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**
PLEASE CHECK BACK SOON
Download the files above while you wait.







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: 1819677
Sex: M
Age: 83
State: TX

Vax Date: 10/18/2021
Onset Date: 10/27/2021
Rec V Date: 10/27/2021
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: No

Symptom List: Dysphagia, Epiglottitis

Symptoms: I thought I had shingles at first but later diagnosed with eczema: rash and redness, extreme itching supposedly caused by autoimmune overactive system. I just wonder if it could be related to booster shot received three weeks earlier. No big deal but wanted to make the info available. Condition improving after cortisone shots and topical ointment application.

Other Meds: Warfarin and Plavix

Current Illness: None

ID: 1819678
Sex: F
Age: 54
State: OH

Vax Date: 10/25/2021
Onset Date: 10/26/2021
Rec V Date: 10/27/2021
Hospital: Y

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

Lab Data: All testing on 10/26/21: COVID-19 test (negative result), CBC (stable chronic anemia), CMP (stable CKD), ketones serum (normal), rapid HIV (negative), urinalysis (normal), Chest x-ray (no acute findings), CT Neck/Soft Tissue without IV contrast (Prominent lingual tonsils abut the epiglottis. Mild aryepiglottic fold edema and laryngeal mucosal causes moderate airway stenosis at the level of the larynx with most severe level of stenosis causing diameter of 2.8mm of airway. No evidence of a drainable fluid collection.)

Allergies: None

Symptom List: Anxiety, Dyspnoea

Symptoms: 54-year-old female presented to the emergency room on 10/26/21 at approximately 16:25 with complaint of shortness of breath/wheezing from outpatient MRI department. Patient stated that prior to the MRI she was feeling fine and after multiple unsuccessful IV attempts the patient started to get short of breath. IV was successfully placed and MRI completed without issues aside from the fact that patient remained short of breath. Patient was short of breath prior to IV contrast administration. She received 3 prior MRIs with IV contrast in the past without any issues or allergies. Of note the patient did receive Covid vaccination yesterday on 10/25/21 at 11:30am and is on losartan, not on any ace-inhibitors. Initially on exam the patient appeared to have an expiratory stridor. Due to the stridor we did administer 2 rounds of racemic epinephrine nebulized with no improvement. Patient then received albuterol for which she states she felt slightly better. In the meantime the patient received IV dose of steroids. We then underwent a CT of the neck which showed moderate laryngeal and epiglottic fold edema with the most narrowed area of the airway measuring 2.8mm in diameter. At this time decision was made to transfer the patient to a facility that had ENT as backup in case of the need for intubation which would be considered complicated. Spoke with Dr. at Hospital. At this time the patient had improvement of her symptoms however was still having audible expiratory stridor.

Other Meds: losartan, gabapentin, insulin glargine, Montelukast, melatonin, triamcinolone cream, diclofenac gel, ipratropium0albuterol nebulizer, atorvastatin, fenofibrate, albuterol HFA, cetirizine, omeprazole, liraglutide, amlodipine, amitriptyline,

Current Illness: None

ID: 1819679
Sex: F
Age: 49
State: CA

Vax Date: 10/19/2021
Onset Date: 10/20/2021
Rec V Date: 10/27/2021
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

Allergies: None.

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

Symptoms: muscle pain, under armpit pain, headache, site redness, swollen site, leg and lower back ached

Other Meds: None.

Current Illness: None.

ID: 1819680
Sex: F
Age: 31
State: NV

Vax Date: 10/26/2021
Onset Date: 10/26/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data:

Allergies: Anti-inflammatories, Ibuprofen, advil, walnuts, pecans, avocado, shrimp, Adhesive

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Facial numbness in the lips, chin, and cheeks.

Other Meds: Vitamin D, Allegra, birth control pills, Flonase, Benadryl, aleve

Current Illness: N/A

ID: 1819681
Sex: F
Age: 73
State: TX

Vax Date: 02/05/2021
Onset Date: 02/17/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data:

Allergies: None known

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

Symptoms: Covid Toes - Chilblains -- according to Dr. Dr. instructed me to report my swollen, purple toes on VAERS.

Other Meds:

Current Illness: NONE

ID: 1819682
Sex: F
Age: 20
State: HI

Vax Date: 09/23/2021
Onset Date: 10/15/2021
Rec V Date: 10/27/2021
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: none

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

Symptoms: Pt is a female who was pregnant, estimated 7+ weeks gestation (LMP: 8/3/21, EDD: 5/10/22) when she received her COVID vaccine #1 on 23 SEP 21 following an appt with her PCM. She reported no significant events immediately following the vaccination. She reports soreness at the site of injection/left arm for one week. She reports having occasional mild abdominal cramping in the mornings, but did not think they were out of the ordinary. She otherwise felt well. On 15 OCT 21, she went to her scheduled initial OB appt. Both abdominal and vaginal ultrasounds were performed; no fetal movement or heartbeat was documented. The OB providers notified the pt of her miscarriage. Pt continues to follow up with OB for management.

Other Meds: acetaminophen as needed

Current Illness: none

ID: 1819683
Sex: F
Age: 30
State: CA

Vax Date: 10/17/2021
Onset Date: 10/17/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data: 10/18/21: EMERGENCY ROOM TREATMENT. URINE DIP DONE, NORMAL. RX FOR STEROIDS, ANTIHISTAMINES GIVEN 10/22/21: TELEMED VISIT: HYDROCORTISONE CREAM ORDERED. 10/26/21: LABS/ALLERGY TESTING ORDERED. STEROIDS/ANTIHISTAMINES ORDERED. REFERRED TO ALLERGIST.

Allergies: NONE

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: DEVELOPED HIVES, FACIAL SWELLING, URTICARIA AFTER 2ND VACCINATION INJECTION, SAME NIGHT.

Other Meds: MIRENA IUD

Current Illness: NONE

ID: 1819684
Sex: F
Age: 27
State: MS

Vax Date: 10/21/2021
Onset Date: 10/23/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data: N/A

Allergies: Morphine Kiwi Chronic urticaria

Symptom List: Pharyngeal swelling

Symptoms: Severe itching & redness of palms of both hands & the soles of both feet. Constant itching. Started on Saturday. Progressively got worse. Very mildly relieved by Benadryl. Itching started to MILDLY migrate to other parts of the body, but remained constant & severe in the palms & soles of feet.

Other Meds: Zoloft 50 mg Tylenol Rapid Release 500 mg (2)

Current Illness: N/A

ID: 1819685
Sex: F
Age: 73
State: TX

Vax Date: 02/26/2021
Onset Date: 02/27/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data: There are no medical tests for tinnitus -- only hearing loss. And there is no known medical treatment for tinnitus.

Allergies: None known

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: TINNITUS - growing worse each month. There is no treatment for tinnitus. The only thing that can be done is to track and document the hearing loss. RINGING -- RINGING -- RINGING in my ears. TINNITUS IS ALMOST UNBEARABLE -- AND NO CURE!!! If I had it to do over again, I would NOT submit myself to another experimental vaccine. There are too many side effects for this vaccine. I will not get the booster. PLEASE, PLEASE DO NOT ALLOW OUR CHILDREN TO RECEIVE THE COVID VACCINE!!! We don't know how they will be affected by the vaccine.

Other Meds:

Current Illness: NONE

ID: 1819687
Sex: F
Age: 25
State: VA

Vax Date: 10/22/2021
Onset Date: 10/27/2021
Rec V Date: 10/27/2021
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: Fries and vegetables

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Extremely sick within 1 hour of dose #2 for 4 days - high fever of 102, vomiting, chills. Day 5 noticed red hives EVERYWHERE. Weren't itchy at first, by the afternoon they became itchy and painful.

Other Meds: N/A

Current Illness: N/A

ID: 1819688
Sex: M
Age: 53
State: CA

Vax Date: 10/01/2021
Onset Date: 10/20/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data: didnt go to doctor. wouldnt have been able to get up i was so weak

Allergies: none

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

Symptoms: extreme body aches, shivering, chills but it was the body and joint pain that was unbearable. lasted about 10 hours then I felt normal

Other Meds: none

Current Illness: none

ID: 1819689
Sex: F
Age: 65
State: PA

Vax Date: 09/18/2021
Onset Date: 09/19/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data: none

Allergies: chemical sensitivity

Symptom List: Rash, Urticaria

Symptoms: injection site throbs and hurts every day. Intermittant pain but consistantly each day sunce 2nd shot

Other Meds: none

Current Illness: none

ID: 1819691
Sex: F
Age: 26
State: NJ

Vax Date: 10/21/2021
Onset Date: 10/23/2021
Rec V Date: 10/27/2021
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: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Extreme fatigue on day dose was received. 10/23/2021 began having severe stomach cramping and fatigue 10/24/2021 stomach cramping and fatigue continues with constipation 10/25/2021 stomach cramping and fatigue continue with diarrhea and hot flashes 10/27/2021 symptoms that began 10/25 still occurring with no improvement

Other Meds:

Current Illness:

ID: 1820097
Sex: F
Age: 32
State: CO

Vax Date: 10/15/2021
Onset Date: 10/15/2021
Rec V Date: 10/27/2021
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: NKA

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

Symptoms: Within 10 minutes I had swelling in my arm and had to take my watch off. A couple hours later I had the chills before bed. The next day I was extremely nauseous, I could barely move my arm out without it feeling like my muscle was pulling from my chest, my fingers went numb when I would type or lift them up, my back hurt so bad it felt like I hadn't had water in days, I had a fever, and elevated heart rate. I was very fatigued with the above symptom the next day. The headache and extreme nausea lasted six days.

Other Meds: Vitamin C, Elderberry, & Zinc

Current Illness: None

ID: 1820099
Sex: F
Age: 25
State: CA

Vax Date: 10/24/2021
Onset Date: 10/25/2021
Rec V Date: 10/27/2021
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: NA

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

Symptoms: Moderna COVID-19 Vaccine EUA Severe headache on right side (I have migraines often, 1-2times a week), nausea, vomiting, body ache and light fever started 18hrs after injection, and lasted for 10hrs. Swollen lymph nodes in left side armpit started 36hrs after injection. Very tender to touch or arm movement.

Other Meds: NA

Current Illness: NA

ID: 1820194
Sex: M
Age:
State: PR

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data: Test Date: 20210609; Test Name: heart rate; Result Unstructured Data: Test Result:65 bpm.

Allergies:

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

Symptoms: Chest pain/Mild chest pain.; This is a spontaneous report from a contactable consumer (parent). A 15-years-old male patient received BNT162B2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0217), via an unspecified route, administered in left arm on 09Jun2021 at 09:45 (at age of 15-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. He had no known allergies. Concomitant medication was not reported. He had not received any other vaccine within 4 weeks. He had not received other medications within two weeks. The patient received BNT162B2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0178), via an unspecified route, administered in left arm on 19May2021 at 15:30 (at the age of 14-years-old) as historical vaccine as dose 1, single for COVID-19 immunization. On 09Jun2021 15:00, the patient experienced chest pain/mild chest pain and heart rate was 65bpm. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not received treatment for the event. The outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1820365
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: blisters broke out; Getting over them and had the shot/suspected vaccination failure; getting over them; painful / Felt like an ice pick stabbing; This case was reported by a consumer via interactive digital media and described the occurrence of Suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included knee operation (First a fall, then knee surgery for msnicusi and ligament) and sepsis (then in hospital again with sepsis, sick for a year). Additional patient notes included Tansfusion- iron. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and blister.On an unknown date, the outcome of the vaccination failure and blister were unknown and the outcome of the shingles was recovering/resolving and the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles, pain and blister 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 mentioned that this year was bad year and a half, first fall then knee surgery for meniscus and ligament, then in hospital again with sepsis, sick for a year, then iron transfusions, then shingles. The patient stated he/she just now getting over them (shingles) and had the shingles vaccine. The patient stated they were extremely painful. The worst pain was before the blisters broke out. The patient felt like an ice pick stabbing for 3 solid days. The patient stated he/she wanted to be healthy even though he/she on a heating pad right now at the time of reporting, he/she thankful, it could be worse. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as contact details was not available.

Other Meds:

Current Illness:

ID: 1820366
Sex: F
Age:
State:

Vax Date:
Onset Date: 10/01/2021
Rec V Date: 10/27/2021
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: uncomfortable with PHN.; received two doses of Shingrix/ Last episode/ suspected Vaccination failure; Last episode; This case was reported by a pharmacist and described the occurrence of suspected vaccination failure in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included immunoglobulin therapy, shingles (had 7 breakthrough, refer linked case US2021AMR216523) and pneumonia bacterial. Previously administered products included Pneumovax with an associated reaction of pneumonia viral (received as late as July 2015 yet has had viral pneumonia twice and bacterial pneumonia once), Hizentra and valacyclovir (a maintenance dose of 500 mg valacyclovir qd, increasing to bid and tid if improvement not seen in shingles). Concurrent medical conditions included immunodeficiency. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In October 2021, more than 2 years after receiving Shingrix and Shingrix and an unknown time after starting Valacyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced post herpetic neuralgia. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and prednisone. On an unknown date, the outcome of the vaccination failure, shingles and post herpetic neuralgia were unknown. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. Additional details were provided are as follows: The age at vaccination was not reported. The patient was having immunodeficiency. The patient received 2 doses of Shingrix in the fall of 2018. Since the vaccination, she had 7 breakthrough Shingles infections. The patient's physician had her on a maintenance dose of 500mg Valacyclovir QD, increasing to BID and TID if improvement not seen. Last episode of shingles was about two weeks before the date of reporting, she had to use Valacyclovir 1g TID x1 week, then 500mg TID along with Prednisone. Given that these were happening so often, she wondered if a third dose of Shingrix would be advisable. She was quite uncomfortable with post-herpetic neuralgia. Her physician said the usual 2 shots was the maximum. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles was unknown at the time of reporting. The reporter consented to follow-up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR216523:same reporter

Other Meds:

Current Illness: Immunodeficiency

ID: 1820369
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: got both shots, 6 months later had shingles/ suspected vaccination failure; terrible case of shingles on my face, neck and shoulder; 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, 6 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient stated that vaccine does not work for everyone. The patient received the series of both shots and 6 months later had a terrible case of shingles on face, neck and shoulder. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.

Other Meds:

Current Illness:

ID: 1820371
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: Fainting after getting Shingrix shot; This case was reported by a consumer via (Shingrix GSK) interactive digital media and described the occurrence of faint in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant). On an unknown date, the outcome of the faint was unknown. It was unknown if the reporter considered the faint to be related to Shingrix. Additional details were provided are as follows: The age at vaccination was not reported. The reporter asked that fainting could happen several hours after getting the Shingrix shot. The follow-up could not be possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1820372
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: got the shot and is now having shingles outbreaks/ suspected vaccination failure; shingles outbreaks; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient was the reporter's mother. The age at vaccination was not reported. The patient got the shot and was now constantly having shingles outbreaks all the time. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.

Other Meds:

Current Illness:

ID: 1820373
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: Can I break out in shingles from the vaccine/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. The reporter considered the vaccination failure and shingles to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingrix shot and still got shingles from the vaccine. 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 immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1820374
Sex: M
Age: 66
State: OH

Vax Date: 12/20/2019
Onset Date:
Rec V Date: 10/27/2021
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: Polymyalgia Rheumatica; Fatigue; joint pain; tingling in feet/tingling 6 inches about ankle; Numbness in feet/Numbness 6 inches about ankle; This case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included knee operation (occurred 2 years ago from the date of reporting). Previously administered products included Shingrix (1st dose received 3/4 months before receiving 2nd dose on an date unknown). On 20th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), fatigue, joint pain, tingling and numbness. The patient was treated with prednisone. On an unknown date, the outcome of the polymyalgia rheumatica was not recovered/not resolved and the outcome of the fatigue, joint pain and tingling were recovered/resolved and the outcome of the numbness was unknown. It was unknown if the reporter considered the polymyalgia rheumatica, fatigue, joint pain, tingling and numbness to be related to Shingrix. Additional details provided were as follows: The case was reported by the patient. Within 2 weeks of receiving the 2nd dose, the patient felt numbness and tingling in his feet and 6 inches above his ankle. The patient had knee surgery which occurred 2 years before the date of reporting and that the adverse events that he experienced were not due to the surgery. The patient had joint pain and fatigue that got worse and was referred to his rheumatologist. The patient was prescribed Prednisone for polymyalgia rheumatica and was now weaning off from this medication. The reporter declined to give further information and demographic information for his sister. The reporter consented to follow up. The case had been linked with US2021216680, reported by same reporter for patient's sister.; Sender's Comments: US-GLAXOSMITHKLINE-US2021216680:same reporter

Other Meds:

Current Illness:

ID: 1820375
Sex: F
Age: 77
State: AZ

Vax Date: 12/01/2020
Onset Date: 10/19/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: suspected vaccination failure/received second Shingrix, has possibly shingles; has possibly shingles; non-itchy rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On 1st December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 19th October 2021, more than a year after receiving Shingrix and 322 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix. Additional details provided were as follows: The case was reported by the patient herself. The age at vaccination was not reported for 1st dose of Shingrix. The patient received her 2nd dose in her right arm and at the time of reporting she had a non itchy rash on her left neck around to the mid point of her left back. The patient thought it might possibly be a case of shingles but she had not been to the health care professional to confirm yet. The reporter did not give permission to contact health care professional. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. The reporter did not consented to follow-up.

Other Meds:

Current Illness:

ID: 1820377
Sex: M
Age: 23
State: OH

Vax Date: 10/18/2021
Onset Date:
Rec V Date: 10/27/2021
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: exposed to freezing temperatures; This case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a 23-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis. Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 18th October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient received the vaccines after being exposed to freezing temperatures (minus 1 degree C for total amount of time of 25 min) on 18th October 2021 and 19th October 2021. The reporter consented to follow up. This case is one of the five, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021218244:same reporter US-GLAXOSMITHKLINE-US2021218242:same reporter US-GLAXOSMITHKLINE-US2021218245:same reporter US-GLAXOSMITHKLINE-US2021218239:same reporter

Other Meds:

Current Illness:

ID: 1820378
Sex: F
Age: 26
State: OH

Vax Date: 10/18/2021
Onset Date:
Rec V Date: 10/27/2021
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: exposed to freezing temperatures; This case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a 26-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis. Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 18th October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient received the vaccines after being exposed to freezing temperatures (minus 1 degree C for total amount of time of 25 min) on 18th October 2021 and 19th October 2021, which led to incorrect product storage. The reporter consented to follow up. This is one of five cases, reported by the same reporter. ; Sender's Comments: US-GLAXOSMITHKLINE-US2021218244:same reporter US-GLAXOSMITHKLINE-US2021218242:same reporter US-GLAXOSMITHKLINE-US2021218245:same reporter US-GLAXOSMITHKLINE-US2021218238:same reporter

Other Meds:

Current Illness:

ID: 1820380
Sex: M
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: incomplete doses; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 7-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. 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 incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient received two incomplete doses of Influenza Vaccine Quadrivalent Unspecified Season when he was a new born, which led to incomplete dose administered. There was the reason why it were not full doses. The incomplete doses did not gave the patient an allergic reaction. Then the patient received other Flu shot and had an allergic reaction and for the last 4 years the patient was vaccinated with Flulaval and had a reaction too, refer linked cases. This case is one of the 7 cases, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR220135: US-GLAXOSMITHKLINE-US2021AMR220134: US-GLAXOSMITHKLINE-US2021AMR220133: US-GLAXOSMITHKLINE-US2021218250: US-GLAXOSMITHKLINE-US2021AMR220136: US-GLAXOSMITHKLINE-US2021AMR220131:

Other Meds:

Current Illness:

ID: 1820382
Sex: M
Age: 26
State: OH

Vax Date: 10/21/2021
Onset Date: 10/21/2021
Rec V Date: 10/27/2021
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: Given a vaccine expired on 06/30/2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 26-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number XT4Z7, expiry date 30th June 2021) for prophylaxis. Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 21st October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 21st October 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient received an expired Flulaval shot. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1820383
Sex: F
Age: 2
State: AZ

Vax Date: 10/21/2021
Onset Date: 10/21/2021
Rec V Date: 10/27/2021
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: 2nd dose of Fluarix; given Fluarix, supposed to get Vaqta; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 2-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number HZ2JR, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX TETRA PFS). On 21st October 2021, the patient received the 2nd dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 21st October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient was inadvertently given a 2nd dose of Fluarix on the day of reporting, after receipt of her first dose on 8th October 2021, which led to extra dose administered. The patient was supposed to get Vaqta but received Fluarix, which led to wrong vaccine administered. The reporter consented to follow up via phone.

Other Meds:

Current Illness:

ID: 1820385
Sex: F
Age: 14
State: NY

Vax Date: 08/01/2020
Onset Date:
Rec V Date: 10/27/2021
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: swelling; hives; lost feeling on her arm; This case was reported by a nurse via call center representative and described the occurrence of swelling in a 16-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 724K2, expiry date unknown) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. Concurrent medical conditions included stevens johnson syndrome. In August 2020, the patient received Fluarix Tetra 2020-2021 season. In August 2021, the patient started Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, between 1 and 3 months after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced swelling, hives and loss of sensation. On an unknown date, the outcome of the swelling, hives and loss of sensation were unknown. It was unknown if the reporter considered the swelling, hives and loss of sensation to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details provided were as follows: The case was reported by patient's mother. The nurse reported that the patient received Fluarix dose last year from the date of reporting and she started with hives, swelling and she lost feeling in her arm. They were working with the patient?s doctor to see which component affected and cause this bad reaction to the patient. The reporter consented to follow up by email.

Other Meds:

Current Illness: Stevens Johnson syndrome

ID: 1820386
Sex: F
Age:
State: OK

Vax Date: 10/21/2021
Onset Date: 10/21/2021
Rec V Date: 10/27/2021
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: administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number unknown, expiry date 30th June 2021) for prophylaxis. Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 21st October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 21st October 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter was office manager. The patient received an expired Flulaval shot inadvertently. The reporter consented to follow up.

Other Meds:

Current Illness:

Date Died: 12/02/2020

ID: 1820391
Sex: M
Age: 77
State: KY

Vax Date: 11/01/2020
Onset Date:
Rec V Date: 10/27/2021
Hospital: Y

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: possible drug interaction between Shingrix and Humira; This case was reported by a consumer via call center representative and described the occurrence of drug interaction in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included adalimumab (Humira) for product used for unknown indication. In November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Humira at an unknown dose and frequency. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced drug interaction (serious criteria death and hospitalization). The action taken with Humira was unknown. On 2nd December 2020, the outcome of the drug interaction was fatal. The patient died on 2nd December 2020. The reported cause of death was drug interaction. It was unknown if the reporter considered the drug interaction to be related to Shingrix. Additional details were provided as follows: The reporter was the wife of patient. In November 2020, the patient received Shingrix vaccine on same day (does not have exact date). The reporter asked, were there any contraindications or drug interactions between Shingrix and Humira. She stated that before they received first dose, healthcare professional (HCP) did not ask if the patient was on Humira and she and her husband (who was only one on Humira) received the first dose of Shingrix. Emergency room (ER) Visit Required. The reporter stated that 2 weeks later the patient was hospitalized and died on 2nd December 2020. The reporter stated when she went to get Shingrix dose 2 for herself in January 2021, HCP asked if she was taking Humira and she was not. She then realized that there might have been a connection with those two products (Humira and Shingrix) which encouraged her to provide this information to other pharma company. The reporter consented to follow up.; Reported Cause(s) of Death: Possible drug interaction

Other Meds: HUMIRA

Current Illness:

ID: 1820393
Sex: M
Age:
State: FL

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 10/27/2021
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: Had a bad reaction to the first dose; Did not get second dose in recommended window; This spontaneous case was reported by an occupational therapist and describes the occurrence of VACCINATION SITE REACTION (Had a bad reaction to the first dose) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose in recommended window) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Had a bad reaction to the first dose) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose in recommended window). At the time of the report, VACCINATION SITE REACTION (Had a bad reaction to the first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not get second dose in recommended window) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was temporarily withheld on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. NO Concomitant medication was reported NO treatment Drug was reported

Other Meds:

Current Illness:

ID: 1820394
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/19/2021
Rec V Date: 10/27/2021
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: MIGRAINE; Protocol: 21-0012: A Phase 1 2 Study of Delayed Heterologous SARS CoV 2 Vaccine Dosing Boost After Receipt of EUA Vaccines. Manufacturer Receipt Date: 07-OCT-2021 A clinical investigator reported that subject of unspecified age and sex (subject number and site number were not reported) experienced non-serious grade 1 migraine. The event occurred unknown days after COVID-19 vaccine Ad26.COV2.S was administered intramuscularly for prophylactic vaccination. The action taken with study vaccine was not applicable. The outcome was recovered. The subject's height, and weight were not reported. No past medical history or concurrent conditions were reported. No concomitant medications were reported. On an unknown date, the subject was treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported. On 19-JUL-2021, the subject experienced migraine. The subject recovered from migraine on 19-JUL-2021. Investigator's causality assessment: The event of migraine was related to the study vaccine. Company causality assessment: The event of migraine was related to the study vaccine.

Other Meds:

Current Illness:

ID: 1820395
Sex: M
Age:
State: MI

Vax Date:
Onset Date: 09/16/2021
Rec V Date: 10/27/2021
Hospital: Y

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

Lab Data: Test Date: 20180607; Test Name: Colonoscopy; Result Unstructured Data: not reported; Test Date: 2019; Test Name: Computerised tomogram head; Result Unstructured Data: small meningioma; Comments: small meningioma which was stable in appearance; Test Date: 20210303; Test Name: Colonoscopy; Result Unstructured Data: not reported; Test Date: 202109; Test Name: Creatine kinase; Result Unstructured Data: 8094; Test Date: 202109; Test Name: Renal function test; Result Unstructured Data: normal; Test Date: 202109; Test Name: COVID-19 PCR test; Result Unstructured Data: negative; Test Date: 202109; Test Name: Echocardiogram; Result Unstructured Data: stable ejection fraction; Comments: stable ejection fraction and showed inferior infarct normal Right ventricular size and systolic function and no significant valvular dysfunction; Test Date: 20210926; Test Name: Creatinine renal clearance; Result Unstructured Data: decreased; Test Date: 20210926; Test Name: Echocardiogram; Result Unstructured Data: abnormal; Test Date: 20210926; Test Name: Electrocardiogram; Result Unstructured Data: atrial fibrillation; Comments: abnormal; Test Date: 20210926; Test Name: Fluid balance assessment; Result Unstructured Data: positive; Test Date: 20210926; Test Name: Glycosylated haemoglobin; Result Unstructured Data: normal; Test Date: 20210926; Test Name: Heart rate; Result Unstructured Data: increased; Test Date: 20210926; Test Name: SARS-CoV-2 test; Result Unstructured Data: negative; Test Date: 20210926; Test Name: Troponin; Result Unstructured Data: increased; Comments: elevated at 32 and 30; Test Date: 20210926; Test Name: Urine analysis; Result Unstructured Data: normal; Comments: no evidence of any infection; Test Date: 20210926; Test Name: Computerised tomogram spine; Result Unstructured Data: no acute pathology; Test Date: 20210926; Test Name: Computerised tomogram head; Result Unstructured Data: normal; Test Date: 20210926; Test Name: Bronchogram; Result Unstructured Data: not reported; Test Date: 20210926; Test Name: Blood potassium; Result Unstructured Data: decreased; Test Date: 20210926; Test Name: Blood creatine phosphokinase; Result Unstructured Data: increased; Test Date: 20210926; Test Name: Aspartate aminotransferase; Result Unstructured Data: increased; Test Date: 20210926; Test Name: Alanine aminotransferase; Result Unstructured Data: increased; Test Date: 20210926; Test Name: Angiogram pulmonary; Result Unstructured Data: abnormal; Test Name: Serum creatinine; Result Unstructured Data: 67 mg/dL; Test Name: Creatinine clearance; Result Unstructured Data: 89.3 mL/min; Comments: by C-G formula; Test Name: Angiography; Result Unstructured Data: mild positive fluid balance; Comments: 1. No evidence of acute pulmonary embolism noting that the subsegmental branches in the lower lobes are suboptimally opacified due to artifact 2. Right upper lobe-predominant patchy groundglass airspace disease as seen with COVID-19 infection Volume loss in the lower lobes with small right greater than left pleural effusions No consolidative

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; AGITATION; ATRIAL FLUTTER; CONDITION AGGRAVATED; CORONARY ARTERY DISEASE; DISORIENTATION; DISTURBANCE IN ATTENTION; DYSLIPIDAEMIA; DYSPNOEA; DYSSTASIA; FALL; HYPERTENSION; HYPOMAGNESAEMIA; HYPOPHAGIA; LUNG OPACITY; PLEURAL EFFUSION; NOTHING BY MOUTH ORDER; INTENSIVE CARE; ANTICOAGULANT THERAPY; ELECTROLYTE SUBSTITUTION THERAPY; ALANINE AMINOTRANSFERASE INCREASED; ANGIOGRAM PULMONARY ABNORMAL; ASPARTATE AMINOTRANSFERASE INCREASED; BLOOD CREATINE PHOSPHOKINASE INCREASED; BLOOD POTASSIUM DECREASED; CREATININE RENAL CLEARANCE DECREASED; ECHOCARDIOGRAM ABNORMAL; ELECTROCARDIOGRAM ABNORMAL; FLUID BALANCE POSITIVE; HEART RATE INCREASED; TROPONIN INCREASED; BLOOD GASES; BRONCHOGRAM; COMPUTERISED TOMOGRAM HEAD NORMAL; COMPUTERISED TOMOGRAM SPINE; GLYCOSYLATED HAEMOGLOBIN NORMAL; SARS-COV-2 TEST NEGATIVE; URINE ANALYSIS NORMAL; ASTHENIA; FATIGUE; COVID-19 PNEUMONIA; ACUTE RESPIRATORY FAILURE; PNEUMONIA BACTERIAL; MYOCARDIAL INFARCTION; ATRIAL FIBRILLATION; DELIRIUM; HYPOXIA; HYPOKALAEMIA; COVID-19; MALNUTRITION; RHABDOMYOLYSIS; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System [ID 1761883] concerned a 77 year old male. The patient's height, and weight were not reported. The patient's past medical history included: fatigue, short of breath, right coronary artery stent/ drug eluting stent (RCA/DES), pneumonia due to organism, endoscopy colon/ colonoscopy, adenoidectomy, carpal tunnel release, cataract removal bilateral, cervical fusion, colonoscopy polypectomy, and tonsillectomy, and concurrent conditions included: tobacco use, atrial fibrillation, atrial flutter, coronary artery disease, dyslipidemia, type 2 diabetes mellitus, hypertension, arthritis, benign prostatic hyperplasia, non-ST-elevation myocardial infarction (NSTEMI), chronic obstructive pulmonary disease, emphysema, depression, diabetic neuropathy, non-alcohol user, systolic and diastolic heart failure, cancer and protein-calorie malnutrition. The patient had no known allergies and is widowed. The patient has four children. The patient had no substance and sexual activity history. The patient had a family history of cancer (mother, cause of death), Colon Polyps (brother at 72 years), transluminal coronary angioplasty, heart failure (father, cause of death). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 and expiry: unknown) dose was not reported, 1 total administered on 09-MAR-2021 for an unspecified indication. The drug start period was 201 days. Concomitant medications included metformin for non insulin dependent diabetes mellitus, acetylsalicylic acid (Aspirin), amlodipine besilate (Norvasc), apixaban (Eliquis), lisinopril, paracetamol (Tylenol), salbutamol (albuterol HFA), spiriva and salbutamol sulfate. On 07-JUN-2018, Laboratory data included: Colonoscopy (NR: not provided) not reported. On 2019, Laboratory data included: Computerised tomogram head (NR: not provided) small meningioma which was stable in appearance. On 03-MAR-2021, Laboratory data included: Colonoscopy (NR: not provided) not reported. On SEP-2021, Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) negative, Creatine kinase (NR: not provided) 8094, Echocardiogram (NR: not provided) stable ejection fraction and showed inferior infarct normal right ventricular (RV) size, systolic function and no significant valvular dysfunction. Cardiology recommended to continue metoprolol, and up titrate as needed. Amlodipine and lisinopril were held to allow further up titration of metoprolol. Renal function test (NR: not provided) normal. On 16-SEP-2021, the patient experienced rhabdomyolysis. On 17-SEP-2021, the patient experienced mild protein-malnutrition. On 26-SEP-2021, the patient was presented to the emergency department with hypoxia and shortness of breath. Emergency room (ER) workup showed positive for COVID-19 pneumonia and also with atrial fibrillation (AFib), Rapid ventricular rate (RVR). The Intensive care unit was contacted by ER air in agreement with CC2 level bed and would consult on patient. The patient denied having fevers or chills. The resting history was provided by daughter of the patient at bedside given his inattentiveness and disorientation She states that over the last few days he has become more fatigued and short of short of breath since discharge from recent hospitalization. On 26-SEP-2021, the patient experienced acute respiratory failure secondary to severe COVID-19 pneumonia, covid-19, agitation, atrial fibrillation, atrial flutter, condition aggravated, coronary artery disease, creatinine renal clearance decreased, delirium, dyslipidaemia, dysstasia, fall (in his apartment and was unable to get up for about 12 hours), hypertension, hypokalaemia, hypomagnesaemia, hypophagia, lung opacity, myocardial infarction, nothing by mouth order, pleural effusion, pneumonia bacterial, asthenia and fatigue and was hospitalized (dates unspecified). The patient was treated with electrolyte substitution therapy. Laboratory data included: Alanine aminotransferase (NR: not provided) increased, Angiogram pulmonary (NR: not provided) abnormal, Aspartate aminotransferase (NR: not provided) increased, Blood creatine phosphokinase (NR: not provided) increased, Blood potassium (NR: not provided) decreased, Bronchogram (NR: not provided) not reported, Computerised tomogram head (NR: not provided) normal, Computerised tomogram spine (NR: not provided) no acute pathology, Creatinine renal clearance (NR: not provided) decreased, Echocardiogram (NR: not provided) abnormal, Electrocardiogram (NR: not provided) atrial fibrillation, Fluid balance assessment (NR: not provided) positive, Glycosylated haemoglobin (NR: not provided) normal, Heart rate (NR: not provided) increased, SARS-CoV-2 test (NR: not provided) negative, Troponin (NR: not provided) increased (elevated at 32 and 30), and Urine analysis (NR: not provided) normal. On an unspecified date, the patient experienced suspected clinical vaccination failure. Laboratory data (dates unspecified) included: Computed Tomogram Angiography Thorax (NR: not provided) No evidence of acute pulmonary embolism noting that the sub segmental branches in the lower lobes are sub optimally opacified due to artifact, right upper lobe-predominant patchy ground glass airspace disease as seen with COVID-19 infection, volume loss in the lower lobes with small right greater than left pleural effusions, no consolidative lobar pneumonia, findings suggestive of mild positive fluid balance, question chronic pulmonary arterial hypertension, Creatinine clearance (NR: not provided) 89.3 mL/min (milliliter/minute), HbA1C (glycated hemoglobin) (NR: not provided) 5.4, and Serum creatinine (NR: not provided) 67 mg/dL (milligram/deciliter). Treatment medications (dates unspecified) included: diltiazem, metoprolol, remdesivir, dexamethasone, furosemide, vancomycin, cefepime, precedex and enoxaparin sodium. The patient was planned to start with very low dose insulin sliding scale given that he would be on steroids for covid-19 treatment. It was reported that the patient was unable to tolerate oral intake, hence Eliquis was kept on hold for now and started on Lovenox protocol for COVID-19 and transition back to Eliquis was thought of when patient was able to tolerate orally. The patient was at high risk of clinical deterioration and death due to severe COVID pneumonia requiring high amount of oxygen supplementation, wean oxygen as tolerated to maintain saturations greater than 92%, cardizem drip and metoprolol titration was planned to control heart rate to less than 120. The patient was on nil per oral (NPO) diet. He was evaluated by Physical therapist (PT) and Occupational therapist (OT) and recommendation was for home health therapy. He had no other acute issues and was discharged home in stable condition. The duration of hospitalization were 9 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood cr

Other Meds: METFORMIN; TYLENOL; SALBUTAMOL; PROVENTIL HFA [SALBUTAMOL]; VENTOLIN HFA; PROAIR HFA; ELIQUIS; ASPRIN; AMLODIPINE; LISINOPRIL; SPIRIVA

Current Illness: Abstains from alcohol; Arthritis; Atrial fibrillation; Atrial flutter; Benign prostatic hyperplasia; Cancer; Chronic obstructive pulmonary disease; Coronary artery disease; Depression; Diabetic neuropathy; Dyslipidemia; Emphysema; Heart failure; Hypertension; Non ST segment elevation myocardial infarction; Protein-calorie malnutrition; Tobacco user (everyday smoker. Packs day: 0 25 Years: 46 00 Pack years: 11 50 Types: Cigarettes (3 per day)); Type II diabetes mellitus (Type II or unspecified type diabetes mellitus without mention of complication not stated as uncontrolled)

ID: 1820396
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 09/30/2021
Rec V Date: 10/27/2021
Hospital: Y

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: Test Date: 20210930; Test Name: Body temperature; Result Unstructured Data: 104 F

Allergies:

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

Symptoms: PASSED OUT; WORDS CONFUSED/CANNOT FORM WORDS; MEMORY SLOW; PAIN BEHIND LEG; FELT WEAK; CHEST PAIN; SHORTNESS OF BREATH; CONFUSION; CONSTIPATION; FEELS LIKE HALF BODY IS PARALYZED; MIDDLE OF BACK ON THE LEFT SIDE LIKE STABBING PAIN; DOUBLE VISION; SWELLING FACE; NUMBNESS ON CHEST/ MIDDLE OF HER BACK ON LEFT SIDE/ LEG; TINGLING IN CHEST AND MIDDLE OF HER BACK ON LEFT SIDE/WHOLE BODY; BELLS PALSY; FEVER/TEMPERATURE 104 F; This spontaneous report received from a patient concerned a 50year old female of unspecified race. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) dose was not reported, 1 total administered to right arm on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, after 25 minutes of receiving vaccine, the patient experienced fever/temperature 104F. The patient returned to work the same day. On an unspecified date, the patient experienced left side chest pain, shortness breath, numb/tingling in the chest and middle of her back on the left side like a stabbing pain. The patient legs are numb, face was numb, feels like half body was paralyzed. The patient felt pain behind her leg and patient felt weak as well. The patient words are confused/Cannot form words and memory slow, Double vision, Swelling of face, Constipation, Tingling in chest and middle of her back on left side/whole body. The patient visited emergency on 13-OCT-2021. The patient was kept two hours at Hospital, then patient left the hospital as patient was put outside in the cold, patient waited 2 hours outside. The patient went home and then that same night was admitted to another hospital. After examining the HCP (health care professional) informed he did not have an explanation for her symptoms. On Saturday patient went back to work and patient passed out, the tingling spread to her whole body. patient went to an urgent care. The HCP (health care professional) diagnosed her with Bell's Palsy. And patient symptoms are now getting worse. The Patient was researching on her own and thinks patient may have Guillian Barre Syndrome. Treatment medications (dates unspecified) included: prednisone 20 mg 3 times a day for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever/temperature 104 f, and had not recovered from chest pain, shortness of breath, numbness on chest/ middle of her back on left side/ leg, confusion, constipation, felt weak, bells palsy, pain behind leg, memory slow, feels like half body is paralyzed, tingling in chest and middle of her back on left side/whole body, middle of back on the left side like stabbing pain, double vision, swelling face, words confused/cannot form words, and passed out. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20211038425- Covid-19 vaccine ad26.cov2.s-Bell's palsy, passed out, words confused/cannot form words, memory slow. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20211038425- Covid-19 vaccine ad26.cov2.s-pain behind leg and felt weak. These events are labeled and are therefore considered potentially related.

Other Meds:

Current Illness:

ID: 1820397
Sex: M
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 10/27/2021
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: Test Date: 202104; Test Name: Spinal tap; Result Unstructured Data: Guillain-Barre Syndrome

Allergies:

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

Symptoms: GUILLAIN-BARRE SYNDROME; ANGRY; ANGUISH; DISBELIEF; FEELING BEATEN UP; BREAK DOWN IN TEARS; MENTAL CHALLENGE; REHABILITATION; COLLAPSE FROM EXHAUSTION; WEAK; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient's concomitant medications included nightly unspecified blood-thinning injection. It was reported that the patient felt the onset of symptoms two weeks later vaccination. He experienced strange pangs first struck after a mere 20-minute ride on the stationary bike at the gym. Then he could not sleep through the night, with a fiery, tingly feeling under the skin. His midsection and fingertips grew numb. One morning he woke up slurring with words out the left side of the mouth. Three visits to the emergency room and one spinal tap later, an astute doctor scribbled the diagnosis on the whiteboard of the hospital room as Guillain-Barre Syndrome (GBS). He was in for several more days of anguish, while fresh antibodies injected intravenously tried to call off the friendly fire. And then months of rehabilitation, taking baby steps with a walker, and otherwise spending long hours flat on the back. While at first he was pretty angry. His immune system rigorously executed what it thought were orders to take the hill. Before he was completely in tatters left unchecked, the doctors administered three treatments for what turned out to be the stubborn case. The first was the infusion of fresh antibodies through immunoglobulin therapy, known as intravenous immunoglobulin (IVIg); the second was plasmapheresis, a more-thorough oil change where all the rogue antibodies were sucked out through a tube in the neck and replaced with synthetic plasma. Finally, he was given steroids to tamp down the inflammation that lingered like smoldering fires after the initial bomb blast. Much damage was done, however not only to those myelin sheaths but some of the underlying nerves themselves. He was discharged to rehabilitation hospital, where he spent hours in the gym overlooking harbor, feeling like a toddler and learning to walk all over again. He was outfitted with a walker just like the 90-year-old mother used. Impossibly fit trainers guided him through a rigorous physical and occupational therapy program: up and down practice stairs, in and out of a practice car, exercises on mats, timed tests adorning racks with spring-loaded clips, to help bring back sensory function and fine motor skills, as part of the exercise he picked up small objects in a special machine that whirled shredded corn husks around inside a clear box. He would get back to the room and collapse from exhaustion and disbelief. After weeks at hospital and rehabilitation, it left him with feeling beaten up and weak. The mental challenge has been formidable. He celebrated triumphs like graduating from a walker to a cane, but also he periodically break down in tears. His hands and feet remain numb and tingly. Number of days hospitalized and discharge information was not reported The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the guillain-barre syndrome, anguish, angry, collapse from exhaustion, disbelief, feeling beaten up, weak, break down in tears, mental challenge and rehabilitation was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20211039528.; Sender's Comments: V0: 20211041278- COVID-19 VACCINE AD26.COV2.S- Guillain-Barre syndrome. This event is labeled per RSI and is therefore considered potentially related.

Other Meds:

Current Illness:

Date Died:

ID: 1820398
Sex: M
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: ACUTE KIDNEY INJURY; ACUTE HYPOXIC RESPIRATORY FAILURE; This spontaneous report was received from literature: Characteristics and outcomes of adverse events after COVID-19 vaccination. 2021 Oct 13; 2/5. This report concerned a 92 year old male. The objective of this study was to describe fatal and non-fatal possible Adverse Events after COVID-19 vaccine administration. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, congestive heart failure, chronic kidney disease, and renal cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced acute kidney injury and acute hypoxic respiratory failure. On an unspecified date, the patient died of acute kidney injury and acute hypoxic respiratory failure. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The authors concluded that although reported adverse events (AEs) were not necessarily caused by the vaccination, this study provided further information about possible AEs after COVID-19 immunization, especially those requiring hospital admission. This study also supported prior data that serious AEs post vaccination were much lower than primary COVID-19 infections. Also, need for further studies to investigate causalities between vaccines and reported AEs across all age groups was highlighted. This report was serious (Death).; Sender's Comments: V0: 20211045466-covid-19 vaccine ad26.cov2.s-acute kidney injury. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20211045466-covid-19 vaccine ad26.cov2.s-acute hypoxic respiratory failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: ACUTE HYPOXIC RESPIRATORY FAILURE; ACUTE KIDNEY INJURY

Other Meds:

Current Illness: Chronic kidney disease; Congestive heart failure; Hypertension; Renal cancer

ID: 1820399
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 04/22/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data: Test Date: 20210422; Test Name: Weight; Result Unstructured Data: decreased; Test Name: Colonoscopy; Result Unstructured Data: diverticulitis and ulcer; Test Name: Blood test; Result Unstructured Data: was okay

Allergies:

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

Symptoms: DIVERTICULITIS; ULCER; LOST APPETITE; FELT BAD; LOST WEIGHT; BODY NUMBNESS; BODY WEAKNESS/NO ENERGY; TERRIBLE FATIGUE; This spontaneous report received from a patient concerned an 80 year old female. The patient's weight was 100 pounds, and height was 60 inches. The patient's past medical history included: gastric bypass(has been on vitamins for it unspecified) could not raise arm in 1960 after giving birth was unable raise her arm until a doctor suggested vitamins and patient felt better within 2 weeks, and concurrent conditions included: non-smoker, non-alcoholic, tree allergy, atrial fibrillation, asthma, thyroid deficiency(on thyroid medications), cholesterol issue, and patient had one arm only, lost one arm due to bone cancer. Patient experienced sensitivity to oven cleaner,(which had difficulty breathing and ended up in the hospital and her asthma symptoms started from that point). Patient had no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 18-SEP-2021) dose was not reported,1 in total, administered on 01-APR-2021 for prophylactic vaccination on right arm. Concomitant medications included metoprolol and rivaroxaban for atrial fibrillation. On 22-APR-2021, 3 weeks after receiving the vaccine, the patient felt bad with no energy, terrible fatigue and body weakness and numbness and patient also lost appetite, lost weight and contacted doctor because patient thought that was cancer. Patient primary care physician did blood work and checked everything and it were okay. Primary care physician sent patient for colonoscopy in which it was detected patient had diverticulitis and ulcer that physician addressed. The patient indicated that patient was feeling better(at least 50% better). Laboratory data included: Weight (NR: not provided) decreased, Blood work (NR: not provided) was okay, and Colonoscopy (NR: not provided) diverticulitis and ulcer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost appetite, and lost weight, and was recovering from felt bad, terrible fatigue, body weakness/no energy, diverticulitis, ulcer, and body numbness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211045982-Covid-19 vaccine ad26.cov2.s-Diverticulitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds: METOPROLOL; XARELTO

Current Illness: Abstains from alcohol; Asthma-like condition (is on drug unspecified. sensitivity to oven cleaner, which had difficulty breathing and ended up in the hospital and her asthma symptoms started from that point.); Atrial fibrillation (is on Xarelto and metoprolol); Bone cancer (lost left arm); Cholesterol; Difficulty breathing (ended up in the hospital); Non-smoker; Seasonal allergy; Thyroid disorder (on drug unspecified(thyroid medication))

ID: 1820400
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 03/23/2021
Rec V Date: 10/27/2021
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: Test Date: 20210326; Test Name: COVID-19 virus test positive; Result Unstructured Data: Positive.

Allergies:

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

Symptoms: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the patient experienced confirmed covid-19 infection. On 26-MAR-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint number: 90000198938 The suspected product quality complaint has been confirmed to be voided (this record indicates a medical adverse event for the patient. while a positive covid test result was received after vaccination, insufficient time had elapsed for immunity to develop) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious

Other Meds:

Current Illness:

ID: 1820402
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: EPILEPSY HAS INCREASED/EPILEPTIC SEIZURE; This spontaneous report received from a patient via social media via company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: epilepsy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose and start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient reported that her epilepsy had increased and had an epileptic seizure recently that had caused compression fractures. It was also reported that the patient could not get the booster shot. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of epilepsy has increased/epileptic seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211046186-COVID-19 VACCINE AD26.COV2.S-Epilepsy has increased/ epileptic seizure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness: Epilepsy

ID: 1820403
Sex: F
Age:
State: SC

Vax Date:
Onset Date: 09/10/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data: Test Date: 20210910; Test Name: Pain scale; Result Unstructured Data: 9/10 pain after vaccination; Test Date: 20210915; Test Name: Blood pressure; Result Unstructured Data: 145/96 mmHg; Comments: It stayed up until 08/OCT/2021; Test Date: 20210929; Test Name: Blood test; Result Unstructured Data: Normal; Test Date: 20210929; Test Name: Electrocardiogram; Result Unstructured Data: Normal; Test Date: 20210929; Test Name: Chest X-ray; Result Unstructured Data: Normal; Test Date: 20210929; Test Name: CT scan; Result Unstructured Data: Normal; Test Date: 20211009; Test Name: Electrocardiogram; Result Unstructured Data: Unspecified; Test Date: 20211009; Test Name: Stress test; Result Unstructured Data: Normal; Test Date: 20211009; Test Name: Chest X-ray; Result Unstructured Data: Unspecified; Test Date: 20211013; Test Name: Echocardiogram; Result Unstructured Data: Unspecified; Test Date: 20211013; Test Name: Cardiac stress test; Result Unstructured Data: Unspecified.

Allergies:

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

Symptoms: FELT LIKE HAVING A HEART ATTACK; TERRIBLE PAIN; PRESSURE; CHEST PAIN,CHEST BURNING; SHAKY; DID NOT SLEEP WELL; DRY COUGH; CHILLS; MILD JOINT PAIN; HIP PAIN; WEAKNESS; HEADACHES; NAUSEA; HIGH BLOOD PRESSURE; LITTLE TIRED LIKE A 2/10; SORE ARM; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient never had arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-SEP-2021, the patient experienced sore arm. Laboratory data included: Pain scale (NR: not provided) 9/10 pain after vaccination. On 11-SEP-2021, the patient experienced little tired like a 2/10. On 15-SEP-2021, the patient experienced high blood pressure. Laboratory data included: Blood pressure (NR: 70 - 110) 145/96 mmHg. On 19-SEP-2021, the patient experienced terrible pain. On 19-SEP-2021, the patient experienced pressure. On 19-SEP-2021, the patient experienced chest pain, chest burning. On 19-SEP-2021, the patient experienced shaky. On 19-SEP-2021, the patient experienced did not sleep well. On 19-SEP-2021, the patient experienced dry cough. On 19-SEP-2021, the patient experienced chills. On 19-SEP-2021, the patient experienced mild joint pain. On 19-SEP-2021, the patient experienced hip pain. On 19-SEP-2021, the patient experienced weakness. On 19-SEP-2021, the patient experienced headaches. On 19-SEP-2021, the patient experienced nausea. On 29-SEP-2021, the patient experienced felt like having a heart attack. Laboratory data included: Blood test (NR: not provided) Normal, CT scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, and Electrocardiogram (NR: not provided) Normal. On 09-OCT-2021, Laboratory data included: Chest X-ray (NR: not provided) Unspecified, Electrocardiogram (NR: not provided) Unspecified, and Stress test (NR: not provided) Normal. On 13-OCT-2021, Laboratory data included: Cardiac stress test (NR: not provided) Unspecified, and Echocardiogram (NR: not provided) Unspecified. Treatment medications (dates unspecified) included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure on 08-OCT-2021, sore arm on 15-SEP-2021, and little tired like a 2/10 on 12-SEP-2021, and had not recovered from felt like having a heart attack, terrible pain, headaches, chills, shaky, did not sleep well, dry cough, weakness, mild joint pain, hip pain, nausea, pressure, and chest pain, chest burning. This report was non-serious.

Other Meds:

Current Illness:

ID: 1820404
Sex: M
Age:
State: UT

Vax Date:
Onset Date: 05/31/2021
Rec V Date: 10/27/2021
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:

Allergies:

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

Symptoms: GUILLAIN BARRE SYNDROME; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered at right arm on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the patient experienced bilateral facial paralysis. low back pain and bilateral leg pain. Then, he was diagnosed with guillian barre syndrome. On 18-Oct-2021 the patient was hospitalized and had received treatment of unspecified immunoglobulin. He was hospitalized for 5 days and on 22-OCT-2021 the patient was discharged. The patient was seen a couple of different neurologists (physician's office visit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from guillain barre syndrome. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20211046479 - covid-19 vaccine ad26.cov2.s ? Guillain-Barre Syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1820405
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date (a couple weeks ago) patient caught COVID (suspected clinical vaccination failure) with symptoms of 18 hours of fever and chills, soreness and headache. As per reporter "I had the vaccine and when I caught COVID (a couple weeks ago) I had 18 hours of fever and chills, soreness and headache then nothing. It just broke and was over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for suspected clinical vaccination failure, and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000198899. This case, from the same reporter is linked to 20211047588.; Sender's Comments: V0: 20211047191-Covid-19 vaccine ad26.cov2.s-r suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1820406
Sex: U
Age:
State: WI

Vax Date:
Onset Date: 10/23/2021
Rec V Date: 10/27/2021
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: PART OF THE VACCINE CONTENT SPILLED OUT BECAUSE THE SYRINGE WAS NOT FIRM; THE AMOUNT OF VACCINE ADMINISTERED WAS UNKNOWN; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-OCT-2021, the patient experienced part of the vaccine content spilled out because the syringe was not firm. On 23-OCT-2021, the patient experienced and the amount of vaccine administered was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the and the amount of vaccine administered was unknown and part of the vaccine content spilled out because the syringe was not firm was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1820407
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; CONTRACTED COVID-19; PROBLEMS WITH LIVER AFTER TAKING JANSSEN COVID 19 VACCINE; PROBLEMS WITH PANCREAS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 25-OCT-2021 and 26-OCT-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had problems with liver after taking the Janssen Covid-19 vaccine and problems with pancreas. The patient also claimed that the vaccine was not effective as patient contracted Covid-19 (suspected clinical vaccination failure, suspected Covid-19). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the problems with liver after taking Janssen Covid-19 vaccine, problems with pancreas, contracted covid-19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000198940.; Sender's Comments: V0: 20211047596-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.

Other Meds:

Current Illness:

Date Died:

ID: 1820408
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: DIED DAYS AFTER THE SHOT; This spontaneous report received from a consumer via a company representative concerned a 35 year old male with unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy and an Olympian. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died days after the shot and the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211048841-Covid-19 vaccine ad26.cov2.s-Died days after the shot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1820409
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: NEUROPATHY; SHOULDER WAS NOT NORMAL; This spontaneous report received from a patient via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was a power lifter before the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in AUG-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced neuropathy. Patient stated that as per neurologist, neuropathy was not listed under the side effects of vaccination. Patient reported that no one was knowing that if her shoulder would get back to normal or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder was not normal, and the outcome of neuropathy was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000199077.; Sender's Comments: V0:20211048891-covid-19 vaccine ad26.cov2.s-Neuropathy- This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1820410
Sex: U
Age:
State: MD

Vax Date:
Onset Date: 10/25/2021
Rec V Date: 10/27/2021
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: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 25-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-OCT-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1820411
Sex: F
Age:
State: MD

Vax Date:
Onset Date: 06/20/2021
Rec V Date: 10/27/2021
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: SKIN RASHES THAT BRUISED UP; BIG DARK RED CIRCLES SPOTS ALL OVER BODY (ITCHY, PAINFUL AND BURNING SPOTS ON HANDS, LEGS, ARMS AND PRIVATE PARTS AND THE SPOTS APPEAR FLAT (NOT RAISED)/RED SPOTS ON HANDS AND FINGERS/SKIN RASH; SWELLING AROUND EYES; ITCHY, PAINFUL, AND BURNING DARK PURPLE SPOTS UNDER THE SKIN ALL OVER THE BODY; This spontaneous report received from a consumer via a company representative concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no prior medical history and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 21-OCT-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-JUN-2021, the patient experienced swelling around eyes. On 20-JUN-2021, the patient experienced itchy, painful, and burning dark purple spots under the skin all over the body. On 20-JUN-2021, the patient experienced big dark red circles spots all over body (itchy, painful and burning spots on hands, legs, arms and private parts and the spots appear flat (not raised) /red spots on hands and fingers/skin rash. On an unspecified date, the patient experienced skin rashes that bruised up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling around eyes, big dark red circles spots all over body (itchy, painful and burning spots on hands, legs, arms and private parts and the spots appear flat (not raised)/red spots on hands and fingers/skin rash, and itchy, painful, and burning dark purple spots under the skin all over the body, and the outcome of skin rashes that bruised up was not reported. This report was non-serious.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am