chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US017651 is an initial spontaneous report received from a nurse on 08 SEP 2015. This report refers to a male patient whose age was not reported. Past medical history and concomitant medications were not reported. His vaccination history included administration of FLUVIRIN (batch number: not reported) for twice on an unknown dates which were tolerated. The patient was vaccinated with 0.5 ml of FLUVIRIN 2015/2016 (batch number: 157103) pre-filled syringe (PFS) intramuscularly into left deltoid on 08 SEP 2015 at 14:30 hours. It was reported that the patient received vaccine which was out of temperature range at 33.2 degree Fahrenheit on 08 SEP 2015. The event was reported as non-serious. No adverse events were reported following the inadvertent administration. Follow-up information received from a nurse on 27 OCT 2015: Patient's demographics (height and weight), vaccination history, time of vaccination, site of vaccination and other clinically relevant information updated in the narrative.
Tachycardia, chest tightness, shortness of breath, decreased heart conditioning during any excercise
Pfizer-BioNTech COVID-19 Vaccine EUA  Fever, vomiting, loss of appetite, tiredness/sleepiness.  Side effects started 4 hours after 1st dose.  Good amount of vomit around 9:30pm.   Giving children?s Tylenol every 4 hours.
No additional AE; Caller stated that the VARIVAX and MMR II that underwent multiple temperature excursions had been adminitered; This spontaneous report was received from a Medical assistant referring to a 14-year-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 06-MAY-2021, the patients were inadvertently administered with an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T020652 had been verified to be a valid number; expiration date 16-JUN-2022), and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHa)) (M-M-R II) (lot number S035352 had been verified to be a valid number; expiration date 05-NOV-2021); both vaccines for prophylaxis (strengths, doses, frequencies, routes of administration, and anatomical locations were not reported). It was reported multiple temperature excursions: -14.03 degrees Celsius (C) for a time frame of 1 hour, 15 minutes and 0 seconds, -14.9  degrees C for a time frame of 0 hours, 9 minutes and 0 seconds, -10.3 degrees C for a time frame of 1 hour, 0 minutes and 0 seconds; and -6.3 degrees C for a time frame of 2 hours, 0 minutes and 0 seconds. It was reported that had previous temperature excursions were -14.03 degree C for a time frame of 1 hour, 15 minutes and 0 seconds and -14.9 degrees C for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that the call was due to data logger. No additional adverse events.
Diarrhea, followed by additional diarrhea in the AM of the following morning of the 17th and then repeated diarrhea last night and into this morning (10/18/15). After each episode I took two Loperamides. Now seems to have finally abated.
deemed to have an allergic reaction; localized swelling of the injection site; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to cases 2019SA257583 and 2019SA257582 (same reporter).  This case involves patient (with unknown demographics) who was deemed to have an allergic reaction (hypersensitivity) and localized swelling of the injection site (vaccination site swelling), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via intramuscular route in unknown administration site.  On an unknown date, the patient had deemed to have an allergic reaction (hypersensitivity) and localized swelling of the injection site (vaccination site swelling) (unknown latency) following the administration of INFLUENZA VACCINE. The swelling was larger compared to any other reactions the staff member has had in the previous years.  Other relevant tests not reported.   Final diagnosis was hypersensitivity.  Ice pack was applied as corrective treatment.  The patient recovered from the events.  Information on the batch number was requested.  Documents held by sender: none.
I noticed when I woke up that I had started to develop a rash on the shoulder where I got the injection. The rash also had a small patch on my left collar. The rash is itchy, small, red, raised bumps, like eczema. It's now Wednesday and the rash is spreading to other parts of my body: chin, on thigh near groin, thigh near knee, further down left arm, and tonight, my stomach. The rash is spreading in small circular patches and has progressed since Monday.
C/O throat tightening, difficulty to breath and swallow 911 called ,  gave epi IM left thigh,  taken to hospital ER
After a week, injection site became red , warm, and itchy.  I felt fine, and it lasted about 3-4   days. I still have a little bit of the red spot  on my skin, but no longer warm or itchy. and I?m due for my second shot in 2 days. I?ll use the other arm just in case.  I put ice for warm and cream for itching.  I wasn?t very concerned, but called Dr. she said they?d had several with same thing.
No symptoms noted until 2/1/21 where resident noted redness around the injection site. No other symptoms.
Patient recieved vaccine in right hip on 3/14/05.  Within the next 24 hours she developed erythema, tenderness, just below the site.  This area grew to about 5 inches in diameter and has hard.  Within 96 hours the hardness and tenderness was relieved and the erythema was shrinking
Pt fainted 5 min post injection, pt's BP was low and pt reported dizziness and pt was pale.
diffuse body rash (inner part of the upper arm, lower part of the arm, face, upper leg, lower leg)
Patient states that on 5/22/2023 he was at medical facility for an evaluation and was due for a Tdap vaccine, patient received the Tdap vaccine on that date. Patient reports he initially had soreness in the left arm and several days later noticed a blister had developed and "popped". Patient self treated blister with Neosporin ointment. Patient noticed area was reddened at worsening on 5/28/2023 and called medical facility on 5/30/2023 to report issue. Patient was seen on 5/30/2023 and was started on oral antibiotics.
Information has been received from a pharmacy student concerning a patient who about 1 month ago, was vaccinated with a dose of ZOSTAVAX (Oka/Merck), subcutaneously, site of administration unknown. The patient experienced soreness at the injection site since receiving the vaccine. Patient. Additional information is not expected.
Seizure about 9:52 pm. First time ever having a seizure. No signs.
Pt's caregiver reported that pt had redness/hotness at site of injection couple days after vaccination only where he received Prevnar shot. Stated injection site was tender to touch and swelling was very large. Site for flu shot was ok. Pt's care giver gave pt some OTC pain medications to stop pain.
Day after vaccines only had fever and red and worse 2 days later and very warm. Seen in ER and Dx with cellulitis marked on leg 90 x 102 mm size now resolved and tx with Abx - (R) anterior thigh.  Given DTaP, IPV.
felt achy and it was like her allergies were acting up; Severe headache; Chills; feet are cold; Sleepy; general feeling of unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 05Apr2021 14:30 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PAIN (non-serious) with onset 08Apr2021, outcome "recovering", described as "felt achy and it was like her allergies were acting up"; HEADACHE (non-serious) with onset 08Apr2021, outcome "unknown", described as "Severe headache"; CHILLS (non-serious) with onset 08Apr2021, outcome "recovering", described as "Chills"; PERIPHERAL COLDNESS (non-serious) with onset 08Apr2021, outcome "recovering", described as "feet are cold"; SOMNOLENCE (non-serious) with onset 08Apr2021, outcome "not recovered", described as "Sleepy"; MALAISE (non-serious) with onset 08Apr2021, outcome "recovering", described as "general feeling of unwell". Therapeutic measures were taken as a result of pain, headache, chills, malaise.  Additional information: It is reported that Severe headache Dates for (From: 8 Apr 2021 To: 8 Apr 2021).Her symptoms are hard to explain as she is very healthy and does not even get colds and for 62 years old and getting no colds, nothing this is unusual for me her to feel like this. She took Tylenol and she is not as achy. Severe headache; she woke up last night to take Tylenol like she was told she was supposed to do and it feels like a fluish feel. she is unsure of the outcome as since she took Tylenol and does not know if that is subsiding it. she is sleepy and she usually gets up around 7 or 8 o'clock in the morning no later and works all day and she is tired and that is just not like her. Chills: she stated she is under a blanket and she has a heating pad to her feet. Treatment: Tylenol, under blanket, and heating pad to her feet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had an inflammatory response. I had a huge lump under arm pit; took a week to leave. I had a purplish rash all over- hands, feet and knees. Spoke with a dermatologist and prescribed a topical cream.
Lg area of redness 4 x 2" around vaccine site warm, non tender, no lump, no pain.
Left deltoid became red, sore and a little swollen. Patient stated small amount of nausea. Body ache and fever.
patient received an ACTHIB vaccine in the office that had expired with no reported adverse event; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case from an other health professional via Media Information (under the reference 00799026).  This case involves a 1 years old male patient who received an HIB (PRP/T) VACCINE [ACT-HIB] vaccine in the office that had expired (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 05-Oct-2021, the patient received a dose of suspect ACT-HIB (0.5 ml, total, Once Frequency-1X, lot UJ404AAB and expiration date: 04-oct-2021) via intramuscular route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine administered (same day latency).  It was reported "Caller states that a patient received an ACTHIB vaccine in the office on 05OCT2021 that had expired on 04OCT2021 and wanted to know how soon the patient could be revaccinated. Caller states that only 1 patient received expired ACTHIB and requested that information on expired products be emailed to her."  At time of reporting, the outcome was unknown for the 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.
Very bad headache Very bad chills  Very sore arm. Hard to lift but doable  Tired more than usual
Severe pain at injection site, difficulty doing anything with arm where injection occurred, sporadic stabbing pain at various places all over body, muscle aches, extreme fatigue, weakness, extreme drop in blood pressure, nausea, loss of appetite, irritability, nightmares, depression, weakness, exhaustion, headache.
Information has been received from a registered nurse and a physician concerning a 13 month old female with no know drug allergies, who on 02/20/2001 was vaccinated with Varicella virus vaccine live. On 03/18/2001, the nurse reported the pt. developed less than 50 visible lesions and fever. In follow-up, the physician reported on 03/22/2001, the pt developed " papules vesicle rash (50) after vaccine given." The pt recovered from the rash. Unspecified medical attention was sought. Additional information had been requested.
Given dose of influenza, quadrivalent, Pfree, 3yr + along with routine vaccinations for 6 month old as listed above. Error recognized. Dr. and parent informed. No symptoms, concerns. Advised to call if needed- with any questions.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 13-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
I had fever and chills and headaches. I was fatigued and had arm pain. It went away after two weeks.
This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received three years ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that a patient had not administered second dose yet till the time of reporting, which led to incomplete course of vaccination. The reporter did not know the exact vaccination date, lot number and did not want to share patients demographic information. The reporter consented to follow up.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 29-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R029815 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1907USA001847: US-009507513-1907USA001846: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
A non-serious spontaneous report of chills, fever, coughing, runny nose, and body aches has been received from an employee, concerning herself a 43-year-old female subsequent to the administration of H1N1. Relevant medical history and concomitant medications were not reported. On 15-Oct-2009, the patient received H1N1. On 17-Oct-2009, she began to experience "a reactogenic effect" which includes chills, fever, coughing, runny nose, and body aches. Some of the symptoms were ongoing (not further specified).
Pt experienced severe fatigue, tingling through body, muscle pain, joint pain, rapid heart beat, anemia, stomach pain, pressure in head and eyes, sore throat, numbness in jaw and nose area, and was sick for 8 months before finally being treated with doxycycline.
I woke up at 5AM this morning and I felt nauseous and lightheaded. I went to work this morning but told my boss that I would do the morning route but I could not do the afternoon route. Fever of 100.4. I am have gotten worse since this morning and now I have muscle and body aches that are out of this world. I feel fatigued.
Day of vax pt exp local rxn of swelling & redness up entire arm & down to hand area. Redness noted on shoulder & neck area.
I got a very bad cold at the end of February and I treated the cold over the counter for two weeks. I went to the Doctor on 03/01/22 and was diagnosed with a sinus infection and was prescribed amoxicillin for 10 days which I took. The following day the amoxicillin started giving me stomach issues and I went to a different doctor on 03/15/22 and was told to take over the counter medications and probiotics. Between 03/15/22 and 03/20/22 the stomach pain became worse. I went to the ER twice and was diagnosed with C-diff. I was then prescribed antibiotics for 7 days and I finished that antibiotic and have been finished for a month and I'm still having gastrointestinal issues and fatigue. I went to the ER and had both labs and CT.
Fever; Body ache; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever) and MYALGIA (Body ache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and MYALGIA (Body ache). At the time of the report, PYREXIA (Fever) and MYALGIA (Body ache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   This case was linked to MOD-2021-315935 (Patient Link).
Patient expired 2 days after receiving the  vaccination.  Patient had other signs of deterioration over the course of the previous month with worsening edema and difficulty breathing.  Unlikely to be related according to our assessments, but wanted to err on the side of caution.
Bexsero had expired the day before; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB39AB, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st August 2022, unknown after receiving Bexsero and an unknown time after starting Bexsero 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 Information: GSK Receipt Date: 01-AUG-2022 Reporter's comments: The Healthcare Professional (HCP) office manager reported that a medical assistant had given a dose of Bexsero that had expired the day before. The vaccine administration facility is the same as primary reporter. The reporter did not consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
pt devel illness characterized by low grade fever, runny nose, irritability, dec rash;illness preceded rash by 3 days;rash c/w measles;