chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist via a company representative refers to unspecified number of patients of unknown age and gender with no pertinent medical history reported. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, Lot # and route of administration were not reported). Concomitant medications, drug reactions and allergies were not reported. On an unknown date the patients developed rash at the site of ZOSTAVAX injection. Each of those patients started BENADRYL on unknown date as a treatment. It was unknown if any laboratory diagnostic studies were performed and if the patients sought medical attention. The outcome of patients developed rash at the site of ZOSTAVAX injection was reported as recovered/resolved on an unspecified date. Additional information is not expected.
tiny purple petechiae on lt arm (where shot given) & a few on rt arm;very tired;
For over a year his wife had this AE.; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (For over a year his wife had this AE.) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (For over a year his wife had this AE.). At the time of the report, VACCINATION COMPLICATION (For over a year his wife had this AE.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINATION COMPLICATION (For over a year his wife had this AE.) to be related.    No concomitant medication was reported.  It was reported that the patient had the AE for over a year and went to the doctor all that time. Also, the patient can't associate this AE with anything else other than the vaccine.  No treatment medications was reported.   Reporter did not allow further contact
Client received CanSino COVID vaccine, outside of the US, no reaction. CanSino vaccine not approved by World Health Organization, Janssen given as an alternative on 10/07/21.
Had an achy arm after receiving both doses; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had an achy arm after receiving both doses) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 022M20A) for COVID-19 vaccination.     Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Dry eye, POTASSIUM for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Had an achy arm after receiving both doses). At the time of the report, PAIN IN EXTREMITY (Had an achy arm after receiving both doses) outcome was unknown.            No treatment  information was reported.   This case was linked to MOD-2021-059146 (Patient Link).
Case number PHEH2015US025929, is an initial spontaneous report received from a healthcare professional on 09 Dec 2015. This report refers to a 60-years-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 15735P and expiry date: not reported) on an unknown date. The patient reported that she experienced soreness and trouble moving the arm that was injected on 07 Oct 2015. The outcome of the events was reported as complete recovery on 07 Oct 2015. The seriousness and causality of the events was not reported.
Patient received covid vaccine (unknown type) in january and febuary. Admitted to hospital on 9/11/21 with Covid breakthrough case.
Patient entered the clinic during a COVID-19 Moderna booster clinic.  Everyone had pre-registered and been given EUA/VIS and consent.  He however had not been pre-registered and was under the impression he could just get the vaccine.  Unfortunately given the volume, I had vaccinated him right before my assistant said he had not been properly consented.  At that point I gave him the EUA/VIS info and he consented.
This spontaneous report was received from a 67 year old female patient via a sales representative, reporting on herself. The patient's medical history included heart catheterization and two stents placements on 09-AUG-2013 (the patient was hospitalized due to this procedures). Patient's medical history also included open heart bypass and three previous stents placement. Drug reactions/allergies were not provided. The patient reported that 24 hours after heart catheterization and stents placement, on 10-AUG-2013 at 10:48 AM, the patient received a dose of PNEUMOVAX23 (dose, route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. One hour after vaccination, on 10-AUG-2013 at 11:48 AM approximately, the patient "got very very sick". Post vaccination, the patient developed nausea, headache, dizziness, some vomiting, and felt cold. Patient stated that she might had developed a slight fever. Due to the effects she was experiencing, the hospital staff gave her an unspecified IV and monitored her till that evening. She was to be released from hospital on 10-AUG-2013, but discharge time was delayed/prolonged for several hours. Patient stated she was released on the same day, on 10-AUG-2013, at 06:30PM that night. The patient stated: "I have had stents placed before without this reaction, could this have been a reaction to the vaccine?" At the time of the report, the patient "was feeling better", however she reported on approximately 12-AUG-2013 she was feeling weak. Additional information has been requested.
Patient received vaccine and became dizzy, nauseous, and hypertensive and was taken to the emergency room.
Headache, Arthralgia, Chills, pain and discomfort at injection site Narrative:
This spontaneous report as received from Community Nursing Services Home Health & Hospice refers to a patient of unknown age and gender. Medical history was not provided. On an unknown date the patient was vaccinated with PROQUAD lot # J004322 with expiration date 17-OCT-2014, which was improperly stored (dose and route unknown). Concomitant medication was not provided. Follow up information was received from a registered nurse concerning the patient who was vaccinated with the improperly stored PROQUAD. No symptoms were reported. The patient had been revaccinated. This is one of several reported received from the same source. Additional information is not expected.
Pt received 1st dose of Engerix B  /win 6 hrs developed a generalized rash & aching flu like symptoms which resolved spontaneously
Satellite lesions disseminated underneath area of Tegaderm bandage.  No lesions outside outline of bandage.  No other sxs besides chills, body aches and mild intermittent HA.  Patient given tylenol for body aches, HA and fever prophylaxis.
little arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little arm pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea.    On 20-Apr-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 VACCINATION SITE PAIN (little arm pain). At the time of the report, VACCINATION SITE PAIN (little arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment medication was reported .   This case was linked to MOD-2021-187569 (Patient Link).
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-MAR-2017, the patient was subcutaneously vaccinated with an expired dose of ZOSTAVAX lot# L032397, expiry date 26-NOV-2016 (dose was not reported). There was no side effect reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Throat pain/cramping and difficulty swallowing; sore eyes and very bloodshot and swollen and pus filled; headachey; sleepless. Took 2 Benadryl at advice of pharmacist and doctor 12:30 on 10/01/2015.
Approximately 2 weeks (about 11/12) after the booster I developed round hives on my wrists, ankles, tops of feet, waist area.  Also developed dermatagraphia (skin writting) at same time.  Treated with Claritin and Benadryl until I could get into the dermatologist a week later (about 11/18/22).  Diagnosed with dermatagraphia and treated with Xyzol.  Dermatagraphia is still present even with medication.  Quality of life has been greatly reduced.
Patient given expired fluarix vaccine; This case was reported by a other health professional and described the occurrence of expired vaccine used in a 6-year-old patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number CA599, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th November 2022, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 25th November 2022, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-Nov-2022 Reporter's comment: The reporter was reaching out to saw if they can get some guidance after administering an expired Flu vaccine to a pediatric patient.  The patient's guardian was a physician and would keep an eye out for adverse reactions. The reporter asked that what was next steps, the patient need to be revaccinated. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Fluarix quadrivalent, which led to expired vaccine used.
1:02 PM   Nurse arrived to  find patient siting in recliner with feet elevated. EMS @ patient's site. Patient c/o feeling shaky and chills.  Patient report feeling tense. Vital signs every 5 min x 5.  1:02   148/98, 98, 18, 98%    Lungs clear, reporting shaking and chills 1:09   132/82, 80, 18,  98% 1:13    132/82,  80, 18, 98%  Patient reports less tense. 1:19    136/90, 88, 20, 100% 1:25    143/86, 96, 18, 100%  Patient reports feeling better. Patient ambulating independently. Patient is leaving her car on site and a friend is giving her a ride.
Administer annual flu shot on 1/6/14 patient states developed throat irritation that night. Next am notes small lumpy itchy rash to (R) shoulder blade, rt flank none on (L) side.
This is a spontaneous report from a contactable consumer (patient) received from program. A 65-years-old male (reporter) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8732), via an unspecified route of administration on 28Mar2021 as dose 2, single, and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on 07Mar2021 as dose 1, single, both (at the age of 65-years-old) for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD), he had been diagnosed for 3 years and he is on 3 different inhalers for it. Concomitant medications included BREO ELLIPTA, VENTOLIN, and SPIRIVA RESPIMAT all taken for chronic obstructive pulmonary disease from an unspecified start date and ongoing. On 02Aug2021, the patient tested positive for the delta variant. It was reported that the reporter, patient, had Pfizer COVID vaccines and then tested positive for the delta variant on 02Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive for delta variant on 02Aug2021. The clinical outcome for the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202101075459 Same reporter, drug, event for different patients.
vaccinated with Pentacel on 23 Aug 2017, 14 Nov 2017, and 08 May 2019, rather that receiving the component vaccines; Initial information received on 09-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who experienced vaccinated with pentacel on 23 aug 2017, 14 nov 2017, and 08 may 2019, rather that receiving the component vaccines, while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported.  It was an actual medication error case due to Single component of a two-component product administered..   No adverse event was reported.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a seven-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
On the first day I noticed that an area on my right shoulder was sore. The next two days my left arm was very sore. Didn?t feel any other reaction until day 7 in the evening when my left arm had a large red area that?s warm to the touch. I?ve also felt incredibly fatigued on day 7 as well that continued into day 8.
This spontaneous report was received from a licensed practical nurse referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, drug and allergy history were not reported. The patient's concomitant therapy was not reported.  On an unknown date, the patient may have received one of the improperly stored lots of GARDASIL 9 lot # M035486 and expiration date on 05-JUN-2019 or lot # reported as M018626 and expiration date on 11-MAR-2018, or PNEUMOVAX 23 lot # N005096 and expiration date on 22-OCT-2018 or lot # N003993, expiration date on 22-OCT-2018 or lot # M042599, expiration date on 17-JUN-2018, or with VAQTA lot # M031806 and expiration date on 30-MAR.-2018, or RECOMBIVAX HB lot # M041384 and expiration date on 09-JUN-2019, or lot # M033096, expiration date on 31-MAY-2018, or lot # M041384 and expiration date on 07-JUL-2019. (neither the dose nor the route were provided for any of the vaccines) for prophylaxis. The reporter was not sure which of the vaccines the patient received. On an unspecified day, the data logger registered that during 6 hours and 52 minutes, the temperature under the vaccines were stored, was in the range (9°C to 25°C) and there was a prior temperature excursion in the range (9°C to 25°C) for 10 hours and 15 minutes. no adverse events were reported. Lot number M018626 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Additional information has been requested.
SIDS;pt recv vax 28APR97 & later that afternoon pt was found expired by babysitter who had put pt down fro a nap;pt was transported to ER:ER is attributing incident to SIDS;
02/04/22 presented to ED for "syncope ". PMHx of "ADHD, depression, anxiety, and asthma"
UNSPECIFIED ADVERSE EVENTS; This spontaneous report received from a consumer via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified adverse events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse events was not reported. This report was non-serious.
Started with chills. Progressed to also include fatigue and muscle soreness around 10:00 AM. At 10:30 AM, visible involuntary movement of muscles, trouble walking. Took Advil at 10:45 AM, symptoms started to gradually disappear.
10 pm - arm near injection site was really sore, it hurt to touch or lift my arm.  I was really thirsty (even after drinking lots of fluids throughout the day). I started  getting a headache so took a normal dose of acetaminophen.  Woke up a few times in the middle of the night, still with thirst/headache (drank another 32 oz over the course of the night). The following day continued to have a really bad headache despite taking acetaminophen throughout. I also continued to feel very thirsty/dehydrated despite drinking more water than usual (drank close to 200oz of water/ Vitamin Water). Had a sharp muscle ache on the right side of my chest that continued into the next morning. Went to bed with a slight fever. Woke up with no fever but still felt very dehydrated and had a slight headache throughout that 3rd day. Felt Mostly back to normal by the end of day 4.
Fine, itchy rash 2 days after vaccine, rash was localed on upper chest and arms and neck and joint pain in shoulder.
local reaction 4in x 9 1/2"; erythema, warmth, discomfort;
PATIENT ADMINSTERED CORRECT VACCINE. PHARMACY PROCESSED PFIZER TO INSURANCE INSTEAD OF MODERNA
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. NO information regarding the patients' medical history, concurrent conditions or concomitant therapies were reported. On an unknown date, the patients were inadvertently vaccinated with improperly stored doses of VARIVAX injection (lot # reported as L037356 with expiration date 28-SEP-2017 and lot # reported as M007287 with expiration date 12-FEB-2018) (doses and routes of administration were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
PATIENT WAS GIVEN AN UNDILUTED COVID PEDATRIC VACCINE . NO SYMPTOMS WERE DISCLOSED BY MOM.  MOM  WAS TOLD TO WATCH HIM AND SEEK FURTHER MEDICAL ATTENTION IF NEEDED. MOM TOOK HIM TO EMERGENCY ROOM THAT NIGHT FOR FURTHER EVALUATION.  SPOKE WITH MOM TODAY (NEXT DAY ) TO FOLLOW UP ON PATIENT. SHE STATED HE'S BEING TAKEN CARE OF AND UNDER OBSERVATION. SHE DIDN'T DISCLOSE IF HE HAD SYMPTOMS  OR OUTCOMES .
Pain in armpit (lymph node); vomiting; Involuntary minor convulsions; high fever spiked; delirium; crying and moaning; crying and moaning; sore arm at injection site; Chills; aches /moderate body aches; Nausea; General unwell feeling; light headedness; Sore arm within min of shot, eventually led to very sore arm; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0217), intramuscular in left arm on 07Oct2021 11:00 (at the age of 27-years-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included none. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), intramuscular on 19Jan2021 (at the age of 26-years-old) as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), intramuscular on 09Feb2021 (at the age of 26-years-old) as dose 2, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. Patient did not have any known allergies. The patient experienced involuntary minor convulsions, high fever spiked, delirium crying and moaning on 07Oct2021 20:30, sore arm within min of shot, eventually led to very sore arm on 07Oct2021 16:00, sore arm at injection site, chills, aches /moderate body aches, nausea, general unwell feeling, light headedness on 07Oct2021 20:30, vomiting on 08Oct2021 00:30 and pain in armpit (lymph node) on 08Oct2021 11:00. Patient reported to have fever ranged from low grade to 102 throughout the night from hour 10 to hour 21. Pain in armpit (lymph node) was noticed 24 hours post-dose and still persists 94 hours later. Still have a sore arm at injection site, but mild. Patient's husband almost brought her the hospital during one of high fever/crying/moaning/delirious episodes. Symptoms significantly worse than the flu. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of Involuntary minor convulsions, high fever spiked, delirium, crying and moaning, Sore arm within min of shot, eventually led to very sore arm, Chills and vomiting were resolved on an unspecified date. Nausea was resolved after 4 hours on 08Oct2021 00:30. Events aches /moderate body aches, General unwell feeling and light headedness were resolved on 10Oct2021 08:30. Event sore arm at injection site was resolving and Pain in armpit (lymph node) was not resolved.
Eyes turn red draining large amounts of yellow green puss. High fever on and off for a week. Stress caused angina took several nitro's. Was told to go to hospital but refused. In bed for a week could not walk. (The 1976 flu shot made me sick for years and ruined my never compensated in any way). (Never had a flu shot since 1976 had bad side effect ruined my health). They used big time scare tactics this time.