chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received via a phone call from the mother of a 12 year old female patient (125 pounds, 64 inches tall) with an allergy to tacrolimus and nonsteroidal anti-inflammatory drugs (NSAIDS). The patient had no medical history. Concomitant medication: prednisone, LASIX and ZANTAC. On 23-JUL-2010, the patient received the first dose (and only dose) of GARDASIL vaccine, intramuscular, for the prevention of HPV (lot# and expiration date not provided). Within a month from that time (August 2010) the patient was seen in the emergency room for 20 extra pounds of fluid in her body and was diagnosed with nephrotic syndrome. The patient had two kidney biopsies performed (results not provided). The patient received an unspecified treatment for the nephrotic syndrome. The patient has been under the care of a nephrologist ever since then. The patient has trouble standing and walking due to fluid in her lower extremities. The mother of the patient could not locate the lot# and expiration date of the vaccine but will call back with that information. It was also reported that the patient has been hospitalized up to five days for the flu. The patient was not pregnant at the time of the call; but was noted to have given birth in February of 2019. The patient's present status was reported to be not recovered. The mother of the patient inquired about compensation for the patient's medical expenses. The reporter considered nephrotic syndrome (trouble standing and walking due to fluid in her lower extremities) and flu to be disabling. The reporter considered nephrotic syndrome (trouble standing and walking due to fluid in her lower extremities) and flu to be life threatening. Upon internal review nephrotic syndrome was considered medically significant. Additional information has been requested.
pt states she had a fever of 101.2 degrees. her BP went up to 160/76 had a headache, joint pain, sore throat and overall feeling of "ickiness". There was a bruise and redness about 2x3.5" also.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-FEB-2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX 19400 PFU, lot # L044529, expiration date 09-FEB-2017, for prophylaxis (dose number and route of administration were unknown). No adverse effect was reported. Additional information has been requested.
My dad was taking a shower getting ready to go to a podiatry appointment.  After about 1/2 hour, my mother checked on him and found him on the bathroom floor after his shower unresponsive.  Calling 911, the responders came and found a  faint heartbeat, but were unable to revive him.  He was pronounced dead. medical examiner at the scene.
only about half of the injection went into the patient, the other half went down his arm/no AE; only about half of the injection went into the patient, the other half went down his arm/no AE; needle on the Flublok prefilled syringe was not seated properly/no AE; Initial information was received on 28-Sep-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 66 years old male patient who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] however only about half dose of this vaccine was injected and the other half went down his arm because needle on the syringe was not seated properly (underdose), (exposure via skin contact) and (needle issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given.  On 28-Sep-2020, the patient received less than 0.5 mL (recommended dose) of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2018 and expiry date 30-Jun-2021) via intramuscular route at the deltoid (not otherwise specified) for prophylactic vaccination.   It was a case of vaccine underdose, exposure via skin contact and needle issue(latency was on same day).  It was reported that dose of the vaccine should be repeated.  At the time of reporting, no adverse event reported.  Product technical complaint (PTC) First Noticed: 28-Sep-2020.  Product used: Used.  First time product used: No.  PTC assessment: Physical.  This suspected adverse reaction report is and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Per patient, on 10/31/09 at 2 pm, she began to have flu symptoms of sneezing and congestion.  On 11/1/09 at 4 pm, she felt tired and found it hard to breathe.  She has not sought medical attention yet.
Low grade fever; Sore arm; Felt little sore; This is a spontaneous report from a contactable consumer (patient herself). Follow-up (03Feb2021) information was processed together with initial information:  A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9264,), via an unspecified route of administration, administered in Arm on 12Jan2021 as 1ST DOSE, SINGLE for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. It was reported that, After her 1st dose of the covid vaccine about 3 weeks ago patient experienced a low grade fever, a sore arm and Felt little sore on an unspecified date in 2021. The caller enquired on symptoms she is experiencing post covid vaccination and how long to hold off before she is concerned about the symptoms she is experiencing post covid vaccination. Upon Follow up (03Feb2021), it was reported that, When told about the Pfizer medical information department, consumer stated, "That would be really helpful and because I just need to speak to someone to make sure that I mean, my friend had terrible hallucinations. He had a lot of problem. (Further not clarified) I would give it to you. I do not know if I want to have answers to the questions, 10 minutes questions. I am just letting you know." The patient stated, "I would like to because I just do not feel well that is severe. "Product details (NDC# UPC# and Treatment) and Pharmacy details could not be probed as consumer was unwilling to share further information. Hence further probing could not be done. Limited information available over the call. The outcome of the events was unknown. QR comment: It was not further clarified as the hallucination occurred after taking the Covid 19 vaccine. Hence split case not made.   Follow-up attempts are completed. No further information is expected.
Sickness; Initial information was received on 21-Feb-2022 regarding an unsolicited valid Social media non-serious case received from a consumer.  This case involves an unknown age male patient who reported sickness while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine produced by an unknown manufacturer (formulation, strength, batch number, expiration date: unknown) via unknown route in an unknown administration site for immunization. Information on batch number has been requested.  On an unknown date, the patient reported sickness (illness) (unknown latency) following the administration of Influenza vaccine.  Action Taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (illness).  At time of reporting, the outcome was Unknown for the event (illness).
States that she began experiencing numbness to left forehead and top of head (also tingling sensation) no treatment in ER. 02/04/10 9:20 numbness diminishing. Denies tingling. Feeling better.
Headache, Myalgia, Arthralgia, Fever, & Tachycardia Headache, body aches (joints and muscles), chills, fever (102.5), tachycardia (110-115) with decreased 02 sat (92%).
Shingrix administered subcutaneously; This case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th January 2023, the patient received the 1st dose of Shingrix (subcutaneous). On 19th January 2023, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 19-Jan-2023 Reporter's comment: The patient's daughter called on behalf of the patient. The  dose of Shingrix was administered subcutaneously, in the back of the patient's left arm. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route.
Shortness of breath, fast heart rate, redness, swelling, fever on injection site, weakness, nausea, diarrhea, sore joints, swollen glands, pain.
Painful swelling and welts on arm. Extreme muscle and bone  aches. Painful lumps under injected arm. Adverse neck pain/ stiffness
Pain in shoulder up my neck immediately. Upset stomach, increased diarrhea,  headache,  body aches,  vomiting, fatigue, heart palpitations  started immediately. Contacted doctors office and visited ER. Referred to cardiologist and revisit gastroenteritis. Multiple blood and bowel tests. Doctor refuses to believe its an adverse reaction. Taking Imodium, Ibuprofen changed diet.
post-viral gastroparesis; nausea; stomach swelled; projectile vomiting; diarrhea; stomach pain; This is a spontaneous report from a contactable consumer (patient).   A 39-years-old female (not pregnant) patient received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL3248 ), via an unspecified route of administration, administered in Arm Left on 24Jan2021 10:00 (at the age of 39-years-old) as SINGLE DOSE for covid-19 immunisation.   The patient medical history was not reported. Concomitant medications included mometasone furoate (FLONASE [MOMETASONE FUROATE]) taken for an unspecified indication, start and stop date were not reported; clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported.   The patient experienced post-viral gastroparesis on 02Feb2021 18:00 and required hospitalization, nausea on 02Feb2021 18:00, stomach swelled on 02Feb2021 18:00, projectile vomiting on 02Feb2021 18:00, diarrhea on 02Feb2021 18:00, stomach pain on 02Feb2021 18:00. Clinical outcome of the events was recovered with sequelae.  The patient was hospitalized for post-viral gastroparesis (impaired gastric emptying) for 1 days.  The patient underwent lab tests and procedures which included endoscopy: post-viral gastroparesis on 02Feb2021, sars-cov-2 test: negative on 06Feb2021.
On day 9 post vaccine, he developed a warm, red rash on his L deltoid. It was swollen compared to the other deltoid. It was redness 2x2 inches on L deltoid and itching on L upper extremity with one localized bump on L forearm. On 1/10 at 1 AM, he took Benadryl and applied hydrocortisone to the area. Upon waking up on 1/10 at 1 pm, his itching and rash had spread to both arms, back of neck, ears, and various spots along his forearm. He is having some irregular breathing, but could be due to nerves.
AFTER 2 WEEKS (14 DAYS) FROM MY COVID MODERNA ADMINISTRATION VACCINE DATE , I NOTICED SUDDEN ERECTILE DYSFUNCTION AND ONGOING. I HAD NO ISSUES BEFORE THIS EVENT.  THE ONLY MEDS ADDED WAS VIT D2 50,000 UNIT/WEEK IN THE LAST 2 WEEKS. I WAS SEXUALLY ACTIVE AND NO ISSUES WITH ERECTION PAST DAYS AND YEARS.
The reaction started with a stuffy nose, then runny nose, then went back and forth.  That was followed by a red-spotted rash that began on legs and arms.  The rash is extremely itchy  and in certain areas the spots all ran together into giant red patches which burn and hurt like a severe sunburn.  At the same time the spots were showing up, a small lump formed behind the left ear and was painful.  The pain ran up higher on the head on the same side and down the neck on the same side.  Over the counter pain meds, benadryl, pepcid, and clariton were tried with no results.  An urgent care visit resulted in a steriod pack prescription.
2 hours after vaccine administered, patient turned "ghostly white" per her mother and started vomiting.  She had multiple episodes of vomiting for the next 6 hours.  No diarrhea or fevers to suggest a viral illness.
received Boostrix (tdap) on 10/15/2020 instead of DTaP.; 2 years ago received Boostrix (tdap) on 10/15/2020 instead of DTaP; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9AN49, expiry date 25th March 2022) for prophylaxis.   On 15th October 2020, the patient received Boostrix. On 15th October 2020, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.      Additional Information: GSK receipt date - 31-Aug-2022 Reporters comment: The reporter reported that 2 years ago patient received Boostrix (tdap) instead of DTaP vaccine. The reporter stated that did not know if patient needs a Dtap. No additional details provided.  The reporter wanted to know how to proceed with DTaP series. The reporter did not consent for follow-up. Additional Supportive information: The patient received Boostrix (tdap) instead of DTaP vaccine which led to wrong vaccine administered and inappropriate Age at vaccine administration
This spontaneous report was received from a male patient of unknown age with hepatitis c reporting on himself. On an unknown date, the patient was vaccinated with pneumonia vaccine (manufacturer unknown) (dose and frequency unknown). Confirmation could not have been made if the pneumonia vaccine was PNEUMOVAX 23. On an unknown date, the day after vaccination, the patient experienced some mild symptoms. He experienced a slight headache and shivers, but the symptoms had gone away, the patient recovered (date unknown). The relationship between adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Headache, face hot, eyes red almost blood shot, heart beat fast & some dizziness, choking feeling in my esophagus (at first a metallic taste after shot.) Instructed to take Tylenol
Died from the Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died from the Covid vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: As per the reporter, the vaccine has killed a lot of people and destroyed a lot of peoples lives, including reporter's family. He has family members that had taken 4 shots of the Pfizer Covid vaccine and got cancer. The cancer was getting worse and they continue to got vaccines because of it. Two of his grandparents died from the Covid vaccine. Family members now had auto immune disorders and have had heart attacks and the doctor had said it was due to the vaccine. Caller references a "Pfizer" Pregnancy and Lactation Cumulative Review from Apr2023 by the FDA that documents deaths of pregnant women and their children from the vaccine. He reported that members of his family who have miscarried from the vaccine and are now can no longer have children. He stated there was a list of over 8,000 side effects but he could not find it.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300259085 Same reporter/ Adverse Event, different patient;; Reported Cause(s) of Death: Died from the Covid vaccine
pt recvd vax;inject site react; exp also erythema & swelling to 2x2cm in size & low grade fever w/in 24 hrs post vax;tx w/ erythromycin as a precaution;
pt recv vax & is not feeling well;has low grade fevers & sweats of head for several wk;devel sudden swelling  & pain in shoulder a few days later same sx occurred in rt side;had episode in hands, inner aspect of thigh & lt knee;
I had gotten really bad diarrhea for about a week and a half. I didn't go to the doctor.
Patient is having Nausea, vomiting and diarrhea daily since shot given.
weakness; fatigue; neck aches; A spontaneous report was received from a consumer concerning a 77-years-old male  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events weakness, fatigue, neck aches.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) for prophylaxis of COVID-19 infection.   After 2 weeks, the patient experienced weakness, fatigue, and severe neck aches.  Treatment details included Diclofenac, Lidocaine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), weakness was unknown.The outcome of event(s), fatigue was unknown.The outcome of event(s), neck aches was unknown..
11DEC92 345PM vomiting, t102, lethargy, chills; seen by MD 12NOV92 dx reaction to DTP; rx Phenergan, Tavist, & APAP; pt to see MD again on following day if condition worsens;
Get shot until i was almost 80 then got shingles/suspected vaccination failure; Shingles; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included scales (rough scales area between his/her butt cheeks) and shingles (hell for weeks and weeks).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Get shot until i was almost 80 then got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she had not received shingles vaccine until almost 80 years of age and then experienced shingles. The patient stated that it happened and he/she may have never gotten that painful virus. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Post vaccine day 1 (after 2nd dose) Was at work, began feeling very poorly in the late afternoon - went home & went to bed, slept through night and had sweats on and off. Post vaccine day 2- Fatigue, abdominal discomfort and pressure, constipated.  Nausea and vomiting developed, with dehydration.  Constipated, symptoms consistent with Crohn's flare.  Went to ER but due to long wait was not seen by physician.  Gradually improved, saw GI specialist day 4, felt much better by day 6. Bowels not quite back to normal 2 weeks later
Headache, Fever, Chills, Nausea, Body Aches. Restless. Worst symptoms lasted 24 hours. The next 24 hours was lingering headache, fatigue, but improved from day before.
Had chills upon awakening early Sunday AM after receiving the vaccine Saturday AM.  I took my temperature upon arising in AM at approx. 7AM --it was 100 orally.  I had overwhelming fatigue and malaise-- Went back to bed and slept for periods during the day.  Had no appetite --ate very little. Temperature came down as day proceeded..  The left arm was reddened and very sensitive to touch.  The week after the injection, the arm became less reddened and painful but this took many days
Refill for Epi Pen. This visit was within 6 weeks of receiving the COVID vaccine.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX. In April 2018, the patient received SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was a consumer that visited the pharmacy to get the SHINGRIX injection. The patient was the person working at the pharmacy said that she also took the SHINGRIX vaccine a week before he did and was still experienced some pain at the injection site. This case has been linked with case US2018075817 and US2018075815, reported by same reporter.
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case is cross linked to case 2018SA286322 and 2018SA286331, 2018SA288492 and 2018SA288497 (same reporter). This case involves a 79 year old male patient who experienced swollen about 10-15 cm at the injection site with redness, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history and concomitant medications were not provided. On 10-Oct-2018, the patient received a single dose of suspect FLUZONE HIGH DOSE lot UI985AC, expiry date 22-MAR-2019. On an unknown date, the patient developed a non-serious swollen about 10-15 cm at the injection site with redness, following the administration of FLUZONE HIGH DOSE. (Other relevant tests included no lab tests.) Final diagnosis was swollen about 10-15 cm at the injection site with redness. Corrective treatment was reported as treat with ice and alcohol compresses. The outcome of the event was not reported. List of documents held by sender- none.