chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a Registered Nurse and refers to 8 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 06-SEP-2017, 18-SEP-2017 and 20-SEP-2017; three patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number M031574, expiration date: 11-NOV-2018), for prophylaxis. Additionally, on 01-SEP-2017, 17-SEP-2017, 26-SEP-2017 and 29-SEP-2017, five patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number N000326, expiration date 14-OCT-2019) for prophylaxis (doses, routes, routes of administration and anatomical locations were not reported for any vaccine). Both vaccines were exposed to a temperature excursion of 35.4 Fahrenheit (F) for a time frame of 8 hours. The previous temperature excursion was at 34.9F for a time frame of 2 hours. The call was because of a data logger. No adverse effects were reported. Follow-up information was received from the Registered Nurse on 11-MAY-2018. A request was made for patient identifiers and dates of vaccination. This is a non-valid report due to lack of patient identifiers. Upon receipt of follow-up information, it was determined that this case is now valid because patient identifiers were received. Follow-up information has been received from an unspecified reporter from the office of the physician on 14-MAY-2018. On 29-SEP-2017, the 17-year old patient received the improperly stored dose of GARDASIL 9. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1805USA006935; US-009507513-1805USA006936; US-009507513-1805USA006937; US-009507513-1805USA006938; US-009507513-1805USA006939; US-009507513-1805USA006940; US-009507513-1805USA006941.
Patient stated experienced syncope on 12/7/12 and 12/14/12 which she believes is related to flu shot.
10AM feels weak, shaky, reports dilated eyes, feels can't wake up;malaise;
I had the shot at 1:30pm on 11/18/09. App 1 hr later I had memory loss for about 4 hrs. I went to the ER and was examined and had a CT scan of the head. Everything was neg. About 5hrs later I started remembering the last few hrs. 11/25/09 My Body aches all over still after 1 week my right arm hurts when I move it. It feels like when I move it it falls out of place.
The patient said she never had a dose of a COVID vaccine. Upon billing the vaccine it was discovered she had a dose of the Pfizer COVID vaccine on 4-23-2021 at another pharmacy.
Narrative: Per Pharmacist allergy note entry 02/25/21: "Reports SOB prior to receiving vaccine (after declining any problems during screening) which worsened after receipt of vaccine. Pt also tachycardic and hypoxemic with O2 sat 87% on room air. Given depomedrol and transported to ED." Of note, patient received second dose of Moderna vaccine on 03/25/21 without complications.
Around 5:00 PM the day I got the shot I started to get a slight headache. Shortly after the headache appeared I started to get the chills, I was wrapped up in multiple blankets and started shaking uncontrollably. I then checked my temperature and at this time it was 100.3. I then ate dinner and decided to try and fall asleep. When I lied down my heart began to beat very fast. I tracked my heart rate via a watch and my resting heart rate was around 140 bpm. My fever had also increased to 102. My head ache continued to get worse and I began to have bad neck and lower back pains. I was also having muscle spasm in my calfs. The entire night I could barely sleep because of my high heart rate, body aches, shakes, and the constant change from freezing cold to hot and sweating.
Injection site pain and soreness lasting over a week, huge bruise that lasted two weeks, and a huge rock hard nodule near but not at the actual injection site (this nodule has decreased significantly but is still there two weeks later).
Initial report was received 26 August 2013 from a health care professional. A 17-year-old female patient with no known allergies had received a second dose intramuscular injection of MENACTRA, lot number U4584BA and a first dose intramuscular injection of GARDASIL (manufacturer Merck, lot number H020848) (sites of administration not reported) on 09 August 2013, and 13 days later on 22 August 2013, the patient died. There was no contact with the physician after MENACTRA had been given. The patient had previously received a first dose injection of MENACTRA on 04 September 2008. The reporter had been contacted by the county medical examiner who informed the reporter about the death and requested the patient's medical history. The reporter contacted the CDC (Centers for Disease Control and Prevention) who told them to call and report the event to VAERS. No additional information was provided at the time of the report. Documents held by sender: None.
abrupt onset of rash 3 days p/vax;urticaria all over confluent lower extremities;no systemic findings;
Administration of expired moderna vaccine that were give as booster shot; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were give as booster shot) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were give as booster shot). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were give as booster shot) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Anaphylactic reaction within 15 minutes - this was after taking preemptive allergy medication. Immune response continues to be hyperactive and has yet to recover. Spike protein test showed more than required antibody levels a week after first injection.
missed the third dose/ the third dose has not been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (2nd dose of Engerix B administered on 24th September 2020, batch number L5C49, expiry date 17th May 2022).   On an unknown date, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 details were provided as follows: The age at vaccination was not applicable for this report. The patient received 2nd dose of Engerix B at primary reporter's facility. Till the time of reporting, the patient did not receive 3rd dose of Engerix B, which led to incomplete course of vaccination. The reporter consented to follow up.
Patient received first Pfizer booster at vaccination site. During observation period, patient told medic she was experiencing pruritus in the arm she received the shot in as well as other areas of her body. She had the same reaction after both of her primary series vaccinations and it was relieved with PO Benadryl. Patient was given 25mL of PO Benadryl by on-site paramedic, symptoms relieved 30 minutes after vaccination and left. Reported by on-site paramedic and staff.
Facial twitching; Pain in arm; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150 7121) via an unspecified route of administration in the left arm on 02Apr2021 at 11:45 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included vitamin d deficiency, iron deficiency anemia and seafood allergy. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) taken roughly 2 weeks before vaccine, for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19.The patient had not received any other vaccines within four weeks prior to COVID vaccine.  Since the vaccination, the patient had not been tested for COVID-19.  On 02Apr2021, patient had soreness in arm and headache. The patient reported that the soreness in arm that increased in intensity on 2nd day (now OK) and light but persistent headache over 3 days (now OK). On 04Apr2021, the patient experienced facial twitching. She reported that facial twitching started the 2nd day and onwards (today is the 4th day and was still occurring). The patient underwent COVID-19 test (blood test) on an unknown date in Nov2020 and the test result was negative. The patient did not receive any treatment for the reported adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of pain in arm and headache was recovering at the time of this report. The clinical outcome of the event facial twitching was ongoing at the time of this report.  No follow-up attempts are needed. No further information is expected
Patient received dose 1 of Pfizer at 1300, at 1315 she reported she was starting to itch on her right arm and leg.  She was brought back and vital signs were obtained.  BP: 125/82, P 76, O2 97%, Resp: 18.  At 1330 she was administered 50mg Oral Benadryl per protocol.  She was monitored for 30 minutes past medication administration.  She was feeling better and left at 1405.
10-15 min after receiving the shot, pt got up to pay for a prescription and during the transaction, kneeled down and rolled onto her back and appears to have lost consciousness for approximately 10 seconds after which she sat up for a few minutes then a chair was brought to her to sit. Pt did not want to stay longer despite my recommendation and said she wants to have her mom drive her to the hospital because she is not feeling well.  An associate walked with her out to her car.  Will followup with pt tomorrow.
Fever (100F)  Nausea,  Headache, Fatigue,  Body Aches
Fever (101 F), chills, headache, chills and fatigue. Symptoms have resolved on 8/22/22 with the exception of fatigue and chills.
The child was found by the mother in AM, not breathing and without heart rate. Cause of death stated as complications of cerebral palsy. 07/26/2000 12:00 call to MD nurse who read baby's chart to me. She said she will fax mediccal records to us today. received at 13:00. 07/26/2000 call to coroner's office. Esitmate of what preliminary COD might be "complication of cerebral palsy". Letter of request for final autopsy report sent.
Developed chicken pox rash 3 weeks after vaccine. Cellulitis around lesions. Treated with BACTRIM.
Client fell forward when leaving clinic and hit head on door-fainting episode-cut above R eyebrow area-alert quickly-B/P 84/46-pulse weak-pale-brother witnessed-ice to site and referred to MD for further evaluation.
The patient presented to the office with a very swollen and red left upper arm. The swelling extended almost to her shoulder and slightly below her elbow. It was almost completely encircling the upper arm
fever; she was not feeling well; Graves disease; sick; lost weight; This is a spontaneous report from a contactable consumer(patient).   A 53 year old female patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: EW0161 ) via an unspecified route of administration into arm left on 19Apr2021;17:30 as DOSE 2, SINGLE for covid-19 immunization(at the age of 53 years).The patient medical history and concomitant were not reported. The patient previously took bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number:ER8727) via an unspecified route of administration on 29Mar2021into arm left  as DOSE 1, SINGLE for covid-19 immunization and experienced no adverse events. Patient had a query she  should be getting the flu shot and she had no issue ever for the flu shot and wondered about that as well regarding if she should get a flu vaccine or if the Pfizer covid vaccine triggered this and she should get the booster or should she get the Pfizer booster or another booster and noticed her doctor did not know if the Pfizer Covid vaccine had or had not been related to this and she wanted to know. On an unspecified date after administration of 2nd dose  the patient  became sick and lost weight  , she developed a fever the same night and had the shot at 5:30pm and the fever began about 11:00pm and states she had a high fever the following day but does not remember what it was but she was not feeling well. She was in and out of bed the first four days and was texting her friends overseas and said she lost all the weight and said she went to a weight facility and came to know that in kilos she lost 4 kilos over 4 days and the weight loss is not ongoing but she went overseas and used to be 63 kilos and is really down to 56 kilos and had lost 8 kilos. States her fever began around 11:00pm the same date she had the 2nd dose of the vaccine and it is not ongoing and all of that is gone and while she was overseas she saw doctors there and they found heart arrhythmia in her and thought it was an issue with her heart but turned out it was Graves disease and one symptom of Graves is heart arrhythmia and one symptom of Graves is weight loss. On Apr2021 the patient underwent lab test and procedures which included blood test and diagnosed with unknown results and also underwent  body weight test and diagnosed with really down to 56 kilos and had lost 8 kilos. The clinical outcome of the events were unknown.   No follow-up attempts are needed. No further information is expected.        .  .                   .
Within seconds of getting covid vaccine in right upper arm, felt a tingling sensation  on or near corroded artery on right side of neck leading up the the right lower jaw. Symptoms went away in less than 24 hours.  Felt  a slight pressure in center of chest that lasted less than 15 minutes. Around midnight of 12/10/2021-felt pressure near base of skull at the top of neck. Also felt pressure at the base of lower mid back. Menstrual cycle was to end on 12/9/2021, but menstrual cycle continued until approximately 12/15 or 12/16. Heavier flow was on 12/10/2021 & 12/11/2021. Menstrual flow got lighter around Tuesday 12/14/2021. Had sore right arm more than 3 days.
received / Engerix in November 2019 / 2nd dose in December 2019 / dose of Engerix on 26May2020 / was not converting / titer testing / 20-JUL-2020; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 24-year-old female patient who received HBV (Engerix B) (batch number H2T35, expiry date 29th May 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Hepatitis B vaccine with an associated reaction of therapy non-responder (received 3 series (doses) in 1996, refer case US2021059726).   On 26th May 2020, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. In December 2019, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. In November 2019, the patient received the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 20th July 2020, 55 days after receiving Engerix B and Engerix B Pre-Filled Syringe Device, between 6 and 8 months after receiving Engerix B and Engerix B Pre-Filled Syringe Device and between 7 and 9 months after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder 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 details were reported as follows: On 20th November 2019, the titer was tested, and the patient was found to be not converting. Since the patient was not converting, she then received 3 doses of Engerix B.  On 20th July 2020, the titer was again tested, and the patient was found to be not seroconverting The reporter consented to follow up. For tolerance of 3rd schedule refer case US2021AMR061704.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021059726:same reporter US-GLAXOSMITHKLINE-US2021AMR061704:same reporter
Vasovagal - near syncope. Responded with rest for another 15-25 minutes - released good condition.
Patient given Moderna at age 17, no adverse effect reported. Error discovered when patient came in for second dose
10 minutes after Covid-19 vaccine. Pt started complaining of the sensation of a scratchy throat We then decided to observe patient for 30 minutes. Pt still having scratchy throat. Vitals sign stable. Pt transferred to ER via ambulance, for observation.
Sinus irritation after four hours, mucous and nose-blowing, stopped after four hours. General chills; not too bad. Tiredness; not too bad. "Covid-Arm": large 5" swelling around injection site; feeling hot to the touch; sore/painful arm for the last four days.
Information has been received on 11-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance and for the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus ZOSTAVAX is intended to prevent. During 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX or long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Child complained of feeling dizzy; shortly after slumped over in a chair; noted jerky movements of arms, legs, and head; eyes rolled back; incontinent of urine.
Parent reports that patient received 15mo immunizations on 02 May 2018. She experienced no immediate adverse reaction. She went to bed per usual around 8 PM and woke at 7 AM at which time her mother noted a full body dermatitis affecting face, all extremities and torso. The mom states it was pruritic. She is unsure if the lesions were fixed or transient. The parents are unsure if there are oral lesions. She was not ill, ate normally and had usual activity. She was seen at primary care whose exam notes 'Erythematous blanching papules and plaques generalized no edema, Dermatographism is positive.' Patient was given BENADRYL and prednisolone. Mom states symptoms improved when dosed but would worsen in the interim prior to next dose. The rash resolved in a few days. She had no other illness symptoms in the week to vaccine receipt such as nausea vomiting diarrhea cough, nasal discharge, wheeze congestion or shortness of breath. She had no systemic symptoms such as cough shortness of breath watery eyes, rhinorrhea audible wheezing, nausea vomiting or diarrhea. Parent denies any other known adverse events following immunizations. Parent states patient tolerates ingestion of eggs and gelatin, and denies any known adverse reactions to latex, neomycin, polymyxin, streptomycin, thimerosal, yeast, or formaldehyde.
constant vertigo; feeling of dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 38 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "constant vertigo"; DIZZINESS (non-serious), outcome "unknown", described as "feeling of dizziness".  Additional information: 1-2 days post vaccination, patient experienced reported events from waking up to falling asleep.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received doses from vials affected by a temperature excursion; Received doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Received doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Received doses from vials affected by a temperature excursion) in a 54-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2022 at 3:09 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Jul-2022 at 3:09 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received doses from vials affected by a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Received doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Received doses from vials affected by a temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Treatment medication was not provided by the reporter.  Patient had received full dose from seventh vial. Patient received dose from the lot number 049l21a affected by a temperature excursion as the freezer went out of range.  No adverse event occurred at time of administration or were reported thereafter.
On 1/6 developed tenderness at left axilla and headache. That night began having muscle stiffening especially in back of neck, worsening headache. 1/7 awoke with nausea/vomiting lasting throughout the day and diarrhea also started. 1/8 continued vomiting but diarrhea stopped and also noted confusion and brain fog. 1/11 mostly recovered and back to work with slight headache and body soreness from exhaustion.