chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received my second dose of the vaccine on 9/15/21. Had the normal fever,chills, headache, and body ache which lasted until Saturday 9/18/21. On Monday 9/20 I started feeling very rundown.  On Tuesday I had temps of 102/103,  chills, severe nausea which led me to being unable to eat or drink, dizziness, diarrhea, heart rate in 120s, severe headache, severe body ache, severe joint pain especially in my elbows and knees, my fingers and some of my toes got very red, swollen, and painful, and are very sensitive to touch, water, etc. They have a painful burning which reminds me of when your fingers get really cold outside and then you quickly try to warm them up under hot water. Also burning and prickling sensations in the bottom of my feet. I also have a burning, itchy rash that covers my arms, abdomen,  chest, neck, back and feet/ankles. The severe nausea led me to be severely dehydrated and develop a UTI with 2+ ketones in urine.
Pt received PEDVAXHIB instead of MENACTRA; no symptoms of a reaction seen at time of administration.
This spontaneous report was received from a licensed practical nurse an refers to 6 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # reported as M017348, expiration date: 06-APR-2018 (exact dose and route of administration were not reported). There was no adverse effect reported. The administered doses experienced the temperature excursion between 46 degrees Fahrenheit (F) and 77 F for 6 hours. A data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009339: US-009507513-1701USA009338: US-009507513-1701USA009337.
Period Heavier, longer by a day, and more painful; Period Heavier, longer by a day, and more painful; Dose received 3; This is a spontaneous report received from a contactable reporter (consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administration date an unknown date in 2021 (Lot number: UNKNOWN) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was unknown. Concomitant medications included: FLU SHOT. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Route of administration: Intramuscular), for COVID-19 immunisation and BNT162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Route of administration: Intramuscular), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Dose received 3"; HEAVY MENSTRUAL BLEEDING (non-serious )and DYSMENORRHOEA (non-serious) both with onset date on an unknown date in Mar2021, outcome "not recovered", and all described as "period heavier, longer by a day, and more painful". Therapeutic measures were taken as a result of heavy menstrual bleeding and dysmenorrhoea.   Additional Information: It was unknown if the patient had any allergies. The patient received other vaccine within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was reported patient went from needing ADVIL one day to three or 4.It was tough to give quantitative measurements to heavier, but it was definitely longer by a day, and her meds needs were like clockwork, only 1 day but now more. It was instant change and kind of interesting, and a bit surprising. The patient wondered what the relationship was because it was like this is the new normal and had not gone back. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of heavy menstrual bleeding and dysmenorrhoea and included treatment with ibuprofen (ADVIL).  The lot number for BNT162b2 was not provided and will be requested during follow up.
12/17/2021 This is a 92y.o. female who presents to a local HCF ER due to a cough and lethargy. She was recently tested for COVID as an outpatient at the facility where she resides, and reportedly was negative. The patient herself is a limited historian, and the history is gathered primarily from the chart. Due to her ongoing issues she was sent to the ER for further evaluation. She was found to be febrile in the emergency department, and COVID 19 testing was rechecked and found to be positive. Infectious disease has been consulted. They have already evaluated her.
Immediately after injection I felt a very slight dizziness.  But in about 4-5 mins I felt that I'm passing out. I was still able to stand up and make a few steps to  call for help. A pharmacist helped me to get back to my seat, because i could not stand and move and I didn't hear people around me. The pharmacist gave me three bottles of water and a bottle of juice. After the second bottle of water I felt better.
After receiving vaccines went to exit store and fell down center isle. Patient states he "blacked out" for a few seconds which caused his fall. Patient felt entirely okay after this. Offered no complaints as far as pain, altered mental status, trouble breathing (aside from SOB due to asthma).
It was reported that a 21 year old female pt received a Menomune vaccination and a fluzone vaccination both given in the left arm on 11/09/2000 at 6:17pm. Reportedly at 6:22pm, the pt developed a small area 1x1.5 inches of redness at left inner aspect elbow, not at injection site. Ice was applied for 10 mins and redness resolved. Benadryl was given. The pt reportedly recovered from this experience.
Had shingles vaccine Friday, Dec 18th. Saturday, Dec 19th had large, red, raised rash measuring 6 inches from top to bottom, and around 4 inches wide. Itchy. Sore to touch. Called pharmacist who gave injection, she recommended BENADRYL and cortisone cream. Sunday, Dec 20, the area of redness had grown and was more tender to touch.
Pt devel fever 102 & a febrile convuls w/in 12 hrs p/DTP/OPV; Seen in office & doing fine;
Initial report received from a pharmacist on 28 December 2006. A 6 year old, male patient, developed "eye tics" approximately 2 weeks post vaccination with Fluzone (U2180AA, route of administration not reported) in the right thigh on 10 October 2006. It was not known if the patient had any illness at the time of vaccination. At the time of the report, it was unknown if the patient recovered. No other information was available at the time of the report. Follow-up information received on 30 April 2007. The patient did not have any illness at the time of the vaccinations. It was reported the patient received a hepatitis injection (not specified) 2 weeks after the flu vaccine.
Pt was provided with wrong vaccine. Pt was supposed to receive updated covid booster. Pt was checked on via phone twice after administration she reported symptoms of mild fatigue but, still presented to receive a covid vaccine that evening. Denied any other concerns.
pt recvd vax & slept; when pt woke up next morning could not suck the bottle & took only 5 oz through the day;
Chest pressure, hoarse, dry mouth, feels like a knot at the base of her throat. Chest tightness, SOB, V/S 144/97 - 71 - 16 - 100% R/A.
Herpetic vesicular irruption @ site of 1st VARIVAX inoculation with mild systemic symptoms of low grade fever & fussiness.
really shaky; fever/Pretty wicked fever/low grade fever; wicked chills/Rigors; Headache; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 06Aug2021 13:00 (Lot number: EW0217) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "I suspect I was infected seriously in Mar2020", start date: Mar2020 (unspecified if ongoing), notes: I suspect I was infected seriously in Mar2020; "Hypercholesterolemia", start date: 2001 (unspecified if ongoing), notes: stable. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Time: 13:00, Anatomical site of Injection: L Deltoid, Route of administration: Intramuscular, Batch/Lot number: ER8732), administration date: 16Jul2021, when the patient was 50 years old, for Covid-19 immunization, reaction(s): "Achy", "Chills", "Fever 101.5", "Headache", "Rigors". The following information was reported: TREMOR (non-serious) with onset 06Aug2021 22:00, outcome "recovered" (2021), described as "really shaky"; PYREXIA (non-serious) with onset 06Aug2021 22:00, outcome "recovered" (2021), described as "fever/Pretty wicked fever/low grade fever"; CHILLS (non-serious) with onset 06Aug2021 22:00, outcome "recovered" (2021), described as "wicked chills/Rigors"; HEADACHE (non-serious) with onset 06Aug2021 22:00, outcome "recovered" (2021), described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tremor, pyrexia, chills, headache.  Additional information: There are no relevant test. Patient received treatment for event with Tylenol and Ibuprofen. It was reported that the Wicked chills (really shaky) plus fever for about 24 hours. Then I was fine. I suspect I was infected seriously in Mar2020 but there was no test to confirm (I work at a hospital) and had a low grade fever for 10 days (37-39 degree).The Concomitant Drugs was none.Specific Relevant Test for Thromboembolic events with thromboembolic was none.Pretty wicked fever, chills, headache for about 24 hours. Recovered fully.  Follow-up attempts are completed. No further information is expected.
Local tenderness of (L) deltoid (shot site). She felt ok in AM, & soreness persisted of (L) deltoid. Took LORTAB 5 am for pain. At about 710 am had nausea & vomited 2x. Continuing nausea & HA x about 2d.
Loss of smell since after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell since after first dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST for Allergy and Asthma, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, ROSUVASTATIN for Cholesterol, CLOPIDOGREL BISULFATE (PLAVIX) for Heart disorder.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced ANOSMIA (Loss of smell since after first dose). At the time of the report, ANOSMIA (Loss of smell since after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that he was recommended to take anti bacteria cream but it doesn't helped.
Redness; Itchiness; Hives; A spontaneous report was received from a consumer concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness(erythema), itchiness(pruritus) and hives(urticaria).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, approximately one week later the patient experienced the event redness, itchiness, and hives.  Treatment details were not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The seriousness criteria of all events was non serious.  The outcome of events redness, itchiness, hives was unknown on 12 Feb 2021.; Reporter's Comments: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Cerebral venous sinus thrombosis; received the first and second dose on the same date; This is a spontaneous report from a contactable consumer (patient) reported for herself. This 41-year-old female patient received bnt162b2 (Pfizer COVID 19 VACCINE), dose 1 via an unspecified route of administration administered in right arm on 24Apr2021at 09:45 (at age of 41-year-old) (Batch/Lot Number: ER8729) as single dose, dose 2 via an unspecified route of administration administered in right arm on 24Apr2021 (at age of 41-year-old) (Batch/Lot Number: EW0170) as single dose for covid-19 immunisation. The medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced cerebral venous sinus thrombosis in 2021. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (from 2021), Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment included Lovenox Injections twice a day. The patient received the first and second dose on the same date on 24Apr2021.  The covid test type post vaccination=Nasal Swab was negative on 2021.  The outcome of cerebral venous sinus thrombosis was not recovered, of other event was uknown.  Follow-up attempts are completed. No further information is expected.
Noted blurred vision from left eye on Aug 15, 2022. Triaged on cruise ship by doctor who mentioned possible retina detachment. Continued cruise until returned home. Saw ophthalmologist on first available appointment (Aug 23rd). Doctor stated, had a micro-bleed and retinal detachment and urgent surgery performed the next day. Currently recovering.
No adverse.  Reporting procedural error only.  Pfizer Bivalent Booster formula was mistakenly given as immunocompromised dose.  No harm.
RASH SEVERAL HOURS AFTER VACCINE.  FULL BODY, DENCE, PAPULAR RASH.NOT ANAPHYLACTIC.
Fever to 102 degree Fahrenheit from 6pm of the day of shot at 1:15pm, till 4pm next day accompanied by chill, fatigue, body heaviness, Treatment was rest. Recovered by 3rd day. Vaccination shot site of arm extreme soreness the day after the shot for 2 days
my 43-year-old friend die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570).  A 43-year-old 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), outcome "fatal", described as "my 43-year-old friend die". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course details: Reporter had the following reports on the Pfizer BioNTech COVID-19 vaccine: The reporter sated that everyone taking the vaccines has had COVID once and twice and the reporter thinks they do not work. The reporter also stated that her cousin who is a nurse worked in operating room and had to go to the hospital she can't see she can't get in the highway to drive, and this is a side effect of the vaccine. She also reported that she saw her 43-year-old friend die. She also stated she don't have any confidence in the vaccine.  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 43-year-old friend die
Injection area red with no increased warmth or tenderness. Over the counter steroid cream recommended.
PATIENT FAINTED  AFTER 2 MINUTES OF ADMINSTERING THE FLU VACCINE. EPI-PEN WAS ADMINISTERED AFTER THAT PATIENT REGAINED CONSCIOUSNESS THEN EMT ARRIVED AND TOOK PATIENT TO ER.
exacerbation of neuropathy in hands, feet, and legs; severe itching; pain in throat and nose; pain in throat and nose; swelling of throat; exacerbation of weakness in hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Feb2022 13:00 (Lot number: Fj1620) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing); "MS" (unspecified if ongoing); "chronic upper respiratory illness" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "RA" (unspecified if ongoing); "Known allergies:avocados, pineapple" (unspecified if ongoing); "Known allergies: sulfur" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; DULOXETINE; BUSPAR; nettle leaf liquid. Past drug history included: Known allergies: NSAIDs, salicylic acid, ibuprofen, acetaminophen, avocados, pineapple, sulfur, all Over The Counter drug for pas The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 18Feb2022 03:30, outcome "not recovered", described as "exacerbation of neuropathy in hands, feet, and legs"; PRURITUS (non-serious) with onset 18Feb2022 03:30, outcome "not recovered", described as "severe itching"; OROPHARYNGEAL PAIN (non-serious), NASAL DISCOMFORT (non-serious) all with onset 18Feb2022 03:30, outcome "not recovered" and all described as "pain in throat and nose"; PHARYNGEAL SWELLING (non-serious) with onset 18Feb2022 03:30, outcome "not recovered", described as "swelling of throat"; MUSCULAR WEAKNESS (non-serious) with onset 18Feb2022 03:30, outcome "not recovered", described as "exacerbation of weakness in hands". Benadryl was taken as a Therapeutic measure of neuropathy peripheral, pruritus, oropharyngeal pain, nasal discomfort, pharyngeal swelling, muscular weakness. Clinical course included "On second day after dose 1 severe itching and pain in throat and nose, exacerbation of neuropathy in hands, feet, and legs, swelling of throat, exacerbation of weakness in hands."  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician who reported to the company representative that she heard multiple patients who received GARDASIL and experienced seizure after the vaccination.  In a follow up telephone call to the physician she reported that "there was a little problem".  "This was all from rumors from her patients who heard kids at their school were receiving GARDASIL and having seizures."  The physician reported that not all the kids at the high school who had the seizures even received the GARDASIL vaccination.  The physician said "again a rumor going around."  She mentioned that she called the high school principal requesting further information about the events but she had not got any more information about patients and the events.  She reported that she had no problems with GARDASIL.  The physician would fax the local newspaper that talked about this incidence.  No further information was available at the time of this report.  The outcome was unknown.  Upon internal review seizure was determined to be an other important medical event.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.  Additional information has been requested.
Trouble swallowing saliva at night, hesitation to swallowing saliva. Unable to take deep breathes, chest paint when taking deep breathe.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored (Merck) PROQUAD (lot# reported as 1019995, expiration date: 02-DEC-2016, route and dose were unknown) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
a slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a slight headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, METOPROLOL, MONTELUKAST and LOSARTAN for an unknown indication.   On 12-Mar-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 12-Mar-2021, the patient experienced HEADACHE (a slight headache). On 12-Mar-2021, HEADACHE (a slight headache) had resolved.            Asthma Inhaler used as a Concomitant medication.  Tylenol used as a Treatment Medication. Action taken with mRNA-1273 in response to the event was not applicable.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
Pt had 3" diameter band swath around upper arm - inch below injection site, edematous and red for 3 days post vaccination.