chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 6 months old female patient's grandmother. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, (reported as on a Monday), the patient was vaccinated with the 3rd dose of ROTATEQ, 2 ml, orally (lot number and expiration date were not provided). The patients' concomitant medications were not reported. It was reported by the patient's grandmother, that after vaccination, the patient started to throw up (vomiting) and later developed an "explosive" diarrhea which lasted for several day (date unspecified). On an unknown date (reported as a week later) the patient was in a lot of pain and cried for 2 and a half hours. On 23-APR-2016, reported as on Saturday, the diarrhea and vomiting started again. The reported stated, that the patient has been "throwing up off and on since". The patient sough for medical attention, but it was not reported if treatment was provided to the adverse events. Furthermore, no product quality issue was involved. At the time of the report, the outcome of pain, diarrhea, vomiting and crying were unknown. Causality between the adverse events and vaccination with ROTATEQ was not provided. Additional information has been requested.
Right leg paralysis 14 hours after booster shot lasting 20 minutes Fever of 103 degrees starting 14 hours after booster shot lasting until 10:30pm. Chills lasting until 10:30pm day after booster shot Right arm numbness still present (shot given to left arm)
Mother of child states that after immunizations on 2/20/17 child's feces was green, frothy and foul smelling for a week.
This case was reported by a pharmacist via call center representative and described the occurrence of passed out in a 63-year-old female patient who received SHINGRIX (batch number L9CS4, expiry date 22nd February 2021) and (batch number L349E, expiry date 22nd February 2021) for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th October 2018, less than a day after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant), injection site pain and injected limb mobility decreased. The patient was treated with Pain Medication. On an unknown date, the outcome of the passed out was unknown and the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the passed out, injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: At approximately 2:15 PM, the patient received the SHINGRIX in left arm. The patient claimed that she experienced excruciating pain at the injection site and the patient was still having issues moving her arm on the day of reporting. The patient passed out from the pain and had to go to the emergency room but was not admitted and was provided some medications and they sent her home. The patient claimed that she already had pain medications but she was taking muscle relaxers and something else and the pain issue had not resolved.
severe allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number AFLLA175AA, expiry date 30th June 2009) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was recovered/resolved.   The reporter considered the allergic reaction to be related to FluLaval Quadrivalent.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient reported that she had severe allergic reaction to Flulaval 2008-2009 season. The patient did not gave her email address or age or birth date. The patient thought that the adverse event was already reported. No further information was provided.
24 hours after injection right leg was not moveable/ Mobility is still limited; Right leg was in pain and sore; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30135BA) via an unspecified route of administration in the left arm on 15Oct2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included losartan (MANUFACTURER UNKNOWN) 50 mg for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received ibuprofen (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. On 16Oct2021, 24 hours after injection, the patient's right leg was not moveable and right leg was in pain and sore. Doppler was performed 10 days later and there was no blood clot however the mobility was still limited. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with an unspecified steroid shot. On 26Oct2021, the patient underwent doppler scan and result was no blood clot. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 24 hours after injection right leg was not moveable, mobility is still limited and right leg was in pain and sore was resolved with sequelae on an unknown date in 2021.
Presented with dizziness, tested positive on 8/1. Dx with Covid PNA. Work up initially showed elevated trop. Given his COVID status, obtained D dimer, CT chest. Also included CT head, abdomen given his constituitional symptoms . His CTA chest showed B/L PE with right heart strain, DVT study also came positive . He was initially placed on heparin drip. CT imaging did not show any evidence of lesions given possible concern for occult malignancy. Pulmonary consult was obtained, advised to start oral anticoagulation when able to, no further work up needed. Discharged to HCF for rehab
patient get more sick; Initial information received on 16-Feb-2021 regarding an unsolicited valid non-serious case from non-healthcare professional.  This case involves patient (unknown demographics) who get more sick (illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient get more sick (illness) (non-serious) (Unknown latency), following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome is unknown for illness.  There will be no information on the batch number to be requested for this case.
After administering the vaccines, patient's left FA had a localized reddened area the R deltoid site did as well.  Pt denied pain, no swelling noted.  Dr. assessed the sites.  Pt remained in the office for an additional 30 minutes for observation.  Both sites became less reddened, pt was sent home.
Fluid in ears, swollen lymph nodes in armpit/left arm, elevated blood pressure, (no previous history of high blood pressure) tingling/numbness in arms, fingers, lips, gums and face more than 3 months after injection.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient received BNT162b2 (COMIRNATY), on 29Jan2021 as dose 1, single (Batch/Lot number: unknown), on 19Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 19Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jun2022, outcome "unknown" and all described as "I tested positive for COVID on 02Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) Positive, notes: I tested positive for COVID on 02Jun2022. Event took place after use of product. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt received FLUARIX, MENACTRA, and ADACEL. Approximately 1 minute after last injection, patient fainted/syncope. His father caught him and put him in the chair. He was pale in complexion and slow to respond to questions. After 2 minutes or so, patient started to come back to full consciousness. He did not have any trouble breathing. Gave patient water and reeses peanut butter cups. Pt was ok after about 10 minutes and walked away with his father.
Recurring itchy rash on my abdomen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (Recurring itchy rash on my abdomen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported. No concomitant medication was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Recurring itchy rash on my abdomen). At the time of the report, RASH PRURITIC (Recurring itchy rash on my abdomen) outcome was unknown.      Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Day of injection I was fine, I even felt more energetic than usual, at 2am I woke up feeling Flu like symptoms, fever of 100, and achy all over and my arm hurt terribly.  I Took a Motrin 800, fell asleep and woke only to drink water, take temp, more Motrin, and back to sleep.  I slept about 20 hours only up to move to couch, then back to bed.  I was lethargic, symptoms similar to the flu. That was Sunday, Monday was slightly better but exhausted and barely functional.  I am VERY nervous to get the second shot as I do not want to feel that bad, let alone worse (which I've heard is the case) .  I'm scheduled to go this Saturday 2/6/2021 for the second dose.  I know that these are already noted symptoms so I knew I was in the category with others that experienced the same thing, I just want to confirm that I was another individual that had a tough time after the shot and that perhaps there are more people that have the common feeling just are not reporting.  I am pretty tough usually, (having homebirths, dealing with pain that I didn't think was that bad) this took me down. I was very surprised that I had that tough of a time.
Started with Hive at injection site.  Next day swollen and sore.  Next day VERY swollen, sore, hot to touch, started rash all over trunk and arms, a little on face, upset stomach, headache.
Pt left the pharmacy 20 minutes, after vaccination. He called one hr later regarding numbness on his face. His wife was with him. I told him call 911. On 6/9, We called him, and his MD. He called back on 6/10. He received the Benadryl. I asked him to fax the details to me. He has not done it yet.
Pt recvd Engerix-B because wife has Hep b & was determined to be a nonresponder p/5 doses;
Pt reports rash, hives, and itching that began shortly after receiving the vaccine. He also reports vomiting about once a week.
23APR97 pt given vax 30-45min & pt became very irritable, crying, fine rash throughout body & 100.6 fever;pt was taken by mom to clinic;pt seen in ER by MD;
This spontaneous report was received from a registered nurse referring to a patient of currently 4 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
parents took to ER evening of 14MAY93; pt grunting, stiffness, no involuntary movements, sweating; no LOC; color change etc;
This spontaneous report as received from a consumer refers to her 19 year old son. The patient's pertinent medical history and drug allergies were none. On 05-AUG-2016, the patient was vaccinated with first dose of GARDASIL 9 (dosing details were not reported). Concomitant medications included CLARINEX and unspecified vitamins. On 05-AUG-2016 (same day), while the patient was sitting in the office waiting to check his second appointment, the patient experienced seizures. While "seizing" the patient hit the back of his head against the wall and developed a headache that took days to clear up. The patient sought medical attention and treatment was given for the adverse events. On 07-AUG-2016, the patient completely recovered from headache. The outcome of the events was reported as recovered/resolved. The causal relationship between the events and the GARDASIL 9 was not reported. Upon internal review, the event seizures were considered to be serious, medically significant. Additional information has been requested.
Attention deficit hyperactivity disorder; Feeling sick; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit hyperactivity disorder), MALAISE (Feeling sick) and FATIGUE (Fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa and ATOMOXETINE HYDROCHLORIDE (STRATTERA) for an unknown indication.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free and ATOMOXETINE HYDROCHLORIDE (STRATTERA) (unknown route) at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit hyperactivity disorder) and MALAISE (Feeling sick). The patient was treated with AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) at an unspecified dose and frequency. In 2021, FATIGUE (Fatigue) had resolved. At the time of the report, ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit hyperactivity disorder) outcome was unknown and MALAISE (Feeling sick) was resolving.            No concomitant medications were reported.   On unknown dates, the patient experienced strattera made sick and attention deficit hyperactivity disorder. In 2021, the patient experienced second covid-19 vaccine injection had only fatigue.  In 2021, the second covid-19 vaccine injection had only fatigue resolved. Moderna vaccine and Strattera (atomoxetine hydrochloride) were also considered suspect.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt recv vax on 12/17/98; on same day pt exp fever, chills, myalgia, pain/ swelling at vax site
Client is in for her first dose of the COVID-19 Pfizer pediatric dose (PEDS). Upon administration of the vaccine client received an adult dose .3 ml (30 mcg) of the COVID-19 Pfizer vaccine in the right arm.  After the vaccination administration client had no symptoms or any reactions to the dose administered. This RN informed parent right away of the incorrect dose after vaccination. This RN did check on client the following day and mother shared client had no reactions or problems after leaving the facility.
Information has been received from a registered nurse via field representative, referring a 56 year old female patient. The patient's current condition included meat allergy, information of concomitant therapy and historical condition was unknown. On 10-JUL-2018 the patient was vaccinated with PNEUMOVAX 23 0.5 ml, in the left deltoid (route, lot# and expiration date unknown) for prophylaxis.  At 17:00, soon after the administration, the patient had itching and hives and took diphenhydramine hydrochloride (BENADRYL), At 21:00 of the same night, the patient went to the emergency room (ER), with complaining of throat itching but no throat swelling and no airway restriction. the patient was administered IV famotidine (PEPCID), diphenhydramine hydrochloride (BENADRYL) and dexamethasone(DECADRON )one bag fluids. Then the patient was sent home with a prescription for methylprednisolone (MEDROL DOSEPAK) and ondansetron hydrochloride (ZOFRAN). The physician verified that the prescription information (PI) for PNEUMOVAX 23 did not contain any bovine product prior to administration. The outcome of itching and hives, throat itching were unknown. The causality assessment was not provided by the reporter. Upon internal review, itching and hives, throat itching were determined to be medically significant.
rash 1/12/99 to 1/26/99;hives w/itching devel 1 day p/vax;
shoulder is aching and tender; lower part of arm is starting to join in the painful aching; muscle and shoulder is aching and tender; Injection was painful that night; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 08Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Sep2023, outcome "not recovered", described as "Injection was painful that night"; ARTHRALGIA (non-serious), outcome "unknown", described as "shoulder is aching and tender"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "lower part of arm is starting to join in the painful aching"; MYALGIA (non-serious), outcome "unknown", described as "muscle and shoulder is aching and tender".  Additional information: On 08Sep2023, the patient recieved the ABRYSVO inj. from (Pharmacy name) here in (city name withheld) (state name withheld). The injection was painful that night. Now the Inj is still there and getting worse. The patient's muscle and shoulder is aching and tender. The lower part of arm is starting to join in the painful aching. The patient asked if there was something that they can do to relieve this ache, something to apply, heat, cold, ice, aspirin, balm. The patient asked for a suggestion. The patient does not get "allergy Sx's" (as reported) and is healthy. The patient was not asking for a diagnosis.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
By 7 pm, Thursday sweating began. I was in bed before 9 pm. due to extreme tiredness, and awoke about 40 minutes later with severe leg cramps accompanied by burning sensations throughout leg veins. This lasted about 15 minutes, compared with 90 minutes the month before after vaccination #1. The ensuing 36 hours, through which I mostly slept, had bouts of nausea, fatigue, fever and chills. All these were listed as possible side effects, except leg issues.
Symptoms started about 12 hours later and included: brief dizziness, tachycardia (100 bom), headache, low grade temperate (98.8 F), sweating out my back/neck and from my face (face was HOT), body aches, arm swollen, hard and pink/red (still 4 days later!), and lichen sclerosus flare requiring use of clobetesol.
Headache inj site sore to touch for 2 days after inj day, "little tired" + "brain fog" Narrative:  Other Relevant History:
Adverse Reaction included fever lasting at least 2 days, swollen arm, redness, itchy. Patient has an appointment with primary to get it checked out
after several days fatigue fever brain fog and a loss of smell and taste to follow gradually along with headache
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with RECOMBIVAX HB (lot#, 0.5ml) intramuscularly. The reporter reported that RECOMBIVAX HB were exposed to a lowest temperature of 32F for a total of 1 hour over "four different occasions" and the improperly stored RECOMBIVAX HB were administered to an unspecified amount of patients. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
2-3 minutes after injection, experienced what felt like a drop in blood pressure, tachycardia, tongue tingling and taste, and for a few seconds, my nose stuffed up but then all symptoms went away within a few minutes. I felt completely fine 5 minutes later.
Patient did not want to sit after administration, while walking out of the store he became clammy, lost color, and briefly lost consciousness. His girlfriend helped him into a seat. He was given water and towels. His blood pressure was checked twice. He refused several offers of EMS. After sitting for about 20 minutes, he stated that he felt better. He was able to stand and walk and stated that he was no longer nauseous or dizzy. His girlfriend stated that she would take care of him. I called around 6:30 to check up with them and his girlfriend said that he was feeling better and had eaten. Patient did not have a PCP so no call was made.
patient was hospitalized for weakness, dehydration, rhabdo, arf, dizziness-low probability of it being the vaccine
Patient received DTap and VARIVAX vaccines on 3/18/09 in right thigh. Patient returned to office 3/20/09 with large red circular area around injection site with slight induration at the injection site. Patient was treated with KEFLEX.
Crawling soreness from left shoulder to neck and back started about 4-5 hours later,  eventually extreme full body aches and chronic moderate headache lasting at least until current (4 pm, next day).  Brain fog became concern at 8 pm. Mild Difficulty navigating grocery store.  Extreme soreness has withstood 3 ibuprofen (x2 doses) and today took 1 hydrocodine in cabinet.  Brain fog has continued and not improved. Moderate forgetting.   Definitely not able to work today (Sunday) and doubt I will be able to work tomorrow. I am private practice dr. and will probably loose substantial income tomorrow. Completely NOT worth it and concerning with the brain fog. I strongly regret the second shot.  No symptoms after 1st shot.  The dose should be immediately reduced for 2nd shot. This strong of an immune response is not necessary.
10/27/2001 Lethargy. 10/28/2001 and  10/29/2001 Emotional lability.