chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two day history of red itchy rash that began on left arm, spread to right arm and today was in upper thighs. Difficulty sleeping secondary to the pruritic nature of the rash. Came into office 7/28/17 and found to have diffuse macular papular rash on erythematous base on bilateral upper extremities and upper thighs. Treated with Benadryl and Medrol dose pak.
subjective fever, chills, nausea, vomiting, myalgias, generalized abdominal soreness. May just be side effects to her booster shot.  She also states she had urticaria 1-2 days after her second dose of moderna .
redness at injection site; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Two months ago, from the date of reporting, the patient received 1st dose on left arm and experienced redness and swelling at injection site. The patient's date of birth was not obtained during the call. The reporter consented to follow up. For tolerance to the 2nd dose of Shingrix refer case US2019GSK080183, reported by same reporter.
patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case contains information for the 19th of 19 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941, US-MODERNATX, INC.-MOD-2023-706966 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:Patient 1 of 19 US-MODERNATX, INC.-MOD-2023-706966:Patient 19 of 19
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Severe.
Hospital Course and Significant Findings: PMH sig for OSA / CPAP, CAD, DM2, Gout, HTN.   Pt presents to the ED c/o fever and muscle aches since last pm. Has head congestion beginning this am. No cough. No SOB. Pt scraped his LLE a few days ago while cutting wood and thinks it's infected. Pt found to have Hypotension & AKI d/t dehydration. Also found to have COVID and LLE Cellulitis
Inappropriate Reconstitution Technique; Inappropriate Reconstitution Technique; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 13 Oct 2023 The Pharmacist stated that Arexvy diluent only given to patient. The patient returned to receive a complete dose of Arexvy and was administered a complete dose.  The reporter wanted to know what to the patient should expect after receiving 2 diluents. HCP didn't give permission for Safety follow-up and didn't provide additional details of when Arexvy diluent was administered or the complete dose of Arexvy vaccine was administered to the patient. The patient received Arexvy diluent only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Rapid heart beat,chest pressure, jittery, nausea,neuro problems. Skin sensitivity, internal/external trembling. Uncontrollable movements. Weak. Lasting over 24 hrs.
Mild symptoms of chicken pox, assessed by clinic one day after spots developed. Pt. displayed 4 small red fuid filled spots without signs of puss or scabing development. Pt. presented low grade temperature.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 19-APR-2016, the patient was vaccinated with VATQA "10Pk 25U/0.5 ml SD LLok w Cap Ped", lot # L030442 with expiration date 19-DEC-2016, which was stored at 1.11 Celsius Degrees for 240 hours. The type of excursion was refrigerator and the vaccine status was reported as "in excursion". There were no concomitant medications and adverse effects reported. No product quality complain was involved. This is one of several cases from the same reporter. Additional information has been requested.
Injection given - 10/22/14. Developed erythema/hematoma around injection site -10/24/14. Developed erythema and pruritus around left eye 10/25/14.
pt recvd vax;szs,infantile spasms; tegretol given,stopped no effect;staring episodes w/ eyes rolling up in head,starting dec94 earlier;
Patient had a 1 minute grand mal seizure while at the lake with a relative. Was evaluated in a local ER and later released. No history of any previous seizures.
16DEC93 approx 230PM pt became cranky, lips grey, breathing was rapid, eyes rolled back; babysitter shook pt gently & pt was OK; mom called pvt MD, who felt it not necessary to see child; low grade temp;
Pt is traveling in March and wanted to get imms. Pt prescribed oral typhoid since she would be traveling overseas several times over the next few years. Pt took first dose of live virus capsule at 11 am and at 3pm her face started to swell and she had trouble breathing and swallowing. She called the pharmacy and the pharmacist told her to take BENADRYL. If it didn't resolve or got worse she was to go to the ED. It resolved but came back at 11pm. She took BENADRYL again and it resolved. Pt has had injection for previous travel out of the country without a reaction. She went to travel clinic on 1/2/2019 and received injection of typhoid and did not have a reaction.
Uncontrollable diarrhea... did not make it to a restroom.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly male patient received bnt162b2 (BNT162B2, Solution for injection), administration date 31Mar2021 09:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 31Mar2021 10:00, outcome "unknown", described as "Uncontrollable diarrhea... did not make it to a restroom.". Therapeutic measures were not taken as a result of diarrhea.  Additional information: Reporter stated, I became aware of the event on the same day it was reported. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and unknown if the patient was tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After receiving the vaccine, my eyes got severely dry to the point I had to use drops.  They felt like sand was blown in them.
Fever, chills, body aches, sore throat, lymph node swelling in left neck, decreased hearing in left ear, weakness
Information has been received from a licensed practical nurse (L.P.N.) concerning an 18 year old female, who approximately 30-SEP-2008, was vaccinated with a third dose of GARDASIL (lot# was not reported). 24 hours after vaccination, the patient experienced abdominal cramping, which was not recovered at the of reporting. Nurse and physician do not think abdominal cramp is vaccine related. An office visit is scheduled. Additional information has been requested. Follow-up information was scheduled. Follow-up information was received from a licensed practial nurse (L.P.N). The patient experienced cramping on 7-OCT-2008 and her outcome was unknown. Follow-up information was received from the licensed practial nurse (L.PN.). The patient exerienced cramping on 7-OCT-2008 and her outcome was unknown. Follow-up information was received from the licensed practial nurse (L.PN.). It was reported that the patient was a female stundent with no more problems at time of vaccination who was vaccinated IM into arm with a first and second dose of GARDASIL (lot #661046/0381X) on 18-MAR-2008 and 30-SEP-2008, respectively. Subsequently, the patient experienced abdominal cramping on 30-SEP-2008. The patient recovered on an unspecified date. Follow-up information was received from the licensed practial nurse (L.P.N).  It was reported that the patient was vaccinated with a first, second and third dose of GARDASIL. (lot #661046/0381X for P1 and P3. lot #unknown for P2) on 18-MAR-2008. 01-JUL-2008 and 30-SEP-2008 and 7-OCT-2008. Reporter stated that the patient was never hospitalized and now considered fully recovered. No further information is available.
Body aches; fever; chills; headache; This is a spontaneous report from a contactable other health professional (patient).  A 35-year-old female patient (no pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: El1283) via an unspecified route of administration on the left arm on 08Jan2021 02:00 PM at single dose for COVID-19 immunisation.  Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ek5730) via an unspecified route of administration on the left arm on 18Dec2020 03:45 PM at single dose for COVID-19 immunisation.  Medical history included known allergy to Bactrum and ciprofloxacin hydrochloride monohydrate (CIPRO). The patient's concomitant medications included bupropion hydrochloride (WELLBUTRIN) and lisdexamfetamine mesilate (VYVANSE). No other vaccine in four weeks. On 09Jan2021 at 04:00 AM, patient experienced body aches, fever, chills, headache. Nasal swab covid test post vaccination on 28Dec2020 was negative. No treatment received for the events. The outcome of events was unknown.
In 2/00 the pt received her third dose of Infanrix. Subsequently, the same day as the vax, she screamed and had a fever and soreness at the injection site (leg). No treatment was given. Outcome: resolved. The most recent information received on 3/27/00 reports the condition of the pt as resolved.
Fever, body aches, pain at the injection site. Throbbing headache and pain on one side of neck, shoulder, back of head and eye lasting at least 2 weeks and counting.
Rash, UrticariaPruritus, redness, pruritis lat injection site. Narrative:
Pt developed fever, vomiting and diarrhea from 3/2/01 to 3/3/01.
pt began to feel aches/pains in joints & generalized malaise the day p/vax;went to MD & recv cortisone inj & started on oral dose;
This spontaneous report received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with VAQTA dose 1 (dosing details and lot number unknown). On an unknown date the second dose of VAQTA was administered, 4 months after the first dose (sooner than 6 months). No adverse effects were reported. It was queried if a third dose should be given. Outcome of 'administration of second dose of VAQTA 4 months after the first dose of VAQTA' was not reported. No product quality complaint (PQC) was reported. Additional information is not expected.
No additional adverse effects reported; PROQUAD and VARIVAX were administered instead of M-M-R II and VARIVAX; Both vaccines had a "supported" temperature excursion; This spontaneous report was received from a pharmacy technician referring to a 1-year-old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       The pharmacy technician stated that on 13-JUL-2020, the patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot S017239 and expiration date 01-DEC-2020 (dose and route od administration were not provided) and with varicella virus vaccine live (oka/merck)(VARIVAX) lot S030244, expiration date 26-SEP-2021 (dose and route od administration were not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live  oka/merck) (VARIVAX). Both vaccines were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). No additional adverse effects reported.   The pharmacy technician also stated that both vaccines had a "supported" temperature excursion that was evaluated on 10-JUL-2020
In mid-December 2022 I began to wheeze and cough.  It became more difficult to breath on December 22, 2022.  I had a low-grade fever.  I visited an urgent care on this day and tested positive for Influenza A.  I am still recovering and having trouble breathing.  My cough was a dry, deep, barking.  I then had body aches and slept for 36 hours straight I was so exhausted I could not move.  I was so fatigued I had to crawl to the restroom.  I was prescribed Tamiflu. My fever lasted for about 3 days and was accompanied with chills.  My lingering symptoms are coughing and difficulty breathing as well as fatigue.  I nap all the time and just cannot seem to stay awake.  In early January,  I went to the emergency department at 3:00am because I could not breathe.  They gave me a nebulizer treatment and it did not help.  They did a chest X-Ray and it was negative for pneumonia.
Patient complained about stomach ache first, then tingling in roof of mouth, then throat tightness and shallow breathing.  No elevated blood pressure or elevated pulse was observed.  10ml of Benadryl given.
patient c/o feeling anxious, jittery and worried about vaccine. given H2), 120/80, 84, 98%  stayed on site 30 mins. no symptoms  or sob.  called next day 01/08 1042  am c/o of nausea, chills and fatigue. eating and drinking fluids instructed to call provider if symptoms get worse or 911
Child given MMR + Hep A #2 and 1 week later developed febrile seizure and had RML Pneumonia.
Constant headache; Vomiting; Lower abdominal cramping; This is a spontaneous report from a contactable consumer reporting for herself. A 54-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included systemic lupus erythematosus. The patient was not taking any medication. The patient experienced constant headache, vomiting and lower abdominal cramping on an unspecified date. The outcome of headache was note recovering, for the other events was unknown. The patient took Tylenol for headache. The patient received the second dose on 11Jan2021.
Right after the vaccine - Really bad sore arm for at least a week. I did have chills and aches for maybe a day. My usual joint pain that I experience wasn't worse that usual but I had just gotten cortisone shots a month earlier (March) so it was possible that it was keeping it all under control. But now I've been experiencing pain in joints. My thumb joints are in a lot of pain, very difficult to do almost anything; my lower back is really inflamed - the bones there. Other joints - knees and other joints hurt too but mostly those joints. Had chiropractic care - sometimes that increase inflammation because I'm moving the joints and but also have gotten 7 laser treatments on those joints - which has helped. Another number to call  regarding my joint pain history medical records- haven't seen him since March, though -Doctor - who did -  - he's not listed as my doctor but he did the cortisone shot and was my doctor before.
Pt recv vax on 11/18/98; 2 hr post vax pt exp tender, warm, red vax site
Within 20 minutes I felt like I couldn?t breathe my whole body went numb and I felt like I was gonna pass out. I had chills, cough, nausea, body aches,  loss of appetite , shortness of breath , accelerated heart, and chest pain. Since the day of the vaccine I have been struggling with my physical and mental health. I?ve been in and out of hospitals, doctors, specialist.
1215AM, 9/26/2021, moderate heartburn/indigestion, difficulty swallowing hot/cold beverages 1215AM 9/26/2021, moderate to severe joint pain in both knees and both hips, unable to sleep Treated with Tylenol 300PM, 9/26/2021, adverse symptoms began to subside 1030PM, 9/26/2021, severe joint pain in both knees and both hips, difficulty sleeping, difficulty walking Treated with Tylenol 400PM, 9/27/2021, adverse symptoms began to subside 830PM, 9/27/2021, normal sleep pattern
Irregular period starting 05/12/2021 with heavy bleeding, diarrhea and blood shot eyes
Suspected Vaccination Failure; got cancer in 2021; breakout of shingles earlier this year; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination Failure) (serious criteria GSK medically significant), cancer (Verbatim: got cancer in 2021) (serious criteria GSK medically significant) and shingles (Verbatim: breakout of shingles earlier this year). The outcome of the vaccination failure, cancer and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, cancer and shingles to be related to Shingrix. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure, cancer and shingles to be related to Shingrix. It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-AUG-2023 The patient self-reported this case. The reporter mentioned that the patient had a full course of Shingrix in 2020 and got cancer in 2021.  The doctor recommended that he would get Shingrix again. The patient had a breakout of shingles earlier this year. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
I had Covid in January. I felt fine after 12::30vaccine then  awoke at 4:30an .. chills, earache, hot neck, extreme tiredness... body aches.. lasted until 6:00pm that day
Breakthrough COVID infection. Symptom of shortness of breath. Unsure of onset of symptoms. Reported positive test from nursing home around 10/31/2022, but unsure of exact timeline. Positive test collected 11/06/2022.
20NOV98 began to feel lightheaded in later afternoon by 9PM had chills, runny nose, sl sore throat;had low grade fever 100 & mild body ache following Am;
Individual reported feeling like her tongue was swollen and it was becoming difficult to breathe.  She was flushed.  Denied shortness of breath.  She stated she did have a "bad taste in my mouth."  Administered 1mg Epinephrine and called 911.  Within approximately 5 min. individual stated she was feeling better and felt like she could swallow better.  Individual was taken to our local ER for further evaluation by EMS.  Individual was able to walk, on her own to the stretcher.
This case was reported by a nurse and described the occurrence of injection site reaction in a 50 year old male pt who received Engerix-B. On 1/27/04, the pt received the 3rd dose of Engerix-B. At the time of vaccination, the pt experienced an injection site reaction characterized by "sever" injection site pain. The events were associated with a potential product complaint. On an unspecified date, the events resolved. The nurse considered the events to possibly be related to vaccination with Engerix-B.
Erythema, itching on injection site Diphenhydramine 25 mg 2 tabs Q6h.
A Dtap vaccination was administered at approx 4:00 pm July 31, 2008.  At approx 11:15 on August 1, 2008 patient collapsed in a grand mal seizure.  He was transported by ambulance to the emergency room where he underwent a full blood panel and urinalysis, MRI and observation.  Patient's case was referred to a local neurologist and underwent an EEG.  As of September 8, 2008 we have been advised to not allow patient to drive for three months from the incident, and observe him for further indicators.  No medication was prescribed.
Minutes after the patient received both vaccines. He started to feel weakness on his right arm, in which I had injected PNEUMOVAX 23. About 5-10 minutes later, he was able to regain his strength. I made a second call a few hours later to see if there was any continued weakness or reaction, he said he was doing better.