chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB, lot number L044917 with expiration date of 05-OCT-2018, for prophylaxis, and the administered doses were exposed to a temperature higher than 47 F (Fahrenheit degrees) but lower than 77 F (Fahrenheit degrees) for 4 days 6 hours and 3 minutes (digital data logger) without any previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004450: US-009507513-1707USA004449: US-009507513-1707USA004419.
throat tightness; Frequent throat clearing; During patient's 15 minute waiting period after the injection, the patient began to experience rash, hives, throat tightness and dizziness. The patient denied difficulty b; rash; hives; Itching of skin; headaches; This is a spontaneous report from a non-contactable other health care professional. A 21-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in an unspecified anatomical location on unknown date (at the age of 21-year-old), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications have not been provided. During her 15 minutes waiting period after the injection, the patient began to experience rash, hives, throat tightness and dizziness. The patient denied difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling. Patient complained of frequent throat clearing, itching of skin and headaches. Treatment included antihistamines. Follow up response to treatment was excellent. Patient on discharge was stable to go home and follow up with PCP. The outcome of all the events were unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, expiry: UNKNOWN ) dose, start therapy date were not reported 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. No concomitant medications were reported. On an unspecified date, the patient experienced chills, massive headache, and fever that wouldn't quit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and massive headache, and had not recovered from fever that wouldn't quit. This report was non-serious.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 08-JAN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 160. The highest recorded temperature was 59. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse practitioner referring to unspecified patients of unknown age and gender. The concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot #: K007828, expiration date on 02-MAR-2017 and lot #: K011562, expiration date on 08-APR-2017 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
Initial information received from a healthcare professional on 19 July 2012. A patient (age and gender not reported) whose medical history and concomitant medications were not reported received DAPTACEL and POL on unspecified date (lot number, dose number, route and anatomical site of injection were not reported. On an unspecified date, the patient experienced swelling in arm, 2 days post vaccination. Laboratory details and corrective treatment were not reported. The patient's outcome was not reported. Documents held by sender: None
no aditional AE; freezer underwent an excursion and they did not realize the excursion until later/temperature excursion for VARIVAX and PROQUAD/ VARIVAX and PROQUAD may have been administered to multiple patients; This spontaneous report has been received from a nurse, concerning a 3-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 15-MAY-2023, the reporter's freezer underwent a temperature excursion; in which varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) were stored. On that same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W035466 and W017567 with following expiration dates 06-MAY-2024 and 29-NOV-2023, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided).  Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723 and W031812   with following expirations dates 15-DEC-2023 and 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event). .; Sender's Comments:  US-009507513-2306USA004088: US-009507513-2306USA004087: US-009507513-2306USA004086: US-009507513-2306USA004089: US-009507513-2306USA004085: US-009507513-2306USA004082: US-009507513-2306USA004090: US-009507513-2306USA004083: US-009507513-2305USA007959:
pregnant at time of vaccination O99.824 - Streptococcus B carrier state complicating childbirth O75.9 - Labor and delivery, indication for care
2wks after Rotavirus pt presented to clinic for diarrhea total of 5d. I called pt today to see how she is doing and per mom pt is fine and diarrhea has resolved.
Information has been received from a physician concerning an "almost 5 years old" male who in November 2007, was vaccinated with his second dose of VARIVAX (Merck).  Within the past week, on approximately 22-AUG-2008 the patient developed "4 spots" on his back.  The physician also mentioned that the patient had several "bug bites" on his legs.  No fever had been noted.  Unspecified medical attention was sought.  At the time of this report, the outcome was unknown.  Additional information is not expected.
Swollen lymph nodes, swollen Injection site, itchy injection site, hardness of injection site
Very loud worsening of Tinnitus that interfered with hearing and very weird feeling ears. I went to the doctor and was prescribed Flonase, Sudafed, and an antihistamine. Using those improved the symptoms after about a week.
initially felt light-headed and dizziness, then had flu like symptoms lasting 24 hours. The  lymphedema left axillary area lasting about 24 hours after first dose. Had a mammogram in March 2021 and it showed a spot on the left breast.
her temperature, it was 99.8 close to 100.; cold; Spinning; On the night of 25Sep2023, she complained that she was cold, her head was hurting, and saying my head is bothering me; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), VERTIGO (Spinning), HEADACHE (On the night of 25Sep2023, she complained that she was cold, her head was hurting, and saying my head is bothering me) and PYREXIA (her temperature, it was 99.8 close to 100.) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 205E23A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccines (she had normal reactions and like arm hurting and fever.). Past adverse reactions to the above products included No adverse event with Pfizer vaccines. Concurrent medical conditions included AFib. Concomitant products included METOPROLOL and FLECAINIDE for an unknown indication.    On 25-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced NASOPHARYNGITIS (cold), VERTIGO (Spinning) and HEADACHE (On the night of 25Sep2023, she complained that she was cold, her head was hurting, and saying my head is bothering me). On an unknown date, the patient experienced PYREXIA (her temperature, it was 99.8 close to 100.). At the time of the report, NASOPHARYNGITIS (cold) and VERTIGO (Spinning) had not resolved and HEADACHE (On the night of 25Sep2023, she complained that she was cold, her head was hurting, and saying my head is bothering me) and PYREXIA (her temperature, it was 99.8 close to 100.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 close to 100..     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient's heart was running faster but this time it was hurting. She went to sleep and the next morning she couldn't eat as before and not drinking as much, there is a difference in thirst, and she complained. On 26Sep2023, in night after eating, she wanted to vomit, but didn't.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-742507 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742507:Husband Case (same reporter different patient)
About four and a half months after receiving the vaccine, I got shingles under my breast and abdomen. It seemed to be a pretty light case. It lasted about 2 weeks. In July, I checked with my chiropractor about my thumb. He said he thinks I have trigger finger on my thumb. I saw an orthopedic doctor/hand specialist Dr.  and I am having surgery to fix it in October.
Received varivax on 9/14/00. On 3/23/01 had the disease of full blown varicella.
Pt had 1st episode of Bells - right side symptoms on 12-27-20. She had a very dense paralysis which not completely resolve at this time. She had her 1st Moderna shot on 03-10-21 and on 03-19-21 c/o onset of similar symptoms, but on the left side of her face. The current episode was not as bad as the initial episode in December.  Currently mild residual symptoms, mostly noted when smiling.
Itchy red rash on stomach and around the belly button. It is also on the tops and inside of the thighs.
Narrative: Patient tested positive for Covid-19 and was hospitalized despite full vaccination of Moderna dose 1, 2, and booster which was given 11/10/2021. Hospitalized on 12/12/2021. COVID-19 (MODERNA), MRNA, LNP-S,* 3 11/10/2021 FACILITY* 2 04/02/2021 FACILITY* 1 03/00/2021 FACILITY*
Fever, Chills, Body Aches, Extreme Fatigue, Dizziness, Back Pain
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 at 19:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 15May2021 at 19:00 as dose 2, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type-2 diabetes" (unspecified if ongoing), notes: Type-2 diabetes. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: indication=Treatment of COVID-19; Negative, notes: Rebound after Paxlovid (return of sore throat, achiness - 6 days after negative test and symptom free...). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received anti viral Paxlovid from 04Jul2022 to 08Jul2022 for treatment of COVID-19. Rebound after Paxlovid (return of sore throat, achiness - 6 days after negative test and symptom free. The patient had no known allergies. Other medication in 2 weeks: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Several hours after immunization arm was tender, with muscle ache (as if exercised a lot.). This progressed to severe pain and limited movement due to  pain. Difficult to move arm away from "hanging" position without extreme pain.  Difficult to undress at the end of day due to limited range of motion.  By 10 pm area appeared edematous with pinkish splotches, from shoulder to elbow. Next a.m., flushed facial skin, low grade temp (99.6F).   Malaise.  Extreme pain of right upper arm. Little relief from analgesic (ibuprofen).  No change in arm appearance or feeling until Thursday, when arm symptoms started to subside.  Thursday afternoon, noted achiness in knees,  progressing to overall pain in legs, mainly around joints. Pain did not allow for sleep, as bilateral calves and knee areas felt "tight", almost burning.  More motrin, better this morning.
RED, SWOLLEN (ABOVE ELBOW), SORE, HEADACHE FOR TWO DAYS
Increasing confluent redness and tenderness of proximal left upper extremity extending just below elbow.
Within 10-12 hours, onset of diarrhea, tightness in throat, non-productive persistent cough, feeling of choking in base of throat, hot feeling in lungs, chest pains in upper left chest, laryngitis, anxiety, depression; treatment with prednisone, Diflucan, quaifenisen, codeine cough syrup, Ativan. At present, still have cough, diarrhea and anxiety. On 1/10/01 had yeast infection in mouth, throat and vocal cords; treated with Diflucan (3 rounds). On 5/8/01, had 12 day prednisone treatment begun with Diflucan in case of reoccurrence of yeast.
Pt dev pain in arms & legs which inc til unable to walk. T to 105, shaking, chills, arthritis, incontinent, poor oral intake. Rt wrist edematous /w pain on mvmt, erythema & effusion. Extensive pt hx & hospital course
on Jun 18th 2021, Engerix-B expired dose was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a days-old female patient who received HBV (Engerix B) (batch number CP275, expiry date 13th April 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th June 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 18th June 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: On 18th June 2021, patient received Engerix B, which was expired on 13th April 2021. The reporter consented to follow up.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 2:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 2:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 68.91.  Concomitant products were not provided.  On 03-Mar-2021, excursion time was 09 AM, 10 AM  and 1PM,  and temperature was 51, 34 and 35 respectively, total doses given for the day was 200, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 03-Mar-2021. 20 vial was moved to clinic on  03-Mar-2021. Vaccine BUD date was  26-Mar-2021.  Vial was stored on cooler 1 , on  03-Mar-2021, Excursion duration At, 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 AM: 46, 1PM : 35, 2 PM : 36, 3 PM: 36 and 4 PM: 36.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported
Dermatitis, papular rash left arm, upper back and slightly along the right arm tho worse on left side. Tingling lip.
After 2nd shot, got outbreaks/ Suspected vaccination failure; got outbreaks; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had 2nd Shingles shot and got outbreaks. The patient reported that it has been going on for more than 2 years. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
This spontaneous report as received from a medical assistant referring to an patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # N003703 expiry date: 29-OCT-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Post vax, the pt started getting severe migraine headaches, which have increased periodically over time. Pt states he has seen 3 doctors in reference to migraines.
2hr p/shot pt became pale, nauseated & feb (unk temp)mom initiated motrin @ that time;pt refused to eat & c/o h/a that PM;this AM pt was still pale, nauseated, feb, & w/reddened, sore arm @ inj site;dec activity level;mom saw nurse @ MD ofc
Started with chills and pull body nerve pain. Went to bed and woke up 2 hours later with a 103 degree temperature and violent chills causing extreme pain throughout my body. Was unable to move and everything touching my skin caused extreme shooting pain through my entire body.
Per patient: "I got the booster shot on late Friday afternoon.  On Saturday, I had a headache, sore throat, and earache.  I felt this way after my second COVID shot and it lasted 24 hours then.  I took all my medications Saturday and my sleeping med before bed, but all night Saturday night I had a hard pain in my chest.  It was not a stabbing pain or I would have called the rescue squad.  For 24 hours my chest hurt and for 12 hours I worried I was having a heart attack. I was back to normal by Monday, but thought the FDA and Moderna should know about my side effects."
Right after 2nd dose, had 2 weeks of diarrhea, muscle spasms, both flare-up symptoms of chronic psoriatic arthritis. Also had vaginal bleeding for one week.  My concern now, is after doing  a 6 week physical standing for a job in May and June, I again had a flare-up, which I am still experiencing.  Past 3 months, my body has been in a inflammation flare-up, since July 1st.  Muscle spasms and loose bowels, which I have now scheduled a gastric doctor appointment  for tomorrow, and a rheumatologist, which is not until end of November. I have always been able to recoop after a flare-up after a 2 week period, and my body does not seem to be able to now. Has my basic system changed to inflammation?
Patient originally received Moderna vaccine as 1st dose. Given Pfizer 2nd dose in error.