chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FluLaval administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number GF9PM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comments: The pharmacist called and ask for information about the administration of Flulaval to a staff member. The Flulaval vaccine that was administered were exposed to room temperature for a few weeks. The reporter did not provide exact data about time and temperature of the excursion, but mentioned that vaccines were out of refrigeration approximately from 15th September 2022 to 10th October 2022 and then vaccines were administered to the staff members. The reporter did not provide either the exact date of administration nor the identifiers of the patient that received this vaccine.  The reporter asked about the stability of Flulaval when exposed to temperatures higher than recommended and asked if the staff members had to be re-vaccinated. The reporter consent to follow up. Additional supportive information: The vaccine temperature exposed to temperatures higher than recommended, which led to incorrect storage of drug. This is 1 of the 7 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR157001:Same reporter US-GSK-US2022AMR157002:Same reporter US-GSK-US2022AMR157003:Same reporter US-GSK-US2022AMR157005:Same reporter US-GSK-US2022AMR157006:Same reporter US-GSK-US2022AMR157008:Same reporter
This case was reported by a physician via call center representative and described the occurrence of regurgitation of medication in a infant patient who received ROTARIX for prophylaxis. On an unknown date, the patient received the 2nd dose of ROTARIX (oral). On an unknown date, 15 min after receiving ROTARIX, the patient experienced regurgitation of medication and accidental underdose. On an unknown date, the outcome of the regurgitation of medication and accidental underdose were unknown. It was unknown if the reporter considered the regurgitation of medication to be related to ROTARIX. Additional information was received as follows: The age at vaccination was not reported. The patient regurgitated 15 to 20 minutes after administering the ROTARIX vaccine, which led to accidental underdose.
Ringing in ears started 3 days after injection and is ongoing Hives and itching started 3 days after injection and has almost subsided.
Patient's husband reported patient experienced a red rash, swelling, and warmth from the injection site on the left deltoid down to the elbow.  The symptoms started the day after vaccination and continued to worsen until the 15th.  The symptoms held steady over the 15th and began resolving that night.
I had a stroke the day after receiving the vaccine while I was having a kidney stone pushed out at Hospital.  I was in the hospital for a week.  I went to rehab and was there for 5 months trying to regain my left side mobility.  Vision is now permanently impaired and my left arm is still wonky and my left leg is still having issues.
Chest Pain/Palpitations; Elevated Troponins within a week of vaccination.
Dizziness, Flu like symptoms up to five days-achy all over, chills, sweating, pain in arm and red at vaccine site for six days.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Medical history was not reported. On 22-APR-2014 the patient was vaccinated with ZOSTAVAX, (lot # not reported) 0.65 ml, subcutaneous. Concomitant therapy was not reported. The reporter informed that ZOSTAVAX underwent two temperature excursions. On 11-APR-2014 was the first excursion, the ZOSTAVAX, was on 9.5 F for 2 hours. The second excursion was 11F for 2 hours on 22-APR-2014. The patient received ZOSTAVAX, on 22-APR-2014, prior to second excursion. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
MMR # 2given at 8:30, student returned no sllc approx 09:30 pale & complains of S03/dyspnea. Epi-pen adm. x 2, parents called her. EMS called. Student initially improved talking po repeated. Parents notified students PCP noticed. Student transported to PCP per mother.
other people had experienced a reaction; 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 VACCINATION COMPLICATION (other people had experienced a reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (other people had experienced a reaction). At the time of the report, VACCINATION COMPLICATION (other people had experienced a reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment medications provided.
TROUBLE BREATHING; DIZZY; ELEVATED HEART RATE; TROUBLE WALKING SHORT DISTANCES; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications included baclofen for drug used for unknown indication, buprenorphine hydrochloride/naloxone hydrochloride for drug used for unknown indication, citalopram hydrobromide for drug used for unknown indication, levothyroxine sodium for drug used for unknown indication, and trandolapril for drug used for unknown indication.  On MAR-2021, the subject experienced trouble walking short distances. Treatment medications included: salbutamol. On 17-MAR-2021, the subject experienced trouble breathing. On 17-MAR-2021, the subject experienced dizzy. On 17-MAR-2021, the subject experienced elevated heart rate. The action taken with covid-19 vaccine was not applicable. The patient recovered from trouble breathing, dizzy, and elevated heart rate on 21-MAR-2021, and trouble walking short distances on MAR-2021. This report was non-serious.
no other AE; temperature excursion; This spontaneous report was received from a medical assistant and an office manager and refers to a patient of unknown age and gender (number reported as 65584). There was no information about their concurrent conditions, concomitant therapies or medical history provided.  On 18-MAR-2021 (reported also as between 04-MAR-2021 and 25-MAR-2021), the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) dose/frequency: 1, lot # T021823, expiration date 25-JUN-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was stored in a temperature of 13.5 Fahrenheit degrees (F) for 40 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event was reported.  As of 28-MAY-2021, no further information was available as the office manager stated she was not familiar with the case and the medical assistant has not been working at the facility anymore.  This is one of several reports from the same reporter.
Fever, chills, nausea, headache, body aches Pain from swollen lymph nodes in left armpit
right hand unworkable; Nerve pain in opposite arm, near wrist; Sudden onset of electrical-like pain near the right wrist; This is a spontaneous report from a contactable consumer. A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 18Feb2021 09:15 (age at vaccination 50 years) as dose 1, single for covid-19 immunisation. Medical history included lyme disease from an unknown date and unknown if ongoing. Concomitant medication(s) included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies.  On 18Feb2021 22:00 the patient experienced right hand unworkable, nerve pain in opposite arm, near wrist, sudden onset of electrical-like pain near the right wrist. Patient did not receive any treatment for reported event. The outcome of event was not recovered. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Patient reports a rash develop 4-5 days later - itchy rash - no blister. Pain in side develop the following weekend. Patient called Dr & was prescribes Tramadol for pain. Dr said to take TYLENOL.
Mom called Hlth Dept stating child w/fever 100.4 (ax) & crying refused bottle would not eat or drink- seen by MD.
Swelling and itching of area near and around injection site.  This happened within a week to 10 days after injection and  continues today. No fever... No abnormal effects besides swelling and itching.
Rash on arm starting at injection site, over the course of three days it has spread around the upper arm with swelling.  Treated with topical hydrocortisone cream and oral cetirizine
This spontaneous report was received from a nurse refers to an adult patient of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On 14-OCT-2016, the patient was vaccinated with a pediatric dose of VAQTA lot # L036300, 0.5 ml for prophylaxis. No adverse event was reported. As of 09-DEC-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
fish hook" little bit in skin and then she took it out; Initial information received on 12-May-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 60 years old female patient who received a dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number not reported via unknown route in unknown administration site for prophylactic vaccination in 2019. It was reported that while administration of Adacel in 2019 nurse given the dose as a "fish hook" little bit in skin and then she took it out and mixed with something. She then said she thinks it was mixed arsenic and then she said it was a sedative but she knows it could not have been a sedative.  The patient's past vaccination(s) included TETANUS VACCINE with 14 year ago, TD VACCINE in JUN-2005 with 14 year ago, TDAP in JUN-2006 with 14 year ago, TD VACCINE in JUN-2013 with 14 year ago and TD VACCINE in JUN-2017 with 14 year ago. The patient's past medical history, medical treatment(s) and family history were not provided.   It was an actual medication error due to wrong injection technique.  At the time of reporting, the patient did not experienced any 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 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.  There will be no information available on batch number for this case.
Former premature infant born at 28 weeks gestation & birthweight 697 gm received standard 2 month vaccinations (Pediarix, HIB, Prevnar) at 0550AM on 5/20/05.  Later that AM developed a fever to 102.1 and was given tylenol 15 mg/kg every 6 hr.  The patient continued to feed well and was clincally stable for the remainder of that day.  Pt had recurrent fever at 0600 5/21 & WBC 4.6 (2 bands, 16 seg). At 0900 5/21 pt developed abdominal distension and feedings were stopped & required oxygen.  Blood cultures were drawn & Vancomycin & gentamycin were started. Pt was intubated.  At 0015 5/22 pt had a seizure and fontanel became tense.  she received a loading dose of phenobarbital 20mg/kg and a blood transfusion.  Piperacillin/tazobactam IV given.  Pt transferred to hospital at 0300 5/22/05 for evaluation of ileus/surgical abdomen and Lumbar puncture to rule out meningitis.  Per annual follow up report: Pt had late onset group B Strep meningitis which resulted in static encephalopathy and neurodevelopmental delays.  Discharge summary states diabetes Insipidis, brain syndrome, chronic, cerebral infarct, bacterial infection, hypothyroid, bradicardia, thrombocytapenia, deaf. msv  This was a concurrent GBS meningitis case. Symptoms for the meningitis developed some time as the vaccination was given.  The polt vaccination fever may have raising appropieate concern when she  became febrile. She never recovered from the meningitis. The disease left her disabled developmentally delayed. She died close to a year of age when she received viral infection.
Fever, vomiting, lethargy lasted until approximately 2:30 PM the same day. Treated with Tylenol and hydration.
Information has been received from a pharmacist referring to a 52 year old male patient. The patient's concurrent and historical conditions were not reported. On an unknown date in November 2104 the patient was vaccinated with first dose of GARDASIL (dose, frequency, route, lot # and expiration date were not reported) for benign neoplasm of the larynx (inappropriate schedule of drug administration and drug administration error). Concomitant therapies were not reported. Patient had not received any further doses. No symptoms were reported. Additional information has been requested. Additional information has been requested.
This spontaneous pregnancy report as received from a physician refers to a 25 year old female patient with polycystic ovary syndrome, PCN allergy, endometriosis, hypertension, migraines, smoker and obesity. The physician reported that on 04-NOV-2014 the patient was vaccinated with GARDASIL. Concomitant therapies included Prenatal vitamins. The physician stated that the patient took a home urine pregnancy test on 20-NOV-2014 and the result was positive. The physician reported that the patient was seen in the office today and that the patient is "about six weeks pregnant." The LMP and EDD is not known. The outcome of vaccine exposure during pregnancy is unknown. No further information was provided. Additional information has been requested.
C/O pain and burning sensation from shoulder area that radiated to mid arm. This pain and burning lasted for approximately 12 hrs.
Patient Covid + on 10/06/2021 and vaccinated. Patient hospitalized Per Ed Note: 98-year-old male with past medical history of hypertension, hyperlipidemia, hypothyroidism, and anemia presented to the emergency department with complaint of weakness.  He describes the weakness as a lack of energy and generalized fatigue.  He states he saw his cardiologist 2 weeks ago because he had an abnormal EKG, stating he was told he had a "missed beat."  He states he had a follow-up appointment on Thursday, 9/30/2021 with his cardiologist.  He was told that his EKG is normal and that there is nothing to worry about.  During that appointment he noticed that he was having some constipation.  He was told to take magnesium citrate, and he did take that.  He states over the next 2 days he had multiple episodes of loose stool, and feels as if he may be dehydrated.  He now complains of some myalgias as well as some lightheadedness.  He states he does have a cough, this is nonproductive.  He also states some shortness of breath.  He denies any associated headache, vision changes, neck pain, back pain, chest pain, palpitations, syncope, abdominal pain, nausea, vomiting, dysuria, hematuria, extremity numbness or tingling, or focal weakness.  Patient's daughter was at the bedside and also stated that she believes he could be dehydrated because he has had similar issues when using laxatives; when he is been hydrated in the past he is presented similarly and has required IV hydration eventually goes home.
patient woke up experiencing fever 100.6, chest pain, and shortness of breath.  Told patient to seek doctor consultation through family md or emergency room.
My right hand and arm are numb, weak and tingling, with recurring pain, and have been so for a week, since I received the DTaP vaccine in the right upper arm in the hospital.
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On 03-APR-2014 the patient was vaccinated with ZOSTAVAX lot # J013138; expiry date: 17-JAN-2015) one single shot via "injection". On an unspecified date after vaccination the patient experienced injection site rashes and that were warm and spread across her arms. The patient was still not recovered the rash was still present. The patient had not sought medical attention. This is one of two reports from the same reporter. Additional information has been requested.
On 3/23/2022, I received my first dose of the Moderna booster for COVID-19. On 6/21/2022, I started coughing and feeling sluggish in the evening. I also developed a slight sore throat. I went to bed and woke up on 6/22/2022 with a fever of 101, coughing and with headache and severe sore throat. I called in sick to work and went back to sleep. I periodically had to wake up to take TYLENOL to break the fever and to use the toilet. The TYLENOL would help relieve the fever for a short time, but the fever would return, and I had to take more TYLENOL every 4-6 hours. I stayed in bed all day and all night. I didn't get out of bed until the morning 6/23/2022. I had a little more energy. I didn't eat much, except for a little soup and little bit of beans. I had a fever when I woke up, so I took TYLENOL and then went to urgent care. At the urgent care clinic, I was tested for strep throat, the flu, and COVID. I tested negative for strep throat and the flu, and when I got the COVID test results on 6/24/2022, they were positive. When I got home from the clinic, I camped out on the couch and then went to bed that night. I woke up coughing around 2 AM on 6/24/2022. When I got up on the morning on 6/24/2022, I got a call from urgent care telling me that I had COVID. I asked them if I was eligible to get PAXLOVID. They told me I would have to call my PCP to get a prescription. However, they did give me amoxicillin, prednisone, lidocaine, and benzonatate. I called my PCP's office and was scheduled for a virtual visit with the doctor at 11 AM that day. When we did the virtual visit, we discussed the risks and benefits of PAXLOVID. The doctor determined I would be a suitable candidate for PAXLOVID, but I would need to stop taking CRESTOR and prednisone while I was taking PAXLOVID. I got the PAXLOVID and began taking it. Within a few hours of taking it, I began to see results. I very quickly felt better. On 6/25/2022, the congestion began to loosen up and I developed a productive cough. Since then, I have continued to improve. I have been fever-free since 6/24/2022. I returned to work on 6/27/2022. At the time of this writing, I've still got a slight cough and feel weak and fatigued.
Caller got already the 2 doses of the Pfizer covid vaccine and tested positive for Covid 19 afterwards.; Caller got already the 2 doses of the Pfizer covid vaccine and tested positive for Covid 19 afterwards.; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 on 03Jan2021 in the afternoon (lot number: EJ1685) at the age of 45 years old, dose 2 on 24Jan2021 11:15 (Lot Number: EJ168) at the age of 45 years old , both via an unspecified route of administration as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No Family Medical History Relevant to AE(s). No History of all previous immunization with the Pfizer vaccine considered as suspect. No additional administered vaccines. No Prior Vaccinations (within 4 weeks). Caller wanted to know if it could be possible that she tested positive to Covid 19 and she got a variant. Caller got already the 2 doses of the Pfizer covid vaccine and tested positive for Covid 19 afterwards. She wanted to know about the research statics of the people that fully vaccinated tested positive for Covid 19 after receiving vaccine. Caller wanted to know if she went again to test, she would test positive. Caller wanted to know if the Institute had reported cases where patients tested positive after being vaccinated. Vaccine Administered at Military Facility: No. Caller stated she was calling about the COVID 19 vaccine and was wondering if the department of health notifies Pfizer if a patient got both vaccinations and tested positive for Covid. Caller stated she tested positive and got the test on 16Mar2021 and emailed results on 17Mar2021 to tell her she was positive. Caller stated she had not been to the doctor because she has been in quarantine and caller declined to provide HCP email. Caller tested positive on 16Mar2021 and when asked if the caller was still positive the caller responded if she should get another COVID test. The caller stated that she had not got that far to call the doctor. Caller stated that it had worsened. Caller stated she received the vaccine at the clinic at Hospital in a suite room area for healthcare providers. Treatment inlcuded Tylenol. The events did not require a visit to Emergency Room and Physician Office. Caller asked so far in research what was the statistics that someone has been fully vaccinated and tested positive for COVID. Caller stated she was just curious how many people test positive as the general public seems to think one should not test positive after receiving the vaccine and she should have been protected more. The report was serious per the reporter. The outcome of the events was unknown.