chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on my arm.  3" long at injection site; Fever on day 2 of 101.1; muscle aches; Tingling; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9266) via an unspecified route of administration, administered in Arm Left on 23Feb2021 18:00 (at the age of 62 years old) as dose 2, single for COVID-19 immunisation. Medical history included eggplant allergy, penicillin allergy. The patient's concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3302) via an unspecified route of administration, administered in Arm Left on 05Feb2021 18:00 (at the age of 62 years old) as single for COVID-19 immunisation. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced as, "rash on my arm. 3" long at injection site", fever on day 2 of 101.1, muscle aches, tingling on 24Feb2021 08:00. Event reported as, Rash on patient arm. 3" long at injection site. Appeared 2 days after injection. Lasted for 3 days. Fever on day 2 of 101.1, muscle aches and tingling. No treatment were given for the adverse events. The patient underwent lab tests and procedures which included body temperature: 101.1 on 24Feb2021. Patient did not tested for COVID post vaccination. Outcome of all the events were resolved on 2021.  No follow-up attempts are possible. No further information is expected.
Seizures difficult to control; encephalopathy; tx w/anticonvulsants;
Tachycardia and possibly a panic attack after Pfizer COVID-19 vaccine 0.3 mL IM in left deltoid. Monitored patient. Patient felt more relaxed as time when on, and palpitations went away. Patient felt comfortable leaving the clinic once symptoms resolved.
medication error occurred due to a drug interaction, that the YF vaccine was given along with Menactra, instead of saline with no reported adverse event; Initial information received on 11-May-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who experienced medication error occurred due to a drug interaction and reported that the Yellow Fever Vaccine -  [Yf-Vax] was given along with meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra]  instead of saline with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Yellow Fever Vaccine - , solution for injection (lot number not reported) via unknown route in unknown administration site was with meningococcal A-C-Y-W135 (D CONJ) vaccine, solution for injection (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination which was reported as medication error occurred due to a drug interaction, that the yf vaccine was given along with menactra, instead of saline with no reported adverse event (product preparation error).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event medication error occurred due to a drug interaction, that the yf vaccine was given along with menactra, instead of saline with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I was diagnosed with Thyroid Eye Disease; I had been having bulging eyes; I had been having dryness; I had been having eye pain; I had a sore arm at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease) and EXOPHTHALMOS (I had been having bulging eyes) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Graves' disease since 2019. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) for Graves' disease.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (I had a sore arm at injection site). On an unknown date, the patient experienced ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease) (seriousness criterion medically significant), EXOPHTHALMOS (I had been having bulging eyes) (seriousness criterion medically significant), DRY EYE (I had been having dryness) and EYE PAIN (I had been having eye pain). At the time of the report, ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease), EXOPHTHALMOS (I had been having bulging eyes), DRY EYE (I had been having dryness), EYE PAIN (I had been having eye pain) and VACCINATION SITE PAIN (I had a sore arm at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab data was not provided  Treatment product was not provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Graves disease could be a confounder of the events. Vaccination site pain is consistent with the Known safety profile of the product.   This case was linked to MOD-2021-290495 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Graves disease could be a confounder of the events. Vaccination site pain is consistent with the Known safety profile of the product.
Patient had convulsive seizure, became unresponsive and was cyanotic, sternal rub, patient opened eyes. Heart rate was thready. Patient felt nauseous. Patient was disoriented for 1min and quickly regained orientation. Patient was given water, patient laid on the floor. Discharged to ER  Past Medical Hx Hx of seizure at age 4
This spontaneous report was received from a medical assistant and refers to an unspecified patients of unknown demographics. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unspecified dates since 15-FEB-2017, the patients received an improperly stored doses of PROQUAD injection (lot # M043308 with expiration date at 24-APR-2018, lot # M007961with expiration date at 15-AUG-2017, lot # M007964 with expiration date at 15-AUG-2017, lot # M002056 with expiration date at 11-JUL-2017, lot # L050909 with expiration date at 14-JUN-2017 and lot # reported as M042498 with expiration date at 17-APR-2018; albumin status, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of -0.2 (unit not provided) for 3 hours and 9 minutes (189 min). Data logger was used to track the temperature. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013140:
Patient stated he felt flush, lightheadedness, and heart palpitations after receiving the vaccine at 8:42 am.  Vital signs were taken and within normal limits. EMT also called and checked patient. Patient declined to be transported to the hospital.  Patient left the facility at 9:45 am on his own.
1) Erythematous, nonpruritic papules on left anterior thigh noticed 2 days after vaccination.  2) Hydrocortisone cream (0.1%) BID X 7 days.
Chills began on 7/25 afternoon, then on 7/26/21 in the AM he awoke with swollen lymph node in L underarm the "size of a tennis ball" and tenderness
This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immunization, she appropriately stayed in the waiting area for the 30 minutes. She then got in car and 15 minutes after, she noticed that her tongue was feeling full/swollen and that was experiencing neck swelling. These symptoms persisted and resembled a prior allergic response to Tetracycline and Aleve. Wheezing and breathing difficulty ensued and EMS was activated.   On arrival to the emergency department she was found to have wheezing with stridor.  A dose of epinephrine was administered and she was monitored in the emergency department with an initial improvement in symptoms. Approximately one hour and 30 minutes after initial epinephrine administration patient reported that she was having continued difficulty swallowing and she was starting to feel a little worse.  At this point a second dose of IM epinephrine was administered.    The patient was subsequently  admitted to inpatient medicine team for further monitoring.
This spontaneous report was received from a registered nurse concerning two unspecified patients of unknown age and gender. The patients's 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 GARDASIL 9 lot # M005714, expiration date: 03-OCT-2017 (Strength, dose, frequency and route were not reported) as prophylaxis, which experienced a temperature excursion of 9 Celsius degrees for 20 hours. Previous temperature excursions were reported as from 02-OCT-2016 to 04-OCT-2016 of 9 Celsius degrees for 43 hours 30 minutes. From 25-OCT-2016 to 26-OCT-2016 of 9 Celsius degrees for 23 hours and 30 minutes. On 28-OCT-2016 of 9 Celsius degrees for 48 hours. From 23-DEC-2016 to 24-DEC-2016 of 9 Celsius degrees for 20 hours. Data logger was not involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA015304:
Within a hour and a half my throat was on fire, and I called a virtual care through my insurance and saw a provider via telehealth. She gave me Augmentin and prednisone. My sinuses were irritated. I had flu like symptoms but no fever. I was treated for strep throat. I have had mild throat burning since and have not fully recovered.  I have had a severe headache ever since and have had to rotate Tylenol and  ibuprofen  everyday.  I went into the ER  01/22/2021 with  severe chest pain and they said I had GERD.
This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of MMR II lot # J013131 expiration date 10-OCT-2015, Lot # J016234 expiration date 19-DEC-2015, Lot # K021152 expiration date 02-NOV-2016 (dose and route were not reported). No co-suspect and concomitant therapies were reported. The nurse reported that agency requested glycol thermometer readings that showed improper storage of the vaccine. Doses of vaccine may have been administered to an unspecified number of patients on unspecified dates. Nurse also stated according to the Sensitronic thermometer there had not been a temperature excursion in this refrigerator. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Patient scheduled herself for "1st dose" of COVID vaccine.  When asked if she had ever had vaccine patient said this was her first.  After administering and patient left, it was noticed that patient had competed COVID vaccine series.  The current EMR system does not update until patient arrives, RN did not see that the series was updated.  I called the patient and asked if she had received the vaccine, she hesitated, I shared that I had the dates in the system and she then confessed that she had received the vaccine previously, but lost her card.                                                              Dept of Public Health contacted the pharmacy and asked for this form to be filled out .
Fever (100.5 - 102.5F) persisting now into 4th day following the 2nd dose of the vaccine.  Additionally, chills and night sweats (not normally experienced. Loss of appetite.  Some achiness.
Pt recvd 3 doses of Engerix-B & did not seroconvert; Booster dose was administered; no tx was given;
After leaving clinic, child began crying and thrashing around in car seat. Very brightly flushed all over. 9:50 AM Returned to clinic and evaluated by family doctor. Child observed for 1 hour there and then to hospital for further observation. Only medication given was Benadryl.
Rash in arms and legs, Headeach, strange heart beat and sometimes dizziness.
Had the vaccine after the first time / in 2020, got them again / Suspected vaccination failure; Had the vaccine after the first time / in 2020, got them again; Still suffering from lingering pain in my foot; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and foot pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and foot pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and foot pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had shingles twice, he/she had the vaccine and after the first time had shingles and two years later, in 2020 got them again. The patient was still suffering from lingering pain in his/her foot. The reporter mentioned that, he/she had to talk to his/her doctor to find out if he/she could have the newer vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact details were available.
Fever, vomiting, diarrhea, lethargy, severe abdominal pain.
Itchy rash on both arms. Started after vaccination and has not yet resolved. Itching relieved from oral benadryl.
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 (lot # M036059 with expiration date of 03-JUN-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. The vaccine was exposed from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA008799; US-009507513-1707USA008817: US-009507513-1707USA008818: US-009507513-1707USA008819: US-009507513-1707USA008862: US-009507513-1707USA008863: US-009507513-1707USA008793: US-009507513-1707USA008820: US-009507513-1707USA008821: US-009507513-1707USA008839: US-009507513-1707USA008864: US-009507513-1707USA008865: US-009507513-1707USA008794: US-009507513-1707USA008822: US-009507513-1707USA008823: US-009507513-1707USA008840: US-009507513-1707USA008866: US-009507513-1707USA008867: US-009507513-1707USA008795: US-009507513-1707USA008824: US-009507513-1707USA008825: US-009507513-1707USA008841: US-009507513-1707USA008868: US-009507513-1707USA008869: US-009507513-1707USA008796: US-009507513-1707USA008826: US-009507513-1707USA008827: US-009507513-1707USA008828: US-009507513-1707USA008842: US-009507513-1707USA008870: US-009507513-1707USA008797: US-009507513-1707USA008829: US-009507513-1707USA008830: US-009507513-1707USA008843: US-009507513-1707USA008798: US-009507513-1707USA006643: US-009507513-1707USA008832: US-009507513-1707USA008844: US-009507513-1707USA008845: US-009507513-1707USA008800: US-009507513-1707USA008833: US-009507513-1707USA008801: US-009507513-1707USA008802: US-009507513-1707USA008834: US-009507513-1707USA008846: US-009507513-1707USA008803: US-009507513-1707USA008804: US-009507513-1707USA008835: US-009507513-1707USA008847: US-009507513-1707USA008848: US-009507513-1707USA008805: US-009507513-1707USA008806: US-009507513-1707USA008849: US-009507513-1707USA008850: US-009507513-1707USA008807: US-009507513-1707USA008808: US-009507513-1707USA008851: US-009507513-1707USA008852: US-009507513-1707USA008853: US-009507513-1707USA008789: US-009507513-1707USA008809: US-009507513-1707USA008810: US-009507513-1707USA008854: US-009507513-1707USA008855: US-009507513-1707USA008790: US-009507513-1707USA008811: US-009507513-1707USA008812: US-009507513-1707USA008836: US-009507513-1707USA008856.
Paleness, dizziness, sweating, aching lower back and joints, weakness. Paleness, dizziness & sweating lasted about 2 hrs, followed by chills. Back pain and aching joints continues now (the following morning).
the noc p/vax pt had very itchy feet;pt couldn't go to sleep they were so itchy;there were no bite marks or rash sx on either feet;they were not red or swollen, just very itchy same thing happened again next noc;
Welt like areas where there had been insect bites.  Treated with a steroid cream.
Pt presents with red, swollen and itchy arm... she states that it hasn't gotten worst since it showed up on friday.
This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 11th February 2019, the patient received SHINGRIX. On 12th February 2019, 1 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient was vaccinated with SHINGRIX and presented with shingles symptoms. Clinical manager from urgent care center reported the patient presented to the center the day of reporting for treatment of shingles. Batch number and expiration date were unavailable as the vaccine was administered at an outside facility. Address and contact information of administering facility were unknown.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 19 months old patient of unknown gender. On 06-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
He had a cough, runny nose, a little discharge from his eyes from an ear infection, low grade fever for a day or two. His symptoms lasted about seven days were very mild and then he was back to being himself. We took him in to see the doctor and he was given amoxicillin for the ear infection. He acted more like he had a mild cold.
WAS ADMITTED TO HOSPITAL ONE WEEK AFTER INJECTION WITH "BLOOD INFECTION" AND TREATED WITH IV ANTIBIOTICS & SEPSIS
Initial misuse report received from a nurse on 12 December 2013.  A 65-years-old patient had received FLUZONE in October in extra dose. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
I had the typical side effects but I also had swelling in my neck and throat and I could feel my throat tightening up. the right side swelling went down overnight and then another day went by before the left side swelling went down.
Severe headache-TYLENOL given-was able to sleep after an hour-next morning 2 hive spots on forehead.
Hives; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hives) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Ear infection. Concurrent medical conditions included Drug allergy (Amoxicillin) and Penicillin allergy.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
p/vax pt c/o severe arthralgias; local redness; rash that extended from inj site to shoulder; condition of pt unknown
Patient received the vaccine administered by a pharmacist. About 7 hours later patient started to experience pain and swelling at injection site. She reported to her PCP the following morning at which time she was given a prescription for KEFLEX 500mg and was told to use cold compresses for the swelling. The inflamed portion of her deltoid at injection site appeared red and slightly swollen. Margins measuring approximately 4 inches X 5inches. Pharmacist called PCP to question not prescribing a steroid. PCP did not want to use a steroid due to patient's medical history. Pharmacist recommended to the patient using cold compresses and BENADRYL 25mg OTC every 6-8 hours as needed.