chrisvoncsefalvay/vaers-outcomes huggingface dataset:
As of 8am on Thursday, December 16, 2010, the child still is running a high fever. This has been continuous since the onset of symptoms on the date of vaccination. We do not know yet if there will be any other adverse events related to this episode. If so, we will complete a seperate report. Infant Ibuprofen was administered on Tuesday evening, 12/14/10 to bring down fever, which was 103.5 at the time. Further doses of infant Ibuprofen have been administered on the morning of 12/15/10 around 9am, and approximately every 4 hours since, except that he slept through the night and this morning, on 12/16/10 he received 3/4 tsp of Children's Acetaminophen instead. The temperature this morning was still over 102.2. We are concerned that the fever may continue for several more days and does not seem to be going away. In the past, he has never had a fever more more than a few hours. There was no underlying illness at the time of vaccination.
Blisters in mouth; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 05Mar2021 22:45 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ORAL MUCOSAL BLISTERING (non-serious) with onset 19Mar2021 09:30, outcome "not recovered", described as "Blisters in mouth"; HEADACHE (non-serious) with onset 19Mar2021 09:30, outcome "unknown", described as "headache". Therapeutic measures were taken as a result of oral mucosal blistering. Therapeutic measures were not taken as a result of headache. Additional information: The patient was wondering if the mouth blisters could be a side effect. She never had it before. Treatment received for mouth blisters included Tylenol. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reported dizziness and irregular heartbeat. at 1339.Patient put in anti-gravity chair and given orange juice.  Pt vitals assessed: BP  130 mmHg, HR 122 beats/min, SpO2 100%. Patient's extremities were cold upon palpation.  patient appeared dazed but was AxO x 4 and able to follow commands. Pt reported similar episode due to irregular heartbeat. Pt reported no pain, throat irritation, chest tightness, and itchiness.  Patient offered EMS--pt declined. Patient reassessed in 5 minutes at approx. 1334. Patient reported throat tightness and chest tightness. patient started trembling throughout the body. Pt revealed history of prior hospitalization due to left-sided paralysis. BP 140/80 mmH, HR  fluctuating 85-100 beats/minute, and RR 17 breaths/minute. EMS activated. Paramedics arrive at 1411 and assume care. Pt transported to hospital for further care.
Reported feeling like he was about to pass out-usually reacts this way to needles. Brought to Med. screening for observation and no interventions. Left in stable condition at 14:14 p.m. Recorded RN.
pt was given MMR on 15JUL93 side effects of vax was explained to pt & pt was told that shouldn't get preg x 3 mons; pt called on 10AUG93 & stated was preg; 16AUG93 pt stated planned to terminate pregnancy because of plans of school;
Itchy raised red legions on chest and lower neck, left arm at injection site and above, and one on right hand at base of thumb.  Bright pink in color, edges not well defined, some small bumps inside rash, itchy.  Seven spots total.
Patient's right arm became progressively more painful after vaccination with FLUZONE HIGH DOSE. Says it is increasingly harder to use/lift her arm due to shoulder and muscle pain. She has sought treatment from her PCP.
pt claims devel tender reddened area rt deltoid (just 2 days p/receiving vax in the same site); denies fever, but c/o persistent pain in extremity;
This spontaneous report was received from a physician referring to 9-week-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 10-JUL-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # N000235, expiration date 26-OCT-2019; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 21-JUN-2017 till 01-AUG-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 49 F for the period of up to 46 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Neuropathy from a surgery has resulted in pain" (unspecified if ongoing); "poor sleep" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Neuropathy from a surgery has resulted in pain" (not ongoing); "Neuropathy from a surgery has resulted in pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment as Paxlovid with start date 23Apr2023 and stop date 27Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300208177 same patient, different product/event;
During injection it felt as if my shoulder needed to pop very badly. It felt like I was injected in my joint, not my muscle. Hours later, I could only move my arm a few inches in either direction.  Extreme pain if I try to lift my arm or use great strength from shoulder.  I couldn't undress myself, I couldn't do my hair, and now I will probably lose my job, because my job involves lifting children all day long.
Pt had Pfizer vaccine yesterday. Has severe lymphadenopathy, nausea, SOB, and dizziness. Pt is unsure if this is worse than her baseline issues
My side effects were pain under my left arm where I had gotten inflammation. The pain comes and goes. I had a mammogram on 10/26/2021, and then the doctor called me and told me that one of lymph nodes was swollen. Then I had a biopsy on December 9, 2021. I was diagnosed with breast cancer. I still have pain in my arm, but it doesn't last all day.
UNEXPECTED THERAPEUTIC BENEFIT; 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 past medical history included neural hearing loss.  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. No concomitant medications were reported.  The batch number was not reported. Per procedure, no follow-up will be requested for this case On an unspecified date, the subject experienced hearing restored in right ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hearing restored in right ear was unknown. This report was non-serious.
Pt received ENGERIX 2/24/17 - 40mcg IM (L) upper arm - stated experienced  fever, weakness and nausea at home poste vaccine.
Seizure; This is a spontaneous report from a contactable physician (pediatrician) via a Pfizer-sponsored program. A 12-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) as single dose for immunization; influenza vaccine (reported as flu shot) via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) at unknown dosing regimen for an unspecified indication. The patient's medical history and concomitant medications were not reported. Patient came in for annual flu shot and was behind on several of his shots. The patient received pneumococcal 13-val conj vac (dipht crm197 protein) along with the flu shot. He experienced a seizure (at home). The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: There is a reasonable possibility that the event seizure was related to PREVENAR 13 based on known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient received flu shot and was seated in chair waiting on grandmother who was in line. Passing customer stated the patient was having a seizure. When I saw patient she was not seizing but looked like she was going to pass out. This was approximately 5 minutes after the injection. We lowered patient to the floor and called EMS. Patient was lucid, communicated well, no additional signs of seizure. EMS arrived and loaded patient into ambulance.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were administered improperly stored ROTATEQ (lot # L038536, expiry date 19-AUG-2017, dose not reported), orally. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
I received my second dose on 3/30/21 around noon and was sick for a day (which I had expected) then recovered. I developed a rash on my stomach on 4/15/20, which I thought were bed bug bites. I put liquid benadryl on the spots and they dried up quickly.  On 4/21/21 I went to urgent care because it started to feel painful (not so much itchy anymore) and I suspected it was shingles. Upon confirmation, I was diagnosed with shingles. She prescribed me a week?s worth of prednisone and gabapentin, which I have just began to take as of 4/22/21. I wanted to mention that I?m fine, it could have been much worse and I?d rather have shingles than covid anyday. I just was told to report the adverse effects. Thank you!
arm hurts; feels achy; nauseous; This case was reported by a consumer and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th December 2020, the patient received the 1st dose of Shingrix. On 10th December 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, pain and nausea. On an unknown date, the outcome of the pain in arm, pain and nausea were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, pain and nausea to be related to Shingrix.  Additional details were reported as follows: The patient was nauseous, feels achy and her arm hurts. The reporter did not consented to follow up.
Only given the liquid portion; Only given the liquid portion; This case was reported by a other health professional via interactive digital media and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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 Information: GSK Receipt Date: 08 NOV 2022 Reporter's Comment: This case was reported via interactive digital media. The reporter had Shingrix at office, then was realized that patient was only given the liquid portion of vaccine. The reporter wanted to know that could they give the correct dose now or if there was something, they need to do different. Additional supportive information: The patient received only liquid portion of vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
8 days after I received the shot, my arm starting itching, have a little bit of tenderness, red, & swelling at the injection site.
Feb-28 Felt like coming down with a cold a few hours of receiving the first shot. March 1- injection site felt slightly itchy  March 4- armpit (injection site arm) felt sore and swollen  March- 7 body aches, headache- symptoms of getting a cold March 8- itchy hive on the arm that was injected with Moderna . Armpit still feels swollen.
12 days following my second Covid19 vaccine I developed severe pain in both of my wrists and shoulders.  Soon after, pain manifested  in both hips.  So I had pain in six joints in my body that I'd never before experienced.  The pain grew more severe over the next two weeks, to the point I felt like I wanted to naw the hands off my wrists.  I had trouble walking and getting in and out of bed and chairs.  Only with some creative help (using a back scratcher to pull my clothes on) did I manage to get myself dressed each day.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age from which their concurrent condition, medical history or concomitant medications were unknown. On an unknown date, the patients were vaccinated with VARIVAX (Merck) 0.5 ml once subcutaneously doses (unspecified in series) (lot no: K008824 with expiration date: 19-JUN-2016), the reporter also stated that the aforementioned vaccine was inappropriately stored. At the time of this report, no adverse events were reported and the outcome of the patients was unknown. The physician also reported that another unspecified number of patients were vaccinated with inappropriately stored PROQUAD (Merck) and M-M-R II (please refer to MARRS No. 1504USA005042 and MARRS No. 1504USA005043). The physician reported that the earliest dose administered was on 21-FEB-2014, however it was unknown which vaccine was administered in this date. Additional information has been requested.
At the time of the shot I felt the stuff going into my system and all the way down my whole right side all the way down to my right leg.  It wasn?t painful or anything I was just aware that something was just injected into my body.  About an hour after my injection I had a pain go into my hand a few times and I had to keep moving it around to make it go away which it did.  That night had neck pain.  That night I woke up to a pain in my right calf muscle and I thought I was going to get a Charlie horse so I got up and walked it off. It never got as bad as a Charlie horse.  So I went to sleep and not much longer I woke up to the same thing in my left calf muscle. So I got up and walked around. Next morning Same thing happened. So I called the place I got the shot and they suggested taking magnesium pills and electrolytes as well as did my Dr Office.  So I did that. Two days later I was feeling a pain in my left back shoulder blade.  It eventually went away. I was worried about blood clots, but idk what caused this?  Had diarrhea for a few days. And sweats the next morning.  I?m day 5 into the first shot of Pfizer right now. I?m worried if I should get the second shot because of the leg cramping.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding patients' medical history or concurrent conditions was provided. On unknown dates in May 2016, reported as starting on or after 05-MAY-2016, the patients were orally vaccinated with improperly stored doses of ROTATEQ oral liquid (dose, lot # and expiry date were not reported). There were no concomitant therapies reported. The call was made because of a data logger. The reporter stated that the doses of the vaccine were exposed to a temperature of 1.4 degrees Celsius for a time frame of 138 hours. The vaccine was not exposed to any previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax; became irritable, fussy, inconsolable crying & low grade fever; to er; MD felt it was rxn to MMR;
This case was reported by a nurse via call center representative and described the occurrence of abdominal pain in a 28-year-old female patient who received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced abdominal pain and vomiting. On an unknown date, the outcome of the abdominal pain and vomiting were recovered/resolved. It was unknown if the reporter considered the abdominal pain and vomiting to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not associated with a QA complaint. The registered nurse (RN) reported that the patient (an employee) had an adverse event to last year's FLUARIX QUADRIVALENT. The patient claimed that she had abdominal pain and vomiting for 3 months after vaccination. The nurse reported that the patient did not want to received FLUARIX vaccine of the reporting year due to her last year's reaction. The reported batch number (32TN) of FLUARIX QUADRIVALENT did not exist and was updated to 329TN as per sales database).
Information has been received from a physician concerning a 56 year old female who on 10-SEP-2010 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 663888/0627Y, exp date 10-OCT-2010). The physician reported that on 10-SEP-2010, the patient experienced that the effected arm had multiple raise areas, fever, body ache, skin hurts and she felt like she had the flu. On an unspecified date, the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Mother reported child had been crawling and pulling to stand for several weeks. Mother noticed in the evening of 7/25/2022 about 6 hours after vaccination child's mobility changed: crawled a few feet then just stopped crawling, flopped, spread her arms and legs out across the floor. She became inactive for a minute; then continued crawling, pulled to stand and then bear weight. Mother reported no fever no signs of discomfort but is concerned about possible neurological problems in her otherwise healthy child. Mother reports normal growth and development. Family is new to the area. They have an established MD. Will follow-up with an appointment 7/28/2022.
RIGHT CALF SLIGHTLY BIGGER THAN LEFT; PAIN IN RIGHT LEG; HEADACHES ON AND OFF; This spontaneous report received from a patient 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, and batch number were not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced right calf slightly bigger than left. On APR-2021, the subject experienced pain in right leg. On APR-2021, the subject experienced headaches on and off. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pain in right leg, and headaches on and off, and the outcome of right calf slightly bigger than left was not reported. This report was non-serious.
Came to ER c/o sick about 1 week with cough, sneezing, sob, and chest tightness. Now c/o weakness in legs, feet numb and tingly.  Neck, mouth and tongue have become numb. Having a little trouble swallowing and unable to cough as hard as he usually can.  Claims inability to walk.  Transferred from Medical Center to Hospital with dx. probable Guillain-Barre syndrome.
Caller reported patient received first dose of Shingrix in 2020 and has not yet received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Caller reported patient received first dose of Shingrix in 2020 and has not yet received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-May-2023 and 31-May-2023 The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination
Moderna Bivalent Booster 0.25mcg was given to patient which is the wrong dose.  Patient was to receive 0.5mcg.