VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1712872
Sex: M
Age:
State: PA

Vax Date: 03/04/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: shaking like I had a chills/trembling; feeling real weak and tired; arm was sore; flashes; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (Age at vaccination 44-year) in right arm on 04Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included testosterone taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Mar2021 the patient experienced arm was sore and flashes, on 05Mar2021 the patient experienced feeling real weak and tired, on 11Mar2021 the patient experienced shaking like he had a chills/trembling. It was reported that "He used Testosterone gel. He had been on that about a year now. He used it every morning, it was recommended by the doctor 2 pumps of the gel and he rubs it on his upper arms. He was going to look up his prescription because there is a specific dosage in each pump. Each pump was 20.25 mg, and he uses 2 pumps once daily, 40.5 mg once daily total. He says he had a question; he was having a side effect and he was not sure if it was related to the vaccine. He had the first one, he hadn't had the second one, but he had the first 04 Mar and he felt sick, he felt real weak the next day. He was fine after that, that Friday his right arm was sore and that was sore for a couple days but that subsided, it was fine and then a week later 11Mar, he was trembling, his whole-body trembles and he had hot flashes as well and he does not know if it was related to the vaccine, but he had not been able to stop shaking since last Thursday. He was trying to see if that was associated with product. He confirms he had the first dose 04 Mar and the next day 05 Mar he had weakness. His arm was sore a couple days. He says all of that was recovered completely now. He says the trembling began 11Mar. He says hadn't had a fever, he was trying to explain, it feels like if he was fighting off an infection or something, there was constant shaking as if he did have the chills, but he doesn't. He had hot flashes like he will get hot then he will get cold, but he doesn't run a fever at all, there was constant shaking. Caller was a 44-year-old male who received his first dose of the Pfizer BioNTech COVID-19 vaccine on 4MAR2021 and reports that his arm was sore for a couple of days after. He then states that the next day he began to experience "feeling real weak and tired" but states that passed. He also mentions that that Saturday, his arm was no longer sore. However, the following week on a Thursday, he reports he was trembling and "shaking like he had a chill" but reports not having a fever. He states that it had been "constant shaking" since last week that will "ease up some" but does not fully go away. He also reports hot flashes where he will get cold and then get "real hot" but again reports no fever. Caller states that the only medication he tooks was testosterone gel once a day in the morning and had been taking this for about a year. Caller would like to know if there have been any other reports of this trembling and "constant shaking" after receiving a dose of the vaccine." The clinical outcome of "arm was sore, feeling real weak and tired" was resolved on an unspecified date in Mar2021; outcome of "shaking like he had a chills/trembling" was not resolved; outcome of another event was unknown. Follow-up attempts completed. No further information expected.

Other Meds: TESTOSTERONE

Current Illness:

ID: 1712873
Sex: F
Age:
State: PA

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210311; Test Name: After an hour or 2 later, her temperature went back; Result Unstructured Data: Test Result:98.5 Fahrenheit; Comments: her temperature went back to 98.5*F at 8pm; Test Date: 20210311; Test Name: never had a temperature that low; Result Unstructured Data: Test Result:93 Fahrenheit; Comments: Took her temperature an hour or 2 later, it dropped to 93*F and that she never had a temperature that low; Test Name: normal temperature; Result Unstructured Data: Test Result:97-98 Fahrenheit; Comments: normal temperature was 97-98*F; Test Date: 20210311; Test Name: temperature; Result Unstructured Data: Test Result:94 Fahrenheit; Test Date: 20210311; Test Name: temperature; Result Unstructured Data: Test Result:96 Fahrenheit

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 at the age of 69-years-old as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medication included lisinopril taken for hypertension from an unspecified start date and ongoing; vitamin c [ascorbic acid] taken for supplementation therapy from an unspecified start date and ongoing; multivitamins (MULTIVITAMINS [VITAMINS NOS]) taken for supplementation therapy, start and stop date were not reported; atenolol taken for an unspecified indication from an unspecified start date and ongoing. On 11Mar2021 the patient experienced took her temperature an hour or 2 later, it dropped to 93*f and that she never had a temperature that low as her normal temperature was 97-98*f/temperature was 93, 94, 95, 96, fluctuating , she was extremely tired, there was soreness in her arm. The patient underwent lab tests and procedures which included body temperature: 98.5 fahrenheit on 11Mar2021 her temperature went back to 98.5*F at 8pm , body temperature: 93 fahrenheit on 11Mar2021 Took her temperature an hour or 2 later, it dropped to 93*F and that she never had a temperature that low , body temperature: 97-98 fahrenheit on normal temperature was 97-98*F , body temperature: 94 fahrenheit on 11Mar2021, body temperature: 96 fahrenheit on 11Mar2021. On 11MAR2021 the outcome of event took her temperature an hour or 2 later was recovered. On MAR2021 the outcome of event she was extremely tired was recovered. On an unspecified date the patient experienced she was extremely tired was recovering. Information on the lot/batch number has been requested.

Other Meds: LISINOPRIL; VITAMIN C [ASCORBIC ACID]; MULTIVITAMINS [VITAMINS NOS]; ATENOLOL

Current Illness:

ID: 1712874
Sex: M
Age:
State: IL

Vax Date: 03/05/2021
Onset Date: 03/07/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Insomnia/Sleeplessness; his brain won't shut off it keeps racing; This is a spontaneous report received from a 60-year-old male contactable consumer (patient). The patient reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6202) via an unspecified route of administration on 05Mar2021 (at-60-year-old), as dose 1, single for COVID-19 immunization. The medical history was reported as none. The patient's concomitant medications were not reported. On 07Mar2021 the patient experienced Insomnia /Sleeplessness and his brain would not shut off it keeps racing. The patient wanted to know if it was normal to happen with the vaccine. He clarified it was the Pfizer COVID 19 vaccine. He went to the doctor regarding it yesterday, he could not sleep, his brain would not shut off it keeps racing. It was ongoing, it was getting better but it was lingering and sleep deprivation was never good. He says he was not going to say it is improved he would say it has persisted about the same. The patient had not recovered. Communication: The caller was provided the contact number and hours of operation of Monday through Sunday 8AM-8PM for COVID vaccine calls prior to attempted warm transfer to Medical Information. Due to high call volume caller elects to be placed in the hold queue to continue holding for an agent. Follow-up attempts were completed. No further information was expected.

Other Meds:

Current Illness:

ID: 1712875
Sex: F
Age:
State: TX

Vax Date: 02/21/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: having trouble with her close vision; dry eyes; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9267, and Expiration date: May2021), via an unspecified route of administration on 21Feb2021 (at the age of 74-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included cataract surgery (surgery a year and a half ago) and rubella (when she was a child, she has caught rubella three times when you are only supposed to get the infection once, which was before rubella shots and was back in 1950s). The historical vaccines included Hepatitis B vaccine (she had an immunity of 14 while the cut of was 10, she was barely above immunity which they checked again and she had to start another series of the 4 vaccinations and she had 98, then they never tested it again) and 2 shots of unspecified flu A and flu B vaccine (She said the recommended dosage of vaccines did not work on her, she always tried get this vaccine at the end of September, she knew one date she got it again was February, and then she came down with it again and then they just started giving her two Flu shots a year, one at the end of September, and one at the beginning of January). The concomitant medications for patient were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9265, and Expiration date: May2021), via an unspecified route of administration on 28Jan2021 (at the age of 74-year-old) as dose 1, single for COVID-19 immunization. It was reported that, on an unspecified date in 2021, the patient was "having trouble with her close vision" which she clarified was due to having cataract surgery a year and a half ago. On an unspecified date in 2021, she had "dry eyes" and had not gotten drops yet that she was not allergic to, as well as she had problems with the glasses she got after cataract surgery, they were not right on her close vision, so she was having trouble with it. No further details provided about her dry eye drops. The patient considered herself not getting immunity with the Pfizer COVID-19 vaccine since she had history of not being immune to infections and vaccines before. The patient reported that, her doctor recommended her to get the COVID-19 vaccine and she was wondering if there was a way, she could run a titer to see if she was immune or not to COVID-19. She wanted to know if there a test currently available. The investigation assessment was not provided. The outcome of events was reported as unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1712876
Sex: F
Age:
State: PA

Vax Date: 02/28/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: soreness of arm; headache; steroid pills for 7 days due to infection; This is a spontaneous report received from a female consumer (patient), reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on an unspecified date Patient called to request for cancellation of the 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE schedule on 03/18/21 She received the 1st dose last 02/28/21 and had minor side effects like soreness of arm and headache. She was not sure if she has reported this to DSU but she was able to speak with 2 different people with Pfizer Due to long wait, she requested for callback from us and called the pharmacy to cancel the appointment She was advised by the pharmacist to cancel the 2nd dose appointment as she will have steroid pills for 7 days due to infection and wait until the steroid medication is done 2nd dose will be scheduled within 42 days after the 1st dose. Therapeutic measures were taken as a result of steroid pills for 7 days due to infection (infection). Outcome of event infection was unknown, for the events pain in extremity, headache was recovered on unspecified date. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1712877
Sex: F
Age:
State:

Vax Date: 03/06/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: lump, warmth and itching at the injection site; lump, warmth, and itching at the injection site/the place where she had the shot (injection site) started to get itchy and warm; lump, warmth, and itching at the injection site/the place where she had the shot (injection site) started to get itchy and warm; This is a spontaneous report received from a contactable consumer (patient). A 83-year-old female patient received PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) in right arm on 06Mar2021 (at the age of 83-year-old) as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date in Mar2021, few days after receiving vaccination patient noticed a lump, warmth, and itching at the injection site. Patient asked if she could get the second shot in the same arm if the lump was still there, she was left-handed and sleep on her left side. She would like to get it in right arm which was the same as her first shot. Patient asked if it was normal to occur this many days after. She was reading the side effects and explained after 2-3 days of getting the shot, she was fine. After a few days, she noticed the place where she had the shot (injection site) started to get itchy and warm. Outcome of the events were unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1712878
Sex: F
Age:
State: CA

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 202011; Test Name: covid; Result Unstructured Data: Test Result:positive test

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: fatigue; her arm was sore; bad brain fog/head fog; This is a spontaneous report from a contactable other hcp (Nurse) (patient). A 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 01Mar2021 (at the age of 74-year-old) at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 01Mar2021 the patient experienced fatigue, her arm was sore, bad brain fog/head fog. Reporter would like to know if she may only require one dose of the Pfizer Covid vaccine since she has a history of the Covid infection. Reporter does not wish to hold but agrees to call back from DSU, if required. Caller had Covid infection in Nov2020. She quarantined after a positive test and recalls symptoms of fatigue. She knows she has antibodies because she donated plasma in the following months up to Feb2021. She received her 1st dose of the Pfizer Covid vaccine 1Mar2021. She experienced fatigue, her arm was sore and she had really bad brain fog the next day. She couldn't remember that she needed to put her email in at work and was asleep the day before on the computer. Reporter would like to know if brain fog has been reported as a side effect of the Pfizer Covid vaccine. Reporter would like to know whether her side effect of brain fog would get worse after receiving the 2nd dose of the Pfizer Covid vaccine. Verbatim and Event Description: Inquiring if she can take the second Covid dose. She is getting head fog. The patient underwent lab tests and procedures which included covid: positive test on an unspecified date in Nov2020. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1712879
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: She specified "not at the injection site", but "a general outbreak", "like acne" and "outside the skin"; This is a spontaneous case received from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date patient specified not at the injection site, but a general outbreak, like acne and outside the skin. Patient explained she may have experienced it after the first dose and was not sure. She also mentioned she does not know if it was related to the vaccine and she will consult her Health care professional. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1712880
Sex: F
Age:
State: IL

Vax Date: 03/03/2021
Onset Date: 03/04/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: rash on her forehead; very swollen gland on left side of neck; Eye floaters; Shingles; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809, Expiry date, NDC number: unknown), via intramuscular in left arm on 03Mar2021 at 10:00 as DOSE 1, SINGLE for COVID-19 immunisation at clinic. Medical history included blood pressure and high cholesterol. The patient mentions she has had a weak respiratory system through the years, but she didn't have anything at the time off the vaccination. Concomitant medications include patient takes one estrogens conjugated (PREMARIN) daily, a very small dose. Fluoxetine two per day, telmisartan one per day for blood pressure. The patient was unable to confirm the spelling of the blood pressure medication. The patient also takes atorvastatin for high cholesterol. The patient explains doesn't have these products available to provide further details since they are at home, and the patient was currently at the doctor's office. Prior vaccinations within 4 weeks were reported as none. On 04Mar2021, the patient experienced eye floaters; On 06Mar2021, experienced very swollen gland on left side of neck; On 07Mar2021, experienced rash on her forehead and on an unspecified date in 2021, experienced shingles. Additional context reported as the consumer was calling in regard to the Pfizer COVID vaccine first shot 03Mar2021. The patient state there are three things, but patient doesn't know what relates and what doesn't. The first thing was that patient had a bunch of floaters in her eyes. The patient has had that before, and patient tends to think it didn't correlate with the vaccine. The second thing that patient had was very swollen glands, which patient can read can happen with Pfizer's vaccine. The Monday (07Mar2021) after receiving the shot, patient got a rash on her forehead which didn't look like the COVID rashes that patient saw when she looked online. The patient decided maybe that patient got a spider bite, but it didn't look like that either. It turns out to be shingles. The patient has it around her eye so patient was going to an ophthalmologist, patient primary doctor was sending her now. The patient has never had shingles before. The patient asked the doctor could patient take the second dose so patient will have a life. The patient asked the doctor if it was okay to do the second dose if patient was diagnosed with shingles or if patient should wait between doses. The consumer explains on 04Mar2021, it felt like patient glasses were dirty and patient kept wiping them. The patient had eye strain trying to see through the floaters. The patient mentions the floaters have receded a little bit. The patient had one very swollen gland on her left side. The patient clarifies further she had the vaccine on her left side and the left side of her neck, one gland was swollen like an olive or maybe just a little bigger. The patient noticed this one swollen gland around 5 or 6 in the evening, when patient was turning her head, patient felt it. The patient states it took two more days for it to go away. She confirms 08Mar2021, patient recovered completely. The patient felt the rash happening in the night of 07Mar2021. The patient woke up in the morning and had a rash. The only thing patient has had was anti-viral medicine for the shingles, patient has not had any other shot. The patient confirms the COVID-19 vaccine was administered intramuscularly in her arm. The patient makes the comment, I had no feeling about it, she clarifies it didn't hurt at all. No emergency room visit, the patient went to urgent care yesterday because patient could not get into physician's office. Relevant tests were reported as none. Outcome of the event eye floaters was resolving, event very swollen gland on left side of neck was recovered on 08Mar2021 and other events were unknown.

Other Meds: FLUOXETINE; PREMARIN; TELMISARTAN; ATORVASTATIN

Current Illness:

ID: 1712881
Sex: F
Age:
State: WI

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: her mom experiencing ear buzzing; This is a spontaneous report from contactable consumer was reported for the patient (mother) from a Regulatory Authority. A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 03Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced ear buzzing and had been hearing some kind of noises. Reporter stated that on behalf of her mom to ask for assistance on rescheduling her mom's 2nd dose schedule. Her mom got the 1st shot on 03Mar2021 and her mom is scheduled to return on 21Mar2021 and wants to reschedule the vaccine shot on March 25, 2021 because this is also the day her mom will attend a Physician for general physical exam. The outcome of event was unknown. Information about batch/lot number has been requested. Follow-up (13May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1712882
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Soreness in left arm at injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced soreness in left arm at injection site of COVID-19 vaccine lasting 2 days. The clinical outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712883
Sex: F
Age:
State: UT

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: viral infection; This is a spontaneous report from program. A contactable Female Consumer reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 11Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient had viral infection after the first dose dated 11Feb2021. The patient took antibiotics (unspecified) as a result of viral infection. The patient was asking was it ok to take the second dose. The outcome of the event was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1712884
Sex: M
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: Caller can no longer remember when he takes the 1st shot / He wants to know if he did attend his 2nd dose schedule because he can no longer remember it.; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. As reported "caller (Patient) can no longer remember when he took the 1st shot but he had a paper work that he should be returning on 26Feb2021 for his 2nd dose / he wanted to know if he did attend his 2nd dose schedule because he can no longer remember it." The clinical outcome of the event was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1712885
Sex: M
Age:
State: NC

Vax Date: 02/28/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: felt dizzy; Vertigo; This is a spontaneous report received from a contactable consumer (patient) via Pfizer Sponsored Program COVAX US Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 28Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 07Feb2021 for COVID-19 immunization. On an unspecified date in 2021, patient experienced felt dizzy, vertigo. Therapeutic measures (aspirin, tylenol and pills) were taken as a result of felt dizzy, vertigo. The clinical outcome of events was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1712886
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/12/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: soreness in arm of injection site; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable consumer reported on behalf of the female patient. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 12Mar2021 the patient experienced soreness in arm of injection site. Adverse event details: Reporter wanted to report side effect, soreness in arm of injection site. Outcome of the event was unknown. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1712887
Sex: F
Age:
State:

Vax Date: 03/12/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I felt so fatigue and nauseated; My body was sore, my joints was sore; I felt so fatigue and nauseated; Got this pain in my back on my right shoulders; it hurts when I breathe, I felt like it is down in my muscles; I am in pain I mean my shoulder blade it's hurting and it hurts when I take deep breath; This is a spontaneous report from a contactable consumer. This 67-year-old female consumer (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6199) via an unspecified route of administration on 12Mar2021 (at 67-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included high blood pressure and asthma. Patient was taking blood pressure medication and she does not remember it. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date (at 67-year-old), as dose 1, single for COVID-19 immunization. No investigation assessment was performed. On 13Mar2021 she felt so fatigue and nauseated, her body was sore, my joints were sore and everything and she took Tylenol and stuff yesterday and then today she still felt little fatigue and on an unknown date in Mar2021 she got this pain in her back on her right shoulders, her back on the right side, upper back. She thought it was her asthma (Clarified as other medical condition) but it was not because I took out my asthma medicine and stuff and it hurt when she breathes, she felt like it was down in her muscles. She had none of this before I had that vaccine, this was the second one. The patient had not recovered. Consumer was provided with the number of Pfizer Medical Information Department. No follow-up attempts were possible. No further information was expected.

Other Meds:

Current Illness:

ID: 1712888
Sex: F
Age:
State: CA

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 09/18/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

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

Symptoms: She started feeling cold; Uncontrollably shaking that lasted for like 4 hours; Muscle cramps above her stomach; Hard cramps in her 2 legs all night; This is a spontaneous report from a contactable consumer or other non-Health Care Professional and via from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 06Mar2021 as SINGLE DOSE for Covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported.On 06Mar2021 the patient experienced muscle cramps above her stomach , hard cramps in her 2 legs all night. On 08Mar2021 the patient experienced she started feeling cold, uncontrollably shaking that lasted for like 4 hours. The outcome of events was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1712889
Sex: F
Age:
State: KY

Vax Date: 03/12/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: This is a spontaneous report received from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 12Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included oesophageal carcinoma (Esophageal cancer and undergoing radiation therapy (5 times a week), chemotherapy (once a week)). The patient's concomitant medications were not reported. The patient experienced pain on the injection site of the vaccine on unspecified date in Mar2021. Therapeutic measures were taken as a result of event. The outcome of the event was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1712890
Sex: F
Age:
State: PA

Vax Date: 02/22/2021
Onset Date: 02/28/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: I noticed a rash around my eye on left side and a slight little lesion on the right under but more everything was on the left; Shingles; This is a spontaneous report from a contactable consumer. This 80-year-old female consumer (patient) reported for self. An 80-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9263, Expiration date: unknown), via unspecified route, administered on 22Feb2021 (at the age of 80-year-old) as dose 1, single for COVID-19 immunization. The patient medical history high blood pressure from unknown onset and unknown ongoing and concomitant medications includes Metoprolol 50mg and Rosuvastatin 10mg both from an unknown onset and unknown ongoing. On 28Feb2021, after the vaccination, the patient noticed a rash around her eye on left side and a slight little lesion on the right under but more everything was on the left. So, she called her doctor and he gave her a medicine that starts with a V for shingles, he thought it was definitely shingles, that was on 28Feb almost 6 days later after the shot that she had this which doctor thinks is shingles, doctor is pretty sure but she took the medicine and it looks like it went away, few days later doctor came over to visit because he was concerned and still was questioning because of the one spot on the right side, he said shingles stays on the left side and he knew that I had taken the Pfizer, he said that there is idea that maybe the Pfizer vaccine brought it on or and she wants her to go to dermatologist. she had schedule for other shot on Monday, second shot which doctor told her to cancel because she still has a rash around her eyes, and it looks like its shingles. Her second shot was rescheduled to 29Mar2021. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.

Other Meds: METOPROLOL; ROSUVASTATIN

Current Illness:

ID: 1712891
Sex: F
Age:
State: CA

Vax Date: 03/02/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:140-150; Test Name: blood pressure; Result Unstructured Data: Test Result:High; Test Name: blood pressure; Result Unstructured Data: Test Result:no more than 125; Test Name: Fever; Result Unstructured Data: Test Result:98.5 Fahrenheit

Allergies:

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

Symptoms: face was feeling hot and flushed; blood pressure was high 140-150, usually it is no more than 125; face was feeling hot and flushed; fever; felt jittery; This is a spontaneous report from a contactable consumer (patient herself). An 85-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6198, expiry date: unknown) via unspecified route of administration on 02Mar2021 (age at vaccination: 85-years) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2, via unspecified route of administration, left shoulder as reported on 06Feb2021 (age at vaccination: 85-years) as dose 1, single for covid-19 immunisation and experienced sore arm, face was flushed, Blood pressure high, face was feeling hot and flushed, 98.5F fever and felt jittery. vaccination facility type was building adjacent to the main hospital. Patients medical history included high blood pressure, from an unspecified date and unknown if ongoing (Diagnosed around 2010. Under control with medication). Past drug included sulfameth TMP and Adenosine and experienced allergies. There was no other additional Vaccines administered on same date of the Pfizer suspect. Patient had always been in good health. She did not have any side effects except a sore arm the next day. The next day her face was flushed and then she developed a 98.5F fever, felt jittery then it went away. This was with the first shot. This Saturday the caller began to feel the same thing, her pressure went up pretty high, she took blood pressure medicine every day. On Saturday and Sunday patients blood pres-sure was high 140-150, usually it was no more than 125. She noticed that the same symptoms as the first shot were occurring to her. The patient had a sore arm but went away after 2 days, she put a heating pad on it. Her face was feeling hot and flushed. She did not take her temperature the first day she got the shot. For about a day or 2 days for her blood pressure was high. The second shot she didn't have a sore arm. The patient was concerned that why was it after a couple of weeks or a month she was having the same symptoms. The patient underwent lab test which included, blood pressure measurement, results: 140-150, high, and no more than 125 and fever, result: 98.5 Fahrenheit on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712892
Sex: M
Age:
State: WA

Vax Date: 03/05/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Full blown shingles; left arm was a little bit sore; blisters; Pain in shoulders and upper rib area; Pain in shoulders and upper rib area; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration, administered in Arm Left (Left Arm Close to the shoulder in the muscle) on 05Mar2021 11:00 (at the age of 77 years old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing arthritis, ongoing Little bit of heart disease. There were no concomitant medications. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations within 4 weeks was none. The patient experienced pain in shoulders and upper rib area, left arm was a little bit sore, blisters on Mar2021, full blown shingles on 12Mar2021. Reported as, he had the first shot on 05Mar2021 and everything went fine except for a couple or three days later he experienced a lot of pain in the shoulders and upper rib area. on 12Mar2021 he got full blown shingles. His left arm was a little bit sore right after the shot but no problem there. The pain started a couple days after the shot. It was painful with touches of pain, after that is got worse. It was after that the blister showed up. He went to his doctor and was told he had full blown shingles. 4 days after vaccine was when he noticed blisters and that skin was painful to touch. Adverse event resulted in physician office visit for Pain in shoulders and upper rib area, full blown shingles. Outcome of the event full blown shingles was not recovered and unknown for other events. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Arthritis (Verbatim: Arthritis); Heart disorder (Verbatim: Little bit of heart disease)

ID: 1712893
Sex: F
Age:
State: DC

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

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

Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown result

Allergies:

Symptom List: Unevaluable event

Symptoms: Extremely fatigued and sick to my stomach I had diarrhea for few days but the problem is that I keep feeling worse instead of better and its already been 6 days; Its getting worse; Almost immediately after I had the vaccine my whole body turned red and very hot; Almost immediately after I had the vaccine my whole body turned red and very hot/I did not have the fever but I thought feel like very internally hot; I broke out in rash on my chest; I felt very light headed like I was going to pass out; Nauseous; I have been experiencing extreme fatigue; Feeling very sick to my stomach; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 45-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included hyperthyroidism from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for hyperthyroidism, start and stop date were not reported, diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Consumer stated, On 09Mar2021 Almost immediately after I had the vaccine my whole body turned red and very hot, I did not have the fever but I thought feel like very internally hot, I broke out in rash on my chest and I felt very light headed like I was going to pass out and also nauseous so they gave me Benadryl and steroids and Pepcid and I stayed for a while and I felt a little better went home and then I got up to next day and all reaction they came and since then I have been experiencing extreme fatigue and feeling very sick to my stomach,I have been getting very hot again not a fever it is very hot internally and it has been going on for 6 days. Consumer also stated, Extremely fatigued and sick to my stomach I had diarrhea for few days but the problem was that I keep feeling worse instead of better and its already been 6 days. consumer stated, its getting worse. Patient received treatment for the events as Benadryl every 6 hours and steroids and Pepcid. Consumer stated well I went to emergency room yesterday. The patient underwent lab tests and procedures which included blood test: unknown result on unknown date. The outcome of the events diarrhoea, condition aggravated was reported as unknown and while other events was not recovered. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.

Other Meds: LEVOTHYROXINE; BENADRYL

Current Illness:

ID: 1712894
Sex: F
Age:
State: MA

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210315; Test Name: ANA; Result Unstructured Data: Test Result:Normal; Test Date: 20210315; Test Name: CBC; Result Unstructured Data: Test Result:Normal; Test Date: 20210315; Test Name: Sedimentation rate; Result Unstructured Data: Test Result:Normal

Allergies:

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

Symptoms: the rash progressed and it started spreading, it's not on her face but is everywhere else, it's on her neck, her shoulder, her back; diagnosed with folliculitis; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Arm Left on 17Feb2021 as 2nddose, single for covid-19 immunisation (age at vaccination was 65year). Historical vaccine was A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Batch/Lot Number: EW5313), via an unspecified route of administration, administered in Arm Left on 27Jan2021 as 1st dose, single for covid-19 immunisation. Medical history included ongoing cough diagnosed may be 6 years ago, had the neurogenic cough for 10 years, they thought it was asthma initially, but it was not, pertinent Details: W/U and ruled out over past 10 years asthma, Reflux. ongoing seasonal allergies, pertinent Details: Treated with allegra or clacton flonase. Also included general health condition, cough, sleep disorder, Go to the bathroom and bone disorder from an unknown date and unknown if ongoing. No relevant family medical history was reported. Concomitant medication(s) included nortriptyline (NORTRIPTYLINE) taken for cough from Dec2020 to 25Feb2021; salbutamol (ALBUTEROL HFA) taken for cough from an unspecified start date and ongoing; vitamin d [vitamin d nos] (VITAMIN D) taken for supplementation therapy from an unspecified start date and ongoing; magnesium (MAGNESIUM) taken for cough, sleep disorder, hypertonic bladder, muscle relaxant therapy from an unspecified start date and ongoing; calcium (CALCIUM) taken for bone disorder from an unspecified start date and ongoing. She was on a similar medication previously from the same family (Amitriptyline) for years. They switched her because the Amitriptyline was not really working anymore. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. A few days after the first dose of vaccine, she developed an itchy rash in her scalp, back of neck, and in her hairline. She did not think it was related to the vaccine at the time. So, she bought medicated shampoo and it did not get better. The rash started coming down her neck, but she did not relate it to the shot, so she went ahead and got the second shot, again not thinking it had anything to do with the vaccine because this is an atypical reaction, but the rash progressed, and she went to urgent care on 04Mar2021. They prescribed her high doses of a steroid- started with 60 and went down to 10. She was doing everything to get rid of it herself. She was diagnosed with Folliculitis. They said she was scratching and then developed a bacterial infection. She received treatment with Steroid taper over 12 days, then 10 days of doxycycline over 10 days. She completed it a couple days ago. It was stated that initially everything was on the left side, but it wrapped around her neck to her left shoulder. It was described that the rash as patchy; there was a big patch on the left side of her lower back then down to her left upper buttock area; and there was a small patch on her left arm-ante cube area. It was reported that now the rash had spread across her neck on the right side and chest stops at chin, nothing is on her face- clarified not yet. It was reported that the ones on the back of her head: the big bumps on the back of her scalp decreased in size, but she had new ones going up the top/occipital area. She explained that she went to urgent care and then went to her PCP to get tests to see if there was any underlying disease that presents with a rash. It was stated that everything came back negative; her bloodwork and labs were all normal for autoimmune disease. She had a CBC with diff- normal, ANA-normal, Sedimentation rate was normal. After that, she went to a dermatologist because nothing improved, and it just continued increase. She stated, after the course of antibiotics and steroids, it did 0, nothing, and the rash continued to increase. Dermatology said that this is a reaction to the vaccine. She reported that everyone seemed to be in agreement that it was a reaction to the vaccine. She reiterated the rash was raised, patchy in location, and extremely itchy. She stated that everything was on the left side, but now it was bilateral, started going on both sides about four or five days ago. She clarified the rash started maybe 3 to 5 days after the first dose. She mentioned she went to the hairdressers on 28Jan2021, the day after the vaccine, and did not had any symptoms- she had her hair coloured with no issues and then maybe 5 days after receiving the vaccine, she kind of noticed it. She reported that it was definitely spreading, and she does not feel that it was getting much better. It was clearly visible to the naked eye and when you feel it, it was quite raised and red in colour. The part that scares and concerned her was that she could not find anything about a rash except for rash at the injection site. She wanted to know what to do about it and when was it going to stop. It was also stated rash- woke up with it, noticed it in the morning, itching woke her up. Noticed itching before anything else. Exact time unknown. 4 or 5 days after, it could have been there, but the itchiness made her notice it. Patient went to urgent care on 04Mar2021. She finished treatment from urgent care, then when it did not get better went to PCP and went to dermatology on 16Mar2021. Her husband got the shot on the same day, no reaction at all. Treatment was received for adverse events. Upon follow up received on 17Mar2021 is a follow-up spontaneous report from a contactable Nurse. This nurse reported about patient characteristics (Age at time of onset of reaction, sex, relevant medical history and concurrent conditions, patient medical comments verbatim neurogenic cough, outcome of the events was not recovered, results of tests and procedures for investigation of the patient. Drug information of 1st and 2nd dose (Pfizer Covid Vaccine, lot number, date), reaction related to drug, concomitant drugs, additional information for concomitant products nortriptyline, Investigation assessment, history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. Physician office visit was yes from 15Mar2021 went to urgent care on 04Mar2021. Description of product complaint Upon follow up received on 14Jun2021, it was reported that Onset date: On 01Feb2021 at 3 "a" the patient had rash extreme itch, raised rash scalp back of head seriousness criteria was reported as persistent/ significant disability/ Incapacity. On 18Feb2021, had Rash- Hives, seriousness criteria were persistent/ significant disability/ Incapacity. Main reason for reporting was that if she had known after her first vaccine that an atypical rash (scalp in my case) with extreme itching was possibly a reaction to vaccine she may have waited longer for second dose or asked for dose or passed all together. She was not antivaccine now- encourage all to become vaccinated. This was a miserable experience her skin was hypersensitive (still was) she had hives and rash every-where skin bruised and open from scratching- did not sleep more than 2 hours at a time for 4 months- taking 10 antihistamines daily topical steroids- the only thing that stopped it was Xolair which she was very hesitant to take given that there was no history of giving this med for a reaction post vaccine. Her 'w/n' for other possible causes rule out any other possibilities she reported this to Pfizer-CDC-Mass general. She had sent pics of Rash/ Hives. This was the first time anyone has for followed up although not life-threatening this was a life altering experience, she was misdiagnosed with folliculitis no way was this from vaccine. She said very strange, but timeline was hard to ov

Other Meds: NORTRIPTYLINE; ALBUTEROL HFA; VITAMIN D [COLECALCIFEROL]; MAGNESIUM SULFATE; CALCIUM

Current Illness: Cough resembling asthma; Seasonal allergy

ID: 1712895
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Caller got both Covid doses and after her 2nd dose she experienced a very dry mouth; her lips were numb and so were her cheeks; her lips were numb and so were her cheeks; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced caller got both covid doses and after her 2nd dose she experienced a very dry mouth, her lips were numb and so were her cheeks, her lips were numb and so were her cheeks. The outcome of the events dry mouth, hypoaesthesia, hypoaesthesia oral was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1712896
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Sick for a week; This is a spontaneous report from non-contactable consumer (patient mother). A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 41-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sick for a week. It was stated that caller's son, 41 y/o was sick for a week after his pfizer vaccine dose. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected

Other Meds:

Current Illness:

ID: 1712897
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Felt "crummy" after the second shot; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine BNT162B2 Dose number 1 COVID-19 immunisation. On an unspecified date the patient experienced felt "crummy" after the second shot. Outcome of the event was recovered on unspecified date. No follow-up attempts needed. No further information is expected

Other Meds:

Current Illness:

ID: 1712898
Sex: M
Age:
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: This is a spontaneous report from a non-contactable consumer or other non hcp from Pfizer sponsored program COVAX US Support. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, was suicidal from an unknown date and unknown if ongoing, Hospitalization. Patient had been hospitalized, was suicidal, was treatment and was on medication. The patient's concomitant medications were not mentioned. On an unspecified date in Mar2021, the patient experienced, seems vaccine has cured his anxiety and depression. It was reported that since getting vaccine things have changed drastically. Said was on top of the world. He feels amazing. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1712899
Sex: M
Age:
State: NY

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

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

Lab Data: Test Name: Cytomegalovirus; Test Result: Negative ; Test Name: Mono. a CBC; Test Result: Negative ; Test Name: Herpes Test; Test Result: Negative

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Blister; Mouth ulcer; This is a spontaneous report from a contactable consumer (parent), from a Pfizer Sponsored Program Pfizer Rx Pathway. An 18-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history included type one diabetes. Concomitant medications were not reported. It was reported that, reporter son, age 18 who has type one diabetes probably had a blister, mouth ulcer, severe reaction to his first dose of Your Pfizer covid 19 vaccine. He was seen by his pediatrician, and his DM physician . an immunologist and infectious disease doctor were consulted via photos. All appropriate test were done- herpes, cytomegalovirus, mono. a CBC were all negative . The time frame suggests an adverse reaction. All experts advice was mixed on whether patient should receive his second. The patient underwent lab tests and procedures which included Cytomegalovirus (cytomegalovirus test): negative on an unspecified date, Mono. a CBC (full blood count): negative on an unspecified date, Herpes Test (herpes virus test): negative on an unspecified date. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1712900
Sex: F
Age:
State: NJ

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 28-years-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EP7534) (age at the time of vaccination was 28 years and non-pregnant at the time of vaccination) via an unspecified route of administration on 16Mar2021 16:30 in right arm as dose 1, single for COVID-19 immunisation. The patient medical history included allergy to metals and had reactions to magnesium and was not sure if there was any in the vaccine. Concomitant medication was not reported. No other vaccine in four weeks. On 16Mar2021, the patient experienced she had gone to the emergency room for a migraine and she got rash on her. On 17Mar2021, the patient noticed today a big red rash that formed on her stomach. Therapeutic measures were taken as a result of she had gone to the emergency room for a migraine. The outcome of the event for big red raised rash on stomach was not recovered. The outcome of the event for migraine and she got rash on her were unknown. No follow up attempts are possible. No further information was expected.

Other Meds:

Current Illness:

ID: 1712901
Sex: F
Age:
State: TN

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Extreme fatigue; Severe chills; Heart rate up to 130 while laying down; Severe headache; Injection site sore and swollen; Injection site sore and swollen; This is a spontaneous report from a contactable consumer (patient herself). A 55-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6204), via an unspecified route of administration, administered in left arm on 16Mar2021 15:45 (age at vaccination: 55 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included ongoing High blood pressure , ongoing known allergies to bananas, ancef. Concomitant medication(s) included calcitriol; hctz; levothyroxine; lisinopril; estradiol; metformin; rosuvastatin; desvenlafaxine; colecalciferol (VIT D3); ascorbic acid (+) zinc; biotin and cyanocobalamin (B12-VITAMIIN). The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266) in the left arm on 24Feb2021 16:15 as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 17:00, the patient experienced extreme fatigue with in 30 minutes of injection, severe chills in excess of 8 hours, heart rate up to 130 while laying down, severe headache, injection site sore and swollen. The patient did not receive any treatment for the adverse events. The patient was not diagnosed with covid-19 prior to vaccination nor was tested since vaccination. The outcome of the events was recovered on an unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: CALCITRIOL; HCTZ; LEVOTHYROXINE; LISINOPRIL; ESTRADIOL; METFORMIN; ROSUVASTATIN; DESVENLAFAXINE; VIT D3; VITAMIN C + ZINC; BIOTIN; B12-VITAMIIN

Current Illness:

ID: 1712902
Sex: F
Age:
State: PA

Vax Date: 03/13/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: fever blister on top lip; Swollen arm; throwing up; Diarrhea; tired; swelling and redness, it is really itchy.; swelling and redness, it is really itchy.; She has been putting ice on the arm and as soon as she takes it off it gets warm and hot again.; This is a spontaneous report from a contactable consumer (Patient). A 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot Number: EN6208), Solution for injection, via an unspecified route of administration, administered in Arm Left on 13Mar2021 14:00 (at the age of 81-year-old) as single dose for covid-19 immunisation. Medical history included diabetes, high cholesterol, blood pressure high, breast cancer and lymph nodes removed. he patient's concomitant medications were not reported. Family medical history was reported as none. No additional vaccines were administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historic vaccine included first dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot Number: EL9266), Solution for injection, via an unspecified route of administration, administered in Arm Left on 20Feb2021 (at the age of 81-year-old) as single dose for covid-19 immunisation. On 14Mar2021, the patient experienced swollen arm, throwing up, diarrhea, on 16Mar2021, fever blister on top lip, on an unspecified date in Mar2021, tired, swelling and redness, it is really itchy, she has been putting ice on the arm and as soon as she takes it off it gets warm and hot again. The patient did not have any reactions from the first dose, but she got the second dose on Saturday 13Mar2021. Sunday afternoon, her arm was swollen, she was tired, throwing up, and had diarrhea. On Tuesday the patient had a fever blister on her top lip. Patent had been putting ice on her arm to help with the swelling and redness, it was really itchy. She was unable to put her dentures in because she was throwing up. Her stomach still feels like it was not good. She was fine as far as she can tell with the diarrhea. She had been putting Abreva on her fever blister on her top lip. She got both doses in her left arm because she had lymph nodes removed from her right arm because of breast cancer. Therapeutic measures were taken as a result of swollen arm, fever blister on top lip, swelling and redness, it is really itchy, swelling and redness, it is really itchy. Patient did not visit emergency room or physician office due to adverse events. No relevant test was performed. The outcome of event swollen arm, fever blister on top lip was not recovered and outcome of all other events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712903
Sex: M
Age:
State: TN

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

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

Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:low temperature of 96.2, and the highest it reache; Comments: He said his fever ranged from a low temperature of 96.2, and the highest it reached was 99.8

Allergies:

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

Symptoms: fever; thought his lungs were inflamed; headache; felt unwell; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (Solution for injection), dose 1 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from Jul2020. He had Covid-19 on July last year, allergic to NSAIDs. The patient's concomitant medications was not reported. The patient previously took montelukast for allergies and experienced pneumonia. He has already been taking Montelukast to treat his allergies. The patient after receiving the 1st dose of the vaccine, he had fever, felt unsettled, and thought his lungs were inflamed so he took Montelukast. He said he only took it one time and wants to know if this has affected the vaccine. Low grade fevers ranging from 99.7 to 99.8. He said his fever ranged from a low temperature of 96.2, and the highest it reached was 99.8. He said the fever comes and goes for a week now. He also said he had headache and felt unwell. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1712904
Sex: M
Age:
State: KY

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210319; Test Name: Temparature; Result Unstructured Data: Test Result:Increase in temperature by 1 degree; Comments: Small increase in temperature by 1 degree; Test Date: 20210320; Test Name: Temparature; Result Unstructured Data: Test Result:Normal; Test Date: 20210319; Test Name: Heart rate; Result Unstructured Data: Test Result:103; Comments: Heart rate went up to 103 bpm; Test Date: 20210319; Test Name: Heart rate; Result Unstructured Data: Test Result:159; Test Date: 20210319; Test Name: Heart rate; Result Unstructured Data: Test Result:103-179; Comments: For the next 8 hours bpm rates ranged from 103 to 179.; Test Date: 20210320; Test Name: Heart rate; Result Unstructured Data: Test Result:79

Allergies:

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

Symptoms: Slight swelling of throat; Heart rate went up to 103 bpm then 159 bpm. For the next 8 hours bpm rates ranged from 103 to 179; Had small increase in temperature by 1 degree; No events other than slight soreness of injection site until 24 hours after injection; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 62-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Right on 18Mar2021 12:00 (age at vaccination: 62-years-old) as single dose for covid-19 immunization. (Vaccination facility: Other). Medical history included covid-19, heart rate increased from Jul2020 to an unknown date (I did have COVID the last two weeks of July2020 and increased heart rates were very common during that time). had a 50% collapsed left lung from 2020 to an unknown date (I had a 50% collapsed left lung shortly after contributed to the COVID infection and also contributed to COPD-like lung conditions). chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient did not receive any other vaccine four weeks. It was reported that on 19Mar2021 12:00 patient experienced no events other than slight soreness of injection site until 24 hours after injection. Had small increase in temperature by 1 degree and slight swelling of throat. Main issue was heart rate went up to 103 bpm, then 159 bpm. For the next 8 hours bpm rates ranged from 103 to 179. After taking Tylenol and a nights sleep, bpm back down to 79 bpm and temperature/throat are now normal. Therapeutic measures were taken as a result of events. Patient did not tested for covid post vaccination. The patient underwent lab tests and procedures which included body temperature: increase in temperature by 1 degree on 19Mar2021, body temperature: normal on 20Mar2021, heart rate: 103 on 19Mar2021, heart rate: 159 on 19Mar2021, heart rate: 103-179 on 19Mar2021, heart rate: 79 on 20Mar2021. The outcome for the events was reported as resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1712905
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6206, Expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 09:15 as dose 2, single for COVID-19 immunisation. Medical history included hypertension (High Blood Pressure managed by medication) and known allergies to Penicillin and Sulphur Drugs. Concomitant medications included Losartan at 100mg and Hydrochlorothiazide 25mg tablets taken for hypertension. It was reported that she was not a pregnant at the time of vaccination. She did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 25Feb2021 09:45 as dose 1, single for COVID-19 immunisation. On 18Mar2021 22:30, patient experienced, on the night of the second shot she woke up with fever. On 18Mar2021, patient experienced headache, ache and chills which they say can happen. On 20Mar2021, the patient experienced, on sunday patient woke up with like a rash on her neck and part of her face and she did not like the way it looked. On 21Mar2021, the patient experienced several quarter size hives on her neck. On an unspecified date patient experienced shingles. Patient did not received treatment till she went to doctor. The outcome of the events fever, chills, headache was recovering, for the events several quarter size hives on her neck and itchy was not recovered and rash on my neck and part of my face, ache, shingles was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: LOSARTAN; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1712906
Sex: F
Age:
State: MN

Vax Date: 03/08/2021
Onset Date: 03/09/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: shingles; sores in mouth; mouth felt weird; eyelids felt heavy; felt tired; Headache; chills; fever and chills; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6199) via an unspecified route of administration, administered in Arm Left on 08Mar2021 as DOSE 2, SINGLE (at the age of 72-year-old) for covid-19 immunisation. Medical history included hypertension, blood pressure abnormal, blood potassium decreased. Concomitant medications included triamterene taken for blood pressure abnormal; potassium chloride taken for blood potassium decreased. Patient received the first dose of the Covid-19 vaccine on 15Feb2021. Lot: EM9809, NDC and Expiry not provided.On 09Mar2021, patient had the normal fever and chills, headache and all that stuff for a day or two. On 11Mar2021, patient developed sores in her mouth. The patient thought she had a canker sore. The patient went to the dentist. The dentist was able to see the sores and thought it was shingles. On an unspecified date patient had the shingles vaccine. On 10Mar2021, her mouth felt weird two days after she received the Covid-19 vaccine. Patient didn't relate this to the sores. Patient rinsed her mouth with Listerine 3-4 times day. It was sore when patient rinsed her mouth. Patient dentist appointment was previously scheduled. Patient kept rinsing with Listerine and it improved. The dentist took a picture of the sores and send it off to get another opinion. Patient added that her eyelids felt heavy and felt tired. After she got home remembered she had the vaccine and the dentist probably didn't know that she had it. The outcome of sores in mouth and mouth felt weird was resolving and other events was resolved on 10Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds: TRIAMTERENE; POTASSIUM CHLORIDE

Current Illness:

ID: 1712907
Sex: F
Age:
State: FL

Vax Date: 02/08/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210303; Test Name: creatinine; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210303; Test Name: potassium; Result Unstructured Data: Test Result:tends to run low; Test Date: 20210303; Test Name: HBA1c; Result Unstructured Data: Test Result:Boderline

Allergies:

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

Symptoms: blotchy; scratching; Not feeling very good; Really bad headache; Rashes; Blood pressure was way out, sky-high; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN5318, expiration date: 31May2021), via an unspecified route of administration, administered in upper left arm on 08Feb2021 09:50 (at the age of 80-years-old) as dose 2, single for Covid-19 immunization. The patient medical history included surgeries (Reported had Bowel obstruction that she had to go to the emergency room for from all the adhesions from all of her surgeries), polymyalgia rheumatica (Reported she has had Polymyalgia rheumatica (PMR) which she reported is a prerequisite for Rheumatoid arthritis which she has now. Probably one of the worst things that causes her the most pain), rheumatoid arthritis (Probably one of the worst things that causes her the most pain), mild glaucoma, slight hearing loss, fibromyalgia, osteopenia, high blood pressure (She has had high blood pressure since she was in her early 50s probably), allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity. Concomitant medications included bisoprolol fumarate/HCT (10mg/6.25mg) taken for hypertension and ongoing taken for many years, potassium chloride (3 daily: 30mg taken daily) taken for hypokalemia, hydroxychloroquine taken for malaria, ezetimibe taken for blood cholesterol increased, prednisone (4mg taken daily) taken for polymyalgia rheumatica, raloxifene hydrochloride (60mg) taken for osteoporosis. The patient historical vaccine included first dose of BNT162B2 (lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 18Jan2021 09:47 as dose 1, single for COVID-19 immunization. The patient historical vaccine also included flu shots taken in 1998, on an unspecified date, in Aug2020 and patient experienced fever, achy, arm was sore, little tender (She has been taking flu shots since about 1998 and events depends; the first years she took the flu shot she would get a little fever and feel achy. Sometimes her arm hurts for a day. The last flu shot she was administered in Aug2020 her arm was sore for like 1 day with, a little tender, but not incapacitating, Vaccine/Brand Names/Lots/NDCs/Expiries were unknown other than that they were flu shots that she gets at Publix grocery store pharmacy counter, does not have any of the products or further information with her). No additional vaccines were administered to the patient on same date of the pfizer suspect. The patient did not receive any prior vaccinations within 4 weeks. It was reported that, this consumer is the patient who was administered her first dose of Pfizer-BioNTech COVID-19 Vaccine 18Jan2021 and second dose of Pfizer-BioNTech COVID-19 Vaccine 08Feb2021. Approximately 01Mar2021 or 02Mar2021 she went in for her checkup with her Nurse Practitioner because she was was not feeling very good, had really bad headache. During that checkup they told her that her blood pressure was way out, sky-high. Since about 01Mar2021 she has had rashes which have worsened. She asked if these events are reactions to the second dose of the Pfizer-BioNTech COVID-19 Vaccine. She gained 10lbs in this COVID year. Blood pressure was way out, sky-high: Onset date approximately 01Mar2021 or 02Mar2021. She has had high blood pressure since she was in her early 50s probably, but her blood pressure has been under control with medication Bisoprolol fumarate/HCT until after the second dose of Pfizer-BioNTech COVID-19 Vaccine. The provider adjusted her blood pressure medication which seemed to control the blood pressure. Outcome of this event is unknown, she has not taken blood pressure again but she has a really bad headache so she knows her blood pressure is going to be high. She will have to go to the emergency room to bring her blood pressure down because she does not know how to bring her blood pressure down herself; she has never had this problem before because her high blood pressure has always been under control before this event. Described as slight rashes, that were very light starting approximately 01Mar2021 on her hands. She did not think anything of it at that time, thought maybe it was from washing dishes or something, but did not initially associate rashes with the Pfizer-BioNTech COVID-19 Vaccine. The rashes then left her hands and went to her wrists and lower arms. The rashes sort of died down but now, 5 weeks out from the second dose of Pfizer-BioNTech COVID-19 Vaccine, have gotten really bad; up her arms and what caller initially reported as all over her neck almost to her shoulders. She later clarified that the rashes are all the way up to her neck and looks like a collar around the bottom of her neck, like a big red blotchy itchy stuff; got really bad last night and she was scratching and scratching. When she got up and looked in the mirror it looked like someone took a blow torch and put a collar around her neck about 5 inches wide just below her neck. Patient reported that she had some lab work done on 03Mar2021: A1C because the rheumatologist said her sugar counts were too high so they ran an A1C for her sugar which is borderline; they also did a BMP w/GFR which she does not know what is, but it's a list with all the labs like creatinine, potassium-her potassium tends to run low, that is why she was started on Potassium chloride to make up for diuretic draining the potassium out; she also had another blood test but did not get a copy of that. The only product she was able to provide at time of the call was Prolia. She took Prolia for 2 years as 1 injection every 6 months. Prolia was stopped in 2018 because she is one of the rare people that Prolia inhibited the circulation of blood in the upper jaw of so she had to stop taking that. She found this out because she went in to have an implant put in and discovered she did not have enough circulation to perform the implant. She had to stop Prolia and wait almost a year before she could proceed with the bone graft for the implant. She did not keep track of all the medications she is allergic to and has no further information to provide at the time of the call. She reported that there is a lot wrong with her, a lot of surgeries and emergency room visits, hospitalizations. She is on a lot of medications but declined to provide further information on other medical conditions, concomitant products and medical history at this time. If someone wants her to fax that information to them she can fax her whole medical record and the sheet that she has it all listed on, all the medications, ailments, major surgeries and times she was in the hospital, the last time was last year in 2020. The patient underwent lab tests and procedures which included (HBA1c) glycosylated haemoglobin: borderline on 03Mar2021, creatinine (blood creatinine): unknown result on 03Mar2021, potassium (blood potassium decreased): tends to run low on 03Mar2021. The adverse events not feeling very good; really bad headache; blood pressure was way out, sky-high resulted in physician office. The patient was not hospitalized. The outcome of the event rashes was not recovered and outcome was unknown for other events. No follow-up attempts are needed. No further information is expected.

Other Meds: BISOPROLOL; POTASSIUM CHLORIDE; HYDROXYCHLOROQUINE; EZETIMIBE; PREDNISONE; RALOXIFENE HYDROCHLORIDE

Current Illness:

ID: 1712908
Sex: U
Age:
State: MA

Vax Date: 03/15/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: severe diarrhea; low-grade fever; abdominal pain; headache; chills; fatigue; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 15Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient received first dose of the Pfizer covid vaccine. The patient's medical history and concomitant medications were not reported. Patient received second dose of the Pfizer covid vaccine on March 15 and experienced chills and fatigue within five hours of receiving the dose. Within 24 hours experienced severe diarrhea low-grade fever abdominal pain and chills and headache. The patient continued to feel the side effects for days after the second dose administration. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be requested.

Other Meds:

Current Illness:

ID: 1712909
Sex: F
Age:
State: OH

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: itching had gotten a little worse/ boil looked like it had worsened; had itching on her face, head, and everything; felt like a dog with the worse case of fleas ever; had a boil on her back; her skin redness had spread out; itching really bad; This is a spontaneous report from a Contactable consumer. This 67-year-old female consumer reported for herself. A 67-year-old Caucasian female patient received first dose of BNT162B2 (Pfizer COVID-19 vaccine, formulation: solution for injection, lot number: EN6199) via unknown route of administration in left arm on 03Mar2021 at 6:40 PM (at the age of 68 years old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was none. On 03Mar2021, a half an hour after getting the COVID-19 Vaccine, she started itching really bad, she said she had kept itching since then, saying the itching had lasted for 2 weeks. On 15Mar2021, she now had a boil on her back, her skin redness had spread out. Reported she had a lot of medical conditions but doesn't know if any of them were relevant to her itching and boil. She clarified she had a heart problem that she was taking Metoprolol for. She said her doctor had increased her Metoprolol once, and she started itching. She said she went off the Metoprolol completely, and she stopped itching. She said she went back on the Metoprolol and itched some. She said when she got her first COVID-19 Vaccine shot, it was like the COVID-19 Vaccine enhanced the itching she was already experiencing from the Metoprolol. She stated she takes Metoprolol 50mg tablets that are dispensed in a pharmacy bottle. She said there was no NDC, Lot, and Expiration Date listed. She clarified she started itching for the first time in May2020 while taking Metoprolol. She said when she told her doctor the Metoprolol was causing her to itch, her doctor told her she had been taking the Metoprolol for 5 years, and she had been taking the Metoprolol for too long to have the Metoprolol to cause itching. She clarified in May2020 the itching started on the inside of both her legs and was a constant itching. She said the itching on her legs was so bad, she had bruising on her legs from the itching. She said she was given no treatment at that time for the itching she thought was caused by the Metoprolol 50mg tablets. Reported the itching she had after getting her first COVID-19 Vaccine was all over. She said she felt like a dog with the worse case of fleas ever. She said she had itching on her face, head, and everything. It was reported that her itching had gotten a little worse since it had first started over 2 weeks ago and the boil looked like it had worsened, clarifying her skin redness had spread out. She said her doctor had given her a cream (clarified as Mupirocin 2% Ointment) to put on the boil and her doctor gave her 3 medications to take, including an antibiotic, and a medication to calm her itching down. It was reported that for her boil her doctor prescribed Cephalexin 500mg (light green) capsules. She said she took her first Cephalexin 500mg dose last night on 18Mar2021. She said she had to take 1 Cephalexin 500mg capsule every 12 hours for 7 days. She stated 14 Cephalexin 500mg capsules were dispensed in a pharmacy bottle, and had no NDC, Lot, and Expiration Date listed, for her itching her doctor prescribed Hydroxyzine 25mg tablets. She said she was to cut the Hydroxyzine 25mg tablet in half (12.5mg dose) and took a half tablet (12.5mg dose) every 8 hours, as needed. She stated that started the Hydroxyzine last night on 18Mar2021. She said the Hydroxyzine was dispensed in a pharmacy bottle, and had no NDC, Lot, and Expiration Date listed. Reported for her boil her doctor prescribed Mupirocin 2% Ointment. She said she was to apply the Mupirocin 2% Ointment (NDC Number: 0093-1010-42, Lot Number: 686100, Expiration date: Apr2022) to her boil three times a day. She said she started the Mupirocin 2% Ointment last night on 18Mar2021. No history of all previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines Administered on Same Date of the Pfizer vaccine. The patient went to physician office and did not go to emergency room. Patient did not receive prior vaccinations within 4 weeks. The outcome of the events she started itching really bad, she now had a boil on her back, her skin redness had spread out were not recovered and other events were unknown. No follow-up attempts were possible. No further information was expected.

Other Meds:

Current Illness:

ID: 1712910
Sex: F
Age:
State: PA

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: arm hurt; back of shoulder hurt; chest tightness/Chest was like a little tight; Voice was Rusty/had a hoarse voice; lethargic; Wheezing; sweats; body aches; fatigued; allergies; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EN6207), dose 1 via an unspecified route of administration, administered in Left arm on 19Mar2021 at 01:00 (58-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included hbp (high blood pressure) from an unknown date and ongoing and thyroid disorder from an unknown date and unknown if ongoing. The patient had allergies. Concomitant medications included Levothyroxine sodium (LEVOXYL), Pregabalin (LYRICA), Salbutamol Sulfate (INHALERIN); all for unknown indications from unknown dates and unknown if ongoing. On 19MAR2021, the patient was very lethargic. On 20MAR2021, the patient experienced her arm and back of shoulder hurt, chest tightness/Chest was like a little tight and Voice was Rusty/had a hoarse voice. On an unspecified date in 2021, the patient experienced sweats, body aches, fatigued, allergies and wheezing. The patient got the vaccine on Friday, and did not have any symptoms in the morning but then the next day her arm and back of shoulder hurt, also with her chest she had tightness, the patient also had a hoarse voice and was fatigued. The patient was concerned with chest tightness and the hoarseness, wanting to know if that was a normal side effect and if she is okay to get the second dose. Because of the patient's allergies, is the second dose going to be worse. Last night the patient had sweats and body aches, she does not know if that was normal. The patient stated that all her symptoms at the moment are getting better, but she is still just tired. The patient wanted to know if her main concern if she will be okay to get the second shot, since she had the chest tightness, wheezing, and hoarse voice. The outcome of the events were un-known. No follow-up attempts are needed. No further information is expected.

Other Meds: LEVOXYL; LYRICA; INHALERIN

Current Illness: Blood pressure high (Verbatim: Blood pressure high)

ID: 1712911
Sex: F
Age:
State: FL

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: dizziness; diarrhea; tingling sensation; knee joints electric shock feeling; hives; This is a spontaneous report from a contactable female consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizziness, diarrhea, tingling sensation, knee joints electric shock feeling and hives. Patient took anti-allergy medication and tylenol the second night after her first dose. The clinical outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1712912
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 03/19/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: I slept all day; allergic reaction; I have huge red circle on the injection site, it's warm, red and lumpy; I have huge red circle on the injection site, it's warm, red and lumpy; I have huge red circle on the injection site, it's warm, red and lumpy; This is a spontaneous report from a contactable consumer. This 53-year-old female consumer reported. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN5318), dose 2 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had second vaccine on Friday, and on 19Mar2021, had huge red circle on the injection site, it's warm, red and lumpy. She slept all day yesterday, had a fever, just like pure exhaustion, and still not feeling great today, headache, nauseas on Friday a little bit. The Pharmacist was that she was having an allergic reaction. The patient recevie treatment with Tylenol. Outcome of the event hypersomnia was unknown and rest all event was not recovered, at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712913
Sex: F
Age:
State: NJ

Vax Date: 03/20/2021
Onset Date: 03/22/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210323; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210323; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Pending

Allergies:

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

Symptoms: Strep throat; Swollen tonsils; Extreme pain; This is a spontaneous report from a contactable other healthcare professional, the patient. A 32-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown, Expiry date: unknown, at the age of 32-year-old), via an unspecified route of administration, administered in left arm on 20Mar2021 15:30 as dose 1, single for covid-19 immunisation. Medical history included fibroids. The patient was allergic to latex. It was unknown if the patient was pregnant. Concomitant medications included montelukast sodium (SINGULAIR), amlodipine, sertraline, aripiprazole (ABILIFY). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 22Mar2021 08:00, the patient experienced strep throat, swollen tonsils, extreme pain. The patient received amoxicillin as a therapeutic measure for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent nasal swab test twice on 23Mar2021 and the results were negative and pending. The outcome of events was not recovered. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.

Other Meds: SINGULAIR; AMLODIPINE; SERTRALINE; ABILIFY

Current Illness:

ID: 1712914
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: allergic reaction; tongue felt weird; Tongue swelling; nausea; accelerated heart rate that night and pain when rolling onto left side; accelerated heart rate that night and pain when rolling onto left side; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 23-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6200), via an unspecified route of administration (at the age of 23-years), administered in arm left on 03Mar2021 at 17:39 as dose 1, single for COVID-19 immunization. Medical history included migraine and reported that when she was about 11 she started having these, concussion and stated that she had 8 previous concussions. Her first was around 2013 or 2014, and the last one she had was in 2016, asthma from an unknown date and unknown if ongoing. It was further stated that she had 8 previous concussions and it would be bad if she got sick. A couple of patients of her doctor resembled getting sick with post-concussion syndrome which she has had a few times. She does not have any additional information regarding this. Concomitant medications included marijuana (MEDICAL MARIJUANA), she started taking probably about 2 years ago for migraine and neurological issues and taken as half an ounce every 2 weeks is the amount the dispensary follows her for start and stop date were not reported. The vaccination facility type and contact, which she drove through which was kind of cool. She was not sure if it was a special facility. She thinks that it was their airport. On an unspecified date, the patient experienced allergic reaction. On 03Mar2021, experienced tongue felt weird, tongue swelling, nausea, accelerated heart rate that night and pain when rolling onto left side. The adverse event does not resulted in emergency room and physician office visit. She received the Pfizer shot 2 weeks ago and today she was going for her second one. Her parents are family doctors and they want her to call because she had a small allergic reaction to the first vaccine. She stated that her parents read somewhere about if somebody has tongue swelling, the second vaccine will be worse. Her parents were reading behind the idea of possibly it being recommended to get the Johnson and Johnson vaccine instead of the Pfizer vaccine if somebody has a reaction to the first vaccine. She has a pretty good connection with her care provider and she feels like it is okay. She was calling because she wants to report her symptoms and to make her parents feel more comfortable. She gets to the facility for her second vaccine, she will tell them that she had a small reaction to the first dose. She adds that she goes through the drive through one. Allergic reaction these were not normal reactions so her family believes they were allergic reactions. Around 3 minutes after she got her shot, her tongue felt weird. Tongue felt weird her tongue felt heavy and bigger in the back. She got up to get somebody but by the time she went to get someone the tongue feeling went away. Caller later clarifies this was on 03Mar2021 and completely recovered on 03Mar2021. About 40 minutes after the shot she felt nauseous for about an hour or so and also reports that during that same night, she also had 4 different times with really accelerated heart rate that was painful when rolling onto her left, she stated that she has never felt anything like that before. It would be there for a minute or two and then it would go away. She stated that these were not too bad. She has chronic illness so this what not too bad. Tongue swelling came and went within a minute. She has been to the emergency room before for migraines and they give her a lot of different IVs and she had this same feeling, but she can't really explain it. No further details provided about the different IVs. Nausea Lasted around an hour and a half. Accelerated Heart Rate only lasted about a minute or two starting 03Mar2021 and maybe into the morning 04Mar2021, it happened about 4 times total. Suspect Product Indication caller adds that the list for people who can get the vaccine now say people with neurological conditions not limited to Alzheimer's and dementia, and so the caller got the vaccine because of her chronic neurological migraines, and adds she also has asthma. The clinical outcome of the event allergic reaction was reported as unknown while for events tongue felt weird, tongue swelling, nausea was reported as recovered on 03Mar2021 and for the event accelerated heart rate that night and pain when rolling onto left side was reported as recovered on 04Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds: MARIJUANA

Current Illness:

ID: 1712915
Sex: F
Age:
State: TX

Vax Date: 03/18/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: rash; shingles; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 18Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced rash and shingles. It was reported that, slight rash turned into shingles. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1712916
Sex: F
Age:
State: OH

Vax Date: 02/15/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Name: whole blood work; Result Unstructured Data: Test Result:Unknown results; Test Name: white count; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Vomiting

Symptoms: 1st and 2nd dose- swollen glands; 1st and 2nd dose- injection site pain in right arm; sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200) via an unspecified route of administration in right arm on 15Feb2021 (at the age of 61 years old) as single for covid-19 immunisation. Medical history included 2 time breast cancer survivor, she had it twice but her last diagnosis was 10 years ago, lymph nodes removed, she had two removed she thinks and it was on the same side as the shingles, low thyroid. Concomitant medications included famotidine (PEPCIDAC), two at night and two in the morning every other day, alternating with Nexium; levothyroxine sodium (SYNTHROID), 25 mg orally once daily, she started it about 5 or 6 months ago for low thyroid; vitamin d [vitamin d nos] (VITAMIN D [COLECALCIFEROL]), 2000 IU capsule once daily by mouth; esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), two 40 mg tablets, once every other day, alternating with Pepcidac ; ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+), 1 tablet daily by mouth ; acetylsalicylic acid (BABY ASPIRIN), once daily by mouth, she doesn't know, may be 60 mg. She doesn't have it in front of her. Patient previously took shingles vaccine on an unknown date (reported as number of years ago) for immunization, flu shots on an unknown date for immunization. The patient did not receive any other vaccines within 4 weeks. The patient did have history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive additional vaccines on same date of the Pfizer suspect. She was calling about the COVID vaccine to report an adverse side effect. She stated having what was considered typical, like a sore arm and did have some swollen glands with the first and second dose. The swollen glands started within 24 hours, as well as, the sore arm. It wasn't anything she didn't expect. Like with the flu shot maybe a little worse, but it wasn't severe. After the first dose of the Swollen glands came back when the shingles first happened, but they initially began within 24 to 48 hours, for both doses. After the first dose of the vaccine, she took two extra strength Tylenol that night and by the time she woke up the next morning it was gone. After the second dose she took two extra strength Tylenol again on the first night again; she just took it once after the 2nd dose. No further information provided. Pain in the hand is 98 to 95 percent better. The patient experienced injection site pain in right arm after 1st and 2nd dose. Investigations included her doctor did whole blood work up just to see her white count to rule out something else. No further information provided. The patient did not visit emergency room. The outcome of events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected. Follow-Up (15Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds: PEPCIDAC; SYNTHROID; VITAMIN D [COLECALCIFEROL]; NEXIUM [ESOMEPRAZOLE SODIUM]; CENTRUM SILVER WOMEN 50+; BABY ASPIRIN

Current Illness:

ID: 1712917
Sex: F
Age:
State: MO

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:shows communicated bursitis; Test Date: 20201231; Test Name: Nasal swab; Result Unstructured Data: Test Result:negative; Test Date: 20201231; Test Name: X-Rays; Result Unstructured Data: Test Result:N/A

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: This is a spontaneous report from a contactable other healthcare professional. A 69 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 30Dec2020 09:45 (Batch/Lot Number: EL3246) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient previously took levoquin. She is known allergic to levoquin. The patient experienced arm, neck, shoulder pain causing pain in extremity on 30Dec2020 09:45 with outcome of not recovered, she was given the covid vaccine in her upper bursa, nausea, muscle spasms, on 30Dec2020 09:45 with outcome of not recovered, can't sleep causing insomnia on 30Dec2020 09:45 with outcome of not recovered , headaches and bursitis on 30Dec2020 09:45 with outcome of not recovered. The patient underwent lab tests and procedures which included magnetic resonance imaging which showed communicated bursitis, sars-cov-2 test: negative on 31Dec2020, x-ray n/a on 31Dec2020..Therapeutic measures were taken as a result of this. No follow-up attempts are needed. No further information is expected.

Other Meds: Levothyroxine Sodium

Current Illness:

ID: 1712918
Sex: M
Age:
State: TN

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: blood work; Result Unstructured Data: Test Result:Unknown

Allergies:

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

Symptoms: nasau; diarrhea; Soreness then pain in the left arm; Later during the night, severe chills; Later sweats; This is a spontaneous report from a contactable consumer (patient) reported himself. A 61-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot Number: ER8727), via an unknown route of administration in left arm on 23Mar2021 at 16:00 (at the age of 61-years-old) as single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient's medical history included allergies, high cholesterol, acid reflux, prostate cancer and COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. Yes, other medications in two weeks. Other vaccine same date was none. On 23Mar2021 at 22:00, the patient experienced soreness then pain in the left arm. Later during the night, severe chills and Later sweats. Next day, same thing with nausea and diarrhoea. Event resulted to visit emergency room/department or urgent care. No COVID tested post vaccination. Received fluids, medicine for nausea and pain as treatment and blood work was unknown. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1712919
Sex: F
Age:
State: CA

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Mild itching near the injection sight and all over body.; Mild itching near the injection sight and all over body.; This is a spontaneous report from a contactable other HCP. This 23-year-old other HCP (Patient) reported for herself that: A 23-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER3782), via an unspecified route of administration, administered in Arm Left on 26Mar2021 (at the age of 23-year-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. The patient's concomitant medications were not reported. Patient was not received any other vaccine four weeks prior vaccination. The patient experienced mild itching near the injection sight and all over body on 26Mar2021. Since vaccination patient not tested for covid-19. The case assessed as non-serious by the reporter. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as unknown. No follow up attempts are possible. Information related to batch/lot number could not be requested.

Other Meds:

Current Illness:

ID: 1712920
Sex: F
Age:
State: IL

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Swelling of throat, neck pain, headache, shortness of breath; Swelling of throat, neck pain, headache, shortness of breath; Swelling of throat, neck pain, headache, shortness of breath; Swelling of throat, neck pain, headache, shortness of breath; This is a spontaneous report from a contactable Consumer or other non-HCP (Patient). A 61-year-old Adult female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 12:00 PM (at the age of 61-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included Crohn's Disease and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included Vedolizumab (ENTYVIO); Colestipol; Losartan; Ergocalciferol (VIT D); Cyanocobalamin (VIT B12), all taken for an unspecified indication, start and stop date were not reported. The patient previously took penicilline and experienced allergy. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Arm Left on 03Mar2021 (at the age of 61-year-old), as single for covid-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 12:15 PM, the patient experienced Swelling of throat, neck pain, headache and shortness of breath. The adverse event resulted to Emergency room/department or urgent care. The patient received treatment with Benedryl and Zytec to treat the events. The case was reported as non-Serious. The events did not Result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. The patient outcome of the events was Resolved on an unspecified date in Mar2021. No follow-up attempts are needed. No further information is expected.

Other Meds: ENTYVIO; COLESTIPOL; LOSARTAN; VIT D; VIT B12

Current Illness:

ID: 1712921
Sex: F
Age:
State: TX

Vax Date: 03/26/2021
Onset Date: 03/27/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: App. 1 hour ago I broke out in itchy; fat hives on my neck; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old female patient received bnt162b2 (BNT162B2) solution for injection, dose 1 (Lot Number: EN6207 expiry date was unknown) via an unspecified route of administration at arm right on 26Mar2021 10:00 (at the age of 67-years-old) as a single dose for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing, depression, hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included hydrochlorothiazide, levothyroxine, fluoxetine taken for an unspecified indication, start and stop date were not reported. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. Patient was not in pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. List of any other medications the patient received within 2 weeks of vaccination: Fluoxetine, hydrochlorothiazide, levothyroxine. Allergies to medications, food, or other products: cipro. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 12:00 the patient experienced app. 1 hour ago she broke out in itchy, fat hives on his neck. Outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: HYDROCHLOROTHIAZIDE; LEVOTHYROXINE; FLUOXETINE

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am