already isolating and she was at home with the kids. States her husband was the one that brought it in. She did start to have COVID symptoms until 23Jan2021, she had fever, chills, body ache, runny nose, shortness of breath and diarrhea. She was prescribed a z pack, azithromycin, and it helped with cough, the congestive cough and nasal spray for her runny nose. It was water coming out of her nose, most runny she has ever felt. She got testing and kept going for testing because she felt so sick and it was negative (on 13Jan2021 and 18Jan2021). She finally tested positive on 25Jan2021. No additional therapies for COVID-19. No other test performed, they see patients that keep testing positive 3 months later after no symptoms and just want to wait for symptoms to go down. The patient was not hospitalized, not admitted to an Intensive Care Unit. The outcome of the event paralyzed jaw was resolved on 07Jan2021, neck pain/ tension was resolved on 11Jan2021, headache was resolved on 03Feb2021, throbbing eye was resolved on 19Jan2021, pain in arm was resolved on 09Jan2021, "feeling she had something in her throat" and swallowing impaired was resolved on 14Jan2021, of other events were unknown. Reporter seriousness for Jaw was paralyzed: unknown Reporter seriousness for headache: serious, affected her ability to perform and no one wanted to see her in person and only had virtual visits with the doctor Reporter seriousness for tested positive for COVID-19 after receiving the first dose of the COVID-19 vaccine: Unspecified Reporter seriousness for tension on her neck that felt like a neck injury: Not serious Reporter seriousness for left eye was throbbing: Medically significant Reporter seriousness for pain in arm: Not serious Reporter seriousness for feeling she had something in her throat: Not serious The primary reporter considered the events paralyzed jaw, neck pain, headache, throbbing eye, pain in arm, "feeling she had something in her throat" were related to BNT162B2; while event tested positive for COVID-19 was unrelated. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events

Other Meds: AMITRIPTYLINE; VITAMIN B2 [RIBOFLAVIN SODIUM PHOSPHATE]; MAGNESIUM

Current Illness:

ID: 1278407
Sex: F
Age:
State: FL

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

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: feeling run down/Fatigue; Headache; This is a spontaneous report by a contactable consumer (patient's daughter). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 immunisation. The patient medical history included diabetic, feeling run down, fatigued and weak. The concomitant medication included vitamin C, Zinc and B12. The patient had undergone laboratory tests which include vitamin D levels were 9.5 and sodium level was low. On an unknown date, the patient experienced headache and fatigue/ feeling run down. It was reported that reporter wanted to know if patient would be allowed to have a vitamin B12 shot without interfering with the vaccine. On 04Apr2021, the patient was also had second dose of the Pfizer Covid-19 vaccine and wants to know how much time after she may present side effects. It was reported that patient was in hospital for the event feeling run down on an unknown date. The reporter also wants to know how long the symptoms of a headache and fatigue last. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: VITAMIN C; VIT B12; ZINC

Current Illness: Diabetes

ID: 1278408
Sex: F
Age:
State:

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 05/01/2021
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: Itchy skin/itchiness; Blotchy rash on her body; Skin was splotchy different areas; Had sort of an allergic reaction to the vaccine; Red rash; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via unknown route of administration on 14Apr2021 at single dose for COVID-19 immunisation. The patient's medical history was allergies included egg allergy and seasonal allergy. There were no breathing problems. Concomitant medications were not reported. It was reported that patient received her first dose of the Pfizer-Biontech Covid19 vaccine, yesterday, and developed itchiness and a "blotchy" rash on her body about 1 hour afterward on 14Apr2021. She took an antihistamine and had some relief. she was treated with an antihistamine. she also mentioned that she found it interesting that the rash was not at the injection site. 30 minutes after the vaccine, skin was splotchy different areas, itchy skin. antihistamine 1 hour after that. had some relief. Some residual itchiness. Patient had red rash that occurred more immediate. Patient also had sort of an allergic reaction to the vaccine and all on 14Apr2021. The outcome of all the events was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278409
Sex: F
Age:
State: MA

Vax Date: 04/13/2021
Onset Date: 04/14/2021
Rec V Date: 05/01/2021
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: Mild fever (101.0 F); This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, (Batch/Lot Number: EP6955),via an unspecified route of administration, administered in left arm on 13Apr2021 at 11:00 AM as SINGLE DOSE for covid-19 immunization. Patient was 62 years old at the time of vaccination. Patient medical history and concomitant medications were not reported. The patient was not allergic to medications, food, or other products. The patient received first dose of bnt162b2 via an unspecified route of administration, administered in left arm on 23Mar2021 at 12:00 PM (Batch/Lot Number: EP6955) as single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination patient has not been tested for COVID-19. On 14Apr2021 at 19:00 PM, the patient experienced mild fever (101.0 F). In Apr2021, the event was recovered. Followup#01(20Apr2021): No new information received. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1278410
Sex: F
Age:
State: AZ

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 05/01/2021
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: knot under her skin; a lump in her chest and that spot is red; a lump in her chest and that spot is red; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID mRNA VACCINE, solution for injection, Lot Number: EW0162, Expiry Date: Unknown), via an unspecified route of administration, administered in arm Left on 14Apr2021 at 13: 00 (at the age of 63-year-old) as single dose for covid-19 immunization. The patient medical history included COVID (a year ago she had got COVID), and she had no allergic reaction, the patient's concomitant medications were not reported. Patient stated that when it came out a year ago, she had got COVID so that is why she took the vaccine this year. She took her first dose of the Pfizer Covid-19 vaccine yesterday and about 4 to 5 hours later she noticed a knot under her skin on her chest with a red area and at 18: 00 to 19: 00 when she was at work, she got a reaction which was a lump in her chest and that spot was red. She probed if the lump was still there, and she stated that she went to bed with it and she woke up with it that's why she was called. She wanted to know what it was. Patient stated that her second dose is scheduled for 08May2021. On an unspecified date, 5 hours later of vaccination, the patient experienced knot under her skin, a lump in her chest and that spot is red, a lump in her chest and that spot is red. The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1278411
Sex: F
Age:
State: CA

Vax Date: 03/31/2021
Onset Date:
Rec V Date: 05/01/2021
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: fatique; Sore arm; This is a spontaneous report from a contactable consumer (patient). A female patient received the first dose bnt162b2 (Batch/Lot number was not reported) on 31Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatique and sore arm in 2021 with outcome of unknown. The patient was scheduled for her second vaccine 21 days after but then the clinic offered her an appointment for 4 days earlier. She was calling to ask if that was ok to do, she still was scheduled for the 21 days though. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278412
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 05/01/2021
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: Methylprednisolone for a sprained rotator cuff; lightheaded and dizzy/ light headedness and dizziness; did not feel well; Feel like I am sort of out of it; This is a spontaneous report from a non-contactable consumer from a Jubilant Cadista pharmaceuticals. A female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; methylprednisolone 4 mg tablet (Batch/Lot Number: 2DL0026P; Expiration Date: 30Sep2022), oral from 26Mar2021 to Mar2021 "Per the card in the pack" and then from Mar2021 and ongoing, at Dose lowered "per the instructions"for Sprained rotator cuff. Medical history included Sprained rotator cuff, High blood pressure, and High cholesterol. The patient's concomitant medications included an unspecified blood pressure medication and an unspecified cholesterol medication. The patient previously took the first dose of BNT162B2 on an unspecified date in 2021 for COVID-19 immunisation. In Mar2021, after starting the products, the patient was lightheaded and dizzy, she did not feel well, and felt like she was "sort of out of it". She was trying to observe Holy Week and not eat much; she should have been fasting, but she needed to take Methylprednisolone with food. She thought that when she took Methylprednisolone with food, she did better and felt better. It had really worked to help her shoulder, but she thought that she had "a lot in her system now" with both the Covid vaccine and Methylprednisolone, and it was "just a bit for her system" because all she took was a blood pressure and a cholesterol medication. On an unspecified date in Mar2021, the patient reduced her dosage of Methylprednisolone "per the instructions". As of 29-Mar-2021, the patient continued treatment with Methylprednisolone, and her light headedness and dizziness, not feeling well, feeling sort of out of it, were ongoing. The action taken in response to the events for methylprednisolone was Dose Reduced. The outcome of the events was not resolved. Pfizer is a marketing authorization holder of [methylprednisolone] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [methylprednisolone] has submitted the same report to the regulatory authorities. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278413
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: Patient experienced body aches, light headed, headache, fever; Patient experienced body aches, light headed, headache, fever,; Patient experienced body aches, light headed, headache, fever,; Patient experienced body aches, light headed, headache, fever,; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender 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 SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced body aches, lightheaded, headache, fever, all on an unspecified date with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278414
Sex: F
Age:
State:

Vax Date: 03/27/2021
Onset Date: 03/28/2021
Rec V Date: 05/01/2021
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: Very fast blood flowing, the heart beat for the whole time; Fatigue; feel sick and is still sick; Weakness; but feels very feverish all the time.; soreness in her arm; I had a swollen arm that was painful for 4 days; This is a Spontaneous report from a contactable consumer (patient) and Other HCP. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 27Mar2021 as SINGLE DOSE for covid-19 immunisation. Medical history included neutropenia. The patient's concomitant medications were not reported. She was administered the first dose of Pfizer-BioNTech COVID-19 Vaccine on 27Mar2021. She is supposed to schedule her second dose of Pfizer-BioNTech COVID-19 Vaccine for this weekend. She reported having very swellingness of her arm, her arm hurt for 3-4 days on 28Mar2021. But this last weekend she has gotten to feel sick and is still sick, very weak in Apr2021. She does not have a high fever, has no fever, but feels very feverish all the time in Apr2021. She gets these kind of symptoms, these kind of flu-like symptoms all the time because she has neutropenia where she has very, very low white blood cells, so she gets sick very frequently. She had fatigue, very fast blood flowing, the heart beat for the whole time. The patient underwent lab tests and procedures which included covid-19: pending on 12Apr2021. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278415
Sex: M
Age:
State: MO

Vax Date: 04/01/2021
Onset Date: 04/13/2021
Rec V Date: 05/01/2021
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: listening to a slow ceiling fan motor whooshing and constantly hears it in both ears; began experiencing hearing loss, noise disappeared suddenly in both ears; very deadening sound in both ears; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733), via intramuscular route of administration on 01Apr2021 at 09:30 (at the age of 70 years) at a single dose in the left arm for COVID-19 immunization. Medical history included blood clot in leg almost 10 years ago. Concomitant medications included rivaroxaban (XARELTO, strength: 20 mg) taken for blood clot in leg and other unspecified medications. The patient previously took silodosin (RAPAFLO) a number of years ago for urination and he broke out in hives. Patient had no family medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had first shot done on 01Apr2021 at 09:30. On the evening of 13Apr2021 at 19:30, he kind of got a very deadening sound in both ears and then began experiencing hearing loss, noise disappeared suddenly in both ears. He woke up the next day (14Apr2021 at 05:00) with what he described as listening to a slow ceiling fan motor whooshing and constantly hears it in both ears. He called his doctor because he thought it may disappear but his doctor instructed him to see an ear and throat doctor about this (for clarification). He called to report the events and to know if it's safe to get the second dose of the vaccine. The outcome of the events was not recovered.

Other Meds: XARELTO

Current Illness:

ID: 1278416
Sex: F
Age:
State: OH

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 05/01/2021
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: constant pain in my neck. On a scale of 1-10 it's a 6-7; Upon getting shot in my left arm, not only did my arm bleed; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 15:00 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation, at 22 years old. The patient has no medical history. The patient's concomitant medications were not reported. Patient is not pregnant. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient has no known allergies. On 15Apr2021 15:15, upon getting shot in patient's left arm, not only did patient's arm bleed after, but a minute or two (15:16) after she had a constant pain in her neck. On a scale of 1-10 it's a 6-7. Treatment was not given. Outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1278417
Sex: M
Age:
State: NC

Vax Date:
Onset Date: 04/13/2021
Rec V Date: 05/01/2021
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: 100.3 fever; Minor lethargy; Occasional chills; Minor headache; This is a spontaneous report from a contactable consumer (Patient). A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL3247), dose 2 via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient medical history was not reported. Concomitant medication included finasteride, 1mg daily for several years. The patient previously took first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. On 13Apr2021 the patient experienced 100.3 F fever, occasional chills, minor headache, and minor lethargy after 2nd dose of Pfizer vaccination. symptoms started approximately 20 hrs after vaccination. Patient stated that it was just his body immune response. He no underlying conditions, borderline obese and no significant allergies. No follow-up attempts are needed. No further information is expected.

Other Meds: Finasteride

Current Illness:

ID: 1278418
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/14/2021
Rec V Date: 05/01/2021
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: came in for her second dose of the Pfizer covid vaccine, but tested positive for covid 19 yesterday; came in for her second dose of the Pfizer covid vaccine, but tested positive for covid 19 yesterday; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The pharmacist reported that a patient came in for her second dose of the Pfizer COVID vaccine, but tested positive for COVID 19 yesterday (14Apr2021) and asked if they need to start the series over. The outcome of the events was unknown. Information about the lot/batch number requested.; Sender's Comments: Based on the limited information in the case report and known drug safety profile, A possible causal relationship between event Covid-19 and suspect drug BNT162B2 cannot be excluded.

Other Meds:

Current Illness:

ID: 1278419
Sex: F
Age:
State: KY

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 05/01/2021
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: Headache; presented tightness of chest; bad taste in her mouth./she still has the taste in her mouth; she has acid reflux; she felt really dizzy; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 15Apr2021 09:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 15APR2021, the patient experienced headache, presented tightness of chest, bad taste in her mouth/she still has the taste in her mouth, she has acid reflux, she felt really dizzy. Caller states she wants to know if that is normal and if she can take the second one. The events were considered as non-serious. The outcome of the event bad taste in her mouth was not recovered and other events was recovered in Apr2021.

Other Meds:

Current Illness:

ID: 1278420
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: felt like he had kidney stones; couldn't swallow his food and it felt like the "food wouldn't go down/wouldn't pass; almost turned blue; felt like his airway was closed up; felt deathly ill; he might throw up; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included the patient had "many health conditions" (unspecified) and was a smoker. Concomitant medications were not reported. On an unspecified date, after the first dose, the patient felt like he had kidney stones. On an unspecified date, the patient could not swallow his food and it felt like the food would not go down/ would not pass. His wife stated that he looked so uncomfortable and almost turned blue. The patient stated it felt like his airway was closed up. He said he laid in bed, feeling like he was deathly ill and like he might throw up for about 5 minutes, then the sensation passed. This happened at 4 meals following vaccination and has since resolved. The clinical outcome of felt like he had kidney stones was unknown; of "couldn't swallow his food and it felt like the "food wouldn't go down/wouldn't pass", almost turned blue, felt like his airway was closed up, felt deathly ill, he might throw up was resolved on an unspecified date. No follow-up attempts are needed; information about lot or batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278421
Sex: M
Age:
State: NY

Vax Date: 02/10/2021
Onset Date: 03/10/2021
Rec V Date: 05/01/2021
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: psoriasis its been the worst ever in his 40 years; started itching; It had welts; red marks; He sees his leg is all red, almost looks like shingles.; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received the second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 10Feb2021 'about 3PM' (Batch/Lot Number: EM9810; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunization. Facility in which the vaccine was administered was a hospital Medical history included psoriasis (In the summer, his psoriasis is greater and in the winter, his skin is more dry) . Patients family history (patients daughter) includes coeliac disease and psoriasis. The patient's concomitant medications was reported as 'taking regular medication for years' (details not provided). Historical Vaccine Dose 1 received 22Jan2021 between 1100-1300, (Lot: EL3246 Expiration Date: 30Apr2021, Route of administration: left arm). No other vaccines were given within 4 weeks. Caller has received flu Vaccine and Pneumonia Vaccine in the past and had no problem at all. Caller mentioned he will be 78 years old in May. On 10Mar2021, The patient experienced psoriasis really got bad, terrible, on both legs its been the worst ever in his 40 years, started itching/ itch like crazy, He has never seen psoriasis this bad in his life. It was up his legs, on the elbows, few patches on the sides and it had welts,, it was almost like welts or like red marks his on upper thighs and side. Caller has one big patch on the side of thigh and one in the back of the thigh. Reports the patches were always there but seems they got worse and redder. It was as red as anything up on the side, both of his legs got really big. He never saw them this bad in his life on an unspecified date. The clinical outcome of the events was unknown. Caller also inquired how long it would take to get the immunity from the 2nd dose of the covid vaccine. Patient states this has to be from the vaccine because in 45 years he has never had psoriasis this bad. As a result of the event the patient visited his Dermatologist (this was the same Dermatologist he has been going to for years. He last visited the dermatologist September or October and was given the regular cream). The caller told the dermatologist it might be due to the Pfizer Covid Vaccine, and the dermatologist said it may be due to stress. Patient stated he is not under stress or stressed out. Caller states he uses different creams, but clarifies the one his dermatologist gave him as treatment is called Betamethasone Dipropionate cream 0.05. Caller states he was given him 3 tubes of cream because the caller guesses his psoriasis is so bad. Caller reported a little improvement, stating it doesn't itch as much he guesses because of the cream. He sees his leg is all red, almost looks like shingles. He clarifies the psoriasis is on both legs and calves, but one calf is not as bad; on his thigh, on the side, and one patch is on the back of his thigh. He has had Psoriasis on both legs as years went on but very little. The cream helped out, also sun and salt water,, but he's never seen it this bad. Everything broke out like crazy. No Follow-up attempts are needed. No further information is expected. The clinical outcome of the events was recovering while almost looks like shingles was unknown. No Follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1278422
Sex: F
Age:
State: FL

Vax Date: 03/28/2021
Onset Date:
Rec V Date: 05/01/2021
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: so his granddaughter went to get tested and was positive for COVID/probably contracted COVID before the vaccine but tested positive after receiving the vaccine; so his granddaughter went to get tested and was positive for COVID/probably contracted COVID before the vaccine but tested positive after receiving the vaccine; This is a spontaneous report from a contactable pharmacist. A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 28Mar2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient had her first Pfizer COVID 19 vaccine on 28Mar2021 and her coworker tested positive so the patient went to get tested and was positive for COVID. The reporter stated that the patient was feeling much better now but she had the vaccine on 28Mar2021 and probably contracted COVID before the vaccine but tested positive after receiving the vaccine. The reporter stated the patient was scheduled for her second dose on 18Apr2021 and wondering if she can get the vaccine since she has had COVID in between the vaccines. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine.

Other Meds:

Current Illness:

ID: 1278423
Sex: M
Age:
State: CA

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 05/01/2021
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: sore arm next day; This is a spontaneous report from a contactable consumer (patient). This 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 18:15 (Lot :EN9581) at single dose for COVID-19 immunisation. Medical history included hepatitis b chronic from 05Sep2002 , high blood pressure from 25Jan1995 , late effect of cardioembolic stroke from 14Jan2005 , nerve entrapment of hand ,neuroma hand from 10Jan2006 , diabetes type 2 without retinopathy from 20Dec2006 , atrial fibrillation from 23Aug2007 , coronary artery disease from 01May2009 , depression from 06Mar2010 , left heart failure from 29Apr2013 , slow heart rate from 18Apr2014 and bradycardia from 27Apr2014, duodenal ulcer from Apr1997, gallstone and acute cholecystitis with obstruction from 27Jul2016, clotting or bleeding disorder (coagulopathy) from 27Jul2016, lipoma (fatty mass) from 27Aug2016, moderate chronic kidney (disease) from 16Sep2017, left ventricular (hypertrophy) from 16Sep2017, Chronic low back pain with lumbar radiculopathy from 16Jan2019 and lumbar disc herniation with radiculopathy from 17Jan2019, iliac artery aneurysm (left and right) from 27Feb2019, right iliopsoas bursitis from 26Mar2018, Benign prostatic hyperplasia from 11Apr2018, Arthritis of (right and left hand) from 17Apr2018. Concomitant medications included warfarin; entecavir; metoprolol; losartan; bupropion; glipizide; metformin; diltiazem hydrochloride (DILT-XR); atorvastatin, all were ongoing. Patient felt sore arm next day on 28Jan2021. Outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: WARFARIN; GLIPIZIDE; ENTECAVIR; METOPROLOL; LOSARTAN; BUPROPION; METFORMIN; DILTIAZEM HYDROCHLORIDE; ATORVASTATIN

Current Illness:

ID: 1278424
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: chest congestion for one and half week; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at an unknown age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient had chest congestion for one and half week and was prescribed azithromycin (Z-PAK) and MUCINEX (expectorant). The outcome of the event chest congestion was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278425
Sex: F
Age:
State: OR

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 05/01/2021
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: Low body temperature; Fatigue; Anxiety; Brain fog; High BP/Pressure in head and high blood pressure; Severe chills; Strange redness across her shoulders; Arm hurt after shot; Pressure in head; Very loose stools; Nausea; This is a spontaneous report from a contactable consumer reporting for herself. A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 13:30 (Batch/Lot Number: EP7533) as single dose for covid-19 immunisation (Age at vaccination: 59 years) . Medical history included liver disorder , hypersensitivity, hepatitis C from , osteopetrosis , arthropod sting allergy , drug hypersensitivity , gluten sensitivity (She is borderline celiac, and she will get really bad gastro problems for 2 or 3 days after digesting gluten) , penicillin hypersensitivity (She has itching, rash, nausea) , peanuts allergy (Keeps an EPI pen for this). Concomitant medications included d-ribose, polypeptide (TRANSFER FACTOR [D-RIBOSE;POLYPEPTIDE]) taken for hepatitis C from 2003 to 03Apr2021; ascorbic acid (VITAMIN C ACID) taken for an unspecified indication from an unspecified start date to 03Apr2021; vitamin D3 (VITAMIN D3) taken for osteopetrosis from an unspecified start date to Apr2021; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. The patient experienced high bp/pressure in head and high blood pressure on 05Apr2021 with outcome of unknown , fatigue on an unspecified date with outcome of unknown , severe chills on 05Apr2021 with outcome of unknown , low body temperature on an unspecified date with outcome of unknown , strange redness across her shoulders on 05Apr2021 with outcome of recovered , arm hurt after shot on 05Apr2021 with outcome of unknown , pressure in head on 05Apr2021 with outcome of unknown , very loose stools on 05Apr2021 with outcome of unknown , nausea on 05Apr2021 with outcome of unknown , brain fog on 06Apr2021 with outcome of not recovered , anxiety on an unspecified date with outcome of unknown. Hypertension was considered an Important Medical Event. The remaining events were non serious. The patient underwent lab tests and procedures which included blood pressure increased: 179/98, 170/97 on unknown date , blood pressure measurement: 152/87 on 06Apr2021 , body temperature decreased: low No follow-up attempts are needed. No further information is expected.

Other Meds: TRANSFER FACTOR [D-RIBOSE;POLYPEPTIDE]; VITAMIN C ACID; VITAMIN D3; PROBIOTICS

Current Illness:

ID: 1278426
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: Pain; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. On an unspecified date, after the first dose of vaccination, the patient had pain to the point of needing to get a steroid shot. The outcome of the event was unknown. The patient had not taken the second dose of vaccination (at the time of reporting) because of her rheumatoid arthritis, and was asking for data on the effect of vaccination to rheumatoid arthritis on patients who do not take steroids. Follow-up attempts are possible. Information of lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1278427
Sex: M
Age:
State: ME

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 05/01/2021
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: fever; Aches and pains all over body; Right arm soreness at injection site; Severe chills; too tired and too chilled; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0158, Expiration date: 31Jul2021), via an unspecified route of administration in right arm on 13Apr2021 at 10:45 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER2613, Expiration date: 31Jul2021), via intramuscular route of administration in left arm on 23Mar2021 at 11:45 am as single dose for COVID-19 immunization. The patient's medical history included diagnosed on Jul2016, colonoscopy on 07Apr2021. Patient had no family history. The patient concomitant medications included supplements. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Patient had no additional vaccines administered on same date of the suspect vaccine. The patient stated he had no reaction to the first dose of the vaccine and after the second dose on tuesday (13Apr2021 at 21:00) and had chills when he went to bed that night. He went to bed that night with severe chills. On 14Apr2021 at 09:00, the next morning, he had a fever of 101 and aches and pains all over his body. Earlier, about a half hour before shot, he had a COVID test because he had a procedure today to give birth to a kidney stone which was cancelled due to fever aches and pains. He previously had COVID test and they all came ack negative. The procedure had to be cancelled. Today, he went back in to get another COVID test. He will know results within a couple of hours or before tomorrow whether it comes back positive or not. He does not believe the vaccine gave him COVID, but will find out when the test is tomorrow. He asked if the second dose is the same as the first dose. He said he has been reading and it is essentially the same but depends on the person that dilutes it and the temperature it is at. After verbal response he stated the second shot was definitely building a strong immune response. It was reported that first shot primes the immune system, helping it recognize the virus, and the second shot strengthens the immune response. Chills were gone by wednesday gone but still had a fever and aches and pains. He was too tired and too chilled to take his temperature tuesday night. He has a hazardous material thermometer. He called his urologist that night and said he may need to reschedule procedure tomorrow which is today. The fever improved during day but at night it crept back up to 101 and this morning is 98. His pulse ox is 98%. This morning other than feeling stiff for sleeping 16 hours, he has a couple of aches and pains this morning, but they are gone now. He was diagnosed with this kidney stone for 4 years. It is a bladder stone and his urologist said it is a nuisance stone. Once he got where insurance would cover it, he said lets take care of it. It was diagnosed Jul2016 and it was prescheduled to get it removed. Patient had a colonoscopy that was prescheduled. It was 15 years since he had one. He kind of wondered if the doses are different. He wanted to know if the second dose was a little more powerful. He takes supplements but does not think any would be relevant. Taking same supplement with first dose. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 23Sep2020, 05Apr2021 before Colonoscopy and last test was 13Apr2021 two days prior to when he was going to have kidney stone removed. He had an additional one done today and does not have results yet. The outcome of the event fever was recovering, too tired was unknown and rest all events was recovered on 2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1278428
Sex: U
Age:
State: UT

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: sore arm; This is a spontaneous report received from a contactable consumer (patient). This consumer reported that a patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included rheumatoid arthritis, chronic fatigue, and hasimotoes disease. There were no concomitant medications. The patient stated that received both covid-19 vaccinations with minimal side effects, sore arm. Outcome of event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1278429
Sex: M
Age:
State: MI

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 05/01/2021
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: he is having lower back pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the 1st dose of the Pfizer covid19 vaccine, but he was having lower back pain. He would like to confirm if he can take any pain reliever. 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: 1278430
Sex: F
Age:
State:

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 05/01/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: O2 dropped to 92; Coughing; having itching in throat within 10 minutes of the shot; This is a spontaneous report from a contactable consumer. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. Medical history included severe allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient who has a history of severe allergies started coughing and having itching in throat within 10 minutes of the shot, O2 dropped to 92. Patient was given an EpiPen and was taken to the hospital, and was there for a few hours. Patient was given 'an IV,' Benadryl and steroids and then released. The outcome of the events was recovered on an unspecified date in 2021. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1278431
Sex: M
Age:
State:

Vax Date: 02/14/2021
Onset Date: 02/14/2021
Rec V Date: 05/01/2021
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: he had was a sore arm for 24 hours; heavy chills; This is a spontaneous report received from a contactable consumer (patient). A male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: EN6201 and expiry date was not provided), via an unspecified route of administration, in the right arm, on 14Feb2021 at 14:00 as a single dose for covid-19 immunisation. Medical history of the patient was reported as none. Concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect. Patient did not have adverse event following prior vaccinations. Patient did not receive other vaccine in four weeks of vaccination. No additional vaccines administered. On 14Feb2021, patient experienced sore arm (for 24 hours) and heavy chills (for 4 hour). Reporter seriousness for events were unspecified. No treatment was received. The outcome of events was resolved on 14Feb2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1278432
Sex: F
Age:
State: SC

Vax Date: 04/03/2021
Onset Date: 04/03/2021
Rec V Date: 05/01/2021
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: pulled a scab off and it bled; itching at the injection site; swollen; soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female (not pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 09:00 (Lot Number: EW0151) as single dose for covid-19 immunisation. Medical history included known allergies to mold, penicillium plant, dogs, cock roaches. Concomitant medication(s) included valsartan and montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. The patient previously took metoclopramide hydrochloride (REGLAN) and experienced drug hypersensitivity, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6207) via an unspecified route of administration in Mar2021 09:15 AM at left arm single dose for covid-19 immunisation. Twice since second shot patient had itching at the injection site. In inadvertently pulled a scab off and it bled the first time (a few days ago). It's itching again and feels swollen. Interestingly, soreness at the injection site is the only symptom patient have had. The first time it went away and that was it. But this is the second time since the swelling went down that patient have had itching at the injection site and this time it's swollen a little. the initial post shot swelling subsided but it has returned in the past week or so. And it didn't even bleed after the shot. Patient's band-aid came off clean the next day. Patient have not received treatment. Patient filled out this form as soon as the itching returned and realized it was the same. Events onset date reported as 03Apr2021 09:00 AM. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: VALSARTAN; SINGULAIR

Current Illness:

ID: 1278433
Sex: F
Age:
State: FL

Vax Date: 04/12/2021
Onset Date: 04/12/2021
Rec V Date: 05/01/2021
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: Facial swelling.; Some swelling in mouth on right side.; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration, administered in right arm on 12Apr2021 at 16:15 (at the age of 46 year old) as single dose for Covid-19 immunization. The patient's medical history included seafood, antibiotics, and shellfish allergy. The patient's concomitant medications were not reported. The patient previously took 2 Benadryl before vaccination. Patient historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration as single dose for COVID-19 immunization and experienced facial swelling. The patient did not take any other medication within two weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, it was unknown if patient was diagnosed with COVID-19. It was unknown whether the patient had been tested for COVID-19 since the vaccination. On 12Apr2021 at 17:45, the patient experienced facial swelling and some swelling in mouth on right side. The patient did not receive treatment for events. The outcome of the events recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1278434
Sex: M
Age:
State: CA

Vax Date: 04/12/2021
Onset Date: 04/12/2021
Rec V Date: 05/01/2021
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: Parts of the face, sides of cheek and neck had an itchy, rash; Eyelids puffy and swollen; Underneath eye and part of cheek, swollen and puffy; Face got red, like a sunburn; Pain in arm; Tiredness and fatigue; This is a spontaneous report from a contactable male consumer. The 57-year-old male consumer (patient) received second dose (Batch/Lot Number: unknown) on 12Apr2021 at 3 pm and first dose (Batch/Lot Number: ER8727) on 22mar2021 via unspecified route of administration as a single dose for Covid-19 immunisation. The medical history was not reported. Patient reported he was on 9 medications. The patient experienced Pain in arm on 12Apr2021 in the evening and it was resolved on 13Apr2021, Tiredness and fatigue on 12Apr2021 at 3 PM, Face got red, like a sunburn on 13Apr2021 in the evening, Parts of the face, sides of cheek and neck had an itchy, rash on 13Apr2021 at 5 PM, Eyelids puffy and swollen on 13Apr2021, Underneath eye and part of cheek, swollen and puffy on 13Apr2021 at 5 PM. Patient did not specified seriousness. Patient did not have prior Vaccinations within 4 weeks. Patient did not have any relevant tests. Patient reported that there were side effects to the first shot, patient reclarified, his face getting super red, eyes swelling, upper cheeks swollen, under eyes swollen, face was very itchy, earlobes red and swollen" all occurring 24 hours after he got the second dose of the vaccine. Patient stated then last night his face got red, stated it was like he had sunburn on his face and he had an itchy, rash, swollen under his eyes. Patient had a skin Cancer treatment a couple of months ago and he was told to stay out of the sun. Patient did not think about the vaccine being the cause of, his skin being red. Patient used this new facial cream and he thought he was having a reaction to that, but now he doesn't thing so, it could be from the vaccine. Patient stated redness hasn't gone away, and he is itching in certain areas of his face and neck. He had looked on the internet to see what anaphylaxis looks like, and the pictures do not look like what he is experiencing. Patient's rest of face is super red, like sunburn with a red, itchy rash. Patient took Benadryl and it Benadryl relieved the itching and swelling. Patient didn't think he was allergic to the main ingredient in the vaccine. Patient stated that he had an allergy to Tegretol. patient stated he had a reaction, a rash, and the medication was stopped immediately. Patient doctor put him on a strong antihistamine with good effect. Patient did not get any vaccine on the same day. Patient did not require visit to Emergency Room and Physician Office. Patient stated that his friend that got the Pfizer vaccine and her throat closed up on her at night and she was told not to get her second vaccine. Upon follow-up further information was received patient stated 45 days ago he had a preventative skin cancer procedure on his face and used Fluorouracil 5% topical cream applied daily on his face. patient said it made his face get "super red", which is what it was supposed to do. Patient stated that the medication contained Polysorbate 60. He is wondering if his reaction to the vaccine could be a "cross reactive. Patient further reported a delayed reaction to the second dose of the Pfizer Covid 19 vaccine. Patient stated he had no side effects after the first dose. However he reported the following: face getting super red, eyes swelling, upper cheeks swollen, under eyes swollen, face was very itchy, The outcome Pain in arm was recovered, tiredness and fatigue ? recovering, face got red, like a sunburn was not recovered, parts of the face, sides of cheek and neck had an itchy, rash was not recovered, underneath eye and part of cheek, swollen and puffy was not recovered, eyelids puffy and swollen was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: Benadryl; Fluorouracil

Current Illness:

ID: 1278435
Sex: M
Age:
State: AR

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 05/01/2021
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: Some of worst pain he had in his life in his arm; he was not able to raise his arm up, it was agonizing; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of bnt162b2 (BNT162B2, lot number: EW0158), via an unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Some of worst pain he had in his life in his arm, the patient guess it just the fourth day it was better today (unspecified), the patient could nearly lift arm all the way up, it had been very sore but for two days he was not able to raise his arm up, it was agonizing, the third day he could, yesterday he could kind of raise a little bit but today he raised it but it's still hurt. The last 11 years he was on top of the world, he never had a vaccine for anything that hurt like this did and he was not really feeling safe about going and getting another one if it is going to be worse. The patient would like some guidance from somebody. He had not talked to anybody that hurts like this (Clarification unknown). Treatment just took Tylenol. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1278436
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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; Cough; Headache; Upset stomach; This is a spontaneous report from a Non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Medical history, concomitant medications and past drug history were not reported. Reporter stated that she had a couple questions nothing bad. Her question was, if she had the first vaccine and there was no symptom, just a sore arm, but then she starts to develop couple weeks later a cough, headache, upset stomach, unsure if its related to the vaccine or could be covid 19 exposure. Patient asking is it possible to still get the second vaccine, if there were body aches but no fever and did not test positive for covid. At the time of this report event outcome was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278437
Sex: F
Age:
State:

Vax Date: 03/29/2021
Onset Date: 04/05/2021
Rec V Date: 05/01/2021
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: She started spotting and having periods way earlier than she normally does; Difficulty picking that foot up on that side; Not really feeling herself; She started spotting and having periods way earlier than she normally does.; Left side pelvic pain; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 29Mar2021 at single dose for covid-19 immunization. Medical history was not reported. The patient's concomitant medications were not reported. On 29Mar2021 and exactly a week, 7 days after first dose, 05Apr2021, she started to have left side pelvic pain. The pain had consistently been there. She started spotting and having periods way earlier than she normally does. This was concerning to her. She had since then started experiencing a little difficulty picking that foot up on that side, referring to her left side; and she was not really feeling herself. Her second dose was this upcoming Monday on 19Apr2021. This report is not related to a study or program. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278438
Sex: F
Age:
State: NJ

Vax Date: 04/03/2021
Onset Date: 04/03/2021
Rec V Date: 05/01/2021
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: her left arm that is swollen; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 03Apr2021 11:00 as SINGLE DOSE (at the age of 57-years) in Arm Left for covid-19 immunization. The patient had no relevant medical history. The patient did not receive any prior vaccinations (within 4 weeks). The patient's concomitant medications were not reported. On 03Apr2021 at 12:00, the patient's left arm was swollen after her first shot. She reported that her left arm that is swollen, the arm she got the shot in. It was still swollen and worsened. She enquired whether she should go to the hospital. The patient did not receive any treatment. The outcome of event was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278439
Sex: F
Age:
State:

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 05/01/2021
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: Patient reports a normal resting heart rate in the 70s, immediately after inject felt her heart racing and had tachycardia to the 140s; Patient reports a normal resting heart rate in the 70s, immediately after inject felt her heart racing and had tachycardia to the 140s; This is a spontaneous report from a non-contactable physician. A 21-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Left Arm on 15Apr2021 16:00 (Batch/Lot Number: EW0150) as SINGLE DOSE (at the age of 21 years) for covid-19 immunisation. Medical history included seasonal allergy from an unknown date, hypersensitivity of environmental allergies from an unknown date and food allergy from peanuts from an unknown date. Concomitant medications included loratadine (LORATADINE) taken for an unspecified indication; pseudoephedrine (PSEUDOEPHEDRINE) taken for an unspecified indication; albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for an unspecified indication and montelukast (MONTELUKAST) taken for an unspecified indication. The patient was not pregnant when she received the vaccine. The patient did not have any other vaccine in four weeks. The patient reports a normal resting heart rate in the 70s, immediately after injection felt her heart racing and had tachycardia to the 140s (palpitations) on 15Apr2021 16:00 with outcome of recovering. The patient underwent lab tests and procedures which included heart rate: 70s on unspecified date and palpitations: 140s on 15Apr2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of patient heart racing and had tachycardia to the 140s. The events persisted for 5 hours and improved only after IV (0.9% normal saline) fluid bolus. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Heart racing and Tachycardia cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.

Other Meds: LORATADINE; PSEUDOEPHEDRINE; ALBUTEROL [SALBUTAMOL]; MONTELUKAST

Current Illness:

ID: 1278440
Sex: F
Age:
State: DC

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: tongue swelled immediately; chin and lip remained swollen; chin and lip remained swollen; This is a spontaneous report received from a contactable consumer (the patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history included: allergy and blood clots. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient received both shots. After receiving the second shot, the patient's tongue swelled immediately; after a week the tongue swelling went down, but the chin and lip remained swollen. The outcome of tongue swelled immediately was recovering. The outcome of chin and lip remained swollen was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278441
Sex: M
Age:
State: FL

Vax Date: 04/07/2021
Onset Date: 04/12/2021
Rec V Date: 05/01/2021
Hospital: Y

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: Low fever beginning on 1:00AM Monday 12Apr; Experienced nausea Monday 12Apr evening and seizure; Experienced nausea Monday 12Apr evening and seizure; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: ENG201) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nausea monday 12Apr evening and seizure and low fever beginning on 1:00am monday 12apr at 01:00. The patient was hospitalized for experienced nausea monday 12apr evening and seizure and for low fever beginning on 1:00am monday 12apr for 4 days. Therapeutic measures were taken as a result of low fever beginning on 1:00am monday 12apr. It was unknown if therapeutic measures were taken for the events Experienced nausea Monday 12Apr evening and seizure. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1278442
Sex: F
Age:
State:

Vax Date: 04/12/2021
Onset Date: 04/12/2021
Rec V Date: 05/01/2021
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: super numb; exhausted; This is a spontaneous report from a non-contactable consumer (patient's friend). A female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 12Apr2021 (Lot Number: ER8730) as single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 22Mar2021 (Lot number: EN6207) for COVID-19 Immunization and did not presented any symptoms. On 12Apr2021 , the patient mentioned that her arm in which she received the vaccine (left arm) got super numb for 6 or 7 hours after receiving the vaccine, as if she did not even could feel the arm normally that she was exhausted as if it was a run over sensation. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1278443
Sex: M
Age:
State: MI

Vax Date: 04/07/2021
Onset Date: 04/08/2021
Rec V Date: 05/01/2021
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: bruises around injection site and all around the left arm; bruises around injection site and all around the left arm; severe fatigue; This is a spontaneous report from a contactable consumer(patient). A 21-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8733; Expiration Date: 31Jul2021), first dose via an unspecified route of administration, administered in left arm on 07Apr2021 as SINGLE DOSE for covid-19 immunization. Patient was 21 years old at the time of vaccination. Patient's medical history and concomitant medications were not reported. Patient did not receive any prior vaccinations within 4 weeks of first administration of vaccination. On 08Apr2021 patient experienced severe fatigue, stated it was really bad. On 11Apr2021 patient had bruises around injection site and all around the left arm, a lot of them. States the fatigue has improved some but he was just so exhausted. Wanted to also know is there any chance he is having low platelet counts. The outcome of the event bruises around injection site and all around the left arm was unknown and severe fatigue was reported as recovering. No follow-up attempts are needed; No further information is expected.

Other Meds:

Current Illness:

ID: 1278444
Sex: F
Age:
State: FL

Vax Date: 02/11/2021
Onset Date: 02/25/2021
Rec V Date: 05/01/2021
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: Fever; lack of appetite/ lost her appetite, she is having a hard time eating and very rarely felt like eating anything; weight loss/ lost 8 pounds; Headaches; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 83-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration in right arm on 11Feb2021 at 17:00-18:00 and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration on 03Mar2021 at 12:00, both as single dose for COVID-19 immunization. The patient's medical history included flu vaccination for years and pneumonia vaccine. Concomitant medication(s) included Vitamin D 2000. On 25Feb2021, patient had headaches starting 2.5 weeks after her first shot. On 15Mar2021, patient experienced weight loss/ lost 8 pounds, patient also stated she was between 129-130 pounds when this started. On 15Mar2021, patient experienced lack of appetite/ lost her appetite, she was having a hard time eating and very rarely felt like eating anything. Patient also stated that she used to enjoy breakfast and lunch but then she was forcing them down, sometimes she could eat dinner. On an unspecified date, patient experienced fever. Patient mentioned that one night she felt like mashed potatoes and so her husband made her mashed potatoes and she ate a lot of them. Also mentioned that she forced herself to eat because she knows she had to. Patient was not losing anymore weight but she was not putting any back on like she thought she should be either. In the evening, she tried to eat pasta or potatoes. Patient mentioned that she had been to the doctor on 10Mar2021 and he gave her a B12 shot for her lack of appetite and said if she doesn't improve, to come back; she had been to the doctor twice. Patient stated that she lived on Tylenol and started taking it every 7-8 hours then down to every 4 hours because she needed relief. Her temperature would go from 97.1 to 99. Patient reported that no fever now and the highest it got was 99.8 and as soon as she took Tylenol, her temperature would go down. Patient wanted to know if anyone else has had this reaction. Outcome of the fever was recovered on an unspecified date, headache was recovered on 14Mar2021 while the events; lost her appetite and weight loss was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: VITAMIN D 2000

Current Illness:

ID: 1278445
Sex: F
Age:
State: CT

Vax Date: 04/11/2021
Onset Date: 04/11/2021
Rec V Date: 05/01/2021
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: lost height; Had numbness in both hand & fingers.; Tingling in left hand & fingers / tingling in right hand to wrist / tingling in left hand to wrist; tingling around my mouth /tingling from cheek bones to chin and around mouth; This is a spontaneous report from a contactable consumer. This consumer(patient) reported that the 69-year-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE ), via an unspecified route of administration, administered in Arm Left on 11Apr2021 16:45 (Batch/Lot Number: EP7533) as single dose for covid-19 immunisation. Medical history included hypersensitivity from an unknown date and unknown if ongoing. No Family Medical History. The patient previously took first dose of bnt162b2 (BNT162B2, lot number: EN6208) on 21Mar2021 04:45 PM in Left arm for covid-19 immunization and experienced sore arm and mild headache. Concomitant medications were unknown. The patient experienced had numbness in both hand & fingers on 11Apr2021 17:00 with outcome of unknown, tingling in left hand & fingers / tingling in right hand to wrist / tingling in left hand to wrist on 11Apr2021 17:00 with outcome of unknown, tingling around my mouth /tingling from cheek bones to chin and around mouth on 11Apr2021 17:00 with outcome of unknown. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No other vaccine in four weeks. No other medications in two weeks. Allergies to medications, food, or other products. The clinical course was reported as follows: "Had numbness & tingling in left hand & fingers. within 15 min after injection of Pfizer vaccine. Approx half hr later numbness & tingling started in my right had & fingers. As of today April 13th still have tingling in both hands & fingers. I also have tingling around my mouth." Caller states that she received second dose last Sunday 11Apr2021. She states that on the first dose she received just a sore arm and mild headache. On the second dose within 10-15 minutes her left hand became numb, and her fingers were all numb. She states that she got the vaccine and that the vaccine was given in her left arm. She says that they had her stay at the facility extra long due to her reaction. She states that after a little while the numbness went away and she just had tingles in her left hand. The nurse at the facility said that if it gets worse then she should go to the emergency room. She states that on her way home the tingling started in the right hand. Since then she has still been having the tingling all in through her fingers and up to her wrist. She states that starting the same evening her cheek bones and around her mouth was tingling. She states that it almost feels like ants are crawling on you. She says it like when your hand falls asleep and the tingling starts and you get the funny feeling. She states that it comes and goes. The tingling is there constantly. She is concerned that it is not leaving her. She wants to know if it will go away, and if it will go away then she is fine, but she is very concerned about the ongoing tingling. When providing height, caller stated she has lost height. Caller asked if other people have been complaining about this. She states she got the vaccine around 4:45 in the evening. She states that ever so often her fingers tips will be a little numb, but it goes quickly. Is basically all tingling. She states that her pinky and ring finger seems to be more severe on her hands. She states that the tingling doesn't go past the wrist. The tingling on her face from her cheek bone through the chin. She states that it comes and goes but it is happening everyday. The numbness started within 10 to 15 minutes and then turned into tinging in her left hand. The tingling in the face was later on that evening. The right hand the tinging started on the way home. She states the tingling is still ongoing. Each day she wakes up and she thinks maybe it will be gone today. She is very concerned. She states that the tingling seems that it is not as bad as it was the first time it started. However, sometimes it increases in intensity. She states that it is a little over mild, like a notch over mild, not severe but just a notch over mild. She states she got the vaccine because she doesn't want to get COVID. She states it's a no brainer to get the vaccine. She states that she does have little baby grand children, and god forbid she doesn't want them to get anything or vise versa. She states that her husband and daughter and son-in-law got the vaccine, and that everyone is getting it. She states that some people, she has seen, are getting sick, flu like symptoms, headache and fever from the vaccine but she just got the tingling and she is concerned. No Anatomical Location of Administration of Pfizer vaccine considered as suspect. Vaccination Facility Type was (Name) . No vaccine Administered at (Name) Facility. She states that there were (Name) people there helping out. No history of all previous immunization with the Pfizer vaccine considered as suspect. No AE(s) require a visit to emergency Room or Physician Office. The caller got the second dose of the vaccine on 11Apr2021 and has been experiencing tingling in her hands up to her wrist and on her face from her cheek bones down to her jaw. She stated this started with numbness and went to tingling into her right hand and also in her face, which comes and goes.This started immediately after the vaccine, within 10-15minutes. On the way home from the vaccine it started in the other hand. She assumed this would go away but it has been a little over a week now. She asked will this ever go away. She stated she will give it longer and call her MD. She stated when she got the vaccine on Sunday the nurse said 2 people the day before, 10Apr2021, complained of tingling in their hands and this was the first time she had heard of tingling and numbness in hands.The nurse was was unsure how they made out. follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1278446
Sex: M
Age:
State:

Vax Date:
Onset Date: 03/21/2021
Rec V Date: 05/01/2021
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: He had a reaction, his tongue was swelling on the left side; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer Covid-19 vaccine), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: EP6955) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had a reaction, his tongue was swelling on the left side on 21Mar2021 (not clarified further). Also, like two days after like on the 23rd, patient woke up at 8:30 and his tongue was swollen. So, reporter had to give patient Benadryl (treatment) and it did go down. The outcome was recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm