chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 29-SEP-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
woke up next morning with fever, chills, body aches, nausea. I felt like I had been run over by a train and slept all day and night. After about 36 hours, I felt back to normal.
Initial information received from a health care professional on 02 April 2007. A 17-year-old male patient received a dose of Menactra, lot number U2171AA, administered intramuscularly on 16 March 2007. The patient had no reported past medical history. Approximately three to five days later, the patient developed chronic, intermittent abdominal pain. He was diagnosed with acute pancreatitis and was hospitalized on 29 March 2007. A CT scan of the abdomen was normal. Ultrasound of the gallbladder and pancreas was normal. Amylase was 400 on admission and lipase elevated at 2,500. MRCP was pending. At the time of this report, the patient remained hospitalized and had not recovered from the events. 05/02/07-records received from facility for DOS 4/9-4/13/07-DC DX:Resolving Diarrhea and Dehydration. Previously admitted one week prir for pancreatitis which resolved itself. Possible immunologic reaction to a possible Menactra shot administered five days before initial onset of abdominal pain and pancreatitis. Dehydration elevated lipases and amylases. 10 pound weight loss. Current medication includes Protonix.
About 18 hours after the vaccine was given, the patient developed chest pain. The chest pain progress over about 24 hours to 9/10. He presented to the ER where he was found to have elevated troponin (up to 15) and ST changes on EKG. Echo was normal x2. He was treated for myopericarditis with NSAIDs and colchicine. He quickly improved. No clear etiology of his myopericarditis was identified, raising suspicion that it may have been an adverse reaction to the vaccine.
after receiving imms, pt.s eyes rolled back as did his head. Arms and hand contracted and lips went blue.mUnresponsive to name. Had urinary incontinence. Episode lasted 3-5 secs.
headache, low-grade fever (100), malaise, followed within a couple of days by upper respiratory symptoms (pruritus/congestion, croup cough), went to family doc on Monday, July 26 for Decadron shot and treatment of symptoms (tested positive for COVID-19).  Symptoms improving, lost taste/smell July 27.
SoB on 8/12; Started with headaches and my arm was very sore left arm at injection site. 8/13 sore thorat, Headaches, left arm severly sore. SoB, left side only neck pain. I never had headaches. 8/14 ears itchy, sore throat nausea, lips numb. I then develop a rash on my left shoulder looked like a sunburn rash on my chest. My hand cramped & a shooting pain up my arm. 8/15 dull headaches, sore Thorat, cough hurt all over. Tired, left side neck pain, Rash on my Right lower leg severely itch. 8/20 Saw Doctor Phlegm Nasty Blood tinge greenish. My face gets very hot and I am very sun sensitive. I still have headaches & my joints hurt neck pain now. SOB, Headaches, exhausted all the time, Back pain. I don't feel right. I had a case number for Covid From a Patient Jan 6, 2021 he died
had pretty severe back pain that lasted about 10 days; This is a spontaneous report from a contactable consumer reporting for son-in-law via Medical Information Team. A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as a single dose for an COVID-19 immunisation. The patient medical history and concomitant was not reported. On an unspecified date after vaccination, patient had pretty severe back pain that lasted about 10 days. Patient had to call out of work for 2 days because of it. Patient was scheduled to get his second dose on Monday (unspecified date). The outcome of the event unknown.   Follow-up attempts have been completed and no further information is expected.
Vaccine are not listed below as options and are as follows: Date Given 9/6/06 DTaP4 - ID - R. Leg PCV4 - ID - R. Leg MMR1 - IM - L. Leg HIB4 - ID - R. Leg  At on site of MMR1, lump formed.  Was inforred by provider that injection went into musle and to use heat pad and massage to reduce lump.  On 9/12/06, returned to Dr. Office with lump still present.  Dr. notes state: Lumps remaining from immunizat.  lump which began several days ago.  it was located on the left anterior thigh.  She characterized the quality as hard superfiial bump at site of MMR given.  Severity was described as very slight and improving.  Duration is constant.  The timing was progressive and gradual onset.  Assessment: Foreign Body Reaction of the Skin Nos".  On 10/23/06 shea was seen for illness and repeatly seen in office 6 times with 9 emergency room visits and 2 required hospitalization stay totaling 9 days.  01/11/2007: MR received from local hospital documenting 3 ER visits between 11/21/2006 and 12/09/2006. DXs: 1st visit: DX: upper respiratory infection.  2nd visit: DX Pneumonia. 3rd visit:  1) leg pain 2) syndrome, viral. 01/22/2007: MR received from PCP which included multiple office visits and several hospital reports for multiple ER visits and one admission. Well child check (12 mon.) on 09/06/2006 when vax. were given.   Office visit  09/12/2006 for c/o lumps remaining from immunizations. PE describes firm, non-tender, palpable lump at site of MMR (left anterior thigh)-minimal redness, no heat.  Moist heat recommended. Assessment:  Foreign body reaction of the skin (NOS). Additional records received for hospital admission 01/03-07/2007 for c/o fever and diarrhea. Discharge DX:  1) Bilateral Otitis Media  2)  Influenza infection.   02/02/2007 Reporter/parent called with updated information and requests that records be requested and added to file. Records requested per request. 02/12/2007 MR received for 4 day hospital stay (1/23/07) for fevers and refusal to walk.  Consults with Pediatric ID and orthopedic surgery are included.  History as above.  No evidence of osteomyelitis. D/C DX: Fever resolved, likely due to CMV infection (resolved). 04/27/2007 MRs received from hospital visit for insertion of myringotomy tubes on 2/3/07 and for an ER visit for c/o diarrhea and fever on 12/29/2006.  DX:  Febrile Illness. Diarrhea.  Subject continues to have severe health issues, hospitalized without reason or why she is continued to get sick.  Several work ups of test have come back negative. Subject was accepted by a research hospital.  She will begain her cane (exam & even diagnosis) done on Feb. 4, 2008.  Please follow- as we are hoping to see if we can find why subject continues to get ill.  Followup 3/30/2010 We are currently being treated by several doctors/specialists including, care out side the state of Arizona and went to Stanford University in CA.
Case number PHEH2013US008218, is an initial spontaneous report received from a nurse on 08 Apr 2013: This case refers to a 21-years-old female patient. She received only Men C,Y, W-135 liquid conjugate component of MENVEO (batch number: 12013), intramuscularly without being reconstituted with Men A component on 05 Apr 2013. She was not re-vaccinated. No adverse reaction reported following this administration error.
sore arm; feeling a little beat up the next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MALAISE (non-serious), outcome "unknown", described as "feeling a little beat up the next day".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289406 Same patient/vaccine, different dose, similar event;
27 years patient received FLUZONE HD with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 27 years old male patient who received vaccine influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Sep-2022, the patient had received a dose of 0.7 mL total of suspect influenza quadrival a-b high dose hv vaccine (lot number-UT7729CA, expiry date- 30-Jun-2023) (with an unknown strength, formulation) via intramuscular route in the arm NOS (not otherwise specified) for Immunization.  On 26-Sep-2022, (latency same day) the patient developed a non-serious event 27 years old patient had received fluzone HD with no reported adverse event (product administered to patient of inappropriate age) following the administration of influenza quadrival a-b high dose hv vaccine.  No lab data was reported  Action taken with quadrivalent influenza vaccine was not applicable.  At time of reporting, the outcome was Unknown for the event 27 years patient received fluzone HD 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.
A male pt (age not reported) has been treated with Oncotice for an unspecified period. After an unspecified delay he experienced a burning sensation.
armpit was swollen; This is a spontaneous report from a contactable consumer (patient's cousin). An adult male patient in in his late 40s / early 50s received BNT162B2 at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient experienced armpit was swollen after receiving his first COVID-19 shot. Outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain, wrong route of administration and accidental underdose. On an unknown date, the outcome of the injection site pain, wrong route of administration and accidental underdose were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided s follows: The age at administration was not reported. The healthcare professional (HCP) reported that reports that while administering a dose of SHINGRIX a patient pulled away and some of the dose might have been given subcutaneously and also stated that full dose was not administered due to the patient pulled away which led to wrong route of administration and accidental underdose. The HCP further stated the patient then complained of injection site pain.
Has an outbreak of shingles every month/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (Gotten shingles in a small patch on hips in early 20's.).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Has an outbreak of shingles every month/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2023 This case reported by the patient for himself. The reporter reported that he or she got shingles in a small patch on his or her hips since his or her early 20's. The reporter reported that it was happened may be 2 times a year. The reporter reported that someone convinced his or her to get the Shingles vaccine. The reporter reported that he or she get the shingles nearly every month. The reporter reported that her or his life was much worse now. Consumer consents to HCP follow up but has limited details at the time of the call.
I had the Moderna booster on 10/28/2021 with no major side effects. I woke up 12/31/2021 with 6th cranial nerve palsy in my right eye.  I had bumped my head 12/24/2021 and assumed it was from the bump, but maybe it was the vaccine. I have been very symptomatic with inflammation during the time period also. Face swollen, ankles swollen, knee painful, low back pain in SI joint. Hand arthritis.
I started to develop symptoms of cough and runny nose. I lost some loss of taste or smell. I got a positive COVID test on 1/2/2022. My symptoms lasted for approximately 1 week. I found out that I had a miscarriage in January. It seems like the miscarriage was unrelated to COVID due it being a missed abortion. The baby had stopped growing mid Dec.
-5/11/21: patient received initial dose of Moderna vaccine (PFR, COVID-19, mRNA, LNP-S, PF, 0.3mL vaccination on 05/11/2021 with lot number EW0173 at (COVID Clinic). -6/01/21: patient received 2nd dose of Moderna vaccine (PFR, COVID-19, mRNA, LNP-S, PF, 0.3mL vaccination on 06/01/2021 with lot number EW0186 at (COVID Clinic). -8/23/21: patient presented to outside clinic complaining of a bilateral rash that appeared on the hands, forearms, and ankles that reportedly appeared 2 weeks after the COVID vaccine. The patient also complained of episodic dizziness, nausea, back pain, chest pain, groin pain for the past 4 weeks. Pt reported using hydrocortisone cream on rash with minimal effect. Denies new medications, detergents/soaps/other chemicals in household.  At this visit, patient was diagnosed with "rash" and discharged home on a steroid taper and topical hydrocortisone cream. -3/3/23: patient had an appointment to establish care with a PCP. I reviewed the note from the encounter; however, there was not anything written regarding the COVID vaccine allergy. The allergy status in the chart was updated on 3/3/23 to say, "COVID-19 mRNA vaccine - rash, nausea, vomiting, GI bleed. Severity = not specified", however, i was not able to verify that GI bleed occurred. Therefore, I believe that was selected in error and the true allergy should read "rash, nausea, vomiting"
Migraine headache one day during work.  March 2 a headache. Headache continues until today. Everyday almost all day.
pt recv vax;mom reports that pt c/o pain & tingling in lt arm(site of TD);pt also anxious & pacing;no oth sx;referred to MD; PC to mom later by RN & pt reported to be "fine";
Dose administered to patient that was stored outside the fact sheet guidelines; Had a temperature excursion involving 2 doses of the Moderna Covid-19 vaccine today; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE and EXPIRED PRODUCT ADMINISTERED in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 30-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The vaccine coordinator reported that they had a temperature excursion involving 2 doses of the Moderna Covid-19 vaccine today, on 30-Nov-2021. The reported storage condition at the time of the excursion was refrigerator. The maximum or minimum temperatures reached was plus 32F and were kept in the refrigerator at plus 40.02F. Reportedly, the excursion duration was 9 minutes. No patient has been administered with the impacted vaccine. The reporter also informed that there were 3 doses, and one was given to a patient. It was reported that the dose administered to patient that was stored outside the fact sheet guidelines.
18 Month old child developed a fever of 103.2 following DTP/OPV immunization.
35 patients received a 0.25 ml dose as booster from booster dose only presentation vial; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial).    No concomitant product use was reported.   Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022.  It was unknown if patient experienced any symptoms after getting the vaccine.  Treatment information was unknown.
Increasingly worse knife like pain at injection site. Patient reported to hospital 3 weeks after the injection as the pain was unbearable. Notable swelling in arm around injection site. Patient has a noteable leukocytosis = 21.6 x 10^3
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient felt a little dizzy for a few moment, did not pass out. Patient indicated that it may had been becuase she was nervous. Gave patient Gatorade and asked if she wanted to lay down. Ptnt did not want to lay down, imporved right after the Gatorade, indicated that she no longer felt dizzy. Asked if she wanted an ambulance, she indicated that she did not no need one.  Patinets father was present,  drove her home. Follow up call w/ patient at the end of my shift, patinet indicated no issues
sicker; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (received first dose on an unknown date and experienced sickness, refer case US2021AMR198943).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingles shot and got sicker than hell. The patient also stated that it was still better than getting shingles.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198943:same patient 1st dose