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**
PLEASE CHECK BACK SOON
Download the files above while you wait.







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: 1713072
Sex: F
Age:
State:

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 09/18/2021
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: Shingle-like response; Tinnitus; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported for herself. A female patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8733, Expiration date: unknown), via unspecified route, administered in left arm on 26Mar2021 15:30 as dose 1, single for COVID-19 immunization. The patient medical history includes Seasonal allergy and Colitis ulcerative both from an unknown onset and ongoing and concomitant medications includes Fluticasone Propionate and Cetirizine Hydrochloride (ZYRTEC ALLERGY). On 26Mar2021, after the vaccination, the patient experienced reported tinnitus and shingle-like response after being administered that first dose of Pfizer Covid Shot. She already reported this to the VAERS site or whatever but has not reported this to Pfizer previously. She is still experiencing this. Described as a ringing in her ear non-stop. She is assuming it is Meniere's disease; but it is a buzz in her head. It is hard to distinguish whether it is in her head or ears, but she thinks it is probably ears. It was sudden onset particularly when they gave her the Pfizer Covid Shot. She went to sit in that area that they wait in it was severe at that time worse at that time, but it is still ongoing. She does not plan to get the second dose of the Pfizer Covid Shot due to this event. She wanted to get the shot for shingles, but she had to wait. She mentioned that the Pfizer Covid Shot produced a shingle-like response in her system like a shingles rash that lasted like a week which terrified her. She still needs to get the shingles shots. She can't say 100% that event was shingles, but it looked very close to shingles; the rash itched and burned like nothing she has ever felt in her life. According to her brother who had shingles that's what his shingles felt like when he had shingles. Shingle-like response started probably like a week and a half after she was administered Pfizer Covid Shot. No other vaccines were taken four weeks Prior to vaccination. The outcome of the event tinnitus was recovering and herpes zoster was unknown. No follow-up attempts possible. No further information expected.

Other Meds: FLONASE ALLERGY RELIEF; ZYRTEC ALLERGY

Current Illness: Seasonal allergy (Verbatim: Seasonal allergies); Ulcerative colitis (Verbatim: Ulcerative colitis)

ID: 1713073
Sex: F
Age:
State: IL

Vax Date: 04/29/2021
Onset Date: 05/03/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: I have a confirmed case of mild shingles rash on chest.; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ECO0170), via an unspecified route of administration, administered in Arm Left on 29Apr2021 10:45 (at the age of 43-year-old) as dose 2, single for covid-19 immunisation. Medical history included allergy to Sulfa- mild rash. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: CP7533), administered in Arm Left on 08Apr2021 10:30 (at the age of 43-year-old) as dose 1, single for covid-19 immunisation. Patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. The patient reported she had a confirmed case of mild shingles rash on chest on 03May2021 13:00. Patient did not have COVID prior vaccination and COVID was not tested post vaccination. AE resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment for adverse event that included Antiviral medicine and ointment. The outcome of event was not recovered. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1713074
Sex: F
Age:
State: ND

Vax Date: 03/26/2021
Onset Date: 03/31/2021
Rec V Date: 09/18/2021
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: 5 days after the second dose my period started, it was a week early. It lasted from 31Mar to 21Apr, it was extremely heavy. On 28Apr it started again and as of today 09May, it still has not stopped; 5 days after the second dose my period started, it was a week early. It lasted from 31Mar to 21Apr, it was extremely heavy. On 28Apr it started again and as of today 09May, it still has not stopped; developed the "Covid arm" rash around the injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 13:00 (at the age of 37 years), (Batch/Lot Number: ER8732) as DOSE 2, SINGLE for covid-19 immunisation at medical facility. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications included venlafaxine; buspirone and phentermine taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (Batch/Lot Number: EN6204) for covid-19 immunisation. The Patient stated, "5 days after the second dose my period started, it was a week early. It lasted from 31Mar to 21Apr, it was extremely heavy. On 28Apr it started again and as of today 09May, it still has not stopped. It had been extremely heavy the entire time. I also developed the "Covid arm" rash around the injection site". The events resulted in visit to Physician office. Treatment received for events was unknown. The clinical outcome of the events was not recovered at the time of vaccination. No follow-up attempts are possible. No further information is expected.

Other Meds: VENLAFAXINE; BUSPIRONE; PHENTERMINE

Current Illness:

ID: 1713075
Sex: F
Age:
State: PA

Vax Date: 04/17/2021
Onset Date: 04/25/2021
Rec V Date: 09/18/2021
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: confirmed shingles diagnosis; Poison Ivy type rash on torso front and back; pain in rib on left side of body; aches and pain in all joints; Chills; Sweats; Felt Awful; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0162, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 17Apr2021 19:15 (at the age of 50-year-old) as dose 2, single for COVID-19 immunization, at pharmacy or drug Store. The patient medical history included Bi-Polar disorder. Concomitant medications included lithium (LITHIUM), liothyronine sodium (LIOTHYRONINE SOD.), and levetiracetam (LEV). The patient had no known allergies. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8730, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 27Mar2021 at 07:15 PM (at the age of 50-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination. No COVID test was performed post vaccination. It was reported that, the patient felt awful (the week of 25Apr-01May) on 25Apr2021. On 26Apr2021, experienced sweats, chills, and aches and pain in all joints. On 30Apr2021, developed pain in rib on left side of body. The patient thought he had moved the wrong way. On 03May2021, experienced poison ivy type rash on torso front and back. The patient called doctor, who put her on "1 gm Vyosyclovir". On 04May2021, confirmed shingles diagnosis in office. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. The patient received "1 grm Vyocyclovir 2x/day" as treatment. The outcome of the events was reported as not resolved.

Other Meds: LITHIUM; LIOTHYRONINE SOD.; LEV

Current Illness:

ID: 1713076
Sex: F
Age:
State: PA

Vax Date: 04/26/2021
Onset Date: 04/28/2021
Rec V Date: 09/18/2021
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: Heavy menstrual period ongoing from the start of my cycle; On and off cramps; breast tenderness; This is a spontaneous report from a contactable other hcp (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Apr2021 13:30 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 50-year-old) for covid-19 immunisation. Medical history included unusual periods, menopause from 2020 to an unknown, heavy menstrual bleeding from an unknown date and unknown if ongoing. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. Patient did not receive other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heavy menstrual period ongoing from the start of my cycle, on and off cramps, breast tenderness on 28Apr2021. It was reported that Heavy menstrual period ongoing from the start of my cycle on 28/29Apr. On and off cramps and breast tenderness. Although I have had unusual periods with clots being passed due to menopause for the last year. It had never ever lasted this long in my entire life. The outcome for all events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1713077
Sex: F
Age:
State:

Vax Date: 05/05/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: headache; stuffy nose; fever; sweating; ears blocked; sore arm; shingles; felt like a car ran me over; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced headache (headache) (non-serious) on an unspecified date with outcome of unknown , stuffy nose (nasal congestion) (non-serious) on an unspecified date with outcome of unknown , fever (pyrexia) (non-serious) on an unspecified date with outcome of unknown , sweating (hyperhidrosis) (non-serious) on an unspecified date with outcome of unknown , ears blocked (ear discomfort) (non-serious) on an unspecified date with outcome of unknown , sore arm (limb discomfort) (non-serious) on an unspecified date with outcome of unknown , shingles (herpes zoster) (non-serious) on an unspecified date with outcome of unknown. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of , shingles (herpes zoster).

Other Meds:

Current Illness:

ID: 1713078
Sex: M
Age:
State: PA

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 09/18/2021
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: Bell's palsy/Caller is calling about a family member who received the first dose and felt Bell's Palsy; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable Pharmacist reported for a 28-year-old male patient that received BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection), dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Apr2021, the patient experienced bell's palsy/caller was calling about a family member who received the first dose and felt bell's palsy. It was reported that her concern was now for the second dose because he had held off because he doesn't want to get Bell's Palsy again because it took some time to resolve and it could affect his work. Caller stated she would like to know why was it a difference in the labeling and was there a way to get a medical exemption for the second dose at this time because of that. Caller would like to know what guidance does Pfizer suggest for her family member to receive the second dose of the vaccine. Caller stated he was seen by a physician and put on medicines and so on. Caller states the main reason for this call was the difference that she found in the United Kingdom versus what she could find in the United States. Caller stated was it not still the Pfizer vaccine in the United Kingdom. Caller stated she was hoping Pfizer would have more information about their drug in United Kingdom but they do not and this very disappointing. Caller stated if you cant get the information from the manufacturer and don't know it gets a little frustrating. Caller stated unfortunately this was her second call to Pfizer and she knows where we are coming from and this is not that helpful which is too bad because there was not for sure a cause and effect of anything and in one labeling it says its a rare side effect and in another it doesn't and it just doesn't make sense to her. At the time of this report, the outcome of event was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of event Bell's palsy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1713079
Sex: F
Age:
State: WA

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Ulcers on tongue; administration date: 12May2021, dose 2; administration date: 28Apr2021, dose 1.; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: unknown), via an unspecified route of administration, administered in the left arm on 12May2021 at 08:00 (at the age of 17-year-old), as dose 2, single for COVID-19 immunization. Medical history was not reported. The patient did not receive any other medications within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: unknown), via an unspecified route of administration, administered in the left arm on 28Apr2021 at 16:00 (at the age of 17-year-old), as dose 1, single for COVID-19 immunization. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021 at 08:00, the patient experienced administration date: 12May2021, dose 2; administration date: 28Apr2021, dose 1. On 13May2021, the patient experienced ulcers on tongue. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with Ibuprofen and cold liquids. The clinical outcome of the event ulcers on tongue was not recovered at the time of this report and outcome of another event was unknown. The lot number for the vaccine (BNT162b2) was not provided and will be requested during follow up. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1713080
Sex: F
Age:
State:

Vax Date: 05/16/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: body aches; muscular pains; Chills; Bone pain; Fever; uterus pain as if I were about to get my period /uterus is hurting; nausea; vomiting; fatigue; gastritis; period lasting 2 weeks/early menstrual period; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 16May2021 (at the age of 46 year) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for COVID-19 immunisation and experienced fevers, nausea, vomiting and early menstrual period that lasted for 15 days. On an unspecified date, consumer reported that she was so terrible, since 2 days ago she have had body aches, muscular pains and she was in bed right now. Consumer reported that yesterday she got her second vaccine dose and afterwards has experienced chills, bone pain, body aches, fever, nausea, vomiting, gastritis and once again, uterus pain as if she were about to get her period and her uterus was hurting along with fatigue, an early menstrual period, a period lasting for 2 weeks. She also took omeprazole for her gastritis. Consumer reported that she has never experienced this before, and reports having gone to the emergency room twice (not admitted to the hospital) where she reported being told that this was a normal side effect from the vaccine. Consumer reported that she has heard many reports of women experiencing heavy or changed periods after getting the vaccine and she wanted to make sure it was normal and that it was not going to cause any permanent long-term damage. The outcome of all events as unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1713081
Sex: M
Age:
State: WA

Vax Date: 05/17/2021
Onset Date: 05/17/2021
Rec V Date: 09/18/2021
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: Whole body (and teeth) started to shiver severely beyond my control; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 38-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0175), via an unspecified route of administration in arm right on 17May2021 at 16:45 (at the age of 38-years-old) as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 17May2021, the patient experienced i was able to walk away after 30 minutes but it was a traumatic experience and on 17May2021 at 16:45, the patient experienced whole body and teeth started to shiver severely beyond my control. The patient reported right after receiving his Pfizer first dose, his whole body and teeth started to shiver severely beyond his control. He wasn't feeling cold or anything bad apart from that. That lasted for about 15 minutes or so and then it got milder by time. The pharmacist called an ambulance and paramedics checked his vital signs. He was able to walk away after 30 minutes but it was a traumatic experience. The events resulted in emergency room visit. It was unknown if the patient received treatment for the events. The patient recovered from the event on an unspecified date in May2021. 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 completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1713082
Sex: M
Age:
State:

Vax Date: 05/10/2021
Onset Date: 05/11/2021
Rec V Date: 09/18/2021
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: Shingles; rash in one leg; Pain in leg; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 10May2021 as 2ND DOSE, SINGLE for covid-19 immunisation. After receiving the second dose of COVID-19 vaccine last 10May2021, that's Pfizer COVID-19 vaccine. So, patient experienced pain in the leg, rash in one leg and had shingles. So 10May2021 was Monday, so he had pain in the leg Tuesday, Wednesday is rash in the leg, one leg and had shingles Thursday. The outcome of the events was unknown. Information on lot number/batch number was requested. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1713083
Sex: F
Age:
State: MA

Vax Date: 05/14/2021
Onset Date: 05/16/2021
Rec V Date: 09/18/2021
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: Really painful rash on the caller's hip; Shingles; Second dose: Last night, 17MAY2021 all of a sudden was getting the sweats like body, just a heat came all over whole body; Second dose: Last night, 17MAY2021, started getting random fast heart beat; Second dose: Woke up yesterday, 17MAY2021, and had a rash on side; Second dose: Sunday, 16MAY2021, was getting headaches, really bad headaches back and forth; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8736 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 14May2021 at 11:15 (age at vaccination: 37 years), as a single dose for COVID-19 immunization. The patient's medical history was not reported. Family history included the patient's sister had Covid and stomach cancer (she had to receive the Pfizer Covid Vaccine because the caller was on the list, because of genetics and testing positive for stomach cancer in genetic testing. Caller states its weird, a lot of cancer going on right now). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0158 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 23Apr2021 at 10:15 (age at vaccination: 37 years), as a single dose for COVID-19 immunization and had head-ache which began that Sunday, 25Apr2021 and recovered from the headache, just made sure to stay hydrated and took Ibuprofen. Concomitant medications were not reported. The patient did not receive any additional vaccination prior vaccinations (within 4 weeks). Sunday, on 16May2021 the patient was getting headaches, really bad headaches back and forth. The caller took Ibuprofen to keep the headaches down. Sunday, on 16May2021 the patient was getting headaches, really bad headaches back and forth. The patient took Ibuprofen to keep the headaches down and were okay now. The patient reported that she woke up yesterday, 17May2021, and had a rash on her side. On Monday, 17May2021, the patient hasn't received any headaches. The patient was reading paperwork that said normally people would have fast heart beat and rash within the first 15 minutes within the first day of receiving the Pfizer Covid Vac-cine. The patient stated that she was experiencing some of these symptoms after this time period. The patient clarified that last night, 17May2021, the patient started getting random fast heart beat. Second dose: Woke up yesterday, 17May2021, and had a rash on side: the patient woke up yesterday morning, 17May2021 and there was a really, really painful rash on the caller's hip. The rash was probably about 3 inches by 1.5 inches and was really, really sore to the touch. Second dose: Last night, 17May2021 all of a sudden was getting the sweats like body, just a heat came all over whole body. The patient was sweating really bad. The patient stated she was not getting the sweats with the heart beat now and so far the patient hasn't had another episode of this. Hopefully, that was the only one. The patient stated it probably lasted about 20 minutes and occurred at 22:00 on 17May2021. The patient didn't think she recovered completely right away. Second dose: Woke up yesterday, 17May2021, and had a rash on side: the patient stated the rash has gotten a little bit bigger and was more painful, not itching or anything just really painful. The patient stated that heart beat was ongoing a little bit. The heart beat was about the same. The patient stated she has not had Covid or anything like that. The adverse events did not require a visit to Emergency Room and Physician Office. The patient was calling about the Pfizer covid vaccine. The patient received the vaccine on Fri-day and she called yesterday, 18May2021, and reported her symptoms. The patient went to the urgent clinic yesterday, 18May2021, and was told she has shingles from the vaccine. The patient was calling today to add this to the safety report. This was the only thing that the patient wanted to add to her safety report. The patient was told that her rash on her side was shingles. The rash hasn't gotten better, the patient just started medication yesterday for it. There was no product complaint to report and medical information request. Outcome of the event second dose: Woke up yesterday, 17May2021, and had a rash on side, really painful rash on the caller's hip, and shingles was not re-covered, second dose: last night, 17May2021 all of a sudden was getting the sweats like body, just a heat came all over whole body was recovering, second dose: last night, 17May2021, started getting random fast heart beat recovered on an unspecified date in 2021, and second dose: sunday, 16May2021, was getting headaches, really bad headaches back and forth was recovered on 18May2021. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1713084
Sex: F
Age:
State: IL

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 09/18/2021
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: colonoscopy; Result Unstructured Data: Test Result:unknown; Test Name: endoscopy; Result Unstructured Data: Test Result:unknown; Test Name: MRI; Result Unstructured Data: Test Result:Unknown; Test Date: 20210509; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: Nausea; loss of appetite; unintended weight loss; chronic fatigue; weakness; light headed; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCIBE Solution for injection Lot Number: EN6207) via an unspecified route of administration in arm left on 23Mar2021 as dose 1, single and bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EW0158) via an unspecified route of administration in arm right on 23Mar2021 as dose 2, single (age at vaccination: 59 years) for COVID-19 immunisation. Medical history included COPD, fibromyalgia, depression, allergies, all from an unknown date and unknown if ongoing. Concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination and tested COVID post vaccination. On 23Mar2021 12:00 PM, the patient experienced nausea, loss of appetite, unintended weight loss, chronic fatigue, weakness, light headed. The adverse event resulted in doctor or other healthcareprofessional office/clinic visit. Treatment received was medication endoscopy colonoscopy MRI. The patient underwent lab tests and procedures which included sars-cov-2 test resulted as negative on 09May2021, MRI resulted as unknown on an unknown date, endoscopy resulted as unknown on an unknown date, colonoscopy resulted as unknown on an unknown date. The clinical outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1713085
Sex: F
Age:
State: CA

Vax Date: 05/20/2021
Onset Date: 05/20/2021
Rec V Date: 09/18/2021
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: Pruritis; Redness around the injection site that spread down her left arm; rash appeared as a raised linear wheal with surrounding erythema; rash appears most similarly to dermatographic urticaria.; This is a spontaneous report from a contactable physician.A 14-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20May2021 at 13:45 (at the age of 14-year-old) as dose 1, single for COVID-19 immunization.The patient had no known allergies to medications, food or other products. Medical history included childhood asthma. Concomitant medications included drospirenone; ethinylestradiol betadex clathrate (YAZ) and iron supplementation (MANUFACTURER UNKNOWN).Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.It was unknown if patient received any other vaccines within four weeks prior to the vaccination.On 20May2021 at 13:45 PM, within 15 minutes of receiving the first vaccine, the patient developed pruritis and redness around the injection site that spread down her left arm. The rash appeared as a raised linear wheal with surrounding erythema, but no pain or sloughing of skin. She had no difficulty breathing, no swelling of her tongue or throat, no fevers/chills/malaise. The patient was well in the ED and the rash appears most similarly to dermatographic urticaria.Therapeutic measures were not taken as a result of the events. The events resulted in emergency room/department visit or urgent care. The patient recovered from all events in May2021. 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: YAZ

Current Illness:

ID: 1713086
Sex: M
Age:
State: CA

Vax Date: 05/14/2021
Onset Date: 05/16/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Swelling upper and lower lip areas, down to about the chin; Hives; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration administered in Left arm on 14May2021 at 12:00 (53-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. Medical history included hives (had episodes in recent months) from an unknown date and unknown if ongoing. The patient had allergies to birch, dust mites, some grasses and Seasonal allergies. Concomitant medications included antihistamines (unspecified) from an unknown date for unknown indication. Historical vaccine included, the patient received first dose of 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 23Apr2021 at 12:00 PM (53-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 16May2021 21:00, the patient experienced swelling upper and lower lip areas, down to about the chin. Some hives reappeared, but the patient had episodes in recent months. No therapeutic measures were taken as a result of the reported events. The outcomes of events were recovered on an unknown date in May2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1713087
Sex: F
Age:
State: OH

Vax Date: 05/08/2021
Onset Date: 05/08/2021
Rec V Date: 09/18/2021
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: Tingling; Very mild numbing sensation in the vaccinated arm (left arm); Left hand started warming up; Heart rate became rapid; Shaking uncontrollably; muscles became incredibly weak; panic attack; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 29-year-old non pregnant female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch no: not reported/ Lot number: unknown) via an unspecified route of administration in left arm on 08May2021 at 17:00 (at the age of 29-years-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date to unknown stop date. Concomitant medications were not reported. Prior to vaccination, patient was diagnosed with COVID-19 and Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination and did not receive any other vaccines within 4 weeks prior to the vaccination. After receiving first vaccination, the patient was ushered to the waiting room to wait 15 minutes. On 08May2021 at 17:05, about after 5 minutes after sitting in chair, the patient noticed slight tingling and very mild numbing sensation in the vaccinated arm which was left arm. Then the patient had started warming up and the sensation progressed to the left side of face. The sensation did not proceed to move to the right side of the body. However, the patient's heart rate became rapid, was shaking uncontrollably and muscles became incredibly weak. The patient stated against the will of her muscles she was shaking like a person with Parkinson's disease. The patient made it to the counter to alert the nurse. The patient stated to nurse that she might be having a panic attack but had no idea what would have triggered it and she never experienced anything on this level. The staff proceeded to set patient back down in chair and fan was switched on. The patient did not need it as by that time, literally only about 4 minutes into this episode, the patient's body was beginning to calm down and was totally fine over after 30 minutes. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events slight tingling and very mild numbing sensation, warming up and the sensation progressed to the left side of face, shaking uncontrollably, muscles became incredibly weak and panic attack were resolved on 08May2021 at 17:35. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1713088
Sex: F
Age:
State: OH

Vax Date: 04/20/2021
Onset Date: 04/20/2021
Rec V Date: 09/18/2021
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: flu like symptoms for 3-4 days; nurse a 9 month old; nurse a 9 month old; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number was unknown), via an unspecified route of administration in the right arm on 20Apr2021 at 15:45 as dose 2, single for COVID-19 immunisation (at the age of 29-year-old). The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any medication within two weeks of the COVID vaccine. The patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number was unknown), via an unspecified route of administration and location on 30Mar2021 at 15:45 as dose 1, single for COVID-19 immunisation (at the age of 29-year-old). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was breastfeeding a 9-month-old male fetus and the baby ingested some of her blood due to latch issues at the time of vaccination. On 21Apr2021 at 04:00, the patient experienced "flu like symptoms for 3-4 days". The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the event flu like symptoms was recovered (reported with a duration of 3-4 days) on an unknown date in Apr2021. The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1713089
Sex: F
Age:
State: TX

Vax Date: 05/19/2021
Onset Date:
Rec V Date: 09/18/2021
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: blood clot disorder; This is a spontaneous report received from contactable consumer, the patient via Medical Information from Pfizer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 19May2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced blood clot disorder. She was not asked about this on the 1st dose. The outcome of the event 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: 1713090
Sex: M
Age:
State: CO

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: I am having trouble breathing and feel like my lungs do not hold as much air and retain as much oxygen.; This is a spontaneous report from a contactable consumer (Other HCP, patient). A 23-year-old male patient (age at vaccination: 23 years) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on an unspecified date, as a single dose for COVID-19 immunization and 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 at nursing home/senior living facility. The patient's medical history included Tourette s syndrome and sleep apnea. Concomitant medications were not reported. The patient did not have known allergies. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that he was having trouble breathing and feel like my lungs do not hold as much air and retain as much oxygen on an unspecified date. There was no hospitalization prolonged. The adverse event result in emergency room/department or urgent care. It was unknown if the patient received treatment. Outcome of the event was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1713091
Sex: F
Age:
State: TX

Vax Date: 02/26/2021
Onset Date: 02/28/2021
Rec V Date: 09/18/2021
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: erythema was seen around site of vaccination.; swelling; pruritus; bruising; erythema; This is a spontaneous report from a contactable physician. A adult female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if the patient was pregnant. On 28Feb2021, the patient experienced erythema, swelling, pruritus. The patient was presented 45-60 days later to clinic with persistent pruritus in upper extremities and around the knee and inner thigh. Erythema was seen around site of vaccination. Bruising and erythema were in other locations as well. The physician was unsure if it was from the vaccine or resultant scratching due to pruritus. Therapeutic measures were taken as a result of erythema, swelling, pruritus and bruising and included treatment with loratidine (MANUFACTURER UNKNOWN) and topical steroids (MANUFACTURER UNKNOWN). The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcomes of the events erythema, swelling, pruritus, erythema was seen around site of vaccination and bruising in other locations as well was unknown at the time of reporting. The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up Follow up (16Sep2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1713092
Sex: M
Age:
State: MN

Vax Date: 05/19/2021
Onset Date: 05/19/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:101.5 degree Fahrenheit

Allergies:

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

Symptoms: headache; chills; Fatigue; sleepless night; 101.5 degree fever; weak; flu like feeling; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19May2021 15:00 (at the age of 49-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid prior vaccination from an unknown date and unknown if ongoing. There were no concomitant medications. Patient previously took first dose of bnt162b2 (Batch/Lot number was not reported) administered in Left arm on28Apr2021 03:00 PM (at the age of 49-years-old) for covid-19 immunisation and patient experienced chills, headache, was lethargic which lasted 24 hours. Patient previously had Covid in late October and also recently had an antibody test that was positive for short term and long term antibodies in Apr2021 prior to the Pfizer vaccines. The second vaccines effects were much greater and patient had headache, chills, fatigue, sleepless night, 101.5 degree fever, weak, flu like feeling, all events on 19May2021, lasted 36 hours. Patient did not receive any treatment for adverse events. The patient had not received any other vaccine within 4 weeks and other medications in two weeks. Patient had not been tested since the vaccination. Patient did not have any known allergies. It was reported that Pfizer needed to study whether or not those who had Covid and still had antibodies need two vaccines. Seems like the guidance was one size fits all and was not make sense. Could it be studied as to whether one dose was adequate for those that have had Covid. Reporter felt worse from the vaccine each time then when he did have Covid. Outcome of all events were recovered on an unspecified date in 2021. The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1713093
Sex: F
Age:
State: UT

Vax Date: 05/10/2021
Onset Date: 05/01/2021
Rec V Date: 09/18/2021
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: administration date: 26Apr2021, dose number: 1/ administration date: 10May2021, dose number: 2; Rash showed up on face 8 days after dose #2; Body aches began the day after dose #2.; The day after receiving dose #2 of the vaccine Headache began and lasted over a week; shingles; One week after receiving dose #2 skin sensitivity on face began; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received bnt162b2, second single dose via an unspecified route of administration, administered in Arm Left on 10May2021 10:30 (Batch/Lot number was not reported) for covid-19 immunisation at age of 35-year-old. The patient previously received first dose of bnt162b2 26Apr2021 at 10:30 for COVID-19 Immunization on arm Left at age of 35-year-old. The patient's medical history was not reported. Concomitant medications were none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The day after receiving second dose of the vaccine headache began on 10May2021 and lasted over a week. Body aches began the day after second dose on 11May2021. One week after receiving second dose skin sensitivity on face began in May2021. Rash showed up on face 8 days after second dose in 18May2021. Regulatory Authority visit on 21May2021 confirmed shingles. The events as resulted in emergency room/department or urgent care. The patient received Antiviral medication as treatment. The outcome of event headache was recovered in May2021 (duration: 1 week), outcome of the other events was not recovered. 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 completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1713094
Sex: F
Age:
State: AZ

Vax Date: 05/21/2021
Onset Date: 05/22/2021
Rec V Date: 09/18/2021
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: Upper lip swelling; Upper lip swelling and numbness; This is a spontaneous case received from a contactable other healthcare professional. A 44-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration on 21May2021 (age at vaccination 44-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included hypertension and supraventricular tachycardia. The patient was allergic to penicillin and sulfa drugs and the patient previously took amoxicillin and experienced allergy. Concomitant medications include CARVEDILOL, LISINOPRIL and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22May2021, the patient experienced upper lip swelling and numbness. These events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of these events. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information was expected.

Other Meds: CARVEDILOL; LISINOPRIL; LO LOESTRIN FE

Current Illness:

ID: 1713095
Sex: M
Age:
State: CT

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Fever; Chills; Pain in the muscle and joints; Pain in the muscle and joints; Had continued fatigue for the two following weeks; This is a spontaneous report from a contactable consumer. A 34-years-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 05May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. On 05May2021, 12 hours after injection of the second dose of the vaccine, the patient experienced fever and chills, along with pain in the muscle and joints. He took paracetamol (TYLENOL) to reduce the fever. The patient had continued fatigue for the two following weeks. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of fever which included treatment with paracetamol (TYLENOL) (self-administered) to reduce the fever. The outcome of the events was recovered on an unspecified date of May2021. The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1713096
Sex: F
Age:
State: NE

Vax Date: 05/22/2021
Onset Date: 05/23/2021
Rec V Date: 09/18/2021
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: loss of taste; short of breath; body aches; loss of appetite; Night sweats; burning muscles; tired; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non-pregnant female patient received bnt162b2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on 22May2021 at 13:15 (at the age of 48-year-old) in right arm as dose number unknown, single for covid-19 immunisation. The patient medical history included COVID long hauler, ptsd, shoulder surgery in November and COVID-19. Concomitant medication(s) included vitamin d nos (VITAMIN D NOS); vitamin b [vitamin b nos] (VITAMIN B [VITAMIN B NOS]); calcium (CALCIUM); duloxetine (DULOXETINE); alprazolam (XANAX) and multi vit (MANUFACTURER UNKNOWN) taken for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID prior vaccination, the patient was diagnosed with COVID-19. Not tested for COVID post vaccination. On 23May2021 02:00, the patient experienced night sweats, body aches/burning muscles, tired, loss of appetite, short of breath and loss of taste. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the events. The clinical outcome of the events were not recovered. Follow-up activities closed. Batch/lot number not available for [Vaccine, BNT162B2].

Other Meds: VITAMIN D NOS; VITAMIN B [VITAMIN B NOS]; CALCIUM; DULOXETINE; XANAX

Current Illness:

ID: 1713097
Sex: F
Age:
State:

Vax Date: 04/10/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: tender swollen lymph node in her armpit; This is a spontaneous report from a contactable consumer. This consumer reported for a 17-year-old female patient (Daughter). A 17-year-old old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: unknown), via unknown route of administration on 10Apr2021 (at the age of 17 years old), DOSE 1 SINGLE for covid-19 immunisation. The patient did not have Known allergies and other medical history. The concomitant medication of the patient was not reported. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient experienced a very tender swollen lymph node in her neck (same side as the shot) beginning a day or two after the first vaccine. The patient did not teste for COVID post vaccination. At the time of this report the outcome of the event was unknown. Information on the lot/batch number had been requested.

Other Meds:

Current Illness:

ID: 1713098
Sex: F
Age:
State: PA

Vax Date: 05/22/2021
Onset Date: 05/22/2021
Rec V Date: 09/18/2021
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: Swollen lips; Tingly lips; Scratchy throat; Dizzy; Vomiting; Headache; This is a spontaneous report from a contactable consumer (patient). A 14-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiry date: not reported, at the age of 14-year-old), dose 1 via an unspecified route of administration, administered in left arm on 22May2021 17:15 as dose 1, single for covid-19 immunisation. The patient previously took penicillin and experienced penicillin allergy. Concomitant medication was none. The patient did not receive any other mediations in two weeks of vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22May2021 19:00, the patient experienced swollen lips, tingly lips, scratchy throat, dizzy, vomiting, headache. Therapeutic measures were taken as a result of reported events which included treatment with benadryl and other unspecified over the counter medications (OTC) from an unspecified date in May2021 and unknown if ongoing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of events was recovering. The lot number for BNT162b2, was not provided and will be requested during follow up. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1713099
Sex: F
Age:
State: MA

Vax Date: 05/18/2021
Onset Date: 05/20/2021
Rec V Date: 09/18/2021
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: Rash developed 2 days after vaccine. rash was on legs only (and NOT at site of injection); This is a spontaneous report from a contactable consumer (patient). A 12-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown, Expiry Date: Not Reported), via an unspecified route of administration in the left arm on 18May2021 at 18:00 (at the age of 12 years) as dose number unknown single for COVID-19 immunisation. The patient was allergic to pecans, walnuts, hazelnuts. The patient had no known concomitant medications. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other medications within two weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20May2021, patient experienced rash which developed 2 days after vaccine, rash was on legs only (and NOT at site of injection). The rash was not clearly associated with vaccine, but patient thought worth reporting, given that patient don't have another explanation for the rash. It resolved after 2 days. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken for the reported events. Outcome of the events were recovered on 22May2021. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1713100
Sex: F
Age:
State: OR

Vax Date: 05/17/2021
Onset Date: 05/18/2021
Rec V Date: 09/18/2021
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: Fever began early afternoon day after vaccine; Sweats; Shortness of breathe/labored breathing; Tight chest; Chills; Sore arm morning after vaccine; Nausea began in late morning the day after vaccine; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: unknown) via an unspecified route of administration in the left arm on 17May2021 at 17:00 (at the age of 34-year-old) as a dose number unknown, single for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), migraines, allergies, chronic stomach issues/irritable bowel syndrome (IBS) symptoms and possible allergy to latex. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received any other vaccines within four weeks prior to the vaccination. On 18May2021, the patient experienced sore arm morning after vaccine (Tuesday), nausea began in late morning the day after vaccine (Tuesday), fever began early afternoon day after vaccine (Tuesday at 15:00), chills, sweats, nausea persisted consistently for about 36 hours (through Thurs morning), fever broke but chills and nausea continued for remainder of day (Thursday). Tight chest/labored breathing when laying down to sleep for Tuesday and Thursday nights and still experiencing much quicker shortness of breath. Therapeutic measures were not taken as a result of these events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever was recovered on an unknown date in May2021. The clinical outcome of the events sore arm morning after vaccine, nausea, chills, sweats, tight chest, shortness of breathe/labored breathing was recovering at the time of this report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: IBUPROFEN

Current Illness:

ID: 1713101
Sex: M
Age:
State: CA

Vax Date: 04/08/2021
Onset Date: 04/09/2021
Rec V Date: 09/18/2021
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: Tender left clavicular lymphadenopathy; fatigued (mild)/significant fatigue; sore deltoid/Myalgias (mild); This is a spontaneous report from a contactable other health professional (patient himself). A 51-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8737) via an unspecified route of administration in left arm on 08Apr2021 16:30 as dose 1, single (at the age of 51-years-old) for COVID-19 immunization. Patient was not diagnosed with COVID-19, prior to vaccination. Patient had not been tested for COVID-19, since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient medical history included as hypertension. He had no covid prior vaccination. There were no known allergies. The concomitant medications included lisinopril from an unspecified date in 2001 (at a dose of 5mg for 20 years). The patient stated that he had a sore deltoid on Friday (09Apr2021), he was fatigued (mild) and had myalgia (mild) on Sunday (11Apr2021) and he had significant fatigue, myalgia and tender left clavicular lymphadenopathy on Monday (12Apr2021). He did not work on Monday. The symptoms of severe fatigue and myalgia improved by 13Apr2021 and resolved by 14Apr2021. The tender lymphadenopathy persisted until 28Apr2021. He did not receive treatment for adverse events. Patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8735) via an unspecified route of administration in left arm on 30Apr2021 as dose 2, single for COVID-19 immunization. He experienced severe fatigue, myalgia and headache with fever and occasional rigors with recurrence of tender lymphadenopathy of the left clavicular area and tinnitus with the second dose of vaccination. The outcome of events fatigue and sore deltoid/myalgia was resolved on 14Apr2021 and outcome of event tender left clavicular lymphadenopathy was resolved on 28Apr2021. Follow-up attempts were completed. No further information was expected.

Other Meds: LISINOPRIL

Current Illness:

ID: 1713102
Sex: F
Age:
State: NY

Vax Date: 05/21/2021
Onset Date: 05/21/2021
Rec V Date: 09/18/2021
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: Side effect for the 2nd shot: Slight singles; headache for 1 day; tiredness; vomit; nausea; funny stomach; no appetite for the first two days; sleepy; This is a spontaneous report from a non-contactable consumer. This 39-year-old female consumer (patient) reported that. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186), dose 2 via an unspecified route of administration, administered in Arm Left on 21May2021 16:30 as (At the age of 39-years) dose 2, single for covid-19 immunisation. Medical history included Polycystic ovary syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No Other medications in two weeks. No Known allergies ware reported. Patient did not test covid post vaccination. It was Unknown if patient had covid prior vaccination. The patient previously took first dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0175), dose 1 via an unspecified route of administration, administered in Left arm on 30Apr2021 06:30 PM as At the age of 39-years dose 1, single for covid-19 immunisation and experienced muscle pain on left arm, tiredness, and extreme period cramps on 1st day. The patient experienced Side effect for the 2nd shot Slight singles, headache for 1 day, tiredness, vomit, nausea, funny stomach, no appetite for the first two days, sleepy on 21May2021 18:45. Patient did not receive any other treatment for events. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1713103
Sex: U
Age:
State: NJ

Vax Date: 03/29/2021
Onset Date: 04/07/2021
Rec V Date: 09/18/2021
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: people who have received the Pfizer Covid vaccine having shingles after the dose/Shingles on left arm, lasted 10 days; The initial case was missing the following minimum criteria: unspecified number of patients. Upon receipt of follow-up information on 02Aug2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 81-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration of left arm on 29Mar2021 14:00 (Batch Number: ER8727, Lot Number EN6205) DOSE 2, SINGLE for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration of left arm on 06Mar2021 13:00 as DOSE 1, SINGLE for covid-19 immunisation. Caller was a patient who was calling to ask if the Pfizer covid vaccine causes shingles, because she has been experiencing side effects since receiving the vaccine on 29Mar2021, and since April developed shingles and continued pain to injection site. Caller stated that she wants to ensure that it gets reported since information has been found online of other people who have received the Pfizer Covid vaccine having shingles after the dose. Shingles on left arm, lasted 10 days. Began on 07Apr2021 after pain in left arm for a few months. Patient visited physician office. Therapeutic measures were taken as a result of shingles. The patient received treatment Famciclovir 500 Mg 3perday x 7days. The outcome of the event was recovering. Follow-up attempts completed. No further information expected.; Sender's Comments: Shingles on left arm, lasted 10 days. Began on 07Apr2021 after pain in left arm for a few months.

Other Meds:

Current Illness:

ID: 1713104
Sex: F
Age:
State: MI

Vax Date: 04/09/2021
Onset Date: 05/24/2021
Rec V Date: 09/18/2021
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: an outbreak of Shingles; an outbreak of Shingles; This is a spontaneous report from a contactable consumer (Patient). A non-pregnant female patient 63-year-old received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 13:15 (at the age of 63-year-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Patient had no known allergies. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (Batch/Lot Number: EN6207) dose 1 via an unspecified route of administration, administered in Arm right on 18Mar2021 at 13:15 (at the age of 63-year-old) as dose 1, single for covid-19 immunisation and experienced 3 outbreaks of genital herpes. The patient experienced an outbreak of shingles on 24May2021 at 16:00. Therapeutic measures were taken as a result of an outbreak of shingles. Treatment drug included 1 gm Valacyclovir per day. The patient received no other vaccine in four weeks. The patient reported that she had Shingrix shots on 14Sep and 13Nov2020. She was also on a suppressive dose 1g per day of Valacyclovir and the Shingles still broke through. She was getting very concerned about this. The only change in her lifestyle was the 2 covid shots. Patient was not covid prior vaccination. Patient did not test covid post vaccination.The outcome of the events were not recovered. No follow up attempts are possible. No further information expected.

Other Meds:

Current Illness:

ID: 1713105
Sex: F
Age:
State: NC

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Why was the patient taking Pfizer covid vaccine (Verbatim): The caller was 84 and has had difficulties maintaining weight and appetite.; Why was the patient taking Pfizer covid vaccine (Verbatim): The caller was 84 and has had difficulties maintaining weight and appetite.; mild case of shingles; This is a spontaneous report from a contactable other healthcare professional. A 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date (at the age of 87-years-old) in Right Arm as dose 2, single for COVID-19 immunization. The patient medical history included colitis microscopic from an unknown date and unknown if ongoing Verbatim: microscopic colitis/Diagnosed about 5 years ago. The patient concomitant medication included budesonide (BUDESONIDE) taken for colitis microscopic, start and stop date were not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 19Feb2021 (at the age of 87-years-old) in Left Arm as dose 1, single for COVID-19 immunization. Reason for no lot number of Pfizer covid vaccine is the caller does not have her vaccination card. why was the patient taking pfizer covid vaccine (verbatim): the caller was 84 and has had difficulties maintaining weight and appetite, On unspecified date, the caller had a side effect after Pfizer covid vaccine. The caller developed a mild case of shingles in less than a week or 10 days after the second dose of the Pfizer covid vaccine, her doctor has the exact date. The caller has had the two dose shingles vaccine within the last 2 years. The caller got the first shingles vaccine after it came out over 10 years ago. The caller went to the doctor and got an anti-viral for the mild case of shingles. Pfizer covid vaccine: mild case of shingles related and not serious. Caller states event happened after the second dose of the Pfizer covid vaccine. The shingle blisters were on the one side under the shoulder blade. The shingles were relieved with hydrocortisone and the anti-virals that were prescribed. The shingles lasted about 10 days at the most. Once the caller started the anti-viral prescription, the shingles weren't as bad as a sunburn. Has Pfizer had anyone else call in with shingles post covid vaccine? The Patient received treatment for shingles with hydrocortisone and the anti-virals that was prescribed. The outcome for the event shingles was recovered. Description of Product Complaint: The caller had a side effect after Pfizer covid vaccine. The caller developed a mild case of shingles in less than a week or 10 days after the second dose of the Pfizer covid vaccine, her doctor has the exact date. The caller has had the two dose shingles vaccine within the last 2 years. The caller got the first shingles vaccine after it came out over 10 years ago. Shingles vaccine lot, NDC, and expiration date not probed as it is not a Pfizer product. No follow-up attempts are needed. No further information is expected. Follow-up (01Jul2021): Follow-up attempts completed. No further information expected.

Other Meds: BUDESONIDE

Current Illness:

ID: 1713106
Sex: M
Age:
State:

Vax Date: 05/20/2021
Onset Date: 05/21/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Pain and itching on right lower chest, under right arm and radiating into middle back followed by a rash (vesicles with a red base); Pain and itching on right lower chest, under right arm and radiating into middle back followed by a rash (vesicles with a red base); Pain and itching on right lower chest, under right arm and radiating into middle back followed by a rash (vesicles with a red base); Pain and itching on right lower chest, under right arm and radiating into middle back followed by a rash (vesicles with a red base); Pain and itching on right lower chest, under right arm and radiating into middle back followed by a rash (vesicles with a red base); My wife who is a doctor has said is definitely shingles; This is a spontaneous report from a contactable consumer (patient). A 39-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0177, Expiry Date: not reported) via an unspecified route of administration, administered in arm left on 20May2021 at 18:00 (age at vaccination 39-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0175, Expiry date: not reported) via an unspecified route of administration, administered in arm left on 29Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination, patient had not been diagnosed with COVID-19 prior and had not been tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 21May2021 at 19:00, the patient experienced pain and itching on right lower chest, under right arm and radiating into middle back followed by a rash (vesicles with a red base) that my wife who was a doctor has said is definitely shingles. The patient did not receive treatment for the adverse event. The patient was not hospitalised for the events. The outcome of events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1713107
Sex: F
Age:
State: GA

Vax Date: 04/19/2021
Onset Date:
Rec V Date: 09/18/2021
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: Could not function correctly; Headache; body aches; Chills; swelling pain; This is a spontaneous report from a contactable consumer or other non hcp. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration in left arm on 19Apr2021 11:30 as dose 1, single for COVID-19 immunization (at the age of 44-year-old). The patient's medical history and concomitant medications were not reported. Family medical history relevant to AE(s) was none. Prior vaccinations within 4 weeks and AE(s) following prior vaccinations was none. Additional vaccines administered on same date of the Pfizer Suspect was none. The patient could not function correctly, headache, body aches, chills and swelling pain on an unspecified date. Event could not function correctly, body aches, swelling, pain was reported as worsened. Patient explained that her headache came and went when she was in pain. Her body aches and was swollen. Pain was all over the body on the right side. Adverse events did not require visit to emergency room and required physician office visit. Patient went to first care where she was given an antibiotic and nerve pain medicine. These were Diclofenac 75 mg, Prednisone 20mg, Valacyclovir 1gm and Gabapentin 300mg as a treatment for events. The outcome of the events was not recovered. Follow up needed, further information has been requested. No follow-up attempts are completed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1713108
Sex: F
Age:
State:

Vax Date: 07/30/2020
Onset Date:
Rec V Date: 09/18/2021
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: problems with rheumatoid arthritis during bad weather; tired; Inflammation; Itching all over; pain in joints at times; body aches/ pain; diarrhea; cold symptoms; Sinus infection; Vaccination site pain; Pain stomach; This is a non-interventional study report from the marketing program received from a non-contactable consumer and a physician based on information received by Pfizer (manufacturer control number: 21K-163-3847510-00) that: A 55-year-old female consumer (patient) received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), dose 1 intramuscular on 01May2021 (Batch/Lot number was not reported) at the age of 55-year-old as DOSE 1, SINGLE, dose 2 intramuscular on 07Jun2021 (also reported as on 07Jul2021, pending clarification) (Batch/Lot number was not reported) at the age of 55-year-old as DOSE 2, SINGLE for covid-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from 30Jul2020 (Batch/Lot number was not reported) to an unspecified date, at 40 mg, weekly for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. On an unknown date she was tired, had inflammation, itchy all over, after taking covid-19 vaccine, pain in joints at times, during cold weather, body aches/pain, diarrhea, cold symptoms and sinus infection. Upon follow up (09Jul2021) & (06Aug2021) the patient experienced Vaccination site pain and pain in stomach on an unknown date. The patient was treated with Vitamin C. Solicited report from the USA by a consumer of an adult female with events of non-serious leaking HUMIRA pen in Mar2021 and problems with rheumatoid arthritis during bad weather with HUMIRA (adalimumab). There was no reported medical history. On unknown dates, the patient experienced leaking HUMIRA pen and problems with rheumatoid arthritis during bad weather. Pfizer Biontech Covid-19 Vaccine (TOZINAMERAN)) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01May2021, she received first dose COVID-19 Vaccine manufactured by Pfizer. On 07Jun2021, she received second dose COVID-19 Vaccine manufactured by Pfizer. The action taken for adalimumab was unknown. The outcome of inflammation was recovering and other events it was unknown. The reporter causality between bnt162b2 and events for tiredness, Itching all over, General body pain, Diarrhea, Cold symptoms, Sinus infection were not reported, for Inflammation, Painful joints as no reasonable possibility, for Rheumatoid arthritis was possible. No follow-up attempts are possible. No further information is expected. Follow up(09Jul2021 and 06Aug2021): New information received from the same consumer (Patient) includes: Suspect (BNT162B2) dosage regime was added, New events added (Vaccination site pain and pain in stomach), Event outcome for Inflammation was updated to recovering from unknown, causality and clinical course was updated.' The reporter causality between bnt162b2 and events for tiredness, Itching all over, General body pain, Diarrhea, Cold symptoms, Sinus infection were not reported, for Inflammation, Painful joints as no reasonable possibility. No follow-up attempts are possible. No further information is expected. Follow-up (01Sep2021): New information received from a contactable consumer based on the information received by Pfizer (Manufacturer Control No: 21K-163-4051133-00) included: Vaccine information, new events (rheumatoid arthritis) and event details, reporter's causality assessment for event rheumatoid arthritis. Causality as per reporter (Drug/Vaccine) of Adalimumab for device leakage was not reported, for Rheumatoid arthritis was no Reasonable possibility. Causality as per reporter (Drug/Vaccine) of Pfizer Biontech Covid-19 Vaccine for device leakage not reported, for Rheumatoid arthritis was possible. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained. No further information is expected.; Sender's Comments: Based on the limited information in the case report, a possible causal relationship between events rheumatoid arthritis, fatigue,inflammation,pruritus,arthralgia,pain,diarrhoea,nasopharyngitis,sinusitis, vaccination site pain, and upper abdominal pain and suspect product BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1713109
Sex: U
Age:
State: MI

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Shingles; This is a spontaneous report from a Pfizer-sponsored Program Pfizer from a Contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. the patient previously received first dose of BNT162B2 (solution for injection) on an unspecified date as single dose for COVID-19 immunisation. The patient reported that the chest and back covering case of Shingles received after the second dose of the Covid Vaccine on an unspecified date. No doubt scaring patient for life. If patient knew that this was Even a Possibility, patient Never would have gotten their vaccine. Patient telling everyone to Avoid their Poison injections. The outcome of the events was reported as unknown. Information about Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1713110
Sex: M
Age:
State: TX

Vax Date: 05/12/2021
Onset Date: 05/14/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Skin rash near injection site; Severe migraines; This is a spontaneous report from a contactable consumer or other non hcp. A 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0178) via an unspecified route of administration in Arm Left on 12May2021 (age at vaccination 31 years old) as single dose for covid-19 immunisation. Medical history included no from an unknown date and unknown if ongoing. The patient did not have known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks and other medications in 2 weeks prior to the COVID vaccine. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0175) via an unspecified route of administration in Arm Left on 12May2021 (age at vaccination 31 years old) as single dose for covid-19 immunisation. There were no concomitant medications. Since the vaccination, the patient had not been tested positive for COVID-19. On 14May2021 the patient experienced skin rash near injection site, severe migraines. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1713111
Sex: F
Age:
State: MN

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 09/18/2021
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: Fatigue; Severe armpit; Edema; Muscle Aches; Chills; Diarrhea; Nausea; Right Arm pain; This is a spontaneous report from a contactable nurse. This 26-year-old female nurse (patient) reported that she (Weight :200 lb, Height :5' 8 in) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302), dose 2 via an intramuscular route of administration on 21Jan2021 at 15:45 in right arm (at the age of 26 years-old) as DOSE 2, SINGLE for covid-19 immunisation. Vaccine facility type was reported as hospital. Vaccine was not administered at the facility. Patient's medical history included Covid-19 contracted. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2, Lot number; EJ1685 via an intramuscular route of administration on 30Dec2020 at 15:45 at right arm (at the age of 26 years-old) for covid-19 immunisation. Adverse event after the first dose was Fatigue, muscle aches, R arm pain, nausea, diarrhea, fever, chills, cough. There were no relevant tests performed. None culture tests were performed. Predisposing factors included Covid-19 contracted in Aug2020. Antipyretic use included XS Tylenol with Ibuprofen orally on 23Jan2021 after vaccination with onset of symptoms. Patient was not admitted in the hospital. On 22Jan2021 at 15:00, patients experienced fatigue, severe armpit, edema, muscle aches, chills, diarhea, nausea, right arm pain. Causal relationship was provided as yes, serious or life threatening events : no. Patient was not deceased. No treatment was required for the events. No AEs required a visit to emergency room or physician's office. The outcome of events was recovered on 24Jan2021.

Other Meds:

Current Illness:

ID: 1713112
Sex: F
Age:
State: OH

Vax Date: 05/25/2021
Onset Date: 06/04/2021
Rec V Date: 09/18/2021
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: Left side swollen lymph nodes; total of three Shingles on set just started meds; This is a spontaneous report from a contactable other hcp. A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 25May2021 15:00 (at the age of 42 years) (Batch/Lot Number: Ew0168) as DOSE 2, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included thyroid, Diabetes Type 2 from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had known allergies to Penicillin, Sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 17:00 (Batch/Lot Number: Ee0171) as DOSE 1, SINGLE for covid-19 immunisation. 04Jun2021, the patient experienced, Left side swollen lymph nodes total of three Shingles on set just started me. The events resulted in visit to Physician office. The patient received treatment for the events. The clinical outcome of the events was unknown at the time of report. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1713113
Sex: F
Age:
State: MA

Vax Date: 03/22/2021
Onset Date: 03/27/2021
Rec V Date: 09/18/2021
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: Exacerbation of the tinnitus, with a new, louder sound in both ears; caused panic attacks; with tinnitus, the back of my neck has been stiff since the shot; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 10:00 (Lot Number: EN6204) as single dose (at the age of 31 years old) for COVID-19 immunisation. Medical history included tinnitus (I had very mild pre-existing tinnitus). There were no concomitant medications. The vaccine was administered at Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 20:00, the patient experienced exacerbation of the tinnitus, with a new, louder sound in both ears; caused panic attacks; with tinnitus, the back of my neck has been stiff since the shot. The outcome of the events was not recovered. The events required a visit to the emergency room and a visit to the physician's office. Therapeutic measures were taken as a result of the events included IV steroids, anxiolytics. The clinical course was reported as follows: "I had very mild pre-existing tinnitus. On 27Mar, five days after receiving the first shot, I noticed exacerbation of the tinnitus, with a new, louder sound in both ears. New tinnitus got worse for about a week. Tinnitus became so loud it severely interfered with my daily life, and caused panic attacks. Checked into the ER, received IV steroids, had no effect on the tinnitus. The volume started to go down after about 10 days from onset. Now, 2.5 months from the shot, I still have the new tinnitus, and while it seems to be slowly improving over time, healing is non-linear, with a lot of tinnitus spikes and variability in volume. Together with tinnitus, the back of my neck has been stiff since the shot. Consulted with PCP, the best explanation he gave me is neuroinflammation following an excessive immune response to the vaccine". Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1713114
Sex: F
Age:
State: PA

Vax Date: 06/04/2021
Onset Date: 06/04/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210604; Test Name: Fever; Result Unstructured Data: Test Result:102 dg; Comments: fever 102 degrees

Allergies:

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

Symptoms: diarrhea; felt very weak; felt very tired; got chills; fever 102 degrees on and off for 3 days; This is a spontaneous report from a contactable consumer(patient). A 15-years-old female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0217,Expiry date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 04Jun2021 01:15 as DOSE 2, SINGLE for covid-19 immunisation,(At the age of vaccination-15 years). Medical history included food allergy for an unspecified date and unknown if ongoing. Concomitant medication(s) included montelukast sodium taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0182,Expiry date was not reported) dose 1 via an unspecified route of administration, administered in left arm on 14May2021 at 1.00PM for covid-19 immunisation, amoxycillin and experienced drug hypersensitivity. On 04Jun2021 20:00 the patient experienced felt very tired, got chills, fever 102 degrees on and off for 3 days, And also on 05Jun2021 the patient experienced diarrhea, felt very weak. The patient underwent lab tests and procedures which included body temperature: 102 dg on 04Jun2021 fever 102 degrees. Patient received no treatment for the event. The patient had not received any other vaccine within 4 weeks. Patient received no treatment for the event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the event was recovered. Follow-Up (02Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds: SINGULAIR

Current Illness:

ID: 1713115
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Delayed period 45 days; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), left arm, on 26May2021, at dose 2, single and dose 1 single (lot number, expiration date was not reported), on an unspecified date; both via an unspecified route of administration (at the age of 28-years-old) for covid-19 immunization from doctor's office/urgent care. Medical history included covid-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient was not tested with covid-19 after the vaccination. The patient experienced delayed period of 45 days on an unspecified date. No treatment was administered for the event. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1713116
Sex: F
Age:
State: TX

Vax Date: 03/31/2021
Onset Date: 04/14/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: Blood work; Result Unstructured Data: Test Result:unknown results; Test Name: EKG; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptom List: Vomiting

Symptoms: Nausea; Fatigue; Tingling in left arm (both injections in left arm); Headache; Itchy skin all over but no rash; metallic taste in mouth; light headedness; Heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EP6955, expiration date was not reported) via an unspecified route of administration, in left arm, on 31Mar2021 15:45 (at the age of 61-years-old), at dose 2, single for covid-19 immunization. Medical history included GERD (gastroesophageal reflux disease)/acid reflux. The patient had no known allergies. Concomitant medications included dexlansoprazole (DEXILANT); simvastatin; zolpidem; sertraline hydrochloride (ZOLOFT); ibuprofen (ADVIL). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6204, expiration date was not reported) via an unspecified route of administration, in left arm, on 10Mar2021 16:00 (at the age of 61-years-old), at dose 1, single for covid-19 immunization. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. After three months (as reported) on 14Apr2021, the patient experienced nausea, fatigue, tingling in left arm (both injections in left arm), headache, itchy skin all over but no rash, metallic taste in mouth, light headedness, heart palpitations. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood test and EKG (electrocardiogram) with unknown results on an unspecified date. Therapeutic measures taken for the events included: blood work and EKG. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.

Other Meds: DEXILANT; SIMVASTATIN; ZOLPIDEM; ZOLOFT; ADVIL [IBUPROFEN]

Current Illness:

ID: 1713117
Sex: F
Age:
State:

Vax Date: 03/11/2021
Onset Date: 06/16/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: vomiting; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), dose 2 via an unspecified route of administration, on 11Mar2021 (at the age of 43-year-old), as dose 2, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single, for COVID-19 immunisation. The patient experienced vomiting on 16Jun2021. The outcome for the event 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: 1713118
Sex: F
Age:
State:

Vax Date: 05/27/2021
Onset Date:
Rec V Date: 09/18/2021
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: Pain in leg for a few days, burning sensation developed and rash; diagnosed with the shingles through a swab; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 27May2021 (at the age of 32-years-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took clarithromycin (MACROBID) and experienced allergy. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On an unspecified date, the patient experienced pain in leg for a few days, burning sensation developed and rash; diagnosed with the shingles through a swab. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included valacyclovir (VALTREX). Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1713119
Sex: F
Age:
State: NY

Vax Date: 06/13/2021
Onset Date: 06/13/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:1st fever 99.8; Test Name: fever; Result Unstructured Data: Test Result:second fever was 102.3

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Exhaustion; lack of appetite for 3 days pounding headaches; pounding headaches; light headedness; fevers 1st fever 99.8 second fever was 102.3; vomiting; seeing stars weakness; I could barely walk or move; This is a spontaneous report from a contactable consumer or other non hcp. A 30-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173), dose 2 via an unspecified route of administration, administered in Arm Left on 13Jun2021 at 08:15 (at the age of 30-years-old) as dose 2, single for covid-19 immunisation. Medical history included Tetrology of Fallot with pulmonary atresia and known allergies. Historical Vaccine included BNT162B2 (lot number: Ew0177) on 23May2021 at 08:15 AM (at the age of 30-years-old) as dose 1, for Covid-19 Immunisation. Patient received no other vaccine in four weeks. Other medications in two weeks was reported as yes. On 13Jun2021, the patient experienced exhaustion, lack of appetite for 3 days pounding headaches, pounding headaches, light headedness, fevers 1st fever 99.8 second fever was 102.3, vomiting, seeing stars weakness and i could barely walk or move. The patient underwent lab tests and procedures which included body temperature: 1st fever 99.8, body temperature: second fever was 102.3. Treatment drug included advil/Tylenol for the events and also included hot baths, sleep and cooling cloth. Patient was not covid prior vaccination. Patient did not test covid post vaccination. Outcome of the events were recovering. Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected. Follow-Up (04Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1713120
Sex: F
Age:
State: PA

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210421; Test Name: Nasal Swab; Test Result: Negative ; Comments: COVID test post vaccination: Nasal Swab COVID test name post vaccination: Don't nnow COVID test date: 21Apr2021 COVID test result: Negative

Allergies:

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

Symptoms: headaches; hot flashes; cramping; fatigue; 2 weeks after getting my second shot I got an unusually heavy period that last 2 weeks along with hot flashes, cramping, fatigue, and headaches. I got the Mirena IUD in Sept 2020 and hadn't had any pe; 2 weeks after getting my second shot I got an unusually heavy period that last 2 weeks along with hot flashes, cramping, fatigue, and headaches. I got the Mirena IUD in Sept 2020 and hadn't had any pe; Other vaccine same date vaccine date: 01Mar2021; This is a spontaneous report from a contactable consumer (patient). A 24-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204), via an unspecified route of administration in left arm on 01Mar2021 (at the age of 24-years-old) as DOSE 2, SINGLE for covid-19 immunisation and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: E N6204), via an unspecified route of administration in left arm on 01Mar2021 at 02:00 (at the age of 24-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The medical history included known allergy to Penicillin and Mirena IUD in Sep2020 and hadn't had any periods since then or had any after, birth control for 5 years and never had a surprise period like this. Patient's concomitant medications were not reported. Patient had no other vaccine in four weeks or no other medications in two weeks. On 05Apr2021, at 12:00, 2 weeks after getting second shot the patient experienced an unusually heavy period that last 2 weeks along with hot flashes, cramping, fatigue, and headaches. Patient stated I got the Mirena IUD in Sep2020 and hadn't had any periods since then or had any after. I never had a period that heavy or with those symptoms before. I had been on birth control for 5 years and never had a surprise period like that before. Patient had not covid prior vaccination and tested COVID tested post vaccination. The patient underwent lab tests and procedures which included Nasal swab resulted negative on 21Apr2021 COVID test post vaccination. The patient did not receive any treatment for events. The outcome of event were recovered on unspecified date on 2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1713121
Sex: M
Age:
State: CA

Vax Date: 06/09/2021
Onset Date: 06/12/2021
Rec V Date: 09/18/2021
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: Unable to see things normally; Vision seriously blurred; This is a spontaneous report from a contactable consumer. A 62-year-old male consumer (patient) received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 09Jun2021 16:00 as single dose for COVID-19 immunisation. Medical history included chronic bronchitis. There were no concomitant medications in 2 weeks. There was no other vaccine in four weeks. The patient previously took bnt162b2, dose 1, administered in left arm on 19May2021 at 04:00 PM for COVID-19 immunisation. The patient was not tested positive for COVID prior vaccination. The patient experienced vision seriously blurred and unable to see things normally; both after second dose of Pfizer vaccine on 12Jun2021 at 12:00 AM. Outcome of the events was not recovered. The patient was not tested positive for COVID post vaccination.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am