chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Small nodule at site of injection (Left thigh) non tender to touch. Pts father reports ongoing since Hep A  injection.
I have constant headaches. Inam also experiencing abdominal pain, cramps and pain in my sides where kidneys are.
Body aches, headache, chills, arms sore, coughing, sore throat, fatigue.
Incomplete course of vaccination; sneezing; running nose; This case was reported by a consumer via call center representative and described the occurrence of sneezing in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 10th January 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 24th February 2020, 410 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sneezing and runny nose. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the sneezing, runny nose and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the sneezing and runny nose to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but it could be 59 or 60 years. The patient received the first dose of the Shingrix vaccine and now she was due for the second dose of the Shingrix vaccine, but the patient was experiencing sneezing with running nose symptoms.  No additional information provided.
2AM elev T 102.6 (ax) sponge bath & tylenol given; 330AM T 102.8 (ax) sponge bath given; 930AM mom took child shopping noted groggy & sleepy while riding in cart; Developed sz & eyes rolling back in head; Temp 105.7; Dx ear infect
warmth, swelling & tenderness in entire arm where vax given inc over 1st 72 hrs;
A bout a half hour after getting the shot she became dizzy. About 2 hrs later she started having palpitations which lasted 9 days.  2 days after the vaccine her right armpit became inflame and hot. She also devleoped a vagnial infection. She had severe pain in her right foot and shin, her foot became hot and she wasn't able to walk for 2 days. She also had inflammation under her eyes and neck like she had the mumps. She spoke with an ER dr and they told her that she might have a blood clot.
24MAY93 12PM; fever under 100, sore throat, stomache, pain in lower rt leg, very tired given Padadol for fever; was the same @ 6AM then by 7AM pt was same as above; felt as if both legs were asleep; 27MAY93 h/a, rt leg aches; cough; leg pai
This spontaneous report as received from a physician refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 19-MAY-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # M046140 with expiration date on 27-SEP-2019 (dose and route of administration were not reported). Since 25-APR-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
mom administered APAP x 2 on 17MAY94; no apparent problems; for no appearent reason about 7pm 20APR94 pt began screaming & crying unconsolably for 4 hrs;
A report has been received from a pharmacist via Pfizer concerning a female patient. The patient's medical history included venous insufficiency, falls and psoriasis. The patient's concurrent diseases included penicillin allergy and sulfa allergy. Concomitant medications included carvedilol, fexofenadine hydrochloride, simvastatin, torsemide, warfarin sodium, prednisone for rheumatoid arthritis and unspecified. On an unknown date the patient started receiving nasal FLUMIST (intranasal) with unknown dose for unknown indication and oral XELJANZ lot: 36117, 10 mg, daily (5 mg, two times) for rheumatoid arthritis, started on 15-Jan-2016. The patient experienced wound/chronic wound (preferred term:wound) and she was administered thousands of dose of FLUMIST - misuse (preferred term:intentional product misuse). The action taken of FLUMIST was unknown. Tofacitinib was continued. At the time of reporting, the event of wound/chronic wound was improving and the outcome of the event of administered thousands of dose of FLUMIST - misuse was unknown. The event of administered thousands of dose of FLUMIST - misuse was considered as serious with the serious criteria of important medical event by company physician. The event of wound/chronic wound was considered as non-serious by company physician. Sender's Comments: The report concerns a 75 years old female patient who experienced intentional product misuse while on FLUMIST. It was reported that the patient administered thousands of doses of FLUMIST. There is missing information on the indication and dosing of the suspect drug, concurrent diseases, circumstances and results of the event.
Parent called and reported headache and vomiting after reporting to school.  Unable to stop vomiting.  Referred parent to ER for patient to be assessed.  All occurred within 1 hour past vaccination.
Pain at injection site; Muscle pain; Headache; Fatigue; drifted in and out of sleep all day; the patient has received third/ booster dose; the patient has received third/ booster dose; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 07Oct2021 at 14:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies environmental.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an intramuscular route of administration in the left arm on 14Jan2021 (at the age of 39-year-old), as a single dose for COVID-19 immunisation and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an intramuscular route of administration in the left arm on 02Feb2021 (at the age of 39-year-old), as a single dose for COVID-19 immunisation.  On 08Oct2021 at 05:00 the patient experienced pain at injection site, muscle pain when moving that was noted around 5 am, headache and fatigue. Patient also reported that headache was starting to lift after 24hrs, muscle pain and fatigue was still present, pain at injection site was still present when holding arm at shoulder height or above, but there was no pain in neutral position. The patient had called into work around 07:20 am, drifted in and out of sleep all day.  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain, headache, fatigue and pain at injection site , drifting  in and out of sleep all day were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Within 12  hours I experienced the usual flu like symptoms, fever, etc.  Also a very sharp pain in my lower left quadrant of the abdomen.  Symptoms subsided until the sharp abdominal pain came back two weeks after which turned out to be diverticulitis.  I spent 7 days total between the emergency room and  the hospital.
Intususception diagnosed by hospital. 04/24/07-records received  from facility for DOS 03/13-03/16/07. DC DX: Intussusception. C/O fussy for 2 days large emesis, bloody stools. Multiple mucousy bloody stools. Abdomen fullness palpated in right lower quadrant. Unsuccessful attempt at reduction via enema. Laparotomy including appendectomy.
Pt had symptoms of rash, swelling, itching and pain of injection site. Physician examine and observed. Pt advised to follow-up in the next 48 hours if worsen.
Day after PREVNAR vaccine patient inconsolable with complaints of leg pain. Patient limping. No fever, swelling or redness at site. Some improvement after TYLENOL.
I was in bed for two weeks as if I had severe flu. Chills, headaches, muscle pains, exhaustion
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated by a physician/MD for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Symptoms of runner?s dystonia: Feeling unbalanced/unstable while running, loss of coordination while running (seems to be right leg only), dizziness while running, has also happened while walking.  Had never experienced any of these issues in my 27 years as a runner until receiving COVID vaccine.
Metallic taste in mouth; tingling nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 at 12:30 as dose 4 (booster), single (Lot number: GJ5342) at the age of 38 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DYSGEUSIA (non-serious) with onset 16Oct2022 at 12:30, outcome "recovering", described as "Metallic taste in mouth"; PARAESTHESIA (non-serious) with onset 16Oct2022 at 12:30, outcome "recovering", described as "tingling nose". Therapeutic measures were not taken as a result of dysgeusia, paraesthesia.  Additional information: Patient had no other vaccine in four weeks. Patient also had no COVID prior vaccination and was not COVID tested post vaccination.
Once needle was inserted into patient she pulled from needle and medication filled the inject-safe barrier bandage, because she said that it felt like a burning sensation that lasted just at the injection site just seconds. No redness or blood at site. She said she felt the poke.
night sweats; sore joints; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A adult male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8732, Expiry date: not reported), via intramuscular route of administration in left arm on 02Apr2021 as dose 2, single for covid-19 immunization. Medical history included infectious mononucleosis (Re-occurrence of symptoms experienced when subject had mononucleosis 30 years ago). Patient had no known allergy or other medical history. Concomitant medication(s) included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6207, Expiry date: not reported), via intramuscular route of administration in left arm on 12Mar2021 as dose 1, single for covid-19 immunization. On 05Apr2021, the patient experienced night sweats, sore joints and fatigue. The events did not result in physician office visit/ emergency room visit. No therapeutic measures were taken in response to the events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Syringe malfunction.  Vaccine leaked from syringe during vaccination in right deltoid.  Per vaccinator, less than half of dose administered.  Revaccinated in opposite arm  per CDC  for use of mRNA COVID19 vaccines
patient complained of  little itchy throat after the end of 15 minutes of observation. Patient received the pfizer 5-11 dose.  Patient given benadryl, patient was alert and oriented for the entire time. did not require a higher level of care
The patient did not experience any adverse effects.    I accidentally gave this student an adult dose of Hep A,   using Havrix instead of Vaqta.     I informed my supervisor when the mistake was discovered.   I phoned the parent to explain the mistake.   We agreed he would monitor his son for any ill effects.   His son is 16 and adult-sized.   I followed up with a phone call the next day and no ill effects were observed by the patient or his family.
Voice Hoarseness, hives, bp 199/97 hr 140-150's
On 3/13/09 pt. received 3rd dose of PENTACEL, HEP B, PREVNAR & ROTATEQ.  Within 4 hours pt. developed large area of confluent erythema (see picture).  Pt. treated with BENEDRYL, 1/2 tsp. qid.  Seen on 3/14/09. <- erythema had greatly improved.  No wheeze, and pt. appeared to act normally.
Leg weakness and numbness, bladder dysfunction. Diagnosed with Gullian Barre after hospitalization 3/17/21.
Acute hypoxemic respiratory failure; opioid overdose; COVID positive.  she was given narcan with some improvement in wakefulness but resulted in more agitation than orientation.  Her dexamethasone was stopped and levaquin continued as the source of hypoxia was more likely bacterial pneumonia. Psychiatry was consulted regarding her polypharmacy and recommendations were made however patient was resistant to some of those. She was discharged to home with Remote Patient Monitoring. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
0.3 ml dose was drawn up from Pediatric Pfizer vial and administered to patient. Patient received 0.3 ml of the Pediatric Pfizer vaccine instead of 0.3 ml of the adult Pfizer. The patient was notified as soon as it was discovered and advised to return to get 0.3ml of the 12+ adult pfizer vaccine Patient returned on 12/03/202 at 0800 and was given the replacement dose of 0.3ml of the adult pfizer vaccine Lot number 30145BA expiration 12/31/2021 to Left deltoid No adverse events were reported.
Information has been received from a nursing student concerning herself, a 42 year old female with no history of drug reactions or allergies and possibly may have had chickenpox as a child, who on 20-AUG-2003 was vaccinated with the first dose of VARIVAX (Merck) (lot # 642682/0481M) and on 21-OCT-2003 was vaccinated with the second dose of (lot # 646141/0540N) for working in hospital (titers not detected). There was no concomitant medication. A couple of months after the second dose was given, she had a titer of 3.54. In Sep-2006 her titer was 1.25. The nursing student stated now her test from Mar-2008 says she was not immune, less than 0.91. The patient was not recovered as of 15-Apr-2008. The patient sought medical attention with a telephone call and physician office visit. Additional information has been requested.
Info has been received on 6/27/02 from a health care prof'l concerning a 5 mt old male PT who was vax'd with the first dose of Infanrix, Comvax, and IPV on 10/29/01. PT presented w/2-3 lumps in both legs w/in the first few wks after receiving the first set of immunizations. On 6/7/02, PT was also vax'd with Infanrix, Comvax, IPV, and Prevnar. On 1/22/02, PT's mother called the MD's office to report that PT's left leg was infected. PT developed nodules to inject sites. Nodules were drained and the cultures revealed sterile abscess. On 2/5/02, new lumps also presented and recheck showed 4-5 mm area that will scar. PT was referred to a local dermatologist at that time. He was evaluated for nodular areas on 3/27/02 at a local university. It was determined that the lumps were due to an aluminum allergic reaction. At the present, PT is doing some follow-up w/the local university. His last visits were on 5/16/02 and 6/14/02. According to the MD's report received on 6/1/02, PT presented w/a palpable subcutaneous nodule of unknown origin in the middle of his right anterior thigh, which is a typical reactionary nodule that develops after vax's which contain aluminum. The pathology report on the biopsy material obtained from the PT shows an inflammatory granuloma consisting of lymphohistocytic reaction and eosinophils was observed, which is consistent w/a vax reaction.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: she got vaccine on 05-28, on 5/30 she started to  have itchy, swelling, raised, red, hot to touch area below the injection site, when to urgent care and was prescribed triamcinolone, mupirocin, hydroxyzine and bactrim ds. She got better on 6/1
Information was received via a telephone message left from a Merck representative on 27-JUN-2017 regarding a physician assistant who had reported to him that an unspecified patient had received a dose of GARDASIL 9 on 16-SEP-2016 and received a second dose on 25-APR-2017.  No further information about the patient was provided. Additional information was requested.
Pt recvd flu vax & approx 1 wk later devel cutaneous vasculitis;
Sudden arrest /p feeding @ baby sitters. DOA 6 days /p vaxs. Baby was fine before, mother went to work. With baby sitter. Autopsy prelim DX-SIDS death, no abnormalities found
pt recv vax & exp prolonged high pitched cry, not sleeping @ noc, afeb, no swelling @ inj site;Ibuprofen given & message to MD came to office 27MAR w/c/o still high pitched cry @ times but not sleeping more than usual;fussy & not eating;
Rash on torso/rash on bicep; This is a spontaneous report from a contactable consumer. A 70-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in Arm Right on 02Feb2021 (Batch/Lot Number: EL9264) at single dose for covid-19 immunisation. Medical history included he contracted Covid in late Oct2020, blood clots from Nov2020 to an unknown date. Concomitant medication included apixaban (ELIQUIS) taken for blood clots from Nov2020 and ongoing. It was reported that patient received the first dose of Covid-19 vaccine 2 days ago. He has a red rash on each side of his torso and a little rash on his right bicep. This is the same type of rash he developed when he contracted Covid in late Oct2020. Typically, he has a rash when he gets a virus. Patient's weight was between 158-160lbs. The rash does not itch. He wouldn't know that he has it other than seeing it. Outcome of the event was unknown.
Extreme facial flushing while vaccine being administered, severe itching and swelling of injection site within 1 minute of vaccine administration. Lightheadedness within 1 hour of administration. headache and feeling of body being inflamed lasting greater than 4 hours.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX lot # M030139, expiry date: 18-AUG-2017 (route of administration and dosing details were not reported) following a temperature excursion of 18.9F for 12 hours. No adverse effects were observed. There were no product quality complaints (PQC) involved. Additional information is not expected as the reporter did not wish further contact.
Patient presented to clinic with her family for flu and Covid Bivalent booster vaccine.  Vaccines were administered without incident, patient was walking from exam room to lobby and mentioned to her mother that she felt like she was "blacking out" at this time mom was hugging patient and I inquired if everything was ok.  At this time, the patient was lowered to the ground by mom, she sustained no injury from the fall.  The patients pupils were enlarged but she was responsive within 5 seconds.  Her blood pressure, pulse oxygen saturation and HR were all evaluated and were normal.  After about 5 minutes she was moved to a chair in the lobby were she was monitored for an additional 30 minutes.
We did not administer the vaccine.  This was done at  the Nursing Home where she works.  She presented to our Urgent Care c/o of headache, dizziness and fatigue for the last 11 days that started when she had the vaccine.  She had felt fine for 8 weeks prior to this after recoverying from Covid the first week of December.
she had an injection site reaction; she did get really bad mouth sores and they're pretty severe; This is a Spontaneous report based on the information received by Pfizer. A contactable female consumer reported that a female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as second dose, single for COVID-19 immunization. The patient medical history and Concomitant drugs were not reported. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date were unknown) on an unknown date for COVID-19 immunization. On an unspecified date, the patient experienced she had an injection site reaction, she did get really bad mouth sores and they are pretty severe. On an unknown date, she had taken her second Pfizer COVID vaccine, she had spoke to her doctor and took the COVID vaccine. Two days later after she took her second COVID vaccine, it was time to take her Kevzara injection which she did. No treatment reported for she had an injection site reaction (unknown if from Kevzara injection or from the COVID vaccine); and she did get really bad mouth sores and they are pretty severe. Unknown treatment for she felt the Kevzara did not work like it usually does for her RA pain. The doctor knows about the consumer taking the COVID vaccine and the mouth sores but does not known that consumer felt the Kevzara did not work like it usually does for her RA pain. Consumer does follow-up with her physician this week. Consumer will have her next injection of Kevzara this Monday, 15Feb2021. At the time of the report, Kevzara is continued. The outcome of the events was recovered.  Information about lot/ batch number has been requested.