chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHES; TIRED; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy induced asthma, and exercise induced asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced tired. On 01-APR-2021, the subject experienced slight headache. Laboratory data (dates unspecified) included: Blood group B (NR: not provided) B +. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, tired, and slight headache on 02-APR-2021. This report was non-serious. This case, from the same reporter is linked to
8/7/15-Given 3rd dose of ROTATEQ, admit to hospital on 8/11/15 for intussusception.
By the evening pt was feeling lethargic, out of it, could barely get into the shower. Pounding headache,  patient was cold and had to cover with double blankets and was in and out of sleep. Patient was feverish and had nausea for 2 days.  Today; day 3 patient has itchy blisters on her RT hand by her thumb area.  Entire body is extremely sensitive to touch aside from the weakness and she looses her balance and is close to falling.    Patient feels foggy, can not keep a thought together and can not focus.  Having problems focusing her eyes.  Shoulder where injection was given is red, very painful and swollen since day 1 to the point she can't lay on it.   FLU Shot given same day at same location.
Patient fainted while sitting down for the required 15 minutes after vaccine administration.  Patient fainted but remained in chair. Mother of patient was sitting next to the patient.  She had some water and remained for an additional 20 minutes sitting down. She refused EMS . She walked out of pharmacy 30 mins after fainting in chair.  Called mother at 7pm same day of event and patient's mother reported she was feeling okay.
has been 3 years since my first Shingrix vaccine; This case was reported by a consumer via interactive digital media 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 1st dose on an unknown date 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient enquired that should he/she start over the vaccine schedule.
Crying, choking 30 min w/pallor; poss apnea 30 seconds; episode required overnight observation;
1ml of vaccine is given instead of 0.5ml; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (1ml of vaccine is given instead of 0.5ml) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (1ml of vaccine is given instead of 0.5ml). At the time of the report, ACCIDENTAL OVERDOSE (1ml of vaccine is given instead of 0.5ml) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
SICK AS A SICK DOG; HIGH FEVER; NAUSEOUS; RAGING HEADACHE; TOTALLY EXHAUSTED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sick as a sick dog, high fever, nauseous, raging headache, and totally exhausted. The action taken with covid-19 vaccine was not applicable. The outcome of the sick as a sick dog, high fever, nauseous, raging headache and totally exhausted was not reported. This report was non-serious.
Patient presented to ED via ambulance at 5:00am on 5/19/2021 after experiencing difficulty breathing and facial swelling about an hour prior. The patient has experienced significant allergic reaction in the past. On arrival of EMS the patient was noted to have difficulty breathing and angioedema of the lips. Patient received epinephrine 0.3mL IM and Benadryl 25 mg IV prior to arrival. On arrival to the ED the patient was noted to have no respiratory distress, signs of urticarial skin rash, vomiting, abdominal pain or diarrhea; no noted stridor or dysphonia; patient denied difficulty swallowing. ED notes state patient possibly ingested peanut-containing food prior to reaction onset, but this was not confirmed.
Pt developed right deltoid pain, post vax. Also had induration and redness at site.
Patient stated she received here 2nd COVID-19 Vaccination on 06/07/2021. Patient stated that she received her vaccination at 10:00am. Patient stated that right away she started feeling burning, soreness, weakness in arm, rash,  and hot to the touch. Patient stated later in the day she started having elevated blood pressure, stiff arm, super fatigue and sleeping to much, anxious, palpitation, slightly elevated heart rate at 99, and lower grade fever. Patient stated today (06/10/2021) that her arm is still very sore, red, swollen, fatigue, and stiff arm.
PT. INADVERTANTLY GIVEN A SECOND DOSE OF MCV4. SANOFI PASTEUR AND CDC INFO LINE CONTACTED RE: POSSIBLE ADVERSE REACTIONS, PT. GIVEN VIS AND MANUFACTURER INSERT WITH ADVERSE REACTIONS HIGHLIGHTED AND EXPLAINED TO BOTH PT. AND MOTHER. MOTHER ALSO GIVEN INSTRUCTIONS TO MONITOR FOR ANY ADVERSE REACTIONS AND UPDATED WITH INFO THAT TO DATE, ACCORDING TO THE CDC, THRE HAVE NOT BEEN ANY SERIOUS ADVERSE REACTIONS OR EVENTS RELATED TO RECEIPT OF A SECOND DOSE OF MCV4.
On 7-30-13 Mom stated that the patient had a local reaction to flu vaccine given on 1-18-13 the size of a soft ball. He had no other reactions or complaints. Mom did not have pt checked at the time.
Weakness in the arm unable to lift arm til today. Big bruise at the site, surrounding area with redness.
Information has been received from a physician concerning an 8 year old male who was vaccinated subcutaneously with a dose of varicella virus vaccine live.  The physician reported that the patient subsequently developed breakthrough varicella.  Unspecified medical attention was sought and at the time of this report, the outcome was unknown.  Additional information has been requested.
Started not feeling well 10 days after YF vaccine. Developed jaundice with increased LFT, encephalopathic, work up for bilary pathology, process was E (see below #12). Eventually LFT's normalized and became awake, alert, oriented. No prior YF vaccine administered.
Likely Guillain Barre syndrome. 11/10 and 11/12/2009  walk-in clinic and ED notes from 11/6/2009 and 11/8-11/9/2009. Patient seen at clinic initially with c/o's fever, sore throat, arthralgias, painful swallowing. Tx: Viscuous lidocaine swish/swallow and Ibuprofen. Dx was pharyngitis. ED records from 11/8-11/9/2009 patient had c/o's numbness/weakness UE's. elevated CPK and abnormal EMG. Neuro exam noted decreased strength rt deltoid, trace to absent reflexes in UE's. Tx: IVF, respiratory monitoring. DC DX Most likely mild GBS.
I kind of felt flush a couple hours after. Later that evening I felt really tired, I got really cold and couldn't get warm. I had a tingling feeling all over and cold, I wasn't running a fever. I ate supper and threw everything up and started shaking because I was really cold. I took Tylenol and Phenergan. The next morning I felt weak, I tried to get ready to work and my joints ached, I was sore/achy and I threw up again. I took  Tylenol and Phenergan again and called out of work. Then mid- morning I woke up in a cold sweat and I felt better.  Each time I checked my temp. I wasn't running a fever.  My employer had me take a Covid test and it was negative.
Pneumonia; Dementia; This is a spontaneous report from a non-contactable consumer reporting for patient (Reporter's aunt). An elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included dementia and Coagulation disorder from an unknown date. Concomitant medications included warfarin sodium (COUMADIN SODIUM) taken as blood thinner, start and stop date were not reported; warfarin sodium (WARFARIN SODIUM) taken as blood thinner, start and stop date were not reported. The reporter stated that her elderly aunt was not told about the blood thinners. She stated that her aunt was on coumadin and warfarin and had dementia. The reporter stated her aunt got both of the Pfizer covid 19 vaccines and developed pneumonia in the hospital and complete dementia after on an unspecified date. The reporter asked, is bleeding disorder/been on blood thinners a contraindication. The reporter stated that there have been 1000s and 1000s of cases among all ages noting especially blood clots. She stated she wants to know it is passed and effective and be OK for everybody to take and nothing happens. She specified what she meant by nothing happens to mean nothing happens to people with blood disorder. The reporter stated she would love to provide the information to report her aunts experience but she does not trust anything going on and did not want to provide demographics for AE. She had questions about the Pfizer covid 19 vaccine. She asked if the vaccine is completely FDA approved, still under clinical trials or EUA. She wanted to know if the vaccine is through the clinical trials and can be given safely. She wanted to know if the vaccine is completely passed and 100 percent FDA approved. She stated the person she spoke to before said the clinical trials would end in 2023. She stated the person she spoke with earlier provided her the information about persons with medical conditions. She stated that one of the things on the list was having a bleeding disorder or on a blood thinner. The case was reported as non-serious. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 4:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 4:08 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.56 for dose administered on 02-Mar-2021 and 73.64 for dose administered on 30-Mar-2021. No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 35 degrees Fahrenheit from 10:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021. Batch number 019B21A - This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a  traceable temperature monitor at every hour. No treatment medications were reported.
Pt. was given PNEUMOVAX on 8/22/12. Pt. discovered hives on 8/23/12 and has pain in left upper arm. Pt. was given Prednisone taper, advised to continue Naprosyn and ice as needed.
Patient was brought to ED at Hospital by family member and was DOA. Patient was intubated and CPR was performed for 25 minutes until patient was pronounced dead at 16:18 on 10/5/17.
Patient fainted within 2 minutes of vaccine. She then appeared to have seizure activity shook for 1-2 minutes. Very pale and appeared to have a green hue to skin tone. O2 Sat 90% Pulse 40 B/P 60/42. Pt. sweating profusely. Transferred to Hosp ER.
Strong metallic taste in mouth at all times; Significantly increased salivation interfering with daily activities; This is a spontaneous report from a contactable Other HCP (patient). A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Unknown lot number) via intramuscular route administered on left arm on 21Jan2021 9:00 AM ((age at vaccination: 37 years) as a dose 2, single for COVID-19 immunisation. The medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Unknown lot number) via intramuscular route administered on left arm on 07Jan2021 9:00 AM (age at vaccination: 37 years) as dose 1, single for Covid-19 immunisation. Patient had no covid prior vaccination. Patient did not test Covid post vaccination. On 21Jan2021, patient had strong metallic taste in mouth at all times. Significantly increased salivation interfering with daily activities. The patient did not receive any treatment for the events. The outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Around 8pm on 3/8/21, I started having chills (teeth chattering),  entire body in pain, extreme fatigue, extremely thirsty & headaches. I continue to have these issues & went to bed with my clothes on. At 3pm, I woke up, put on my pajamas  & took 2 Aleves. Then started sweating.  At 6 am, I called into work sick. Went back to sleep & woke up at 9:30am. I felt like I was in a fog, headache & some  body aches. Felt that way the rest of the day. About 9 pm, I started getting hot & a headache, took 1 Aleve.
Loss of taste. Fatigue. Headache. Arm soreness. Covid tested with negative result for loss of taste.
Pt was complaining of symptoms for as long as a month after shot given. Patient called pharmacy with symptoms of tingling at site of shot , muscle pain & soreness in arm given. And feels like she lost some range to motion in her arm.
64 yo female without medical problems and not taking blood thinners or nsaid/asa . pt vaccinated first dose pfizer 3/19/2021  and 3/24/2021 reported bleeding from nipple of left breast without pain or swelling or palpable mass  . no h/o trauma. no easy bruising no bleeding from gums or nose no blood in stool or urine no heavy menstrual bleeding. pt denies myalgia or arthralgia or fatigue or other constitutional symptoms. patient felt related to covid vaccination. pt instructed to f/u pmd and get cbc with platelet coutn and anticoag studies
sore and itching around the site; after the shot arm turned red like a rash; sore and itching around the site; after the shot arm turned red like a rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (sore and itching around the site), VACCINATION SITE RASH (after the shot arm turned red like a rash), VACCINATION SITE PAIN (sore and itching around the site) and VACCINATION SITE ERYTHEMA (after the shot arm turned red like a rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (sore and itching around the site), VACCINATION SITE RASH (after the shot arm turned red like a rash), VACCINATION SITE PAIN (sore and itching around the site) and VACCINATION SITE ERYTHEMA (after the shot arm turned red like a rash). At the time of the report, VACCINATION SITE PRURITUS (sore and itching around the site), VACCINATION SITE RASH (after the shot arm turned red like a rash), VACCINATION SITE PAIN (sore and itching around the site) and VACCINATION SITE ERYTHEMA (after the shot arm turned red like a rash) outcome was unknown.            No concomitant medications provided. No treatment information was provided.
Patient received an expired vaccine. Vaccine was given on 3/25/21 and expired on 2/9/21.
This case was reported by a nurse, via a sales representative, and described the occurrence of injection site redness in a 4-year-old male subject who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. On 4 May 2007 the subject received unspecified dose of Infanrix (unknown, unknown thigh). On 4 May 2007, immediately after vaccination with Infanrix, the subject experience injection site redness. Possible incorrect of administration may have occurred. The nurse reported that the Infanrix may have been injected subcutaneously rather than the intended intramuscular route, because the child is a thin little boy and he tensed up at the last minute before the injection and this may have affected the injection angle. It was unknown if the redness reaction was due to the Infanrix itself or the technique error that may have resulted in subcutaneous administration. Due to the evens, the subject required medical attention at the health department. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were probably related to vaccination with Infanrix.
Pfizer vaccine was administered outside of the clinic - reported by patient  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/5/2021 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, WO BEHAVIORAL DISTURBANCE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/5/2021 OSTEOMYELITIS
Eight spots exposed 3 weeks ago with chicken pox. Afibrile, abdominal pain. Classical chicken pox lesions.
Patient moved from another country and did not have immunization record. Patient started all vaccines on this day and was given Kinrix (DTap, Ipol) and Energix instead of Pediarix. This was 8 days prior to her 4th birthday. Patient has not had an adverse event
Received flumist on 3 Oct 07, on 5 Oct developed soreness in pad of right thumb (thenar surface). This became much more sore by 2 wks after flumist.  Was seen by provider and given Motrin (didn't help), was seen again one wk later and was given tramadol (didn't help either). Today 6 Nov, hand is still sore.  Is being worked up now by different provider.
1/12/2021: Dose #1. Felt fatigue, headache, pain in the arm, and lower back sensation of burn and pain. All symptoms last for about two weeks after the 1st dose of vaccine. Patient took Tylenol to treat the symptoms. Patient did not report the symptom to her PCP  2/9/2021: Dose #2. After two week of the 2nd dose, patient felt weakness on the right leg. Patient admitted to facility.
Subsequent to receiving a second dose of varicella virus vaccine live the pt experienced chickenpox from head to toe. Pt was noted to have 60 - 80 itchy lesions scattered over his trunk to extremities. The lesions were maculopapular vesicles with all three stages present. The pt had scabbed lesion on both arms. The rash had spread by day three and the healing had begun by day 6.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients who received LIQUID PEDVAXHIB (lot#, dose, frequency and route unspecified) between 09-AUG-2014 and 06-SEP-2014. healthcare worker stated LIQUID PEDVAXHIB had been improperly stored with a low temperature of 33.6F for 6 hours. No adverse effects reported. Healthcare worker stated currently no patient data available.  This is one of several reports received from the same source. Additional information has been requested.
rash started around 9PM-sl on face, neck & ears;started on 27MAR97;by 29MAR97 rash had spread over entire body & was itchy;MD prescribed cream & mom states on this day 2APR97 pt still has a sl rash;
Patient states that he had an Itch and that he starched the area and within a couple of hours his arm became swollen and mild red hot to the touch. Patient states it was the size of 3 50 cent. patient was advised to mark the edges and to watch it if it grows to go to UC or ER, also to do cold washcloth, Ice packs.
Pt had just worked out - after injection, routine blood from site of injection accompanied by 1-1 1/2 inches of swelling (subdermal bleed) within seconds, ice was administered for 5-10 minutes. Pt had no other sx & left with ice pack - Pt called at 3pm to let me know he was okay.
Information has been received from a physician concerning a 13 year old (also reported as 10 year old) male who on 03-AUG-1998 and 21-JAN-2002 was vaccinated with the first and second dose of MMR II (HSA) respectively. On 29-NOV-2009 the patient experienced mumps. On 30-NOV-2009, the patient was afebrile and was diagnosed with mumps. The patient had left parotitis. At the time of the report, the outcome was unknown. No further information is available.