chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 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 an unspecified date, the patient experienced pain. Treatment medications (dates unspecified) included: bacitracin zinc/neomycin/polymyxin b sulfate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain. This report was non-serious.
Immediate (less than 5-6 minutes) onset of dizziness, chills, minor tremors, fear of falling, extreme fatigue. Symptoms went away by the following day but reappeared after two weeks, which remained for several days. Symptoms have not been present for several weeks
Information has been received via medical records from a licensed practical nurse and refers to a 3 year old female patient. On 06-OCT-2009, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose, lot# and expiration date were not reported). This is one of two reports concerning the same patient. Additional information is not expected. All available medical records will be provided upon request. Sender's Comments: US-009507513-1705USA009102.
started series in 2017, never got second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2017).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 25th March 2022 Reporter's Comments: Pharmacist stated that the patient started the Shingrix series in 2017 but never got the second dose. The pharmacist did not consent to follow up from safety. Additional Supportive Information: Till the time of reporting patient did not received 2nd dose which led to incomplete course of vaccination.
Patient requested a HAVRIX (Hep A) injection and after she received the vaccine she left the IMZ booth and she collapsed on the floor in front of pharmacy. No medication was given, she felt better after a few minutes and I let her go with her consent.
After 1st dose Moderna developed sores in her mouth - blisters that formed and broke.    She took the 2nd dose Moderna  3/19/2021.  The blisters continued to form and break.  One lesion was large, approx the size of a dime, and filled with blood.   She saw her physician 4/6/2021 and received a prescription for Prednisone.
This spontaneous report was received from a certified medical assistant concerning eleven patients of unknown age and genders. The patients concurrent conditions and medical histories were not reported. On an unknown dates, eleven patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # K024552, expiration date 22-OCT-2016, (frequencies, doses, strengths and routes were not reported). Co-suspect therapies or concomitant medications were not provided. The pharmacist reported. No adverse symptoms reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Shortness of breath starting less than 24 hours after vaccine. Shortness of breath is still currently experienced intermittently to this day. Air hunger and feelings of not being able to breathe correctly. Throat swelling.  Chest pains that occurred infrequently throughout first few months after vaccine.  Elevated heart rate and blood pressures. Normal blood pressure prior to vaccine was 100s/70s. Now blood pressure consistently 130/80s.   Tx- I was prescribed Prednisone for 5 days, 6 weeks after my first shot by my PCP. This did not help my breathing issues or change any other symptoms.
Pt experienced lightheadedness , nausea approx 10 min after vaccine administration.  Pt was brought to recovery area for vitals check and assessment . Pt chose to be brought to hospital via ambulance . Pt was feeling better after lying down for a bit before transport.
feeling like I had the flu without the high fever; had a very bad headache; soreness in the arm where I received the shot; This is a spontaneous report from a contactable consumer reported for self. This 65-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL8982) at single dose in right arm on 20Jan2021 at 10:30 AM for COVID-19 immunization. Medical history included hypothyroidism. Allergies to medications, food, or other products were unknown. Concomitant medications included duloxetine; levothyroxine; montelukast; trazodone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient felt fine the day she received the vaccine, with only soreness in the arm where she received the shot. The next day at 11:00 AM, she started feeling like she had the flu without the high fever. The worse symptom was that she had a very bad headache. These symptoms were continuing 48 hours after the vaccine was administered. She was generally very healthy, had a very active life, and didn't get headaches. She was rarely sick. She just didn't seem to be feeling any better. Seriousness was no: not results in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. There was no treatment received for the adverse events. The adverse events was not resolved.
Day 8 after vaccination: large red,warm, tingly rash on injection site arm. Has lightened in appearance but has not responded to Benadryl or Claritin over thr last 36 hours
Urticarial reaction developed approximately 72 hours after vaccines were given.  Several hours prior to the reaction developing the patient ate pork for the first time ever.
FELT LIKE KICKED HER ASS; FEVER 100 (PLUS) DEGREE; NAUSEA; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced felt like kicked her ass, fever 100 (plus) degree, and nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 plus degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 100 (plus) degree, nausea and felt like kicked her ass was not reported. This report was non-serious.
Became fussy, leg hot & edematous, temp 101; became more grumpy then to sleep; approx 7 hrs post vax awoke screaming & cont screaming whenever touched; Temp 105 mom gave APAP q4hrs gave cool sponge bath;Restlessness grad dec;
Headache, chills, muscle aches. Improving after acetaminophen 500mg x2 over 4 hrs.
The evening of the vaccination arm became slightly sore. When awakened next morning, L arm was extremely sore and warm to the touch. Then second day post vaccination, awakened to redness at two areas on L arm distal to injection site is 3x2.5"  red area, warm to touch and very sore. Another site above injection site 2x2" area is right above axillary area is lightly red but very sore.
Reconstituted vial drawn up into single use syringes and stored in refrigerator was used up to 9hrs after reconstitution instead of the maximum of 6hrs as outlined in package insert.
On right arm: red rash/welts & swelling at injection site, skin at injection site warm to touch, feeling groggy, itchy sore throat.
Gone down sick; Dizzy; Feels weak; Fever; Headache; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Gone down sick), DIZZINESS (Dizzy), ASTHENIA (Feels weak), PYREXIA (Fever) and HEADACHE (Headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Gone down sick), DIZZINESS (Dizzy), ASTHENIA (Feels weak), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle ache). At the time of the report, VACCINATION COMPLICATION (Gone down sick), DIZZINESS (Dizzy), ASTHENIA (Feels weak), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Ibuprofen. Concomitant medicines taken by the patient  included arthritis pills and cholesterol pills.
Chronic joint pain, headache, fatigue, soreness at the site (large bump immediately following & blood-very small amount but now have a bruise)
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: post administration, patient felt light headed, became ghost white and had mild flushing. patient was brought to floor in sitting position and given water. patient fully recovered 10 minutes later with no further issues.
Pulsative tinnitus developed within the first week with some hearing loss. Effects are ongoing. Sought treatment from GP on October 13 and ENT. There is rhythmic rushing and ringing sound in both ears constantly. Had MRA of head and no abnormalities of blood vessels found.
My blood pressure has shot up; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A 72-years-old female patient second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP7533), via an unspecified route of administration, administrated in Left upper arm on 08Jun2021 (age at the time of vaccination 72-years-old), as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Patient previously received first dose of BNT162B2 (COMIRNATY COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER2613), via an unspecified route of administration on 18May2021 (age at the time of vaccination 72-years-old), as a single dose for COVID-19 immunization. On 21Jul2021, the patient experienced My blood pressure has shot up. On 21Jul2021, the patient underwent lab tests and procedures which included Blood pressure measurement: shot up, my blood pressure has shot up. Patient stated that, I have never had a blood pressure issue before, I am on Losartan Potassium 15mg medication now for my high blood pressure I just came from my doctor's office. The outcome of the event was unknown.  Follow-up (22Sep2021): Follow-up attempts are completed. No further information is expected.
Patient had Dtap to Right thigh 10/06/2003.  Now on 10/08/2003 redden warm area 3x3 in. Non tender, ithcy neg. fluid, local reaction.  Gave Benedryl.
This is a 37-year-old male who presented to the hospital with chest pain and shortness of breath.  He admitted to the cardiology service with concern for vaccine induced myocarditis. Patient was in his USOH until 10/5/22   Timeline of events: 10/5/ 2022: Patient received Moderna bivalent booster vaccine as well as flu shot.  Patient was previously vaccinated against COVID with 4 previous Moderna vaccines tolerated each.  Patient also had mild COVID infection in July 2022. That evening had fatigue and mild fever. 10/7/22 flew away for the weekend with his wife. Did not eat any raw fish or undercooked meats. Was still having fevers and chills during this trip 10/9 fevers and chills persisted.  -developed chest pain and SOB -developed rash. First noted small nodules on fingers, then lesions in mouht and finally rash on trunk.  Non-pruritic. The nodules nor mouth lesions are not painful.  Denies anogenital lesions.  Went to Urgent care who directed him to ED. Went to hospital. His troponins were 242-- >202-- >108, and echo showed his heart "wasn't pumping optimally". He underwent Chest Ct but was told it would take 2 days to get results so he left and came here instead (10/10)      Pt has been having night sweats since 10/5/22 No arthralgias or LAD No nausea, vomited once 10/9 Feels like scalp on top of his head is "sensititve". This is worse when febrile  +mild cough productive of brown sputum SOB and Chest pain have now resolved.  Today notes some pain on his L 1st MTP great toe. No erythema or warmth +mild sore throat    Pt has a 7 year old son who has not been ill Works in finance No exposures to pets, farm animals, birds No outdoor hobbies No known exposure to TB. Had ppd testing 2019 that was negative   6 weeks ago had a sinus infection; was treated with Medrol dose pack, Zpack and albuterol.
From correspondence received from manufacturer received on 1/4/02. It was reported that a 2 mt old male PT received his first injection of Engerix-B on 9/21/01. On 9/28/01, the PT experienced fever and vomiting, was seen in the MD's office and was subsequently admitted to the hospital. The PT was seen in the MD's office on 10/1/01 for follow-up. He subsequently received DTP and Prevnar "w/no problems". On 11/27/01, the PT received his 2nd dose of Engerix-B and an injection of Ipol. Approx 2 days later, the PT experienced "severe" vomiting and was seen by the MD. The PT recovered from this experience.
Approx 20 min after vaccine pt felt dizzy, weak and blacked out. Caught by mother before falling to ground. Also felt hot. Taken home (was at grocery store). Felt slightly weak and then at 9 pm that night felt very cold and weak at 9pm. No rxn at injection site.
Developed non-productive mild cough and UR secretions and low grade fever  Took Paxlovid for 10 days beginning on 10-14-22
Patient awoke at 1:00 AM on 2/10/2021, five days after his Moderna COVID-19 booster, with chest pain radiating to the back and worse with deep inspiration. Patient arrived in our office on 2/10/2021 at 9:30 AM for an evaluation. Patient was noted to have new EKG changes with new concave-up ST elevation across the precordium. Bedside echocardiogram showed no pericardial effusion and no pericardial friction rub was appreciated. Due to ongoing chest pain, patient was transported to Emergency Department by medics for further workup and evaluation for possible pericarditis.  Formal echocardiogram in ED was normal. Acute myocardial infarction ruled out. ST changes improved. Patient now being discharged in stable condition 2/11/2021.
The pt experienced 2 erythematous indurations which measured 4cm  and 12mm in diameter, slightly elevated, slightly tender, no fever. 4cm lesion is just inferior to the 12 mm lesion.
bullous pemphigoid post Shingrix vaccination; This case was reported by a other health professional and described the occurrence of bullous pemphigoid in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was unknown.   It was unknown if the reporter considered the bullous pemphigoid to be related to Shingrix.  Additional details were reported as follows: The age at vaccination were not reported but adult has been selected as age group according to the vaccine. The reporter stated about hearing of an anecdotal report of bullous pemphigoid post shingrix vaccination. No additional details were provided. This case is linked with case US2020AMR178549, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR178549:same reporter
Pt was seen in the Emergency Department at Medical Center with rash consistent with shingles on 12/1/19.  Rash started on 11/28/19.  He was brought to his well child check on 12/3/19 and exam was entirely consistent with shingles.  Pt does not have known history of chickenpox.  He received his varicella vaccine at his one year well child check.  He was started on acyclovir and is recovering as expected.
This is a spontaneous report from a contactable consumer or other non HCP (patient himself). A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), dose 2 via an unspecified route of administration, administered in Arm Right on 27Apr2021 (at the age of 63-years-old) as 2nd dose, single for COVID-19 immunization. The patient's medical history included ongoing diabetes mellitus diagnosed decades ago and wasn't feeling good from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient took 1 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 10:00 AM as 1st dose, single for COVID-19 immunization and no reaction on exposure to vaccine. The patient had no history of previous immunization with the Pfizer vaccine. No additional vaccines administered on same date of the Pfizer suspect. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient stated he went to the hospital because he wasn't feeling good in Dec2020 of last year and all the test results were fine, so he got his first vaccine, believes it was, 05Apr2021 for the first dose and 27Apr2021 for the second one. After that, the patient had extreme itching in his body and his liver enzymes are off and he just wanted to report what was going. The itching began after the first shot in Apr2021. He had to go to the hospital one time, and he had to go to the doctor 3 times, they say liver enzymes are off. He has a copy of the test. The patient stated prior to that, they were way higher when he went to the doctor. The patient's blood urea nitrogen (BUN) was 25 high, Aspartate aminotransferase (AST) was 100 high, Alanine aminotransferase (ALT) 176 high, alkaline phosphatase was 318 high, albumin was 3.2 low. He was also lost like 30 pounds. He has been experiencing extremely dizzy. Sometimes he stands up and he feels very dizzy and sometimes he feels strange, he has no other way to explain. He doesn't feel himself. He stated 8 days after the shot, he started feeling bad. It all started all together. The patient stated Pfizer can get that information from the doctor, he doesn't feel so good to keep up with that. The patient stated the extreme itching and extremely dizzy was worsened, that's why he had to go to the emergency room on 11Jun2021. Regarding the liver enzymes were off the patient stated, Pfizer can speak to the doctor. His doctor knows who he was and will give specifics. According to his doctor, the doctor was going to report it wherever it has to be reported to. He doesn't feel good, he was itching, and he doesn't know what to do about it. The event extreme itching and extremely dizzy required emergency room and physician office visit. The outcome of the events extreme itching and extremely dizzy was not recovered. The outcome of the events liver enzymes are off, lost like 30 pounds and he feels strange was unknown.
pt vaccinated for covid, diagnosed on 12/03/201, passed away on 12/10/2021
Sx: pt reported rash/hives starting 01-25-13 (Lips, forearm, upper thigh, groin, waist, back of (R) leg) rash would come and go every 30 min to 2 hrs Tx - antihistamines.
On day 10 (Sun, Feb 6th) in the evening, I started getting very itchy on my stomach. Overnight it continued and moved around my trunk and head/scalp. Has continued ever since and worsened slightly. No raised hives, but red inflamed, burning areas as it moves around and itches. After 48 hours of constant itching, I took Zyrtec, which alleviated the redness and itchiness. Today is day 13 from the date of my booster shot that I believe triggered this undesired immune response.
Aches and pain from neck to lower back; Aches and pain from neck to lower back; Sore left arm site of injection; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 13:45 (at the age of 53-years-old) as 1ST DOSE, SINGLE DOSE for Covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient did not have any allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not received any treatment and diagnosed with Covid 19 and has not been tested for COVID-19 Since the vaccination. On 10Mar2021 16:00 the patient experienced aches and pain from neck to lower back and Sore left arm site of injection. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 18Oct2023 to 23Oct2023. Clinical course: Patient didn't have any known allergies.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300351934 Same reporter/patient, different drug, different AE.;