VAERS 2021 Database www.vaers.hhs.gov

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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: 1660811
Sex: F
Age: 48
State: IA

Vax Date: 05/06/2021
Onset Date: 06/01/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 202011; Test Name: Blood test; Result Unstructured Data: Normal general health, including thyroid functions

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: distractive and extremely uncomfortable at work, disruptive; fully awaikning at night; Hot flush; cold sore; muscle soreness/ body aches; fatigue; hot flashes and changes in cycle; hot flashes and changes in cycle; Rising heat sensation in upper body, chest, arm, shoulder, face; patient had regular period in june but then she did not have her period in July and still no period as of now in August; cold sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOT FLUSH (hot flashes and changes in cycle), MENSTRUAL DISORDER (hot flashes and changes in cycle), ORAL HERPES (cold sore), COLD SWEAT (cold sweats) and DISTRACTIBILITY (distractive and extremely uncomfortable at work, disruptive) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Vitamin D deficiency since 2019 and Cold sores (Last one more than 6 months ago). Concomitant products included VITAMIN D NOS for Vitamin D deficiency. On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced HOT FLUSH (hot flashes and changes in cycle), MENSTRUAL DISORDER (hot flashes and changes in cycle), FEELING HOT (Rising heat sensation in upper body, chest, arm, shoulder, face) and MENSTRUATION IRREGULAR (patient had regular period in june but then she did not have her period in July and still no period as of now in August). On 03-Jun-2021, the patient experienced MYALGIA (muscle soreness/ body aches) and FATIGUE (fatigue). In June 2021, the patient experienced COLD SWEAT (cold sweats). On 16-Jun-2021, the patient experienced ORAL HERPES (cold sore). In July 2021, the patient experienced HOT FLUSH (Hot flush). On an unknown date, the patient experienced DISTRACTIBILITY (distractive and extremely uncomfortable at work, disruptive) and INSOMNIA (fully awaikning at night). On 05-Jun-2021, MYALGIA (muscle soreness/ body aches) and FATIGUE (fatigue) had resolved. On 24-Jun-2021, ORAL HERPES (cold sore) had resolved. At the time of the report, HOT FLUSH (hot flashes and changes in cycle) had resolved, MENSTRUAL DISORDER (hot flashes and changes in cycle), COLD SWEAT (cold sweats), FEELING HOT (Rising heat sensation in upper body, chest, arm, shoulder, face), MENSTRUATION IRREGULAR (patient had regular period in june but then she did not have her period in July and still no period as of now in August) and HOT FLUSH (Hot flush) had not resolved and DISTRACTIBILITY (distractive and extremely uncomfortable at work, disruptive) and INSOMNIA (fully awaikning at night) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Blood test: normal (normal) Normal general health, including thyroid functions. It was reported that patient had a cold sore for a couple of days after second dose of the vaccine. Patient experienced hot flashes almost hourly after about 3 weeks after second dose. It was reported that patient had sudden heat in face and upper body for about a minute and then cold sweats afterwards, about 10 times a day around the clock. She reported that her normal period was in June and then didn't have it since (25 days late according to calendar). No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: significant follow up appended, added patient medical history, concomitant medication, and event details. On 14-Aug-2021: Follow-up received on 14-AUG-2021, included no new information.

Other Meds: VITAMIN D NOS

Current Illness: Cold sores (Last one more than 6 months ago); Vitamin D deficiency

ID: 1660877
Sex: F
Age:
State: NY

Vax Date: 06/22/2021
Onset Date: 06/22/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: no additionall AEs reported; expired dose of PNEUMOVAX 23 was administered; This spontaneous report was received from a nurse prescriber concerning an unspecified patient of unknown age and gender. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-JUN-2021, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), expiration date reported as 10-JUN-2021 (lot number, dose, schedule, anatomical location, and route of administration were not reported) for prophylaxis. No additional adverse events (AEs) were reported. This case was considered non-valid due to the lack of patient's identifiers. Follow-up information was received from the nurse on 27-AUG-2021. The patient was a female patient of unknown age. It was stated that it was the only vaccine that the patient received that day and she had not received any vaccines in the four weeks prior. She also confirmed that no adverse events were reported.

Other Meds:

Current Illness:

ID: 1660878
Sex: F
Age: 58
State: IL

Vax Date: 07/28/2021
Onset Date: 07/28/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: PROQUAD was administered to a 58 year old patient; MMRV was ordered and given by mistake; Patient was to recieve an MMR vaccine, MMRV was ordered and given by mistake; This spontaneous report was received from a nurse concerning a 58-year-old female patient. Information regarding the patient's current conditions, medical history and historical drug was not provided. Concomitant vaccines administrated varicella zoster vaccine rge (CHO) (SHINGRIX) On 28-JUL-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter subcutaneous route on the left arm, lot number T034612 expiration date 10-APR-2022 as prophylaxis. However, it was reported that it was intented to be vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) by mistake. No additional adverse event was reported.

Other Meds: SHINGRIX

Current Illness: Prophylaxis

ID: 1660879
Sex: U
Age:
State: MI

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

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: No additional AE reported; a temperature excursion was administered to a patient; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided. On 09-AUG-2021, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml; lot # T029522, expiration date reported as 13-MAR-2022, but upon internal validation established as 13-MAR-2023; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The storage temperature was -4.8 Celsius degrees for 20 minutes. There was no previous temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) was reported. No data logger was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T029522; expirationdate: 13-MAR-2023; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1660880
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: she is one week behind on the second dose of GARDASIL 9.; The caller reported being one week behind due to the clinic not having the available supply for GARDASIL 9.; The caller reported being one week behind due to the clinic not having the available supply for GARDASIL 9.; No AE/PQC reported; This spontaneous report was received from a female patient concerning herself. No concurrent condition, medical history, or concomitant therapy was reported. On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. She was one week behind on the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) due to the clinic not having the available supply for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (product supply issue, circumstance or information capable of leading to medication error and inappropriate schedule of product administration). She refused to provide any additional information regarding the adverse event (AE) for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). No AE was reported.

Other Meds:

Current Illness:

ID: 1660881
Sex: U
Age:
State: AR

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No other AE; temperature excursion on VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 12-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The following lot numbers were involved in the temperature excursion: U002398 (expiration date 22-JAN-2023), T041687 (expiration date 10-DEC-2022), T035399 (expiration date 16-OCT-2022), T028304 (expiration date 20-AUG-2022) and S036637 (expiration date 14-NOV-2021). The vaccine was stored in a temperature of 7.3 degree Fahrenheit (?F) for 20 minutes. There was a previous temperature excursion reported (details not provided). This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 1660882
Sex: M
Age:
State: UT

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: The patient is not experiencing any side effects; Both PROQUAD and MMR-II administered on 19-AUG-2021; This spontaneous report was received from a medical assitant and refers to a 12 months and 15 days old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 19-AUG-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 ml and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 ml for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). Laboratories were not performed and tretament was not given. At the reporting date, the patient was not experiencing any side effects.

Other Meds:

Current Illness:

ID: 1660883
Sex: U
Age:
State: UT

Vax Date: 08/05/2021
Onset Date:
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Improperly stored administered VARIVAX; No additional AE details provided; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # S032356 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 14-OCT-2021) (strength, dose, route of administration and anatomical location were not provided). The temperature of storage and time frame of the excursion were 9.6? Celsius (C) for 80 minutes respectively. If a digital data logger was involved was not reported; varicella virus vaccine live (oka/merck) (VARIVAX) did not experience a previous temperature excursion. No adverse event reported.

Other Meds:

Current Illness:

ID: 1660884
Sex: U
Age:
State: UT

Vax Date: 07/01/2021
Onset Date: 07/01/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Improperly stored administered PROQUAD vaccines; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 01-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # T029103, expiration date 23-FEB-2022 for prophylaxis (dose, anatomical location and route of administration were not reported). The vaccine was stored at the temperature that was reported as 9.6 degrees of Celsius for 80 minutes. There was no previous temperature excursion reported. No additional adverse event reported. This is one of several reports received from the same reporter.

Other Meds:

Current Illness: Prophylaxis

ID: 1660885
Sex: U
Age:
State: UT

Vax Date: 07/26/2021
Onset Date: 07/26/2021
Rec V Date: 09/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: No additional AE details provided; Improperly stored PROQUAD administered vaccine; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported. On 26-JUL-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose, route were not reported, lot # T029103, expiration date: 23-FEB-2022) for prophylaxis (product storage error). It was reported that the suspect vaccine was exposed to a temperature of 9.6 degree Celsius for a time frame of 80 minutes. There were no previous temperature excursions. No additional adverse event (AE) information was provided.

Other Meds:

Current Illness:

ID: 1660886
Sex: U
Age:
State: PA

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

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

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Patient who received their first dose of GARDASIL 9 a couple of years ago. The patient did not receive any additional doses after first dose; No other Adverse Events; This spontaneous report was received from a customer concerning a patient of currently 35-year-old. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter. On an unknown date (couple of years ago/unable to specify date of administration), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route, lot#, and the expiration date were not reported) for prophylaxis. The patient did not receive any additional doses after the 1st dose. Confirmed with customer no other AE occurred (inappropriate schedule of product administration and no adverse event).

Other Meds:

Current Illness:

ID: 1660887
Sex: M
Age:
State: VT

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

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

Lab Data: Test Name: Varicella serologies; Test Result: Negative

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Disseminated VZV; Patient is quite ill; This spontaneous report was received from a physician, and refers to a 33 year old male patient. The patient's concurrent conditions included seronegative inflammatory arthritis, and his concomitant medications included methotrexate, etanercept (ENBREL), and prednisone (all given for the concurrent condition). The patient had no prior history of primary varicella. On an unknown date (reported as one month prior), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, route, anatomical location, lot #, and expiration date were not provided) as his serologies were negative for varicella. On an unknown date, the patient experienced disseminated varicella zoster virus (VZV) and was quite ill (illness). Subsequently, on an unknown date, the patient was admitted to hospital because of the events. The outcome of the events was unknown. The reporter's causality assessment between the events and the suspect vaccine was not provided. Upon internal review, disseminated varicella zoster virus (VZV) was determined to be a medically significant event.

Other Meds: METHOTREXATE; ENBREL; PREDNISONE

Current Illness: Seronegative arthritis

ID: 1660888
Sex: F
Age: 67
State: CA

Vax Date: 03/09/2017
Onset Date:
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Inappropriate schedule of vaccine administered; Inappropriate schedule of vaccine administered; This spontaneous report was received from an adult female patient, concerning to herself via medical record from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs# 1902USA002572). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported. On 09-MAR-2017, the patient was vaccinated with pneumococcal polysaccharide PPV23 (manufacturer unknown) (dose, route of administration, anatomical site, vaccination scheme, lot number, and expiration date were not provided). It was reported that other doses of pneumonia (manufacturer unknown) (dose, route of administration, anatomical site, vaccination scheme, lot number, and expiration date were not provided) were administered on approximately 2019 and 2020, she did no recall that exact date (inappropriate schedule of product administration). This is one of two reports received from the same patient. ; Sender's Comments: US-009507513-1902USA002572:

Other Meds:

Current Illness:

ID: 1660889
Sex: U
Age:
State: AR

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No other AE; temperature excursion on VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 12-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The following lot numbers were involved in the temperature excursion: U002398 (expiration date 22-JAN-2023), T041687 (expiration date 10-DEC-2022), T035399 (expiration date 16-OCT-2022), T028304 (expiration date 20-AUG-2022) and S036637 (expiration date 14-NOV-2021). The vaccine was stored in a temperature of 7.3 degree Fahrenheit (?F) for 20 minutes. There was a previous temperature excursion reported (details not provided). This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 1660890
Sex: U
Age:
State: AR

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No other AE; temperature excursion on VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 12-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The following lot numbers were involved in the temperature excursion: U002398 (expiration date 22-JAN-2023), T041687 (expiration date 10-DEC-2022), T035399 (expiration date 16-OCT-2022), T028304 (expiration date 20-AUG-2022) and S036637 (expiration date 14-NOV-2021). The vaccine was stored in a temperature of 7.3 degree Fahrenheit (?F) for 20 minutes. There was a previous temperature excursion reported (details not provided). This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 1660891
Sex: U
Age:
State: AR

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: No other AE; temperature excursion on VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 12-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The following lot numbers were involved in the temperature excursion: U002398 (expiration date 22-JAN-2023), T041687 (expiration date 10-DEC-2022), T035399 (expiration date 16-OCT-2022), T028304 (expiration date 20-AUG-2022) and S036637 (expiration date 14-NOV-2021). The vaccine was stored in a temperature of 7.3 degree Fahrenheit (?F) for 20 minutes. There was a previous temperature excursion reported (details not provided). This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 1660892
Sex: U
Age:
State: AR

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No other AE; temperature excursion on VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 12-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The following lot numbers were involved in the temperature excursion: U002398 (expiration date 22-JAN-2023), T041687 (expiration date 10-DEC-2022), T035399 (expiration date 16-OCT-2022), T028304 (expiration date 20-AUG-2022) and S036637 (expiration date 14-NOV-2021). The vaccine was stored in a temperature of 7.3 degree Fahrenheit (?F) for 20 minutes. There was a previous temperature excursion reported (details not provided). This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 1660893
Sex: U
Age:
State: AR

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/01/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: No other AE; temperature excursion on VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 12-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The following lot numbers were involved in the temperature excursion: U002398 (expiration date 22-JAN-2023), T041687 (expiration date 10-DEC-2022), T035399 (expiration date 16-OCT-2022), T028304 (expiration date 20-AUG-2022) and S036637 (expiration date 14-NOV-2021). The vaccine was stored in a temperature of 7.3 degree Fahrenheit (?F) for 20 minutes. There was a previous temperature excursion reported (details not provided). This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 1660894
Sex: U
Age:
State: AR

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: No other AE; temperature excursion on VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 12-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The following lot numbers were involved in the temperature excursion: U002398 (expiration date 22-JAN-2023), T041687 (expiration date 10-DEC-2022), T035399 (expiration date 16-OCT-2022), T028304 (expiration date 20-AUG-2022) and S036637 (expiration date 14-NOV-2021). The vaccine was stored in a temperature of 7.3 degree Fahrenheit (?F) for 20 minutes. There was a previous temperature excursion reported (details not provided). This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 1660895
Sex: U
Age:
State: AR

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/01/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: No other AE; temperature excursion on VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 12-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The following lot numbers were involved in the temperature excursion: U002398 (expiration date 22-JAN-2023), T041687 (expiration date 10-DEC-2022), T035399 (expiration date 16-OCT-2022), T028304 (expiration date 20-AUG-2022) and S036637 (expiration date 14-NOV-2021). The vaccine was stored in a temperature of 7.3 degree Fahrenheit (?F) for 20 minutes. There was a previous temperature excursion reported (details not provided). This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 1660896
Sex: U
Age:
State: AR

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No other AE; temperature excursion on VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 12-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The following lot numbers were involved in the temperature excursion: U002398 (expiration date 22-JAN-2023), T041687 (expiration date 10-DEC-2022), T035399 (expiration date 16-OCT-2022), T028304 (expiration date 20-AUG-2022) and S036637 (expiration date 14-NOV-2021). The vaccine was stored in a temperature of 7.3 degree Fahrenheit (?F) for 20 minutes. There was a previous temperature excursion reported (details not provided). This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 1660897
Sex: U
Age:
State: AR

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: No other AE; temperature excursion on VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 12-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The following lot numbers were involved in the temperature excursion: U002398 (expiration date 22-JAN-2023), T041687 (expiration date 10-DEC-2022), T035399 (expiration date 16-OCT-2022), T028304 (expiration date 20-AUG-2022) and S036637 (expiration date 14-NOV-2021). The vaccine was stored in a temperature of 7.3 degree Fahrenheit (?F) for 20 minutes. There was a previous temperature excursion reported (details not provided). This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 1660898
Sex: U
Age:
State:

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: No additional AE reported; An expired dose of M-M-R-II was administered to the patient; This spontaneous report was received from a physician concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported. On 19-AUG-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter, for prophylaxis (lot number S025155, has been determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and establish as 13-AUG-2021) (strength, route of administration and anatomical location were not provided). No adverse event reported.

Other Meds:

Current Illness:

ID: 1660899
Sex: U
Age: 33
State: IN

Vax Date: 08/18/2021
Onset Date: 08/25/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: No other AEs reported; Patient received VARIVAX less than 28 days after MMRII; This spontaneous report was received from a nurse concerning a 33 year old patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported. On 18-AUG-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T013727 was determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and establish as 21-APR-2022) (strength, dose, route of administration and anatomical location were not provided). On 25-AUG-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (inappropriate schedule of product administration) for prophylaxis (lot number U002399 was determined to be valid for varicella virus vaccine live (oka/merck), expiration date reported and establish as 22-JAN-2023) (strength, dose, route of administration and anatomical location were not provided). No adverse event reported.

Other Meds:

Current Illness:

ID: 1660900
Sex: U
Age:
State: MD

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: No additional AE reported.; PROQUAD was administered on 08/24/2021 following a temperature excursion.; This spontaneous report was received from an office manager and refers to a patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies. On 24-AUG-2021, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella, and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (concentration, dose, vaccination scheme frequency, route, and anatomical site of administration were not reported; lot number U009260 was verified to be a valid lot number with an expiration date reported and established as 19-SEP-2022) for prophylaxis. It was reported that the administered vaccine experienced a temperature excursion of minus (-)10.7 degrees Celsius (?C) for a time frame of192 hours (product storage error). If there was any previous temperature excursion this information was not reported. No additional adverse event was provided. This is one of two reports reported by the same reporter. Sender's Comments: US-009507513-2108USA007542.

Other Meds:

Current Illness:

ID: 1660901
Sex: U
Age:
State: CA

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: no adverse event; the patient was accidentally administered VARIVAX instead of VAXELIS; 11 month old patient was accidentally administered VARIVAX; This spontaneous report was received from a consumer via representative and refers to an 11-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-AUG-2021, the patient was accidently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter (formulation, route of administration, lot#, expiry date were not reported) for prophylaxis instead of intended diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS). It was reported that there was no further adverse event.

Other Meds:

Current Illness:

ID: 1660902
Sex: U
Age:
State: MD

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: No additional AE reported; Administration following an excursion event; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 24-AUG-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella, and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin) (PROQUAD) lot #T031825 was confirmed to be valid, expiration date 16-MAR-2022, for prophylaxis (dose, route, and site of administration were not reported). The administered dose was exposed to the temperature of -10.7 degrees Celsius for 192 hours. No additional adverse event was provided.

Other Meds:

Current Illness:

ID: 1660903
Sex: F
Age: 66
State: MN

Vax Date: 10/01/2020
Onset Date:
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: SORE ARM; This spontaneous report has been received from a lawyer and the patient, via a Plaintiff from a case in litigation for ZOSTAVAX (MARRS # 2105USA000853), concerning a currently 67-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In October 2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis and with influenza vaccine (FLU) (doses, routes, anatomical location, lot # and expiration dates were not reported). On an unknown date, the patient experienced sore arm. At the reporting time, the outcome of sore arm was unknown. The reporter considered sore arm to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) and influenza vaccine (FLU).; Sender's Comments: US-009507513-2105USA000853:

Other Meds:

Current Illness:

ID: 1660904
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Neuropathy; Injection site itching; Trouble sleeping last night; felt fatigue and weak; felt fatigue and weak; unspecified rotator cuff tear or rupture of right shoulder,; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from the Regulatory Authority (manufacturer control number: US-AMGEN-USASP2020214057), license party for etanercept (ENBREL). This serious spontaneous report (USASP2020214057) was reported to Regulatory Authority on 08/DEC/2020 by a consumer and involves a female patient who had a neuropathy [PT: neuropathy peripheral], injection site itching [PT: injection site pruritus], trouble sleeping last night [PT: insomnia] while receiving Enbrel, Reusable Autoinjector. Off label use was reported. No historical medical condition was reported. The patient's current medical condition included unspecified rotator cuff tear or rupture of right shoulder, not specified as traumatic, and rheumatoid arthritis. The patient's concomitant medications included Albuterol (salbutamol sulfate), Dicyclomine, diltiazem, Enulose (lactulose), Irbesartan HCT (hydrochlorothiazide, irbesartan), Janumet (metformin hydrochloride, sitagliptin phosphate monohydrate), leflunomide, montelukast, omeprazole, pentoxifylline, prednisone, sertraline HCL, simvastatin, Symbicort (budesonide, formoterol fumarate), Alendronate (alendronate sodium). No co-suspect medications were reported. The patient began Enbrel with Reusable Autoinjector on an unknown date. On an unknown date, the patient had itching at injection sites. Also, the patient had neuropathy and was having trouble sleeping on last night. The patient was taking Enbrel for the indication unspecified rotator cuff tear or rupture of right shoulder, not specified as traumatic which was an off label use. No treatment information was received. The outcome of the events neuropathy peripheral, injection site pruritus, and insomnia was reported as not recovered/not resolved. Action taken with Enbrel and Reusable Autoinjector was reported as unknown for the events injection site pruritus, neuropathy peripheral and insomnia. The consumer reported that the events injection site pruritus, neuropathy peripheral and insomnia was possibly related to Enbrel. The causal relationship between the events injection site pruritus, neuropathy peripheral, insomnia and Reusable Autoinjector was not provided by the consumer. The reporter declined consent to contact. No follow up attempts are possible. No further information is expected. RA comment: This safety report does not necessarily reflect a conclusion by RA that etanercept, device,caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product. Follow-up (20Aug2021): This is a follow-up spontaneous report based on information received by Pfizer from Regulatory Authority (Manufacturer control number US-AMGEN-USASP2020214057) from a contactable consumer, license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 20/AUG/2021: In the additional information it was reported that the patient felt fatigue and weak [PT: fatigue and PT: asthenia] while receiving Enbrel with Reusable Autoinjector. The patient's co-suspect medication included COVID-19 Vaccine. On an unknown date, the patient felt fatigue and weak after first dose of COVID-19 vaccine. The outcome of the events fatigue and asthenia was reported as unknown. Action taken with Enbrel and Reusable Autoinjector was reported as unknown for the events fatigue and asthenia. The causal relationship between the events fatigue, asthenia and Enbrel with Reusable Autoinjector was not provided by the consumer. No follow up attempts are possible. No further information is expected. Previous version dated 08/DEC/2020, Enbrel indication was incorrectly captured as "rheumatoid arthritis" instead of "unspecified rotator cuff tear or rupture of right shoulder". Enbrel indication has now been updated as unspecified rotator cuff tear or rupture of right shoulder'. Additional comment: This safety report does not necessarily reflect a conclusion by RA that Denosumab and device, etanercept caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.

Other Meds: Alendronate; Albuterol [Salbutamol Sulfate]; Dicyclomine; Diltiazem; Enulose; Irbesartan HCT; Janumet; Leflunomide; Montelukast; Omeprazole; Pentoxifylline; Prednisone; Sertraline HCL; Simvastatin; Symbicort; Enbrel Mini

Current Illness: Rheumatoid arthritis; Rotator cuff tear (unspecified rupture of right shoulder, not specified as traumatic)

ID: 1660905
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: red under where it was injected; felt warm; elbow pain; hurt down to my elbow; Still hurts to left my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In August 2021, the patient received the 1st dose of Shingles vaccine. In August 2021, several hours after receiving Shingles vaccine, the patient experienced pain in arm, injected limb mobility decreased and pain in elbow. On 20th August 2021, the patient experienced erythema of extremities and feeling of warmth. On an unknown date, the outcome of the pain in arm, injected limb mobility decreased and pain in elbow were not recovered/not resolved and the outcome of the erythema of extremities and feeling of warmth were recovering/resolving. It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, erythema of extremities, feeling of warmth and pain in elbow to be related to Shingles vaccine. Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine and hurt bad down elbow a few hours later, and still hurts to lift patient arm. it's red under where it was injected felt warm last night less today. The patient stated that he/she didn't expect that. The follow up would not be possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1660906
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: gave me an injection at the time I had the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of off label use in a patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included shingles. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown. Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The doctor gave an injection at the time patient had the shingles, which led to off label use. The follow up would not be possible as no contact details were available.

Other Meds:

Current Illness: Shingles

ID: 1660907
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: that vaccine hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient stated that vaccine hurt. The patient further specified that the patient's tetanus shot didn't hurt at all, for reference but if shingles was worse and the patient heard it was, then the patient regret nothing. No contact details were reported.

Other Meds:

Current Illness:

ID: 1660908
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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, 1 day after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient received Shingles vaccine and experienced sickness. For tolerance of 2nd dose of Shingles vaccine, refer case US2021AMR178221, reported by the same reporter. This case has been linked to US2021AMR178143, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR178143:comment response case US-GLAXOSMITHKLINE-US2021AMR178221:Same reporter

Other Meds:

Current Illness:

ID: 1660909
Sex: U
Age:
State:

Vax Date: 08/20/2021
Onset Date: 08/21/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: sick; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, refer case US2021AMR178217). On 20th August 2021, the patient received the 2nd dose of Shingles vaccine. On 21st August 2021, 1 days after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On 22nd August 2021, the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient just got second shot on Friday. The patient was sick the next day after first so the patient expected to be sick 21st August 2021 as well and sure enough the patient was. The patient reported that on the day of reporting all was well. This case has been linked to US2021AMR178143, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR178143:comment response case US-GLAXOSMITHKLINE-US2021AMR178217:Same reporter

Other Meds:

Current Illness:

ID: 1660910
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: broke out with chicken pox; This case was reported by a consumer via interactive digital media and described the occurrence of chickenpox in a male 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, less than a week after receiving Shingles vaccine, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was unknown. It was unknown if the reporter considered the chickenpox to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingles vaccine he broke out with chicken pox. The follow-up would not possible as no contact details were available. For tolerance of 2nd dose of Shingles vaccine, refer link case US2021AMR178363.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR178363:Same reporter

Other Meds:

Current Illness:

ID: 1660911
Sex: M
Age:
State:

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

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: broke out with chicken pox; 2. Vaccines in two days.They gave him vaccine again; off label use; This case was reported by a consumer and described the occurrence of chickenpox in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concomitant products included Herpes zoster (Shingles vaccine). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced chickenpox, drug dose administration interval too short and off label use. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the chickenpox was not recovered/not resolved and the outcome of the drug dose administration interval too short and off label use were unknown. It was unknown if the reporter considered the chickenpox to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingles vaccine and experienced chicken pox. For tolerance of 1st dose of Shingles vaccine, refer case US2021AMR178362. The physician gave two vaccines to the patient in two days and broke out with chicken pox. He got the Shingles vaccine, then he broke out. The reporter took him back to physician, who gave him Shinles vaccine again, he broke out still. The patient received 2nd dose earlier than the recommended schedule, which led to shortening of vaccination schedule. The follow-up would not possible as no contact details were available.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR178362:Same reporter

Other Meds: Shingles vaccine

Current Illness:

ID: 1660912
Sex: M
Age: 62
State: SC

Vax Date: 08/01/2019
Onset Date:
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Approx 15 outbreaks since first and second dose; Rash is itchy; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (experienced approximately 15 outbreaks of Shingles since receiving first). In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles and itchy rash. On an unknown date, the outcome of the shingles and itchy rash were recovered/resolved. It was unknown if the reporter considered the shingles and itchy rash to be related to Shingrix. Additional details were reported as follows: This case was reported by the patient for himself. The patient received shingrix vaccine and experienced approximately 15 outbreaks of Shingles. The patient reported that outbreak always occurs on the left side, on the upper buttocks, lower back where the waistband of the underwear lies. The patient stated that rash was itchy and had the appearance on mosquito or spider bites. The reporter consented to follow up. For second dose refer this case US2021177371,reported by the same patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021177371:

Other Meds:

Current Illness:

ID: 1660913
Sex: U
Age:
State:

Vax Date: 08/19/2021
Onset Date: 08/01/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: hurt; This case was reported by a consumer and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to Shingles vaccine. Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient took the shingles on thursday and stated was not suffered much but it did hurt a lot.

Other Meds:

Current Illness:

ID: 1660914
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Suspected vaccination failure; got them really bad after the shot; 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 mother in law. The age at vaccination was not reported. The patient got shingles really bad after the shot. 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: 1660915
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: shingles; 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 twice). In August 2021, the patient received the 1st dose of Shingles vaccine. In August 2021, less than a day after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and overnight got shingles all over the area of shot. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1660916
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Had the shot, still got Shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient had got the shingle shot and still got shingles. 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: 1660917
Sex: U
Age:
State:

Vax Date: 10/01/2020
Onset Date: 02/01/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included chickenpox (patient had very bad chickenpox when he/she was young which left scars). In December 2020, the patient received the 2nd dose of Shingles vaccine. In October 2020, the patient received the 1st dose of Shingles vaccine. In February 2021, between 1 and 3 months after receiving Shingles vaccine and between 3 and 5 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 and Shingles vaccine. Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient received two doses of Shingles vaccine and still got shingles. The patient was glad that he/she got the shingles vaccine. This case was considered as suspected vaccination failure as details regarding laboratory test confirming herpes zoster were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1660918
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: suspected vaccination failure; shingles; pain; I have been miserable; 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, pain and feeling miserable. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and feeling miserable were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, pain and feeling miserable 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 nonstop for almost 2 years since the patient got the shot. The patient was miserable and in pain since received the shots. 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: 1660919
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: 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, 3 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 details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The patient received shingles shot for shingles and 3 months later patient experienced shingles. 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: 1660920
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: perforation in my small intestine; shingles; pain; nerve damage; This case was reported by a consumer via media and described the occurrence of intestinal perforation 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 intestinal perforation (serious criteria GSK medically significant), shingles, pain and nerve damage. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the intestinal perforation, shingles, pain and nerve damage were unknown. It was unknown if the reporter considered the intestinal perforation, shingles, pain and nerve damage 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 this summer from the date of reporting. The steroids used to treat them caused a perforation in small intestine. Unspecified Steroids used for treatment were also considered as suspect for intestinal perforation. The pain was unbearable and at the time of reporting the patient had nerve damage. The patient could get the vaccine in 6 month but the patient had one shot before and was not told to get a 2nd shot of vaccine. No contact details were reported.

Other Meds: STEROIDS

Current Illness:

ID: 1660921
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: suspected vaccination failure; another attack; 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 (in 40's). 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 vaccine then better one was available then the patient had another attack. The patient said that the patient did not want them again, it was bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.

Other Meds:

Current Illness:

ID: 1660922
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: suspected vaccination failure; so did I. Ive had 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 and had a mild case. 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. This case had been linked with case US2021AMR104430, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR104430:comment response

Other Meds:

Current Illness:

ID: 1660923
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: felt awful; This case was reported by a consumer and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown. It was unknown if the reporter considered the feels awful to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shingle shot and said that if you did not feel bad on the 1st one did not let it fool, because he/she felt awful on the 2nd one, but still the patient was glad he/she did it. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1660924
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: suspected vaccination failure; shingles five times; they hurt bad; 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), 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 patient had reported for himself/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles five times in one year. The patient reported that, it was not fun to get shingles, they hurt bad. The patient finally stayed clear enough to get the shot. The patient suggested that, if you had not got the shot, it was a lot better to get it than to get the shingles. The patient again stated that, shingles hurt like crazy. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1660925
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 himself/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The patient stated, it was not an absolute and wished it were and also stated, they were not fun as you too know. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am