chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lost consciousness & crashed car Extreme diarrhea Cramping Very dry mouth Face flushing, rash on cheeks Face skin under eyes tight  Assessed by fire rescue on scene.  Vitals OK.  Hospital transport recommended and declined.
Patient received a flu shot. About 3 minutes after receiving the shot she passed out in front of the pharmacy.
Information has been received from a pharmacist referring to a 66 year old female patient. There are no pertinent medical history and drug reactions/allergies reported for the patient. On 08-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose was unknown), lot # L000449, expiration date 08-MAR-2016, subcutaneously in the right arm and a dose of PNEUMOVAX 23 (dose, lot# and expiration date were unknown) intramuscularly in the left arm. There is not concomitant drug. On 08-JUL-2015, the patient developed warmth, redness, and swelling at the injection site of the ZOSTAVAX in the right arm. The patient did not develop an adverse reaction at the injection site of the PNEUOMVAX 23. The patient came to pharmacy for medical attention. The pharmacist suggested the patient apply ice packs to the area of reaction in right arm and the patient followed the advice. No lab diagnostics studies was performed. At the time of reporting, the patient was not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX. On 26th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain and injection site tingling. On an unknown date, the outcome of the injection site pain and injection site tingling were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injection site tingling to be related to SHINGRIX. Additional details were provided as follows: The reporter was the dispensing pharmacist. The patient was still complaining about the symptoms. The pharmacist did not have the lot number or further details available during the time of call. Due to time constraints, she declined to continue answering specific form questions and was contacted to the GlaxoSmithKline team to first discuss her inquiry of whether or not how long the symptoms were expected to last. The call was transferred to the GlaxoSmithKline team upon request. The reporter granted permission to be contacted; due to time constraints no other information provided.
pt exp tingling over both shoulders 1 day; 25MAY93 recvd 2nd dose of vax & tingling persisted x 2 wks;
Received Pfizer vaccine on 03/4/21 and 3/24/21. COVID positive on 1/9/22. Presented to ER on 1/9/22 and under hospice care. Received ceftriaxone and switched to augmentin. Passed away on 1/16/22
pt recv vax 4MAR97 & on 23JAN97 pt was dx w/probable chickenpox in MD office;
10 days post immunization, pt had 3 days of fever, body aches, joint aches (shoulders, knees and hips). 4 (0-10) with extended ROM - TYLENOL for fever, aches, pain. Sx all resolved 3 days later in f/u call.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of injection site swelling (1st dose received on 29th August 2018, refer linked case US2019061889). On 3rd April 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd April 2019, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, pain in arm, injection site swelling and drug dose administration interval too long. On 4th April 2019, the patient experienced fever, chills, influenza-like symptoms, general body pain and tiredness. The patient was treated with ADVIL. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site erythema, pain in arm, fever, chills, influenza-like symptoms, general body pain, tiredness and injection site swelling were recovering/resolving and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the injection site erythema, pain in arm, fever, chills, influenza-like symptoms, general body pain, tiredness and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The batch number was not reported. The patient received SHINGRIX vaccine on left arm and same day she experienced some arm soreness, redness at the injection site, a bump on the injection site. After 1 day after vaccination, the patient had flu like symptoms consisting of chills, feverish, tired, and body aches. The injection site reactions occurred on the same day, and the other events occurred the next day. The patient received 2nd dose more than the recommended schedule, which led to lengthening of vaccination. At time of report, events are improving after the patient took ADVIL. The reporter consented to follow up.
Moderna COVID-19 Vaccine  Nausea, vomiting, headache, muscle pain, lightheaded, fatigue, joint pain, chills, NO FEVER beginning about 12 hours after vaccine.  24 hours later headache, chills followed by sweating, joint pain, fatigue, lightheadedness, muscle pain continuing 42 hours later headache, joint pain, chills/sweating continuing
Headache Chills Neck and body aches Tylenol extra strength  2 doses over 12 hour period All symptoms subsided within 24 hours
Grandmother called stating  grandchild received vaccine on Thursday 08/03/2023 and 2 nights later on Saturday night into Sunday child began to have swelling around her eyes, states that she gave her a Benadryl , stating she thought it was maybe allergies bothering her but the Benadryl did not help and swelling became worse and started having hives on Monday 08/07/2023. Advised for child to go to pediatrician or urgent care. Grandmother stated she would try and get in contact with Peds and Parents. Attempted to contact grandmother for follow up on client, left voicemail to return call.
Flushing sensTION, ITCHING OF ROOF OF MOUTH Narrative:
Patient presented to Hospital on 12/26/10 due to worsening respiratory status.  Mom stated that patient had been suffering from a upper respiratory infection for about 3 weeks prior to admission.  She seemed to improve slightly but on day of admission appeared lethargic and was not taking mych by mouth.  She was initially admitted to the hospital for dehydration and respiratory difficulty, but progressively became worst and was transferred to the Pediatric Intensive Care Unit and found to be areflexic and hypotonic.  A Neurologist was consulted and the diagnosis of Guillain Barre was made.  She was treated with IVIG and has started to slowly improve.  A Neurologist on staff stated that it is possible that the Guillain Barre could be connected to the influenza vaccine since she started developing symptoms about 20-25 days following administration.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 10-AUG-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Thimerosal free) (lot# R006746 and expiration date 19-NOV-2020) intramuscularly for prophylaxis (product storage error). The Merck Sterile Diluent (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959.
Covid19 second vaccination dose at 1030am 1/8/21 into L arm, which became more sore and faster than the first dose. Tired in evening so went to bed early. Around 2100pm chilling/fever began lasting about 5 hours. This was associated with headache, nausea, and arthralgias. No sleep.  All day on 1/9/21 very lightheaded, headache, and some nausea.  Spent the day lying on the couch. On 1/10/21 while headache still there in am, much improved. Still some uneasiness of stomach.  L axillary soreness. Over all feel much better though not fully normal on afternoon of 1/10/21.
Client at clinic for MCV4 vaccine for college and was given MMR in error. No side effects stated or adverse outcome.
This patient was vaccinated on this date with the Moderna vaccine. He was previously, on 3/25/21, vaccinated with the Pfizer vaccine. No adverse reaction noted or since reported.
I had a sore arm almost immediately following the shot that slowly got worse throughout the evening. In the morning my arm was very sore. I woke up around 6:30 with a headache and chills. throughout the morning, my headache worsened as did my chills. I felt fatigued and noticed my lungs felt the same as they did when I had COVID. Essentially all my COVID symptoms came back I never lost my sense of smell or taste. I slept most of the morning and then felt nauseous around 3 pm. I vomited around 3:30 and almost felt completely better after that. My headache, chills, and fatigue were still present but significantly less once I vomited. In the morning I woke up with a headache that lasted through the morning the second day after vaccine administration. By the end of the second day, I felt completely fine. My arm soreness was almost completely gone. I also had some aches and chills on the second day in the morning upon waking up but those were gone by mid-day. On day three I feel completely fine.
I had severe chest pains  around 24 hours later. I continued to intermittently have chest pains over a week?s time. In total the number of chest pain events were about 4 times.
had a sore arm; since getting the vaccine/ has had no cold sores, but previously had them.; after the second / had a fever of 100 degrees; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores. Previously administered products included Shingrix with an associated reaction of pain in extremity (also experienced unexpected therapeutic drug effect after receiving 1st dose on an unknown date, refer case US2021AMR141632).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, fever and unexpected therapeutic drug effect. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and fever were recovered/resolved and the outcome of the unexpected therapeutic drug effect was unknown.   It was unknown if the reporter considered the pain in arm, fever and unexpected therapeutic drug effect to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Three years ago, from the reporting date, the patient received 2nd dose of Shingrix in an unknown arm and experienced sore arm and had fever of 100 degree F for 24 hours. In the 3 years since getting the vaccine the patient has had no cold sores, but previously had them. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR141632:same reporter and same patient
Injection site soreness; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Dec2022 at 17:30 as dose 4 (booster), single (Lot number: GJ3274) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "congenital heart disease" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies: aspirin"; Ibuprofen, reaction(s): "Known allergies: ibuprofen". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 07Dec2022 at 09:00, outcome "recovered", described as "Body aches"; VACCINATION SITE PAIN (non-serious) with onset 07Dec2022 at 09:00, outcome "recovered", described as "Injection site soreness". Therapeutic measures were taken as a result of vaccination site pain, pain which included Tylenol.  Additional information: The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient did not had covid prior vaccination and not tested covid post vaccination.
Tingling in bilateral lower legs, red rash and itching bilateral lower legs, anxious-took 2 Benadryl 25mg and then started itching on arms, went back to employee health but regular MD called but out of office, sent to ED-txd with po prednisone 50mg and gave prescription to take daily 40mg x4 days, prn Benadryl.
Caller stated that she received her vaccine today and an hour later she became flushed in the face. She denies other symptoms.
Information has been received from a nurse concerning a females who was vaccinated in 2007 with a first dose of Gardasil. Subsequently, both patient fainted. Unspecified medical attention was sought. The patient recovered from fainting before leaving the office. No laboratory or diagnostic tests were performed. Additional information has been requested.
On 12/07/2021 vaccines were picked up from the state department to be stored in the fridge and used by 01/07/2022. This patient received the vaccine 5 days after the vaccine use by date. This patient reported no known symptoms.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; SOME EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. 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) dose, 1 total (dose number in series was 1) start therapy date were not reported 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. On an unspecified date, the patient reported that she had some effects and caught Covid but came out (coded as suspected covid-19 infection), suspected clinical vaccination failure (dose number in series was 1) and some effects (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, some effects, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000209719.; Sender's Comments: V0 20220100227-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Left upper arm swollen, sore, and warm. Measured both left and right upper arms and left is 44cm and right is 41.5cm.
arm pain at the injection site; arm pain at the injection site; headache; feeling cold; extremely tired; Low grade fever; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "arm pain at the injection site"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FEELING COLD (non-serious), outcome "unknown", described as "feeling cold"; FATIGUE (non-serious), outcome "unknown", described as "extremely tired"; PYREXIA (non-serious), outcome "unknown", described as "Low grade fever".  Additional information: Low grade fever was also present on day 2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mild upper lip and facial swelling over course of one hour; normal vital signs.  no progression to anaphylaxis treated with cetirizine 10 mg x 1
pt recv vax 8DEC95 & became pregnant (LMP 7DEC95);A sonogram on 31JAN96 revealed a positive heart beat;however an ultrasound on 27FEB96 revealed no fetal heart beat & D&C was performed 28FEB96;
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 06-AUG-2018, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX lot # R002051, expiration date: 22-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) indicated for prophylaxis which was reconstituted with MERK STERILE DILUENT (lot# and expiration date not reported) properly stored. The administered dose of the Oka/Merck VARIVAX experienced multiple temperature excursions of 6 degrees Fahrenheit (°F) to 14 degrees Fahrenheit (°F) for 303 minutes, as recorded by a data logger. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA00203: US-009507513-1809USA002035: US-009507513-1809USA002036: US-009507513-1809USA002033: US-009507513-1809USA001866: US-009507513-1809USA002032: US-009507513-1809USA002031.
fever; chills; body aches; lethargy; sweats; headache; This is a spontaneous report from a contactable consumer (patient). A 41-year-old consumer of an unspecified gender received first dose of BNT162B2 (COVID-19, Pfizer, Formulation: Solution for injection) on 21Jan2021 01:15 PM to left arm at single dose for Covid-19 immunization. The patient's medical history included thyroidectomy. There were no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included liothyronine sodium (CYTOMEL) and levothyroxine sodium (TIROSINT) which were received within two weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Jan2021 05:00 PM, the patient experienced fever, chills, body aches, lethargy, sweats and headache. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had tested for Covid-19 by polymerase chain reaction (PCR) test. On 30Jan2021, Covid tests post vaccination included nasal swab and PCR, which showed negative. The patient received antibiotics (doctor thought that the patient had Covid) as the treatment for the events. Outcome of the event was recovering. Vaccine Facility information and ethnicity information was available.  Information on the lot/batch number has been requested.
breakthrough covid case; breakthrough covid case; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 26Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 26Jan2022, outcome "recovered" (2021) and all described as "breakthrough covid case". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Jan2022) positive. Therapeutic measures were not taken as a result of covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
patient received a dose of Hiberix which had expired on August 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Hib (Hiberix) (expiry date 31-AUG-2023) for prophylaxis.   On 06-NOV-2023, the patient received Hiberix. On 06-NOV-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: patient received a dose of Hiberix which had expired on August 2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 7-NOV-2023 A pharmacy intern reported that patient received a dose of Hiberix in unknown facility and the dose had expired on August 2023. There was no patient data available just that the patient would be getting a splenectomy done. The reporter did not consent to follow up. The patient received an expired dose of Hiberix, which led to expired vaccine used.