chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day 1 (8/12) afternoon, fever of 99.9, baby acted as if he didn't feel well; evening fever of 101.1, gave ibuprofen, and fever went away. Day 2 (8/13) baby woke with fever of 99.9, gave ibuprofen, fever went away; afternoon baby woke with a fever of 101, gave ibuprofen and the fever went away, that evening fever of 102, have ibuprofen, fever went away. Saturday (8/15), baby woke with a mild raised rash over head, face, neck, chest, stomach, back, and diaper area. Rash got worse over the course of the day. No itching or fever was associated with the rash. Baby didn't seem to notice it, and he played, ate, eliminated, and slept normally. Sunday (8/16) Rash lightened over the course of the day, with no other symptoms. Monday (8/17) rash was barely visible on stomach and back, not visible on face, head or neck. (8/18) no symptoms. Symptoms reported to the doctor's office. No additional visit was deemed necessary.
No adverse event; Patient received the monovalent booster instead of bivalent booster; received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 2SEP2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received the monovalent booster instead of bivalent booster), PRODUCT AVAILABILITY ISSUE (received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 2SEP2022) and NO ADVERSE EVENT (No adverse event) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received the monovalent booster instead of bivalent booster). 02-Sep-2022, the patient experienced PRODUCT AVAILABILITY ISSUE (received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 2SEP2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received the monovalent booster instead of bivalent booster), PRODUCT AVAILABILITY ISSUE (received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 2SEP2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received the monovalent booster instead of bivalent booster) and PRODUCT AVAILABILITY ISSUE (received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 2SEP2022).    Concomitant medication was not reported.  It was reported that no expired dose was given to the patient on 2SEP2022.  Patient was fine and did not experience any side effect.  Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2022: Significant information received. Patient details, event information updated.
Within 10 mins after taking the vaccine he felt dizzy, lightheaded and had a hard time breathing.  His heart started to race. His BP kept rising it went to 180/20. The EMTs came to check him out but he continued to feel worse and worse. It went on from 45mins to an hour. His oxygen level went up to 98. Mom stated that he was so dizzy he couldn't walk on his own. He had chills and severe muscle aches in his lower parts of his body. Within 24hrs of this it had subsided.
On my vaccination there is an expiration date that has passed; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On my vaccination there is an expiration date that has passed) 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.   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (On my vaccination there is an expiration date that has passed). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On my vaccination there is an expiration date that has passed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No Treatment medications reported.   Reporter did not allow further contact
patient called to report that 1 day post vaccination of both into same deltoid muscle patient experiencing temperature of 102F, headache, chills, and decreased range of motion of effected arm; prescribing MD recommended Benadryl and Tylenol with instruction to call back if symptoms persist >48 hrs
fainted; This spontaneous report as received from a health professional via Pfizer (manufacturer control # 202101076767) refers to an approximately 16 or 17 years old patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.     On an unknown date in 2017, in the same visit, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis and meningococcal vaccine b rfhbpa/fhbpb (TRUMENBA) (dose, route of administration, anatomical location, lot # and expiration date were not reported).  In in 2017, after receiving meningococcal vaccine b rfhbpa/fhbpb (TRUMENBA), the patient fainted. The outcome of fainted was unknown.  Causality assessment was not provided.  Upon internal review, the event of fainted was determined to be medically significant.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 28-APR-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "1", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
body aches; bad tooth; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A male patient with age 57 received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on 25Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced body aches and bad tooth. The patient wants to know when can take ibuprofen for his tooth. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
HOSPITALIZED 3 TIMES; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced hospitalized 3 times, and was hospitalized (date unspecified). The of days hospitalized was not reported. It was reported that, "My family member was hospitalized 3 times from your discusting injection & now you want to hurt more? GROSS...Evil...Eff off..." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalized 3 times was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220909468-COVID-19 VACCINE AD26.COV2.S- hospitalized 3 times . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Information has been received from a health professional concerning a female pt who was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot 640577/0995L). Subsequently, the pt experienced severe cellulitis from her shoulder to her elbow. Unspecified medical attention was sought. Follow-up information indicated that within 1 day of vaccination, the pt called the office complaining of swelling, redness and heat at the injection site extending down her arm. She was seen in the office. The pt was treated with antibiotics and Medrol. It was reported that the pt did not require hospitalization and she subsequently recovered. It was reported that the pt received the 1st dose on an unknown date. The nurse reported that 2 other pts had similar experiences following exposure to pneumococcal vaccine 23 polyvalent (WAES0201USA02826 and 0201USA02827). The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Upon internal review, the pt's cellulitis was considered an "Other Important Medical Event". Additional information has been requested.
Patient received his flu vaccine was fine. About 5 minute later said he didn't feel well - he stiffen up and pass out. He was put on the table. He came to fairly soon - color was pale.
No additional AE; Patient was administered expired MMRII; This spontaneous report was received from a nurse practitioner, referring to patient of unknown age and gender. The patient's medical history, and concurrent conditions were not reported. Concomitant medications included sterile diluent (DILUENT MRK).   On 07-JUL-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot #T020656 has been verified to be a valid lot, expiration date: 16-JUN-2022) (strength, dose regimen, and route of administration were not provided) (expired product administered). No additional adverse events were reported.
very hot area 5 inches x 1.5 inches, shaped like a dirigible or a hot dog, just under the injection site; not an average round bump
Mother reporting 3 spots at the varicella injection site last night and that patient was itching at them.  No fever and child okay otherwise per mother.  Today the site became red and "hard" and about the size of a plum per mother. Still denies a fever and denies child still itching it.  The child had tubes placed this morning, so fussy for other reasons.  Mother stated that she would follow up with Dr. today and would try to put a cool compress to the site.
Satelite infection on left shoulder 1 cm  below vacination site and two on left upper back.
Trihibit vaccine given for 2nd dose when it is only licensed for the 4th dose. No adverse reactions reported by parent.  Medical Director notified.
Hot Scalp after first dose; Itching constantly scalp  after first dose; Constant pain on scalp  after first dose; Rash on the scalp  after first dose; Sore arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot Scalp after first dose), PRURITUS (Itching constantly scalp  after first dose), PAIN OF SKIN (Constant pain on scalp  after first dose), PAIN IN EXTREMITY (Sore arm after first dose) and RASH (Rash on the scalp  after first dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore arm after first dose). On 12-Aug-2021, the patient experienced FEELING HOT (Hot Scalp after first dose), PRURITUS (Itching constantly scalp  after first dose), PAIN OF SKIN (Constant pain on scalp  after first dose) and RASH (Rash on the scalp  after first dose). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency; TEA TREE OIL for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 15-Aug-2021, PAIN IN EXTREMITY (Sore arm after first dose) had resolved. At the time of the report, FEELING HOT (Hot Scalp after first dose), PRURITUS (Itching constantly scalp  after first dose), PAIN OF SKIN (Constant pain on scalp  after first dose) and RASH (Rash on the scalp  after first dose) outcome was unknown.            No concomitant medication provided.  On 12-Aug-2021, 24 hours after vaccination, the patient had rash on the scalp which was hot to touch, itching constantly with constant pain.   Treatment medication like Hydrocortisone OTC cream on scalp, Tea tree oil on scalp, Tylenol for discomfort were provided.   This case was linked to MOD-2021-326242.
Received ADACEL in left deltoid; FLUARIX QUAD and PNEUMOVAX in right deltoid on 10/03/16. Patient has had TDAP and flu shots previously with no adverse reactions. Experienced immediate pain upon injection of the Pnemovax that never ceased. Could not sleep on right arm the night following the vaccines. Following day (10/04/16) had headache that was non-responsive to OTC painkillers and was unable to lift right arm without extreme pain. Later that night began experiencing chills and a fever of 100.4. The next morning (10/05/16) at 5am, fever was at 101.4. Went into doctor at 9am and discussed steroids to lessen immune response or tramadol for headache/arm pain. Only tramadol was given. Went home, took tramadol, and took a nap. Waking up from nap with chills, fever was 102.7. Promptly went to urgent care at 6pm to get steroids. 24 mg of methylprednisolone taken at 7pm. All symptoms were resolved the following morning. Hard to say which vaccine caused adverse reaction or if one large immune response to getting 3 vaccines at once.
her brother who got a dose of the vaccine experienced rashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)   A male 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: RASH (non-serious), outcome "unknown", described as "her brother who got a dose of the vaccine experienced rashes".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
fainting after first vaccine; Headache, after first vaccine; Fever, after first vaccine; Chills, after first vaccine; Dizziness; Loss of smell after first vaccine; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Aug2021 (at unknown age) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Agent states the Caller took her first dose of the Pfizer vaccine on 04Aug2021. Agent states the Caller reports having a headache, fever, chills, dizziness and fainting, and loss of smell, all on Aug2021. Caller confirms she is calling about the Pfizer COVID vaccine. Caller states she was calling her doctor, because she still had some dizziness and a loss of smell, and all of her other symptoms went away. Caller states she was trying, to make an appointment with her doctor, and they told her to call Pfizer. So she is not really sure what to do. The outcome of the events dizziness and a loss of smell was not recovered, for other events was recovered in Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Around 9:00 PM the day of the vaccine patient started to develop pain and soreness in the area he received the vaccine. Later around 2:00 he started to break out in sweats and developed a fever. In addition, he stated his muscles and joints became super sensitive to the touch where he could not get out of bed. 9:00 Am that morning the symptoms starts to subside and he was able to get out of bed and take acetaminophen. The symptoms have started to lessen but he has developed some nausea in the meantime.
I developed mild chest pain on 5/27/21.  I saw a doctor on 5/28 who found that my troponin level was elevated.  I was sent to the ER and then hospitalized.  My troponin remained elevated throughout my 2-day hospital stay.  On an echocardiogram, the cardiologist found borderline pericardial effusion and borderline abnormality in wall motion.  My troponin level has now normalized but my chest pain continues.  I continue to follow up with my cardiologist and primary care doctor.
high heart rate, muscle weakness, exhaustion, sensitivity to heat, nausea, shortness of breath
Chills, fever, headache, fatigue, severe all over body aches, pain under left armpit. Symptoms started about 17 hours after shot and continued throughout the next day, almost 48 hours. Fever was the last symptom early morning of day 2 but broke with Tylenol. The body aches were the worst symptom.
On the way out of the doctor's office the patient had an unprovoked fall in the lobby of the office (did not trip), followed by 2 more unprovoked falls at home later that night. The next day had a generalized afebrile seizure and was seen at our Urgent Care office. Remained well there and had a normal exam. Released, and later that night had another generalized seizure at home. Was then brought to ED and admitted for a full evaluation. CT and MRI of head normal. Bloodwork normal. EEG very abnormal. Had a few more seizures at the hospital. Diagnosed to have grand mal and atonic seizures. Was started on Keppra which controlled seizures successfully, and discharged home with Neurology follow up.
I experienced excruciating pain in my middle back--it woke me from my sleep. It felt like that entire area was in pain. I could not been over without twinges of spasms. I could walk without problems--including up and downstairs (with extreme caution).  On 1/16/21 I started taking Bayer for Body and Back pain and using  Icy Hot on the area that hurt. I called my doctor's office for med for spasms and she said I need to see a doctor. I wanted to be compliant with her recommendations. The doctor suggested Extra Strength Tylenol every three hours.
Patient experienced redness and itching at injection site on right shoulder. This is believed to be from PNEUMOVAX.
This spontaneous report as received from a pharmacy student with a doctor of pharmacy degree refers to a 66 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route and lot # unknown) at 61 years of age. On an unknown date, the patient had a kidney transplant, became immunocompromised and needed a cochlear transplant following vaccination with PNEUMOVAX23. No treatment was given. The patient contacted pharmacy to seek medical attention. The healthcare student had no other information on the patient's kidney transplant and becoming immunocompromised following vaccination with PNEUMOVAX. The healthcare student reported that the patient was scheduled to have a cochlear transplant, but had no other information about the cochlear transplant. The outcome of the events was unknown. Upon internal review, kidney transplant was considered to be medical significant. Additional information has been requested.
Local pain to injection site, widespread body aches, fever and chills by that night.   Next day: persistent fever and body aches, headaches, nausea   First Week: developed skin rash on right lateral thigh, later diagnosed as eczema (still persistent and uncontrolled to this day)  Bilateral Respiratory wheezes and chest pain when working out (never had pre vaccine)