chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from consumer. The report concerns , Male patient, Height: 75.0 Inches; Weight: 230.0 Pounds, who had been received Nasal FLUMIST (INTRANASAL) for SO WE DONT GET THE FLU  and Nasal FLUMIST QUADRIVALENT (INTRANASAL) for SO WE DON'T GET THE FLU. The patient's medical history included WOULD GET SICK 3 TIMES A YEAR DURING WINTER, SPRING, SUMMER. It was reported that the patient had been prescribed FLUMIST in 2011 and 2012 and FLUMIST QUADRIVALENT 2013, 2014 and 2015 for flu prevention. The reporter stated that since taking the FLUMIST, her husband would get a cold (Preferred Term: Nasopharyngitis) once a year instead of three times a year prior to starting the FLUMIST. She also stated that after the FLUMIST was administered, sniffing would occur because otherwise the vaccine would run out of from the nose after administration) (Preferred Term: Circumstance or information capable of leading to medication error). The outcome of the event of COLD and AFTER FLUMIST WAS ADMINISTERED SNIFFING WOULD OCCUR BECAUSE OTHERWISE THE VACCINE WOULD RUN OUT FROM THE NOSE  AFTER ADMINISTRATION (MEDICATION ERROR) is unknown. The reporter's description of the event(s) was as follows: would get sick 3 times a year during Winter, Spring,  Summer. Additional JASPERs will be submitted for additional AE mentioned for other people. The report was considered to be non-serious. Corrected report  08-Nov-2016: Suspect product  FLUMIST QUADRIVALENT was added. Dosing regimen was corrected. Associated case id was added. Narrative updated.
Severe abdominal pain, vomiting and diarrhea for 12 hours. Immediately followed by upper respiratory symptoms. All of this in an extremely healthy person who has not missed work in 20 + years for any medical issues.
arms hurts a lot; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (arms hurts a lot) 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 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PAIN IN EXTREMITY (arms hurts a lot). At the time of the report, PAIN IN EXTREMITY (arms hurts a lot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were provided.   Reporter did not allow further contact
Localized erythema, edema right anterior thigh. Acute localized cellulitis right anterior thigh status post immunization DTaP #4, IPV #3. Treatment: Augmentin 250mg/5ml 1.5 tsp POB for 7 days. Rulone 15mg/5ml for 7 days. Benadryl liquid 2.5mg/5ml tsp q 80 for 7 days.
A report was received from a health care professional on 10/23/03 concerning approximately 10 pediatric vaccinees less than 4 years old, of unknown sex, who were inadvertently administered Fluvirin vaccine between 10/8/03 and approximately 10/22/03. Between 10/8/03 and approximately 10/22/03, approximately 10 pediatric vaccinees less than 4 years old were inadvertently administered Fluvirin vaccine. No adverse reactions were recorded at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 12/9/03: A follow up report was received from a health care professional indicating that a one year old male vaccinee inadvertently received Fluvirin on 10/14/03. On 10/14/03 the vaccinee inadvertently received 0.25ml Fluvirin. At the time of reporting, the vaccinee did not exhibit any adverse symptoms. No follow up pending. All information received.
Monovalent Pfizer was given instead of bivalent was given to patients. Patient experience no adverse affects aside from normal response to vaccine: arm soreness, feeling  a bit tired
This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-JUN-2017 (reported as "today"), the patient was vaccinated with expired dose of GARDASIL lot # M014929, expiration date 27-MAY-2017 (dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Developed severe abdominal pain and bloating. Irregular  bowl movements.  Weakness .  No fever.
received a 3rd dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (already completed the original 2 dose Shingrix series in 2018).   In December 2021, the patient received the 3rd dose of Shingrix (intramuscular) 50 µg. In December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The patient self-reported the case. The patient received a 3rd dose of Shingrix in December 2021 (exact date not given), which led to extra dose administered. She stated that, she restarted the series because her doctor had misplaced the records of her receiving the original 2 dose Shingrix series in 2018. The patient did not obtain the lot or expiration date of the Shingrix vaccine or the patient email. The reporter did not consent to follow-up to contact HCP (Health care professional) as she stated he was retired and she had not re-established with a new physician.
Pt. called the afternoon of injection with c/o severe cramps, nausea and vomiting. (Did also start menses.) Called pt. back this am and is doing better.
A spontaneous report has been received from a Pharmacist concerning a female patient of unknown age. No medical history and concomitant history provided. No concomitant medications were provided. The patient receiving FLUMIST QUADRIVALENT (intranasal), started on an unknown date. A female called to ask a pharmacist what happens if they received FLUMIST QUADRIVALENT in the same nostril on unknown date. The action taken with FLUMIST QUADRIVALENT was not applicable. The outcome of the event was unknown. The report was considered to be non-serious.
I was exposed and had a home test COVID-19 test and it was positive with mild symptoms, at the 3rd day I called my doctor and prescribed PAXLOVID, after 36 hours it was a better; I had headache, take aspirins, sore throat, I tested again on Saturday, Monday was Negative, and all symptoms were gone.
Dizziness, nausea, weakness in arms and legs, sluggish, tight throat and chest, itching within 2 hours of shot. Treated at ER with Epi shot, benadryl and other meds. Most symptoms continued day two with fever in cheeks and neck and high blood pressure. Some dizziness, nausea, weakness on day three and four. Treat with benadryl at home.
breakthrough bleeding / early menstruation; breakthrough bleeding / early menstruation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single and administered in arm left, administration date 09Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SERTRALINE. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUATION IRREGULAR (non-serious) all with onset Apr2021, outcome "unknown" and all described as "breakthrough bleeding / early menstruation". Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstruation irregular.  Additional information included: It was reported that after the last two shots, there was breakthrough bleeding / early menstruation. The patient was not due for her period and it came heavy that same evening. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Device Date: 04Dec2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient was administered the ACTHIB 2 days ago but it was diluted with another diluent and not the one that came with the ACTHIB with no reported adverse event; Initial information received on 23-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1-year-old female patient who was administered the vaccine HIB (PRP/T) vaccine [ACT-HIB] 2 days ago but it was diluted with another diluent and not the one that came with the ACTHIB with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine CONJ 7V (CRM197) (Prevnar), Varicella Zoster Vaccine (Varicella Vaccine), Measles Vaccine, Mumps Vaccine, Rubella Vaccine (Mmr) And Hepatitis A Vaccine (Hepatitis A Vaccine), all for Immunisation.  On 21-Aug-2023, the patient received a dose of 0.5 ml (Frequency = once) of suspect HIB (PRP/T) vaccine of standard strength powder and solvent for solution for injection (lot: UJ801AA, Expiry date: 05-OCT-2023) via intramuscular route in the right thigh for Prophylactic Vaccination (Immunisation), patient was administered the vaccine but it was diluted with another diluent and not the one that came with the ACTHIB with no reported adverse event (product preparation error) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was 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 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.
Brought to emergency room due to weakness and spouse being unable to lift patient up. Found to have COVID. Treatment includes admission, oxygen, dexamethasone, therapy.
This spontaneous report as received from a consumer (mother of the patient) refers to a 15 year old female patient. Patient's medical history and concurrent conditions was not reported. On 08-AUG-2013 the patient was vaccinated with GARDASIL (reported as GARDASIL INJ 120 Y) Strength 120MCG, dose 1. Concomitant therapies included ALLEGRA. On an unknown date in November 2012 the patient experienced migraine headaches. On an unknown date the patient experienced chronic fatigue, is missing a lot of school due to her not feeling well (disability), is having difficulty in school and her grades are dropping, can't focus, is sensitive to light and noise, nauseous, feels dizzy, has her period every 2 weeks, low blood pressure, fainted, vision problems (double vision), and neck pain. The reporter stated that her daughter's migraine headaches started on an unspecified date in November 2013 and lasted for 4 days. The patient had a second migraine headache in February 2014. The reporter also stated that the patient was a swimmer and used to swim 4 hours per day and was in good health prior to receiving GARDASIL. The reporter stated that the patient had fainted and had an irregular EKG after fainting. The patient's second EKG was normal. It was reported that in November 2013 the CT of Brain done by the neurologist was normal. The patient was treated for the adverse events with cyproheptadine and Ondansetron. The outcome of the events was unknown. The reporter's causality assessment was not provided. The patient developed severe stomach problems, hyperthyroidism and early menopause after taking VIOXX (MARRS ID 1404USA014704). Additional information has been requested.
PATIENT REPORTED THAT ARM WAS SWOLLEN AND RED THE DAY AFTER INJECTION AND SHE LATER IN YEAR DEVELOPED THE FLU.
PATIENT HAD REDNESS AND HEAT IN THE LEFT ARM FROM THE APROXIMATE SITE OF THE INJECTION AND EXTENDING ABOUT 6 INCHES DOWN AND ABOUT 3/4 OF THE WAY WRAPPED AROUND HER ARM.  PATIENT SAID IT WAS HOT AND ITCHY. THIS REACTION BEGAN ABOUT 2 DAYS AFTER HER INJECTION.
Information has been received on 14-JUL-2017 from a certified medical assistant (CMA) referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. The medical assistant reported that improperly stored doses of PROQUAD (Lot number M043309, expiration date 24-APR-2018 and Lot number N000678, expiration date 05-JUL-2018) were administered to multiple unspecified patients on multiple unspecified dates. (The doses, routes of administration and sites of administration were not reported.) The excursion information was reported as: The temperature was reported as 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (F) (9F).  Time frame was reported as 24 hours. There was no previous temperature excursion. The call was not because of a data logger. Product quality complaint was not involved. No adverse effects reported. No additional information was provided. Additional information has been requested.
Information has been received from a physician concerning a 14 year old female patient with a family history of neurological conditions of unknown origin who "in summer 2009", in approximately June 2009, completed three dose series of GARDASIL (lot number, dose and site of administration not reported). In 2009 "right after" receiving the third dose, the patient had a "slow downward path" and developed nausea, weakness, fatigue, hair loss, lost control of her bowels, sore joints, anxiety, a movement disorder and seizure like activity. It was also reported that "currently", she could not walk with out assistance and was bedbound and she was currently in the hospital since she took a "turn for the worst last week". Also, the physician reported that the patient was a straight a student two years ago. Unspecified treatment was given for the adverse event. At the time of the report, the patient had not recovered. The sister's experience has been captured in WAES # 1104USA00837. Additional information has been requested.
Pain in arm; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain in arm on an unspecified date. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Blister - Information has been received from a health care proessional concerning a 13 month old caucasian male patient who on 02 Feb 2000 was vaccinated with the second dose of varicella virus vaccine live sc  in the right thigh.  On 10 mar 2000 the patient developed approximately 20 vesicls on his head, forehead and temple area.  On 16 Mar 2000 the patient recovered from his experience.  no futher information is available.
severe disabling pain at injection site (entire left shoulder) moderate to severe aches/fatigue/chills, only partially responsive to maximum dose NSAID symptoms lasted 3 days
Pt had onset of pain in arm starting 3 hrs after vaccine given, The pain spread to (L) side of neck and (L) anterior chest wall over the next few days. Movement of arm became extremely painful. Hive like rash started 6 days after injection and was still present along with pain on 11/11/2019 - day of exam.
a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN, CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE + D [CALCIUM CARBONATE;COLECALCIFEROL]) and DENOSUMAB (PROLIA) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a sore arm). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-048113 (Patient Link).
Numbness and tingling in Lt hand and Lt foot. Last approx 15-20 minutes.
Significant bruising at injection site approximately 2 inches in diameter lasting approximately 10 days to 2 weeks.  No treatment and bruise eventually dissipated.  Never had this happen with any other vaccine and the injection was uneventful.
Elevated fever, chills, aches.  Lasted for 4 days and I was bedridden except to use the bathroom.
Warm to the touch; Itch; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch) and VACCINATION SITE ERYTHEMA (Redness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. No treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Contact information was updated, Patient First name, Address ,Email was updated.
Cellulitis (received immunization for Diptheria, Tetanus and Pertussis).
Was given kinrix and proquad. A few hours later at home the kinrix site became red, warm to the touch and swollen raided area the measures 4.5 " x  5 ". Came into the office on Monday, injection site is looking and feeling better.
by 3rd day had a sty in my left eye; Morning after shot, woke up with pain in my left eye when I blinked.; Both eyes felt heavy; Eyes dry like sandpaper; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 09:00 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history included blood pressure high and asthma. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan potassium (LOSARTIN) and montelukast sodium (SINGULAIR); both for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Mar2021, morning after shot, the patient woke up with pain in left eye when blinked. Both eyes felt heavy and eyes dry like sandpaper. By third day, on 20Mar2021, patient had sty in left eye. Took 2 weeks to heal. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events woke up with pain in left eye when blinked, both eyes felt heavy and eyes dry like sandpaper and sty in left eye was recovered on unknown date of Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt recieved regular vaccines at two months and began spitting up blood for the following 24 hours.  At 4 months we administered only one vacc/week in order to see if one of the imm. caused this problem.  There were no further problems until we gave the Prevnar when the patient was 5 months.  She began spitting up blood again for the next 24 hours.
Pt recvd Td/MMR 3OCT91 in the AM & returned 1 hr later w/ c/o chest tightness, cough, pruritis, & hives;
Excruciating headache for the first day. Nausea and vomiting for 5 days after the injection was given.
Temperature of 103F and above, since this morning at 03:30 on 5/17/01.
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 33-year-old, adult, female patient. The patient had no relevant medical history and did not take any concomitant medications at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. On 10-Oct-2018, one day after vaccination, the patient felt like she was getting the flu. In addition, the patient experienced body aches and dry eyes. At the time of this report, the patient was recovering from the events. This case 201804678 was cross-linked to the source case: 201804657 reported by the same reporter.
Child received vaccination around 2:30 PM. Was fussy and drowsy for remainder of day and went to sleep around 7:00PM.  Child woke up screaming at 9:00 PM. He was inconsolable and continued screaming and crying for 4 hours.  Touching or holding him seemed to make it worse.  Called nurse at 12:30 AM.  Said to take him to hospital. He was taken to the emergency room at 1:00 AM. The doctor said that it was probably a reaction to the vaccine and to give him more Tylenol.  He began to settle down and would alternate between crying and going in and out of sleep.  The next two days he would not eat or drink from a bottle and would sleep only for an hour at a time.  He would nurse a little bit and take Pedialite from a syringe.  He lost 1 pound over the next 3 days.  He was irritable and would stopped reacting as usual to family members or toys for the next week.  His eating and sleeping pattern gradually returned to normal after 8 days and he has begun responding to stimuli again.