chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to an approximately 14 year old male patient. Information about pertinent medical history, concurrent conditions, and drug reactions/allergies was not provided. Concomitant medication included diphtheria toxoid, pertussis acellular vaccine, tetanus toxoid (reported as "TDAP")  and a meningococcal vaccination. On an unspecified date in 2016, the patient was vaccinated with the first dose 0.5 milliliter GARDASIL 9 (frequency, route, lot # and expiration date were not reported) for prophylaxis at the age of 13 years old. The patient then came back to the office again and got his second dose 0.5 milliliter GARDASIL 9 (frequency, route, lot # and expiration date were not reported) for prophylaxis on an unspecified date in 2016. The patient subsequently finished the series by getting his third dose 0.5 milliliter GARDASIL 9 (frequency, route, lot # and expiration date were not reported) for prophylaxis on an unspecified date in 2017. Sometime in 2017, the patient started complaining of joint pain. Information about lab diagnostics/studies and medical attention was unknown by the reporter. The outcome of the event was unknown. The causality between GARDASIL 9) and the event was not provided.
Diarrhea; Headache; Whole right arm sore; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 14Apr2021 at 14:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), taken for an unspecified indication from an unknown date and unknown if ongoing. On 14Apr2021 at 14:15, the patient experienced diarrhea, headache, whole right arm sore and fatigue. The events did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. 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 diarrhea, headache, whole right arm sore and fatigue were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a elderly female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a month after receiving SHINGRIX, the patient experienced injection site warmth, injection site muscle pain and injection site induration. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site warmth, injection site muscle pain and injection site induration were recovered/resolved. It was unknown if the reporter considered the injection site warmth, injection site muscle pain and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination could be 71 years or 72 years. The patient was 72 years old at the time of reporting. The patient received SHINGRIX in the left deltoid. The patient experienced warmth, hardness and soreness of the muscle at injection site for about 2 days and that she was treated with Ibuprofen. The patient gave contact details of the physician. For tolerance to 2nd dose of SHINGRIX, refer case US2018GSK134425.
Flushing/sweating. Blood pressures 148/84 (pulse 81), 141/84 (pulse 78). O2 sat 97%.
Patient developed rashes in the back day after the shot was administered. Rash was itchy and eventually went away after 2-3 days.
First vaccine on 4/12/21.  Second dose on 5/10/21.  Rash around injection site developed on 5/11/21.  On 5/13/21 while at home and simply walking, I fell to the ground due to sudden onset, excruciating pain and total loss of use of my left arm.  I could not move it at all.  Screaming for help, my husband drove me to the Emergency Room They did a  MRI Cervical Spine Wo Contrast, Us duplex venous upper extremity, XR Shoulder 2+ Vw Left.  Diagnosed with PARSONAGE-TURNER SYNDROME and discharged with sling and swathe and instructions to follow up with neurologist and begin physical therapy.  Neuro consult and PT began on 5/14/21.  As of today, 09/27/2021, I am still in Physical Therapy, see pain management doctor and am still without the use of several muscles and have limited feeling in my left thumb.   I have had to use acupunture, PT, Pain meds, many neurology and pain management visits.
My mom also received the Pfizer vaccine and had gallstones after as well; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that I'm not sure if this was caused by the vacccine or not, but I got gallstones and had gallbladder removal surgery after. My mom also received the Pfizer vaccine and had gallstones after as well (cholelithiasis) (non-serious) on an unspecified date with outcome of unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
forty three children were administered varicella virus vaccine from a shipment that was stored out of the refrigerator for 5 days; This spontaneous report has been received from unspecified reporter via company representative concerning a children of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. The reporter stated that the patient was vaccinated from a shipment that was stored out of the refrigerator for 5 days.   This is one of 45 case reported by the same reporter..
Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD ((i.e. past 30 days at fridge temperature); previously received 1 dose of AstraZeneca; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD ((i.e. past 30 days at fridge temperature)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (previously received 1 dose of AstraZeneca) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination.    No Medical History information was reported.   On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD ((i.e. past 30 days at fridge temperature)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (previously received 1 dose of AstraZeneca). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD ((i.e. past 30 days at fridge temperature)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (previously received 1 dose of AstraZeneca) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not given Treatment information was not provided by the reporter.  The reporter had confirmed that the individuals did not report any adverse events after receiving their vaccine dose.   This case was linked to MOD-2021-321072, MOD-2021-320812, MOD-2021-320876 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Patient demograhics (age, gender) updated. Cosuspect (AstraZeneca) was added. Dose number, route of administration and expiry date was updated for suspect. On 22-Sep-2021: Follow up document received on 22-sep-2021 contains no significant information.
Information has been received from a physician concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 651321/1036P). Subsequently, the day after vaccination, the patient developed severe arm soreness, high fever, nausea, vomiting, and weakness. The patient sought unspecified medical attention. Subsequently, the patient recovered. The physician requested a lot check of lot 651321/1036P. The physician felt that the patient's severe arm soreness, high fever, nausea, vomiting and weakness were disabling. Additional information has been requested.
2nd dose of vaccine > 63 days after 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of vaccine > 63 days after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of vaccine > 63 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of vaccine > 63 days after 1st dose) outcome was unknown.        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.
mom of client approached front desk clerk @ 3:25PM telling her that child had rolled eyes back & could only see the whites;child also shook, which had not done before for a short amount of time;tonic clonic extremity x 10sec or so;
Sore; Not feeling well; Flucelvax Quadrivalent and Shingrix vaccine were administered on the same day in the same arm; This spontaneous case was retrieved on 24-Nov-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2504348-1) reported by other healthcare professional and concerned a 62-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications included albuterol, used for shortness of breath. The patient had no known drug allergy.  On 09-Nov-2022, the patient was vaccinated with non-company, co-suspect Shingrix (varicella zoster vaccine rge (cho); route of administration: intramuscular, anatomical location: right arm, dose, and indication: not reported). The batch number reported was 2LC3P.  On 09-Nov-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular, anatomical location: right arm, dose, and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was 351711. The reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent instead of reported suspect product Fluad Quadrivalent. Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On the same date, after receiving Flucelvax Quadrivalent and non-company, co-suspect Shingrix, the patient experienced just sore and not feeling well.  The outcome of the events of 'feeling unwell' and 'pain' was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 62-year-old female patient was vaccinated with Fluad Quadrivalent and with non-company, co-suspect Shingrix, on the same arm and in the same day (explicitly coded as 'Product administration error'). On the same day following vaccination, patient experienced pain and malaise. Despite confounding by co-suspect vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to suggestive temporal relationship. Product administration error is assessed as not related as per company specific guidelines.; Sender's Comments: A 62-year-old female patient was vaccinated with Fluad Quadrivalent and with non-company, co-suspect Shingrix, on the same arm and in the same day (explicitly coded as 'Product administration error'). On the same day following vaccination, patient experienced pain and malaise. Despite confounding by co-suspect vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to suggestive temporal relationship. Product administration error is assessed as not related as per company specific guidelines.
Generalized weakness mainly legs, vertigo 1 day after PREVNAR 13. Unable to walk, hospitalized 9/7-9/13/16, no other etiology found.
get shingles after had the shots /suspected vaccination failure; shingles; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had shot and got painful flares of shingles on side and back. The reporter stated that, causes lots of serious side effects too. The reporter thought, ongoing stress was a primary cause of shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. This case was linked with case US2021AMR198924, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198924:same reporter
01/20/21 @ 07:00 am Body ache, temp, 101 degrees F, chills, light headache and runny nose for two days. Verbalize feeling well and recovered.
Patient had pain at the injection site starting evening of 12/2/21.  He developed chest pain and difficulty breathing around 8pm on 12/3/21 and went to the emergency room , where he had a cat scan and was treated.  According to the after visit summary from the hospital provided to the patient he was diagnosed with atrial fibrillation with RVR, Dyspnea, and adverse reaction to covid-19 vaccine.
Information has been received from a pharmacist concerning a 12 year old male who was vaccinated about 1 month ago with Vaqta. In approximately July 2006, a week after the vaccination, the patient experienced a red rash on his chest that "seemed to form in lines." "The rash seems to have come and gone several times over the last three weeks". Unspecified medical attention was sought. No other symptoms were noted. There was no product quality complaint. Additional information has been requested.
administrating an expired daptacel vaccine with no reported adverse event; Initial information received on 27-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of unknown age and gender who was administered an expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (strength: standard) (lot number: expiry date not reported) via unknown route in unknown administration site for Immunization.  On an unknown date the patient was administered an expired daptacel vaccine with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 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.
1 1/2 hrs p/shot pt called occupational hlth & said was not feeling well; pt was advised to go to ER, but pt did not do @ that time; later, around 9PM pt felt dizzy; pt passed out & then went to ER; pt given DPH & sent home; pt recovered;
pt woke up w/extreme temp @ 2AM; mom took clothes off x/diaper gave APAP; pt played w/dad 10 mins; convuls came then laid pt down-lasted 3 minutes;
Called 4-5 hrs post receiving PCV7 in R leg stating R leg warm and red above knee. VIS sheets were given out the AM. Instructed to apply warm compresses give bath. Monitor area and call if any A's.
Patient given 10 microgram Moderna Bivalent dose for 6m-6y instead of 25 microgram dose per new recommendations
Patient stated that she felt light headed and could feel her heart pounding. Patient was diaphoretic and had a rapid pulse. Patient was taken to recovery via wheelchair to lay down on cot,  an ice pack was placed on the back of her neck. Patient stated that she felt better after 20 minutes and walked to her car without incident.
later that night at home about 6:15 I stared to get a red rash across my chest and on to my left arm and was very itchy, then was hard to take deep breaths. I also got a pretty good size bruise on arm I got the shot in and arm was sore for 2 days. I also had lil bit of rash around where shot was.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovering/resolving. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. After receiving SHINGRIX, the patient had redness localized to around the injection site. The redness was approximately 5-6 inches around and has lasted 2 weeks. The patient stated that redness was improving and she has not sought any interventions or seen her PCP due to this reaction.
Climbing Fever starting around 9:00 pm with current temp of 102.2 as of 10:50 pm (body temperature usually <97). Severe chills onset around 9:30 pm. Mild Soreness at injection site starting approximately two hours after vaccination.
information has been received concerning a pt with varicella exposure on approximately 06/04/00 who in June of 97 had been vaccinated with varicella vaccine. The pt experienced breakthrough chickenpox that consisted of 2 vesicles on 06/14/00. Pt had 11 vesicles on 6/15/00, and 37 vesicles by 06/17/00. Otic temperature was 98.5F. The pt symptoms resolved quickly and he was asymptomatic by 06/19/00.
Was sitting at home and my ears began ringing, they have been ringing everyday non stop since.
LARGE RED INFALAMMED RASH 2' X 4' -  WITH RASH INVOLVED ON BICEP...SORE BUT FULL RANGE OF MOBILITY...
stomach irregularity and stated her bowels are now acting differently; has been "gassier"; started out with diarrhea; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of BOWEL MOVEMENT IRREGULARITY (stomach irregularity and stated her bowels are now acting differently), FLATULENCE (has been "gassier"), DIARRHOEA (started out with diarrhea) and VACCINATION SITE PAIN (arm pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BOWEL MOVEMENT IRREGULARITY (stomach irregularity and stated her bowels are now acting differently), FLATULENCE (has been "gassier"), DIARRHOEA (started out with diarrhea) and VACCINATION SITE PAIN (arm pain). At the time of the report, BOWEL MOVEMENT IRREGULARITY (stomach irregularity and stated her bowels are now acting differently) was resolving and FLATULENCE (has been "gassier"), DIARRHOEA (started out with diarrhea) and VACCINATION SITE PAIN (arm pain) outcome was unknown.            No concomitant medication details was reported.  Patient had the 3rd full dose three weeks ago. She reported experiencing arm pain that lasted two days after the injection. The caller also stated that she had stomach irregularity and stated her bowels were now acting differently and she had been "gassier" since received the 3rd dose.  She stated that initially the stomach irregularity started out with diarrhea but progressed into stomach irregularity. The caller stated that the stomach irregularity had gotten a little better now but was still ongoing.   No treatment medication details was reported.
sudden  blurry left eye vision- has had to get  eye shots for macular degeneration to left eye. He states the left eye was his good eye and he hsa lost  good vision now and still  with visual defects and flaoters and blurry  Also  worsened diarrhea form celiac at a time when he was stable with the disease
Patient thinks she had a reaction to the flu shot. Had nausea and throat started to swell within about 3 hours from having shot. Was out to dinner when it happened. Pt was fine within a few hours. Pt allergic to thimersal but HD is preservative free without thimersal. Pt thought that was what caused reaction.
Blurred Vision, Dizziness, given juice, evaluated by paramedic on site,  mom reported he didn't eat breakfast and mowed the lawn,  color returned, went home with mom
Went to the ER for mild swelling of the mouth and throat, also had chills, body aches, fatigue, muscles aches.
Per staff at hospital. Dr. stated patient had weakness, numbness and tingling and symptoms of Guillain-Barre.