chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative referring to approximately 14 year old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unspecified. On 28-MAR-2014 the patient was vaccinated with GARDASIL, [lot # not reported], intramuscular (dose and frequency not reported). No other concomitant therapies reported. On 28-MAR-2014, the physician reported that the patient stood up after receiving GARDASIL in an office visit and fainted. On 28-MAR-2014 the patient fell and received concussion, busted lip and had seizure activity. It was reported that the patient was taken to the emergency room but was not admitted. The patient received the treatment (unspecified) for the events. The patient sought medical attention in doctor's office. There was no intervention to prevent the seriousness criteria. The event was not life-threatening. There was no PQC reported. The outcome of the events, had seizure activity, fainted, the patient fell and received concussion and busted his lip was unknown. The causality of the events was unspecified. Additional information has been requested.
SHORT-DATED PRODUCT (LOT FL2757, EXP 9/30/22) ADMINISTERED TO PATIENT ON 10/1/22
Pain in right arm that started 1 day after administration and continued to worsen; pain down right arm, difficulty actively moving arm due to pain
School event for vaccines in the school parking lot.  Pt came for her routine vaccines appropriate for age, Men-B vaccine.   Pt  patient had two  MCV4 .   A 3rd. dose was administer. Pt did not have any reaction or presented any difficulty at moment of vaccination.   The patient was in the  routine visit to get her 1st dose of dose of Men-B.   The staff notice after the event that the patient had a third dose of MCV4.
Patient called complaining about fever that lasted more than 24 hours and pain all over. Also had a very large blister around the injection site. On 09-29-2019, talked to patient and she no longer has fever or aches and site blister getting better.
Vertigo, memory and cognitive issues, headaches, stomach aches, fatigue, shortness of breath,difficulty with concentration
Patient began having shortness of breath about 5-10 minutes after vaccines were given, she complained of feeling like her throat was closing. Provider assessed throat and lungs, RN gave 50 mg Diphenhydramine and brought in EPI PEN. Patient took Diphenhydramine without issue, she said her throat was feeling better but then became nauseated. Vital signs were taken, oxygen and blood pressure were within normal limits. Provider ordered 8 mg Ondasteron which was given. Patient remained nauseated but stated her throat felt fine and her breathing was improving. Patient was being observed in clinic but was pale and still feeling nauseated. 911 was called for transport. About 40 minutes after vaccines were given, patient began complaining of her throat itching, difficulty breathing and severe chills, she was extremely pale and lips had blue tint. 15 liters non-rebreather oxygen started and 0.3 mg IM epinephrine given. About 5 minutes after EPI was given, ambulance arrived and transferred patient to ED.
Patient developed a rash with redness and  swelling around injection site. Patient took diphenhydramine 25mg and rash improved over 3-4 days. Patient says it's total resolved now.
Initial report was received 10 June 2009 from a newspaper article: Two college students (one identified as a male and the other unidentified), had received an unspecified meningococcal vaccine (manufacturer, lot number, route/site and date of administration not reported), and an unspecified amount of time later, they were diagnosed with bacterial meningitis. According to the report, these two students had been diagnosed "earlier this year" and had fully recovered. The specific bacteria and strain were not identified in the report. No additional information was provided at the time of the report. The reporter for this case is the same as case number 2009-02503. Documents held by sender: None. 6/25/09-Follow-up information fromMeningitis Branch staff indicated that the cause of the bacterial meningitis was serogroup B.
Developed dizziness, high-fever (103), and headache approximately 19 hours after administration of Menactra and Adacel.  We treated the patient with Motrin, Tylenol and watchful waiting
Tingling in hands & feet, went to ER, diagnosed with Guillain-Barre, admitted to hospital for 5 days, received IVIG.
Left arm deltoid muscle region distal area of erythema, warmth, slight tenderness, minimal induration, no fluctuation or oozing. Treatment Advil for pain, cool compress, RTC if worsens or fever.
Hot red circular patch around injection site. Skin is a little rough and feels warm to touch and a little itchy. Started yesterday and remains today.
On Wednesday, Feb 17, I experienced an earache in my left ear and an eye twitch in the left eye, which continued to Thursday , Feb 18.  On Feb 18,  also experienced extreme fatigue and a jabbing, throbbing pain behind my left ear that came and went all day.  I also noticed when I brushed my teeth that I had a hard time swishing water in my mouth, especially on the left side.  On Friday morning, I woke up and noticed my left eyelid was drooping and my smile was lopsided.  As I have a history of hemiplegic migraine, I assumed I was experiencing a migraine, although this was not the usual course of these migraines, and I had not had one of these types of migraines in many years.  The left side of my head, behind my ear, and wrapping from my neck to my temple continued to hurt (but not as painful as a normal migraine).  Thinking I was in a chronic migraine state, I took 40 mg of Prednisone, as I have done before to 'cut through' the migraine.  When the facial weakness did not resolve by the next day, I suspected this was not migraine and instead suspected Bell's Palsy and consulted my physician.  Looking back in time, I also realized that I had experienced some adverse tingling/taste sensations on part of my tongue as far back as February 8, that felt similar to burning your tongue from drinking too hot liquids that I realized later could have also been part of the Bell's Palsy.
I received a Flu vaccine and RSV but do not know which they were but was at same time/ It started with a head ache, then chills and i could not stop shaking, I think because i had a 101.2 fever. I became sick to my stomach and dizzy/unstable while walking.  trouble focusing vision. This is day two after shot and I still have head ache and low grade 101 fever.   Head ache id back of skull and low neck.
Breast pain, breast swelling, leaking breast milk, itchy breasts. Lasted for 2 months.
Pt received Kinrix, MMR II, and varicella vaccination. Following vaccination pt nose began to bleed.
Approx 10-15 post vaccine, employee said she felt lightheaded and like her heart was racing. Within 10 minutes she said she felt difficulty breathing, She then vomited. The observation nurse at the clinic administered Epi Pen and called a Code. The employee was transported to the Emergency Dep't and then to intensive care. She was placed on an Epi drip.
Heart beating fast, low grade fever, soreness and body ache. Patient has not seen a doctor but is going to schedule an appointment.
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 7 years old male patient who was vaccinated with the vaccine QUADRACEL (Batch number: C5497AA) (expiry date, dose, dose in series, route and site of administration were not reported) on 25-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because the vaccine was administered to a seven year old patient. It was unknown if any adverse event occurred or not following the administration of vaccination. 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 and Module VI of the 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.
HIGH ANXIETY ISSUES; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's height, and weight were not reported. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced high anxiety issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of high anxiety issues was not reported. This report was non-serious.
bottom lip on left side got kind of big, started itching; left hand can barely open and close; little finger on right hand got swollen; This spontaneous case was reported by a patient and describes the occurrence of LIP PRURITUS (bottom lip on left side got kind of big, started itching), HYPOKINESIA (left hand can barely open and close) and PERIPHERAL SWELLING (little finger on right hand got swollen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bronchitis.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Feb-2021, the patient experienced LIP PRURITUS (bottom lip on left side got kind of big, started itching), HYPOKINESIA (left hand can barely open and close) and PERIPHERAL SWELLING (little finger on right hand got swollen). At the time of the report, LIP PRURITUS (bottom lip on left side got kind of big, started itching), HYPOKINESIA (left hand can barely open and close) and PERIPHERAL SWELLING (little finger on right hand got swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
This spontaneous case, initially received on 10-Feb-2017, was reported by a health professional and concerns a patient of unknown age and gender. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA. Dose regiment: Not reported, Route of administration. Batch number: Not reported. No additional suspect drugs. Adverse event description: It was reported that the patient had already received 2 shots this flu season (outcome: not reported). There was no information about any adverse events an no reaction was reported. Special circumstances: extra dose administered without adverse event. Reporter's comments: The reporter assessed the event as non-serious.
This prospective pregnancy case was reported by a consumer (also the subject) and described the occurrence of injection site soreness in a 20-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. Concurrent medications included TYLENOL and prenatal vitamins. On 5 October 2011 at 12:30 the subject received a dose of FLULAVAL (unknown route, left arm), and experienced vaccine exposure during the first trimester of her pregnancy. Date of last menstrual period was not provided. Estimated deliver date was 01 June 2012. On 5 October 2011, 30 minutes after vaccination with FLULAVAL, the subject experienced injection site soreness. On 6 October 2011, she experienced sensation of fever. On 7 October 2011, she experienced headache. On 8 October 2011, the subject began "feeling stuffy" (stuffiness [nos]) and thought that she was getting a cold. The injection site soreness resolved on 6 October 2011. The sensation of fever and headache resolved on 7 October 2011. At the time of reporting the events of stuffiness and cold were worse. The consumer considered that the stuffiness and cold were not related to vaccination with FLUARIX, but that the other events were possibly related.
BODY ACHES; SORE ARM; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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,) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, fever, chills and body aches was not reported. This report was non-serious.
information has been received from a medical assistant referring to a patient of unknown age and gender. Concurrent condition and medical history of the patient was not reported. On 22-APR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX23 (lot # reported as L003188, expiration date: 06-JUL-2016 (dose and route unspecified) (Incorrect storage of drug). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Called with arm pain, Patient went to doctor. Doctor states the injection was not deep enough and that caused the discomfort.
Muscle aches, dizziness, weakness. Temperature of 103 degrees developed in the night. No treatment except aspirin and sleep.
Flu shot given RUA and covered with Band Aid. When Band Aid removed at bedtime, employee noted a wheal, approximately 10 mm, "like a positive TB skin test."  Subsided by next morning.
About 6 hours after the shot, I started to have very bad chills followed by high fever and joints pain. All of these made it hard to sleep. I didn't have a thermometer to measure but it's probably the highest fever I ever had. There was a lower fever, headache,  joint pain, and fatigue the next day.  I didn't take any medicine just drank a lot of water and my body is back to normal the third day.
Patient received anthrax re-booster vaccine on 9 Oct 2002 (he has a history of completing past 6 sweries of the anthrax vaccine with 2 sppisodes of moderate induration).  He presented to aid center on 11 Oct 2002 with erythema, swelling (firm & taut), increased warmth to touch, mild pain, and mild pruritis.  The area involved covered 3/4 triceps region on left upper arm.  No streaking observed.  The area was outlined to monitor for spread and patient treated for cellulitis.  Treatment was benadryl 50mg caps po hs and erythromycin 250mg tabs, one tab po QID x 10 days (allergic to PCN).  Warm compresses to area TID.  F/U in 48 hours revealed no continuation of cellulitis - a response to therapy and by day 4, he was noted to have resolution of erythema with mild palpable swelling.
A report has been received from a Pharmacist concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 09-Jan-2013. The patient experienced EXPIRED FLUMIST GIVEN which started on 09-Jan-2013. The outcome of the event of EXPIRED FLUMIST GIVEN is unknown. Expired FLUMIST was administered. The report was considered to be non-serious.
Gastric problems; This is a spontaneous report from a non-contactable consumer. This consumer reported for a male patient (father). A male patient of an unspecified age received first dose bnt162b2 (Solution for injection) via an unspecified route of administration on 27Jan2021 as single dose for covid-19 immunisation. Medical history included ongoing sleeping and pain in joints. Concomitant medication included insulin injection, ropinirole 0.5 mg for sleeping, metformin, lisinopril 40 mg, then we have acetylsalicylic acid (ASPIRIN) 51 mg, blood thinner, acetaminophen for pain in joints, cyanocobalamin (VITAMIN B12), ferrous sulfate (iron)". Caller stated he was not a healthcare professional, he called on behalf of his father, his father received first dose of Pfizer-BioNTech COVID-19 Vaccine on 27Jan2021, already reported "having several side effects, gastric problems in 2021. The outcome of the event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Cold sore on my bottom lip nose and the roof of my mouth; Cold sore on my bottom lip nose and the roof of my mouth; This case was reported by a consumer via interactive digital media and described the occurrence of cold sores in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced cold sores and sores roof of mouth. On an unknown date, the outcome of the cold sores and sores roof of mouth were recovered/resolved.   It was unknown if the reporter considered the cold sores and sores roof of mouth to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the consumer for himself/herself. The age at vaccination was not reported. The patient got the first shot, and had every side effect possible,12 days of hell.  The patient had cold sore on bottom lip, in nose and the roof of the mouth. The patient was very very concerned about the second shot.
Mixed dose series (first is pfizer, second shot is moderna); This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Mixed dose series (first is pfizer, second shot is moderna)) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Mixed dose series (first is pfizer, second shot is moderna)). At the time of the report, WRONG PRODUCT ADMINISTERED (Mixed dose series (first is pfizer, second shot is moderna)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were provided
Initial report received from a healthcare professional on 10 October 2012. A female patient whose age, medical history and concomitant medications were not reported; had received a dose of FLUZONE intradermal vaccine (lot number, anatomical site of administration were not reported) on an unspecified date. On an unspecified date, the patient reported that she had very large swollen upper arm following the administration. Lab investigations and corrective measures were not reported. The patient's outcome was not reported. Documents held by sender: None.
Patient presented to the clinic for bloodwork and asked to receive influenza vaccine as well. RN failed to check patient's immunization record and thus, gave an extra dose of the 2022-2023 influenza vaccine. Patient did not have appear to have any side affects post-administration. RN apologized and asked if patient had any questions/concerns. Patient stated that she had no questions and that she was not concerned.