chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient vaccinated around 9:57 AM. In observation and felt it was "hard to swallow". RN walked patient to the bed and took vital signs. DOC of the day called to assess the patient. Patient reporting difficulty swallowing. Speaking in full sentences. Denies itchiness, vomiting, or hives. Patient given water which visibly looked difficult to swallow. 50 mg IM Benadryl given to patient. Will continue to monitor.  After giving Benadryl, patient reported improvement in symptoms. About 10 minutes later, patient stated symptoms were coming back and were worse with posterior tongue swelling and throat constriction. 0.3 mg EPI pen administered to patient. EMS transport recommended to patient when EPI was given. Patient denied transport at that time. Patient instructed and educated on the risks of denying EMS transport. After ten minutes post EPI pen, patient and provider both agreed it necessary to call 911 because patient reported no significant improvement after EPI pen. 911 called at 1041 and arrived on scene at 1055. Patient taken to hospital. Patient awake and alert speaking in full sentences at the time of transport.
Patient experienced at least 4 severe seizures on the day after the vaccine was administered.  It is now three days since the vaccine and he has been unable to eat anything and has been incapacitated in bed with severe headaches and body aches and pain whenever he tries to move.  He also fell during the seizure and sustained scrapes and rug burn.
Pt had tetanus injection last week in employee health, today the area is warm, swollen with a hard center. Area of redness is the size of a hand, Denies chills.
This spontaneous report was received from a back office lead and refers to a 45 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L042846 and expiration date: 15-SEP-2017) 1 ml, intramuscularly (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Seen in the ED 5/3/2021 with weakness and chronic cough that was worsening over past several days.  COVID-19 PCR positive.  Contains critical data CORONAVIRUS (COVID 19) RT PCR Status:  Final result    Ref Range & Units 5/3/21 1530 CORONAVIRUS SARS COV 2 PCR (RESP)  POSITIVE   Panic
This spontaneous report was received from a medical assistant concerning an unkonwn number of patients of an unknown gender and age. On an unknown date, the patients were vaccinated with a dose PEDVAXHIB (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The medical assistant reported doses of PEDVAXHIB that were exposed to a supported temperature excursion have been administered to unspecified patients on unspecified dates. No adverse effects have been observed or reported. This is one (1) of five (5) reports from the same source. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016") the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally, strength, dose and site of administration were unspecified). The administered vaccine underwent the temperature excursion of 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Mouth sore; Swelling of gums; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 00:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take other medication in two weeks of vaccination. The patient previously received naproxen sodium (ALEVE) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 00:00 4 days after shot the patient experienced mouth sore and swelling of gums. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events mouth sore and swelling of gums was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
This spontaneous report has been received from a medical assistant referring to multiple patients of unknown age or gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of VAQTA (dose, route and anatomical location were not reported), strength of 25/0.5 (units not reported), lot # reported as M043731 with expiration date on 22-MAY-2019 and lot # N005274 with expiration date on 03-APR-2018, for prophylaxis; which experienced a temperature excursion between 47 and 77 Fahrenheit degrees for 50 minutes. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported and no additional information was provided. A product quality complaint was not involved. This is one of the multiple reports received from the same reporter. Lot number M043731 is an invalid lot number for VAQTA. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001034: US-009507513-1705USA008599: US-009507513-1706USA001033:
had both old and new shingles shots in past years. I recently got shingles/Suspected vaccination failure; shingles / my case was only about a 4 out of 10 compared to the worst cases; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (old shingles vaccine received on an unknown date in past years).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received both old and new shingles shots in past years and recently got shingles. The patient stated that, so the word prevent was BS (unspecified) and however, his/her case was only about a 4 out of 10 compared to the worst cases. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Vertigo/it is now full blown vertigo; Stuffy head; She does not feel safe walking in her home; Nausea/ Acute nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK3730, expiration date: 20Mar2021), via an unspecified route of administration on 17Dec2020 at left deltoid, at single dose for covid-19 immunization. Medical history included patent foramen ovale in patient's heart from 2013 and ongoing, and the patient used to be 5'4" and noticed the shrinkage before the Covid 19 vaccine and baby aspirin. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) from 2013 and ongoing for patent foramen ovale. The patient got the Pfizer vaccine on 17Dec2020 and on 25Dec2020 had experienced acute nausea and dizziness that persisted during weekend. Stated that it is now full blown vertigo. Stated that her doctor and pharmacist stated that people reported symptoms but did not know if these were symptoms of the vaccine because it is not listed. The patient experienced stuff head on 28Dec2020. Stated that the nausea comes and goes. Stated that she got physical therapy treatment Epley for vertigo on 28Dec2020 and it did some good but she woke it with it again this morning on 29Dec2020. Stated that the therapy lessened her nausea as well. Stated vertigo was manageable 25-26 and then did not feel safe walking in her home on 26Dec2020. Stated that she had no symptoms after she received it up until 25Dec2020. Stated that she will get the second dose 07Jan2021. The outcome of the events was not recovered.
1st dose Unknown date ( around August or September)@ 3:00. had severe chills and fever. Took Tylenol for fever. Sick for about 8 hours. 2nd Dose 10/26/20: Around 8pm started having chills. 2am started having chills and fever.
Patient was registered with incorrect date of birth. The incorrect chart was pulled. Patient was given vaccines that he did not need. Date of birth was not verified at two different intervals of his care.
About 5 minutes after vaccine given Lg. reddened area, hot to touch, faint rash noted on chest- Benadryl .25mm/5ml-2tsp PO
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in an unspecified number of an adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. SHINGRIX was discontinued. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional stated that all of my patients were complained about the side effects of SHINGRIX such as the redness and pain at injection site and did not want to get the 2nd dose. The healthcare professional did not provide any further details about all of her patients' complaints. This case has been linked with case US2018107240, reported by same reporter.
Fever, chills, body aches all around 11pm same day as shot and throughout the night until about 3pm the next day. I did have COVID in Jan 2021
no adverse reaction at the time the vaccine was given, vaccine was expired. Manufacture was called and there is a 2 day grace period that vaccine was given in
It felt like my allergies were acting up. I got real stopped up, lightheaded and additionally started getting body aches. I completed an at home COVID-19 test on February 20th and it was negative. The next day I felt a lot worse. I went to the walk-in clinic and was retested for COVID-19 and was positive. I was prescribed PAXLOVID. My symptoms improved after 2 to 3 days. I still get shortness of breath worse than I ever have and it took me 2 or 3 weeks to stop being tired all the time.
Fever, chills, headache and achy. 2nd day after vaccine & still with these side effects. Took Tylenol & advil.
During a review of the Department of Health?s records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
FAINT, PAIN AT THE INJECTION SITE, TINGLING IN BOTH ARMS.
Patient had adverse reaction to HPV vaccine. He had dizziness, nausea, after the vaccination. Vitals were taken and monitored for 15 minutes. Patient stabilized and discharged with some instructions.
Pt stated her arm hurt and she felt tingling, was confused and couldn't answer questions properly. The Pt became catatonic and unresponsive to questions. EMS called. She was evaluated and pt started to come around and started answering questions and stated behavior is normal for her due to her neurological condition.
5 days after my vaccination, I began to have itching on my right arm where my vaccine was given.  in the next few hours multiple raised lesions appeared on my right deltoid area.  The itching has continued since that time, and has not yet resolved.  I am taking Benadryl for the itching, and using Benadryl lotion as well.  No other systemic affects.
Fever up to 103 F, fatigue, malaise, body aches, redness and pain at Menactra site and pain in L axillary area for 26 hours. 2 cm area of erythema at vaccine site.
MID-STROKE; BLOOD CLOTS IN BRAIN; POST STROKE DEPRESSION; CANE USER; This spontaneous report received from a consumer (sister) concerned a 69 year old female. The patient's weight, height, and medical history were not reported. Patient was a completely healthy woman and was not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency once total, dose, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient suffered a mid-stroke. Stroke showed that she suffered from blood clots in her brain. All of this happened after receiving Janssen vaccine. Patient had to walk with a cane (coded as cane user) and had been prescribed medication. Patient had to deal with other issues including depression (coded as post stroke depression) because of her new life long issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mid-stroke, blood clots in brain, cane user and post stroke depression was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210455571-Covid-19 vaccine.ad26.cov2.S-MId-stroke,Blood clots in Brain,Post stroke depression. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
ANXIETY; FEELING SPACY/FELT BLAH; LIGHT HEADEDNESS; NERVOUS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height and weight were not reported. The patient's concurrent conditions included slight anxiety and worrying when he had to have a medical procedure (for example, an upcoming colonoscopy).  The patient previously received covid-19 vaccine ad26. cov2. s (Janssen dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 07-JUN-2021 for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s (dose in series 1), the patient felt okay and just experienced some achiness and little tiredness. The patient received covid-19 vaccine ad26.cov2.s (Janssen dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 02-DEC-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Following vaccination with covid-19 vaccine ad26.cov2.s (dose in series 2), the patient had the same experience initially (similar to dose in series 1) and felt good on Sunday, 05-DEC-2021. On an unspecified date in DEC-2021, the patient experienced feeling spacy/felt blah, anxiety and light headedness for the past 2-3 days. The patient had been experiencing the same post coffee, but these symptoms felt different which last all day. The patient was able to drive. On an unspecified date in DEC-2021, the patient felt nervous due to the feeling spacy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anxiety, feeling spacy/felt blah, light headedness, and nervous. This report was non-serious. This case, involving the same patient is linked to 20211222743. This case, from the same reporter is linked to 20211223201.
No additional adverse events reported; The vaccine coordinator is reporting the patient was administered a dose of VARIVAX on 1/13/2020 , that had been improperly stored.; This spontaneous report has been received from a vaccine coordinator (also reported as office manager), referring to a patient of unknown age and gender. The patient's historical condition and concurrent condition were not reported.  On-13-JAN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# S021926 with expiration date: 15-JUL-2021; dose, strength, frequency and route unknown) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT).  The vaccine was stored under 1.2 Celsius (C) for 3 hours and 9 minutes. There was no previous temperature excursion. The digital data logger was involved.
The next day I had the normal symptoms that I had expected. I worked through the next two days with headaches. On the fifth day I had a sudden onset of severe abdominal pain and a migraine like headache followed by the chills. These symptoms repeated two to four times daily for four days. I also had low grade abdominal cramping which is ongoing. I am unsure whether this is contractions or abdominal problems. I communicated with my Obstetrician and my GI doctor. My water broke at 21 weeks, but I did not lose the baby. I am currently 22 weeks pregnant and on bed rest.  I was hospitalized for four days. On Monday the 29th I had a CRP of 85 and by Friday April 2nd it dropped to 35. On Monday my WBC was 14.1. I am unsure of the outcome right now.
within 10 minutes of injection felt my throat start to get Tingley & tighten. Pharmacist gave me 2 Benadryl and I waited almost 1 hour to have symptoms lessen.  Kept taking Benadryl for the next 12 hours.
chills; fever; This spontaneous case was reported by a patient and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
This case was reported by a physician and described the occurrence of injection site swelling in a 4 year old male subject who was vaccinated with Infanrix. On 6/20/05, the subject received the 5th dose of Infanrix (lot AC14A011AA). On 6/20/05, the subject also received injections of MMRII and IPOL. The sites of injection for the 3 immunizations were not provided. On 6/21/05, 1 day after vaccination with Infanrix, the subject experienced swelling at the injection site of Infanrix and was seen at a physician's office. The injection site swelling resolved on an unspecified date after 6/22/05 and on or before 7/25/05. The physician considered the injections site swelling to possibly be related to vaccination with Infanrix.
Pt developed rash on chest and arms, lasted x 5 days. Took no meds. Rash resolved. No other symptoms.
Patient received vaccinations on 9/18/18 at around 5-6PM and went home. At 1AM, patent woke up with a fever, muscle pain and body weakness. He did not take any pain medications. Patient called pharmacy at 4:08PM to complain of adverse reactions.
Pt devel a fever following 1st dose of  MMR; No further details were provided;
a month ago, the patient received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received first dose in 2016).   In AUG-2023, the patient received the 2nd dose of Engerix B. In AUG-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: a month ago, the patient received the second dose).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 7-Sept-2023 A pharmacist asked if the first dose was considered valid and if so, what was the recommended interval between the second and third dose. The reporter declined to share patient information and had no data of the first Engerix-B dose administered (lot number, expiry date). Did not consent to follow-up. The patient received second dose of Engerix-B (a month ago) later than a recommended interval, which led to lengthening of vaccine schedule.
Later the day on january 28th had a fever felt so tired had a headache runny nose and felt so hot. This lasted the whole weekend .
Left arm was sore to move for one day after the shot.  I began developing a dull headache and low grade fever around 1:00 pm the day after the shot.  My fever started at 100.3 degrees F and rose to 101.9 degrees F by 10:00 pm.  I did not take any pain reliever until midnight.  The fever was gone by 3:00 am on 2/6/21, and the headache dissipated by noon the same day.  My left arm has continued to be sore to the touch and pressure (like a bruise) at the shot site, but there has never been any redness or swelling.  This pain is going away slowly each day.
pt recv vax;"throat feels funny" like something in it;kind of numb;BP 140/80; P-76;c/o abd tightness; legs numb;pt able to swallow & is alert;911 called for assistance;to er; to hosp;epi IV used;
doses administered past 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient had received 2nd booster.  The dates of administration were 03-May-2022, 04-May-2022, 09-May-2022, 11-May-2022, 17-May-2022, and 20-May-2022.  Treatment information was not reported.
Skin rash developed on underside of forearm.  Very itchy red rasied bumps covering about 50% of the underside of the forearm.