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: 1677005
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: shortage and I got the second shot about 8-10 months after the first; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in 2018). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, due to shortage, got 2nd dose of Shingrix vaccine about 8 to 10 months after the first, which led to product supply issue. The patient had 1st dose about 3 months ago.

Other Meds:

Current Illness:

ID: 1677009
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: paralyzed my arm and side; Excruciating pain; This case was reported by a consumer via media and described the occurrence of arm paralysis 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 arm paralysis (serious criteria GSK medically significant) and pain. On an unknown date, the outcome of the arm paralysis and pain were recovered/resolved. It was unknown if the reporter considered the arm paralysis and pain to be related to Shingles vaccine. Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient decided to get the shot and had bad choice and experienced excruciating pain and paralyzed arm and side which lasted for 2 days. The reporter stated not to get any more vaccine. The follow up would not be possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1677010
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: 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 patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.

Other Meds:

Current Illness:

ID: 1677011
Sex: U
Age:
State:

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/07/2021
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: Second shot 2 or 3 years after the first; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received 3 years ago). In August 2021, the patient received the 2nd dose of Shingrix. In August 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, received 2nd dose of Shingrix late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter asked did need to take 3rd shot.

Other Meds:

Current Illness:

ID: 1677015
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: sore arm; This case was reported by a other health professional and described the occurrence of pain in arm in a female 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were reported as follows: The case was reported by the patient. Age at vaccination was not reported. The patient stated that with her 1st Shingrix shot she had a sore arm which was not a big deal. No contact details were reported. For tolerance in 2nd dose refer case US2021AMR186215.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR186215:same reporter

Other Meds:

Current Illness:

ID: 1677019
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: 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, 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 patient's wife. The age at vaccination was not reported. The patient received all the Shingles shots. After receiving Shingles vaccine, the patient got shingles twice. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1677020
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: suspected vaccination failure; shingles / have them now; 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 provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine couple of years ago from the date of reporting. Ater receiving Shingles vaccine, the patient had shingles. The patient stated that, it sucked. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided. This case had been linked with case US2021AMR184719, reported by the same reporter.

Other Meds:

Current Illness:

ID: 1677021
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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; getting them; 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 (got every year since 4 years ago from the date of reporting). 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 provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient got shingles every year for last 4 years from the date of reporting. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1677022
Sex: U
Age:
State:

Vax Date:
Onset Date: 01/10/2021
Rec V Date: 09/07/2021
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; eye shingles; 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. On an unknown date, the patient received Shingles vaccine. On 10th January 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine. Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient had been suffering with eye shingles since 10th January 2021. The patient stated that, Shingles vaccine did not prevent this from happening. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1677023
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: myalgia in shoulders and neck; Provider stated she will not give 2nd dose; This case was reported by a physician and described the occurrence of myalgia in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included arthritis (patient has pre-existing arthritis). On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced myalgia and incomplete course of vaccination. On an unknown date, the outcome of the myalgia was recovered/resolved and the outcome of the incomplete course of vaccination was unknown. The reporter considered the myalgia to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient has pre-existing arthritis. The patient received Shingrix and experienced sever myalgia in shoulders and neck. The reporter believed this severe myalgia was a result of vaccination with Shingrix. The patient did go to emergency room for care. The patient's myalgia resolved after a few days. The provider stated she would not give 2nd dose, which led to incomplete course of vaccination. No additional information was provided. The reporter did not consent to follow up

Other Meds:

Current Illness:

ID: 1677024
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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; 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 was unknown and the outcome of the shingles was recovering/resolving. 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 patient's wife. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. At the time of reporting, the patient was recovering. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1677025
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: Allergic rex; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a female 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 allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and experienced mild allergic reaction. The reporter wanted to know that should he/she get the 2nd dose. The follow up would not be possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1677026
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: First shot over 2 years ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st shot received over 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: This case was reported by patient himself/herself. The age at vaccination was not applicable for this report. The patient stated he/she had 1st Shingrix shot and asking advised on whether to get 2nd shot. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1677027
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: First shot 2 years ago, not advised to get a 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date 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. This case was reported by patient's wife. Till the time of reporting, the patient did not received 2nd dose, which led to incomplete course of vaccination. This case is linked with the case US2021AMR187241, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR187241:Same reporter. Reporter's case.

Other Meds:

Current Illness:

ID: 1677028
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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; 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 sister in law of the reporter. The age at vaccination was not reported. The reporter stated that, his/her sister in law got the Shingles vaccine and guess what, she got a bad case of shingles. 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: 1677029
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: both shots and still got them; still got them; less painful; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles and pain. 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), 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 and Shingles vaccine. Additional details were provided as follows: The reporter was the patient's friend. The age at vaccination was not reported. The reporter stated that, he/she thought shingles vaccine was supposed lessen the severity and not make it worse. The reporter stated that, the patient got both the Shingles shots and still got the shingles but ere less painful then what she had before the shots. 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.

Other Meds:

Current Illness:

ID: 1677030
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: suspected vaccination failure; shingles; was sick; had painless bumps on it; 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, sickness and skin disorder. On an unknown date, the outcome of the vaccination failure, shingles, sickness and skin disorder were unknown. It was unknown if the reporter considered the vaccination failure, shingles, sickness and skin disorder to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got the shingles vaccine a few years ago. Ithe patient was sick and went to the physician for something else. The patient had painless bumps on it , and when asked , the physician looked and said it was shingles. It was very light, painless case because the patient had the vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1677031
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: 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 case was reported by patient. The age at vaccination was not reported. The patient received shingles and still got the shingles. The patient stated that like all vaccines just because you got it does not mean you won't get it. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1677032
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. 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 provided as follows: The reporter was patient's son/ daughter. The age at vaccination was not reported. The patient got shingles vaccine and had a terrible case of shingles. The ad shouldn't say you would not get shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1677033
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: more than 6 months since first dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination 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 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 received 2nd dose, which led to incomplete course of vaccination. The patient also inquired what can be done if 1st dose of Shingrix vaccine has been more than 6 months.

Other Meds:

Current Illness:

ID: 1677034
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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 / have had them 11 times since the vaccine; have had them 11 times; 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 patient self-reported this case. The age at vaccination was not reported. The patient had Shingles 11 times since the Shingles vaccine. The patient would never have let the doctor talk him/ her into it if the patient would have known. The patient stated that the stupid pneumonia shot the doctor had talked him/ her into last year almost killed the patient. The patient would not take any more vaccine of any kind. 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: 1677035
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: 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. 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 details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1677036
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: 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 patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles anyway. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

Date Died:

ID: 1677037
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: allergic reaction; This case was reported by a consumer via media and described the occurrence of allergic reaction 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 allergic reaction (serious criteria death and GSK medically significant). On an unknown date, the outcome of the allergic reaction was fatal. The reported cause of death was allergic reaction. It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine. Additional details were provided as follows: The case was reported for the reporter's sister in laws mother. The age at vaccination was not reported. After receiving Shingles vaccine, the patient passed due to allergic reaction complications to the Shingles vaccine about a month ago from the date of reporting. This case had been linked with case US2021AMR188219, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR188219:same reporter; Reported Cause(s) of Death: Allergic reaction

Other Meds:

Current Illness:

ID: 1677038
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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 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 had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1677039
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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; 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 patient had reported for him/herself. The age at vaccination was not reported. The patient did not get shingles until he/she got Shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1677040
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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 male 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 details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

Date Died:

ID: 1677041
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: allergic reaction; This case was reported by a consumer via media and described the occurrence of allergic reaction 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 allergic reaction (serious criteria death and GSK medically significant). On an unknown date, the outcome of the allergic reaction was fatal. The reported cause of death was allergic reaction. It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. After receiving Shingles vaccine, the patient passed due to allergic reaction complications to the Shingles vaccine about a month ago from the date of reporting. This case had been linked with case US2021AMR188176, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR188176:same reporter; Reported Cause(s) of Death: Allergic reaction

Other Meds:

Current Illness:

ID: 1677042
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: 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 age at vaccination was not reported. The patient received every Shingles vaccine out there. After receiving Shingles vaccine, the patient got shingles three times. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1677043
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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 shots, it made the other times much easier / suspected vaccination failure; other times much easier; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 77-year-old female 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 Shingles 2.5 years ago) and pregnancy (had four children with natural birth). 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 reporter was patient itself. The age at vaccination was not reported. The reporter stated if you had suffered like how she did or do you would feel differently. The patient had shingles 2.5 years before day of reporting. It was so bad she could not walk. She had four children with natural birth and the pain combined did not exceed the pain of Shingles. The patient had never hurt so bad from anything in my 77 years. Unfortunately, had the aftermath of Shingles, meaning she would have this pain the rest of her life. Her side and back hurts to touch. She could not even wear the clothes she want to wear because she could not stand for her clothes to touch her skin. The patient suggested to get the shots. Her family did after seeing she suffer. The patient got the shots after my first attack and it made the other times much easier. The patient not selling but trying to save others from pain. 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: 1677044
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: received first dose in January; This case was reported by a other health professional via (Shingrix GSK interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in January 2020). 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 asked should the series be restarted now or just completed with the second dose now.

Other Meds:

Current Illness:

ID: 1677045
Sex: F
Age:
State: CT

Vax Date: 08/18/2021
Onset Date:
Rec V Date: 09/07/2021
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: has a rash going up and down her arm that resembles chicken pox/Rash going up and down her arm; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 18th August 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced vesicular rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the vesicular rash was not recovered/not resolved. It was unknown if the reporter considered the vesicular rash to be related to Shingrix. Additional details were provided as follows: This case was self-reported by the patient. The patient received first dose and had rash which were going up and down her arm that resembled chickenpox. The patient's doctor prescribed her Benadryl. The patient did not want to provide health care professional information. The patient was hesitant to provide any adverse event details, demographic and information. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1677046
Sex: F
Age: 55
State: IL

Vax Date: 08/25/2021
Onset Date: 08/01/2021
Rec V Date: 09/07/2021
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: Injection site is painful / Injection site is tender; Injection site is sensitive; Red near the injection site; red, raised spot near the injection site; Tired; Easily distracted; Can't focus; Not sleeping well; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included Herpes zoster (Shingrix). On 25th August 2021, the patient received the 2nd dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site hypersensitivity, injection site erythema, injection site papule, tiredness, distractibility, mental concentration difficult and poor sleep. On an unknown date, the outcome of the injection site pain, injection site hypersensitivity, injection site erythema, injection site papule, tiredness, distractibility, mental concentration difficult and poor sleep were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site hypersensitivity, injection site erythema, injection site papule, tiredness, distractibility, mental concentration difficult and poor sleep to be related to Shingrix. Additional detail were provided as follows: The age at vaccination was not reported. The patient stated that, she had her first Shingrix shot on 25th June 2021 and had no side effects. She had got her second dose of Shingrix and was experienced the following side effects like tired, easily distracted, could not focus, was not sleeping well, injection site was sensitive, painful, and tender, and a red, raised spot near the injection site. The patient did not want to provide her HCP (health care professional) information. The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1677048
Sex: U
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: Missed the second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 20th September 2019). 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. The health care professional stated that, 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: 1677049
Sex: F
Age: 73
State: MD

Vax Date: 06/28/2021
Onset Date: 06/29/2021
Rec V Date: 09/07/2021
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: Nausea; Headache; This case was reported by a consumer and described the occurrence of nausea in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 28th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th June 2021, 1 days after receiving Shingrix, the patient experienced nausea and headache. On 30th June 2021, the outcome of the nausea and headache were recovered/resolved. It was unknown if the reporter considered the nausea and headache to be related to Shingrix. Additional details were provided as follows: This case was self-reported by the patient. The patient received 1st dose of Shingrix and on next day experienced nausea and headache for 1 day. Patient declined to provide health care professional information. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1677050
Sex: F
Age: 58
State: MA

Vax Date: 06/01/2021
Onset Date:
Rec V Date: 09/07/2021
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: Sore arm (at the injection site); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. In June 2021, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be unrelated to Shingrix. Additional details were provided as follows: This case was self-reported by the patient. The patient received 1st dose of Shingrix in the left deltoid and experienced injection site pain. The patient had her routine physical checkup in May 2021. The patient did not know if the shot was given intramuscularly. The patient said that doctor's office did not think her symptoms were due to Shingrix. The patient did not have information about lot number and expiration date. The patient did not receive any paperwork from pharmacy. The patient did not want to provide her doctor of medicine (MD) contact information. The reporter did not consent to follow up. For the tolerance of 2nd dose, refer case US2021AMR185129.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR185129:Same reporter.

Other Meds:

Current Illness:

ID: 1677054
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: suspected vaccination failure; experienced cases of Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix. Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. It was reported that the patient had completed the series of Shingrix but experienced cases of Shingles after that and now Physician indicated a 3rd dose. Also Pharmacist reported that physician told her to re start the series. No vaccination details. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1677056
Sex: M
Age: 54
State: IL

Vax Date: 08/26/2021
Onset Date: 08/26/2021
Rec V Date: 09/07/2021
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: reconstituted with a liquid other than the supplied AS01B adjuvant.; reconstituted with a liquid other than the supplied AS01B adjuvant.; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis. On 26th August 2021, the patient received the 1st dose of Shingrix. On 26th August 2021, unknown after receiving Shingrix, 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 pharmacist reported that another colleague administered to a patient 1st dose of Shingrix which was reconstituted with a liquid other than the supplied AS01B adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1677058
Sex: F
Age:
State: KY

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: 1st dose on October 17th 2019, didn?t received second dose; 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 17th October 2019). 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. The pharmacist stated that, till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2019055807, reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2019055807:same reporter

Other Meds:

Current Illness:

ID: 1677059
Sex: M
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: has not received the second dose yet; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on December 2019). 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 reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter declined to provide his date of birth or health care professional information. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1677061
Sex: F
Age: 56
State: WI

Vax Date: 08/30/2021
Onset Date: 08/30/2021
Rec V Date: 09/07/2021
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: administered only adjuvant; administered only adjuvant; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date 15th November 2022) for prophylaxis. On 30th August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 30th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The patient received dose of Shingrix in the right deltoid. The reporter stated that, administered only Shingrix adjuvant to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The nurse then got another vial of adjuvant, mixed it with the lyophilized powder and administered a full dose of Shingrix to the patient. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1677062
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: administered after temperature excursion of 31.0F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in an unspecified number of patients who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, Flu Seasonal TIV Dresden (Fluarix) (batch number 2235P, expiry date unknown) for prophylaxis and Flu Seasonal TIV Quebec (Flulaval) (batch number 2235P, expiry date unknown) for prophylaxis. On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Havrix, Engerix B, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Boostrix, Fluarix and Flulaval. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Havrix, Engerix B, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Boostrix, Fluarix and Flulaval, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage 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 are as follows: The case was reported immunization coordinator for multiple patients. The age at vaccination was not reported. Immunization coordinator reported that the administration of Pediarix, Kinrix, Havrix, Engerix B, Rotarix, Boostrix, Fluarix and Flulaval after below temperature excursion of 31.0 degree F. Health care professional was unable to provide any adverse event information for the vaccinations at the time of call. This adverse event had affected multiple patients from October 2020 to June 2021. The reporter had provided phone number and email address. The reporter was ok with the safety team to follow-up about the adverse event information. Note- Referring sales data sheet was also out of scope, therefore reported batch number (2235P) was captured in both Fluarix and Flulaval.

Other Meds:

Current Illness:

ID: 1677063
Sex: F
Age:
State: DE

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: received the first dose did not return within the recommended time frame to receive the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 25th September 2020). 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. The pharmacist stated that, the patient did not return within the recommended time frame to receive the second dose, which led to incomplete course of vaccination. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1677068
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: market shortage; This case was reported by a consumer and described the occurrence of product supply issue in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in February 2020). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, not able to get 2nd dose of Shingrix becasue of market shortage, which led to product supply issue. The reporter asked, it was been 1.5 years could go ahead and get second dose now or did have to restart the series. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1677069
Sex: U
Age:
State: WI

Vax Date: 08/31/2021
Onset Date: 08/31/2021
Rec V Date: 09/07/2021
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: 56 years old received Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 56-year-old patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 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 31st August 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 31st August 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. The action taken with Bexsero Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 a patient of age 56 years old received dose of Bexsero, which led to inappropriate age at vaccine administration. The reporter wanted to know if it was likely to happen any side effects. The reporter stated that, reported with the data obtained before the call disconnected. Tried to contact health care professional so as to finish collecting missing data but without success. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1677071
Sex: F
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/07/2021
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: FALL; HURT MY KNEES; FELT LIKE I GOT HIT BY A TRUCK; BODY ACHES SO BAD; MIGRAINE; COLD SWEATS ARE INSANE/SWEATING; EXHAUSTED SO TIRED; FEVER; This spontaneous report received from a patient concerned a female 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: Unk) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced body aches so bad. On AUG-2021, the patient experienced migraine. On AUG-2021, the patient experienced cold sweats are insane/sweating. On AUG-2021, the patient experienced exhausted so tired. On AUG-2021, the patient experienced fever. On 31-AUG-2021, the patient experienced felt like i got hit by a truck. On an unspecified date, the patient experienced fall, and hurt my knees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold sweats are insane/sweating, and the outcome of body aches so bad, migraine, exhausted so tired, fever, felt like i got hit by a truck, fall and hurt my knees was not reported. This report was non-serious.

Other Meds:

Current Illness:

Date Died:

ID: 1677072
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: DIED; This spontaneous report received from consumer social media via a company representative concerned a 20 year old female of unknown race and ethnicity. 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, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death and it was unknown if an autopsy was performed. The action taken with covid-19 vaccine was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210902775.; Sender's Comments: V0:20210902754-covid-19 vaccine Died. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1677073
Sex: F
Age:
State: UT

Vax Date:
Onset Date: 03/08/2021
Rec V Date: 09/07/2021
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: 20210503; Test Name: Spinal tap; Result Unstructured Data: ruled out clotting, Rheumatoid arthritis, gout; Test Date: 20210503; Test Name: Inflammatory marker test; Result Unstructured Data: found inflammation markers; Test Date: 20210503; Test Name: Diagnostic ultrasound; Result Unstructured Data: ruled out clotting, Rheumatoid arthritis, gout; Test Date: 20210504; Test Name: Diagnostic ultrasound; Result Unstructured Data: ruled out clotting.

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: PARALYZED/FROZEN TOES; SCAR ON KNEE STARTED SWELLING; SCAR ON KNEE PAINFUL; FOOT PAIN; TORN MENISCUS; FALL; TIGHTENING OF THE JAW/ PARALYZED/ FROZEN JAW; SWOLLEN ARM/ FOOT SWELLING; TENDER ARM; This spontaneous report received from a patient concerned a 57 year old White female. The patient's weight was 169 pounds, and height was 65 inches. The patient's past medical history included: scalp psoriasis, colon cancer, 18 inches of transverse colon removed, depression, lymph nodes removed (due to prior colon cancer surgery), abscess tonsil, freezing of jaw, fall, and past injuries on the left side, and concurrent conditions included: non-smoker, non-alcoholic, and scar on knee. The patient had no history of drug abuse or illicit drug usage. The patient was previously treated with citalopram for depression, bupropion hydrochloride for depression, omeprazole for depression; and experienced muscle spasms when treated with procaine hydrochloride for drug used for unknown indication, and drug allergy when treated with epinephrine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total, administered on right arm on 05-MAR-2021 at afternoon around 16:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient experienced a small amount of swelling underneath the arm that was a little tender that started for 3-4 days and only lasted a couple of days. On 08-APR-2021, the patient started experiencing a tightening of the jaw, similar to temporomandibular pain. On 21-APR-2021, the patient's jaw was paralyzed/frozen. The patient could only fit a finger in the jaw. The patient visited emergency room on same day for the jaw and was not admitted. They ruled out infection, referred her to ENT and gave a shot for the pain. The surgery was recommended, but she preferred to due surgery. The scar on knee from the fall 15 years ago started swelling (was not too painful at the time and also given as knee pain and swelling). Her small toe and two toes in from the left became paralyzed (paralyzed/frozen toes). On 02-MAY-2021, she was in a lot of pain and started walking with a cane. Around 03-MAY-2021, her knee "ballooned out" and foot started swelling. She had visited her primary care physician, ENT, and orthopedic guy. The patient also had emergency room visit for the knee/foot on 03-MAY-2021. They ruled out clotting, rheumatoid arthritis and gout. They found inflammation markers and performed spinal tap and ultrasound. On 04-MAY-2021, the patient had DVT ultrasound, which ruled out clotting. At the end of MAY-2021, she took a fall and tore her meniscus. In JUL-2021, she had surgery to repair it. She was now doing rehab to help with the swelling and pain. All of the ailments affected her right side. The residual symptoms were pain in foot, right foot, pinky foot and next toe in had not woken up (still paralyzed). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tightening of the jaw/ paralyzed/ frozen jaw, torn meniscus, scar on knee started swelling, and scar on knee painful, and tender arm on MAR-2021, had not recovered from paralyzed/frozen toes, and foot pain, and the outcome of swollen arm/ foot swelling and fall was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210903197-JANSSEN COVID-19 VACCINE Ad26.COV2.S -paralyzed/frozen toes -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). V0:20210903197- JANSSEN COVID-19 VACCINE Ad26.COV2.S -torn meniscus -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 medical history, underlying condition (fall )

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker; Scar.

Date Died:

ID: 1677074
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: COVID-19; This spontaneous report received from a company representative concerned multiple patients of unknown race and ethnic origin. No past medical history or concurrent conditions were reported. 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. Per procedure no follow up will be requested for this case. No concomitant medications were reported. It was reported that "529 people had died of COVID-19 since 01-APR-2021. According to the ADPH, this included twenty people who were vaccinated, who did their part in the fight against COVID-19". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210903589- JANSSEN COVID-19 VACCINE Ad26.COV2.S- COVID-19. 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.; Reported Cause(s) of Death: COVID-19

Other Meds:

Current Illness:

ID: 1677075
Sex: F
Age:
State:

Vax Date:
Onset Date: 08/18/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: BODY ACHES; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose and frequency were not reported from 23-JUL-2021 for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On 18-AUG-2021, the patient experienced body aches. On 18-AUG-2021, the patient experienced nausea. On 18-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with risankizumab was withdrawn. The patient recovered from body aches, nausea, and headache on 20-AUG-2021. This report was non-serious.

Other Meds:

Current Illness: Plaque psoriasis

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am