chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient had a temperature of 101 / she no longer has a fever; flu-like symptoms; stiff neck; whole body itching and pain; whole body itching and pain/whole body aches; inflammation and redness of the whole deltoid starting right away after the patient received the vaccination and lasting for two weeks; inflammation and redness of the whole deltoid starting right away after the patient received the vaccination and lasting for two weeks; the area where she received the vaccination is very itchy/itching continued at the site of injection; This spontaneous report has been received from a pharmacist referring to a 57 year old female patient. No information was provided regarding the patient´s medical history, concurrent conditions, drug and allergy history or concomitant medications.   On 11-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscularly (strength, dose and frequency were not provided) lot # R018731, expiration date 27-FEB-2020 for prophylaxis.    The reporter stated that, on 11-NOV-2019, right away after the patient received the vaccination, she experienced whole body itching (pruritus) and pain, inflammation (vaccination site inflammation) and redness (vaccination site erythema) of the whole deltoid. On 12-NOV-2019, the patient had a temperature of 101 (units not provided)(pirexia), flu-like symptoms (influenza like illness), stiff neck (musculoskeletal stiffness) and whole body aches (pain). On an unspecified date in November 2019, the whole body itching went away but continued at the site of the injection (vaccination site pruritus). On 30-NOV-2019, the patient reported to the pharmacist that she went to the doctor because the area where she received the vaccination was very itchy. The doctor prescribed topical diphenhydramine (BENADRYL) which helped a little bit. As of 30-NOV-2019, the patient's deltoid was no longer inflamed, red and sore. She no longer had a fever, flu-like symptoms, stiff neck and whole body aches. The whole body itching had resolved but continued at the site of the injection. At the reporting time, the causal relationship between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported. The reporter considered the events to be medically significant.
I did not have an adverse reaction to the vaccine. I tested positive with a home test for COVID-19 on 7/31/2022. I had a cough and runny nose. I had an appointment with my doctor, and I was given a steroid for my symptoms.
rash, arthralgias of hands, sore throat, chills 12-14 days p/rubella vax; seen in clinic 16MAR94;
Patient had vaccine administered and stood up, and began to walk around as normal. Within approximately 5 minutes the patient passed out while standing next to his mother. I was notified and immediately rendered aid. The patient was unconscious upon arrival, though he opened his eye by the time I kneeled down on the floor. Patient's parents stated he had not eaten much more than popcorn all day and has passed out one other time like this. Patient stayed sitting for approximately 20 minutes before the parents continued on with their day. Upon departure the patient and parents seemed fine. They were instructed to follow up with a healthcare provider if any other signs or symptoms developed.
Chills; Injection site pain; Fatigue; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Apr2021 01:15 (Lot number: EP6955) at the age of 16 years as dose 2,single for covid-19 immunisation. Relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing). Concomitant medication(s) included: FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Suspected drug: Pfizer covid vaccine, Dose number-1,, Lot number= EN62041, lot unknown=False,, Administration time=11:15 AM, Vaccine location=Right arm), administration date: 22Mar2021, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 12Apr2021 23:30, outcome "recovered" (Apr2021), described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset 12Apr2021 23:30, outcome "recovered" (16Apr2021), described as "Injection site pain"; FATIGUE (non-serious) with onset 12Apr2021 23:30, outcome "recovered" (16Apr2021), described as "Fatigue"; HEADACHE (non-serious) with onset 12Apr2021 23:30, outcome "recovered" (16Apr2021), described as "Headache". Therapeutic measures were taken as a result of chills, vaccination site pain, fatigue, headache.  Additional Information: It was reported that no other vaccine received in four weeks.Treatment medication included Ibuprofen, acetaminophen. It was reported that patient was not Covid tested prior and post vaccination. No known allergies. Vaccine Facility information available.Ethnicity information is available. Race information is available.It was reported that The Pfizer Drug safety unit recently received the report submitted by reporter via Pfizer safety reporting.com. They asked to confirm the date that reporter became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date reporter became aware of the occurrence of the reported events. If reporter is the patient in the case, the awareness date would be the date that she became aware in experiencing the reported events. If she is not the patient in the case, the awareness date would be the date she became aware of the occurrence of the reported events.This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If she learned of these events from another Pfizer colleague, they asked to provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events.Reporter replied she was aware of these AEs when they started on 12APR2021, and reported when they resolved to completion on 16APR2021. Pfizer US Drug safety unit asked to provide delay comment for the same.  No follow-up attempts are possible. No further information is expected.
Patient received Daptacel vaccine that expired on 1/30/2020.  Patient has not had an adverse effects, but will need to be revaccinated.  I called patients mother, patient has an appointment on 2/20/2020 and will receive Daptacel vaccine at that time.
On 6-6-2021 at 5 pm I suddenly spoke in disjointed words,  adjitated,  confusion, and left arm numb.  Son drove me to hospital.  I remember nothing of the drive, ER, admission, and only brief flashes of my stay.  Aphasia.  Stayed in hospital for 2 and a half days. Treatment was heparin at 1st, then Lipitor 80mg and 81mg aspirin, speech therapy for memory loss.  I still have no memory of my activities the entire day before having the stroke.  And for several months following the stroke, crowds and noises agitated me. Was not able to concentrate on reading, etc.  Then on 07/15/2021  ( 2pm  5 weeks after my stroke) I experienced aphasia.  Sister drove me to hospital ER.  I couldnt say my address,make a phone call o or explain how I felt.  This lasted for over 2 hrs.  I was admitted to Hospital again since it had only been 5 weeks ago that i had the stroke.  Stayed overnight: 7/15/21 CAT scan negative as were troponin levels.  MRI on 7/16/21  was negative. Diagnosed as TIA Treatment: Plavix 75mg
W/in 30 seconds: tingling & numbness down arm to fingers.  Then, blurred vision, dilated pupils, wain skin, light headedness, shallowed breathing.  After 15-20 min, symptoms dissipated treatment. laid down, called 911(arrived)
Approximately 1 hour after injection patient started to itch and hives formed. They were seen by an urgent care clinic who gave them a prednisone script. Two days later there was still evidence of the hives seen on her arms.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 16-APR-2015, the patient was vaccinated with improperly stored (23-valent) PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 0.55 degrees C for 712 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Numbness and tingling and burning sensation that has traveled from feet to hands administered prednisone, symptoms have improved.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EL9267), in right arm, on 02Mar2021 as dose 2, single (Lot number: EN6202), in right arm and on 18Sep2021 as dose 3 (booster), single (Lot number: EWO172) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive; (2022) Negative. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Reported Event was rebound mild symptoms positive home antigen test 6 days after stopping Paxlovid and 4 days after second day of negative home antigen test.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.
Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported 19 patients were administered vaccine  on 29-Mar-2022, 30-Mar-2022, 31-Mar-2022, 01-Apr-2022 and 04-Apr-2022.The Vials did not undergo any temperature excursions. The doses were administered after 30-day Use By Date and after manufacturer date of expiry.  Treatment information was not reported.
rapid heart beat with pressure high in chest and a very faint feeling with a loss of senses that lasted a few seconds per episode.  Episodes repeated frequently over several days and decreased in frequency each day.
Red, itchy, round rash at injection site appearing approximately eight days after injection and lasting approximately one week. The rash was probably two inches across in diameter but was not measured.
HEADACHE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no relevant medical history. The patient experienced drug allergy when treated with bisoprolol, naproxen sodium, and diazepam for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 19-year-old male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 4 days due to MYOCARDITIS. At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging heart: abnormal (abnormal) cardiac MRI Findings typical of myocarditis of other causes. In 2021, Troponin: 6.8 plus minus 4.1 ng/ml mean peak troponin I, 6.8 plus minus 4.1 ng/mL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    No concomitant information were reported. Treatment information was not provided.  These 5 patients were all males with age ranging from 16 to 19 years (mean, 17.2+/-1.0 years) who presented within 4 days of the second dose of COVID-19 mRNA vaccine. All 5 patients had a favorable hospital course and were discharged in stable condition with improved or resolved symptoms after mean hospitalization length of 4.8 days  This case concerns a 19-year-old, male patient with no relevant medical history reported, who experienced the expected serious AESI event of Myocarditis. The event occurred approximately at an unknown day after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events happened after the second dose and no additional dosing is expected. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received by safety 04-Nov-2021 included an Email and does not contain any new information. Only reporter details are updated.Updated lab test in patient tab and Hospitalized info event tab from initial report.; Sender's Comments: This case concerns a 19-year-old, male patient with no relevant medical history reported, who experienced the expected serious AESI event of Myocarditis. The event occurred approximately at an unknown day after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events happened after the second dose and no additional dosing is expected. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
2 year old (25 months) patient received the product FLUBLOK QIV today with no reported adverse event; Initial information was received on 22-Nov-2022 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a male patient of 2 year old (25 months) patient received the product flublok qiv today with no reported adverse event while receiving vaccine influenza quadrivalent recombinant vaccine [Flublok QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Nov-2022, the patient received a dose of suspect influenza quadrivalent recombinant vaccine with total frquency (lot QFAA2210, expiry date: 20-Jun-2023) (formulation, strength: unknown)  via intramuscular route in the right thigh.  On 22-Nov-2022 the patient had a non-serious event of, "2 year old (25 months) patient received the product flublok qiv today with no reported adverse event (product administered to patient of inappropriate age)" following the same day of administration of influenza quadrivalent recombinant vaccine.  It was reported, "This situation is reported as a medication error due to use of vaccine to a patient younger than indicated Additional Description of event Adverse events. Nurse reporting that a 2-year-old (25 months) patient received the product FLUBLOK QIV today. Nurse calling for guidance moving forward."  Action taken: not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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
Patient reports that arm where the PREVNAR vaccine is still sore to touch. He reports can move arm all around however if presses where vaccine was administered it is still sore (also when he lays down to sleep if on that side). There is no local reaction or nothing visible to report.
Mother reports decreased interest in solid foods, actually refusing solids and only drinking from botle, + no longer babbling, since 6 mo immunizations. Had been fussier more than normal, crying for 2-3 hours after vaccines with an elevated temp (102-103)  within 24 hours of administration.
Within 2 hours of receiving J&J vaccine, my lower lip became numb and I had itching all over my body.  I took Benydrl twice (4 hour increments) to ease itching.  The second day the itching/numbness went away. I was nauseous, had body aches and headaches off and on for five days after receiving the vaccine.  No treatment was used for these symptoms.
Honestly, not sure why I'm filling this out.  I responded to a survey that I had been sick with sinus infection since having the Moderna shot.  It could be that I had covid again but wasn't tested for that as by the time I went to the doctor it had been over 10 days.  I was given antibiotics for my sinus infection and  was better within a couple of days.
inflammation in his joint; torn disc from basketball; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (inflammation in his joint) and INTERVERTEBRAL DISC INJURY (torn disc from basketball) in a male patient of an unknown age 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (inflammation in his joint) and INTERVERTEBRAL DISC INJURY (torn disc from basketball). The patient was treated with MELOXICAM for Joint inflammation, at a dose of 1 UNK. At the time of the report, ARTHRITIS (inflammation in his joint) and INTERVERTEBRAL DISC INJURY (torn disc from basketball) outcome was unknown.            No concomitant medication reported.  This case concerns a male patient of an unknown age with no medical history, who experienced the unexpected non-serious adverse event of special interest, Arthritis, and other non-serious events. The event of occurred on an unknown interval after receiving an unspecified and undated dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was given. It was reported that the outcome of the events was unknown. Patient was treated with Meloxicam for joint inflammation, no other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a male patient of an unknown age with no medical history, who experienced the unexpected non-serious adverse event of special interest, Arthritis, and other non-serious events. The event of occurred on an unknown interval after receiving an unspecified and undated dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was given. It was reported that the outcome of the events was unknown. Patient was treated with Meloxicam for joint inflammation, no other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Pain started in shoulder upon injection. I felt he did it too high on shoulder and was about to tell him that when he injected. It still hurts almost a year later and now am having issues with certain motions.
approximately 5" after receiving injection, headache developed.  Progressively got worse within 30", rated 6/10.  described as "felt like the Hulk was squeezing the back of my neck".  Returned back to CVCU and coworkers commented on how red he looked- "face and arms were red like he had just ran a marathon, but not blotchy or rash".  HIs entire arm began hurting and has been hurting and waking him up every night and needing repositioned several times throughout the night.  L arm shakes/tremors, constantly - described incident where he was holding a plate at home a few days after injection and his left arm involuntary shook, uncrontrollably.
body aches have gotten progressively worse; some headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches have gotten progressively worse) and HEADACHE (some headache) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), LISINOPRIL, METOPROLOL TARTRATE, OMEPRAZOLE and UBIDECARENONE (COQ-10) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced MYALGIA (body aches have gotten progressively worse) and HEADACHE (some headache). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches have gotten progressively worse) and HEADACHE (some headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-237462 (Patient Link).
Nausea/vomiting, migraine, body ache, fatigue, hot/ cold flashes, dizziness and pain/soreness in site of injection