chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 70 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 30/40 which was not suggestive of malingering (<6). The patient was diagnosed with moderate mircrosmia (34th percentile). The PEA (phenyl ethyl alcohol) test scores were -4.25 left, -3.75 right and -3.00 bilateral. The Whole-Mouth test identification test score was 88% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
I was given the Shingrix vaccine in the late morning.  By about 7pm I was feeling unwell with fever, severe headache, shivering, pain at injection site, nausea, and tired.  This continued the entire next day and I stayed in bed all day.  I finally was able to take an aspirin (too nauseous up to this point)  the following evening which helped the headache some.  The second day, I was still weak, but able to get out of bed. I could not eat much until the third day.
pt recv vax 25OCT95 & 28OCT95 reported a lopsided smile & droopy lt eyelid;reportedly,MD suspects Bell's palsy,although has not yet examined the pt
SM developed a severe HA within a few hours of receiving each anthrax vaccine he has gotten worse since 1999. HA lasts 2-3 days and he is sensitive to noise/light during this period. HA usually resolve on their own.
2cm abscess on right hip at injection site. Abscess drained and cultured on 4/21/01. Treated with Keflex X 10 days. Pt has had 2 previous abscess events, always at immunization injection site.
Severe headache (frontal and temporal area) 1 day on 4/6/2021 for 15 hours. Took Ibuprofen and Advil OTC.   Rt hip/leg pain 4/15/2021 for 18 hours. No medications.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates in 2017 (reported as between 01-MAR-2017 and 01-SEP-2017), the unspecified number of improperly stored doses of M-M-R II lot number L047133 with expiration date 24-NOV-2017 (doses, routes of administration and anatomical locations were not reported) were administered to the patients. The doses were reconstituted with improperly stored sterile water diluent (MRK) lot# reported as M012217 (lot# invalid for sterile water diluent (MRK)) with expiration date 19-SEP-2017. The doses were stored in temperature of -59 degrees Fahrenheit for 6 months. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Product quality complaint was not involved. This was one of several reports received from the same reporter. Sender's Comments:  US-009507513-1709USA011984:
Tachycardia Fatigue Chills Muscle aches Joint pain  Site pain
The patient came in and got her third pfizer dose for being immunocompromised. I asked her if there were any problems with vaccines, allergies, or anything that has made her throat close up. She only said potassium. I told her per recommendations she'd have to wait 30 minutes which she did not want to do with all the people in the lobby. She then called and spoke to another pharmacist here saying her throat was closing up with no problem breathing. She was instructed to take benadryl and seek medical help. I called her back around 415 to check on her and she said that the benadryl may be helping a little and she has a call out to her doctor. I told her that it is a holiday and probably wont respond today. I reminded her that if the swelling got worse minutes are precious with airways. She agreed to get her husband to take her to get examined.
myocarditis following mRNA vaccination; This is a literature report for the following literature source(s): "One year follow up for case series of myocarditis following mRNA vaccination against SARS-CoV-2.".  A patient (no qualifiers provided) received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis following mRNA vaccination".; Sender's Comments: Considering a plausible drug-event temporal association and/or known drug safety profile, a reasonable possibility that the event myocarditis is related to BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN) cannot be excluded.  This case will be reassessed should additional information become available.,Linked Report(s) : US-PFIZER INC-202300140924 Same article/ drug/event and different patient;US-PFIZER INC-202300140925 Same article/ drug/event and different patient;US-PFIZER INC-202300140926 Same article/ drug/event and different patient;
Severe headache and fever up to 100.4 no treatment, resolved on own in a few hours
facial swelling; She would like to know if Accutane will interfere with the efficacy of the Pfizer COVID vaccine?; This is a spontaneous report received from a Pfizer sponsored program COVAX US support. A contactable consumer or other non healthcare professional. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number/ Expiration was not reported), via an unspecified route of administration on 28May2021 as 1st dose single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included isotretinoin (ACCUTANE) taken for an un-specified indication, start and stop date were not reported. Caller's son was scheduled for Pfizer's COVID vaccine first dose today, 28May2021. Her son started Accutane 2 days ago and was currently experiencing side effects of facial swelling this morning. She would like to know if Accutane will interfere with the efficacy of the Pfizer COVID vaccine. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a registered nurse refers to a 6 month old patient of an unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 19-OCT-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M006112 with expiry date: 16-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014706.
persistent headache; even touching her head hurts/hurts to the touch; with this shot her arm really hurt when getting it/pain in the arm the shot was given/uncomfortable pain/in their arm after receiving the injection; insist on giving the next dose in 4 weeks; insist on giving the next dose in 4 weeks; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1283) via an unspecified route of administration in the left upper arm on 06Jan2021 09:40 at a single dose as COVID vaccine. The patient had no medical history. Concomitant medications noted as on other medications but nothing new. She previously got the shingle shot for immunization then her arm hurt a few days. She had no other reaction to vaccines in the past. She received no vaccine on the day of or in the prior 4 weeks. Last Wednesday on 06Jan2021, the patient took the vaccine and has had a headache since; even touching her head hurts. She had a persistent headache that started the day after the vaccine and has continued since. The next day on 07Jan2021 was when the headache started. She took regular Motrin (lot OFE3249A, expiry: May2022) and Tylenol extra strength (lot: LMA051, expiry: Jul2019, perhaps not working anymore) sometimes but they didn't really seem to help. She felt the best when she was standing up or laying down, and she would rather be laying down. She asked "Is this a normal side effect, am I dying? I am not a headache kind of person, I take a Motrin, it goes away and I do not have one for months. It actually hurts to the touch." Should she be worried? She did call the clinic about the headache and was told if it got serious to go to the emergency room, she didn't think it was that serious. It was just persistent. She could leave with the pain if it kept her from getting COVID but the fact it was persistent worried her. It was also reported that on 06Jan2021 with this shot her arm really hurt when getting it and that day but that was all (pain in the arm the shot was given), the next night there was no pain. Her and her husband both oooo'd and ahhhh'd with the pain in the arm but that was it (a very uncomfortable pain they experienced in their arm after receiving the injection). She asked how long a side effect lasts after the vaccine? She also stated that on Jan2021, they insist on giving the next dose in 4 weeks. Asked if the vaccine was given a week later would the efficacy be lower? The outcome of persistent headache was not recovered; of vaccination site pain was recovered on 07Jan2021; and of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021036651 same reporter and drug, different patient and AE
ITCHY RASH ON ARM WITH LARGE RED LESION.  FIRST SHOT ARM ITCHY AND HARD AT SITE.  VACCINE 2 VERY ITCHY ARM WITH RED LESION AND A BRUISE AND FEW SCABS.  USING TRIMCINOLONE ACETONIDE A CREAM TO HELP WITH ITCHING.  HELPING SOMEWHAT RIGHT NOW IT'S ITCHING AGAIN.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient was vaccinated with the first dose of GARDASIL on 04-NOV-2011, was in the office on 19-NOV-2012 to receive the second dose in the GARDASIL immunization series (dose, route and lot #, expiration date not reported). It was unspecified if the patient sought medical attention. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 15:00 as dose 4 (booster),  single (Lot number: GJ2524) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure"; "obesity"; "Known allergies: Sulfa". The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with PAXLOVID from 18Mar2023 to 22Mar2023.
Abdominal cramping and loose stools which began after first dose of VIVOTIF and persisted throughout course of dosing.
It was reported that a 61 year old female received Fluzone 98-99 on October 6, 1998. Reportedly at 6:00 PM that same day the pt's eyes were red, felt she had sand in her eyes, (also experienced) ears itching and vaginal itching. The pt reportedly took Benadryl which stopped the itching. On 10/7/98 her eyes remained red. Reportedly the pt recovered from this experience.
no additional AE; an expired dose of VAQTA given to 12 month old on June 23,2020; This spontaneous report was received from a medical assistant referring to a 12 months old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not provided.  On 23-JUN-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot# S002505, expiration date 04-APR-2020, 0.5 milliliter; route was not provided) for prophylaxis (expired product administered). No additional adverse event was reported.
Crying for 3 days, post vax. Crying for 7 days after the 2nd immunization. Above reported by mother on 5/8/02.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Slight headache on day 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 15:15 (Lot number: EW 0158) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; ZOLPIDEM; LISINOPRIL. Vaccination history included: Bnt162b2 (dose1, lot number: EP6955, administration time: 15:15, vaccine location: left arm), administration date: 24Mar2021, when the patient was 54 years old, for Covid-19 immunisation, reaction(s): "extremely tired", "hoarse in my speech ", "lip sore". The following information was reported: HEADACHE (non-serious) with onset 17Apr2021 07:00, outcome "recovering", described as "Slight headache on day 3". Therapeutic measures were not taken as a result of headache.  Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Approximately 25 min after receiving the vaccine in the Right Deltoid, numbness and tingling to the right hand. Unable to grip to hold onto a glass of water.  Feels as if the skin is swollen.
Subsequent to receiving first and second doses of varicella virus vaccine live the pts laboratory tests revealed her IgC level to be 0.42.
it is sensitive, not itchy; appeared a rush, it at the injection site; sore right arm at the the injection site, very mild; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (it is sensitive, not itchy), VACCINATION SITE RASH (appeared a rush, it at the injection site) and VACCINATION SITE PAIN (sore right arm at the the injection site, very mild) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST and MULTIVITAMIN & MINERAL.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore right arm at the the injection site, very mild). On 05-Feb-2021, the patient experienced VACCINATION SITE REACTION (it is sensitive, not itchy) and VACCINATION SITE RASH (appeared a rush, it at the injection site). On 05-Feb-2021, VACCINATION SITE PAIN (sore right arm at the the injection site, very mild) had resolved. At the time of the report, VACCINATION SITE REACTION (it is sensitive, not itchy) and VACCINATION SITE RASH (appeared a rush, it at the injection site) outcome was unknown.            Concomitant medication also include injection for osteoporosis. Treatment information was not provided. Action taken with mRNA -123 is not applicable.   Reporter did not allow further contact
After this second in a series of 3 shots, I experienced severe aches and pains as well as a fever for about 2 days. About 10 months later, I was diagnosed with optic neuritis. I was eventually treated with steroids for this, but my eye sight took about one year to come back to normal. After the optic neuritis, I was diagnosed with multiple sclerosis due to the spots that showed up on my MRI. There was also lots of lab work and other tests.
MUSCLE PAIN PERSISTING SINCE IMMUNIZATION, DENIES WEAKNESS. CLIENT REPORTED EVENT TODAY 4/12/2012: ALSO REPORTED THAT SHE HAD INJURED LEFT BODY 1 YEAR AGO.  CLIENT SAID THAT SHE HAD SEEN HER DOCTOR.
4 days after injection where shot was given it hurt deep.  In the morning it was itchy, inflamed and hurt. deep pain in areas down to fingers.. enflamed area has increased still with itching and deep pain along the arm and fingers.
He had hive like bumps. They were course bumps spread out. It is still going on at this time. They prescribed Benadryl, Zyrtec during the day, and a hydrocortisone cream.
body aches; fatigue; chills; headache; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 52 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 16Mar2021 09:15 (Lot number: EN6203) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, lot number: EL3247), administration date: 23Feb2021, for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 17Mar2021 04:00, outcome "recovered" (18Mar2021), described as "body aches"; FATIGUE (non-serious) with onset 17Mar2021 04:00, outcome "recovered" (18Mar2021), described as "fatigue"; CHILLS (non-serious) with onset 17Mar2021 04:00, outcome "recovered" (18Mar2021), described as "chills"; HEADACHE (non-serious) with onset 17Mar2021 04:00, outcome "recovered" (18Mar2021), described as "headache". Therapeutic measures were not taken as a result of pain, fatigue, chills, headache. Additional information: The patient had not received other vaccine in four weeks or other medications in two weeks. The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Shortness of breath; Body aches; Positive COVID-19 Test; Headache; Loss of smell; A spontaneous report was received from a nurse concerning a 46-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID 19 along with headache, loss of smell, shortness of breath, and body aches.  The patient's medical history, was  not provided by the reporter. No Concomitant medications reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273  intramuscularly for prophylaxis of COVID-19 infection.   The consumer reports having weekly COVID-19 testing per her employers safety protocols.  While the consumer was waiting to receive the second dose of the Moderna COVID-19 Vaccine, she was exposed.  On 11 Jan 2021 she Tested Positive for COVID-19.  The consumer reports the onset of symptoms as occurring on 09 Jan 2021. These symptoms included a Headache and Loss of Smell.  On 12 Jan 2021, the consumer reports that she began to experience Shortness of Breath and Body Aches. The consumer reports that all of the symptoms went away 12 days after she first reports experiencing symptoms, on 21 Jan 2021.   The consumer is scheduled to receive the second dose of the Moderna COVID-19 Vaccine on 27JAN2021. Action taken with mRNA-1273 in response to the events was not reported.
severe allergic reaction; fever; rash; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction), PYREXIA (fever), RASH (rash) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Multiple allergies.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (severe allergic reaction), PYREXIA (fever), RASH (rash) and FATIGUE (fatigue). At the time of the report, HYPERSENSITIVITY (severe allergic reaction), PYREXIA (fever), RASH (rash) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter.  No treatment was reported   Reporter did not allow further contact
Sl fever 4 hrs post immun; erythema  24AUG91 8-9PM on that date area extended to 15 cm  on 25AUg began having blister like spots extending out from inject areas;
Low grade fever, swelling in upper left arm, muscle spasms in both arms and right leg.
Patient reported expanded red petechia (red spots)  on bilateral lower extremities including feet and knee area.  Patient got CBC and went to PCP.  CBC was normal except platelets low-normal 150,000.  No itching, swelling, etc.  This occurred about 9 days after vaccination.  Improved gradually and mostly normalized 3 weeks out when receiving 2nd dose of vaccine.  No other symptoms reported besides sore arm for 2 days.
Flu-like symptoms,  extreme fatigue, skin sensitivity,  fever-like symptoms, pain on arm at injection site.  Symptoms lasted 2.5 days.