chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Phastosmia/ odd smell no matter where I am/ t's strong and constant; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Phastosmia/ odd smell no matter where I am/ t's strong and constant) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third 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 PAROSMIA (Phastosmia/ odd smell no matter where I am/ t's strong and constant). At the time of the report, PAROSMIA (Phastosmia/ odd smell no matter where I am/ t's strong and constant) had not resolved.            Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-419222 (Patient Link).   Reporter did not allow further contact
General achey, shivering but not cold. Feeling as if getting ill. Skin sensitivity. Only sleep helped.  Laid down and didn't get up for 17 hours.
right deltoid cellulitis, swollen, red hot to touch. Febrile 102. Give rocehphin 500mg IM injection and Keflex 350mg PO x 10 D TID.
Had tested covid + on 8/-22-25 at another facility. Admitted on 9/14 with large right cerebellar stroke, edema, compression and hydrocephalus. Has required multiple admissions to ICU for neuro status changes. Covid + on admission by PCR. Family requested no aggressive treatment. Ventriculostomy stopped draining and removed. Family requested comfort care only.
25JUN96 in evening 2 red spots appeared 8cm below distal to inj;by 26JUN96 in AM area increased proximally to presumed inj site & distally;no 15cm x 8.5cm w/a band of uninvolved tissue between 2 red areas;
had an anaphylactic reaction to the Pfizer Covid vaccine; it was the preservative in the vaccine that was causing this reaction; blood pressure dropped; had a racing heart; had this sense of impending doom; She got very, very dizzy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: PAA16596S/062) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: patient stated that in Mar2021, she had an anaphylactic reaction to the Pfizer Covid vaccine. She states that she is not someone who has anplyactic reactions. This is the first time she has ever had one and it was in response to that vaccine. The patient stated that in Mar2021 her blood pressure dropped and had a racing heart. She got very, very dizzy and had this sense of impending doom. She was told she had an anaphylactic reaction. This all lasted for about an hour. She stated that she did not require any hospitalization or anything and she was lucky. This occurred around 2:00 or 3:00pm that day it occurred in Mar2021.  She wanted to report this to Pfizer because she was told that it was the preservative in the vaccine that was causing this reaction. The preservative is PEG, polyethylene glycol, which is a nanoparticle representative in the vaccine. Therapeutic measures were not taken as a result of events. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable consumer by way of Claim Letter and Medical Records. This 70-year-old, female patient of an unknown race was injected PREVNAR 13 vaccine 0.5 ml on 31Oct2016 in the left arm through intramuscular route for pneumonia. The lot number was reported as N34936, expiration date was Oct2017 and NDC number was 00005-1971-02. The frequency was unknown. The relevant medical history included chronic lung disease on an unknown date. The concomitant medication and past drug history were unknown. On 31Oct2016, the patient developed cellulitis in the left arm. The relevant lab data was unknown. The action taken with pneumococcal 13-val conj vac (dipht crm197 protein) in response to the event was unknown. The therapeutic measures taken were unknown. As of 02Dec2016, the clinical outcome of the event cellulitis in the left arm was unknown.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 29 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: STELARA, start date: 11Jul2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Sep2023) Positive; (09Sep2023) Positive; (10Sep2023) Positive; (11Sep2023) Positive, notes: it got noticeably lighter every day; (12Sep2023) Positive, notes: it got noticeably lighter every day; (13Sep2023) Positive, notes: it got noticeably lighter every day; (14Sep2023) Positive, notes: it got noticeably lighter every day; (15Sep2023) Positive, notes: it got noticeably lighter every day; (16Sep2023) Positive, notes: it was very dark again; (17Sep2023) Positive; (18Sep2023) Positive; (19Sep2023) Positive; (20Sep2023) Positive; (21Sep2023) Positive. Patient tested herself with an antigen test every day. It was positive every day from 08Sep to 21Sep, but between 11Sep and 15Sep it got noticeably lighter every day. On 16Sep it was very dark again. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 08Sep2023 to 12Sep2023.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Beginning 1 day after Flu shot, began to feel slightly dizzy and nauseous. I had already been having an allergy attack for 1 week or so. The dizziness and nausea continued intermittenly. It ceased 1 mo. later when cold weather arrived.
Expired vaccine administered to 155 patients/ 80 Patients received expired moderna COVID-19 vaccine; Vaccine expired on 01-Apr-2022 and date moved to refrigeration on 04-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients/ 80 Patients received expired moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and date moved to refrigeration on 04-Apr-2022) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients/ 80 Patients received expired moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and date moved to refrigeration on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients/ 80 Patients received expired moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and date moved to refrigeration on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that pharmacist thought the vaccine expiry was on Jun 2022, however vaccine expired on 01 Apr 2022. Date the vial was initially stored in refrigerator was found to be 04 Apr 2022. Vial did not undergone any temperature excursion. No treatment medications were provided.
On 5/3/19 pt noticed a new lump on the (L) side of  her neck that was tender. She was seen at urgent  care and was told that it was possibly from the  Tdap shot. She was prescribed prednisone. Within the day she started the prednisone, the lump  was gone.
Fluzone Quadrivalent 0.25 was administered to a 10 year old girl instead of the Fluzone Quadrivalent 0.5 ml/No AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA281572 same reporter.  This case involves a 10 years old female patient who received 0.25 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot U6653BD, Expiration Date: 30-Jun-2020 via unknown route in the right deltoid on 04-Oct-2019, instead of 0.5 mL dose.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient didn't receive other vaccines on that day.   It was a case of actual medication error due to vaccine underdose.  No side effects noted.  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 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.  Documents held by sender: none.
I had an episode of chills in the middle of the night (4:17 am), and I had a 100.9F fever at 6:20 a.m. on 1-5-2021
Injection site pain x 2 days, fatigue, malaise, rash on b/l legs and arms.
A lot of pain, very hot , swelling from the day of the vaccine to not being able to move my hand at all. But the Surgeon can explain a little more with the diagnosis and more.
post-menopausal bleeding for one day after vaccine, cramps Narrative:  After both doses of covid vaccine, patient experienced post-menopausal bleeding and abdominal cramps for one day.
Pt received vaccine around 10:30 and at approx. 16:00 that evening, she started feeling achy, possible fever and diarrhea started the following day (10/20/01).
Mother called stating son had Tdap injection Monday, 7/27/09 and today (7/29/09) has a hard quarter to golf ball size knot with redness and pain.
Patient sated "feel lightheaded".  B/P stable  130/80; Resolved past 10 minutes.  Advised passenger to drive patient home.   Patient waited > 30 minutes before leaving the site.
Mild fever; Trouble sleeping; Lethargy; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an intramuscular route of administration in the arm left on 30Sep2021 at 15:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The medical history included penicillin allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included cetirizine hydrochloride (CETRIZINE) and ibuprofen (MANUFACTURER UNKNOWN), all from unknown dates, for unknown indications and unknown if ongoing. On 01Oct2021, the patient experienced mild fever, trouble sleeping and lethargy. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild fever, trouble sleeping and lethargy were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Ischemic stroke treated with TPA at Hospital. Hospitalized November 22-24, 2018. CT scans of brain, MRI of brain.
Both of my calves became really hard, muscles were tight. Then a day later (5th) I started to get continuous muscle spasms/twitches from my knee down. Waited a week and it didn't subside, I set a Telemedicine appt with my doctor. She asked that I go and get blood work done. I had to go to the Urgent Care while waiting for my bloodwork appt because of the pain. When I went and got my bloodwork, it came back normal. My Vitamin D was low so my doctor asked that I take Vitamin D and Calcium. Twitches continued. Doctor thinks that the vx could have triggered an underlying condition. Doctor asked that I go for an Ultrasound to check for blood clots, nothing unordinary was found. Recommended that I wear compression socks.
Arm swelled and red 4 inch red circle. Ache and itchy. Lasted until April 2.
Chills; Body aches; Sore injection site; Tiredness; Heartrate high 90s; feeling Unwell; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263) via an unspecified route of administration at left arm on 06Feb2021 10:30 (50-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (prior vaccination), hypertension, asthma, anxiety, and allergies to honey. Concomitant medications in two weeks included losartan and montelukast sodium (SINGULAIR). There was no other vaccine in four weeks. On 06Feb2021 02:00 (as reported), the patient experienced chills, body aches, sore injection site, tiredness, heartrate high 90s, and feeling unwell. Adverse events did not result in emergency room visit or physician office visit. COVID-19 was not tested post vaccination. Therapeutic measures were taken as a result of the events and included Tylenol 1000 mg. The outcome of the events was not recovered.
Patient states pain increased left extremity around 1800 hours the day of vaccination, woke during the night with feverish, chills, sweating, pain/swelling in left arm, radiating into left breast area. Presents on 9/1/11 to health department, redness/swelling to left arm-medial-states has improved, warm to touch.
pt recv vax 21NOV95 & devel a rash approx 1mo p/vax;pt was seen in MD office on 5DEC95 & c/o tiredness & achiness & had a rash on upper extremities & sore throat;rash was typical of pityriasis rosea which was confirmed by a dermatologist
Child had 3 HIB vaccines on a delayed schedule, the third injection being after 13 month with no reported adverse event; Initial information received on 12-Aug-2022 regarding an unsolicited valid non-serious case received from a patient  mother. Gmi number: 01233057  This case involves a 13-month-old male patient who had 3 HIB (PRP/T) VACCINE [ACT-HIB] vaccines on a delayed schedule, the third injection being after 13 months with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received dose 1 and 2 of ACT-HIB vaccine at (unknown: formulation, strength, dose, route, administration site) for prophylactic vaccination.  On unknown date, the patient received 3rd dose of suspect ACT-HIB at (unknown: formulation, strength, dose, route, administration site) for prophylactic vaccination on a delayed schedule, the third injection being after 13 month with no reported adverse event (inappropriate schedule of product administration) at same day latency.  It was reported that "Patient mother reported her son was on a delayed schedule for Hib administration. She asks if ActHib is effective immunity when not on recommended schedule? She asks what is recommended, because agency says no additional dose after a year old but we recommendation a dose 15 - 18 months?"   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.     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 guidelines. 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 falsified date of birth on consent form and let us know the correct date of birth after the vaccine had been administered. Patent is under 65 and received the high-dose influenza vaccine for individuals over the age of 65.
Sunburn feeling of her skin; This case was reported by a consumer via call center representative and described the occurrence of burning sensation skin in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th June 2019, the patient received the 1st dose of Shingrix. On 8th June 2019, less than a day after receiving Shingrix, the patient experienced burning sensation skin. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the burning sensation skin was recovering/resolving.   It was unknown if the reporter considered the burning sensation skin to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient had sunburn feeling of her skin after receiving vaccine. The patient had no redness, rash or bumps, just a feeling of a sunburn on her back. The reporter consented to follow up. For tolerance to the VALTREX, refer case US2019166358.
PER ER REPORT 1-25-2020 C/O RAISED AREAS OF SKIN & ITCHING ON THE BILATERAL UPPER EXTREMITIES X 2DAYS ALSO C/O DIZZINESS, CONGESTION & INTERMITTENT SOB X 2DAYS ZYRTEC 10 MG GIVEN
Urticarial rash, large diffuse; treated with Prednisone PO and PO Benadryl, No improvement
Loss of appetite; High fever; chills; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (High fever) and CHILLS (chills) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus, Mitral valve disease, Irritable bowel syndrome, Blood pressure high, Drug allergy, Drug allergy and Drug allergy.    On 20-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite), PYREXIA (High fever) and CHILLS (chills). At the time of the report, DECREASED APPETITE (Loss of appetite), PYREXIA (High fever) and CHILLS (chills) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient had received all Moderna COVID-19 vaccines so far and her reactions have been high fever, chills, loss of appetite. She would only have to stay at home for a couple of days after which she was able to return to work. With one of the doses, her fever went to 104F.   This case was linked to MOD-2023-747892, MOD-2023-747880 (Patient Link).
face swollen; rash under arms and on groin; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face swollen) and RASH (rash under arms and on groin) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, POTASSIUM, METOPROLOL, CLOPIDOGREL, HYDROCHLOROTHIAZIDE and SIMVASTATIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced SWELLING FACE (face swollen) and RASH (rash under arms and on groin). At the time of the report, SWELLING FACE (face swollen) and RASH (rash under arms and on groin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details reported.
My moms mental state started changing first, forgetting things not remembering who I was. Then she started having trouble breathing. So she was rushed to the emergency room. I stated to the doctors at the hospital. That I started noticing her health decline after she had gotten the COVID-19 vaccine. I asked the hospital if they was going to report the side effects to your facility meaning VAER. I was told by hospital staff that they didn?t know who VAER was and that they would not report my moms side affects to your facility. That I could do it myself now back to my mother?s condition do you getting vaccinated. She was admitted to the hospital on April 5th 2021. Her body was shutting down and doctors didn?t know why. She is currently in a rehabilitation center. With  conditions she didn?t have before getting vaccinated. She has since been diagnosed with chronic obstructive pulmonary disease, unspecified, muscle weakness, difficulty walking,cognitive communication deficits,chronic kidney disease stage 4,and elevated white blood cells. All of these problems she never had before being vaccinated.