VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1332391
Sex: F
Age: 18
State: MN

Vax Date: 05/16/2021
Onset Date: 05/16/2021
Rec V Date: 05/19/2021
Hospital:

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Lab Data:

Allergies: Amoxicillin

Symptom List:

Symptoms: Moderna COVID-19 Vaccine EUA, numbness in the arm and hand of the vaccination site, touch sensitivity around upper arm/area of vaccination site. Both lasted into the next 2 days (05/17-05/18) until fading throughout the day of 05/18.

Other Meds: Pro air

Current Illness: Cold

ID: 1332393
Sex: F
Age: 16
State: CA

Vax Date: 04/09/2021
Onset Date: 04/27/2021
Rec V Date: 05/19/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies: none

Symptom List:

Symptoms: see prior

Other Meds: aspirin 81mg

Current Illness: Patient was admitted on 3/30-3/31/21. To briefly summarize her prior hospital course, she was first evaluated at hospital for RUE numbness, RUE/RLE weakness and garbled speech. NIHSS 5, CT head and CTA/CTV head and neck was normal with no evidence of infarct or vessel abnormality. She was started on aspirin 81mg daily

ID: 1332394
Sex: M
Age: 27
State: CA

Vax Date: 05/17/2021
Onset Date: 05/18/2021
Rec V Date: 05/19/2021
Hospital:

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Lab Data:

Allergies: None

Symptom List:

Symptoms: Pooping 5 times per day (not diarrhea), fatigue, weakness, chills, intense muscle aches and intense headache.

Other Meds: Multivitamin, calcium supplement, magnesium supplement, zinc supplement, joint supplement, vitamin D3 supplement

Current Illness: Hayfever

ID: 1332395
Sex: M
Age: 19
State: CA

Vax Date: 05/18/2021
Onset Date: 05/18/2021
Rec V Date: 05/19/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies: No

Symptom List:

Symptoms: Injection site pain, headache, fatigue, muscle pain.

Other Meds: No

Current Illness: No

ID: 1332396
Sex: M
Age: 47
State: NJ

Vax Date: 05/11/2021
Onset Date: 05/12/2021
Rec V Date: 05/19/2021
Hospital:

Vax Type:
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Lot:
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Lab Data:

Allergies: None

Symptom List:

Symptoms: Extreme Tinnitus

Other Meds: None

Current Illness: Slight Tinnitus

ID: 1332398
Sex: M
Age: 33
State: CA

Vax Date: 05/01/2021
Onset Date: 05/09/2021
Rec V Date: 05/19/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

Symptom List:

Symptoms: I have tinnitus in both ears. I keep hearing loud, very high pitched ring.

Other Meds:

Current Illness:

ID: 1332399
Sex: M
Age: 44
State: TX

Vax Date: 05/15/2021
Onset Date: 05/15/2021
Rec V Date: 05/19/2021
Hospital:

Vax Type:
Manufacturer:
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Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: Dizziness

Other Meds:

Current Illness:

ID: 1332400
Sex: M
Age: 59
State: OR

Vax Date: 04/24/2021
Onset Date: 04/24/2021
Rec V Date: 05/19/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: none known

Symptom List:

Symptoms: SON OF PATIENT CALLED TO CANCEL 2ND DOSE APPOINTMENT STATING PATIENT HAD STRANGE FEELING FROM HIS SHOULDER TO HIS HAND IMMEDIATELY AFTER VACCINE, THEN 13 MINUTES LATER HAD TINGLING IN HIS FACE AND NUMBNESS IN HIS TONGUE. HE WAS TAKEN TO THE EMERGENCY ROOM WHERE HE WAS UNABLE TO CONSUME WATER BECAUSE OF ADVERSE EFFECTS

Other Meds: unknown

Current Illness: none known

ID: 1332401
Sex: F
Age: 39
State: CA

Vax Date: 04/09/2021
Onset Date: 04/11/2021
Rec V Date: 05/19/2021
Hospital:

Vax Type:
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Lab Data:

Allergies: allergic to tetracyclines (have DRESS, drug-related eisinophilic with systemic symptoms syndrome induced by tetracyclines)

Symptom List:

Symptoms: Exact same symptoms as with DRESS syndrome - swollen, itchy eyes; red, burning sensation on skin on face

Other Meds: multivitamin, vitamin c, calcium, glucosamine chondroitin, vitamin d, ashwaghanda, turmeric, finacea, topical steroid (acne)

Current Illness: NONE

ID: 1385555
Sex: F
Age: 52
State: IN

Vax Date: 05/16/2021
Onset Date: 05/16/2021
Rec V Date: 05/19/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: pt arm very sore/swollen @ inj. site. Pt taking around the clock ibuprofen for past 2days & massaged area. Also altern w/hot & cold compress.

Other Meds:

Current Illness:

ID: 1407280
Sex: M
Age: 34
State: CA

Vax Date: 05/14/2021
Onset Date:
Rec V Date: 05/19/2021
Hospital:

Vax Type:
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Lab Data:

Allergies: NKDA

Symptom List:

Symptoms: NON. INTRACTABLE HEAD ACHE MYALGIA NAUSEA CHILLS REPORTED 4 DAYS POST VACCINE

Other Meds: NONE

Current Illness: NONE

ID: 1407292
Sex: M
Age: 60
State:

Vax Date: 05/19/2021
Onset Date: 05/19/2021
Rec V Date: 05/19/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: PATIENT HAD BEEN SHOPPING IN THE STORE AND WAS IN AND OUT OF CONSCIOUSNESS WHEN I WAS CALLED OVER FROM THE PHARMACY TO CHECK ON HIM. PT ALSO USES OXYGEN AT HOME AND DID NOT BRING WITH HIM. BLOOD SUGAR WAS HIGH (>220) AND PARAMETICS ARRIVED ON SCENE AND TOOK HIM INTO AMBULANCE TO BE EVALUATED. THEY WERE NOTIFIED THAT HE RECEIVED VACCINE APPROXIMATELY 1 HOUR BEFORE EVENT.

Other Meds:

Current Illness:

ID: 1407321
Sex: M
Age: 25
State: PA

Vax Date: 05/19/2021
Onset Date: 05/19/2021
Rec V Date: 05/19/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Patient passed out around 5 minutes after receiving the second dose of the Moderna vaccine. He hit his head hard on the ground and felt dizzy and lightheaded for about 15 minutes after the fall.

Other Meds:

Current Illness:

ID: 1409931
Sex: F
Age: 12
State: OH

Vax Date: 05/15/2021
Onset Date: 05/15/2021
Rec V Date: 05/19/2021
Hospital:

Vax Type:
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Allergies:

Symptom List:

Symptoms: About 5 mins after vaccine administration patient passed out. She came back to a few seconds later. 911 called EMS examined her & she went home

Other Meds: n/a

Current Illness: n/a

ID: 1332321
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Lichen Sclerosus; spinal stenosis; trigger finger on the right hand; difficulty waking; dry mouth; My arm was sore after the pneumonia vaccine and the flu shot; This spontaneous report was received from a 86-year-old female patient via company, who was reporting on herself. Information regarding the patient's pertinent medical history, concurrent conditions, and concomitant therapies was not provided. On an unknown date in 2020 (reported as "last year"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (formulation, dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported). Additionally, it was reported that her arm was sore after the pneumonia vaccine and the influenza vaccine (reported as "flu shot ") (pain in extremity). On an unknown date in 2020, the patient had Lichen Sclerosus, spinal stenosis, trigger finger on the right hand, difficulty waking (somnolence), and dry mouth, which started after the vaccination. The patient did not take any prescription medications. Additionally, it was reported that the patient was allergic to an antibiotic that starts with an "e" and it caused her to have a severe long lasting headache but she cannot recall the name of the medication (class of product), but it was not reported if this happened before or after the vaccination. The outcome of the events lichen sclerosus, pain in extremity, dry mouth, somnolence, trigger finger and spinal stenosis, and the causal relationship between the above-mentioned events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and influenza vaccine were not provided.

Other Meds:

Current Illness:

ID: 1332325
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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Lab Data:

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Symptom List:

Symptoms: hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received shingrix and experienced hives. The reporter reported to always check out the side effects before getting any vaccine.

Other Meds:

Current Illness:

ID: 1332327
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
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Symptoms: got the shot and got it anyway/suspected vaccination failure; got the shot and got it anyway; Hope she is getting better with it now.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling unwell. On an unknown date, the outcome of the vaccination failure, shingles and feeling unwell were unknown. It was unknown if the reporter considered the vaccination failure, shingles and feeling unwell to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient got the Shingles shot and got it Shingles anyways. The reporter hoped that she was getting better with it till the time of reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1332328
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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Symptoms: sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (for 25 years on head, eyes and throughout my body) and general body pain (for 25 years on head, eyes and throughout my body). On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had shingles and the pain for 25 years which was on head, eyes and throughout body. It was considered chronic case. The patient stated that the shots didn't do anything but make the patient sick for three days. The patient advised to consult with doctor. For tolerance of 2nd dose refer case US2021AMR104369.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR104369:1st dose ,same patient,same event,same SP,Same reporter

Other Meds:

Current Illness:

ID: 1332329
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

Vax Type:
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Lot:
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Lab Data:

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Symptom List:

Symptoms: sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (for 25 years on head, eyes and body) and pain (for 25 years). Previously administered products included Shingrix with an associated reaction of illness (1st dose received on an unknown date and experienced sickness refer case US2021AMR104366). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient said that Shingles shot did not do a thing for his/her but made sick for 3 days. The follow up would not possible as no contact details were available.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR104366:1st dose ,same patient,same event,same SP,Same reporter

Other Meds:

Current Illness:

ID: 1332330
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/01/2020
Rec V Date: 05/20/2021
Hospital:

Vax Type:
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Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: I had the shot when it first. Amen out. I now need it again,because I got them Aug 26 of last yr./ suspected vaccination failure; I had the shot when it first. Amen out. I now need it again,because I got them Aug 26 of last yr./ suspected vaccination failure; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In August 2020, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient said he/she needed the vaccine again, because patient got Shingles on 26th August 2020. No vacation or nothing along with the epidemic of covid. The patient was stuck in the house ,like a house plant. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. This case has been linked with US2021AMR104380 and US2021AMR104377, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR104377:same reporter (1st folks case) US-GLAXOSMITHKLINE-US2021AMR104380:same repoter (2nd folks case)

Other Meds:

Current Illness:

ID: 1332331
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

Vax Type:
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Lab Data:

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Symptom List:

Symptoms: suspected Vaccination failure; had both doses of the vaccine two years ago - and the shingles last month; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. 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: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient had both doses of the vaccine two years ago and the shingles last month. The patient experienced shingles 3rd time. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles not provided.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR088540:

Other Meds:

Current Illness:

ID: 1332332
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Suspected vaccination failure; pretty bad case of them; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that his friend that has a pretty bad case of them even though he was vaccinated previously. This case was considered as suspected vaccination failure since the details dose number, time to onset and regarding laboratory confirmation of shingles not provided.

Other Meds:

Current Illness:

ID: 1332333
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Site:

Lab Data:

Allergies:

Symptom List:

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

Other Meds:

Current Illness:

ID: 1332334
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: I got the vaccine and for two or three days had very tiny; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced blister. On an unknown date, the outcome of the blister was recovered/resolved. It was unknown if the reporter considered the blister to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient for herself. The age at vaccination was not reported. The patient currently was in her 80's and still did not had shingles. The patient's husband and aunt had shingles badly. The patient got the Shingles vaccine and for 2 or 3 days she had very tiny blisters here and there on her body. The patient felt glad to take the vaccine because she probably would have them as bad as others as she got older. The follow-up would not possible as no contact details were available.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR104871:Same reporter. Invalid-Hearsay case.

Other Meds:

Current Illness:

ID: 1332337
Sex: F
Age:
State:

Vax Date: 08/13/2020
Onset Date: 09/01/2020
Rec V Date: 05/20/2021
Hospital:

Vax Type:
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Symptoms: Guillain Barre Syndrome; paralysis of her feet up to her waist; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis. On 13th August 2020, the patient received Shingrix (intramuscular). On 1st September 2020, 19 days after receiving Shingrix, the patient experienced paralysis (serious criteria GSK medically significant). On 2nd September 2020, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome and paralysis were unknown. It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to Shingrix. Additional detail: The patient received her Shingrix vaccine on 13 August 2020. By 01 September 2020 she developed paralysis of her feet up to her waist and lost the ability to walk. She also lost control of her bowel and bladder; she was terrified. She was rushed to the hospital on her island where they performed a lumbar puncture and then emergency airlifted her from that hospital she was admitted for a week. She has required extensive treatment and physical therapy for her injury of Guillain Barre Syndrome on 02 September 2020.

Other Meds:

Current Illness:

ID: 1332338
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

Vax Type:
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Symptoms: she was anaphylactic / ER Visit Required; difficulty breathing and she was rushed to the hospital / ER Visit Required; swollen arm at the vaccination site; This case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced anaphylaxis (serious criteria GSK medically significant), difficulty breathing (serious criteria other: Serious as per reporter) and swelling arm (serious criteria other: Serious as per reporter). The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the anaphylaxis, difficulty breathing and swelling arm were recovered/resolved. It was unknown if the reporter considered the anaphylaxis, difficulty breathing and swelling arm to be related to Shingrix. Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient had a swollen arm at the vaccination site and a week later she had difficulty breathing and she was rushed to the hospital. The patient visited the emergency room. They gave the patient massive amounts of Benadryl and it took a full month for her to fully recover. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1332339
Sex: F
Age: 11
State: NY

Vax Date: 05/13/2021
Onset Date: 05/13/2021
Rec V Date: 05/20/2021
Hospital:

Vax Type:
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Allergies:

Symptom List:

Symptoms: administered the liquid conjugate only (without the lyophilized portion); administered the liquid conjugate only (without the lyophilized portion); This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA391A, expiry date 20th July 2022) for prophylaxis. On 13th May 2021, the patient received Menveo. On 13th May 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The nurse practitioner administered only liquid conjugate of Menveo (without lyophilized portion) to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reported batch number AMXA391A was not found in sales data sheet, hence was updated to AMVA391A. No symptoms were reported. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1332344
Sex: F
Age: 1
State: TX

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 05/20/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: kinrix given to a 19 month old; was due for 3rd dose of ipv and dtap / Kinrix was administered on 3/4/2021 as a 3rd dose in the series; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number yz97n, expiry date 26th August 2022) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included DTPa-IPV vaccine (Received 2nd dose on March 2020.). On 4th March 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 4th March 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follow: The patient received 3rd dose of Kinrix at 19 months of age which leads to inappropriate age at vaccination and inappropriate schedule of vaccine administered. Medical administrator called to inquire how should they continue with vaccination. Forget to ask for follow up, , however did collect contact information if necessary.

Other Meds:

Current Illness:

ID: 1332353
Sex: F
Age: 28
State: TN

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 05/20/2021
Hospital:

Vax Type:
Manufacturer:
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Lot:
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Symptom List:

Symptoms: received dose 1 of Twinrix on 11/18/2020 and 2nd dose on 01/20/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 28-year-old female patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Concomitant products included HAB (Twinrix). On 20th January 2021, the patient received the 2nd dose of Twinrix. On an unknown date, the patient started Twinrix Pre-Filled Syringe Device. On 20th January 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient received 1st dose of Twinrix on 18th November 2020. The patient received 2nd dose twinrix more than recommended interval, which led to lengthening of vaccination schedule. The reporter wanted to know when the patient could receive 3rd dose. The batch number and expiration date were asked but were not available. No further clarifications were performed. The reporter did not consent to follow-up.

Other Meds: Twinrix

Current Illness:

ID: 1332354
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 05/20/2021
Hospital:

Vax Type:
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Symptoms: CONFIRMED COVID-19 INFECTION; BAD SINUS HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no medical condition. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 07-MAR-2021 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. On MAR-2021, the subject experienced confirmed covid-19 infection. On MAR-2021, the subject experienced bad sinus headache. On 13-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 17-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The outcome of the confirmed covid-19 infection and bad sinus headache was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be it was confirmed that no pqc was identified within the reported complaint and this was a duplicate case to pqms 90000178956. voided based on the pqc evaluation. based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210517426. This report was associated with product quality complaint: 90000178962 The suspected product quality complaint has been confirmed to be voided as it was confirmed that no PQC was identified within the reported complaint and this was a duplicate case to PQMS 90000178956. Voided based on the PQC evaluation.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1332357
Sex: F
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: CONVULSIONS/SEIZURES; HYPERTHYROIDISM; DRUG INTERACTION; FLUCTUATING HEART RATE; NUMBNESS DOWN FACE; NUMBNESS AND TINGLING IN ARM; ABNORMAL VISION; SKIPPED DOSES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included neurological issues related to covid, and seizures. On 19-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency once total, administered for prophylactic vaccination. The patient received Topiramate (capsule, hard, oral, batch number was not reported) 100 mg, 1 time every 1 day, from OCT-2020, 100 mg, 1 time every 1 day, from 08-MAY-2021, and 200 mg, frequency, and therapy dates were not reported for neurological issues related to covid. The batch number was not reported and has been requested. Concomitant medications included thyroid. On an unspecified date in 2021, the patient experienced hyperthyroidism, and was hospitalized (date unspecified) and experienced convulsions/seizures, numbness down face, abnormal vision, fluctuating heart rate, numbness and tingling in arm and had skipped doses (coded as drug dose omission). Patient went to the hospital where she had stopped Topamax for 6 days to check whether electroencephalogram (EEG) would show up, and thyroid function test (NR: not provided) high (hyperthyroid). levels had dropped. The hospital ultimately could not found anything. But she went back to a different hospital for more neurological testing and was taken off of Topamax again. She had another thyroid test and her levels had dropped. On, 07-May-2021, the patient was discharged and started taking it again from the night of 08-May-2021.The numbness had came back. She saw online that Topamax and Armour Thyroid should not be combined. She mentioned that at some point her dose was increased to 200 mg a day and she had experienced more seizures. On an unspecified date in 2021, the patient experienced drug interaction The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with Topiramate was not reported. The patient recovered from hyperthyroidism, had not recovered from numbness down face, and abnormal vision, convulsions/seizures, fluctuating heart rate and numbness drug interaction and tingling in arm was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint 90000179114.; Sender's Comments: V0. 20210522141-COVID-19 VACCINE AD26.COV2.S -Convulsions/Seizures, Hyperthyroidism, Drug interaction. 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). 20210522141-TOPOMAX-Convulsions/Seizures. This event(s) is labeled per RSI and is therefore considered potentially related. 20210522141-TOPOMAX-Hyperthyroidism, Drug interaction. 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: TOPAMAX; ARMOUR THYROID

Current Illness: Nervous system disorder; Seizures

ID: 1332358
Sex: M
Age:
State:

Vax Date:
Onset Date: 05/06/2021
Rec V Date: 05/20/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: COVID-19 INFECTION (FLU LIKE SYMPTOMS/COUGH); This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 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. On 06-MAY-2021, the subject experienced covid-19 infection (flu like symptoms/cough). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The outcome of covid-19 infection (flu like symptoms/cough) was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Other Meds:

Current Illness:

ID: 1332359
Sex: M
Age:
State: AR

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 05/20/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Symptom List:

Symptoms: CARDIAC ARREST (SEVER CHEST PAIN); CLOGGED VEIN; LEFT ARM GOES TO SLEEP; This spontaneous report received from a patient concerned a 62 year old white male. The patient's past medical history included blood clot, heart attack, lump in leg, and stents in main arteries, and concurrent conditions included heavy smoker, and heart issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808025, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-MAR-2021 to left arm as prophylactic vaccination. The patient was previously treated with clopidogrel bisulfate for blood clot. On an unspecified date in 2021, Laboratory data included: Echocardiogram (NR: not provided) unknown, and Lab test (full workup)(NR: not provided) unknown. On an unspecified date in Mar-2021, a week later vaccination, the patient experienced that left arm went to sleep which felt worse next day, on 25-APR-2021, patient experienced severe pain in chest, called ambulance and was taken to hospital. On same day patient was hospitalized. Patient went to full cardiac arrest twice same day. It was stated that vein that was 60 percent good earlier was 100 percent clogged (clogged vein) in one month after getting the vaccine. They tried to put stent in, clear vein out, and put piece of metal and expanded it, to make alley way for blood flow. Patient stated that patient would not take Plavix this time. According to patient, stent was reacting with Plavix, and decided to take something different. They did same job twice. It was stated that patient was discharged on 05-May-2021 from hospital. On 12-MAY-2021, patient went to consult the health care professional to make sure everything was okay. The patient gave lot number 1808025, then stated that, patient thinks it is 180, and then either 5 or 8, and next it was either D or 0, and then after the space it is 25. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cardiac arrest (sever chest pain), left arm goes to sleep and clogged vein was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210523134-COVID-19 VACCINE AD26.COV2.S-CARDIAC ARREST (SEVERE CHEST PAIN), CLOGGED VEIN. 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, UNDERLYING DISEASE

Other Meds:

Current Illness: Heart disorder; Heavy smoker

ID: 1332360
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 04/28/2021
Rec V Date: 05/20/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: STROKE; RIGHT CAROTID ARTERY BLOCKAGE; This spontaneous report received from a patient concerned a 62-year-old white female, ethnicity unspecified. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, hypertension, hyperlipidemia, and allergy to latex, and other pre-existing medical conditions included allergy to Provaxin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 06-JUN-2021) dose was not reported, 1 in total administered on 06-APR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On 28-APR-2021, the patient experienced stroke. On 10-MAY-2021, the patient was hospitalized. On 11-MAY-2021, the patient was discharged. On an unspecified date, the patient experienced right carotid artery blockage (60 percent). Laboratory data included: CT scan (NR: not provided) stroke, Echocardiogram (NR: not provided) stroke, Laboratory test (NR: not provided) stroke, and MRI (NR: not provided) stroke The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and the outcome of right carotid artery blockage was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210523342-covid-19 vaccine ad26.cov2.s -stroke, right carotid artery blockage. 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

Other Meds:

Current Illness: Diabetes; Hyperlipidemia; Hypertension; Latex allergy

ID: 1332361
Sex: F
Age:
State: AK

Vax Date:
Onset Date: 05/11/2021
Rec V Date: 05/20/2021
Hospital: Y

Vax Type:
Manufacturer:
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Symptom List:

Symptoms: ANAPHYLACTIC SHOCK; This spontaneous report received from a company representative concerned a 22 year old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylactic reaction with unknown cause. The patient had no known allergies. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry date were Unknown) dose was not reported, 1 total, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 11-MAY-2021, the patient experienced anaphylactic shock, and was hospitalized and given high dose of steroids to manage adverse reaction. Patient was discharged on the same day (11-MAY-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anaphylactic shock. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210523394-COVID-19 VACCINE AD26.COV2.S-Anaphylactic shock. 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: 1332362
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer (company representative) concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total administered on 2021(about three months prior to this report) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, after vaccination, the patient got coronavirus infection a month ago prior to this report for two weeks (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on 2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint-90000179462. The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210523713-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: 1332363
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/20/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: ABDOMINAL PAIN; HOT FLASHES; DIARRHEA; ITCHY RASH ALL OVER BODY; NO ENERGY; CHILLS; HEADACHE; TIREDNESS/ FATIGUE; CHEST TIGHTENING; GENERAL BLAH FEELING; ARM PAIN; MISSING WORK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (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 and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced missing work. On 04-MAY-2021, the subject experienced chest tightening. On 04-MAY-2021, the subject experienced general blah feeling. On 04-MAY-2021, the subject experienced arm pain. On 04-MAY-2021, the subject experienced headache. On 04-MAY-2021, the subject experienced tiredness/ fatigue. On 12-MAY-2021, the subject experienced abdominal pain. On 12-MAY-2021, the subject experienced hot flashes. On 12-MAY-2021, the subject experienced diarrhea. On 12-MAY-2021, the subject experienced itchy rash all over body. On 12-MAY-2021, the subject experienced no energy. On 12-MAY-2021, the subject experienced chills. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, diphenhydramine hydrochloride/zinc oxide, and avena sativa. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from tiredness/ fatigue, headache, itchy rash all over body, no energy, abdominal pain, chills, and diarrhea, and the outcome of arm pain, chest tightening, general blah feeling, hot flashes and missing work was not reported. This report was non-serious.; Sender's Comments: v0-Medical Assessment Comment is not required as per standard procedures, as event was assessed as non-serious.

Other Meds:

Current Illness:

ID: 1332364
Sex: U
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: WASN'T SATISFIED WITH EFFICACY RATE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 11-MAR-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 wasn't satisfied with the efficacy rate of covid-19 vaccine ad26.cov2.s , On 26-APR-2021,patient scheduled to get the first dose of Pfizer-BioNTech vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wasn't satisfied with efficacy rate was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210524437-Covid-19 vaccine ad26.cov2.s-Wasn't Satisfied with Efficacy rate.. 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: 1332365
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media via a company representative and concerned seven patients. Patients weight, height, and medical history were not reported. Patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 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. On an unspecified date, seven patients experienced suspected covid-19 infection, and suspected clinical vaccination failure. on unspecified date 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 outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210524793.; Sender's Comments: V0: 20210524955-COVID-19 VACCINE AD26.COV2.S-SUSPECTED CLINICAL VACCINATION FAILURE. 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: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1332366
Sex: F
Age:
State: KY

Vax Date:
Onset Date: 05/12/2021
Rec V Date: 05/20/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
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Lab Data:

Allergies:

Symptom List:

Symptoms: ARM FROM SHOULDER TO PINKY FINGER HURTS IF SOMETHING TOUCHES IT; FEELS IRRITATED; FEELS LIKE NERVE DAMAGE; FEELS LIKE THE HAIR ON ARMS HURT; PASSED OUT TWICE; SUNBURN LIKE FEELING IN VACCINE INJECTION ARM WITH NO REDNESS OR RASH; SEVERE STOMACH ISSUES FOR A WEEK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient donated blood and passed out twice. 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. 4 days later, the patient donated blood and for the first time ever, passed out twice. The patient had severe stomach issues for about a week but that have resolved. The patient's arm that she received the vaccine in, felt like a sunburn- no redness, rash or swelling. The patient's arm didn't hurt unless something is touching it. It was not hot to the touch but felt very strange and very sensitive from her shoulder all the way to the tip of her pinky finger on the outer portion of arm. It was very sensitive even when washing the hands. The patient mentioned that it felt like nerves have been damaged. It felt like hair on arm hurt. It fell irritated. The caller mentioned that her daughter got the vaccine the same day and experienced the same thing but didn't last as long-maybe a couple of days and it was gone. On an unspecified date, the patient felt like passed out twice, sunburn but no redness, no rash and it started from the shoulder to pinky finger (coded as sunburn like feeling in vaccine injection arm with no redness or rash), arm from shoulder to pinky finger hurts if something touches it, feels irritated, feels like nerve damage and feels like the hair on arms hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach issues for a week on MAY-2021, and the outcome of passed out twice, sunburn like feeling in vaccine injection arm with no redness or rash, arm from shoulder to pinky finger hurts if something touches it, feels irritated, feels like nerve damage and feels like the hair on arms hurt was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210531194.; Sender's Comments: V0:20210525585-covid-19 vaccine ad26.cov2.s-Passed out twice. 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

Other Meds:

Current Illness:

ID: 1332367
Sex: M
Age:
State: GA

Vax Date:
Onset Date: 05/10/2021
Rec V Date: 05/20/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SEIZURES; PAIN IN JOINTS; VISION BLURRY; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included he had been healthy individual all his life. The patient's concurrent conditions included patient was non-alcohol user, and non-smoker. The patient had no history of comorbidities. The patient had no known allergies and drug abuse or illicit drug usage. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 11-MAY-2021) 1 total dose was administered at left arm on 10-MAY-2021 (reported as Monday) for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the patient experienced blurry vision (vision blurry) which had happen all of sudden. On 12-MAY-2021, (reported as Wednesday) after taking JNJ vaccine he was taken to the emergency room because he had developed seizures (seizure), the patient experienced pain in joints (pain in the joints) which had happen all of sudden and was hospitalized. The patient was treated with Levetiracetam 500 mg for seizure. He was hospitalized for a day. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from seizures, and had not recovered from pain in joints, and vision blurry. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210529765-COVID-19 VACCINE AD26.COV2.S-Seizures. 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). V0: 20210529765-COVID-19 VACCINE AD26.COV2.S-Pain in joints. This event(s) is labeled per RSI and is therefore considered potentially related.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1332368
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 05/11/2021
Rec V Date: 05/20/2021
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Symptoms: SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a 57 year old male patient. The patient's weight was 70 kilograms and height was 64 inches. The patient's concurrent conditions included penicillin allergy (PCN). 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 1 in total administered in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAY-2021, Laboratory data included: COVID-19 antibody test was negative and the patient reported suspected immunological vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179796.; Sender's Comments: V0: 20210530196-Covid-19 vaccine ad26.cov2.s- Suspected immunological vaccine 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: Penicillin allergy

ID: 1332369
Sex: F
Age:
State: NV

Vax Date:
Onset Date: 04/28/2021
Rec V Date: 05/20/2021
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Symptoms: UPPER CHEST WAS BLACK AND BLUE; CHEST TENDER TO THE TOUCH; CHEST HAD LIKE BROKEN BLOOD VESSELS; CHEST WAS TIGHT; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included veins burning, vomiting, redness, burning sensation, swelling, sick, faint, and anaphylactic reaction, and concurrent conditions included multiple sclerosis, non alcoholic, non smoker, sulfa allergy, and steroid allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. Patient was not pregnant at the time of vaccination. Patient had red light therapy as well. The patient experienced drug allergy when treated with teriflunomide, influenza vaccine, interferon, prednisone, cimetidine, and glatiramer acetate. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin for drug used for unknown indication, losartan for drug used for unknown indication, and ibuprofen. On 28-APR-2021, the subject experienced chest was tight. On 14-MAY-2021, the subject experienced upper chest was black and blue. On 14-MAY-2021, the subject experienced chest tender to the touch. On 14-MAY-2021, the subject experienced chest had like broken blood vessels. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from upper chest was black and blue, chest was tight, chest tender to the touch, and chest had like broken blood vessels. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Other Meds: LOSARTAN; ATORVASTATIN; IBUPROFEN

Current Illness: Abstains from alcohol; Allergic reaction to antibiotics; Drug allergy; Multiple sclerosis (FOR 40 YEARS); Non-smoker

ID: 1332370
Sex: U
Age:
State: MO

Vax Date:
Onset Date: 05/13/2021
Rec V Date: 05/20/2021
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Symptoms: MEDICATION ERROR; INCORRECT STORAGE OF VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced medication error. On 13-MAY-2021, the subject experienced incorrect storage of vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of the medication error and incorrect storage of vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1332371
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
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Symptoms: HOT FLASHES; CHILLS; JOINT PAIN; MUSCLE PAIN; ON AND OFF POUNDING HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (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 subject experienced hot flashes, chills, joint pain, muscle pain, and on and off pounding headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from on and off pounding headache, and the outcome of muscle pain, chills, hot flashes and joint pain was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1332374
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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Symptoms: HORRIBLY SICK; This spontaneous report (social media) received from a consumer via a company representative concerned a 38 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, mild headache, and fatigue. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported 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. On an unspecified date, the subject experienced horribly sick. The action taken with covid-19 vaccine was not applicable. The patient recovered from horribly sick. This report was non-serious.

Other Meds:

Current Illness:

ID: 1332382
Sex: F
Age:
State:

Vax Date:
Onset Date: 05/13/2021
Rec V Date: 05/20/2021
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Symptoms: BODY ACHES; UP ALL NIGHT; THROWING UP; FEVER; HEADACHE; SICK TO STOMACH; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAY-2021 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. On 13-MAY-2021, the subject experienced body aches. On 13-MAY-2021, the subject experienced up all night. On 13-MAY-2021, the subject experienced throwing up. On 13-MAY-2021, the subject experienced fever. On 13-MAY-2021, the subject experienced headache. On 13-MAY-2021, the subject experienced sick to stomach. The action taken with covid-19 vaccine was not applicable. The patient recovered from throwing up on 14-MAY-2021, and the outcome of fever, headache, body aches, sick to stomach and up all night was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1332390
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
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Symptoms: HELLISH FOR ONE NIGHT; NEVER FELT SICKER; COULD NOT SLEEP; INSANELY TIRED; SUPER HIGH FEVER; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced hellish for one night, never felt sicker, could not sleep, insanely tired, super high fever, and nausea. The action taken with covid-19 vaccine was not applicable. The outcome of the hellish for one night, never felt sicker, insanely tired, super high fever, nausea and could not sleep was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1332397
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
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Symptoms: UNSPECIFIED ADVERSE REACTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes.The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included mrna 1273. On 2021, the subject experienced unspecified adverse reaction. The action taken with covid-19 vaccine was not applicable. The outcome of unspecified adverse reaction was not reported. This report was non-serious.

Other Meds: MRNA-1273

Current Illness: Diabetes

ID: 1332402
Sex: F
Age: 46
State: CO

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 05/20/2021
Hospital:

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Allergies: No know

Symptom List:

Symptoms: That evening high fever, chills nausea and then few days later Bell?s palsy, face is tingling, eye won?t shut and speech hindered.

Other Meds: Armorthyroid

Current Illness: None

Total 2021 VAERS Injuries: 704,237

Page last modified: 03 October 2021 5:28pm