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: 1646104
Sex: F
Age:
State: FL

Vax Date: 07/11/2021
Onset Date: 07/19/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 20210719; Test Name: covid 19 test; Test Result: Positive

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Pneumonia; Tested positive for Covid; Her body is too week right now; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A contactable consumer (husband) reported for wife. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8736 and Expiry date: Unknown), via an unspecified route of administration on Arm Left on 11Jul2021 as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pneumonia, her body is too week right now. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 19Jul2021. Treatment included patient went to the hospital 3 times and stayed in the hospital for about week and half second time. Patient developed pneumonia. It was reported that Second dose is schedule today. The reporter (Patient husband) reported that there was little bit of confusion here in the hospital. She was supposed to get second shot today, her doctors told her she has to wait several weeks before she can get another shot because her body was too week right now. The outcome of events was unknown. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1646105
Sex: F
Age:
State:

Vax Date: 07/30/2021
Onset Date: 07/31/2021
Rec V Date: 08/28/2021
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: Severe chest pain; This is a spontaneous report from a non-contactable consumer or other non hcp. A 33-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jul2021 at 13:00 (at the age of 33-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced severe chest pain on 31Jul2021 at 14:00. Patient received no other vaccine in four weeks. The event resulted in Emergency room/department or urgent care visit. No treatment was given for the event. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1646106
Sex: F
Age:
State: FL

Vax Date: 07/11/2021
Onset Date: 07/19/2021
Rec V Date: 08/28/2021
Hospital: Y

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 Date: 20210719; Test Name: Tested for Covid-19; Test Result: Positive

Allergies:

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

Symptoms: Pneumonia; COVID-19; This is a spontaneous report from a contactable consumer reporting for her wife. A 35-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 11Jul2021 (Batch/Lot Number: ER8736) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date with outcome of unknown. The patient also had covid-19 on 19Jul2021 with outcome of unknown. The patient was hospitalized because of the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 19Jul2021. It was reported that the patient went to the hospital 3 times and stayed in the hospital for about week and half the second time. She developed pneumonia. She was supposed to get second shot today, her doctors told her she has to wait several weeks before she can get another shot because her body is too weak right now. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646107
Sex: F
Age:
State: MI

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Noticeable fatigue ongoing since the vaccinations; This is a spontaneous report from a contactable nurse, the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249) via an unspecified route of administration in the left arm on 19Jan2021 at 18:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN) and allergy to penicillin. Concomitant medication was not reported. The patient previously received naproxen (NAPROSYN) on an unknown date taken for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 the patient experienced noticeable fatigue ongoing since the vaccinations. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event noticeable fatigue ongoing since the vaccinations was not recovered at the time of this report.

Other Meds:

Current Illness:

ID: 1646108
Sex: F
Age:
State: CA

Vax Date: 05/24/2021
Onset Date: 06/05/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: bloodwork; Result Unstructured Data: Test Result:Unknown Results; Test Name: ekg; Result Unstructured Data: Test Result:Unknown Results; Test Name: pelvic exam; Result Unstructured Data: Test Result:Unknown Results; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown Results

Allergies:

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

Symptoms: Tense sore chest; Tense sore chest/elbows/knees/shoulders; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 49 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 24May2021 13:15 (Batch/Lot Number: EW0187) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication from an unspecified start date and ongoing; caffeine, paracetamol (EXCEDRIN [CAFFEINE;PARACETAMOL]) taken for an unspecified indication from an unspecified start date and ongoing; diphenhydramine hydrochloride, paracetamol (TYLENOL PM) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced tense sore chest on 05Jun2021 with outcome of unknown , tense sore chest/elbows/knees/shoulders on 05Jun2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood test, electrocardiogram, gynaecological examination and ultrasound pelvis with unknown results. Follow-Up (10Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds: ASPIRIN (E.C.); ZYRTEC ALLERGY; EXCEDRIN [CAFFEINE;PARACETAMOL]; TYLENOL PM

Current Illness:

ID: 1646109
Sex: F
Age:
State: FL

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
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: Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Test Result:low grade temperature

Allergies:

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

Symptoms: within 30 seconds of vaccine i had a strong metal taste in my mouth; Lips numb; Very bad pain in left arm; Low grade temp in the evening; Bad pain in shoulder; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: FA7485) in the left arm on 01Aug2021 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were reported but not specified. On 01Aug2021 within 30 seconds of vaccination, the patient experienced strong metal taste in her mouth, lips were numb and a few hours later, the patient experienced very bad pain in her left arm and shoulder, also a low-grade temperature in the evening. On 01Aug2021, in the evening, the patient underwent lab tests and procedures which included body temperature which was of low grade. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events metal taste in mouth, lips were numb, very bad pain in left arm, bad pain in shoulder and low-grade temperature were recovering at the time of this report.

Other Meds:

Current Illness:

ID: 1646110
Sex: F
Age:
State: OH

Vax Date: 05/03/2021
Onset Date: 05/03/2021
Rec V Date: 08/28/2021
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: When trying to sleep O experienced what I now know to be low tone pulsative tinnitus/ experiencing high pitched ringing in my left ear (seeming to originate from my left rear side of my head); Affected my concentration; Affected ability to sleep; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 41-years-old, via an unspecified route of administration, administered in Arm Left on 03May2021 12:00 (Batch/Lot Number: EW0172) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included angioedema (seen her immunologist, who didn't have concerns about the vaccine). Concomitant medications included levocetirizine dihydrochloride (XYZAL) and cetirizine hydrochloride (ZYRTEC) both taken for an unspecified indication, start and stop date were not reported. The patient previously took doxycycline and experienced drug allergies. COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The evening of her shot when trying to sleep she experienced what she now knows to be low tone pulsative tinnitus. When she awoke the following day, she began experiencing high pitched ringing in my left ear (seeming to originate from my left rear side of my head). It has not stopped since then. It varies in frequency from mild to screaming loud. It has affected her concentration and ability to sleep. Her immunologist directed her to the GP who directed her to an ENT and she have been unable to get an appointment but after researching it doesn't seem there's much of a treatment. This could be a lifelong illness. The events occurred on 03May2021 21:00 which resulted to disability/ permanent damage. No treatments received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: XYZAL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1646111
Sex: F
Age:
State: NY

Vax Date: 05/04/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
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: 2021; Test Name: antibody test; Result Unstructured Data: Test Result:she has 50 antibodies; Comments: it was very high

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Felt very euphoric after getting the vaccine.; Her eyes would barely open and were bothering her; 2 days later she started throwing up and she threw up for 4 days straight.; She passed out for 4 days; I had a horrible reaction. I thought I was dying/She said that she thought she was going to die; This is a spontaneous report from a contactable consumer (patient) A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 04May2021 (Batch/Lot Number: EW0175) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took COVID19 Vaccine Pfizer and started suffering issues, she had bad reactions to the vaccine. The patient said that she had the vaccine and felt very euphoric after getting it; she said that they gave her a bottle of water and she stayed at the vaccine location for 20 minutes and felt so good that she actually bought some make up. The patient said that after that she went home and she passed out for 4 days and after she woke up, she said that her eyes would barely open and were bothering her. 2 days later she started throwing up and she threw up for 4 days straight. The patient called her doctor and her doctor told her to drink Gatorade and she did, and felt better. The patient said that she thought she was going to die. It was very frightening and she was very concerned about taking the second dose. It was also reported that "she had a antibody test and she has 50 antibodies and the pharmacist told her it was very high". The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646112
Sex: M
Age:
State: SC

Vax Date: 07/26/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: diagnosed with 'RSV'; Sinus infection; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jul2021 (Batch/Lot Number: EW0170) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient was diagnosed with 'RSV' (respiratory syncytial virus infection) on 2021 with outcome of unknown , had a sinus infection on 2021 with outcome of unknown. The patient was hospitalized because RSV infection. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646113
Sex: F
Age:
State: DE

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
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: Left leg soreness; Pins and needles almost feels like restless leg syndrome - like I need to be moving leg around.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO217) via an unspecified route of administration in the left arm on 01Aug2021 at 10:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took cefaclor (CECLOR) and experienced a drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Aug2021, the patient experienced left leg soreness, pins and needles which almost felt like restless leg syndrome - like she needed to move her leg around. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left leg soreness, pins and needles which almost felt like restless leg syndrome- like she needed to move her leg around was not resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1646114
Sex: F
Age:
State: NY

Vax Date: 07/27/2021
Onset Date: 07/31/2021
Rec V Date: 08/28/2021
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: Rash on my abdomen; Scalp and palm were very itchy; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the arm right on 27Jul2021 at 19:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 as prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Jul2021 at 01:30, the patient woke up with a rash on abdomen and her scalp and palms were very itchy. The events resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the reported events and included treatment with diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID) from an unknown date. The clinical outcome of the events rash on abdomen and scalp and palm were very itchy was not resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1646115
Sex: F
Age:
State: MA

Vax Date: 03/05/2021
Onset Date: 03/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 202107; Test Name: Antigen test; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Rash, Urticaria

Symptoms: This is a spontaneous report from a contactable consumer (patient herself). A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6206, expiry date: unknown) via unspecified route of administration, in right arm on 05Mar2021 12:00 (age at vaccination: 66-years-old) as dose number unknown, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history of patient included heart attacks, gall stones/gall bladder removal, low thyroid on an unspecified date (2 heart attacks, gall stones/gall bladder removal, low thyroid good health altogether). Patient had no known allergies. Concomitant medications included Synthroid and Prasugrel al, (in two weeks) taken for unspecified indication start and stop date not known. No other vaccine in four weeks was administered. On an unspecifed date in Mar2021, patient experienced intermittent diarrhea. It's gotten better, but still patient got it at least every other week. No treatment was given for the adverse event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient underwent lab test for antigen test (nasal swab) with negative results on an unspecified date in Jul2021. The outcome of event was recovering.

Other Meds: SYNTHROID; PRASUGREL AL

Current Illness:

ID: 1646116
Sex: F
Age:
State: TN

Vax Date: 07/12/2021
Onset Date: 07/12/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: passed out in the car; tingling in my hand; pain above my ear followed by a warm sensation from the spot over my ear and into my jaw which became numb just in front of my ear; pain above my ear followed by a warm sensation from the spot over my ear and into my jaw which became numb just in front of my ear; Numbness in jaw persisted for two days; Dizziness; nauseous; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was 8R8731 and expiration date was not reported), via an unspecified route of administration, administered in Right Arm on 12Jul2021 08:30 (at the age of 47-years-old) at dose 1, single for covid-19 immunization. Medical history included known allergies to Penicillin, sulfa, lots of food and chemicals. Concomitant medications included ethinylestradiol, norethisterone acetate (MICROGESTIN); calcium; magnesium; acetylcysteine (NAC); vitamin d nos; vitamin c [ascorbic acid]. Patient was not pregnant. The patient previously took e-mycin [erythromycin], c-flox [ciprofloxacin hydrochloride] and experienced drug allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination and patient was not tested post vaccination. The patient had most recent COVID-19 vaccine at Public Health Clinic/Veterans Administration facility. It was reported that fewminutes after injection patient felt a tingling in hand then a sharp pain above ear followed by a warm sensation from the spot over her ear and into her jawwhich became numb just in front of her ear. After 35 minutes of waiting, patient left and was dizzy walking out. She became nauseous and passed out in the car. Numbness in jawpersisted for two days. Dizziness came and went for two weeks. The events occurred on 12Jul2021 at 08:30am. The events were resulted in Doctor or other healthcare professional office/clinic visit. No treatment was given for the events. The outcome of the events was recovered. Information on the lot/batch number has been requested.

Other Meds: MICROGESTIN; CALCIUM; MAGNESIUM; NAC [ACETYLCYSTEINE]; VITAMIN D NOS; VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1646117
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 04/16/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: I had a DVT in leg, then has a stroke 2 months after the DVT.; I had a DVT in leg, then has a stroke 2 months after the DVT.; This is a spontaneous report from a contactable other health care professional (nurse/patient). A 22-years-old non pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EK9231, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 30Dec2020 10:00 as dose 1, single for covid-19 immunization at the hospital. Patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL3249, expiration date unspecified), via an unspecified route of administration, administered in Arm right on an unknown date as dose 2, single for covid-19 immunization at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. Medical history included systemic Diagnosed with lupus from an unknown date, (APLS) antiphospholipid syndrome from an unknown date. The patient's concomitant medications were not reported. On 16Apr2021 01:0, the patient had a DVT in leg (deep vein thrombosis) and on an unknown date 2 months after DVT in leg the patient had a stroke. The patient was hospitalized due to the event for 6 days. The patient was treated with blood thinners during her stay in hospital. The outcome of the events was reported as recovered. No follow-up attempts are possible. No further information is expected. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event Deep vein thrombosis and cerebral vascular accident and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1646118
Sex: F
Age:
State: IL

Vax Date: 02/26/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
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: 20210704; Test Name: CAT scan; Result Unstructured Data: Test Result:found nothing; Test Date: 20210704; Test Name: MRI; Result Unstructured Data: Test Result:found nothing

Allergies:

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

Symptoms: having Bell's Palsy symptoms; Her tongue on left side becomes numb; numbness across left side of face, nose and tops of cheek and sometimes like this morning, will go up towards the eye and when it gets severe, get to left side of the upper and lower lips; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration on 26Feb2021 (at the age of 76-year-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Family medical history relevant to AE included none. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in left arm on 05Feb2021 (at the age of 76-year-old) as dose 1, single for covid-19 immunization. On an unspecified date in May2021, the patient experienced having bell's palsy symptoms, her tongue on left side becomes numb which is a funny sensation according to patient, numbness across left side of face, nose and tops of cheek and sometimes like this morning, will go up towards the eye and when it gets severe, get to left side of the upper and lower lips. Patient wanted to know if there had been any case studies like her experience. Patient reported that It's the nose and cheek and travels sporadically to the nose and tongue and then its more forceful and goes up the left eye. The patient underwent lab tests and procedures which included computerized tomogram: found nothing on 04Jul2021, magnetic resonance imaging: found nothing on 04Jul2021. The events resulted in emergency room visit and physician office visit. Therapeutic measures were taken as a result of events. The outcome of the event were not recovered.

Other Meds:

Current Illness:

ID: 1646119
Sex: F
Age:
State:

Vax Date: 02/02/2021
Onset Date: 02/01/2021
Rec V Date: 08/28/2021
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: experienced sick like symptoms; fever; headaches; This is a spontaneous report received from a contactable consumer (patient) reported for herself via a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 02Feb2021 as single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021 the patient experienced sick like symptoms with a fever and headaches. Outcome of the events was resolved on an unspecified date in 2021. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1646120
Sex: F
Age:
State: NY

Vax Date: 07/07/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: heart beat; Result Unstructured Data: Test Result:115-120; Test Date: 2021; Test Name: heart beat; Result Unstructured Data: Test Result:high 220 and it goes low, it can go lower like 47; Comments: have abnormal heartbeat it goes high 220 and it goes low, it can go lower like 47 or 50

Allergies:

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

Symptoms: I have abnormal heartbeat it goes high 220 and it goes low, it can go lower like 47 or 50 but I am not taking any medication."; little out of breath; stomach infection; Cramps with Diarrhea; Cramps with Diarrhea; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0217), via an unspecified route of administration on 07Jul2021 (at the age of 63-years-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included allergic slightly, itchy mouth (she was allergic slightly, she gets an itchy mouth after she has certain tropical fruits like kiwi and watermelon. The patient stated that, sometimes she also gets the same reaction to very ripe bananas or the skin of an apple), osteoporosis, uterine hyperplasia, acid reflux, irritable bowel syndrome, heartburn, (patient takes tums antacid), asthma, (patient uses Asthma Pump, sometimes when having trouble with weather allergy), on an unspecified date in Oct2020, biopsy (patient had seen a Gynaecologist on an unspecified date in Oct2020 before the Covid Vaccine, patient didn't remember the day of the month (October) but they gave me a biopsy and they wanted to do a little surgery BNC (further not clarified) but they were waiting for the vaccines to come) and allergy. The patient's concomitant medications included vitamin b [vitamin b nos], vitamin d [vitamin d nos], calcium and calcium carbonate, magnesium carbonate (TUMS [CALCIUM CARBONATE; MAGNESIUM CARBONATE]), taken for heartburn. On an unspecified date in 2021, the patient experienced her heartbeat went up after taking the first dose and diarrhea for a couple of days. It was reported that patient had cramps with diarrhea on Friday and yesterday that was improved but she also had some issues with her stomach infection. Stated that, she didn't know that was 2 weeks after the shot, she didn't know if it was connected to the shot (vaccine). Stated that, her heart was going faster like around 3 hours or within less than 3 hours after the shot but then it got better by itself. Stated that, she didn't call the doctor. Stated that, she had a question if she didn't get a serious allergic reaction to the first shot, would she get an allergic reaction to the second shot. The patient stated that, she had abnormal heartbeat it went high 220 and it went low, and also stated that it can go lower like 47 or 50 but she was not taking any medication. The patient mentioned that she was scheduled to get her second dose and she was a little worried. She stated that she wanted to know that whether there might be a severe allergic reaction to the second dose if she didn't get one from the first dose or was it less likely. Patient reported that around three hours after she got the first shot her heart beat became heavy. Stated that, she sat down and she didn't know if one would call it racing but she was checking it and it was up to like 115-120 for a while, maybe a couple of hours it stayed around there. Stated that, she was just resting, she was either sitting or half-lying and it was going like that and then it fully resolved itself after a while. Then over the next couple of days it was elevated but not as bad and then it went back to its normal speed. During all that time she stated, she was still able to do things but she was feeling a little out of breath as if she was exercising but she wasn't. She stated that, she didn't call the doctor about it and it went away but she also had that before she took the vaccine so she wasn't sure. She stated that, she talked to a nurse because she didn't have a doctor and the nurse stated that, it might have been because she was out in the sun and she hadn't had anything to eat or drink in 4 hours around getting the shot because things got complicated. Stated that, the nurse wasn't sure whether it was an after effect of that being a bit dehydrated. Stated that, after she drank and was sitting for a while she got better. She was wondering if that reaction would happen with the second shot or could that reaction be worse with the second shot. Stated that, it did resolve itself. She wanted to know whether the ingredients in erythromycin which gave her a fast heart beat so they stopped giving it to her as an antibiotic and wanted to know if any of those ingredients are in the Pfizer COVID-19 vaccine. She stated that, she looked at the ingredients for the Pfizer COVID vaccine but she couldn't tell if it had any of the same ingredients and if that's the case then maybe that was why her heart rate went up. She was talking about a reaction to the ingredients to the Pfizer vaccine would have happened to the first shot rather than the second or wanted to know if it would be an accumulation or if would get a severe reaction to the second dose adding to the first. Stated that, she was trying to reassure herself because she was sort of scared of getting a severe reaction. She stated that she didn't understand when she was reading on the site they were breaking down the cases 17 of 21 patients that had anaphylaxis some of them had had reactions in the past to medicine, medical products, food, or insect stings. She was just wondering since she didn't get an anaphylactic reaction to fruits, she just breaks out to a rash in her mouth in the back and the top and then it went away over time, if that meant since they mentioned fruit and she got some allergies as long as her food allergies were not that severe probably her food allergies would be similar because obviously and there were not the same ingredients in fruit, besides maybe potassium she was not sure as in the Pfizer vaccine so it doesn't make since to her that people with fruit allergies have gotten an anaphylactic reaction but she never had it from fruit she just had the itchy mouth. So she guessed that meant she only has mild allergies and also because she didn't get any kind of itchiness in her mouth from the vaccine it probably wouldn't happen again. Patient wanted to know whether the symptoms she had from the 1st vaccine will be worse on the second vaccine. It was reported that the missed the second dose on 28Jul2021. On an unspecified date in 2021, the patient underwent lab tests and procedures which included heartbeat, resulted as 115-120 and heartbeat, resulted as high 220 and it goes low, it can go lower like 47, have abnormal heartbeat it goes high 220 and it goes low, it can go lower like 47 or 50. The outcome of the events for cramps with diarrhea was recovering, for infection was unknown while for the other events was recovered on an unspecified date in 2021.

Other Meds: VITAMIN B [VITAMIN B NOS]; VITAMIN D [VITAMIN D NOS]; CALCIUM; TUMS [CALCIUM CARBONATE;MAGNESIUM CARBONATE]

Current Illness:

ID: 1646121
Sex: F
Age:
State: TX

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: body aches; chills; joint pain; fever; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 592671000001) via an unspecified route of administration in the left arm on 01Aug2021 at 11:00 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Aug2021 at 23:00 the patient experienced body aches, chills, joint pain and fever. Therapeutic measures were taken as a result of events included treatment with paracetamol (TYLENOL) for pain and fever. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events general body pain, chills, joint pain and fever were recovering at the time of this report.

Other Meds:

Current Illness:

ID: 1646122
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Nausea; Diarrhea; This is a spontaneous report received from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number: Not Provided) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient mentioned that "Well I tried going to the website but I can't even go through the website for some reasons, but I had the COVID vaccine on Thursday and I have been expect. I have been having these different things like injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea and diarrhea that different things here on an unspecified date. The patient want to find out how long these stuff was going to last, I mean if it last a few days, or weeks, or what I don't know, that's my question Well if I have any problems I will come back. Outcome of all events was unknown. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646123
Sex: F
Age:
State: FL

Vax Date: 07/24/2021
Onset Date: 07/31/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Lump under armpit; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 24Jul2021 at 11:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included chronic asthma and a known allergy to seafood. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 31Jul2021, the patient experienced lump under armpit. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lump under armpit was not resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1646124
Sex: M
Age:
State: FL

Vax Date: 07/30/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
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: Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Test Result:101.1 Units:{DF}; Comments: Fever of 101.1

Allergies:

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

Symptoms: Fever of 101.1; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fa7485) via an unspecified route of administration in the left arm on 30Jul2021 at 15:00 (at the age of 13-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. On 01Aug2021 at 06:00, the patient experienced fever of 101.1. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room/ department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with ibuprofen (MOTRIN) 400 mg. On 01Aug2021 at 06:00, the patient underwent lab test and procedure which included body temperature and result was shown as 101.1 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever of 101.1 was unknown at the time of this report.

Other Meds:

Current Illness:

ID: 1646125
Sex: M
Age:
State: FL

Vax Date: 06/28/2021
Onset Date:
Rec V Date: 08/28/2021
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: Fingers are tight like they are paralyzed; Fingers are tight; Pain from shoulder to wrist; Cannot carry anything heavy in his hands; Spot where vaccine was placed is purple colored; Intense pain in bones; Itching and little zits; This is a spontaneous report from a contactable consumer. This 62-year-old male consumer (patient) reported for himself that he started to receive BNT162B2 (Bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection) via unknown route of administration on 28Jun2021 at DOSE 1, SINGLE on left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient got the first dose in a pharmacy a month ago, he went for the second dose and told them about the problems he had and they told they couldn't give him the second dose and to talk to Pfizer to make the report. It was reported that patient started having problem on 28th when he had the vaccine. Two days after that, started having this problem. Been having this problem for one month now. It's the first time this happened to him. This is the first time he had a vaccine like this. Clarified side effects as: First day after the vaccine, 1-2 day after that, the spot where the vaccine was placed, it was purple colored. Three days after that, started having pain from the shoulder to wrist. Experiencing an intense pain in the bones. Cannot carry anything heavy in his hands. Cannot even carry his phone in his left hand. Wakes up and his fingers are tight like they are paralyzed. Caller clarified he is only experiencing this on the left side where he received the vaccine. Outcome: lasted one week more or less. It was the whole area. Stated pain from shoulder to wrist and in his bones is the same. Has not improved at all. Will see the doctor tomorrow because he is not ok. It is not worse. Fingers are tight like they are paralyzed: Today was worse. He feels terrible today. Itching and little zits: Itches a lot from the wrist to elbow. There are little zits there and looks like he has been bitten by insects. Lots of itching. Is only on the left side. Received vaccine in left arm. It is nowhere else. Started 2-3 days after the vaccine. Still has it now. While he is reporting to this agent, he is experiencing the pain and itching. Patient reported that everyone in his family got the vaccine. He didn't want to have it. People said it was important. Didn't want to be the difficult child in the family. Stated the after results were worse. History and Investigations: Is not a friend of medicines. He doesn't like taking medications. He stated that tomorrow will see doctor about cholesterol tests. Will take advantage of tests, cholesterol tests, and will have blood work done as well. He is worried about it a lot. The outcome of events for paralysis, musculoskeletal stiffness, pain in extremity, muscular weakness, bone pain, and pruritus was not recovered. Outcome for event vaccination site discoloration was recovered. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646126
Sex: F
Age:
State: SC

Vax Date: 12/01/2020
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: fever; chills; muscle weakness; diarrhea; basically had the flu; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unknown route in Dec2020 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, chills, muscle weakness, diarrhea and basically had the flu. The outcome of events was unknown. Information about the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1646127
Sex: F
Age:
State: MO

Vax Date: 07/29/2021
Onset Date:
Rec V Date: 08/28/2021
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: Small seizures; Extreme vaginal bleeding; Vomiting; Difficulty breathing; Severe body cramping; This is a spontaneous report from a contactable consumer (the patient). A 16-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: fa7484), via an unspecified route of administration, in the right arm, on 29Jul2021 at 11:00 (at the age of 16-year-old), as single dose, for COVID-19 immunization. The patient's medical history none. No known allergies. The patient received other medicine within 2 weeks of vaccination included ciprofloxacin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient's historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ep7533), via an unspecified route of administration, in the right arm, on 08Jul2021 at 11: 00 (at the age of 16-year-old), as single dose, for COVID-19 immunization. On an unknown date in 2021, patient woke up with extreme vaginal bleeding, vomiting, difficulty breathing, severe body cramping and small seizures. Events resulted in emergency room/department or urgent care visit. No treatment for events. Outcome of the events was recovering. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds: CIPROFLOXACIN

Current Illness:

ID: 1646128
Sex: F
Age:
State: MI

Vax Date: 07/29/2021
Onset Date: 07/29/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 202108; Test Name: blood work; Result Unstructured Data: Test Result:Clear; Test Date: 202108; Test Name: EKG; Result Unstructured Data: Test Result:Clear; Test Date: 20210729; Test Name: heart rate; Result Unstructured Data: Test Result:faster than normal

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: chest pains; heart rate has been faster than normal; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 19-year-old female patient (Non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0175 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 29Jul2021 14:15 (at the age of 19 years) as dose 1, single for covid-19 immunisation. Patient Medical history was not included. Concomitant medication(s) included ibuprofen (UNKNOWN MANUFACTURER) taken for an unspecified indication, start and stop date were not reported. Patient had no reported allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and Since the vaccination, patient was not tested for COVID-19. The patient received Ibuprofen within 2 weeks of vaccination. Patient had been having chest pains and heart rate has been faster than normal. Patient went to the hospital on august 1st and EKG, and blood work came back clear. Patient stated "They didn't give me an MRI and I've started feeling this way since the day I got my vaccine which was 29Jul2021. The adverse led to Hospitalization. On 29Jul2021 the patient underwent lab tests and procedures which included heart rate found to be faster than normal. On unspecified date of Aug2021 the patient underwent lab tests and procedures which included blood test and electrocardiogram found to be clear. Patient did not receive any treatment for events. The outcome of the event was not recovered.

Other Meds: IBUPROFEN

Current Illness:

ID: 1646129
Sex: F
Age:
State: FL

Vax Date: 07/29/2021
Onset Date: 07/30/2021
Rec V Date: 08/28/2021
Hospital: Y

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: 20210730; Test Name: pulse oximeter; Result Unstructured Data: Test Result:84 to 86 %; Comments: oxygen levels; Test Date: 20210801; Test Name: PCR COVID test; Test Result: Positive ; Test Date: 20210730; Test Name: Rapid COVID test; Test Result: Positive

Allergies:

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

Symptoms: diagnosed with COVID-19; shortness of breath; This is a spontaneous report from a Pfizer sponsored program. A contactable Nurse reported for Patient (Reporter's daughter). A 16-year-old female received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Deltoid Left, on 29Jul2021 at 11:00 (age at vaccination: 16 years), as a single dose for COVID-19 immunization. The patient's medical history included ongoing asthmatic (she had first asthma attack and end up in hospital at age 4). Concomitant medications were not reported. The reporter called on behalf of her daughter (patient) who received the COVID-19 Vaccine Thursday 29Jul2021. The next day, on 30Jul2021, after patient received the vaccine, the patient started having shortness of breath and her mother, ICU nurse, took her to the ER where she was diagnosed with COVID-19. The patient was hospitalized on an unspecified date. She had put the pulse oximeter on and oxygen level was 84 to 86%. The patient's lungs and there were no crackles. The patient was taking shallow breaths. In the ER they gave her a breathing treatment and ordered a spacer for her inhaler. She has been ok since. The reporter had questions regarding her 2nd dose of the vaccination and if the series will have to be restarted. Caller stated that when she was caring for patients in the ICU they were advising them at discharge to wait 6-8 weeks to get the vaccine after having COVID related illness/hospitalizations. Vaccination of people with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and they have met criteria to discontinue isolation. This recommendation applies to people who experience SARS-CoV-2 infection before receiving any vaccine dose and those who experience SARS- CoV-2 infection after the first dose of an mRNA vaccine but before receipt of the second dose. While there was no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of SARS-CoV-2 reinfection was low in the months after initial infection but may increase with time due to waning immunity. Advised the caller that this document did not advise to restart the vaccination series but to wait until after isolation period and recovered from acute illness as noted above with no "designated minimal time interval." The patient underwent lab tests and procedures which included oxygen saturation: 84 to 86 % on 30Jul2021 oxygen levels, sars-cov-2 test: positive on 01Aug2021, sars-cov-2 test: positive on 30Jul2021. Outcome of the event shortness of breath was recovered on an unspecified date in 2021 and for another event, it was unknown. There was a Product Complaint and description of complaint included Caller's daughter received first COVID19 Vaccine dose on Thursday. The next day she started having shortness of breath. Caller took her daughter to the hospital and she tested positive for COVID. The reason caller took her daughter to get tested is because her daughter is a severe asthmatic and said she was having trouble breathing. She had put the pulse oximeter on and oxygen level was 84 to 86%. In the ER they gave her a breathing treatment and ordered a spacer for her inhaler. She has been ok since. COVID19 Vaccine: the writing is a little bad on the card. The lot number is FAY485 or FAYU85. It was first dose. Product strength and count size dispensed: unknown Additional lot numbers: n/a Is a sample of the product available to be returned, if requested (Y/N): Not Provided Packaging sealed and intact? Not Provided; Sender's Comments: As there is limited information in the case provided, the causal association between the events covid-19 and dyspnea the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness: Asthmatic (she had first asthma attack and end up in hospital at age 4)

ID: 1646130
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: nausea; headache; tired; felt like she has to throw up; I was feeling a little light headed; she cant shake this feeling it wont leave her; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0164), via an unspecified route of administration on an unspecified date 2021 (age at the time of vaccination 50-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date 2021, the patient experienced nausea, headache, tired, felt like she has to throw up, I was feeling a little light headed, and she cant shake this feeling it wont leave her. Consumer was informed about the role of Pfizer Drug Safety. Consumer was suggested to contact Medical Information Department for the concern. As the consumer was unwilling to complete the report, further probing could not be done. Hence, limited information available over the call. The outcome for all the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1646131
Sex: F
Age:
State:

Vax Date: 07/31/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: antibodies; Result Unstructured Data: Test Result:really good.

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Fever; Nausea; Headache; Fainted twice this morning; This is a spontaneous report from a contactable consumer. This consumer reported events for both herself and her daughter. This case refers to reporter's daughter. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,), via an unspecified route of administration on 31Jul2021 (Batch/Lot Number: EW0196) as single dose for covid-19 immunisation. Medical history included covid-19 from 2020 to an unknown date. The patient's concomitant medications were not reported. On 01Aug2021, patient experienced fainted twice this morning , fever, nausea , headache . In the place where patient had vaccine, they only say to take Tylenol (treatment), or to go to emergency room. The mother does not want to go there. She is wondering if she can skip the second dose as she does not want to put in danger her daughter's life. The patient underwent lab tests which included antibody test for COVID-19 on unknown date and she has really good antibodies. Outcome of the events was unknown. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1646132
Sex: F
Age:
State: TX

Vax Date: 07/30/2021
Onset Date: 07/30/2021
Rec V Date: 08/28/2021
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: shortness of breath; chest tightness; hives; This is a spontaneous report from a contactable nurse (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0198), via an unspecified route of administration in left arm on 30Jul2021 at 14:15 (at the age of 54-years-old) at dose 1, single for COVID-19 immunisation. Medical history included diabetes type 2 and asthma. She has no history of COVID prior to vaccination. Concomitant medications included metformin, dulaglutide (TRULICITY), empagliflozin (JARDIANCE), and omeprazole (PROTONIX). The patient previously took lisinopril and IMITREX and experienced allergies to both. There were no other vaccines administered in four weeks. The vaccine was administered at a pharmacy or drug store. The patient was not tested for COVID post vaccination. On 30Jul2021 at 14:45, the patient experienced shortness of breath, chest tightness, and hives which required doctor or other healthcare professional office/clinic visit and treatment with steroids, BENADRYL, and ZYRTEC. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events dyspnea, chest discomfort, urticaria and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: METFORMIN; TRULICITY; JARDIANCE; PROTONIX [OMEPRAZOLE]

Current Illness:

ID: 1646133
Sex: F
Age:
State: NC

Vax Date: 02/11/2021
Onset Date: 08/02/2021
Rec V Date: 08/28/2021
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: 20210802; Test Name: COVID-19 TEST; Test Result: Positive.

Allergies:

Symptom List: Nausea

Symptoms: Tested (+) for Covid; Tested (+) for Covid; This is a spontaneous report from a contactable other hcp. A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: El3247, Expiration date: Unknown), intramuscular, administered in left arm on 11Feb2021 06:45 (at the age of 50-years-old) as dose 2, single and first dose via intramuscular, administered in left arm on Jan2021 04:45 (Batch/Lot Number: EL3247) as dose 1, single for covid-19 immunisation. It was unknown that, other vaccine was administered in four weeks. It was unknown that, other cations were given in two weeks. The patient did not have Covid prior vaccination. It was unknown that, if Covid tested post vaccination. Known allergies was reported as unknown. The patient's medical history and concomitant medications were not reported. On 02Aug2021, the patient tested positive for covid. The patient underwent lab tests and procedures which included COVID-19 test: positive on 02Aug2021. No treatment was received for the event. The outcome of the event was recovering. Sender's Comments: As there is limited information in the case provided, the causal association between the event Covid 19 and Vaccination failure and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the drug is evaluated as part of 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, as appropriate.

Other Meds:

Current Illness:

ID: 1646134
Sex: F
Age:
State: NJ

Vax Date: 02/27/2021
Onset Date:
Rec V Date: 08/28/2021
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: 2021; Test Name: Tested for antibodies; Test Result: Negative ; Comments: not showing that she has any antibodies

Allergies:

Symptom List: Injection site pain

Symptoms: Rheumatoid Arthritis; she is not showing that she has any antibodies; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 27Feb2021 (lot number and expiry date was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included methotrexate (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on 06Feb2021 for COVID-19 immunization and had no reaction on previous exposure to vaccine. It was reported that the patient has rheumatoid arthritis since an unknown date and had a Rituxin infusion on 25Mar2021, and then again 2 weeks later. The patient reported that she is not showing that she has any antibodies in 2021. She wanted to know why she got a negative antibody test. The patient also wanted to know if Pfizer has already provided as statement on the need for a booster dose (3rd dose). The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds: METHOTREXATE

Current Illness:

ID: 1646135
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: 2021; Test Name: Covid-19 test; Test Result: Positive

Allergies:

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

Symptoms: tested for covid-19 and the test was positive; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received the 1st dose of the vaccine and then 3 days later tested for Covid-19. The patient's husband stated his wife got the first dose last Tuesday, then clarified and stated it was two weeks ago. Then after the first dose, three days later on an unspecified date in 2021, she got covid-19. He further clarified and confirmed after the vaccine she went to a lab, was tested for covid-19 and the test was positive. Now it has been 15-16 days since, he stated she passed, but clarified 'she passed' as she is okay. Right now, she is doing okay. He stated patient is scheduled for the second dose and he has questions. The second dose is scheduled for 03 Aug2021. He does not know what he should do. He wants to know if she should get the second dose and when she should get the second dose. The outcome of the event was recovered in 2021.

Other Meds:

Current Illness:

ID: 1646136
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: blood and protein in urine; Result Unstructured Data: Test Result:significant/visible amount of blood and protein; Test Name: Body temperature; Result Unstructured Data: Test Result:noted of 100

Allergies:

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

Symptoms: significant/visible amount of blood and protein in urine; significant/visible amount of blood and protein in urine; mild fever noted "of 100"; chills; headache; This is a spontaneous report from a contactable consumer (mother) reported for her son from a Pfizer-sponsored program. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced significant/visible amount of blood and protein in urine, mild fever noted "of 100", chills, headache. The outcome of the events was unknown. The visible blood in urine prompted mother to take son in for HCP evaluation. Finally, she explains he is due for second dose of vaccine in a couple of days and would like to know if he is a candidate. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1646137
Sex: F
Age:
State: NY

Vax Date: 03/27/2021
Onset Date: 03/29/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: hives; rash all over the body; she almost passed out; bloated stomach; stomach pain; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A 54-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 27Mar2021 (Batch/Lot number: ED6955; also reported as EP6955) (at the age of 54-years-old) as dose 1, single for COVID-19 immunisation. The patient has no medical history and no concomitant medications. The patient received first dose of the vaccine on 27Mar2021, then two days later (on 29Mar2021), she developed a bloated stomach, and stomach pain. She had so much stomach pain she almost passed out. Two days after that (four days after the vaccine on 31Mar2021) she developed hives and that's when she went to urgent care. She sought out medical assistance and had prednisone shots for 5 days and took Benadryl for 2 weeks for her symptoms. She was asking if it is safe for her to take the second dose of the COVID vaccine. Patient said that she has gotten different opinions from different doctors so that didn't help her. Her reaction was a pretty bad reaction. Two days after her stomach was bloated, she got hives and when she went to urgent care her stomach was still hard like a rock, it was crazy. It was so bad she had to call her husband and get him to come home from work because she felt like she was passing out. After that she got hives which lasted for 2 weeks but because she was on Benadryl, she didn't get a lot of hives after that and she had already taken prednisone. Patient clarified that she had problems with her stomach for probably about 2 weeks and then the hives lasted about two weeks too. After the prednisone, she had to take Benadryl. Both things lasted for quite some time. The doctor who treated her told her to not go for the 2nd dose because she could have anaphylaxis since the second is usually stronger than first. But her primary doctor, who wouldn't even get on the phone, just said to take two Tylenol and go get the second. She didn't think that was very smart because if she is not being treated with anything, she can't just take Tylenol if she had just had a bad reaction. Upon follow-up on 02Aug2021, the patient reported that she had a rash all over the body and had stomach problems. The outcome of the events was recovered in Apr2021. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100985870 similar report from same reporter

Other Meds:

Current Illness:

ID: 1646138
Sex: F
Age:
State:

Vax Date: 07/01/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Developed an environmental illness (mast cell activation syndrome) from mold exposure; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp (Patient, self-reporting). A 30-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Jul2021 as single dose for COVID-19 immunization. No medical history and no concomitant medications were not reported. It was reported that she got the first dose a few weeks ago. She has now developed an environmental illness caused by molds which has resulted in her developing a symptom called mast cell syndrome. The patient explains she was at a fragile state and finds she was reacting to benign medication and supplements. She goes on to explain she had delayed reaction to the first dose that started a week later, for 2 weeks was very fatigued. The patient wants to know if have any information on people with environmental illness getting the shot and if it is recommended that she take the second shot. The outcome for the events was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up (05Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1646139
Sex: M
Age:
State: OR

Vax Date: 06/03/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: emergency appendectomy; This is a spontaneous report from a contactable pharmacist received from medical information team and Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on 03Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer BioNTech COVID-19 vaccine last 03Jun2021 and "underwent emergency appendectomy (which was not related to the vaccine as per reporter) so the patient missed his schedule for the second dose of the vaccine". Reporter wanted to know if the patient can still get the second dose of the vaccine. The outcome of the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: There is no reasonable possibility of causal association between the event Appendix disorder and the suspect product BNT162B2 .The case will be reassessed if additional information becomes available.

Other Meds:

Current Illness:

ID: 1646140
Sex: F
Age:
State:

Vax Date: 04/19/2021
Onset Date: 04/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer. A 69-year-old female consumer (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 19Apr2021 on left arm as dose 2, single for COVID-19 immunization. The patient's medical history, concomitant medications and information about investigation assessment were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date, as dose 1, single for COVID-19 immunization and experienced no adverse events. On an unknown date in Apr2021 the patient complained that her left arm was continuously feeling as if it had gone to sleep and had ants walking down her arm after the second dose of the Pfizer Covid-19 vaccine. Caller asked if this was a reported side effect of the Pfizer Covid-19 vaccine. Caller asked how these symptoms would resolve. The event outcome was unknown. The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.

Other Meds:

Current Illness:

ID: 1646141
Sex: F
Age:
State: KS

Vax Date: 04/16/2021
Onset Date: 04/17/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210510; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Primarily exhaustion; Lack of energy; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8731) via an unspecified route of administration in the right arm on 16Apr2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Patient had medical history which was unspecified. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received other medications within two weeks of taking COVID-19 vaccine, names were unspecified. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8727) via an unspecified route of administration in the right arm on 25Mar2021 at 14:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021, the patient experienced primarily exhaustion, lack of energy. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 10May2021, the patient underwent SARS-CoV-2 PCR (Nasal Swab) and the result was Negative. The clinical outcome of the events primarily exhaustion, lack of energy was not recovered at the time of this report.

Other Meds:

Current Illness:

ID: 1646142
Sex: F
Age:
State:

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/28/2021
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: From the first dose she had body pain in the arm and slight headache; From the first dose she had body pain in the arm and slight headache; My wife was Pregnant and she received her vaccine at one week of gestation; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband). This consumer reported for a 35-year-old female Patient (Wife) that: A 35-years-old Pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 35-year-old). Patient has ongoing pregnancy. The patient's concomitant medications were not reported. The reporter stated that the patient was pregnant, and she received her first dose of vaccine at one week of gestation on 17Mar2021. The reporter also stated that on an unspecified date after first dose the patient had body pain in the arm and slight headache. The mother was 1 Weeks pregnant at the onset of the event and her last menstrual cycle was on 10March2021. The mother was due to deliver on 24Dec2021. The outcomes of the events were unknown.

Other Meds:

Current Illness: Pregnant

ID: 1646143
Sex: M
Age:
State:

Vax Date: 07/31/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: fever; Result Unstructured Data: Test Result:99.4

Allergies:

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

Symptoms: Has a fever like 99.4; Sore throat; Stuffy nose; This is a spontaneous report from a contactable consumer. This contactable consumer (mother) reported for a male patient (son). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31Jul2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration (Batch/Lot was not reported) as dose 1, single for covid-19 immunisation. On an unspecified date in 2021, the patient had a fever like 99.4 and he had a sore throat and he had like a stuffy nose and she just wanted to know that like how long the side effects was supposed to be or he was experiencing something else. The patient underwent lab tests and procedures which included body temperature: 99.4 on an unspecified date in 2021. The clinical outcome of the events were unknown. Follow-up activities closed. Batch/lot number is not available.

Other Meds:

Current Illness:

ID: 1646144
Sex: M
Age:
State: TX

Vax Date: 08/01/2021
Onset Date: 08/02/2021
Rec V Date: 08/28/2021
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: 202108; Test Name: temp; Result Unstructured Data: Test Result:99; Comments: going up; Test Date: 202108; Test Name: temp; Result Unstructured Data: Test Result:100.5; Comments: max; Test Date: 202108; Test Name: temp; Result Unstructured Data: Test Result:trending downward; Test Date: 202108; Test Name: temp; Result Unstructured Data: Test Result:101; Test Date: 202108; Test Name: temp; Result Unstructured Data: Test Result:100

Allergies:

Symptom List: Pain in extremity

Symptoms: fevers/starting off at 99 and going up to 100.5/101; chills; nausea; shortness of pain; felt unwell; short of breath; joint pain; muscle pain; mild arm soreness; sweating; This is a spontaneous report from a contactable consumer (patient's mother). A 54-year-old male patient (son) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 01Aug2021 16:00 (batch/lot number FA7484 and expiry date 30Sep2021, NDC 59267-1000-02) at 54 years of age as dose 2, single (also reported as "unknown dosage; 1 cc 034") for covid-19 immunization. Medical history included stroke from Sep2020, slurred speech, vision damage (40% in both eyes), depression, infection in mouth. Concomitant medications included celecoxib (CELEXA) taken for depression, ibuprofen taken for an unspecified indication, codeine phosphate, paracetamol (TYLENOL WITH CODEINE) taken for an unspecified indication, amoxicillin taken for infection in mouth, atorvastatin taken for an unspecified indication; all start and stop date were not reported. The patient previously took dose 1 of BNT162B2 on 13Jul2021 (batch/lot number EW0198 and expiry date 30Sep2021, NDC: 59267-1000-02) at 54 years of age for Covid-19 immunization. The patient's mother informed that her son received his first dose of the Pfizer COVID-19 Vaccination 13Jul2021 and then his second dose 01Aug2021 (4:00 pm) (2 days early). The patient's mother informed that the patient was having fevers, headache, chills, nausea; all at 06:00 (02Aug2021); and joint pain, muscle pain, mild arm soreness, although no swelling noted, and sweating this morning; all on 02Aug2021. The mother informed that the patient has no rash, no swelling of his face and seemed like his heart was okay. The patient's mother was giving him fluids as well as treating fevers with antipyretics. The patient's mother informed that the patient fevers has been noted as starting off at 99 and going up to 100.5 temp max and trending downward during the call (unspecified date in Aug2021). The patient's mother informed that the patient was okay when he got the shot and then this morning he has a little bit of a headache, a fever, some chills, and a little bit of nausea but he hasn't thrown up, there was no swelling. The patient's temperature kept going up, it was 99 and now it was 101 (unspecified date in Aug2021). The patient has been taking ibuprofen (expiration date 27Jul2022) and Tylenol. The patient's mother asked if there was anything that the patient need to do in case it was not going down, and how high can the fever get before the patient needs to go in. The patient mother informed that the patient got side effects this morning today at 6:00 am. The patient's mother informed the patient also has some "shortness of pain". The patient's mother informed that she didn't know what to do. The patient's mother informed that the patient wanted to know about the maximum fever and what the side effects were doing to his body. The patient's mother later clarified and confirmed that the patient did not take Tylenol but took acetaminophen and codeine tablet. The patient's mother provided information off of the pharmacy bottle. The patient's mother informed that the patient took Benadryl last night. The patient's mother informed that the patient was also a stroke patient. The patient's mother informed that the patient felt unwell (02Aug2021) and has chills and later clarified and confirmed that the patient did not have a headache. The patient's mother informed that the fever went down to 100. The patient's mother informed that the patient was okay last night, the fever was hovering about 101. The patient's mother informed that the patient felt a little short of breath (02Aug2021) and sweating. The patient's mother informed that all of these events were ongoing. The patient's mother that the patient was to have a routine visit with his doctor tomorrow. The patient's mother was concerned about where she would take her son if he were to worsen because the hospitals were full everywhere was full, you hate to be a part of it. The patient's mother reiterates her desire to continue to take care of her son and monitor him closely. The reporter considered the events non-serious. The outcome of the events was not recovered.

Other Meds: CELEXA; IBUPROFEN; TYLENOL WITH CODEINE; AMOXICILLIN; ATORVASTATIN

Current Illness:

ID: 1646145
Sex: F
Age:
State: IN

Vax Date: 07/24/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
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: 202107; Test Name: tested negative for strep throat; Test Result: Negative ; Comments: She also got swabbed and tested negative for strep throat

Allergies:

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

Symptoms: Sore throat and "white crap" all over in the back of her throat; Spots on the tongue; "white crap" all over in the back of her throat; sore arm; she does not feel well; the lymph nodes in her neck is swollen; feeling really down; extremely tired; extremely weak; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 24Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced sore arm on Jul2021, sore throat and "white crap" all over in the back of her throat on 31Jul2021, spots on the tongue on 31Jul2021, in 2021 patient was not feeling well, the lymph nodes in her neck was swollen, feeling really down, extremely tired, and extremely weak. The patient reported having sore arm for a couple of days which was fine now and 2 days ago, she woke up with sore throat and "white crap" all over in the back of her throat as well as white patches and spots on the tongue and did not manifest until a week later. She reported she was not running a fever but a sore throat and does not feel like a normal cold since there was no congestion of the nose. Caller described it as a "not regular sore throat" and that she does not feel well and the lymph nodes in her neck was swollen. She also mentioned feeling really down and extremely tired and not feeling well. She stated that she was fine and then 6-7 days later, she woke up with a freaking sore throat and have had it for a couple of days now. She also got swabbed and tested negative for strep throat in which the they told her that it was "something viral." She never had white crap in the back of her throat and all she knows is that she feels like "crap." She was thinking that it might be from the vaccine. The patient was unsure if it was related with the vaccine and was wondering if it is possible to manifest side effects 6-7 days after and how long they last. She wanted to know if there are any reports of people that have gotten sick and not getting better after receiving the vaccine. Seriousness of the events was provided as unspecified. Investigation Assessment was not provided. The patient has been extremely weak. She has a sore throat, feels really weird and off. This is not like a normal cold. She did not feel good and is most concerned about that. The patient underwent lab tests and procedures which included culture throat: negative on Jul2021. She also got swabbed and tested negative for strep throat. The clinical outcome of the events extremely weak, extremely tired, feeling really down, the lymph nodes in her neck is swollen, she does not feel well, was unknown. The clinical outcome of the event sore arm was resolved on an unspecified date in Jul2021 and clinical outcome of all other events was not resolved. The lot number for the vaccine was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646146
Sex: F
Age:
State: MA

Vax Date: 07/28/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 202107; Test Name: Blood pressure elevation; Result Unstructured Data: Test Result:185/91; Test Date: 202107; Test Name: Blood pressure elevation; Result Unstructured Data: Test Result:141/79; Test Date: 20200501; Test Name: Covid 19 test; Test Result: Negative

Allergies:

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

Symptoms: Felt her blood pressure go up and reclarifies, early Saturday morning at 1 am it was 185/91; She was not breathing properly; Her heart was pounding in her chest and had palpitations; Her heart was pounding in her chest and had palpitations; She began to shake forcefully/the next day she was feeling shaky again; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 28Jul2021 13:35 (Batch/Lot Number: EW0198) as dose 1, single (at the age of 75 years old) for COVID-19 immunisation. Medical history included ongoing hypertension from: maybe 15 years ago, around age 60, diabetic type 2 from 2006 and ongoing, thyroid condition from 2012 and ongoing, pericarditis in 1996 she had her first episode, a small effusion, and a couple years later, another small effusion, and in 2016, a moderate effusion and was hospitalized, ongoing glaucoma for more than 10 years, suspected covid-19 from 13Mar2020, she was never tested for Covid. Her symptoms lasted 8 weeks. She believed she might have gotten inflammation in chest but was not diagnosed. She felt chest tightness, but the doctors didn't want to do test that year. In May2020, she was negative for Covid, and all the other symptoms went away, except chest tightness and chest tightnessConcomitant medications included valsartan (DIOVAN) taken for hypertension, amlodipine besilate (NORVASC) taken for hypertension, insulin human injection, isophane (HUMULIN N) taken for diabetes mellitus, levothyroxine taken for thyroid disorder, acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, brimonidine tartrate (ALPHAGAN P) taken for glaucoma from 2008 and ongoing; bimatoprost (LUMIGAN) taken for glaucoma. The patient will be seeing her PCP this week to double check her health, her heart rate and her blood pressure. She did experience and adverse effect, she is considering where to get the second dose which is suppose to be two weeks from Wednesday. She has a history of pericarditis and does have hypertension. She felt her blood pressure go up and reclarifies, early saturday morning at 1 am it was 185/91 on 31Jul2021 01:00. She was not breathing properly, hypertension, her whole body was shaky, at around 10 in the evening, she began to shake forcefully and the next day she was feeling shaky again. Her heart was pounding in her chest and had palpitations. She did not go to the emergency room, because her blood pressure came down to 143/82. On Saturday morning, she had a normal blood pressure of 141/79, but she still had the shakes and palpitations. The outcome of blood pressure go up was recovered on an unspecified date, not breathing properly was unknown and other events was not recovered.

Other Meds: DIOVAN; NORVASC; HUMULIN N; LEVOTHYROXINE; BABY ASPIRIN; ALPHAGAN P; LUMIGAN

Current Illness: Diabetic; Glaucoma (more than 10 years.); Hypertension (From: maybe 15 years ago, around age 60.); Thyroid disorder NOS

ID: 1646147
Sex: F
Age:
State:

Vax Date: 02/23/2021
Onset Date: 02/01/2021
Rec V Date: 08/28/2021
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: bad arm pain; Pain at injection site; This is a spontaneous report from a contactable consumer or other non HCP (patient reported for herself) Pfizer sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2; Solution for an injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 2, single on 23Feb2021 for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included patient received first dose of bnt162b2 (BNT162B2; Solution for an injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on 02Feb2021 for covid-19 immunisation. Patient reported that she received first dose of the COVID-19 vaccination 02Feb2021 and then her 2nd dose 23Feb2021. After the 1st dose she did experience sick like symptoms with a fever and headaches that resolved. On 23Feb2021, patient experienced bad arm pain was intermittent although it continued to persist and affect her ability to raise her arm after the 2nd dose of the vaccine. Patient also had pain at injection site and its not going away post second vaccine on unspecified date in Feb2021. Patient wanted to know what she could do for the pain. At the time of this report, outcome of events was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646148
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:ok

Allergies:

Symptom List: Vomiting

Symptoms: dizziness; Pass out; Fall; Around my injection site; It feels like there is something cold like cold water running down my arm; This is a spontaneous report from a contactable consumer. This male consumer reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced around my injection site; it feels like there is something cold like cold water running down my arm, dizziness and queried if that is normal. He had his first dose of the vaccine yesterday and is now having dizziness and asks if this is a side effect. The vaccine he felt a cold dripping, and then today he slept 14 hours and is feeling dizzy, but his blood pressure is ok, he feels like he going to fall or feels like he does right before he is going to pass out. The patient underwent lab tests and procedures which included blood pressure resulted as ok on an unspecified date. The clinical outcome of the event dizziness was not resolved, and rest of the events was unknown. Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1646149
Sex: F
Age:
State:

Vax Date: 07/24/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: tested positive after the first dose; Test Result: Positive

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: received their first dose of the Pfizer covid vaccine on 24JUL2021 but both of them tested positive after the first dose; This is a spontaneous report from Pfizer sponsored program. A contactable female consumer(patient) reported for herself that: A female patient of an unspecified age received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 24Jul2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she received the first dose of the Pfizer covid vaccine on 24Jul2021 but tested positive after the first dose on unspecified date in 2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test which was positive on 2021. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1646150
Sex: F
Age:
State: OH

Vax Date: 07/29/2021
Onset Date: 07/29/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Felt like she was going to black out; Felt like she was dying; Generalized hotness / whole body was super hot; Lightheadedness/dizziness; Vision troubles/ couldn't see; Nervous; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 29Jul2021 (at the age of 42 years old) (Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 29Jul2021, patient got the vaccine, and was driving she felt generalized hotness (whole body was super hot), dizziness, lightheadedness, vision troubles (couldn't see), nervous, felt like she was dying and felt like she was going to black out. She had these complaints for five minutes and denied the events at the time of reporting. The outcome of the events was recovered on 29Jul2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646151
Sex: F
Age:
State: AZ

Vax Date: 04/15/2021
Onset Date: 07/27/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210727; Test Name: Covid positive; Test Result: Positive.

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: This is a spontaneous report from a sponsored program via a consumer (patient). A 44-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP7533, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 25Mar2021 (age at vaccination was 43 years) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8735, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 15Apr2021 (age at vaccination was 43 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. Concomitant medications were not reported. There was no history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received both COVID 19 vaccines, one in Mar2021 and the other in Apr2021. On 27Jul2021, the patient was COVID positive and tested positive for COVID. She really wanted to know if she could receive a 3rd dose asap when she was COVID negative without waiting 6 months after her last dose. She had a question about getting a third dose when she was negative. She cannot go through that again. It had been awful. There are six people in her house, and they all got COVID. She and her husband both got COVID and were both vaccinated. She did not have a prescribing doctor. After the second vaccine, she didn't feel anything at all. The adverse events did not require a visit to Emergency Room or Physician Office. The patient underwent lab tests which included SARS-COV-2 test: positive on 27Jul2021. There was a Product Complaint. Product-Description: COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 Lot# ER8735. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot ER8735 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. Analytical release test results were also reviewed. The final scope included the reported finished goods lot ER8735, fill lot EP8687, and 6040511 the formulated drug product lot EP8574. A complaint sample was not returned, and photographs investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EP7533, fill lot EP7531, and the bulk formulated drug product lot EP7527. A complaint sample was not returned. No related quality issues were identified. Product Complaint Exchange had the vaccine double shot. And I have the COVID I feel really bad asthma is chronic now. Brief Complaint Description: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE-ER8735- Lack of Effect. This record will not require further investigation as the Lot reported has been previously investigated as part of ID 5881105 and the following is the Conclusion of the field from that investigation. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8730 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot ER8730, fill lot EP8682, and the formulated drug product lot EP8569. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root causes were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for Lack of Effect related to lot ER8735 of PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation is limited to the reported finished goods lot ER8735 pending review of lot genealogy. The investigation will include a include a review of the returned complaint sample (if received) and reserve samples, if necessary. The initial scope of the investigation was limited to the reported finished goods lot. The final scope was expanded to include the reported finished goods lot ER8735, fill lot EP8687, and the formulated drug product lot EP8574. Manufacturing and packaging batch records were reviewed for the reported complaint lot. Did not receive photographs or a complaint sample for examination. The complaint was not confirmed. No probable root cause for the complaint related to the manufacturing process of the reported lot was identified. There were no corrective or preventative actions taken as a result of this complaint investigation. No related quality issues were identified during the investigation. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The drug product is stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the logs confirmed that all times were within allowable limits. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch meets potency specifications. There is no impact to the quality of the lot. It is unknown how the product was handled, stored, or administered after it left the site. Quality could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. Review of the manufacturing and packaging batch records and release test results confirmed that the batch continues to meet potency specifications. It is unknown how the product was handled, stored, or administered after it left the site. Impact Analysis Based on the final scope of the investigation, which was limited to the reported finished goods lot and associated fill and formulated drug product lots, and that a root cause related to the production process was not identified, the reported issue is not representative of the lot and does not indicate a negative impact on product quality. No regulatory notification is required. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8735 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. Analytical release test results were also reviewed. The final scope included the reported finished goods lot ER8735, fill lot EP8687, and the formulated drug product lot EP8574. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root causes corrective, preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The scope of this investigation included the reporte

Other Meds:

Current Illness:

ID: 1646152
Sex: F
Age:
State: UT

Vax Date: 07/29/2021
Onset Date: 07/29/2021
Rec V Date: 08/28/2021
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: 20210729; Test Name: heart/beat; Result Unstructured Data: Test Result:heart was beating fast and hard; Comments: heart was beating fast and hard

Allergies:

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

Symptoms: Felt she was going to pass out; Began experiencing a hot, flushed and tingly sensation to her whole arm/whole body went completely hot and flush and tingly; Began experiencing a hot, flushed and tingly sensation to her whole arm/whole body went completely hot and flush and tingly; Began experiencing a hot, flushed and tingly sensation to her whole arm/whole body went completely hot and flush and tingly; Heart was beating fast and hard; The back of her nose, throat, and tongue was tingly and hot; The back of her nose, throat, and tongue was tingly and hot; The back of her nose, throat, and tongue was tingly and hot; The back of her nose, throat, and tongue was tingly and hot; The back of her nose, throat, and tongue was tingly and hot; This is a spontaneous report from a contactable consumer (patient, reported for herself). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in left arm on 29Jul2021 12:45 (at the age of 48 years old) as dose 1, single for covid-19 immunization. Medical history included a fib (atrial fibrillation as one isolated event) from an unknown date to an unknown date; patient had a cardiac ablation in 2018; and allergy to penicillin from an unknown date and unknown if ongoing. The patient had no family history. Concomitant medication included aspirin [acetylsalicylic acid] at 81 mg taken for an unspecified indication, start and stop date were not reported. Patient had no prior vaccinations (within 4 weeks). The patient had no history of all previous immunization with the Pfizer vaccine suspect product. Most recent vaccine was administered at military facility. Patient received her first dose of the Pfizer Covid-19 Vaccine on 29Jul2021. As soon as it was injected, she began experiencing a hot, flushed and tingly sensation to her whole arm. She went and sat down and the feeling went to her entire body, then to her nose, throat, and tongue. Her heart was beating fast and hard. She felt she was going to pass out. Everything subsided after 10 minutes and went away. Patient further reported that when the lady put the needle in the patient's arm and pushed the medicine the patient's arm went hot and tingly. The patient sat down for a minute and then her whole body went completely hot and flush and tingly. The back of the patient's nose, throat, and tongue was tingly. Then it felt like the patient's heart started beating fast and hard. Patient asked if this was normal. These events happened within 5 minutes of the patient getting the shot. Behind the patient's nose, throat and tongue was also hot. Patient asked if she could get the second dose. The events were non-serious as per reporter. The events did not require emergency room or physician office visits. The outcome of the events was reported as recovered on 29Jul2021. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1646153
Sex: M
Age:
State: KS

Vax Date: 07/13/2021
Onset Date: 07/13/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210718; Test Name: ALT; Result Unstructured Data: Test Result:about 150; Comments: they were 3 times the normal range; Test Date: 20210718; Test Name: AST; Result Unstructured Data: Test Result:about 150; Comments: they were 3 times the normal range; Test Date: 20210427; Test Name: Blood Work; Result Unstructured Data: Test Result:ALT and AST were 20 each, Prolactin level was 30; Comments: Blood work done on 27Apr2021, transaminase ALT and AST were about 20 each, prolactin level 30 something.; Test Name: Exam; Result Unstructured Data: Test Result:No enlarged liver; Comments: He stated the patient had no enlarged liver on exam.

Allergies:

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

Symptoms: tonic-clonic seizure; ALT and AST were around 150/ they were 3 times the normal range; ALT and AST were around 150/ they were 3 times the normal range; had some shoulder soreness; soreness in arm after injection; Tired and his appetite was down; Tired and his appetite was down; This is a spontaneous report from a contactable physician via Medical Information Team. A 16-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 13Jul2021 as dose 1, single (at the age of 16-years-old) for COVID-19 immunization. Patient medical history included seizure from Apr2021 to an unknown date, seizure disorder (Epilepsy) from an unknown date and unknown if ongoing (maternal great aunt had a seizure disorder when she was tired or stressed). Physician stated that there was a family history that included maternal grandfather pancreatic cancer, paternal grandfather pancreatitis, mom had one single seizure one time. The patient did not receive any other product prior to COVID-19 vaccine. Stated that his patient, a 16-year-old male, experienced a seizure in Apr2021, but it was nothing that prompted starting medication. Patient then received the Pfizer Covid-19 vaccine on 13Jul2021 and had some shoulder soreness, soreness in arm after injection, but then on 18Jul2021 (5 days after his first dose) the patient had a tonic-clonic seizure. He stated the patient had no enlarged liver on exam. He stated the patient ALT and AST were around 150, but he is not sure of the exact value, but they were 3 times the normal range on 18Jul2021. Stated he had been searching for information on how the vaccine affects liver function or adverse effects on the liver. He stated the patient was also due for his next vaccine tomorrow. He stated he was a physician, all his searches returned no results stated he met his patient in early Apr2021, at that point he had had a brief unprovoked seizure, stated he noticed at that time he had a chemical panel that was unremarkable and with a single provoked seizure he did not usually start medication but enough information on imaging that he thought there could be something going on, stated the patient had blood work done on 27Apr2021, transaminase ALT and AST were about 20 each, prolactin level 30 something, a little high, no exact values known at this time. He stated the patient on 13Jul2021 had first Pfizer Covid shot, stated he reported a little bit of shoulder soreness not much else, stated 5 days later on 18Jul2021 the patient experienced a tonic clonic seizure, 5 days after vaccine, stated the patient went to ER, noticed the labs they drew at this time his ALT, AST were about 150, exact values unknown, stated this was close to three times the top of normal levels, at the time of that seizure he stated he started the patient on Keppra, stated this medication did not usually change liver function or make people tired, stated the patient was complaining of being a little tired and his appetite was down on an unspecified date in 2021. He stated the patient was due for his next shot tomorrow, a chem panel today which had not been done yet, clarified it had been done but it had not been resulted yet, stated there was no information he can find about the vaccine causing any liver adverse effects, thinking it was coincidental, nothing to tell him it was not coincidental, would like any information about the vaccine and liver adverse events. The patient underwent lab tests and procedures which included alanine aminotransferase: about 150 on 18Jul2021 they were 3 times the normal range, aspartate aminotransferase: about 150 on 18Jul2021 they were 3 times the normal range. The outcome of all the events was reported as unknown at this time of the report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship there is reasonable possibility of causal association between the event generalized tonic clonic seizure and other reported events and the suspect drug BNT162B2. Consider also possible contributory effects from patient's pre-existing risk factors, namely, Epilepsy. 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:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am