VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1631013
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: I got it and got a rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got vaccine and got a rash but the after effects sucked. No contact details were available.

Other Meds:

Current Illness:

ID: 1631014
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: going through shingles right now who had the vaccine./Suspected Vaccination Failure; going through shingles right now who had the vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient received the vaccine and was going through shingles at the time of reporting. The reporter said who knew, hoping it prevents a severe case. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.

Other Meds:

Current Illness:

ID: 1631015
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: sweating; allergic to all medications since; reaction of pins & needles; This case was reported by a consumer via interactive digital media and described the occurrence of sweating in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced sweating, drug allergy and pins and needles. On an unknown date, the outcome of the sweating and pins and needles were unknown and the outcome of the drug allergy was not recovered/not resolved. It was unknown if the reporter considered the sweating, drug allergy and pins and needles to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the consumer for himself/herself. The age at vaccination was not reported The patient reported that, he/she had the Shingles vaccine 3 years ago & his/her body has had a terrible reaction since, within 3 days the patient was sweating & have been allergic to all medications since. The patient also had a reaction of pins & needles over all his/her upper body. The patient reported that, he/she was never allergic to anything in entire life. now the patient was miserable.

Other Meds:

Current Illness:

ID: 1631016
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: rash where I got the injection; rash / spread more along the side of my arm every day; itching on my left arm; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site rash, rash and itchy rash. The patient was treated with loratadine (Claritine) and cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the injection site rash, rash and itchy rash were not recovered/not resolved. It was unknown if the reporter considered the injection site rash, rash and itchy rash to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination not reported. The patient got the Shingle shot and had skin rash where got the injection, It goes away after taking Claritin for a day then it comes back again on the day of reporting. It's been going since he/she got the vaccine shot but the rash seemed to spread more along the side of arm every day. The reporter woke up itching on left arm now. They gave no papers and said nothing else after getting vaccine. No follow up to see how he/she doing. The patient called clinic to see if it was normal and they told to put cortisone cream on it.

Other Meds:

Current Illness:

ID: 1631017
Sex: F
Age:
State:

Vax Date:
Onset Date: 09/01/2020
Rec V Date: 08/25/2021
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: Suspected Vaccination Failure; had shingles; terrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In September 2020, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were provided as follows: The patient was the reporter's mother. The age at vaccination was not reported. The patient received shingles vaccine and she had shingles since the end of September 2020. The patient was still in terrible pain. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.

Other Meds:

Current Illness:

ID: 1631018
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: inflammation; CFS; This case was reported by a consumer and described the occurrence of inflammation in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inflammation and chronic fatigue syndrome. On an unknown date, the outcome of the inflammation and chronic fatigue syndrome were not recovered/not resolved. It was unknown if the reporter considered the inflammation and chronic fatigue syndrome to be related to Shingrix. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination not reported. The patient received Shingrix shot and experienced inflammation and chronic fatigue syndrome. The patient said that he/she never got shingles.

Other Meds:

Current Illness:

ID: 1631019
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: Shingles vaccine, Shingles/ suspected vaccination failure; Loss of mobility, wheelchair; Stroke; Shingles; Incontinence; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included methylenetetrahydrofolate reductase gene mutation (MTHFR). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), immobile (serious criteria disability and GSK medically significant), stroke (serious criteria GSK medically significant), shingles and incontinence. On an unknown date, the outcome of the vaccination failure, immobile, stroke, shingles and incontinence were unknown. The reporter considered the vaccination failure, immobile, stroke, shingles and incontinence to be possibly related to Shingles vaccine. Additional details were reported as follows: The patient was reporter's uncle. The age at vaccination was not reported. The patient did not have shingles exposure before the shot. The patient got the new shingles vaccine. The reporter stated that the patient's vaccine injuries from that deadly shot were too numerous to mention included Shingles, stroke, loss of mobility (wheelchair), incontinence and much more. The reporter stated that the people with Methylenetetrahydrofolate reductase (MTHFR) should never be vaccinated. Polio, of course, and we did not have a booster for that. The reporter worked with Big Pharma and said he or she know them inside and out. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.

Other Meds:

Current Illness: Methylenetetrahydrofolate reductase gene mutation (MTHFR)

ID: 1631020
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: you can get shingles even when vacinated I have had this experience/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The reported stated that you could get shingles even when vaccinated. The reporter had this experience and it sure was not fun. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1631021
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: super ill; was that awful; This case was reported by a consumer via interactive digital media and described the occurrence of illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced illness and feeling bad. On an unknown date, the outcome of the illness and feeling bad were recovered/resolved. It was unknown if the reporter considered the illness and feeling bad to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient reported that vaccine made him/her super ill. The patient did not want to take the second shot but the nurse convinced him/her to take the shot. The patient said he/she would never had taken the shots if his/her body would react, it was awful. For tolerance of 2nd dose, refer case US2021AMR176100.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR176100:Same reporter

Other Meds:

Current Illness:

ID: 1631022
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: I got that shot and still got them/ suspected vaccination failure; still got them; try and stay out from under stress; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and stress. On an unknown date, the outcome of the vaccination failure, shingles and stress were unknown. It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got that shot and still got them. Doctor told, try and stay out from under stress which causes it. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1631023
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: Suspected Vaccination failure; shingles 2 times AFTER MY SHINGLES VACCINE; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had the shingles, before the 1st shingles shot). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient had shingles 4 times, once in between the 1st and 2nd shot of the vaccine and 2 times after his/her shingles vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided. For tolerance of 1st dose refer case US2021AMR176133.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR176133:Same reporter

Other Meds:

Current Illness:

ID: 1631024
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: suspected vaccination failure; got it 10 times worse; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The patient self reported the case. The age at vaccination was not reported. The patient got the vaccine and got shingles, 10 times worst. Therfore this patient was angry and called the vaccine is a lie. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.

Other Meds:

Current Illness:

ID: 1631025
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Suspected vaccination failure; shingles on my face; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The patient self reported the case. The age at vaccination was not reported. The patient got the vaccine and had shingles on face. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.

Other Meds:

Current Illness:

ID: 1631026
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The patient's husband reported the case. The age at vaccination was not reported. The patient got the shingles shot last year and went to doctor, the day before reporting day because she had the shingles. The patient was not happy. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.

Other Meds:

Current Illness:

ID: 1631027
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: got the shot, a couple of years later got shingles again; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The patient self reported the case. The age at vaccination was not reported. The patient stated, he/she got shingles, then got the shot and couple of years later got shingles again. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.

Other Meds:

Current Illness:

ID: 1631028
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: had shingles vaccinations and they still got it /Suspected Vaccination Failure; they still got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient's son or daughter. The age at vaccination was not reported. The reporter stated that, his or her father had shingles vaccination still had shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided. This case was linked with case US2021AMR176955, reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR176955:same reporter

Other Meds:

Current Illness:

ID: 1631029
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: got shingles after taking the vaccine /Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient's sister or brother. The age at vaccination was not reported. The reporter stated that, his or her sister had shingles vaccination still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1631030
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: I had the vaccination & then later got shingles/Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had the vaccination and then later got shingles, luckily had a very mild case. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1631031
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: Shingles. One before the shot and one after /Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles before vaccination, and was worst). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received the Shingles vaccine and had shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1631032
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had 1st episode on an unknown date). On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: The patient self reported the case. The age at vaccination was not reported. The patient had the vaccines 2 doses and it did not prevent me from getting Shingles. The patient added that, this was the 2nd time, he/she experienced shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.

Other Meds:

Current Illness:

ID: 1631033
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient received the Shingle shot and still got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1631034
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: I got my shot and ended up with the shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and ended up with the shingles. The patient said that, the shot did not keep you from getting the shingles and it keeps them from being so bad, but shingles were horrible and if you get them at all. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1631035
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: I got vaccinated /and got shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital and described the occurrence of suspected vaccination failure in a 55-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional case details were reported as follows: The patient reported case for himself or herself. The patient got vaccinated for shingles and got shingles when he or she was 55. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.

Other Meds:

Current Illness:

ID: 1631036
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: got the shot and got the shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient got the shot and 6 months later got the shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. This case has been linked with US2021AMR177114 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR177114:same reporter

Other Meds:

Current Illness:

ID: 1631037
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: it hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingle shot and it hurt but it was worth it.

Other Meds:

Current Illness:

ID: 1631038
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: had the vaccine, got shingles bad, a new better vaccine and he got them again / Suspected Vaccination failure; got shingles bad, got them again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included shingles (patient had it twice). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient had the vaccine, and got shingles bad. The physician informed him there was a new better vaccine and he got them again. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting The follow up was not required.

Other Meds:

Current Illness: Shingles (patient had it twice)

ID: 1631039
Sex: U
Age:
State:

Vax Date: 07/01/2021
Onset Date:
Rec V Date: 08/25/2021
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: shingles; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis. In July 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The patient had one shot 4 weeks before day of reporting. In 2021, patient had shingles. The patient enquired did this normal. The follow up was not required.

Other Meds:

Current Illness:

ID: 1631040
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: Got the shot still got shingles / Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The patient got the shot and still got shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.

Other Meds:

Current Illness:

ID: 1631041
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: I got it after getting the shingles vaccine / suspected vaccination failure; got it after shingles vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The patient got shingles after getting the shingles vaccine. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.

Other Meds:

Current Illness:

ID: 1631042
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: got the shingles after I got the shot / suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The patient got the shingles after he or she got the shot. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.

Other Meds:

Current Illness:

ID: 1631043
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: My friend got Shingles shot and got severe case of shingles / suspected vaccination failure; severe case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional case details were reported as follows: The reporter was patient's friend. The age at vaccination was not reported. The patient got Shingles shot and got severe case of shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.

Other Meds:

Current Illness:

ID: 1631044
Sex: M
Age:
State: IA

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: missed the Infanrix dose/ Use of Kinrix as the 4th DTaP; Wrong vacine administered/missed the Infanrix dose/Use of Kinrix as the 4th DTaP; This case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a child male patient who received DTPa-IPV (Kinrix) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Pediarix (received already the 3 doses of pediarix). On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and wrong vaccine administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The patient was 4 to 5 years of age. The nurse practitioner reported that, the patient received already the 3 doses of Pediarix and missed the Infanrix dose and probably would be administered Kinrix as 4th DTaP dose, which led to inappropriate schedule of vaccine administered and wrong vaccine administered. The reporter did not consent to follow up.

Other Meds: Kinrix Pre-Filled Syringe Device

Current Illness:

ID: 1631045
Sex: F
Age:
State: CA

Vax Date: 07/22/2021
Onset Date: 07/22/2021
Rec V Date: 08/25/2021
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: shingles; burning sensation on left hip; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 22nd July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 22nd July 2021, 3 hrs after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced shingles and burning sensation. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles and burning sensation were not recovered/not resolved. It was unknown if the reporter considered the shingles and burning sensation to be related to Shingrix. Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received 1st dose of Shingrix and right after experienced burning sensation on her left hip. The patient went to the health care professional who confirmed the case of shingles. The health care professional had started the patient on acyclovir treatment. The patient said that the shingles were not cleared up completely. The reporter did not consented to follow up. Note- there was discrepancy in the reported time to onset for the event burning sensation. In the event section of source document, TTO is provided as 3 hrs but in narrative it is mentioned as right after. However TTO for burning sensation and shingles captured as per structured field.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR175923:Vaccine case (Shingrix)

Other Meds:

Current Illness:

ID: 1631046
Sex: M
Age:
State: CA

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 08/25/2021
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: Customer received 3 doses of shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in December 2020) and Shingrix (2nd dose received in February 2021). In August 2021, the patient received the 3rd dose of Shingrix. In August 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional details were provided as follows: The age at vaccination was not reported. The registered pharmacist called on behalf of a customer who received 3 doses of shingrix at another pharmacy and was now concerned about his health, which led to extra dose administered. The health care professional also reported that the patient was not vaccinated at the pharmacy where the call was made. The reporter did not have the information since the patient received these doses at another pharmacy The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1631047
Sex: F
Age: 16
State: CA

Vax Date: 03/31/2020
Onset Date: 03/31/2020
Rec V Date: 08/25/2021
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: Bexsero after Trumemba dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA68AA, expiry date 30th October 2021) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis. On 31st March 2020, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and TRUMENBA. On 31st March 2020, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The medical assistant reported that, the patient received a dose of Trumemba followed by a dose of Bexsero, which led to overdose. The reporter consented to follow up. No product details on Trumemba dose. The case has been linked with the case US2020238766 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020238766:Same reporter

Other Meds:

Current Illness:

ID: 1631048
Sex: F
Age: 12
State: MI

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 08/25/2021
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: reconstituting Menveo with saline water; reconstituting Menveo with saline water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva5218, expiry date 30th April 2022) for prophylaxis. On 19th August 2021, the patient received Menveo. On 19th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were reported as follows: This case was reported by a nurse. The nurse reported that sterile water was used to reconstitute Menveo,which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consent to follow up.

Other Meds:

Current Illness:

ID: 1631049
Sex: M
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: lyophilized portion of Menveo reconstituted with the wrong diluent; lyophilized portion of Menveo reconstituted with the wrong diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The nurse reported that the patient was administered with lyophilized portion of Menveo that had been reconstituted with a diluent other than the liquid conjugate portion of vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Health care professional did not have any other details at time of call than gender and age of patient. The reporter consented to follow up. This case is linked with case US2021025190 and US2020177025, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021025190:Same reporter US-GLAXOSMITHKLINE-US2020177025:Same reporter

Other Meds:

Current Illness:

ID: 1631050
Sex: F
Age: 12
State: UT

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 08/25/2021
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: administration of Bexsero instead of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB298A, expiry date 30th June 2022) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. On 17th August 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: Health care professional reported administration of Bexsero instead of Menveo to a patient which led to wrong vaccine administered. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1631051
Sex: U
Age:
State:

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 08/25/2021
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: vaccine was given with a diluent other than what is provided with it; vaccine was given with a diluent other than what is provided with it; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis. On 20th August 2021, the patient received Hiberix. On 20th August 2021, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were reported as follows: The age at vaccination was not reported. Health care professional reported, Hiberix vaccine was given with a diluent (MMR diluent) other than what was provided with it, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1631052
Sex: U
Age:
State: MD

Vax Date:
Onset Date: 08/17/2021
Rec V Date: 08/25/2021
Hospital: Y

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: UNSPECIFIED ADVERSE EVENT; EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a patient of an unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, frequency time was 1 total administered on 17-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-AUG-2021, the patient had used expired vaccine (reporter stated that the patient administered vaccine at approximately 22:00, it was administered approximately 23 hours after the beyond use date 16-AUG-2021). On an unspecified date, the patient experienced unspecified adverse event, and was hospitalized (reported as for an unrelated issue, not related to the vaccine) for an unspecified number of days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unspecified adverse event and expired vaccine used was not reported. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and unspecified adverse event was not related. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210837798-covid-19 vaccine ad26.cov2.s-unspecified adverse event . This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1631053
Sex: M
Age:
State: OK

Vax Date:
Onset Date: 08/03/2021
Rec V Date: 08/25/2021
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: Coagulation factor V level; Result Unstructured Data: Negative.

Allergies:

Symptom List: Pain in extremity

Symptoms: TOOTH WAS NOW DEAD; PAIN ON UPPER MOLAR RIGHT SIDE; ONE VEIN WAS COMPLETELY BLOCKED AND THREE OTHER VEINS PARTIALLY BLOCKED; BLOOD CLOT; This spontaneous report received from a patient concerned a 60 year old white male of unknown ethnicity. The patient's weight was 193 pounds, and height was 73 inches. The patient's concurrent conditions included drinks alcohol, and was non smoker. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, 1 total administered at left deltoid around 12:00 in noon on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, the patient noticed red marking and pain on the right leg. On 05-AUG-2021, diminished the use of right leg and walk was affected. On 06-AUG-2021, patient went to emergency room and diagnosed with blood clot and one vein was completely blocked and three other veins partially blocked. As of 06-AUG-2021, the patient was started on Eliquis 20 mg per day for 7 days. On 11-AUG-2021, the patient begins to feel pain on upper molar right side, so patient went to dentist on 18-AUG-2021. The patient was informed that the tooth was now dead, may had been micro clot blocking of circulating. At the time of this report the patient was on Eliquis 10 mg daily and regimen will last for six months. On an unspecified date, patient underwent factor 5 genetic marker test which was negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tooth was now dead, and the outcome of blood clot in vein and one vein was completely blocked and three other veins partially blocked was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210838162- covid-19 vaccine ad26.cov2.s-blood clot, one vein was completely blocked and three other veins partially blocked, tooth was now dead. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness: Alcohol use (1 glass daily); Non-smoker.

ID: 1631054
Sex: F
Age:
State: WA

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Name: Grip strength; Result Unstructured Data: strong grip; Comments: grip tests on the left and right side.

Allergies:

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

Symptoms: SHOOTING PAINS IN LEFT LEG AND FOOT; FELT ACHY FROM HER NECK AND AT THE SCAPULAR REGION; FELT VERY WEAK; PERIPHERAL NEUROPATHY EXACERBATED; NOTALGIA PARESTHETICA; COULD BARELY WALK; BRAIN FOG; STIFFNESS ON LEFT SIDE; TENDERNESS ON HER LEFT SIDE; This spontaneous report was received from an 87-year-old, White (Caucasian), not Hispanic or Latino female patient. The patient's height, and weight were not reported. The patient's concurrent conditions included peripheral neuropathy, allergies to an extensive list of medications (unspecified), and sleeping problem (not specified). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1805029, and expiry: unknown) dose was not reported, 1 total, administered on right arm on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included diltiazem hydrochloride, spironolactone used for unknown indications; and zolpidem for an unspecified sleeping problem. On 13-MAR-2021, right after vaccination, the patient felt very weak, the left side of her body was very stiff and she felt achy which originated from her neck and at the scapular region. The patient could barely walk at that time and also experienced itchiness and brain fog. The patient also had tenderness on her left side and was tender to touch. She felt that the vaccine exacerbated her condition of peripheral neuropathy. On 31-MAR-2021, the patient visited her dermatologist who stated that the reason for chronic itching was due to notalgia paresthetica. On an unspecified date, grip tests were done. On an unspecified date, the patient saw her primary care physician (PCP) and neurologist and they both stated that the patient was pretty strong during her grip tests on the left and right side. The patient stated that the PCP and neurologist were not too concerned that the adverse event could be due to the vaccine and hence, she reported her symptoms via call. The patient stated that the itchiness and the tenderness on her left side had gone away. The patient felt better at the time of reporting however, she continued to experience residual stiffness on her left side and nerve discomfort. The patient stated that she still felt achy at times and that there was shooting pains in her left leg and foot that bothered her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from notalgia paresthetica, and tenderness on her left side, was recovering from stiffness on left side, peripheral neuropathy exacerbated, and felt achy from her neck and at the scapular region, had not recovered from shooting pains in left leg and foot, and the outcome of could barely walk, brain fog and felt very weak was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210838529-COVID-19 VACCINE AD26.COV2.S-peripheral neuropathy exacerbated. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.

Other Meds: Diltiazem HCL Exte-Rel; Spironolactone; Zolpidem

Current Illness: Drug allergy (The patient stated that she had an extensive list of allergies to medications but did not list them); Peripheral neuropathy; Sleep problem.

ID: 1631056
Sex: F
Age:
State: ME

Vax Date:
Onset Date: 08/19/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ACCIDENTAL EXPOSURE TO EYE (DOSE RESIDUE); SAFETY PROCESS HAVE BEEN DONE OUTSIDE THE ARM (ADMINISTRATION ERROR); MINOR REDNESS OF EYE; MINOR SWELLING OF EYE; This spontaneous report received from a pharmacist concerned a 59 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, and expiry: 21-OCT-2021) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-AUG-2021, the patient experienced accidental exposure to eye (dose residue). On 19-AUG-2021, the patient experienced safety process have been done outside the arm (administration error). On 19-AUG-2021, the patient experienced minor redness of eye. On 19-AUG-2021, the patient experienced minor swelling of eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from accidental exposure to eye (dose residue), and the outcome of minor redness of eye, minor swelling of eye and safety process have been done outside the arm (administration error) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631057
Sex: F
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: BLOOD CLOTS; This spontaneous report received from a consumer concerned multiple female patients of unknown race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose, start therapy date were not reported 1 total, administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the consumer mentioned that women were having blood clots from the covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210840534-Covid-19 vaccine ad26.cov2.s-Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1631058
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a patient via pharmaceutical company concerns a patient, sex, age, race, and ethnic origin not provided. The patient's height, weight, and medical history was not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced Guillain-Barre syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain-Barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient via pharmaceutical company concerns a patient of unknown age who experienced Guillain-Barre syndrome (GBS) unspecified time after vaccination. Patient past medical history , concomitant medications and concurrent medications were not reported. No other pertinent details reported. The information available precludes a complete and meaningful assessment . Information regarding other potential etiologies was insufficient, and the occurrence of GBS could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.

Other Meds:

Current Illness:

ID: 1631059
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Name: Rhesus antibodies; Result Unstructured Data: Positive, Blood appears to be Rh sensitized; Comments: A few weeks later after blood donation, the patient received notification as blood appears to be rH sensitized.

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: NO LONGER ABLE TO DONATE BLOOD BECAUSE IT APPEARS TO BE RH SENSITIZED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Due to the rarity of A- blood type patient donates blood regularly. Patient had never been pregnant nor had a blood transfusion before vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced no longer able to donate blood because it appears to be rh sensitized. Laboratory data (dates unspecified) included: Rhesus antibodies (NR: not provided) Positive, Blood appears to be Rh sensitized. The action taken with covid-19 vaccine was not applicable. The outcome of no longer able to donate blood because it appears to be rh sensitized was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631060
Sex: U
Age:
State: NY

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Date: 202104; Test Name: COVID-19 virus test; Result Unstructured Data: Positive

Allergies:

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

Symptoms: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631061
Sex: F
Age:
State: MD

Vax Date:
Onset Date: 08/02/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Date: 20210514; Test Name: SARS-CoV-2 ELISA test; Result Unstructured Data: 25.3; Test Date: 20210802; Test Name: SARS-CoV-2 IgA antibody test; Result Unstructured Data: 0.13; Test Date: 20210802; Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: 0.13.

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 60 year old white and non Hispanic or Latino female. The patient's weight was 118 pounds, and height was 62 inches. The patient's concurrent conditions included: primary immunodeficiency along with 3 to 4 other autoimmune diseases, dog allergy, cat allergy, and iodine allergy, and other pre-existing medical conditions included that he patient had allergy to various medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, the patient tested positive for the Protein receptor binding domain (antibody) test (SARS-CoV-2 ELISA (Enzyme linked Immunoassay) test) (NR: not provided) 25.3. On 02-AUG-2021, the patient tested negative for SARS CoV-2 s1 IgA (Immunoglobulin A) IgG (Immunoglobulin G) test (SARS-CoV-2 IgA antibody test) (SARS-CoV-2 IgG antibody test) (NR: not provided) 0.13 (confirmed immunological vaccine failure). The patient visited to the physician office. The immunologist suggested for a second shot of the Janssen Covid-19 (Corona virus) Vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210842932-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness: Allergy to animals; Immunodeficiency; Iodine allergy.

ID: 1631062
Sex: M
Age:
State: OK

Vax Date:
Onset Date: 08/20/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: PUNCTURED VIAL ADMINISTERED AFTER HALF AN HOUR OF EXPIRATION; OFF LABEL USE; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 20-AUG-2021 for prevention of covid19. No concomitant medications were reported. On 20-AUG-2021, the patient experienced punctured vial administered after half an hour of expiration. On 20-AUG-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vial administered after half an hour of expiration and off label use was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631063
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 08/11/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Date: 20210811; Test Name: Antibody test; Result Unstructured Data: Negative

Allergies:

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

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included that the patient had two heart attacks, and concurrent conditions included: cancer, and rheumatoid arthritis, and other pre-existing medical conditions included that the patient had no known drug allergies and was suffering from multiple ailments. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1082068 expiry: Unknown) dose was not reported, 1 total administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The patient was not pregnant at the time of reporting. On 11-AUG-2021, the patient visited her Infectious Disease doctor who carried out the COVID (Corona virus) antibody test which came out to be negative (confirmed immunological vaccine failure). The patient never had COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210842984-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness: Cancer; Rheumatoid arthritis

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am