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: 1720697
Sex: M
Age: 20
State: CA

Vax Date: 08/24/2021
Onset Date: 08/25/2021
Rec V Date: 09/22/2021
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: keflex

Symptom List: Dysphagia, Epiglottitis

Symptoms: Patient had severe swelling and redness to joint of left knee the following day after vaccine. It then worsened to include swelling to both knees and ankles although the left knee remained the most swollen, red and painful.

Other Meds: vedolizumab

Current Illness:

ID: 1720698
Sex: F
Age: 70
State: MI

Vax Date: 02/25/2021
Onset Date: 03/01/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: none

Allergies: Acetaminophen

Symptom List: Anxiety, Dyspnoea

Symptoms: Progressively severe oral stomatitis. Multiple lesions of varying sizes developed over about 5-7 days, up to at least 12 at one time.; scattered throughout the mouth, throat, & on soft palate. Treated by both my MD & 12 days later by my dentist. RX from each of "Magic Mouthwash" to swish & swallow. Contents of each very similar...visc lidocaine, antibiotic, & steroid combination. Lesions healing & recurring over 3-4 weeks. Resolved after about 5 weeks.

Other Meds: Ritalin LA, Escitalopram, Aller-tec, Famotidine, Vit D, Multivitamin, Ibuprofen

Current Illness: No

ID: 1720699
Sex: M
Age: 35
State: OH

Vax Date: 05/27/2021
Onset Date: 05/28/2021
Rec V Date: 09/22/2021
Hospital: Y

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: Echo EKG MRI On dates 7/13 -7/21

Allergies: None

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

Symptoms: 2 Seizures and a Stroke due to a blood clot that split into two

Other Meds: Novolin N Novolin R

Current Illness:

ID: 1720700
Sex: F
Age: 53
State: NJ

Vax Date: 08/04/2021
Onset Date: 08/04/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: n/a

Allergies: penicillin

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Immediately after received shot I became disoriented and had severe headache. I had to sit down. About 20 minutes after I had pain in back of my neck in area of lymph nods and under arms. That lasted for less than 1 week, but headache never stopped. I have never experienced this type of pain, its located in the lower part in back of my head, feels like stabbing pain and pressure, almost like heavy head. Past two days the stabbing pain is stronger and I can not sleep. I also have pain in the back of my right knee for 2 weeks and joints on my left hand are enlarged and hurt.

Other Meds: Irbesartan 75 mg

Current Illness: n/a

ID: 1720701
Sex: F
Age: 26
State: CA

Vax Date: 09/15/2021
Onset Date: 09/19/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies: No

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

Symptoms: Pain in armpit. No sense of lumps, but slight pain raising the arm and putting some pressure on the armpit.

Other Meds: No

Current Illness: No

ID: 1720703
Sex: F
Age: 60
State: CA

Vax Date: 09/04/2021
Onset Date: 09/19/2021
Rec V Date: 09/22/2021
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: INR home test

Allergies: Iodine dye

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

Symptoms: INR went very high. 5.6 and Warfarin dose had to be suspended for two days. I also started to have blood in my urine.

Other Meds: Metoprolol Warfarin Losarten Zetia Folic acid Aspirin Folic acid Biotin

Current Illness: Rheumatoid Arthritis Congenital Heart Defect

ID: 1720704
Sex: M
Age: 35
State: VA

Vax Date: 09/17/2021
Onset Date: 09/17/2021
Rec V Date: 09/22/2021
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: none

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: About 2 hours after vaccination site was very sore (similar to Anthrax shot), about 6 hours after shot slight fever and chills/sweating started, along with fatigue and headache. Symptoms persisted for approx. 48 hours and receded.

Other Meds: none

Current Illness: none

ID: 1720705
Sex: F
Age: 76
State: NY

Vax Date: 04/01/2021
Onset Date: 09/13/2021
Rec V Date: 09/22/2021
Hospital: Y

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

Lab Data: COVID positive 9/13/21

Allergies: alendronate (nausea), lisinopril (cough), prednisone (nausea)

Symptom List: Pharyngeal swelling

Symptoms: COVID positive on 9/13/21 despite being fully vaccinated. Now with acute respiratory failure due to covid pneumonia requiring ICU admission and BIPAP. Still in process of being treated. Receiving decadron (requiring increased ARDS dosing due to progressively worsening respriatory status) and remdesivir. Received dose of tocilizumab 800 mg IV today.

Other Meds: amlodipine, aspirin, insulin, gabapentin, metformin...

Current Illness: n/a

ID: 1721188
Sex: F
Age: 26
State: AZ

Vax Date: 09/03/2021
Onset Date: 09/19/2021
Rec V Date: 09/22/2021
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: Previously normal period. First period after vaccine with significantly increased and painful cramping not relieved by otc pain medication. Large clots present. I do not normally have any clots

Other Meds: Effexor, busiporone, valtrex

Current Illness:

ID: 1721189
Sex: F
Age: 23
State: NY

Vax Date: 08/26/2021
Onset Date: 08/27/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: X-Rays. MRI.

Allergies: NA

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Diagnosed with scoliosis and this year 2021 due to back pain and lower lumbar nerve damage from previous knee surgeries on both knees in past years. Got my first dose of Pfizer and felt okay throughout the day until bedtime and woke up the next day in pain.Could NOT feel my back or left arm. It was Stiff, tiggling and Hot/burning feeling all on my upper left side of my body. Felt half dead. No OTC medicine fixed this. I suffered for days. I am due for my next dose to keep my job, BUT i will NOT put myself through this again. I request exemption due to this and WILL NOT harm my body while still under-going my scoliosis process.

Other Meds: NA

Current Illness: NO

ID: 1721190
Sex: M
Age: 35
State: CA

Vax Date: 08/07/2021
Onset Date: 08/09/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: Allergic Conjunctivitis in both eyes

Other Meds: Finasteride, Descovy, hydrochlorothiazide,

Current Illness: None

ID: 1721191
Sex: F
Age: 47
State: NC

Vax Date: 08/30/2021
Onset Date: 09/16/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: 9/19/21 CBC, x-Ray, vascular ultrasound

Allergies: Aspirin; Ibuprofen; All NSAIDS

Symptom List: Rash, Urticaria

Symptoms: Blood clots left arm (1 superficial and 1 DVT)

Other Meds: citalopram 30mg; Qunol 1500mg; D3 1000; zinc; vitamin C; Le-Vell Thrive 1-2-3

Current Illness: None

ID: 1721192
Sex: F
Age: 51
State: NC

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

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

Lab Data:

Allergies: N/a

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

Symptoms: I have a red raised,feverish big heart shape rash at an below my injection site. 6 days later my arm is burning and hot to the touch.

Other Meds: None

Current Illness: N/a

ID: 1721193
Sex: F
Age: 27
State: CO

Vax Date: 09/20/2021
Onset Date: 09/21/2021
Rec V Date: 09/22/2021
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: None

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

Symptoms: Body aches, fever, headache, body rash, dizziness.

Other Meds: None

Current Illness: None

ID: 1721194
Sex: M
Age: 45
State: UT

Vax Date: 09/13/2021
Onset Date: 09/13/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: None

Allergies: None

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

Symptoms: Severe muscle soreness spread from left arm injection site throughout the entire body, Subsided 3 days later and was normal 5 days post injection.

Other Meds: None

Current Illness: None

ID: 1721313
Sex: U
Age:
State: PR

Vax Date:
Onset Date: 04/14/2021
Rec V Date: 09/22/2021
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: 20210414; Test Name: Pulse rate; Result Unstructured Data: 130 {beats}/min; Test Date: 20210414; Test Name: Blood pressure; Result Unstructured Data: very high; Test Date: 20210414; Test Name: Lab test; Result Unstructured Data: negative; Test Date: 20210414; Test Name: Electrocardiogram; Result Unstructured Data: tachycardia; Test Name: Cardiovascular evaluation; Result Unstructured Data: not reported; Comments: very fast heartbeat; Test Name: Lab test; Result Unstructured Data: not reported

Allergies:

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

Symptoms: TACHYCARDIA; VERY HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 04321A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the patient experienced tachycardia. On 14-APR-2021, the patient experienced very high blood pressure. Laboratory data included: Blood pressure (NR: not provided) very high, Electrocardiogram (NR: not provided) tachycardia, Lab test (NR: not provided) negative, and Pulse rate (NR: not provided) 130 {beats}/min. Laboratory data (dates unspecified) included: Cardiovascular evaluation (NR: not provided) not reported, and Lab test (NR: not provided) not reported. Treatment medications (dates unspecified) included: metoprolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tachycardia, and very high blood pressure. This report was non-serious.

Other Meds:

Current Illness:

ID: 1721314
Sex: F
Age:
State: PR

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 09/22/2021
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: Swelling in face, hands and ankles.; Swelling in face, hands and ankles.; Swelling in face, hands and ankles.; Mild numbness and redness in hands; Mild numbness and redness in hands; rash in veins; This is an Initial (PRD/SRD 07Apr2021) and Follow-up (PRD 07Apr2021/SRD 09Apr2021) spontaneous report from a contactable reporter (patient, self-reported). A 64-year-old female patient (age at vaccination:64 years) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP7533 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 05Apr2021 at 09:45 AM, as a single dose for COVID-19 immunization and first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: PAA165969 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 05Mar2021 at 07:30 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included Hashimoto's disease, hypotiroidism, arterial hypertension, and allergies to medications, food, or other products: Penicilina. Concomitant medications included levothyroxine and lisinopril. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 05Apr2021 at 17:30, the patient experienced swelling in face, hands and ankles and mild numbness and redness in hands and rash in veins. The patient did not receive treatment for the adverse event. No lab data was available. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: LEVOTHYROXINE; LISINOPRIL

Current Illness:

ID: 1721350
Sex: M
Age: 44
State: TN

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 09/22/2021
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: Waking up for 20-30 minutes a couple times a night with fitful sleep until I finally get up around 6-630 am; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Waking up for 20-30 minutes a couple times a night with fitful sleep until I finally get up around 6-630 am) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced SLEEP DISORDER (Waking up for 20-30 minutes a couple times a night with fitful sleep until I finally get up around 6-630 am). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SLEEP DISORDER (Waking up for 20-30 minutes a couple times a night with fitful sleep until I finally get up around 6-630 am) had not resolved. Not Provided mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications were reported. Ongoing sleep problems. Taking Zyrtec and is helping a tiny bit. Melatonin is not working. Waking up for 20-30 minutes a couple times a night with fitful sleep until I finally get up around 6-630 am.

Other Meds:

Current Illness:

ID: 1721351
Sex: F
Age: 65
State: MD

Vax Date: 04/01/2021
Onset Date: 05/17/2021
Rec V Date: 09/22/2021
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: fever; chills; Paralyzed right diaphragm and breathing difficulty; Paralyzed right diaphragm and breathing difficulty; This spontaneous case was reported by a consumer and describes the occurrence of DIAPHRAGMATIC PARALYSIS (Paralyzed right diaphragm and breathing difficulty) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced DIAPHRAGMATIC PARALYSIS (Paralyzed right diaphragm and breathing difficulty) (seriousness criterion medically significant) and DYSPNOEA (Paralyzed right diaphragm and breathing difficulty). On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, DIAPHRAGMATIC PARALYSIS (Paralyzed right diaphragm and breathing difficulty) and DYSPNOEA (Paralyzed right diaphragm and breathing difficulty) had not resolved and PYREXIA (fever) and CHILLS (chills) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Lab data included Xrays, CT scans, MRI's and pulmonary function test. No results provided. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter Company comment: The case concerns a 65-year-old female patient with concurrent medical history of asthma who, presented with unexpected event of paralyzed right diaphragm and breathing difficulty 14 days after receiving the second dose of mRNA 1273 vaccine. The patient was not responsive to use of inhalers for underlying disease and no result of diagnostic tests performed (X-ray, CT scan, MRI) were provided. Rechallenge was not applicable, as the event only occurred after the last dose. Causality assessment for the event was not provided by the reported. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: The case concerns a 65-year-old female patient with concurrent medical history of asthma who, presented with unexpected event of paralyzed right diaphragm and breathing difficulty 14 days after receiving the second dose of mRNA 1273 vaccine. The patient was not responsive to use of inhalers for underlying disease and no result of diagnostic tests performed (X-ray, CT scan, MRI) were provided. Rechallenge was not applicable, as the event only occurred after the last dose. Causality assessment for the event was not provided by the reported. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness: Asthma

ID: 1721352
Sex: F
Age:
State: AL

Vax Date:
Onset Date: 08/25/2021
Rec V Date: 09/22/2021
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: Swollen lymph nodes and a hard knot close to breast; Swollen lymph nodes and a hard knot close to breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (Swollen lymph nodes and a hard knot close to breast) and LYMPHADENOPATHY (Swollen lymph nodes and a hard knot close to breast) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Allergic to morphine). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced BREAST MASS (Swollen lymph nodes and a hard knot close to breast) and LYMPHADENOPATHY (Swollen lymph nodes and a hard knot close to breast). At the time of the report, BREAST MASS (Swollen lymph nodes and a hard knot close to breast) and LYMPHADENOPATHY (Swollen lymph nodes and a hard knot close to breast) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness: Drug allergy (Allergic to morphine)

ID: 1721371
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: Abnormal pap smears; This spontaneous report was received from a company representative concerning to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter. Prior to her the vaccine, she never had any issues with her pap smears. In approximately 2011 (reported as 10 years ago), the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose route, frequency, lot# and the expiration date) for Human Papillomavirus (HPV) prevention. After receiving the vaccine (unknown date), she started having abnormal pap smears, year after year. The friend had to repeat pap smears numerous times and even had to perform a colonoscopy (unknown results). She sought medical attention. At the time of reporting, the outcome of smear cervix abnormal was unknown. The reporter considered smear cervix abnormal to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9), reported as "the friend blames hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for giving her abnormal pap smears".

Other Meds:

Current Illness:

ID: 1721376
Sex: F
Age:
State: IA

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: Patient had the first two doses of GARDASIL 9 and now she is 46 years old; Patient had the first two doses of GARDASIL 9 and now she is 46 years old; This spontaneous report was received from a registered nurse, referring to a 46 year old female patient. The patient's medical history, concurrent conditions, and concomitant medications were not reported. On unknown dates (reported as when the patient was 45 years old), the patient received the first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, anatomical location, lot #, and expiration date were not reported) for prophylaxis. At the time of the report (stated by the patient as now), the patient was 46 years old (product administered to patient of inappropriate age and circumstance or information capable of leading to medication error).

Other Meds:

Current Illness:

ID: 1721377
Sex: M
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: Patient received his first administration of GARDASIL 9 at the age of 26 and has not received the rest of recommended doses; No additional adverse events reported; This spontaneous report was received from a pharmacy intern, referring to a 32 year old male patient. The patient's medical history, concurent conditions, and concomitant medications were not reported. On an unknown date (reported as at the age of 26), the patient was vaccinated with the first and only hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, anatomical location, lot #, and expiration date were not provided) for prophylaxis. At the time of the report, the patient had not received the rest of the recommended doses (Inappropriate schedule of product administration). No additional adverse events were reported.

Other Meds:

Current Illness:

ID: 1721383
Sex: F
Age:
State:

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

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

Lab Data: Test Name: autoantibodies; Test Result: Positive

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Autoimmune/ inflammatory syndrome; Primary ovarian failure; Autoimmune/ inflammatory syndrome; Secondary amenorrhea; Low estradiol levels; Increased FSH and LH; Increased FSH and LH; Specific autoantibodies were detected (anti-ovarian and anti-thyroid); This spontaneous report was received from a physician via social media and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (lot#, expiration date, dose, route of administration and anatomical location were not reported). On an unknown date, the patient experienced primary ovarian failure, autoimmune/ inflammatory syndrome, blood follicle stimulating hormone (FSH) and blood luteinising hormone (LH) increased, low estradiol levels, secondary amenorrhoea; and specific autoantibodies were detected (anti-ovarian and anti-thyroid). The outcome of the events unknown. Causality assessment was not provided. Upon internal review, the event of autoimmune syndrome was considered to be medically significant.

Other Meds:

Current Illness:

ID: 1721384
Sex: M
Age:
State: PA

Vax Date: 04/02/2021
Onset Date: 05/01/2021
Rec V Date: 09/22/2021
Hospital: Y

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

Lab Data: Test Date: 202105; Test Name: APTT; Result Unstructured Data: 30.5 sec (23.1-34.3 sec); Test Date: 20210509; Test Name: Cerebral angiography; Result Unstructured Data: revealed an absence of opacification in the anterior 1/2 of the superior sagittal sinus, consistent with acute venous sinus thrombosis with collateral drainage through the cavernous sinus; Test Date: 202105; Test Name: Angiotensin converting enzyme; Result Unstructured Data: 32 (9-67 U/L); Test Date: 202105; Test Name: Anti-neutrophil cytoplasmic antibody IgG; Result Unstructured Data: <1: 20 (<1: 20); Test Date: 202105; Test Name: Myeloperoxidase ab; Result Unstructured Data: 0 (0-19 AU/mL); Test Date: 202105; Test Name: Serine Proteinase 3 AB IgG; Result Unstructured Data: 0 (0-19 AU/mL); Test Date: 202105; Test Name: ANA, Hep-2 Antibody IgG; Result Unstructured Data: <1: 80 (<1: 80); Test Date: 202105; Test Name: Anti-nuclear antibodies; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 202105; Test Name: HCO3; Result Unstructured Data: 7.1 (unit not reported); Test Date: 202105; Test Name: Calcium; Result Unstructured Data: 10.2; Test Date: 202105; Test Name: Chloride; Result Unstructured Data: 99; Test Date: 202105; Test Name: Creatinine; Result Unstructured Data: 134.4 umol/L (1.52 mg/dL); Test Date: 202105; Test Name: Blood gas analysis; Result Unstructured Data: revealed a pH of 7.32, PO2 168, PCO2 34, HCO3 18, with lactic acid of 28 mmol/L (on arrival to the ED); Test Date: 202105; Test Name: Blood glucose; Result Unstructured Data: 237 mg/dL; Test Date: 202105; Test Name: Glucose; Result Unstructured Data: 19.25 mmol/L (347 mg/dL); Test Date: 202105; Test Name: Lactic acid; Result Unstructured Data: 28.3 mmol/L; Test Date: 202105; Test Name: Magnesium; Result Unstructured Data: 2.9 (unit not reported); Test Date: 202105; Test Name: Potassium; Result Unstructured Data: 3.9; Test Date: 20210509; Test Name: Blood pressure; Result Unstructured Data: 147/48 mmHg (hypertensive); Test Date: 20210509; Test Name: Blood pressure; Result Unstructured Data: 198/98 mmHg (on arrival to the emergency department); Test Date: 202105; Test Name: Sodium; Result Unstructured Data: 142 (unit not reported); Test Date: 202105; Test Name: BUN; Result Unstructured Data: 8.93 mmol/L (25 mg/dL); Test Date: 202105; Test Name: Cardiolipin IgA, IgM, IgG; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 202105; Test Name: Chest X-ray; Result Unstructured Data: Normal (On arrival to the ED); Test Date: 202105; Test Name: Glasgow coma scale; Result Unstructured Data: 3; Test Date: 202105; Test Name: Glasgow coma scale; Result Unstructured Data: GCS on arrival to the ED had improved to 6/15.; Test Date: 202105; Test Name: Computed tomography (CT) scan brain without contrast; Result Unstructured Data: revealed a left frontal lobe intracerebral hemorrhage (ICH) along with subarachnoid hemorrhage (SAH); Test Date: 202105; Test Name: CT scan of the chest, abdomen and pelvis; Result Unstructured Data: which ruled out any occult m

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Cerebral haemorrhage/ left frontal lobe intracerebral hemorrhage; Cerebral venous sinus thrombosis; Mental status changes/ altered mental state; Seizure; Subarachnoid haemorrhage; Superior sagittal sinus thrombosis; Post-ictal state accompanied by tachypnea; Post-ictal state accompanied by tachypnea; Hypertensive; For the first few days, he had local adverse effects, including soreness on the site of injection and arm pain.; This literature-non-study case was reported in a literature article and describes the occurrence of CEREBRAL HAEMORRHAGE (Cerebral haemorrhage/ left frontal lobe intracerebral hemorrhage), CEREBRAL VENOUS SINUS THROMBOSIS (Cerebral venous sinus thrombosis), MENTAL STATUS CHANGES (Mental status changes/ altered mental state), SEIZURE (Seizure), SUBARACHNOID HAEMORRHAGE (Subarachnoid haemorrhage), SUPERIOR SAGITTAL SINUS THROMBOSIS (Superior sagittal sinus thrombosis), POSTICTAL STATE (Post-ictal state accompanied by tachypnea), TACHYPNOEA (Post-ictal state accompanied by tachypnea) and HYPERTENSION (Hypertensive) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: Central venous sinus thrombosis with subarachnoid hemorrhage following an mRNA COVID-19 vaccination: are these reports merely co-incidental? The patient's past medical history included Crush injury (open fracture to left thumb). Concurrent medical conditions included Diabetes mellitus. Concomitant products included CEFALEXIN (KEFLEXIN), DOCUSATE SODIUM (COLACE), IBUPROFEN, METFORMIN and GABAPENTIN for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral haemorrhage/ left frontal lobe intracerebral hemorrhage) (seriousness criteria hospitalization, disability, medically significant and life threatening). 09-May-2021, the patient experienced CEREBRAL VENOUS SINUS THROMBOSIS (Cerebral venous sinus thrombosis) (seriousness criteria hospitalization, disability, medically significant and life threatening), MENTAL STATUS CHANGES (Mental status changes/ altered mental state) (seriousness criteria hospitalization, disability and life threatening), SEIZURE (Seizure) (seriousness criteria hospitalization, disability, medically significant and life threatening), SUBARACHNOID HAEMORRHAGE (Subarachnoid haemorrhage) (seriousness criteria hospitalization, disability, medically significant and life threatening) and SUPERIOR SAGITTAL SINUS THROMBOSIS (Superior sagittal sinus thrombosis) (seriousness criteria hospitalization, disability, medically significant and life threatening). In May 2021, the patient experienced POSTICTAL STATE (Post-ictal state accompanied by tachypnea) (seriousness criterion medically significant), TACHYPNOEA (Post-ictal state accompanied by tachypnea) (seriousness criterion medically significant) and HYPERTENSION (Hypertensive) (seriousness criterion medically significant). In 2021, the patient experienced VACCINATION SITE PAIN (For the first few days, he had local adverse effects, including soreness on the site of injection and arm pain.). The patient was treated with LORAZEPAM (intravenous) in May 2021 for Adverse event, at a dose of 4 milligram; ESMOLOL (intravenous) in May 2021 for Intracerebral hemorrhage and Subarachnoid hemorrhage, at a dose of 50 mcg/kg/min; NIMODIPINE in May 2021 for Intracerebral hemorrhage and Subarachnoid hemorrhage, at a dose of 60 milligram every four hours; LEVETIRACETAM in May 2021 for Seizure prophylaxis, at a dose of 500 milligram twice a day; HEPARIN (intravenous) from 09-May-2021 to 2021 for Cerebral venous sinus thrombosis, at an unspecified dose and frequency; WARFARIN SODIUM (COUMADIN) on 09-May-2021 for Cerebral venous sinus thrombosis, at an unspecified dose and frequency; Surgery (Extubation) for Cerebral haemorrhage and Surgery (Endotracheal intubation) for Cerebral venous sinus thrombosis. At the time of the report, CEREBRAL HAEMORRHAGE (Cerebral haemorrhage/ left frontal lobe intracerebral hemorrhage), CEREBRAL VENOUS SINUS THROMBOSIS (Cerebral venous sinus thrombosis), MENTAL STATUS CHANGES (Mental status changes/ altered mental state), SEIZURE (Seizure), SUBARACHNOID HAEMORRHAGE (Subarachnoid haemorrhage), SUPERIOR SAGITTAL SINUS THROMBOSIS (Superior sagittal sinus thrombosis), POSTICTAL STATE (Post-ictal state accompanied by tachypnea), TACHYPNOEA (Post-ictal state accompanied by tachypnea), HYPERTENSION (Hypertensive) and VACCINATION SITE PAIN (For the first few days, he had local adverse effects, including soreness on the site of injection and arm pain.) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Angiogram cerebral: abnormal (abnormal) revealed an absence of opacification in the anterior 1/2 of the superior sagittal sinus, consistent with acute venous sinus thrombosis with collateral drainage through the cavernous sinus. On 09-May-2021, Blood pressure measurement: 147/48 mmhg (High) 147/48 mmHg (hypertensive) and 198/98 mmhg (High) 198/98 mmHg (on arrival to the emergency department). On 09-May-2021, Magnetic resonance imaging head: abnormal (abnormal) revealed intracranial hemorrhage within the anterior left frontal lobe without a definitive underlying enhancing mass, bifrontal subarachnoid hemorrhage, and anterior superior sagittal sinus thrombosis (when the patient was in ICU).. In May 2021, Activated partial thromboplastin time: 30.5 sec 30.5 sec (23.1-34.3 sec). In May 2021, Angiotensin converting enzyme: 32 (9-67 u/l) 32 (9-67 U/L). In May 2021, Antineutrophil cytoplasmic antibody: <1: 20 (<1: 20) <1: 20 (<1: 20), 0 (0-19 au/ml) 0 (0-19 AU/mL) and 0 (0-19 au/ml) 0 (0-19 AU/mL). In May 2021, Antinuclear antibody: <1: 80 (<1: 80) <1: 80 (<1: 80) and negative (Negative) Negative. In May 2021, Blood bicarbonate: 7.1 7.1 (unit not reported). In May 2021, Blood calcium: 10.2 10.2. In May 2021, Blood chloride: 99 99. In May 2021, Blood creatinine: 134.4 umol/l (1.52 mg/dl) 134.4 umol/L (1.52 mg/dL). In May 2021, Blood gases: abnormal (abnormal) revealed a pH of 7.32, PO2 168, PCO2 34, HCO3 18, with lactic acid of 28 mmol/L (on arrival to the ED). In May 2021, Blood glucose: 237 mg/dl 237 mg/dL and 19.25 mmol/l (347 mg/dl) 19.25 mmol/L (347 mg/dL). In May 2021, Blood lactic acid: 28.3 mmol/l 28.3 mmol/L. In May 2021, Blood magnesium: 2.9 2.9 (unit not reported). In May 2021, Blood potassium: 3.9 3.9. In May 2021, Blood sodium: 142 142 (unit not reported). In May 2021, Blood urea: 8.93 mmol/l (25 mg/dl) 8.93 mmol/L (25 mg/dL). In May 2021, Cardiolipin antibody: negative (Negative) Negative. In May 2021, Chest X-ray: normal (normal) Normal (On arrival to the ED). In May 2021, Coma scale: 3 3 and 6/15 GCS on arrival to the ED had improved to 6/15.. In May 2021, Computerised tomogram: ich with sah (abnormal) revealed a left frontal lobe intracerebral hemorrhage (ICH) along with subarachnoid hemorrhage (SAH) and normal (normal) which ruled out any occult malignancies or other thrombosis.. In May 2021, Electrocardiogram: not reveal any acute st-t changes (normal) EKG on arrival did not reveal any acute ST-T changes. (On arrival to the ED) and normal (normal) showed a normal ejection fraction, no septal defects, and no intracardiac clots or valvular pathologies.. In May 2021, Factor II mutation: not detected (normal) Not detected. In May 2021, Factor V Leiden mutation: negative (Negative) Negative. In May 2021, Haemoglobin: 15.7 g/dl 15.7 g/dL. In May 2021, Heart rate: 140 bpm 140 bpm and 157 bpm 157 bpm. In May 2021, International normalised ratio: 1.2 1.2. In May 2021, Lipoprotein (a): 32 (=29 mg/dl) 32 (=29 mg/dL). In May 2021, Oxygen saturation: 86% 86% on room air and 96% improved with jaw thrust and a nasal trumpet to 96%. In May 2021, Platelet count: 255?10e3/ul 255?10E3/

Other Meds: KEFLEXIN; COLACE; IBUPROFEN; METFORMIN; GABAPENTIN

Current Illness: Diabetes mellitus

ID: 1721385
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: Gave Expired Dose of HEPLISAV-B; Initial Report Received on 20-Aug-2021 A pharmacist reported that a patient (age, gender, race, and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. Relevant medical history was not reported. Relevant concomitant medications were not reported. On an unknown date, the patient received an expired dose of HEPLISAV-B (Lot #, expiration date, NDC #, and serial # not provided) from a nurse. At the time of reporting, no additional information was provided. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.

Other Meds:

Current Illness:

ID: 1721386
Sex: U
Age: 68
State: MS

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/22/2021
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: Received 40 mcg of Heplisav-B; Initial Report Received on 23-Aug-2021 A registered nurse ) reported that a 68 year-old female patient (race and ethnicity not provided) received a 40 mcg dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on the same day. The patient was on dialysis and does not have any allergies. No other relevant medical history was reported. No relevant concomitant medications were reported. On 23-Aug-2021, the patient received a total of 40 mcg dose of HEPLISAV-B (Lot # 935840, expiration date 11-Sep-2022, NDC # 43528-003-05; serial number not reported). One dose of 20 mcg of HEPLISAV-B was given in the right deltoid and the other dose of 20 mcg was given in left deltoid; totaling 40 mcg of HEPLISAV-B given that day. The patient did not report any side effects. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.

Other Meds:

Current Illness:

ID: 1721387
Sex: U
Age: 52
State: FL

Vax Date: 08/31/2021
Onset Date: 08/31/2021
Rec V Date: 09/22/2021
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: Gave an Expired Dose of Heplisav-B; Initial Report Received on 31-Aug-2021 A registered nurse reported that a 52 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. The patient does not have any known allergies. Other relevant medical history was not reported. Relevant concomitant medications were not reported. On 31-Aug-2021, the patient received an expired dose of HEPLISAV-B (Lot # 933624, expiration date 10-Aug-2021, and NDC # 43528-003-05; serial # not reported) in the left deltoid by the registered nurse (reporter). The patient did not experience any adverse effects. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.

Other Meds:

Current Illness:

ID: 1721388
Sex: U
Age: 32
State: NY

Vax Date: 08/10/2021
Onset Date: 09/08/2021
Rec V Date: 09/22/2021
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: Administered Engerix Instead of Heplisav-B for Second Dose; Initial Report Received on 08-Sep-2021 and 10-Sep-2021 A nursing operation supervisor in the US reported that a 32 year-old male (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and Engerix as the second dose of the series. The patient did not have any allergies. No other relevant medical history was reported. No relevant concomitant medications were reported. On 10-Aug-2021, the patient received the first dose of HEPLISAV-B (Lot # 934601, expiration date 16-Mar-2022, and NDC # 43528-002-05; serial # not reported) in the right deltoid. On 08-Sep-2021, the patient received the second dose with Engerix (Lot # and expiration date not available) from a licensed practical nurse instead of HEPLISAV-B. No adverse effects were reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.

Other Meds: Engerix b

Current Illness:

ID: 1721389
Sex: U
Age: 31
State: LA

Vax Date: 08/23/2021
Onset Date: 09/07/2021
Rec V Date: 09/22/2021
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: 2nd Dose was Given 2 Weeks and 1 Day after the 1st; Initial Report Received on 10-Sep-2021 A registered nurse in the US reported that a 31 year-old female (race and ethnicity not provided) received a second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization two weeks and 1 day after the first dose. Relevant medical history was not reported. Relevant concomitant medications were not reported. On 23-Aug-2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, and serial number not reported). On 07-Sep-2021, two weeks and 1 day after the first dose of HEPLISAV-B, the patient was given the second dose of HEPLISAV-B (Lot # 934975, expiration date 13-Aug-2022, NDC # 43528-003-05, and serial # 565252922606) in the left deltoid. No adverse reactions were reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.

Other Meds:

Current Illness:

ID: 1721390
Sex: F
Age:
State: LA

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Suspected vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had a case of shingles in 2017) and shingles (had shingles on forehead and cheek and also had sore arm post vaccination in September 2020, refer case US2021AMR197172). On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix (intramuscular). In September 2021, 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 was unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not reported. In 2019, the patient received 2 doses of Shingrix in left arm. In September 2021 the patient again had a case of shingles. The patient stated that the current case of shingles, involves shingles on the left side of the face, two lines across forehead, around the left eye, on the left side of the nose but not on the bridge of the nose, under the chin, chest, left side of torso, and right arm and were not resolved. The patient did not have the exact date of administration; therefore, it could not be determined how soon were the shingles experienced post vaccination. The patient stated that she had an appointment with eye doctor and was told that shingles were surrounding the left eye, but not in the eye. The reporter gave a consent to follow-up with health care professional. The patient does not have an email address to health care professional. The patient provided her personal email. The patient provided contact information to the pharmacy where she received both doses of Shingrix. The reporter consented to follow-up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR197172:same reporter

Other Meds:

Current Illness:

ID: 1721391
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles, but it was not very bad. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1721392
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

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

Other Meds:

Current Illness:

ID: 1721393
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles anyways. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1721394
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: suspected vaccination failure; shingles; it hurt to much; had a total of three singles vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and extra dose administered. On an unknown date, the outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles and pain were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine, 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. The patient received total of three doses of Shingles vaccine which led to extra dose administered. After receiving Shingles vaccine, the patient got shingles above right hip and he/she could not lay down on right side when went to bed and it hurt too much. 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: 1721395
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: Suspected vaccination failure; Had it once after vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1721397
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: Bad case near my eye; Bad case on face; This case was reported by a consumer via media and described the occurrence of ophthalmic herpes zoster in a adult 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 ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were recovered/resolved. It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingles vaccine. Additional details were provided are as follows: The case was reported by patient herself/herself. The patient received shingles vaccine and 2 years before the date of reporting, got bad case all over one side of face and near eye. The follow-up could be not possible as no contact details were available. The case was linked with case US2021AMR196932 reported by same reporter for same patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR196932:Same reporter

Other Meds:

Current Illness:

ID: 1721398
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: Had the shot and had them 3 times; Had them 3 times lately; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient had the shot and had them 3 times lately. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1721399
Sex: F
Age: 69
State: NY

Vax Date: 09/13/2021
Onset Date: 09/14/2021
Rec V Date: 09/22/2021
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: itchy bumps; very tired.; chills; extreamly weak/ feeling weak; couldn't get out of bed; every joint in her body was in pain; This case was reported by a consumer via other manufacturer and described the occurrence of itchy rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 13th September 2021, the patient received Shingrix. On 14th September 2021, 1 days after receiving Shingrix, the patient experienced chills, weakness, activities of daily living impaired and generalized joint pain. On 15th September 2021, the patient experienced itchy rash and tiredness. On an unknown date, the outcome of the itchy rash, chills, weakness, activities of daily living impaired, generalized joint pain and tiredness were unknown. It was unknown if the reporter considered the itchy rash, chills, weakness, activities of daily living impaired, generalized joint pain and tiredness to be related to Shingrix. Additional details were provided are as follows: The case was reported by patient herself. The patient received a dose of Shingrix at pharmacy and had chills, extremely weak, could not get out of bed, total every joint in her body was in pain. On 15th September 2021, in morning patient woke up with woke up feeling weak and very tired, had 3 bumps in her left temple near her hairline. The patient stated that those bumps were not blisters which she knew that usually shingles presents with a blister type thing but the bumps were a bit itchy, but not painful which were also not typical to shingles. The patient was concerned about what she should do, if she should be seen by her doctor as she did not know how to proceed. The patient stated about a scary arrangement with the pharmacist, who did not even do proper hygiene with hand washing, it was scary. The reporter consented to follow-up.

Other Meds:

Current Illness:

ID: 1721402
Sex: F
Age:
State: DE

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: lost the use of her legs; couldn't eat; This case was reported by a consumer via media and described the occurrence of paralysis legs in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced paralysis legs (serious criteria hospitalization, disability and GSK medically significant) and unable to eat (serious criteria hospitalization). On an unknown date, the outcome of the paralysis legs and unable to eat were unknown. It was unknown if the reporter considered the paralysis legs and unable to eat to be related to Tdap Vaccine. Additional details were provided as follows: This case was reported patient's family member. The age at vaccination was not reported. The patient got the Tdap shot and lost the use of her legs and could not eat. The patient ended up in hospital. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1721403
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: I got mine, 3 years later, got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingles shot and 3 years later got shingles. The Shingles were not too bad. After that, the patient had to get 2 more shots. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR197180:same reporter

Other Meds:

Current Illness:

ID: 1721405
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got a horrible case of shingles. The patient's doctor said, worse case that the patient had ever seen. 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: 1721406
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got the two shots of shingles vaccine and still experienced shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1721407
Sex: U
Age:
State:

Vax Date: 09/15/2021
Onset Date: 09/15/2021
Rec V Date: 09/22/2021
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: first dose on on 10-18-19 / second dose almost 24 months later; This case was reported by a consumer via Shingrix GSK and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 18th October 2019). On 15th September 2021, the patient received the 2nd dose of Shingrix. On 15th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 2nd dsoe almost 24 months later the 1st dose of Shingrix. The patient received 2nd dose later than the recommended time interval, which led to lengthening of vaccination schedule The reporter asked under this situation, did you recommend that, get a third does in 4 to 6 months.

Other Meds:

Current Illness:

ID: 1721409
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: suspected vaccination failure; shingles; rash; 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 rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown. It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient received shingles vaccine and experienced the shingles earlier this year. The patient was so glad that he/she had gotten the vaccine. The patient did not experience pain, just had a rash. 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: 1721410
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: sick; pain; This case was reported by a consumer via (facebook) interactive digital media and described the occurrence of sickness in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced sickness and pain. On an unknown date, the outcome of the sickness and pain were recovered/resolved. It was unknown if the reporter considered the sickness and pain to be related to Influenza 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 Flu shot and got a little sick and pain for about 2 days. The follow-up would not possible as no contact details were available. The case had been linked with US2021AMR171208 reported by the same reporter for same patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR171208:same reporter

Other Meds:

Current Illness:

ID: 1721411
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: I had the shot had shingles/ suspected vaccination failure; 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. 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 got the shingles shot and had shingles twice. 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: 1721412
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: 3 got shingles after vaccine/ Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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 got shingles after getting the Shingles vaccine. The reporter stated to stop with the big pharma propaganda. 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. This case is linked with the case US2021AMR197923 and US2021AMR197942, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR197923:Same reporter. Pt 1/3 US-GLAXOSMITHKLINE-US2021AMR197942:Same reporter. Pt 3/3

Other Meds:

Current Illness:

ID: 1721413
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: 3 got shingles after vaccine/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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 got shingles after getting the Shingles vaccine. The reporter stated to stop with the big pharma propaganda. 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. This case is linked with the case US2021AMR197923 and US2021AMR197941, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR197941:Same reporter. Pt 2/3 US-GLAXOSMITHKLINE-US2021AMR197923:Same reporter. Pt 1/3

Other Meds:

Current Illness:

ID: 1721414
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: Shingles even after the shot/ suspected Vaccination failure; Shingles 3 times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional case details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles 3 times even after getting the shot. The reporter said that beware one can get shingles again. 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 unknown at the time of reporting.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am