chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an approximately 4 month old male with no pertinent medical history who on 27-NOV-2007 and 29-JAN-2008 was vaccinated PO with his first and second doses of ROTATEQ. Concomitant vaccinations included "other vaccines." After the first dose, the patient experienced severe vomiting and loose stools for two weeks. The patient eventually recovered. After the second dose, the patient experienced the same symptoms of severe vomiting and loose stools that lasted about two weeks as well. The patient sought unspecified medical attention. There was no product quality complaint. Therapy with ROTATEQ was discontinued after the second vaccination. Additional information has been requested.
c/o Right arm numbness and heaviness.  BP 190/96, P 80, R Patient states that is she prescribed blood pressure medicine (amlodipine) but cannot afford it so she does not take it in weeks.  Patient denies HA, SOB or chest pain.  Nurse advised patient to report to medical facility immediately because BP is not declining.  Vaccine site(left deltoid) not affected
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown ages and genders. On an unknown date unknown number of patients were vaccinated with a dose of improperly stored MMR II (lot number, expiration date, dose, frequency, route were not reported). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Gave varicella & HPV at 1600.  1610 pt felt dizzy & fell to floor.  Became pale.  Gave Gatorade & sat for few minutes, pt admits not eating lunch prior to appt.  Last ate at breakfast.
First dose: Little chemical taste; First dose: Tired; This is a spontaneous report from a contactable consumer(patient).  A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EW0167) via an unspecified route of administration, administered in Arm Left on 27May2021 15:00 (at the age of 68-year-old) and received second dose of BNT162B2 administered in Arm Left on 15Jun2021 14:00 (lot: EW0186) as single dose for covid-19 immunisation. Medical history included thyroid disorder from 1999 and ongoing. Concomitant medication(s) included latanoprost (LATANOPROST) Ongoing taken for Thyroid condition, levothyroxine sodium (TIROSINT) taken for thyroid disorder from 1999 and ongoing. On 15Jun2021 20:00 she had headache decided to take some Tylenol and it never went away, it just took the edge off. She took 500mg Tylenol and it did not work (Lot: LJA101, expiration date: Jun2021). At midnight and the whole night, she had a pressure in her head. Arm soreness, felt dehydrated, blood pressure elevated. Patient stated that she had a slight fever in the morning. Her temperature was usually 95 or 96, and if it goes a little higher, her temperature was about 98 on 16Jun2021 and experienced Heart racing and palpitations. She had a little chemical taste in her mouth for like a half hour after getting the first shot. It was strange and then passed. She was recovered completely from her symptoms after the first dose. The patient underwent lab tests and procedures which included magnetic resonance imaging: MRI no contrast on 14Jun2021.The patient had not recovered from Headache, Little fever, recovered from little chemical taste in her mouth, tired on27May2021 and outcome was unknown for remaining events.   Information on Lot/Batch number was available. Additional information has been requested.
rash on back; rash on chest; rash on arms; very itchy; sore arm; allergies; headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on back), RASH (rash on chest), RASH (rash on arms), HEADACHE (headache) and PRURITUS (very itchy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Latuda(lurasidone),Zyprexa(olanzapine), levo-dromoran(levorphanol), halzal and adhesive tape.).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced RASH (rash on back), RASH (rash on chest), RASH (rash on arms), PRURITUS (very itchy), INJECTION SITE PAIN (sore arm) and HYPERSENSITIVITY (allergies). On 18-Feb-2021, HEADACHE (headache) had resolved. At the time of the report, RASH (rash on back), RASH (rash on chest), RASH (rash on arms), PRURITUS (very itchy), INJECTION SITE PAIN (sore arm) and HYPERSENSITIVITY (allergies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were  not reported.  Treatment Started using cortisone cream from 10Mar2021.
This is a spontaneous report from a contactable consumer reporting for his wife. A 69-year-old female patient received PREVNAR 13, via an unspecified route of administration in the arm right, on 04Jan 2017 at 08:00 AM, at single dose, for immunisation. Relevant medical history included stroke from 2014 and unknown if ongoing, high blood pressure (diagnosed about 8 years before), diabetes (diagnosed about 8 years before). Concomitant medications included acetylsalicylic acid (ASPIRIN), from an unspecified date and ongoing, for cardiac disorder; atorvastatin calcium (unspecified trade name), from 11May2016 and ongoing, for cholesterol; minerals nos, vitamins nos (CALCIUM PLUS) tablet, from an unspecified date and ongoing (has been on this for years), for build bones up; clonidine hydrochloride (CLONIDINE HCL) tablet, from Apr2014 to an unspecified date, for blood pressure; clopidogrel besylate (CLOPIDOGREL BESILATE) tablet, from Mar2014 and ongoing, for heart and control blood pressure; gabapentin (unspecified trade name) capsule, from Mar2015 and ongoing, for diabetic foot pain; hydralazine hydrochloride (HYDRALAZINE HCL), from Mar2014 and ongoing, for hypertension and chronic kidney disease stage 2; isosorbide mononitrate (unspecified trade name), from Mar2014 and ongoing, for blood pressure; labetalol hydrochloride (LABETALOL HCL) tablet, from May2015 and ongoing, for blood pressure; losartan potassium (unspecified trade name), from Mar2014 and ongoing, for blood pressure; metformin hydrochloride (METFORMIN HCL), from Mar2014 and ongoing, for diabetes;  nifedipine (NIFEDIPINE-ER), from Mar2014 and ongoing, for hypertension with chronic kidney disease stage 2; omeprazole (unspecified trade name) capsule, from May2014 and ongoing, for hypertension with chronic kidney disease stage 2 with diabetic gastro reflux disease; paraffin, liquid, white soft paraffin (REFRESH PM) ointment, from Jul2016 and ongoing, for dry eye; carmellose sodium  (REFRESH TEARS), from Jul 2016 and ongoing, for dry eye; sertraline hydrochloride (SERTRALINE HCL), from Nov 2016 and ongoing, for sedative; trazodone hydrochloride  (TRAZODONE HCL) tablet, from Mar2015 and ongoing, for sleep disorder; vitamin b complex (unspecified trade name), capsule, from an unspecified date and ongoing (forever); ergocalciferol (VITAMIN D), capsule, from an unspecified date and ongoing (forever); tocopherol (VITAMIN E), capsule, from an unspecified date and ongoing (forever). Before vaccination her physical and blood pressure was normal (138/54). Previously in the past the patient received several other vaccinations including influenza vaccine shots and pneumococcal vaccine shots, and had a bunch in the 70's, all for immunisation with no adverse effect. The patient experienced blood pressure shot up on 04Jan2017 at 11:15 AM, blood pressure was 220/80. The event required a visit to physician office. At 11:40 AM it was 260/80. At 12:00 PM she took her medications and it went to 160/something, bottom number was unknown. At 08:00 PM it was 128/54. The event recovered on 04Jan2017. On 05Jan2017 her blood pressure was normal, at 08:00 AM it was 128/63.
From telephone contact received at manufacturer on 07/23/2002, it was reported that an 11-year-old female received 3 doses of Imovax IM to the deltoid for post exposure prophylaxis. The pt developed large local reactions at site of injection after each dose. The areas were red, warm, tender to touch, but size not reported. This report, phoned in by pt's mother, who is a nurse practitioner at a different facility from where the vaccines were administered. No lot number info available, doses were administered at family physician's office. Mother wasn't sure if this was reported to VAERS through her health department. A VAERS form was faxed to her requesting she obtain as much info as possible and return to manufacturer.
This case was reported by a other health professional via sales rep and described the occurrence of laceration in a female patient who received Herpes zoster (shingrix) (batch number H54CA, expiry date 18th May 2023) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received shingrix. On an unknown date, unknown after receiving shingrix, the patient experienced laceration, inadvertent exposure to vaccine and pharmaceutical product complaint. On an unknown date, the outcome of the laceration, inadvertent exposure to vaccine and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the laceration to be related to shingrix. The additional details were provided as follows: Field representative initially called to report a potential shingrix PQC on behalf of HCP. However, he did not have detailed information. GRC agent called reporter directly to obtain detailed information. The reporter reported that 1 shingrix antigen vial was cracked in the carton and all the other vials were fine, which led to pharmaceutical product complaint. The reporter did not have lot/expiry for adjuvant vial or the vaccine box as they were discarded. No patient involvement with the suspect vial. 1. The package/carton or blister tray was not damaged upon receipt. 2. There was not any evidence of leakage or product in package/carton (ex. wet PIL, powder in box). 3. There were a piece of glass is missing on the vial and was found in the carton. Since that piece of glass came off from the vial, the vial has a hole in the vial. The piece of glass that came off from the vial was discarded safely. 4.There was some product still present in the vial. 5. If cracked, it was extended and branched. 6.The crack/breakage was observed on the vial. The reporter reported that due to cracked vial, one of the staff members (who was handling the vaccine) got cut. The reporter gave a consent to follow-up with herself. The reporter provided fax number and an email address. The reporter did not have staff members date of birth. Please send 1 Single vial dose pack (1 adjuvant vial and 1 antigen vial): 704742 to replenish their stock. The reporter still had the suspect vial in possession. She would return to GlaxoSmithKline. Related PQC/AE reports completed.
Per patient contacting pharmacy, she indicated approximately 24 hours after her first COVID-19 vaccine (Moderna), patient experienced a grand mal seizure that caused unconciousness for approximately 2 minutes.  While unconcious, she bit her tongue and her time to get full functionality was 30-60 minutes after.  Patient indicated she contacted her primary neurologist via email and left messages at the office, however still has not heard from her doctor.  She did not seek out other medical treatment.  Patient has a history of grand mal seizures, but has not experience an event since starting medication.
Client received MMR but did not need this vaccine. Foreign record of MMR given was not transcribed to state immunization registry prior to client's appointment.
Fever of 100.9 all day (day after vaccination), achey, chilled.
This spontaneous report as received from another health professional refers to a 3 year old female. On 25-NOV-2013 the patient was vaccinated with second dose of RECOMBIVAX HB, intramuscular. Previously on 27-DEC-2011, the patient was vaccinated with first dose of RECOMBIVAX HB, intramuscular. Concomitant medications were/reported as none. Medical history and drug allergies were also reported as  none. On approximately 09-DEc-2013 (reported as approximately two weeks after that second dose of RECOMBIVAX), the patient experienced hives and skin rash which comes and goes. The mother has give BENADRYL to the child. The patient currently has the hives now. The outcome of hives was reported as not recovered. The outcome of skin rash was unknown. Causality assessment was not provided by the reporter. The patient present4ed to the office today, but no additional doses of RECOMBIVAX HB were administered. No patient contact details provided. No further information provided. Additional information is not expected.
Had nausea fifteen minutes after getting the vaccine . Then got chills , body aches and fever for three days .
Information has been received from a physician concerning a patient who was vaccinated with a dose of Gardasil.  Subsequently the next day the patient's lip puffed up.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  The physician reported that the puffed lip may not be related to the Gardasil.  Additional information has been requested.
Patient came by the pharmacy a week after receiveing her first Moderna immunization and had a red rash at the injection site. I told her if it is itching to try taking Benadryl and if it doesn't resolve in a few days to contact her PCP.
Information has been received from a pharmacist concerning a 78 year old female with no known allergies who was hospitalized for cardiac reasons with a medical history of pericardial effusion who on 12-NOV-2006 was vaccinated intramuscularly with 0.5 mL dose of Pneumovax 23 (Lot number not specified).  Concomitant therapy included TENORMIN, aspirin, ascorbic acid, glimepride, LOVENOX, iron (unspecified), folic acid, LASIX, SYNTHROID, simvastatin (MSD), ALDACTONE and DIOVAN.  On 12-NOV-2006 the patient developed a swollen arm at the injection site.  The patient was treated with warm compresses.  The patient had not received the Pneumovax 23 vaccine in the past 5 years.  The patient's swollen arm at the injection site did not prolong the patient's hospital stay.  At the time of the report, it was not reported if the patient recovered.  Additional information has been requested.
Noted severe fatigue, diffuse pain, facial twitching on eye and mouth r side first day.  Second day fatigue, and diarrhea, headache  Third day-today abdominal pain, GI bleed
Initial report received from a health care professional on 08 November 2011. A 60-year-old female patient received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur lot number UT499AB, on 05 November 2011. Within 10 minutes of receiving the injection of FLUZONE, the patient had a funny taste in her mouth and tongue and her pallet felt funny. The next day she had a red, hot lump at the injection site with swelling of the lips and tongue and tingling in the hands, feet and legs that all persisted. The patient required a doctor visit. The outcome was reported as not recovered. The reporter refused to give any further information. Documents held by sender: None.
Severe pain from her neck to her arm (to wrist). No redness  (some swelling in upper arm and shoulder).
approximately 2 hours after the patient received the vaccine  she became dizzy, experienced slurred speech....symptoms similar to mini-stroke. She went to the hospital and was given test that ruled out clogged arteries, blockage. The CT scan did not reveal anything abnormal. After about 2 hours at the hospital, she began to feel better. She received MRI today, January 24,2023 and awaiting results.
Test positive for COVID 19 1/01/11/2022. My symptoms was moderate and I had fever, cough running nose and I cold think because of the fever that I had for 5 days. After my fever broke I was able to think.
Oral lesions; This is a spontaneous report from a contactable nurse, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 19Aug2021 at 10:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy, hypothyroidism and hiatal hernia. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levetiracetam (KEPPRA), levothyroxine sodium (SYNTHROID) and omeprazole (MANUFACTURER UNKNOWN); all from an unknown dates for an unknown indications and unknown if ongoing. On 03Sep2021, the patient experienced oral lesions. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event oral lesions was not resolved at the time of this report.
pain in his arm where the vaccine injected; This is a spontaneous report from Pfizer. A contactable consumer (patient) reported that a male patient of an unspecified age received second dose of BNT162B2 (Pfizer Covid-19 Vaccine, solution for injection, Batch/Lot number and expiry: not reported), via an unspecified route of administration on 24Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose BNT162B2 on 03Mar2021 for COVID-19 immunization. It was asked about the expiration date of the vaccine, upon stating he mentioned that his wife (name) had a reaction with Pfizer vaccine like diarrhea, and he added that he experienced a pain in his arm where the vaccine injected on an unspecified date in 2021. Their 1st dose was last 03Mar2021 and the 2nd dose was 24Mar2021. Both of them received the 1st dose and 2nd dose on the same date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021349482
Patient has h/o anxiety with needles. Upon receipt of the vaccine, experienced dizziness, profuse sweating, pallor, and weakness. Vital signs checked x 4 - stabilized. 120/42, 74/43, 97/60, 104/84.
on her arm, a hot red rectangle that looks like cellulitis; fever of 102°F; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (on her arm, a hot red rectangle that looks like cellulitis) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced PYREXIA (fever of 102°F). On an unknown date, the patient experienced CELLULITIS (on her arm, a hot red rectangle that looks like cellulitis) (seriousness criterion medically significant). On 15-Jul-2021, PYREXIA (fever of 102°F) had resolved. At the time of the report, CELLULITIS (on her arm, a hot red rectangle that looks like cellulitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 102°f (High) fever of 102°F.         No concomitant medications were reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I had been over my normal menstrual cycle for 3-4 days but it came back with lots of cramping after my first dose of vaccine. I received my first dose a week ago and am still bleeding heavy enough to need a pad/tampon and cramping woke me up last night.
mom phoned 22MAR95 to say daughter given TD 20MAR95 & next day very sleepy-had a h/a & vertigo lasted almost 3 days; no temp
Looks like what is referred to as covid arm from photos found on google.  The rest of body is normal temperature except for the site of the "rash". The redness is located about an inch away from the injection site. Note that patient took a covid booster (Moderna) and a flu shot within minutes.
arthralgias;Koebner phenomenon;achiness in all joints especially hands;stiffness;rash;energy dec;
Mother states off balance, falling backwards. Referred to neurologist for evaluation; failed to keep appointment. Treated by Pediatrician with cough medicines, etc. Otherwise, physical findings unremarkable.
This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 28-year-old female subject who was vaccinated with Influenza vaccine (unspecified), (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, site of injection and batch number). Two weeks after vaccination with Influenza vaccine (unspecified), the subject experienced anti-neutrophil cytoplasmic antibody positive vasculitis (cytoplasmic/ proteinase 3) and granulomatosis with polyangiitis. The kidney and the lung were the organs which were implicated. This case was assessed as medically serious by GSK. The subject was treated with cyclophosphamide and prednisone. At the time of reporting, the subject was in remission. This case is linked to 7 cases coming from the same publication.
General Fatigue at first. Realized reaction was happening and took temperature (100.3). ~6:30AM on 2021-04-07 took Tylenol  for fever and ache. ~3PM on 2021-04-07 Fever was not present (temp ~98) Felt much better. on 2021-04-08 - still tired, but no fever (temp ~98) with no Tylenol since late afternoon on 2021-04-07
67-year-old female who is a patient of MD and presents to the urgent care with the complaint of lip swelling, tongue itching and throat tightness and swelling.  Denies any shortness of breath at this time.  Patient received her COVID booster 35 min prior to presentation.  Patient reports that she was feeling well previously.  Patient does have a history of allergic reactions. PLAN: 1. Patient was given EpiPen, 125 mg of Solu-Medrol IM, 50 mg of Benadryl IM in clinic. 2. Patient is being transferred to ER for further evaluation and treatment. 3. Patient is stable at time of transfer. 4. Report was called and given to ER.
Severe muscular pain in lower calf of both legs.  I have been using bio freeze to relieve some of the pain.  It?s constant.