chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of doctor gave my child a full dose of FLUMIST in one nostril and a full dose of H1N1 in the other nostril was received from a registered nurse/father in nurse USA concerning his 46-month-old daughter. On 14-Oct-2009, the patient received a full dose of FLUMIST in one nostril and a full dose of H1N1 in the other nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Required follow-up attempts have been performed requested information unable to be obtained.  01-MAR-2010.
Patient became "itchy" within 5 minutes after injection.  She also was very nervous and anxious about getting her shot.  She didn't seem to have a problem with the first dose.  She was monitored by paramedics on scene at the mass vaccination clinic.  Given Benadryl by paramedics and unsure if this was PO or IM.  Patient felt better after 10 minutes of monitoring from paramedics.
heart began 4acing and pounding; problems breathing; wheeze; asthma attack; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot no.: EN6204) via unspecified route of administration at single dose on 10Mar2021 10: 00 AM at left arm for Covid-19 Immunization. Medical history included splenectomy from 2002. The patient has not reported any allergies. Concomitant medication within 2 weeks included 10 mg of fluoxetine hydrochloride (PROZAC) every other day. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not tested positive for COVID-19 after vaccination. On 11Mar2021 after 4 hours of sleep patient woke up and went to urinate, returned to bed at that time (reported as 3hich time) her heart began 4acing and pounding like nothing she had never experienced before. Event start time was 11Mar2021 12:45 AM. The patient slept another 12 hours. At hour 16 after cardio event, she had problems breathing and began to wheeze and had an asthma attack. No therapeutic measures were not taken for the events. Patient had recovered from the events on an unknown date in 2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care.  No follow-up attempts possible. No further information expected.
Pt experienced local induration with erythema, nausea, vomiting and arthralgia.
Patient received his second dose of Moderna on 4/9/21. The evening following the second Moderna vaccine, he developed fever, chills and sweats. He started to develop chest pain in May 2021 that lead to an Emergency Department visit, in which he was treated and released. On May 25, 2021, he was hospitalized at Hospital due a Myocardial Infarction that lead to Cardiac Arrest. He was successfully resuscitated spent 5 days in the Intensive Care Unit. He was informed  that he developed Kidney Damage as a result of this event.
Chills, sinus headache, stomach discomfort, body ache, fever, arm pain, muscle pain, nausea, feeling unwell, decrease appetite
arm was sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date refer case US2021AMR256463).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that getting shingles shot was no big deal. The patient's arm was sore for one night after 2nd dose of Shingles. The follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR256463:same reporter - 1st dose
10/29/10 - slight swelling, redness and warm to touch on deltoid. AUGMENTIN ES-600 given. 10/30/10 - swelling and redness continues. Normal WBC, but sent to ED for evaluation, admitted. Clindamycin 300mg X 7 days. Discharged 11/1/10.
15 plus days of heavy vaginal bleeding 1 day after 2nd dose of Pfizer vaccine. Experiencing large blood clots and cramping throughout period. Never had a period this long with this amount of blood and clotting.
expired dose of Fluzone HD administered to the patient, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA268346, 2019SA268355, 2019SA268356, 2019SA268357, 2019SA268358, 2019SA268359, 2019SA268360 and 2019SA268362 (same reporter).  This case involves a 81 years old female patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI994AA, Exp. Date 09-Apr-2019) via intramuscular route in the right deltoid on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  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.  List of documents held by sender: none.
Extreme fatigue onset, felt heavy limbed and sore throat. The next morning, had allergic reaction - head congestion, eyes streaming, violent headache. 9/14 in am, had stiff, painful neck and migraine, photosensitivity that lasted for 3 days.
Shot was received Sunday evening. The following Friday after school, our son has a pretty substantial rash in the crotch area and on his back. That looked better in the morning with a dose of Benadryl overnight, but more rash had developed on his stomach and under his arms. Another dose of Benadryl was administered Saturday night. All the rash had pretty much resolved by Sunday and was totally gone by Monday. We sent our doctor a message on Monday. She said the timing and appearance would make her more suspicious of a mild allergic reaction to something he came in contact with rather than the vaccine, but she thought it worth noting and reporting to VAERS.
This spontaneous report as received from medical assistant refers to a patient of unknown age and unknown gender. No information on medical history and concomitant medication was provided. On 15-NOV-2013 the patient as vaccinated with MMR II (lot # 0705AA, expiration date 05-NOV-2013), intramuscular for an unknown indication. This was the only dose of MMR II this patient has ever been administered. On 15-NOV-2013, the patient was administered an expired dose of MMR II. No adverse effect was reported. The outcome of was administered an expired dose of MMR II is unknown. Additional information is not expected.
Temperature up to 100.9 for two days. Red, hard, swollen, painful area 2 inches in diameter lateral to injection site.
DEATH; HEMORRHAGING AND BLEEDING; FELT BAD; BACK PAIN; This spontaneous report received from a patient via a company representative concerned a 37 year old female of an unspecified race and ethnic origin. The patient's weight height and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) dose was not reported, 1 total administered on 02-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-SEP-2021 (Saturday), the patient experienced back pain and felt bad and went to the emergency room. She had tests run and was then sent home. On 05-Sep-2021, she developed hemorrhaging and bleeding and ambulance returned for her. On 07-Sep-2021, she died due to unknown cause. It was not reported, if the autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 07-SEP-2021, and the outcome of feeling bad, back pain and hemorrhaging and bleeding was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210924439-JANSSEN COVID-19 VACCINE Ad26.COV2.S-  Death, Hemorrhaging and bleeding. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
patient woke up the morning after vaccination with 3 red bumps on face (right below L eye, nose, jawline L side) and one fluid filled spot of L arm.  Mother reported to this nurse, who reported to a provider in the office.  Discussed symptomatic care (antihistamine PRN, hydrocortisone/calamine lotion, staying away from unvaccinated persons).
Pt received 6 MO immunizations 10/18/16. Later that night pt started with a fever of 103.7. Mom gave him TYLENOL, pt seen at urgent care 10/19/16. Morning of 10/20/16 mom woke up pt felt very warm was going to give him TYLENOL and pt started to have a seizure, taken to the ER.
Experienced a severe allergic reaction 3 days after my second dose of the Pfizer vaccine.  It happened after eating dinner a restaurant.  At the time I was 29 years old and had never experienced any type of food allergy (mild or severe).  I experienced hives and redness all over my body including my face and neck.  I was treated with prednisone and Benadryl.  The symptoms faded an hour after taking medication.  The reaction did not cause any airway problems.  Additionally I had a similar allergic reaction 30 days later after eating breakfast.  This time benadryl was the only drug available and symptoms also faded afterwards.  Obviously one could assume this is a coincidence.  Six months have now passed and I have not had any further allergic reactions.  So in my 30 years living I have had only 2 reactions. And both were 3 days and 30 days following Pfizer vaccine.  All of the foods I ate during the 2 meals which caused the reaction were not new to me.  I had eaten them before with no reaction.  I thought I should share this with your database.
body was aching; Diarrhoea; and I felt like I got to throw up but nothing was coming up; I was not feeling well; This is a spontaneous report received from a contactable consumer or other non hcp. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC) via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunization. The pa-tient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Lot: Unknown) on 20May2021 via an unspecified route of administration for COVID-19 immunization. Patient stated, I got my second shot on Thursday but, On unknown date my body was aching and I got Diarrheas and I felt like I got to throw up but nothing was coming up and now since yesterday it as worse as today. Well that did not work for me because I was not feeling well. Reported that, I need to speak to somebody because this was not normal. I had my first shot on May 20th and then I had my second shot. Consumer was suggested to reach out to the nearest ER or call in case of urgency. The outcome of the events was reported as unknown.   Information about lot/batch number has been requested.
Information has been received on 04Jun2003 from a RN concerning a female hospital employee who possibly in the past few weeks was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt's unvaccinated child had developed varicella after being exposed in day care (noted to be unknown if it was transmission or live virus exposure) The child had broken out with lesions. Subsequently, the mother "broke out with lesions, but the mother's lesions did not look the same. One lesion reportedly looked like varicella but other lesions were atypical. She had a total 20 lesions. She started with symptoms on 20May2003 to 26May2003. The mother again broke out on 02Jun2003 and saw her doctor. It was noted that the mother received no treatment. It was also reported that the pt had two other vaccinated children who developed varicella. Additional information had been requested.
No Adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No Adverse event) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 014F21A, 030L20A and 025L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
Soreness; Light headache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EP6955, Expiration Date: 30Jun2021) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Soreness"; HEADACHE (non-serious), outcome "unknown", described as "Light headache".  Additional information: Description of Event: Soreness Light headache. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Information received from a RN, post vaccine the pt received a spot type band aid at the injection site. Three weeks to one month later the pt noted circular discoloration on the left arm that was described as a round light area with a darker center circle at the injection site. F/U updated box 24, pt name, dob, date of vaccine, date of report,adverse event onset 10/00.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Lot number: GJ3277), in left arm and on 13Jul2023 as dose 6 (booster), single (Lot number: GH9702) at the age of 65 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: ER8729), in left arm, on 30Apr2021 as dose 2, single (Lot number: EW0173), in left arm and on 21Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).
A four month old patient was administered Quadracel instead of Pentacel, no AE; A four month old patient was administered Quadracel instead of Pentacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information inbound (reference number- 00506213) and transmitted to Sanofi on 05-Mar-2021.  This case involves a 4 month old male patient who was administered 0.5 ml second dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (batch number C5656AA and expiry date: 31-Aug-2021; Strength: regular) via unknown route in unknown administration site for prophylactic vaccination on 05-Mar-2021, instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered and product administered to patient of inappropriate age)  The patient's medical history, medical treatment(s), vaccination(s), and family history were not provided.  The patient's concomitant medications included HEPATITIS B VACCINE, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.   It was a case of an actual medication error due to inappropriate age at vaccine administration and Wrong vaccine administered (latency same day).  The medical assistant reported that earlier today, a 4-month-old child was prescribed Pentacel vaccine, but was inadvertently administered Quadracel. They would administer Act-HIB at 6 months of age. Therefore, the reporter was requesting a guidance.  At the time of this report, it was unknown if the patient experienced any adverse events.  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 2001/3/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.  There will be no information available on batch number for this case.
Patient is a 55-year-old female who had presented to the vaccination clinic this afternoon to receive her COVID-19 vaccine.  She does have a history of migraine headaches and other comorbidities as described below.  Has had reactions to a number of medications, mostly narcotics as noted in her allergy list some of which could in theory be compatible with urticaria.  Does not have true anaphylaxis in her history. Today at about 15 minutes after administration of her COVID-19 vaccine she began to rather precipitously developed an itchy crawling feeling in her skin, nausea with retching and some shortness of breath.  She did not have the sensation of her throat closing off.  Did not have coryza.  Within about 10 minutes she did develop difficulty with speech that she says is typical for her migraine headache.  She received, in the vaccination Clinic, epinephrine 0.3 mg subQ, 125 mg of Solu-Medrol and 50 mg of Benadryl all IV.  An IV was started and a 500 mL bolus of saline was initiated.  With this she was then transferred to the emergency room for further evaluation.   In the emergency room she did develop chest heaviness but no palpitations.  She was not dyspneic.  Her nausea and vomiting by then had seem to resolve.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer product on 03/18/2021, 04/08/2021, and 11/08/2021. The individual reported no symptoms, but was tested after a known COVID-19 exposure. They tested positive for COVID-19 on 01/10/2022 via PCR test. They were admitted to hospital on 01/10/2022 and discharged 01/14/2022. However, they were admitted to a different hospital on 01/16/2022 and remained hospitalized until their death on 01/31/2022.
Tdap vaccination given instead of DTaP. Telephone call to CDC. No action needed. Child does not need to receive DTaP in addition. Tdap to be given at time of regular booster
This was the second in the series of shots. The first caused mile aches and pains which ended after a day. This time she had Flu-like symptoms including headache, muscular aches, nausea and vomiting, and inflammation of the eyes, tightening of throat. She was so sick that at on December 12, about 24 hour after she got the injection we went to Hospital Urgent Care. They said she was suffering from anaphylactic shock and administered epinephrine and another injection (not sure what it was) and called an ambulance to transport her to Emergency Department. At the ED she was given two IV's and other treatment. After about three hours she was sent home.