chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 23:45, on 8/20/01, the baby vomited stomach contents and continued vomiting until it was pink streaked bile-like substance. Parents took baby to ER at approx. 01:00 on 8/21/01. The baby was limp and dusky in color. While waiting in ER, child returned to normal state. Discharged home with parents.
Initial symptoms included a feeling of slight panic with associated need to take deep breaths.  Once I left the facility 20 minutes later, I felt slightly lightheaded with sensitivity to light and sound.  These symptoms were mild overall. The feeling of anxiety and mild sensory symptoms persisted for several hours. That night, I experienced night sweats.  I have been feeling fine overall since that point.
Large area of redness, swelling, tenderness and itching over upper arm and shoulder.  Follow up on 05/15/2000: "Patient recovered from adverse event."
Pt became dizzy and called for help. Upon arrival ambulance was called and pt was ALOC w/bilateral weakness slowly progressing and sweating profusely. Pt was A&O x 3  to self and location. Then patient seemed to have lost consciousness completely for about a minute. Pt was still breathing normally, and was tachycardic. Left sided drooling was present. By the time the ambulance arrived patient regained consciousness and strength. Pt stated this happened before when he had a root canal fixed. Stated he seems to have anxiety induced seizures. Pt VS were taken by EMTs and where stable, Pt refused to go to the hospital. He called his wife to pick him up and pt was monitored until she arrived.
Headache, chills, fever (102.6) "achy", slight sore throat developed on 5/8/08 after receiving both immunizations on 5/7/08 here in office.
poss pertussis; recvd vax on 7MAY89 8A9119, 10JUL89 8E01005, 18SEP89 9J01114 & 1OCT90 0611097; brother is confirmed case of pertussis;
This case was reported by a consumer (subject's mother) and described the occurrence of eczema in a 3-month-old male subject who was vaccinated with DTaP (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included dairy allergy and dog allergy. Concurrent vaccination included Hib; manufacturer unspecified; unknown; unknown given in 2012; HepB ; manufacturer unspecified; unknown; unknown given in 2012; pneumonia vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given in 2012; IPV (non-gsk); non-GSK manufacturer; unknown; unknown given in 2012. It was not clear which vaccines were administered with each dose of DTaP. On January 2012 and May 2012 the subject received 1st dose and 2nd dose of DTaP (unknown route, unknown thigh). In February 2012, 1 month after vaccination with 1st dose of DTaP, the subject experienced eczema and either in May 2012 or June 2012 within months of vaccination with 2nd dose of DTaP, the subject experienced eczema flare up. The subject developed eczema after the 1st dose and then the eczema flared up after the second dose. The subject was seen in the physician's office. The subject was treated with Steroid cream "which is helping the eczema". At the time of reporting the events were unresolved.
No adverse event reported. The vaccine had expired 9/30/2022 and administered 11/10/2022.
PAIN IN BOTH LEGS; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced pain in both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in both legs. This report was non-serious.
came back from walk, had nausea, was unsteady, sweating profusely, low BP, having difficulty completely sentences
Headache, Fever, Bodyaches, Skin feels like it Tingling Narrative:  Reports mild symptoms. Low grade subjective fever, skins has 'tingling' feeling. Will treat at home with OTC Tylenol
This was my first shot. sore arm that hurts to move. 7am on 4/16 work up made cup of coffee, too exhausted to drink. Went back to sleep. Slept until 5pm. Eat soup, exhausted, fell back to sleep until 10pm. Talked on phone a bit, exhausted. Had chills, very hot feeling in head, ears, mouth when I was awake. Got body aches 10pm.  I literally could not keep myself awake all day. Went back to sleep until 6am Saturday. arm still sore but a little better. Stayed awake all day. Still have hot feeling in head, ears, mouth. Dizziness. Fatigue, but better than Friday. Sunday, still the same as Saturday.  I read people who get first shot side effects may have gotten covid and not known it. Oddly, On 1/3/21 I went to  ER. Had pain in abdomen for days, winded walking in kitchen and out of breath when using stairs. Had high white blood on blood test. Was not tested for covid. If I had covid, that was probably it. It took a while to get better and I had the same hot feeling in head, ears, mouth like I do now. I hope I don't get worse reaction with 2nd shot
a temperature excursion for PROQUAD/Information obtained for vaccines that were administered to patients; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 25-JUL-2021, there was a previous temperature excursion between 6 to 14 degrees Fahrenheit (7.3 degrees Fahrenheit) for 37 minutes that was not reported.   On 19-AUG-2021, the patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (0.5mL subcutaneous (SQ) x 1 dose, lot # T016990, expiration date 11-NOV-2021) for prophylaxis (product storage error).
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patiens were orally vaccinated with ROTATEQ (dosage schedule was not reported) which had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe Nausea, Headache, Fatigue, Body aches. kidney stones and sore throat.
pharmacist says that fluzone hd qiv may have been given to a 45 year old with no reported ae; a fluzone high-dose vaccine for her, but then she said she thought she might have already gotten it, so they did not administer. prepared syringe was placed back in the refrigerator with no reported ae; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases 2022SA454572(CLUSTER), 2022SA455035(CLUSTER) and 2022SA455035(CLUSTER).  This case involves a 45 years old female patient and pharmacist says that INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] may have been given with no reported ae(adverse event) and a fluzone high-dose vaccine for her, but then she said she thought she might have already gotten it, so they did not administer. prepared syringe was placed back in the refrigerator with no reported ae.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation was unknown, lot UJ93788 and expiry date was unknown) via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event of pharmacist says that fluzone hd qiv may have been given to a 45 year old with no reported ae (product administered to patient of inappropriate age) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. On an unknown date the patient developed a non-serious event of a fluzone high-dose vaccine for her, but then she said she thought she might have already gotten it, so they did not administer. prepared syringe was placed back in the refrigerator with no reported ae (product storage error) (latency: unknown) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  SanofiPVPortal20221103000136:
Pain left arm for 36 hours. Headache for 36 hours.  Very tired for 48 hours.
This spontaneous report was received from a registered nurse and refers to a 31 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # M008173 with expiration date of 16-FEB-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 8 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1705USA014053:
developed rash on arms and legs (papular acrodermatitis), also known as Gianotti-Crosti syndrome
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients had been administered RECOMBIVAX HB (dose, frequency, route, lot # and expired date were not reported) that fell to refrigerator temperatures outside the prescribing information, despite being supported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
3 hours injection given, broke out into a red rash from upper chest to stomach. Rash was also at injection site. Rash lasted three days. Did not miss any work and no other reaction.
Between 7-28 hours after injection experienced severe chills, headache, nausea, body aches.  It was completely incapacitating and I needed assistance.  Had very difficult time keeping Tylenol down.  Was able to get up and use bathroom with assistance.  Worsts headache I have ever had.  Tylenol didn?t help much. All I could do was try to sleep and not move for fear of throwing up and worsening headache.   Will not take this vaccine again as this was a terrible experience.    Resolved mostly after  28 hrs after injection
pt exp no reaction following DTP/HIB/OPV vax on 5OCT92; 8OCT92 pt was found dead; autopsy dx SIDS;
Scheduled for the first infusion of Vyepti for the treatment of migraines; This case was reported by a pharmacist via call center representative and described the occurrence of migraine in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced migraine. On an unknown date, the outcome of the migraine was unknown.   It was unknown if the reporter considered the migraine to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The pharmacist contacted medical information reporting that a patient needed to receive the second dose of Shingrix but was also scheduled for the first infusion of Vyepti for the treatment of migraines. No further information was available. The reporter did not consent to follow-up.
Started with headaches, then tightness in chest (on left side) with extreme soreness on left side of neck, shoulder and arm.  That night felt "flu like" symptoms. Symptoms lasted for 36 hours. Today only symptoms is left arm is sensitive to touch. 01/30
pt recv vax 24JAN96 & pt devel flu-like sx;no other details were known @ the time of this report;pt was evaluated in the reporter's office p/sx had resolved;
patient inadvertently received a dose of Menquadfi, she was intended to receive MMR/Varicella with no reported adverse event; Initial information was received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 5 years old female patient who reported that inadvertently received a dose of Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi], she was intended to receive MMR/VARICELLA with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A vaccine and diphtheria vaccine toxoid, pertussis vaccine acellular, polio vaccine inact, tetanus vaccine toxoid (TDAP IPV) for Prophylactic vaccination.  On 21-Aug-2023, the patient received a dose 1 of 0.5 ml of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot U7643AB, Expiry date : 27-Jun-2025, strength was unknown) via intramuscular route in the right arm for Immunization and  inadvertently received a dose of Menquadfi, she was intended to receive MMR/VARICELLA with no reported adverse event (wrong product administered) (latency : same day).  It was reported that "Caller reporting the patient has not received prior doses of meningococcal vaccinations on their records, but she didn't think it was approved for a 5-year-old to receive. This situation is reported as a medication error due to administering vaccination in error."  No lab data reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient inadvertently received a dose of Menquadfi, she was intended to receive MMR/VARICELLA with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recv vax 17AUG95 & on 2NOV95 pt exp grand mal sz;
Information has been received from a registered nurse concerning a 6 year old male with an allergy to Augmentin who on 06-MAY-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 00326). On 23-MAY-2007, the patient experienced acute febrile illness with sore throat and headache. Subsequently, the patient recovered from acute febrile illness, sore throat and headache. The reporter indicated it's unlikely vaccine related as sister had been sick earlier in week with the same. No product quality complaint was involved. Additional information has been requested.
Vial initially stored in refrigerator on 20-Jul-2022 and administered on 20-Aug-2022, after 30 days use by date; No adverse event; Patient received dose after 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after 30 days use by date), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 20-Jul-2022 and administered on 20-Aug-2022, after 30 days use by date) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 055A22A) for COVID-19 vaccination.     It was unknown if the patient was ever been diagnosed with or tested positive for covid-19.Also it was unknown if the patient had any acute illness at the time of vaccination and up to one month before. It was unknown if the patient had any chronic or long standing health conditions. It was unknown if the patient had prescriptions, over the counter medications, dietary supplements or herbal remedies taken at the time of vaccination or at the time of the adverse event.     On 20-Aug-2022 at 10:46 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Aug-2022 at 10:46 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 20-Jul-2022 and administered on 20-Aug-2022, after 30 days use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after 30 days use by date), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 20-Jul-2022 and administered on 20-Aug-2022, after 30 days use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose after 30 days use by date) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 20-Jul-2022 and administered on 20-Aug-2022, after 30 days use by date).    No concomitant medications were reported.  On 20-Jul-2022, the pharmacy received the vials and stored them in refrigerator. It was stored in the refrigerator for 31 days after which it was administered to the patient. The pharmacist did not realize it was only good for 30 days in the fridge. The vial had no temperature excursion. No adverse reaction was reported. And it was enquired by the pharmacist if the patient's needs to be re-dozed.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-632107 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-632107:Master case
Mild upper lip swelling after observation period. No airway compromise. Given zyertc 10mg.
Patient developed a fever to 102 or greater several days after the inoculation,and missed two days of work. Fever and symptoms abated so worker returned to work; however, approximatedly ten days later developed tachycardia such that the employee was at near collapse. Tachycardia eventually abated and individual was seen by physicians in the hospital. Studies were done including EKG,cardiac enzymes, and routine laboratory with nothing of significance being found. However, there was concern so employee was referred to the contract cardiologist for a stress test and other laboratory studies. UPDATE: 8-12-2003 - Talked with patient who is a physician. He states that the stress test and all the other tests came back normal. States he has had no further problems. Denies any history of cardiac problems.
On 3/15/2021 Moderna COVID19 Vaccine Vial Lot #014M20A was punctured at 10:45A, vaccine was given at 4:53P.  Vaccine expired at 4:45P (6 hours after punctured).  Reported to Moderna same evening, received response from Medical Affairs 3/18/2021.  Representative gave instruction that repeat dose was not needed as viability of vaccine was demonstrated 12 hours after puncture time, however as there was no preservative there was increased likelihood of infection.  Patient was informed, patient denied signs of infection.  Patient was instructed to monitor for signs of infection at vaccine site.
NOSE BLEED; BODY ACHES; HEADACHE; FATIGUE; NAUSEA; DIZZINESS; WARM FEELING IN THE VEINS OF THE PALMS AND FEET; SEVERE CHILLS; This spontaneous report received from the patient concerned a 74 year old mixed race female. The patient's height and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient took no concomitant medications. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of admin not reported, batch number: 1805020 expiry: 25-MAY-2021) dose was not reported,1 total, administered on 09-MAR-2021 to left arm for prophylactic vaccination. On 09-MAR-2021, the patient experienced severe chills at around 21:00, 5 hours post vaccination. On 10-MAR-2021 around 04:30, the patient woke up with a pounding headache, chills, body aches. During day the patient also felt fatigue, nausea, dizziness and a feeling of warmth in the veins of her palms and feet. It was reported that the symptoms disappeared on the morning of 11-MAR-2021, which was 2 days post vaccination. It was reported that about 30 minutes prior to call on reporting day of 25-APR-2021, the patient blew her nose and she said a little bloody clot came out, followed by a nose bleed lasting about 30 minutes. The patient reported that she never got nose bleeds and she had no fever, shortness of breath or chest pain. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient recovered from dizziness, warm feeling in the veins of the palms and feet, body aches, severe chills, fatigue, nausea, and headache on 11-MAR-2021, and nose bleed on 25-APR-2021. This report was non-serious.
This case was reported by a other health professional and described the occurrence of wrong vaccine administered in a 65-year-old female patient who received INFANRIX (batch number 32PC3, expiry date 14th December 2015). On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: INFANRIX was administered to a 65 years old patient instead of Tdap.
His wife hips and Knees are painful; his wife is not feeling well; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 27Mar2021 at a single dose for COVID-19 immunization. Medical history included ongoing disability (disabled). The patient's concomitant medications were not reported. The reporter stated his wife was scheduled for the second dose on the day of reporting (17Apr2021). She will not make it because she was not feeling well. Her hips and knees were painful. Onset date of the events was not provided. The reporter was asking if it was okay to take the second dose on the next day. The events had not resolved at the time of the report.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a female between 6-7 weeks old who, "within the last week," on approximately 06-Feb-2007, was vaccinated with a first oral dose of Rotateq. "Within the first five days," on approximately 06-Feb-2007, the patient developed diarrhea. It was reported that the diarrhea was mild. Subsequently, the patient recovered. There was no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Patient experienced body aches, fever >103 , pain and tightness  in chest.  Patient called 911 and was brought to hospital ER
Doctor ordered DTaP/Hib/IPV and patient received the PEDIARIX vaccine. Patients mother is aware.
Swollen, red, itchy round patch about 1 1/2 inches in diameter. Treating with hydrocortisone cream.