chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician, via a company representative, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-MAR-2016, the patient was vaccinated with a dose of ROTATEQ, "2ml, 10 unit dose tube", lot # K020183, expiry date: 25-JUN-2016, orally, which was improperly stored at 1.11 Celsius Degrees (34 Fahrenheit) for 24 hours, 11.66 Celsius Degrees (53 Fahrenheit) for 120 hours and 8.88 Celsius Degrees (48 Fahrenheit) for 32 hours. The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
THE LOCATION WAS INSTRUCTED TO PICK UP PFIZER VACCINE FROM A STORE FOR USE ON 3/24/21 AND 3/25/21. THERE WAS NO EXPIRATION DATE OR SIMILAR INFO ON THE PACKAGING IN WHICH WE RECEIVED THE VACCINE AND DILUENT. SINCE WE WERE TOLD TO USE THE VACCINE ON THESE DAYS ONLY (WE NORMALLY USE MODERNA), THE ASSUMPTION WAS THAT THE VACCINE WOULD BE WITHIN ITS DATE/TIME. OUR MANAGER WAS INFORMED AT END-OF-DAY ON 03/25/21 THAT THE VACCINE HAD EXPIRED AT 11:00 AM THAT DAY CONSULTATIONWITH PFIZER INDICATED THAT THE DOSE DID NOT HAVE TO BE REPEATED FOR PATIENT.
fatigue next day after vaccine, second day  fatigue gone but muscle pain all over and severe neck muscle spasm.
Coughing with heavy phlegm. Glands swollen in neck. Chest pain.
itchy red raised bumps torso and scalp developed 2weeks after last vaccine shot. rash will leave and reappear in different location on torso. have been evaluated by dermatologist and skin biopsy with no answers.
SWOLLEN ARM; ARM HURTS ALL THE TIME EVERY DAY; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 was not reported, administered on JAN-2022 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JAN-2022, the patient experienced swollen arm, and arm hurts all the time every day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm hurts all the time every day, and the outcome of swollen arm was not reported. This report was non-serious.
Fever; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and PAIN IN EXTREMITY (Sore arm) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and PAIN IN EXTREMITY (Sore arm). At the time of the report, PYREXIA (Fever) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  He has previously received 2 doses of the primary series and 2 booster doses of the Moderna COVID-19 vaccine. He stated that he does not have his vaccination records on him at this time and he will not be able to provide that information as he was driving right now. He said that he could have possibly received his vaccinations in the year 2021, but he was not sure. With all 4 shots, he was sick for a day with fever and a sore arm. He said that the fever did not last one full day and that he would only be sick the night of the vaccination and felt okay the next day. The biggest thing for him was the sore arm. However, he said that he usually gets a sore arm from all his vaccinations. He said that he received his first two doses from the stated and thought that they were not careful in giving the shot. Therefore, he experienced more soreness in his arms with the first two shots. He received the 2 booster shots at a local pharmacy and he said that they were more careful in giving the shot, so he did not experience arm soreness as much as the primary series. He declined to provide the name of his vaccination provider. He did state that he had less reaction with the booster shots, possibly because of the low dosage.  No treatment information was reported.   Reporter did not allow further contact
UNABLE TO FUNCTION/DAILY ROUTINE INTENSE PAIN   "10"  ON 1-10 Scale MiGRAiNE LEVEL HEADACHE MUSCLES BECAME TIGHT ALL OVER  INTENSE CONTRACTIONS ALL OVER   HAD TO TAKE TRAMADOL  102 Degrees -  SHIVERING, FULL BODY ACHES - STILL SORE NECK, ABDOMINAL PAIN  FATIGUE
Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On 21-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 21-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate increased: unknown (High) rapid heartbeat.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant  and Treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up received start date of the suspect
Patient had 2 shots in one arm. Hept A and a booster of Hep B. He came in the waiting room and said he didn't feel well and put his head down. He went into a seizure, his eyes rolled back and he body was stiff. He was ill the rest of the nite.
Discovered Breast Lump in right breast during routine self exam. Had Office visit with my Primary Care Physician on June 18th. Scheduled an Ultrasound and Mammogram on June 25th. July 1st - had cyst in right breast drained.
tender spot a day or before inflamed; tender spot a day or before inflamed; Headaches/ Migraines; two flares during menstural cycle, on right buttock and left underarm; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (tender spot a day or before inflamed), TENDERNESS (tender spot a day or before inflamed), MIGRAINE (Headaches/ Migraines) and CONDITION AGGRAVATED (two flares during menstural cycle, on right buttock and left underarm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for an unknown indication.    Concurrent medical conditions included Sulfonamide allergy (sulfer drugs) and Allergy to antibiotic. Concomitant products included ERYTHROMYCIN for an unknown indication.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2022, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to CF. On an unknown date, the patient experienced INFLAMMATION (tender spot a day or before inflamed), TENDERNESS (tender spot a day or before inflamed), MIGRAINE (Headaches/ Migraines) and CONDITION AGGRAVATED (two flares during menstural cycle, on right buttock and left underarm). At the time of the report, INFLAMMATION (tender spot a day or before inflamed), TENDERNESS (tender spot a day or before inflamed) and MIGRAINE (Headaches/ Migraines) outcome was unknown and CONDITION AGGRAVATED (two flares during menstural cycle, on right buttock and left underarm) was resolving.     It was reported that, on 29-Jan-2023, the patient experienced three new flares immediate after being without medication.  On unknown date event condition aggravated was recovered. For Pfizer, the reporter's causality for events Inflammation, condition aggravated, tenderness reported as reasonable possibility and for events migraine headache as not provided. For Humira, the reporter's causality for events migraine headache, Inflammation, tenderness, condition aggravated as not provided. No treatment medication was provided.
Everything was fine at time of shot which was at 11:45. I had no effects, I left clinic  around 12: 30 that afternoon, and went to do a job. I headed home around 4 pm and started to feel warm, but thought it was the sun. Around 5:15 I got the chills, very bad. So bad my jaws were shaking. I tried to use a heating blanket to get warm, but was very miserable. About an hour later I started running a fever that kept going up. My ears started to hurt and the ringing was really bad. By 8:30 my fever had spiked to 102 and I was so nauseous I had a hard time moving around, I almost used the bathroom on myself twice. Started burning up but still unable to move, I went outside to cool down and had a family member take me to the urgent care. They said my arm was swollen from the injection site and that everything was normal and that it was a good thing I was having these experiences because it means the vaccine was working.  Gave me nausea medicine and aspirin and sent me home. I was unable to sleep from all the pain in my body and just laid here in pain starting to get really hot. Woke up around 4 soaking wet where I broke the fever and then continued to have a mild fever all day Sunday, April 11, with mild sweats on and off when my body would get too hot. Today just been trying to move around but very tired and exhausted. Had hard time sitting up to do some work at the table, so been laying down most of the day.
States on 04/25 approximately 3:30 pm started to experience body aches.  Over weekend, 04/26-04/27, experienced flu-like symptoms - headache, low-grade fever, malaise, body aches, missed work 04/28 due to symptoms.
I felt perfectly fine after receiving the shot until about 7 to 7.5 hours later.  All of a sudden, I was overcome with a wave of fatigue and chills. This was followed by headache, nausea, joint and muscle aches, and shaking from the chills.  I had difficulty sleeping overnight and the next morning, I had a fever of 101-degrees and was still very fatigued.  The symptoms all went away within 24 hours.
About 20 minutes after receiving the vaccine I developed tingling of my lips and face, including left eyelid. It improved over several hours. I had no swelling or drooping of my face, or trouble breathing.
Rash and itching on right arm approximately 2 inches below injection site. Started 8 days after vaccine and lasted 4 days. No treatment needed. Rash self-resolved
acute cerebrovascular accident in the left posterior frontal cortex; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On or around 22-APR-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered an acute cerebrovascular accident in the left posterior frontal cortex. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the Company's product. The pt also experience mental and emotional distress due to resulting physical limitations, and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company conduct, the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was reported as not recovered. The causality assessment between the event and the zoster vaccine live (ZOSTAVAX) was reported as related.  The event of acute cerebrovascular accident in the left posterior frontal cortex was considered to be disabling.  Upon internal review, the event of acute cerebrovascular accident in the left posterior frontal cortex was determined to be medically significant.
Extreme tired; Chills; Arm pain; This is a spontaneous report from a contactable consumer (patient) . A 54-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318) via an unspecified route of administration in left arm on 01Feb2021 at 07:30 (at 54 years) at single dose for covid-19 immunisation. Medical history included kidney donor.No known allergy. There were no concomitant medications. On 01Feb2021 at 10:00 the patient was extreme tired and experienced chills and arm pain.No treatment given and patient recovered from the events in Feb2021.No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021201495 same patient, different drug/AE
Postmenopausal bleeding started 17 hours after 2nd dose, lasting 3 days which caused me to go to gynecologist and endometrial biopsy was performed.  Currently still having bleeding but not as severe as days 1 and 2.
multiple, unspecified patients received improperly stored doses of ROTATEQ on multiple, unspecified dates from 4/10/2019 to 5/15/2019; No adverse effects reported; This spontaneous report was received from a nurse concerning multiple unspecified patients.   The patients' medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not provided.  From 10-APR-2019 to 15-MAY-2019, multiple unspecified patients were vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R016792 with expiration date: 29-APR-2020; and lot # R016790 with expiration date: 20-APR-2020). (strength, dose, frequency, anatomical location and route of administration were not provided), administered for prophylaxis.  The lowest storage temperature of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was reported as below 36 degrees Farenheit (°F) (also reported as 34.3°F) for a time frame of 2 hours and 26 minutes. There was no previous temperature excursion. The call was due to a data logger.  No adverse effects were reported. No additional information was provided.
severe allergic reaction I had to the first Moderna Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction I had to the first Moderna Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (severe allergic reaction I had to the first Moderna Vaccine). At the time of the report, HYPERSENSITIVITY (severe allergic reaction I had to the first Moderna Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 3-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
2:30 am I awoke and got up to go to the bathroom and get a drink of water. After urination, I went unconscious for a brief period and fell onto the tile floor. I was able to pull myself up and proceeded to the refrigerator where it happened again while filling a glass. Again, I came to and attempted to get back to bed when it happened a third time. My wife awoke and assisted me back to bed. No serious injury just bruised and sore. Took my BP at 10:00am and it was lower than usual (110/62). No further incidents have occurred and blood pressure is normal.
Patient had local reaction two days after vaccine administration = warmth, redness, & slight swelling with minimal induration. Measurements = redness 6 x 5 1/2 cm, induration 4 x 4 cm. Gave mom symptom treatment directions.
Per patient  Received my first shot on Thursday, December 24 at approximately 11:20 am in my right arm. I felt fine with no reaction and returned home. On Wednesday evening (December 30), my right arm began to itch around the sight of injection.  Upon inspection, my arm was swollen and bright red in an area about four inches wide around the sight of injection.  As of the writing, the swelling and redness have disappeared.  I feel fine with no other symptoms
Pt vax w/ hepta B; devel diffuse arthralgias & myalgias. Persisted for 1 month and are subsiding.
no symptoms; adult patient inadvertently received a pediatric dose; This spontaneous report was received from a medical assistant and refers to a 40-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.  On 06-FEB-2020, the patient was inadvertently vaccinated with a pediatric dose (0.5 mL) of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot# R031055, expiration date: 04-JUN-2021) (route of administration and frequency were not provided) for prophylaxis as a first dose in immunization series instead of an adult dose (1.0 mL). No confusion was reported, it was a medication error. No symptoms were reported.
Pentacel was given and it was not mixed with the powder, no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7 months old patient who was vaccinated with a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ018AAA, expiry date: 12-Oct-2020 via intramuscular route in the right deltoid on 21-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate reconstitution technique. It was reported that the diluent part of Pentacel was given and it was not mixed with the powder.  At the time of reporting, no adverse event was reported.  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 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.