chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe Ankylosing Spondylitis flare: inflammation of sacroiliac (SI) joint evidenced by stiffness and pain. I was unable to bend or walk. After 5 days, of this reaction with no lessening, I received a steroid (depro?) 40mg intramuscular shot and symptoms lessened gradually.   There was also the expected fever, fatigue, and sore injection site
Patient mentions that it gave him a headache, vaccination site on left arm is red and swollen. Patient presents a lesion on the left side of the back that appears to be like a papule that is painful to the touch and there is redness.
Patient claimed the next day her arm because black and blue at site of PREVNAR-13. Six days after she claims the site became red, warm and visible red spots. I advised patient to see her primary. Her primary administered an antihistamine shot at the office.
I went in for a seasonal influenza vaccine at my doctor's office on 9/10/22 at about 11:00 am  (I do not know the exact name of the vaccine but the information sheet they handed me said "Influenza (Flu) Vaccine (Inactivated or Recombinant)".  At about 6:00 pm that same day, I looked into the mirror and noticed that my eyes were very red.  I recalled that it happened the last time I had a seasonal flu vaccine.  My eyes did not feel irritated and it did not affect my vision - it's just that the whites of my eyes became extremely red.  The redness gradually wore off over the following day and my eyes returned to normal by 9/12/22.
pt recvd vax & devel mumps left side; swelling of parotid w/ pain & tenderness; otitis external & enlarged tonails;
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications. On an unspecified date in April 2016, at age 11 years old, the patient was vaccinated with first dose of GARDASIL injection, lot number K016966 with expiration date on 10-MAY-2017 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. On 22-JUN-2018, the patient was vaccinated with first dose of GARDASIL 9 injection, lot number N025428 with expiration date on 19-JUN-2020 (strength, dose, route of administration and anatomical location were not reported) as the second dose of Human papillomavirus (HPV) vaccine, for prophylaxis. No adverse effect were reported.
Low-grade fever for 3 days, extreme fatigue, I could not stay awake the whole day and slept 2-4 hours extra. I also had a painful swollen lymph node for 5 days under my right armpit.
Still caught COVID-19; Still caught COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Still caught COVID-19".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Shot administered upper Left arm. Soreness in bicep area started with reddening of skin. I worried I was getting a Cellulitis. Treated topically with Neosporin until I got MD appt. By Wednesday morning area subsided. Area was as big as my Right hand covering my arm to inner aspect about 4 inches from injection site.
pt recieved a tdap on 7/17/23 and on 10/30/23  no harm done to pt
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 80-year-old male patient who received SHINGRIX for prophylaxis. On 19th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th March 2019, 1 days after receiving SHINGRIX, the patient experienced shingles, erythema and blister. On an unknown date, the outcome of the shingles, erythema and blister were unknown. It was unknown if the reporter considered the shingles, erythema and blister to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife, along with the patient was on the line. The patient received a dose of SHINGRIX on the right arm. The patient noticed that, a quarter inch to one inch red line behind his groin area. The next day it broke out with blisters and a new red line appeared on the right back near the waist line. The next day the red line on his back broke out with blisters. The patient went to see his physician on Friday and his physician told that it looks like Shingles. At the time of reporting, there were two more red lines appeared, one next to groin and one his back. The redness had gotten more red since the first time the red line appeared. The patient also casually mentioned that, the patient had read online where people were experiencing similar side effects as his and they were worse with the second dose. The patient did not provide any specific details. No further details were provided. The reporter did not consent to follow up.
Chills, fever, fatigue the day following vaccination. Took ibuprofen and paracetamol. Upon waking up the following night, feeling of narrowing of senses, feeling of not having complete senses and control. Following day - spatial orientation "errors": missing targets, increased clumsiness. For example: banging a tray in the wall - miscalculated the distance needed when moving the item. Brought cup to drink and hit my teeth.. Symptoms tapered off over the span of a few days. Still feeling fatigue more than usual, 12 days post second dose.
due to test showing low to no titers; received 2nd dose on 28 Feb 2023 and 3rd dose in 5/1/2023; received 1st dose in Aug 2022 and 2nd in Feb 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 52-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) (batch number NT9X3, expiry date 09-SEP-2024) for prophylaxis and HBV (Engerix B adult) (batch number NT9X3, expiry date 09-SEP-2024) for prophylaxis.   On 01-MAY-2023, the patient received the 3rd dose of Engerix B adult. On 28-FEB-2023, the patient received the 2nd dose of Engerix B adult. In AUG-2022, the patient received the 1st dose of Engerix B adult. On 28-FEB-2023, not applicable after receiving Engerix B adult and Engerix B adult and an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too long (Verbatim: received 1st dose in Aug 2022 and 2nd in Feb 2023). On 01-MAY-2023, the patient experienced drug dose administration interval too short (Verbatim: received 2nd dose on 28 Feb 2023 and 3rd dose in 5/1/2023). On an unknown date, the patient experienced therapy non-responder (Verbatim: due to test showing low to no titers).  The outcome of the therapy non-responder, drug dose administration interval too long and drug dose administration interval too short were unknown.   Additional Information: GSK Receipt date: 09-OCT-2023 A pharmacist reported a patient was there to receive a dose of Engerix.  RPH explained that last year the patient received 2 shots (separate not same day) of Engerix around August 2022 (RPH was unaware of these), then one dose on 28 February 2023, and another Engerix on 01 May 2023.  HCP mentioned the patient stated they changed jobs and the job was requiring restart series due to test showing low to no titers.  Patient came in today for potentially another dose of Engerix. What to do. The patient received 2nd dose of Engerix later than the recommended interval, which led to lengthening of the vaccine schedule. The patient received 3rd dose of Engerix shorter than the recommended interval, which led to shortening the vaccine schedule. The reporter did not consent to follow-up.
Severe abdominal cramping & pain that worsened so much from 9pm to midnight that I had to go to the local ER and receive IV medication.  After I received one dose of IV Zofran and one dose of IV Toradol the pain decreased to a manageable level and I was able to be discharged.
Rash on my back and my stomach; This spontaneous case was reported by a consumer and describes the occurrence of rash in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No medical history information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on my back and on my stomach). At the time of the report, RASH (Rash on my back and on my stomach) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I received my second dose of Moderna in the late morning of February 26, 2021. I felt fine while at want as well as driving home.  Within a few hours of getting home I had the sensation that my eyes were swollen and took my contact lenses off.  When I looked in the mirror I could not see signs of swelling.  Within 24 hours I felt pressure across the forehead and face.  Within 36 hours after vaccination I had a severe headache.  I was extremely light and sound sensitive. The area where I had received the shot had a very large round shaped red circle that was warm to the touch.    I was treated for a sinus infection at first with Ceftin.  The headache persisted. Took Motrin.  Headache persisted. I was then treated for migraine.  butalb-acetaminphen- caffeine (no codeine).  Excedrin migraine. Headache persisted. Then given Prednisone, which gave me some relief. Headache, sound sensitivity , burning around lower eyelids persisted. Neck discomfort and ear fullness. Seen by Neurologist who said he believed I had a reaction to the second dose of the Moderna Covid vaccine. resulting in a severe holistic headache.  He believed this may have been aseptic meningitis.  He believed the steroids which I was given would be effective without further intervention.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster) , single (Lot number: FF2590) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: AMPHETAMINE SALTS. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), all with latency 6 days after the suspect product(s) administration, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.No known allergies. other medication in 2weeks product Amphetamine Salts 20 mg. Initially she began to feel 1000% better in about a day and a half. It took away my breathing issues and my coughing. After I finished the five days dosage, the next day I came down with fatigue, fever, chills/sweats, and headache form two days. She did not have any of these symptoms before. Then about 3 days after completing the meds I began to recover again. Treatment included Paxlovid from 19Apr2022 to 23Apr2022 for treatment of covid-19.
I gave adjuvant and didn't mix shingrix; I gave adjuvant and didn't mix shingrix; This case was reported by a pharmacist and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) (batch number ASKU, expiry date unknown) for prophylaxis.   On 29th April 2021, the patient received Shingrix. On 29th April 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient age group was not  reported however captured as adult as per vaccine indication. The age at vaccination was not reported.  The pharmacist given adjuvant to the patient without mixing, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consented to follow-up. The pharmacist abruptly discontinued webchat prior to provided an details regarding patient, Shingrix lot number and expiration date or administration date.  No additional details were available. The pharmacist was called and left a message for him to call back.; Reporter's Comments: Pharmacist reports I gave adjuvant and didn't mix shingrix. Did not consent to follow-up. Call Notes:Pharmacist abruptly discontinued webchat prior to provided an details regarding patient, Shingrix lot# and expiration date or administration date. No additional details available. Called pharmacist and left a message for him to call back
I received my 4th dose of Moderna COVIFD-19 vaccine  on 04/06/2022. My COVID-19 symptoms started on 07/25/2022 in the morning around 08:00AM. I had fever, body aches,  chills,  and loss of appetite.  I called the clinic the day I tested positive for COVID-19 which was on July 25. They told me since I had no long standing health conditions I wasn't qualified for any medications. I called back again to the same clinic on 07/30/2022 since my symptoms got worst. They  prescribed me  with Paxlovid for 5 days.  On July 30th   after COVID-19 infection I got lesions on my scalp. It was burring and itchy. I went to the urgent care they thought it was shingles or ring worms. They didn't  do anything to verify it.  They prescribed Anti fungal medications for my scalp. It didn't help at all. On December I called the Clinic  back again and they prescribed me with  2 weeks of Antibiotics.  On 12/28/2022 they prescribed me with Temovate Cream 2 times daily external solution for my scalp. I am still using it.  From September- November I was experiencing brain fog so I went to my Homeopathic doctor on 11/10/2022. She prescribed me Catclaw, Feverfew,  and Ginkgo Biloba. This really helped to clear the brain fog.
developed tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 09:00 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 16Mar2021 16:00, outcome "not recovered", described as "developed tinnitus".  Additional information: The caller reported, that was really bad for 1-2 days then subsided nothing that it was still at a persistent level as they spoke. The caller asked, had tinnitus been reported and was Pfizer recommended a treatment for it. Stated that, he had talked to other people in conversations and they said that, some people get tinnitus from the vaccine. Stated that, upon calling back, caller stated he had seen three HCP for the tinnitus. The caller reported the AE and stated that, he reported the date of his first dose and reported that he has not had his second dose yet. Enquired, the caller asked, what percentage of protection did he had from the first vaccine. The caller asked, how long did the antibodies continue to show up. What are the 6 months topline analysis results of the Pfizer-BioNTech COVID-19 Vaccine. Enquired that, the caller asked, whether he was still showing antibodies, could he donate plasma to himself instead of getting a second shot. The caller asked that, could he forget about the second shot altogether and just get the third shot. Also, the caller asked, when was the third shot coming out. Stated that, he was past 21 days and asked how much further out he could still get it. Caller stated that, the 6 week mark was tomorrow. The caller asked, could he go 3 to 4 months.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
was in the hospital with them & had the shots yrs earlier/ Suspected vaccination failure; was in the hospital for 2 weeks with them; This case was reported by a consumer via interactive digital media and described the occurrence of 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, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant) and shingles (serious criteria hospitalization). 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 Information: GSK Receipt Date: 01-Nov-2022  Reporter's Comment: This case was reported by a patient's cousin via interactive digital media. The reporter stated that getting vaccine dose did not mean that you would not get them. But if you dose did it then it would be not be as bad. The patient was in hospital for 2 weeks with shingles and the patient had the Shingles shoots shots 2 years earlier. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule,and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 03-APR-2014 the patient was vaccinated with the second dose of MMR II lot # 0496AE (route and dose not provided), which had expired on 07-MAR-2014. Nurse stated the product had not had any previous temperature excursions. No adverse symptoms were reported. Additional information has been requested.
1 WEEK POST VACCINATION WITH NEW ONSET LOSS OF TASTE.  COVID PCR TESTS X2 ARE NEGATIVE.
scleral injection of one eye morning after vaccination, following day bilateral injection but slowly improving throughout the day
This spontaneous report was received from a  licensed practical nurse and refers to multiple patient of unknown age and gender. Information regarding medical history and concurrent conditions were not provided. The licensed practical nurse noted that on multiple unspecified dates, patients were vaccinated with improperly stored vaccine (temperature of 62.2 F, time frame of 3.75 hours) of ROTATEQ, orally, lot # L023870 with expiration date 20-APR-2017 and lot # L035511 with expiration date 21-MAY-2017, orally(dose was not reported). No known adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
on date of admission, patient awakened very short of breath, found to be hypoxemic and intubated for respiratory failure.  Since 9/8 patient has remained severely hypoxemic and intubated.  She was discovered to have an acute cardiomyopathy, EF 10%.  A CT angio of the chest on admission showed extensive b/l infiltrates, some ground glass, scattered nodules, adenopathy and no pulmonary embolism.  An infectious or inflammatory source has not been identified.  Condition has not responded to steroids, antibiotics or diuresis.  She does not have active covid-19 infection either
Nausea that has lasted for at least 7 days.  I am still experiencing it.  So, it may go on even longer.
Pt had pain at site of injection 3-4 hrs after administration. Then noticed redness from site (deltoid) to elbow 2 days prior to injection. Has been taking ibuprofen & was instructed to use cold compresses.
Redness at site of injection, pain at site of injection, fever/chills, joint aches
before he has asthma but after taking the second dose he is virtually asthma-free.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 66-year-old male patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: He was asthmatic before. Concomitant medication(s) included: XOLAIR taken for asthma. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 06Feb2021, for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Feb2021, outcome "unknown", described as "before he has asthma but after taking the second dose he is virtually asthma-free.".   Additional Information: Caller's concern: Caller wants Pfizer to know that he extremely got a successful side effect for the Pfizer covid vaccine. He mentioned that he already took, first, second, and booster doses for the vaccine and before he has asthma but after taking the second dose he is virtually asthma-free. Resolution: Gathered information (name, phone number and zip code). Advised that I will transfer the call to Pfizer. Verbatim and Event Description: Suspect Product(s): Pfizer COVID-19 Vaccine: Start Date: 06Feb2021, Stop Date: 27Feb2021. Caller called in because he wants to share his good experience after taking the 2nd dose of Pfizer Covid-19 vaccine. He mentioned that he already got the 1st, 2nd and booster dose. The 1st shot was taken on 06Feb2021, the 2nd dose on 27Feb2021 and the booster shot on 18Aug2021. He asked if he could take the fourth shot. He was asthmatic before but after taking the 2nd dose he is already asthma free. He has taken Xolair before but now there is no need for him to take it that often. He also mentioned that he had a sore arm but only for a couple of hours. He mentioned that he is a Pfizer fan. Resolution: Gathered caller's concern. Gathered caller's demographics. Isi not read, caller mentioned he only got 3 minutes left on the phone. PMI number and hoo not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 12JAN99 & 5hr post vax pt exp T102, achiness, cough & chills;no tx given;
On 4/06/2021, Pt received 1st dose Moderna vaccine in L deltoid at 3:20pm. Approx 3:25pm, pt c/o central chest pain rating pain 5 on a 1-10 pain scale. No SOB noted. Pt denied any SOB . Stated has history of allergies to 3 medications history of 3 stent placements in past. Nurse and ambulance personnel on site. VS obtained B/P 144/86, HR 64,  02AT 100% Benadryl 25mg  PO administered per nurse pt observed. Refused ambulance transport to ER stated chest pain had subsided left side.