chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer-sponsored program from a contactable certified chemical medical assistant (CCMA) and a non-contactable consumer. A 17-year-old male patient received, on 14Jul2017, TRUMENBA (Lot. R56659, Expiration date: Jan2019, NDC number: 005010005) at 10:15 AM, intramuscularly, in left arm, at 0.5 ml, single dose; and the second dose of meningococcal vaccine (Lot. U5751AA, Expiration date: 12Nov2018, NDC-4928158905, Manufacturer: Sanofi Pasteur) intramuscularly, in right arm, both for immunization. Relevant medical history and concomitant medications were none. The patient received previously a dose of meningococcal vaccine for immunization at the age of 11 years. On 15Jul2017, the patient experienced migraine, body weakness, swelling and pain at injection site, and he was not able to get out of bed. On an unspecified date, the patient developed also headache, and he was not able to move arm over the head and felt heavy. No treatment was received. The patient did not recover from the events, swelling and pain at injection site; clinical outcome of the events, headache, vaccination site movement impairment and heavy feeling in arms & legs was unknown; while clinical outcome of the other events was recovering.
Left deltoid swollen, red, hot to touch, vomited x 1 5-17-07, temp 101.6 orally, given water, to give Motrin and refer to MD.
Information has been received from a registered nurse concerning a 6 year old male with ringworm of scalp who was vaccinated with first and second doses of VARIVAX (Merck) on 26-JUN-2003 (lot# 644567/1151M) and 08-MAR-2007 (lot # 656123/1310F) respectively. Concomitant therapy included Griseofulvin. On 17-APR-2008 the patient was diagnosed with chickenpox in the office, the patient had less than 50 lesions on his upper chest, upper arms and neck. There was no fever. The patient outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Patient goes to the emergency room a few hours after being vaccinated against Covid 19. Patient indicated to the nurse on duty " I have tremors, dizziness, fever and blurred vision after being vaccinated the symptoms began". Doctor on duty orders laboratories and treatment.
I had cloudy urine in November that led me to go to the clinic to get checked out to make sure that I did not have a UTI or kidney infection. They did run a urinalysis that came back negative, they also ran cultures for yeast infection that came back negative. I was given an antibiotic, BACTRIM to help clear the cystitis, I was also given fluconazole, we discovered I am allergic to it. I have had this reoccur four different times and I have been advised to see a urologist if it does come back.
Initial and follow-up information has been received from a physician concerning a female patient who on 08-OCT-2007, was vaccinated with her first dose of GARDASIL (Lot # 657622/0388U). On 07-DEC-2007, was vaccinated with her second dose of GARDASIL (Lot # 659435/1265U). On 23-JUN-2008, was vaccinated with her third dose of GARDASIL (Lot # 660393/0067X). After receiving the vaccine "the patient experienced numbness at injection site. The physician stated that she may have thrombocytopenia, she required platelets." The patient sought unspecified medical attention. In follow-up, the nurse reported that the patient had a concurrent condition of Idiopathic thrombocytopenic purpura (ITP). The nurse stated that the patient's mother inquired if the GARDASIL vaccinations had anything to do with the problems her daughter was experiencing with ITP. The nurse stated that the patient made a general statement that the injection was painful and the patient did not complain of injection numbness. Upon internal review, thrombocytopenia was determined to be an Other Important Medical Event. No further information is available. This is follow-up to report(s) on 09/09/2008: Information has been received from a physician concerning a female patient who was vaccinated with GARDASIL. After receiving the vaccine "the patient experienced numbness at injection site. The physician stated that she may have thrombocytopenia, she required platelets." The patient sought unspecified medical attention. Additional information has been requested.
Tachycardia HR 100-92 bpm, blood pressure 148/96, Impending feelings of doom.
a few weeks- months my tonsils got swollen; arm swollen/ inflammation; arm swollen/ inflammation; This is a spontaneous report from a contactable Other Health Professional (patient). A 24-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EH9899), dose 1 via an unspecified route of administration on 18Dec2020 (at the age of 24-year-old) as dose 1, single for COVID-19 immunization. Medical history included ITP and blood disorder from an unknown date and unknown if ongoing. There were no concomitant medications. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not have any relevant past drug history. On 05Jan2021, patient experienced for few weeks- months tonsils got swollen, arm swollen/ inflammation. Patient stated, went to urgent care got a shot decreased my tonsils slightly, went to doctors, tried allergy meds did not work. Referred to ENT, tried strong meds did not work. Stated it was odd, I have never had issues with my tonsils. Pending if I need surgery to removed them. Due to events patient visited doctor or other healthcare professional office/clinic and emergency room/department or urgent care. Patient received medications as a treatment for the adverse events. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient underwent lab tests and procedures which included flu/mono test, Covid-19 and strep: negative on 05Jan2021. Therapeutic measures were taken as a result of a few weeks- months my tonsils got swollen, arm swollen/ inflammation. The outcome of events was not recovered.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, there is a reasonable possibility that event tonsillar hypertrophy were related to suspect drug based on the temporal relation between the vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This is a spontaneous report from a contactable consumer, the patient, from a Pfizer-sponsored program, Inbound Call Center for HCPs (IBCC).  A 44-year-old male patient received PREVNAR 13, via an unspecified route of administration in the left arm on 19Dec2016 at a single dose for immunisation. Medical history included drug allergy to many medications and sinus infections.  Concomitant medications included cefuroxime axetil (CEFTIN).  On 20Dec2016, the patient experienced fatigue, headache, fever, chills, muscle pain, and joint pain.  The clinical course was as follows: The headache, fever, and chills started around 4:00 PM on 20Dec2016.  The fever was up to 100 degrees Fahrenheit.  The fever and chills went away around 8:00 PM or 8:30 PM.  The fatigue started around noon on 20Dec2016.  The muscle pain and joint pain started around 7:00 PM on 20Dec2016.  He was so sore when he woke up on 21Dec2016.  The muscle pain and joint pain were the worst it had been.  It hurt when he started moving, but the more he moved around the better it seemed to get.  He stated moving hurt, but it felt better. Therapeutic measures were taken as a result of the fever and included treatment with ibuprofen (ADVIL) which did not work. The clinical outcome of the event, fatigue, was not recovered. The clinical outcome of the events, fever and chills, was recovered on 20Dec2016 at around 8:00PM or 8:30PM. The clinical outcome of the events, headache, muscle pain, and joint pain, was recovering.  No follow-up attempts are possible. No further information is expected.
After receiving vaccine patient started experiencing dizziness. According to him he didn't eat anything before receiving vaccine. He was able to eat banana & drank water afterward. EMS came and checked him out and he was able to go home.
Pt recvd 2 doses of Engerix-B & following each dose devel diarrhea @ 48 hrs; vomiting & irritability; both time events resolved w/in 1 1/2 wks w/o treatment;
Patient developed a small erythematous spot at the site of injection of the vaccination; this area is slightly warm and itchy.  She reports that the symptoms are not severe and has read on-line that this should go away after about a week.  She has no SOB, wheezing, arm pain.  Plan for patient to take an OTC anti-histamine like Claritin and use topical hydrocortisone ointment for itching if needed.
Received IM injection in hip/buttocks area patient complaining of lower back pain still a month after receiving injection.
No adverse events observed. Expired vaccine was given. The expiration time was 1448 and the vaccine was administered at 1520.
Both Moderna doses were given at age 17. Per Alert, first Moderna dose was given on 1/22/21 and second Moderna dose was given on 2/24/21 and states "Not Valid" for both.
Three year old was inadvertantly administed Tdap vaccine instead of Flu vaccine. Mother was notified and educated for signs and symptoms. No adverse outcomes noted at this time.
cholesterol tripled; This spontaneous case was reported by a consumer and describes the occurrence of CHOLESTEROSIS (cholesterol tripled) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013-M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety, LISINOPRIL for Blood pressure management, MELATONIN for an unknown indication.   On 07-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced CHOLESTEROSIS (cholesterol tripled). At the time of the report, CHOLESTEROSIS (cholesterol tripled) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Blood cholesterol: 149 (Inconclusive) 149. On 05-May-2021, Blood cholesterol: 305 (High) Tripled than last year.         Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was unknown.
right bell's palsy symptoms started on 3/17/2021, became severe on 3/18/2021, with severe right facial droop and inability to close right eye, minimal improvement over past 6 weeks. Younger sister also developed Bell's Palsy after her second Covid vaccination.
I broke out in Hives over my whole body and my throat was swelling a bit. Got dizzy and shaky. I was given 2 shots in Hips and a steroid.
On the morning of 4/5/2021 about 8am I start having a mild headache. By 10am it was a migraine and my manager at work set me home I could not function at work. After that day I would have mini headaches 4 to 5 day a week thru out the days. On 4/24/2021 I had another migraine headache but I also felt dizzy and nauseous. I haven't had a headache over 10 years.
headache, nausea, acid reflux, joint and muscle aches, nausea, malaise, fatigue, restlessness
Patient mentions that he has a strong fear of needles/vaccinations. A few short minutes (1-3 mins) after vaccination patient appeared to have vasovagal syncope. When patient regained alertness, he began to display hyperhidrosis.  He was given cold water to drink and fan current was directed at the patient. After a few minutes (10-15 mins) he started to return back to his normal state and was further observed for at least 20-25 additional minutes.
Light headed at first, but subsided after about 10 minutes.  Inj. sight was very tender & sore for 4 days.  It hurt to even move my arm. Lymph node under shot arm was very swollen & sore.  I could not raise my arm, reach or carry anything of weight with injected arm.  Neck muscles & back also seemed to be "stiff".  All side effects seem to disappear on or about day 4.
Patient was administered flu vaccine on left arm first and was well, no reactions after vaccine given. Then I administered Men B vaccine on right arm and shortly after (approx 10 seconds) I had finished giving vaccine to patient, he passed out and he was beginning to fall forward towards me. I grabbed patient and as I was laying him down onto bed his eyes started rolling backwards and he started clenching up his fists and his body began to mildly shake. Patient was unresponsive and would not answer me when I would ask if he was ok. I went and called Dr. to the room. As doctor was coming into the room, patient started to become responsive and responding to me. Patient was pale and was saying he was dizzy and kept trying to sit up but was a bit confused. I told him to lay down and as Dr. was walking into the room, he passed out again and became unresponsive and he began clenching his fists up, eyes started going backwards again, and his body started shaking mildly again. Dr. went out room and told (office manager) to call EMS.  This episode lasted approx. 10-15 seconds. After this episode, patient became responsive and started talking to us and telling us he remembered passing out the first time and woke up to mom hugging him and remembers passing out again.  EMS arrived to clinic and pt was taken to hospital for further evaluation.
intermittent gen convuls lasted for 15min about 5hr p/vax given;
My friend died right after getting his shot. Athletes are dying on the field after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), 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 "My friend died right after getting his shot. Athletes are dying on the field after getting the vaccine". The date and cause of death for the patient were unknown. Clinical course: Reporter was asking why it was hidden that the Pfizer Covid-19 virus caused more problems than people know about. Like heart problems. Reporters friend died right after getting his shot. Athletes were dying on the field after getting the vaccine. This was being hidden from people said didn't know how this spike protein will affect organs in the long run.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: My friend died right after getting his shot
Injection site reaction (localized) as well as generalized rash beginning 3 days after vaccination initially itchy rash on buttocks, spread to trunk, extremities. No treatment.
facial itching; throat swelling; lump in throat; hoarse voice; This is a spontaneous report from a contactable nurse. A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140), via intramuscular on left arm on 23Dec2020 at 09:45 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient experienced facial itching, throat swelling, lump in throat and hoarse voice, all at 11:30 on 23Dec2020. The most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit for the patient. The patient received IV benadryl and Epi pen as the treatment for the events. Prior to vaccination, the patient was unknown if diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pruritus, pharyngeal swelling, sensation of foreign body and dysphonia cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Body aches, fatigue, and general malaise began at 6:30pm. EXTREMELY intense shivering, to the point where I couldn't safely walk, around 1am. Vomiting, despite having nothing in my stomach to vomit, and a peak fever of 102F at about 3am. Whole body aches, probably made worse by the intense shivering, are continuing as I type.
Patient states a "shingle-like" rash developed on her lower back as well as redness and itching around the site of injection.
Phantom smell , the sudden smell of fumes, ammonia, acetone or smoke like smells.
Double vision; Sensitivity to light/ had to wear sunglass siting inside; has not been able to work; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision), PHOTOPHOBIA (Sensitivity to light/ had to wear sunglass siting inside), VACCINATION COMPLICATION (has not been able to work), FATIGUE (Fatigue) and PYREXIA (Fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced DIPLOPIA (Double vision), PHOTOPHOBIA (Sensitivity to light/ had to wear sunglass siting inside), VACCINATION COMPLICATION (has not been able to work), FATIGUE (Fatigue) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, DIPLOPIA (Double vision), PHOTOPHOBIA (Sensitivity to light/ had to wear sunglass siting inside), VACCINATION COMPLICATION (has not been able to work), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.            This case was linked to -MODERNATX, INC.-MOD-2021-062372, -MODERNATX, INC.-MOD-2021-062392, -MODERNATX, INC.-MOD-2021-062392 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-062372:Cross linked with first dose -MODERNATX, INC.-MOD-2021-062392:wife case -MODERNATX, INC.-MOD-2021-062392:Cross linked with Husband case
Jaw pain and uncomfortable to bite down. Was seen at urgent care. MD prescribed naproxen and flexeril and adverse event has since improved.
PCV given today at 4 weeks a part. CDC recommends PCV given at 8 weeks if infant is younger than 7 months.
TENDERNESS AROUND SITE OF  INJECTION; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, kidney disease, high blood pressure, high cholesterol, bipolar, and glaucoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced tenderness around site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tenderness around site of injection. This report was non-serious.
11 days after receiving booster shot (booster was approx 7 months after second shot), began itching. Itching seemed random. No change in diet or clothing or exposure to unusual chemicals. Later found out that itching was caused by clothing irritating my skin, or pressure on the skin, or scratching the skin. Can gently scratch an unaffected area and will get red itchy lines in the same spot in 10-15 min. Itching then goes away from spot in 30-40 min but stays red and raised for awhile after. Taking Benadryl to ease itching which gives reducing itching somewhat. Welts and itching can appear anywhere - back of head itches after getting up in the morning, inside of ears itch if earbuds are used. Some spots on palms itch after doing manual work.   No reaction after first shot other than sore arm. Reaction after second shot was sore arm and flu-like symptoms starting 6 hours after and going away 24 hours after shot.
had the vaccine and Shingles/Suspected Vaccination Failure; shingles; terrible burning pain on right side and back area/pain; apparently, it centered on one nerve forever/terrible burning pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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: had the vaccine and Shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), pain (Verbatim: terrible burning pain on right side and back area/pain) and nerve pain (Verbatim: apparently, it centered on one nerve forever/terrible burning pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported and the outcome of the nerve pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and nerve pain to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure, shingles, pain and nerve pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient actually had shingles vaccine a few years prior.  The patient went to emergency room . The reporter stated that three years ago in such pain. It was shingles and went around his/her and was treated but he/she continued to have the terrible burning pain on his/her right side and back area. The reporter stated that apparently, it centered on one nerve forever. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.