chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The reporter was reporting 2 doses of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (dosage, strength and route unknown), that had been improperly stored (temperature and time frame: 34 degree F for 3 hours 24 minutes and 47 degree F for 6 minutes), were inadvertently administered to the unspecified patients on unspecified dates. No adverse effect was reported. Follow up information has been received from medical assistant on 26-APR-2016 via a phone call. On 12-MAR-2016, patient was vaccinated with improperly stored GARDASIL 9 (Therapy type: Digital Data Logger). This is one of several reports received from the same reporter. Additional information has been requested. Onset date, start date of product, patient demographics and the narrative was updated.
Dizziness, Headache, UrticariaPruritus, Diarrhea & NauseaVomiting Narrative:  Pt reported initial symptoms immediately after vaccine administration including dizziness, blurred vision, hypotension, diaphoresis, and fuzzy hearing. She was monitored briefly, then sent to ED for additional evaluation/monitoring. Kept in ED for approx 30 minutes, no medications given, discharged home. Pt reported feeling fatigued for several days after injection, also some intermittent nausea and diarrhea. Some injection site itchiness a few days after injection.
The day after the vaccine, patient experienced a local site reaction that eventually turned looking like a severe burn, patient stated that the skin blstered and the spot lost the first layer of skin and was draining a clear liquid. The spot scabbed over and is currently healing and pink.  It has a hard spot the size of a nickel still. Patient has been cleaning with soap and water and using Neosporin to help heal.  Patient did not want to visit a doctor regarding the reaction.
Chest Pain, chills and aches, elevated heart rate and dizzy within the first few hours.  The next two days chest pain, dizzy and elevated heart rate continued.  Three days later the symptoms were so severe that I could not get off the couch and if I did I began to shake from how dizzy I was.  continued for three more days that extreme.  To this day i get elevated heart rate and dizzy off and on depending on how much I am doing or just ramdomly.
sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 13-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Upon the reception of the first covid-19 mRNA vaccine produced by Pfizer, the patient reported severe fatigue lasting 3 to 5 days and full resolution of symptom by day 7. No other symptoms were reported by the patient. After receiving the second covid-19 (Pfizer) dose,  the patient reported the occurrence of a headache within the 15 minute recommended waiting period. The patient reported persistent migraine headaches with nausea and vomiting with associated sore throat, and an earache with associated balance disturbances. The patient reported seeking medical attention on day 14 due to persistent migraine headache and continuation of associated symptoms. Due to the frequency and duration of the migraine headaches, the patient reported seeking medical attention at the emergency department 2 months after the second covid-19 (Pfizer) dose.
Starting Saturday 3/6 I have had hives and itching everyday. I have never had a hives in my life until this. I have been taking Benedryl which helps a little but gave not gotten complete relief , now going on 5 days.
Felt lousy; covid 19/ tiredness and low grade fever; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19/ tiredness and low grade fever) and FEELING ABNORMAL (Felt lousy) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045B21A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1 Lot number: 002A21A) on 26-Feb-2021 and Moderna COVID-19 Vaccine (Dose 2 Lot number: 047A21A) on 25-Mar-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 06-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced COVID-19 (covid 19/ tiredness and low grade fever). On an unknown date, the patient experienced FEELING ABNORMAL (Felt lousy). On 03-Jan-2021, COVID-19 (covid 19/ tiredness and low grade fever) had resolved. At the time of the report, FEELING ABNORMAL (Felt lousy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
arm started to pain him, the arm he got the shot in has pain and like swelling; arm started to pain him, the arm he got the shot in has pain and like swelling; was a little fatigued that day after the shot and feeling a bit tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Apr2021 (Lot number: Unknown) at the age of 72 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CHOLESTEROL; PROSTATE 1. The following information was reported: FATIGUE (non-serious) with onset 14Apr2021, outcome "unknown", described as "was a little fatigued that day after the shot and feeling a bit tired"; VACCINATION SITE SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 18Apr2021, outcome "unknown" and all described as "arm started to pain him, the arm he got the shot in has pain and like swelling".  Additional information: Concomitant medication included: blood pressure. Like everyone else that takes the shot, he is trying to avoid getting Covid 19. The patient got the Pfizer shot on Wednesday and he had a problem he had a little fatigue and it didn't bother him much. States yesterday he woke up and his arm started to pain him, the arm he got the shot in has pain and like swelling and wants to know what to do. His daughter told him it is one of the allergic symptoms that happen to some people. Caller is asking what he should do and would like advice. Caller is asking if we have any healthcare providers. He would like to let us know what symptoms he is suffering from and if anyone here can give advice on what to do with his arm he will gladly receive that. States making a report may help other people that need the help. He had the flu shot Nov2020 states that sometimes with flu shots he gets tired for a day or 2 and snaps out of it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
that expired ACTHIB had been administered twice with no reported adverse event; Initial information received on 24-Mar-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 5 months old female patient who received expired HIB (PRP/T) vaccine [ACT-HIB] twice with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On 20-Mar-2023, the patient received 0.5ml dose of suspect HIB (PRP/T) vaccine (frequency- once, strength - standard, lot - UJ649AAA, expiry date  - 03-Mar-2023) via intramuscular route in the thigh nos for prophylactic vaccine.   On 20-Mar-2023 the patient received expired acthib twice with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  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.
post herpetic neualgia; shingles; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 07-MAY-2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a physician office for shingles and post herpetic neualgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was unknown. The events were considered related to zoster vaccine live (ZOSTAVAX).
This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient previously received one dose of M-M-R, one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 18-JUN-2018 the patient was vaccinated with PROQUAD from lot R003292 dose 1, subcutaneous in the left arm for prophylaxis. On the same day, the patient was also vaccinated with KINRIX from lot 74G79 dose 1, intramuscular in the right deltoid for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The medical assistant was not sure which sterile diluent (manufacturer unknown) lot numbers were used. The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1808USA000454: US-009507513-1808USA000455: US-009507513-1808USA000456: US-009507513-1808USA000457: US-009507513-1808USA000459: US-009507513-1808USA000460: US-009507513-1808USA000461: US-009507513-1808USA000462: US-009507513-1808USA000463: US-009507513-1808USA000464: US-009507513-1808USA000465: US-009507513-1808USA000466: US-009507513-1807USA007589.
pt recvd vax; ha, v, chest pain, bloody urine, petechial rash on face; 1feb94 urinalysis at time of event:SG 1.025, PH5,Protein trace, blood ++; recovered;
administered an expired dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 51-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 09-AUG-2023, the patient received Havrix. On 09-AUG-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Havrix). 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: 9-Aug-2023 The nurse consented to follow-up via email. The patient received an expire dose of Havrix, which led to expired vaccine used.
This is a cluster of patients who experienced adverse reactions following administration of FLUZONE INTRADERMAL (UT464AA). One patient has been identified and captured in case numbers 2011-10344. Initial report was received on 21 October 2011 from a healthcare provider. The patients (gender, ages and date of birth not reported) had received FLUZONE INTRADERMAL, lot number UT464AA (route and site of administration were not reported). The patients did not like the huge bleb left on the arm after administration. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
My tinittus became much worse.  It was always mild before having the vaccine.  After the shots it is always present as a loud buzzing noise that is especially loud .  It is most annoying when I am in a quiet setting.  After 6 months the noise has not reduced.
patient developed a headache the next day that was graded as a 8/10 in severity, described as deep-seated and lasting for several days.  After that, a got down to about a 4/10 and stayed there for the next 6 months.
Severe leg cramps in left calf muscle overnight, strong enough to wake me from sleep between 3:00-4:00 AM, with lingering pain in that muscle and in hip joints still present at time of reporting approximately 24 hours later.  Ongoing treatment with naproxen sodium and regular stretching.
After the 1st dose he had more frequent gout attacks.; This spontaneous case was reported by a patient and describes the occurrence of GOUT (After the 1st dose he had more frequent gout attacks.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient received  other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Seasonal allergy, Bladder cancer, Barrett's esophagitis, Osteoarthritis and Thyroiditis.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced GOUT (After the 1st dose he had more frequent gout attacks.). At the time of the report, GOUT (After the 1st dose he had more frequent gout attacks.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.   Treatment information was not provided.   This case was linked to MOD-2023-713982 (Patient Link).
Information has been received from a certified medical assistant (C.M.A), concerning a 22 years old female patient. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL (dose, route and frequency were not reported) (Lot # and expiration date were not reported) as part of the pregnancy registry program. Then, on 09-JUL-2012, the patient received the second dose of GARDASIL (dose, route and frequency were not reported) (Lot # and expiration date were not reported). Subsequently, on an unspecified date, the patient became pregnant, and because of this, she did not receive the third dose of GARDASIL that was due in September 2012. The patient's last menstrual period (LMP) and estimated delivery date (EDD) were not known. The patient's history of previous pregnancies and live births was not known. There were no adverse effects. No treatment was given for the event. Patient called office for medical attention. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from the medical assistant. It was reported that she could not find anyone with the patient's name in their system. She also looked under the reported date of birth and there was no patient with that date of birth/name combination either. She apologized but said she had no additional information to provide. This patient was lost to follow up. Additional information is not expected.
Flu vaccine given Tues 10/4/16. Thursday AM area of injection red, warm and painful to touch. At examination, area approximately 3-4 in in diameter with erythema, swelling and pain. No fever. Treated with Cephalexin. NP.
Sciatica type pain starting from hips and going into legs and feet.; Tingling in legs and feet.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On 18Apr2021, the patient experienced sciatica type pain starting from hips and going into legs and feet and tingling in legs and feet. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sciatica type pain starting from hips and going into legs and feet and tingling in legs and feet was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sore arm; fatigue; sore muscles; This is a spontaneous report from a non-contactable consumer (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN620159267100002, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 10Feb2021 at 13:00 as dose 2, single for COVID-19 immunisation. Medical history included heart pacemaker installed and known allergies: sulfa, inhibitors penicillin. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included amiodarone and levothyroxine sodium (LEVOTHYROXIN) both taken for an unspecified indication, start and stop date were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number: EL324659267100002, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 21Jan2021 at 14:00 for COVID-19 immunisation. On 11Feb2021, the patient experienced sore arm, fatigue, and sore muscles. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information expected.
Rash and pustules all over body prednisone 5 mg - 2/3/13. Methylprednisolone 4mg 2/5/13. MD thinks was what was mixed in not shingles or chickenpox.
REFROZEN VACCINE ADMINSITERED TO MULTIPLE PATIENTS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  The batch number was not reported and has been requested. On an unspecified date, the subject experienced refrozen vaccine administered to multiple subjects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of refrozen vaccine administered to multiple patients was not reported. This report was non-serious.