VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1634223
Sex: F
Age: 47
State: NJ

Vax Date: 08/24/2021
Onset Date: 08/26/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Dysphagia, Epiglottitis

Symptoms: Woke up to what felt like a runny nose and i noticed a trickling that wouldn?t stop. After running to the bathroom my face had clotted blood and my kept bleeding. Bleeding stopped after 15/20 minutes

Other Meds: None

Current Illness: None

ID: 1634224
Sex: F
Age:
State: AZ

Vax Date: 08/01/2021
Onset Date: 08/06/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: I have not taken any tests as of this date but I plan to.

Allergies: None

Symptom List: Anxiety, Dyspnoea

Symptoms: Several minutes after having the vaccine I became so dizzy I thought I was going to pass out. I sat for at least 45 minutes before I felt I could walk safely. Since then I have had chills, nausea, a headache and more recent I have been extremely tired and itch terribly. I feel the symptoms are all connected to the vaccine. I feel unwell and did not before taking the vaccine. I do not plan on taking the second dose.

Other Meds: Losartan. Ativan. Clopidogrel. Simvastatin. Ropininole. Gabapentin

Current Illness: None

ID: 1634225
Sex: M
Age: 31
State: CA

Vax Date: 03/23/2021
Onset Date: 03/25/2021
Rec V Date: 08/26/2021
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: Checked to see if it?s medication, it?s been changed about five times and no difference, tested for vertigo ( negative), ultrasound on neck test came back normal, bunch of blood work and all came back normal, just did cat scan waiting for results.

Allergies: No

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

Symptoms: Went to the hospital because my legs swelled up and I was in pain. Things got worse less then 24hrs after the second shoot. Now I feel tired/ dizzy/ drunk all the time. Almost 24/7. It?s making life really hard for me.

Other Meds: Yes 10mg lisinopril

Current Illness: High blood pressure

ID: 1634226
Sex: F
Age: 31
State: OH

Vax Date: 08/10/2021
Onset Date: 08/10/2021
Rec V Date: 08/26/2021
Hospital: Y

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

Lab Data: Cardiac Stress Test, Cardiac Enzymes, EKG, Chest Xray

Allergies: None

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Chest pain, palpitations

Other Meds: None

Current Illness: None

ID: 1634227
Sex: F
Age: 36
State: TX

Vax Date: 08/21/2021
Onset Date: 08/22/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies: Penicillin

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

Symptoms: Full body itchiness

Other Meds: Multivitamin Prozac Singulair Omprazole

Current Illness: None

ID: 1634541
Sex: F
Age: 50
State: TN

Vax Date: 08/23/2021
Onset Date: 08/24/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies: Penicillin

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

Symptoms: Arm swelling spread down past my elbow to my forearm. Very hot and tender, dark red nearly bruised looking

Other Meds: Metformin, lantus, victoza, invokanna

Current Illness: None

ID: 1634565
Sex: F
Age:
State: TX

Vax Date: 04/07/2021
Onset Date: 04/12/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Date: 20210412; Test Name: Body temperature increased; Result Unstructured Data: over 100 ?F

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Fatgued; Joint pain; Fever over 100 ?F; Severe body ache/ severe pain; Felt very sick/ feels really bad; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt very sick/ feels really bad), FATIGUE (Fatgued), ARTHRALGIA (Joint pain), PYREXIA (Fever over 100 ?F) and MYALGIA (Severe body ache/ severe pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced MALAISE (Felt very sick/ feels really bad), ARTHRALGIA (Joint pain), PYREXIA (Fever over 100 ?F) and MYALGIA (Severe body ache/ severe pain). On 19-Apr-2021, the patient experienced FATIGUE (Fatgued). At the time of the report, MALAISE (Felt very sick/ feels really bad), FATIGUE (Fatgued), ARTHRALGIA (Joint pain), PYREXIA (Fever over 100 ?F) and MYALGIA (Severe body ache/ severe pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: over 100 ? (High) over 100 ?F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient on 16-Apr-2021 felt a little better and felt better even on 19-Apr-2021. Treatment information was not provided. This case was linked to MOD-2021-150415 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up was received on 19 may 2021 included no new information about first dose.

Other Meds:

Current Illness:

ID: 1634654
Sex: F
Age:
State: PR

Vax Date: 07/10/2021
Onset Date: 07/11/2021
Rec V Date: 08/26/2021
Hospital: Y

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

Lab Data: Test Date: 20210715; Test Name: Influenza A y B; Test Result: Negative ; Comments: Blood test; Test Date: 20210715; Test Name: SARS-COV-2 RNA (RT-PCR); Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210711; Test Name: white blood cells; Result Unstructured Data: Test Result:17,000

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: respiratory distress; inflammatory systems and response syndrome; High fever; body aches; severe headache; high blood pressure; cough; lab results white blood cells 17,000; dehydration; This is a spontaneous report from a contactable nurse (patient). A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in Arm Left on 10Jul2021 16:00 (Lot Number: SEY0584, expiration date unknown) at age of 69 years old as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hypothyroidism due to totalthyroidectomy surgery, high blood pressure, allergies: Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID); diltiazem hydrochloride; hydroxychloroquine sulfate (PLAQUENIL). The patient experienced respiratory distress, inflammatory systems and response syndrome, high fever, body aches, severe headache, high blood pressure, cough, lab results white blood cells 17,000, dehydration, all on 11Jul2021 08:00. The patient was hospitalized for all events for 4 days. The patient underwent lab tests and procedures which included influenza virus test: negative on 15Jul2021 Blood test, SARS-COV-2 RNA (RT-PCR): negative on 15Jul2021 Nasal Swab, white blood cell count: 17,000 on 11Jul2021. The outcome of the events was resolving. Therapeutic measures were taken as a result of all events. The treatment included respiratory therapy with albutero,methilpredniloz. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds: SYNTHROID; DILTIAZEN CLORHIDRATO; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]

Current Illness:

ID: 1634655
Sex: F
Age:
State: PR

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Head ache, diarrhea and myalgia all over body still two weeks after 1st dose.; Head ache, diarrhea and myalgia all over body still two weeks after 1st dose.; Head ache, diarrhea and myalgia all over body still two weeks after 1st dose.; This is a spontaneous report from a contactable consumer or non hcp reported for herself. A 29-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on Apr2021 10:00 hr (at the age of 29-years-old) as DOSE 1, SINGLE for covid-19 immunisation at hospital. The patient was not pregnant at the time of vaccination. Medical history included known allergies to Lobster from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. No other vaccine received in four weeks, no covid prior vaccination and covid was not tested post vaccination. The patient experienced headache, diarrhea and myalgia all over body still two weeks after 1st dose on Apr2021. AE resulted in none of the above (unspecified details). Patient received no treatment. Clinical outcome of events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: ADVIL [IBUPROFEN]; TYLENOL

Current Illness:

ID: 1634694
Sex: M
Age: 65
State: KY

Vax Date: 04/03/2021
Onset Date: 04/17/2021
Rec V Date: 08/26/2021
Hospital: Y

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: organ failure; rash; Dress syndrome; This spontaneous case was reported by a consumer and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome), ORGAN FAILURE (organ failure) and RASH (rash) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 100006) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high and Thyroid disorder. On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) 1 dosage form. On 17-Apr-2021, the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced ORGAN FAILURE (organ failure) (seriousness criterion hospitalization prolonged) and RASH (rash) (seriousness criterion hospitalization prolonged). At the time of the report, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome) had not resolved and ORGAN FAILURE (organ failure) and RASH (rash) outcome was unknown. Patient taking thyroid medication .Treatment history was not reported . Patient was hospitalized due to organ failure, rash and multiple other issues. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Blood pressure high; Thyroid disorder

ID: 1634695
Sex: F
Age:
State:

Vax Date: 02/28/2021
Onset Date: 03/01/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Maternal exposure during pregnancy; unwell; Miscarriage; This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 23-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criteria hospitalization prolonged, medically significant and congenital anomaly). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (unwell). The delivery occurred on an unknown date, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 01-Mar-2021, ABORTION SPONTANEOUS (Miscarriage) had not resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved and MALAISE (unwell) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ABORTION SPONTANEOUS (Miscarriage) to be related. No further causality assessments were provided for MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (unwell). It was reported that the patient was pregnant at the time she received the second dose, 1st trimester. This was her first pregnancy. Right after she was given the vaccine, she started feeling unwell, 2 days later, she miscarried her baby No information on concomitant medication were reported. No treatment details were reported. Company comment: This is a case of vaccine exposure during pregnancy with associated AEs of malaise and serious of event Spontaneous abortion for this 23 year old female after receiving the second dose of the vaccine.; Sender's Comments: This is a case of vaccine exposure during pregnancy with associated AEs of malaise and serious of event Spontaneous abortion for this 23 year old female after receiving the second dose of the vaccine.

Other Meds:

Current Illness:

ID: 1634760
Sex: F
Age: 3
State: MI

Vax Date: 07/26/2021
Onset Date: 07/26/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: No additional adverse effect reported; The vaccine was not fully administered due to the child moving the leg while getting the injection; needle was bent; This spontaneous report was received from a registered nurse, referring to a 3-year-old female patient. The patient's current condition included autism spectrum disorder. Information regarding the patient's pertinent drug reactions/allergies and concomitant medication was not provided. On 26-JUL-2021, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # V005271, was evaluated and changed to the valid lot # U005271, expiration date 21-NOV-2022, 0.5 milliliter, intramuscular in the left thigh) for prophylaxis. During vaccine administration, the patient removed needle from leg due to movement, needle was bent (needle issue). The vaccine was not fully administered due to the child moving the leg while getting the injection (incorrect dose administered). The operator was a trained healthcare professional. There was no treatment for the events. Re-dosing was recommended, and the patient's mother declined at this time. No additional adverse effect reported. The outcome of the events was also reported as recovered. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: U005271; expirationdate: 21-NOV-2022; deviceage and unit: 0 ; operatorofdevice: Other Health Care Professional; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds:

Current Illness: Autism spectrum disorder

ID: 1634761
Sex: U
Age:
State: KS

Vax Date: 07/23/2021
Onset Date: 07/23/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No additional AE reported; Patient was administered an expired dose of MMR II; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-JUL-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S020961, expiration date 07-JUL-2021 (0.5 milliliter, indication was not reported) (expired product administered). The suspect measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) had no previous temperature excursions. No additional adverse event was reported.

Other Meds:

Current Illness:

ID: 1634762
Sex: U
Age:
State: DC

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No additional AE reported; 12 doses of PNEUMOVAX 23 were administered to 12 different patient's instead of Prevnar 13; She reports out of those 12 patients, 6 were under the age of 2; This spontaneous report was received from a physician referring to 11 patients, 5 were under the age of 2 years old, (one youngest patient was 6 months old was captured in case# 2107USA007992). Information regarding the patients' pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided. On an unknown date in June 2021, these patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (0.5 ml, lot # T021485, expiration date 15-MAR-2022, strength and route were not provided) for prophylaxis instead of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (wrong product administered and product administered to patient of inappropriate age). No additional adverse event reported. This is one of two reports received from the same reporter. This is a non-valid case due to no patients' identifiers. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T021485; expirationdate: 15-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments: US-009507513-2107USA007992:

Other Meds: PNEUMOVAX23 SYRINGE (DEVICE)

Current Illness: Prophylaxis

ID: 1634763
Sex: U
Age:
State: DC

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No additional AE reported; 12 doses of PNEUMOVAX 23 were administea dose of PNEUMOVAX 23 was inadvertently administered to the patient instead of Prevnar 13red to 12 different patient's instead of Prevnar 13; a dose of PNEUMOVAX 23 was inadvertently administered to the patient instead of Prevnar 13; This spontaneous report was received from a physician referring to a 6-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided. On an unknown date in June 2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (0.5 ml, lot # T021485, expiration date 15-MAR-2022, strength and route were not provided) for prophylaxis instead of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (wrong product administered and product administered to patient of inappropriate age). No additional adverse event was reported. This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck; devicelotnumber: T021485; expirationdate: 15-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments: US-009507513-2107USA007986:

Other Meds:

Current Illness:

ID: 1634764
Sex: F
Age:
State: IL

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

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

Lab Data:

Allergies:

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

Symptoms: Pneumococcal vaccine uptake in pregnant individuals; Information has been received from the authors in a published literature article, entitled as stated below, referring to a retrospective cohort study on pregnant woman, to evaluate the pre and post-guideline cohorts to determine if Tdap vaccine uptake and timing improved after the new Tdap guidelines. Additionally the cohort examined influenza and pneumococcal vaccine uptake before and after guidelines. The authors found that nearly one-third (N = 675, 29.5%) of individuals were eligible for the pneumococcal vaccine. No information was provided regarding the patients' medical history, concurrent conditions, past drug history or concomitant medications. Frequency of receiving the pneumococcal vaccine during pregnancy was low throughout the study period, with only 3.8% (N = 8) of eligible individuals in the pre-guideline cohort and 7.3% (N = 32) of eligible individuals in the post-guideline cohort receiving the pneumococcal vaccine (manufacturer unknown) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported). Also the authors observed that there was no significant difference in uptake of the pneumococcal vaccine during pregnancy among eligible individuals in the post-guideline cohort compared to the pre-guideline cohort. The authors stated that among their study cohort, pneumococcal vaccine uptake was low throughout the study period, consistent with prior reports of poor obstetric provider knowledge about the pneumococcal vaccine. The also stated that a 2020 survey assessing resident knowledge on pneumococcal vaccine during pregnancy found that obstetrics and gynecology residents expressed a comfort level of 3.8/10 in regards to understanding potential candidates for the vaccine. Another study on a nationally representative sample of residents found that the majority of residents demonstrated low or moderate knowledge of the indications for pneumococcal vaccine during pregnancy. The authors pointed out that areas for future work include examining whether improving provider knowledge of pneumococcal vaccine eligibility criteria results in improved patient receipt of indicated vaccines A copy of the published article is attached as further documentation of the patient's experience. Literature Report: Association of Tdap vaccine guidelines with vaccine uptake during pregnancy. 2021-07-01. 16: 1-12.

Other Meds:

Current Illness:

ID: 1634765
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: temperature excursion for GARDASIL 9. The vaccine was gien four times today.; no additional adverse effect reported; This spontaneous report was received from a medical assistant and concerns an approximately 18-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown date, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 ml (lot # 1687291; expiration date (exp) 11-SEP-2022) (route of administration was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 80.6 Fahrenheit degrees (F) for 14 hours and 51 minutes. There were previous temperature excursions for 73.2 F for 9 hours and 25 minutes; 73.4 F for 8 hours and 48 minutes. The event was reported due to digital data logger. No further information was provided and no additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments: US-009507513-2107USA008709:

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1634766
Sex: M
Age: 0
State: PR

Vax Date: 07/27/2021
Onset Date: 07/27/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Improperly stored vaccines administered; This spontaneous report was received from an administrator, referring to a neonate male patient (reported as baby boy). The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 27-JUL-2021, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot# T022566, expiration date 03-NOV-2022, for prophylaxis (strength, dose, route and frequency were not reported). The temperature excursion was of -1.4 Centigrade degrees (?C); -26.4?C, for 1 hour; 4 hours. A previous temperature excursion was not reported. A digital data logger was involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-2108USA001905: US-009507513-2108USA001815: US-009507513-2108USA001990:

Other Meds:

Current Illness:

ID: 1634767
Sex: U
Age:
State: IN

Vax Date: 08/10/2021
Onset Date: 08/10/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: No additional adverse effect reported; an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was administered 10-AUG-2021.; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. Information about the patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 10-AUG-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (strength, dose, formulation, vaccination scheme, route and anatomical location of administration were not reported, lot number T003714, has been verified to be valid, expiration date reported and established as 29-JUL-2021) for prophylaxis (expired product administered). No previous temperature excursion and no additional adverse event were reported.

Other Meds:

Current Illness:

ID: 1634768
Sex: U
Age:
State: DC

Vax Date: 08/05/2021
Onset Date: 08/05/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No additional adverse events reported; administration of improperly stored PROQUAD; This spontaneous report was received from a physician, referring to patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided. On 05-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5 milliliter (ml) (route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number U006314 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA), expiration date reported and upon internal validation established as 24-AUG-2022) as prophylaxis (product storage error). The administered dose of the vaccine experienced a temperature excursion of 45.3 degrees Fahrenheit (F) for 17 hours. There was no previous temperature excursion reported. It was unknown if a digital data logger was involved. No adverse events were reported.

Other Meds:

Current Illness:

ID: 1634769
Sex: U
Age:
State: PA

Vax Date: 08/11/2021
Onset Date: 08/11/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No additional adverse events reported; Caller reports that PNEUMOV AX 23 was given to a 2 month old in error/ Caller reports that PREVNAR 13 was intended to be given to the patient and that this error occurred due to miscommunication; This spontaneous report was received from a medical assistant, referring to a 2-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided. On 11-AUG-2021, the patient was vaccinated in error with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number T020639 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent) prefilled syringe, expiration date reported and upon internal validation established as 13-MAR-2022) as prophylaxis, however, the reporter stated that pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) was intended to be given to the patient and that this error occurred due to miscommunication (wrong product administered). Additionally, the reporter was inquiring about the contraindications to the use of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in this population. No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T020639; expirationdate: 13-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: PNEUMOVAX23 SYRINGE (DEVICE)

Current Illness:

ID: 1634770
Sex: U
Age:
State: DC

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: No additional adverse events; administration of improperly stored PROQUAD; This spontaneous report was received from a physician who refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-AUG-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) (lot # U006314, expiration date: 24-AUG-2022) (strength, route of administration and exact dose were not provided) for prophylaxis. No adverse events were reported. According to the reporter, the temperature excursion was 45.3 degrees Fahrenheit for a time frame of 17 hours on an unspecified date, without any previous temperature excursion.

Other Meds:

Current Illness:

ID: 1634771
Sex: U
Age:
State: TX

Vax Date: 08/07/2021
Onset Date: 08/07/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No other AE; Vaccine excursion occurred on 06-AUG-2021 and was administered on 07-AUG-2021.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, pertinent medical history, concomitant therapies and drug and/or allergies reactions was not provided. On 06-AUG-2021, a temperature excursion was called for a varicella virus vaccine live (oka/merck) (VARIVAX) vaccine, at a temperature of 8.0 degrees Fahrenheit for a time frame of 45 minutes. On 07-AUG-2021, the patient was inadvertently administered with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose reported as "1 time dose") (strength, vaccination scheme, route and anatomical location of administration were not provided, with lot number T032319 verified as valid and upon internal review expiration date established as 22-SEP-2022) for prophylaxis. No previous temperature excursions were reported, no information was provided about the use of a data logger. No additional adverse event was reported.

Other Meds:

Current Illness:

ID: 1634772
Sex: U
Age: 61
State: CA

Vax Date: 03/31/2017
Onset Date:
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: heart attack; Bell's Palsy; other zoster related injuries; other zoster related injuries; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 31-MAR-2017 (61 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by healthcare providers and physicians for the following injuries resulting from zoster vaccine live (ZOSTAVAX): heart attack, Bell's Palsy and other zoster related injuries. The outcome of these events was unknown. Upon internal review, heart attack and Bell's Palsy were determined to be medically significant.

Other Meds:

Current Illness:

ID: 1634773
Sex: U
Age: 61
State: VA

Vax Date: 10/01/2015
Onset Date:
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: vision loss; shingles; other zoster related injuries; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-OCT-2015 (61 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX): shingles, vision loss and other zoster related injuries. The outcome of these events was unknown. Upon internal review, vision loss was determined to be medically significant.

Other Meds:

Current Illness:

ID: 1634774
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: life threatening illnesses; This spontaneous report was received from a person told a friend who then told the employee's wife referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date (reported as in the past), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot# and expire date were not reported) for prophylaxis. On an unknown date, the patient experienced life threatening illness. The outcome of the event was unknown. Causality assessment was not provided. This is one of two reports received from the same reporter (link case # 2108USA005903).; Sender's Comments: US-009507513-2108USA005903:

Other Meds:

Current Illness:

ID: 1634775
Sex: F
Age:
State: MI

Vax Date: 08/11/2021
Onset Date: 08/01/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: diarrhea with "some" blood in the stool; the patient was "spitting" up a lot.; vomiting the entire day; the patient is still "fussy"; This spontaneous report was received from a doctor concerning a 4-month-old female patient. Pertinent medical history included prolonged jaundice, persistent direct hyperbilirubinemia and hemangioma. Concomitant therapies included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13V (CRM197) (reported as PCV 13). On 11-AUG-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (1 DS X 10 TUBES 00006404741; lot # 1707460 has been verified to be valid, expiration date reported as 14-MAR-2022; strength was unknown), 1 time dose, orally for prevention of rotavirus gastroenteritis. On 11-AUG-2021, about an hour after the patient had some food, she experienced vomiting the entire day. The next day the patient was spitting up a lot. On 14-AUG-2021, the patient had diarrhea with some blood in the stool, and streaks of blood in the stool that continued for 2 days. The patient came in to see the doctor on 16-AUG-2021 (also reported as yesterday), and on exam it was noted no abdomen distention and no signs of intussusception. The doctor confirmed that the patient was still "fussy" (onset date: on unknown date in August 2021). The treatment was not given for the events. The patient was recovering from the events. The doctor was reporting this adverse event for rotavirus vaccine, live, oral, pentavalent (ROTATEQ). The reporter considered all events to be related to Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ). Upon internal review, blood in the stool was determined to be medically significant.

Other Meds:

Current Illness: Direct hyperbilirubinaemia; Haemangioma; Jaundice

ID: 1634776
Sex: U
Age:
State: MO

Vax Date: 08/21/2016
Onset Date:
Rec V Date: 08/26/2021
Hospital: Y

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: Shingles; other zoster-related conditions; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 19-AUG-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On or about 21-AUG-20106 the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for the long-term prevention of shingles and zoster related conditions. Subsequently, to patient's Zoster Vaccine Live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles and other zoster-related conditions. Then, on an unknown date, the patient was hospitalized due to the event .As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries including but not limited to cost for hospitalization, physician care, monitoring, treatment, medications, and supplies, diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. At the reporting time, the outcome of herpes zoster and zoster related conditions was not provided. The reporter considered the event herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).

Other Meds:

Current Illness:

ID: 1634777
Sex: U
Age:
State: MA

Vax Date:
Onset Date: 08/17/2021
Rec V Date: 08/26/2021
Hospital: Y

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: the patient was voiting and the vomit had visible blood clots; This spontaneous report was received from a medical assistant via company representative and refers to a 2-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date (on the same day), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(strength, dose, dosing schedule, lot# and expiration date were not provided), orally, with diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid(VAXELIS) and pneumococcal vaccine conj 13v (crm197)(PREVENAR 13)(strength, dose, dosing schedule, lot#, expiration date and route of administration were not provided for both). Vaccines were administered for prophylaxis. On 17-AUG-2021, the patient was vomiting, and the vomit had visible blood clots. The medical attention was sought. Approximately in August 2021, the patient was admitted to hospital due to event and hospitalized for a one day. The patient received unspecified treatment. The patient had made a full recovery approximately in August 2021 and the physicians did not believe that the vomiting was linked to the vaccines that were administered. The reporting medical assistant did not provide her causality assessment between the subject therapies and the event. Upon internal review, the event of haematemesis was considered to be medically significant.

Other Meds:

Current Illness: Prophylaxis

ID: 1634778
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: life threatening illnesses; This spontaneous report was received from a person told a friend who then told the employee's wife referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date (reported as in the past), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot# and expire date were not reported) for prophylaxis. On an unknown date, the patient experienced life threatening illness. The outcome of the event was unknown. Causality assessment was not provided. This is one of two reports received from the same reporter (link case # 2108USA004631).; Sender's Comments: US-009507513-2108USA004631:

Other Meds:

Current Illness:

ID: 1634779
Sex: U
Age:
State: UT

Vax Date:
Onset Date: 07/30/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: No additional AE details provided; Improperly stored PROQUAD admnistered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with an improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (lot # T021301 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 19-DEC-2021) (strength, dose, route of administration and anatomical location were not provided). The temperature of storage and time frame of the excursion were 9? Celsius (C) for 80 minutes respectively. If a digital data logger was involved was not reported; measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) did not experience a previous temperature excursion. No adverse event reported.

Other Meds:

Current Illness:

ID: 1634780
Sex: U
Age:
State: CA

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No other AE; expired dose of MMR II was administered to a patient; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported. On 16-AUG-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rha) (M-M-R II) 0.5 milliliters (ml), administered subcutaneously (SQ) as prophylaxis (dose number, vaccine scheme and anatomical site of vaccination were not reported; lot number S006051 has been verified to be valid, expiration date reported and established as 27-FEB-2021) (expired product administered). No additional adverse events (AE) reported.

Other Meds:

Current Illness:

ID: 1634781
Sex: U
Age:
State: IA

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No additional AE; a patient was administered with a dose of PEDVAXHIB and ROTATEQ that were improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age or gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, and drug reactions or allergies was provided. On an unknown date, a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number T024020 has been verified to be valid, lot number reported and validated as 31-MAR-2023) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) ((lot number T033812 has been verified to be valid, lot number reported and validated as 29-DEC-2021) were improperly stored at a temperature of -2.3 degrees Celsius for 9 hours and 12 minutes. There wasn't a previous temperature excursion. On 20-AUG-2021, the patient was administered with the improperly stored vaccines at a dose of 0.5 milliliter (ml) for prophylaxis (dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) (product storage error). No additional adverse events (AE) were reported

Other Meds:

Current Illness:

ID: 1634782
Sex: U
Age:
State: VA

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: No signs or symptoms reported. No other AE or PQC reported.; Medical assistant called to report a temperature excursion. PROQUAD (lot/exp. U009260 9/19/2022) was administered to one patient after the excursion occurred.; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies. On 20-AUG-2020, the patient was vaccinated with one (1) time dose Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (dose number, vaccination scheme frequency, route and anatomical site of administration were not provided; lot number U009260 was verified to be a valid lot number with an expiration date reported and established as 19-SEP-2022) for prophylaxis. It was reported that the administered vaccine had experienced a temperature excursion of 4.6 degrees Celsius (C) with a time frame of 3 hour and 57 minutes (product storage error). No data logger was reported. No previous temperature excursion was reported. No signs or symptoms were reported. No additional adverse event (AE) was reported.

Other Meds:

Current Illness:

ID: 1634783
Sex: U
Age:
State: MD

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: No additional AE reported. No PQC reported. No additional information provided.; Customer called and reported that ROTATEQ was administered to one patient following a temperature excursion.; This spontaneous report has been received from an administrator (also reported on physician's field) (conflicting information) referring to a patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions, or allergies. On 20-AUG-2021, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (dose number and vaccination scheme frequency were unknown by the reporter; lot number 1707572 was verified to be a valid lot number with an expiration date reported and established as 11-MAR-2022) for prophylaxis. It was reported that the administered vaccine had experienced a temperature excursion of 47.3 degrees Fahrenheit (F) with a time frame of 1 hour and 10 minutes (product storage error). No data logger was reported. It was stated that the vaccine had a previous temperature excursion (no details provided). No additional adverse event (AE) was reported.

Other Meds:

Current Illness:

ID: 1634784
Sex: U
Age:
State: UT

Vax Date: 07/26/2021
Onset Date: 07/26/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No additional AE details provided; Improperly stored PROQUAD administered vaccine; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided. On 26-JUL-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T029103, expiration date 23-FEB-2022; strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The storage temperatures of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was 9.6 Celsius degrees for 80 minutes. There was no previous temperature excursion. No additional adverse event details provided (no adverse event). No product quality complaint (PQC) was reported.

Other Meds:

Current Illness:

ID: 1634785
Sex: F
Age:
State: IN

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

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: Hospitalized after MMR vaccine in 1989, unknown cause; This spontaneous report was received from a consumer via Pfizer (reference # 2021417258) and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date in 1989, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, lot #, expiration date, dose, route, frequency and indication were not reported). On an unknown date, the patient experienced an unspecified adverse event and, due to that, she was hospitalized on an unreported date. At the reporting time, the outcome of adverse event was not reported. The reporter did not provide a causal relationship between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).

Other Meds:

Current Illness:

ID: 1634786
Sex: M
Age: 76
State: CA

Vax Date: 02/19/2021
Onset Date: 02/26/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: shingles; bumps on his neck; This spontaneous case was reported by a health care professional and describes the occurrence of HERPES ZOSTER (shingles) and RASH (bumps on his neck) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The patient's past medical history included Arthritis of neck (lower back and neck arthritis). Concomitant products included VALACYCLOVIR [VALACICLOVIR] for an unknown indication. On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HERPES ZOSTER (shingles). 26-Feb-2021, the patient experienced RASH (bumps on his neck). On 05-Mar-2021, HERPES ZOSTER (shingles) had resolved. At the time of the report, RASH (bumps on his neck) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. medical history of lower back and neck arthritis was reported. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Treatment drug (Valcyclovir) was prescribed and medical history was reported.

Other Meds: VALACYCLOVIR [VALACICLOVIR]

Current Illness:

ID: 1634787
Sex: U
Age:
State: CT

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

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

Lab Data:

Allergies:

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

Symptoms: Swelling in her arm; Inappropriate schedule of product administration; A spontaneous report was received on 03AUG2021 from another pharmaceutical company. On 30JUL2021, a 55 year-old female patient reported experiencing swelling in her arm (PT: Injection site swelling) after receiving the "Anthrax shot". The patient received BioThrax (anthrax vaccine) 0.5cc on 03MAY2004, 17MAY2004 and 01JUN2004 (Inappropriate schedule of product administration). After each dose, she developed swelling in her arm. She described that after receiving the first dose she had swelling slightly, after receiving the second dose, she had a little more swelling, and after the third dose she had really bad swelling in her right arm and it was a lot. Expiry date and Lot Number were unknown. The patient attributes the swelling in her arm as related to the anthrax vaccine. The outcome of the events were resolved. Medical history includes Methicillin-resistant Staphylococcus aureus (MRSA) infection in 2012. Concomitant medications were not reported. No further information is available. Company comment: Injection site reaction is one of the most common adverse events associated to BioThrax vaccination. As the patient developed the same reaction with the three vaccination (rechallenge), the causality has been assessed as "Definite" related. Because it is assumed that the reported schedule was for pre-exposure, medication error was added and because medication errors are not AE per se, cannot be associated to the vaccination.; Sender's Comments: Injection site reaction is one of the most common adverse events associated to BioThrax vaccination. As the patient developed the same reaction with the three vaccination (rechallenge), the causality has been assessed as "Definite" related. Because it is assumed that the reported schedule was for pre-exposure, medication error was added and because medication errors are not AE per se, cannot be associated to the vaccination.

Other Meds:

Current Illness:

ID: 1634788
Sex: U
Age:
State:

Vax Date: 10/01/2020
Onset Date:
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: got my 2 vaccine back in October and I have shingls/ suspected Vaccination failure; I have shingls; 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. In October 2020, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with dermatologicals nos (Cream (Nos)) and antibiotics nos. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got 2 vaccine and had shingles now at the time of reporting, but luckily very little and no pain, treated with cream and antibiotic and that was it. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1634789
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Had 2 shots still got them /suspected Vaccination failure; Had 2 shots still got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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 reporter was the patient. The age at vaccination was not reported. The patient stated that, had 2 shots still get shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1634790
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Get that shot. I had them/ suspected vaccination failure; I had them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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 reported case for himself or herself. The age at vaccination was not reported. The patient got that shot and had them. The patient was going to ask about another shot for himself or herself. The patient stated that for years after patient got them and would feel pain deep down in that area, but forget that he or she was not into pain. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR175994:same reporter

Other Meds:

Current Illness:

ID: 1634791
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Face paralysis; Ramsay Hunt Disease; got single dose years ago; This case was reported by a consumer via media and described the occurrence of facial paralysis 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, several days after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced facial paralysis (serious criteria GSK medically significant), ramsay-hunt syndrome (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the facial paralysis and ramsay-hunt syndrome were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the facial paralysis and ramsay-hunt syndrome to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient's child. The age at vaccination was not reported. The patient received single dose of shingles vaccine years ago and experienced facial paralysis. Within days, the patient experienced Ramsay-Hunt disease. Till the time of reporting, patient did not receive 2nd dose of shingles vaccine, which led to incomplete course of vaccination. This case has been linked with the case US2021AMR176023, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR176023:Dad's wife case

Other Meds:

Current Illness:

ID: 1634792
Sex: U
Age:
State:

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Myarm hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 18th August 2021, the patient received Shingles vaccine. On 18th August 2021, less than a day after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient stated that got the shingles vaccine and arm hurt from that shot. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1634793
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: heart attack; This case was reported by a consumer via media and described the occurrence of heart attack in a 51-year-old 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 heart attack (serious criteria GSK medically significant). On an unknown date, the outcome of the heart attack was unknown. It was unknown if the reporter considered the heart attack to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient got the shingle shot and had heart attack, which was more difficult to recover. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1634794
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Face paralysis; Bells palsy; Incomplete course of vaccination; This case was reported by a consumer via media and described the occurrence of facial paralysis 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced facial paralysis (serious criteria GSK medically significant), bell's palsy (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the facial paralysis and bell's palsy were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the facial paralysis and bell's palsy to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient's child. The age at vaccination was not reported. The patient received single dose of shingles vaccine years ago and experienced facial paralysis. Within days, the patient experienced bell's palsy. Till the time of reporting, patient did not receive 2nd dose of shingles vaccine, which led to incomplete course of vaccination. This case has been linked with the case US2021AMR176003, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR176003:Dad's case

Other Meds:

Current Illness:

ID: 1634795
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: sick; slight fever; left arm got real red; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (shingles on the inside of the body all 3 times its even worse). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness, fever and erythema of extremities. On an unknown date, the outcome of the sickness, fever and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the sickness, fever and erythema of extremities to be related to Shingrix. Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she did get the 2 Shingrix shots for shingles this was in 2019, it was the best thing the patient did for himself/herself and yes it made him/her sick with a slight fever and his/her left arm got real red but after 2 days the patient was fine and have been ever since, the patient pay dollar 300, for both out of pocket, patient said he/she on but had to do it, hope who ever gets the shots would get better. The patient also had both Covid shots (Pfizer), was only sick for 2 days with fever this was 6 months ago from the time of reporting. The patient was doing fine, he/she did this for himself/herself and the patient just went to get his/her Flu shot last week, from the time of reporting that one patient get every year. For the tolerance of the 2nd dose, refer case US2021AMR178357 , reported by the same reporter; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR178357:Same reporter

Other Meds:

Current Illness:

ID: 1634796
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: suspected vaccination failure; My dad still got them and does not prevent them from happening; This case was reported by a consumer viainteractive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient was reporter's father. The age at vaccination was not reported. The patient received shingles vaccine but still experienced shingles. The reporter stated that the vaccine did not prevent shingles. The follow-up would not possible as no contact details were available. 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 had been linked with the case US2021AMR176054 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR176054:Same reporter

Other Meds:

Current Illness:

ID: 1634797
Sex: F
Age: 58
State: CA

Vax Date: 07/14/2021
Onset Date: 07/14/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Received only the adjuvant; Received only the adjuvant; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 75XA2, expiry date 28th January 2023) for prophylaxis. On 14th July 2021, the patient received Shingrix. On 14th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The reporter stated that, the patient received only adjuvant portion of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, reconstitution liquid administered not the actual vaccine it self. The Glaxosmithkline was contacted and were informed that we should wait 4 weeks before giving repeat dose. The patient was advised to came in 4 weeks from the date of injection to have shingrix vaccine readministered. The VAERS details were updated. This case was linked with case US2021167751, reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021167751:Patient 1

Other Meds:

Current Illness:

ID: 1634798
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Came down with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included nerve pain and pruritus. Concomitant products included gabapentin. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient had 1st shot and experienced shingles. The patient was due for the second shot when Covid hit hard. For the tolerance of second dose, refer case US2021AMR176125.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR176125:Same reporter.

Other Meds: GABAPENTIN

Current Illness: Nerve pain; Pruritus

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am