VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1790859
Sex: F
Age:
State: TX

Vax Date: 09/27/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
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: her right eyeball is bloody; her right eyeball is bloody, red, swollen and painful; her right eyeball is bloody, red, swollen and painful; her right eyeball is bloody, red, swollen and painful; eye watering; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 27Sep2021 10:00 (Lot Number: FF2587) as DOSE 1, SINGLE for COVID-19 immunization at the age of 72 years old. Medical history included breast cancer and lymph nodes were removed from an unknown date. There were no concomitant medications. The patient experienced right eyeball is bloody, red, swollen and painful, eye watering, and swollen still on 28Sep2021 07:30. The patient feels hesitant to get the second injection, as she doesn't want this to happen again. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790860
Sex: U
Age:
State: NH

Vax Date: 03/25/2021
Onset Date: 07/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: I have a stroke in July; This is a spontaneous report from a contactable consumer (patient). A 78-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration at the age of 78-year-old on 25Mar2021 (Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history included High blood pressure (on High blood pressure medicine), blood disorder (on blood thinners), immunisation. Concomitant medications included influenza vaccine taken for immunisation, start and stop date were not reported; acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported; on blood thinners medication (unspcified), on High blood pressure medicine (unspcified). The patient previously took first dose bnt162b2 (The LOT# for first is EL9266) at the age of 78-year-old on 26Feb2021 for COVID-19 immunisation and experienced arm is sore. The patient experienced 'I have a stroke in july' in Jul2021. The outcome of event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: INFLUENZA VACCINE; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1790861
Sex: F
Age:
State: CA

Vax Date: 09/14/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
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: Test Name: Height; Result Unstructured Data: Test Result:about 5 (Feet) and 7 (Inches); Test Name: Weight; Result Unstructured Data: Test Result:about 198 lbs

Allergies:

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

Symptoms: when menstrual cycle came on 10Sep2021, it was like a light period and then today it was like a normal period, heavy cycle with heavy blood clots; when menstrual cycle came on 10Sep2021, it was like a light period and then today it was like a normal period, heavy cycle with heavy blood clots; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FD0809), via an unspecified route of administration in right arm on 14Sep2021 (at the age of 45-years-old) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications included amlodipine taken for high blood pressure; losartan taken for high blood pressure. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0217), via an unspecified route of administration in right arm on 24Aug2021 (at the age of 45-years-old) as dose 1, single for COVID-19 immunization and experienced menstrual cycle has been unbalanced; It has been on and off and menstruation was three weeks delayed. The patient experienced when menstrual cycle came on 10Sep2021, it was like a light period and then today it was like a normal period, heavy cycle with heavy blood clots on 27Sep2021. It was reported that patient received second dose of Vaccine on 14Sep2021 but ever since she received the first dose, her menstrual cycle has been unbalanced. It has been on and off. So, basically, she got the first vaccine on 24Aug2021, the same day when her menstrual cycle was about to start, and it was three weeks delayed. And then when it did come, it was not a normal cycle. Like normally her cycles are heavy but they were light. The cycle was started on 10Sep2021. And on the day of this report, it was like a heavy cycle with heavy blood clots. So, it was like starting like the first day of menstrual. Patient talked to the doctor on the day of this report, and today patient should monitor it for 7 days and so, she said that it sounds like it is just starting like a fresh menstrual. So, patient will wait for 7 days and if still is happening then patient need to come and re-seen and then if she is using more than like a pad or the tampons fill with up the blood within an hour. Then patient need to go to the urgent care of the hospital. Outcome of events was not resolved. No follow-up attempts are possible. No further information is expected.

Other Meds: AMLODIPINE; LOSARTAN.

Current Illness:

ID: 1790862
Sex: M
Age:
State: WA

Vax Date: 03/13/2021
Onset Date: 03/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210901; Test Name: SARS-CoV-2 test (Nasal Swab); Test Result: Negative

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: His edema started to get worse; This is a spontaneous report from a contactable consumer (patient's wife). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6208), via an unspecified route of administration, administered in the left arm on 13Mar2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization. Medical history included diabetic, hypertension, edema, and allergy to not fresh seafood. The patient received unspecified medications in two weeks prior to the COVID-19 vaccine. The patient did not receive other vaccines within four weeks of the COVID-19 vaccine. The patient's wife reported that after the patient got his first vaccine in March his edema started to get worse. The event was considered life-threatening. On an unspecified date, the patient received the second single dose of BNT162B2 (lot number: ER8737) administered in the left arm. On 02Sep2021, the patient got his third single dose of BNT162B2 (lot number: FC3182) administered in the left arm. Therapeutic measure was not taken as result of the event. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on 01Sep2021. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1790863
Sex: F
Age:
State: TN

Vax Date: 04/15/2021
Onset Date: 04/22/2021
Rec V Date: 10/16/2021
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: 20210422; Test Name: Biopsy; Result Unstructured Data: Test Result:psoriasis; Comments: now I have had a spot biopsied and I now have psoriasis; Test Date: 20210422; Test Name: fever; Result Unstructured Data: Test Result:105.2; Comments: fever of 105.2 for 3 days

Allergies:

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

Symptoms: Covid symptoms again; Besides losing taste and smell for 3 months; Besides losing taste and smell for 3 months; fever of 105.2; the vaccine induced skin issues; psoriasis; This is a spontaneous report from a contactable consumer or other non-HCP. A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0153), via an unspecified route of administration, administered in Left Arm on 15Apr2021 02:30 as DOSE 1, SINGLE for covid-19 immunization. Medical history included thyroid disorder, hypertension, migraine, covid-19 If covid prior vaccination: Yes. On 22Apr2021 the patient experienced covid symptoms again. besides losing taste and smell for 3 months, fever of 105.2, the vaccine induced skin issues, psoriasis. The patient underwent lab tests and procedures which included biopsy: psoriasis on 22Apr2021 now she has had a spot biopsied and she now have psoriasis , body temperature: 105.2 on 22Apr2021 fever of 105.2 for 3 days. Therapeutic measures were taken as a result of covid symptoms again, besides losing taste and smell for 3 months, besides losing taste and smell for 3 months, fever of 105.2, the vaccine induced skin issues, psoriasis. The outcome of all events was recovering. Follow-Up (01Oct2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790864
Sex: F
Age:
State: OK

Vax Date: 07/21/2021
Onset Date: 07/27/2021
Rec V Date: 10/16/2021
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: New onset diagnosed alopecia Areata within 11 days of vaccine.; 2 large bald patches on the scalp as well as overall thinning; 2 large bald patches on the scalp as well as overall thinning; Fist signs were 6-7 days out; This is a spontaneous report from a contactable consumer (Patient). A 17-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ew0150), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jul2021 at 14:00 (Age at vaccination: 17 years) as dose 1, single for covid-19 immunisation. Medical history was reported as None. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. Patient did not test covid post vaccination. Patient did not had allergies. The patient reported fist signs were 6-7 days out (hypoaesthesia) on 27Jul2021 and reported new onset diagnosed alopecia areata within 11 days of vaccine, 2 large bald patches on the scalp as well as overall thinning 02Aug2021. Adverse events resulted Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of new onset diagnosed alopecia areata within 11 days of vaccine, 2 large bald patches on the scalp as well as overall thinning, fist signs were 6-7 days out. Steroid injectons in scalp, topical steroid was received as a result of events. Patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ew0176), dose 2 via an unspecified route of administration, administered in Arm Left on 11Aug2021 at 02:00 PM. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790865
Sex: F
Age:
State: CA

Vax Date: 09/07/2021
Onset Date: 09/14/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Myocarditis; headache; body aches; joint pain; Fatigue; This is a spontaneous report from a non-contactable consumer or other non hcp. A 36-years-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 07Sep2021 09:00 (Lot Number: FC3181) as single dose (at the age of 36) for covid-19 immunisation. Medical history was none. No known allergies. There were no concomitant medications. No other vaccine in four weeks. The patient experienced myocarditis on 14Sep2021 18:15, headache on 14Sep2021 18:15, body aches on 14Sep2021 18:15, joint pain on 14Sep2021 18:15, fatigue on 14Sep2021 18:15. No treatment received. No covid prior vaccination. Unknown if covid tested post vaccination. The events outcome was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1790866
Sex: F
Age:
State: NY

Vax Date: 04/18/2021
Onset Date: 08/10/2021
Rec V Date: 10/16/2021
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: 20210907; Test Name: Covid test; Test Result: Negative

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: bloody diarrhea; foul-smelling stools; abdominal urgency for 1 month; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Apr2021 (Lot Number: ER6955), at the age of 55-year-old, as dose 2, single for COVID-19 immunization. The vaccine was administered at Pharmacy or Drug Store. The patient did not receive other vaccine in four weeks. Medical history included hyperthyroidism and hypercholesterolaemia and COVID-19 prior to vaccination. The patient was not pregnant. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=8731, as reported) via an unspecified route of administration on 28Mar2021, at the age of 55-year-old, at single dose for COVID-19 immunization. The patient had known allergies to methimazole: she previously took methimazole and had allergy. On 10Aug2021 the patient experienced bloody diarrhea, foul-smelling stools, abdominal urgency for 1 month. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. No treatment was administered for the events. It was reported that the patient recovered with lasting effects from the events. Abdominal urgency recovered with sequelae in Sep2021, the other events recovered with sequelae on an unspecified date. The patient was tested for Covid-19 post vaccination on 07Sep2021 and the test result was negative.

Other Meds:

Current Illness:

ID: 1790867
Sex: F
Age:
State: CO

Vax Date: 09/17/2021
Onset Date: 09/18/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Since the Covid shot I was diagnosed with RA.; severely fatigued; headaches; muscle weakness/soreness; muscle weakness/soreness; This is a spontaneous report from a contactable consumer (patient herself). This 44-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FC3183), via an unspecified route of administration administered in the left arm, on 17Sep2021 14:30 (at the age of 44-year-old) at single dose for COVID-19 immunisation, administered at clinic. No relevant medical history was provided. The patient did not have COVID-19 before the vaccination. Past drug history included benzylpenicillin potassium (PENICILLIN). Relevant concomitant medications included gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Sep2021, the patient was diagnosed with rheumatoid arthritis (RA). From 18Sep2021, the patient was severely fatigued, she had headaches, muscle weakness/soreness, joint pain and joint swelling. The patient was not treated for the events. No COVID-19 test was done post vaccination. The patient had not recovered from the events.

Other Meds: GABAPENTIN

Current Illness:

ID: 1790868
Sex: F
Age:
State: LA

Vax Date: 09/16/2021
Onset Date: 09/26/2021
Rec V Date: 10/16/2021
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: Confirmed Miscarriage; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Sep2021 07:15 (Lot Number: FP8448) at the age of 29-year-old, as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine was administered in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=FP8448) via an unspecified route of administration, administered in Arm Left on 26Aug2021 at 08:00 AM at the age of 29-year-old at single dose for COVID-19 immunisation. The patient had confirmed miscarriage on 26Sep2021. The event resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Abortion spontaneous 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: 1790869
Sex: F
Age:
State: TX

Vax Date: 06/09/2021
Onset Date: 06/11/2021
Rec V Date: 10/16/2021
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: left index finger hurting and swollen under side of index finger hurts to move finger; left index finger hurting and swollen under side of index finger hurts to move finger; Side to side fast vision is floaties for about hour/Grey boxes floating sideways; white tear drops floating left side down to up; ears ringing; sometimes when I am outside the color is dimmer like a filter is put over my eye; headache after the side to side; have in spots like a magnifying effect top left and lower right side lately; when I blink I have a Vaseline effect but goes away; depth perception is off more than usual, vision blurry up close when close up was clearer to read that's with glasses; depth perception is off more than usual, vision blurry up close when close up was clearer to read that's with glasses; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown), via an unspecified route administered in the left arm, on 09Jun2021 11:00 (at the age of 56-year-old) at single dose (dose number unknown) for COVID-19 immunisation, administered at Pharmacy/Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included Hepatitis C, coconut allergy, 'daladas' (as reported) allergy, and lactose intolerance. The patient was in menopause. The patient did not have COVID-19 before vaccination. Past drug history included sulfanilamide (SULFA) allergy. The patient did not have concomitant medications. The patient verbally reported as follows: on 11Jun2021, side to side fast vision is floaties for about hour, grey boxes floating sideways, white tear drops floating left side down to up, ears ringing, sometimes when I am outside the color is dimmer like a filter is put over my eye, headache after the side to side but ibuprofen and darkness help, sometimes I have in spots like a magnifying effect top left and lower right side lately, if I wear my sunglasses when outside eye doesn't bother me when I could be without. Sometimes when I blink I have a Vaseline effect but goes away, depth perception is off more than usual, vision blurry up close when close up was clearer to read that's with glasses. On 20Sep2021, the patient woke up with left index finger hurting and swollen under side of index finger hurts to move finger. No seriousness criterion was provided. The patient was treated for 'headache', 'sometimes when I am outside the color is dimmer like a filter is put over my eye' and 'have in spots like a magnifying effect top left and lower right side lately'. No treatments were given for the remaining events. Post vaccination COVID-19 test was not done. The patient had not recovered from the events. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness: Menopause

ID: 1790870
Sex: M
Age:
State: ND

Vax Date: 09/22/2021
Onset Date: 09/24/2021
Rec V Date: 10/16/2021
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: Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 22Sep2021 10:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE, vaccinated at the age of 32 years old, for covid-19 immunisation. Medical history included penicillin allergy, covid-19. There were no concomitant medications. Patient received the first dose of bnt162b2 on 01Sep2021 10:00, at the age of 32 years old for covid-19 immunisation. The patient experienced bell's palsy on 24Sep2021 with outcome of not recovered. The event was reported as serious with criteria medically significant. Event resulted in Doctor or other healthcare professional office/clinic visit and treatment included Steroid The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790871
Sex: F
Age:
State: IL

Vax Date: 09/01/2019
Onset Date: 09/14/2021
Rec V Date: 10/16/2021
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: 20210914; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever; Test Date: 20210914; Test Name: Heart beat; Result Unstructured Data: Test Result:Rapid; Test Date: 20210914; Test Name: Breathing rate; Result Unstructured Data: Test Result:Slow

Allergies:

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

Symptoms: Dizzy; Nausea; Fever; Rapid heart beat; Slow breath; Chest pain; Sweats; Unable to stand; Headache with Tylenol; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm, on 14Sep2021 at 13:00, at the age of 40 years old, as 1st single dose, for COVID-19 immunisation, and paracetamol (TYLENOL) at an unspecified dose and frequency, in Sep2021, for an unspecified indication. Medical history included autoimmune hepatitis. Past drug history included drug hypersensitivity with clarithromycin (BIAXIN) and clindamycin. There were no other vaccines administered in the four weeks prior to the BNT162b2 administration. The patient was not pregnant at the time of the reporting and vaccination. Regarding concomitant medications, it was reported the patient had took or was taking unspecified other medications in the two weeks prior to BNT162b2. The patient had not had COVID-19 prior to vaccination with BNT162b2 and was not tested for COVID-19 post vaccination. On 14Sep2021, at 16:00, the patient felt dizzy, had nausea, fever, rapid heart beat, slow breath, cheat pain, sweats, was unable to stand, had headache with Tylenol, she was scared and though she was close to death. No treatment was required for the above mentioned events. The patient was recovering from the above mentioned events. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1790872
Sex: M
Age:
State: TX

Vax Date: 08/21/2021
Onset Date: 08/22/2021
Rec V Date: 10/16/2021
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: 20210822; Test Name: Body temperature; Result Unstructured Data: Test Result:Low grade fever; Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Test Result:103 Fahrenheit; Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Test Result:100-101 Fahrenheit; Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Test Result:104 Fahrenheit

Allergies:

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

Symptoms: Fever (low grade, then 103 to 104 F); Feeling kind of ill; Arm was really sore; Sluggish; Body aches; Nausea; Vomiting; Diarrhea; Hurting chills; Muscle aches; headache; This is a spontaneous report from a contactable consumer (patient's mother). A 17-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on 21Aug2021, at the age of 17 years old, as 1st single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. The patient woke up the following morning, on 22Aug2021, and started feeling kind of ill, his arm was really sore, he was just sluggish, with low grade fever, body aches, and as the days progressed the symptoms kept getting worse, he had nausea, vomiting, diarrhea, hurting chills, body aches, muscle aches, headache, and for 2 or 3 days he started running fever like a 103 F to 104 F and then fever 100-101F. According to the patient, no treatment was needed for the events. The outcome of the events was not specified. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101281780 similar report from same reporter

Other Meds:

Current Illness:

ID: 1790873
Sex: F
Age:
State: MI

Vax Date: 08/31/2021
Onset Date: 09/09/2021
Rec V Date: 10/16/2021
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: 20210913; Test Name: Bio Nova; Test Result: Negative

Allergies:

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

Symptoms: Burning in the left side of my neck; Burning in the left side of my neck; My arm was also tingling and numb.; My arm was also tingling and numb.; Heart was pounding out of my chest; Extreme shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: FF2588), via an unspecified route of administration, administered in left arm on 31Aug2021 10:30 (age at vaccination 46 years) as single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccine within four weeks. No List of any other medications the patient received within 2 weeks of vaccination. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was reported that on 09Sep2021 05:00, the patient woke up with a burning in the left side of her neck; her arm was also tingling and numb, left arm. Her heart was pounding out of her chest. Got up to walk around. That day had extreme shortness of breath. It was ended up going to the ER the next day for shortness of breath. Ended up in the ER again less than a week later and have been seeing a doctor. Shortness of breath was not getting better. The patient underwent lab tests and procedures which included Bio Nova test: negative on 13Sep2021. Patient was not tested positive for COVID-19 since the vaccination. The patient was not received any treatment for the events. Outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790874
Sex: F
Age:
State: UT

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Severe itching both sides of both hands, plus both elbows; BNT162B2 co-administered with other vaccines; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 at the age of 74-years-old via an unspecified route of administration, administered in Arm Right on 27Sep2021 11:45 (Batch/Lot Number: FF2587) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX), via an unspecified route of administration administered in arm left on 27Sep2021 11:45 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunisation; influenza vaccine (FLUZONE), via an unspecified route of administration administered in arm left on 27Sep2021 11:45 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunization. Medical history included known allergies: Penicillin (Penicillin Allergy). Concomitant medication included an unspecified medication. The patient received the first and second doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified dates for covid-19 immunisation. The patient experienced severe itching both sides of both hands, plus both elbows on 27Sep2021 21:00 and BNT162B2 was co-administered with other vaccines on 27Sep2021 11:45. Therapeutic measures were taken as a result of severe itching both sides of both hands, plus both elbows which included Zyrtec and Benadryl. The patient did not recover from Severe itching both sides of both hands, plus both elbows. Prior to the vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination.

Other Meds:

Current Illness:

ID: 1790876
Sex: F
Age:
State: NJ

Vax Date: 06/10/2019
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: neuropathy has increasingly gotten worse/neuropathy in hands; neuropathy has increasingly gotten worse/neuropathy in hands; reaction from Covid vaccine; muscle pain in her pelvis area; fever chills; fuzzy in the head; voice was funny; itching; hairy though; bleeding on the biidged of her nose; black and blue on top of her left eye lids; flare ups are not going away; DUPIXENT MY WAY This is a solicited report form a contactable consumer (patient), based on the information received by Pfizer (MFR Control No.2019SA243843). A 79-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 31Aug2021 (at the age of 79-years-old) as dose 3 (booster), single for COVID-19 immunisation; and dupilumab, subcutaneous from 10Jun2019 (Batch/Lot Number: 9LOO5A; Expiration Date: 31Dec2020) and ongoing, at 600 mg, 1x/day, and via an unspecified route of administration from 31Aug2021 (Batch/Lot number was not reported) to 31Aug2021, at unspecified dose for eczema. Previously the patient received the first dose of bnt162b2 in Feb2021, and the second dose on an unspecified date. Medical history included small fiber neuropathy from Oct2017 and ongoing, atopic dermatitis from an unknown date and unknown if ongoing. Concomitant medications included hydrocortisone, acetic acid, pimecrolimus and triamcinolone acetonide, all taken for an unspecified indication, start and stop date were not reported. On an unspecified date in 2021, the patient experienced small fiber neuropathy has increasingly gotten worse/neuropathy in hands, reaction from covid vaccine, muscle pain in her pelvis area, fever chills, fuzzy in the head, voice was funny, itching, hairy though, bleeding on the biidged of her nose, black and blue on top of her left eye lids and flare ups are not going away. It was reported that patient had neuropathy in her hands a reaction from covid vaccine, muscle pain in her pelvis area, fever chills. felt fuzzy in the head, her voice was funny small fiber neuropathy has increasingly gotten worse, itch-ing is much better, hairy thouch, lot number is 91, it is hard to read not sure if the next digits are o's or d's, think they are o's, bleed-ing on the bridged of her nose, black and blue on top of her left eye lids, flare ups are not going away. On an unknown date (latency unknown for all the events), the patient's small fiber neuropathy had increasingly gotten worse (small fiber neuropathy, condition aggravated), itching was much better (pruritus), hairy though (hypertrichosis), lot number was 91, it was hard to read, she was not sure if the next digits were o's or d's, she thought they were o's (visual impairment), bleeding on the bridged of her nose (Epistaxis), black and blue on top of her left eye lids (eyelid contusion). and flare-ups are not going away (eczema). Upon follow, patient reported neuropathy in her hands (neuropathy peripheral) (stan date, latency. unknown) and off label use (start date, latency: unknown) Patient reported that she found the needle cover very hard to remove for the syringe because it was very tiny and tight, and she had neuropathy in her hands. Upon follow up, patient advised she had neuropathy in hands and struggles with taking off the needle covers. Patient advised was almost like the needle cover was vacuumed. patient advised needle cover was also small, making it more difficult for her to take off the needle cover. Patient was reporting a reaction from Covid vaccine in Feb2021 (vaccination complication) and she had muscle pain in her pelvis area for 36hrs (myalgia) (un-known latency) and on Tuesday 31Aug2021 she had a booster vaccine and she had fever chills (pyrexia), her voice was funny (dysphonia) she felt fuzzy in the head for a day and a half (feeling abnormal) (latency: 2 years 2 months 21 days). No treatment and consumer reports she is doing better. She had also had Dupixent injection 30Aug2021 a-day before her shot. The action taken with dupiluman in response to events was dose not changed. Neuropathy and hairy though were not resolved, myalgia was resolved, the outcome of events bleeding on the biidged of her nose, black and blue on top of her left eye lids and eczema aggravated was unknown, and the other events were resolving. Reporter causality: Not reported for all events. Company causality; reportable for vaccination complication, myalgia, pyrexia, dysphonia, feeling abnormal and not reportable for all other events. The reporter's assessment of the causal relationship of the reported events 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- The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: As per the information in the case provided, the causal association between the events Neuropathy peripheral, Condition aggravated,Vaccination adverse reaction, Myalgia, Pyrexia, Feeling abnormal, Dysphonia, Pruritus, Hypertrichosis, Epistaxis, Eyelid contusion, Eczema and the suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: HYDROCORTISONE; ACETIC ACID; PIMECROLIMUS; TRIAMCINOLONE ACETONIDE

Current Illness: Small fiber neuropathy

ID: 1790877
Sex: F
Age:
State:

Vax Date: 04/13/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: MRI of the brain; Result Unstructured Data: Test Result:tumor

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Dr, suggested MRI of the brain and they noticed tumor; extreme lethargy; brain fog; imbalance; This is a spontaneous report from a contactable consumer. A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) at age of 52-year-old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced extreme lethargy; brain fog, imbalance etc. for days after 2nd dose in 2021. Dr, suggested MRI of the brain and they noticed tumor. The events resulted in doctor or other healthcare professional office/clinic visit. No hospitalization prolonged. The outcome of events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790878
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: Covid; Test Result: Positive

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: had Covid; had Covid; This is a spontaneous report from a Regulatory Authority. A non-contactable consumer reported that a male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated she knew a gentleman in withheld who, along with his wife, had Covid. He got the Pfizer vaccine and now needs quadruple bypass. The patient underwent lab tests and procedures which included Covid: positive on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1790879
Sex: F
Age:
State: CA

Vax Date: 03/31/2021
Onset Date: 04/16/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: tests; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: pretty bad headaches/headache was consistent; disorientation; brain fog; dizziness; I can no longer concentrate; episodes of fainting; bad memory/memory issues; some hand tremor in both hands; She cannot drive. She had fainted a couple of time/I can no longer drive or exercise since that makes it more likely for me to black out; problems have been escalating more at the cognitive level; This is a spontaneous report from a contactable consumer (patient) and another contactable consumer (patient's mother). A 29-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as a single dose, in her left arm, on 31Mar2021 11:00 (lot number ER8737), at age of 29-year-old of vaccination, for Covid-19 immunization, in a pharmacy or drug store. The patient had no medical history or known allergies. The patient did not have Covid-19 before vaccination and did not test post vaccination. The patient did not receive other vaccines in four weeks and she received vitamins in two weeks. Started with pretty bad headaches/ consistent headaches, and then the patient started to present memory issues, brain fog, disorientation, dizziness, and overall the problems had been escalating more at the cognitive level. She could no longer concentrate, she had episodes of fainting, bad memory, some hand tremor in both hands. She could no longer drive or exercise since that made it more likely for her to black out. Her family kept her under constant supervision to avoid any accidents from happening. After the vaccine not only the patient but her parents as well experienced some of these issues but in their case the side effects had been disappearing while in her case had been getting worse. The events occurred on 16Apr2021 08:00. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. Patient received doctors' appointments, tests, referrals to special (including neurologist), and received unspecified treatment. The patient did tests and everything but the doctors could not find anything wrong but the symptoms started worsening. The patient had her second dose of vaccine on 22Apr2021. The outcome of the events was not resolved at the time of reporting.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101289277 Same reporter/ drug, different patients/ events;US-PFIZER INC-202101289278 Same reporter/ drug, different patients/ events

Other Meds:

Current Illness:

ID: 1790880
Sex: F
Age:
State: KS

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: spontaneous bleeding from nose; rapid heartbeat upon awakening; dose 1 on 13Jan2021 and dose 2 on 27Jan2021; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 27Jan2021 (Batch/Lot number was not reported) as dose 2, single at the age of 51 years old for COVID-19 immunisation. Medical history and concomitant medications reported as none. No known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 in left arm at the age of 51 years old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 29Jan2021, (2 days after the vaccination) the patient experienced rapid heartbeat upon awakening. The patient also experienced spontaneous bleeding from nose in the middle of the night on 30Jan2021 (3 days after 2nd shot). The patient has no history of nose bleeds. The patient did not receive treatment for the events. The patient recovered from the events in 2021. The events were assessed as non-serious. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1790881
Sex: F
Age:
State: WV

Vax Date: 09/26/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
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: Diarrhea; very sick/very ill; just not feeling well/feel very ill; Very weak; feel like she want to throw up; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in Arm Left on 26Sep2021 (at the age of 72-year-old) (Lot Number: FF8334) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2, on Sep2021 (at the age of 72-year-old) (Lot Number: FF2588) as single dose for covid-19 immunization and no adverse event. The patient experienced diarrhea, very sick/very ill, just not feeling well/feel very ill, very weak on 28Sep2021 07:30; feel like she want to throw up on 28Sep2021. She has a reaction from the shot she had Sunday. She was having a reaction to it. She was having diarrhea. She was very sick, very weak, very ill. She had not been this ill in a long time. She just got her shot Sunday afternoon. She had got diarrhoea, she was very ill. She was just not feeling well. She had been ill since 7:30 the morning. She had diarrhoea all morning and she felt very ill. She felt like she was going to throw up right now. She felt like she want to throw up. This was really bad diarrhoea this morning that's how bad the diarrhoea is. She chew some Pepto Bismol tablet (Treatment). She had diarrhoea. It's not working exactly because she was just in near about 10 minutes ago. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1790882
Sex: F
Age:
State: WA

Vax Date: 07/09/2021
Onset Date: 07/09/2021
Rec V Date: 10/16/2021
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: 202107; Test Name: CT scan; Result Unstructured Data: Test Result:Clear

Allergies:

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

Symptoms: Facial numbness; tingling on the right side of her face; This is a spontaneous report from a contactable other HCP. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Deltoid Right on 09Jul2021 15:00 (Lot Number: EW0161; Expiration Date: 31Jul2021, NDC number of Pfizer Covid shot: 5926710001) at the age of 41-year-old as 0.3 ML single for covid-19 immunisation. Medical history included penicillin allergy (Just to penicillin. It looks like it is on her allergies. It could have been when she was a child, she did not know). Patient's other medical history (including any illness at time of vaccination) reported as none. Family medical history Relevant to AE(s) reported as no. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect reported as no. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as no. Prior vaccinations (within 4 weeks) reported as no. On 09Jul2021, 6 hours after receiving the vaccine, the patient had facial numbness and tingling on the right side of her face, which resolved after 14 hours. She had no other symptoms. She was a healthy 41 year old. The patient ended up in the emergency room(ER) and they did a CT scan at the hospital and everything was clean. She was not admitted to the hospital, it was just to the emergency room. The numbness went away after 14 hours. Caller stated she guesses it was somewhat serious, it was facial numbness. Events required a visit to emergency room and physician office. The outcome of the events was completely recovered on 10Jul2021 11:00. Causality reported as "they think so, that is what they are trying to figure out". Patient was greater than 42 days past her first dose. Caller was asking if it was okay for her to receive the second dose after having some side effects from the first dose, so addressed timing as well.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event hypoaesthesia, paraesthesia and the suspect drug BNT162B2.

Other Meds:

Current Illness:

ID: 1790883
Sex: F
Age:
State: TN

Vax Date: 08/30/2021
Onset Date: 08/30/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: 2 weeks after receiving developed shingles from nose to lips and swollen area in jaw.; 2 weeks after receiving developed shingles from nose to lips and swollen area in jaw.; 3rd dose (booster); 3rd dose (booster); This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FC3184 and expiration date was not reported) via an unspecified route of administration at left arm on 30Aug2021 12:15 pm (age at vaccination 62-year-old) as dose 3 (booster), single for covid-19 immunization. The patient medical history included Sicca Syndrome and DLBCL - remission from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The other medications in two weeks included nortriptyline, nadolol, omeprazole, vitamin C (ascorbic acid), vitamin D (vitamin D NOS) taken for an unspecified indication, start and stop date were not reported. The patient received historical vaccine included dose 1 and dose 2 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported) via an unspecified route on an unknown date of 2021 single for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced 2 weeks after receiving vaccine developed shingles from nose to lips and swollen area in jaw on 13Sep2021 07:00 am. Therapeutic measures included valacyclovir for 2 weeks after receiving developed shingles from nose to lips and swollen area in jaw. The outcome of the events 2 weeks after receiving developed shingles from nose to lips and swollen area in jaw was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: NORTRIPTYLINE; NADOLOL; OMEPRAZOLE; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1790884
Sex: F
Age:
State: NC

Vax Date: 09/23/2021
Onset Date: 09/27/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 202109; Test Name: Blood work; Result Unstructured Data: Test Result:unknown results; Test Date: 202109; Test Name: cultures; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Lipschutz genital ulcersAcute Non sexually active teen no STD No virus No Covid nothing; This is a spontaneous report from a contactable other HCP (patient, as reported). A 13-year-old female patient (also reported as 16-year-old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 23Sep2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at Pharmacy or Drug Store. The patient medical history was not reported. The patient did not have COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included methylphenidate hydrochloride (JORNAY PM) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 26Aug2021 at the age of 13-year-old at single dose for COVID-19 immunisation. The patient has known allergy to cephalosporins. On 27Sep2021 the patient experienced 'Lipschutz genital ulcers acute, non sexually active teen, no Sexually transmitted disease (STD) no virus no covid nothing'. The event resulted in Doctor or other healthcare professional office/clinic visit and treatment of steroids, 5% lidocaine was administered. The patient underwent cultures, and blood work. The event had not resolved. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Lipschutz genital ulcers acute" and suspected vaccine BNT162B2 cannot be completely 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: JORNAY PM

Current Illness:

ID: 1790885
Sex: F
Age:
State:

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210927; Test Name: Fever; Result Unstructured Data: Test Result:101 Fahrenheit

Allergies:

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

Symptoms: Loss of appetite; Fever 101F; muscle, bone, joint, nerve pain.; muscle, bone, joint, nerve pain; muscle, bone, joint, nerve pain.; muscle, bone, joint, nerve pain.; Difficulty walking; Severe Headache; Patient received booster dose; Patient received booster dose; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: FF8839) via an unspecified route of administration, administered on the left arm on 27Sep2021 10:00 (at the age of 67-year-old) as dose 3 (booster), single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose on an unspecified date and second dose in 2021 of BNT162B2 for COVID-19 immunisation and experienced being sick. The booster was given 7 months after dose 2. On 27Sep2021 22:00, the patient experienced Fever 101F, muscle, bone, joint, nerve pain; difficulty walking, severe headache, loss of appetite. Duration continuing. "Was the sickest I ever felt. Much worse than the two prior doses. Even worse than any illness I have ever had". No treatment was received for the events. Events were considered non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1790886
Sex: F
Age: 29
State: CO

Vax Date: 06/04/2021
Onset Date: 06/04/2021
Rec V Date: 10/16/2021
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: Pending

Allergies: Minocycline

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Five hours after injection I broke out into hives on my wrists/forearms, ankles, inner thighs, and armpit. I went to urgent care the next morning and got steroids and the rash subsided after a few days. The itchiness lingered until September 13, (vaccine was given 6/4) when I broke out in the same rash but this time my ankles became very red and very very swollen. The rash was both painful and itchy. I returned to urgent care to revive steroids and again after several days (4-5) the rash subsided bit itchiness lingering. I broke out a third time the first week of October but this time a home rememdy of 2000 IUs of Vitamin D and garlic pills both taken twice daily were able to help the rash subside. Benedryl and hydrocortisone did not do much to help. Hydrocortisone helped somewhat soothe the intensity but didn?t help a whole lot and if I took more than two benedryl it would also soothe symptoms mildly but if only taken one or two benedryl, the rash seemed to worsen. The rashes when present would appear in the evening, get less intense over night, and progressively grow in intensity until fully flared before bedtime. This pattern would repeat until treated. Also during this time, beginning after my first rash, I was on my period for THREE MONTHS. It was very light for the most part but I am 30 years old and have never had an irregular period in my adult life. Things resolved the second week of October but it is a October 16th and I?m sure issues will continue.

Other Meds: Spirinolactone Wellbutrin

Current Illness: None

ID: 1790887
Sex: M
Age:
State: NJ

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Headache/ mild headache; severe pain in neck and shoulder to shoulder; severe pain in neck and shoulder to shoulder; malaise/general feeling of moderate malaise; swollen lymph nodes that are sore; swollen lymph nodes that are sore; received the booster dose of the Pfizer Covid-19 vaccine/ 3rd dose; received the booster dose of the Pfizer Covid-19 vaccine/ 3rd dose; This is a spontaneous report from contactable consumer (patient) via regulatory authority. A 79-year-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Right on 27Sep2021 16:45 (lot number: 30145BA; expiry date: unknown) at the age of 79-years-old, as dose 3 (booster), single for Covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient had no known allergies. The patient was not diagnosed with Covid-19 prior vaccination. Concomitant medication included influenza vaccine (FLU) taken for immunization in the left arm on 24Sep2021. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 29Jan2021 (lot number: EN9581); and second dose on 19Feb2021 (lot number: EL9266) in left arm for COVID-19 immunization. On 27Sep2021, at 21:00, the patient experienced mild headache, severe pain in neck and shoulder to shoulder, and malaise/general feeling of moderate malaise, and swollen lymph nodes that were sore. The patient did not receive treatment for the events mild headache, severe pain in neck and shoulder to shoulder, and malaise/general feeling of moderate malaise. Outcome of the event swollen lymph nodes that are sore was unknown, while for events mild headache, severe pain in neck and shoulder to shoulder, and malaise/general feeling of moderate malaise was recovering. Since vaccination, the patient has not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790888
Sex: M
Age: 39
State: TX

Vax Date: 10/14/2021
Onset Date: 10/15/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Started with mild headache that got progressively worse. As the headache worsened body temperature and heart rate rose. Body temp spiked at 103? and resting heartrate rose to 98bpm. Headache began to relieve within 12hrs of onset and heartrate is lower but still elevated.

Other Meds:

Current Illness:

ID: 1790889
Sex: M
Age:
State: RI

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Myocarditis; This is a spontaneous report from a contactable nurse. A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, as single dose (unspecified if 1st or 2nd), for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The nurse stated that the patient was admitted to hospital on an unspecified date where he was diagnosed with myocarditis in Jun2021. The nurse believed the patient was still hospitalised. The outcome of the event was not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile, a possible contributory role of BNT162B2 to the development of myocarditis cannot be excluded.

Other Meds:

Current Illness:

ID: 1790890
Sex: M
Age:
State: MO

Vax Date: 05/04/2021
Onset Date: 05/20/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: joint pain in his shoulders, fingers and knees; overall pain; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received 2nd single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: Ew0151, expiration date unknown) via an unspecified route of administration in the arm right on 04May2021 at 13:00 at age of 63-year-old for COVID-19 immunization. Medical history included depression. Patient previously received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: Ew0170, expiration date unknown) via an unspecified route of administration in the right arm on 15Apr2021 at 02:00 PM at age of 63-year-old for COVID-19 immunisation. Patient previously received acetylsalicylic acid (ASPIRIN ) and experienced stomach reaction. There was no other vaccine in four weeks. Concomitant medications included sertraline hydrochloride (ZOLOFT). After the second dose, patient had about 3 days of muscle pain and overall pain. Then within 10 days, patient started having joint pain in his shoulders, fingers and knees. Knees got better after a week or two but shoulder pain in his left side and fingers got more severe for 2 month afterwards. Then gradually lessened to a tolerable level. And now, 5 months later he still had pain in his fingers and shoulders. Patient never had shoulder pain or hand pain before. His right hand got the worst of it and his left shoulder after that. Most of the pain in his fingers were concentrated in the first joints from the tip of fingers. The events didn't result in emergency room visit or physician office visit. Onset date of the events was reported as 20May2021 at 12:00AM. No treatment received for the events. Outcome of the events was recovered with sequel. Patient had no COVID prior vaccination. Patient was not tested for COVID post vaccination.

Other Meds: ZOLOFT

Current Illness:

ID: 1790891
Sex: F
Age:
State: TX

Vax Date: 09/26/2021
Onset Date: 09/26/2021
Rec V Date: 10/16/2021
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: redness / redness all above the upper arm; there was a little bruise at the site where injected; she has swelling on her upper arm, near the injection site about two inches by 2 inches; a little tired; sore arm; she received the booster dose on Sunday, 26Sep2021; she received the booster dose on Sunday, 26Sep2021; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Sep2021 (Batch/Lot Number: 301358A) (at the age of 70 years old) as single dose for Covid-19 immunisation. The patient medical history was not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 04Feb2021 (Lot: EL9269, Expiration: Unknown) (at the age of 69 years old) via an unspecified route of administration, administered in left arm for Covid-19 immunisation and experienced a little tiredness and soreness in arm. The second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 26Feb2021 (Lot: EN6203, Expiration: Unknown) (at the age 69 years old) via an unspecified route of administration, administered in left arm and experienced a little tired and had little bit like had the flu. The patient also had a second dose of Pneumonia vaccine 2 years ago for immunization and arm became swollen. The patient's concomitant medications were not reported. The patient received the booster dose on Sunday, 26Sep2021 and felt a little tired and had sore arm. On 29Sep2021, the patient experienced she has swelling on her upper arm, near the injection site about two inches by 2 inches. There was also some redness. Redness all above the upper arm and there was a little bruise at the site where injected. She noted that she just started experiencing this today (29Sep2021). She had taken Benadryl to reduce the swelling. The patient recovered from tiredness on 27Sep2021. Outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790892
Sex: F
Age:
State: GA

Vax Date: 09/12/2021
Onset Date: 09/12/2021
Rec V Date: 10/16/2021
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: Severe tiredness/Fatigue; Red face; Hot face/Hot; Swollen glands on face; Pinching quick pains in lymph areas of body; Joint stiffness; Muscle soreness for days/Muscle pain; Hot; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Sep2021 13:00 at the age of 60-years-old (Lot Number: FC3182) as single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included Known allergies: Sulfa, Sulfates. There were no concomitant medications. On 12Sep2021 13:15, the patient experienced adverse events: "Red face. Hot face. Swollen glands on face. Pinching quick pains in lymph areas of body. Joint stiffness. Muscle pain. Fatigue. Hot. Severe tiredness. Muscle soreness for days." AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment for AE. The outcome of events was recovered with sequelae.

Other Meds:

Current Illness:

ID: 1790893
Sex: M
Age:
State: SC

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/16/2021
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: Fever; Result Unstructured Data: Test Result:101.6; Comments: last night it was 101.6

Allergies:

Symptom List: Tremor

Symptoms: rash; photo sensitivity; over 101 fever; nausea; fatigue; headache; This is a spontaneous report from a contactable Nurse. A 72-year-old male patient (reporter's Husband) received the third dose (booster) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EW0186), on 27Sep2021 (at the age of 72-years-old) at single dose for COVID-19 immunization. The patient had received the first dose of BNT162B2 (lot number: EK923) on 12Jan2021 and the second dose of BNT162B2 l(ot number: EL9261) on 29Jan2021. The patient was a veteran and Caller volunteers at the clinic there. She was able to get their shots early because of working with patients. They were one of the first ones to get Pfizer Vaccine. She didn't want to abuse it and go since they are not immune compromised, but the clinic approved the booster dose. Medical history included Insulin Dependent Diabetes and high blood pressure, Cholesterol. Concomitant drugs included Statin 10 for Cholesterol, Lantus on it probably a year and a half at the maximum dose of 50 daily for Insulin Dependent Diabetes. Prior to that he was on NPH and regular insulin, this has been really good for him. He took Losartan for his blood pressure has been really good. He has been on it probably six or seven months. He was on something else before, but he had angioedema after many years. That was a crisis during COVID. Because of the mask caller didn't see his lips swelling. He had to change his medication due to that. The caller reporte that the patient had received his flu vaccine as well as the 1st dose of the shingles vaccine 2 weeks prior to the COVID booster vaccine and questioned if his symptoms may be possibly related to this. On 27Sep2021 the patient experienced headache and fatigue and on 28Sep2021 he had fever and nausea. He had over 101 fever, headache at 3 point, and nausea. Caller has been medicating him for symptoms. She gave him Dramamine ( lot number: 2O1495, Expiration: May2023) Strength: 25mg and gave him 2000mg of Extra Strength Tylenol over 24 hours (Manufacturer: Tylenol Gelcaps,lot number: AFA091, Expiry: Apr2023). When he woke up the day of reporting he still felt fatigue. The headache is 3 on a 10 point scale. Caller gave him Extra Strength Tylenol. She was not sure if it is within the normal side effects. She called hosptial in and they said if he is not any better to go to the hospital. He was breathing and fine. Caller didn't want to make her husband anxious. When she took fever last night it was 101.6 but she told him it was 101.1 because it would freak him out. Her husband is a diabetic and it hasn't been quite 48 hours post vaccination and he has been quite incapacitated. Headache the day before reporting it was a 10. He also had nausea like a severe migraine. Seriousness Criteria: He has some photo sensitivity. It is a little disabling. The nausea was normal for the headache that he had. Fatigue was still present, but has improved. The caller stated he remained fatigued and was currently laying down with a headache that was rated as a "3." The wife, also the caller, is and has been giving Tylenol to help manage his symptoms. She states she "cleared up right away. He is "getting better." Caller states with his high fevers he was "incapacitated" and notes his symptoms to have been "quite debilitating" and was "out yesterday" although today he is better. The husband also received his flu vaccine and 1st shingles vaccine 2 weeks ago. The caller is not sure if this could have precipitated the fevers he is experiencing. Caller says her husband got like a shingle type rash on the arm where his shingles vaccine was given. The event nausea was recovered on 28Sep2021, fever recovered on 29Sep2021, the outcome event shingle type rash on the arm and photo sensitivity was unknown and the outcome of other events were recovering.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event pyrexia and the suspect drug BNT162B2. 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.,Linked Report(s) : US-PFIZER INC-202101289286 same drug, different AE/patient

Other Meds: LOSARTAN; LANTUS; STATIN [ATORVASTATIN CALCIUM]; INFLUENZA VACCINE; SHINGLE VACCINE

Current Illness:

ID: 1790894
Sex: F
Age:
State: FL

Vax Date: 08/30/2021
Onset Date: 09/03/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210903; Test Name: Fever; Result Unstructured Data: Test Result:103

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: hot and swollen red arm; hot and swollen red arm; hot and swollen red arm; Swelling radiating down to elbow; severe sensitivity to touch; pressure in arm; fever 103; body aches; fatigue; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) dose 1 via an unspecified route of administration, administered in left arm on 30Aug2021 (Batch/Lot Number: EW0171) as dose 1, single for COVID-19 immunisation. Patient had no medical history (None, otherwise healthy). There were no concomitant medications. The patient previously took CECLOR and experienced allergies. The patient experienced 5 days post-vaccine 03Sep2021 17:00, hot and swollen red arm. Swelling radiating down to elbow, severe sensitivity to touch or pressure in arm, unresolved. 24-48h maintain post-vaccine fever 103, body aches, fatigue, resolved after 2 days. Patient received topical biofreeze; otc NSAIDs. No COVID prior to vaccination and has not been tested for COVID-19. The outcome of fever 103, body aches, fatigue was recovered on 05Sep2021 and other events was recovering. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1790895
Sex: M
Age:
State:

Vax Date: 09/28/2021
Onset Date: 09/29/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210929; Test Name: Fever; Result Unstructured Data: Test Result:101.1

Allergies:

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

Symptoms: 101.1 fever; headache; body ache; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Sep2021 at 17:45, at the age of 39 years, as the second single dose, in left arm, for COVID-19 immunization. Medical history included COVID prior vaccination. Known allergies no. Other medical history: no. The patient received the first dose of BNT162B2 vaccine on 01Sep2021 at 17:30, in left arm, at the age of 39 years. No other vaccine was administered in four weeks. Concomitant medications were not reported. The morning after, on 29Sep2021 at 08:00, the patient had 101.1 fever, also headache and body ache. The events were resolving without any treatment. COVID was not tested post vaccination. No No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1790896
Sex: U
Age:
State: PA

Vax Date: 09/16/2021
Onset Date: 09/16/2021
Rec V Date: 10/16/2021
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: 20210606; Test Name: Covid antibodies; Result Unstructured Data: Test Result:No antibodies found

Allergies:

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

Symptoms: Aankylosing spondylitis; second vaccine dose on 06May2021 and third booster dose on 16Sep2021; This is a spontaneous report from a contactable consumer. A 51-year-old patient of unknown gender received third dose booster of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EW0179), intramuscular into the Right Arm on 16Sep2021 at 18:30 (at the age of 51-years-old) at single dose for COVID-19 immunization. The patient had received the first dose of BNT162B2 (lot EP7533) in the Right Arm on 15Apr2021 and the second dose of BNT162B2 (lot ER8735) in the Right Arm on 06May2021. No Prior Vaccinations Within 4 Weeks. Medical history included Underactive thyroid, Bi-Polar with Psychotic Episodes, Osteo/ Rheumatoid arthritis and Chondritis, Scoliosis. Concomitant Drugs included Synthroid 15 mg oral daily for Thyroid, Aleve oral for Joint pain/ Arthritis, Tylenol oral for Pain and Miralax oral. On 17Sep2021 the patient was newly diagnosed with ankylosing spondylitis following ongoing symptoms and requested a lab test to check antibodies to rule out any concern that she was also suffering from COVID. The patient was concerned that she has been vaccinated and on 06Jun2021 the antibodies were not found. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: SYNTHROID; ALEVE; TYLENOL; MIRALAX

Current Illness:

ID: 1790897
Sex: M
Age:
State: NC

Vax Date: 04/29/2021
Onset Date:
Rec V Date: 10/16/2021
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: daily severe headaches, debilitating at times; This is a spontaneous report from a non-contactable nurse (patient). A 52-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Apr2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There is no other vaccine in four weeks, no other medications in two weeks. The patient experienced daily severe headaches, debilitating at times on an unspecified date. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. The outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the limited information in the case, a contributory role of BNT162B2 to the reported event Headache cannot be ruled out. 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: 1790898
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: in a lot of pain; Inadvertently, she was given 2 COVID vaccines instead.; Inadvertently received dose 3 and 4 the same day; Inadvertently received dose 3 and 4 the same day; Received Pfizer Covid vaccine instead of flu vaccine; This is a spontaneous report from a contactable consumer (the patient) . A female patient of an unspecified age received bnt162b2 (BNT162B2) dose number three, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation . Medical history included knee arthroplasty. The patient's concomitant medications were not reported. The patient experienced in a lot of pain (non-serious) on Sep2021 with outcome of unknown , inadvertently, she was given 2 covid vaccines instead. (non-serious) on Sep2021 with outcome of unknown , inadvertently received dose 3 and 4 the same day (non-serious) on Sep2021 with outcome of unknown , received Pfizer Covid vaccine instead of flu vaccine (non-serious) on Sep2021 with outcome of unknown. Course of the event The caller was supposed to get the flu vaccine and the Covid 19 vaccine booster or third dose but the pharmacy gave the caller 2 Covid 19 booster vaccines. She wants to know what to do. Caller states she is recovering from a knee replacement surgery and is in a lot of pain. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790899
Sex: F
Age:
State: NJ

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 10/16/2021
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: lips became swollen; This is a spontaneous report from a contactable consumer (patient). A 98-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 20Jan2021 (Batch/Lot number was not reported) (at the age of 98-years-old) as DOSE 1,SINGLE for covid-19 immunisation. Medical history included she had a history of allergies her whole life, lips became swollen years ago after taking a blood pressure medicine from an unknown date. The patient's concomitant medications were not reported. The patient stated she had a history of allergies her whole life. On 20Jan2021, she was given the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. An hour after, she said her lips became swollen. She said she had the same reaction years ago after taking a blood pressure medicine. She was told to take Benadryl, and it went away after. However, that night, her lips swelled again so she took another Benadryl and it went away. She was told not to get the 2nd dose so she didn't. She said it had been 8 months and she wanted to socialize. She said that her daughter read something about taking Benadryl or steroids prior to receiving the booster. The patient would like to know if that was advisable. Therapeutic measures were taken as a result of lips became swollen included Benadryl. The outcome of the event was resolved on an unspecified date. The lot number for [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790900
Sex: F
Age:
State:

Vax Date: 03/08/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Rheumatoid arthritis flare up; This is a solicited report based on information received by Pfizer (Mfr. Control No.: 21K-163-4090213-00) received from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 intramuscular on 08Mar2021 (at the age of 70 years old, Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen) subcutaneous from an unspecified date (Batch/Lot number was not reported) at unspecified dose for moderate to severe rheumatoid arthritis. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 intramuscular on 15Feb2021 (Batch/Lot number was not reported) for covid-19 immunisation. Patient with an event of non-serious Rheumatoid arthritis flare up after the second Covid shot with Humira (Adalimumab). The patient experienced rheumatoid arthritis flare up in 2021 with outcome of recovered in 2021. In 2021, the patient experienced Rheumatoid arthritis flare up after the second Covid shot. In 2021, the Rheumatoid arthritis flare up after the second Covid shot resolved. Pfizer BionTech COVID-19 Vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the event for adalimumab was unknown. The reporter's causality for the event of rheumatoid arthritis flare up and BNT162B2 as possible and not provided for adalimumab. No follow-up attempts are needed. Information about lot/batch number cannot been obtained. No further information is expected.; Sender's Comments: Based on possible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported event. 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: HUMIRA

Current Illness:

ID: 1790901
Sex: F
Age:
State: MN

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210217; Test Name: blood pressure; Result Unstructured Data: Test Result:200; Test Date: 20210217; Test Name: blood pressure; Result Unstructured Data: Test Result:189/96; Test Date: 20210217; Test Name: blood pressure; Result Unstructured Data: Test Result:200; Comments: second time; Test Date: 20210929; Test Name: blood pressure; Result Unstructured Data: Test Result:130/67; Test Date: 20210929; Test Name: blood pressure; Result Unstructured Data: Test Result:168/69

Allergies:

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

Symptoms: blood pressure and noted that it was almost at 200/blood pressure which was 189/96 / second time they took it, it was almost 200/ blood pressure was elevated already; felt weird; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 16Feb2021 (Lot Number: EL9261, unknown expiration) as dose 2, single at the age of 83 years old for COVID-19 immunization. Medical history included ongoing high blood pressure (she takes a blood pressure medicine, the only prescribed medicine she takes. It has been many years like 35 or 40 years ago, she was in her 50s). Concomitant medication included unspecified blood pressure medicine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246) via injection in left arm at unknown dosage on 26Jan2021 at the age of 83 years old for COVID-19 immunisation with no reaction. The patient was asking if there is any information about elevated blood pressure after receipt of the COVID vaccine. She got her second dose on 16Feb2021, and the next morning on 17Feb2021 at 11:00, she felt weird, so she took her own blood pressure and noted that it was almost at 200. She called the clinic and the doctor saw her immediately and took her blood pressure which was 189/96. The patient asked if this was a reaction from the shot and was told they did not know. The second time they took it, it was almost 200. The patient was prescribed some medicine/pill, she took two on that day. She took one right after lunch and was supposed to take another one in the evening if the blood pressure hadn't gone down considerably, which it hadn't, but by the next morning her blood pressure was pretty much back to normal, she recovered, and she did not have to take any more pills, it seems as though it was a reaction to the COVID shot. Today (on 29Sep2021), the patient went to get a booster dose, but her blood pressure was high, probably because she was anxious since she has just moved in a new town and has a new doctor. The clinic reported that they were concerned because her blood pressure was elevated already and did not want to administer the vaccine for fear her blood pressure would go up again like it had before and will have stroke. Blood pressure before she went to the clinic was about 130/67. She was surprised when she got to the clinic knowing that her blood pressure was that high. The patient also mentioned that she had some changes in her life, she recently moved to a new area, a new apartment, lots of changes, she went to a new doctor and a new clinic, and was probably a little anxious, she's assuming that's why her blood pressure was elevated today. She did not call about it back in February but called today to ask if there is any information about the vaccine causing an elevated blood pressure. Today (on 29Sep2021), her blood pressure is 168/69 but normally with her medication it runs in the 120s and sometimes in the one teens. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient recovered from weird feeling on 18Feb2021, while not yet recovered from blood pressure elevated. No follow-up attempts are possible; information about batch number was already obtained.

Other Meds:

Current Illness: Blood pressure high (She takes a blood pressure medicine, the only prescribed medicine she takes.)

ID: 1790902
Sex: F
Age:
State: TX

Vax Date: 08/05/2021
Onset Date: 08/05/2021
Rec V Date: 10/16/2021
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: chest pain; tunnel hearing/partial hearing loss; This is a spontaneous report from a contactable consumer. A 36-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 05Aug2021 13:00 (Batch/Lot Number: FA7484) (at the age of 36-years-old ) as single dose for covid-19 immunisation. Medical history included cough from 30May2021 to 06Sep2021. There were no concomitant medications. The patient had received the first dose of bnt162b2 (lot EW0181) on 13Jul2021 Intramuscular Left arm and experienced prolonged period as well as late period. On 05Aug2021 at 22:00 the patient experienced tunnel hearing, partial hearing loss happens about 1-2 days out of the week since the second Pfizer vaccine was given. On 11Aug2021 at 03:00 chest pain started a week after second Pfizer vaccine given . Chest pain got so severe that the patient had to go to the ER. Medication at ER helped with further severe pain (so far). The event tunnel hearing, partial hearing loss were considered serious as Persistent/Significant disability and Important medical event. The outcome of the event was not recovered, the outcome of the chest pain was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021892717 Same reporter/ patient, different dose/ AEs.

Other Meds:

Current Illness: Cough

ID: 1790903
Sex: M
Age:
State: OR

Vax Date: 09/07/2021
Onset Date: 09/12/2021
Rec V Date: 10/16/2021
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: Shingles; This is a spontaneous report from a contactable consumer (patient) and other HCP. A 37-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: FF2589), via an unspecified route of administration, administered in arm left on 07Sep2021 at 11:00 (at the age of 37-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included asthma and allergic contact dermatitis. The patient's concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) taken daily; fluticasone propionate (FLONASE) taken 1x daily; fexofenadine hydrochloride (ALLEGRA) taken 1x daily all three received within 2 weeks of vaccination. The patient previously took propylene glycol, methylisothiazolinone, formaldehyde and experienced allergies. 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. Since the vaccination, the patient had not been tested for COVID-19. On 12Sep2021 at 17:00 (5 days after receiving the 1st dose), the patient developed a case of shingles. First symptoms were a tingly and numb right leg from his hip to his knee. A rash appeared on his lower back and right hip a few days later then became inflamed and blistered. The patient was first diagnosed about shingles from emergency room/department or urgent care, then he got a second opinion from the dermatologist. Valacyclovir was taken as a therapeutic measure as a result of the events. Outcome of event at the time of last observation was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: ADVAIR; FLONASE; ALLEGRA

Current Illness:

ID: 1790905
Sex: F
Age:
State: NM

Vax Date: 06/03/2021
Onset Date: 06/03/2021
Rec V Date: 10/16/2021
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 Date: 20210602; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210610; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210821; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210925; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Vomiting

Symptoms: Uveitis; Cystoid Macular Edema; dose 1 on 03Jun2021 11:00/dose 2 on 03Jun2021; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in left arm, on 03Jun2021 11:00, at the age of 55-year-old (not pregnant), (Lot Number: FC2336) as dose 1, single; and dose 2 via an unspecified route of administration in left arm, on 03Jun2021 at the age of 55-year-old (not pregnant), (Lot Number: EW0181) as dose 2, single; for covid-19 immunisation. The patient medical history was not reported. No other vaccine in four weeks, no other medications in two weeks. Patient did not have COVID prior vaccination. Patient had no known allergies. The patient's concomitant medications were not reported. On 28Jun2021 06:00, the patient experienced uveitis and cystoid macular edema. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Patient tested COVID post vaccination included COVID test (Nasal Swab) was negative on 02Jun2021; was negative on 10Jun2021; was negative on 21Aug2021; and was negative on 25Sep2021. Therapeutic measures were taken as a result of uveitis and cystoid macular edema included "call me/15 visits and still no cure". The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790906
Sex: F
Age:
State: OR

Vax Date: 09/27/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
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: Vomiting into the second day.; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old non pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: FF8839), via an unspecified route of administration on 27Sep2021 at 16:30(at the age of 69-years-old) administered in Arm Left as a single dose for COVID-19 immunisation at Pharmacy or Drug Store. The patient medical history was not reported. Concomitant medication(s) included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication from 27Sep2021 to 27Sep2021; atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. The patient had previously received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number: not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies. On 28Sep2021 at 12:00 PM, Vomiting into the second day. This was her booster. She had no special adverse events with her first two doses. No treatment was given for the event. The outcome of the event was not recovered. Follow-Up (05Oct2021): Follow-up attempts are completed. No further information is expected.

Other Meds: FLU VACCINE VII; LIPITOR; ASPIRIN

Current Illness:

ID: 1790907
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 08/24/2021
Rec V Date: 10/16/2021
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: 20210824; Test Name: Covid 19 infection; Test Result: Positive.

Allergies:

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

Symptoms: tested positive for covid 19 infection on 24Aug2021/had the Covid virus 24Aug2021; tested positive for covid 19 infection on 24Aug2021/had the Covid virus 24Aug2021; This is a spontaneous report from a Program from a contactable other healthcare professional (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date as single dose, first dose via an unspecified route of administration on Jan2021 as single dose, for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that he was fully vaccinated with Pfizer BioNtech covid 19 vaccine back in Jan2021. He tested positive for covid 19 infection on 24Aug2021. Patient stated that he was still having some side effects from decreased lung capacity however he had completed his required isolation and was back to work. Patient stated that he would like to know when it was safe for him to get his booster dose of the Pfizer Biontech covid 19 vaccine? Patient had the Covid virus 24Aug2021 and was asking how long to take the booster and what was the recommended month to get the booster shot. Patient stated that was what he really wanted to know and no one can answer. Patient stated it was too soon as he was still having side effects with his lung capacity, he was over the Covid for a little bit now. Patient was asking when it was safe for him to get it. The outcome of the events was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up. Based on the temporal association, a causal relationship between the events and BNT162B2 cannot be completely excluded. Of note, the efficacy of a drug varies from patient to patient and can be affected by different factors, and the mutated coronavirus strains would also alter the efficacy of the vaccine. The case will be reassessed when additional information becomes available.

Other Meds:

Current Illness:

ID: 1790908
Sex: M
Age:
State: NJ

Vax Date: 09/26/2021
Onset Date: 09/26/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: shaky; my hands having a slight twitch; tired; slept all day; sustained readings of "signs of atrial fib."; This is a spontaneous report from a contactable consumer. A 68-year-old male consumer (patient) reported that received the third dose (booster dose) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on 26Sep2021 at 12:30 (at the age of 68-years-old) at single dose for COVID-19 immunization. The patient had received another dose of BNT162B2 on 15Feb2021 at 12:45 PM in the Left arm. Within 4 weeks prior the booster dose on 13Sep2021, the patient had received flu vaccine - left arm. Medical history: included atrial fib; mild asthma; high blood pressure; high cholesterol; thoracic aortic aneurysm. No known allergies. Concomitant drugs included eliquis; montelukast; amlodipine; melatonin, budes. Prior to vaccination, the patient was not diagnosed with COVID-19. On 26Sep2021 04:30 PM approximately four hours after the shot the patient's Apple Watch showed sustained readings of "signs of atrial fib." On the next morning he was shaky, with his hands having a slight twitch. He was tired and slept all day. On the subsequent day (i.e. day 2) he was fine. The event resulted in Doctor or other healthcare professional office/clinic visit. no treatment was given. Since the vaccination, has the patient has not been tested for COVID-19. The outcome of the event was recovered on 28Sep2021. The Lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds: ELIQUIS; MONTELUKAST; AMLODIPINE; MELATONIN; BUDES

Current Illness:

ID: 1790909
Sex: U
Age:
State: TX

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210205; Test Name: Nasal swab; Result Unstructured Data: Test Result:Negative; Test Date: 202103; Test Name: Nasal swab; Result Unstructured Data: Test Result:Negative

Allergies:

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

Symptoms: started having a reaction and started w/itching; large hives like blisters on neck and face; Face was all red like a sunburn/red face palms and bottom of feet red; large hives like blisters on neck and face; This is a spontaneous report from a contactable consumer (patient). This 61-year-old patient of unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number EL9269), intramuscularly on the right upper arm on 12Feb2021 at 3:00 PM (at the age of 61-year old) at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were none. On 12Feb2021 at 17:00, 10 hours after vaccination the patient started having reaction and started with itching, large hives like blister on neck and face. Face was all red like a sunburn. The patient took diphenhydramine (BENADRYL) 25 mg, waited 30 minutes took another diphenhydramine 25 mg. "A prednisone pill (left over from poison IVY 2019) patient called Pfizer and talked to someone to repeat. Went to bed and the next morning it took like nothing happened. On 05feb2021 the patient had a nasal swap the was negative. Patient's work required to be tested every week, all results were negative. The outcome of the events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021259921 same patient/drug, different dose/AE

Other Meds:

Current Illness:

ID: 1790910
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Right sided paralysis; Mottled skin; Joint range of motion decreased; Short-term memory loss; Headache; This is a Solicited report from FACILITATED COLLECT based on the information received by Pfizer manufacture number (21K-163-4088291-00). A contactable consumer (patient) reported that a 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunisation; risankizumab (SKYRIZI), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 150 mg (1 in 12 Wk) for psoriasis. The patient's medical history and concomitant medications were not reported. The patient experienced right sided paralysis, mottled skin, joint range of motion decreased, short-term memory loss, headache, all on an unspecified date. The action taken in response to the events for risankizumab was unknown. The outcome of headache was not recovered, the rest events was unknown. All events were resulted in physician office visit. Solicited report by a consumer of an adult female with events of right side paralysis and non-serious mottled skin knees upward, unable to lift head, short term memory loss and unrelieved headache with SKYRIZI (RISANKIZUMAB). There was no reported medical history. On unknown dates, the patient experienced right side paralysis, mottled skin knees upward, unable to lift head, short term memory loss and unrelieved headache. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient had a severe reaction of right side paralysis, mottled skin knees upward, unable to lift head, unrelieved head ache to Pfizer covid vaccine. She was under care of a neurologist, headache has never gone away. She had short term memory loss. She pending an electroencephalogram 81 magnetic resonance imaging. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received COVID-19 Vaccine manufactured by Pfizer. Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the events of right side paralysis, mottled skin knees upward, unable to lift head, short term memory loss and unrelieved headache was not provided. Opinion is that there is no reasonable possibility that the events of right side paralysis, mottled skin knees upward, unable to lift head, short term memory loss and unrelieved headache are related to SKYRIZI(RISANKIZUMAB). Causality for BNT162B2: the reporter's causality for all events was not provided. The reporter's assessment of the causal relationship of all events with the suspect products 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 needed; information about lot/batch number cannot be obtained.; Sender's Comments: The information provided is very limited and does not allow a meaningful medical assessment of the case. Patient's medical history, lab investigations, diagnostic procedures, concomitant medications, treatment aspects etc would have allowed better to assess the case. However, based on the available information and considering drug event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events of right sided paralysis, mottled skin, joint range of motion decreased, short-term memory loss and headache. The case will be reassessed further upon receipt of additional information. 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: SKYRIZI

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am