chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case symptom onset 8/1/21 which included subjective fever, muscle aches, sore throat, olfactory disorders, headache, fatigue, cough, shortness of breath and congestion. Case was not tested for Covid 19 but contact tracer treated as a positive case due to symptoms and 2 household contacts who had tested positive for Covid19.
Growing redness which led mom to ED 1st night. No meds given by doctor. Continued to grow/tender. Seen by ED doc following night; started on Keflex. Mom reports response.
Migraine, nausea, within 12 hrs lymph nodes all swollen hard again like in November after first round of HPV Vaccine. Throwing up started by day 2 after vaccine....continues for a week. Lost over 4 lbs.
Seizures; fall; was scheduled for his 2nd dose on 29-Mar-2021 but did not receive it due to him being in the hospital; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of SEIZURE (Seizures) and FALL (fall) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizure (Has a history of a stroke and seizure for the past 2 years.) and Stroke.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced SEIZURE (Seizures) (seriousness criterion hospitalization) and FALL (fall) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (was scheduled for his 2nd dose on 29-Mar-2021 but did not receive it due to him being in the hospital). The patient was hospitalized on 27-Mar-2021 due to FALL and SEIZURE. At the time of the report, SEIZURE (Seizures), FALL (fall) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (was scheduled for his 2nd dose on 29-Mar-2021 but did not receive it due to him being in the hospital) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.  The patient has been hospitalized since. He was waiting to go to rehab but was uncooperative. No fractures were noted.
Sharp burning pain radiating from the right deltoid to the 2nd/3rd digit fingertips, diagnosed with C7 neuritis and started on gabapentin for pain.
passed out; hit chin on the sink; vomited; Fever; chills; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 at single dose on unspecified date for covid-19 immunization. Patient had one of the worst nights, fever/chills on 18Jan2021. Got up at 1:30 on 19Jan2021 to use the bathroom, passed out and hit chin on the sink. Then vomited. Still low fever. Patient didn't receive treatment for events. Outcome of all events was recovering. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report was considered as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No additional adverse event; Caller stated the patient received two administrations of PNEUMOVAX 23- one on 4/22/2022 and the next on 5/5/2022.; This spontaneous report was received from a nurse concerning a patient (gender and age were not reported). Patient's medical history, concurrent conditions and concomitant therapies were not reported.    On 22-APR--2022, the patient was vaccinated with the first dose of pneumococcal vaccine polyvalent (PNEUMOVAX-23) pre-filled syringe, 0.5 milliliter (route of administration and anatomical location were not provided), lot#U027357, expiration date reported as 18-AUG-2023, but upon internal review it was established as 25-MAY-2023 (conflicting information), as prophylaxis. Later in 05-MAY-2022 the patient was revaccinated with another dose of pneumococcal vaccine polyvalent (PNEUMOVAX-23) pre-filled syringe, 0.5 milliliter (route of administration and anatomical location were not provided), lot#U027357, expiration date 25-MAY-2023 (extra dose administered) as prophylaxis. The reported stated there were no know adverse events related to the double administration (no adverse event).
Multiple febrile seizures the day following immunizations.  Seizures, with blank staring and limpness, reportedly lasted 5-15 minutes each. Temp was 102.2 F in ER.  5/19/2008 MR received for DOS 4/9-11/2008 with D/C DX:  Febrile Seizures, most likely viral illness.  Infant transfered from local hospital after presenting with new onset seizures and fever.  he had subsequent episodes in the ER which included shaking of the extremities and eyes rolling back lasting 5-15 minutes.  Infant also had episodes of limpness with staring.  PE  WNL and no further episodes in this facility.
Starting on February 24, 2021, I started to have shortness of breath. This slowly got worse until on March 2, 2021 I was unable to breathe in all the way and was getting a sharp pain in my side/back when I tried to breathe in more than half way. I then went to the emergency room recognizing the symptom as likely being a pulmonary embolism, as I had experienced one four years earlier. It was, in fact, a PE. I was in the hospital for five days as they treated the clots with blood thinners. I slowly got my breathing more back to normal and was discharged. They are still runnying myriad tests to try to determine the cause or causes, but I thought it wise to report here in case the vaccine is a factor. I received my second dose on 2/26/21, a few days before I went to the hospital but my symptoms started a few days before that.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 93-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) had resolved. Unknown          Diarrhea lasted for day and then the patient was fine.  Concomitant medication were not provided by the reporter.  Treatment information was not provided. Action taken with mRNA-123 is not applicable. Treatment medication were not provided.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 10-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 24, 49 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Client not feeling well, stated he was dizzy.   He was pale and sweaty.  Administering nurse said he was a little nervous to get his second dose.  Client was fanned, given water and advised to take deep breaths.  Client alert and responsive.  His partner came over,  Client asked to go to bathroom to have bowel movement but was advised against getting up.  Client's partner was talking to him and he suddenly slumped over in the chair.  Staff called 911.  Ammonia tab was popped, restrictive clothing was loosened and client given chest rub.  Nurse told client to look at her and he moved his head but eyes were unresponsive, fixed and dilated.  Ammonia tablet under his nose the whole time.  After thirty sec., started blinking and pushing the tablet away.  Partner told him to open his mouth and his jaw locked for 10 sec.  Client stated "I got the vaccine and then all this."  Client was fanned, kept talking and cold water bottle placed on his neck.  He said he had breakfast and lunch.  Paramedics arrived.  Client's bp 107/70, heart rate 103.  Client is an avid runner, running 9 miles this morning.  Paramedics considered his blood pressure normal.  Client refused any other treatment and decided not to go to the hospital.  He stated he takes antidepressants and blood pressure medication but cannot remember their names.  After 5 min. left with partner on his own power.
patient said pain in arm radiated to neck, jaw and up through head also. developed fever overnight along with bloody nose. Heart felt fluttering. side effects lasted 3 days. Patient refuses to get 2nd dose.
Severe itching started 1 hr after immunization given. Antihistamine obtained from pharmacy. No further complications.
no issues during administration. patient called at 12:25 reporting that she had developed vision issues 15 minutes prior that had not gone away.  patient reports a sparkling in right part of right eye.  patient reports not being able to clearly read literature online as she looked up this issue via internet.  she reported no pain at the time.  patient was recommended to monitor and if problem continues or progresses to seek medical help immediately.  patient reported having tiredness after previous shots and stated she would take a nap and see how she was when she woke up.  I requested she follow up with us regarding conditition.
Syncope; Seizure; This case was reported by a physician via call center representative and described the occurrence of syncope in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced syncope (serious criteria GSK medically significant) and seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope and seizure were unknown.   It was unknown if the reporter considered the syncope and seizure to be related to Shingrix.  Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The reporter asked that, if syncope and seizures one day after Shingrix had been reported. No further information provided and unable to clarify any information. The reporter did not consent to follow-up.
This spontaneous report was received from a other health professional refers to an unspecified patients of unknown age and gender. On 02-AUG-2014, doses of RECOMBIVAX HB were exposed to an unsupported temperature excursion of -1C for "5 to 16 hours". On an unspecified dates since 02-AUG-2014, RECOMBIVAX (lot # J012567; expiration date 30-JAN-2016) (dose and route were not reported) were administered to unspecified patients. No adverse effect has been observed or reported. Follow up has been received from a pharmacist on 14-OCT-2014 concerning 12 patients. For the 7 patients demographics was updated. This is one of several report received from the same reporter. Follow up has been received from a pharmacist on 20-OCT-2014 concerning a patient of an unknown age and gender. The reporter provided another RECOMBIVAX HB lot number J012520, expiration date: 30-JAN-2016 that was improperly stored and would have been included in the original report. Additional information has been requested.
Pt vaccinated w/3 doses of vax; Lab eval revealed Hep titer less than 10 IU; Rec'd 4th dose developed rash on chest & back w/moderate itching;
Right upper lateral arm- 6.8  by 8 cm area of very mild erythema, mildly warm, mild tenderness, slight induration noted
my arm had swelled up  very large the first day of the shot, as of today the swellness has not decrease. My Dr. insist that I take warm baths and use a heating bad everyday.
Ongoing shoulder pain since time of injection at site of injection (high on shoulder) especially when patient lifts arm.
mild localized reaction this many days later  in upper left arm close to injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (mild localized reaction this many days later  in upper left arm close to injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-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 SITE REACTION (mild localized reaction this many days later  in upper left arm close to injection site). At the time of the report, VACCINATION SITE REACTION (mild localized reaction this many days later  in upper left arm close to injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold".  Additional information: The reporter received first dose and wanted to reschedule her appointment for the second dose because she has a cold. She mentioned that not only her who get a cold and wanted to reschedule but there was 3 others in her household as well. This case is for 1/3.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021508100 same reporter, drug, event, different patient
This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site hemorrhage and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site hemorrhage and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site hemorrhage to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) administered SHINGRIX to heavy a patient with a 1 mm syringe and noticed a small drop of blood after administering the vaccine at the injection site. The HCP was not sure if the injection got into muscle, which led to possible incorrect route of vaccine administration. The HCP did not wish to provide any further details including product, event or patient.
Insufficient dose quantity given - 0.3 mls vs. 0.5 mls
Information has been received through the manufacturer pregnancy registry from a health professional concerning a 17 year old female who on 1/20/2006 was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live (lot 648303/0218R). It was noted that the patient may be pregnant. The reporter did not have confirmation that the patient was pregnant. No symptoms were noted. Follow up information indicated that the pregnancy was terminated. No additional information was available. Upon internal review, pregnancy termination was considered to be an other important medical event (OMIC). No additional information was available.
This spontaneous report as received from a nurse refers to a 19 year old female patient. The patient's medical history was unspecified. On 02-JUN-2014 or 03-JUN-2014, the patient was vaccinated with GARDASIL (Dose/Frequency: "Standard dose"/"First dose", Therapy Route: Injection). Concomitant medications included TDAP (manufacturer unspecified). On 02-JUN-2014 or 03-JUN-2014, the patient was vaccinated with GARDASIL and TDAP (manufacturer unknown) at the same time. On the same day (02-JUN-2014 or 03-JUN-2014)  the patient experienced very lightheaded and it took few minutes for the patient to recover. Lab Diagnostics Studies Performed were none. The causality was not reported. Additional information has been requested.
Patient c/o dizziness after receiving first dose of Pfizer vaccine. Vitals taken X 2 and were normal. patient stated she felt better after lying down for a few minutes and refused transport. Patient walked out of clinic on her own.
TESTED  positive for covid 7-8-22.   Admitted to Medical Center 7-23-22 altered mental status     His baseline is bedfast hospice patient.  discharged to home with hospice on 7-25-22.  dc dx:  drug induced encephalopathy  ; Co2 narcossis; delerium; UTI, abnormal CT of head; type 2 diabetes, chronic kidney disease.                                    expired  9-8-22.
Information has been received from a physician concerning a 44 month old male with no known allergies or pertinent medical history who on 12-APR-2007 was vaccinated in his left arm with a 0.5 ml (25U) first dose of VAQTA (lot # 656017/1280F). There were no illnesses at the time of vaccination. There was no concomitant medication. Immediately after vaccination on 12-APR-2007 the patient's arm became swollen and red. The area was reported to be 10 cm x 5 cm. Medical attention was sought and the patient was treated with ice packs and BENADRYL. No lab tests were performed. On 13-APR-2007 the patient recovered from the adverse events. There was no product quality complaint involved. No further information was provided. The physician requested a lot check of the vaccine, a lot check has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government and was released by the regulatory agency. Additional information is not expected. This is one of several reports from the same source.
PAIN OF LEFT SHOULDER, SHE CAN BARELY MOVE IT WITHOUT PAIN.
Patient had hives, rash, fever, and body aches. Patient took ibuprofen, tylenol, benedryl, and prednisone that she found at home. The rash and body aches have improved. Patient is still having a fever. Patient has been out of work March 1-4.
Redness, swelling, pain and  Hot to touch at injection site. Pain traveling down left arm. Diagnosed with cellulitis from moderna vaccine on 1/18/21. Prescribed keflex.
This Spontaneous case, initially received on 03-Nov-2017 was reported by a Other Non Health Professional and concerns a 55 years old patient of an unknown age. On an unspecified date, the patient received influenza vaccine, (dose, route, anatomical location: arm, manufacturer, brand name and batch number not reported). On an unspecified date, the patient also received COSENTYX solution (dose 150 mg route: subcutaneous, once a month) for unknown indication. The patient stated that he had been on the medication for approximately a year, unable to locate an exact date for initial dose for the patient. Earliest recorded interaction with the patient was from late Jun-2016. On an unknown date after flu shot administration, the patient had appeared bruise (reported as 3 to 4 weeks ago before administration of COSENTYX) as if he was slugged in the arm. Patient stated he did not experience bruising problems before taking COSENTYX and that the bruising had begun approximately 4 months ago, but he did not have an exact date. He stated that the bruising has gotten worse and appears at injection site. The outcome of the event was not reported.
Patient reported hearing that vaccine can make you numb all over. Informed pt I hadn?t heard of that as a side effect to this point. Pt still requested vaccine. 30-60s after vaccine, patient kicked his leg against wall, and was unresponsive for 5 seconds or so. Then said he was fine and could talk again, but felt numb all over. Pt seemed fine but shaken within 2-4 minutes of incident. Began calling EMS but pts mother told me to hang up since her child was feeling fine. Requested she bring her son to a doctors office or hospital to follow up. Mother agreed.
-Headache, chills, fatigue, muscle aches, and joint pain; no treatment; chills subsided after 5 hours, headache lasted 3 days, extreme fatigue lasted 2 days with general fatigue for 1 additional day, moderate to severe muscle aches and joint pain for 2 days with mild aching for 1 additional day -injection site pain; no treatment; resolved in 3 days
really painful and hemorrhagic menstrual cycles; really painful and hemorrhagic menstrual cycles/hemorrhagic cycle and cramps and pain. excruciating painful, hemorrhagic cramps and pain; Painful arm first and second dose; This is a spontaneous report from a contactable consumer (mother) reported for patient(daughter). A 13-year-old female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The medical history of the patient was reported as no. The concomitant medications of the patient were not reported. The patient previously received first dose of BNT162B2(solution for injection) on an unspecified date as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The reporter stated her daughter got vaccinated with the Pfizer vaccine and had adverse event. She had swollen not swollen, Painful arm first and second dose and she got a really, really painful and hemorrhagic menstrual cycles, she usually doesn't have menstrual cramps for anything like that but she was up in the middle overnight one hour in excruciating pain. Cramps and pain which was not the usual course, so reporter thought for the safety report it was really important hemorrhagic cycle and cramps and pain. On a scale of 0 to 10 on the 'EVA' she had 9, so it was excruciating painful which was again it was very, it was not at all that usual mode of operating. Therapeutic measures were not taken as a result of events. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.