chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M036156 with expiration date 23-FEB-2019, lot # M037248 with expiration date 21-FEB-2019, lot # M031574 with expiration date 11-NOV-2018 and lot # L048848 with expiration date 09-AUG-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 13.1 degrees Celsius for 7 hours and 50 minutes. A Digital Data Logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014902: US-009507513-1705USA007308: US-009507513-1705USA007306: US-009507513-1705USA007307: US-009507513-1705USA007303: US-009507513-1705USA007305.
Dizziness; Vision Changes; Nausea; Headache; This case was reported by a other health professional via sales rep and described the occurrence of dizziness in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced dizziness, visual disturbance, nausea and headache. On an unknown date, the outcome of the dizziness, visual disturbance, nausea and headache were unknown.   It was unknown if the reporter considered the dizziness, visual disturbance, nausea and headache to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The caller was a health care professional field Representative called in the report on behalf of the certified medical assistant.   The patient received Bexsero and had complaints of dizziness, vision changes, nausea and headache. The reporter did not consent to follow up. The field representative had no information regarding the two reported patients as for their gender or names or medication lot Numbers or when the medication had been given.  This case linked with US2020159631, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159631:same reporter
Information has been received from a physician concerning a 4 year old male who was vaccinated with the second dose of MMR II "standard dose" (lot # not available). The patient experienced a "gelatin anaphylaxis" after receiving the second dose of MMR II. The patient was given "epinephrine injection" (manufacturer unknown). It was unknown if the patient experienced AE with the first dose of MMR II. On an unknown date, the patient recovered from gelatin anaphylaxis. The patient sought medical attention with the physician. Gelatin anaphylaxis was considered to be an other important medical event by the physician. Additional information has been requested.
The employee developed a rash to arms, torso and legs after receiving TDAP vaccine 6/5/12. Was seen in emergency room and was prescribed Dexamethasone 0.75mg Dospak tapering dose. The rash and itching diminished with the Dexamethasone.
inconsolable crying for 4hr p/vax;no other sx;afeb;no treatment;asymptomatic following day p/vax;
pt recv vax 11JAN99 & 14JAN99 mom called & stated pt had a knot in lt leg @ inj site;mom told to bring child to hlth dept;mom stated would come by;15JAN99 mom didn't come to hlth dept 14JAN99knot the size of quarter & tenderness @ site;
Cardiac Inflammatory Response - chest pain, dizziness, hypertension, numbness, heart palipitations
Pt got shot on 9-1. On 9-11 pt was standing and all of the sudden pt collapsed (legs felt weak). Pt went to hospital. Hospital said was vasovagal and discharged pt. Pt went to cardiologist and was on a heart monitor for a week. Pt went to see md, doctor said heart is fine, call primary because patient said had flu shot recently. PCP called pt, said think having a reaction to flu shot, and sent pt to neurologist. Pt went to neurologist, and collapsed twice in office and was sent to hospital. was there 6 days, Had 2 MRI, spinal tap, all came back ok. Hospital said mild reaction to flu shot. Pt sent to rehab for 2 weeks. Home now and getting therapy at home.
I had no Covid symptoms, but I was getting a pre-op Covid test and it came back positive. Over the next several days I had mostly mild symptoms like sore throat and then fatigue, but then I had 24 hours of vomiting and diarrhea and that quit and then I had an ocular migraine with weird floating things in my vision for awhile. It eventually moved into a stuffy nose and I'm currently in the stuffy nose and headache portion of Covid. It's been more of a nuisance that anything, except the vomiting.
Mom called on call RN consult services 3d post injection described left arm swollen approximately 2" x 2", red warm where shot given - able to use arm, tender, itch, no streak no fever
Patient describes her arm feels like there is a cuff around her bicep area.  She reports it is constant.  Full range of motion for patient.  No clear discoloration on patient's arm to date (10/25/2016) patient reports no pain on injection site rather arm below injection site.
Several yrs go pt recvd Hep-b series; several months ago tested for antibodies to Hep B; pts antibody test was neg; pt indicated gave myself a booster dose waited several wks & repeated the antibody study & asked for an absolute titer;
Fever, fatigue Narrative: Per supervisor report: "received his COVID Vaccine on 8/10/2021 and is reporting symptoms of fever, fatigue, and is requesting [leave]."
Approx. 30 min after receiving 4 vaccines Pt became nauseous, felt feverish, arms felt like they were swelling.
DOS: 12/19/16. Chills, dysuria on and off, arthralgias and swelling, erythema L upper arm skin. TX: Cold therapy.
had pretty severe side effects after the primary doses; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had pretty severe side effects after the primary doses) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (had pretty severe side effects after the primary doses). At the time of the report, IMMUNISATION REACTION (had pretty severe side effects after the primary doses) outcome was unknown.            No concomitant information was reported. No treatment information was provided.   Reporter did not allow further contact
Flu like symptoms; This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for 3 patients. This is the third of 3 reports.  A patient of unspecified age and gender received first dose of meningococcal group b rlp2086 (TRUMENBA), at single dose and second dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), both via an unspecified route of administration on the same unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms on an unspecified date for 3 days with outcome of unknown.  The information on the lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019166742 Same reporter/products/events, different patients;US-PFIZER INC-2019170863 Same reporter/products/events, different patients
Pain in biceps/triceps muscle. 2 inch wide band of redness and edema wrapping from just below injection site to the inside of elbow. Warm to the touch, painful. Symptoms resolved 10/11/11 - patient has had previous influenza vaccines with no adverse reactions other then malaise/soreness at injection site.
pt calls Monday morning to report that event started about 3 hours later with severe itching all over including bottom of feet and palms of hands.   At this time he has not taken anything.  He has been instructed by this nurse to get OTC benadryl  for the itching.   He reports he has a raised rash all over his body but "it goes away but comes but come back when I start scratching again."   " I am just miserable. "  Pt states he did have a short episode of SOB and difficulty swallowing last evening  "but it only lasted for a little bit and I thought it was from my COPD but I'm not a doctor.  But I've never had anything like that happen before. "  Pt was instructed to go to the nearest ER if this happens again.  verbalized understanding.
5/5/21 Abdominal discomfort. Clear liquid and mucous anal discharge. Multiple times over 6 hours. Continued discomfort into 5/7/21.
Developed Miller Fisher syndrome - started with fatigue and headache on 10/27, developed diplopia and fever (fever lasted ~3 days) on 10/29 as well as weakness. Admitted and evaluated - ultimately treated with IVIG
pain at the injection site (similar to the 1st and 2nd doses); she had small adverse effect with the 2nd dose,she had boy on her forearm 2 days after getting the shot; This spontaneous case was reported by a consumer and describes the occurrence of FOREARM FRACTURE (she had small adverse effect with the 2nd dose,she had boy on her forearm 2 days after getting the shot) and VACCINATION SITE PAIN (pain at the injection site (similar to the 1st and 2nd doses)) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 2001A21A) 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) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FOREARM FRACTURE (she had small adverse effect with the 2nd dose,she had boy on her forearm 2 days after getting the shot). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site (similar to the 1st and 2nd doses)). At the time of the report, FOREARM FRACTURE (she had small adverse effect with the 2nd dose,she had boy on her forearm 2 days after getting the shot) outcome was unknown and VACCINATION SITE PAIN (pain at the injection site (similar to the 1st and 2nd doses)) had resolved.            no concomitant medication were reported.  no treatment medication were reported.  She had to clean and drain the boy.   She has had boy in her armpit before but never on her forearm   This case was linked to MOD-2021-423448, MOD-2021-422951 (Patient Link).
Pt has severe headaches with no specific area and problems with bright lights and noises. This started approximately 7/6/2021
Fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) 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 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication reported. No treatment information was provided.
Patient was 13 year old M who received booster dose vaccine although not approved for his age. Incident occurred by accident but patient observed for 15 minutes after vaccination and no adverse outcomes noted. No other phone calls received regarding any adverse outcomes to date.
Pt recvd 1st dose of Hep B vax on 10OCT91 & shortly following vax pt devel hot area around inject site which was red & swollen & was 8" long by 3" wide; it was warm to touch; w/in 1 1/2 hr following vax sx resolved;
Tingling in esophagus and chest.; warm/burning sensation in esophagus; warm/burning sensation in chest.; This is a spontaneous report from a contactable Other Health Professional (patient). This is the 1st of 2 reports for the second dose.  A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in right arm at age of 34-years, on 11May2021 14:00 (Lot Number: EW0173) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included systemic lupus. And the patient diagnosed with COVID-19 prior to vaccination. She had not tested for COVID-19 since the vaccination. The patient was not pregnant. There were concomitant medications but unspecified (the patient received other medications within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical Vaccine included the first dose of BNT162B2 that was administered in right arm at age of 34-years, on 22Apr2021 10:15 (Lot Number: ER8730) for covid-19 immunisation. The patient experienced tingling and warm/burning sensation in esophagus and chest on 11May2021. Treatment received included Benadryl for above events. Events outcome was unknown.  No follow-up attempts needed. No further information expected.; Sender's Comments: Based on the available information the events Paraesthesia, Oesophageal pain and Chest pain are most likely related to an intercurrent or underlying condition which is not related to the subject drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a physician who is the mother of a 4 year old "normal, healthy" male patient with "no significant medical history" who in approximately 2000 (at ate 12-18 months of age) was vaccinated with a dose of varicella virus vaccine live and "has now developed breakthrough varicella". There was no concomitant medication . On "Sunday" 10-Aug-2003, the mother first noted that he had 2 lesions. On "Tuesday" 12-Aug-2003, "he had an obvious rash" and now had "approximately 100 lesions", most were papular and "approximately 10" were vesicular. It was noted that he did not have any fever or other complications, however, he had not complained of his "belly hurting" though he had "no obvious digestive problems." It was also noted that he has not had any "known, recent exposure to varicella", he attends daycare and the mother was not aware of any recent varicella outbreakes at the daycare center. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous case initially received on 15-Nov-2016, was reported by a health professional and concerns a 63-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 11-NOV-2016 to 11-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT54206. No additional suspect drugs. Adverse reactions/events and outcomes: On 11-Nov-2016, the patient experienced an injection site reaction (outcome: Not recovered / Not resolved). On an unknown date, a knot developed this same day at the injection site (outcome: Not recovered / Not resolved), the knot became itchy (injection site) (outcome: Not recovered / Not resolved), the knot became red (injection site) (outcome: Not recovered / Not resolved) and the vaccine stung after injection (outcome: Not recovered / Not resolved). Symptoms were still occurring on 14-Nov-2016. The patient was referred to a medical doctor by the pharmacist. Reporter comments: The healthcare professional considered all events as non-serious and related (probable) to AFLUIRA. Case correction (31-Jan-2017): The event 'injection site reaction' was removed as the injection site reactions were specified.
This spontaneous report as received from a physician refers to a female patient of unknown age. No concurrent conditions or medical history were provided. On an unknown dale, the patient was vaccinated with a dose of M-M-R II, injection (strength, dose, route of administration, lot# and expiry date unspecified). No concomitant medications were reported. The physician reported that the patient experienced a lo rubella titer after receiving M-M-R II on an unknown date. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Oct2021 at 11:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "4 autoimmune diseases" (unspecified if ongoing), notes: 4 autoimmune diseases; "Penicillin" (unspecified if ongoing), notes: known allergies Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive, notes: Rebound Covid. First positive, 30May2022; (05Jun2022) Negative, notes: Tested negative twice (5 & 9 June); (09Jun2022) Negative, notes: Tested negative twice (5 & 9 June); (14Jun2022) Positive, notes: Symptoms reoccurred and tested positive 14Jun2022. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
generalized urticaria over entire body; t100; was given DPH & pt's rash disappeared next day;
Numbness; paresthesia starting at toes, progress up to ankle and invalving hand; poor balance; acoustic neuroma; general sense of incordination, decreased sensation; mild ataxia in legs; postural tremors of hands bilaterally; Guillain Barre Syndrome/AIDP; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (3 July 2019).   On 6th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 12th December 2019, 97 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Initial information received on 27 May 2021 via medical record. The patient received 1st dose of Shingrix on 3 July 2019 and 2nd dose on 6 September 2019. The patient experienced  guillain barre syndrome and AIDP on12 December 2019. The patient had numbness, paresthesia starting at toes, progress up to ankle and involving hand, poor balance, acoustic neuroma, general sense of incordination, decreased sensation, mild ataxia in legs, postural tremors of hands bilaterally.
Adacel immunization from shipment that was too long in transit / no adverse event; Initial information received on 04-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 5 patient (with an unknown demographic) who was vaccinated with dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and Expiry date unknown) via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error due to incorrect product storage. It was reported that 5 patients who received Adacel immunization from shipment that was received last week that was too long in transit.  It was not reported that if any adverse reaction was experienced or not.  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 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.  Information on the batch number was requested.  List of documents held by sender: none.
Skin around site of injection became very red & warm to the touch w/ itching. Redness peaked at 24 hr & measured 7 cm.
feeling tired; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and FATIGUE (feeling tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 12-Mar-2021, the patient experienced FATIGUE (feeling tired). On 11-Mar-2021, PAIN IN EXTREMITY (Arm soreness) had resolved. At the time of the report, FATIGUE (feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Patient received Moderna Vaccine yesterday 03/03/2021 and woke this morning 03/04/2021 with swollen eye. Patient called the hospital and was advised to go to ER. Patient took Benadryl and called the health department to notify us of reaction Patient was advised to follow up with ER if swelling continues and if difficult breathing or tongue swelling occurs.