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: 1690670
Sex: F
Age: 38
State: FL

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: None

Allergies: None

Symptom List: Dysphagia, Epiglottitis

Symptoms: Moderate rash around the neck and the lower right side of the face. Soreness and redness around the injection site. Fatigue.

Other Meds: None

Current Illness: None

ID: 1690671
Sex: M
Age: 47
State: NJ

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/11/2021
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: none

Symptom List: Anxiety, Dyspnoea

Symptoms: Intense ringing in both my ears about 90-120 minutes after receiving the vaccine. Called a Dr and he said that this is a rare but known side effect. He said nothing can be done except wait and see if it goes away.

Other Meds: none

Current Illness: none

ID: 1690672
Sex: M
Age: 49
State: FL

Vax Date: 09/09/2021
Onset Date: 09/09/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: None to report.

Allergies: None.

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

Symptoms: Approximately 12 hours after injection, began having weakness, fatigue, chills, nausea. At 14 hours developed dizziness, loss of balance, sensitivity to light, exceptionally painful headache, cycle of shivering and chills to extreme fever, full body pain and feeling as though I were being scalded with hot water. Symptoms continued through the entire night. Arose in the morning at 10:30 am feeling extreme weakness, nausea, loss of balance, fatigue, severe headache, extreme sensitivity to light (which compounded headache pain). Symptoms began subsiding around 1:00 pm. Finally felt normal at approximately 8:00 pm this evening with exception of high level of soreness of right arm at injection site. In short, this was the most horrible feeling I have ever experienced, and I came very close to dialing 911. I did not take anything to try and alleviate any of the symptoms, as I was fearful that it exacerbate some of the conditions.

Other Meds: Daily multi-vitamin and no others.

Current Illness: None.

ID: 1690673
Sex: F
Age: 32
State: HI

Vax Date: 08/31/2021
Onset Date: 09/01/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: No test or labs.

Allergies: N/A

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: After first dose started feeling tingling and numbness in my uppper spine base of neck. After 2nd dose pain in my upper spine base of neck, upper left side of back through my collar bone and shoulder. Went to urgent care on 9/10/21 was told I have Musculoskeletal pain and have been put on pain meds and a muscle relaxer.

Other Meds: Prenatal vitamins

Current Illness: N/A

ID: 1690674
Sex: F
Age: 30
State: AZ

Vax Date: 05/01/2021
Onset Date: 07/15/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Hsv1 genitalia outbreak. First in 6 years.

Other Meds: Magnesium

Current Illness:

ID: 1690675
Sex: F
Age: 26
State: UT

Vax Date: 09/09/2021
Onset Date: 09/09/2021
Rec V Date: 09/11/2021
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: Did not go to ER because of outstanding medical debt.

Allergies: None

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

Symptoms: Fever, body aches, chills, difficulty breathing (had to use inhaler three times). Spasms, severe abdominal pain and pain in lungs after inhaler use. Deliriousness from fever. Nausea, dry heaving but no vomiting. The symptoms started around 4:00pm, about two hours after receiving the vaccine. The worst of it lasted for about 14 hours, until around 6:00am the next morning, when I took painkillers to be able to sleep.

Other Meds: None

Current Illness: None

ID: 1690676
Sex: F
Age: 42
State: CA

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/11/2021
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: Antibiotics.

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: After vaccine, arm hurt, swollen for 3 days. Lips got swollen, rash on lips and surrounding lips, very itchy and burning, whole body itchy and rashy.

Other Meds: None

Current Illness: None

ID: 1690677
Sex: F
Age: 48
State: CA

Vax Date: 04/03/2021
Onset Date: 04/03/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: No labs have been done as of this date.

Allergies: Sulfa

Symptom List: Pharyngeal swelling

Symptoms: Since the first shot, my left arm where the injection was given is still painful and sore. After five months, the pain is still there. I have tried taking pain medications and massage, but nothing works. Sleeping is very hard.

Other Meds: No prescriptions.

Current Illness: Pneumonia for six weeks starting on May 3rd.

ID: 1690678
Sex: F
Age: 45
State: VA

Vax Date: 09/01/2021
Onset Date: 09/10/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies: Skin periodically reacts to prolonged contact with nickel

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: On 9/1/2021 I received my first Moderna vaccine, and on the morning of 9/10/2021 noticed a fist-sized rash at the injection site. Rash does not itch, but I do feel a burning sensation coming from it.

Other Meds: Modafinil

Current Illness: N/A

ID: 1690679
Sex: M
Age:
State: UT

Vax Date: 03/01/2021
Onset Date: 07/13/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Developed chronic knee pain in right knee, despite losing 180 lbs. Only appeared after vaccine.

Other Meds: Lisinopril Vit d2 Escalitopram Wellbutrin

Current Illness:

ID: 1690681
Sex: F
Age: 34
State: NC

Vax Date: 09/02/2021
Onset Date: 09/10/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: N/a

Allergies: N/A

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

Symptoms: Excessive sleepiness about 12 hours after injection lasting almost a day and a half. A large hard red itchy bump at injection site starting about a week and 44 minutes after injection. (I still have it and so I don't know how long it will last so far it has been almost 14 hours)

Other Meds: Wellbutrin

Current Illness: None

ID: 1690682
Sex: F
Age: 35
State: HI

Vax Date: 08/15/2021
Onset Date: 08/28/2021
Rec V Date: 09/11/2021
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: Penicillin, Sulfa

Symptom List: Rash, Urticaria

Symptoms: Change in menstruation. This is my first ever "long period" in my 24 years of menstruation. Usually, I have a 5 day cycle with extremely predictable flow. Scheduled period dates were August 27 through August 31. I experienced two days of spotting commencing on August 28th before starting seven days of moderate bleeding, with the last day of normal menstrual bleeding occurring on September 5th. This last day of normal period bleeding was followed by three days of spotting. This menses was accompanied by the extension of other menstrual symptoms including several days of migraines. Usually I experience a two-day easily manageable migraine beginning a day before my period and extending into my second, and another two-day, easily manageable migraine beginning on the last day of my cycle and extending into the day after. During the "long period" my migraine commenced on the first day of spotting and ended at the end of my first day of menstruation. The end-of-cycle migraine occurred from the last day of my regular period through the period of spotting after, lessening each day. Emotional moodiness followed the same pattern as the migraines.

Other Meds: None

Current Illness: None

ID: 1690683
Sex: M
Age: 24
State: TX

Vax Date: 09/09/2021
Onset Date: 09/10/2021
Rec V Date: 09/11/2021
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: Cough, sinus pressure, body covered in rash, fever, hard time breathing, white splotches on skin.

Other Meds:

Current Illness:

ID: 1690684
Sex: F
Age: 29
State: CA

Vax Date: 04/23/2021
Onset Date: 06/04/2021
Rec V Date: 09/11/2021
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: N/A

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

Symptoms: I start having a light bleed 1 week prior to my actual period start time. It last 1-2 days if I continue taking my birth control pills on time. This last month (10/28) it was heavier than normal and I decided to not take my birth control. My period ended 9/4. This is very unusual. Being on birth control for 12+ years, I am normally right on track with the pill vs sugar pills

Other Meds: Trevora (birth control for 6+ years)

Current Illness: Nond

ID: 1690685
Sex: M
Age: 35
State: OH

Vax Date: 09/10/2021
Onset Date: 09/11/2021
Rec V Date: 09/11/2021
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: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Vomiting, nausea, chills, fatigue, headache, dizziness, coughing, runny nose, sinus pressure

Other Meds: Omeperazole

Current Illness: None

ID: 1690686
Sex: F
Age: 41
State: CA

Vax Date: 09/05/2021
Onset Date: 09/10/2021
Rec V Date: 09/11/2021
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: Azithromycin

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

Symptoms: Extremely thick vaginal discharge- like a full cup of jelly on Friday. I have never seen that before. Today it feels like I will be getting a period soon- cramping and uncomfortable.

Other Meds:

Current Illness:

ID: 1690855
Sex: F
Age:
State:

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 09/11/2021
Hospital: Y

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: Headache; Feeling queasy; Pyrexia; (Reference number: 2021TJP083289) on 29-Aug-2021 and was forwarded to Moderna on 09-Sep-2021. This case was reported by a family member. On 24-Aug-2021, the patient received this vaccine (unknown number of doses). Headache, feeling queasy, and pyrexia developed after the vaccination. A call for an ambulance was made. On 29-Aug-2021, the symptoms resolved. The outcome of headache, feeling queasy, and pyrexia was reported as recovered. No follow-up investigation will be possible due to the reporters non-cooperation. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter's Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1691016
Sex: F
Age: 33
State: OH

Vax Date: 03/31/2021
Onset Date: 04/05/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies: Allergic to Abilify

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Skipped my upcoming period for an entire month including the PMS symptoms. That has never happened since I?ve started my period as an adolescent. My periods have always been regular.

Other Meds: Wellbutrin Nikki birth control

Current Illness: None

ID: 1691017
Sex: M
Age: 48
State: LA

Vax Date: 08/29/2021
Onset Date: 09/10/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Sugar level measured with Accu-Check machine is 47

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Muscle ache on left arm, hypo sugar level

Other Meds: Insulin, levotiroksin

Current Illness:

ID: 1691019
Sex: F
Age: 36
State: NE

Vax Date: 08/05/2021
Onset Date: 08/08/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: I self medicated with benadryl for the hives and continue to have issues with menstration.

Allergies: erythromycin Latex

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

Symptoms: First vaccine 8/5/21: I have an IUD and have not had a period requiring tampons in about 6 years. 8/7/21 had experienced extreme cramping in my lower abdomen. In the morning of 8/8/21 I had bright red heavy menstruation blood; something I have not had in over 6 years. The bleeding continued for about 2 weeks. I also had weird large dark red/purple blood clots coming out. After about 2 weeks, the bleeding decreased, however, I still have weird discharge, clots, and spotting. After I received the second Pfizer vaccine on 8/27/21, the bleeding turned bright red again and increased for a few days. Second vaccine 8/27/21 in the AM: On 8/28/21 I woke up covered in full body hives that were itchy, welted patches. Some with red around them. My right arm, which is the one I had the vaccine on, had different type of hives. My right arm was covered with flat red itchy hives that also burned. I continued to have the full body hives until 8/31/21. Now I get random welted hive patches.

Other Meds: Aubagio Adderall Kyleena (IUD)

Current Illness: Multiple Sclerosis

ID: 1691045
Sex: M
Age: 55
State: IN

Vax Date: 08/24/2021
Onset Date: 08/25/2021
Rec V Date: 09/11/2021
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: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1691046
Sex: F
Age: 48
State: FL

Vax Date: 08/28/2021
Onset Date: 08/29/2021
Rec V Date: 09/11/2021
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: Sore arm; Myalgia; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Myalgia), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Myalgia), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Myalgia), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment medication was not provided. Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Additional information received on 30 Aug 2021 contains non-significant information.

Other Meds:

Current Illness:

ID: 1691047
Sex: F
Age: 48
State: FL

Vax Date: 08/28/2021
Onset Date: 08/30/2021
Rec V Date: 09/11/2021
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: Vomiting/ just threw up; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting/ just threw up) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced VOMITING (Vomiting/ just threw up). At the time of the report, VOMITING (Vomiting/ just threw up) outcome was unknown. Relevant concomitant medications were not provided. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: non significant follow up appended

Other Meds:

Current Illness: Diabetes

ID: 1691048
Sex: F
Age: 45
State: CA

Vax Date: 08/05/2021
Onset Date: 08/18/2021
Rec V Date: 09/11/2021
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: head pressure; feet hands prick pins; itching; Tight cough; Feverish; Pain chest; ringing ears; weakness; Eyes watering; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain chest), TINNITUS (ringing ears), ASTHENIA (weakness), LACRIMATION INCREASED (Eyes watering) and HEAD DISCOMFORT (head pressure) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Rash and Chest pain. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced CHEST PAIN (Pain chest), TINNITUS (ringing ears), ASTHENIA (weakness), LACRIMATION INCREASED (Eyes watering), PAIN (feet hands prick pins), PRURITUS (itching), COUGH (Tight cough) and PYREXIA (Feverish). On an unknown date, the patient experienced HEAD DISCOMFORT (head pressure). On 03-Sep-2021, CHEST PAIN (Pain chest), TINNITUS (ringing ears), ASTHENIA (weakness), LACRIMATION INCREASED (Eyes watering), PAIN (feet hands prick pins), PRURITUS (itching), COUGH (Tight cough) and PYREXIA (Feverish) had resolved. At the time of the report, HEAD DISCOMFORT (head pressure) had resolved. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Patient's medical history included Nerves. The patient had ear dizzy. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, 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 events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1691097
Sex: U
Age:
State: MI

Vax Date: 08/04/2021
Onset Date:
Rec V Date: 09/11/2021
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: ARDASIL 9 that experienced a temperature excursion was administered to a patient; No additional AE reported; This spontaneous report was received from a Medical Assistant, referring a patient of an unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies were not reported. On 04-AUG-2021, the patient was vaccinated with an improperly storage dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T029522 with expiration date on 13-APR-2022 (but upon internal validation established as 13-APR-2023), 0.5 milliliter dose (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported) for prophylaxis. The vaccine administered was stored at temperature -4.8C for a time frame of 20 minutes. There was no previous temperature excursion. No adverse events were 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); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T029522; expirationdate: 13-MAR-2023; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1691106
Sex: F
Age: 60
State: MA

Vax Date: 05/12/2021
Onset Date: 05/01/2021
Rec V Date: 09/11/2021
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: fever; chills,; diarhea; throwing up; she also wanted to sleep; she got sick.; made herself late on the dupixent shot while being treated; The consumer mentioned coming in contact with the COVID-19 Delta variant on vacation twice; shingles three days after taking her first shingles vaccine; arm was also so sore and she could not even lift it,; arm was also so sore and she could not even lift it,; nervous,; many problems with her spine; lower back as the pain was killing her,; getting bruises at the injection site; the site also gets a little bit sore; Information has been received from a 61-year-old female patient via Sanofi, referring on herself. The patient's medical history, medical treatment(s), family history and concomitant therapies were not reported. As concurrent conditions were reported rheumatoid arthritis, carpal tunnel syndrome and hand deformity. On an unknown date, the patient started taking dupilumab(DUPIXENT) solution for injection (strength: 300mg/2ml) at an unknown loading dose and frequency, followed by 300 mg maintenance dose every other week, subcutaneously (batch number and expiration date were unknown) for atopic dermatitis. On an unknown date, the patient received the first dose of varicella zoster vaccine rge (cho)(SHINGRIX) (lot #, expiration date, administration route and anatomical location were not reported) and on 12-MAY-2021, the patient received the second dose of varicella zoster vaccine rge (cho)(SHINGRIX) (route; formulation; strength; batch number and expiry date were unknown). On the same date (on 12-May-2021), the patient also received a dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid(TDAP) (route; formulation; strength; batch number and expiry date were unknown) and a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) ) (route; formulation; strength; batch number and expiry date were not reported) all the vaccines as prophylaxis. All the vaccines administered at the doctor's office. She said that she did not know that she was getting any of these shots. On 13-MAY-2021, the patient got sick, developed fever (pyrexia), chills, diarrhea (diarrhoea), throwing up (vomiting) and she also wanted to sleep (somnolence). On unknown dates, the patient experienced herpes zoster(reported as "shingles three days after taking her first shingles vaccine"); arm was also so sore (pain in extremity) and she could not even lift it (mobility decreased), she was nervous (nervousness), presented many problems with her spine (spinal disorder), lower back pain (reported as the pain was killing her), bruises at the injection site (injection site bruising), the site also gets a little bit sore (injection site pain) and she got off her dupilumab(DUPIXENT), made herself late on the dupilumab(DUPIXENT) shot (inappropriate schedule of product administration). The patient also had a magnetic resonance imaging (MRI) on 20-MAY-2021, but no results were provided. She stated that she forgot to inform the people who conducted the MRI that she was on dupilumab(DUPIXENT) and she was nervous. On an unknown date, the patient also reported that she had to go to the pain center as she has so many problems with her spine. Trigger injections were done on her neck and lower back twice. The patient mentioned coming in contact with the COVID-19 Delta variant on vacation twice: once on her husband's birthday and one at a restaurant that she was at, where 5 employees got COVID. She went to get tested (no result was available). The outcome of pyrexia, somnolence, vomiting, diarrhoea and chills was reported as resolved. The outcome of herpes zoster, exposure to sars-cov-2, illness, inappropriate schedule of product administration, injection site pain, injection site bruising, back pain, spinal disorder, nervousness, mobility decreased and pain in extremity was unknown. The causality assessment between all the suspect products and the aforementioned events was not provided.

Other Meds: DUPIXENT

Current Illness: Carpal tunnel syndrome; Dermatitis atopic; Hand deformity; Prophylaxis; Rheumatoid arthritis

ID: 1691107
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: This literature marketed report has been received from authors of a published article, titled as above, referring to a female patient of unknown age (age between 21-38 years). The patient's histologic diagnosis showed cervical intraepithelial neoplasm (CIN) 3 and human papillomavirus (HPV) genotype detected was type 16. Concomitant medication was unknown. On an unknown date (reported as at 14 years old), the patient was vaccinated with the first quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. The patient only received 2 doses of vaccine (incomplete course of vaccination) A copy of the published article is attached as further documentation of the patient's experience. This is one of two reports received from same literature.; Sender's Comments: US-009507513-2109USA002363:

Other Meds:

Current Illness: Cervical intraepithelial neoplasia III; Human papilloma virus infection

ID: 1691116
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: now has something that looks like a genital wart /the possibility of getting human papillomavirus (HPV); she received the vaccine series after the age of 45; This spontaneous report as received from a consumer refers to a female patient, of unknown age. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On an unknown date, the patient was vaccinated 3 months after turning 46 year old with the vaccine series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (doses, route of administration, lot number and expiration date were not reported). The patient called inquiring about the possibility of getting human papillomavirus (HPV) after taking the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). On an unknown date, she had something that looked like a genital wart that it had recently appeared.It was reported that the patient had not been diagnosed with genital wart at this time as she had not seen her physician yet for this. No treatment was given for the adverse event. She received the vaccine series after the age of 45-year-old and possible development of HPV after getting the vaccine. The outcome of anogenital warts was reported as not recovered. Causality of the event of human papillomavirus (HPV) and genital wart was not reported,

Other Meds:

Current Illness:

ID: 1691117
Sex: U
Age:
State: MS

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: herpes zoster; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. The patient was vaccinated with zoster vaccine live (ZOSTAVAX) (vaccination date, strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was considered to be not recovered and causal relationship was assessed as related. The lawyer considered the event herpes zoster to be disability.

Other Meds:

Current Illness: Routine health maintenance

ID: 1691118
Sex: M
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: multiple outbreaks of herpes zoster; scarring; Information has been received from a lawyer referring to a male patient of unknown age regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered multiple outbreaks of herpes zoster, resulting in scarring. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events multiple outbreaks of herpes zoster and scarring were considered to be not recovered and causal relationship was assessed as related. The lawyer considered the events multiple outbreaks of herpes zoster and scarring to be disability.

Other Meds:

Current Illness: Routine health maintenance

Date Died: 09/23/2018

ID: 1691119
Sex: U
Age:
State: MO

Vax Date: 09/01/2012
Onset Date: 09/23/2018
Rec V Date: 09/11/2021
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: encephalitis; shingles; death; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 02-SEP-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around September 2012, the patient was inoculated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered shingles and encephalitis. As a direct and proximate result of these injuries, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 23-SEP-2018. As direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious and dangerous side effects, including death, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of patients conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of encephalitis and shingles was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX). Upon internal review, the event of encephalitis was considered to be medically significant.

Other Meds:

Current Illness: Routine health maintenance

ID: 1691121
Sex: M
Age: 15
State: NJ

Vax Date: 06/05/2013
Onset Date: 09/03/2021
Rec V Date: 09/11/2021
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: tingling and numbness in left arm and hand; tingling and numbness in left arm and hand; nausea; light headedness/dizziness; headaches; the patient was tired(experienced fatigue).; vomiting; she gave the patient another dose. This dose was the fourth dose of GARDASIL 9 that the patient had received; overdose; This spontaneous report was received from a consumer (the patient's mother) referring to her son, a 23-years-old male patient. His medical history and concurrent conditions were not reported. Drug reactions/allergies included insect stings. Concomitant therapies included influenza vaccine (FLU SHOTS). On 05-JUN-2013, the patient was vaccinated with the first dose of human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 virus-like protein (vlp) vaccine (yeast) (GARDASIL 9) injection in the right arm (exact dose, route of administration, lot # and expiration date were not provided) as prevention of Human papillomavirus (HPV). On 09-SEP-2013 and 25-JAN-2014, the patient received the second and third dose of human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 virus-like protein (vlp) vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, vaccination site, lot # and expiration date were not provided) as prevention of HPV. The three doses were administered by the patient's Pediatrician. On 03-SEP-2021, the patient went to see a doctor who treated adult patients for the first time. The new doctor misread the patient's medical history and thought that the patient had never received human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 virus-like protein (vlp) vaccine (yeast) (GARDASIL 9) before, so she gave the patient another dose (that was the fourth dose) (extra dose administered and accidental overdose), no exact dose, route of administration, vaccination site, lot # and expiration date were reported. On the same date, roughly four hours after the shot, due to the overdose, the patient began having adverse reactions that included nausea, light headedness and dizziness, vomiting, headaches, tingling and numbness in left arm and hand, and the patient was tired (experienced fatigue). No treatment for the events was given. At the time of the report, the patient was being checked into the emergency room, so he had not yet been admitted to the hospital or had any lab/diagnostics/studies performed. The Company is unable to retrieve the product because the vaccine was administered at a doctor's office and then thrown away. The outcome of the events was not recovered. No product quality complaint reported. The causality assessment between human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 virus-like protein (vlp) vaccine (yeast) (GARDASIL 9) and nausea, light headedness and dizziness, vomiting, headaches, tingling and numbness in left arm and hand, and fatigue was related.

Other Meds: FLU

Current Illness: Allergy to insect sting

ID: 1691122
Sex: F
Age:
State: TX

Vax Date: 05/25/2021
Onset Date: 08/24/2021
Rec V Date: 09/11/2021
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: The site was tender; She developed a nodule at the vaccination site. The nodule continually got "bigger and worse"; This spontaneous report was received from a medical assistant, via company representative, referring to a 42-year-old female patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions, or allergies were unknown by the reporter. On 25-MAY-2021, the patient received her first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in the left arm (administered dose, vaccination scheme, route of administration, lot number and expiration date were unknown by the reporter) as prophylaxis (reported as "vaccination"). Subsequently, on an unknown date in 2021, the patient developed a nodule at the vaccination site. The nodule continually got "bigger and worse". On 29-JUN-2021, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in her right arm (administered dose, vaccination scheme, route of administration, lot number and expiration date were unknown by the reporter) as prophylaxis. There wasn't a reaction to that injection site. On 24-AUG-2021, the patient went to the physician's office, and the site was tender (vaccination site pain). The doctor prescribed sulfamethoxazole, trimethoprim (BACTRIM) as treatment. The outcome of the events was not reported. The reporter did not provide a causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), vaccination site nodule and vaccination site pain.

Other Meds:

Current Illness:

ID: 1691123
Sex: M
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data: Test Name: ALT; Test Result: 3075 IU; Test Name: AST; Test Result: 4895 IU; Test Name: bilirubin; Test Result: 16.3 mg/dl; Test Name: anti-HBc IgM; Test Result: Positive ; Test Name: HBeAg; Test Result: Positive ; Test Name: anti-HBs; Test Result: Negative ; Test Name: HBsAg; Test Result: Positive

Allergies:

Symptom List: Tremor

Symptoms: ACUTE HEPATITIS B; Therapy non-responder; Anti-HBs antibody negative; Information has been received from the authors of a published literature article, regarding to a 32 year old male patient. The patient's concurrent conditions was not reported. The patient's medical history included depression. Family history was notable for hemochromatosis in his father. He denied having unprofessional tattoos, IV drug use, heavy alcohol use, recent acetaminophen use, ingestion of non-commercial mushrooms or herbal supplements, but reported unprotected sexual intercourse with male partners. On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), for prophylaxis (dose, route of administration, lot# and expiration date were not provided). On an unknown date, the patient experienced hepatitis b, requiring hospitalization. On an unknown date, he was transferred to our hospital, for escalation of care, after presenting with 4-day history of nausea, vomiting, jaundice, body aches, abdominal pain, and worsening lethargy. Upon arrival, his lethargy resolved, but >jaundice and RUQ abdominal pain persisted. Initial labs showed elevated aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) of 3075/4895 IU, respectively; bilirubin of 16.3 mg/dL, INR greater than 2 and ferritin levels 17,000 ng/ml. Ceruloplasmin levels and alpha-1 antitrypsin clearance were within normal limits. Blood toxicology ruled out acetaminophen, alcohol, and salicylate toxicity. Evaluation for Hereditary Hemochromatosis showed a heterozygous H63D-mutation of HFE. However, Viral Hepatitis panel was positive for HBsAg, anti-HBc IgM, HBeAg, and negative for anti-HBs and a Viral Hep B DNA of 579000 copies. Hepatitis D Antigen and CMV evaluations were inconclusive. He improved over a few days with supportive care and n-acetylcysteine, until his transaminase levels dropped below 1000 (units not provided). No tenofovir or entecavir were required. He was then discharged with outpatient follow up. The outcome of acute hepatitis b was resolving. The outcome of therapy non-responder and hepatitis b surface antibody negative was unknown. The reporter considered therapy non-responder, hepatitis b surface antibody negative and acute hepatitis b to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB). Upon internal review, Hepatitis b was considered to be medically significant. A copy of the published article is attached as further documentation of the patient's experience.

Other Meds:

Current Illness:

ID: 1691125
Sex: F
Age: 11
State: OH

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/11/2021
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: the patient went "unconscious/unresponsive for about 30 seconds."; the patient went "unconscious/unresponsive for about 30 seconds."; The patient's eyes were open but they were not able to speak; the patient had no recollection of the event; This spontaneous report has been received from a healthcare professional (who was a nurse or medical assistant), referring to an 11-year-old female patient. Her pertinent medical history included anxiety. The patient's concomitant medications, previous drug reactions or allergies, and historical conditions were not reported. On 07-SEP-2021, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), one dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), and one dose of meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) (doses, vaccine scheme, anatomical sites of vaccination, lot numbers and expiration dates were not provided), intramuscularly as prophylaxis. On 07-SEP-2021, after the vaccination, the patient went unconscious (loss of consciousness) and unresponsive (unresponsive to stimuli) for about 30 seconds. Additionally, the reporter stated that the patient's eyes were open, but she was not able to speak (speech disorder) and when she regained consciousness, the patient had no recollection of the event (amnesia). The patient did not seek medical attention, and no treatment was given for the events. The patient recovered from loss of consciousness, unresponsive to stimuli, speech disorder and amnesia. The reporter's causality assessment between the suspect vaccines and the events was not provided. Upon internal review, the loss of consciousness and the unresponsive to stimuli were determined to be medically significant events.

Other Meds:

Current Illness: Anxiety; Prophylaxis

ID: 1691127
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: Blood clots in lungs; This is a solicited report from a non-Pfizer sponsored program, from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (BMS) (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-087002), license party for apixaban. This 71-year-old female patient was involved in a patient support program. The patient received APIXABAN. The report describes a case of PULMONARY THROMBOSIS (Blood clots in lungs). Co-suspect products included tozinameran (Pfizer Biontech Covid-19 Vaccine) for an unknown indication. On an unknown date, the patient started APIXABAN (unknown route), (unspecified dose and frequency). On an unknown date, the patient experienced PULMONARY THROMBOSIS (seriousness criterion medically significant). The action taken with APIXABAN(Unknown) was unknown. At the time of the report, PULMONARY THROMBOSIS outcome was unknown. The patient took Pfizer Covid Vaccine and developed blood clots in lungs. For APIXABAN(Unknown), the reporter did not provide any causality assessments. The primary reporter was non-health professional. The indication for apixaban was unknown. Follow-up is unable to be performed. The reporter's assessment of the causal relationship of the event with bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Agency medical evaluation comment: This patient had pulmonary thrombosis after receiving apixaban therapy along with co-suspect Covid-19 vaccine. Based on the limited information available regarding event details, relevant medical history, therapy details and indication, it cannot be ascertained with reasonable possibility that the suspect therapy contributed to the reported event. Causality Assessment: The event thrombosis pulmonary was not related to apixaban per company (Bristol-Myers Squibb) and was no information per reporter. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Pending the clinical course, temporal association, and relevant medical history, the company does not attribute the event pulmonary thrombosis to Pfizer suspected drug bnt162b2. The event is considered unrelated to apixaban by assessment.

Other Meds: Apixaban

Current Illness:

ID: 1691128
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: Neurocardiogenic syncope; On 26AUG2021, a spontaneous report was received from another pharmaceutical company. On an unknown date, a female patient (age at time of event unknown) experienced "Neurocardiogenic syncope" (PT: Syncope) after receiving BioThrax (anthrax vaccine) on an unknown date. No treatment for the event or outcome was reported. The patients medical history included gulf war illness, asthma, allergies (unspecified), and Ehlers-Danlos syndrome. She was also being monitored for autoimmune disease. The patient also reported previous history of taking penicillin, doxycycline, clindamycin, Cymbalta, and "higher doses of sertraline." No additional information with regards to this event was provided. Company comment: Vasovagal syncope is a self limited loss of consciousness caused by a neurological reflex that produces hypotension due to a lack of blood flow and almost always associated with bradycardia. Because it is produced in response to a stressful or emotional distress and not the vaccine, the Company considers that the vasovagal syncope is not related to BioThrax. ?; Sender's Comments: Vasovagal syncope is a self limited loss of consciousness caused by a neurological reflex that produces hypotension due to a lack of blood flow and almost always associated with bradycardia. Because it is produced in response to a stressful or emotional distress and not the vaccine, the Company considers that the vasovagal syncope is not related to BioThrax.

Other Meds:

Current Illness:

ID: 1691129
Sex: F
Age:
State:

Vax Date: 07/01/2019
Onset Date:
Rec V Date: 09/11/2021
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: already has Shingles/ severe skin issues.; no information was provided about needing a booster shot; This case was reported by a consumer and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and COVID-19 VACCINE MRNA (MRNA 1273) (COVID 19 VACCINE MODERNA) for prophylaxis. On 1st July 2019, the patient received the 1st dose of Shingles vaccine. On an unknown date, the patient received the 2nd dose of Shingles vaccine and COVID 19 VACCINE MODERNA. On an unknown date, less than 2 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient had the shingles vaccine 2 years ago and in 2021, the patient received Moderna covid vaccine and less than 9 months after Moderna covid vaccine and the patient already had shingles. It was reported that the vaccine was supposed to be 90 percent effective for 5 years, and no information was provided about needing a booster dose shot, which led to incomplete course of vaccination. The reporter had a call coming in and had to hang up, so could not obtain further information. The reporter consented to follow-up.

Other Meds:

Current Illness:

ID: 1691130
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: passed out; super dizzy; falling into the walls trying to walk; blood pressure plummets; can?t eat and then drive or do much of anything. It?s very strange; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of dizziness (1st dose received on an unknown date, and also experienced falling into the walls trying to walk, blood pressure plummets, refer case US2021AMR178275). Concurrent medical conditions included blood pressure high. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced passed out (serious criteria GSK medically significant), dizziness, walking difficulty, blood pressure decreased and feeling abnormal. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal were unknown. It was unknown if the reporter considered the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at the vaccination was not reported. The patient came home super dizzy, falling into the walls tried too walk. Ever since the vaccine the patient, every time the patient ate his/her blood pressure plummets and had passed out once. The patient could not eat and then drive or do much of anything and it as very strange. The patient had a weekly medical consultation to try to figure out how to counter that.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR178285:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR178284:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR178275:Same reporter, same patient, different dose (1st)

Other Meds:

Current Illness: Blood pressure high

ID: 1691131
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: passed out; super dizzy; falling into the walls trying to walk; blood pressure plummets; I can't eat and then drive or do much of anything. It's very strange; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included blood pressure high. 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 passed out (serious criteria GSK medically significant), dizziness, walking difficulty, blood pressure decreased and feeling abnormal. On an unknown date, the outcome of the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal were recovered/resolved. It was unknown if the reporter considered the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient came home super dizzy, falling into the walls tried too walk. Ever since the vaccine, the patient every time the patient ate his/her blood pressure plummets and had passed out once. The patient could not eat and then drive or do much of anything and it as very strange. The patient had a weekly medical consultation to try to figure out how to counter that. For 2nd dose, refer case US2021AMR169473, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR178284:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR178285:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR169473:Same reporter, same patient, different dose (2nd)

Other Meds:

Current Illness: Blood pressure high

ID: 1691133
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: Covid hit, didn't receive second dose / doctor says that i need to start over; This case was reported by a consumer via (Shingrix GSK and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose 20 months ago on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had received first dose of Shingrix just before Covid hit. The patient did not receive second dose and it had been about 20 months since the first shot, which led to social problem. The patient's doctor said that the patient needed to start over-get two doses. The patient stated that the site said that there was no need to start over.

Other Meds:

Current Illness:

ID: 1691136
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: small shingles rash; This case was reported by a consumer and described the occurrence of vesicular rash in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown. It was unknown if the reporter considered the vesicular rash to be related to Shingrix. Additional details were reported as follows: This patient self reported the case. The patient's 5 years old nephew got shingles from the chicken pox vaccine. He got shingles on his neck. It started the day after the shot. They took him to the doctor to confirm. He was 22 and had shingles 2 more times. The patient received Shingrix vaccine and got a small shingles rash the next day. The patient commented that, shingles are very painful though so did not regret his/her decision.

Other Meds:

Current Illness:

ID: 1691138
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: gouty arthritis; Pain; stayed in bed all day; This case was reported by a consumer and described the occurrence of gouty arthritis in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced gouty arthritis, pain and bed rest. On an unknown date, the outcome of the gouty arthritis, pain and bed rest were recovered/resolved. The reporter considered the gouty arthritis, pain and bed rest to be related to Shingrix. Additional details were provided as follows: The patient was the reporter's mother. The age at vaccination was not reported. The reporter stated that, the patient received her first dose and experienced suspected gouty arthritis, the day after the Shingrix shot. The reporter stated that, could not recall the date, but the patient now fine at the time of reporting, after being in pain. The reporter stated that, no hospitalization or death, patient just stayed in bed all day. The patients thought it was related to Shingrix

Other Meds:

Current Illness:

ID: 1691140
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: were vaccinated to avoid Shingles! both 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 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 reported as follows: The case was reported by the patient's spouse. The age at vaccination was not reported. The patient were vaccinated with Shingles to avoid shingles and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR187392:Same reporter, different patient

Other Meds:

Current Illness:

ID: 1691141
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: I HAD TWO SHINGLE VACCINATION.SOME GOT SHJINGLE TWICE/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 73-year-old 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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had 2 Shingles vaccination and got shingles. The patient said that some got shingles twice and some did not get 2nd for their lifetime. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case has been linked with the case US2021AMR187365, reported by the same reporter.

Other Meds:

Current Illness:

ID: 1691146
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: more painful than the flu shot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of pain (received first dose on an unknown date and experienced pain, refer case US2021AMR188159). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received flu shot and experienced pain. The patient received the second shingles shot and felt like he/ she had the flu for a day. This case is one of the 4 cases reported by the same reporter.

Other Meds:

Current Illness:

ID: 1691153
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: only the diluent administered not mixed; only the diluent administered not mixed; This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate 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 information was provided as follows: The age at vaccination was not reported. The reporter stated that the patient received adjuvant only and not the active component of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The mistake was realized, and the correct formulation was re administered on the same day. The reporter did not consent to follow up. This case is linked to case US2021AMR189327 reported by the same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR189327:Same reporter

Other Meds:

Current Illness:

ID: 1691154
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: only the diluent administered not mixed; only the diluent administered not mixed; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster Shingrix for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate 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 information was provided as follows: The age at vaccination was not reported. The reporter stated that the patient received adjuvant only and not the active component of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The mistake was realized, and the correct formulation was re administered on the same day. The reporter did not consent to follow up. This case is linked to case US2021AMR189269 reported by the same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR189269:Same reporter

Other Meds:

Current Illness:

ID: 1691155
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: Guillen Barre Syndrome; bedfast; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (serious criteria GSK medically significant) and bedridden. On an unknown date, the outcome of the guillain barre syndrome and bedridden were unknown. It was unknown if the reporter considered the guillain barre syndrome and bedridden to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by the patient's wife. The reporter stated that the patient had been bedfast with Guillen barre syndrome for 3 years. The reporter also asked that could we refer her to someone who might know if this was caused by the shingles vaccine. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1691156
Sex: U
Age:
State:

Vax Date: 11/01/2020
Onset Date:
Rec V Date: 09/11/2021
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: passed out on day 3 post vaccine; I think I had Guillen Barre; severe muscle weakness of lower extremity; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a patient who received Herpes zoster (Shingrix) for prophylaxis. In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), guillain barre syndrome (serious criteria GSK medically significant) and lower extremities weakness of. On an unknown date, the outcome of the passed out and guillain barre syndrome were unknown and the outcome of the lower extremities weakness of was not recovered/not resolved. It was unknown if the reporter considered the passed out, guillain barre syndrome and lower extremities weakness of to be related to Shingrix. Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient passed out on day 3 post vaccine and less than a year after vaccination, then had severe muscle weakness of lower extremity, the patient though he/she had Guillen Barre, the patient's doctor would not listen to him/her. The patient still had leg weakness this far out. The patient asked would it get better. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am