chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection area just a small tender bump; Injection area just a small tender bump; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious social media case from the non-health care professional (patient's wife).  This case is linked to case 2020SA289784 (same reporter).  This case involves a 76 years old male patient who had a small tender bump at injection area (vaccination site pain and vaccination site mass), after he received INFLUENZA VACCINE.  The patient had received flu vaccines in the past for prophylactic vaccination.  The patient's medical history, past medical treatment, family history and concomitant medication were not reported.   On an unknown date, the patient received a high dose of suspect senior INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious a small tender bump at injection area (vaccination site pain and vaccination site mass), (unknown latency) following the administration of INFLUENZA VACCINE. Otherwise the patient was perfectly fine.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome of the events was not reported.  There will be no information available on the batch number for this case.
Left armpit felt swollen and painful started 2 days after the shot; Left armpit felt swollen and painful started 2 days after the shot; This is a spontaneous report from a contactable pharmacist. A non pregnant female (adult) patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6203) via an intramuscular route of administration in the left arm on 02Mar2021 at 10:30, as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), on an unknown date, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced left armpit pain and swollen arm (two days after the shot) on 04Mar2021. On 11Mar2021,the patient underwent COVID-19 virus test (nasal swab) and was tested negative. The clinical outcome of the events armpit pain and swollen arm was unknown.   No follow-up attempts are needed. No further information is expected.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose was not reported approximately 4 months ago from date of report for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-SEP-2021, the patient was diagnosed with COVID-19 through rapid antigen test and this was a breakthrough infection (suspected clinical vaccination failure, and suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with RA: 90000192472.; Sender's Comments: V0. 20210913849-COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccine failure. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: SPECIAL SITUATIONS
VERY sore even two days later. Woke Sunday early morning (shot was on Saturday afternoon) with chills/shivering, upset stomach, dry heaves from the stomach, and headache. Vaccination site still red (about a two inch circumference), and warm and sore.
Dizzy, fever 101.9, stomach queazy, headache, arm very sore, red and raised at injection site, fatigued. Called Dr, told to take tylenol.
Information has been received from a 79 year old female with no drug allergies and with high blood pressure and gastrooesophageal reflux (GI reflux) and a history of shingles on or about 04-JUL-2008 who in August 2008 ("approximately one month later"), was vaccinated with a SC dose of ZOSTAVAX (Merck). Concomitant therapy included aspirin, TOPROL XL tablets and PRILOSEC. In August 2008, the patient experienced raised, swollen, itchy bumps on the left side of her face from her forehead down to her left eye. The condition rarely subsided and had persisted since August 2008. No lab diagnostics studies were performed. The patient had not sought medical attention for this. Follow up information was received from a nurse practitioner who reported that on 07-JAN-2009 (previously reported as August 2008), the 80 year old female patient (previously reported as 79 year old) with malaise and weight loss at time of vaccination and allergy to codeine, DEMEROL, morphine and T/GEL, was vaccinated with the first dose of ZOSTAVAX (Merck) SC into her left deltoid (lot # 663178/1414X). The reporter was not aware the patient experienced adverse reaction. It was not reporter to the reporter. The onset of the adverse experience previously reported as "August 2008". Additional information is not available.
Patient started with chills, fevers to 100.5 , sore throat, oral mucosal aphthous ulcers within 24 hrs of receiving vaccine.   Patient  continues with these symptoms
Pfizer-BioNTech COVID-19 Vaccine EUA Beginning at 3 am, I became exceedingly nauseated; followed by violent vomiting and extreme diarrhea. Unable to keep down water until now 11:45 am, 2/8. Fatigue and fogginess throughout.
Unable to get out bed for ~18 hours, had 2 incidents where my heart was pounding and I felt like my blood pressure was very high, attempted to take my own blood pressure, wife brought the tester in but it wouldn?t work.  Felt fine the next morning but I think I would take my chances with Covid than do that again.
I was not asked to wait after receiving the vaccine. Within 5 minutes of leaving the left side of my face and left ear began to turn bright red and swell slightly. My ear began throbbing a few minutes later and both my ear and cheek were very hot to the touch. About 30 minutes after receiving the vaccine my symphony?s remained and my left eye also began to hurt. Within 2 hours my symptoms subsided.
NERVE HURT FOR A WEEK; WEAKNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced nerve hurt for a week, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nerve hurt for a week, and weakness. This report was non-serious.
Right Bundle Brach Block Flutter Heart Beat Been taken to Emergeny Romm jan. 11, 13, 18, 21, feb. 04, 13, 18
Arm soreness, on day 4 the arm pain was quite severe and persisted at rest; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration on left arm on 17Mar2021 at 14:00 as a single dose (at the age of 50-year-old) for COVID-19 immunisation. The patient was not allergic to any medications, food, or other products. The patient medical history was reported as hyperthyroidism. Concomitant medications included synthroid (MANUFACTURER UNKNOWN), valacyclvir (MANUFACTURER UNKNOWN), levonorgestrel (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on left arm on 24Feb2021 at 14:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 21Mar2021 at 17:00 (first few days after vaccine), the patient experienced minor arm soreness however on day 4 the arm pain was quite severe and persisted even when patients arm was at rest. On day 5 and not as severe but still hurts every time when she moves her arm. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as result of events and included treatment with meloxicam. The clinical outcome of arm pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt received a Gardasil shot #1 in (Lt) delt on 4-8-08 at 3:00 pm-she got a "vasovagal reaction." She recovered within a few minutes.
4/4/2023 in the afternoon I had a sore throat, muscle aches, fatigue, and headache. 4/5 at home COVID-19 test positive. Televisit with doctor who prescribed PAXLOVID. 4/6 I started to feel much better. Fatigue lingered for about 10 days after the beginning of taking PAXLOVID.
Patient fully vaccinated for COVID on 3/8/21 and 3/29/21, but hospitalized with COVID symptoms on 9/7/21
Pain in arm; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: 1284, expiration date was unknown), via an unspecified route of administration in the left arm on 07Jan2021 at 16:00 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was the hospital. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Jan2021 at 16:00, the patient experienced pain in arm, which was still bad after more than 3 weeks. The patient assessed the event as non-serious. Therapeutic measures were taken as a result of pain in arm, which included paracetamol (TYLENOL) or ibuprofen (ADVIL). The patient was not recovered from the event.
15JUL98 pt recv vax & 22JUL98 dx urticaria rxn @ ped urgent care;fever 101.9;13AUG98 MD office w/ c/o excessive bruising;temp 100x4 noc;
accidentally gave DAPTACEL instead of ADACEL with no reported adverse event; Initial information received on 22-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 11-year-old female patient, accidentally gave diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] instead of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (strength: unknown) (lot: 2CA28C1, expiry date: 04-Nov-2024) via unknown route in unknown administration site for Immunization (immunization) and diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength, batch number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On an unknown date the patient had an event of accidentally gave daptacel instead of adacel with no reported adverse event (wrong product administered) (latency: same day) following the administration of diphtheria-15/tetanus/5 AC pertussis vaccine and -2/tetanus/5 AC pertussis vaccine.  It was unknown if any lab data/test results available.  Action taken with diphtheria, tetanus and acellular pertussis vaccine (Daptacel) and diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was not applicable.  Outcome: 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.
Patient received her vaccination along with 4 other family members. She had received her vaccination 2nd and watched the rest of her family receive theirs. During that time there were no issues or concerns; however, once she left the immunization room she became pale and fainted while seated but regained consciousness rapidly. She was given liquids, wet towels and an ice pack until she felt able to stand up on her own. The entire event lasted about 10-15 minutes. Patient had stated this has only happened one other time and it was while she was getting her blood drawn. Patient left with her family members, walking on her own and color back in her face.
Patient in today for WCE. He needed catch-up immunizations-Tdap & MMR. Adacel was given instead of Decavac by mistake. Review with the state. Mom was notified and this was documented in patients chart.
It started about 20 minutes after vaccination. I started to feel a rush of heat like a hot flash and my heart was racing while I was driving home. My cheeks and lips were swelled up. My tongue was starting to swell but I could still breathe. I was wheezing so I took a Benadryl and then took another four hours later. I felt very light headed for the rest of the day. The light headedness and dizziness stayed for a few days with a headache. I did not have second dose on the recommendation of my doctor. I ended up contracted Covid-19 three weeks after the vaccine.
Redness at site and swelling of arm. Benadryl 50 mg IV given.
AE for improperly stored vaccine administered after temperature; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions and allergies were not provided.  On 10-SEP-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot number 1707460 and expiration date 14-MAR-2022 for prophylaxis (strength, route of administration and anatomical location were not provided; dose and frequency were unknown by the reporter) and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), lot number T026961 and expiration date on 02-APR-2023, for prophylaxis (strength, route of administration and anatomical location were not provided; dose and frequency were unknown by the reporter) (product storage error).  The vaccines were stored at a temperature of 48.7 Fahrenheit (F), for a timeframe of 10 minutes, with no previous temperature excursion.
Was very sick in bed with flu like symptoms for 36 hours after the 3rd Moderna booster shot.  It included fever, chills, fatigue, migraine, and pain in joints. 3 weeks later, I experienced a period of constant dizziness, nausea, and extreme fatigue  for a period of 7 days.  I was unable to do my normal activities.  I scheduled an appointment with my primary physician, but I couldn't get an appointment for another 1-1/2 weeks.  I was already feeling back to normal by the time I had a chance to see him.  So, no further action was warranted.
began having dizziness and mild swelling in skin about both eyes, mild headache, still present, but somewhat less
LEFT DELTOID SWOLLEN,RED, HOT, ITCHING, AND PAINFUL. ALSO LEFT EYE SWOLLEN.
1-2 weeks after dose of vaccine, developed nausea, chills, diarrhea. Presented 1 month after vaccine to ED with embolic strokes and new renal failure.
PATIENT RECEIVED THE PEDIATRIC PFIZER BIVALENT BOOSTER DOSE INSTEAD OF THE ADULT PFIZER BIVALENT DOSE. PATIENT DID NOT RECIEVE A SECOND VACCINE AFTER. PATIENT HAD NO SYMPTOMS OR ADVERSE EVENT. PATIENT WAS TOLD SHE WOULD BE CONTACTED AFTER REVIEWING CDC GUIDELINES, WHICH STATES PATIENT CAN BE REVACCINATED WITHOUT A PERIOD OF TIME IN BETWEEN.
About 10 minutes after the vaccine, pt began to feel bad, vision went black, hearing was muffled/ringing, sweating and dizzy. Pts mom requested an ambulance. He drank a few sips of water and we put cool, damp cloths on his neck.  We considered laying pt flat but he refused saying he was feeling better. His vision cleared, hearing returned , sweating stopped and by the time the fire department arrived he was just shaky. His vitals were all normal by then. He then said now that he thought about it, he flet like it was a panic attack and he almost passed out. i checked on pt again today and he stated that he is now fine.
12 hours post vaccine an approximate 1-inch by 2-inch raised redness area appeared adjacent to the vaccination location. Treated with ice pack and ibuprofen. At 36 hours post vaccination, area of raised redness grew to 4-inches round. Area is hot to the touch and produces pain when touched. clinic examined and prescribed antibiotic (cephalexin 500mg)
spongiotic dermatitis; Hives; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Hives) and ECZEMA (spongiotic dermatitis) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 immunization.     No Medical History information was reported.    On 04-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced URTICARIA (Hives). On an unknown date, the patient experienced ECZEMA (spongiotic dermatitis). The patient was treated with PREDNISONE at a dose of 2 courses of prednisone and TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) at a dose of daily for 2 months. At the time of the report, URTICARIA (Hives) and ECZEMA (spongiotic dermatitis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: revealed spongiotic dermatitis. Revealed spongiotic dermatitis..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Action taken with mRNA1273 is not applicable.
About 5 minutes after vaccination, Patient's mouth and ears started getting tingly.  It became itchy.  About 10 minutes later she felt warm and her throat felt swollen, although it was never difficult to breath.    I asked patient if she would consider taking benedryl.  She said she would take it.  Patient was given 50 mg of benadryl liquid.  Patient stayed one hour past injection time.  Patient was stable after leaving the pharmacy.  Upon follow up the next day, patient said the sensations returned and her husband gave her an undisclosed amount of prednisone (from personal supply at home).  She was markedly improved after that.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted after receiving covid vaccine (Janssen). He was sitting for the required 15 mintute interval and collapsed from his seat after about 5 to 7 mintutes. I quickly help position pt. against the wall. He was disoriented and slighlty confused. He was conscious and alert but dazed. I immediately had by technician call 911 and the paramdeics attended to pt. After doing thorough evaluation of symtoms, pt. declined further treatment. His friend picked him up
clear liquid started leaking down her arm; clear liquid started leaking down her arm; clear liquid started leaking down her arm; after the syringe was inserted, a clear liquid started leaking down her arm/wanted to know if she would have to repeat this process and get the 2nd dose again; This is a spontaneous report from a Pfizer Sponsored Program via a contactable consumer reporting for herself. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration (arm) on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown) on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that after the syringe was inserted, a clear liquid started leaking down her arm on an unspecified date. Patient wanted to know if she would have to repeat this process and get the 2nd dose again.  Information on Lot/batch number has been requested.
Received Expired Dose of Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication history not provided.
About 8 minuets after receiving the vaccine patient began to have a severe runny nose. Then about another 5 min after patient began to have difficulty swallowing with dyspnea.
Patient received vaccine and was waiting her time outside of the pharmacy. About 3 minutes post-vaccine patient came to the window reporting that her throat was beginning to feel tight and she was having difficulty swallowing. Patient was immediately taken into the clinical services room and 1 dose of adult EpiPen was administered. Patient immediately started feeling symptoms resolved and was able to swallow/drink water. The ambulance was called and patient was checked out by EMS. Patient was monitored for more time and declined being take to the hospital by the ambulance.
pt recv vax & exp redness, hot & swelling @ the inj site w/in 48hr of vax;
Just irregular menstrual periods since the booster. Spotting in between. Went from consistent 33 days to 25 days in between periods. It wasn't just one month; it's been 3 months that it has continued that way. Will be seeing new doctor for issue in the upcoming weeks.
Pt attended well peds clinic on 14AUG91; according to exam pt well that day & had no problems w/previous immun; DTP #2, OPV #2, HIB #2 given w/o difficulty; Mom given standard instr for fever control; Death occured 3 days later; dx SIDS;