chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 7/1/2021, received information from pharmacy regarding vaccination placed on 17 yo patient. On Tuesday, 6/8/2021, patient received the Moderna vaccination placed by RN working in the COVID -19 vaccination clinic.  Patient is 17 years of age.  On Thursday, 7/1/2021, Father informed daughter  received Moderna vaccine which is indicated for 18 years of age and older and I was calling to find out how his daughter was doing.  Father states, "she's fine".  Then he called out to his daughter how she did after the vaccination, any symptoms.  Daughter reported headaches and the father stated, "you always have headaches." Father denies any further questions or symptoms. 7/1/2021 1810 Called father back to  further review symptoms needing medical attention or if severe symptoms needing ER visit, such as SOB, HA, abdominal pain, N/V, father verbalized understanding.
No symptoms or adverse effects reported; 3 patients received unspecified dose of ROTATEQ that was improperly stored.; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 20-MAY-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1660958, expiration date 23-MAR-2021 (strength and dose not provided) for prophylaxis. Administered dose of vaccine was stored in temperature of 46.9 degrees Fahrenheit (F) for 1 hour. Data logger was involved. There were no previous excursions reported. No symptoms or adverse effects reported.; Sender's Comments:  US-009507513-2006USA003741:
Patient reportedly briefly lost consciousness, later recovered around 15-20 minutes later. Reported saying hear ringing in the ears, 'felt like she was going to faint' and slight shaking on the hands. Patient wore a mask, the room was small (confined) and the weather was slightly warmer than usual.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Vaccines work, dam it! It's the omicron break thru got us". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive for omicron, notes: Wife got BA4/5 from (name-withheld) Duty. Clinical course: Patient got BA4/5 from (name-withheld) Duty. It was reported that "Vaccines work, Dam it, Its the omicron break through got patient". Pfizer not the problem! Evolution is the culprit. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
KNOT AND REDNESS AT INJECTION SITE; TIREDNESS; CHILLS; FEELING SLEEPY; This spontaneous report received from a patient concerned a female of unspecified age. 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced feeling sleepy. On an unspecified date, the subject experienced knot and redness at injection site, and tiredness. Treatment medications (dates unspecified) included: acetylsalicylic acid, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the knot and redness at injection site, tiredness, chills and feeling sleepy was not reported. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Vertigo" (unspecified if ongoing); "known allergies: Bee stings" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures (PAXLOVID)  were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Swollen lymph node in right armpit on Sunday (Day 5) Arm pain, redness and itching  on Wednesday (Day 8)
Suspect varicella with vaccination.  5-12-04 cranky, 5-13-04 papules - primarily upper trunk, neck and face. puritis - changing to vesicles - possible pustules - lesions cratered with scratching.
light headedness; she just has a weird feeling; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (COMIRNATY), administered in deltoid left, administration date 01Dec2021 09:00 (Lot number: FH8030, Expiration Date: 31Mar2022) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "has sinus problems" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, lot No: FF2593, expiry date:30Mar2022, Time the Vaccination Was Given:2:00pm, Anatomical Location of Administration: left deltoid), administration date: 10Nov2021, when the patient was 57 years old, for Covid-19 Immunization, reaction(s): "when she took the 1st dose of the vaccine she lost hearing in her left ear for three days and felt stopped up". The following information was reported: DIZZINESS (non-serious) with onset 02Dec2021 10:00, outcome "not recovered", described as "light headedness"; FEELING ABNORMAL (non-serious) with onset 02Dec2021, outcome "unknown", described as "she just has a weird feeling".  Additional information: Caller states the lightheadedness began this morning about a couple of hours ago at 10:00am and when she took the 1st dose of the Pfizer Covid vaccine she was pressured into getting it and at that time she could not work unless she got it which her work changed yesterday; states when she took the 1st dose of the vaccine she lost hearing in her left ear for three days and felt stopped up; States she does not know when the hearing loss began and felt like her ear was stopped up like a cotton ball was there but she did not loose hearing and was not able to being able to hear like if you are flying on a plane the pressure changes and it felt like that; states she does not know when the hearing issue began but it was just a few days after the 1st dose of the vaccine and is not ongoing but lasted like 3 days. States the lightheadedness is ongoing and about the same and even talking to the agent she just has a weird feeling not dizzy and just lightheaded. Caller states the lightheadedness began this morning about a couple of hours ago at 10:00am and when she took the 1st dose of the Pfizer Covid vaccine she was pressured into getting it and at that time she could not work unless she got it which her work changed yesterday; states when she took the 1st dose of the vaccine she lost hearing in her left ear for three days and felt stopped up; states she took a nasal congestion tablet and Flonase and with blowing her nose those products did not work and she could not hear from her left ear and it was stopped up. AE(s) does not require a visit to emergency room/physician office. Additional vaccines administered on same date of the Pfizer suspect was none. Prior vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none.   No follow-up attempts are possible. No further information is expected.
I told the doctor (he identified himself as a doctor) inserting the shot that it hurt a whole lot as he was removing needle.  He said it was an "advanced vaccine," and dismissed it.
no adverse event; lot that had been expired was administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients) and NO ADVERSE EVENT (no adverse event) in a 46-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients).    Patient age was reported as 46 Year 7 Months.  No concomitant medication was provided.   ID number was reported as 80777027399.   Lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  Treatment medication was not provided by the reporter.
Within a day of receiving my Janssen vaccine, I experienced  a sudden and severe onset of tinnitus, which I am still suffering with, to the point that it disturbs sleep and daytime activities.
Noted pox like blister at injection. One on top of head, one on face and one on chest.
Prior to vaccination Patient reported being light-headed following previous vaccination. After discussing with Patient and Mother, it was decided to vaccinate Patient in a recumbent position. Patient was placed on yoga mat on the floor, supine. Feet were elevated on a chair. Patient was vaccinated. Patient returned to a sitting position within five minutes but then reported feeling light-headed. He was returned to a supine position, and a cold compress was applied to his forehead. VS at 1910: HR-68, B/P-120/68, O2 Sat-97%, Room Air. Patient was observed for 20 minutes at which time he reported feeling better. VS at 1925: HR-102, B/P-106/56, O2 Sat-99% Room Air. HR was regular. Mother declined EMS. Instructions given to go to the ER if any further problems arise. Mother verbalized understanding. Patient exited site with Mother. Follow-up phone call made and spoke with Mother who stated Patient is feeling fine, ate a good supper, and has had no further problems.
Nausea, dizziness, visual disturbance, headache, heart racing. Pt. had to cancel a dentist appt b/c of symptoms.
Information has been received concerning a 5 year old male who on 14-aug-2000 was vaccinated in the right leg with a dose of varicella virus vaccine live (Oka/Merck) (Lot #634838/1863J). On 09-Aug-2004 the patient experienced papules and vesicles on the abdomen and buttocks. It was reported that he was itchy and afebrile and that he recovered on an unknown date.  Additional information has been requested.  OMIC
My daughter received the second dose of the Pfizer vaccine for COVID-19 on 12/10/2021. When she came home from school on 10/17/2022, she had a severe headache and she immediately went to bed and went to sleep. On 10/18/2022, she went to school. She complained of feeling cold, but I didn't give it much thought. About an hour after she got to school, I had to go pick her up. She had a fever of 102.1-102.4. When she got home, she slept for what seemed like 15-20 hours, all while she had the fever. Every six hours, I would alternate between giving her Advil and Tylenol to help her fight the fever. After 24 hours, the fever finally dropped down to 99 degrees. On 10/18/2022, she took a home antigen test and got a positive result. After her fever dropped, she felt perfectly fine and showed no other signs of illness. However, she tested positive every day for about 5 days on home antigen tests, so she still was not able to return to school. The entire family got COVID-19 at this time. While the rest of us were extremely ill, she was doing perfectly fine. Per her school's policy, since she still continued to test positive up until the fifth day, she had to stay out of school for 5 more days, even though she had no more symptoms. Altogether, she missed 10 days of school.
Muscle aches in armpits began a few hours after receiving the dose.  Within 8 hours of dose, a mild fever and chills began (around 100 degrees F). I attempted to take a bath to soothe aches but it did not help, and instead tried to go to sleep at 8:30 pm. A slight red rash appeared on chest and arms around this time.  I was woken up at 10:30 pm feeling disoriented and hot, with a fever of 104.5 degrees F. My wife noticed slurring of words and that I seemed unstable and confused, and symptoms were severe enough we considered going to the emergency room.  I experienced ringing in my ears and a severe headache.  I took 2 extra strength Tylenol, put a cold cloth on forehead, and drank fluids to fall back asleep.  Fever dropped to around 102 but continued throughout the night.  I woke up at 6:30 am and took two more Tylenol.  The severe headache continued and I vomited twice.  I attempted to take a shower and rinse off, and continue to rest.  Fever is reduced to 99 degrees F with help of Tylenol.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-month-old patient of unknown gender. On 11-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Severe Headache, Flu-Like Symptoms, Fever, Aches Chills, Weakness, general malaise lasting 3 days.  Symptoms worsened on the afternoons of days 2 and 3. Needed to stay in bed for the whole 3 days. Unable to go about my daily business. Slept most of the time.   Based on my experience, no one should take this immunization unless they are prepared and able to spend 3 days sick in bed.
Patient reports severe burning down the spinal cord for several days and is still happening as of 6-29. She went to the Dr. and received cyclobenzaprine.
pulling sensation on right arm and right leg; sick; tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (pulling sensation on right arm and right leg), ILLNESS (sick), FATIGUE (tired) and HEADACHE (headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 031M20) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 25-Mar-2021, the patient experienced ILLNESS (sick), FATIGUE (tired) and HEADACHE (headache). On 27-Mar-2021, the patient experienced LIMB DISCOMFORT (pulling sensation on right arm and right leg). On 28-Mar-2021, LIMB DISCOMFORT (pulling sensation on right arm and right leg), ILLNESS (sick), FATIGUE (tired) and HEADACHE (headache) had resolved.            Concomitant product details was not provided by the reporter. Treatment information was not provided.      Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Initial Additional-1 document Containing AE information reported for husband; Sender's Comments: 1st dose
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 07May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DLBCL" (unspecified if ongoing); "papillary thyroid cancer" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 15Apr2022. Past drug history included: Penicillin, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Positive Covid test 3 days after negative test following completion of Paxlovid; Positive, notes: Positive Covid test 3 days after negative test following completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2weeks Levothyroxine. Patient received Anti-viral details: product=COVID 19 Treatment, indication=Treatment of COVID-19. Rebound (Positive Covid test 3 days after negative test following completion of Paxlovid Tx) started on 30Dec2022, received no treatment and was recovering at the time of this report. Dose 2 vaccine lot unknown reason stated as unable to locate or read the details.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300000100 Same patient, different product and event;
Post vax, the pt developed a fever to 104, slight body twitching. Seen at urgent care with normal physical.
Pt complained of sore chest around heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 (Lot number: FK5127) at the age of 6 years as dose 2,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FL0007, Location of injection: Left Arm), administration date: 22Nov2021, when the patient was 5 years old, for Covid-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 21Dec2021, outcome "recovered", described as "Pt complained of sore chest around heart". Therapeutic measures were not taken as a result of chest pain.  Additional Information: Prior vaccination within 4 weeks was reported as none. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Painful outbreak of pruritus and shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and/or zoster-related conditions.   On an unspecified date, shortly after to patient's dose zoster vaccine live (ZOSTAVAX) vaccine, the patient presented a painful outbreak of pruritus and shingles. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. The patient's symptoms had resulted in physical limitations not presented prior vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. The patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Chills, headache, muscle soreness, insomnia and fatigue.  Treatment - Tylenol -Moderna COVID Vaccine EUA
DTaP IM and MMR SW in left upper arm on 9/10/03; 2 days later redness, heat, swelling and pain in deltoid area. Dx cellulitis and Rx Cefzil 250mm/5ml - 1 1/2 tsp PO BID for 10 days.`
No additional AE; A pediatric patient who was given adult VAQTA vaccine; This spontaneous report was received from a nurse prescriber and refers to a 12-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 05-NOV-2020, the patient received an adult hepatitis A vaccine, inactivated (VAQTA) vaccine, 1 milliliter, lot # T014590, expiration date: 15-APR-2021 (strength, frequency and route of administration were not reported) as prophylaxis. That was the first dose of the vaccine administered to the patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability