chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrheas; Headaches; Vision changes; sore arm; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 65 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 28Feb2021 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single for covid-19 immunization. Relevant medical history included: "allergies: Latex" (unspecified if ongoing); "Slight depression" (ongoing). Concomitant medication included: ACYCLOVIR [ACICLOVIR]. Past drug history included: Nsaids, reaction "allergies: NSAIDS"; Epinephrine, reaction: "allergies: Epinephrine"; Penicillin, reaction: "allergies: Penicillin". Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown, Anatomical location: Left arm, Administration time: 02:30 PM), administration date: 07Feb2021, when the patient was 64 years old, for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "sore arm"; DIARRHOEA (non-serious), outcome "not recovered", described as "Diarrheas"; HEADACHE (non-serious), outcome "not recovered", described as "Headaches"; VISUAL IMPAIRMENT (non-serious), outcome "not recovered", described as "Vision changes". The events "sore arm", "diarrheas", "headaches" and "vision changes" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity, diarrhoea, headache and visual impairment.  Additional information: The first and second days were sore arm. After each shot and until the 16th day, patient had ongoing diarrheas, headaches and vision changes. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No antibodies after fully vaccination as a child; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 19-year-old female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The age at vaccination was not reported. There were no antibodies for Hepatitis B after receiving Hepatitis B full vaccination as a child. On 14th September 2021, the patient received an adult dose of Engerix B with batch number N4GN4 and expiry date 2nd January 2023. The nurse utilized an alternate dosage given 1 ml dose to 19 years of age.  The reporter did not consent to follow-up.
Patient just turned 12, one month prior to receiving Pfzier covid vaccine.  Patient was incorrectly given the pedi-Pfizer for ages 5-11yo. Patient was supposed to receive the adult Pfizer, for ages 12+ instead.  After understanding that an error had occurred, the patient's mother was notified about what had happened.  Patient's mother verbalized and understand the situation and the event that had occurred.  Patient's mother was also counseled on speaking with the patient's pediatrician and the next course of action in regards to his second dose.
Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 15-MAR-2017, the patient was vaccinated with expired dose of ZOSTAVAX (lot # L037791 with expiration date 30-DEC-2016) with diluent (lot# M041813 with expiration date 27-MAY-2019) (strength, frequency, route of administration and anatomical location were not provided), for prophylaxis. No side effects were reported. There was no product quality complaint involved. Additional information has been requested.
following hepta B vax pt devel red maculopapular rash over entire body. rash persisted for several days.
a patient received the booster dose of the Moderna COVID-19 vaccine 3 hours after the 12 hour post-puncture expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient received the booster dose of the Moderna COVID-19 vaccine 3 hours after the 12 hour post-puncture expiration) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient received the booster dose of the Moderna COVID-19 vaccine 3 hours after the 12 hour post-puncture expiration). On 16-Dec-2021, EXPIRED PRODUCT ADMINISTERED (a patient received the booster dose of the Moderna COVID-19 vaccine 3 hours after the 12 hour post-puncture expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The vaccine was administered at night. The patient was not experiencing symptoms after receiving the expired dose. The reporter mentioned that, the patient received the dose in the recommend way, but 3 hours after it expired. Date the vial was initially stored in the refrigerator: Probable within 5 days (as per the reporter); Date(s) and time(S) vial was first punctured: 16-Dec-2021 07.35 am, the syringe was at RT, not in the refrigerator, 3 hour after the 12-hour expiration. The vaccine did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 15 hours.   Reporter did not allow further contact
On the 8th day after the vaccine I soreness in the R deltoid, arm felt warm and when I looked there was a large red area with some raised redness. My arm was also itching. Day 9 the area was larger, but had the same itching, warmth,  redness and raised area, also had some hives on top of upper R shoulder. Day 10 the area was slightly smaller, still itching and tender. Taking 25mg Benadryl twice daily for the itching. This is day 10 as I turn this in.
no adverse event; Caller is vaccine coordinator reporting administered doses of improperly stored VARIVAX; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date, doses of varicella virus vaccine live (oka/merck) (VARIVAX) Lot #U039948, expiration date: 16-DEC-2023, underwent a temperature excursion of 6 to 14 fahrenheit degree for 6 hours and 15 minutes, and from 14 to 46 fahrenheit degree during 1 hour and 30 minutes, with no previous temperature excursions.  On 08-AUG-2022, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U039948, expiration date: 16-DEC-2023(strength, dosage regimen, anatomical location, and route of administration were not provided), administered for prophylaxis (Product storage error). No adverse event was reported.  This is one of the several cases reported by the same reporter.; Sender's Comments:  US-009507513-2208USA004548:
This spontaneous report has been received from a consumer regarding an unknown number of female patients of unknown ages. The patients' relevant medical history, concurrent conditions, and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL (doses, frequencies, route of administration, lot numbers and expiration dates were not reported) for prophylaxis.  It was stated by the reporter that GARDASIL was "injuring girls" and "ruining lives" (dates unknown). The outcome of the events and the causality assessment between "injuring girls" and "ruining lives" with GARDASIL were unknown. Additional information is not expected as there is no contact information.
Rash on my skin now and it is not going away; on both of my legs; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6208 and expiry date not reported), via an unspecified route of administration, administered in Arm Right on 18Mar2021, as dose 1, single, for COVID-19 immunisation. Medical history included ongoing diabetes mellitus, ongoing thyroid, ongoing peripheral neuropathy, and ongoing blood pressure problems. Concomitant medications included levothyroxine taken for thyroid; lisinopril taken for blood pressure; gabapentin (NEURONTIN) taken for neuropathy peripheral and 2 different kinds of insulin (further not clarified) all from an unspecified start date and ongoing. On 19Mar2021, the patient got a rash on skin and on both legs. There was no itching but had a rash on skin and it was not going away. The patient called a doctor and she said that for second dose, she should go get Johnson and Johnson. It was reported that the second dose of Pfizer vaccine was scheduled on 09Apr2021. The patient had labs 3 months ago. The patient tried Benadryl to see if it did anything, but it did not seem like it did anything and the events were same as the day it came on. The outcome for the events was not recovered.  No follow-up attempts are possible. No further information is expected.
On 8/1/00, pt was vaccinated and in August, 2000, the pt developed chills, felt feverish and weakness. The pt went to his doctor's office and had a pulse of 124, BP 94/66 and fever of 100.2F. The pt was treated with Benadryl IV and Motrin. That night, the pt had an increase in temperature, felt feverish, chills, nausea and weakness and ended up in the ER. His BP was 82/56. He was hydrated with normal saline, Benadryl po, Solu-Medrol and Phenergan. The pt was in the ER for 3-4 hours and was sent home on oral prednisone. The reporter stated that the pt is "now much improved" although he still feels tired and "not himself". ER records, on that date, noted that the pt had received the Hep-B vaccine and 30 minutes, post vax, began feeling shaky and developed a fever. It was noted that the pt had a decreased appetite, body aches and was hyperventilating and tachypenic. It was noted that the pt's throat was slightly erythematous and the airway was slightly "full". He was given 2L oxygen via nasal cannula and placed on a cardiac monitor. The pt was also given Tylenol for a temperature of 102.9F. The pt was placed on 10L NC of O2. The dx was acute allergic reaction to Hep-B vaccine. The pt was advised to avoid the other 2 shots of Hep-B, drink fluids and take Tylenol for fever. Prednisone 40 mg, 1 X a day for 5 days was prescribed. Upon internal review, the pt's "acute allergic reaction to Hep-B IZ" was considered to be an "Important Medical Event". No further information is available.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-JUN-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid  (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Muscle pain, sore arm,  injection site is red and raised, fatigue, mild nausea
Arm hurts extremely bad; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Apr2021 at 16:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 21Apr2021 at 11:15, the patient experienced arm hurt extremely bad. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm hurt extremely bad was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approx 5-10 minutes after vaccines were administered, patient developed facial flushing and a few blotchy macules on right lower leg then spread to Trunk. Patient was well appearing, lung exam normal, no labored breathing, no swelling of lips, face or extremities. No Urticaria. Patient was monitored for 30 minutes, rash faded but did not fully resolve. Mom given instructions to call if symptoms persist or worsen.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 73-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 15-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805484 was crossed linked to original case 201804863 due to same reporter.
a little bit of sore throat; The patient states she's been around people that have tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (a little bit of sore throat) and EXPOSURE TO SARS-COV-2 (The patient states she's been around people that have tested positive for COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (a little bit of sore throat) and EXPOSURE TO SARS-COV-2 (The patient states she's been around people that have tested positive for COVID). At the time of the report, OROPHARYNGEAL PAIN (a little bit of sore throat) and EXPOSURE TO SARS-COV-2 (The patient states she's been around people that have tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2022, SARS-CoV-2 antibody test: negative (Negative) Negative.         The patient had  been around people that have tested positive for COVID, but she doesn't know if they had it when she was around them. She was with them on Thursday 30-Dec-2021, but they tested positive on Friday 31-Dec-2021. No concomitant medications details were reported. No treatment information details were reported.   Reporter did not allow further contact
PARENTS REPORT CHILD WITH MILD SWELLING OF FACE NEAR EYES.  FACE WITH SLIGHT REDNESS AND SWELLING AROUND EYES DR. CALLED.  BENADRYL 12.5MG (5CC) GIVEN TO 4 YR OLD AT 4:50PM.  CLIENT RECOVERED. NO DIFFICULT BREATHING NOTED.  CLEINT LEFT CLINIC AT 5:20 PM AND REDNESS AND SWELLING SUBSIDING. 9/2/09 CALL TO PARENT CLIENT FULLY RECOVERED.
Anaphylactic reaction 10 mins after shot - drop in blood pressure, swelling of lips and upper palate and throat.  Treated with epi-pen.  Symptoms subsided with some residuals for about 90 minutes.
Patient was standing at the checkout desk, felt lightheaded and "tingling tongue" and passed out. Falling backwards and hitting her head.
Having what feel like nerves pain that shot all the way from my thumb  to the injection site/ arm is what not getting any better; headache; This is a spontaneous report from a contactable consumer, the patient. A 36-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 25Jul2021 at 14:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included carpal tunnel syndrome. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 27Jul2021 at 12:00, the patient had felt like nerves pain that shot all the way from the thumb to the injection site and headache, but the arm was what not getting any better. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nerves pain that shot all the way from the thumb to the injection site and headache was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Confused, fevers, hallucinations, restlessness, diarrhea, lower extremity pain
This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action taken was not reported. All telephone attempts to obtain follow-up information have been unsuccessful.   Follow up information was provided by the register nurse refers to a 1 day female patient. Current conditions and concomitant medications were not reported. On 18-JUN-2014 at 10:34 AM, the patient was vaccinated with the first dose of RECOMIBAX HB (Thimerosal Free) (intramuscular, lot number J012520 and expiry date 30-JAN-2016). On 18-JUN-2014 at 10:34 AM, the patient received the RECOMBIVAX HB stored to 0-1 of temperature x18 different episodes, according to minimum/maximum. All recorded temperature were with 2-8 degrees.  The issue that occurred was that they had a temp of 0-1 degrees on 18 different episodes between May 14th and July 21st, they were not able to identify how long the temps were down because it was not documented accordingly. They knew that when the temps were checked each AM and each PM they were within the normal 2-8 degrees. The vaccine was removed once problem was identified and has not been used after 21-JUL-2014. This is one of several reports received from the same reporter.  Additional information is not expected, because all follow up information has been received.
Fever, pain at injection site. Redness and swelling below the injection - 3 days.
No adverse event; Patient has received a dose of GARDASIL 9 on 4/9/2021 for an indication not approved in the prescribing Information; Gardasil 9 administerd to 7 years old patient; This spontaneous report was received from a physician referring to a 7-year-old patient of unknown gender.  The patient's concurrent conditions included juvenile onset recurrent respiratory papillomatosis. The patient's medical history and concomitant medications were not reported.  On 09-APR-2021, the patient began a 3-dose vaccine series with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection (frequency, route of administration, anatomical location, lot number and expiration date were not reported) for an indication outside of the Prescribing Information and the vaccine was being administered to potentially decrease disease recurrence (juvenile onset recurrent respiratory papillomatosis). No further adverse events (AEs) reported, no further information provided.
Initial misuse report received from a healthcare professional on 12 November 2013. This case is invalid as no information regarding patient was provided. It was reported that sterile water is used for reconstitution of ActHIB and administered. (No information regarding patient was provided). No adverse event was reported. List of documents held by sender: none.
I stayed for about an hour for observation because of my allergy history. Immediately after getting shot -within minutes- i began developing several headaches, After about an hour, or aAbout 10-15 min after I left the observation site and exited the store, I started getting swelling and numbness in my lips. (I have Bee allergy and know the symptoms of anaphalaxis but luckily my pattern is -- so far at least - a little slow motion and I was able to take benedryl immediately and halt it. The symptoms did not progress  - it didn't block my airways. I happened to have a friend who lives just blocksfrom the facility, I met her outside, showed her how to use an epipen, and called my husband as I didn't feel safe driving alone to my home a half hour away.   Immediately followed up with primary care provider (described below) The numbness in my lips did not go away though -- took about 8 or 9 hours to begin to subside and it did not resolve until the next day.
Approximately 48 hours after vaccines, client experienced golf ball size lump under left arm, tender to touch and movement. Four days later, lump unchanged with slight swelling at junction of left shoulder/breast. Felt feverish 1st 2 days with some anxiety. By 7/14/06 symptoms resolved.
The evening following the vaccination my son became so violent and upset. He would pinch us, hit us, cry all the time, run around screaming as if he was in so much pain. This lasted for 6 weeks.
Varicella-like lesions over neck face trunk and extremities (<50) Last Lesion 5-30-07
On 08/07/2023 arount 9:00am Medical Assistant administrate expired vaccine to patient. Medical assitant was documenting the administration of vaccine whe Medical Assitant realized that the vaccine had expired on 06/14/2023. Medical assitant report to clinic practice director who contact Merck. Merck has reported that due vaccine was recently expire and properly storage at the right temperature has reported that vaccine still has the same potency and they do not recommend that the patient be vaccinated again but they will leave up to health provider. Patietn did not have any symptoms.
On March 22nd, I felt poorly. I had a stomachache and headache. on the next day I took a COVID test it was positive. I was now tired, no appetite and achy. I felt poorly. I maintained and didn't do anything. I waited 6 days before calling my PCP. I was past the five days, and they could not give me Paxlovid. On that Tuesday I went to the urgent care. I started feeling better from the neck down, but my sinuses and ears were completely clogged. I was given Prednisone and Azithromycin and take some Allegra over the counter. I just finished the Prednisone today and I feel better.