VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1806549
Sex: F
Age: 39
State: WA

Vax Date: 10/15/2021
Onset Date: 10/15/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data: -EKG and evaluation at Urgent care was completed

Allergies: Celexa

Symptom List: Dysphagia, Epiglottitis

Symptoms: -2 hours after injection of booster, Experienced sudden onset tachycardia with HR or 130-140 lasting for approx 30-40 min after injection time. Experienced shortness of breath and mild chest discomfort. Blood pressure at this time was 140-90's, much higher than normal. Was advised by Nurse consult to be evaluated. While waiting in Urgent Care, tachycardia suddenly resolved to HR of 80-90's. Felt extreme fatigue afterwards.

Other Meds: Fluvoxamine, Risperidone, Clonazapam, Clariton

Current Illness: Common Cold (COVID negative) approx 4 weeks prior

ID: 1806923
Sex: F
Age: 76
State: MN

Vax Date: 10/15/2021
Onset Date: 10/19/2021
Rec V Date: 10/22/2021
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: CTA Chest (PE protocol), 10/19/2021. Report as follows: Report: Interpretation: There are large thromboemboli involving the central pulmonary arteries and extending into multiple segmental and subsegmental branches, bilaterally. Right ventriculomegaly is evident, with bowing of the interventricular septum. A left atrial appendage occlusion device is present, with adherent clot. The lungs are clear, allowing for subsegmental atelectasis. Negative for bronchiectasis or other airway abnormalities. No pleural or pericardial effusion. No intrathoracic lymphadenopathy by size criteria. Conclusion: 1. Bilateral pulmonary thromboembolism involving the central, segmental, and subsegmental branches with signs of right heart strain. 2. Left atrial appendage occlusion device in situ, with adherent clot. The patient was advised to remain at the imaging center without referral for an emergency care is being coordinated through the referring clinics clinician's office.

Allergies: Allergies Allergen Reactions ? Hydrocodone-Acetaminophen Other reaction(s): vomiting, migraines ? Oxycodone-Acetaminophen Other (See Comments) and Nausea and Vomiting Migraine and nausea

Symptom List: Anxiety, Dyspnoea

Symptoms: Patient reports receiving the 3rd dose of Pfizer vaccine on 10/15/2021. The next day, she had increased shortness of breath and weakness. Her primary care provider ordered a CT chest PE study, which was completed on 10/19/2021. This reported bilateral pulmonary emboli with associated right heart strain. Patient presented to the emergency room, initiated on heparin infusion. There was consideration for catheter-directed thrombolytic therapy but we ultimately did not pursue. She had no other known risk factors or instigating events for development of a pulmonary embolism. She denies a history of blood clots. No recent surgeries or immobilization. No recent travel. No long airplane rides or car rides. She has 1 sister who has a blood clot, diagnosed recently, but otherwise no family history. SHE IS CURRENTLY HOSPITALIZATION, STILL ADMITTED.

Other Meds: HOME MEDICATION LIST: acetaminophen (TYLENOL) 500 MG tablet, Take 500-1,000 mg by mouth every 4 hours as needed for pain albuterol (PROAIR HFA/PROVENTIL HFA/VENTOLIN HFA) 108 (90 Base) MCG/ACT inhaler, Inhale 1-2 puffs into the lungs every

Current Illness: 1. Watchman device placed 4/7/2021. Stopped Eliquis 1 month later. Started Plavix 05/2021 until 10/11/2021. 2. Patient reports feeling short of breath for the last 3 to 4 weeks. About 2 weeks ago, she was evaluated and treated with prednisone, azithromycin, and has used nebulizer x2. States started feeling better after treatment. She had a lot of energy on the day of her vaccination 10/15/2021. The next day, she felt fatigue and worsening shortness of breath.

ID: 1807217
Sex: M
Age:
State: PR

Vax Date:
Onset Date: 05/30/2021
Rec V Date: 10/22/2021
Hospital: Y

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

Lab Data: Test Name: Reflex test; Result Unstructured Data: Reflexes diminished; Comments: but still there; Test Name: Blood pressure; Result Unstructured Data: High; Test Name: Laboratory test; Result Unstructured Data: Subjective; Test Name: Spinal tap; Result Unstructured Data: Not reported; Test Name: Blood pressure decreased; Result Unstructured Data: 70/40 mmHg

Allergies:

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

Symptoms: PAIN; BP DROPPED; REALLY HIGH BLOOD PRESSURE; DIMINISHED REFLEXES; DEPRESSED; COMPLETELY DISABLED; This spontaneous report received from a consumer concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood pressure high (high/ normal). Patient was usually very healthy. The patient was previously treated with testosterone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 043A214, expiry: UNKNOWN) dose was not reported, 1 total administered on 15-MAY-2021 around late morning to early afternoon to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, 2 weeks after vaccination, patient became immediately and completely disabled. On 01-JUN-2021, he went to a clinic as he experienced so much pain and he received pain medication but was not sure what it was called. He went home and they were not really able to help him. He has been to multiple emergency room (ER) hospitals, doctor visits and several neurologists. The reporter does not have exact dates and stated would provide the information later. The initial tests were all subjective. He also went to a pain management specialist to try to get the pain under control. The pain management doctor recommended spinal tap and magnetic resonance imaging (MRI). He was in the hospital for a week trying to get these test done, and no one actually performed these tests. The spinal tap machine was broken and when he went to do the MRI, they tried to do the MRI on his brain instead of his spine. The patient just left and did not have either of the test done. He got his reflexes tested. His reflexes had been diminished, but were still there. A lot of doctors said he did not have Guillain Barre Syndrome (GBS) as he still had his reflexes. He received different opinion from multiple doctors regarding having and not having GBS. Then he was prescribed for a lumbar puncture spinal tap to be done. He then struggled to walk and had a cane. He had lab results from the spinal tap, once it was finally done. He did not want to go back to the ER unless someone in the hospital knew he was coming, and they put him in the right place, as they did not give him pain medications, and it was a poor basic care, otherwise. He had a lot of trouble getting down the stairs and into the car. He was depressed. He also had really high blood pressure (BP) since this started that he was having trouble controlling it. BP stayed too high most of the time and one day it dropped to 70/40 mmHG. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from completely disabled, pain, really high blood pressure, diminished reflexes, and bp dropped, and the outcome of depressed was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20211033651-covid-19 vaccine ad26.cov2.s-pain, completely disabled, BP dropped. 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: Blood pressure high (High/ normal)

ID: 1807246
Sex: F
Age: 50
State: RI

Vax Date: 10/19/2021
Onset Date: 10/21/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data: None

Allergies: Vicodin and tetanus vaccine

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Having pain and swelling on left side of chest, left underarm and left side of left breast. Painful to light touch. Started in the early morning hours on 10/21/21. Have not been seen by PCP yet.

Other Meds:

Current Illness: None

ID: 1807247
Sex: F
Age: 29
State: IL

Vax Date: 10/01/2021
Onset Date: 10/21/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies: Amoxicillin

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

Symptoms: Elevated heart rate, fever over 101.0, sweating, severe shivering, headache, sleeplessness, weakness, and nausea.

Other Meds: Sertraline

Current Illness: None

ID: 1807248
Sex: M
Age: 38
State: NE

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data: n/a

Allergies: seasonal codeine

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

Symptoms: On April , 2020 at 2pm I received Johnson and Johnsons Janseen Covid 19 vaccination. Shortly thereafter within the first four to six hours I could feel my body transition into a mode of what I can only relate to OxyContin/Heroin withdrawal. That first night my body felt like I was freezing and burning. I was shaking profusely. My legs began to hurt so bad I couldn?t walk. And I was sweating so badly I soaked any and all clothes I attempted to wear. The following day I could barely walk. I was in massive pain. And shivering so bad had to light a fire in my fireplace and nearly severed off my left index finger trying to cut wood. The third day I still felt like hell. But began to move around and ventured out to the pharmacy for pedialyte and flu meds to treat the flu like symptoms the vaccine brought on. This is where the First tru sign of trouble began. As while walking thru pharmacy my legs completely locked and gave out causing me to literally just collapse to the floor. I was fine (in my head) but my legs just stopped. This would cause me the need for help back to my feet. Since that day my legs constantly lock at the joints as well as my wrists. At times. But the legs hurt so bad I began to scream for help. In fact I?m reluctant to obtain any other vaccinations in my state as the state was pitiful at addressing Covid. And still pathetic at its response. My body is far from the same as it was. And before the pandemic I work at a job that?s physically demanding. That I probably can?t do anymore. I am grateful for the vaccine however so far have only had regrets to what it?s done to my body.

Other Meds: Nexium Alprazolam Zyrtec

Current Illness: n/a

ID: 1807249
Sex: M
Age: 54
State: PA

Vax Date: 10/20/2021
Onset Date: 10/20/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies: NKDA

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Chills Aches Headache Fever Diarrhea Knee pain Using Tylenol

Other Meds: Antidepressants

Current Illness:

ID: 1807330
Sex: F
Age:
State:

Vax Date: 04/23/2021
Onset Date: 04/24/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Severe pain on skin; Severe pain at joints; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 23Apr2021 at 09:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 02Apr2021 at 10:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 01:00, the patient experienced severe pain on skin and at joints. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events severe pain on skin and at joints were unknown at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

Date Died:

ID: 1807334
Sex: U
Age: 63
State: CA

Vax Date: 03/13/2015
Onset Date:
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: wrongful death; shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant therapy were not reproted. On or aobut 13-MAR-2015, the 63-years-old patient was vaccinated with a dose of zoster vaccine live( ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions in a pharmacy by a pharmacist. Subsequently, the patient was treated by a healthcare provider at a family practice for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of shingles was unknown. Specific allegations also included wrongful death on an unspecified date. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).

Other Meds:

Current Illness:

Date Died:

ID: 1807335
Sex: U
Age: 68
State: CA

Vax Date: 10/19/2014
Onset Date:
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: wrongful death; shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On or about 19-OCT-2014, the 68-years-old patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions in a pharmacy by a pharmacist. Subsequently, the patient was treated by a healthcare provider at a hospital (unspecified if hospitalized or not) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of shingles was unknown. Specific allegations also included wrongful death on an unspecified date. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).

Other Meds: ZOSTAVAX

Current Illness:

ID: 1807336
Sex: F
Age: 77
State: MI

Vax Date: 11/04/2011
Onset Date:
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Herpes Zoster, Ophthalmicus/herpes zoster with ocular movement; Zoster-related injuries; Herpes Zoster, Ophthalmicus/herpes zoster with ocular movement; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, historical conditions and concomitant therapies were not reported. On or about 04-NOV-2011, the 77-years-old patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions by a pharmacist in a pharmacy. Subsequently, the patient was treated by healthcare providers, including but not limited to a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: Herpes Zoster, Ophthalmicus/herpes zoster with ocular movement, and other Zoster-related injuries. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of ophthalmic herpes zoster was considered to be medically significant.

Other Meds:

Current Illness:

ID: 1807337
Sex: U
Age:
State: MI

Vax Date: 10/03/2013
Onset Date:
Rec V Date: 10/22/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: herpes zoster; ill-defined disorder; This spontaneous report was received from a lawyer and refers to a patient of unknown age and gender concerning a case in litigation. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 03-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions. On an unknown date (reported as subsequent to inoculation), the patient experienced herpes zoster and other zoster-related conditions (ill-defined disorder). The patient was treated with unspecified medications. The patient would continued suffering ongoing injuries. Significant medical and related expenses included care for hospitalization. The outcome of the events was reported as not recovered. The reporter considered herpes zoster and ill-defined disorder to be related to Zoster Vaccine Live (ZOSTAVAX).

Other Meds:

Current Illness:

ID: 1807342
Sex: F
Age:
State: UT

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Severe itching on both hands and elbows; This case was reported by a consumer via other manufacturer and described the occurrence of itching both hands in a 74-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (FLU SHOT)) for prophylaxis and COVID-19 VACCINE PFIZER (batch number FF2587, expiry date unknown) for covid-19 prophylaxis. Previously administered products included Penicillin. Additional patient notes included Ethnicity - Caucasian. On 27th September 2021, the patient received Boostrix and FLUZONE (FLU SHOT). On 27th September 2021 11:45, the patient received COVID-19 VACCINE PFIZER. On 27th September 2021 21:00, less than a day after receiving Boostrix, the patient experienced itching both hands. The patient was treated with cetirizine hydrochloride (Zyrtec) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the itching both hands was not recovered/not resolved. It was unknown if the reporter considered the itching both hands to be related to Boostrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Boostrix on the arm, Fluzone on the left upper arm, Covid-19 vaccine Pfizer on right arm. The patient experienced severe itching on both sides of both hands, plus both e bows. 9 hours 15 minutes after the Covid-19 vaccine Pfizer vaccine the patient developed itching both hands. Less than a day after receiving Fluzone, the patient experienced itching both hands. It was unknown if the reporter considered the itching both hands to be related to Fluzone and Covid-19 vaccine Pfizer.

Other Meds:

Current Illness:

ID: 1807346
Sex: F
Age: 63
State: VA

Vax Date: 07/18/2018
Onset Date: 10/12/2019
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Suspected vaccination failure; Shingles; first dose on 07/18/2018, second dose on 10/12/2019; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 12th October 2019, the patient received the 2nd dose of Shingrix. On 18th July 2018, the patient received the 1st dose of Shingrix. On 12th October 2019, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. In February 2020, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. Additional details were provided as follows: This case was reported by the patient. The patient received 2nd dose of Shingrix late than the recommended schedule, which led to lengthening of vaccination schedule. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The reporter consented to follow up and provided phone number for healthcare professional (HCP) reference. For another occurrence of shingles in 2021 refer linked case US2021213520, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021213520:same reporter

Other Meds:

Current Illness:

ID: 1807351
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: severely sick; This case was reported by a consumer via social media interactive digital media and described the occurrence of sickness in a 4-year-old 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 sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: This case was reported by the patient's parent. The age at vaccination was not reported. The patient had got the flu shot and got severely sick. This case was liked with US2021AMR216445, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR216445:same reporter

Other Meds:

Current Illness:

ID: 1807353
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: took both shots and come down shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient was reporter's son. The age at vaccination was not reported. The patient received both Shingles shots and has now came down with shingles. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.

Other Meds:

Current Illness:

ID: 1807354
Sex: U
Age:
State: OH

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

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

Lab Data:

Allergies:

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

Symptoms: Got the shingles shot. Then got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included chickenpox (had as a kid). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient was reporter's son. The age at vaccination was not reported. The patient received the Shingles shot and then got shingles. The reporter stated no extra stress. 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: 1807355
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Shingles, 3 month after I got the shot/ suspected vaccination failure; bad case of Shingles, came down with it with a bang; 3 years of awful rash on the whole right side of my face eye; 3 years of awful pain on the whole right side of my face eye. able to keep right eye open now; 3 years of awful pain on the whole right side of my face eye. able to keep right eye open now; 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, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, eye pain and facial pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the rash, eye pain and facial pain were recovering/resolving. It was unknown if the reporter considered the vaccination failure, shingles, rash, eye pain and facial pain to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient developed a bad case of Shingles 3 month after receiving the Shingles shot. The patient was just getting to a low pain level with it after 3 years of awful rash and pain on the whole right side of her face and eye. The patient was able to keep right eye open at the time of reporting and stated that it has improved a lot on the reporting month. The patient came down with shingles with a bang when she lost her husband of 68 years with a heart attack. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and laboratory confirmation for shingles were unknown.

Other Meds:

Current Illness:

ID: 1807361
Sex: F
Age: 63
State: VA

Vax Date: 07/18/2018
Onset Date:
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: suspected vaccination failure/lack of effect; Her current outbreak is in eye; Her current outbreak is located on the left side of her: scalp, mouth; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (developed shingles in February 2020 refer case US2021AMR214345). On 12th October 2019, the patient received the 2nd dose of Shingrix. On 18th July 2018, the patient received the 1st dose of Shingrix. On an unknown date, more than a year after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix and Shingrix. Additional details were reported as follows: The case was reported by the patient. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule refer case US2021AMR214345. The patient currently had shingles and her current outbreak was located on the left side of her scalp, mouth, and eye. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles were unknown. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR214345:same reporter

Other Meds:

Current Illness:

ID: 1807382
Sex: F
Age: 71
State: TN

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Tingling and redness at the injection site; Redness at injection site; Injection site was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (Tingling and redness at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Injection site was sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A e) for COVID-19 vaccination. Concomitant products included SPIRONOLACTONE, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), ALPRAZOLAM (XANAX), FLUOXETINE HYDROCHLORIDE (PROZAC) and PRAVASTATIN for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PARAESTHESIA (Tingling and redness at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Injection site was sore). At the time of the report, VACCINATION SITE PARAESTHESIA (Tingling and redness at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Injection site was sore) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. This case was linked to MOD-2021-350630 (Patient Link).

Other Meds: SPIRONOLACTONE; NEXIUM [ESOMEPRAZOLE SODIUM]; XANAX; PROZAC; PRAVASTATIN

Current Illness:

ID: 1807383
Sex: F
Age: 77
State: GA

Vax Date: 10/11/2021
Onset Date: 10/11/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported by reporter No treatment medications provided by the reporter. Reporter stated that vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.

Other Meds:

Current Illness:

Date Died: 04/26/2021

ID: 1807384
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 10/22/2021
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: Unevaluable event

Symptoms: DEATH; INTENSIVE CARE; MECHANICAL VENTILATION; GUILLAIN-BARRE SYNDROME; This spontaneous report was received from a health care professional via a Regulatory Authority the VAERS (Vaccine Adverse Event Reporting System) via literature. This report concerned a 57-year-old male of unknown race and ethnicity. The objective of this study was to assess reports of Guillain-Barre Syndrome (GBS) received in the Vaccine Adverse Event Reporting System (VAERS) following vaccination with covid-19 vaccine ad26.cov2.s. 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, intramuscular, batch number: 1808609 and expiry: UNKNOWN) dose and vaccination site not reported, 1 total administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications were not reported. On an unspecified date in APR-2021, within a week after vaccination, the patient experienced pain and weakness, the patient experienced Guillain-Barre syndrome and was hospitalized (date unspecified), including 6 days on a ventilator. The patient was in intensive care on mechanical ventilation. Reporter's contact with the patient and doctor was unsuccessful but attempts were continuing. The patient was treated with a course of intravenous immunoglobulin. On 26-APR-2021, 25 days after vaccination the patient died from unknown cause of death. It was unknown if an autopsy was performed. Duration of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The author suggests a potential small but statistically significant safety concern for Guillain-Barre Syndrome following receipt of the covid-19 vaccine ad26.cov2.s. However, the findings are subject to the limitations of passive reporting systems and presumptive case definition, and they must be considered preliminary pending analysis of medical records to establish a definitive diagnosis. The patient died due to unknown cause of death on 26-APR-2021, and the outcome of guillain-barre syndrome, intensive care and mechanical ventilation was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening). This case, from the same reporter is linked to 20211021308. This case, from same literature article is linked to 20211021340, 20211021338, 20211021361 and 20211021284. Additional information was received on 11-OCT-2021. It was determined that Manufacture Case number (20211021308) was a duplicate of this case. All relevant information (new event death and date of death added) this case will be submitted under a Manufacturer Case Number (20210514945).; Sender's Comments: V1- This follow up updates- . All relevant information (new event death and date of death added) regarding duplicate Manufacture Case number (20211021308). 20210514945-COVID-19 VACCINE AD26.COV2.S-Guillain-Barre syndrome, This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). 20210514945-COVID-19 VACCINE AD26.COV2.S- Intensive care, mechanical ventilation. 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). 20210514945-COVID-19 VACCINE AD26.COV2.S ?Death. Follow-up received regarding Clinical Details. 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: 1807385
Sex: F
Age:
State: TX

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

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

Lab Data: Test Date: 2021; Test Name: Laboratory test; Result Unstructured Data: Reduced vascularization; Test Name: Echocardiogram; Result Unstructured Data: going at 35; Comments: not 55-60 in my left ventricle

Allergies:

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

Symptoms: ANTIPHOSPHOLIPID SYNDROME; REDUCED VASCULARIZATION IN LEFT HAND; HEART ISSUES GOING AT 35 NOT 55-60 IN HER LEFT VENTRICLE; CUT ON HAND WITH POSSIBLE INFECTION; ISSUE WITH BACK OF CALVES; HEADACHE; This solicited report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient had issues with her abdominal cavity and high blood pressure when she was first diagnosed with Crohn's disease and had been on one medicine ever since but her cardiologist added a new medication recently. The patient stated she was fine as far as Crohn's disease and was off steroids. The patient was treated with ustekinumab (injection, route of admin, batch and expiry was not reported) dose, frequency were not reported from 30-APR-2021 and received the most recent injection on 20-AUG-2021 for Crohn's disease. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch and expiry was not reported) 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. The patient stated that she started Stelara and received the Covid vaccine around the same time. On unspecified date, the patient experienced a headache in the afternoon for 3-4 days after injection. The patient noticed her hand was tingly and at first they thought it was Raynaud's but after testing they found that she had reduced vascularization in left hand and might need surgery in the future. The patient had a cut on her hand, she thought was infected and her primary care prescribed her antibiotics. On an unspecified date after vaccination, the patient developed circulatory issues and was diagnosed with APS (antiphospholipid syndrome) an autoimmune clotting disorder. In OCT-2021, the patient had bypass on brachial artery. On an unspecified date, the patient experienced an issue with the back of her calves (calf discomfort), heart issues (heart disorder) and a echocardiogram was performed and stated she was going at 35 not 55-60 in her left ventricle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with ustekinumab was not reported. The outcome of the reduced vascularization in left hand, cut on hand with possible infection, headache, antiphospholipid syndrome, issue with back of calves and heart issues going at 35 not 55-60 in her left ventricle was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and antiphospholipid syndrome, reduced vascularization in left hand, heart issues going at 35 not 55-60 in her left ventricle, cut on hand with possible infection, issue with back of calves, and headache was related; between ustekinumab, and antiphospholipid syndrome, reduced vascularization in left hand, heart issues going at 35 and not 55-60 in her left ventricle, cut on hand with possible infection, issue with back of calves, and headache was related. This report was serious (Other Medically Important Condition). Additional information was received from patient on 11-OCT-2021. The following information was updated and incorporated into the case narrative: Added patient concomitant disease (high blood pressure, issue with abdominal cavity), event (antiphospholipid syndrome, calf discomfort, heart disorder), lab (echocardiogram) and causality and narrative updated.; Sender's Comments: V1: 20210904390-covid-19 vaccine ad26.cov2.s-antiphospholipid syndrome, reduced vascularization in left hand. This event(s) is considered related. 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). 20210904390-ustekinumab-antiphospholipid syndrome, reduced vascularization in left hand. This event(s) is considered related. 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: Blood pressure high; Crohn's disease

ID: 1807387
Sex: M
Age:
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: MIGRAINE; EMESIS; SEVERE HEADACHE; SUBJECTIVE FEVER; This spontaneous report received from a health care professional concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis, and other pre-existing medical conditions included: The patient had No known allergies. 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 06-APR-2021 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 migraine, emesis, severe headache, and subjective fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, emesis, severe headache and subjective fever was not reported. This report was non-serious.

Other Meds:

Current Illness: Psoriasis

ID: 1807388
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; JOINT PAIN; This spontaneous report received from a patient through 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) 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, the patient had chills, high fever and joint pain after shot. Patient stated, probably had covid (suspected covid-19 infection) but didn't have antibodies (suspected clinical vaccination), so the patient was not really opposed to a shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure and joint pain was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000197797.; Sender's Comments: V0: 20211031588-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:

ID: 1807389
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 10/15/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data: Test Date: 20211015; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive

Allergies:

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

Symptoms: SARS-COV-2 TEST POSITIVE; This spontaneous report received from a patient concerned a female of unspecified age. 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-OCT-2021, the patient experienced sars-cov-2 test positive. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sars-cov-2 test positive was not reported. This report was non-serious. This case, from the same reporter is linked to 20211033119.; 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: 1807390
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 09/16/2021
Rec V Date: 10/22/2021
Hospital: Y

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

Lab Data: Test Date: 202110; Test Name: Blood test; Result Unstructured Data: Not reported; Test Date: 202110; Test Name: Haemoglobin; Result Unstructured Data: Little low; Test Date: 202110; Test Name: Platelet count; Result Unstructured Data: Low

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: BLEEDING GUMS/SEVER BLEEDING IN THE MOUTH; BRUISES TO ARMS; PLATELET COUNT LOW; HEMATURIA; This spontaneous report received from a patient (retired nurse) concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included: hysterectomy in 1992, removed thyroid gland in 2019, dental implant in 25-SEP-2021, and thyroid problems. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-SEP-2021, the patient started to had hematuria, had blood in the urine. The color of the urine was like a cranberry color, then in the night there was some real blood clots observed in the urine. She spent a whole day in emergency room (ER). On 01-OCT-2021, 02-OCT-2021 and 03-OCT-2021, the patient started to had severe bleeding in the mouth/bleeding gums. She was very worried and she admitted to the hospital on 05-OCT-2021. On 17-OCT-2021 (last night), she started to bleed again from her mouth during her shower but she used some peroxide and put some sterile gauze and pressed on that area in her mouth and it stopped bleeding. Her dentist told her that there is no problem in the bones and the bleeding can be either from the soft tissue or due to the vaccine. On 18-OCT-2021 in the morning, she was doing some blood work. On an unspecified date in OCT-2021, the patient experienced bruises to her arms from many intravenous (IV's) while she was hospitalized for hematuria and severe bleeding in the mouth/bleeding gums. They did a several blood tests and didn't find out any reason for bleeding. During hospitalization, her platelets count was low as she was still bleeding and her hemoglobin was a little low. Two bags of plasma were received as a treatment. Patient discharged on 12-OCT-2021 and was hospitalized for 8 days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bleeding gums/sever bleeding in the mouth, and the outcome of hematuria, bruises to arms and platelet count low was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20211034387.; Sender's Comments: V0: 20211032981-Covid-19 vaccine ad26.cov2.s-Hematuria, Bleeding gums/sever bleeding in the mouth, Bruises to arms, Platelet count low. 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: 1807391
Sex: U
Age:
State:

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

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

Lab Data: Test Name: Scan; Result Unstructured Data: diagnosed with pneumonia

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: PNEUMONIA; ATTACK OF DIVERTICULITUS; SHOT DID NOT WORK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic obstructive pulmonary disease (COPD), and peripheral arterial disease (PAD). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) with unknown dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient went to hospital and had an attack of diverticulitis. Further patient underwent Scan and diagnosed with pneumonia. The patient experienced shot did not work. Patient believed since patient got the vaccine patient's lungs and breathings had been better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pneumonia, attack of diverticulitus and shot did not work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211033699-COVID-19 VACCINE AD26.COV2.S-Attack of diverticulitus. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211033699-COVID-19 VACCINE AD26.COV2.S-Pneumonia. This event(s) is considered not related. The event(s) has an unknown/unclear 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 20211033699-COVID-19 VACCINE AD26.COV2.S-Shot did not work. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness: Chronic obstructive pulmonary disease; Peripheral arterial disease

ID: 1807392
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 10/22/2021
Hospital: Y

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

Lab Data: Test Date: 20210924; Test Name: Body temperature; Result Unstructured Data: 102 F; Test Date: 20210929; Test Name: MRI; Result Unstructured Data: not provided; Test Date: 20210929; Test Name: CSF protein; Result Unstructured Data: protein levels at 69; Test Date: 20210929; Test Name: MRI brain; Result Unstructured Data: not provided; Test Date: 20210929; Test Name: CT brain scan; Result Unstructured Data: ruled out stroke; Test Date: 20210929; Test Name: Lumbar puncture; Result Unstructured Data: Guillain-Barre syndrome

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: GUILLAIN-BARRE SYNDROME; STRESS; ENTIRE BODY SHAKES; HEADACHE; PALPITATIONS; EXTREME CHILLS; DEEP MUSCLE PAIN; HIGH TEMPERATURE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection(DEC-2020), and concurrent conditions included: wolff-parkinson-white syndrome, heart palpitations due to malformed heart blood vessel, alcohol user, non-smoker, and seizure and other pre-existing medical conditions included: Patient did not have any drug abuse or illicit drug usage. The patient experienced drug allergy when treated with diazepam for seizures. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, 1 total, administered on 23-SEP-2021 13:00 at right arm for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021 (midnight), patient experienced high temperature (about 102 F), extreme chills, deep muscle pain, tingling from neck to lower back to extremities. By 4:00 am, patient was paralyzed. During paralysis, she did not lose feeling, but she was unable to move. Patient stated that she was terrified and she refused to go to the hospital. Her husband did range of motion in all of her extremities. Within 5 hours, with husband's assistance, patient was able to get on a walker and shuffle. The next day, the patient had shortness of breath and palpitations and she called the family doctor and made an appointment On 29-SEP-2021, patient was still on walker, and her vision was affected. Patient could not see clearly, and had headaches. The patient described it as a headache, not a migraine. The family doctor sent the patient to the emergency room was reported. The patient underwent through computerized tomogram scan of brain which ruled out stroke, cerebral spinal fluid with lumbar puncture 69 protein. A lumbar puncture diagnosed her with Guillain-Barre syndrome and on 29-SEP-2021, she was admitted to the hospital to the neuro floor. A magnetic resonance imaging of the brain and the entire spinal column was performed. Treatment with Intravenous immunoglobulins of 5 infusions. On 05-OCT-2021 the patient was discharged after 7 days was reported. At the time of reporting on 18-OCT-2021, the patient was able to walk 0.25 miles, but then got tired. The patient was still having tingling on the left side, in particular left foot and left hand. The patient was still getting a headache that would get up at night, but medication was not needed. Her vision was back. It was reported that the patient does not understand, if she got stressed, her entire body shakes for 15 mins. She could not get upset. The patient felt embarrassed of losing control of her body was reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from palpitations on 01-OCT-2021, and extreme chills, and high temperature on 24-SEP-2021, was recovering from headache, and guillain-barre syndrome, had not recovered from deep muscle pain, and the outcome of stress and entire body shakes was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211033707-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: Alcohol use (once in every six months); Non-smoker; Palpitations; Seizure; Wolff-Parkinson-White syndrome (no medication)

ID: 1807393
Sex: M
Age:
State: PA

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

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

Lab Data: Test Date: 202104; Test Name: CT scan; Result Unstructured Data: No activity with the tumor; Test Name: Weight; Result Unstructured Data: Lost

Allergies:

Symptom List: Nausea

Symptoms: ACTIVATED KIDNEY CANCER STAGE 4; PARALYZED AFTER TAKING JANSSEN COVID 19 VACCINE; JANSSEN COVID 19 VACCINE JUST TOOK LIFE; LOST WEIGHT; This spontaneous potential legal report received from a patient concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 19-OCT-2021. The patient's height, and weight were not reported. The patient's past medical history included: left kidney removed, and concurrent conditions included: kidney cancer stage 4, and kidney cancer metastasized into right hip. 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 was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, Laboratory data included: Computerized Tomography (CT) scan normal which showed no activity with the tumor. On an unspecified date (after receiving the vaccine), the patient was paralyzed for a whole week and he had lost weight. On an unspecified date (within 4 months after vaccination), the patient experienced growth of full additional tumors from the original one and had a feeling that cancer got activated (activated kidney cancer stage 4). The patient also reported that he felt as Janssen Covid-19 vaccine just took his life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paralyzed after taking janssen covid 19 vaccine, and the outcome of activated kidney cancer stage 4, janssen covid 19 vaccine just took life and lost weight was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211033874-COVID-19 VACCINE AD26.COV2.S-Activated kidney cancer stage 4. 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 V0 20211033874-COVID-19 VACCINE AD26.COV2.S-paralyzed after taking janssen covid 19 vaccine. 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: Bone metastases; Kidney cancer stage IV

ID: 1807394
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SEVERE BREAKTHROUGH CASE OF VACCINE / SUSPECTED COVID-19 INFECTION; This spontaneous potential legal report received from a consumer concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 20-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 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 and has been requested. No concomitant medications were reported. On an unspecified date, the consumer reported that patient experienced a severe breakthrough case of the vaccine/suspected covid-19 infection. On an unspecified date, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe breakthrough case of vaccine/suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000198020.; Sender's Comments: V0: Medical Assessment comment not required as per standard operating procedure for legal case.

Other Meds:

Current Illness:

Date Died:

ID: 1807395
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: DEATH; This spontaneous report received from a consumer via a company representative via social media concerned three patients of unspecified gender, age, race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, frequency time 1 total was administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. "The reporter stated that the JnJ covid vaccine has caused three deaths". It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event death was fatal. This report was serious (Death).; Sender's Comments: V0: 20211036297-COVID-19 VACCINE AD26.COV2.S-Death. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1807396
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media (article) via a company representative concerned multiple patients of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical histories or concurrent conditions were reported. The patients 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 were not reported for prophylactic vaccination. The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified dates, the patients experienced suspected covid-19 infection and suspected clinical vaccination failure. As per reporter, "COVID-19 has been diagnosed in 3,648 J and J recipients in total". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcomes for the multiple patients of suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211036916. This report was associated with product quality complaint: 90000198150.; Sender's Comments: V0:20211036641-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:

ID: 1807397
Sex: U
Age:
State: NJ

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data: Test Date: 20211018; Test Name: EMG; Result Unstructured Data: unknown; Test Name: MRI; Result Unstructured Data: diagnosed with lupus; Test Name: EMG; Result Unstructured Data: abnormal; Comments: neuropathy that looked like autoimmune; Test Name: Blood test; Result Unstructured Data: normal; Test Name: MRI brain; Result Unstructured Data: unknown; Test Name: Laboratory test; Result Unstructured Data: high (5120)

Allergies:

Symptom List: Tremor

Symptoms: LUPUS; This spontaneous report received from a patient concerned a 69 year old white of unspecified sex and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Patient never had arthritis or lupus. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, 1 total, start therapy date were not reported to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had increased joint pain which got severe. They sent patient to neurologist and did Laboratory test MRI brain (NR: not provided) unknown and MRI (NR: not provided) diagnosed with lupus. When patient asked them could it be from vaccine. They said that they couldn't rule it out or say for sure. Patient was walking with a cane now. Patient used to run. Patient's ANA (Antinuclear antibody test) Laboratory test (NR: not provided) high (5120). Since APR-2021, the patient had increased difficulty to move joints and difficulty balancing. Patient had multiple evaluations from primary physician, cardiologist who ruled out heart and neurologist. Laboratory data (dates unspecified) included: Blood test (NR: not provided) normal, Electromyography (EMG) (NR: not provided) abnormal (EMG with neuropathy that looked like autoimmune). On 18-OCT-2021, Laboratory data included: EMG (NR: not provided) unknown. The patient visited to physician office. The action taken with covid-19 vaccine was not applicable. The outcome of lupus was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211036658--COVID-19 VACCINE - lupus. 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: 1807398
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: PERIPHERAL NEURITIS; This spontaneous report received from a patient via a company representative concerned a female 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 (suspension for injection, route of administration not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on 04-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had a neurologic complication diagnosed as peripheral neuritis concerned by primary care physician. She had arm pain, weakness with tingling and weakness in her legs. Her doctor told her to give it time and she was reporting improvement in strength but still had tingling mainly in her legs. The action taken with covid-19 vaccine was not applicable. The patient was recovering from peripheral neuritis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211036875-covid-19 vaccine -Peripheral neuritis. This event(s) is considered unassessable. The event(s) has an unknown/unclear 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: 1807399
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: PSORIASIS; FLARE UP; UNEXPECTED BENEFIT; SORE JOINTS AFTER COVID-19 VACCINE; This spontaneous report received from a patient concerned a 33 year old female. 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, intramuscular, batch number was not reported) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose and frequency were not reported from an unspecified date to 12-MAY-2021 for moderate to severe adult crohn's disease, and ankylosing spondylitis. No concomitant medications were reported. On an unspecified date, the patient experienced psoriasis, flare up, unexpected benefit, and sore joints after covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from psoriasis, and the outcome of flare up, unexpected benefit and sore joints after covid-19 vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1807400
Sex: F
Age:
State:

Vax Date:
Onset Date: 10/14/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a physician concerned a 78 year old female. 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: 1820095 expiry: UNKNOWN) dose was not reported, administered on 14-OCT-2021 09:49 for prophylactic vaccination. No concomitant medications were reported. On 14-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1807401
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: PAIN IN ARM; HEADACHE; This spontaneous report received from a patient concerned a 27 year old female. 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, intramuscular, batch number was not reported) dose was not reported, administered on 09-OCT-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for non-infectious intermediate posterior and panuveitis ankylosing spondylitis. No concomitant medications were reported. On 10-OCT-2021, the patient experienced pain in arm. On 10-OCT-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm, and headache on 11-OCT-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1807402
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 19 year old male. 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, intramuscular, batch number: 201A21A, and expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-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. This case, from the same reporter is linked to 20211038507, 20211038614, 20211002617, 20211034734, 20211038664, 20211038411, 20211039749, 20211038442, 20211040433 and 20211039732.

Other Meds:

Current Illness:

ID: 1807403
Sex: F
Age:
State:

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned an 18 year old female. 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, intramuscular, batch number: 201A21A, expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211002617 and 20211038614.

Other Meds:

Current Illness:

ID: 1807404
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: SICKEST; CHILLS ALL NIGHT; TERRIBLE HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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, the patient experienced sickest, chills all night, and terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sickest, chills all night and terrible headache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1807405
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 21 year old male. 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, intramuscular, and batch number: 201A21A expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211002617, 20211038507 and 20211038614.

Other Meds:

Current Illness:

ID: 1807406
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: COVID-19 virus test; Result Unstructured Data: Positive

Allergies:

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

Symptoms: POST COVID ISSUES IN LUNGS; CONFIRMED CLINICAL VACCINATION FAILURE; BREAKTHROUGH COVID INFECTION; CHILLS; FEVER; This spontaneous report received from a consumer concerned a 20 year old not hispanic or latino and Asian female. Initial information was processed along with the additional information received on 19-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 not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the reporter noted that the patient had fever and chills when having the vaccine initially, which was severe and lasted a few days. On AUG-2021, the patient experienced confirmed clinical vaccination failure. On AUG-2021, had a breakthrough covid infection. The patient received the positive test result in London while visiting her parents. Reporter was unsure of how severe the symptoms were, confirmed that the patient have covid symptoms. The patient did not get hospitalized, still has post-covid issues in terms of lungs. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough covid infection, and chills, and fever on APR-2021, had not recovered from post covid issues in lungs, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000198165.; Sender's Comments: V0; 20211038430-COVID-19 VACCINE AD26.COV2.S- confirmed 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: 1807407
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned an 18 year old male. 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, intramuscular, batch number: 201A21A, and expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-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. This case, from the same reporter is linked to 20211002617, 20211038507 and 20211038614.

Other Meds:

Current Illness:

ID: 1807408
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned an 18 year old male. 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, intramuscular, batch number: 201A21A expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-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. This case, from the same reporter is linked to 20211002617, 20211034734, 20211038269, 20211038411, 20211038664, 20211039749, 20211038614, 20211039732, 20211038269, 20211038442 and 20211040433.

Other Meds:

Current Illness:

ID: 1807409
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 55 year old male. 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, intramuscular, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-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. This case, from the same reporter is linked to 20211038507, 20211038269, 20211039749, 20211039732, 20211002617, 20211038442, 20211038411, 20211038664, 20211034734, 20211038276 and 20211038664.

Other Meds:

Current Illness:

ID: 1807410
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned an 18 year old male. 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, intramuscular, batch number: 201A21A expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-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. This case, from the same reporter is linked to 20211038507,20211002617, 20211034734, 20211038269, 20211038411,20211039749, 20211038614, 20211039732, 20211038269, 20211038442 and 20211040433.

Other Meds:

Current Illness:

ID: 1807411
Sex: M
Age:
State: WA

Vax Date:
Onset Date: 10/19/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: QUARTER SIZE 6-8 INCHES REDNESS AROUND THE CENTER OF CHEST HEART AREA; FLUSHED CHEST; BLOTCHY CHEST AND AROUND NECK; FELT A LITTLE UNDER THE WEATHER; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, non-smoker, grass allergy, and animal allergy, and other pre-existing medical conditions included: The patient had no medical issues and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 18-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-OCT-2021, the patient experienced felt a little under the weather. On 20-OCT-2021, the patient experienced quarter size 6-8 inches redness around the center of chest heart area. On 20-OCT-2021, the patient experienced flushed chest. On 20-OCT-2021, the patient experienced blotchy chest and around neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt a little under the weather, and the outcome of quarter size 6-8 inches redness around the center of chest heart area, blotchy chest and around neck and flushed chest was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Allergy to animals; Grass allergy; Non-smoker.

ID: 1807412
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: A BIT OF SORENESS IN ARM; A STRANGE HEADACHE THE DAY AFTER VACCINATION; This spontaneous report received from a patient via a company representative 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, 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 experienced a bit of soreness in arm, and a strange headache the day after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a bit of soreness in arm and a strange headache the day after vaccination was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1807413
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 09/18/2021
Rec V Date: 10/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 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 concurrent conditions included: no alcohol use, and non-smoker, and other pre-existing medical conditions included: Patient had no known drug allergies and no previous medical history. Patient did not have had any drug abuse or illicit drug use. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-SEP-2021, the patient experienced incontinence. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from incontinence. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker.

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am