chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable pharmacist.  A 73-year-old male patient of an unspecified ethnicity received PREVNAR 13 , lot number N16515 , expiration date 01Oct2017 NDC number 0005197102, intramuscular in Upper arm on 23Sep2016 at 0.5 ml, single for immunisation.  Medical history included blood pressure abnormal from an unknown date and unknown if ongoing.  Concomitant vaccine included influenza vaccine (AFLURIA).  The patient previously took varicella zoster vaccine, and influenza vaccine (FLU VACCINE).  The patient experienced has mild pain at the site of injection and felt as though something was where injected from Dec2016 with outcome of not recovered.
Initial information received on 24-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 9 months old female patient who was given only the hib component of PENTACEL diluted with sterile water from Merck. The patients past medical history and family history were not provided. Concomitant medications included HEPATITIS B VACCINE and PNEUMOCOCCAL CONJUGATE VACCINE (Lot number, expiry date and dose not reported on unknown date. On 16-Aug-2018, the patient received a third dose 0.5ml of suspect PENTACEL VACCINE, lot C5451AA, expiry date 07 Dec 2018 via intramuscular route in the left thigh. It was an actual medication error due to inappropriate reconstitution technique. It was reported that patient received only the Hib component of PENTACEL, diluted with sterile water from Merck. The patient had no known reported symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender- none.
Syncope; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the right arm on 15Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient is not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) and methylfolate. The patient experienced syncope on 15Jan2021. The event was assessed as serious (medically significant). The outcome of the event was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. 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.
Case number PHHY2011CN51645 is an initial literature report received on 06 Jun 2011. The authors presented a case of ischemic stroke after H1N1 vaccination. This report refers to a 75 year old male patient. His medical history was not reported. He was vaccinated with H1N1 vaccine (manufacturer and batch number: unknown). He experienced posterior circulation ischemia after vaccination. The outcome was not reported. The author commented that the causal relationship between vaccination and ischemic stroke was still unsettled.
Sore throat, joint pain (hands, elbows) started 1/27/08.  Unable to write well with right hand.  Joint pain moderate.  Missed one day of school.  8/20/08-records received-presented to physician office 2/14/08 with C/O pain involving wrists and fingers began on 1/27/08 and on 1/29/08 pain in ankles, elbows and left TMJ with some swelling of right ankle and left knee, diffuse swelling of wrist and fingers, tenderness and morning stiffness. Pain interferes with sleep, unable to write. Fever, nausea and vomiting, abdominal pain. Erythema and pruritis, daily headaches, dry cough, diarrhea, occasional constipation. PE: full ROM, tenderness noted. Neuro exam normal. Impression: Marked myofascial pain with tenderness.  No additional visits to clinic.
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No current condition was reported. No historical medication was reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (route- intramuscularly, dose strength was not reported). No concomitant medication was reported. On an unknown date the patient experienced very swollen injection site which was painful and red. The outcome of very swollen injection site which was painful and red was reported as not resolved. Causality was unknown. Patient sought medical attention was reported as yes, contacted pharmacy. Treatment provided for adverse event and laboratory diagnostics studies performed was reported as none. No PQC was involved. No further information reported. No further information provided. This is one of the several reports. Additional information is not expected.
Rash/hives on Right buttock and back of upper right thigh. Started like a few small bug bites, spread to larger area and became itchy, irritated and red.  Doctor treated it as an allergic reaction, with a 9 day course of Prednisone and topical Triamcinolone 0.5% cream on July 28. Saw good results, but returning symptoms (somewhat milder) on August 29.
Case number PHEH2015US020445 is an initial combined spontaneous report received from a pharmacist on 09 Oct 2015 with a follow up information received on 09 Oct 2015 with a follow up information received on 19 Oct 2015. This report refers to an 81 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 161211, expiry date: May 2015) pre-filled syringe (PFS) at a dose of 0.5 ml intramuscularly on 02 Oct 2015. It was reported that the administered vaccine was expired. The case was reported non-serious. No adverse events were reported following the maladministration.
15 min after the injection I rose to leave and my leg seemed to be ?asleep? with pins and needles. When I got in my car a had a sharp pain in my left shoulder blade. Within 5 min the ?asleep? feeling of pins and needles spread all over my body. This was accompanied by occasional sharp stabbing pains. By evening the feeling had progressed to numbness and cold in my left hand. The cold feeling stayed in my left hand only. The symptoms continued for two days.  On day three my tinnitus acted up. Unsure if I should get the second dose.
Rash and erythema surrounding injection site with warmth, itching and burnng. Mild headache and myalgias.
Patient's immunized arm became red and swollen for 3 months after immunization received 9/6/15. Area is still sensitive to the touch as of 3/25/16, but swelling has decreased.
pain has migrated up in her neck; arm is improving; arm was really hurting; couldn't raise left arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain has migrated up in her neck), PRE-EXISTING CONDITION IMPROVED (arm is improving), PAIN IN EXTREMITY (arm was really hurting) and LIMB DISCOMFORT (couldn't raise left arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, High cholesterol, Tetanus and Penicillin allergy. Concomitant products included PRAVASTATIN, LOSARTAN, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), BIOTIN and FISH OIL for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was really hurting) and LIMB DISCOMFORT (couldn't raise left arm). On an unknown date, the patient experienced NECK PAIN (pain has migrated up in her neck) and PRE-EXISTING CONDITION IMPROVED (arm is improving). At the time of the report, NECK PAIN (pain has migrated up in her neck), PRE-EXISTING CONDITION IMPROVED (arm is improving), PAIN IN EXTREMITY (arm was really hurting) and LIMB DISCOMFORT (couldn't raise left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a consumer concerning her 12 month old daughter who has no pertinent medical history, who "about two weeks ago" (approximately 25Jun2003) was vaccinated with a dose of varicella virus vaccine live. It was noted the lot number was not provided. There was no concomitant medication. The mother reported her daughter started to develop a rash a few days after receiving the vaccine. The mother reported the rash was all over her daughter's body and has gotten worse. It was noted the rash has not gone away, and the pt has seen her Dr. It was noted treatment has not been required, but unspecified blood work was performed. There was no product quality complaint involved. Follow up information that was received from the physician via returned correspondence stated , "We did not diagnose here with chickenpox or adverse reaction to vaccine". Unspecified medical attention was sought. No further information is expected.
experiencing side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (I am experiencing side effects i think) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I am experiencing side effects i think). At the time of the report, VACCINATION COMPLICATION (I am experiencing side effects i think) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported  Treatment information was not provided
This spontaneous report was received from a nurse, referring to unspecified patient's of unknown age and gender. Patient's medical history and concurrent condition was reported. On unknown dates in July 2015 the patients were vaccinated with improperly stored oral, ROTATEQ lot # K017576, expiry date 12-JUN-2016. 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.
"Approximately 4-5 hours after receiving the vaccine I started having a stuffy nose and minor cough. By 6:30, I began having significant chills requiring several blankets. By 7 pm, I had a temperature of 105, extreme lethargy, throwing up. I took 2 Advil and 2 Benadryl, and drank a gallon of water over the next several hours. By midnight, my temperature had decreased to 102. Temperature greater than 101 and has persisted intermittently for a week. Other than extreme fatigue, fever and chills, no other symptoms such as cough and nasal stuffiness"
pt recv vax & pt exp breakthrough chickenpox w/scattered macular papular lesions from head to lower legs;
1st dose 01Dec2021, 2nd 29Mar2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number D9CB9, expiry date 24-SEP-2023) for prophylaxis.   Previously administered products included Shingrix  (received first dose on 1st December 2021).   On 29-MAR-2023, the patient received the 2nd dose of Shingrix. On 29-MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 01Dec2021, 2nd 29Mar2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 29-Mar-2023 The patient did not receive the second dose until the day of reporting. The reporter did not had lot number or expiration date information for the first dose. The reporter consented to follow-up. The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. The case was linked with case US2023047403, reported by same reporter.; Sender's Comments:  US-GSK-US2023047403:Same reporter/different patient
After waiting the 15min post vaccine, went to my car, I took 1 Tylenol 500mg pill and ate a banana, noticed trouble swallowing, coughed up some banana , took a drink of water.  I then felt my lymph nodes in my neck were swollen. Waited another 15 min in the parking lot, went back into the to use the bathroom and to make sure symptoms were not progressing. At this point it had been approx 45min post vaccine and no other symptoms. 24 hrs later symptom had resolved.
Rash. Day 6 post vaccine.  Received Prednisone, dexamethasone, Benadryl, famotidine.  Rash continuing to worsen at day 11
Father called on 07/28/2005, stated on 07/22/2005, outside washing car in heat for 1 hour went inside, after 20 minutes was standing then blacked out, convulsed at 4-5 seconds, then woke up like nothing happened.  This was 6 hours after TD given.
Pt recvd vax on 6AUG92 & that day exp diarrhea; tx Imodium & diarrhea resolved p/24 hrs; No further details were provided;
Subsequent to receiving vax, the pt developed hepatitis B surface antigenemia. Testing two days post vax indicated that the pt was core antigen and antibody negative as well as surface antibody negative. The most recent information received, reports the condition of the pt is ongoing.
Gave vaccine to pt and realized after I was going to chart it that it was expired. 2/26/2023 was the expiration date.
Vaccine was administered to child under the age guidelines of CDC and manufacturer. The vaccine was not administered by this reporter or this store. There are no known adverse events.
Initial information was received on 19-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involves Adult and unknown gender patient who experienced been not feeling well (malaise) after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expire date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious been not feeling well (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome of events was reported as unknown.  There will be no information available on the batch number for this case.
Fatigue started about 12 hours after 2d dose. About 13 to 14 hrs in, I felt chilled, then feverish, then intense nausea. The fever lasted about 24 hrs and went down slowly from over 100 to 98, while the nausea lasted only 2 or so hrs. No vomiting.  Slept all day long and was fatigued. About 24 hrs after the symptoms began, I felt fine. Perhaps the fatigue lasted into the next morning as did the fogginess, but I was all better within 48 hrs from the dose.
The patient was to get Moderna Bivalent; instead Moderna Pediatric age 6-11 was administered
Nauseous, dizzy.; Dizzy; This is a spontaneous report from a non-contactable consumer, the patient. A 86-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Feb2021 (at the age of 86-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to iodine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced nauseous and dizzy. Since the vaccination, the patient has not been tested for COVID-19. The clinical outcome of the event nauseous and dizzy was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Heightened immune response to the vaccine with observed symptoms of intense headaches, facial and body pain, increased fatigue, and severely decreased energy levels. Note: because there is a positive rheumatoid factor, immune system is already heightened. The vaccine simply triggered flare ups.
Patient went to sleep and died within 12 hours of vaccination; feeling sick; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at the age of 45-year-old on 20May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 45-year-old healthy male patient received Pfizer Covid vaccine in the morning, reported feeling sick by the evening on 20May2021. Patient went to sleep and died within 12 hours of vaccination on 20May2021. Event took place after use of product. The patient died on 20May2021.  It was not reported if an autopsy was performed. The outcome of event feeling sick was unknown. The outcome of event 'Patient went to sleep and died within 12 hours of vaccination' was fatal.   Information on lot number/batch number has been requested.; Reported Cause(s) of Death: Patient went to sleep and died within 12 hours of vaccination
Vasovagal Syncope after IPV and PCV-13 vaccination. Nurse administered vaccination and patient looked stable. He left the room and and 1 minute later mom states patient started to look white and green and then the patient passed out. She hit the back of her head on the wall but the nurse and mom were able to prevent her from falling off the exam table. She lost consciousness for 1-2 seconds. Vital signs were taken and the patient was hemodynamically stable and had pulse ox of 100%. We placed a cold wash cloth on forehead and her neck. She laid down for 15-20 minutes. She was given apple juice. We called the sign language interpreter to talk with patient when she was better. She returned to baseline and was sent home.
Metallic  Taste in Mouth  Fever, Chills, extreme body aches, chills, stiff joints, headache, heart racing, sore stiff arm.  Metallic taste started right after dose given, headache started couple hours other symptoms evening of  3/27 continued as of 3/28
patient was fully vaccinated with Pfizer vaccine, had tested, through a PCR test, positive for COVID; patient was fully vaccinated with Pfizer vaccine, had tested, through a PCR test, positive for COVID; This is a spontaneous report from a contactable consumer. A 16-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and expiration date: not provided) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date: not provided) via unspecified route of administration on an unspecified date as DOSE 2, SINGLE both for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient was fully vaccinated with Pfizer vaccine, had tested, through a PCR test, positive for COVID. Symptoms were mild including runny nose, stuffed up and were getting better. The patient underwent lab tests and procedure which included SARS-CoV-2 test/ PCR test was positive on an unspecified date. The events outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This was booster after getting J&J. I feel that?s important to capture. Symptoms: aches, joint pain, chills, fatigue, pain and swollen armpit in injection arm. The weirdest one was exactly 24 hours I got a huge sore inside my bottom lip that made my lip go numb but yet was completely gone after an hour.
Pain (arthralgia & myalgia) from injection site. From injection site all the way down to fingers since innoculation. Also a knot at injection site. Suggested ice, analgesics, and/or M.D. visit.
Injection site soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9269) via an unspecified route of administration in the left arm on 01Mar2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included bupropion hydrobromide (APLENZIN) and sertraline (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Mar2021 at 00:00, the patient experienced injection site soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event injection site soreness was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Narrative:  Patient was found unresponsive at home on 11:40 AM on 11/26/21 and was pronounced deceased at 12:10PM.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The pertinent medical history and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with doses of improperly stored GARDASIL (lot # K010215, expiration date: 05-MAY-2017; lot # L035105, expiration date: 04-MAY-2017, lot # L040460, expiration date: 27-MAY-2017 (dose and route unspecified). This is one of several reports received from the same source. Additional information has been requested.
At a routine CBC weekly lab, the day after receiving the first vaccine shot, my platelet count jumped from 287 to 483. The day after my 2nd vaccine shot, my platelets jumped from 367 to 499, then to 582 the next week.
09/14/22 presents to ED for "abdominal pain". PMHx of "MVP, HOCM, GERD, depression, and hypothyroidism"