chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever blisters, two in nose 3 days after injection. On Wed Nov 18th I received a shingles vaccine injection at clinic. Three days later, two fever blisters, or cold sores broke out inside my left nostril. They were very painful and the one that was highest up inside the nose was like a running sore that oozed clear fluid mixed with bright red blood for over 9 days. The sore highest in the nostril never did scab up or dry up. It did run less and less each day and seems to be healing somewhat by Sunday Nov 29th. I went on the internet to see if there was any connection between the shingles vaccine and the break out of cold sores. I couldn't find anything, but I know that a break out of blisters is a side effect of other vaccines, so it is not unheard of. I just wanted to let you know what happened to me.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly storage PEDVAXHIB, lot number as reported M036057, expiration date 18-MAY-2019, lot number M027882, expiration date 14-APR-2019, lot number L042258, expiration date 18-AUG-2018, (strength, dose, dose number, route and  anatomical location were not reported), for prophylaxis. The temperature excursion was reported below 32 Fahrenheit degrees (0 Celsius degrees), time frame of 25 hours 5 minutes. The vaccines did not experience any previous temperature excursion. Digital data logger was involved. No product quality complain was involved. This is one of several reports received from the same reporter. Additional information has been requested.
I had excrutiating lower back spasms and piriformis sciatica that took three urgent care visits to control.  Standard anti-inflammatories and opioids weren't effective, and finally large doses of prednisone managed to stop the spasms.  The predinisone treatment and tapering lasted six weeks.  Even so, I experienced one final back spasm on the second to last day of the prednisone taper (5mg).  I am still somewhat "crampy" in that I feel a few places in my body are ready to cramp up if I'm not careful. I did not think this was related to the vaccine booster 9 weeks before, but I now recall a similar upper back event that happened 6 weeks after the second Phizer shot, where I had to go to the emergency room for upper back pain due to a muscle spasm that I couldn't stop with heat or cold or increased electrolytes/magnesium/potassium.
On Wednesday, had itching between fingers. On Thursday hands were itching. Didn't realize anything was wrong until 7pm that day. By 715pm, left side of tongue swelled up. Hives and welts over 20-25% of body.
This spontaneous report as received from nurse refers to unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date in 2014 the unspecified number of patients were vaccinated with ROTATEQ. Concomitant medications were not reported. It was reported that the ROTATEQ vaccine was exposed to 11 degree celsius (C) for 84.5 hours, and then for -2.5C for 47 hours in January 2014. These doses of ROTATEQ are administered consistently throughout the period of January 2014 to May 2014. No adverse effects were reported. The outcome of administered vaccine exposed to 11c for 84.5 hours and then for -2.5c for 47 hours and no adverse effects was unknown. This case was linked to 1406USA000152, 1406USA000392, 1406USA000393 and 1406USA000395 (same reporter link). Additional information has been requested.
Received flu shot high dose and 4 days later started itching under arms, chest, back, neck, abdomen, groins and upper thighs severely. Itching so bad had trouble sleeping for 2 nights. After 2 nights of not hardly sleeping, bought anti-itch lotion, stopped itchy 2 days later.
Information has been received from a physician concerning a 16 year old female on an unspecified date who was vaccinated with her first dose of Gardasil (lot number unknown). The physician reported that on an unspecified date the patient developed an abscess on her left breast two weeks after her first dose of Gardasil. Medical attention was sought. Additional information was not provided. Additional information has been requested.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 prophylaxis.     It was unknown if patient was diagnosed or tested positive for COVID-19. It was unknown if patient was  diagnosed acute illness at the time of vaccination and or up to one month before. It was unknown if patient was having chronic or long standing health condition.     On 12-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 23 years and 1 months. No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process.  Patient received third dose of vaccine. Moderna vaccine Ndc code reported as 80777-0273-99. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines.   No treatment medication information was provided.
For the last year and half, I've experienced violent nausea, cramping and vomiting. It becomes debilitating and it has happened 4 times. I've been to the ER twice. I cannot work due to it putting me down at random times of the day.
Pt called and spoke with RN on 2/19/09 with c/o tremors and high BP since vaccination on 11/4/08.  She reported that she did not know side effects of vaccination but would check with other RN.  Other RN called pt on 2/23/09.  He reported fluctating blood pressure: 200/100's to below 100/50's.  C/o intermittent tremors.  Pt stated that he didn't have these symptoms prior to vaccination and have persisted since.  Pt saw PA-C on 11/13/08 and "several times since."  Pt has also seen MD.  BP meds have been added and adjusted.  Also c/o left arm "deltoid" pain without redness, swelling or palpable lump.
Anxious, tearful, chest pain, palpitations - onset about 3 hours after injection. Vaccine required by employer, patient reluctantly received it near deadline to meet work requirement. Stated she "wished she didn't have to get it." Paramedics called, patient then refused medical evaluation or transport to a hospital ER for further evaluation. She stated her usual BP was 160/100 but her "PCP is OK with it and said I could stop my meds." During adverse event BP 156/116. Patient strongly advised to go to ER but refused. Advised to make sure she called 911 for any worsening or if she changes her mind.
Episodes of Syncope; This case was reported by a consumer via call center representative and described the occurrence of syncope in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of syncope (received 1st dose in October 2021, refer link case US2022AMR191767).   In January 2022, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced syncope (serious criteria GSK medically significant). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the syncope was not recovered/not resolved.   It was unknown if the reporter considered the syncope to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR191767   Additional Information: GSK Receipt Date: 21-DEC-2022 Reporter's Comments: The reporter was a patient.  The reporter stated that since receiving his first dose he was experienced episodes of syncope. No additional details were provided by the reporter. The reporter was consented to follow up. Note: Conservatively case was kept valid for 2nd dose as it was said since 1st dose but no outcome was provided, and it seems it was continued till 2nd dose.; Sender's Comments:  US-GSK-US2022AMR191767:Same reporter
Had hives around trunk area and groin. Some of the hives had a "welt" look to them.  Did not itch and was not painful.  Only had a "prickly" feeling.  Started in the evening and went away by morning.  It happened for 3 nights, with the 3rd night coming on later in the evening and a little less.  Then it stopped completely.  Took a generic form of Benadryl on the first two nights and a Zyrtec the third night.  Also used hydrocortisone cream on affected areas all 3 nights.  This was on February 4, 5 and 6.  This happened 4 days after I received the 2nd shot of the vaccine for coronavirus.
5 minutes after injections pt states she had blurred vision and nauseous & pt had syncope. Patient had full recovery by 10:40.
after the patient got vaccinated his relative tested positive; after the patient got vaccinated his relative tested positive; This is a spontaneous report from a Pfizer-sponsored program . A contactable nurse (relative of the patient) reported for a patient of unspecified age and gender received the first dose of bnt162b2 (also reported as Pfizer Covid-19 Vaccine, lot no. and expiry date was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse called in because his relative got the 1st dose of vaccine but after the patient got vaccinated his relative tested positive on unspecified date. The nurse called in if the patient can take the 2nd dose of vaccine. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) but after the patient got vaccinated his relative tested positive on unspecified date.  The case will be reassessed should additional information become available.
vaccine was administered to the patient at 1 month short of 18 yrs with parental consent. No post vaccine reaction .
Injection site arm pain; muscle aches; This is a spontaneous report received from a contactable consumer, the patient. A 30-year-old non pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. No medical history of the patient was reported. The patient reported of no known allergies. The other medication received in two weeks was cetirizine hydrochloride (ZYRTEC) for unknown indication. The patient did not receive other vaccines within 4 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination the patient had not been tested for COVID-19 . On 26Mar2021, the patient experienced vaccination site arm pain and muscle aches. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vaccination site arm pain and muscle aches was recovering at the time of report.   No follow-up attempts possible. No further information expected.
incurable chronic blindness disease; This is a spontaneous report received from contactable reporter(s) (Nurse). Other Case identifier(s): 2022MED00439 (Medexus Pharma, Inc.).  A 64-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLINDNESS (medically significant), outcome "unknown", described as "incurable chronic blindness disease".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-Blindness. 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.
Arm/back pain, chills, fever, lethargy, joint pain for 36 hours - unable to work one day.
she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/She just took it now and it is 100.4 degrees Fahrenheit; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer reporting  for herself.  A 54-y ears-old female patient received bnt162b2 (BNT162B2) vaccine, intramuscular in the right arm  on 23Dec2020 07:00 at single dose for covid-19 immunisation .  Medical history included covid-19 from Jul2020 to an unknown date.  There were no concomitant medications.  The patient experienced chills  on 24Dec2020 with outcome of recovering , nausea  on 23Dec2020 23:00 with outcome of recovering , headache  on 24Dec2020 with outcome of recovering , running temperature at 100.4 degrees Fahrenheit  on 24Dec2020 with outcome of not recovered , feeling unwell  on 23Dec2020 with outcome of not recovered , resting heart rate went to 130  on 24Dec2020 with outcome of recovering , she could not stop shaking  on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included body temperature: 99.8 Fahrenheit; 99.2 Fahrenheit,  100.4 Fahrenheit, heart rate: 130   (66-72.  Normally) , sars-cov-2 test: negative   on 21Dec2020   , sars-cov-2 test: negative on 24Dec2020  .    Information on the lot/batch number has been requested.
Child missed appt for Well Child Clinic and RN called to remind parents. She spoke with dad and he said that child had a "high fever of 102.7-103" followed by a cough which then developed into pneumonia within a week of last immunizations. He took her to Urgent Care where she was diagnosed with pnuemonia and placed on amoxicillin for 7 days. The whole family also became ill. Dad stated he felt like at least the high fever was due to the shots and questions if the pneumonia was too. He also stated that within two days of treatment with the amoxicillin she was much better.
Subsequent to receiving three doses of Lymerix, the pt stated that the Lymerix did not work and that he experienced Lyme disease in May/June, 2000. As of 08/16/2000 the outcome of the event is unknown.
down for a week so weak; Initial information received on 15-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who experienced down for a week so weak (asthenia), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided. The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was down for a week so weak (asthenia) with in an hour following the administration of INFLUENZA VACCINE (whenever the patient got one ).  It was unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine was not provided.  There were no lab data/results available.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for asthenia.  There will be no information available on the batch number for this case.
Painful upper left arm, lumps and rash.  Triamcinolone Acetonide Cream USP, 0.1 for rash, and Diclofenac Sodium Topical Gel for upper arm pain.
SWOLLEN HOT HARD AREA ROUGHLY 3 IN IN DIAMETER, LOCALIZED TO DELTOID, PT DESCRIBED AS STARTED SELLONG SAME DAY AND CONTINUED TO SWELL. WHEN SHE CAME IN TODAY 4 DAYS POST VACCINATIONS SHE STATED THAT SHE BELIEVED THE SWELLING WAS RECEDING. I ADVISED ICE PACKS AND HYDROCORTISONE CREAM TOPICALLY AS WELL AS ORAL BENADRYL TO HELP HER SLEEP AT NIGHT. I ALSO MARKED THE AREA WITH A SHARPIE AND DIRECTED HER TO SEE MD IS SWELLING GREW BEYOND MARKED AREA OR DID NOT CONTINUE TO RECEDE BY MONDAY. I MARKED HER ALLERGIC IN THE PHARMACY PROFILE SO AS TO NOT RECHALLANGE HER AT A LATER DATE IF CDC RECOMMENDATIONS CHANGED ON THIS IMMUNIZATION.
Patient is a 78 yo M with a history of OSA on CPAP with symptoms consistent with COVID-19.  He was fully vaccinated in February, but attended a wedding a few days prior to onset of symptoms 7 days ago.  His symptoms have included feeling short of breath, dry cough to the point that because discomfort with his abdominal muscles, fatigue, weakness, fever, diarrhea, malaise, myalgias, altered taste, and poor oral intake.
patient has had no reported side effects; expired dose of PROQUAD was accidently administered to a patient; This spontaneous report was received from a physician and refers to a 4-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, concomitant medications and medical history was provided.  On 23-MAR-2022, the patient was vaccinated with an expired Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHa (recombinant Human albumin) (PROQUAD) lot number T030481, expiration date 07-MAR-2022 0.5mL, one dose subcutaneously (SQ) (strength and anatomical location were not reported) for prophylaxis (expired product administered). The vaccine was used with sterile diluent, lot U015345 established to be valid, expiration date 04-OCT-2023. No temperature excursions was reported for the vaccine and sterile diluent. The patient had no reported side effects (no adverse event).
no adverse events as of yet.  8 month old received immunizations scheduled for a 4 year old.
Parents notified. Pt fell dizzy, pale, diaphoretic, lightheaded approx 15 min. after vaccine. Positioned flat, raised lower extremities 12:10/P  BP 132/84 P-84 12:20 140/84 80 12:45, pt sitting up. 12:30 PM rescue here color improved, mom opted out of rescue support to hosp. Sent home via Dad (arrived). 12:30 144/84 AP=82 rescue 12:45 BP 150/78.
Severe muscle pain at injection site radiating to elbow and shoulder, lasted 48 hours.  Pain at injection site after 4 days since injection, although it has begun to subside and I can move arm freely with only feeling pain when pressure is applied approximately 2 inches below injection site.
4 hours after receiving vaccine  I developed hives. large hives, almost welts. very itchy. They remained for over a week. some disappearing and some new ones added. They were in both arms, and stomach (left side) a very few on legs and a few on back
Hyperpigmentation white spots on inner thighs, anus, and leg folds of child; Diagnosis is vitiligo; Its flush with skin; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 5-year-old female patient received BNT162b2 (BNT162B2), on 27May2022 as dose 1, single (Lot number: F18095) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN HYPERPIGMENTATION (non-serious) with onset 09Jun2022, outcome "not recovered", described as "Hyperpigmentation white spots on inner thighs, anus, and leg folds of child"; VITILIGO (non-serious) with onset Jun2022, outcome "not recovered", described as "Diagnosis is vitiligo"; FLUSHING (non-serious) with onset Jun2022, outcome "not recovered", described as "Its flush with skin". The events "hyperpigmentation white spots on inner thighs, anus, and leg folds of child", "diagnosis is vitiligo" and "its flush with skin" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter was calling in regards to the COVID vaccination for a 05-year-old. This was the fourth nurse she has spoken with in the last 45 minutes. Spent 30 minutes on the phone with another call handler doing a report. Caller now has some pieces to add to the case that she didn't have originally. She was transferred to medical information person who was of no use at all. It was granddaughter's first dose. The reporter daughter (the mother of the patient) gave the child a bath on 09Jun2022 and noticed hyperpigmentation white spots on inner thighs, anus, and leg folds of child. The child was half samoan, so the spots are very pronounced. There was no exudate, no pain, its flush with skin. Took her to pediatrician and the preliminary diagnosis was vitiligo. Had a whole slew of lab work down to check for everything. Awaiting those results. Looked that up this morning to see if it was a problem with COVID and kids. Found two articles that said that there were hyperpigmentation problems and vitiligo concerns in children about two weeks after getting the vaccine. Wanted to let Pfizer know what was going on. Had provided her daughter's information (the mother of the child) in the original report as well. The mom was very anxious right now, so the grandmother decided to make the call to Pfizer for her. Have no family history of this. It would be so horrific and devastating that it could be caused by the vaccination a couple weeks ago. She was very upset about the possibility of the COVID Vaccination causing hyperpigmentation in her skin.  No follow-up attempts are possible. No further information is expected.
1:30 pt screamed for 30 mins-both feet were swollen 2x seen by MD t99 in ear; by 930PM 7MAR pt was well-feet still sl swollen;