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: 1634799
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: shingles once in between the first and 2nd shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles once before first dose). 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 shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. Additional details were reported as follows: This 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. The follow-up would not possible as no contact details were available. For second dose refer linked case US2021AMR176140, reported for the same patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR176140:Same reporter

Other Meds:

Current Illness:

ID: 1634800
Sex: U
Age: 58
State: FL

Vax Date: 08/16/2021
Onset Date: 08/01/2021
Rec V Date: 08/26/2021
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: Upsted stomach after first dose; This case was reported by a consumer via call center representative and described the occurrence of stomach discomfort in a 58-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 16th August 2021, the patient received the 1st dose of Shingles vaccine. In August 2021, 4 days after receiving Shingles vaccine, the patient experienced stomach discomfort. On an unknown date, the outcome of the stomach discomfort was unknown. It was unknown if the reporter considered the stomach discomfort to be related to Shingles vaccine. Additional details were provided as follows: The patient self reported the case. The patient reported that, he/she got the vaccine for shingles on Monday and four days later the patient still having stomach discomfort. The patient asked anything he/she could do about this

Other Meds:

Current Illness:

ID: 1634801
Sex: U
Age:
State:

Vax Date: 08/19/2021
Onset Date: 08/01/2021
Rec V Date: 08/26/2021
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: 2nd shot side effects - Feeling achy; Feeling tired; This case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (1st dose received on an unknown date). On 19th August 2021, the patient received the 2nd dose of Shingles vaccine. In August 2021, less than a week after receiving Shingles vaccine, the patient experienced pain and tiredness. On an unknown date, the outcome of the pain and tiredness were unknown. It was unknown if the reporter considered the pain and tiredness to be related to 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 received Shingles vaccine, the day before reporting date and was feeling achy and tired.

Other Meds:

Current Illness:

ID: 1634802
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: I thought I was dying.; migraines; chills; fever; This case was reported by a consumer via interactive digital media and described the occurrence of migraine in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Moderna with an associated reaction of pain in extremity (had two Moderna vaccine shots on an unknown date, experienced nothing but a sore arm). On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, between 3 and 4 weeks after receiving Shingles vaccine, the patient experienced migraine, chills, fever and impending doom. On an unknown date, the outcome of the migraine, chills and fever were recovered/resolved and the outcome of the impending doom was unknown. It was unknown if the reporter considered the migraine, chills, fever and impending doom to be related to 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 stated that, 5 months after receiving 2 Moderna vaccine shots, the patient went to saw doctor on routine appointment and they suggested the patient to take Shingles vaccine and the 2nd one would be given in two months. Well, for 3 and half weeks after receiving the Shingles vaccine, the patient thought he/she was dying, had 21 days of migraines, chills, fever, etc. The patient could not figure it out why he/she had such a reaction, but the patient had a hard time deciding to go get the 3rd Moderna shot.

Other Meds:

Current Illness:

ID: 1634803
Sex: U
Age:
State:

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 08/26/2021
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: tiredness; This case was reported by a consumer and described the occurrence of tiredness in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). In August 2021, the patient received the 2nd dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown. It was unknown if the reporter considered the tiredness to be related to Shingrix. Additional details were provided as follows: The case was reported by the patient for himself/herself The age at vaccination was not reported. The patient got the second Shingrix vaccine on Friday afternoon and experienced tiredness. The patient asked how long it would last.

Other Meds:

Current Illness:

ID: 1634804
Sex: U
Age:
State:

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 08/26/2021
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: fever; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 18th August 2021 02:15, the patient received Shingrix. On 18th August 2021, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received Shingrix vaccine and had a slight fever last night. The follow up would not be possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1634805
Sex: F
Age: 59
State: CO

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 08/26/2021
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: Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 11th February 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: The patient received first dose of Shingrix and experienced arm soreness and it was resolved shortly. The reporter did not consented to follow up. For tolerance of 2nd dose refer case US2021176172, reported with same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021176172:same reporter

Other Meds:

Current Illness:

ID: 1634806
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: 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 (Family History) (patient's dad and son both had 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 took the shingles shot and shortly afterwards, he/she came down with the worst case of the shingles ever. The shingles developed under the breast and around back down to mid thigh. The patient had to go to hospital and was prescribed with steroid shots and creams. It was horrible thing for him/her. 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: 1634807
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Suspected vaccination failure; had a bad case of shingles and I had already had the shot.; 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 had a bad case of shingles and he/she had already had the shot. The patent said it did not work for him/her. 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: 1634808
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: nonspecific autoimmune; got hives if anything of weight touched my body; This case was reported by a consumer via media and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced autoimmune disorder (serious criteria GSK medically significant) and hives. On an unknown date, the outcome of the autoimmune disorder and hives were not recovered/not resolved. It was unknown if the reporter considered the autoimmune disorder and hives to be related to Shingrix. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got only one dose of Shingrix and it threw him/her into nonspecific autoimmune where he/she got hives if anything of weight touch to the body of patient, like purse straps, bra straps, panty lines or the bottom of his/her feet against the shovel to dig. As per the the patient, Shingrix only prevents 40 percent.

Other Meds:

Current Illness:

ID: 1634809
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Had the vaccine and also had 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 had Shingles vaccine and also had shingles. 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.

Other Meds:

Current Illness:

ID: 1634810
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: had 2 Shingle shots just got over them for the third time/suspected vaccination failure; they were inside my ear; bells palsy; got over them for the third time/ they were inside my left side of my head; This case was reported by a consumer via 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. 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), herpes zoster otitis externa (serious criteria GSK medically significant), bell's palsy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and bell's palsy were unknown and the outcome of the herpes zoster otitis externa and shingles were recovered/resolved. It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, bell's palsy and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was reported. The patient had 2 Shingle shots and just got over shingles for the 3rd time. This time shingles were inside his/her left side of head and inside ear. The patient had bells palsy at the same time and stated that it was rough month. This case was considered as suspected vaccination failure as details regarding completion of time to onset and laboratory confirmation were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1634811
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: 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 female 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 patient reported case for herself. 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 US2021AMR177122 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR177122:same reporter

Other Meds:

Current Illness:

ID: 1634812
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: got the shot and had shingles afterwards/suspected vaccination failure; Shingles; mild case, hurt anyway; 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 pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient got the shot and had shingles afterwards. The patient stated that the doctor said because of the shot it was a mild case. The patient stated it hurt anyway. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available

Other Meds:

Current Illness:

ID: 1634813
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Suspected Vaccination Failure; had the shingles shot and got it anyway; 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 case was reported by the consumer for himself/herself. The age at vaccination was not reported. The reporter stated that, he/she had the Shingles shot and got shingles anyway. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1634814
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: 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 patient was the reporter's friend. The age at vaccination was not reported. The reporter stated that, the patient got the Shingles shot and got shingles anyway. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1634815
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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 the shots and have had more breakouts than before / Suspected Vaccination failure; had more breakouts than before. Got about 4 that time.; 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. Concurrent medical conditions included shingles (patient had shingles for about 6 years). 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 case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The patient would get a break out about every 3 weeks. The patient got the shots. After the first shot went a month and was feeling good and no headaches (which are daily). Then got the second shot and have had more breakouts than before. Last time as soon as one spot cleared up I had another one. Got about 4 that time. 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 shingles for about 6 years)

ID: 1634816
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: 2 series shot is a doozy; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal 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 feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown. It was unknown if the reporter considered the feeling abnormal 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. After the 1st shot patient was doozy, but so much better than contracting shingles. The follow up was not required. For tolerance of 2nd dose refer case US2021AMR178148.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR178148:same reporter, same patient, 2nd dose

Other Meds:

Current Illness:

ID: 1634817
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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 had the two dose shot 3: years ago and I have the shingles/suspected vaccination failure; I have the shingles right now for the 2nd time; 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. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years 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 case was reported by the patient. The age at vaccination was not reported. The patient had the 2 shots of Shingles 3 years prior to the report and had the shingles right now for the 2nd time and not as bad as of the 1st time. 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.

Other Meds:

Current Illness:

ID: 1634818
Sex: U
Age:
State:

Vax Date: 08/19/2021
Onset Date: 08/01/2021
Rec V Date: 08/26/2021
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: Arm extremely sore; violently vomiting; This case was reported by a consumer via media and described the occurrence of pain in arm in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had the Shingles on my hip/back about 10 years ago, at age 49 years.). On 19th August 2021, the patient received Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced pain in arm and vomiting. On an unknown date, the outcome of the pain in arm and vomiting were unknown. It was unknown if the reporter considered the pain in arm and vomiting to be related to Shingrix. Additional case details were reported as follows: The patient reported case for herself or himself. The patient was violently vomiting last night Friday before day of reporting. Arm extremely sore but that could be expected with almost any shot, just keep massaging it. The follow up was not required.

Other Meds:

Current Illness:

ID: 1634819
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: I had both vaccines. I am currently dealing with shingles / suspected vaccination failure; shingles, in my mouth; 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. 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. 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had both vaccines and currently dealing with shingles in mouth. This case was considered as suspected vaccination failure, as details regarding 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: 1634820
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: got the shot then 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 patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, several 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 itself. The age at vaccination was not reported. The patient got the shingles shot and ended up getting the shingles a few months later. The porter asked so much for that shot and requested no more shots of any kind for him or her. 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: 1634821
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: got first shot knocked me on my butt for 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal 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 feeling abnormal. On an unknown date, the outcome of the feeling abnormal was recovered/resolved. It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine. Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. After having a bout of shingles, patient got first shot and knocked him or her my butt for 2 days The reporter stated getting second shot soon but well worth it. Would rather not have shingles again. The follow up was not required.

Other Meds:

Current Illness:

ID: 1634822
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: shingles; VERY PAINFUL; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown. It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine. Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had the first shot and still got shingles. The patient did not wish it on anyone. It was very painful. Now the patient had the second shot, hope patient did not get them again. The follow up was not required.

Other Meds:

Current Illness:

ID: 1634823
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: 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 99-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, several 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 provided as follows: The age at vaccination was not reported. The patient got shingles after several years later receiving the shot and it was bad. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting. This case was linked with US2021AMR178214, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR178214:same reporter

Other Meds:

Current Illness:

ID: 1634824
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Suspected Vaccination failure; came down with 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 was unknown and the outcome of the shingles was recovered/resolved. 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 patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and came down with shingles. The patient stated that it was three months of he/she never ever want to go through it again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1634825
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: 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 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 patient himself/herself. The age at vaccination was not reported. The patient got the vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1634826
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: suspected vaccination failure; shingles, Dr said it was the worse case he'd ever seen; 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 patient himself/herself. The age at vaccination was not reported. The patient got shingles vaccine and got shingles. Doctor said that it was the worst case he had ever seen. 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 test confirming herpes zoster were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1634827
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: got shingles after each inlection/Suspected Vaccination failure; got 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. 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 reported as follows: The age at vaccination was not reported. The reporter stated that vaccine was not 100 percent either. The reporter knew someone (patient) who after each shingles vaccine injection got shingles. The follow-up would not possible as no contact details were available. For tolerance of 1st dose refer case US2021AMR178307, reported by the same reporter. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR178307:Same reporter, same patient, diferent dose (1st)

Other Meds:

Current Illness:

ID: 1634828
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: 24/7 arthritis; This case was reported by a consumer via media and described the occurrence of arthritis in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced arthritis (serious criteria GSK medically significant). On an unknown date, the outcome of the arthritis was not recovered/not resolved. The reporter considered the arthritis to be possibly related to Shingrix. Additional details were reported as follows: This case was reported by the patient. The age at vaccination was reported. The patient reported that the Shingrix triggered unbelievable 24 by 7 arthritis. The patient stated he/she would give anything to go back in time and not take that 2nd dose. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1634829
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Suspected vaccination failure; shingle; 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 patient self reported the case. The age at vaccination was not reported. The patient got shot and still had shingle. 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: 1634830
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: made me sick; slight fever; left arm got real red; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (shingles on the inside of the body all 3 times its even worse). Previously administered products included Shingrix with an associated reaction of illness (1st dose received in 2019 and made sick with a slight fever and left arm got real red, refer case US2021AMR176045). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness, fever and erythema of extremities. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sickness, fever and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the sickness, fever and erythema of extremities to be related to Shingrix. Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she did get the 2 Shingrix shots for shingles this was in 2019, it was the best thing the patient did for himself/herself and yes it made him/her sick with a slight fever and his/her left arm got real red but after 2 days the patient was fine and have been ever since, the patient pay dollar 300, for both out of pocket, patient said he/she on but had to do it, hope who ever gets the shots would get better. The patient also had both Covid shots (Pfizer), was only sick for 2 days with fever this was 6 months ago from the time of reporting. The patient was doing fine, he/she did this for himself/herself and the patient just went to get his/her Flu shot last week, from the time of reporting that one patient get every year.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR176045:Same reporter

Other Meds:

Current Illness:

ID: 1634831
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Suspected vaccination failure; Get vaccinated if you want the Shingles had the shot and got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 50-year-old 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 age at vaccination was not reported. The patient stated that, get vaccinated if you want the Shingles. The patient had shingles 50 years ago and was told that it could come back. The patient had the shot and got the shingles. This case has been linked to US2021AMR178370, reported by the same reporter. 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. ; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR178370:Same reporter

Other Meds:

Current Illness:

ID: 1634832
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: had the shot and got it so did my husband/ Suspected Vaccination failure; got it so did my husband groin area not happy; 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 wife. The age at vaccination was not reported. The reporter stated that, did her husband's groin area not happy. The reporter stated that the patient had the shot and got shingles in groin area. 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 has been linked with case US2021AMR178369, reported by same reporter for reporter herself.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR178369:Same reporter

Other Meds:

Current Illness:

ID: 1634833
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Suspected Vaccination Failure; outbreaks; 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 got vaccinated but still had outbreaks. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization schedule, time to onset for event and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1634834
Sex: M
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: first dose / on 5/26/21 / not received any further doses; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Twinrix (1st dose received on 26th May 2021). On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. No additional information provided. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1634835
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: had shot dose #1 in August 2020 has not yet received shot #2 AFTER the Shingrix shot she received her covid-19 shot(s); This case was reported by a consumer via call center representative and described the occurrence of social problem in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in August 2020,1 intramuscularly in unspecified upper arm). Concomitant products included covid-19 vaccine and prednisone. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of shingrix, due to covid-19 shot, which led to social problem. The reporter did not have the exact date of the shot or the lot/exp but did provide the contact information for the pharmacy who administered it. The medical director said did not have an internist and had been without one for years. The reporter stated that, the patient received prednisone tablets in January or February 2021. The reporter stated that, an unspecified time after the Shingrix shot, the patient received covid-19 shot(s).

Other Meds: COVID-19 VACCINE; PREDNISONE

Current Illness:

ID: 1634836
Sex: F
Age: 61
State: CA

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 08/26/2021
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: two doses administered on 07/20 and 08/17; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included Herpes zoster (Shingrix). On 17th August 2021, the patient received the 2nd dose of Shingrix. On 17th August 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional details were provided as follows: The nurse reported that, the patient received 2nd dose of Shingrix early than the recommended time interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1634837
Sex: M
Age:
State: VT

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: received dose 1 on june 2018. Never got 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in June 2018). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No information on vaccine available. The reporter stated that, did not receive in the same facility. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1634838
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Only first dose was administrated on 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 2nd March 2019, batch number 4g58x, expiry date 9th July 2021). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1634839
Sex: F
Age:
State:

Vax Date: 08/15/2021
Onset Date: 08/01/2021
Rec V Date: 08/26/2021
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: genital herpes outbreak; This case was reported by a consumer via call center representative and described the occurrence of genital herpes in a female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included genital herpes (one and half year before reporting date). Previously administered products included Covid vaccine (1st and 2nd shot received on unknown date) and Acyclovir (genital herpes treated with acyclovir). On 15th August 2021, the patient received the 2nd dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced genital herpes. On an unknown date, the outcome of the genital herpes was not recovered/not resolved. It was unknown if the reporter considered the genital herpes to be related to Shingrix. Additional details were provided as follows: The case was reported by the patient herself. The age at vaccination was not reported. The patient refused to provide her last name or phone number. The patient received the 2nd dose of Shingrix on sunday and less than a week after the vaccination the patient experienced genital herpes outbreak which was getting worse. The patient did not want an answer any further questions. The reporter did not consent to follow up. The patient did not want an answer any further questions therefore reporter did not ask her MD (doctor of medicine) contact information.

Other Meds:

Current Illness:

ID: 1634840
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: received his first dose on 4-November-2020; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 4th November 2020, 0.5 ml, intramuscularly). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up. The VAERS details were reported for 1st dose of Shingrix.

Other Meds:

Current Illness:

ID: 1634841
Sex: M
Age:
State: SD

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 08/26/2021
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: On 19Jul2021,received first dose, on 20Aug2021, received the second dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included Herpes zoster (Shingrix). On 20th August 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 20th August 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional details were provided as follows: The age at vaccinaation was not reported. The patient received dose of Shingrix in the left deltoid. The reporter stated that, the patient received 2nd dose of Shingrix, which led to shortening of vaccination schedule. The reporter consented to follow up.

Other Meds: Shingrix

Current Illness:

ID: 1634842
Sex: M
Age:
State: VA

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 08/26/2021
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: third dose 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) (batch number kb97c, expiry date 13th November 2022) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date). On 19th August 2021, the patient received the 3rd dose of Shingrix. On 19th 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 pharmacist stated that, the patient received 3rd dose of Shingrix, which led to extra dose administered. No further events were reported. The health care professional agreed to be contacted only via email for follow-up.

Other Meds:

Current Illness:

ID: 1634843
Sex: F
Age: 72
State: IL

Vax Date: 03/08/2018
Onset Date: 12/01/2018
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: Low blood count; Result Unstructured Data: (Test Result:Low blood count,Unit:unknown,Normal Low:,Normal High:)

Allergies:

Symptom List: Vomiting

Symptoms: Suspected vaccination failure; diagnosed with shingles; first Shingrix dose on March 8, 2018 and the second dose on December 1, 2018; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 1st December 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 8th March 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st December 2018, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On 27th July 2021, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure and drug dose administration interval too long were 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 Shingrix and Shingrix. Additional details were reported as follows: The case was reported by the patient. At the time of reporitng, the age of the patient was 75 years. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of the vaccine schedule. On 27th July 2021, 969 days after receiving the 2nd dose and 1237 days after receiving the 1st dose, the patient was diagnosed with shingles. The patient was prescribed with Valacyclovir and that cause vomiting and went to the emergency room for the vomiting, refer case US2021AMR177242. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR177242:same reproter, same patient, different product (valacyclovir)

Other Meds:

Current Illness:

ID: 1634844
Sex: F
Age:
State: NE

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: received her first dose about 2 years ago has not received her second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received 2 years ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not know the lot number or expiration date of the Shingrix vaccine originally administered. No additional information provided. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1634845
Sex: M
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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 Name: Blood pressure; Result Unstructured Data: 151/89; Test Name: Respiratory rate; Result Unstructured Data: 18; Test Name: Heart rate; Result Unstructured Data: 93; Test Name: Physical examination; Result Unstructured Data: Erythematous grouped vesicles on the left side of the face; Test Name: Visual acuity tests; Result Unstructured Data: limited; Test Name: Hemoglobin; Result Unstructured Data: 15 g/dL; Test Name: Platelet count; Result Unstructured Data: 274000 cells/microL; Test Name: Body temperature; Result Unstructured Data: Afebrile; Test Name: White blood cells; Result Unstructured Data: 5.50 cells/microL

Allergies:

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

Symptoms: IPSILATERAL HERPES ZOSTER OPTHALMICUS; GENERALIZED WEAKNESS; This spontaneous report was received from literature: . This report concerned a 42 year old male of an unspecified race and ethnicity. The objective of this study was to describe Ipsilateral HZO (Herpes Zoster Ophthalmicus), an opthalmological emergency of herpes zoster (HZ) seen post Covid-19 vaccination in healthy young adults. The patient's height, and weight were not reported. The patient's past medical history included: admitted chickenpox at the age of 10, and concurrent conditions included: asthma. The patient denied any sick contacts, recent emotional or physical stress, recent travel, or steroid usage in the past one year. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, frequency time 1 total administered at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, post COVID-19 vaccination the patient experienced generalized weakness for two days. One week after receiving the vaccination, the patient noticed that skin lesions started appearing as small pimples on the left side of his forehead that were associated with burning pain and itching. The lesions had then rapidly progressed to the left side of the scalp, the tip of the nose, and the left upper eyelid. Associated symptoms were watery discharge from the eyes and blurred vision. He denied having any other complaints. On an unspecified date, the patient presented to the emergency room with the above mentioned complaints. Laboratory data included: blood pressure which was found to be 151/89, body temperature was found to be afebrile, heart rate was found to be 93, hemoglobin (NR: 13.5 - 17.5) was found to be 15 g/dL. Physical examination revealed erythematous grouped vesicles on the left side of the patient's forehead, left upper eyelid, left side of the scalp and tip of his nose. The left eyelid appeared to be edematous with conjunctival injection and watery discharge, with no visible corneal endothelial decompensation. There was restricted ocular movement noticed due to edema of his upper eyelid. Visual acuity test was also found to be limited. Platelet count (NR: 150000 - 450000) was found to be 274000 cells/microL, Respiratory rate was 18, and White blood cells (NR: 4500 - 11000) were 5.50 cells/microL. Based on clinical examination findings, the diagnosis of ipsilateral HZO (Herpes Zoster Ophthalmicus) was made. He was started on systemic antiviral (antivirals for systemic use) and antiviral eye drops, which halted the progression of vesicles and improved his vision. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized weakness, and the outcome of ipsilateral herpes zoster opthalmicus was not reported. The authors emphasized on the awareness that must be created among physicians, as well as the general public by reporting any associations with the COVID-19 vaccine and HZ (Herpes zoster) to CDC (Centers for Disease Control and Prevention). It was recommended that immunocompromised individuals greater than 50 years of age be vaccinated against HZ (Herpes zoster). Early recognition and antiviral usage can halt the progression of the disease and thus prevent debilitating complications. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210832958-Covid-19 vaccine ad26.cov2.s-ipsilateral herpes zoster ophthalmicus. 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: Asthma

ID: 1634846
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: ATRIAL FIBRILLATION; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total administered, 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 number. The patient received rivaroxaban (Xarelto) (film-coated tablet, route of admin not reported, batch number: Unknown) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. After receiving vaccine, On an unspecified date, the patient experienced atrial fibrillation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with rivaroxaban was not reported. The outcome of atrial fibrillation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210833202- covid-19 vaccine ad26.cov2.s-atrial fibrillation. 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). 20210833202-Xarelto -atrial fibrillation. 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: Stroke

ID: 1634847
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: DECREASED ANTIBODY RESPONSES TO AD26.COV2.S; This spontaneous report was received from literature report. Decreased Antibody Responses to Ad26.COV2.S Relative to SARS-CoV-2 mRNA Vaccines in Patients with Inflammatory Bowel Disease. Gastroenterology. This report concerned multiple patients. Initial information was processed along with the additional information received on 24-AUG-2021. The patients' height, and weight were not reported. The patients' concurrent condition included: inflammatory bowel disease. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 1 total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Currently, three vaccines have been granted emergency use authorization for coronavirus disease 2019 (COVID-19) prevention. These include the mRNA platform vaccines (mRNA-1273 (Moderna/NIH) and BNT162b2 (Pfizer-BioNTech)) and an adenovirus vector vaccine (Ad26.CoV2.S (J&J)), which were 94%, 95%, and 67% effective against COVID19 infection in their Phase III registry trials against the endemic variants at the time, respectively. The Patients with inflammatory bowel disease (IBD) on corticosteroids, immunomodulators and advanced therapies may have normal to slightly decreased humoral responses to the SARS-CoV-2 mRNA vaccine platforms and patients receiving infliximab and/or thiopurines have significantly lower rates of seroconversion than those on vedolizumab monotherapy following a single dose of either BNT162b2 or ChAdOx. Among 353 vaccine recipients with IBD participating in a prospective SARS-CoV-2 vaccine registry without prior COVID-19 infection who had completed a full vaccine regimen, 148 (42%), 193 (55%), and 12 (3%) received mRNA-1273, BNT162b2 and Ad26.CoV2.S respectively. Demographic and disease characteristics were similar across vaccine groups. Approximately 290 (83.1%) of participants were on immune-modifying therapies (IMT) as defined by receipt of advanced therapies (biologics or Janus kinase (JAK)-inhibitors, 80.2%), immunomodulators (16.6%), and/or systemic corticosteroids (6.6%) at the time of initial vaccination. Upon completion of vaccine regimen, whole blood was collected from local patients by venipuncture at three different time points, after regimen completion (2-13 days after completing regimen), week 2 (14-29 days after completing regimen), and week 8 (42-84 days after completing regimen). For participants unable to provide in-person samples, whole blood was collected using the TASSO-SST device at week 8 only (42-84 days after completing regimen). The plasma antibodies to the viral spike protein receptor binding domain [IgG(S-RBD)] were analysed using the SARS-CoV-2 IgG-II assay at each time point, IgG(S)=50 AU/mL was defined as a positive response. Two weeks after completion of the vaccine regimen, positive antibody levels was detected in 121 (100%), 142 (99%), and 9 (90%) patients receiving mRNA-1273, BNT162b2 and Ad26.CoV2.S, respectively. Quantitative log10 (anti-Spike IgG) levels at both two weeks (14 ? 29 days after regimen completion) and eight weeks (42 ? 84 days after regimen completion) were significantly higher among recipients of mRNA-1273 and BNT162b2 compared with Ad26.CoV2.S (two weeks: 4.20 vs 3.92 vs 1.96 for mRNA-1273, BNT162b2 and Ad26CoV2.S, respectively; at least eight weeks: 3.72 vs 3.41 vs 2.65, respectively). Positive levels of IgG(S) was achieved in all IBD vaccine recipients regardless of vaccine type and IMT use. However, it was found that recipients of Ad26.CoV2.S had significantly lower antibody levels than recipients of mRNA platform vaccines, independent of IMT use. Conclusion: The clinical implications of qualitatively positive but quantitatively lower antibody levels among Ad26.CoV2.S recipients were unknown. It was not known whether lower antibody titers increase susceptibility to SARS-CoV-2 clinical infection; correlations between immune responses and protection from COVID-19 hospitalization and death are needed. Although the clinical implications of positive but low titers were unclear, further comparative effectiveness research of humoral, cellular, and clinical immunity across SARS-CoV2 vaccine platforms was urgently needed to clarify optimal booster vaccine strategies, particularly among immunocompromised patients. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of decreased antibody responses to ad26.cov2.s was not reported. This report was serious (Other Medically Important Condition). The case is associated with Product Quality Complaint number: 90000190820 This case, from the same reporter is linked to 20210514981, 20171211088, 20171206472, 20180416031 and 20121202239.; Sender's Comments: V0- 20210834287covid-19 vaccine ad26.cov2.s-Decreased antibody responses to ad26.cov2.s-. 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: Inflammatory bowel disease

ID: 1634848
Sex: F
Age:
State: WA

Vax Date:
Onset Date: 03/12/2021
Rec V Date: 08/26/2021
Hospital: Y

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: 20210722; Test Name: COVID-19 virus test; Result Unstructured Data: Positive; Test Date: 20210722; Test Name: COVID-19 virus test; Result Unstructured Data: Positive; Test Name: Oxygen saturation; Result Unstructured Data: 100 %; Test Name: Blood test; Result Unstructured Data: Not reported; Test Name: CT scan; Result Unstructured Data: not reported.

Allergies:

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

Symptoms: SUSPECTED COVID-19 INFECTION; BLOOD WITH NO FECAL MATTER COMING OUT OF THE RECTUM; BLOOD WITH NO FECAL MATTER COMING OUT OF THE RECTUM; SUSPECTED CLINICAL VACCINATION FAILURE; MILD ACHINESS; MILD TIREDNESS; This spontaneous report received from a patient concerned a 69 year old female of an unspecified race and ethnic origin. The patient's weight was 148 pounds, and height was 65 inches. The patient's past medical history included, gastric ulcer (no medication received) and concurrent conditions included, allergy of shell fish, spinach, kale, dark leafy vegetables, contrast dye and antibiotics. She was alcohol user (very rarely, less than once a month) and non-smoker. She had no history of drug abuse or illicit drug use. She experienced drug allergy when treated with Cipro (ciprofloxacin) used for an unknown indication. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: 25-MAY-2021) dose was not reported, frequency one total administered on 12-MAR-2021 for prophylactic vaccination. Patient did not receive any medication. On 12-MAR-2021 (after vaccination), the patient experienced mild achiness and mild tiredness that lasted for a day. On 22-JUL-2021, she performed a Covid-19 test at home, result was positive. Another Covid-19 test was performed at the hospital and she was diagnosed with Covid-19 (suspected Covid-19 infection and suspected clinical vaccination failure). On 23-JUL-2021, she was hospitalized for 2.5 days. On an unspecified date, the symptoms of Covid-19 infection had hit the intestinal tract for 3 days. She had blood with no fecal matter coming out of the rectum (9 events of a lot of blood coming out) and couldn't move because she was in much pain. Her gastric doctor stated that the delta variant might have hit the intestinal tract. She also, had lingering cough, but it did not affect her oxygen levels and remained 100% throughout her hospitalization. Her computerized tomography (CT) scan and blood tests, the results were not reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood with no fecal matter coming out of the rectum, and blood with no fecal matter coming out of the rectum on JUL-2021, and mild achiness, and mild tiredness on 13-MAR-2021, was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210835203 -COVID-19 VACCINE AD26.COV2.S- blood with no fecal matter coming out of the rectum (rectal bleeding, constipation), suspected COVID-19 infection. This event is considered unassessable. The event 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. 20210835203-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination 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: Alcohol use (very rarely (less than once a month)); Allergy; Allergy to antibiotic; Allergy to plants; Non-smoker; Shellfish allergy.

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am