chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. In approximately 2011 (about 4 years ago), the patient was vaccinated with the first dose of GARDASIL (lot#, expiration date, strength, dose and route were unknown) and did not get any other dose. The patient was in the office but did not get another dose yet. No adverse effect reported. Additional information has been requested.
The patient received a vaccine which was exposed to a low temperature of 30.9 degrees F for 2 hours, no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 76 year old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which was exposed to a low temperature of 30.9 degrees F below the recommended range for 2 hours (product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received no other concomitant vaccines   On 22-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ453AB, expiry date: 30-Jun-2021, form: prefilled syringe) once via intramuscular route in unknown administration site for prophylactic vaccination.  The vaccine was exposed to freezing temperature below the recommended range for 2 hours, reaching a low temperature of 30.9 degrees F, due to refrigerator malfunction.  It was a case of an actual medication error due to product storage error temperature too low.  At the time of report, no adverse event was reported.  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 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
Injection site warm; lnjection site little bumps almost like blisters; Injection site itchy; Area where she got the vaccine was sensitive; Injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE VESICLES (lnjection site little bumps almost like blisters), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Area where she got the vaccine was sensitive) and VACCINATION SITE SWELLING (Injection site swollen) in a 58-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE VESICLES (lnjection site little bumps almost like blisters), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Area where she got the vaccine was sensitive) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE VESICLES (lnjection site little bumps almost like blisters), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Area where she got the vaccine was sensitive) and VACCINATION SITE SWELLING (Injection site swollen) outcome was unknown.        The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown.       No treatment  information was provided.  Concomitant medication included thyroid medication (unspecified).
Patient received a booster dose of Moderna from a vial that was 4 days expired. Per Moderna, the dose was valid.
Information has been received from a physician concerning a female who approximately a year and a half to 2 years ago was vaccinated with a dose of GARDASIL. The patient experienced syncope after receiving the dose of GARDASIL. The patient sought medical attention through her physician. The patient's outcome was unknown. Additional information is not expected.
difficulties in breathing; This is a spontaneous report received from a contactable consumer (patient) through Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COIVD-19 VACCINE; Lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced difficulties in breathing on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
erythema and edema at site, generalized itching. Caregivers feel he had same reaction to vaccine last year
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered at a medical office (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2016, the patient was treated (by an unspecified healthcare professional) at a medical office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Tenderness at injection site; Tiredness; Headache; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN; EXP:31Jul2021) via an unspecified route of administration in the right arm on 24Mar2021 at 11:45 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. The patient medical history included ADD (attention deficit disorder), Hashimoto's, sleep apnea. The patient was allergic to molds, but not PCN (penicillin). Concomitant medications included Levothyroxine (MANUFACTURER UNKNOWN), piroxicam (PAXIL), bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3) and Iron (MANUFACTURER UNKNOWN). Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Mar2021, the patient experienced tenderness at injection site, tiredness and headache, all symptoms were mild. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had taken treatment for the events which included two extra strength acetaminophen (TYLENOL) caplets. The clinical outcomes of the events vaccination site tenderness, tiredness and headache were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a 18-year-old female patient who received BEXSERO. Previously administered products included BEXSERO (1st dose received on an unknown date). On 22nd August 2016, the patient received the 2nd dose of BEXSERO. In August 2016, less than a week after receiving BEXSERO, the patient experienced injection site pain, injection site swelling and injection site erythema. On 22nd August 2016, the patient experienced screaming. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and screaming were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and screaming to be related to BEXSERO. Additional details were provided as follows: The patient did not receive any concomitant medication. The patient screamed during vaccination and the next day, she reported pain, redness and swelling at the injection site (left deltoid).
9:19 Going to sit in seat for observation, seized, fell onto ground, hit head.  VS: BP 108/52 HR: 57 RR: 22 O2sat: 100%; 9:20 911 was called; 9:21: BP:   132/84 HR: 72 O2: 99% RA  Pupils: PERRLA; 9:27:  Alert & Oriented, difficulty remembering wife's name:  BP:  156/73 HR: 75 O2: 99%; 9:30 EMS arrived, transferred to ED for further treatment and eval.
PAIN IN LEGS; CHILLS; This spontaneous report received from a patient via a company representative concerned a 42 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 12-APR-2021, the subject experienced pain in legs. On 12-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in legs and chills was not reported. This report was non-serious.
Received flu mist on a Thursday afternoon. By Thursday evening she said she felt "weird." Rested on Friday. Seemed fine on Saturday and Sunday. By Monday night she could not eat, was running a fever of 101 and had developed soars that appeared to be white and pus filled that covered her tonsils.  Inside of her mouth was very red. Tonsils were very swollen. She kept complaining that her eyes "hurt and felt hot." Took her to Urgent Care when symptoms did not get better. They assumed it was strep and started her on anti-biotics.  Received notification that strep cultures came back negative, as did mono testing.
She tested positive again two days ago; She tested positive again two days ago; more hunger; This is a spontaneous report from Pfizer. A female patient of an unspecified age (Age: 65; Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on 14Jan2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received first dose of the BNT162B2 on 14Jan2021 and then tested positive for covid on 25Jan2021. She tested positive again two days ago, but has no symptoms other than more hunger. She was scheduled to take the second dose of the vaccine tomorrow, however she was tested positive for Covid. She was under quarantine until Sunday or Monday. It was questioned that can she receive the vaccine as scheduled for today, did she have no symptoms/ such a mild case of covid because she already received the first dose of the vaccine. Outcome of the events were unknown.  Information on the lot/batch number has been requested.
mom reports pt has vomiting & diarrhea, low grade fever-unsure of coincidental or rxn;Tigor supp;
Information has been received from the Merck Pregnancy Registry for Gardasil from a consumer concerning her 24 year old daughter with no pertinent medical history or drug reactions/allergies who in August 2007 "about 5 months ago" was vaccinated with Gardasil (lot# unknown) 0.5 mL injection.  There was no concomitant medication.  In July 2007, "about 6 months ago" the patient experienced pain during her pregnancy.  No further information was provided.  Medical attention was sought.  On unspecified dates ultrasounds were performed.  The outcome was not reported.  The patient's date of last menstrual period was 01-JUL-2007 "about 6 months along" and the estimated date of delivery is 06-APR-2008.  Additional information has been requested.
This spontaneous report as received from a healthcare worker who refers to a group of seven patients of unkonwn age and gender. Patients' medical histories were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (doses, frequencies, indications and lot numbers were not provided, default route of administration: orally). Concomitant medication was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Swollen lymph glands in left arm pit, extreme chills, fever of 101, then rash over upper torso two days later
A non-serious report of "eye exposure to mist" was received from a licensed practical nurse concerning a 33-year-old female. The patient's medical history was not reported. On 30-Oct-2009, some of the administered H1N1, Intranasal went in the patient's eye. The eye was immediately flushed with water. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Mother reported two episodes of vomiting the day after receiving the two-month-old vaccinations in our office. One of the vaccines was the first dose in the series of Rotateq. Mom also reported more frequent stools, but no blood or mucous noted in the stools and vomitus appeared to be recently ingested milk.  NO fever, no apparent pain or discomfort.  Better today and seen as a follow-up in our office today. (September 14, 2023)
shoulder is not better in this two months after getting the shot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (shoulder is not better in this two months after getting the shot) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (shoulder is not better in this two months after getting the shot). At the time of the report, MUSCULOSKELETAL DISCOMFORT (shoulder is not better in this two months after getting the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that his shoulder was not better in these two months after getting the shot, and was going to blow his brains out if he had to get another one. No concomitant medications provided. No treatment medications provided.
Stopped breathing x 1 min. Baby was pale, but not blue. Mom picked her up + stimulated her, she came around gasping for air. Baby was fine prior to this. Mom brought baby to office the following morning. Baby put on apnea monitor
6/16/2020 - Patient called the office to report that starting on 6/15/2020 at 6:30pm she was experiencing nausea, left arm pain, fatigue and chills. Patient called the office again on 6/18/2020 having the same symptoms, along with a headache and felt very hot (temp not taken). Patient also reported tenderness to the touch and left arm very sore if she put arm over her head and also decreased appetite. Patient was advised to make an appointment to see the doctor. Patient was seen by Dr. on 6/18/2020 and diagnosed with Vaccine Reaction and Left arm pain. Per the patient, chills had improved, but still having other symptoms. patient was advised to take Ibuprofen q 8hrs and Zofran q 8hrs prn. The adverse Event stopped on 6/24/2020
Post imms X 4 days,pt would awaken with high-pitched cry, was fussy, still fed, no fever, no soreness (normal growth and development). This by history today, 08/07/02, Since 03/29/02, wasn't seen in interim.
A week later, the patient was hospitalized again and diagnosed with acute, recurrent, cerebral artery cerebrovascular accident; Patient was hospitalized and diagnosed with acute left hemispheric cerebrovascular accident; This initial spontaneous report was received from a lawyer on 27-MAR-2020, regarding a case in litigation and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medication were not reported. On or around 19-DEC-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the patient suffered slurred speech and right sided weakness. The patient was hospitalized and diagnosed with acute left hemispheric cerebrovascular accident. A week later, the patient was hospitalized again and diagnosed with acute, recurrent, cerebral artery cerebrovascular accident. As a direct and proximate result of vaccination, the patient's symptoms had resulted in physical limitations not present prior to vaccination. He suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. He sustained severe and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. He suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages.  Upon internal review, cerebrovascular accident was considered to be medically significant.
Red swollen and sore arm where shot given. Flu like symptoms. Very achey, chills, with headache and nausea. I missed 1 1/2 days of work.
At 2:43pm patient received the vaccine in her arm. At 2:50pm my pharmacy technician witnessed the patient standing up from her chair and walk up to the pharmacy counter then faint into the pharmacy immunization booth. My technician states the patient did not hit her head on a wall. At 2:51pm my pharmacy technician brought the incident to my attention and we both ran to the patient to address the situation.  The patient was unresponsive, so I ran and dial 911 then instructed my tech to take the phone. I then ran back to the patient and patted her back, said her name and asked her if she could hear me.  It was at that moment the patient's eyes flickered and the patient had what looked to me like a 10 second seizure in the chair inside the pharmacy booth.  Once the patient was done what I could only identify as seizing, she came to and I asked her if she new her name and where she was. The patient answered correctly and then asked me "Have you had anyone with a reaction like this before?". I answered that I have not personally witnessed a reaction like this before. My technician had 911 still on the phone and they instructed her to stand out front of the store to await the ambulance. A first responding officer came in and asked about the witnesses to the incident then took over for caring for the patient.
Uncontrollable vomiting 3 hours after receiving vaccine. Admitted to ER for fluids and medication. Still recovering at time of this submission
very sore arm; felt really sick; started getting sick with like a cold or flu/felt like she was getting a bad cold; started getting sick with like a cold or flu; body aches/achy; joint pain/joints hurt; lost some taste; Cough; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the right arm, on 29Jan2021 (Batch/lot number unknown), at age 78 years old, as dose 2, single, for COVID-19 immunisation. Relevant medical history included chronic obstructive pulmonary disease (COPD) from 2015 and ongoing (diagnosed about 6 years ago, been on oxygen for about 4 years). Concomitant medication oxygen taken for COPD, from 2017 and ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), administered in the left arm, received on 08Jan2021 (Batch/lot number unknown), at age 78 years old, as dose 1, single, for COVID-19 immunisation. On 28Jun2021, the patient received the second dose of BNT162B2. On an unspecified date, after the second dose, the patient had a very sore arm. The patient stated that the first dose did not hurt at all. On 10Feb2021 (reported as 8-10 days later), the patient felt really sick with body aches and joint pain, but no fever, she lost some taste and had a cough. She started getting sick like a cold or flu, her joints hurt, she was achy, but no fever and she never lost her appetite. She felt like she was getting a bad cold. At the time of the report, the patient was feeling better and the events were going away finally. The patient asked if these could be from the vaccine or if it was cold. She also asked if it was safe for her to go out to the grocery store or out to eat. The outcome of the event very sore arm was unknown. The patient was recovering from the remaining events. The reporter assessed this report as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
745AM 12MAY92 pt was reaching for a spoon & passed out on kitchen floor-mom picked pt up & was staring but would not respond; pt felt very warm & mom attempted to give pt APAP & pt went limp briefly; pt taken to ER; MD found mild UTI;
Patient received Flucelvax vaccine yesterday at 12pm. Patient called this morning at 930am describing feeling achy and having flu like symptoms that began earlier this morning. At 1230pm today her husband called and indicated that they went to the walk in clinic because she began experiencing abdominal pain, N/V, and diarrhea. The walk in clinic recommended that she go to the ER. Awaiting further details
Low fever; mild headache; fatigue; This is a spontaneous report from a non-contactable consumer (reported for herself). A 20-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in right arm on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history was not reported.  The patient was not pregnant at the time of the report. The patient had no Covid prior vaccination. There were no concomitant medications. The patient no other vaccine in four weeks. The most recent vaccine was administered in a public health. On an unspecified date, the patient experienced low fever (body temperature), mild headache, and fatigue. No treatments received in response to the events reported. The patient was not tested for Covid post vaccination. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.