chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine past its 30-days, Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days, Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022 at 2:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022 at 2:08 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days, Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days, Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was reported by reporter. Vaccine was in thaw state (2 to 8 degree Celsius) on or about 20-Dec-2021. No treatment medication was reported by reporter.
Heart racing; Head pounding; This non-serious case was reported by a other health professional via call center representative and described the occurrence of heart racing in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced heart racing (Verbatim: Heart racing) and pounding in head (Verbatim: Head pounding). The outcome of the heart racing and pounding in head were unknown.   It was unknown if the reporter considered the heart racing and pounding in head to be related to Shingrix.     It was unknown if the company considered the heart racing and pounding in head to be related to Shingrix.   Additional Information: GSK Receipt date- 13-MAR-2023 The reporter had a patient who had heart racing and head pounding after the 1st dose of Shingrix and was wondering if she should receive the 2nd vaccine or not. No patient demographics provided. The reporter was consented to fallow up
The patient had a syncopal episode following vaccine administration.  The patient reported a fear of needles and reported no injuries after the event.
Had shingles flare up recently. I was in pain, unable to conduct my day-to-day business. Given that I am a healthy 40 y.o. person, I can't help but think that it is related to COVID vaccination.
Reporting completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose: 02/11/21,Pfizer Lot#EM9810 2nd dose:   03/04.21,Pfizer,Lot# EN6202 Diagnosed covid positive:03/18/21 Exposure:Home Symptoms:Asymptomatic
No additional AE's reported; Gardasil 9 that had a temperature excursion and was administered; This spontaneous report was received from a registered nurse and refers to an 11-year-old male patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On 25-AUG-2020, the patient was vaccinated with the first dose of an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S020254, expiration date: 09-DEC-2021; dose, route of administration and anatomical location were not reported) for prophylaxis. On 19-AUG-2020, the vaccine had a temperature excursion and was not supported. The vaccine was exposed to temperature below 2 Celsius degrees (-1.0 Celsius degrees) for 18 hours and 13 minutes; digital data logger was involved. There was no previous temperature excursion. It was the first dose out of a 3 dose series. No additional adverse events (AE's) were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020254; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
syringe was drawn up on 01JUN2023 and administered on 02JUN2023 (within 24 hours) with no reported adverse event; Initial information received on 05-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient for whom syringe was drawn up on 01jun2023 and administered on 02jun2023 (within 24 hours) with no reported adverse event while receiving vaccine Typhoid VI polysaccharide vaccine [Typhim VI].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 01-Jun-2023 syringe was drawn and on 02-Jun-2023, the patient received a dose of suspect Typhoid VI polysaccharide vaccine solution for injection (lot: W1A441M, Expiry date: 07-Mar-2025) with unknown strength via unknown route in unknown administration site for Immunization (within 24 hours) with no reported adverse event (wrong technique in product usage process) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  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 guidelines. 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.
Severe back pain; joint pain; Unable to walk without pain; Arm pain; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6199 and Expiration date: unknown), dose 1 via an unknown route of administration, in left arm on 07Mar2021 15:15 as single dose for covid-19 immunisation (age at vaccination was 48 years). Medical history included kidney stones. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]). Patient has not received other vaccine in four weeks. Patient has no known allergies. Patient has not tested positive for covid prior and post vaccination. On 08Mar2021 at 12:00 AM, the patient experienced severe back pain and joint pain. She was unable to walk without pain 1-3 days after injection. The arm pain went away 2 days after injection. Outcome of events back pain, arthralgia, gait inability was recovering. Patient recovered from pain in extremity on 09Mar2021.  No follow-up attempts are possible. No further information is expected.
I had my first shingles vaccine,  I feel like I have shingles.  pain on skin across my ribs and into my abdomen  for two months now.
Information has been received from a medical assistant concerning a 12 month old male patient with no known drug allergies or pertinent medical history who on 01-APR-2010, was subcutaneously vaccinated in the left upper arm with a 0.5 mL dose of VARIVAX (Merck) (Lot# 665959/1408Y). Secondary suspect vaccination included VAQTA (MSD). Concomitant vaccination included PREVNAR. Subcutaneously, on approximately 01-APR-2010, the patient experienced red, raised areas "the size of a silver dollar" at the injection site of the left upper arm. The office was contacted by phone, on 15-APR-2010. There were no lab tests performed. It was unknown if the patient required medical treatment. At the time of the report, the patient outcome was unspecified. Additional information has been requested. This is one of several cases reported by the same source.
After receiving the second dose of the moderna covid vaccine, I began experiencing pain in my lower back on the right side (kidney area). The pain is a constant pressure accompanied by intermittent sharp pains. The pain is so bad that it wakes me up at night frequently, 2-4x per night. The pain is worse when I am lying down. I am hydrating and treating the pain with ibuprofen. However, the ibuprofen does not relieve the pain. I was hoping that it would resolve on it's own, and have not seen a doctor yet, but will plan to see a doctor if it continues and/or gets worse.
Pt received DTaP and IPV in left arm arm (07/23/02).  Mom noted edema,erythema, induration that evening. Returned to clinic 2 days post vaccinations 07/25/2002 with significant circumferential edema, Induration of left UE from elbow to shoulder, Left arm circl-21cm, Right circle 165 cm, Pt tx with Keflex for possible cellulitis although looked more like reaction to immunization
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not reported. Concomitant therapies included properly stored sterile diluent. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX lot # N017700, expiration date: 09-JUN-2019 (concentration and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour 9 minutes. Previous temperatures excursions: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 76 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour and 23 minutes. The patient did not experience any adverse effects. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA002012: US-009507513-1711USA004383: US-009507513-1711USA004384: US-009507513-1711USA004385: US-009507513-1711USA004386: US-009507513-1711USA004387: US-009507513-1711USA004388: US-009507513-1711USA004389: US-009507513-1711USA004390: US-009507513-1711USA004391: US-009507513-1711USA004392: US-009507513-1711USA004393: US-009507513-1711USA004394: US-009507513-1711USA004395: US-009507513-1711USA004396: US-009507513-1711USA004397: US-009507513-1711USA004398: US-009507513-1711USA004399: US-009507513-1711USA004400: US-009507513-1711USA004401: US-009507513-1711USA004402: US-009507513-1711USA004403: US-009507513-1711USA004382: US-009507513-1711USA004381: US-009507513-1711USA004379: US-009507513-1711USA004380.
This case was reported in a literature article and described the occurrence of Hashimoto's thyroiditis in a subject aged between 10 and 18 years of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). Medical records showed that symptoms and or clinical suspicion such as fatigue or abnormal laboratory results were present either on or before the day of vaccination, or family history of thyroid disease was present. On an unspecified date, the subject received unspecified dose of BOOSTRIX. Within 6 months of vaccination with BOOSTRIX, the subject experienced Hashimoto's thyroiditis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case is one of the 11 cases (B0643778A, B0667819A, B0667865A, B0667866A, B0667868A, B0667869A, B0667867A, B0667867, B0667872A and B0667873A) described in the literature article and classified as 'new onset of chronic illness'. The case referred to 3 subjects who onset Hashimoto's thyroiditis. This literature article summarizes the results of an open, prospective, observational study that was carried out in a Organization. The primary aim of this study was to estimate the incidence of specific categories of adverse events (medically attended neurologic and hematologic events, allergic reactions, and new onset of chronic illnesses) following administration of a single dose of BOOSTRIX (GlaxoSmithKline) to adolescents in a postlicensure setting. The study monitored safety outcomes among 13,427 10 to 18-year-old adolescents who received TDAP vaccination as part of their normal health care. The subjects were evaluated using self-control analysis comparing days 0 to 29 to days 30 to 59 post-vaccination for neurological events, hematological events and allergic reactions. Furthermore the study evaluated new onset chronic illnesses within 6 months of TDAP vaccination by comparing with histological TD controls matched for age at vaccination, season, sex, and geographic area. The study also compared the incidence of events of interest between the TDAP and historical cohorts as exploratory analyses. The study showed no increased risk for medically attended neurological or allergic reactions following TDAP vaccination when comparing the first 30 postvaccination days to the second 30 postvaccination days. There was one hematologic event within 30 days of TDAP, compared with 0 events within days 30 to 59. When compared with matched historical TD recipients, no increase in new onset chronic illnesses was seen after TDAP. No deaths occurred in the TDAP cohort during the study. In conclusion, this study provided no evidence for an increased risk for neurological, hematological, allergic events, or new onset of chronic illnesses among adolescents vaccinated with TDAP.
Client received #2 Hep B vaccination around 8:15am. C/o H/A throughout day, felt bad after work so went home and went to bed. Around 8:30pm woke and says had severe cramps in legs all the way down, and feet. Reports one time (R) hand turned inward with feet bilateral cramping, got so bad, with numbness & tingling. Reports 5 episodes of this within 2 hours.
On 2/5/21 a 66y/o Female arrived to recieve a CoVID Vaccine. PT recieved vaccine and after was placed in observation for 15min. After the 15minute pt began to have a c/c of Numbness and tingling in face. Pt was assessed by onsite paramedic with a determination for a pt to refuse transport. PT signed AMA after hospital contact was made.
This spontaneous report was received from a other health professional refers to a patient of unknown age. On 25-SEP-2014 the patient was vaccinated with GARDASIL lot # H021861, expiry: 09-OCT-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 25-SEP-2014, the patient received doses that were exposed to temperatures outside of the proper storage range. No adverse effect reported. The outcome of patient received doses that were exposed to temperatures outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
63-year-old male with sepsis. Patient resides in a nursing home. Staff at the nursing home noticed he was altered and somnolent. The nursing home staff started CPR for unresponsiveness though he never lost a pulse. He was transferred to the hospital where workup revealed sepsis, pneumonia, UTI and a lactic acid of 4.6. He was treated with supportive care but failed to improve. His intake was poor and he remained confused and bed bound. His family wanted comfort measures with hospice. He needs GIP level of care for management of his dyspnea.
starting 4/4/21 patient reports onset of right side  facial sensation, constant to 4/7/21.  During 4/7/21 telephone encounter,  patient was unable to describe sensation characteristics, denies pressure denies pain, denies marked swelling, denies onset of new symptoms, or worsening symptoms.  Patient was scheduled 4/8/21 for evaluation.
About 12-24 hours After receiving the vaccine I experienced the common side effects, sore arm, tiredness, headache, nausea and lightheaded. However, I have been noticing that ever since I completed the 2 dose series I have been feeling dizzy randomly. First I thought it was normal but now is been months and I constantly feel dizzy. I check my blood pressure and heart rate thinking it may be due to that but they?re usually within normal ranges and the dizziness episodes just come and go throughout the day.
Patient called on 10/14 before closing at 6pm to explain that 12 hours after her shot at 1pm on 10/12 she had flu-like symptoms that lasted until 10/13 midday. On the morning on the 14th, she woke with  a rash all over her body. The rash did not hurt nor did it itch. She is concerned about a possible allergy and any issue with the upcoming booster.
hands turned blood red; ein on top of knuckle middle digit, bubbled up and turned bluish red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (hands turned blood red) and VEIN DISCOLOURATION (ein on top of knuckle middle digit, bubbled up and turned bluish red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Hyperthyroidism (treated in the past for Hyperthyroidism). Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) and CICLOPIROX for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (hands turned blood red) and VEIN DISCOLOURATION (ein on top of knuckle middle digit, bubbled up and turned bluish red). At the time of the report, ERYTHEMA (hands turned blood red) and VEIN DISCOLOURATION (ein on top of knuckle middle digit, bubbled up and turned bluish red) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD-2022-461617, MOD-2022-461618 (Patient Link).
swelling, painful, multiple areas of his body, chilbrains; swelling, painful, multiple areas of his body, chilbrains; swelling, painful, multiple areas of his body, chilbrains; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (swelling, painful, multiple areas of his body, chilbrains), CHILLBLAINS (swelling, painful, multiple areas of his body, chilbrains) and MYALGIA (swelling, painful, multiple areas of his body, chilbrains) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced SWELLING (swelling, painful, multiple areas of his body, chilbrains), CHILLBLAINS (swelling, painful, multiple areas of his body, chilbrains) and MYALGIA (swelling, painful, multiple areas of his body, chilbrains). At the time of the report, SWELLING (swelling, painful, multiple areas of his body, chilbrains), CHILLBLAINS (swelling, painful, multiple areas of his body, chilbrains) and MYALGIA (swelling, painful, multiple areas of his body, chilbrains) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Events outcome was updated.
This spontaneous report as received from a health are worker refers to unspecified number of patients with unspecified demographics. On an unkown date, unspecified patients received improperly stored VAQTA (dose and frequency unspecified) that were exposed to 26.2 F for 5.5 hours. Concomitant therapy was unspecified. No adverse effects were reported. No product quality complaint was involved. The outcome of patients received improperly stored VAQTA that were exposed to 26.2 F for 5.5 hours was unknown. No further information was provided. This case is linked with MARRS # 1405USA003490 and MARRS # 1405USA003794 as same reporter cases. Additional information has been requested.
Fever (101), overall extreme body aches, severe headache, body weakness, light headedness, severity of symptoms such that I had to go to bed and stay there lying as still as possible through that day (symptoms began later in the day of vaccination) and all the next
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 03/10/2021 and 04/07/2021. It is not known if this person had a specific symptom onset date. However, they presented to emergency department on 01/12/2022 with hypoxia and confusion, and tested COVID-19 positive via PCR test upon hospital admission on 01/12/2022. They remained hospitalized until their death on 01/22/2022. They were a resident of a nursing home.
Extreme pain that interfered with sleep on the first night. The injection site still aches severely at the time of this report.
Intense red eyes cough neck/back tightness BENADRYL 50 mg Q 4 needed x 4 doses.
1/4/00, reports chicken pox-afebrile. Approximately 25 lesions on scalp, lip, roof of mouth, stomach, back, arms & legs.
severe back pain; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced severe back pain (non-serious) on Feb2021. Therapeutic measures were taken as a result of severe back pain (back pain). The caller got first dose last 05Feb2021. After the vaccine she was prescribed by her doctor to take prednisone for her severe back pain. She took the medicine today and needs to continue until 18Feb2021. The second dose will be on 26Feb2021. She had the first dose of the Pfizer covid vaccine on 05Feb2021. Yesterday she saw her doctor since she was having severe back pain which the doctor thought was a bulging disc. The doctor wrote a prescription for prednisone. She wanted to know if taking prednisone would compromise anything. She trusted her doctor. When she received the vaccine she was asked if she was on prednisone and she told them no. She was wondering why it was asked. She wanted to know if prednisone is ok to take. She would take it for 8 days and then be off of prednisone 7 days before she gets the second dose. She used the v-safe and will ask them. She declined to provide mailing address or email. She was upset since she has been on hold for almost an hour and the transferring agent took down all her information and transferred to this department to answer her question. She declined to complete report or provide any further details. The outcome of event was unknown.  Information about the Lot/batch number has been requested.
Headache, chills, sweats, fatigue, body aches; These all started within a few hours of receiving the vaccine. They lasted four days.
ANXIETY WITH LEFT ARM HEAVINESS, FATIGUE AND GERD Narrative:  Other Relevant History:
Gave a pediatric dose of Hep A to an adult. NO ADVERSE REACTION.
Lower Abdominal pain started Sunday evening,  Comes and goes with anorexia for 7 days.  Seen by provider on 1/22.