chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt fine to begin with, ate supper per usual, then at 7:10 pm sudden onset of symptoms, nausea & extreme diarrhea and chills for 2 1/2 hours.  Temp of 99.9  Then headache, very severe, trouble seeing, disorientated.  Sat in chair all night.  Left arm and left side hurt into teeth and jaw.  Thought about calling ambulance at 4:00 am, but decided not to.  Headache lasted through Sunday and Sunday evening, until 3 am on Monday.  Now at 11:30 am on Monday it is a 2 on a scale of 1-10.  Had Tylenol #3 on hand, and took every 5-6 hours since Saturday night.    Missing work today 12/28/20.
unable to lift head/body x5-7d, cries of "agony," fever cont 5-7d, describes developmental delays, weakness, pain listlessness, change in vocalization. progress resumed in 11th month
Patient had seizure  of clonic tonic activity was post-ictal.  Non verbal  and did not respond to questions.. Transferred to ER via squad.
There was a delayed reaction, not from bandaid, began to itch day 7 after injection, Day 8-9 became hard, red 2 inch in diameter hot spot that lasted 2-3 days that she treated w/ benadryl and resolved
4 days after receiving  vaccination, in AM woke up w both eyes slightly blood shot & broken blood vessel in left eye.  Took a little over a week to go away. Also had low grade migraine
Initial case was received on 09 July 2010 from a healthcare professional. A nine month old female patient received on 28 June 2010, a left thigh intramuscular injection of PENTACEL (lot number C3658AA) and a right thigh intramuscular injection of PREVNAR (manufacturer Wyeth, lot number E60221). On 01 July 2010, the patient developed a "spot" at the left thigh injection site, which continued to "grow" and appeared necrotic. The reporter stated the patient had no fever or redness. She had no illness at the time of the vaccinations and had no pre-existing medical conditions, allergies or concomitant medications. She was given no vaccinations within 4 weeks prior. On an unspecified date, the patient was evaluated by a physician, but the results of the evaluation were not provided. The outcome of the adverse event was not reported. Documents held by sender: None.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 22-SEP-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
This spontaneous report was received from a pharmacist, refers to a 60 year old female patient with hypersensitivity to penicillin (MARRS # 1511USA010009) and some opioids. There was not medical history. On 04-NOV-2015 the patient was vaccinated with ZOSTAVAX vial 19400 PFU, lot # L012476, expiration date 20-JUL-2016 (dosage and route were not reported). Also was reported that the same day, she received two additional vaccines; pneumococcal vaccine (manufacturer unknown) (strength, dose, route and lot number were not reported) and influenza virus vaccine (unspecified), reported as "unspecified "flu" vaccine and unspecified "pneumonia" vaccine". The pharmacist reported that on an unknown date in November 2015 the patent experienced injection site rash and injection site pain, reported as "the patient experienced a rash at the injection site which was a little bigger than quarter and which also the patient described as a flat, warm and little painful". The patent sought medical attention, returning to pharmacy, there was not laboratory diagnostic performed. The patient was taking an unspecified dose of BENADRYL to treat the symptoms. The outcome of injection site rash and injection site pain was reported as not recovered at the time of this report. Additional information has been requested.
During the event on 11/30/2021, client who was 17yr was given non FDA approve booster shots for adult. No reaction was noticed during the 15 observation period for the kid.
Information has been received from a health professional concerning an approximately 9 year old male who on 29-JUN-1998 was vaccinated with a dose of Varivax (Oka/Merck) (lot 625045/1573E). Subsequently, the patient experienced a rash with <50 lesions. This case was documented or evaluated by a physician. The child was not hospitalized. It was noted that the patient had known contact with another case of varicella. No additional information was provided. Additional information has been requested.
On 11/20/2021, I began to feel ill. I had a stuffy nose. On 11/21/2021, I still had a stuffy nose and also felt fatigued. I lost my sense of smell, and it was then that I decided to take an at-home test for COVID-19. The result was positive, so I had a breakthrough case. I also went on to lose my sense of taste. The loss of sense of taste lasted for 8 days, and the loss of sense of smell lasted for 7. I felt so fatigued that I spent a great deal of time sleeping. However, I never had a cough or fever.
getting a tickle down at the bottom of our throat to our chest; coughing our heads off; This is a spontaneous report from a contactable consumer (reported for her husband) via medical information team. A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0172, Expiry date: unknown) via an unspecified route of administration in arm left on 27Apr2021 (at the age of 66-years-old) 14:00 as dose number 2, single for COVID-19 immunization. Patient was diabetic from an unknown date which was diagnosed 4 years ago and had blood pressure high from an unknown date and was diagnosed when he was 16 years old and patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0150, Expiry date: unknown) via an unspecified route of administration in left arm 06Apr2021 as dose number 1, single for COVID-19 immunization. The patient's concomitant medications were not reported. Patients wife stated that she and her husband (patient) both got vaccinated at the same time. They had no symptoms of anything and stayed there for 15 minutes. On their way home, 20 minutes into the drive, they started getting a tickle down at the bottom of their throat to their chest. Before they got home, they both started coughing their heads off. It has continued until yesterday (which was one week from receiving the vaccine) and now they still have a cough. The patient came down with a cough after receiving the shot which has lasted about a week. These events happened after the second dose, the first dose was fine, they did not have any side effects with the first one. Reporter and her husband experienced an adverse event with the second dose of the Pfizer Covid-19 vaccine. They received both doses. Outcome of event getting a tickle down at the bottom of our throat to our chest was recovering and coughing our heads off was recovered on unspecified date in May2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021503831 same reporter/drug/event, different patient
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 54-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6199), in left arm and on 02Apr2021 as dose 2, single (Lot number: EP6ASS) for Covid-19 immunisation. 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 Jan2022, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive. No follow-up attempts are possible. No further information is expected.
Patient died from a flu shot; Initial information was received on 12-Feb-2021 regarding an unsolicited valid serious case from a consumer or non-health care professional via social media.  This case involves a male patient (age unspecified) who died (death), after he received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient died (death), (unknown latency) following the administration of INFLUENZA VACCINE. This event was also assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events before death.  It was unknown if there were laboratory data/results available.   It was not reported if the patient received any corrective treatment before death.  It was unknown if an autopsy was done. The cause of death was not clearly specified (patient was died from flu shot).  At the time of reporting it was reported that, product name was not provided and it was reported via public post on the Sanofi flu shot campaign hence reporter assumed that the consumer was referring to the Sanofi flu vaccine.  There will be no information available on the batch number for this case.; Sender's Comments: This was a poorly documented social media case received from involved a male patient (age unspecified) who died (death) after administration of INFLUENZA VACCINE. The time to onset is unknown. Further information regarding medical history, concomitant disease or risk factor, concurrent condition during vaccination, previous vaccination and tolerance, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient died from a flu shot
The patient did not report any adverse effects due to vaccine. However, the vaccine given to the patient was expired. The expiration date on the vaccine was 01/30/2023 and the vaccine was given 03/29/2023. Follow CDC and GlaxoSmithKline guidance the patient was asked to come in for a repeat dose on 03/30/2023 with new vaccine.
Screaming uncontrollably. Vomiting in the mornings, looks like he's cramping up. 11/27/06 Received medical records from hospital which reveal patient was admitted from birth on 8/26/06 to 9/3/06. Developed grunting respirations & episodes of apnea & bradycardia.  Tx with IVF & antibiotics & caffiene for suspected apnea of preemie.  Then continued to improve.  D/c home on apnea monitor & oral caffiene.  D/C weight 4 lbs 9 oz. Birth hx: 36 wks, NSVD, small for gest age.  Apgars 7 & 8.  Some concern about maternal infection, Mom had fever s/p delivery & placenta was malodorous. Final Dx: 36 wk gestational age infant w/initial respiratory distress, hypoxia & suspected sepsis, all resolved; hypospadias; apnea of preemie/ss
Redness and swelling at injection site; Redness and swelling at injection site; Redness and swelling at injection site; very swollen gland in left armpit; low grade fever; aches in joints; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 18:00 (Lot number: FG3527) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation; typhoid vaccine polysacch vi (TYPHIM VI), administered in arm left, administration date 14Sep2021 (Lot number: T2A371m) as unk unk, single. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Other medical history: blood pressure; "Known allergies: Yes" (unspecified if ongoing), notes: Known Allergies: Yes. Concomitant medication(s) included: AMLODIPINE; FAMOTIDINE; LARIAM. Vaccination history included: Bnt162b2 (Dose Number: 2, lot number=ER8729, administration time=10:00 AM, vaccine location=Left arm), administration date: 14Apr2021, when the patient was 64 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, lot number=EN6207, administration time=10:00 AM, vaccine location=Left arm, ), administration date: 17Mar2021, when the patient was 64 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE REACTION (non-serious), ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 30Oct2021 18:00, outcome "recovering" and all described as "Redness and swelling at injection site"; LYMPHADENOPATHY (non-serious) with onset 30Oct2021 18:00, outcome "recovering", described as "very swollen gland in left armpit"; PYREXIA (non-serious) with onset 30Oct2021 18:00, outcome "recovering", described as "low grade fever"; ARTHRALGIA (non-serious) with onset 30Oct2021 18:00, outcome "recovering", described as "aches in joints"; FATIGUE (non-serious) with onset 30Oct2021 18:00, outcome "recovering", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site reaction, erythema, vaccination site swelling, lymphadenopathy, pyrexia, arthralgia, fatigue.  Additional information: Facility type vaccine was Pharmacy or Drug store. No covid prior vaccination and was not tested covid post vaccination  Follow-up attempts are completed. No further information is expected.
Pt exp chills, fever, & weakness approx 1 hr p/receiving Typhoid vax; This was 2nd Typhoid inject of the series; Pt recvd Cholera vax one day prior;
Dose administered greater than 2 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 2 hours post puncture) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 2 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 2 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Alternative email. 2 vials that were first punctured on 30-Nov-2021 and put on the refrigerator since then.  Concomitant medications were not provided.  Treatment information was not provided.
During intake with student nurse, patient reports acute, sudden onset of lightheaded/dizziness, joint and muscle soreness with fall in parking lot without loss of consciousness after receiving first vaccination.  Vaccine given in right deltoid at 1243 per student nurse.  1250: Nursing instructor moved patient to separate room in clinic for further monitoring.  1255: Patient reports onset of dizziness, lightheaded. 1258: Clinic RN notified and updated on events and patient current condition.  1300: BP 135/83 (MAP 94), HR 93, SpO2 97%; patient alert and oriented x4, pupils PERRLA, flushed to face, reports continued and unchanged dizziness/lightheaded.  Denies increase in joint/muscle pain, headache, shortness of breath, sensation of swelling to face, throat, neck, numbness or tingling. Patient states works night-shift, last ate food when getting home from work this morning at 0430/0500.  Patient states has only had a "couple" cups of coffee since waking up "around 1100."  Patient notified RN of fall in parking lot when leaving after first dose -- patient denies needing help to get up; he states was not seen in prompt care at facility.  He drove home where he and his wife monitored his BP.  Patient denies any changes to BP from his norm once home.  Reports he called PCP office the next morning and told the "receptionist," but had never talked to the doctor or nurse regarding events.   1305: BP 126/82 HR 93; Dr notified for evaluation of patient. 1310: Dr to patient's room to evaluate current condition.  Patient denies any change (better or worse) of symptoms. Vitals stable BP 128/82, HR 92.   1320: Patient escorted out of clinic with MD at side.
1 of 4 pt exp an inj site rxn described as a 3x3" area w/redness, swelling & hot to touch the day p/vax;sx resolved p/3 days;MD described swelling, redness, warm to touch, hardened area for several days;
Fever, runny nose, sneezing, coughing, chest pain, chills, loss of smell and taste
Nausea, Vomiting, Diarrhea, Severe Headache, Fatigue, Cough
JOINT PAIN; HAD A HEADACHE FOR ALMOST A  WEEK AFTERWARDS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) 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 number. No concomitant medications were reported.  On an unspecified date, the subject experienced joint pain, and had a headache for almost a week afterwards. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had a headache for almost a week afterwards and joint pain was not reported. This report was non-serious.
This spontaneous report as received from a physician refers to a 12 month old female patient with no pertinent medical history or drug reactions/allergies. On 28-AUG-2014 the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (lot#, expiration date, dose, route not reported) for prevention of chicken pox. There was no concomitant medication. On 30-AUG-2014, The patient developed a chicken pox like rash. The patient's mother called the physician and also sent pictures of the rash to the physician, the physician described the rash as "a few vesicles on the patient's arm and three on the patient's face". The outcome of the event was unknown. Additional information has been requested.
Skin Rash, Hives, Lump at injection site, Muscle soreness, Overall Tiredness Urgent Care visit on 4/7/2021 for rash and hives Prescribed Prednisone 4mg tablets for 6 days.  Lump subsided after daily massaging of injection site. Muscle soreness and tiredness subsided in 24-48 hours after injection.
nausea, diarrhea, upset stomach, dizziness, lack of appetite, extreme fatigue. still ongoing since 2nd shot, now nearly 8 weeks later. worst in the morning after waking up.
Sore muscles and joints. Headache, very tired. lasted around 16 hours total.
FAINTING (SYNCOPE) EPISODE; This spontaneous report received from a consumer concerned a 3 decade (approximately 23 year) old female of unknown race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced fainting (syncope) episode. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting (syncope) episode. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210834926.; Sender's Comments: V0:20210834795-COVID-19 VACCINE AD26.COV2.S-Fainting (syncope) episode. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This is a spontaneous report from a contactable consumer. A 52-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0161, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 14Apr2021 14:30 (at the age of 52-years-old) as single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP7534), via intramuscular, administration on left arm on 25Mar2021 as a single dose for covid-19 immunization. The patient's medical history included, covid-19 from Dec2020 and concomitant medications were not reported. The patient had no other vaccine within four weeks. On 15Apr2021, the patient had a COVID-19 Virus PCR Test and COVID-19 Virus RPR (rapid) test which was negative. On 16Apr2021, COVID-19 Virus PCR test came back positive. Clarified it was the second time the patient had tested positive for the COVID-19 Virus. As reported, the patient had the COVID-19 Virus in Dec2020 and at that time he had a sore throat and cough. At this time, he didn't have any COVID-19 Virus symptoms. Reported, the patient hadn't gone to the doctor since Jan2021. He had retested for the COVID-19 Virus in Feb2021, so he could fly to Honduras and was negative in Feb2021. The patient did not receive any treatment. Outcome of the events was unknown.  No follow-up attempts are needed. No further Information is expected