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
88,334
AK1,815
AL6,133
AR3,993
AS45
AZ14,539
CA64,759
CO12,159
CT8,719
DC1,747
DE1,868
FL41,499
FM3
GA16,132
GU92
HI2,477
IA4,739
ID2,763
IL21,496
IN23,655
KS4,844
KY8,414
LA5,328
MA15,281
MD13,105
ME3,277
MH8
MI20,143
MN12,873
MO10,275
MP30
MS3,073
MT2,392
NC17,450
ND1,440
NE3,023
NH3,124
NJ19,456
NM4,089
NV4,600
NY36,525
OH20,140
OK6,525
OR8,918
PA24,920
PR2,483
QM2
RI2,092
SC6,952
SD1,243
TN10,038
TX38,745
UT4,482
VA15,477
VI62
VT1,780
WA15,487
WI11,573
WV2,461
WY894
XB5
XL1
XV2

ID: 1458612
Sex: F
Age: 45
State: OK

Vax Date: 04/21/2021
Onset Date: 04/22/2021
Rec V Date: 07/09/2021
Hospital: Y

Vax Type:
Manufacturer:
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Lab Data:

Allergies: None

Symptom List:

Symptoms: I had a stroke sometime between 11pm on April 22, 2021 and 8am on April 23, 2021. I'd had the vaccine at 4pm on April 21, 2021. I felt ill during the day on 4/22/2021 but took a nap and woke up feeling better before heading to bed at about 10pm.

Other Meds: Trintellix, Estarylla, progesterone, NP thyroid, vitamin D, vitamin B, antacid

Current Illness: None

ID: 1458613
Sex: F
Age: 14
State: CA

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

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Lab Data:

Allergies: Peanut allergy

Symptom List:

Symptoms: Red circle appeared RUA at injection site, itchy ?under the skin? on Friday,. Saturday it was about 1 inch round. Probably grew to about 2 inches round at 4 days post injection. Started getting smaller/better on day 5 (Tues)?1 week after injection red spot is small and more like a bruise., but still a little itchy. We treated it with Tylenol, Ice to site, benadryl for itching.

Other Meds: Ceterizine 10mg, multi vitamin, flonase sensi-mist,

Current Illness: Has OCD lesion of left ankle that was aggravated. Pt was in air cast boot at time of vaccination.

ID: 1458614
Sex: F
Age: 51
State: CA

Vax Date: 06/30/2021
Onset Date: 06/30/2021
Rec V Date: 07/09/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies: N/A

Symptom List:

Symptoms: REDNESS; ITCHINESS; SWOLLEN

Other Meds: N/A

Current Illness: N/A

ID: 1458615
Sex: F
Age: 77
State: FL

Vax Date: 04/02/2021
Onset Date: 04/16/2021
Rec V Date: 07/09/2021
Hospital:

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Lab Data:

Allergies: Pennicillan, Sulfa,Cipro, Erythromyacin,Celexa,Zomig, Amytriptiline,Tricot,

Symptom List:

Symptoms: Approximately April 16 (2 weeks after second shot) Left leg went out from under me unexpectledly. Few days later happened again but continued to be weaker and Blood pressure increased to 207/140 while I was out shopping. Drove myself to hospital ER and they admitted me. from 04/26 to 04/29. On 04/29 they did MRI brain scan and determined that I had suffered a right quadron brain bleed which left me left side leg weakness and balance issues. Sent me home on 04/29 and told me see primary Dr. right away.. They ordered in home therapy for a few weeks and in 2 weeks I start outpatient therapy . Since this 3 of my Dr's agreed to have a Heart loop monitor inserted in my chest which I agreed to. Staples come out next week.

Other Meds: Metoprolol Success ER,Synthroid,Clopidogrel,Clonazepam,Fluticasone Propionate,Losartan, Generic Nexium

Current Illness: None

ID: 1458616
Sex: F
Age: 49
State: ID

Vax Date: 05/14/2021
Onset Date: 05/14/2021
Rec V Date: 07/09/2021
Hospital:

Vax Type:
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Lab Data:

Allergies: Phenergen

Symptom List:

Symptoms: The first two nights I was not able to sleep because when I laid down my throat was too constricted. I did not realize at the time that it was a reaction to the shot. My glands have been swollen since that day. I have had a chronic cough since that day, to the point that it has been uncontrollable. Different atmosphere still affect my breathing. It is not nearly as bad as the first week but the first 45 days have been awful. After returning from vacation from a moist climate to a dry climate it seems a bit better but still keeps me awake at night. I tried to ask the pharmacist, they referred me to my Dr, who said it was allergies without even seeing me. After I developed a lump in my left arm on day 7 and site swelling at day 10 I went back to the pharmacist. Ironically I had to make a call to our local health department they referred me to the hospital who referred me back to my Dr who could not see me before I left on vacation. They referred me to Urgent care who refereed me to an ENT which I saw today. They are telling me it is allergies. I don't by it. So here I am.

Other Meds: None

Current Illness: None

ID: 1458617
Sex: F
Age: 60
State: PA

Vax Date: 04/01/2021
Onset Date: 04/20/2021
Rec V Date: 07/09/2021
Hospital:

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Lab Data:

Allergies: None

Symptom List:

Symptoms: Approximately one week after first Pfizer vaccine, I developed pronounced and constant high pitched ringing in my ears(tinnitus). It never stops. Surges louder. Hearing test shows unusual partial loss of hearing on left side as well. Oral steroids did not help. Steroid injection into ear drum has not helped.

Other Meds: Latanoprost eye drops

Current Illness: None

ID: 1458618
Sex: F
Age: 44
State: MI

Vax Date: 06/08/2021
Onset Date: 06/17/2021
Rec V Date: 07/09/2021
Hospital:

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Lab Data:

Allergies: Penicillin

Symptom List:

Symptoms: Rapid, fast rising heart rate Twice in about an hour and a half time period Second time went from resting heart rate about 70 to 180 in just a couple minutes No activity when it had happened. Was lying down trying to sleep

Other Meds: None

Current Illness: None

ID: 1458619
Sex: F
Age: 59
State: WA

Vax Date: 07/08/2021
Onset Date: 07/08/2021
Rec V Date: 07/09/2021
Hospital:

Vax Type:
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Lab Data:

Allergies: NKDA

Symptom List:

Symptoms: Patient returned to pharmacy 30 min after injection complaining of generalized itching to head, neck, back and arms. Denied SOB, dyspnea, facial swelling. Observed x10 min. Symptoms continuing. Administered 50 mg diphenhydramine po. Observed x15 min. Symptoms continuing but not worsening. Highly recommended pt get ride home. Pt cannot get ahold of husband or daughter. Offered to find ride home. Pt declined as she lives close and doesn't want to leave car at store. Observed x15 min. Itching somewhat better around head. Preexisting TMJ pain starting. Pt wants to drive home as it is close by. Recommended to go to ER if she develops any facial swelling or difficulty breathing. Pt left store and texted about 20 min later that she arrived home safe but itching is continuing.

Other Meds: Unknown

Current Illness: Unknown

ID: 1458620
Sex: F
Age: 37
State: CA

Vax Date: 12/22/2020
Onset Date: 12/23/2020
Rec V Date: 07/09/2021
Hospital:

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Lab Data:

Allergies: N/a

Symptom List:

Symptoms: Chest discomfort left side sharp in nature for about 2 weeks following vaccine. Worse with activity. Went away before second shot then returned for a shorter time (about one week) less severe following second shot

Other Meds: Aldactone Multi vit Vit d B1

Current Illness: N/a

ID: 1458621
Sex: F
Age: 36
State: CO

Vax Date: 07/03/2021
Onset Date: 07/05/2021
Rec V Date: 07/09/2021
Hospital:

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Lab Data:

Allergies: Betamethasone

Symptom List:

Symptoms: Stubbing chest pain for a couple times for 1 day, bloating and pain stomach and anxiety (in the morning of July 4th and a few hours in afternoon) Following day mild chest pain and anxiety ( July 5th late afternoon and night) July 6th in morning I went to Emergency room to get checked.

Other Meds: Iboprufen

Current Illness:

ID: 1458623
Sex: F
Age: 56
State: GA

Vax Date: 07/06/2021
Onset Date: 07/06/2021
Rec V Date: 07/09/2021
Hospital:

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Lab Data:

Allergies: Sulfur, penicillin, codeine, eggs, soy, wheat, peanuts, corn, sorbitol, potassium sorbate, preservatives, MSG

Symptom List:

Symptoms: Chest tightness after second dose 40-45 minutes afterwards. No wheezing. Experienced Shortness of breath upon activity. Difficulty exhaling. O2 level was 96%. Took mucus, no relief. Multiple inhalations of Pro-Air, no relief. Took Albuterol nebulizer treatment, no relief. Took children?s Benadryl approximately 4:30 PM and experienced immediate relief in 20 minutes. Took more Benadryl proper to bedtime. Woke up next AM and felt like I felt prior to the vaccine.

Other Meds: Symbicort Pro-Air

Current Illness:

ID: 1458624
Sex: F
Age: 22
State: WA

Vax Date: 07/08/2021
Onset Date: 07/08/2021
Rec V Date: 07/09/2021
Hospital:

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Symptom List:

Symptoms: 15 seconds after second dose, could not breathe, nausea, dizziness, lost completely feeling in both arms, side cramps, chest tightness, uncontrollable shaking, feeling super cold. Vision suddenly got narrow , began seeing stars, black patches Got an epipen injected and was finally able to breathe. Paramedics arrived and took vitals and I stayed for 45 mins until vitals were back to normal. Suggested I drive in the ambulance to the ER to be monitored but it wasn?t bad enough for me to ride. Someone separately drove me to the hospital just in case and I was ok.

Other Meds:

Current Illness:

ID: 1458625
Sex: F
Age: 38
State: CA

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

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Lab Data:

Allergies: PCN, Sulfa Antibiotics

Symptom List:

Symptoms: My body broke out into hives 2-4 hours after receiving the vaccine. This lasted approx 4 days, while taking Benedryl for symptoms. I broke out into hives again on 6/21/2021 and they are still present on 7/8/2021.

Other Meds: Wellbutrin, Gabapentin, and Lexapro

Current Illness:

ID: 1458627
Sex: F
Age: 18
State: CA

Vax Date: 07/08/2021
Onset Date: 07/08/2021
Rec V Date: 07/09/2021
Hospital:

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Lab Data:

Allergies: amoxicillin

Symptom List:

Symptoms: patient complains of pain & weakness in left arm 4 hours after vaccine

Other Meds: Buspar 15 mg qid

Current Illness:

Date Died: 05/02/2021

ID: 1458628
Sex: M
Age: 35
State: IL

Vax Date: 04/17/2021
Onset Date: 04/21/2021
Rec V Date: 07/09/2021
Hospital: Y

Vax Type:
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Lab Data:

Allergies: N/A

Symptom List:

Symptoms: My previously healthy brother received the Pfizer vaccine (1st dose) and 4 days after he was hospitalized with shortness of breath, heart failure, blood clots in his arm, lungs and leg along with a stroke and many medical conditions kept arising as he was hospitalized. He was in the CICU for a week and a half. Unfortunately, my brother passed away from the Pfizer vaccine. Until his last day the doctors still "didn't know" what was wrong with him. A lot happened during his hospital stay, but this is just a brief statement. They have been keeping his medical records from me. They tested him repeatedly there from covid and he wa salways negative. They had no other explanation to what was happening and all along they wanted it to be COVID-19 and were so quick to say it was not the vaccine.

Other Meds: None

Current Illness: None

ID: 1458629
Sex: M
Age: 29
State: CA

Vax Date: 05/12/2021
Onset Date: 06/13/2021
Rec V Date: 07/09/2021
Hospital: Y

Vax Type:
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Lot:
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Lab Data:

Allergies: N/A

Symptom List:

Symptoms: Sudden chest pain, near syncope, light headed, dizzy, shortness of breath. Went to urgent care and was sent home after negative EKG. Continue to have intermittent chest pain, light headedness, fatigue, and shortness of breath. Went to the hospital but EKG showed nothing abnormal. Referred to a cardiologist. Wearing a heart monitor and MRI scheduled. Continue to have fatigue, shortness of breath, and chest pains.

Other Meds: N/A

Current Illness: N/A

ID: 1458630
Sex: F
Age: 44
State: OR

Vax Date: 04/29/2021
Onset Date: 05/03/2021
Rec V Date: 07/09/2021
Hospital:

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Lab Data:

Allergies: Sulfa, flu vaccine

Symptom List:

Symptoms: Symptoms started with severe muscle cramping in calves and progressed to numbness and parasthesias in legs, arms, and torso. Muscle weakness and inability to continue workouts followed over weeks. Before my vaccine I was riding my bike 15 miles and running 6 miles. I now find it hard to walk one mile due to muscle cramping and weakness.

Other Meds: Vitamin D

Current Illness: None

ID: 1458631
Sex: M
Age: 12
State: TX

Vax Date: 07/06/2021
Onset Date: 07/08/2021
Rec V Date: 07/09/2021
Hospital:

Vax Type:
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Lab Data:

Allergies: No

Symptom List:

Symptoms: My kid reported both jaws pain in early morning on 8 July and he woke up with pain. I gave him Ibuprofen 200 mg 1 tablet after 1-2 hrs he feel relaxed. He got first dose of Pfizer vaccine on 6th July at 2 30 PM at Kroger Pharmacy

Other Meds: None

Current Illness: No

ID: 1458632
Sex: M
Age: 27
State: CA

Vax Date: 06/21/2021
Onset Date: 06/25/2021
Rec V Date: 07/09/2021
Hospital:

Vax Type:
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Lab Data:

Allergies: None

Symptom List:

Symptoms: About 4 hours post injection ring finger nerves became painful at tip with pins and needles feeling. Still present, but not as painful. About 1 week post injection, began getting chest pains, difficulty breathing, and dizziness/lightheadedness. We to urgent care 1 week after symptoms started to appear as they got worse. EKG ran showing potential heart attach in past, but I don't think I've had one before. Was noted and told might have been due to crutches. Symptoms got worse next day so went to urgent care at different facility. Brought to ER for x-ray, blood , and EKG. Told no myocarditis, but potentially pericarditis.

Other Meds: Zinc and men's daily gummies

Current Illness: None

ID: 1458633
Sex: F
Age: 21
State:

Vax Date: 06/10/2021
Onset Date: 06/10/2021
Rec V Date: 07/09/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: Fever, muscular pain, dizziness, nocturnal diuresis, headache.

Other Meds:

Current Illness:

ID: 1458686
Sex: M
Age:
State: PR

Vax Date: 03/14/2021
Onset Date: 03/22/2021
Rec V Date: 07/09/2021
Hospital:

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Lab Data:

Allergies:

Symptom List:

Symptoms: Cough; Minor breath problems; No energy; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207), via an unspecified route of administration in the right arm on 14Mar2021 at 09:30 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medication included montelukast sodium (SINGULAIR) from unknown date for unspecified indication. The patient previously received acetylsalicylic acid (ASPIRIN) on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, the patient experienced cough, minor breath problems, no energy. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events cough, breathing difficult, loss of energy was recovered with sequelae. No follow-up attempts are needed. No further information is expected.

Other Meds: SINGULAIR

Current Illness:

ID: 1458747
Sex: U
Age: 12
State: NY

Vax Date: 06/07/2021
Onset Date: 06/07/2021
Rec V Date: 07/09/2021
Hospital:

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Symptom List:

Symptoms: a dose of PEDVAX HIB was given to a 12 year old patient by mistake; a dose of PEDVAX HIB was given to a 12 year old patient by mistake; a dose of PEDVAX HIB was given to a 12 year old patient by mistake instead of GARDASIL 9; No additional adverse events reported; This spontaneous report was received from a licensed practical nurse, referring to a 12 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided. On 07-JUN-2021, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S036818, expiration date 22-APR-2022, 0.5 milliliter, route was not reported) for prophylaxis by nurse's mistake instead of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) that was ordered (product administered to patient of inappropriate age, product confusion and wrong product administered). No additional adverse events reported. Nurse also reported that the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine had not been administered at that time and patient would have to come in at a later date for administration.

Other Meds:

Current Illness:

ID: 1458748
Sex: U
Age: 0
State: FL

Vax Date: 06/21/2021
Onset Date: 06/21/2021
Rec V Date: 07/09/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: There have been no additional adverse experiences reported; A single dose of Rotateq was inadvertently administered to a 10 year old infant; This spontaneous report was received from a physician and refers to a 10-day old patient of an unknown gender. The patient pertinent medical history, concurrent conditions and concomitant therapies were not provided. On 21-JUN-2021, the patient was inadvertently vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707408 and expiration date 07-JAN-2022) one single dose for prophylaxis. No additional adverse experiences were reported as a result of the administration of the vaccine.

Other Meds:

Current Illness:

ID: 1458749
Sex: F
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 07/09/2021
Hospital:

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Symptom List:

Symptoms: convulsions; very high fever; This spontaneous report has been received from a patient's father via Pfizer concerning a female patient of unknown age (reported as when she was younger). The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient had a bad reaction including a very high fever and convulsions. She never received the second dose of the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) due to this reaction. The patient had recovered from the events on unknown dates. The reporter and his wife were told that the patient did not actually have a reaction to the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) itself but that she already had immunity that was passed through to her by her mother and that was what caused her to have a reaction to the first dose of the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (causality was entered as related conservatively). Upon internal review, the event convulsions was determined to be medically significant.

Other Meds:

Current Illness:

ID: 1458751
Sex: U
Age:
State: TX

Vax Date: 06/26/2021
Onset Date: 06/26/2021
Rec V Date: 07/09/2021
Hospital:

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Lab Data:

Allergies:

Symptom List:

Symptoms: A pharmacist reported VARlVAX was improperly stored and administered; This spontaneous report has been received from a pharmacist, referring to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies. On 26-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) 0.5 milliliter (mL) once (lot number T028306 and expiration date 20-AUG-2022 were verified as valid) (route of administration, vaccination scheme and anatomical site of vaccination were not provided) as prophylaxis. The vaccine was improperly stored at 41 Fahrenheit degrees for 24 hours (product storage error). The temperature excursions were not detected by a data logger. There was no previous temperature excursion; Sender's Comments: US-009507513-2107USA000237: US-009507513-2107USA000111:

Other Meds:

Current Illness:

ID: 1458754
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/09/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: Suspected vaccination failure; I Had And Still Do Have The Shingles / I Have Had Them Again, After Vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles, burning sensation, pain and mastectomy. 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 case reported by the patient herself/himself The patient received the dose of Shingles vaccine and patient experienced shingles The reporter stated that patient had shingles and that was rare case. The patient stated that the first time patient got shingles The patient got vaccine and it did help to ease the pain but burning was unbelievable and he/she was like on fire. The burning was on side and back. The reporter stated that these all after the Mastectomy,which was much less painful than the shingles. The reporter stated that he/she would ran for the vaccine as he had it again and after the vaccine it did help a lot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1458755
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/09/2021
Hospital:

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Lab Data:

Allergies:

Symptom List:

Symptoms: suspected vaccination failure; they still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a unspecified number of patients 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 he/she knew the patients received the dose of Shingles vaccine and they still got shingles. The reporter stated that shingles could not be prevented unless you are completely stress free 100 percent of the time. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1458758
Sex: F
Age:
State: AK

Vax Date:
Onset Date:
Rec V Date: 07/09/2021
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Symptoms: pregnant women patient recieved a shot of Infanrix; 25 year old / recieved a shot of Infanrix; received Infanrix instead of Boostrix; This prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a 25-year-old female patient who received DTPa (Infanrix) (batch number K92A4, expiry date 9th February 2021) for prophylaxis. On an unknown date, the patient received Infanrix. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Infanrix at an unknown time during the pregnancy. On an unknown date, unknown after receiving Infanrix, the patient experienced vaccine exposure during pregnancy and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown. The pregnancy was ongoing. Additional details were provided as follows: The age at vaccination was not reported. The pregnant patient recieved a shot of Infanrix instead of Boostrix, which led to vaccine exposure during pregnancy and inappropriate age at vaccine administration. The reporter consented to follow up. Doctor gave phone number office and personal cell phone. Upon internal review below correction is done on 14th September 2020: Additional narrative updated. Follow up information was received on 2nd July 2021: The additional event was added as wrong vaccine administered. The pregnancy outcome was updated as lost to follow up. No further information was reported.

Other Meds:

Current Illness:

ID: 1458759
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 07/09/2021
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Symptoms: 14 years old who received a shingrix dose.; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patientreceived dose of Shingrix at the age of 14 years old, which led to inappropriate age at vaccine administration. The pharmacist clarified that she was reporting the case, but the administration provides from a clinic. So, the health care professional did not have more information about the patient or the vaccine. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1458760
Sex: F
Age:
State: PA

Vax Date: 06/28/2021
Onset Date: 06/28/2021
Rec V Date: 07/09/2021
Hospital:

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Symptoms: patient received 3 doses; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date). On 28th June 2021, the patient received the 3rd dose of Shingrix. On 28th June 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, the patient received 3 doses of Shingrix, which led to extra dose administered. No further details were provided at the time of the call. The health care professional was in a hurry and did not provide any patient demographics, vaccine information or consent. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1458761
Sex: M
Age: 51
State: KS

Vax Date: 06/28/2021
Onset Date: 06/30/2021
Rec V Date: 07/09/2021
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Symptoms: Now has a localized injection site reaction; Now has / blurred vision in his right eye.; This case was reported by a physician via call center representative and described the occurrence of injection site reaction in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 28th June 2021, the patient received the 2nd dose of Shingrix. On 30th June 2021, 2 days after receiving Shingrix, the patient experienced injection site reaction and blurred vision. On an unknown date, the outcome of the injection site reaction and blurred vision were unknown. It was unknown if the reporter considered the injection site reaction and blurred vision to be related to Shingrix. Additional details were reported as follows: This case was reported by a physician. The physician reported that, the patient received his second dose of the Shingrix Vaccine. The patient experienced a localized injection site reaction and blurred vision in his right eye. The reporter does not know the lot number or expiration dat e of the vaccine the patient received. Did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1458763
Sex: F
Age:
State: LA

Vax Date:
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Rec V Date: 07/09/2021
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Symptoms: doctor wants a 32 year old patient to get Shingrix / doctor sent the prescription / to a pharmacy / pharmacy declined it. (No mention of patient being administered); This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 32-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown. Additional details were reported as follows: This case was reported by a pharmacist. Age at vaccination was not applicable. Pharmacist called in to inquire on information on Shingrix and under 50 years of age. Pharmacist reported a doctor wants a 32 year old patient to get Shingrix and also mentioned the doctor sent the prescription for Shingrix to a pharmacy and the pharmacy declined it. (No mention of patient being administered), which led to intercepted drug prescribing error. The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1458764
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/09/2021
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Symptoms: experienced vomiting after a dose; This case was reported by a other health professional via sales rep and described the occurrence of vomiting in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix and experienced vomiting. No additional information was provided. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1458765
Sex: F
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 07/09/2021
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Symptoms: Got / shot #1 / 16 months ago / appointment to receive / shot #2 / 01-Jul-2021 / pharmacist told / to start the series over; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose intramuscularly on upper arm 16 months ago.). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were reported as follows: The reporter was a patient. The age at vaccination was not applicable for this report. The reporter did not have a computer (no email). She did not have the exact date of the 1st dose of Shingrix vaccine administered. She did not have the lot number available. She provided the contact information of the pharmacy where the 1st shot was given. She had an appointment to receive Shingrix 2nd dose on 01st July 2021. She stated that pharmacist told her that since it has been 16 months, she had to start the series over. It was not confirmed, if the patient received 2nd dose till the time of reporting, which led to incomplete course of vaccination. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1458766
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/09/2021
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Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media platform via company representative concerned a 24 year old male patient. Initial information was processed along with the additional information received on 02-JUL-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) dose was not reported,1 total administered on an unspecified date in 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 after vaccination, the patient tested positive for the covid-19 virus (suspected covid-19 infection and suspected clinical vaccination failure). It was reported that the patient had a breakthrough and had experienced severe symptoms and also had the infection. The patient felt run down and had a worst cold. It was reported that patient got sick even though after stayed masked and vigilant. The patient was quarantined. 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). The case is associated with Product Quality Complaint number 90000184770. The suspected product quality complaint has been confirmed to be not void (meets PQC criteria) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210703179.; Sender's Comments: V0:20210703022 -Covid-19 vaccine ad26.cov2.-Suspected Clinical 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:

ID: 1458767
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 04/07/2021
Rec V Date: 07/09/2021
Hospital:

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Symptoms: OFF LABEL USE; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; This spontaneous report received from a pharmacist concerned a 17 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, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced off label use. On 07-APR-2021, the subject experienced inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate age at vaccine administration was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1458768
Sex: M
Age:
State: IL

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 07/09/2021
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Symptoms: VIAL INITIALLY PUNCTURED AND HAD BEEN MAINTAINED IN THE REFRIGERATOR FROM THE TIME OF INITIAL PUNCTURE; This spontaneous report received from a pharmacist concerned a 41 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, route of admin not reported, batch number: 1816022, expiry: 15-AUG-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced vial initially punctured and had been maintained in the refrigerator from the time of initial puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vial initially punctured and had been maintained in the refrigerator from the time of initial puncture was not reported. This report was non-serious. This case, from the same reporter is linked to 20210703146.

Other Meds:

Current Illness:

ID: 1458769
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 06/28/2021
Rec V Date: 07/09/2021
Hospital:

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Symptoms: BLURRED VISION; TOE CRAMPING; FACE BROKE OUT/PIMPLES; NIPPLE HYPERSENSITIVITY; JOINT PAIN; FLU LIKE SYMPTOM,FEVER,HEADACHE,CHILLS,FATIGUE; This spontaneous report received from a patient concerned a 50 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: 1808986, and expiry: 18-AUG-2021) dose was not reported, administered on 28-JUN-2021 09:30:00 for prophylactic vaccination. No concomitant medications were reported. On 28-JUN-2021, the subject experienced flu like symptom, fever, headache, chills, fatigue. On 28-JUN-2021, the subject experienced joint pain. On 29-JUN-2021, the subject experienced nipple hypersensitivity. Treatment medications included: paracetamol. On 30-JUN-2021, the subject experienced toe cramping. On 30-JUN-2021, the subject experienced face broke out/pimples. On 03-JUL-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from face broke out/pimples, and had not recovered from joint pain, flu like symptom, fever, headache, chills, fatigue, blurred vision, toe cramping, and nipple hypersensitivity. This report was non-serious.

Other Meds:

Current Illness:

ID: 1458770
Sex: U
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 07/09/2021
Hospital:

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Symptoms: PLAQUE FORMED AT THE INJECTION SITE; PSORIASIS OUTBREAK; 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 not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced plaque formed at the injection site, and psoriasis outbreak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the plaque formed at the injection site and psoriasis outbreak was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1458771
Sex: M
Age:
State: AZ

Vax Date:
Onset Date: 06/28/2021
Rec V Date: 07/09/2021
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Symptoms: UP EVERY 2 HOURS TO GO TO THE WASHROOM; PRESSURE UNDER THE SKIN; ARM HURT A LITTLE; This spontaneous report received from a patient concerned a 79 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included gout, blood pressure, and cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 22A21A, and expiry: UNKNOWN) dose was not reported, administered on 28-JUN-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 28-JUN-2021, the subject experienced pressure under the skin. On 28-JUN-2021, the subject experienced arm hurt a little. On 01-JUL-2021, the subject experienced up every 2 hours to go to the washroom. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pressure under the skin on 28-JUN-2021, and arm hurt a little on 29-JUN-2021, and had not recovered from up every 2 hours to go to the washroom. This report was non-serious.

Other Meds:

Current Illness: Blood pressure; Cholesterol; Gout (takes medicine)

ID: 1458772
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/26/2021
Rec V Date: 07/09/2021
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Symptoms: ANEMIA; EXCESSIVE HAIR LOSS; 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 no known history of 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: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 26-MAR-2021, the subject experienced anemia. On 26-MAR-2021, the subject experienced excessive hair loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anemia, and excessive hair loss. This report was non-serious.

Other Meds:

Current Illness:

ID: 1458773
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 06/24/2021
Rec V Date: 07/09/2021
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Symptoms: ITCHINESS; RED BUMPS ALL OVER BODY (ON CHEST, STOMACH, BACK, AND LEFT, RIGHT ARM/UNDERARM, WHICH VACCINE WAS ADMINISTERED); This spontaneous report received from a patient concerned a 34 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. Concomitant medications included terbinafine for drug used for unknown indication. On 24-JUN-2021, the subject experienced itchiness. On 24-JUN-2021, the subject experienced red bumps all over body (on chest, stomach, back, and left, right arm/underarm, which vaccine was administered). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchiness and red bumps all over body (on chest, stomach, back, and left, right arm/underarm, which vaccine was administered) was not reported. This report was non-serious.

Other Meds: TERBINAFINE

Current Illness:

ID: 1458774
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 07/02/2021
Rec V Date: 07/09/2021
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Symptom List:

Symptoms: SWOLLEN LEG; BRUISE GREEN PURPLE BRUISE, IT HURTS UPON TOUCHING, ON THE INNER THIGH , LEFT SIDE , BIG SIZE, ABOVE THE KNEE AND ALL THE WAY TO THE TOP; HEADACHE (BUT SHE THINKS IT WAS HANGOVER FROM LAST NIGHT'S DRINKS); FELL DOWN ON BACK NOT RELATED TO SIGHT OF PROBLEM; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known health issue, no known allergies and no drug abuse or illict drug usage, patient was not pregnant at the time of vaccination.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 07:00 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced fell down on back not related to sight of problem. On 03-JUL-2021, the subject experienced bruise green purple bruise, it hurts upon touching, on the inner thigh, left side, big size, above the knee and all the way to the top. On 03-JUL-2021, the subject experienced headache (but she thinks it was hangover from last night's drinks). On an unspecified date, the subject experienced swollen leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise green purple bruise, it hurts upon touching, on the inner thigh , left side , big size, above the knee and all the way to the top, and headache (but she thinks it was hangover from last night's drinks), and the outcome of swollen leg and fell down on back not related to sight of problem was not reported. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (Once a week); Non-smoker

ID: 1458775
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 06/28/2021
Rec V Date: 07/09/2021
Hospital:

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Symptom List:

Symptoms: MIGRAINE; NUMB TO FINGERS; ARM SWOLLEN; PRESSURE IN ARM/ARM TIGHTNESS; CHILLS; HEADACHE; FELT FEVERISH; INJECTION SITE TINGLING (DOWN THE ARMS TO THE FINGERS AND UP TO THE SHOULDER BLADE); FELT HOT; DIZZINESS; This spontaneous report received from a patient concerned a 32 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: Unk) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 28-JUN-2021, the subject experienced injection site tingling (down the arms to the fingers and up to the shoulder blade). On 28-JUN-2021, the subject experienced felt hot. On 28-JUN-2021, the subject experienced dizziness. On 28-JUN-2021, the subject experienced numb to fingers. On 28-JUN-2021, the subject experienced arm swollen. On 28-JUN-2021, the subject experienced pressure in arm/arm tightness. On 28-JUN-2021, the subject experienced chills. On 28-JUN-2021, the subject experienced headache. On 28-JUN-2021, the subject experienced felt feverish. On 29-JUN-2021, the subject experienced migraine. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt hot, dizziness, chills, and felt feverish on 30-JUN-2021, was recovering from headache, had not recovered from injection site tingling (down the arms to the fingers and up to the shoulder blade), pressure in arm/arm tightness, numb to fingers, and arm swollen, and the outcome of migraine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1458776
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 06/02/2021
Rec V Date: 07/09/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: ON AND OFF TINNITUS; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's past medical history included gall bladder surgery, and cataract extraction, and concurrent conditions included hypertension, general osteoarthritis, high cholesterol, osteopenia, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and 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, and batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced on and off tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from on and off tinnitus. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Generalized osteoarthritis; High cholesterol; Hypertension; Non-smoker; Osteopenia

ID: 1458777
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 03/29/2021
Rec V Date: 07/09/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: FELT KIND OF YUCKY; BURNED A LITTLE; MALAISE/DON'T FEEL GOOD; SORE ARM; FELT LIKE ALLERGIES; COLD; FATIGUE/TIRED/FEELING RUN DOWN; SHIVERING/CHILLS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hip and knee pain arthritis, and other pre-existing medical conditions included consumer took an antidepressant and blood pressure medicine and centrum multivitamin when she could afford it. The patient was previously treated with pneumococcal vaccine, influenza vaccine, and varicella zoster vaccine rge (cho) for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included naproxen for hip and left knee arthritis, and paracetamol for to prevent headaches. On 29-MAR-2021, the subject experienced shivering/chills. On 29-MAR-2021, the subject experienced fatigue/tired/feeling run down. On 30-MAR-2021, the subject experienced cold. On 30-MAR-2021, the subject experienced felt like allergies. On an unspecified date, the subject experienced felt kind of yucky, burned a little, malaise/don't feel good, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, felt kind of yucky, malaise/don't feel good, sore arm, shivering/chills, felt like allergies, and fatigue/tired/feeling run down, and the outcome of burned a little was not reported. This report was non-serious.

Other Meds: ACETAMINOPHEN; NAPROXEN

Current Illness: Arthritic pains

ID: 1458778
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/09/2021
Hospital:

Vax Type:
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Symptoms: SIDE EFFECTS; MAJOR HEADACHE; SOME FATIGUE; This spontaneous report received from a patient via a company representative concerned a 21 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: Unknown 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 side effects, major headache, and some fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side effects, major headache, and some fatigue. This report was non-serious.

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Current Illness:

ID: 1458779
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 07/06/2021
Rec V Date: 07/09/2021
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Symptoms: ITCHY, RED RASHES ALL OVER BODY INCLUDING LEGS, ARMS, STOMACH, CHEST AND BACK.; 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, and batch number were not reported) dose was not reported, administered on 29-JUN-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 06-JUL-2021, the subject experienced itchy, red rashes all over body including legs, arms, stomach, chest and back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy, red rashes all over body including legs, arms, stomach, chest and back. This report was non-serious.

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Current Illness:

ID: 1458780
Sex: M
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Rec V Date: 07/09/2021
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Symptoms: FELT KINDA SICK THE NEXT DAY; This spontaneous report received from a patient via a company representative concerned a male 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: 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 felt kinda sick the next day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt kinda sick the next day was not reported. This report was non-serious.

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Current Illness:

ID: 1458781
Sex: M
Age: 69
State: IN

Vax Date: 01/29/2021
Onset Date: 02/26/2021
Rec V Date: 07/09/2021
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Symptoms: leg pain; Body aches that went berserk; A lot of internal gas, was very flatulent, couldn't stop belching; A lot of internal gas, was very flatulent, couldn't stop belching; He hasn't been able to sleep through the night; almost paralyzed from the pain, he couldn't move; right hip pain; Thought that his diverticulitis was acting up; Started having back trouble: started as a lower back pain that increased to the point that it got to the right hip and all his right side; "acute" "severe"; immediately had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Thought that his diverticulitis was acting up), BACK PAIN (Started having back trouble: started as a lower back pain that increased to the point that it got to the right hip and all his right side; "acute" "severe"), PAIN IN EXTREMITY (leg pain), ARTHRALGIA (right hip pain) and MYALGIA (Body aches that went berserk) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Back disorder. Concurrent medical conditions included Diverticulitis. Concomitant products included DOXYCYCLINE for Diverticulitis. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (immediately had a sore arm). On 27-Feb-2021, the patient experienced DIVERTICULITIS (Thought that his diverticulitis was acting up) (seriousness criterion medically significant), BACK PAIN (Started having back trouble: started as a lower back pain that increased to the point that it got to the right hip and all his right side; "acute" "severe") (seriousness criterion medically significant), ARTHRALGIA (right hip pain) (seriousness criterion medically significant), ERUCTATION (A lot of internal gas, was very flatulent, couldn't stop belching), FLATULENCE (A lot of internal gas, was very flatulent, couldn't stop belching), INSOMNIA (He hasn't been able to sleep through the night) and MOBILITY DECREASED (almost paralyzed from the pain, he couldn't move). On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain) (seriousness criterion medically significant) and MYALGIA (Body aches that went berserk) (seriousness criterion medically significant). The patient was treated with TIZANIDINE at a dose of 1 dosage form; IBUPROFEN for Pain, at a dose of 1 dosage form and MENTHOL, METHYL SALICYLATE (SALONPAS [MENTHOL;METHYL SALICYLATE]) at a dose of 1 dosage form. At the time of the report, DIVERTICULITIS (Thought that his diverticulitis was acting up), MYALGIA (Body aches that went berserk), ERUCTATION (A lot of internal gas, was very flatulent, couldn't stop belching), FLATULENCE (A lot of internal gas, was very flatulent, couldn't stop belching), INSOMNIA (He hasn't been able to sleep through the night), MOBILITY DECREASED (almost paralyzed from the pain, he couldn't move) and VACCINATION SITE PAIN (immediately had a sore arm) outcome was unknown and BACK PAIN (Started having back trouble: started as a lower back pain that increased to the point that it got to the right hip and all his right side; "acute" "severe"), PAIN IN EXTREMITY (leg pain) and ARTHRALGIA (right hip pain) had not resolved. Patient reported that his blood type 0+ and he considered him self to have a really good immune system. Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. events arthralgia, myalgia and back pain are consider serious as per medical judgement based on duration and refractory to treatment. This case was linked to MOD-2021-248408 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up information received on 04 MAY 2021, added treatment medication, updated patient demographics and reporter email id. On 05-Jul-2021: Follow-up information received on 05 JUL 2021, added new event leg pain and changed outcome to not resolved for event back pain and hip pain.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. events arthralgia, myalgia and back pain are consider serious as per medical judgement based on duration and refractory to treatment.

Other Meds: DOXYCYCLINE

Current Illness: Diverticulitis

Total 2021 VAERS Injuries: 679,999

Page last modified: 03 October 2021 5:28pm