VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1288390
Sex: F
Age:
State: PA

Vax Date: 04/16/2021
Onset Date: 04/01/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: passing blood clots/having a total of 4 of them she has passed/noticing one when she went to the bathroom to urinate; she went into the bathroom and wiped, without actually going to the bathroom, she noticed the blood clot(s); felt like she needed to go to the bathroom/felt weird like something needed to come out; headache; dizziness; hot and cold sweats; This is a spontaneous report from a contactable consumer (who is also the patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 16Apr2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In Apr2021, after the first vaccination, the patient experienced "some of the usual side effects" described further as headache, dizziness, and hot and cold sweats. On 18Apr2021, 2 days after the first vaccination, the patient experienced passing blood clots having a total of 4 of them she has passed. She reported noticing one when she went to the bathroom to urinate. For the other blood clots, she reported it felt like she needed to go to the bathroom further described as "felt weird like something needed to come out." When she went into the bathroom and wiped, without actually going to the bathroom, she noticed the blood clot(s). The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1288391
Sex: U
Age:
State:

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

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

Lab Data: Test Name: COVID-19 test; Test Result: Positive

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable nurse via Medical information team. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 in between doses. The person who tested positive has not yet received the second dose. The patient tested positive for COVID-19 after receiving the first dose of BNT162B2 on unspecified date. The outcome of the event was unknown. information on about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1288392
Sex: F
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 05/05/2021
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: skin melanoma; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient said she had surgery for her skin melanoma on Monday (unspecified date), and received her second dose of the Pfizer-BioNTech Covid-19 Vaccine on Friday. She wants to know if the Novocaine they gave her during the surgery affected the vaccine. They told the patient that there is no information in the Pfizer-BioNTech Covid-19 Vaccine Prescribing Information about a potential interaction or administration with Novocaine. They also referred the patient to her HCP for more guidance. Patient said she had no problems with the first dose of the Pfizer-BioNTech Covid-19 Vaccine. On 20Apr2021, the patient was calling about the COVID 19 vaccine. She had the vaccine 3 weeks ago and she had no side effects or symptoms and she had received text messages everyday to see how she was feeling everything and she always answered none or no. Patient declined to complete report at this time wished to be transferred to MI for her question. The outcome of the event was unknown. Therapeutic measures were taken as a result of skin melanoma. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1288393
Sex: F
Age:
State: IN

Vax Date: 02/22/2021
Onset Date: 04/11/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data: Test Date: 20210420; Test Name: Hearing test abnormal; Result Unstructured Data: Test Result:Left ear hearing loss due to nerve damage

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Hearing loss due to nerve damage; sudden and unexpected hearing loss in her left ear; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6200), via an unspecified route of administration on 22Feb2021 (at the age of 68-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were reported as none. There were no other vaccines administered within 4 weeks or on the same date as the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9263) on 01Feb2021 (at the age of 68-years-old) for COVID-19 immunization. On 08Mar2021, the patient had a cataract extraction in both eyes after which she started taking prednisolone acetate USP 1% (UPC: 6075811910, Lot: T0557, Expiry: Jun2023) steroid eye drops on approximately 10Mar2021 for an unspecified length of treatment. On 11Apr2021, the patient experienced sudden and unexpected hearing loss in the left ear only, which worsened. Per the appointment with the ear, nose, and throat (ENT) doctor, there was no reason for the unexpected hearing loss in her left ear, and the hearing loss was not related to anything medical. The ENT doctor started the patient on a steroid treatment (prednisone) for 10 days. On 20Apr2021, the patient had an abnormal hearing test which showed left ear hearing loss due to nerve damage (as of an unspecified date). The events did not require an emergency room visit. The clinical outcome of sudden and unexpected hearing loss in her left ear was not resolved, while of hearing loss due to nerve damage was unknown.

Other Meds:

Current Illness:

ID: 1288394
Sex: F
Age:
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: She picked at a little bump and it started to bleed; little bumps on her chest; sunburn; Chest top of shoulders, back of shoulders turned bright red/ Her chest, shoulder, and upper part of back turned red; She was burnt, but did not have any blisters. She described her skin feeling like she poured peroxide on an open cut.; Nauseous; The inside of her body did not feel right. She felt like something was attacking the inside of her body.; sun allergy reaction; Rash on the top part of the chest; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 17Mar2021 15:00 (Lot Number: EN6202) in the arm as SINGLE DOSE for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took advil [ibuprofen], tylenol regular and vitamins. The patient went on a boat ride two weeks later with minimal exposure to the sun and developed chest, top of shoulders, back of shoulders turned bright red. She put after sun lotion on and it didn't go away. She was told by her pharmacist to take bendryl and use cortisone with aloe. She used topical benadryl gel first and it wasn't helpful. She took oral liquid benadryl and was able to sleep. The patient stated, It felt like "I had an open wound and poured peroxide on it- my entire chest." She couldn't stand to have clothes on her chest. She did not develop any blisters. Her doctor recommended she not get the second dose so she missed the second dose. She believes that she had a reaction to the covid vaccine. She received the first dose of the covid vaccine, and the inside of her body did not feel right. She felt like something was attacking the inside of her body. A couple of weeks later, she went on a boat ride with her friends. Her chest, shoulder, and upper part of back turned red. She was burnt, but did not have any blisters. She described her skin feeling like she poured peroxide on an open cut. She tried treating it with aloe vera and a cloth with cold water. Hydrocortisone 1% with aloe vera made it hurt worse. She took liquid Benadryl and it put her to sleep. She has been reading up on side effects and about people calling to report. She thinks that she had a sun allergy reaction. The redness has still has not gone away. She now has little bumps on her chest. She is going to go to the dermatologist. She thinks that she had this reaction from the covid vaccine. She is 72 years old. She has never had anything happen to her like this before. She is out in the sun often. The day that she took the boat ride, she was only out for a little period. It goes from the upper part of her breast to her shoulder. She is not allergic to the sun, so she is not sure why she had a reaction. Because sun allergies are common, but not often reported, she wanted to call and report about her experience. The inside of her body did not feel right. She felt like something was attacking the inside of her body. It began on the same day she received the covid vaccine, 17Mar2021. It is now recovered completely. It lasted for several weeks, at least two weeks. Her chest, shoulder, and upper part of back turned red. She was burnt, but did not have any blisters. She described her skin feeling like she poured peroxide on an open cut: She clarifies that it is like a redness, like a sunburn. It began on 31Mar2021, two weeks after she received the first dose of the covid vaccine. It is a lot better now. But now she has these little bumps, she picked at a little bump and it started to bleed. She is asking about sun allergies. She is asking what can she do about this. She is asking if she can take anything. Hydrocortisone 1% with aloe vera made it hurt worse. She also used After Tan that had aloe vera in it. After Tan is a lotion made by Banana Boat that is sold over the counter. It is raining cats and dogs outside, so she is not able to go and get the bottle. She took liquid Benadryl and it put her to sleep. Benadryl gel made her skin burn. The patient had rash on the top part of the chest in Mar2021. The outcome of the event did not feel right, shoulders turned bright red and skin feeling like she poured peroxide on an open wound and nauseous was recovering. The outcome of the rest of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1288395
Sex: F
Age:
State: NY

Vax Date: 04/19/2021
Onset Date: 04/20/2021
Rec V Date: 05/05/2021
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: Experienced syncope approximately a half hour after getting out of bed; Passed out on kitchen floor; Dizziness episode lasted for approximately an hour, of which half was spent on the floor.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 46 years of age), via an unspecified route of administration, administered in arm left on 19Apr2021 17:00 (Batch/Lot Number: EW0164) as a single dose for COVID-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing as it was reported that the patient had covid prior vaccination. The patient's concomitant medications were not reported. The patient had not been given any other vaccine in four weeks prior to covid vaccine. The patient was not pregnant. On 20Apr2021 12:15 PM, the patient experienced syncope approximately a half hour after getting out of bed. She passed out on kitchen floor. Dizziness episode lasted for approximately an hour, of which half was spent on the floor. The outcome of 'Experienced syncope approximately a half hour after getting out of bed' and 'Passed out on kitchen floor' was recovering while Dizziness was recovered on 20Apr2021 13:15 (lasted for approximately an hour). No treatment received for the events. The patient had not been tested for covid post vaccination.

Other Meds:

Current Illness:

ID: 1288396
Sex: F
Age:
State: CA

Vax Date: 03/29/2021
Onset Date: 04/01/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data: Test Date: 20210401; Test Name: HR; Result Unstructured Data: Test Result:high

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Experiencing A-Fib symptoms for last 3 weeks; Jittery; high HR (normally very low); palpitations; shortness of breath with any exertion; This is a spontaneous report from a contactable consumer. A non-pregnant 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 29Mar2021 09:30 (Batch/Lot Number: ER8737) as single dose for COVID-19 immunisation. Medical history included fibromyalgia, gastrooesophageal reflux disease, IBS, Ehlers Danlos Hypermobility Symdrome, POTS, hypothyroidism and hyperparathyroidism. Patient has no known drug allergies. Concomitant medications included duloxetine hydrochloride (CYMBALTA), buspirone hydrochloride (BUSPAR) and levothyroxine sodium, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 dose 1 (Lot number: EN6199), ON 08Mar2021 08:45 AM, on left arm for COVID-19 immunisation. The patient has no COVID prior vaccination and not tested post vaccination. 3 weeks (2nd vaccine was on 29Mar) and just put 2 and 2 together. 7+ A-Fib instances recorded on smartwatch. Jittery, high HR (normally very low), palpitations and shortness of breath with any exertion, all on 01Apr2021 06:30. It was unknown if treatment was received. The outcome of the events was not recovered.

Other Meds: CYMBALTA; BUSPAR; LEVOTHYROXINE SODIUM

Current Illness:

ID: 1288397
Sex: F
Age:
State: VA

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 05/05/2021
Hospital:

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

Lab Data: Test Name: antibodies the test was positive; Test Result: Positive ; Comments: producing antibodies the test was positive

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: alpha-gal allergy; horrible rashes; her lips were swollen; This is a spontaneous report from a contactable consumer (the patient) and from the same consumer (the patient) from a Pfizer-sponsored program COVAX Support. A female patient (Age: 76, Units: not provided) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 19Mar2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history included: allergies when she eats meat. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 22Feb2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. After the second COVID vaccine dose, the patient ended up in the Emergency Room, because she experienced horrible rashes, and her lips were swollen. Her Doctor prescribed her prednisone and diphenhydramine hcl (BENADRYL), and she took those medications. She stated she was pretty sure it had to do with alpha-gal. At first, she thought it was not in the vaccine, but now she was not sure. The patient stated that when she first searched animal products, she went back and researched in cholesterol, lipids, and stearic acid products that were not in the initial information provided, and felt that these may be a contributing factor to the alpha-gal allergy she was experiencing. The patient had already obtained information prior to the vaccine regarding our alpha-gal and animal product information, but she felt there was more that has not been addressed. She took substantial BENADRYL and cortisone and had symptoms. When she was getting the antibody test administered, the girl saw the picture of how she looked. She was producing antibodies (unspecified, not further clarified); the test was positive. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1288398
Sex: F
Age:
State: PA

Vax Date: 04/13/2021
Onset Date: 04/14/2021
Rec V Date: 05/05/2021
Hospital: Y

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: superficial thrombophlebitis clot behind left knee; chills; headaches; This is a spontaneous report from a contactable consumer reporting for herself. A 36-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in the Left Arm on 13Apr2021 11:45 (Batch/Lot Number: Ew0162) as single dose for covid-19 immunisation . The patient medical history was not reported. Concomitant medication(s) included hydroxychloroquine (HYDROXYCHLOROQUINE) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient experienced superficial thrombophlebitis clot behind left knee on 14Apr2021 with outcome of recovering , chills on 14Apr2021 with outcome of recovering , headaches on 14Apr2021 with outcome of recovering. The reported events were considered serious because caused the patient to visit Emergency room/department or urgent care. Follow up information has been requested. Lot number has already been provided.

Other Meds: HYDROXYCHLOROQUINE; ZOLOFT

Current Illness:

ID: 1288399
Sex: F
Age:
State:

Vax Date: 03/27/2021
Onset Date: 03/30/2021
Rec V Date: 05/05/2021
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: This is a spontaneous report from a non-contactable consumer (patient). A 25-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 27Mar2021 (at the age of 25 years old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included hepatitis b vaccine (HEPATITIS B VACCIN). Other vaccine that was given within 4 weeks included HEPATITIS B VACCINE. On 30Mar2021, The patient experienced Loss hearing in one ear (medically significant) and now constant ringing in both. Treatment was given as a result of loss hearing in one ear, ringing in both which included Anti biotic and steroid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of the events was not recovered. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: HEPATITIS B VACCIN

Current Illness:

ID: 1288400
Sex: M
Age:
State:

Vax Date: 01/01/2021
Onset Date: 02/01/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Herpes Zoster infection; This is a spontaneous report from non-contactable Other healthcare professional (HCP). A 27-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on Jan2021 (Lot Number: EL9262) as SINGLE DOSE (at age of 27 years old) for covid-19 immunisation. Medical history included infant chicken pox (positive varicella titer) from an unknown date and unknown if ongoing. The patient did not have a history of allergies. Concomitant medication(s) included escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported. Historical vaccine information included BNT162B2 lot number= EL0142, administration date Jan2021, dose number 1 for Covid-19 immunisation (at 27 years old). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received the vaccine at clinic. Approximately 4 weeks following the second dose, he experienced Herpes Zoster infection in Feb2021. He had no prior history of Zoster or any other herpes infection aside from infant chicken pox (positive varicella titer). Therapeutic measures were taken as a result of herpes zoster infection included Valtrex. Outcome of the event was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Other Meds: ESCITALOPRAM

Current Illness:

ID: 1288401
Sex: M
Age:
State: MD

Vax Date: 04/19/2021
Onset Date: 04/19/2021
Rec V Date: 05/05/2021
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: Seizure; No recollection of anything that happened between 2000 and 2100 hours; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Not comprehending; He was very cold; Very tired; Very Sweaty; Headache; This is a spontaneous report from a contactable consumer (Patient's wife). A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 12:30 (Lot Number: EW0164) as SINGLE DOSE (at age of 53 years old) for covid-19 immunisation. Medical history included ongoing epilepsy diagnosed with this when he was 15 years old, seizure from an unknown date and unknown if ongoing (then at 2015 he had a seizure). Concomitant medications included levetiracetam (KEPPRA) 1250 mg, daily (250mg; 5 pills a day) taken for epilepsy from an unspecified start date and ongoing; carbamazepine (CARBAMAZEPINE) 1000 mg, daily (200mg; 5 pills a day) taken for an unspecified indication from an unspecified start date and ongoing. Family Medical History Relevant to events was none. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 19Apr2021, the patient experienced seizure, Very foggy, not thinking properly, repetitive in what he was saying, very distant, like he was looking at his wife but not seeing her or hearing her, Headache, He was very cold, Very tired, Not comprehending, Very Sweaty, No recollection of anything that happened between 2000 and 2100 hours. The patient received his vaccine yesterday 19Apr2021 at 1230. On 19Apr2021 by 1500 he was very foggy, not thinking properly, and repetitive in what he was saying. He was very distant, like he was looking at the consumer but not seeing her or hearing what she was saying. He was very cold, very tired, and not comprehending. Then at 2015 he had a seizure. She called the paramedics, her husband was very sweaty on 19Apr2021 and that point and had no recollection of anything that happened between 2000 and 2100 hours. Patient was not taken to the Emergency Room or admitted to the hospital. Her husband is completely aware and recovered now. Consumer reported on 19Apr2021 he had a headache that is persisting since the seizure. The consumer reported that her husband is epileptic, but he hasn't had a seizure in over 10 years and hasn't missed any doses of his medication. Patient was evaluated by the Paramedics that came to his home but was not taken to the Emergency Room. Relevant Tests were none. Outcome of Seizure was Recovered/Resolved with Sequel on 19Apr2021. Outcome of Very foggy, not thinking properly, repetitive in what he was saying, He was very cold, Very tired, Not comprehending, Very Sweaty was recovered on 19Apr2021. Outcome of headache was not recovered. Outcome of No recollection of anything that happened between 2000 and 2100 hours was unknown.

Other Meds: KEPPRA; CARBAMAZEPINE

Current Illness: Epilepsy (diagnosed with this when he was 15 years old.)

ID: 1288402
Sex: F
Age:
State: MS

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 05/05/2021
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: Bell's palsy; tongue went numb; body aches; regular sore arm; headache; This is a spontaneous report from a contactable consumer reporting for herself. A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0153/expiration date: not provided), via an unspecified route of administration, on 15Apr2021 10:45 (at the age of 21 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021, the patient experienced regular sore arm, headache. On 16Apr2021, the patient experienced body aches. On 17Apr2021, the patient's tongue went numb. On 20Apr2021, the patient experienced Bell's palsy and described it as getting worse. The outcome of the event regular sore arm was recovered on 16Apr2021. The outcome of the event body aches was recovered on 19Apr2021. The outcome of the events headache, tongue went numb and Bell's palsy was not recovered.

Other Meds:

Current Illness:

ID: 1288403
Sex: M
Age:
State:

Vax Date: 03/12/2021
Onset Date: 04/02/2021
Rec V Date: 05/05/2021
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: Test Date: 20210402; Test Name: bone biopsy; Result Unstructured Data: Test Result:came out good with one exception, they found a clu; Comments: came out good with one exception, they found a cluster of T-cells that pathology was unable to explain

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient received the 1st dose of BNT162B2 on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he had both of the Pfizer Covid 19 vaccines and the last one was on 12Mar2021. The patient stated that on 02Apr2021 he had a bone biopsy and it came out good with one exception, they found a cluster of T-cells that pathology was unable to explain. The patient further stated that he has multiple myeloma. The patient added that they theorized it may have come from the vaccination and was not concerned about it nor did the HCP want to follow up with it. The patient added that in previous years the T-cells did not show up but this time they did. The outcome of event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1288404
Sex: F
Age:
State: NY

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 05/05/2021
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: got covid-19 after the first dose; got covid-19 after the first dose; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The pharmacist stated having a patient who got COVID-19 after the first dose of the PFIZER-BIONTECH COVID-19 VACCINE on 23Mar2021. The patient got COVID-19 disease after the first dose and went to Urgent Care due to COVID-19 symptoms. The patient has now fully recovered and is planning to get her second dose of the PFIZER-BIONTECH COVID-19 VACCINE at the time of reporting. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1288405
Sex: F
Age:
State: NJ

Vax Date: 04/06/2021
Onset Date:
Rec V Date: 05/05/2021
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 Name: Covid-19 test; Test Result: Positive

Allergies:

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

Symptoms: stated that she has Covid; stated that she has Covid; This is a spontaneous report from a contactable consumer (cousin). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) (at the age of 52-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she had COVID on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The patient outcome of the event was unknown. The information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1288406
Sex: M
Age:
State: MI

Vax Date: 03/30/2021
Onset Date: 04/01/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data: Test Date: 20210405; Test Name: COVID-19 test; Result Unstructured Data: Test Result:positive

Allergies:

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

Symptoms: positive COVID-19 test with symptoms; headache; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8730), via an unspecified route of administration in the left arm on 30Mar2021 at 19:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included "maybe" was exposed to COVID-19 in Apr2021. Concomitant medications were none. There were no other vaccines administered on the same date or within 4 weeks of BNT162B2. Within a couple of days of the first vaccination dose (Apr2021), the patient went for a trip and "maybe" was exposed to COVID-19. On Apr2021, the patient felt some kind of tiredness and headache. The patient took ibuprofen (ADVIL) and paracetamol (TYLENOL) for the tiredness and headache. The patient reported that he drove a lot of distance and did a lot of things during the trip, so these were not COVID-19 symptoms. On 05Apr2021, the patient tested positive for COVID-19 via a nasal COVID-19 test and experienced COVID-19 symptoms. On an unspecified date, the patient had some cough, so he went to the emergency room and was given azithromycin and a cough tablet and cough syrup. The patient queried when he can receive his second dose as he had already completed his 2-week isolation period and had no more symptoms. The clinical outcome of "positive COVID-19 test with symptoms", headache and tiredness was resolved on Apr2021.

Other Meds:

Current Illness:

ID: 1288407
Sex: M
Age:
State: CO

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data: Test Name: EKG; Result Unstructured Data: Test Result:Unknown results; Test Name: EKG; Result Unstructured Data: Test Result:Unknown results; Test Name: EKG; Result Unstructured Data: Test Result:Unknown results; Test Name: Tests; Result Unstructured Data: Test Result:Unknown results.

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Extreme fatigue; brain fog; Passed out; Told possible seizure; Felt ill shortly after receiving shot; Threw up; This is a spontaneous report from a contactable consumer (the patient) and then from a contactable consumer (the patient's wife). A 59-year-old male patient received the first dose of BNT162B2 (lot number not provided), via an unspecified route of administration in the left arm on 31Mar2021 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included: fish oil (OMEGA 3 FISH OIL). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient felt ill shortly after receiving the shot. Told to sit down. Passed out. Awoke on the floor. Told possible seizure. Sat up. Threw up. Told to lie back down. Ambulance came and took him to the hospital. He spent 90 minutes in the Emergency Room. He was unable to work for a couple of days. He had extreme fatigue and brain fog. He was not back to relatively normal for at least 10 days. Treatment received was reported as yes: ran tests including 3 EKGs, on an unspecified date. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.

Other Meds: OMEGA 3 FISH OIL [FISH OIL]

Current Illness:

ID: 1288408
Sex: F
Age:
State: IL

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: ulcerated ankles bled into her shoe/ bled more; ulcerated ankles bled into her shoe/ bled more; bleeding disorder; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732), first dose via an unspecified route of administration, administered in Arm Right on 01Apr2021 (at 67 years old), single dose for covid-19 immunisation. Medical history included ongoing ulcerated ankles, joint bleeding diagnosed prior to the vaccine in her 40s. The patient had no concomitant medications. On 04Apr2021, 3 days post-vaccination her ulcerated ankles bled. She explained this bleeding has happened before, but she bled more, and it reached into her shoes which is "unusual". Patient came home from shopping three days after the vaccine and her shoes were saturated with blood, states this lasted for about a day and resolved two days later around 06Apr2021. She was reading through the paperwork and it said to let them know if you have a bleeding disorder. She is scared. Her ankles have bled like this before, wants to know if this is considered a bleeding disorder, does the vaccine make you bleed more. The outcome of the events was recovered on 06Apr2021.

Other Meds:

Current Illness: Ankle ulcer (diagnosed prior to the vaccine in her 40s); Joint bleeding

ID: 1288409
Sex: F
Age:
State: DC

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

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

Lab Data: Test Date: 20210406; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: fainted; weak; tired; itching; trouble breathing; face swelling; unstable vital signs; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration, administered in left arm on 05Apr2021 10:00 as single dose for covid-19 immunisation. Medical history included hypothyroidism, high cholesterol, allergies to penicillin and shell seafood. here were no concomitant medications. The patient previously took Percocet [oxycodone hydrochloride;paracetamol] and experienced allergies. The patient experienced fainted, weak, tired, itching, trouble breathing, face swelling and unstable vital signs on 05Apr2021 21:30. The patient was hospitalized. It was unknown if the patient received any treatment. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1288410
Sex: F
Age:
State: CT

Vax Date: 04/10/2021
Onset Date: 04/15/2021
Rec V Date: 05/05/2021
Hospital: Y

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: Test Date: 20210415; Test Name: MRI; Result Unstructured Data: Test Result:increased synovial fluid; Comments: increased synovial fluid in the left hip joint, analysis showed highly elevated immune infiltration present in the synovial fluid; Test Date: 20210416; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: Acute inflammation of the left hip joint; excruciating pain; increased synovial fluid in the left hip joint; unable to move, walk of bare weight on the left side; unable to move, walk of bare weight on the left side; elevated markers of inflammation in peripheral blood; highly elevated immune infiltration; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Left on 10Apr2021 14:15 (Lot Number: EW0150) (received at 34-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included herniated lumbar discs. The patient was not pregnant. Concomitant medication(s) included levonorgestrel (MIRENA) taken for an unspecified indication, start and stop date were not reported. The patient experienced Acute inflammation of the left hip joint, excruciating pain, unable to move, walk of bare weight on the left side, elevated markers of inflammation in peripheral blood, MRI showed increased synovial fluid in the left hip joint, analysis showed highly elevated immune infiltration present in the synovial fluid, with no presence of concurrent infection or elevated markers of systemic autoimmune disease, or secondary conditions that could lead to joint inflammation, all on 15Apr2021 05:00 AM. The patient underwent lab tests and procedures which included magnetic resonance imaging (MRI): increased synovial fluid on 15Apr2021 increased synovial fluid in the left hip joint, analysis showed highly elevated immune infiltration present in the synovial fluid; nasal swab test: negative on 16Apr2021. Therapeutic measures were taken as a result of the adverse events which included aspiration of fluid from joint, anti-inflammatories. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 4 days. Outcome of the events was recovering.

Other Meds: MIRENA

Current Illness:

ID: 1288411
Sex: F
Age:
State: TX

Vax Date: 04/12/2021
Onset Date: 04/18/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: sustain cramps in her right leg; limited range of motion; not sure if there was a nerve that has been damaged or early stage of thrombosis; not sure if there was a nerve that has been damaged or early stage of thrombosis; severe arm pain; This is a spontaneous report from a contactable consumer reporting for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 12Apr2021 at 09:30 (at the age of 56 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication was none. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. On 18Apr2021 at 18:00, the patient experienced severe arm pain that was described as arm pain was too painful and have been woken up out of her sleep and she has limited range of motion and she was not sure if there was a nerve that has been damaged or early stage of thrombosis. On 20Apr2021, the patient experienced sustain cramps in her right leg. The patient did not receive treatment for the events. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1288412
Sex: F
Age:
State: NY

Vax Date: 02/07/2021
Onset Date: 03/28/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data: Test Date: 20210414; Test Name: PCR; Result Unstructured Data: Test Result:Negative; Comments: Nasal swab

Allergies:

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

Symptoms: Debilitating migraines; This is a spontaneous report from a contactable other HCP. A 44-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 07Feb2021 12:00 (Batch/Lot Number: EN5318) as single dose at the age of 43-year-old for COVID-19 immunisation, administered at a facility. The patient medical history was none. No known allergies. The concomitant medications were not reported. The patient had not experienced Covid-19 prior vaccination. Patient was not pregnant. The female patient received bnt162b2 (BNT162B2), dose 1 on in arm left 17Jan2021 04:00 PM (Batch/Lot # EL8992) at the age of 43-year-old for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced debilitating migraines on 28Mar2021. The event was considered serious as per disability or permanent damage. No treatment received for the event. COVID was tested post vaccination: Nasal Swab, PCR, resulted negative on 14Apr2021. The outcome of event was recovered with sequelae/lasting effects.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of migraine. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1288413
Sex: F
Age:
State: FL

Vax Date: 03/17/2021
Onset Date: 04/20/2021
Rec V Date: 05/05/2021
Hospital: Y

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: body weight; Result Unstructured Data: Test Result:patient has lost between 10-15 lbs; Comments: about 10% body weight

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: This is a spontaneous report from a contactable physician. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 48-year-old, dose 2 via an unspecified route of administration on 17Mar2021 (Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included Huntington's disease diagnosed in 1995, due to this her voice crackles a bit. The patient's concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: EL9263) at the age of 48-year-old, for COVID-19 immunisation and she experienced 4 days of severe nausea, vomiting, couldn't get out of bed, couldn't eat, and diarrhea. The patient got her second dose on 17Mar2021 and had worsening of nausea, vomiting and fatigue on an unspecified date. The patient couldn't keep food down, can't sleep and keeps falling down, and he states "that really concerns me, she's going to knock her teeth out or bleed in her brain, that's not good". She's barely able to get around, doesn't leave unless she has a doctor's appointment. The problem is this, it's not the vaccine, it's the genetic modification this patient has Huntington's disease she was told it was safe, but don't think they took into consideration that it's a genetic modification and she has Huntington's which was also the genetic modification, don't know what to do at this point. He mentions that her nausea and dizziness was getting worse now that were a month out. She's falling down more than before. He wants to help her keep down food because she lost approximately 10% of her body weight. She's dizzy and weak, he states "she's wiped out, not sleeping". He also mentions that she's had hospitalizations. The reported was asking what do to next and if there was an on-staff physician for special cases. Patient reports going to the hospital 8 days after the second shot, she wasn't eating or sleeping. The second shot of Pfizer COVID vaccine was on 17Mar2021, patient began having severe vertigo, falling down, breathing hard, afraid she was going to knock her teeth out or break a bone, insomnia on an unspecified date. Patient reports she took a sip of water and threw up all over the side of the car today 20Apr2021. The Doctor states that this was not normal for her. Patient and reporter stated that the patient has lost between 10-15 lbs, about 10% of body weight. Reporter states that Ivermectin comes in custom lozenges and that it gets rid of inflammation so that it doesn't hurt the whole body. Ivermectin can make the GI upset. Caller states that it was not actually a vaccine that Pfizer was offering, reporter explains that Huntington Disease was when there was a repetitive code in the DNA, to the point it effects muscles and nerves and renders you. What Pfizer and Moderna was offering was a genetic modifier, mRNA was a genetic modifier, not a vaccine. In a Vaccine, they take a piece, make sure its dead, expose it to you and your body makes an antigen, that's a typical vaccine but this is not. Patient says Friday Saturday and Sunday she was stuck in the house. She cannot do anything. Reporter says the patient needs professional help. Her voice fluctuates so people take her seriously. (institute name), told the patient it would be ok to take the Pfizer COVID vaccine, but they didn't take into consideration is it was a genetic modifier. This was not a typical vaccine. Reporter states that he needs help escalating this please help with escalating this, needs help to know what to do for this patient because of the MRNA genetic modification. The mRNA may have affected the Huntingtons. The events resulted to hospitalization except for vertigo and breathing hard. The outcome of the events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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: 1288414
Sex: M
Age:
State: PA

Vax Date: 04/09/2021
Onset Date: 04/11/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:140s and 150s

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: bilateral pulmonary embolism; right DVT; sinus tachycardia; Afib with RVR.; This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 68-year-old male patient received BNT162B2 (Pfizer COVID vaccine), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: Unknown) as single dose for Covid-19 immunisation. Medical history included hypertension, gastrooesophageal reflux disease (GERD), and deep vein thrombosis (DVT) original diagnosis from Jan2018. The patient previously received the first dose of BNT162B2 on 19Mar2021 for Covid-19 immunisation. The physician reported the patient had bilateral pulmonary embolism and a right DVT on 11Apr2021. The patient went to the ER on 11Apr2021. She confirms the pulmonary embolisms and the DVT were diagnosed 11Apr2021 when the patient went to the ER. She has more of the patient's story, caller does not think this would be linked to the vaccine but that is for someone else to decide she is reporting. The day of the event the patient's heart was racing, he passed out and went to the ER, he had sinus tachycardia and Afib with RVR (date/s unspecified). His heart rate was up to 140s and 150s. The patient has history of hypertension, GERD, and previous DVT, the original DVT that patient had was diagnosed in Jan2018 and he was placed on Xarelto at that time and he was on Xarelto until Jun2019. He has not been on anything for this since that time, until this episode. Caller says reporter did not provide any specific treatment information that the patient has received for the event she is reporting. Reporter provided the patient went to the emergency room, he did not say if the patient was admitted or had hospitalization. The outcome of events was unknown. Information about the Lot/batch number has been requested.; Sender's Comments: Drug causality would seem unlikely for BNT162B2. The reported events may be regarded as natural progression of patient's pre-existing conditions. The impact of this report on the benefit/risk profile of the Pfizer drug 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 Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1288415
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 05/05/2021
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 Name: now has Covid; Result Unstructured Data: Test Result:now has Covid

Allergies:

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

Symptoms: patient has Covid after receiving the vaccine; patient has Covid after receiving the vaccine; This is a spontaneous report from a contactable physician reporting for a patient via a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported. The patient received the first dose of the Covid vaccine and now has Covid. They want to give the patient a treatment of antibodies. The patient underwent lab tests and procedures which included sars-cov-2 test: now has COVID on an unspecified date. Reporter has questions on how that would affect the vaccine. Outcome of the event was unknown. Information about lot/batch has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agencies as appropriate.

Other Meds:

Current Illness:

ID: 1288416
Sex: M
Age:
State: PA

Vax Date: 04/17/2021
Onset Date: 04/17/2021
Rec V Date: 05/05/2021
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: increased seizure activity/mini seizures; increased seizure activity/mini seizures; confusion and memory issues; confusion and memory issues; fatigue/tired; This is a spontaneous report from a contactable consumer. A 17-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 17Apr2021 09:00 (Lot Number: EW1064) as SINGLE DOSE (at age of 17 years old) for covid-19 immunisation. Medical history included epilepsy (interactable epilepsy) from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine information included BNT162B2 dose 1 on 25Mar2021 09:00, lot number as ER8733, in the left arm for COVID-19 immunisation(at age of 17 years old). On 17Apr2021, the patient experienced increased seizure activity, fatigue/tired, confusion and memory issues. After the 2nd shot, about 4-5 hours, he experienced increased seizure activity and it has progressed to today, today he is a little bit better but it has progressed to point he is having a lot of confusion and memory issues. He has several different types of seizures but he has what are called mini seizures, the blank stare, the confusion. Nothing has stopped completely, he isn't back to his baseline as far as his seizures. He always has seizures, daily so she is calling about the increased activity and when she says his baseline she means he has not returned back to his baseline activity, but he is doing better than yesterday. Saturday, Sunday, and Monday were horrible. Today he started to get back to his normal self. The events did not require a visit to the Emergency Room or Physician Office. Outcome of the increased seizure activity/mini seizures, confusion and memory issues were recovering. Outcome of fatigue/tired were not recovered.

Other Meds:

Current Illness:

ID: 1288417
Sex: F
Age:
State: VA

Vax Date: 04/13/2021
Onset Date: 04/01/2021
Rec V Date: 05/05/2021
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: 20210416; Test Name: cultures; Result Unstructured Data: Test Result:everything was negative; Test Date: 20210416; Test Name: tested for Covid, Strep, Influenza; Test Result: Negative ; Test Date: 20210416; Test Name: pulmonary test; Test Result: Negative ; Test Date: 20210416; Test Name: tested for Covid, Strep, Influenza; Test Result: Negative ; Test Date: 20210416; Test Name: tested for Covid, Strep, Influenza; Test Result: Negative ; Test Date: 20210416; Test Name: urine test; Test Result: Negative

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swallow; Ears were itching, scratching her arms; Ears were itching, scratching her arms; really, really sick; Sore throat; throat and gland started swelling really big; throat and gland started swelling really big, glands were swollen; complaining about stomach; I noticed that my ear started swollen so bad; it is like an allergic reaction; Severe Flu-like symptoms, COVID-like symptoms; Migraine from back of her head, headaches; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 13Apr2021 (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Lyme disease. Concomitant medication was none. On 14Apr2021, the patient experienced severe flu-like and COVID-like symptoms which included body aches which was very strong, and feeling feverish, she was complaining about stomach, her throat and gland started swelling really big, her ear started to swell so bad, it is like an allergic reaction. On 15Apr2021, the patient experienced sore throat, and she got really, really sick. On 16Apr2021, the patient experienced glands were swollen, she could barely swallow, ears were itching, and she was scratching her arms. On 18Apr2021, the patient experienced I had rash, small tiny pimple a rash. On 19Apr2021, the patient experienced apnea episodes, felt like she couldn't breathe. On an unspecified date in Apr2021, the patient experienced, migraine from back of her head, headaches. On 16Apr2021, the patient went to urgent care, and she was tested for COVID, strep, influenza and they did a urine test, because she was also reporting stomach aches and pulmonary test. All the test results were negative. Cultures, to the previous tests were performed and everything was negative. The events required and emergency room visit and the emergency room doctor, didn't think it was an allergic reaction to the vaccine, because it took so long, to happen. The patient was treated for the events in the emergency room, with steroids, Benadryl and an intravenous infusion. The patient said that she was fine now. The outcome of the events was recovered on an unspecified date in Apr2021. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1288418
Sex: F
Age:
State: PA

Vax Date: 04/06/2021
Onset Date: 04/08/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data: Test Date: 20210410; Test Name: Bloodwork to test for Lyme Disease; Test Result: Negative

Allergies:

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

Symptoms: Bell's palsy; This is a spontaneous report from a contactable consumer (the patient). This 51-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm, upper arm, on 06Apr2021 14:00 (at the age of 51-year-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient denied being sick at the time of vaccination. The patient's medical history was not reported. No relevant family medical history was reported. There were no concomitant medications. On the night of 08Apr2021, the patient was having intense pain down her neck and behind her left ear, and it has been waking her up at night. On 09Apr2021, she went to Urgent Care and they misdiagnosed her with a possible oncoming ear infection. On Saturday morning (10Apr2021), she woke up and could not move the left side of her face so she went to the ER (emergency room) and they diagnosed her with Bell's Palsy. On 10Apr2021 at the ER, blood test for Lyme disease was negative. The ER gave the patient a steroid and antiviral pill and told her to follow up with her primary doctor in 8 days. The patient went to her physician's office on 19Apr2021 to follow-up with her Bell's Palsy. The patient stated that intense pain (down her neck and behind her left ear) was apparently a symptom of the Bell's Palsy. The only improvement with the Bell's Palsy was that she can sip out of straw a little easier but lips are still to the side. The clinical outcome of the event Bell's Palsy was resolving. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1288419
Sex: F
Age:
State: WI

Vax Date: 03/11/2021
Onset Date: 03/01/2021
Rec V Date: 05/05/2021
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: fatigue; Eyesight; Dizzy; bell's palsy; This is a spontaneous report from a contactable consumer (patient's son). A 97-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EN6207) intramuscularly in the right arm on 11Mar2021 at 14:00 as a single dose for COVID-19 immunization. Patient's medical history included glaucoma for more than 25 years - 'implants caser' (as reported), thyroid disorder for more than 25 years, eye disorder, and gastrointestinal disorder. The patient had no other prior vaccinations to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EN6201) intramuscularly in the right arm on 18Feb2021 at 15:00 as a single dose for COVID-19 immunization and experienced cannot focus with her eyes and full body aches and pains. Ongoing concomitant medications included timolol ("Timnol") drops for the eyes since more than 5 years, levothyroxine sodium (LEVOTHYROXIN) pill for thyroid since more than 20 years, and omeprazaole pill for stomach for 5 years. One week after the second injection (Mar2021), the patient experienced Bell's Palsy at 20:30, reported as serious for important medical event. On 12Mar2021 at 22:00, patient was dizzy and 'eyesight', both events reported as non-serious. It was further described as, "She saw patient over everything so she slept. Day after 2nd she had to had most of day as too Dizzy/fatigued to be mobile. Dangling/twisting side of face last 7 days ongoing." The patient did not receive treatment for Bell's palsy, dizzy or eyesight. The clinical outcome of Bell's palsy was not recovered, of dizzy was recovering, of eyesight was recovered on unspecified date, of fatigued was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021185916 Same patient, reporter, event, different vaccine dosing

Other Meds: TIMOLOL; LEVOTHYROXIN; OMEPRAZOLE

Current Illness:

ID: 1288421
Sex: M
Age:
State:

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

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

Lab Data: Test Date: 2017; Test Name: Blood pressure; Result Unstructured Data: Test Result:Drop; Test Name: Blood work; Result Unstructured Data: Test Result:Normal; Test Date: 2018; Test Name: Magnetic resonance imaging; Result Unstructured Data: Test Result:Normal; Test Date: 2008; Test Name: X-ray; Result Unstructured Data: Test Result:Normal

Allergies:

Symptom List: Injection site pain

Symptoms: Watering eyes/recurrent eyes watery; Runny nose/recurrent runny nose; Drop in blood pressure; Seasonal allergy; Postural orthostatic tachycardia syndrome; tachycardia syndrome; Psoriasis flare-up/flare off of psoriasis/Psoriasis flare-up/Psoriasis flare-up -Worsened; Scalp swelling/ scalp swelling - Worsened/swollen scalp; Knee swelling; Psoriatic arthritis aggravated/-Worsened/flare off of psoriatic arthritis; Itchy scalp/Itchy scalp -Worsened/Localised itching -Worsened/itch on back, arms, knees; Local swelling / Local swelling -Worsened/swollen back; Scalp pain/Scalp pain Worsened/painful scalp; Pain back/Pain back - worsened/painful back; Painful arm/Painful arm - worsened; Painful knee/Painful knee Worsened; Swollen arm /Swollen arm -worsened; This is a non-interventional study report based on the information received by Pfizer (Mfr Control No. 21K-163-3740568-00) received from a contactable consumer (patient). A 37 yearsold male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 25Mar2021 (at the age of 37 years old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2017 (Batch/Lot number was not reported) to 25Mar2021, at unknown dose weekly[1 in 2 wk] for Moderate to Severe Chronic Plaque Psoriasis . Medical history included non tobacco, abstains from alcohol, Klippel feil syndrome, spinal fusion surgery, seasonal allergy, postural orthostatic tachycardia syndrome from 2017 to an unknown date , blood pressure decreased from 2017 to an unknown date. The patient concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced psoriatic arthritis aggravated/-worsened/ flare off of psoriatic arthritis (medically significant) on 25Mar2021, postural orthostatic tachycardia syndrome on an unspecified date, tachycardia syndrome on an unspecified date. psoriasis flare up/ Psoriasis flare up -Worsened on 25Mar2021, scalp swelling/ scalp swelling - worsened/ painful scalp on 25Mar2021, knee swelling on 25Mar2021, watering eyes/recurrent eyes watery on an unspecified date, runny nose/recurrent runny nose on an unspecified date, drop in blood pressure on an unspecified date, seasonal allergy on an unspecified date, itchy scalp/itchy scalp -worsened/localised itching -worsened/ itch on back, arms, knees on 25Mar2021, local swelling / local swelling -worsened/ swollen back on 25Mar2021, scalp pain/scalp pain worsened/painful scalp on 25Mar2021, pain back/pain back - worsened/ painful back 25Mar2021, painful arm/painful arm - worsened on 25Mar2021,painful knee/painful knee worsened on 25Mar2021, swollen arm /swollen arm -worsened on 25Mar2021, psoriasis flare-up/psoriasis flare-up -worsened on 25Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: drop on 2017 blood test: normal o an unspecified date, magnetic resonance imaging: normal on 2018, x-ray: normal on 2008. The action taken in response to the event for adalimumab was permanently withdrawn on 25Mar2021(also reported as dose not changed). The clinical outcome of the event Psoriatic arthritis aggravated, Psoriasis flare-up, Scalp swelling, Knee swelling, Itchy scalp, Local swelling , Scalp pain, Painful arm, Knee pain, Swollen arm, Psoriasis flare-up was not recovered, while Postural orthostatic tachycardia syndrome, tachycardia syndrome, Watering eyes, Runny nose, Drop in blood pressure recovered, and the remaining events was unknown. Causality for Humira (Adalimumab) the reporter's causality for the event(s) of postural orthostatic tachycardia syndrome, swollen scalp, swollen knee, recurrent eyes watery, recurrent runny nose, blood pressure drop, seasonal allergies, itch on scalp, itch on back, arms, knees, swollen back, flare off of psoriasis, flare off of psoriatic arthritis, painful scalp, painful back, painful arms, painful knees, swollen arm and recurrent congestion with humira (adalimumab) was no reasonable possibility. The reporter assessment of the causal relationship of the (enter the event term) 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. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, the reported events are attributed to underlying or intercurrent medical conditions which were unlikely related to BNT162B2 vaccine.

Other Meds:

Current Illness:

ID: 1288422
Sex: M
Age:
State:

Vax Date: 06/02/2015
Onset Date:
Rec V Date: 05/05/2021
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: Deafness right ear; Urinary tract infection; Feeling bad; Weakness; This is a solicited report based on the information received by Pfizer. A 85-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation; ibrutinib (IMBRUVICA), oral from 02Jun2015 (Batch/Lot number was not reported) to an unspecified date, at 140 mg, 3x/day [(140 mg, 3 in 1 D)] for chronic lymphocytic leukaemia; ibrutinib (IMBRUVICA), oral from an unspecified date (Batch/Lot number was not reported) and ongoing, at 420 mg, 1x/day [420 mg (420 mg, 1 in 1 D)] for Chronic Lymphocytic Leuk of B-Cell Type Not Achieve Remis The patient had no known medical history The patient's concomitant medications were not reported. The patient experienced deafness right ear, urinary tract infection, feeling bad and weakness. All events involved hospitalization and were medically significant. The patient's hospitalization was prolonged as a result of deafness right ear, urinary tract infection, feeling bad, weakness. The action taken in response to the event(s) for ibrutinib was permanently withdrawn on an unspecified date , for ibrutinib was dose not changed. The clinical outcome of the events was recovering. Solicited report by a consumer of an elderly male with events of couldn't hear from right ear and urinary tract infection and non-serious feel crummy and weakened with Imbruvica (Ibrutinib) and Imbruvica (Ibrutinib). There was no reported medical history. On unknown dates, the patient experienced couldn't hear from right ear, urinary tract infection, feel crummy and weakened. Covid-19 vaccine 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, lot number unknown, expiration date unknown. Patient was in hospital for a week and had lots of tests. And came out to being urinary tract infection that made him feel crummy and was weakened. Patient also reported that couldn't hear from right ear it could be from Pfizer vaccine. Which was finished a month ago. And never had much trouble with Imbruvica. Causality for Imbruvica (Ibrutinib) The reporter's causality for the event(s) of couldn't hear from right ear, urinary tract infection, feel crummy and weakened was not provided. Company's opinion is that there is no reasonable possibility that the event of couldn't hear from right ear is related to Imbruvica (Ibrutinib). Company's opinion is that there is a reasonable possibility that the events of Urinary Tract Infection, feel crummy and weakened are related to Imbruvica (Ibrutinib). Causality for Imbruvica (Ibrutinib) The reporter's causality for the event(s) of couldn't hear from right ear, urinary tract infection, feel crummy and weakened was not provided. Company's opinion is that there is no reasonable possibility that the event of couldn't hear from right ear is related to Imbruvica (Ibrutinib). Company's opinion is that there is a reasonable possibility that the events of Urinary Tract Infection, feel crummy and weakened are related to Imbruvica (Ibrutinib). Suspect Drug (s): Seq.No . : 1 Drug: Imbruvica (capsule) (Ibrutinib), Unknown Daily dose: 420 mg (140 mg, 3 in 1 D) Route of Admin: Oral Therapy dates/Duration: 02Jun2015-Discontinued Indications for Use: Chronic Lymphocytic Leuk of B-Cell Type Not Achieve Remis Causality Deafness right ear (Deafness unilateral) Action(s) taken with drug: Drug discontinued Causalis per reporter (Drug/Vaccine): Not Reported Causality as per Mfr. (Drug/Vaccine): No reasonable possibility Dechallenge: Unk Urinary Tract infection (Urinary Tract infection) Action(s) taken with drug: Drug discontinued Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge: Unk Feeling bad (Feeling abnormal) Action(s) taken with drug: Drug discontinued Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge: Unk Weakness (Asthenia) Action(s) taken with drug: Drug discontinued Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge: Unk Seq No.: 2 Drug: Imbruvica (Tablet) (Ibrutinib) Daily dose: 420 mg (420 mg, 1 in 1 D) Route of Admin: Oral Therapy dates/Duration: Unk-Ongoing indications for Use: Chronic Lymphocytic Leuk of B-Cell Type Not Achieve Remis Causality Deafness right ear (Deafness unilateral) Action(s) taken with drug: Dose not changed Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr. (Drug/Vaccine): No reasonable possibility Dechallenge: N/A Urinary Tract infection (Urinary Tract infection) Action(s) taken with drug: Dose not changed Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge: N/A Feeling bad (Feeling abnormal) Action(s) taken with drug: Dose not changed Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge: N/A Weakness (Asthenia) Action(s) taken with drug: Dose not changed Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge: N/A Seq No.: 3 Drug: COVID-19 Vaccine (COVID-19 Vaccine), Unknown Daily dose: Pfizer Vaccine Route of Admin: Intra-muscular Indications for Use: COVID-19 Vaccination Causality Deafness right ear (Deafness unilateral) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Reasonable possibility Dechallenge: N/A Urinary Tract infection (Urinary Tract infection) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A Feeling bad (Feeling abnormal) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A Weakness (Asthenia) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A The reporter assessment of the causal relationship of the events UTI, Feeling bad and Weakness with the suspect product 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. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information, the reported events deafness right ear, urinary tract infection, feeling bad and weakness are attributed to underlying or intercurrent medical conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). 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: 1288423
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Blood clots in her nose; Nose bleed; her arms are both numb on her; Couldn't move them; She feels lethargic; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, enquired have people died from the vaccine or not. Enquired what do you know about the news in the media about reports of death in nursing home elderly patients. Response: Pfizer and BioNTech are aware of reported deaths following administration of Pfizer-BioNTech COVID-19 vaccine . We are working with the (withheld) to gather all the relevant information. (Withheld) Authorities have prioritized the immunization of residents in Nursing Homes, most of whom are very elderly with underlying medical conditions and some which are terminally ill. (Withheld) confirm the number of incidents so far was not alarming, and in line with expectations. All reported deaths would be thoroughly evaluated by (Withheld) to determine if these incidents are related to the vaccine. (Withheld) Health Authorities have now changed its recommendation in relation to vaccination of the terminally ill (Clinical Frailty Scale 8 or higher). Our immediate thoughts are with the bereaved families. The Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 Vaccine Safety subcommittee met virtually on Tuesday, 19Jan2021, to review available information and data on deaths reported in frail, elderly individuals who had received the Pfizer BioNTech COVID-19 mRNA vaccine, BNT162b2 (hereafter, BNT162b2). Experts invited from the (Withheld) and the (Withheld) provided an overview of deaths reported in (Withheld) and in the WHO global database (VigiBase) following vaccination with BNT162b2." Based on a careful scientific review of the information made available, the subcommittee came to the following conclusions: The current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of BNT162b2. Reports are in line with the expected, all-cause mortality rates and causes of death in the sub-population of frail, elderly individuals, and the available information does not confirm a contributory role for the vaccine in the reported fatal events. In view of this, the committee considers that the benefit-risk balance of BNT162b2 remains favourable in the elderly, and does not suggest any revision, at present, to the recommendations around the safety of this vaccine." Enquired what was the efficacy after one dose. Caller had a terrible experience after her first dose of the Pfizer BioNTech COVID19 vaccine. She had blood clots in her nose, every time she blew her nose, blood clots would come out. She never had a nose bleed before. She also added that her arms are both numb on her. She couldn't move them, she feels lethargic. She's supposed to get her second dose next Friday. Enquired do we have any information regarding blood clots or not. Caller was upset and disconnected the call before some of the answers were given. Caller also asked the following questions: Has there been deaths reported from the vaccine or not, what was the efficacy after 1 dose, any guidance on getting the second dose after having side effects after the first dose. Response: Proposed response : CONS-Blood clots. Caller said "this was ridiculous" when I tried providing her with a long website with more information. She feels like we are withholding information from the public. She thinks the deaths should have been on the media. Caller hung up. Enquired do you have any guidance on getting the second dose after having side effects with the first dose. I had a side effect after the first dose of the vaccine. Should I get the second dose or not. Caller disconnected before agent could provide response. Response: Proposed response: As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason could not be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome of the events was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1288424
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 05/05/2021
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 Name: Covid virus; Test Result: Positive

Allergies:

Symptom List: Tremor

Symptoms: tested positive for Covid virus; tested positive for Covid virus; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, in Mar2021, as single dose, for COVID-19 immunisation. Medical history included being exposed to COVID virus on an unspecified date. The patient's concomitant medications were not reported. The patient received her first dose at the end of Mar2021 and she was exposed and tested positive for COVID virus on an unspecified date. She was scheduled for her second dose on 20Apr2021 and asked if it was safe for her to receive the vaccine. The outcome of the event was unknown Information of the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1288425
Sex: F
Age:
State: FL

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 05/05/2021
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 Name: blood pressure went high to 163; Result Unstructured Data: Test Result:163; Comments: increased

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: blood pressure went high to 163/blood pressure was elevated; dizzy; tightness in collar bone area; cold; neck tightness; freezing really cold for 30 to 40 minutes; pain at the bottom of my neck; exhaustion; it sounds like paresthesia; my body started shaking, involuntary shaking for about an hour; Disoriented; confused; my heart beating fast, tachycardia; This is a spontaneous report from a contactable physician, the patient. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient had the first Pfizer covid Vaccine 2 weeks ago today, and states, "I felt dizzy within first 5 minutes, my blood pressure went high to 163/, tightness in collar bone area, cold right away. I think I panicked at the same time. Not like a chest pain, but bottom of my neck tightness, it went away in half an hour on its own. I was freezing really cold for 30 to 40 minutes they brought me blanket and orange juice to drink and it went away about 5:30ish it took 45 minutes to feel better. The pain at the bottom of my neck went away the next day or a few hours later, it was at the bottom of my collar of my neck, my blood pressure was elevated, I was cold and freezing. Besides the typical side effects of exhaustion, I went to urgent care near my house, and they said it was vaccine stuff, a week ago Monday was when I went. I spoke with my doctor this Monday on virtual call, and she said it sounds like paresthesia, shaking of the body related to vaccine. My doctor called it paresthesia, my body started shaking, involuntary shaking for about an hour. I was disoriented, confused and my heart beating fast, tachycardia. The outcome of the events neck tightness, freezing really cold for 30 to 40 minutes and pain at the bottom of my neck was recovered on an unknown date in Apr2021 and all other events was unknow. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on a temporal association a causal relationship between the reported events and suspect drug BNT162B2 is assessed as possible. 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1288426
Sex: F
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 05/05/2021
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: swelling; malar edema; This is a spontaneous report based on the information received by Pfizer. (Reference Number: GL-041221-9190). A contactable physician reported for a 60-year-old female patient that: Reported Adverse Events: Patient injected with Sculptra Aesthetic and Restylane Silk 18 months ago. Recently returned to physician after 2nd COVID vaccine (unspecified) with swelling and malar edema; treating with steroids and antihistamines; ongoing; Sender's Comments: Based on chronological connection to the vaccine and known the potential for allergic reactions post Covid-19 vaccination, causality between events swelling and malar edema and BNT162B2 vaccine 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: 1288427
Sex: F
Age:
State: SC

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

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

Lab Data:

Allergies:

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

Symptoms: Extremely tired; Sore arm; 2nd shot-muscle pain; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration in the right deltoid on 18Feb2021 (Batch/Lot Number: ENb298) as a single dose for COVID-19 immunization. Medical history included diabetes-onset date: years, stroke on 12Feb2002, breast cancer in Dec2015 and cholesterol, headaches, restless legs. Concomitant medications included rosuvastatin calcium (ROSUVASTATIN CALCIUM GENERIC) taken for cholesterol from an unspecified start date and ongoing; tocopherol, ubidecarenone (COQ-10 ST) taken for cholesterol from an unspecified start date and ongoing; gabapentin enacarbil (HORIZANT) taken for headaches, restless legs from an unspecified start date and ongoing; anastrozole (ANASTROZOLE) taken for an unspecified indication from an unspecified start date and ongoing; empagliflozin (EMPAGLIFLOZIN) taken for an unspecified indication from an unspecified start date and ongoing; eicosapentaenoic acid ethyl ester (VASCEPA) taken for an unspecified indication from an unspecified start date and ongoing; denosumab (PROLIA) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, first dose, lot number: EL1298) on 28Jan2021 for COVID-19 immunization and experienced blood pressure systolic high and dizziness. The patient felt extremely tired on an unspecified date and was hospitalized for about a week (7 days), had a sore arm on an unspecified date and was hospitalized for 2 days and experienced muscle pain on an unspecified date. No treatment was administered for the event extremely tired, for the muscular pain Tylenol was taken starting 24 hours after shot - stayed in shot area. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: ROSUVASTATIN CALCIUM GENERIC; COQ-10 ST; HORIZANT; ANASTROZOLE; EMPAGLIFLOZIN; VASCEPA; PROLIA

Current Illness:

ID: 1288428
Sex: F
Age:
State: WV

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Tingling in throat, after first vaccine.; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced tingling in throat, after first vaccine on an unspecified date. The outcome of the event was not reported. Information on the Lot/Batch number has been requested

Other Meds:

Current Illness:

ID: 1288429
Sex: F
Age:
State: CA

Vax Date: 03/29/2021
Onset Date: 03/29/2021
Rec V Date: 05/05/2021
Hospital: Y

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

Lab Data: Test Name: Endoscopy; Result Unstructured Data: Test Result:Unknown result; Test Name: Sigmoidoscopy; Result Unstructured Data: Test Result:Unknown result; Test Name: Ultrasound of legs; Result Unstructured Data: Test Result:Unknown result

Allergies:

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

Symptoms: I went back to the hospital and couple days later they told me that actually I have Deep vein thrombosis now in my legs; my Crohn's had caused really bad flare up/I have been in the hospital for 5 days now with the clot and Crohn's Flare; I also have superficial clot in that left leg that was the pain began on the edges/blood clot; the arm is much better now. You know that's not really sore; I just was too tired/extreme fatigue; really bad like pain; Shortness of breath; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 29Mar2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, ileostomy from an unknown date and unknown if ongoing, back surgery from an unknown date and unknown if ongoing, Crohn's disease from an unknown date and unknown if ongoing , blood clot in arm back from 2014 to an unknown date. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on 08Mar2021 and experienced terrible diarrhea and neuralgia. Concomitant medication(s) included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; valaciclovir hydrochloride (VALTREX) taken for an unspecified indication, start and stop date were not reported; diazepam (DIAZEPAM) taken for an unspecified indication, start and stop date were not reported; (ZOFRAN) taken for an unspecified indication, start and stop date were not reported; oxycodone (OXYCODONE) taken for an unspecified indication, start and stop date were not reported; lansoprazole (PREVACID) taken for an unspecified indication, start and stop date were not reported. After second dose on 29th (29Mar2021) immediately he was really bad like pain and had shortness of breath. The patient stated that she had a back surgery and so she always felt bad, so she didn't think anything of it. But then she ended up into ER after the second dose and discovered that her Crohn's had caused really bad flare up. She mentioned her foot was looking strange but she was just too tired and left the ER. She then went back to the hospital and couple days later they told her that she actually had deep vein thrombosis now in her legs. She also had superficial clot in that left leg where the pain began on the edges. The patient reported that the vaccine was basically started the Crohn's flare up. The patient also stated that "the arm was much better now and not really sore". The patient was hospitalized for DVT from unknown date and for Crohn's flare up for 5 days. The patient underwent lab tests and procedures which included endoscopy, sigmoidoscopy, ultrasound scan: all on unknown date with unknown result. The patient was treated with Entyvio and on blood thinners now for a blood clot. The outcome of pain in extremity was recovering while others was unknown.

Other Meds: GABAPENTIN; VALTREX; DIAZEPAM; ZOFRAN [ONDANSETRON]; OXYCODONE; PREVACID

Current Illness:

ID: 1288430
Sex: F
Age:
State: OH

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

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

Lab Data:

Allergies:

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

Symptoms: she was spent; She had terrible depression. She said she had a history of depression and took medication for the depression; 2 days after her second Pfizer COVID-19 Vaccine shot, she had terrible nausea. She said the nausea was like morning sickness or being punched in the stomach; Stomach ache; she was having trouble processing information since her second Pfizer COVID-19 Vaccine shot. She said things get jumbled easily; She was having trouble expressing herself and speaking. She found it very difficult to find words during a conversation.; her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose; Event: her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose was reported as worsened.; 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: unknown), dose 2 via an unspecified route of administration on 09Mar2021 as SINGLE DOSE (at the age of 57 years-old) for covid-19 immunization. Medical history included depression from an unknown date and unknown if ongoing for at least 30 years, breast implant placed about 31 years ago and started having cognitive issues, struggling with words, and following instructions since Dec2020. She said when she takes her medicine, fluoxetine, she couldn't even tell she had depression. She said she had been on fluoxetine for a decade fluoxetine. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) and experienced slight fatigue in 2021 and recovered. She said she was OK on 10Mar2021. In Mar2021, the patient was having trouble processing information since her second Pfizer covid-19 vaccine shot. She said things get jumbled easily on Mar2021, 2 days after her second pfizer covid-19 vaccine shot, she had terrible nausea like morning sickness or being punched in the stomach on 11Mar2021, stomach ache on 11Mar2021, terrible depression, having trouble expressing herself and speaking, found it very difficult to find words during a conversation on Mar2021, her cognitive issues had gotten worse after the second pfizer covid-19 vaccine dose on Mar2021, event: her cognitive issues had gotten worse after the second pfizer covid-19 vaccine dose was reported as worsened on Mar2021. She said she had seen many doctors with her nausea. She said her nausea had nothing to do with her bowels. She said it had been about a month since the nausea and depression started, and she felt she had just turned the corner on both of them. On an unknown date, she was spent. Treatment for depression worsened included depression medication. The clinical outcome of trouble processing information and cognitive issues had gotten worse was not recovered, recovering for nausea, stomach ache and depression and unknown for trouble expressing herself, spent and speaking. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1288431
Sex: M
Age:
State: IL

Vax Date: 04/09/2021
Onset Date: 04/01/2021
Rec V Date: 05/05/2021
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: 202104; Test Name: Body temperature; Result Unstructured Data: Test Result:100 degrees or more

Allergies:

Symptom List: Pain in extremity

Symptoms: was unsure if the patient had COVID-19 virus; was unsure if the patient had COVID-19 virus; Inability to eat; Severe sweating; Stomach cramping/pain; Headaches that wouldn't go away; Diarrhea; A fever of of 100 degrees or more; Felt like his eyes were going to pop out; Stomach burning; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer sponsored program. A male patient of unspecified age (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included headache. The patient's concomitant medications were not reported. The reporter stated her husband got his first dose on 09Apr2021, and she (the reporter) received her second dose on 12Apr2021. The reporter is concerned about the patient because he began having severe sweating, stomach cramping/pain, headaches that wouldn't go away, diarrhea, inability to eat, a fever of 100 degrees or more and felt like his eyes were going to pop out along with stomach burning after receiving the first dose of COVID-19 vaccine (in Apr2021). The reporter stated the patient had a headache before his first dose and was unsure if the patient had COVID-19 virus or if it is side effects after his first dose of COVID-19 vaccine. The reporter clarified side effects several times. The reporter also stated she had no side effects with the COVID-19 vaccine. The patient had not yet recovered from headache, while unknown outcome for the remaining events. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1288432
Sex: F
Age:
State: NV

Vax Date:
Onset Date:
Rec V Date: 05/05/2021
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: My grandma got a PFIZER COVID VACCINE and has now experienced a blood clot that caused a stroke.; My grandma got a PFIZER COVID VACCINE and has now experienced a blood clot that caused a stroke.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that "my grandma got a pfizer covid vaccine and has now experienced a blood clot that caused a stroke." The patient experienced a cerebrovascular accident on an unspecified date with outcome of unknown and thrombosis on an unspecified date with outcome of unknown. No further information was provided. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1288433
Sex: F
Age:
State: TN

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

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

Lab Data:

Allergies:

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

Symptoms: Diagnosed with cancer on the nose and cheeks; This is spontaneous from a Pfizer sponsored program A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (Pfizer Covid-19 Vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient went to a dermatologist and was diagnosed with cancer on the nose and cheeks after first dose. Outcome was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1288434
Sex: M
Age:
State: OK

Vax Date: 02/09/2021
Onset Date: 02/11/2021
Rec V Date: 05/05/2021
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: Cellulitis of the leg; This is a spontaneous report from a contactable physician. A 38-year-old male patient received first dose of BNT162B2 (Lot/batch number and expiry date was not reported), via an unspecified route of administration on 09Feb2021 as a single dose for COVID-19 immunization. Medical history included ongoing eczema (Topical steroids), deep vein thrombosis (DVT) since 10 years ago and stopped 6months after treatment, Fasciotomy for compartmental syndrome s/p gunshot wound (Stop date: After surgery) and ongoing Allergies (PRN medication), all on an unknown dates. Patient has history of gunshot wound subsequent compartment syndrome of DVTs status post treatment 10 years ago of the left lower extremity. Family medical history of gunshot wound of compartment syndrome DVT on this side following. Patient had cellulitis of the leg 1 month prior to "11Feb". The patient experienced cellulitis of the leg on 11Feb2021. The outcome of the event was recovered on an unknown date. The physician reported that the patient provided information regarding the reported adverse event with the use of the product. The physician considered that the Pfizer vaccine had no causal effect to the adverse event. The following information on the lot/batch number has been requested.; Sender's Comments: Based on information provided, the event cellulitis is an inter-current condition, thus unrelated to the suspect drug.

Other Meds:

Current Illness: Allergy (PRN medication); Eczema (Topical steroids)

ID: 1288435
Sex: F
Age:
State: NY

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

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

Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:very slight elevation of inflammation

Allergies:

Symptom List: Vomiting

Symptoms: feels like crawling on the caller's skin, similar to neuropathy; pins and needles on her skin; feels like crawling on the caller's skin, similar to neuropathy; very slight elevation of inflammation; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number & Expiry date not reported), via unspecified route of administration on 05Apr2021 as Single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. The patient doesn't know if it is considered an adverse event but she has experienced what feels like pins and needles on her skin on an unspecoified date. It feels like crawling on the patient's skin, similar to neuropathy. The patient went to her doctor and he did blood work and she had a very slight elevation of inflammation and the doctor didn't seem too concerned, the doctor thought it was an effect of the vaccine. Patient inquired if Pfizer heard of any of this. The Patient doesn't want to get the second dose until these symptoms go away. The outcome of the reported events were unknown. Communication: The Patient declines to file a safety report as she is heading into a doctor's appointment at this time, no further information or details were captured at this time. The Patient would like for Pfizer to email her the contact information as she would like to talk to an agent about her questions but does not have the time to do so today. In response to it mention no information found on "pins and needles" possible AE, and refer to HCP for guidance. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1288436
Sex: M
Age:
State: TX

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 05/05/2021
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: Approximately 3 hours after injection, I became very dizzy, lightheaded, and passed out for a few minutes.I experienced vertigo for 24 hours, and was unable to sleep for longer than an hour at a time; Approximately 3 hours after injection, I became very dizzy, lightheaded, and passed out for a few minutes.I experienced vertigo for 24 hours, and was unable to sleep for longer than an hour at a time; Approximately 3 hours after injection, I became very dizzy, lightheaded, and passed out for a few minutes.I experienced vertigo for 24 hours, and was unable to sleep for longer than an hour at a time; Was unable to sleep for longer than an hour at a time for 5 days; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at school or student health clinic on 15Mar2021 16:45 (at the age of 57-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient had no medical history. The patient had no allergies to medication, food, or products. Concomitant medications included finasteride and morniflumate (FLOMAX [MORNIFLUMATE]). On 15Mar2021 at 19:15, approximately 3 hours after injection, the patient became very dizzy, lightheaded, and passed out for a few minutes. The patient also experienced vertigo for 24 hours, and was unable to sleep for longer than an hour at a time. There was no treatment for the events. On an unspecified date, the patient recovered from all events. Information about batch/lot number has been requested.

Other Meds: FINASTERIDE; FLOMAX [MORNIFLUMATE]

Current Illness:

ID: 1288437
Sex: F
Age:
State: MI

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 05/05/2021
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: exhausted / Fatigue; she could hardly sleep; Mild sore throat; Headache; No energy; Myalgia; Arthralgia; This is a spontaneous report from a contactable physician. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 16Apr2021 at 18:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing asthma, attention deficit disorder, and depression. Concomitant medications included ongoing methylphenidate hydrochloride (CONCERTA) for attention deficit hyperactivity disorder and ongoing bupropion for depression. Family history included brother had Covid. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Apr2021, the patient developed headache (important medical event - IME), no energy (disability), myalgia (disability), arthralgia (IME), and mild sore throat. On 18Apr2021, she could hardly sleep and exhausted/fatigue (disability). The patient had no shortness of breath, even though she has asthma and it was not an anaphylactic reaction. The patient took TYLENOL for the events which helped somewhat but didn't relieve it fully. It resolved as time passed. The outcome of the events headache, no energy, myalgia, arthralgia, mild sore throat was recovered on 18Apr2021. The outcome of the events could hardly sleep and exhausted/fatigue was recovered in Apr2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine and known product safety profile, causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE0 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: CONCERTA; BUPROPION

Current Illness: Asthma

ID: 1288438
Sex: F
Age:
State:

Vax Date: 04/16/2021
Onset Date: 04/20/2021
Rec V Date: 05/05/2021
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: Test Name: Body temperature; Result Unstructured Data: Test Result:less than 100.3; Comments: low fever

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: having period pain and bleeding discharge; having period pain and bleeding discharge today; have a low fever (less than 100.3); This is a spontaneous report from a contactable consumer (the patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 16Apr2021 at 11:00 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history included: COVID-19 and known allergies: penicillin, sulfa drugs, and shellfish. The patient was not pregnant at the time of vaccination. Concomitant medications included: creatine, glutamine, and beta-alanine, all taken for an unspecified indication, start and stop date were not reported; and levonorgestrel (KYLEENA) for an unspecified indication from an unspecified date and ongoing. The patient previously took and had allergies to amoxicillin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated she had a KYLEENA IUD (intrauterine device) and had not had a menstrual cycle in 3 years. On 20Apr2021 08:00, the patient started having period pain and bleeding discharge, 4 days after the first dose. She continued to have a low fever (less than 100.3) for the fourth day. No treatment was received. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information about lot number has been requested.

Other Meds: CREATINE; GLUTAMINE; BETA-ALANINE; KYLEENA

Current Illness:

ID: 1288439
Sex: M
Age:
State: WV

Vax Date: 03/31/2021
Onset Date:
Rec V Date: 05/05/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Caller stated he went to the ED with a "large red bump on my arm" and "they numbed it and lanced it and blood and pus came out.; the same thing happened on my face, around my mouth; got bumps on my left arm shoulder where I got the shot; Also got bumps on my arms, hands, back, left side of my chest and my left shoulder where I got the shot; the same thing happened on my face, around my mouth; This is a spontaneous report from a contactable consumer, the patient. A male patient of unspecified received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 via unspecified route of administration, 31Mar2021 (Batch/Lot number not reported) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 on 10Mar2021 for COVID-19 immunisation and had after my 1st dose, my mouth and lips developed cold blisters outside and inside my mouth. I had bumps on the inside of my mouth, and it took 7-10 days for the cold blisters to go away. Bumps inside my mouth are still there and the size of kidney beans. On an unspecified date in 2021, the patient stated, when I got my 2nd vaccine dose the same thing happened on my face, around my mouth and I also got bumps on my arms, hands, back, left side of my chest and my left shoulder where I got the shot. The patient stated he went to the ED with a large red bump on my arm and they numbed it and lanced it and blood and pus came out. They gave me antibiotics but that did not help with the bumps on my body. The patient stated his HCP said that was what you get for getting vaccinated. The patient stated his HCP does not wear a mask or believe we need the vaccinations. Can you tell me what these bumps are and is it a normal reaction to the vaccine? The outcome of the events was not recovered. No follow up attempts are needed, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1288440
Sex: F
Age:
State:

Vax Date: 03/31/2021
Onset Date:
Rec V Date: 05/05/2021
Hospital: Y

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: she has been diagnosed with a GI infection and is currently experiencing bloody stools.; she has been diagnosed with a GI infection and is currently experiencing bloody stools.; she got sick; I have been having joint pain ever since I got the first dose and don't feel like maybe should take it today.; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program and also via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration, on 31Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she had her first dose of Pfizer Covid-19 vaccine on 31Mar2021 and was scheduled to take her second dose on 26Apr2021. On an unspecified date in 2021, she got sick and was admitted at the ER and was told that she has an inflammation and infection in her intestine/colon. She was diagnosed with GI infection and experiencing bloody stools at the time of the report. She also reported that she was having joint pain ever since she got the first dose and did not feel like taking the vaccine. The outcome of the events was unknown. Information about Lot/Batch number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am