chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A consumer report has been received. The report concerned a five year-old female patient. No concomitant medication or relevant medical history has been reported. the patient had been receiving nasal FLUMIST on 13-Sep-2012. The patient experienced flu-like symptoms for 10 days started on 13-Sep-2012. The flu-like symptoms resolved on 24-Sep-2012. The report was considered to be non-serious by the reporter. Summary of follow-up information received on 25-Sep-2012 from the reporter: the outcome of the event added as recovered. The patient's details added. Start date and stop date of the adverse event added. Narrative updated. The start date of the suspect drug added. Corrected report: have you reported this adverse event previously and form completed by and relation to patient added to the first reporter instead of the second reporter. Fever added to lab page. The reporter's phone number added.
Becam ill 18MAR92 t100 ax, nasal congestion, watery eyes, very fussy, restless-not sleeping well; Had these same things happen p/other immun; by 21MAR92 no further temp, no congestion, less fussy;
Information has been received from a nurse referring to a 5 year old (also reported as 6 year old) male patient. Concomitant therapies included sterile diluent. Information about concurrent condition and medical history was not provided. On 09-AUG-2018 the patient was vaccinated with PROQUAD via subcutaneous, (lot # N023966, expiration date 28-FEB-2019), for prophylaxis (strength, dose and frequency were not reported) and VARIVAX, (lot # N002203, expiration date 19-JAN-2019), subcutaneously for prophylaxis (strength, dose, frequency were not reported) (overdose). No adverse effect reported.
Moderna 4/1/21, 4/29/22. Positive on 7/29/22
post administration syncope. VS taken - stable. Pt gieven water and snack. Pt monitored and released to uncle after 90 minutes.
Patient started feeling numbness from head down to her legs at 2:56pm, call 911 at 2:59pm, then chest tightness at 3:03pm and given Epi pen at 3:04pm. EMS took over care at 3:10pm
Developed fever of 103 overnight; sore arm; headache; myalgia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 11Jul2022 at 12:40 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Jul2022, outcome "unknown", described as "Developed fever of 103 overnight"; HEADACHE (non-serious) with onset Jul2022, outcome "unknown"; MYALGIA (non-serious) with onset Jul2022, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset Jul2022, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Event took place after use of product.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Rash appearing 2-3 hours after vaccine administration. Erythematous macular popular rash on abdomen, back, Left arm. Not itchy, not painful, not vesicular. No mucosal involvement. No fevers, chills, evidence of systemic involvement. Rash stable in appearance and distribution at time of clinic visit which was 1 week after vaccine administration.
This is spontaneous case, initially received from other-health professional (nurse) on 07-Dec-2017, concerning a 69-year-old elderly female patient. The patient's medical history and concomitant medications were not reported. It was reported that FLUCELVAX was out of recommended range for few days which occurred on 12-Nov-2017 for about 30 minutes lowest temperature 34.7 degrees F and reoccurred on 27-Nov-2017 through 01-Dec-2017 with the lowest 27.5 degrees F. On 01-Dec-2017, the patient was administered with FLUCELVAX QUADRIVALENT (batch no: 195250 and expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported). The reporter assessed this case as non-serious. Follow up report received on 29-Jan-2018: It was reported that, the nurse did not want to provide any further information, hence the case was lost to follow up. Non-significant case correction received with IRD 07-Dec-2017: The case comment was corrected. No changes were made in the narrative.
pt recvd flu vax & 3 days later devel a reaction @ the inject site consisting of erythema & rash; pt also devel a pruritic rash on arms, back, face, & scalp;
I had chills and thought I had fever, but I didn't.  I was really tired and sleeping all the time for about a week.
Raised; Itchiness; Redness; Firmness; Sore; Red Spot; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (Red Spot), ERYTHEMA (Redness), PRURITUS (Itchiness), MYALGIA (Firmness) and RASH PAPULAR (Raised) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M201A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced RASH MACULAR (Red Spot). On 16-Feb-2021, the patient experienced ERYTHEMA (Redness), PRURITUS (Itchiness), MYALGIA (Firmness), RASH PAPULAR (Raised) and MYALGIA (Sore). The patient was treated with HYDROCORTISON [HYDROCORTISONE] at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Red Spot), ERYTHEMA (Redness), PRURITUS (Itchiness), MYALGIA (Firmness), RASH PAPULAR (Raised) and MYALGIA (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included Ice.   Reporter did not allow further contact
Patient was given Dtap (DAPTACEL) instead of Tdap (ADACEL). Patient is 17 yo female. Mix up was in verbal order to medical assistant from nurse practitioner in what vaccine to give. Paper chart order was correct. Patient and parent told of error in vaccine given. In future NP and medical assistant will communicate better verbally and by checking charts before giving vaccines.
pt recv vax 3FEB97 & pt w/fever, swollen glands (parotid), mild fussiness;pt examined negative neuro;+parotitis bilat;T101.2;seen in f/u 24hr later w/improvement of parotitis but w/RAOM;
I got the shot early in the AM but didn't start feeling poorly until around 4:00 pm.  I first noticed I was feeling flu'ish with a very bad headache, felt like I was getting a fever (but did not), all over body aches but worse in my neck, shoulders and back.  However I didn't get alarmed until I had trouble breathing.  That's when I looked at the "reaction page" and realized it was one of the "sever allergic reactions" listed.  I took Benadryl and was able to breath more comfortably.  Saturday the symptoms lessened but were still bad enough to keep me in bed and taking more Benedryl.  By Sunday, I was feeling 80% better.
After receiving the first dose of the shingrix, pt started having pain radiating down to her fingers, along with decreased function in her hand.  pain subsided after 24 hrs.  Pt experienced swelling in her hand, as well as fever and aches.  All symptoms resolved within 72 hours
right arm was paralyzed; Caller experienced pain in her Rt arm on Friday, 12March2021 (injection was in Lt arm); Caller also noticed  pain in her breast/stinging pain in breast; aggrevated joint pain; She reports a diagnosis of Sjogren's; This is a spontaneous report from a contactable consumer (patient) via medical information team. An 83-year-old female patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206, Expiration date was not reported), via an unspecified route of administration in left arm on 11Mar2021 02:00 as single dose for covid-19 immunisation. Medical history included blood pressure high. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was none and additional vaccines administered on same date of the Pfizer Suspect reported as none. Patient received the Covid-19 vaccine. Patient had a really bad reaction to it and has to have an ultrasound. Patient has been having problems with joint pain. Patient has Sjogren's Disease on Mar2021. patient had the vaccine last Thursday. Patient woke at 2:00 in the morning and her right arm was paralyzed on 12Mar2021. Patient took Motrin for that. On Friday patient felt a stinging pain in her right breast and pain in her Rt arm (injection was in Lt arm) on 12Mar2021. patient felt better after taking Motrin. Her doctor advised her to have an ultrasound. She typically has joint pain. After having the vaccine it was aggravated on 12Mar2021. patient was unsure if patient should have the second dose. patient saw her doctor on Monday. She will need to have an ultrasound of her right breast. She takes two blood pressure medications and other medications. Therapeutic measures were taken as a result of right arm was paralyzed (monoparesis). The outcome of the event breast pain was recovered on 12Mar2021, right arm paresis was recovered on Mar2021 and unknown for other events.
Information has been received from a physician and a practice manager via company representatives referring to a patient of unknown age and gender. On 23-FEB-2016, the patient was vaccinated with an improperly stored dose of VAQTA, pediatric (PED), lot # L004743, expiration date 01-JUN-2017 (dose and route unspecified). This specified lot number vaccine was exposed to temperature excursions twice. The storage criteria was refrigerator (R). The total cumulative excursion times (hour), the lowest recorded temperatures (Fahrenheit degree) and the type of excursions (R/F) were as following: the first time excursion 768, 34 and R; the second time excursion 168, 32 and R. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 25-SEP-2014 the patient was vaccinated with an improperly stored dose of PROQUAD (lot#, strength, dosage, frequency and route). This is one of several reports received from the same reporter. Additional information is not expected.
The Menactra dose that was given on 31Jan2022 had expired on 09Jan2022, with no reported adverse event; Initial information received on 07-Feb-2022 regarding an unsolicited valid non-serious case was received from a pharmacist.  This case involves an unknown age and unknown gender patient who received meningococcal a-c-y-w135 (d conj) vaccine (Menactra) dose that was given on 31-Jan-2022 had expired on 09-Jan-2022, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Jan-2022, the patient received a 0.5 ml, total dose of suspect meningococcal a-c-y-w135 (d conj) vaccine (lot number not reported, expiry date: 09-Jan-2022) via unknown route in unknown administration site for immunization (expired product administered, latency: same day).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (The Menactra dose that was given on 31Jan2022 had expired on 09Jan2022, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event the menactra dose that was given on 31jan2022 had expired on 09jan2022, with no reported adverse 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.
Wrong bivalent was given. He was given the 0.2ml volume (yellow label) instead of the 0.25ml (gray label) Moderna bivalent. MD was made aware. Pt with no signs of symptoms of adverse reaction. Pt was discharged home in stable condition.
Patient received her first dose of shingles (shingrix) vaccine in April and subsequently developed a one sided itchy, painful rash on her thigh, groin, and up to her stomach.  Patient sought care from her doctor who treated the rash with oral anti-virals and various topical creams.  The rash has since improved but has not completely healed.  (Patient also has psoriatic arthritis).   Please note I do not know the exact date the rash started.
Severe nephrotic syndrome relapse. She has been in remission for over 2 years, off of ay treatments. Developed massive proteinuria > 20000 mg per day, 2 weeks after 1st dose.
One week after my injection, my multiple sclerosis symptoms were exacerbated.  I was very numb,   severe headaches, mental fog and balance issues. These symptoms were intense and continued throughout  the summer. On September 23, 2020, I scheduled an appointment with my doctor.  We discussed the events from the vaccine and debated the choices for receiving the second injection.  We decided on a wait and see option to be reassessed before December.  We also decided to make contact with my neurologist for a consultation.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 29-OCT-2008 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. The patient received the 2nd dose of GARDASIL 08-JAN-2009 and the 3rd dose of GARDASIL on 19-MAR-2014. (Consider inappropriate schedule of vaccine administration.) Additional information has been requested.
pt recvd vax;after leaving clinic, pt began crying & would not stop;MD saw pt & gave advil elixir & baby finally quit crying after 2 or 3 hrs;
Patient complained of swelling and soreness at injection site.  Patient states the injection was given subcutaneously rather than intramuscularly.
Acute myopericarditis: chest pain, presenting w/ EKG findings of pericarditis and elevated troponins; improved w/ pain medications and supportive care; no significant complications at time of report (patient remains admitted for care coordination)
2 of their staff members received expired FLUZONE QIV NP with no reported adverse event; Initial information received on 13-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient(s) who received expired Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] 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 0.5 ml of suspect Influenza quadrival a-b vaccine Suspension for injection (lot number: UT7731MA, Expiry date: 30-Jun-2023) via unknown route in unknown administration site for immunization.  On an unknown date, the patient(s) received expired Influenza Quadrival A-B Vaccine with no reported adverse event (expired product administered) (latency: same day).  It was reported, Nurse explains that they share a building with another program; explains that the other program had been storing FLUZONE QIV NP that was past expiration date, and the other program had sent the expired product to them; states that 2 staff members were given expired FLUZONE QIV NP. He asks if there is any extension on the expiration date; asks if it is safe to use: No additional information available at time of call; caller declined to respond to questions and has accepted follow-up. This situation is reported as a medication error due to expired product was administered.  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.
vaccine administration error:  Vaccine recipient had primary series of Moderna.  Vaccine recipient requested Moderna booster.  Pt received Pfizer covid 19 booster.  Vaccine recipient was made aware and given phone number to call if concerns.
Fever - 11/01 morning and still ongoing  Chills - 11/01 pm and ongoing Tiredness - 11/01 morning and ongoing  Body aches - 11/01 morning and ongoing  Nausea - 11/01 pm and ongoing
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 12-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Severe pain in shoulder joint - unable to move or lift arm without excruciating pain. No redness or swelling.  Severe shaking due to pain.
9/25/02 parent report: 24 hrs after receiving immunizations on 9/12/02. Child's right upper arm became "red, swollen and itched." No fever. Child was given Advil. Parent reported child's symptoms to his physician's office the same day. Parent states she was told to continue Advil and apply warm/moist compresses to child's arm. Parent states symptoms were gone in 4 days.
LEGS FEEL LIKE LEAD; PAIN IN THE JOINTS; CHILLS; DIFFICULTY BREATHING; COLD LEGS; LACK OF APPETITE; This spontaneous report received from a patient concerned a 72 year old male. The patient's weight was 170 pounds, and height was 72 inches. The patient's concurrent conditions included allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: 04-JUL-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced difficulty breathing. On 29-MAY-2021, the subject experienced cold legs. On 29-MAY-2021, the subject experienced lack of appetite. On 29-MAY-2021, the subject experienced pain in the joints. On 29-MAY-2021, the subject experienced chills. On an unspecified date, the subject experienced legs feel like lead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the joints, cold legs, lack of appetite, difficulty breathing, chills and legs feel like lead was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Oval, bright-red, bumpy rash 2x3 in diameter; Itching near site of rash; Oval, bright-red, bumpy rash 2x3 in diameter; Oval, bright-red, bumpy rash 2x3 in diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAPULE (Oval, bright-red, bumpy rash 2x3 in diameter), VACCINATION SITE PRURITUS (Itching near site of rash), VACCINATION SITE RASH (Oval, bright-red, bumpy rash 2x3 in diameter) and VACCINATION SITE ERYTHEMA (Oval, bright-red, bumpy rash 2x3 in diameter) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAPULE (Oval, bright-red, bumpy rash 2x3 in diameter), VACCINATION SITE PRURITUS (Itching near site of rash), VACCINATION SITE RASH (Oval, bright-red, bumpy rash 2x3 in diameter) and VACCINATION SITE ERYTHEMA (Oval, bright-red, bumpy rash 2x3 in diameter). On 13-Mar-2021, VACCINATION SITE PAPULE (Oval, bright-red, bumpy rash 2x3 in diameter), VACCINATION SITE RASH (Oval, bright-red, bumpy rash 2x3 in diameter) and VACCINATION SITE ERYTHEMA (Oval, bright-red, bumpy rash 2x3 in diameter) had resolved. On 17-Mar-2021, VACCINATION SITE PRURITUS (Itching near site of rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
This spontaneous report as received via social media who reported multiple patients (unknown age and gender) who on an unspecified date were vaccinated with a dose of GARDASIL (dose and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that on an unspecified date, the patients were severely affected from the vaccine. No treatment information was reported. At the time of the report, the patients outcome for the adverse event was unknown. The relatedness for the adverse event was related for GARDASIL. This is one of the several reports from the same source. Additional information is not expected.
Sore mouth and red lips after 1st dose. Swollen tongue after 2nd pill. Patient was treated with Lidocaine solution.
The  areas around the old smallpox vaccine scar became inflamed and started to itch about 24 hours after Moderna booster injection.  It stops itching with oral citirizine, but starts itching again when the antihistamine effects start to wear off.  First two doses of covid  vaccine were Pfizer in the same arm at the same site and there were no adverse side effects after both Pfizer doses.
VASO VAGAL RESPONSE, FAINTING, ABNORMAL JERKING MOVEMENTS