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: 1661479
Sex: U
Age:
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Inflammation in the face; This is a Spontaneous report based on the information received by Pfizer from Reference Number: GL-020821-3546). A contactable Other HCP reported similar events for two patients. This is 1st for 2 report. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced inflammation in the face where previous filler (Restylane) was injected in. Inflammation occurred within days of 2nd covid vaccination. The outcome of event was unknown. No other information provided. No follow-up attempts are needed. Information about Lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223811 same reporter/product/event, different patients.

Other Meds:

Current Illness:

ID: 1661480
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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: inflammation in the face; This is a Spontaneous report from a contactable Other HCP reporting for a patient based on the information received by Pfizer Reference Number: GL-020821-3457). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took restylane on unspecified date. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that on an unspecified date, the patient experienced inflammation in the face where previous filler (Restylane) was injected in. Inflammation occurred within days of 2nd covid vaccination. No other information provided. The outcome of event was unknown. No follow-up attempts are needed. Information on Lot/Batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1661481
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

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

Symptoms: Swelling; This is a spontaneous report based on the information received by Pfizer from a contactable Other-HCP via GALDERMA Laboratories LP. (Galderma Reference Number: GL-020821-3448). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2, via unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Past drug included Restylane-L, injected in tear troughs, since 14Sep2021, unknown if ongoing, for unspecified indication. Patient experienced swelling occurred to tears troughs 24 hours following 2nd vaccine, on an unspecified date. The outcome of event was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1661482
Sex: M
Age:
State: TX

Vax Date: 02/20/2021
Onset Date:
Rec V Date: 09/01/2021
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: Diarrhea; Swelling; body pain; This is a Spontaneous Report from contactable consumer via Pfizer Sponsored Program. An unspecified age of male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 20Feb2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Diarrhea, Swelling, and Body pain. The outcome of the events was unknown. Information about lot/batch number has been requested. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1661483
Sex: F
Age:
State: OK

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

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

Lab Data:

Allergies:

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

Symptoms: Joint pain; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself) communicated to Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 2 via an unspecified route of administration on 06Jan2021 (Lot number and Expiration date: unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported), as single for covid-19 immunisation. On an unspecified date in Jan2021, the patient experienced joint pain. The patient stated that the reason she called, 06Jan2021 was her second dose of the COVID-19 vaccine. She said she had some joint pain after the second dose, and it run away after three days and she was calling to see how long the vaccine lasts. She wanted to know if it is for 3 months or if a year. Patient stated the only thing that she wanted to know was it going to expire in 3 month or a year. The patient outcome of the event was resolved on an unspecified date in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1661484
Sex: F
Age:
State: CA

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sore arm; low-grade fever; vomited; intense malaise; fatigue; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL8982), via an unspecified route of administration in the left arm on 20Jan2021 at 18:45 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included seizure, controlled on meds and migraine from an unknown date and unknown if ongoing. Concomitant medication(s) included valproic acid, rizatriptan benzoate (MAXALT) and colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient previously cefuroxime and doxycyclin and experienced drug hypersensitivity. Historical vaccine included first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EH9899), via an unspecified route of administration in the left arm on 30Dec2020 at 18:45 (at the age of 54-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient stated that ill-effects started 16 hours after injection, sore arm, brief low-grade fever, vomited, intense malaise for 24 hours followed by 2.5 days of fatigue on 21Jan2021 10:00. The patient did not receive any treatment. The clinical outcome for the events was recovered on an unspecified date in 2021 for all events except intense malaise and fatigue which recovered on an unspecified date in Jan2021. Follow-up attempts completed. No further information expected.

Other Meds: VALPROIC ACID; MAXALT; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1661485
Sex: F
Age:
State: MT

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 09/01/2021
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: hoarseness; Tightness in face; Tightness in throat; Tightness in neck; This is a spontaneous report from a contactable consumer. A 46-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: En6203), dose 1 via an unspecified route of administration, administered in left arm on 24Feb2021 at 15:30 (at the age of 46-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included diabetes mellitus, overweight, food allergy (melons and squashes) from an unknown date and unknown if ongoing. Concomitant medications included metformin (METFORMIN) and lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported received other medications in two weeks. The patient previously took codeine (Codeine and other narcotics used during surgery) and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination. Facility type vaccine at Public Health Clinic/ Administration facility. On 24Feb2021 at 15:45, the patient experienced tightness in face and neck, throat, throat clearing- like something caught in throat and hoarseness. Adverse event resulted in Doctor or other health care professional office/clinic visit. No treatment received. The outcome of the events were unknown. Follow-up attempts completed. No further information expected.

Other Meds: METFORMIN; LISINOPRIL

Current Illness:

ID: 1661486
Sex: F
Age:
State: LA

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 09/01/2021
Hospital:

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

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

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Still got the rash but it is not that bad but it is all over my body; I am hard of hearing; Started itching really bad, first on my arm and then all over my body, it is very red; It was horrible and it was itching me so bad; My chest, it felt heavy and when I breathe in, it was hurt under that shoulder blade; Tightness or the heaviness in my chest which was coming and going; pain; This is a spontaneous report from a contactable consumer (Patient, reported for herself). A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL9262), via an unspecified route of administration, in left arm on 17Feb2021 (at the age of 73-years-old) as a dose 2, single for COVID-19 immunization. Patient medical history included blood pressure. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), amlodipine (AMLODIPINE), pravastatin (PRAVASTATIN) patient took it on Monday, Wednesday and Friday, one, cyanocobalamin (B 12). Patient further stated, "she took once a month a shot it was B12 shot, once a month she get it from her doctor, it was Cyanocobalamin shot because her blood doesn't produce or get B12 from food. It was reported that patient had gone to the emergency room on Sunday on unspecified date. Patient had her second Covid shot which was Pfizer and that was 17Feb2021, that was the rash that started Sunday but the day after she received the shot she was having pain on 18Feb2021 under her left shoulder blade and she still have it. she had it Thursday, Friday, Saturday and it was bad, but she didn't know what that was. which was last Wednesday and Sunday morning on 21Feb2021 08:30 around that time, she started with itching really bad, first on her arm and then all over her body, it is very red. It was horrible and it was itching her so bad. she had a friend to call and check on her and she said to take Benadryl (treatment) and patient said that she already had one. Patient friend suggested to visit a pharmacist and ask him, and as this was Sunday, there wasn't anybody open. Patient went to the pharmacist and then came home and take one more Benadryl and take a Claritin (treatment). Patient came home and pharmacist suggested to take a warm bath with the oatmeal soap which she purchased it from the pharmacy and she couldn't wait to get home because she was still itching so badly. So, she came home, and she took another Benadryl which made two and then she did the oatmeal bath. So, she was ill, and it was terrible. The pharmacists told patient to take two Benadryl every four hours but the Claritin, she can only take one per day and then she took Benadryl every four hours and one Claritin per day. Patient further stated that she had this pain that started that Thursday after the shot under her left shoulder blade, Sunday evening and she still had that. So, that evening she started having pain and on 21Feb2021 her chest, it felt heavy and when she breathe in, it was hurt under that shoulder blade and then after it was calming down she let that go. When she went to the emergency room, they did blood work and they did all kinds of tests but they think that the rash was caused from the Covid shot and after she left, she was there from 4 o' clock to 12 that night and she was told to follow up with her Primary care physician, he felt like that rash was caused from the Covid shot but he didn't feel like that the hurting that she was having under her shoulder blade and the tightness or the heaviness in her chest which was coming and going, Primary care physician didn't think that was from the Covid shot. Patient didn't work yesterday on unspecified date all day because last night she was itching so bad. She was not experiencing the pain under the shoulder blade. She was not experiencing any now. she still got the rash but it was not that bad but it was all over her body. Patient also taking Pepcid 10 mg because when she followed up with her doctor yesterday, on Monday, he told her to also take Pepcid with the two Benadryl and Claritin. He told her the three medications. Patient further reported that she was hard of hearing so she had to ask everything to repeat it. Outcome of events Started itching really bad, first on my arm and then all over my body, it is very red; It was horrible and it was itching me so bad and Still got the rash but it is not that bad but it is all over my body was recovering, pain, My chest, it felt heavy and when I breathe in, it was hurt under that shoulder blade; Tightness or the heaviness in my chest which was coming and going and I am hard of hearing was unknown. QR Comment: 'I am hard of hearing'- captured as event conservatively since further clarifications were unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: BABY ASPIRIN; AMLODIPINE; PRAVASTATIN; B 12

Current Illness:

ID: 1661487
Sex: F
Age:
State: MO

Vax Date: 02/19/2021
Onset Date: 02/22/2021
Rec V Date: 09/01/2021
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: 20210222; Test Name: blood count; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Disseminated rash/whole body rash; This is a spontaneous report from a contactable nurse. This nurse reported for a 50-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 19Feb2021 (at age of 50-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included ovarian cancer from an unknown date and unknown if ongoing, had ongoing chemotherapy. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on an unspecified date for COVID-19 immunization. On 22Feb2021 it was reported that, patient was undergoing chemotherapy (chemotherapy not captured as suspect) but patient got COVID vaccine it was the Pfizer vaccine and did end up with rash it was disseminated rash; had whole body rash. Therapeutic measures were taken as a result of disseminated rash/whole body rash as patient had received Benadryl. The patient underwent lab tests and procedures which included blood count: unknown results on 22Feb2021. The outcome of event was unknown. When probed for causality, nurse stated; she got the injection on that Friday and then on that following Monday that was the 22nd and she had a whole body rash. No follow up attempts are needed; Information about Lot and batch number could not be obtained. No further information is expected.

Other Meds:

Current Illness: Chemotherapy

ID: 1661488
Sex: F
Age:
State: NY

Vax Date: 02/16/2021
Onset Date: 02/21/2021
Rec V Date: 09/01/2021
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: swollen lymph nodes armpit; itchy skin; mild headache; mild chills; This is a spontaneous report from a contactable consumer. A 67-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 16Feb2021 09:00 AM (at the age of 67-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Diabetes mellitus and Chronic lymphocytic leukaemia from an unknown onset and unknown ongoing and concomitant medications include Insulin Glargine (TOUJEO), Metformin, Dapagliflozin Propanediol Monohydrate (FARXIGA), Simvastatin. On 21Feb2021 06:00 AM, after the vaccination, the patient experienced swollen lymph nodes armpit, itchy skin, mild headache, mild chills. Patient received treatment with antihistamine and Tylenol. The events assessed as non-serious. No other vaccines were taken in four weeks. Patient was not found covid prior vaccination. Patient was not tested covid post vaccination. The outcome of the events was recovering at the time of this report. No follow-up attempts possible. No further information expected. Follow-up (PRD/SRD (17May2021): 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: TOUJEO; METFORMIN; FARXIGA; SIMVASTATIN

Current Illness:

ID: 1661489
Sex: F
Age:
State:

Vax Date: 02/21/2021
Onset Date: 02/22/2021
Rec V Date: 09/01/2021
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: Swelling and pain of lymph nodes in left axilla; Chills; lowgrade fever occurring 18 to 30 hours after 2nd dose; This is a spontaneous report from a contactable physician (patient). A 68-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an intramuscular route on 21Feb2021 14:30 (at the age of 68-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included hypothyroidism and Known allergies to Sulfa, PCN, verapamil. The patient concomitant medications included levothyroxine sodium (SYNTHROID) for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 24Jan2021 14:30 (at the age of 68-years) as dose 1, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Feb2021 at 13:00, the patient experienced chills and low grade fever occurring 18 to 30 hours after 2nd dose and swelling and pain of lymph nodes in left axilla. The patient did not receive treatment for events. The outcome of the events was resolved on unspecified date of 2021. No follow-up attempts are Possible. Information on lot/batch cannot be obtained.

Other Meds: SYNTHROID

Current Illness:

ID: 1661490
Sex: F
Age:
State: GA

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Red patchy rash on stomach, right side; This is a spontaneous report from a contactable consumer (patient herself). A 52-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 23Feb2021 11:30 (age at vaccination: 52 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included hypertension, obesity, latex allergy and Motrin allergy. Concomitant medication(s) included lisinopril; fluoxetine hydrochloride (PROZAC) and paracetamol (TYLENOL) 500, multivitamin and pr. On 23Feb2021 18:00, the patient experienced red patchy rash on stomach, right side. The patient required physicians office visit. The patient did not have any other vaccine if four weeks. The patient did not receive any treatment for the adverse event. The patient did not have covid prior to vaccination nor was tested since vaccination. The outcome of the event was not recovered. Information on the lot batch number has been requested. Follow-up attempts completed. No further information expected.

Other Meds: LISINOPRIL; PROZAC; TYLENOL

Current Illness:

ID: 1661491
Sex: F
Age:
State: WI

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 09/01/2021
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: COVID test; Result Unstructured Data: Test Result:Unknown results; Comments: She has taken a COVID test many times.

Allergies:

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

Symptoms: Headache; Muscle pain; Joint pain; her lymph nodes under her throat were swollen; she was too tired to get up to check the paper; lost her taste and smell; lost her taste and smell; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198, NDC number and Expiry Date are unknown), via an unspecified route of administration on 18Feb2021 at the age of 68-years-old as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration on 28Jan2021 at the age of 68-years-old for covid-19 immunisation and experienced lost her taste and smell. There was no Investigation assessment. The Reporter was calling about the Pfizer vaccine she took the first one 3 weeks ago and she did really good. She got the second one, she took that on Thursday and she wanted to report that on 18Feb2021, she had a headache, muscle pain, joint pain, the one she most noticed was at her lymph nodes under her throat were swollen, the one on the left still was swollen, the one on the right went down a little, she can still feel them, the one on the left she can still feel but the one on the right went down a little bit. She said right after she felt it and she was like oh, she was too tired to get up to check the paper to see if it was on the paper, she said she thought it was on there. She called the previous day and could not get through, but she got in today and she wanted to let them know what happened and she appreciates getting the shot she does not care what she gets as long as she was okay with shot. She was at the (name). She went to the (name) for her shot but they had switched her over for that. She would be 69 in May. she got the second dose on Thursday, 18Feb2021. She said that the headache was right after shot that night, she was going through the evening she did not expect that because she doesn't have headaches. She confirms the headaches started the same day. The muscle pain and joint pain started the same day. She said everything started the same day as the second dose of the vaccine. The aches and pains have recovered now her lymph nodes are still there on the left more than the right, they were pretty swollen on both side. The right went down, the other one is going down but she still feels that one. She would say the lymph node swelling was ongoing but improved. The headaches have recovered completely. It was reported that she has taken a COVID test many times. It was last year she had gone to the store, she wore her mask but her niece didn't. She told her doctor she lost her taste and smell and it stayed gone up until that first shot and then everything began to come back and she was happy. Everyone was saying how do you feel some, she knows some of her friends and family had problems but she got her taste and smell back. Then she went Friday or it may have been Thursday and she took the second one and all of it disappeared again and she called her doctor and she said what happened and she said she lost it again. She did not have the COVID, she had been tested a couple times, the symptoms came and never really went away until that first dose and then boom it came back and then now, she can't taste or smell after the second shot on 18Feb2021. She clarified that she has not been tested for COVID since it the taste and smell came back, she will see at her doctors appointment next month, what was going on. The second dose looks like EN or it could be another EL but looks like EN6198 and that was the 18Feb2021. it says Pfizer and then EN6198 it is either an N or L or 7 she knows it has to be another letter, she just can't make it out for sure. She does not see any expiration dates or NDC numbers. She clarified and confirmed that it was actually Thursday 18Feb2021 that she was given the second dose. She says they may give that information downtown at the convention center but not where she went, they did not even give her a mask, she still loves them though, she has her own mask. She was the first out of her mom's 12 children to get her shots. She was going to ask for ENT because she doesn't like this. She thought that the second shot was going to make her whole again but anyway they will figure it out. The patient underwent lab tests and procedures which included COVID test (sars-cov-2 test): unknown results on unspecified date. The outcome of event, Swollen lymph nodes was recovering and for Tiredness, lost her taste and smell was unknown while other events were recovered on an unspecified date in 2021 Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1661492
Sex: F
Age:
State: MA

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: chills; severe body aches; fever; fatigue; This is a spontaneous report from a contactable consumer. A 23-Year-old female patient received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: EL3247, Expiration date: Unknown, Solution for injection), on 22Feb2021 around 09:30 AM on left Arm as Dose 2 single for covid 19 immunization (age at vaccination: 23-Year-old). Medical history included unspecified known Allergies. Concomitant medications were reported as unknown. Patient previously received first dose of BNT162B2 (Batch/Lot number: EL3247,Expiration date: unknown, solution for injection) on 01Feb2021 on left Arm as Dose 1 single for covid 19 immunization. The patient had not received any other vaccine and other medication in four weeks. The patient had not affected with covid19 before or after vaccination. On 22Feb2021 patient experienced chills, severe body aches, fever and fatigue. No therapeutic treatments were received. The outcome of the events was reported as unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1661493
Sex: M
Age:
State: VA

Vax Date: 02/05/2021
Onset Date: 02/13/2021
Rec V Date: 09/01/2021
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: 20210218; Test Name: COVID test/RT-PCR; Test Result: Negative ; Comments: covid test post vaccination covid test type post vaccination=Nasal Swab, covid test name post vaccination=RT-PCR, covid test date=18Feb2021, covid test result=Negative

Allergies:

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

Symptoms: mild rash on abdomen and back (bilateral), sides of torso and armpit (bilateral), left lower arm, inside of both thighs; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809 and Expiry date was not reported), via an unspecified route of administration administered in Arm Left on 05Feb2021 11:00 (at the age of 56-years-old) as dose 1, single for COVID-19 immunization. Patient had no known allergies. Medical history included mycotic allergy, seasonal allergy and food allergy from an unknown date and unknown if ongoing Various environmental and food allergies: Mold, tree pollens, tomato, variety of beans. Concomitant medication(s) included fluvoxamine maleate (FLUVOXAMINE MALEATE) and trazodone (TRAZODONE), both taken for an unspecified indication, start and stop date were not reported.Patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. Post vaccination the patient tested negative for COVID 19. It was reported that on 13Feb2021 20:00, adverse event mild rash on abdomen and back(bilateral), sides of torso and armpit (bilateral), left lower arm, inside of both thighs.Patient did not received any treatment for the event. The patient underwent lab tests and procedures which included sars-cov-1 test with nasal swab was negative on 18Feb2021. The outcome of rash was recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: FLUVOXAMINE MALEATE' TRAZODONE

Current Illness:

ID: 1661494
Sex: F
Age:
State: SC

Vax Date: 02/02/2021
Onset Date:
Rec V Date: 09/01/2021
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: headache; arm was a little sore; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EZ9204, Expiration date: unknown) via an unspecified route of administration, administered in left arm (left shoulder) on 02Feb2021 a little after 12:00 pm (age at vaccination was 72 years) as dose 1, single for COVID-19 immunization. The patient's medical history included ongoing blood pressure, ongoing sinus, ongoing acid reflux and ongoing stress from an unknown date. Concomitant medications included famotidine taken for acid reflux, amlodipine taken for blood pressure (her blood pressure was about normal but since she was on a low dose they told her to stay on it), montelukast sodium (SINGULAIR) taken for sinus pill, oxymetazoline hydrochloride (CLARITIN ALLERGIC) taken for sinus pill and vitamins. She also takes a medication as needed for stress, but she has not taken it recently. She couldn't remember the name of the medication. No additional vaccines were administered on same date of the Pfizer suspect. On an unspecified date, the patient had a headache after the first dose for 3 to 4 days and her arm was a little sore and it went away on the second day. She didn't have fever, chills, cough, or sore throat with the first dose. The adverse events did not require a visit to Emergency Room and Physician Office. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198, Expiration date: unknown) via an unspecified route of administration, administered in left arm (left shoulder) on 23Feb2021 a little after 12:00 pm (age at vaccination was 72 years) as dose 2, single for COVID-19 immunization. There was a Product Complaint. The outcome of the events was resolved on an unspecified date in 2021. No follow up attempts are possible. No further information is expected.

Other Meds: FAMOTIDINE; AMLODIPINE; SINGULAIR; CLARITIN ALLERGIC

Current Illness: Acid reflux (oesophageal); Blood pressure abnormal; Sinus infection; Stress

ID: 1661495
Sex: F
Age:
State:

Vax Date: 02/18/2021
Onset Date: 02/23/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: small red bumps that developed on her neck, chest; skin was itching for 2 days, starting on her hands and arms, and progressing to her abdomen, back and one leg; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on Thursday, 18Feb2021 the patient received the first Covid-19 vaccine and on 23Feb2021 her skin was itching for 2 days, starting on her hands and arms, and progressing to her abdomen, back and one leg, she took Benadryl for the itching 2 nights in a row. This morning she sent me a photo of small red bumps that developed on her neck, chest and back, she reported that she does not have any itching today. She has not yet seen a healthcare provider. Therapeutic measures were taken as a result of itching. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1661496
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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: Bulls eye itch; it is still itchy; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9264) via an unspecified route of administration on an unspecified date (at the age of 64 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bulls eye itch; it is still itchy on an unspecified date. Reported as, patient have bulls eye itch from the first shot 10 days after and it was still itchy, like a week already. Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1661497
Sex: U
Age:
State:

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

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

Lab Data: Test Name: biopsy; Result Unstructured Data: Test Result:showed that I had an allergic reaction

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Developed a rash on my body from kind of like head to toe; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. After Pfizer Covid vaccine shot, patient developed a rash on body from kind of like head to toe and patient went to dermatologist, she does not think, because they did two biopsy, both of which showed that patient had an allergic reaction to something but she did not feel like it was related to the vaccine and has encouraged me to get the second shot and patient just thought to call her to get a little more information about this side effect that might be a rash. Outcome of the event was unknown. Information about lot/batch was requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1661498
Sex: F
Age:
State:

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 09/01/2021
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: Itching and appearance of hives around neck, on stomach. During next couple of weeks would appear on legs and arms.; Itching and appearance of hives around neck, on stomach. During next couple of weeks would appear on legs and arms.; This is a spontaneous report from a non-contactable consumer or other non-Health Care Professional.A 70-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 10:45 at the age of 70-years-oldas DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. The patient's concomitant medications were not reported.On 03Feb2021 16:30 the patient experienced itching and appearance of hives around neck, on stomach. during next couple of weeks would appear on legs and arms. The outcome of events was recovering. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.

Other Meds:

Current Illness:

ID: 1661499
Sex: F
Age:
State: AR

Vax Date: 01/12/2021
Onset Date: 01/17/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Left under arm lymph node swelling; dyspnea on exertion; lower body edema; This is a spontaneous report from a contactable other healthcare professional (patient, nurse). A 50-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL0142, expiration date: not reported), via an unspecified route of administration in left arm on 12Jan2021 (at age of 50-year-old) as dose 2, single for covid-19 immunization. Medical history included asthma, drug hypersensitivity (Known allergies: Sulfa). Concomitant medication(s) included bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported; rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EJ1685, expiration date: not reported), via an unspecified route of administration in left arm on 23Dec2020 (at age of 50-year-old) as dose 1, single for covid-19 immunization. On 17Jan2021, the patient experienced left under arm lymph node swelling, dyspnea on exertion, lower body edema. The adverse events resulted in doctor's clinic visit. No therapeutic measures were taken as a result of the events. The outcome of events were recovered with sequel. No follow-up attempts are possible. No further information is expected.

Other Meds: WELLBUTRIN; SYMBICORT; CRESTOR

Current Illness:

ID: 1661500
Sex: F
Age:
State:

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 09/01/2021
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: Soreness in arm; severe headache; body aches; tiredness; thirst; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). A 31-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration (at the age of 31-years administered in arm left on 16Feb2021 at 13:30 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, on 26Jan2021 at 11:30 as dose 2, single for COVID-19 immunization and experienced soreness in arm. The patient did not received any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. On 17Feb2021, the patient experienced soreness in arm of injection for both shots, after second shot: severe headache, body aches, tiredness, thirst. The treatment was not received for all the events. The clinical outcome for the events was reported as recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021353701 Same reporter, patient, product/ different dose

Other Meds: ADVIL [IBUPROFEN]

Current Illness:

ID: 1661501
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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: he developed rashes after.; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Covid 19 vaccine, and he developed rashes after on an unspecified date. Got the second dose and still had rashes after receiving the dose. He asked on what to do on this. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1661502
Sex: M
Age:
State:

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Name: Covid test; Test Result: Negative

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: loss of taste; This is a spontaneous report from a Pfizer. A contactable male consumer reported. A male patient with unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Not reported) via an unspecified route of administration on 23Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date the patient experienced loss of taste. The patient was tested for covid 6 or 8 weeks ago and came back negative. Clarified noticed loss of taste after vaccine. The patient underwent lab tests and procedures which included SARS-CoV-2 test and resulted negative on unspecified date. The outcome of the event was unknown. Information of batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1661503
Sex: M
Age:
State: NJ

Vax Date: 02/08/2021
Onset Date: 02/16/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: rashes on chest; fever; headache; This is a spontaneous report from contactable consumer via a Pfizer-sponsored program Support. A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 08Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Feb2021, 8 days after the vaccination the patient experienced rashes on chest, fever and headache and he asked if these side effects are from the vaccine. The clinical outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1661504
Sex: U
Age:
State:

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 20210224; Test Name: Temperature; Result Unstructured Data: Test Result:96.9

Allergies:

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

Symptoms: Severe headache; Nauseous; Temperature was 96.9; Extremely cold feet and hands; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: EN6198) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 24Feb2021, the patient experienced severe headache, nauseous, temperature was 96.9 and extremely cold feet and hands. It was reported that the patient received the Covid19 vaccine yesterday morning and had side effects last night and called the 24-hour (insurance company name) Nurse with my (insurance company name) Provider and she told me to call this number to report side effects. The patient confirmed that it was the Covid19 vaccine of Pfizer. The intention of the call was to report side effects. The patient developed a severe headache immediately after and was kept under observation for 30 minutes, then released and came home. The headache continued most of the night. Also, the patient was very nauseous. My temperature was 96.9 and had extremely cold feet and hands. She just called on the advice of the 24-hour nurse associated with (insurance company name) Health Plan. Further probing could not be done as consumer hung up the call abruptly. Laboratory tests on 24Feb2021 included body temperature: 96.9. The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1661505
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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: When she got the shot, it left a big bruise on her arm; It started to swell up; This is a spontaneous report from a contactable consumer (husband) or other non-healthcare professional reporting for female patient (wife). A 61-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) (at the age of 61-years-old)as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization.Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced when she got the shot, it left a big bruise on her arm, it started to swell up. The reporter was calling regarding my wife. She just had the Pfizer vaccine eight days ago and originally, first of all, when she got the shot, it left a big bruise on her arm, which the nurse who administered the shot said, that never happened before. Eight days later now, it started to swell up. She is going to call her doctor of course but I thought I should go ahead and give you a call just kind of like to see what this particular number is about, what you guys do. There was no treatment received. The clinical outcome of the event was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1661506
Sex: F
Age:
State: NV

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: muscle and joint pain; muscle and joint pain; hot flashes; headaches; stomach pain; diarrhea; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer. A Patient of unspecified age and gender received Covid-19 Vaccine (BNT162B2) (Batch/Lot number: Unknown, Expiration date: Unknown, Solution for injection) via an unspecified route of administration on 18Feb2021 as Dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. On an unknown date patient experienced side effects like muscle and joint pain, hot flashes, headaches, stomach pain and diarrhea. No therapeutic treatments were received. The outcome of the events were reported as unknown. Information on lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1661507
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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: patient experienced a rash since the first dose; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient experienced a rash on an unspecified date since the first dose. The patient has received both doses. Outcome of the event was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1661508
Sex: F
Age:
State: CA

Vax Date: 02/12/2021
Onset Date: 02/01/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: severe loose runny stools/Diarrhea; flu like symptoms; joint pain; muscle pain; tiredness; rash at injectoin site; stomach pain; ugh; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 12Feb2021 (Batch/Lot number was not reported) (at the age of 54-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), 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 and experienced runny, loose stool specified as diarrhea, weight loss, stomach pain, ugh. In Feb2021, the patient experienced severe loose runny stools, flu-like symptoms including joint/muscle pain, tiredness, a giant rash at the injection site. Diarrhea that has lasted for 4 days, ugh, stomach pain as well. Normally she does not have GI issues. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1661509
Sex: F
Age:
State:

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Bit of tightness in chest; Soreness in her arm at site; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on 29Jan2021 as Dose 1,single for covid-19 immunization.treprostinil sodium (TYVASO), via an unspecified route of administration from 26Mar2020 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose, via an unspecified route of administration from an unspecified date (Batch/Lot Number: 2101898; Expiration Date: 31Oct2021) and ongoing, at UNK ug, 4x/day (18-54 mcg (3-9 breaths) for pulmonary arterial hypertension.Medical history included ongoing pulmonary arterial hypertension. Concomitant medication(s) included sildenafil citrate and ambrisentan (LETAIRIS) taken for an unspecified indication, start and stop date were not reported.The patient experienced bit of tightness in chest and soreness in her arm at vaccination site on 2021.On 19Feb2021, the following updates were made in the case with Day zero, 11Feb2021: This correction is being submitted to structure COVID vaccine as a co-suspect Product and to update the action taken with COVID vaccine from not reported to not applicable. Information about lot/batch number has been requested. Follow-up (19May2021): Follow-up attempts completed. No further information is expected.

Other Meds: SILDENAFIL CITRATE; LETAIRIS

Current Illness: Pulmonary arterial hypertension

ID: 1661510
Sex: F
Age:
State: TN

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: upset stomach; dehydration; eyes were red; fatigue; chest tightness; Loss of taste; This is a spontaneous report from a contactable other healthcare professional. A 37 year old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 19Jan2021 (Batch/Lot Number: EL1283) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatigue, chest tightness, upset stomach, dehydration, eyes were red leading to ocular hyperaemia and loss of taste leading to ageusia on 19Jan2021 23:00 with outcome of unknown. Symptoms reoccurred with 2nd dose of covid-19 vaccine, only worse. Had more side effects with the 2nd dose. In which she also filled out a separate questionnaire for. Did not have adverse side effects as far as she know that were serious enough to require immediate medical attention. Took 8 hours after shot before any side effects. Therapeutic antipyretic use:Midol(1st vaccine) plus Tylenol (2nd vaccine) Follow-up (14May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1661511
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Diarrhea for about 2-3 days after COVID vaccine, was not sure if related to vaccine or medications; Shortness of breath; still gets out of breath; This is a spontaneous report based on the information received by Pfizer from United Therapeutics (Manufacturer Report Number: UNT-2021-002485) via a contactable consumer (patient, self-reported). A 85-years-old male patient received a 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, on an unspecified date, as a single dose for COVID-19 immunization, treprostinil sodium (TYVASO, Inhalation gas), via an unspecified route of administration on an unspecified date and on 24Nov2020, for secondary pulmonary arterial hypertension, TADALAFIL and macitentan (OPSUMIT) for drug use for unknown indication. The patient's medical history included secondary pulmonary arterial hypertension. Concomitant medications were not reported. On an unspecified date, the patient experienced diarrhea for about 2-3 days after COVID vaccine, was not sure if related to vaccine or medications and shortness of breath; still gets out of breath. Tadalafil and Opsumit was not reported for the events of diarrhoea and dyspnoea. The patient reported that he had a little improvement, but he still got out of breath (dyspnoea previously reported). The reporter did not provide causality for the events of diarrhoea and dyspnoea. At the time of reporting, the outcome of the event shortness of breath; still gets out of breath was not recovered and for another event, it was unknown. Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected.

Other Meds: TADALAFIL; OPSUMIT; TYVASO

Current Illness: Secondary pulmonary arterial hypertension

ID: 1661512
Sex: F
Age:
State: TX

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Name: Urine culture; Result Unstructured Data: Test Result:Waiting on urine culture; Comments: Her mom thought she had a urinary tract infection.

Allergies:

Symptom List: Tremor

Symptoms: Rash on on her arms; Very itchy on the elbows.; It was itchy; Some of the bigger splotches turned light brown and peeled off missed; This is a spontaneous report from a contactable consumer reported for a patient (Mother). A 88-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 21Jan2021 (age at vaccination was 88 years) as dose 1, single for COVID-19 immunization. The patient's medical history included ongoing blood pressure and hives (her mom has had reaction to Sulfa drugs and had hives before). Concomitant medications included levothyroxine sodium taken for an unspecified indication, losartan taken for blood pressure (he takes Losartan as needed. The doctor said if her blood pressure goes over 140 for her to take it. She was usually low and that was why she stopped taking it daily. When she has spells where her blood pressure is elevated she takes the pill for a few days until it comes down), cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for B12 (gets B12 injection because she was low on B12. She gets it every month or two through her doctor. She hasn't had it near the time she got the vaccine though). 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 got the vaccine in the right arm because the nurse said the second one causes more of a sore arm. She gave it in the right thinking the second one would be in the left. It was reported that when the caller's mom had her shot five weeks ago she was fine. On an unspecified date, the patient got a rash on her arms. It was splotchy. Very itchy on the elbows. The caller's mom didn't show caller the rash until a week later, but her mom had told her that it was there 3 to 4 days after the vaccine. It wasn't a huge bother. It was itchy. It comes and goes. Some days she had spots and other days didn't. Some of the bigger splotches turned light brown and peeled off. The little ones seem to come and go. She thought it was a little overall better. It was the inside of her elbows that were mainly itchy on both sides. She had used Cortisone cream (it was the CVS brand. Her mom just started it yesterday and it was what caller had on hand. It was 1% hydrocortisone), but she may have to go to a dermatologist. She hadn't taken anything new. She called the doctor, but he didn't think it was related to the shot since it was several days later. Her mom saw the doctor this past Monday and he still didn't think it was vaccine related. The caller's mom already had the appointment on Monday for a six month check-up. Her mom thought she had a urinary tract infection. She was waiting on urine culture on an unspecified date. That had been going on for a few days. The patient already had the appointment and her doctor looked at the rash. They did call the doctor about the rash about 3 weeks ago and they didn't think it was related per the CDC guidelines. The patient showed the doctor the rash at her appointment on Monday, 22Feb2021. The caller asked if anyone had that kind of rash lingering after the shot. The caller wanted to make sure. She looked at the reaction list. One of the side effects listed as severe allergic was a bad rash all over the body. She wouldn't say the rash was all over the body. It was just on the arms. Some days it looked better than others. There was a Product Complaint. The patient was due for the second shot today. It was 5 weeks ago when she got the first shot. She was at 35 day and asked if that was ok. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: LEVOTHYROXINE SODIUM; LOSARTAN; B12 [CYANOCOBALAMIN]

Current Illness: Blood pressure

ID: 1661513
Sex: F
Age:
State: NC

Vax Date: 02/21/2021
Onset Date:
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Name: Height; Result Unstructured Data: Test Result:she is 5 foot 4 or 5 foot 5; Comments: she is 5 foot 4 or 5 foot 5 stating that she shrunk; Test Name: check for the virus; Result Unstructured Data: Test Result:she had some sort of virus for about 3 weeks; Test Name: Weight; Result Unstructured Data: Test Result:150 lbs; Comments: Caller states she was 150 pounds and gained to 170

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: itching all over; bad time with allergies; couldn't sleep; asthma was worse; red on her arm; second shot a lot worse than the first; This is a spontaneous report received from a contactable consumer or other non hcp. A 81-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration on 21Feb2021 ,at the age of 81 years old,as Dose 2 single for covid-19 immunization. Medical history included diabetes mellitus, neoplasm malignant Verbatim: cancer twice, asthma, osteoporosis, cardiac disorder, dermatitis contact and blood cholesterol abnormal from an unknown date and unknown if ongoing. The patient experienced itching all over, bad time with allergies, couldn't sleep, asthma was worse, red on her arm, second shot a lot worse than the first. The patient underwent lab tests and procedures which included body height: she is 5 foot 4 or 5 foot 5, stating that she shrunk , investigation: she had some sort of virus for about 3 weeks on, weight: 150 lbs on .Caller stated that she was 150 pounds and gained to 170.The outcome of the event was unknown.The patient previously received her 1st dose of Pfizer covid19 vaccine on 30Jan2021,lot EL892, exp 31May2021.Caller stated that she was asked when she took her 1st shot and was having reaction she thought it was because heart doctor had put on different cholesterol medication and she thought that she was reacting to that a little bit but then it eased off in a couple days. Upon transfer to medical information hold queue caller asked will the shots be as effective if she has taken Benadryl.

Other Meds:

Current Illness:

ID: 1661514
Sex: F
Age:
State: MN

Vax Date: 02/17/2021
Onset Date: 02/22/2021
Rec V Date: 09/01/2021
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: itchy and red spots; lip swelled up and it felt numb; This is a spontaneous report from a contactable Consumer (patient). An 81-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EM9809), via an unspecified route of administration on 17Feb2021 (age at the vaccination 81-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Historical vaccine included first dose of BNT162B2 Lot number: EL1283 on 27Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. Patient and her husband and their got first COVID 19 shot 27Jan2021. Then, three weeks later they got their 2nd vaccine on 17Feb2021, Then, the 22Feb2021, she developed a side effect. The first shots were fine. The second shot they thought was fine. Then, Sunday evening, 22Feb2021, she developed itching and red spots. It was not very comfortable. The small spots were here and there. They were not all over her body. Then patient top right lip swelled up and felt numb on 22Feb2021. It was not painful. It was like waiting for Novocain to go away. By the morning it was way down, and then by afternoon, it was all gone. It has not returned. It felt like she had been to the dentist. At first, she thought it was just hives or something. She put some cortisone cream on it, and she was able to sleep a lot better. Therapeutic measures were taken as a result of both events. The outcome of the event lip swelling was recovered on 22Feb2021 and Itchy was recovering. Follow-up (14May2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1661515
Sex: F
Age:
State: MD

Vax Date: 02/20/2021
Onset Date: 02/01/2021
Rec V Date: 09/01/2021
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: experienced pain in her joints, muscles; she was feeling very tired; she is feeling sick in her stomach; experienced pain in her joints, muscles; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 for covid-19 immunisation. On Feb2021, the patient experienced pain in her joints, muscles, and she was feeling very tired. The patient also reported that she was feeling sick in her stomach. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1661516
Sex: F
Age:
State: PA

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

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

Lab Data: Test Name: Height; Result Unstructured Data: Test Result:5'6.5" and 5'7"; Comments: Caller states that his wife is between 5'6.5" and 5'7"

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: pain in her breast and shoulder; pain in her breast and shoulder; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 (at the age of 78 year) as dose 1, single for COVID-19 immunisation. Medical history included ongoing hypothyroidism, breast cancer (breast cancer 18 months ago), breast conserving surgery, chemotherapy, surgery, radiotherapy, lymphadenopathy. Concomitant medication(s) included ongoing levothyroxine sodium (SYNTHROID) taken for hypothyroidism and ongoing anastrozole (ANASTROZOLE) taken for breast cancer from Nov2020. Consumer reported that his wife went through with the COVID vaccine. Consumer stated that his wife had breast cancer 18 months ago, and she had chemo, and surgery and radiation, she had a partial mastectomy. Consumer stated that on an unspecified date in Feb2021 she experienced pain in her breast and shoulder. Consumer stated that when his wife had a partial mastectomy, they also removed 9 lymph nodes. Caller states that the pain his wife was having, was in the areas where she had her surgery. Consumer stated that his wife was between 5'6.5" and 5'7". Consumer provided that the patient could not say that the pain was constant, although it was constant in her left arm, but it was not constant in her breast. The patient didn't get the shot in her left arm, because that was the side that she had lymph nodes removed. The patient reports that the pain was in her left shoulder and where the lymph nodes were taken out, she had 9 removed, and that pain started a few days after she got the shot. The patient asked the woman giving the shot if the shot would affect her breast or other arm, and the patient was told that it should not affect those, but the patient did have pain in both arms, but especially in the left breast, where she had the cancer. Caller stated that just yesterday evening, she started taking Tylenol for the pain. The outcome of events was unknown. No follow-up attempts are needed. Information about lot/batch cannot be obtained.

Other Meds: SYNTHROID; ANASTROZOLE

Current Illness: Hypothyroidism (Verbatim: Hypothyroidism)

ID: 1661517
Sex: M
Age:
State: MD

Vax Date: 02/19/2021
Onset Date: 02/20/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 20210220; Test Name: low grade fever; Result Unstructured Data: Test Result:low

Allergies:

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

Symptoms: Chills; Low grade fever; Dizziness; joint and muscle aches; joint and muscle aches; Weakness; This is a spontaneous report from a contactable consumer (reported for himself). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9264/Batch number was not reported; Expiration Date: on an unspecified date in May2021), dose 2 via an unspecified route of administration, administered in arm left on 19Feb2021 (at the age of 77-years-old) as dose 2, single for covid-19 immunisation. Medical history included glucose tolerance impaired from an unknown date and unknown if ongoing (diagnosed 10 years) and sleep apnoea syndrome from an unknown date and unknown if ongoing (diagnosed 10-12 years ago). The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN5318/Batch number was not reported; Expiration Date: on an unspecified date in May2021), dose 2 via an unspecified route of administration, administered in arm left on 28Jan2021 (at the age of 77-years-old) as dose 2, single for covid-19 immunisation. On 20Feb2021, chills, low grade fever, dizziness, joint and muscle aches and weakness. The patient underwent lab tests and procedures which included body temperature: low on 20Feb2021. The outcome of the events chills, low grade fever was resolved on 20Feb2021, joint and muscle aches, weakness was resolved on 21Feb2021 and dizziness was resolving. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1661518
Sex: F
Age:
State: NY

Vax Date: 02/21/2021
Onset Date: 02/21/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No taste in my mouth, no scent.; No taste in my mouth, no scent; Cold fever and I had aches and pain; Cold fever and I had aches and pain; Tired; Dizzy/feeling dizzy; Never slept this much in my life; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9267, Expiration date: Unknown) via an unspecified route of administration on 21Feb2021 (30-year-old at vaccination) as a Dose 1, Single for COVID-19 immunization. The patient's medical history reported as none. The patient's concomitant medication(s) included ascorbic acid (VITAMINE C); tocopheryl acetate (VITAMINE E; vitamin b complex (VITAMIN B). She took the vaccine on Sunday (21Feb2021), right and since she took it, right today, it was like 4 days and she had no taste in her mouth, no scent. She was like constantly dizzy and when she took the at first night, she had the cold fever and she had aches and pain like until Monday and then Monday afternoon it went away but now it's like since Sunday till now, she had no taste no scent. She just feeling dizzy and like she was very tired all she wanted was to sleep. On an unknown date in 2021, it was like she never slept this much in her life. She was getting this dizzy like if she goes to drive like she was so dizzy. She was always dizzy. She never a like was person that complained about dizziness even and all if she was sick she never lost her taste and her scent. No investigation assessment was provided. She said that she was old healthcare aid. She cared for older people. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.

Other Meds: VITAMIN C [ASCORBIC ACID]; VITAMIN E [TOCOPHEROL]; VITAMIN B

Current Illness:

ID: 1661519
Sex: F
Age:
State: MI

Vax Date: 02/23/2021
Onset Date: 02/25/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: red knot; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6202, Expiration date: unknown), via an unspecified route of administration in arm left on 23Feb2021 at 11:10 (at the age of 71-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history (including any illness at time of vaccination) included high cholesterol, high blood pressure, diabetic. The patient's concomitant medications included aspirin [acetylsalicylic acid] and colecalciferol (VITAMIN D 3). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9810, Expiration date: unknown), via an unspecified route of administration in arm left on 02Feb2021 (at the age of 71-year-old) as a dose 1, single for COVID-19 immunization. Additional vaccines administered on same date of the Pfizer suspect was reported as none. The AE(s) following prior vaccinations were reported as none. It was reported that, the patient had her second shot on Tuesday. Stated that, she did fine on Tuesday and yesterday. Stated that, this morning on 25Feb2021, she woke up around 07:30 AM and she has a big red knot where she got the shot. Stated that, it was warm touch. There was a red circle around it. Stated that, was that something she should get checked and was that a side effect. The caller clarified shot as COVID-19 Vaccine. Stated that, it was more red today. The circle Band-Aid was still on and she took it off. The circle was getting bigger around it and more red. Stated that, she was not sure whether that was something that might happen. Stated that, she has not put any ice on it. Stated that, on the vaccine card, it said BioNTech. The lot number was EM9810 for first dose. Second dose lot number was EN6202, Expiry for both first and second dose was unknown. Stated that, as she was over 70, doesn't want to get it. Also stated that, her grandkids won't let her see them until she gets it. Stated that, she takes 9 pills. She takes medication for high cholesterol, high blood pressure and diabetes. Stated that, she also takes aspirin and vitamin D. She takes three different pills for diabetes. The caller did not provide list of medication names when queried. Treatment was not received for the event. The outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN D 3

Current Illness:

ID: 1661520
Sex: M
Age:
State: MI

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

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

Lab Data:

Allergies:

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

Symptoms: not feeling well; having a cough; voice feels gone; This is spontaneous report from a Pfizer sponsored program. A contactable male consumer reported. A male patient with unspecified age received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 01Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced not feeling well, having a cough, and voice feels gone. This happened a week before second dose. The events assessed all as non-serious. The outcome of the events was unknown. No follow-up attempts possible. No further information expected. Follow-up (14May2021): 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: 1661521
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: itchy arms; This is a Spontaneous report from a contactable consumer. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced itchy arms. The outcome of the event was unknown. No Follow-up attempts are needed. Information about lot/batch cannot be obtained.

Other Meds:

Current Illness:

ID: 1661522
Sex: M
Age:
State: MA

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 09/01/2021
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: headache; tenderness (sore) in the arm that received the injection; feeling achy in my back; feeling achy in my back and large joints (knees and elbows); This is a spontaneous report from a contactable consumer. A male patient (Age: 46; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced headache, tenderness (sore) in the arm that received the injection and feeling achy in my back and large joints (knees and elbows). Patient took an ibuprofen and the headache and soreness started to go away after a couple of hours. Event took place after use of product. The outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1661523
Sex: F
Age:
State: IL

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

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: bruising at the site; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer. A female patient of an unspecified age 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, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received the 1st dose of the Pfizer Covid-19 Vaccine and had bruising at the site. She was on a blood thinner and we did not mention that before the shot. When she goes for the 2nd shot, I would like to know if she should stop taking Zoral Blood thinner before the shot. Outcome of the event was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1661524
Sex: F
Age:
State: TN

Vax Date: 02/24/2021
Onset Date:
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Headache; feeling tired; little bit of chills; joint pain; This is a spontaneous report from a contactable consumer (patient) via a Regulatory Authority. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 24Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 on unspecified date for covid-19 immunization. The patient experienced headache, feeling tired, little bit of chills, joint pain on an unspecified date. Would like to take Aspirin or Tylenol. Clinical outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1661525
Sex: M
Age:
State: MO

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 09/01/2021
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: experiencing swelling; This is a spontaneous report from a Pfizer-sponsored COVAX US Support program. A contactable consumer reported for male patient (husband) that: A male patient of unspecified age had received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not provided), via an unspecified route of administration, on 29JAN2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. (Reporter name) called on behalf of her husband (Name) who got his 1st dose last 29Jan2021. 2nd dose was cancelled due to the snowstorm. New appointment for the 2nd dose will be 27Feb2021. On an unspecified date, patient had experienced swelling. The took patient to the Emergency room and took 40 shots of Kenalog. At the time of reporting, the outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1661526
Sex: M
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Allergic reaction - pruritis over entire body; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 39-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in Arm Right on 04Mar2021 15:30 (at the age of 39-years-old) as DOSE 1, SINGLE for covid-19 immunization. (Vaccination facility: other). Medical history included hypertension, Hashimoto, depression all from an unknown date and unknown if ongoing. Concomitant medication (other medications in two weeks) included lisinopril (LISINOPRIL), fluoxetine hydrochloride (PROZAC), levothyroxine (LEVOTHYROXINE) all taken for an unspecified indication, start and stop date were not reported. The patient previously took doxycycline and experienced drug hypersensitivity (known allergies to doxycycline). Patient did not receive other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. It was reported that on 04Mar2021 15:30 patient experienced Allergic reaction Pruritus over entire body. Patient was not tested for covid post vaccination. Therapeutic measures were taken as a result event with Self medicated Benadryl. The outcome for the event was reported as unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot been obtained. .

Other Meds: LISINOPRIL; PROZAC; LEVOTHYROXINE

Current Illness:

ID: 1661527
Sex: F
Age:
State: MA

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

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

Lab Data:

Allergies:

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

Symptoms: chills; headache; body aches; Malaise; This is a spontaneous report from a contactable Nurse. This Nurse reported in response to HCP letter sent in across referenced case which included that. A 65-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK9231; Expiration Date: Apr2021), dose 2 intramuscular, administered in Deltoid Left on 11Jan2021 17:30 (at the age of 65-year-old), as dose 2, single for COVID-19 immunization in hospital. Medical history included Crohn's disease from 2011 to an unknown date. The patient's concomitant medications were not reported. On 11Jan2021 the patient received Tylenol per oral prior to vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK5730; Expiration Date: Mar2021), dose 1 intramuscular, administered in Deltoid Left on 21Dec2021 (at the age of 65-year-old), as dose 1, single for COVID-19 immunization. No pneumococcal vaccine was vaccinated within four weeks before BioNTech Vaccine and was not Pfizer vaccine. On 11Jan2021 08:00, the patient experienced chills, headache, body aches, malaise. The patient did not receive any treatment for the events. Emergency Room and Physician Office visit was not required for events. No primary infection site applicable. No predisposing factors were there. No culture performed. No seriousness criteria provided. The clinical outcome of the events was recovered in 2021. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1661528
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: arm soreness, body ache, fatigue 24hour later; arm soreness, body ache, fatigue 24hour later; arm soreness, body ache, fatigue 24hour later; This is a spontaneous report from a contactable other HCP (patient). This other HCP reported in response to the HCP letter sent in cross reference case that, A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL3246; Expiration Date: Apr2021), dose 2 intramuscularly administered in Deltoid Left on 13Jan2021 at 18:00 (at the age of 26-years-old) as SINGLE DOSE for covid-19 immunisation at Hospital. The patient medical history included autoimmune thyroiditis (Hashimoto's thyroiditis) from 2008 to an unknown date. Concomitant medications included levothyroxine sodium (SYNTHROID) Synthroid 62.5 mg PO (oral) daily taken for hypothyroidism from 2008 and ongoing. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EK5730; Expiration Date: Mar2021), dose 1 intramuscularly administered in Deltoid Left on 23Dec2020 at 18:00 (at the age of 26-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Prior Vaccinations (within 4 weeks) and events following Prior Vaccinations were none. The patient experienced arm soreness, body ache and fatigue 24hour later on 13Jan2021 at 18:00. The patient provided information regarding the reported adverse events with the use of the product. Patient considered the Pfizer product had a causal effect to the adverse event. After dose one, patient had arm soreness & headache 24 hour later. After second dose had arm soreness, body ache, fatigue 24 hour later. Event did not require emergency room or physician office.The patient was not deceased, and treatment was not required. Family Medical History Relevant to events were none. Relevant Tests done were none. The patient was not admitted to hospital. There was causal relationship reported as reasonable possibility that the event is related to suspect products. Outcome of all the events were recovered. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

Other Meds: SYNTHROID

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am