chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; Nurse calling for TE evaluation on frozen products states one dose of PROQUAD was administered to one patient.; This spontaneous report was received from a licensed practical nurse and refers to a patient of unspecified age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.   On 16-AUG-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) lot #U026800, expiration date: 26-FEB-2023 (dose, anatomical location and route of administration were not provided) administered as prophylaxis (product storage error).  The improperly stored dose underwent a temperature excursion of 14 degrees Fahrenheit (F) up to 46 F (46.44 F) for 3 hours and 30 minutes without previous excursions. No adverse events were reported.
A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 78 year old female vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.
Pt developed a knot at injection site a day or two after injection. Erythema spread down arm to elbow in the following days.  Pt saw primary doctor who prescribed antibiotic to treat possible infection.
Pt recv vax on 9/28/98; on 9/29/98 pt exp vax site rx
Pt recvd 1 dose of Engerix-B & had rash over entire body & then devel joint pain until could not walk; went to ER where it was thought had virus;
Breakthrough COVID-19 infection. Pt received the J&J vaccine on 8/20/2021
waited 15 minutes after shot and went Home, next morning got out of bed, legs VERY week from knee to foot , both legs, I always had strong legs.
This is a spontaneous report from a contactable pharmacist. This pharmacist reported on behalf of a nurse that a 34-year-old female patient received PREVNAR 13 subcutaneous on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. The pharmacist called on behalf on nurse who inadvertently gave product subcutaneously instead of intramuscularly on an unspecified date. The patient experienced localized irritation at injection site. At the time of the report, the outcome of the event was unknown. The information on the batch number has been requested.
Acute diarrhea that came on suddenly about 5 hours after the vaccine was administered; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8736; Expiration date was not reported), first dose via an unspecified route of administration, administered in arm left on 22Apr2021 10:30 (at the age of 68-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Medical history included hyperthyroidism from an unknown date and unknown if ongoing. Concomitant medications or other medications in two weeks included methimazole (METHIMAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient previously took norco and experienced drug allergy (known allergies). No other vaccine in four weeks. No covid prior vaccination. Covid was not tested post vaccination. The patient experienced acute diarrhea that came on suddenly about 5 hours after the vaccine was administered on 22Apr2021 12:00. Therapeutic measures were taken as a result of the event or treatment was received for AE (details unspecified). AE resulted in none of the above (details unspecified). If patient recovered stated as not recovering. Clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
I had on 09NOV2022 a AFIB attack and then a second on 16MAR2023. I also went the ER because of a rapid heartbeat in the month of March 2023.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 11-APR-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA008203, 1405USA0082972, 1405USA008973, 1405USA008974, 1405USA008975, 1405USA008976, 1405USA008977, 1405USA008979, 1405USA008980, 1405USA008981, 1405USA008982). Additional information has been requested.
Information has been received from a pharmacist referring an unspecified patient. On unknown dates the patient was vaccinated with 3 doses of series of RECOMBIVAX HB (dose and route unknown). On an unknown date, the patient experienced negative titers. The outcome was unknown. This is one of the two cases received from the same reporter. Additional information has been requested.
Experiencing swollen lips; Hives 15-20 minutes after receiving vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of LIP SWELLING (Experiencing swollen lips) and URTICARIA (Hives 15-20 minutes after receiving vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced LIP SWELLING (Experiencing swollen lips) and URTICARIA (Hives 15-20 minutes after receiving vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and STEROIDS ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Experiencing swollen lips) and URTICARIA (Hives 15-20 minutes after receiving vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Breakthrough case admission after 2 vaccines ; Moderna 3/10/21 lot# 011M20A ; Moderna 4/8/21 lot# 010M20A
C/o sore arm that has not resolved "hurts to the bone" reported on 10/23/12 anti-inflammatory pain meds & ice ordered.
We went in for his flu shot on Oct 9th, 2014 and my son who has controlled epilepsy (seizure free with medication for over 2 years) received the inactive influenza shot on his arm. The very next day he woke up and began ticing a few times. I wasn't sure what he was doing at first but after a few days it was evident that his ticing was getting progressively worse. By October 18th, he was ticing with full Tourettes syndrome (copralalia). This lasted for 3 months, subsiding in mid January 2015. Every time I suggested that the shot caused his tics, I was told by his medical team that flu shots would not cause this type of reaction. This is the second time this reaction happened immediately after my son received his flu shot.  Two years prior, my same son began ticing with a milder type of vocalization just three days after receiving his flu shot and it lasted just over 3 months. At that time, I wasn't sure if it was the flu shot or something else that caused it, so I skipped the next year's flu shot. After this second experience, I am 100% sure the flu shot caused his severe tics. He has been seizure free since March 2011 and has only had these symptoms of Tourettes immediately after receiving his flu shot.
Had MMR and has developed rash and fever. Rash (MMR dose #1 given 6/18. Rash started yesterday- ); Fussy (since Monday Possible prodromal stage); and Fever No sick contacts, URI symptoms, exposures, travel. Consistent with transient rash as an adverse side effect of MMR vaccine, in combination with a fever, most likely attributable to the measles vaccine virus, less likely attributable to a viral exanthem or contacts exposure. Unlikely due to wild-type measles.  Physical exam is consistent with measles exam thumb. She has no lymphadenopathy. Chest no pain of joints. The rash is not consistent with wheels or bradycardia. She is overall nontoxic child with intermittent periods of play, no dehydration, a little bit fussy. No angioedema, no wheezes, no wheal and flare, no urticaria. No history of seizure.
My child's immune system became weak after the last vaccine got sick easy developed high heart rate BP problems pain chronic fatigue. Was diagnosed with POTS and chronic fatigue. Was unable to attend school doing home school. Seeing 5 specialists.
Eczema-Iike rash two days after each dose on creases of both arms and with second dose it was on the back of my right leg as well. Rash after first dose cleared up on its own after about 7-10 days. After second dose rash appeared I sought medical attention and was prescribed a cream.
A serious spontaneous report of secondary transmission, miscarriage and non-serious event of nasal swab test positive for H1N1 LAIV and no appetite has been received from a 32-year-old female patient concerning herself, subsequent to H1N1 2009 Monovalent Vaccine Live, Intranasal. The patient's past medical history includes, two in vitro fertilizations and two Cesarean deliveries. The patient did not receive H1N1 2009 Monovalent Vaccine Live, Intranasal. On 28-Oct-2009, the patient's son received H1N1 2009 Monovalent Vaccine Live, Intranasal. On 29-Oct-2009, at 7:30PM she developed vaginal bleeding and experienced abdominal cramping. She called her physician and went for an obstetric ultrasound on 30-Oct-2009 where she learned that there was no fetal heartbeat. She had been 7.5 weeks into gestation at the time of the spontaneous abortion. On 03-Nov-2009, she became ill with flu-symptoms, was tested for the H1N1 flu via nasal swab, and the result was positive. On 03-Nov-2009 to 05-Nov-2009, she ran a fever with the highest recorded temperature peaking at 102.9. She self medicated herself with acetaminophen for the fever and took baths to keep her temperature down. Fever resolved in the evening of 05-Nov-2009. On 04-Nov-2009, her physician prescribed oseltamivir 75 mg tablets, BID, PO for 5 days. She followed the directions and completed this prescription. On 11-Nov-2009 and 10-Nov-2009, she reported that she was feeling better, but was still ill. On 11-Nov-2009 and 12-Nov-2009, she felt better, but remained with no appetite. On 16-Nov-2009, she reported that she had recovered and felt 100% like herself. The outcome of these adverse events was resolved. Additional information received on 16-Nov-2009 and incorporated in narrative: medical history, details about events and outcome of events.  11/25 and 12/1/2009 PCP and OB records for visit dates 11/4 and 11/2/2009. Visit to PCP for c/o's hoarseness, cough, nausea, anorexia, fatigue, myalgias and fever. Nasal swab + for Influenza, Rx'd Tamiflu Visit to OB is S/P a miscarriage 10/29/2009, no problems, brought placental tissue for chromosone analysis.
Patient given monovalent dose after date of authorization. Authorization expiration  date was 8/31/22. Provider unaware of expiration date at the time of administration. Notified of expiration date on 9/14/22, at which time the Department of Health directed the provider to complete an event report. Shipment of bivalent booster doses was not received until 9/12/22.
Right arm quarter size area bright and red surrounded by light pink border. Slightly warm to touch. No streaking noted. Minimal edema.
severe muscle aches; headache; some facial nerve type pain; joint soreness; difficult to walk; This is a spontaneous report from a contactable consumer (patient).  A 69-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER2613), via an unspecified route of administration, administered in left arm on 18Mar2021 at 18:45 (at the age of 69-years) as dose 1, single for covid-19 immunization. The patient medical history included situational depression. The patient had known allergies to sulfa (mild), flagyl and lactose intolerance. The patient previously received morphine and experienced severe itching; received naproxen and experienced stomach pain. The patient was not pregnant at the time of vaccination. The patient concomitant medications included bupropion (BUPROPION) 100 mg per day. The patient had not received any other vaccine within 4 weeks prior vaccination. Following vaccination on an unspecified date in 2021, the patient had experienced severe muscle aches, headache, some facial nerve type pain, joint soreness, difficulty to walk. The headache lasted for 3 days, muscle aches and joint soreness lasted for 2 weeks. The patient had not received any treatment for the events. The patient recovered with lasting effects. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events was recovered with sequelae on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
Headache, Myalgia, chills, pain at injection site Narrative: Employee states: With the first dose of vaccine on 12/22/2020, he experienced minor pain in the left arm starting about 8 hours after the injection and lasting about 12 hours relieved with naproxen With the second dose on 1/19/21, again minor pain at the injection site left arm, but around 10pm ha chills, headache, muscle aches, (did not check for fever). Around 5 am the chills broke and did not recur. Took tylenol and naproxen for myalgias with good resilts. no recurrences
Two days after Recieving 2nd vaccine, my lymph node under my left arm swelled to about baseball size.  Slight painful and uncomfortable.  Took about 10days for the swelling to go down
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with an unspecified number of doses of ROTATEQ (dose, route, lot # and expiration date were not provided) and M-M-R II (dose, route, lot # and expiration date were not provided). The certified medical assistant noted that on an unknown date an unspecified number of patients were administered unsupported ROTATEQ and M-M-R II, after temperature stability was not able to be provided. No adverse effect was reported. Additional information is not expected.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB lot # M010212 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. Additional information has been requested. Sender's Comments: US-009507513-1708USA012766.
woke up during noc 8NOV97 w/fever & arm pain;felt like flu;took ASA;9NOV97 had swollen upper arm;went to ER T101.4;swollen up 1/3 of arm above elbow;was given ATB & antihistamine;
Headache  Sharp pain radiate in arm and belly  Loss taste and smell then it came back
This spontaneous report was received from a pharmacist refers to a 53 year old female patient. Patient medical history and current condition was not reported. On 22-APR-2015 the patient was vaccinated with ZOSTAVAX single dose (Lot # K020802 and expiry date 31-01-2016) via subcutaneous route in the right arm. Other co-suspects and concomitant medication were not reported. On 22-APR-2015 (reported as on the same day) the patient developed a small red, itchy, swollen area on her right shoulder. The pharmacist states it looks like a bug bite. The patient sought medical attention, reported as visited pharmacy. Cancer and overdose was not reported. The outcome of the event was reported as not recovered. Causality assessment was not provided by the reporter. Additional information has been requested.
Developed blotchy skin on left thigh 1 day post vaccine, then swelling and induration from hop to below knee, followed by greenish bruising throughout thigh. On day 4 all SX improving but still significant swelling.
Patient was given the flu shot at the beginning of the appointment, then seen later by his NP. Patient was sitting down, seemingly normal, then asked for the trash can and had acute onset severe vomiting approximately 30 minutes after the administration of the vaccination lasting for about 5 minutes.  Patient was given promethazine 25 mg/mL 1 mL once . There was no evidence of rash around the injection site or anywhere else.  Patient's vomiting stopped and he was wheeled out of the doctor's office in a wheel chair feeling nauseated.  Patient returned home after appointment.
Seizure found, resolved after about 3 seconds , answered well . Dr. Monitored pt's medical status. * Mother states no previous side effect or medical reaction to JEV and All other vaccines.
pt exp an inc in bilirubin levels following vax w/Hep B vax; pt was dx w/Epstein-Barr infection, infectious mononucleosis w/liver involvement; No further details were provided;
Developed severe hives all over body from scalp to feet that lasted 5 days and have now become constant dermatographia. Was treated with two rounds of prednisone for the hives and have been on antihistamines ever since 12/31/2021 to ease the swelling and itching.
This case was reported by a healthcare professional (also the subject's mother) and described the occurrence of cyanosis in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), and PEDVAXHIB (non-gsk). On 27 September 2006, 10 November 2006 and 20 February 2007 the subject received 1st dose, 2nd dose and 3rd dose of PEDIARIX (0.5 ml, unknown route, left thigh), and 1st dose, 2nd dose and 3rd dose of PEDVAXHIB (details unknown). The same day after each vaccination with PEDIARIX and PEDVAXHIB, the subject experienced cyanosis and went into respiratory distress, and he had a high pitched cry. He also experienced diarrhea and irritability. The subject visited the doctor's office or the Emergency Room by the next day each time. The subject was hospitalized; he was admitted overnight on three separate occasions and was treated with steroids and antibiotics. The symptoms were reported to last until almost time for the next vaccinations. Approximately 15 months later (date not specified), it was determined that the subject had Haemophilus influenza in his lungs and ears. The subject had not experienced a cyanotic spell since December 2007. The subject's immune system remains compromised and he "gets sick easily". The subject's skin color is "sick-looking", described as whitish yellow. The subject's bowel movements remain abnormal, described as "like putty, yellowish white, then sometimes black then sometimes green". It was determined that the subject has an unspecified parasite in his bowel. At the time of reporting, the cyanosis, respiratory distress, high pitched crying, diarrhea and irritability were resolved. All the other reported events were unresolved. The reporting healthcare professional does not known whether the events are related to the vaccinations with PEDIARIX and PEDVAXHIB, but was "leaning more towards suspecting the PEDVAXHIB", but does not know if the events are due to either vaccination, and possibly due to being "over vaccinated".
Moderna COVID?19 Vaccine EUA  Big red circle and swelling at the location of the vaccine.  It's day four and the swelling is larger.  The red circle is large.  I have a picture to send you.  Fever of 102 the first night, no fever now.  Not sure if it's infection or from the vaccine itself but today is the 4th  at 4:45 pm and she got the vaccine on the 1st at 1:30 pm.  I have  yet to taken her to the doctors for the increased swelling because I caused the covid vaccine number and a vaccine specialist said this could be normal and to watch it.  I have a picture it looks BIG!
Swollen lymph node near right arm; Diarrhea; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea), PAIN IN EXTREMITY (Pain in arm) and LYMPHADENOPATHY (Swollen lymph node near right arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIARRHEA (Diarrhea) and PAIN IN EXTREMITY (Pain in arm). On 08-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node near right arm). On 27-Feb-2021, DIARRHEA (Diarrhea) and PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph node near right arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications was provided.  No treatment information was provided.
Boostrix given instead of Daptacel; Boostrix given to a 3-year-old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9ZK5T, expiry date 07-OCT-2024) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Boostrix given instead of Daptacel) and inappropriate age at vaccine administration (Verbatim: Boostrix given to a 3-year-old). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 9-Mar-2023 The reporter did not consent to follow-up. The patient received a dose of Boostrix instead of Daptacel at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Vaccine was administered 10/07/2021 and expired on 10/03/2021
Abou 3:30 am on April 2  I woke up scratching my face.  My face was red and swollen and itching a lot.  I rubbed some lotion and Bendryl on my face.  I have never had problems with those two products before.
A welt-like red area that is hot in temperature. The red area is golf ball sized. The welt went away after 2 days but as of the morning of  1/21/21, the welt is back and is extremely itchy this time.
Crying x 2 hours, redness leg and buttock ---> resolved, tender hematoma right thigh
Mom states was limping on Wed 14AUG91 p/immun; 15AU91 lt leg became red & hot also feverish; 16AUG91 evening lt leg bright red & raised hot to touch, red area larger than an orange; Also has fever; Taken to clinic for eval;