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: 1705997
Sex: M
Age: 59
State: VA

Vax Date: 09/08/2021
Onset Date: 09/08/2021
Rec V Date: 09/17/2021
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: Error: Wrong Dose of Vaccine - Too Low-

Other Meds:

Current Illness:

ID: 1705998
Sex: M
Age: 59
State: VA

Vax Date: 09/08/2021
Onset Date: 09/08/2021
Rec V Date: 09/17/2021
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: Error: Wrong Dose of Vaccine - Too Low-

Other Meds:

Current Illness:

ID: 1706313
Sex: F
Age: 63
State: PA

Vax Date: 04/04/2021
Onset Date: 05/05/2021
Rec V Date: 09/17/2021
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: Inflammation Sciatic Nerve; Stabbing pain right hand, left knee, left arch; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL NERVE LESION (Inflammation Sciatic Nerve), PAIN (Stabbing pain right hand, left knee, left arch) and CHILLS (chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 025C21A) for COVID-19 vaccination. The patient's past medical history included Sacroiliitis (lasted for months.), Radiculopathy (Patient had 2 pinched nerves. he felt electric shocks every time he moved during sleep and upon walking which lasted for 2 months and in middle of August, the pain had resolved) and Accident automobile (The patient was injured in 2002, in a car accident) in 2002. Previously administered products included for an unreported indication: FLU (flu shot every year.). On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Stabbing pain right hand, left knee, left arch). On 06-Jun-2021, the patient experienced PERIPHERAL NERVE LESION (Inflammation Sciatic Nerve). In 2021, the patient experienced CHILLS (chills). At the time of the report, PERIPHERAL NERVE LESION (Inflammation Sciatic Nerve) was resolving, PAIN (Stabbing pain right hand, left knee, left arch) outcome was unknown and CHILLS (chills) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Additional information provided by the reporter includes that he had experienced electric shock on left side of body radiating from left buttock to foot. Symptoms were continuing every day upon walking. After treatment and chiropractic therapy the pain had shifted to right side but less severe. Patient had reported that he took Steroids for treating severe left side pain. He also stated that after 2nd dose of vaccine, he had experienced stabbing pain in left knee in middle of night and radiated towards left foot which continued for 30 minutes. Additional information includes for lab data where patient had underwent Ultrasound test on an unknown date and results were inconclusive. Treatment information was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1706314
Sex: F
Age:
State: WA

Vax Date: 09/04/2021
Onset Date:
Rec V Date: 09/17/2021
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: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had not resolved. No concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1706315
Sex: M
Age: 25
State: UT

Vax Date: 08/26/2021
Onset Date: 09/02/2021
Rec V Date: 09/17/2021
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: Stain of blood visible every once in a while I blow my nose; My lips were badly dry and cracked; Sense of smell and taste off; Sense of smell and taste off; soar throat; Soar nose; muscle weaker; fever; chills; headache; Weak bones; Migraine; This spontaneous case was reported by a consumer and describes the occurrence of RESORPTION BONE INCREASED (Weak bones), MIGRAINE (Migraine), EPISTAXIS (Stain of blood visible every once in a while I blow my nose), LIP DRY (My lips were badly dry and cracked) and ANOSMIA (Sense of smell and taste off) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Sleep apnea. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced RESORPTION BONE INCREASED (Weak bones), MIGRAINE (Migraine), ANOSMIA (Sense of smell and taste off), AGEUSIA (Sense of smell and taste off), OROPHARYNGEAL PAIN (soar throat), NASAL DISCOMFORT (Soar nose), MUSCULAR WEAKNESS (muscle weaker), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). On 05-Sep-2021, the patient experienced EPISTAXIS (Stain of blood visible every once in a while I blow my nose) and LIP DRY (My lips were badly dry and cracked). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, RESORPTION BONE INCREASED (Weak bones), MIGRAINE (Migraine), ANOSMIA (Sense of smell and taste off), AGEUSIA (Sense of smell and taste off), OROPHARYNGEAL PAIN (soar throat), NASAL DISCOMFORT (Soar nose), MUSCULAR WEAKNESS (muscle weaker), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) had not resolved and EPISTAXIS (Stain of blood visible every once in a while I blow my nose) and LIP DRY (My lips were badly dry and cracked) outcome was unknown. No Concomitant Drug was provided Treatment Drug: Ibuprofen

Other Meds:

Current Illness: Sleep apnea

ID: 1706385
Sex: F
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/17/2021
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: Test Date: 20210830; Test Name: COVID-19; Test Result: Positive

Allergies:

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

Symptoms: had two doses of the COVID-19 vaccine, completed them in APR/2021; States it is covered with single blisters; developed a new rash over her entire anterior trunk./ viral rash; have symptoms of a severe cold/congested nose, severe headache, extreme muscle/body aching; she began to have symptoms of a severe cold on 8/26/2021 and progressively got worse over the next fewdays/ last week that she had gotten sick and tested positive for COVID; bad headache; Pt states that on day 4 after this injection, her "usual pain came back; usual pain came back/still "hurting"; respiratory distress; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer based on information received by Pfizer from Amgen (manufacturer control number US-AMGEN-USASL2021126859), license party for etanercept (ENBREL). This solicited report (USASL2021126859) was reported to Amgen on 16/AUG/2021 by a consumer from a commercial program and involves a 59 year old female patient who experienced bad headache [PT: headache] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on 11/AUG/2021. Approximately 1 days later, on 12/AUG/2021, the patient had a bad headache. Therefore, the patient took Tylenol (paracetamol) to attempt to relieve. The headache lasted for two days. Treatment for the event included Tylenol (paracetamol). The outcome of the event headache was reported as recovered/resolved. The event headache was resolved on 14/AUG/2021. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the event headache. The causal relationship between the event headache and Enbrel and Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined to provide lot number. The reporter declined consent to contact. No follow up attempts are possible. No further information is expected. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Amgen Assessment: The event headache was assessed as related to etanercept by Amgen. The reporter's assessment of headache with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up (23Aug2021): This is a follow-up solicited report form a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021126859), license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 23/AUG/2021: In this follow up report, the patient's usual pain came back/still hurting [PT: pain], the patient stated that on day four after this injection, her usual pain came back [PT: therapeutic product effect incomplete] while receiving Enbrel with Single Dose Prefilled Autoinjector. On an unknown date in AUG/2021, on day four after this injection, the patient's usual pain came back that she still hurting. Enbrel injection would due in two days. The outcome of the event pain was reported as not recovered/not resolved. The outcome of the event therapeutic product effect incomplete was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was continued for the events pain and therapeutic product effect incomplete. The consumer reported that the event therapeutic product effect incomplete was possibly related to Enbrel. The causal relationship between the event pain and Enbrel and Single Dose Prefilled Autoinjector was not provided by the consumer. The causal relationship between the event therapeutic product effect incomplete and Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent to contact. No follow up attempts are possible. No further information is expected. Amgen Causality Assessment: The events headache and drug effect incomplete was assessed as related to etanercept by Amgen. The event pain was assessed as unrelated to etanercept by Amgen. The reporter's assessment of pain and headache with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up (01Sep2021): This is a follow-up solicited report form a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021126859), license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 01/SEP/2021 AND 08/SEP/2021: The case was upgraded to serious 01/SEP/2021. This serious solicited report was reported to Amgen by a consumer from a commercial program and involves a 59 year old female patient who had respiratory distress [PT: respiratory distress], states it is covered with single blisters [PT: blister], developed a new rash over her entire anterior trunk./ viral rash [PT: viral rash], she began to have symptoms of a severe cold on 8/26/2021 and progressively got worse over the next fewdays/ last week that she had gotten sick and tested positive for COVID [PT: sars-cov-2 test positive], have symptoms of a severe cold/congested nose, severe headache, extreme muscle/body aching [PT: nasopharyngitis] while receiving Enbrel with Single Dose Prefilled Autoinjector. The patient's historical vaccination included COVID-19 vaccine (in APR/2021). On 26/AUG/2021, the patient had gotten sick and was tested positive for COVID-19 on 30/AUG/2021. Patient began to have symptoms of a severe cold on 26/AUG/2021 and progressively got worse over the next few days. On an unknown date in 2021, she had a congested nose, severe headache, extreme muscle/body aching, and some respiratory distress. Patient mentioned she was still feels awful but, her breathing improved and the headache was nearly gone. She had two doses of the COVID-19 vaccine, completed them in APR/2021. Patient was exposed to COVID-19 at work. Patient also mentioned she missed Enbrel doses since 25/AUG/2021. On 05/SEP/2021 three days ago, she developed a new rash over her entire anterior trunk. Patient clarified it was covered with single blisters. She did see her physician and was told that it was not "Shingles", but some other viral rash and patient was given an antiviral to take. On 08/SEP/2021, she reported she was doing somewhat better. The outcome of the events respiratory distress, headache, sars-cov-2 test positive, nasopharyngitis were reported as recovering/resolving. The outcome of the events blister, viral rash was reported as unknown. Action taken with Enbrel was reported as unknown for the event headache. Action taken with Enbrel was temporarily withheld for the events sars-cov-2 test positive, nasopharyngitis and respiratory distress. Action taken with Enbrel was continued for the events pain and therapeutic product effect incomplete. Action taken with Single Dose Prefilled Autoinjector was reported as unknown for the event headache. Action taken with Single Dose Prefilled Autoinjector was continued for the events pain and therapeutic product effect incomplete. Action taken with Single Dose Prefilled Autoinjector was temporarily withheld for the events sars-cov-2 test positive, nasopharyngitis and respiratory distress. The consumer reported that the event therapeutic product effect incomplete was possibly related to Enbrel. The causal relationship between the events headache, pain, sars-cov-2 test positive, blister, viral rash, nasopharyngitis, respiratory distress and Enbrel was not provided by the consumer. The causal relationship between the eve

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1706386
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Fever; Swelling at injection side; Pain and tenderness at injection side; Extremely difficult to sleep or rest in any manner; Side effects impacted daily activity; On 27AUG2021, a spontaneous report was received from a patient. On an unknown date, an adult male (age unknown) experienced "swelling at injection side" (PT: Injection site swelling), "pain and tenderness at injection side" (PT: Injection site pain), and "fever" (PT: Pyrexia) after receiving a second dose (date unknown) of BioThrax (anthrax vaccine adsorbed). The patient, who was also a company representative, reported that "all of these side effects lasted for a couple days and impacted daily activity and made it extremely difficult to sleep or rest in any manner" (PT: Loss of personal independence in daily activities, PT: Insomnia). The reporter stated that he was under the impression that the events he experienced were "standard side effects" of the product, but was advised to report these events. The outcome of the events swelling at injection site, pain and tenderness at injection site and fever were reported as recovered/resolved. The outcome of the events impacted daily activity and difficult to sleep or rest was unknown. The patient's medical history and concomitant medication use was unknown. No additional information was provided regarding these event. Company Comment: The injection site reaction and fever are known phenomenon caused by BioThrax and considered "probable" related. Difficulty sleeping and impaired daily activities were a consequence of the injection site reaction but not due to the vaccine. The Company considers that these events are not related.

Other Meds:

Current Illness:

ID: 1706388
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/05/2021
Rec V Date: 09/17/2021
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: was fully vaccinated against shingles 2 years ago and came down with shingles five days ago; came down with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included covid-19 (came down with covid 3 weeks before the day of reporting in August 2021). Previously administered products included COVID 19 VACCINE MODERNA (was fully vaccinated with COVID 19 VACCINE MODERNA in March 2021). On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On 5th September 2021, between 1 and 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was fully vaccinated against shingles 2 years ago and came down with shingles five days before the day of reporting. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles was unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1706391
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: had them after the shot/ suspected vaccination failure; had them; This case was reported by a consumer via interactive digital media and described the occurrence of 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 reporter stated that, after the shot, had 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. This case was linked with cases US2021AMR195007 and US2021AMR194989, reported by same reporter for different patients.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR194989:same reporter US-GLAXOSMITHKLINE-US2021AMR195007:same reporter

Other Meds:

Current Illness:

ID: 1706392
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Polymyalgia Rhuemetica; This case was reported by a consumer via interactive digital media and described the occurrence of polymyalgia rheumatica 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 polymyalgia rheumatica (serious criteria GSK medically significant). The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the polymyalgia rheumatica was recovered/resolved. The reporter considered the polymyalgia rheumatica to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient reported that the shingles vaccine gave polymyalgia rhuematica a listed side effect. The patient took 30 months of steroids to get it in remission. The patient could not take vaccine because they could trigger it out of remission, not good during a pandemic . The patient wish that had never taken the shingles vaccine. The contact details of patient was not reported hence follow-up not possible.

Other Meds:

Current Illness:

ID: 1706393
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Mother had the shots and still got shingles/ suspected vaccination failure; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 reporter was the patient's son or daughter. The age at vaccination was not reported. The reporter stated that, his or her mother got shot and still had shingles and pain. The reporter stated that, the physician could not seam to have her any thing to help. 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: 1706394
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: got the 2 vaccines/ Suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 the patient's wife. The age at vaccination was not reported. The reporter stated that, her husband got the 2 vaccines and then got 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: 1706395
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: got vaccine/ Suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, got vaccinated then got 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: 1706399
Sex: U
Age:
State:

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/17/2021
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: shingrix shot expires expires on 4-30-21; This case was reported by a consumer via (Shingrix interactive digital media and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 30th April 2021) for prophylaxis. On 10th September 2021, the patient received the 1st dose of Shingrix. On 10th September 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a expired shot of Shingrix expired on 30th April 2021 which led to expired vaccine used. The patient enquired if the expiry date was written wrong in the sheet which they give him/her. Follow-up would not be possible as no contact details available.

Other Meds:

Current Illness:

ID: 1706400
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: had Shingrix vaccine about two years ago,I did not get the second injection; This case was reported by a consumer via (Shingrix) 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 2 years ago on an unknown date). 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 case was reported by the consumer for herself/himself. The age at vaccination was not reported. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient asked, should he/she start the two injection vaccine again.

Other Meds:

Current Illness:

ID: 1706401
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: first shot for Shingrix one year ago and not received 2nd 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. Previously administered products included Shingrix (1st shot received one year ago from the date of reporting). 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 reported as follows: The age at vaccination was not applicable for this report. The reporter asked what was the recommendation when a customer received the 1st shot for Shingrix one year ago from the date of reporting, the patient did not received 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. No contact details were available.

Other Meds:

Current Illness:

ID: 1706402
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: first one like to have killed me; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience 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 near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown. It was unknown if the reporter considered the near death experience 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 reported that, first dose liked to had killed him/her.

Other Meds:

Current Illness:

ID: 1706403
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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. 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. In spring at the time of reporting after receiving both the doses of Shingles vaccine, the patient broke out in shingles across right chest under arm and a tiny bit on the back. Nothing was foolproof, they definitely made him/her notice them, but sure they were not as severe as if he/she had never gotten the shots. 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: 1706404
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: This case was reported by an other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a male 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 reported as follows: The age at vaccination was not applicable for this report. The reporter said if a patient missed his 2nd dose of Shingrix by 1 year, do they have to restart the 2 dose vaccination. The patient did not received 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. No contact details were available.

Other Meds:

Current Illness:

ID: 1706405
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: only the reconstitute agent was given; only the reconstitute agent was given; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown. Additional details were reported as follows: The age at vaccination was not reported. Nurse only administered one part of the product. She explained that only the reconstitute agent was given which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter did not know any more information. The reporter agree to follow up.

Other Meds:

Current Illness:

ID: 1706406
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: received their second dose a week after their first dose; This case was reported by a other health professional via interactive digital media (Shingrix and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included Herpes zoster (Shingrix). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional information was provided as follows: The age at vaccination was not reported. The reporter stated that the patient received the second dose a week after their first dose which led to shortening of vaccination schedule. The reporter asked if the patient would require a third dose in 2 to 6 months.

Other Meds: Shingrix

Current Illness:

ID: 1706407
Sex: M
Age:
State:

Vax Date: 09/13/2021
Onset Date: 09/13/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210913; Test Name: Body temperature; Result Unstructured Data: (Test Result:100.5,Unit:degree F,Normal Low:,Normal High:)

Allergies:

Symptom List: Unevaluable event

Symptoms: low grade temperature; headache; chills; fatigue; nausea; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Men B NVS (Bexsero) 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 13th September 2021 04:30, the patient received Bexsero. On 13th September 2021, the patient started Bexsero Pre-Filled Syringe Device. On 13th September 2021, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fever, headache, chills, fatigue and nausea. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, headache, chills, fatigue and nausea were unknown. It was unknown if the reporter considered the fever, headache, chills, fatigue and nausea to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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 patient was reporter's son. The age at vaccination was not reported. The patient received Bexsero shot and he started having a low grade temperature of 100.5 degree F with Tylenol onboard for an hour. The patient also experienced headache, chills, fatigue and nausea. The reporter asked if these were common side effects. The reporter further stated according to information some was common side effects.

Other Meds:

Current Illness:

ID: 1706408
Sex: U
Age:
State:

Vax Date: 09/13/2021
Onset Date: 09/13/2021
Rec V Date: 09/17/2021
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: This case was reported by a consumer via call center representative and described the occurrence of extremities hot feeling of in a patient who received Herpes Zoster (Shingrix) for prophylaxis. On 13th September 2021, the patient received Shingrix. On 13th September 2021, less than a day after receiving Shingrix, the patient experienced extremities hot feeling of. On an unknown date, the outcome of the extremities hot feeling of was unknown. It was unknown if the reporter considered the extremities hot feeling of to be related to Shingrix. Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient stated that he/she had the shot a couple of hours ago and feeling hot already. The patient wanted to know at what point might the patient start to feel side effects, within a couple of hours or 24 hours. The patient did not think that feeling hot on legs was an adverse event.

Other Meds:

Current Illness:

ID: 1706409
Sex: M
Age:
State: MS

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Suspected vaccination failure; shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 83-year-old male 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 age at vaccination was not reported. The patient received both the doses of Shingrix 2 years ago from the date of reporting. After receiving Shingles vaccine, the patient contracted shingles 2 week ago from the date of reporting. the reporter was not 100 percent sure if the patient got Shingrix but thought so. The reporter did not consent to follow up. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1706411
Sex: U
Age:
State:

Vax Date: 09/12/2021
Onset Date: 09/01/2021
Rec V Date: 09/17/2021
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: Injection site is very red; injection site sore; injection site hot to the touch; i am dizzy; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 12th September 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site pain, injection site warmth and dizziness. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site warmth and dizziness were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site warmth and dizziness to be related to Shingrix. Additional details were provided as follows: The patient self reported this case. Age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced Injection site was very red and sore, hot to the touch, and dizziness. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1706412
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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; I still get 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 (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving 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. Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingrix, the patient still got shingles. The patient stated that, Shingrix did not work for him/her. 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: 1706413
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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; Got shingles; This case was reported by a consumer 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, 2 years after receiving Shingles vaccine and 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 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. 2 years 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 and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1706415
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Suspected vaccination failure; have had them 3 times; very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were 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 three times and it was very painful. The patient would get vaccinated again. 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: 1706416
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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; had shingles; This case was reported by a consumer 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 case was reported for the reporter's sister in law. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. Reporter also had shingles and asked doctor if he could guarantee that he/she would not get them again and he said no. Reporter stated that, there was not been any studies on it to make a guarantee. 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: 1706417
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients 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. Reporter knew few people who after receiving Shingles vaccine, 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: 1706418
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Had both types of vx. Had shingles twice; Had shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles twice on an unknown day before vaccination). 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 had both types of vaccines and still had Shingles twice. The reporter stated that neither type of shot will keep oneself from getting shingles again and will just keep them from being so severe. 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: 1706420
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Patient with prescription for Shingrix first dose at 40 years; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a 40-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (patient had recurrent cases of shingles in the past). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product prescribing error. On an unknown date, the outcome of the intercepted product prescribing error was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was not immunocompromised but had recurrent cases of shingles. The patient was prescribed Shingrix vaccine at 40 years of age, which led to intercepted product prescribing error. The vaccine was not administered till the time of reporting. The patient did not consent to follow-up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021193314:Same reporter.

Other Meds:

Current Illness:

ID: 1706421
Sex: F
Age:
State:

Vax Date: 09/07/2021
Onset Date: 09/01/2021
Rec V Date: 09/17/2021
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: Headache; difficulty swallowing; rash at injection site; sore throat; Red body rash; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of rash (1st dose received on an unknown date, for tolerance refer case US2021AMR194171). Concurrent medical conditions included multiple allergies (taking medication for allergy). On 7th September 2021, the patient received the 2nd dose of Shingrix. On 8th September 2021, 1 days after receiving Shingrix, the patient experienced headache. In September 2021, the patient experienced swallowing difficult, injection site rash, sore throat and red rash. On an unknown date, the outcome of the headache, swallowing difficult, injection site rash, sore throat and red rash were unknown. It was unknown if the reporter considered the headache, swallowing difficult, injection site rash, sore throat and red rash to be related to Shingrix. Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not provided but it could be 59 or 60 years. The patient had allergies and was taking medication for them (allergy pills). The patient received 2nd dose of Shingrix in her left arm and had headache the day after the injection. After 2 days of vaccination, the patient went to hospital emergency room because she had pain, sore throat, had difficulty swallowing and had a rash at injection site but also a red rash on her entire body. No other information was provided. The patient refused to provide name, date of birth or demographics. The patient did not consent to follow-up.

Other Meds:

Current Illness: Multiple allergies (taking medication for allergy)

ID: 1706424
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes Zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 11th March 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. 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 via email.

Other Meds:

Current Illness:

ID: 1706425
Sex: F
Age: 56
State: OH

Vax Date: 08/27/2021
Onset Date: 08/27/2021
Rec V Date: 09/17/2021
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: administered the adjuvant component of Shingrix only.; administered the adjuvant component of Shingrix only.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number MM59F, expiry date 14th October 2022) for prophylaxis. On 27th August 2021, the patient received the 1st dose of Shingrix. On 27th 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 detaails were provided as follows: The medical assistant reported that, the patient was administered the adjuvant component of Shingrix only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1706426
Sex: M
Age: 65
State: VA

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 09/17/2021
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: Malaise; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. In August 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In August 2021, several hours after receiving Shingrix, the patient experienced malaise and fatigue. In August 2021, the outcome of the malaise and fatigue were recovered/resolved. It was unknown if the reporter considered the malaise and fatigue to be related to Shingrix. Additional details were provided are as follows: The case was reported by patient's wife. The patient received 0.5 ml of 2nd dose of Shingrix in the second week of August 2021 and after hours of vaccination, the patient had malaise and fatigue. The malaise and fatigue were resolved after a day and a half. The reporter did not consented to follow-up. The case was linked with case US2021194319 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021194319:Same reporter.

Other Meds:

Current Illness:

ID: 1706427
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: 1st in 2019, hasn't received 2nd dose; This case was reported by a pharmacist 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 in 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. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked, did they need to restart the series. No further details on patient or vaccination. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1706428
Sex: M
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: never got second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 1st August 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. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The health care professional would like to know how to proceed on this case. The health care professional did not have any vaccine information. The reporter stated that, the patient had not received the vaccine at the time of the call. The reporter consented to follow up by phone. The VAERS details were reported for 1st dose of Shingrix.

Other Meds:

Current Illness:

ID: 1706429
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: shot 1 in November 2020, has not received shot 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had mild case of shingles during pregnancy). Previously administered products included Shingrix (1st dose received intramuscularly in an unspecified deltoid during the first week of November 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 reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix and was past the 6 month window, which led to incomplete course of vaccination. The reporter did not consent to follow with physician. The VAERS detail provided for 1st dose of Shingrix.

Other Meds:

Current Illness:

ID: 1706430
Sex: U
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: first dose January 2020, late for second dose; This case was reported by a pharmacist 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 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. No patient's identifiers provided. No lot number and expiration date provided. No specific vaccination date provided. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1706431
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: not received second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received at least 2 years ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not have patient details at time of call, only gender. The VAERS details reported for 1st dose of Shingrix.

Other Meds:

Current Illness:

ID: 1706435
Sex: U
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 09/17/2021
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: First dose April but did not get (second dose); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose April but did not get (second dose)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose April but did not get (second dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose April but did not get (second dose)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment medication was provided.

Other Meds:

Current Illness:

ID: 1706436
Sex: U
Age:
State:

Vax Date: 09/02/2021
Onset Date:
Rec V Date: 09/17/2021
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: not feeling good; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling good), HEADACHE (headache) and MYALGIA (body aches) in a patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 02-Sep-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling good), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, MALAISE (not feeling good), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1706437
Sex: F
Age: 64
State: TX

Vax Date: 12/23/2020
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: IgG antibody test; Test Result: Inconclusive ; Result Unstructured Data: IgG antibody test done and the level was greater than 600

Allergies:

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

Symptoms: Parotid glands became very swollen like mumps; Not feeling well; General fatigue; Headache; Fever; Chills; Perileukoplakia (coating on her tongue); This spontaneous case was reported by an other health care professional and describes the occurrence of LEUKOPLAKIA ORAL (Perileukoplakia (coating on her tongue)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LEUKOPLAKIA ORAL (Perileukoplakia (coating on her tongue)) (seriousness criterion medically significant), PAROTID GLAND ENLARGEMENT (Parotid glands became very swollen like mumps), MALAISE (Not feeling well), FATIGUE (General fatigue), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, LEUKOPLAKIA ORAL (Perileukoplakia (coating on her tongue)) and PAROTID GLAND ENLARGEMENT (Parotid glands became very swollen like mumps) outcome was unknown, MALAISE (Not feeling well), FATIGUE (General fatigue) and HEADACHE (Headache) had not resolved and PYREXIA (Fever) and CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: greater than 600 (Inconclusive) IgG antibody test done and the level was greater than 600. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was reported that approximately five to six months after getting the vaccine, the patient experienced perileukoplakia. Her parotid glands reportedly became tender, like mumps. The patient was not sure if the symptoms were related to the vaccine and her doctors cannot put it together. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment: This case concerns a 65-year-old female patient with no reported relevant medical history, who experienced the unexpected events of leukoplakia, parotid glands became very swollen like mumps, malaise, fatigue, headache, chills and pyrexia. The event occurred following an unknown length of time after the administration of the second dose of Spikevax. Causality assessment for the event was not provided by the reporter. The rechallenge was unknown since there's no information about the first dose. The events of fatigue, headache, chills and pyrexia although consistent with the current understanding of the mechanism of action of the vaccine may not be associated with vaccine administration in this case. The condition appears to be more consistent with an ongoing infection. The benefit-risk relationship of Spikevax in not affected by this report.; Sender's Comments: This case concerns a 65-year-old female patient with no reported relevant medical history, who experienced the unexpected events of leukoplakia, parotid glands became very swollen like mumps, malaise, fatigue, headache, chills and pyrexia. The event occurred following an unknown length of time after the administration of the second dose of Spikevax. Causality assessment for the event was not provided by the reporter. The rechallenge was unknown since there's no information about the first dose. The events of fatigue, headache, chills and pyrexia although consistent with the current understanding of the mechanism of action of the vaccine may not be associated with vaccine administration in this case. The condition appears to be more consistent with an ongoing infection. The benefit-risk relationship of Spikevax in not affected by this report.

Other Meds:

Current Illness:

ID: 1706438
Sex: F
Age: 33
State: MA

Vax Date: 08/22/2021
Onset Date: 08/22/2021
Rec V Date: 09/17/2021
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: Error: Wrong Patient (documentation

Other Meds:

Current Illness:

ID: 1706439
Sex: F
Age: 58
State: CA

Vax Date: 07/30/2021
Onset Date: 07/30/2021
Rec V Date: 09/17/2021
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: Site: Redness at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Visual Changes/Disturbances-Medium

Other Meds:

Current Illness:

ID: 1706440
Sex: F
Age: 16
State: MA

Vax Date: 09/05/2021
Onset Date: 09/05/2021
Rec V Date: 09/17/2021
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: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe

Other Meds:

Current Illness:

ID: 1706441
Sex: F
Age: 59
State: FL

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/17/2021
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: Error: Wrong Dose of Vaccine - Too High-

Other Meds:

Current Illness:

ID: 1706442
Sex: F
Age: 59
State: FL

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/17/2021
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: Error: Wrong Dose of Vaccine - Too High-

Other Meds:

Current Illness:

ID: 1706443
Sex: F
Age: 59
State: FL

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 09/17/2021
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: Error: Booster Given Too Late-

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am