chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SEVERE HEADACHE; COULDN'T KEEP ANYTHING IN STOMACH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 14-MAR-2021 on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced couldn't keep anything in stomach. Treatment medications included: paracetamol. On 14-MAR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't keep anything in stomach, and severe headache on MAR-2021. This report was non-serious.
This spontaneous report as received from a Medical Assistant via company representative concerning a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. It was reported that on an unknown date, the patient experienced zoster-like rash after vaccination with ZOSTAVAX. The outcome of patient was unknown. This is one of two reports concerning the same source. Additional information has been requested.
Severe headache, nausea, fatigue, bodyaches. Unable to work that day after receiving vaccine
Information has been received from a physician concerning one of his family friends, a teenage female who was vaccinated with a dose of GARDASIL vaccine (yeast). Subsequently the patient experienced Guillain-Barre syndrome. At the time of the report, it was unknown if the patient had recovered from the event. Unspecified medical attention was sought. Upon internal review, Guillain-Barre syndrome was determined to be an other important medical event. No further information is available.
SON CAME IN 10/6/21 AND REPORTED HIS MOM WAS REALLY TIRED,LIKE USUAL AFTER HER FLU SHOT,BUT THEY FOUND HER WITHIN 2 DAYS OF FLU SHOT DEAD- APPROXIMATELY 9/19/21 OR 9/20/21
Immunizing technician was administering the flu vaccine to patient. The technician prepared to give the vaccine and administered the stick. However, after the stick the plunger would not move and would not allow administration of the vaccine.  This was most likely a result of the stick occurring to high on the arm based on the placement of band aid and where the actual stick occurred.  When this happened, the technician notified the pharmacist through the window. The pharmacist immediately came out and observed the situation. The pharmacist observed that the placement was too high and removed the needle. In addition, it is believed that no amount was administered during the process.
Patient received TDAP vaccine in the left arm on the afternoon of 4/25/16. On 4/28/16, patient called complaining of symptoms: redness, swelling, warm to touch, tender to touch, feels like huge knot, entire left arm is very sore. Patient reported symptoms began the morning of 4/27/16. Patient instructed to continue putting ice on arm, take OTC pain medicine for pain and inflammation, and to go to ER if experiencing trouble breathing, swelling in throat, chest pain, confusion, fever, etc. Patient presented to ER late evening of 4/28/16 complaining of pain, swelling, and itching of left arm. ER noted 12x8 cm area of redness and swelling. Patient did not have fever or other indication of cellulitis/infection. Patient discharged home and instructed to take cetirizine and avoid TDAP in the future. Swelling, Erythema, Pruritus.
ADMINISTRATION ERROR - Patient received full dose of Covid19 vaccine in left arm (deltoid). When pharmacist went to administer flu vaccine in right arm (deltoid), patient pulled away after needle entered skin and approx. 1/4 of dose was administered. Patient's father was present for administration and after discussing with 3 y.o. patient, decided she was not amicable to receiving rest of dose and therefore vaccine was incomplete. Pediatrician was made aware via fax and state registry updated with incomplete dose information. No adverse reaction.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive Other medication in 2weeks. The patient received Anti-viral product, brand Paxlovid for COVID 19 Treatment started on 22Jan2023 and stopped on 26Jan2023. The patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Administration of the Rotarix Diluent Alone; Administration of the Rotarix Diluent Alone; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) (batch number KB7FJ, expiry date 19-SEP-2024) for prophylaxis.   On 25-OCT-2023, the patient received Rotarix lyophilized formulation. On 25-OCT-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Administration of the Rotarix Diluent Alone) and inappropriate dose of vaccine administered (Verbatim: Administration of the Rotarix Diluent Alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-NOV-2023 Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email. This case is 1 out of 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023152368:Different patient US-GSK-US2023152373:Different patient US-GSK-US2023152365:Different patient US-GSK-US2023152363:Different patient US-GSK-US2023152370:Different patient
it's killing me; Hives; Itch is terrible after I took the booster Shot/Started getting itching like rashes like you know like mosquito bites; I wake up like my lips swelling; Allergy or rash, it''s all over my body; Allergy or rash, it''s all over my body; it don't even let me sleep; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing), notes: I take Synthroid for my thyroid. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder. Vaccination history included: Covid-19 vaccine (Dose:1, single, manufacturer unknown), administration date: 26Mar2021, when the patient was 54 years old, for COVID-19 Immunization; Covid-19 vaccine (Dose:2, single, manufacturer unknown), administration date: 16Apr2021, when the patient was 54 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "not recovered", described as "Booster"; NEAR DEATH EXPERIENCE (medically significant) with onset Nov2021, outcome "not recovered", described as "it's killing me"; URTICARIA (non-serious) with onset Nov2021, outcome "not recovered", described as "Hives"; PRURITUS (non-serious) with onset Nov2021, outcome "not recovered", described as "Itch is terrible after I took the booster Shot/Started getting itching like rashes like you know like mosquito bites"; LIP SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "I wake up like my lips swelling"; HYPERSENSITIVITY (non-serious), RASH (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "Allergy or rash, it''s all over my body"; INSOMNIA (non-serious) with onset Nov2021, outcome "not recovered", described as "it don't even let me sleep". Therapeutic measures were taken as a result of near death experience, urticaria, pruritus, lip swelling, hypersensitivity, rash, insomnia. Clinical course: Well after I got the shot but I didn't realized I started getting itching like rashes like you know like mosquito bites, hives and it's being like every day is getting worse and worse and worse and I don't know what it was. I have been taking like Allegra (non-Pfizer product) once a day and that itch is terrible after I took the booster shot but you know I am getting worse and worse each day. It's so bad that in the morning I wake up like my lips swelling. Additional information: Start date of adverse events reported as on November 19 or November 20. No other vaccination within 4 weeks.  The lot number for bnt162b2 was not provided and will be requested during follow up.
got it twice despite being vaccinated/suspected vaccination failure; got it twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's comment:This case was reported by a consumer via interactive digital media The reporter got it 2 years prior to the reporting. It was mild case, 4 spots right hand and not vaccinated. The reporters husband got it twice despite being vaccinated. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
The left side of my face went numb; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 07Apr2021 at 13:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. On an unknown date in Apr2021, the patient had her left side face went numb and she had diarrhoea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events the left side face went numb and had diarrhoea was resolved on unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I got lip filler 11 months ago and today I have some swelling in my top lip.
shortness of breath/someone sitting on her chest; body aches; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath/someone sitting on her chest), MYALGIA (body aches), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath/someone sitting on her chest), MYALGIA (body aches), PYREXIA (fever) and CHILLS (chills). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath/someone sitting on her chest), MYALGIA (body aches), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Redness, warmth, itchy, swollen. TX: topical triamcinolone, TYLENOL, cool compress. Added to PT allergy list.
5 days after injection, Pt reports pain in shoulder. He feels this is SIRVA.
Rash appeared shortly after vaccine was administered. Within the next day round, blotchy, raised, scabbed, and severely itchy rash appeared down the arms, over the week after administration the rash spread all over the patients body.   approximately 1 month after vaccine the rash is still present and has not improved.
Follow-up info received 10/9/02 from physician reported patient's birth weight and recovery status. Follow up info received 10/4/02 from physician. The isolate from this pt is type 38 (not a Prevnar serotype). Additional info received 9/25/02 from physician. Information contained lot numbers and dates of Prevnar immunizations, additional immunizations received, pt age and gender, laboratory data and treatment medications. A physician reported that a 22 month old male received a 4th dose of Prevnar, HibTiter, and a firt dose of MMR II vaccine vaccines on 4/11/02 when he was 17 months old. The child presented at the physician's office with a fever of 104 deg F. On 9/17/02, a blood culture was performed and Strep. pnumonia was isolated. Laboratory data include: platelet count of 275,000 white blood cell count of 16.4, poly of 71, B of 3, hemoglobin of 11.4, mnocyte count of 8, lymphocyte count of 18 and haematocrit of 33. He was treated with Omnicef. He recovered. An infectious disease physician has the isolate on a slant and is willing to ship it where ever needed. No additional info was available as of the date of this report.
Left Deltoid at Dtap site pt had red raised area approx 3 1/2 cm in length by 4 1/2 min width. No pain. Benadryl given by MD.
On July 8, 2022, I noticed phlegm in the back of my throat. I assumed it was allergies. I used my inhaler but it didn't clear up. By the 10th I didn't feel better and had a cough now. On the 12th I took a test and was positive. After this I reached out to my doctor. They felt it was past the time for antiviral. They prescribed an inhaler, albuterol, and advised to drink water and use MUCINEX DM. My symptoms were congestion, coughing, thick phlegm. Recently I have fatigue. I did not run a fever. I had a headache yesterday. Today I tested negative. Today I still have a little bit of phlegm and slight cough. I feel groggy but I think that is from the cough medicine. The interesting part is I was sick for an entire week but it wasn't until yesterday that my fatigue was so bad I slept all day on the couch.
Chills, Muscle Pain, Headache, Severe pain in both legs, upset stomach (like had to vomit)
Redness, hot sensation, soreness x 2 days. Recommended cold compresses and tylenol.
Developed severe polyhydramnios (excess amniotic fluid) and gave birth prematurely. Son was born at 27 weeks gestation; birth weight 2 pounds, 11 oz.
Pfizer-BioNTech COVID-19 Vaccine in patient with immediate hypersensitivity reaction to the first dose; Urticaria; This is a literature report.  Two mRNA coronavirus disease 2019 (COVID-19) vaccines, Moderna and Pfizer BioNTech, require 2 doses for maximum efficacy. This case series reports the safety and immunogenicity of a graded administration of the second dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines in patients with immediate hypersensitivity reactions to the first dose. A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergic rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TYPE I HYPERSENSITIVITY (medically significant) with onset 2021, outcome "unknown", described as "Pfizer-BioNTech COVID-19 Vaccine in patient with immediate hypersensitivity reaction to the first dose"; URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "Urticaria". The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: 15.85, notes: log 2 dilution. Therapeutic measures were taken as a result of type i hypersensitivity, urticaria.; Sender's Comments: Based on the information currently available, a role of bnt162b2 vaccine in this patient cannot be completely excluded,Linked Report(s) : PFIZER INC-202200151789 Same article/ drug/event and different patient:
Brought to ED on 3/31/18 with reported seizure like activity following fever of 103. Pt had been diagnosed w/ear infection on 3/23/18 and placed on AUGMENTIN. Pt seen 3/30/18 and had improved. DtaP administered on 3/30/18.
No adverse events/outcomes - pt was 61 and received a high-dose flu shot (only recommended in 65 and older) instead of a regular flu shot
Sudden onset of severe joint pain that started in the left arm and progressed to neck, legs, feet, and right arm. Pain started to occur shortly after the flu shot was administered and continued to progress to different joints for the next several days. Symptoms have continued.
fever low grade x 2 days;generalized papular rash blanched w/pressure, irritable, dec appetite;MMR rxn, given atarax;
My left hand where I had the shot went numb an hour or so later until the next day,  arm was very sore for 3 days, sweats,chills, fast heart beat, light headed, dizzy
Pt recvd Hep B vax given 3AUG89, 5SEP89, & 23JAN90; 16MAR90 titer=105; 7MAR91 titer=2; Pt given a 4th dose of Engerix-B vax on 26APR91 p/4th dose titer=185;
he has tested positive for Covid-19; not feeling well; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (he has tested positive for Covid-19) and VACCINATION COMPLICATION (not feeling well) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced COVID-19 (he has tested positive for Covid-19) and VACCINATION COMPLICATION (not feeling well). At the time of the report, COVID-19 (he has tested positive for Covid-19) and VACCINATION COMPLICATION (not feeling well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment medication provided.
pt recvd vax; SOB, heavy chest, coughing & sneezing; observed for 3hr at clinic; tx w/ inhaler
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions and allergies were not reported. On 24-AUG-2015, the patient was vaccinated with an unknown dose of VAQTA that was improperly stored (lot # L009445, expiry date 01-JUN-2017, route was not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial case received from a consumer, who is also the patient, on 24 May 2011. A 43-year-old female patient received an intramuscular shoulder injection of ADACEL (lot number C3476AA) on 23 August 2010. The patient had a history of penicillin allergy, with no other medical conditions. Per the reporter, the injection was administered "incorrectly to shoulder bone", and the day of vaccination she began experiencing pain and limited movement of the arm. She noted that she had been experiencing ongoing arm pain, shoulder ache, and an inability to lift her am since that time. The patient had undergone physical therapy, MRI's, and had been seen by neurologists. In May 2011 she underwent surgery on her shoulder, and stated that she was told she had "an area of her shoulder bone that is deteriorating". At the time of the report, the events had not resolved.
This spontaneous report was received from a consumer who saw a video on the internet referring to several female kids of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patients were vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On unknown dates, the patients died after the vaccination due to an unspecified reason; it was unknown whether an autopsy was performed. The reporter did not provided causality assessment between the patients' deaths and vaccination with GARDASIL 9. Upon internal review the patient's death was determined to be medically significant. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1809USA000416: Reported Cause(s) of Death: Unknown cause of death.
Vaccine (HPV) given 8/27/10. No s/s until Sat. nite. Injection site red, hot to touch, vomiting, & 102 degrees fever (per mom) started to have problems breathing. Sun am 8/29/10 went to emergency. Was given Prednisone & sent home with improvements.
Extensor surface of left upper arm with clustered vesicles with scabbing in the middle. Redness, swelling, itching for 3-4 days. Treatment: oral BENADRYL or topical calamine lotion.
An hour after immunization, experienced increasing congestion, sore throat; over the following few days increased congestion and coughing, laryngitis, inflamed eyes (looked like conjunctivitis).
Resident was end of life care, tested positive for COVID-19 8/26/21 and expired