chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a licensed practical nurse concerning a 35 year old female secretary with asthma exercise induced, Crohn's disease, terminal ileitis, transverse colitis in remission, gastrooesophageal reflux disease, gluten intolerance, lactose intolerance, diarrhea predominant irritable bowel syndrome, pernicious anaemia, vitamin B12 deficiency secondary to malabsorption syndrome, iron deficiency anaemia, migraine, costochondritis, cervical radiculopathy, plantar warts, dysmenorrhoea, penicillin allergy and drug hypersensitivity and a history of motor vehicle accident (01-FEB-2000), Pap smear (March 2006), oesophagogastroduodenoscopy with biopsy secondary to gastritis (19-OCT-2004), negative colonoscopy with biopsies (19-OCT-2004), arthroscopy and appendicectomy (1998) who on 10-JAN-2007 was vaccinated IM into the right deltoid with a first dose of Pneumovax 23 (Lot #651374/0485F).  Concomitant therapy included VENTOLIN HFA, clindamycin, cyanocobalamin, folic acid, iron (unspecified) (+) vitamins (unspecified), ORTHO TRI-CYCLEN and CECLOR.  Illness noted at office visit, same day as vaccination on 10-JAN-2007 included acute right otitis media and externa, refractory pharyngitis and reactive lymphadenitis.  Subsequently, on 10-JAN-2007, the patient developed a localized reaction of the right upper arm and injection site rash that was described as a red welt at the injection site that was warm to touch and painful.  No time line for the development of the rash was available.  The patient was told to take ADVIL with food, BENADRYL and ice the injection site.  The patient was not followed by the office but was considered recovered on an unspecified date.  No product quality complaint was involved.  A lot check was requested by the reporter.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released by the regulatory agency.  Additional information is not expected.
Vaccine expired on 1/2/2022 but was administered on 1/3/2022. No adverse event after vaccine
I didn't have any reactions to the vaccine. On the first day of catching COVID-19 I had an itchy throat. Then on day 2 or 3 I developed a cough. On day 5 or 6, I went to an urgent care because I had chest pain. I was prescribed benzoate. They told me to rest as much as possible because I was getting early signs of bronchitis. I was drowsy and had a little bit of loss of appetite, but I was still able to eat. After about 10 days, I felt pretty normal again. My throat stayed itchy the entire time. I had a cough for a total of about 25 days.
This spontaneous report as received from a medical assistant who administers vaccines refers to a patient of unknown age. The patient was vaccinated with a dose of GARDASIL (lot # reported as H012973; expired on 05-MAR-2015) intramuscularly on 28-NOV-2012 that was exposed to an unsupported temperature excursion (70F for 96 hours). This is the only dose of GARDASIL this patient has received. No other co-suspects were reported. No concomitant medications were reported. It was unknown that if the patient had sought medical attention. NO adverse effect reported. Additional information has been requested.
suspected vaccination failure; I developed shingles on eye; shingles on head, scalp, forehead, nose and inside the upper lip; Absolutely awful!; I had all three shingles shots.; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, feels awful and extra dose administered. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, shingles, feels awful and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and feels awful to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient stated that he/she had all three shingles shots. Despite that the patient developed shingles on the right side of my head, scalp, forehead, eye, nose and inside the upper lip. It was absolutely awful. The follow up would not be possible since no contact details provided. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not reported.
Patient started itching and had mild hives. Reported to her manager who accompanied her back to the Covid Clinic. Patient was assessed and was given Diphenhydramine 25mg orally x 1.
Redness, warmth, elevation of 30mm appearing within 24 hrs and disappearing 48 hrs later.
BI LATERAL LEG SWELLING AND FEVER. TREAT WITH ICE AND TYLENOL AND FOLLOW UP WITH DR. IF SYMPTOMS CONTINUE
patient had redness and itching at the injection site spreading to the entire arm.  Redness further spread up the neck and patient had a tickle in her throat.  Pulse 101, BP 126/88 and O2 was 98%.  Pt was given an ice pack and benadryl then monitored until redness had receded and itching resolved.  Pt given instructions to go immediately to the ER if symptoms resumed or she had other allergic reactions.  Pt was also instructed to dose with benadryl at bedtime.
p/vax pt hosp w/12 hr hx bilious emesis/heme pos jelly stools;dx intuss??;EIA test for rotavirus weakly pos; disch 7/23;dx viral GE;8/4 hosp for emesis & diarrhea; differential dx include recurrent GE;recurrent self-reducing intuss;
Initial information has been received from a registered nurse concerning herself with a history of cataracts, who on 03-AUG-2012, was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. On 05-AUG-2012, the patient developed headache and experienced cloudiness in her vision when moving her eyes. On 06-AUG-2012, the patient visited an unspecified ophthalmologist, who by unspecified means found an unspecified problem with the retina in her right eye. The ophthalmologist sent the patient for further unspecified testing on an unspecified date which found a blood clot in the patient's branch artery of the right eye. The patient did not indicate how or if the blood clot in the right eye was treated, however she reported that the blood clot resolved on an unspecified date. On 21-AUG-2012, the patient visited an unspecified physician due to the continued headaches, cloudy vision and new onset of the neck pain with no nuchal rigidity at which time the unspecified physician prescribed unspecified dose of VALTREX. The patient reported that after starting VALTREX on an unspecified date, the headaches resolved. Additional information has been requested.
Numbness, weakness in hands, feet, arms, legs, fingers, toes. Fatigue/exhaustion. Guillain-Barre syndrome. IVIG infusions given.
an hour or two migraine; arm right hurt/arm pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (an hour or two migraine), PAIN IN EXTREMITY (arm right hurt/arm pain) and MYALGIA (muscle pain) in a 30-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (an hour or two migraine), PAIN IN EXTREMITY (arm right hurt/arm pain) and MYALGIA (muscle pain). At the time of the report, MIGRAINE (an hour or two migraine), PAIN IN EXTREMITY (arm right hurt/arm pain) and MYALGIA (muscle pain) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications reported.  No treatment information was provided.
Right after I finished the shot, pt's head dropped down & had approximately 10 seconds of seizures. But she regained consciousness right away. She didn't remember what happened & was scared. After 10 mins rest we helped her get home & she slept.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ orally, either lot number L033694 with expiration date of 16-JUN-2017 or lot number M019708 with expiration date of 25-OCT-2017 (strength and dose were not reported), which was stored at 48.6 Fahrenheit degree for 128 hours and 15 minutes. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases from the same reporter. Additional information has been requested.
previously have small psoriasis on neck; spot on neck became inflamed, hot, itchy.; spot on neck became inflamed, hot, itchy.; Which lead me to some anxious moments with racing heart; Which lead me to some anxious moments with racing heart; tightness/soreness in chest; tightness/soreness in chest; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ek9231), dose 1 via an unspecified route of administration, administered in left arm on 11Jan2021 07:30, as single dose for COVID-19 immunisation was in hospital. The patient medical history was not reported. Concomitant medications included citalopram and lisinopril. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. On an unknown date in Jan2021, the patient experienced previously had small psoriasis on neck. After each dose, spot on neck became inflamed, hot, itchy. Which lead me to some anxious moments with racing heart and tightness/soreness in chest. The patient underwent lab tests and procedures which included heart rate: racing in Jan2021. The patient did receive treatment to the events. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Patient was sitting up in a chair; Gardasil immunization was administered in left upper arm, at approximately 9:15 to or around 9:30am on August 31, 2007.  Immediately following shot:  Arm pain, then very quickly, within 3-5 seconds, dizziness, "rushing feeling" in head and stomach, tunnel vision, headache, altered, blurred vision, extreme nausea, cold sweat, felt as though she would lose consciousness, had to lay down on examining table, on her right side.  Cold compress applied.  Patient stayed conscious, did not vomit.  Within about one-half hour, patient felt recovered, and was able to sit, then stand, then walk, without syptoms or assistance.  Patient left doctors office ambulatory, without assistance.  It appears that there have been no long-term adverse effects at this time, but this remains unclear.  Had she not been at a doctor's office already, she would have been taken to one immediately for these very serious syptoms, hence the answer to question #8.
vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and administered on 28-May-2022; Administered with vaccine that is past beyond the 30 day use; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and administered on 28-May-2022) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Janssen on 16-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen.   On 13-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and administered on 28-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and administered on 28-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.   No concomitant medications were provided by the reporter.  No adverse events have been reported by the patient at the time of the call.  No treatment medications were provided by the reporter.
I gave a Pfizer booster to the pt and he had already had one the computer did not put a block to it i noticed it once i printed the avs and look at the immunizations.
No additional AE reported; a temperature excursion was administered to a patient; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.    On 09-AUG-2021, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml; lot # T029522, expiration date reported as 13-MAR-2022, but upon internal validation established as 13-MAR-2023; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The storage temperature was -4.8 Celsius degrees for 20 minutes. There was no previous temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) was reported. No data logger was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T029522; expirationdate: 13-MAR-2023; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
On 10/11/17 I received my annual flu vaccination from my PCM clinic. I have never had any issues with my yearly vaccination, however, what took place over the next few days has me questioning whether or not I had a reaction this year. On the evening of 10/12/17 I fell asleep in my recliner and my daughter had a difficult time waking me. From what she has told me, I went to bed, slept all night and most of the next day (10/13/17.)  She was unable to orient me to where I was, and, apparently, I attempted to get out of bed and fell. My memory is only of being in an ambulance and the EMTs? asking me a lot of questions I could not answer in comprehensible terms. At the ER, it was thought I was having a stroke, but, except for not being able to express myself, a severe headache, and high blood pressure, there were no other indications of a stroke. It was then suggested I might have meningitis. That was ruled out two days later with a spinal fluid test. My speech was gradually returning to normal, the headaches resolved. I did continue to have some blood pressure issues, and developed acute pulmonary edema. The physicians then decided I had probably experienced some type of strange migraine syndrome. (Please note, I have no history of migraine headaches.) I was discharged home from the hospital yesterday, 10/18/17, with only a little physical weakness. The discharge diagnosis was ?encephalopathy.)
Two days after injection, patient experienced headache, right side facial numbness, right arm numbness, pain radiating from right jaw to clavicle, bilateral lower extremity pain.
99.8 Fever, sweats, chills, severe arm soreness, fatigue. Symtoms lasting two days
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 44-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid treatment from 04Nov2023 to 09Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367338 same patient, different drug, different event;
Case number PHEH2012US024794 is an initial spontaneous report received from a pharmacist on 12 Dec 2012: This case refers to a 22-years-old male patient. He was received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: X11073), intramuscularly without being reconstituted with Men A component on 12 Dec 2012. No adverse reaction reported following this administration error (inappropriate preparation of medication).
Body aches and muscle pain of arms and legs - lasted about 36 hours  Severe headache - 7 days Fatigue - ongoing, started after vaccine, still persists Chills (no fever)   Hypoglycemic episodes - sporadic (did not have prior to vaccine) Syncope - once (cause unknown, happened on 5/17)
Pts wife called today stating patient was in hospital for past 3 days for cellulitis in arm from immunizations left arm.
Information has been received from a physician concerning a 12 year old (reported as 10 year old) male who on 15-JUN-1999 was vaccinated with the first dose of MMR II (HSA) (lot # reported as 1537A). On 30-NOV-2009 the patient experienced mumps. On 01-DEC-2009, the patient's temperature was 103 F and he was diagnosed with mumps. He had bilateral parotitis. On 01-DEC-2009 1st blood work was performed and the results showed IgM <1:10, IgG 2.71 and serum amylase 422. At the time of the report, the outcome was unknown. No further information is available.
almost paralyzed; caused terrible pain in her body for a week; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), first dose, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications includes: influenza vaccine on an unspecified date for immunization. The patient experienced almost paralyzed, and caused terrible pain in her body for a week on an unspecified date. The patient received a pneumonia vaccine years ago that caused a horrible reaction which almost paralyzed and caused terrible pain in her body for a week. She mentioned that she took it with the flu shot in which she only usually has a sore body from. It was the first time she has experienced that after getting her 1st Pneumonia shot. The outcome of the events was unknown. The patient also had a brain aneurysm and a brain stent put in on 28May2021. She had since been put on a blood thinner and was also taking asprin. She was wanting to know if it's safe for her to take the Covid vaccine.   Information about lot/batch number has been requested.  Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.
Pt recv vax on 11/5/98; 20 min post vax pt exp dizziness & elevated blood pressure
The area where they gave me first vaccine, they applied a band aid and the band aid mark will not go away, it is like a tatoo on my arm.
Feverish to the touch "burning up" became hoarse and started rash on left side of neck with minimal itching. Just went to bed.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-DEC-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5 mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (2.777777778 Celsius) for 696 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Narrative:  Patient received first dose Pfizer COVID-19 vaccine on 3/9/21. Reports having SOB and increased BP starting <30 mins after vaccine and lasting for 3 days. Resolved on it's own, was advised to go to ED but did not seek treatment. Patient reports previous allergy to flu vaccine and was given epi-pen at that time (self-reported, could not verify in chart).