VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
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: 1734156
Sex: F
Age:
State: TN

Vax Date: 09/10/2021
Onset Date: 09/11/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data: Test Date: 20210911; Test Name: Heart rate; Result Unstructured Data: Test Result:148bpm; Comments: heart rate was at 148bpm; Test Date: 20210911; Test Name: Heart rate; Result Unstructured Data: Test Result:Resting heartbeat never dropped below the 120s bpm

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: My vision was going black and I passed out; I had severe ringing in my ears/ Throughout the rest of the day my ears were ringing; Light headed /Dizzy; My heart rate was at 148bpm/ my resting heart beat never dropped below the 120s bpm.; Nausea; Bad headache; This is a spontaneous report from a contactable other health care professional (patient). A 24-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 10Sep2021 17:00 (at the age pf 24-year-old) (Lot Number: Fc3183) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included latex allergy. Concomitant medication included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 11Sep2021 10:30, the patient woke up and got up to brush her teeth and shower and had severe ringing in her ears, was light headed, dizzy, vision was going black and passed out. The patient's heart rate was at 148bpm when she regained consciousness. Throughout the rest of the day her ears were ringing, had a bad headache, nausea, and reported that her resting heart beat never dropped below the 120s bpm. The patient did not receive any treatment for the events. The outcome of the events was recovering.; Sender's Comments: Based on the reported information ,a causal relationship between the event loss of consciousness and suspected drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds: TOPAMAX

Current Illness:

ID: 1734157
Sex: F
Age:
State: OH

Vax Date: 09/03/2021
Onset Date: 09/03/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: With in 30 minutes of receiving my 1st does of the vaccine my mouth started burning like it was on fire and turned white; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FC3183), via an unspecified route of administration, administered in Arm Right on 03Sep2021 16:30 at the age of 57-year-old as dose 1, single for covid-19 immunisation from pharmacy or drug store. Medical history included Sjogren's syndrome, Raynaud's, Chilblains, chronic venous insufficiency, osteoarthritis and allergies to many antibiotics, tetanus shot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. Concomitant medication included vitamin b complex (VITAMIN B COMPLEX) and clonazepam (CLONAZEPAM) taken for an unspecified indication, start and stop date were not reported. The patient previously took antibiotics and experienced drug hypersensitivity, tetanus toxoid for immunisation and experienced allergy to vaccine. On 03Sep2021 17:00 (within 30 minutes of receiving first does of the vaccine) patient experienced mouth started burning like it was on fire and turned white which ae resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The burning sensation has not stopped. Patient take a numbing mouthwash for the event that really doesnt help much. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: VITAMIN B COMPLEX; CLONAZEPAM

Current Illness:

ID: 1734159
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/25/2021
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: left eye problem/if I close my right eye and I look with my left eye I am seeing kind of like a black cloudy spot I never know before; severe pain in my organs: my stomach, ovaries, and chest/feeling a little bit of pain in her stomach area; severe pain in my organs: my stomach, ovaries, and chest; severe pain in my organs: my stomach, ovaries, and chest; numb arm; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included ongoing eye disorder left eye problem. The patient concomitant medications were not reported. Caller states she took her first dose of the Comirnaty Vaccine and experienced "severe pain in his organs: his stomach, ovaries, and chest. Caller states these pains lasted 2 days and subsided by day three without intervention. Caller states she still feels some pain in her stomach area. Caller also states she had a previous "left eye problem" that seemed worse after receiving the vaccine. Caller states she spoke with her doctor about her symptoms and her doctor told her these were all normal side effects and were not related to the Comirnaty Vaccine. Caller asking for explanations of the functions of the ingredients in the vaccine, whether or not any of them can cause cancer, and if graphene oxide is in the vaccine. Caller asking if she can take anything such as an antioxidant and vitamin A to treat/prevent any side effects from Comirnaty. Informed caller that Pfizer Medical Information does not have any information to suggest carcinogenic effects from any component in the Comirnaty Vaccine. Referred to HCP. Later upon Follow-up The caller states well she asks about ingredients in the vaccine. She states that she received her first vaccine at an unspecified date and experienced severe pain in her organs specifically her stomach, ovaries and chest for two days. She stated that these also resided after the third day. She was concerned about carcinogenic side effects (further not clarified) from the vaccine. So, she contacted her doctor and they stated that she was experience normal side effects and they told her that what she was experiencing was not from the vaccine. She called asking what treatment she could use to deal with her side effects, and they told her we don't provide treatment recommendations and referred her back to her doctor. She also stated that she experienced a problem with her left eye. She stated she already had issues with her left eye. She did not specify what those were, but she said they seems to be worse first couple of days and she says she is still feeling a little bit of pain in her stomach area. Consumer stated, she just has some questions about the Pfizer Vaccine and to see there is anything she can take just to prevent any further questions or the problem. So, she had told him took a vaccine and the pain that she was feeling which she think could be one of the side effects, like 'numb arm' but the side effects were supposed to be like scar, pains in that hand, pains in the jaw and fever and all that, she never had all those things, she doesn't have all these things. she only had the pain in his chest, stomach, other basically inside his system and in last shot was for like two days and it went away, it was okay. Ok, so she took the second vaccine, and she had no pain, no nothing so calling to find out if there is anything she can take, she had problems with sight she discovered them, left eye already had a problem with that she was born naturally with left eye issue (further not clarified). So, she discovered that if she close right eye and she look with left eye she is seeing kind of like a black cloudy spot never know before. She was asking the vaccine she take, may be a medication any antioxidant to prevent, any product or Vitamin A or if there is anything she take after taking the vaccine. Consumer stated, she thinks the best to see his doctor. she only called to find out the content and everything that has to do with the Pfizer vaccine. she doesn't want to extend or to exaggerate also expand the whole problem. she just thought supposed to call and something and then get an answer to whatever she needs which is I am just going to call his doctor his primary doctor and follow up from there and so it's not really an issue. When requested to probe further: Consumer stated, "No, No, No. like she said she don't want to expatiate or elaborate or make you go wider all she just wanted was to call and find out what the content is and to find out if there is anything she can take after the medication. So, she going to approach my doctor and talk to his primary doctor. Consumer was unwilling to complete the report. Further probing could not be done. Hence, limited information available over the call. The outcome of event left eye problem/if i close my right eye and i look with my left eye i am seeing kind of like a black cloudy spot i never know before, and numb arm was unknown, outcome of event severe pain in my organs: my stomach, ovaries, and chest/feeling a little bit of pain in her stomach area was not recovered and outcome of events severe pain in my organs: my stomach, ovaries, and chest (adnexa uteri pain and chest pain) was recovered on unknown date. The lot number for BNT162B2 was not provided and will be request during follow-up.

Other Meds:

Current Illness: Eye disorder

ID: 1734160
Sex: M
Age:
State: OH

Vax Date: 08/03/2021
Onset Date: 08/01/2021
Rec V Date: 09/25/2021
Hospital: Y

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

Lab Data: Test Date: 202108; Test Name: COVID 19; Result Unstructured Data: Test Result:Positive; Comments: Dates for Diagnosed with COVID 19: (From: Aug2021 to: Unknown)

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Diagnosed with Covid 19; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA7435 or FA7485) via an unspecified route of administration, in right arm on 03Aug2021 (at the age of 52-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included diabetes mellitus from an unknown date and unknown if ongoing. Reporter states he had been diabetic for years and years. The patient concomitant medication was not reported. Patient had not received any additional vaccines same date of the pfizer suspect. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Aug2021, the patient had been diagnosed with covid-19 a week after first dose of Pfizer COVID Vaccine. Event was considered as serious (hospitalization) by the reporter. The patient was hospitalized for diagnosed with covid-19 for 4 days. Reporter stated that the event resulted in emergency room visit and physician office visit. The patient underwent lab tests and procedures which included a result of sars-cov-2 test positive on an unspecified date in Aug2021. It was reported that he had testing done while he was hospitalized with COVID. The outcome of the event was recovered on an unspecified date in 2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness: Diabetic (Verbatim: Diabetic Patient History: Yes Patient history: Diabetic (From: Unknown to: Ongoing))

ID: 1734161
Sex: F
Age:
State: TN

Vax Date: 03/05/2021
Onset Date: 09/12/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data: Test Date: 20210913; Test Name: ; Test Result: Positive ; Comments: Nasal Swab

Allergies:

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

Symptoms: Testing positive for covid-19; Testing positive for covid-19; Pregnant; This is a spontaneous report from a contactable consumer (Patient). This consumer reported information for both mother and fetus/baby. This is a maternal report. A 32-years-old pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection; Lot Number: EP6955) dose 2 via intramuscular route of administration, administered in Arm Left on 26Mar2021 12:00 as dose 2, single and first dose of bnt162b2 (BNT162B2, solution for injection; Lot Number: EL3248) dose 1 via intramuscular route of administration, administered in Arm Left on 05Mar2021 13:00 as dose 1, single (At the age of 31-year) for covid-19 immunization. Medical history was not reported. Concomitant medication(s) included ascorbic acid, biotin, calcium carbonate, calcium pantothenate, chromium nicotinate, colecalciferol, cupric oxide, cyanocobalamin, ferrous fumarate, folic acid, magnesium hydroxide, manganese gluconate, nicotinamide, Phyto menadione, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, selenomethionine, sodium molybdate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTIVITAMIN FOR WOMEN) taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 12Sep2021 07:00 the patient experienced testing positive for covid-19 on sept 13, 2021, and pregnant. The mother reported she became pregnant while taking bnt162b2. The mother was 28 Weeks pregnant at the onset of the event. The mother was due to deliver. On 13Sep2021 the patient underwent lab tests and procedures which included sars-cov-2 test result was positive, Nasal Swab. The outcome of the event testing positive for covid-19 was recovering for and it was unknown for the rest.

Other Meds: MULTIVITAMIN FOR WOMEN

Current Illness:

ID: 1734162
Sex: F
Age:
State: MA

Vax Date: 08/18/2021
Onset Date: 08/01/2021
Rec V Date: 09/25/2021
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: headache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 49-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered at Public Health Clinic/Military facility, via an unspecified route in left arm on 18Aug2021 14:45 (Batch/Lot Number: EW0164) as single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient didn't receive any other vaccine in the 4 weeks prior to vaccination. She was not diagnosed with COVID-19 before vaccination and was not tested for COVID-19 post vaccination. The patient reported that, after the first vaccine dose, in Aug2021, she experienced a terrible headache for 3 days. The event outcome was unknown at the time of the report. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101198197 Same reporter/vaccine, different dose/event

Other Meds:

Current Illness:

ID: 1734163
Sex: F
Age:
State: IN

Vax Date: 09/11/2021
Onset Date: 09/12/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Passed out; Her lips were white; Slept all day and night; Fatigue; This is a spontaneous report from a contactable consumer (patient's mother) A 15-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 11Sep2021 at 14:00 (Lot Number: 301358A), at the age of 15 years old, as 2nd single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. There were no prior vaccinations within 4 weeks of the BNT162b2 vaccination. Past drug vaccinations included the 1st BNT162b2 single dose (Lot: FA6780) administered on 22Jul2021 at about 10 am, in the left arm. The patient's mother stated that at 11am on 12Sep2021 her daughter woke up and came downstairs, then she saw stars and passed out. This lasted about a minute and then she came too, her lips were white when this happened. She was a lot better at the time of the reporting but after the passing out she slept all day and night. The reporter tried to wake her up to check on her but she kept sleeping. The patient also had fatigue on 12Sep2021 that at the time of the reporting was not all the way gone but the patient was better. The patient was treated with rest and liquids. The patient recovered from passing out and sleeping all day on 12Sep2021. The patient was recovering from fatigue. The outcome for pale lips was not specified. There was no need for a visit to Emergency Room, neither at the physician's office. According to the reporter the events were considered non-serious. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1734164
Sex: F
Age:
State: MA

Vax Date: 09/08/2021
Onset Date: 09/09/2021
Rec V Date: 09/25/2021
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: passed out / unconscious; convulsions; tired; chills; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 49-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered at Health Clinic, via an unspecified route in left arm on 08Sep2021 14:00 (Batch/Lot Number: EW0164) as single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm on 18Aug2021 14:45 (Batch/Lot Number: EW0164) as single dose for COVID-19 immunization, after which the patient experienced a terrible headache for 3 days. The patient didn't receive any other vaccine in the 4 weeks prior to vaccination. She was not diagnosed with COVID-19 before vaccination and was not tested for COVID-19 post vaccination. The patient reported that she was fine on the day of the second shot, but she woke up the following day very tired and with chills. After eating breakfast, she was overcome by nausea and dizziness and she passed out. She had convulsions while unconscious, so her husband called paramedics. All the events were reported to have occurred on 09Sep2021 at 09:00 and required Emergency room/department or urgent care. The events resolved on an unknown date after receiving treatment with ondansetron (ZOFRAN) for nausea, observation and unspecified tests. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1734165
Sex: F
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 09/25/2021
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: Pains in my heart/ sharp pain like in your lung like a growing pain/piercing pain; Headache; Arms numb in and off first couple days; one hive on my face; This is a spontaneous report from a non-contactable consumer (patient herself). A female patient of unknown age received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unspecified route, on unknown date at single dose for COVID-19 immunization. No relevant medical history and concomitant medications were provided. The patient stated that when she went to get her first dose of BNT162B2 the pharmacist pinched her arm when inserting the needle, caller seeking information if is this the correct way to administer. The patient also reported that she sat for 15 minutes in the pharmacy after and then when she left she sat in her car for 10 minutes more and felt sharp pain like in your lung like a growing pain, but that it was low in her uterus, piercing pain happened several times over that day. Also at that time she experienced headache that lasted just a few seconds. Other side effects reported were: arms numb in and off first couple days, pains in my heart, felt similar as when I may have had COVID mildly before, period felt like it was going to start but it never did. These all went away. Then on day 6 and 7 really bad headache 2 and a half hours headaches. Caller also reports one hive on my face last one day and went away. She is scheduled to get her second shot in about 4 days. The patient had recovered from the events on unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1734166
Sex: F
Age:
State: FL

Vax Date: 08/21/2021
Onset Date: 08/23/2021
Rec V Date: 09/25/2021
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: Broke out into a rash; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 21Aug2021 between 10:00-11:00 AM (Lot Number: FC3180), at the age of 45 years old, as 1st single dose for COVID-19 immunisation. Medical history included allergy to many medications (unspecified). There were no concomitant medications. There were no prior vaccinations within 4 weeks from the 1st administration of BNT162b2. The patient reported that on 23Aug2021 she broke out into a rash. The patient was not sure if she was allergic to any of the ingredients in the vaccine. The patient had called her dermatologist and doctor but she did not visit any physician's office, nor went to ER. After a week, the rash went away. The patient got her 2nd dose of BNT162b2 on 11Sep2021 and rash re-appeared on 13Sep2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101199467 same reporter/patient, different dose/similar event

Other Meds:

Current Illness:

ID: 1734167
Sex: F
Age:
State: CO

Vax Date:
Onset Date: 08/07/2021
Rec V Date: 09/25/2021
Hospital: Y

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

Lab Data: Test Date: 20210902; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: 2 strokes in occipital lobe and dissection of artery; 2 strokes in occipital lobe and dissection of artery; This is a spontaneous report from a contactable consumer (patient) A 49-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6208) via an unspecified route of administration in Arm Left on 2021 as single dose for covid-19 immunisation. Medical history included lupus, aplastic anemia (apls) and Raynauds; patient had unspecified allergies. Previously on 09Mar2021 (at 49 years) the patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: En6203) in Right arm for covid-19 immunisation.Concomitant medications included hydroxychloroquine; escitalopram oxalate (LEXAPRO); rivaroxaban (XARELTO) and vitamis, all taken for unspecified indication, start and stop date were not reported. Nasal Swab on 02Sep2021 was negative. The patient experienced 2 strokes in occipital lobe and dissection of artery on 07Aug2021 at 08:00 am. Patient was treated with Lovenox.Events results in Emergency room/department or urgent care and hospitalization for 4 days in Aug2021.Patient recovered with lasting effects on an unknown date in 2021.

Other Meds: HYDROXYCHLOROQUINE; LEXAPRO; XARELTO

Current Illness:

ID: 1734168
Sex: M
Age:
State: TN

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/25/2021
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: Fainted after vaccine; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FE3592), administered in the left arm, in Sep2021 at 09:15 (at the age of 23-years-old) at dose 1, single for COVID-19 immunisation. Medical history was not reported. The patient had not COVID prior vaccination and no COVID was tested post vaccination. Concomitant medications were reported as none. No other vaccine was received in four weeks and no other medications were received in two weeks. The patient experienced fainted after vaccine in Sep2021 at 09:15. The event was reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered in response to the event. The patient had recovered from the event in Sep2021.

Other Meds:

Current Illness:

ID: 1734169
Sex: F
Age:
State: NV

Vax Date: 09/05/2021
Onset Date: 09/08/2021
Rec V Date: 09/25/2021
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: Rash and Blisters on arms and face; Rash and Blisters on arms and face; This is a spontaneous report from a contactable consumer (patient) . A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Fc3184), via an unspecified route of administration in Arm Left on 05Sep2021 (at 42 years) at 13:15 as single dose for covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19; since the vaccination she has not been tested for COVID-19. On 08Sep2021 the patient experienced rash and blisters on arms and face. Events required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse events included prednisone.Outcome of the event was recovering.No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1734170
Sex: U
Age:
State: ND

Vax Date:
Onset Date:
Rec V Date: 09/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I and my whole family came down with COVID. I was fully vaccinated; I and my whole family came down with COVID. I was fully vaccinated; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at dose 2, single and first dose at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient and whole family came down with COVID. Patient was fully vaccinated, and was able to take care of family while they were sick. Patient wrote to thank the company and also to protest the use of aborted fetal stem cells in the production of the vaccine. The outcome of the event was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1734171
Sex: F
Age:
State: TN

Vax Date: 09/08/2021
Onset Date: 09/09/2021
Rec V Date: 09/25/2021
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: Severe constipation and impaction; Severe constipation and impaction; Continual runny nose; Inflamed sinus passages which caused nose bleeds; Inflamed sinus passages which caused nose bleeds; Shingles outbreak in right nostril; Headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female (not pregnant) patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 08Sep2021, at the age of 58 years old, as 2nd single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome with diarrhea, reflux disease (GERD), hypothyroidism, chronic shingles, and known allergies to sulfa, meperidine (DEMEROL), and amoxycillin. Past vaccination history included the 1st dose of BNt162b2 received on 18Aug2021 in the left arm, at the age of 58 years old. There were no other vaccinations within the 4 weeks prior to the 2nd dose of BNt162b2. The patient received unspecified concomitant drugs. The patient had not had COVID prior to vaccination and was not COVID tested post vaccination. On 09Sep2021, the patient experienced continuous runny nose, inflamed sinus passages which caused nose bleeds, shingles outbreak in right nostril, headache, nausea, and severe constipation and impaction. Treatment due to the events included valacyclovir (VALTREX), suppositories, Fleet Enema. The patient was recovering from the above-mentioned events. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness: Shingles

ID: 1734172
Sex: F
Age:
State: NC

Vax Date: 02/18/2021
Onset Date: 04/01/2021
Rec V Date: 09/25/2021
Hospital: Y

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

Lab Data: Test Name: Test; Result Unstructured Data: Test Result: Unknown result.

Allergies:

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

Symptoms: Stroke; AFib; a lot of heart things; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program via Regulatory Authority Support. A 74-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered at Movie theater, via an unspecified route in left arm on 18Feb2021, at 74 years of age, (Batch/Lot Number: EN6201) as single dose for COVID-19 immunization. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm on 28Jan2021, (Batch/Lot Number: EL9262) as single dose for COVID-19 immunization. The patient didn't receive any other vaccine within the 4 weeks previous to vaccination. Medical history included an unspecified neoplasm malignant and lymphoedema from cancer in her right arm, both from an unknown date and that's the reason why she can't receive shots in her right arm. The patient's concomitant medication included blood thinner. In Apr2021 the patient experienced stroke for which she was hospitalized from Apr2021 to an unknown date and it was determined she had atrial fibrillation (onset date unknown), assessed as medically significant and "a whole bunch of other things as well. She states she had just "a lot of heart things". The patient stated she was just trying to find out where she can get the third dose, as per her doctor's recommendation. She states she didn't have any problems with the first two shots, she is just concerned that she didn't get her third one. The patient stated she had tests done (unspecified). The events outcome was unknown at the time of the report.

Other Meds:

Current Illness:

ID: 1734173
Sex: M
Age:
State:

Vax Date: 05/20/2021
Onset Date:
Rec V Date: 09/25/2021
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: Spondylitis ankylosing aggravated; Ache; Sleep excessive; Cough; Fatigue; Illness; This is a Solicited report from FACILITATED COLLECT based on information received by Pfizer from Regulatory Authority (manufacturer control number: 21K-163-3976955-00. A contactable consumer (patient) reported that a 54-year-old male patient received bnt162b2 (Batch/Lot number was not reported), first dose intramuscular on 20Apr2021 at the age of 54-year-old as single dose, second dose intramuscular on 20May2021 at the age of 54-year-old as single dose for covid-19 immunization; adalimumab (HUMIRA, Batch/Lot number was not reported, Solution for injection in pre-filled pen), subcutaneous from an unspecified date and ongoing, at unspecified dose for ankylosing spondylitis. The patient's medical history and concomitant medications were not reported. The patient experienced spondylitis ankylosing aggravated, ache, sleep excessive, cough, fatigue, illness in 2021. Solicited report from the Regulatory Authority by a consumer of an adult male with events of non-serious ankylosing spondylitis flare up, achiness, illness/fatigue/slept for 72 hours and cough with adalimumab (HUMIRA). There was no reported medical history. On unknown dates, the patient experienced ankylosing spondylitis flare up, achiness, illness/fatigue/slept for 72 hours and cough. Pfizer BioNTech Covid-19 Vaccine (TOZINAMERAN) was also considered suspect. On 20Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 20May2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. The action taken in response to the events for adalimumab was unknown. The outcome of events for cough was unknown, for other events was not resolved. The reporter's causality for the events of ankylosing spondylitis flare up and achiness with adalimumab was a reasonable possibility. The reporter's causality for the events of fatigue, slept for 72 hours, cough and was not provided. The reporter's causality for the event of illness with adalimumab was no reasonable possibility. The reporter's assessment of the causal relationship of all events with the bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Spondylitis ankylosing aggravated, Ache, Sleep excessive, Cough, Fatigue, Illness and suspect drug BNT162B2 cannot be excluded.

Other Meds: HUMIRA

Current Illness:

ID: 1734174
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/25/2021
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: Crohn's aggravated; Humira was not stopping problem/did not like it/Lack of drug effect; Loss of energy; Somnolence; Pain; Cramps; Sluggishness; Constipation; Feeling abnormal; feel out of breath; This is a solicited report,( Manufacturer control number: 21K-163-4027682-00) via a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) at age of 60 years old as a single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneously from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at citrate free for moderate to severe adult Crohns disease. The patient's medical history and concomitant medications were not reported. The patient experienced crohn's aggravated, humira was not stopping problem/did not like it/Lack of drug effect, loss of energy, somnolence, pain, cramps, sluggishness, constipation, feeling abnormal, feel out of breath, all in 2021. The action taken in response to the events for adalimumab was unknown. Therapeutic measures were taken as a result of all events. The outcome of loss of energy, pain, crohns aggravated, cramps, sluggishness, all was not recovered, somnolence, humira was not stopping problem/did not like it/Lack of drug effect, constipation, feeling abnormal, all was recovered in 2021, feel out of breath was unknown. Clinical course: Solicited report by a consumer of an adult female with events of non-serious without energy, sleepy all time/drowsy, pain, Crohns flare up, cramps, Humira was not stopping problem/did not like it, sluggish, constipated and covid shot made feel out of breath with Humira (adalimumab). there was no reported medical history. on unknown dates, the patient experienced without energy, sleepy all time/drowsy, pain, Crohns flare up, cramps, Humira was not stopping problem/did not like it, sluggish, constipated and covid shot made feel out of breath. On unknown dates, sleepy all time/drowsy, Humira was not stopping problem/did not like it, constipated and covid shot made feel out of breath resolved. Pfizer Biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. The patient was treated with BENTYL and PREDNISONE. Causality for HUMIRA(ADALIMUMAB): The reporters causality for the events of without energy, Crohns flare up and covid shot made feel out of breath with Humira(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of sleepy all time/drowsy, pain, cramps, Humira was not stopping problem/did not like it, sluggish and constipated with HUMIRA(ADALIMUMAB) was a reasonable possibility. Change History: On 05Sep2021, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. the events of Humira was not stopping problem/did not like it, sluggish, constipated and covid shot made feel out of breath were added. the event of sleepy was amended to sleepy all time/drowsy. Causality for BNT162B2: The reporters causality for the events of without energy, sleepy all time/drowsy, pain, Crohns flare up, cramps, Humira was not stopping problem/did not like it, sluggish, constipation, feel out of breath, were not reported, the reporter's causality for the event of feeling abnormal was possible. The reporter's assessment of the causal relationship of the events (crohn's aggravated, humira was not stopping problem/did not like it/Lack of drug effect, loss of energy, somnolence, pain, cramps, sluggishness, constipation, feel out of breath) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information in the case , the causal relationship between BNT162B2 and the reported events are assessed as Unrelated.

Other Meds:

Current Illness:

ID: 1734175
Sex: U
Age:
State:

Vax Date: 02/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data: Test Date: 20210903; Test Name: Covid-19 test; Test Result: Positive

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Dry cough; Throwing up; My stomach was not right for a couple days; Tested positive for Covid; Tested positive for Covid; Headache; This is a spontaneous report received from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date in Feb2021 as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on an unspecified date in Feb2021 as DOSE 2, SINGLE both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Sep2021, the patient tested positive for covid. On 01Sep2021, patient had headache. On an unspecified date, the patient experienced dry cough, throwing up, my stomach was not right for a couple days. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 03Sep2021. The outcome of the event tested positive for covid was unknown and other events outcome was recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1734176
Sex: F
Age:
State: FL

Vax Date: 09/11/2021
Onset Date: 09/01/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: rash with both vaccines/rash now is on her neck, chest, and shoulder area; her neck is on fire; itchy; hot; This is a spontaneous report from a contactable physician (patient) A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11Sep2021 14:00 (Batch/Lot Number: FC3182) as DOSE , SINGLE for covid-19 immunisation .Age at vaccination 46:years. Medical history included , Allergies: many medications.Age at vaccination :46 years old.The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 21Aug2021 (Time: Between 10:00-11:00AM;LOT: FC3180; vaccine site : left arm ) and experienced rash. There were no concomitant medications.None prior vacciantions within 4 weeks. The patient stated that she experienced rash with both vaccines. She Got her second vaccination Saturday 11Sep2021. This morning, 13Sep2021, noticed the rash. Rash appeared after the same amount of time as it did with the first dose. Rash was reported as worsened but clarified her rash now is on her neck, chest, and shoulder area. All around her neck. Her neck was on fire. Wants to scratch up into her scalp. Might be in her scalp, but not able to see it because of her hair. It is itchy and hot. It is on her back. Therapeutic measures were taken as a result of rash :She Has been taking Benadryl the entire time. The event didn't result in ER or Physician office visit but she spoke with doctor and dermatologist. The outcome of the events was unknown.Additional information: Vaccination Facility Type: Pharmacy or Drug store;; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101198306 same reporter/patient, different dose/event

Other Meds:

Current Illness:

ID: 1734177
Sex: F
Age:
State: CT

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/25/2021
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: vaccine administered that was not reconstituted; vaccine administered that was not reconstituted; This is a spontaneous report from a contactable Nurse. This Nurse reported for 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FD0809; Expiration Date: 25Sep2021), dose 1 intramuscular, administered in Deltoid Left on 10Sep2021 15:30 (at the age of 57 years old) as dose 1, 0.3 ml single for covid-19 immunization. The Patient No medical history was reported. There were no concomitant medications. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Sep2021, the patient experienced vaccine administered that was not reconstituted. Incident report was filled out and it was reported to everyone at their office, including the nurse manager and provider. No follow-up attempts are needed. No further information is expected.; Sender's Comments: As per the information in the case provided, the causal association between the events Wrong technique in product usage process and Poor quality vaccine administered and the suspect drug cannot be excluded.

Other Meds:

Current Illness:

ID: 1734178
Sex: M
Age:
State: OH

Vax Date: 09/08/2021
Onset Date: 09/08/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data: Test Date: 20210908; Test Name: Blood Pressure; Result Unstructured Data: Test Result:178/90 mmHg; Test Date: 20210909; Test Name: Blood Pressure; Result Unstructured Data: Test Result:Normal mmHg; Test Date: 20210908; Test Name: Heart rate; Result Unstructured Data: Test Result:90 beats per minute; Test Date: 20210909; Test Name: Heart rate; Result Unstructured Data: Test Result:Normal

Allergies:

Symptom List: Unevaluable event

Symptoms: Blood pressure was 178/90 mmHg; Heart rate went up/resting heart rate was 90 beats per minute; This is a spontaneous report from a contactable consumer (patient) A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Sep2021 (Batch/Lot Number: FD8448) as DOSE 2, SINGLE for covid-19 immunisation . Age at vaccination :56 years.The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for covid-19 immunization (Anatomical Location: left shoulder). There were no concomitant medications and medical history. The clinical course was reported as follows: on 08 Sep2021 he received his second Covid 19 vaccine last Wednesday at around 9:00AM-9:30AM in the morning. His Covid 19 record card says FD8448. He works nights so after he received the vaccine he went home and slept because he had to work that night. He reports probably about 13 hours after he received the vaccine, around 10:00PM-11:00PM that night, he was sitting at his desk at work and his heart rate went up. His resting heart rate was 90 beats per minute. His blood pressure was 178/90 mmHg and it stayed that way for about 3 hours. He left work and was on his way home when he had to stop and call paramedics. The paramedics came to where he was stopped, and the paramedics checked him out. The paramedics put an ice bag on the back of his neck and he sat there for about 15 minutes. His symptoms calmed down enough that he felt safe enough to finish his drive home although his heartrate and blood pressure were still elevated. It probably lasted a total of about 5 hours and after that his heartrate and blood pressure returned to normal. While he was on his way home and if he was feeling bad when he passed by the emergency department close to his house, he would stop. But he didnt have to stop. He arrived home and he sat down and maybe within a couple hours everything was back to what he would call normal.Therapeutic measures were taken as a results of the events.The outcome of the events was recovered.No emergency room/phiscian office visit.Additional information : Vaccination Facility Type :Pharmacy/Drug Store;No prior vaccination within 4 weeks Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1734179
Sex: U
Age:
State: VA

Vax Date: 09/10/2021
Onset Date: 09/13/2021
Rec V Date: 09/25/2021
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 Name: C-reactive protein; Result Unstructured Data: Test Result:0.4; Test Name: Sedimentation Rate; Result Unstructured Data: Test Result:11

Allergies:

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

Symptoms: I had a allergic reaction that I break out in hives; I had a allergic reaction that I break out in hives; had a little bit of difficulty in breathing; This is a spontaneous report from a contactable Nurse. A 31-years-old patient of an unspecified gender received bnt162b2 (BNT162B2) at age of 31 years via an unspecified route of administration, administered in Arm Left on 10Sep2021 (Batch/Lot Number: EW0164) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation and methylprednisolone acetate (METHYLPREDNISOLONE ACETATE), injection via an unspecified route of administration on 13Sep2021 (Batch/Lot number was not reported) as an unspecified dose for an unspecified indication. Medical history included fibromyalgia and rheumatoid arthritis. Concomitant medications included hydroxychloroquine (HYDROXYCHLOROQUINE) and sulfasalazine (SULFASALAZINE). On 13Sep2021 patient reported that "I had a allergic reaction that break out in hives and "I had a little bit of difficulty in breathing. All events with outcome of unknown. The patient reported that "bit of difficulty in breathing was not to the point that I have got I called the ambulance but I got 25mg Benadryl intramuscular and I got Solumedrol both as treatment. Patient underwent lab tests and procedures which included c-reactive protein: 0.4, red blood cell sedimentation rate: 11. Clinical course: patient received "COVID 19 shot on the 10th of September which is Friday. Today I went to my orthopedics and got methyl prednisolone injection in my 'wrist'. 5 min after leaving my orthopedic I had allergic reaction". I have a question the methyl Medrol the oral and the injection are they different or no?".; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 and methylprednisolone acetate cannot be excluded for the reported events urticaria, hypersensitivity and dyspnoea occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: HYDROXYCHLOROQUINE; SULFASALAZINE

Current Illness:

ID: 1734180
Sex: U
Age:
State: TX

Vax Date: 05/21/2021
Onset Date: 06/02/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data: Test Name: Antobody test to platelet factor IV; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210630; Test Name: Pelvic ultrasound; Result Unstructured Data: Test Result:Normal; Test Date: 20210630; Test Name: Transvaginal ultrasound; Result Unstructured Data: Test Result:Right ovary cyst; Comments: Haemorrhagic Cyst

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: ovarian cyst/ Haemorrhagic Cyst; Irregular menstruation; Abnormal menstruation; Abdominal cramps and bloating; Abdominal cramps and bloating; This is a spontaneous report received from a contactable Physician. This is the second report of two reports. This report is related to the second vaccination dose. A 30-year-old patient of unknown gender received the second dose of bnt162b2 on 21May2021 at 16:00 (lot number: EW0170) Intramuscularly in left arm at single dose for COVID-19 immunization. Medical history included Acute appendicitis in 2011, Laparoscopic appendectomy in 2011. Concomitant medications were reported as none. Historical vaccine included the first dose of bnt162b2 on 30Apr2021 at 04:00 PM (Lot no: ER8731) (at the age of 30-years-old) Intramuscularly in right arm for COVID-19 immunization, experienced Abdominal cramps and bloating. Prior vaccination was reported as None. Family medical history was reported as None. Patient experienced Irregular menstruation (medically significant) on 02Jun2021 at 09:00 am, Abnormal menstruation on 02Jun2021, ovarian cyst/ Haemorrhagic Cyst (medically significant) on 30Jun2021, Abdominal cramps and bloating in 2021. The events were required physician office visit. Patient received treatment for events Irregular menstruation, ovarian cyst/ Haemorrhagic Cyst, Abnormal menstruation. Second vaccine dose administered on 21May2021. Abdominal cramps and bloating persisted. Abnormal menstruation on 02Jun2021. Patient was evaluated by OB/Gyn, FNP and Pelvic and transvaginal Ultrasound ordered 30Jun2021. Patient had ultrasounds at 3:21pm on 30Jun2021. Haemorrhagic Cyst noted on transvaginal ultrasound No history of ovarian cyst in patient prior. Lab data included: Antibody test to platelet factor IV on unknown date: Unknown results; Transvaginal ultrasound on 30Jun2021: Right away cyst, Haemorrhagic Cyst; Pelvic Ultrasound on 30Jun2021: Normal. The outcome of the events was not recovered. Physician considered the Pfizer product had a causal effect to the adverse events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Menstruation irregular, Haemorrhagic ovarian cyst and Menstruation abnormal cannot be totally excluded.The impact of this report the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1734181
Sex: F
Age:
State: IN

Vax Date: 09/01/2021
Onset Date:
Rec V Date: 09/25/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: chest pain; inflammation in her chest; inflammation and stuff for her chest; chest pain; inflammation in her chest; inflammation and stuff for her chest; Headache; Coughing; Fatigue; Stomach cramps; Diarrhea; Nausea; Shortness of breath; Sick; This is a spontaneous report from a contactable consumer (patient). This is the second of two reports. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via unspecified route of administration in right arm on 01Sep2021 (lot number: EW0191) as single dose for COVID-19 immunisation. The relevant medical history was not reported. Concomitant medications included hydrochlorothiazide (THIAZIDE) and the heart medicine (further not clarified). The patient previously received the first dose of BNT162B2 (DOSE 1, SINGLE, lot number: EW0186) on an unspecified date for COVID-19 immunisation and experienced headache, coughing, fatigue, chest pain, inflammation localized. The patient stated that she was calling because she reported the first time with the adverse reaction. Her doctor told her to report, that make sure she reported in, calling in about the second one. She did report the first one but she was supposed to report the 2nd one. The Pfizer (Confirmed as Pfizer Covid19 vaccine). Yeah, she had that one she had been sick, so she was getting report to second one yeah but she has told make sure she calling in. The second one she had on September first. Probed for adverse events the patient stated headache, she was still having them headaches daily, chest pain, and coughing and fatigues. She did let the doctors know. She did have, after second she had some stomach cramps, diarrhea you know, that subsided but she was still having the headache the chest pain she was having nausea too. She was having nausea, fatigue and the shortness of breath, she forgot about that sorry. The patient stated she did have it cause she had to go to the hospital cause she was having chest pain (further not clarified). The patient stated that they gave her they say inflammation in her chest so they getting out and cough too and put that down to overall she was coughing too she didn't know after the first vaccine she ended up developing a cough so she still had the cough. The patient further stated that what you were telling the people about she found out that really too many people didn't know what to do. What you all telling the people what to do because she found out that ain't nobody telling the people what to do. Like they really didn't know like the doctors really didn't know. She was just asking you know, she was taking medications for inflammation and stuff for her chest. She was like, she was asking that what they were really telling people because right she went to urgent care, urgent care sent her to, she went to urgent care last week. They sent her to the Urgent care hospital, she was having chest pain so they sent her to the hospital. Even in the hospital they gave her the treatment for inflammation and stuff, but she was just like and when she went to do the follow up with the doctor she told her to make sure she calling in so that's why she was asking like what you all really telling people like to these things really nobody know how to treat this. First time, she had to go to urgent care, second time she had to go to the hospital though on 04Sep2021. They discharge her that day (confirmed as September 4 2021). Therapeutic measures were taken as a result of the event chest pain; inflammation in her chest; inflammation and stuff for her chest. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101205649 same reporter/patient/product, different events, first dose

Other Meds: THIAZIDE

Current Illness:

ID: 1734183
Sex: M
Age:
State: NJ

Vax Date: 06/01/2021
Onset Date:
Rec V Date: 09/25/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: COVID-19; Test Result: Positive; Comments: Tested positive for COVID-19.

Allergies:

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

Symptoms: Tested positive for COVID-19.; Tested positive for COVID-19.; Was treated for pain and inflammation.; Was treated for pain and inflammation.; This is a spontaneous report from a contactable consumer (Pfizer colleague). An adult male patient received bnt162b2 in Jun2021 (lot number: unknown) via unknown route of administration at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was not reported whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine and the patient received any medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Admitted to ER approximately 6 weeks ago due to shortness of breath and fever. Lungs were determined to be clear. Was treated for pain and inflammation. Released approximately 12 hours later. Tested positive for COVID-19 in 2021. Patient received the treatment for the events including Ivermectin. The outcome of the events was recovered in 2021. The events did not result in death, hospitalization, disability, Congenital Anomaly. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1734184
Sex: F
Age:
State: NY

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 09/25/2021
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: Sensation of throat closure; Localized injection site urticarial; hives/generalized urticaria (hives)- limited to face; an hour out with throat swelling had to take a drink to swallow. /her throat started swelling again but worse; Lip swelling; Difficulty breathing; This is a spontaneous report from a contactable other hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE), dose 1 intramuscularly, administered in arm (deltoid) on 02Mar2021 (Lot Number: EN6202) as dose 1, single at the age of 56-year-old for COVID-19 immunization. Medical history included environment allergy. The patient previously took Adrenaline (Epipen) and experienced allergy. No concomitant medications. The patient did not take any medications prior to the event being reported. No relevant test. No laboratory tests or diagnostic studies performed. The patient did not receive any vaccines for any other conditions prior to the event reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to event being reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient experienced hives, an hour out with throat swelling had to take a drink to swallow. /her throat started swelling again but worse, lip swelling, difficulty breathing on 02Mar2021; sensation of throat closure, localized injection site urticarial on an unspecified date. Organ involved included respiratory yes: difficulty breathing (without wheeze or stridor) and sensation of throat closure; Cardiovascular: No; Dermatological/Mucosal: Yes generalized urticaria (hives)- limited to face and localized injection site urticarial; Gastrointestinal: No; Any other symptoms/signs: No. The patient did not require medical intervention. It was unknown if the patient seen in the Emergency Department. The patient was not hospitalized. The patient was not admitted to an Intensive Care Unit. Treatment received for all the events which included benadryl and famotidine. The outcome of lip sweliing was recovered spontaneously on 02Mar2021. The outcome of hives/generalized urticaria (hives)- limited to face was recovered in 2021. The outcome of other events was unknown.

Other Meds:

Current Illness:

ID: 1734185
Sex: F
Age:
State: NC

Vax Date: 04/09/2021
Onset Date: 05/19/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data: Test Date: 20210312; Test Name: creatinine/bloodwork; Result Unstructured Data: Test Result:1.06; Comments: high; Test Date: 20210428; Test Name: creatinine/bloodwork; Result Unstructured Data: Test Result:1.06; Comments: high; Test Date: 20210506; Test Name: creatinine/bloodwork; Result Unstructured Data: Test Result:1.03; Comments: high; Test Date: 20210519; Test Name: creatinine/bloodwork; Result Unstructured Data: Test Result:1.16; Comments: high; Test Date: 20210805; Test Name: creatinine/bloodwork; Result Unstructured Data: Test Result:1.10; Comments: high; Test Date: 20210816; Test Name: creatinine/bloodwork; Result Unstructured Data: Test Result:1.13; Comments: high; Test Date: 20210908; Test Name: creatinine/bloodwork; Result Unstructured Data: Test Result:1.29; Comments: high

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: 12Mar2021 showing 1.06, on 19May2021 1.16 High, on 05Aug2021 1.10 High, on 16Aug2021 1.13 High, on 08Sep2021 1.29 High; This is a spontaneous report from a contactable consumer and a non-contactable consumer (patient). A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via intramuscular, administered in Arm Right on 09Apr2021 (Batch/Lot number was not reported) (at the age of 53-year-old) as single dose for covid-19 immunisation. Medical history included Hashimoto Disease. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not had covid tested post vaccination. Known allergies was not applicable. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administered in Left arm on 08Mar2021 (Batch/Lot number was not reported) (at the age of 53-year-old) as single dose for covid-19 immunisation and following her 08Mar2021 dose, (name withheld) went to the doctor and bloodwork was done on 12Mar2021 showing 1.06 high creatinine levels. (name withheld) has also reported pain near kidneys. Facility type Vaccine was Health Clinic. Concomitant medications included thyroid (ARMOUR THYROID); hydroxychloroquine sulfate (PLAQUENIL), all taken for an unspecified indication, start and stop date were not reported. Creatinine levels have increased since as follows after second dose: on 28Apr2021 1.06 High, on 06May2021 1.03 High, on 19May2021 1.16 High, on 05Aug2021 1.10 High, on 16Aug2021 1.13 High, on 08Sep2021 1.29 High. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient had not received treatment. The outcome of the event was Not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: ARMOUR THYROID; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]

Current Illness:

ID: 1734186
Sex: F
Age:
State:

Vax Date: 04/07/2021
Onset Date: 08/01/2021
Rec V Date: 09/25/2021
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: swelling under her right eye; swelling to both upper and lower eyelids and upper and lower Iips; swelling to both upper and lower eyelids and upper and lower Iips; inflammation; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Mar2021 for covid-19 immunization, took tacrolimus for dermatitis atopic. Patient was a 36-year-old female who was injected with a total of 1 ml of what she believes to be Restylane Kysse (Lot and exp Unknown) to tear troughs and upper and lower lips on 20Apr2021. She reported that she developed swelling under her right eye one day in Aug2021 and the next day she woke up with swelling to both upper and lower eyelids and upper and lower lips, she reported they were very inflamed. She saw the HCP who administered certisone injections to both eyes and lips and prescribed her with a 5-day course of oral prednisone, swelling resolved. After finishing the oral prednisone, the swelling returned (02Sep2021). She contacted the HCP by phone and sent him photos of the swelling and he prescribed her lisinopril 5 mg daily and advised she take cetirizine dihydrochloride and fexofenadine. She reported that she was reluctant to take the lisinopril because its for high blood pressure. Event has not resolved, still has swelling and inflammation both eyes and upper and lower lips. She reported that she was diagnosed with atopic dermatitis around the eyes 6 weeks prior to injections, she was treated with Tacrolimus ointment which she had stopped about 2 weeks prior to injections. No other medical history, allergies, or medications. Had the Pfizer Covid 19 vaccination 1st dose 15Mar2021 and 2nd dose 07Apr2021. No other vaccines, illnesses, or dental procedures in the last 6-12 months. The outcome of the events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1734187
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/25/2021
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: Bell's palsy; This is a spontaneous report from a contactable consumer. The reporter reported 3 reports, this is the 1 of 3 reports. This case was split from master case 202101198829 for a patient taking Bnt162b2 and experienced Bell's palsy. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization.Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced bell's palsy. First, data reported in the Food and Drug Administration briefings suggest risk of Bell's palsy is greatest within 1 month of a second vaccine dose. The Pfizer briefing notes from dose 1 through 1 month after dose 2, there were three reports of Bell's palsy in the vaccine group and none in the placebo group. The outcome of event was unknown. The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101207187 Same article, different patients with same drug;US-PFIZER INC-202101207188 Same article, different patients with same drug

Other Meds:

Current Illness:

ID: 1734188
Sex: U
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 09/25/2021
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: Bell's palsy; This is a literature report from the The Regulatory Authority Infectious Diseases., 2021, 21 (9); 1211-1212 entitled 'Bell's palsy and SARS-CoV-2 vaccines-an unfolding story - Authors' reply'. This reporter reported 3 reports, this is the 2 of 3 reports. This case was split from master case 202101198829 for a patient taking Bnt162b2 and experienced Bell's palsy. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced bell's palsy. First, data reported in the Food and Drug Administration briefings suggest risk of Bell's palsy is greatest within 1 month of a second vaccine dose. The Pfizer briefing notes "from dose 1 through 1 month after dose 2, there were three reports of Bell's palsy in the vaccine group and none in the placebo group". The outcome of event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101207186 Same article, different patients with same drug;US-PFIZER INC-202101207188 Same article, different patients with same drug

Other Meds:

Current Illness:

ID: 1734189
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: a family friend whose son had myocarditis; almost had a heart attack; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On an unspecified date consumer reported that, a family friend whose son had myocarditis, and almost had a heart attack. The outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1734190
Sex: M
Age:
State:

Vax Date: 09/14/2021
Onset Date: 09/14/2021
Rec V Date: 09/25/2021
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: 20210914; Test Name: Fever; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: fever; This is a spontaneous report from a contactable consumer (patient). 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 14Sep2021 08:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as dose 1, single for covid-19 immunisation and experienced nausea which lasted for a day. The patient experienced fever on 14Sep2021 20:00 which he classified as mild fever. However, patient did not have a thermometer to verify the temperature. The patient underwent lab tests and procedures which included body temperature: unknown results on 14Sep2021. Patient took Tylenol last night (14Sep2021) and today (15Sep2021) around 12:00 to treat post vaccination symptoms. Caller wanted to know if it was safe to take them. Caller also wanted to know if it was recommended to drink plenty of water to help alleviate the symptoms. The outcome of event fever was not recovered. The lot number for [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1734191
Sex: F
Age:
State: TN

Vax Date: 08/13/2021
Onset Date: 08/01/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: Blood pressure; Result Unstructured Data: Test Result:Normal; Comments: She said it took 2 weeks before her blood pressure became normal again; Test Date: 20210818; Test Name: Blood pressure; Result Unstructured Data: Test Result:180/98; Test Date: 20210818; Test Name: Blood pressure; Result Unstructured Data: Test Result:180/100; Test Date: 20210818; Test Name: Chest XRay; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210818; Test Name: CT Scan; Result Unstructured Data: Test Result:Fine; Comments: CT scan of her head; Test Date: 20210818; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210818; Test Name: ECG; Result Unstructured Data: Test Result:Abnormal; Test Date: 20210818; Test Name: EKG; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210818; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Test Date: 20210818; Test Name: Pulse rate; Result Unstructured Data: Test Result:114; Test Date: 20210818; Test Name: Imaging test; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210818; Test Name: 14 different lab tests; Result Unstructured Data: Test Result:Unknown Reaction; Test Date: 20210818; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:Ok; Comments: Carotid neck arteries and they were ok

Allergies:

Symptom List: Tremor

Symptoms: She said they took her blood pressure and it read 180/100.; She felt so odd; She said she noticed that the numbness in her left toes crept up a bit to her ankle on one leg.; Lightheaded/ dizzy; Left arm soreness at injection site; Felt a warm sensation; She said there were numbing and tingling sensations/ gets tingling feeling in feet; A few days later, she felt lightheaded and had motion sickness.; Pulse rate was at 114.; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FA6780, Expiry date: not reported), via intramuscular route of administration in left arm on 13Aug2021 12:00 (at age of 67-years-old) as dose 1, single for covid-19 immunization; rosuvastatin (ROSUVASTATIN), oral from 18Aug2021 (Batch/Lot number was not reported) to an unspecified date, at 10 mg, daily for high cholesterol. Medical history included cardiac disorder from an unknown date and unknown if ongoing Family had heart troubles and they wanted to make sure she was ok and she was. Other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. There were no concomitant medications. 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) was none. Additional vaccines administered on same date of the bnt162b2 suspect were none. The patient had not received any other vaccine within 4 weeks. On 13Aug2021, she said she noticed that the numbness in her left toes crept up a bit to her ankle on one leg, lightheaded/ dizzy (onset time: 14:00 -15:00), left arm soreness at injection site (onset time: 17:00- 18:00). On 18Aug2021 at 16:00, the patient said they took her blood pressure and it read 180/100 (serious, medically significant). On the same day, she felt so odd. On an unspecified date in Aug2021, a few days later, she felt lightheaded and had motion sickness, pulse rate was at 114, felt a warm sensation, she said there were numbing and tingling sensations/ gets tingling feeling in feet. The reporter stated that the patient experienced some symptoms after receiving 1st dose of the bnt162b2 vaccine on 13Aug2021. After receiving first dose, the patient felt lightheaded and then an hour or two later, her right foot on small toes started to feel odd and the patient felt a numbing and tingling sensation on them. A few days later, the patient felt lightheaded and had motion sickness. Five days after 1st dose, she felt odd and went to doctor and had blood pressure checked, and it was 180/100. Doctor's tried to bring it down with a medication, but in the end, it read 180/98 and her pulse rate was 114. She felt dizzy. She was sent to the ER and was just given fluid IV and sent home. She also mentioned it took 2 weeks to get her blood pressure back to normal and also said numbness in left toes crept up a bit to the ankle in one leg. She is taking Rosuvastatin, a cholesterol medication, but stopped before receiving first dose. She also said it has already on Friday, will be 5 weeks since her first dose. Patient clarified information above. The patient had not started the Rosuvastatin yet when she started first shot. It was prescribed, but the patient did not want to start it and wanted to be sure it would not cause any problems with the vaccine. The patient did not start it until 1 week after receiving the first dose of the vaccine. Now, the patient had stopped taking it again. It seemed like numbness and tingling was creeping up leg and yesterday, it went all the way up left leg. The patient called and they told her to stop taking it in case it was that. She was not sure it was related or not. They thought lightheadedness may be anxiety about getting shot. She noticed it within that 5 days period. Once she got her blood pressure back to normal state, it dissipated. Right foot small toes felt numb and tingly. This started an hour or two after she got home. She also felt a warm sensation when she put her foot on the cold floor. The warmth went away but the strange feeling was still there today. The other foot has started doing the same thing and actually yesterday was the worst it ever was. On the left side, it went all the way up leg where it felt tingly and it dissipated and just left her feeling the sensation in toes. She just gets tingling feeling in feet and at night time it gets better. She does not have a history of high blood pressure. It was on the 5th day that her blood pressure was 180.100. That is when it was checked. It took 2 weeks. They did not medicate her, but within 2 weeks, now her blood pressure is back to normal. They gave her a little Clonidine and an Aspiring and it did not take it down. She does not have the dose of the Clonidine or the lot or the expiration. It was very mild amount. It did not say on her paper. It just said 1 Clonidine was given. She thinks they only gave her a half of one. She does not know the normal dose. She does not have a lot or expiration for the Clonidine because she received it at the doctor's office. They gave her the bottle of Aspirin. It was the Low dose aspirin, 81mg. Unknown lot and expiration. She does not know if they were sealed and intact. They gave her the bottle and it was 81 mg low dose. Count size 32 tablets. he does not know if it was sealed. They were in a big hurry to give it to her. A few hours later and by the night her injection site arm was the sorest, and by the next day it was gone. She was overdue to get second one and Friday, they were going to get second one, which was the 5th week. She thought you are supposed to get it no longer than 6 weeks. She said the previous agent told her that the CDC said you should get second dose within 6 weeks of first dose. She is supposed to go this Friday and had all these concerns, so she wanted to know if it was safe to do so. That is why she called and talked to previous agent. Visit to emergency room for blood pressure and increased heart on 18Aug2021. Gave IV fluids and released with no further treatment. They did several tests which did not show up anything that was of concern. She does not know specific tests or results. There was nothing concerning. There were 14 different lab tests and imaging test, Chest XRay, ECG and all those things. They let her go without any treatment. Reason for visit: hypertension, dizziness and abnormal ECG. They did an EKG and it was normal and did not tell her anything of concern. Diagnosis did not list anything about the EKG. It just said lightheadedness and high blood pressure disorder. Visit to physician Office on 18Aug2021 due to high blood pressure and high heart rate. Given Clonidine and low dose aspirin. Dose of Clonidine unknown. The patient said that did not lower her blood pressure, so she was sent to the ER as mentioned above. Number of days was the hospital stay was none. Relevant tests were none or unknown. Five days after 1st dose of Pfizer COVID vaccine, patient felt odd and went to doctor and had blood pressure checked, and it was 180/100. Doctor's tried to bring it down with a medication, but in the end, it read 180/98 and her pulse rate was 114. The medication given was Clonidine and Aspirin, low dose 81mg. She does not know the dose of the Clonidine and said it was a mild dose and she thinks they only gave her half. She does not have the dose, manufacturer, lot or expiration for the Clonidine as it was given in the doctor's office. The Aspirin was given from a bottle that they gave her of 81 mg, count size 32. Product strength and count size dispensed: Unknown for Clonidine. The aspirin was 81mg and the count size was 32 tablets. She does not know if they were sealed and intact as they gave them to her in a hurry. The patient underwent lab tests and procedures which included blood pressure measurement: normal on Aug2021 She said it to

Other Meds:

Current Illness:

ID: 1734192
Sex: M
Age:
State: MA

Vax Date: 02/15/2021
Onset Date: 09/14/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data: Test Date: 20210915; Test Name: antigen; Test Result: Positive ; Comments: Nasal Swab

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: lack of efficacy- Fully vaccinated for CV19 with symptoms 14Sep2021 and positive CV19 test 15Sep2021; lack of efficacy- Fully vaccinated for CV19 with symptoms 14Sep2021 and positive CV19 test 15Sep2021; This is a spontaneous report from a contactable other hcp. A 41-year-old male patient of an received Second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number: EL3247), via intramuscularly, administered in Arm Left on 15Feb2021 (age at vaccination was 41 years old) as DOSE 2, Single and first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number: EL3247) via intramuscularly, administered in Arm Left on 26Jan2021 (at the age of 41 years old) as DOSE 1, Single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was unknown if diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Sep2021, the patient experienced lack of efficacy- fully vaccinated for cv19 with symptoms 14sep2021 and positive cv19 test 15sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test result was positive via Nasal Swab on 15Sep2021. Facility where the most recent COVID-19 vaccine was administered was clinic. The patient did not received any treatment. The outcome of the event was recovering.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reas-sessed once new information is available.

Other Meds:

Current Illness:

ID: 1734193
Sex: F
Age:
State: NC

Vax Date: 09/14/2021
Onset Date: 09/15/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: patient reports the stiffness has gotten worse, she doesn't think it could get any worse.; received her second dose yesterday 14Sep2021 and now her whole body is stiff.; This is a spontaneous report from a contactable consumer (patients fiance). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2588, Expiration date: 14Sep2021), dose 2 via an unspecified route of administration, administered in Arm Left on 14Sep2021 13:10 (age at vaccination 44 years) as dose 2, single for covid-19 immunisation. Medical history included ongoing asthma. The patient's concomitant medications were not reported. Patient received historical vaccine Flu shot 2017 Flu Shot, ended up in the hospital because she got both strains of the flu. NDC, Lot, Expiration: Unknown Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: FA7485) via an unspecified route of administration on 24Aug2021 as single dose for COVID-19 immunization and experienced headache. The patient experienced received her second dose yesterday 14sep2021 and stiffness now her whole body is stiff on 15Sep2021, the stiffness has gotten worse, she doesn't think it could get any worse on an unspecified date. Reporter stated caller is calling on behalf of her fiance. Her fiance received the first dose on 24Aug2021 and had a headache after this that she still has from the first dose and received her second dose yesterday 14Sep2021 and now her whole body is stiff. And asking if this is a side effect. Patient not visited physician office or emergency room. The patient did not receive any treatment for reported events. The outcome of event was not recovered. No follow up attempts are needed, No further information expected.

Other Meds:

Current Illness: Asthma

ID: 1734194
Sex: F
Age:
State: CA

Vax Date: 09/14/2021
Onset Date: 09/14/2021
Rec V Date: 09/25/2021
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: started to flush slightly; First dose: administered on 05Apr2021/Second dose: administered on 14Sep2021; This is a spontaneous report from a contactable consumer (patient herself). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection and Lot Number: EW0185) via an unspecified route of administration in arm right on 14Sep2021 10:23 (age at vaccination 37 year) as dose 2, 0.3 ml, single for COVID-19 immunization. Medical history included Penicillin allergy and compromised immune system. The concomitant medications were none. Patient historical vaccine included hepatitis A for immunization which caused hives (several years ago). The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: ER8729) via an unspecified route of administration in right upper arm on 05Apr2021 at 15:30 as single dose for COVID-19 immunization and experienced with Pain at the injection site of her right upper arm, Severe flushing and tingling in upper lip and tongue. Initially he advised her against getting the second dose of the Pfizer COVID-19 Vaccine until there was more data available. Reporter stated with the new data coming out last month about safety of giving the second dose of Pfizer COVID-19 Vaccine after a patient has a reaction to the first Pfizer COVID-19 Vaccine that the physician felt it was safe to give her the second dose of Pfizer COVID-19 Vaccine. She was approved to get the second dose of Pfizer COVID-19 Vaccine with pre-medication. On 14Sep2021 at (Withheld) Hospital she was pre-medicated with 25mg of Benadryl and 20mg of Pepcid. She was administered second dose of Pfizer Covid-19 Vaccine on 14Sep2021 at 10:23. She started to flush slightly around 10:40. She was administered 25 mg of Benadryl and that resolved the event of started to flush slightly. She had no further incidents, was able to tolerate the second dose. She recovered completely from this event within about 24 hours also. They did not send her to the emergency room this time, they felt that the reaction was well controlled with the antihistamines. On 15Sep2021, the outcome of the event Flushing was resolved.

Other Meds:

Current Illness:

ID: 1734195
Sex: F
Age:
State:

Vax Date: 09/15/2021
Onset Date: 09/15/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data: Test Date: 20210915; Test Name: CPK levels; Result Unstructured Data: Test Result:but didn't have the results listed yet.

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Rhabdomyolysis; This is a spontaneous report from a contactable pharmacist. This pharmacist reporting same events under the same suspect product for 3 patients. This is the first of three reports. A 14-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: FC3180, expiry date: 16Sep2021), via an unspecified route of administration, administered in Deltoid Left on 15Sep2021 (at the age of 14-years-old) as dose 2, 0.3 ml single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: FC3180, expiry date: 16Sep2021,) via an unspecified route of administration, administered in deltoid left on 14Aug2021 (at the age of 14-years-old) as dose 1, 0.3 ml single for covid-19 immunization. The pharmacist was calling about the Pfizer covid 19 vaccine and went out to a facility yesterday on 15Sep2021, gave second dose and experienced Rhabdomyolysis within 20 minutes of the vaccine. It was a mild case of rhabdomyolysis and the patient did not have to stay in the hospital. The patient went to the emergency room but was never admitted as a patient. This event happened with the patients second dose. This patient was not a foreign exchange student. The pharmacist wants to know if Pfizer has any information on this. No Serious was reported. The patient had her CPK levels checked yesterday, on 15Sep2021, but did not have the results listed yet. The outcome of the event was not recovered.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between event Rhabdomyolysis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1734196
Sex: F
Age:
State:

Vax Date: 09/15/2021
Onset Date: 09/01/2021
Rec V Date: 09/25/2021
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: got her first dose of the Pfizer BioNTech Covid-19 vaccine /Afterward, she breastfed her 14 month old son; got her first dose of the Pfizer BioNTech Covid-19 vaccine /Afterward, she breastfed her 14 month old son; Sore arm; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. This is 1 of 2 reports. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 15Sep2021 20:30 as dose 1, single for COVID-19 immunization. Patient got her first dose of the Pfizer BioNTech Covid-19 vaccine yesterday (15Sep2021) at about 20:30 afterward, she breastfed her 14-month-old son. Around 03:00 he started throwing up. Stated she got the vaccine yesterday (15Sep2021) around 20:30. Around 03:00 this morning (16Sep2021) her baby started throwing up. Stated she had breastfed him after receiving her vaccine last night. Said she just had a sore arm for herself on an unspecified date in Sep2021. She stated that her son had no symptoms prior to this. The outcome of the event sore arm was unknown. The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up. Information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101218735 Same reporter/drug, different patient/event (mother/baby case)

Other Meds:

Current Illness:

ID: 1734197
Sex: F
Age:
State: NJ

Vax Date: 03/24/2021
Onset Date: 09/15/2021
Rec V Date: 09/25/2021
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: Test Date: 20210915; Test Name: covid-19 virus test; Test Result: Positive ; Comments: Nasal Swab

Allergies:

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

Symptoms: tested positive for COVID 19; tested positive for COVID 19; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 intramuscular on 03Mar2021 12:00 (at the age of 52-year-old) (Batch/Lot Number: E13247) as DOSE 1, SINGLE and bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 intramuscular, administered in Arm Left on 24Mar2021 12:00 (at the age of 52-year-old) (Batch/Lot Number: EP6955) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Known allergies to Penicillin and Celebrex from an unknown date and unknown if ongoing. Concomitant medication included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) taken for an unspecified indication, start and stop date were not reported. After dose 2, the patient tested positive for covid 19 (vaccination failure) (medically significant) on 15Sep2021 12:00. The patient underwent lab tests and procedures which included covid-19 virus test (Nasal swab): positive on 15Sep2021. Patient did not receive any treatment for adverse events. Patient did not have pregnancy at time of vaccination. Patient did not receive any other vaccine in four weeks. It was reported that the patient had not been diagnosed with covid prior to vaccination. Outcome of events were not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: NEXIUM [ESOMEPRAZOLE MAGNESIUM]

Current Illness:

ID: 1734198
Sex: M
Age:
State:

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 09/25/2021
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: sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced sore arm. The outcome of the event was unknown. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1734199
Sex: U
Age:
State:

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Throwing up/vomiting; This is a spontaneous report from a contactable consumer. This consumer (patient) reported. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on Sep2021 as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On Sep2021, the patient received second dose of Pfizer Vaccine almost an hours ago and started throwing up. So was not sure just if the patient need to go to the hospital or kind just waited out at home. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1734200
Sex: F
Age:
State: FL

Vax Date: 01/16/2021
Onset Date: 02/27/2021
Rec V Date: 09/25/2021
Hospital: Y

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

Lab Data: Test Date: 20210312; Test Name: test; Test Result: Negative ; Test Date: 20210312; Test Name: SARS-CoV-2 test; Test Result: Negative ; Comments: Nasal Swab

Allergies:

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

Symptoms: pulmonary emboli - both lungs; DVT right thigh; shortness of breath; body weakness; passed out; syncope; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non-pregnant female patient received BNT162B2 (PFIZER COVID-19 VACCINE, Batch/Lot Number: EL1284), via an unspecified route of administration, administered in arm left on 16Jan2021 (at the age of 74-year-old) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history included asthma and hypertension. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); fexofenadine hydrochloride (ALLEGRA); diltiazem; simvastatin (SIM), all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 (at the age of 74-year-old) as single dose for COVID-19 immunization. The patient experienced shortness of breath, body weakness, passed out 27Feb2021 at 13:00, March 2nd passed out - admitted to hospital, all negative tests, March 12 passed out -admitted to hospital again, March 12 - pulmonary emboli - both lungs, DVT right thigh - loop recorder implanted, on Eliquis 5mg twice a day. The patient was put on Celexa March 13 - 20mg - SSRI sometimes helps with syncope. The events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. The events were considered as serious due to hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient was hospitalized for 10 days. The patient also received treatment for pulmonary emboli included lovenax injections. Since the vaccination, the patient had been tested for COVID-19 with the type of nasal swab in ER on 12Mar2021: negative result. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) PFIZER INC-202101228425 same patient/vaccine, different dose, similar event

Other Meds: ADVAIR; ALLEGRA; DILTIAZEM; SIM

Current Illness:

ID: 1734201
Sex: M
Age:
State: TX

Vax Date: 09/15/2021
Onset Date: 09/18/2021
Rec V Date: 09/25/2021
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: Real Bad toothache; He had the toothache before he took the vaccine. He has been having it like 2 years; This is a spontaneous report from a contactable consumer. A 21-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left (Batch/Lot Number: FD8448) (age at vaccination 21-year-old) on 15Sep2021 as dose 2, single for covid-19 immunisation. The patient medical history included schizophrenia from an unknown date and unknown if ongoing, was diagnosed 4 months ago. The patient's concomitant medications were not reported. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route at left arm (unable to confirm if he was given in the muscle) on 19Aug2021 at 10:30 (lot number: EW0185) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced real bad toothache on 18Sep2021 and had the toothache before he took the vaccine, having it like 2 years on an unknown date. It was reported that, Yesterday, he got a real bad toothache and she forgot he took the shot. She later stated he has had the toothache on that same tooth for about 2 years. As a response to query, caller confirmed the patient received the COVID Vaccine second dose on 15Sep2021. The date of 15Feb2021 documented as the second dose was captured inadvertently and should have been documented as 15Sep2021. The patient dose not required to visit emergency room. The outcome of the event real bad toothache was not recovered and disease recurrence was unknown.

Other Meds:

Current Illness:

ID: 1734202
Sex: F
Age:
State: GA

Vax Date: 08/07/2021
Onset Date: 08/19/2021
Rec V Date: 09/25/2021
Hospital: Y

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

Lab Data: Test Date: 20210819; Test Name: High blood pressure; Result Unstructured Data: Test Result:High; Comments: High blood pressure; Test Date: 20210809; Test Name: Covid Test; Test Result: Negative ; Test Date: 20210814; Test Name: Covid Test; Test Result: Negative

Allergies:

Symptom List: Vomiting

Symptoms: Stroke; Heart attack; High blood pressure; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07Aug2021 17:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included sleep apnoea syndrome. The patient's concomitant medications were not reported. The patient experienced high blood pressure, stroke, heart attack on 19Aug2021 15:00. The patient was hospitalized for the events for 2 days. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Therapeutic measures were taken as a result of the events including medications. The patient underwent lab tests and procedures which included blood pressure measurement: high on 19Aug2021, Covid test (Nasal Swab): negative on 09Aug2021, Covid test (Nasal Swab): negative on 14Aug2021. The outcome of the events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1734203
Sex: F
Age:
State: NC

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 09/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: like she had something poured on her tongue as she was injected, patient stated that it was the weirdest thing and it was the nastiest tasting stuff; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN9581, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in right arm on 05Feb2021 at 16:15 hours as dose 1, single (at the age of 68-years-old) for Covid-19 immunisation. Medical history included obese and flu (maybe 5 years ago from being in an elevator with little kids on vacation, she knows exactly where she got it and within no time, she had a fever and was sick) (all from an unknown date and unknown if ongoing). Patient had no relevant family medical history. Patient had no prior vaccinations (within 4 weeks). Concomitant medication(s) included rivaroxaban (Xarelto) taken as blood thinner (at this point, she had been on it maybe 2 years) from an unspecified start date and ongoing. Historical vaccine included patient received Polio vaccine (Batch/Lot number and Expiration date was not reported) via unspecified route of administration on an unspecified date for immunisation and patient stated that she does not remember when but, when they applied the Polio vaccine, they prick the skin and had no reaction. That was the way it was administered. She had no issues. Patient stated that she does not take vaccines and does not take the flu vaccine. Patient stated that she does not take them, she never had any of that stuff other than the Polio vaccine (when she was 6). On 05Feb2021 at 16:15 hours, when patient took the first dose, when they administered it, she could taste the vaccine immediately when it was injected in her right arm. She could taste the vaccine, like she had something poured on her tongue as she was injected, patient stated that it was the weirdest thing, and it was the nastiest tasting stuff. It lingered on her tongue and lasted for a good portion of that afternoon. It was the remainder of that first day. Patient stated that it did not happen the second time. No relevant tests were performed. The outcome of the event was recovered on 05Feb2021.

Other Meds: XARELTO

Current Illness:

ID: 1734204
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: constant chest pain; Heart palpitations; Fatigue; This is a spontaneous report from a contactable consumer reporting for husband. This report is not related to a study or programme. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced constant chest pain, heart palpitations, fatigue on an unspecified date. Reporter stated that patient received the vaccine on the 09 and he had this constant chest pain and heart palpitations and fatigue, and he was expensing on the EB. When probed for the confirmation of vaccine name as Pfizer COVID-19 Vaccine, Reporter stated that he had that since he got the first Pfizer COVID vaccine. Reporter was informed about the role of Pfizer drug safety. Reporter stated that she just wanted someone to report it and know what she needed to do from there. Reporter asked what Pfizer would recommend that they do with these adverse side effects. Reason for no lot number of COVID-19 Vaccine was caller unwilling to complete the report. Further probing could not be done as the reporter was unwilling to complete the report. Hence, limited information available over the call. Clinical outcome of events was unknown. Information about 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: 1734205
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/25/2021
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: Severe stomach cramping; Nausea; Bad headaches; Fatigue; Frequent urination; Muscle cramping; Muscles aches all over body; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on an unknown date in 2021 as a single dose for COVID-19 immunisation. The patient had no medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On an unknown date in 2021, the patient experienced severe stomach cramping, nausea, bad headaches, fatigue, frequent urination, muscle cramping and muscles aches all over body. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe stomach cramping, nausea, bad headaches, fatigue, frequent urination, muscle cramping, muscles aches all over body was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1734206
Sex: F
Age:
State: FL

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 09/25/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: COVID-19; Result Unstructured Data: Test Result:Unknown result; Comments: Since the vaccination, has the patient been tested for COVID-19?:Yes; Test Date: 20210312; Test Name: Nasal Swab in ER; Test Result: Negative

Allergies:

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

Symptoms: Contining to have near pass outs; 3rd dose 20Aug2021; 3rd dose 20Aug2021; This is a spontaneous report from a contactable consumer (the patient). A 75 -year-old non-pregnant female patient received the third dose of BNT162B2 (PFIZER COVID-19 VACCINE, Lot Number: FC3181) via an unspecified route of administration, administered in Arm Left on 20Aug2021 10:45 at age of 75 -year-old at single dose for COVID-19 immunisation. Medical history included asthma, hypertension and diagnosed with CML on 06Aug2021. The patient was not diagnose with COVID-19 prior to vaccination. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), fexofenadine hydrochloride (ALLEGRA), diltiazem, and simvastatin (SIM) all taken for unspecified indication(s) from unspecified date(s). The patient did not receive any other medications within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration in left arm on 28Dec2020 10:45AM at the age of 74-year-old for COVID-19 immunization. The patient previously took the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in arm left on 16Jan2021 at the age of 74-year-old for COVID-19 immunization and experienced shortness of breath, body weakness, passed out 27Feb2021 at 13:00; 12Mar2021 - pulmonary emboli - both lungs, DVT right thigh; and syncope. It reported the patient had 3rd dose 20Aug - continuing to have near pass outs in 2021. The patient had 3 episodes of near pass outs this week. The event resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. The event was considered as serious due to hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Hospitalization not prolonged. The patient was hospitalized for 10 days. Nasal Swab in ER was negative on 12Mar2021. Since the vaccination in 2021, the patient had been tested for COVID-19 (unknown result). The outcome of event "contining to have near pass outs" was not recovered.

Other Meds: ADVAIR; ALLEGRA; DILTIAZEM; SIM

Current Illness:

ID: 1734207
Sex: F
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 09/25/2021
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: felt as sick; This is a spontaneous report from a Pfizer sponsored program via contactable consumer (reported for a patient). A 5-decade-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), second dose via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and experienced no adverse event. On an unspecified date, the patient experienced felt as sick. It was reported by the reporter that two people that she knows got their first dose of the Pfizer BioNTech Covid 19 vaccine and were fine, but after their second doses, they said they felt as sick as they did when they had COVID (prior to vaccination). They both recovered Both female, one about 20 years old (college student who lived with her grandparents), one in her 40's. She asked if we could explain why they were that sick, and if they get the booster dose, will they get as sick again. The outcome of the event was reported as resolved on an unspecified date. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101224549 same reporter/drug/AE, different patients

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am