chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was having the symptoms of all of my chronic conditions. On 11/4/2022, I reported an increased cough to my doctor, though no new medications were prescribed. The doctor just recommended that I use more albuterol. On 11/15/2022, I went back to the doctor, because my cough was still bad, and I demanded that something be done. However, no new treatments were offered. On 2/7/2023, I returned to the same doctor with similar complaints of increased cough. I was then prescribed azithromycin and TESSALON for cough. This was to be taken to addition to the albuterol HFA, which the doctor had already prescribed. On 2/9/2023 and 2/23/2023, wheezing was reported. On this occasion, oral prednisone was prescribed. On 2/23/2023, I returned to the same doctor for a follow-up after antibiotic treatments for my cough and wheezing. Additional treatment was an ANORO ELLIPTA inhaler and, additionally, fluticasone propionate nasal spray. On 3/28/2023, I returned to the same doctor for a follow-up regarding the cough and wheezing. The doctor recommended continuing the ANORO ELLIPTA indefinitely until the cough and wheezing improves. On 4/12/2023, I returned to the same doctor with a new complaint of an increased cough. No new medications were prescribed. I was advised to continue taking the ANORO ELLIPTA and the albuterol HFA. On 4/26/2023, I went to express with a complaint of fever, in addition to increased cough. The temperature was up to 101.7. I was self-medicating with TYLENOL and aspirin. The doctor prescribed antibiotics for the fever. He also enhanced my albuterol HFA by prescribing me a chamber. On 5/4/2023, I returned to the doctor for an office visit with a follow-up for increased cough. The plan is to continue using the medications that were already prescribed and to then return in two months for a follow-up.
Incomplete dose; Something happened with the syringe; A spontaneous report was received from a healthcare facility staff member concerning an unspecified patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incomplete dose and something happened with the syringe.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient was administered an incomplete dose of vaccine due to something happening with the syringe. No additional details were provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, incomplete dose and something happened with the syringe, were considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of a patient who experienced non-serious events of incomplete dose, something happened with the syringe (Incomplete dose administered, Syringe issue) for mRNA-1273, lot # unknown), Exp date-unknown. There were no reported AEs associated with the events of incomplete dose, something happened with the syringe.
About 12 days after my booster,  the skin around my right eye became red, itchy and inflamed. I also felt tingling/crawling on an area on my back. A couple of days after that I broke out in hives all over my body. Not on face. Worse on waist and upper thighs. I also developed heartburn and my shoulder is very sore.  Also I had a very revved up/anxious feeling. I have had the hives breakouts daily for over 3 months and they are worse in the evenings. I have seen my primary care doctor and dermatologist who believe it may be a strong immune response from booster. I am currently on 10mg Zyrtec and one zantac every day. It helps with the itchy eyes but not with the hives. I currently have an allergist/immunologist appointment in May.
This literature marketed report was received from a physician refers to a 2 year old female patient with Wolf-Hirschhorn syndrome. The patient's medical history included transient hypogammaglobulinaemia of infancy, routine viral illness and recurrent otitis media, but no other recurrent viral, bacteria, fungal or autoimmune diseases. The patient's drug history included oral rotavirus live virus vaccine with demonstrated adequate humoral response noted at 1 year of age with tetanus and diphtheria antibodies present at appropriate levels. On an unspecified date patient was vaccinated with VARIVAX (Merck) (manufacture unknown). Concomitant medications were not reported. On an unspecified date (3 days after vaccination) the patient developed fever to 100.4 degree F associated with bilateral otorrhea. The patient was treated with acetaminophen and ofloxacin drops. On day 3 of fever the patient was presented to outpatient clinic for initial evaluation. On examination the patient had purulent drainage from the ears with debris preventing effective drop administration and the patient external auditory canals were cleared and the treatment with otic antibiotic drops was recommended. The otorrhea was resolved. On day 10 of fever the patient had rash, the rash started at left thigh near the vaccine administration and the rash spread by the initial onset of lesions to the abdomen, back, neck, face, extremities and it was diagnosed as atypical varicella (varicella post vaccine and vaccination failure) and the patient was admitted to the inpatient pediatric ward, the patient was treated with intravenous acyclovir therapy. Laboratory test were performed to evaluate current immunologic functions included complete blood count, immunoglobulin levels, mitogen and antigen lymphocyte studies. On hospital day 1, the patient was removed from the intravenous access and treated with oral acyclovir until the lesion to resolve. The following day the patient appeared well, maintaining adequate oral intake and fever had decreased so the patient was discharged from the hospital. The outcome of the event atypical varicella (varicella post vaccine) was reported as recovering. The reporter assessed the events atypical varicella (varicella post vaccine and vaccination failure) to be related to the suspect therapy. The event atypical varicella (varicella post vaccine) was considered serious due to hospitalization. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA - About 10 minutes after receiving her second dose of the Pfizer covid-19 vaccine, pt experienced full body itching and ear itching. Pt reported a history of skin allergies and sensitivity to detergent. No history of adverse reactions to any other vaccine. Recommended pt be observed for an additional 15 mins (she waited for 30 mins total). After a total of 30 mins in the observation area pt felt comfortable leaving and symptoms resolved.
redness; huge welts on the leg; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA316200 (same reporter).  This case involves a 3 years old patient who experienced redness (erythema) and huge welts on the leg (urticaria), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ212AA and lot UT6657JA, via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious redness (erythema) and huge welts on the leg (urticaria) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was erythema and urticaria.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for erythema and urticaria.
Information has been received from a health professional concerning a 13 year old female with no pertinent medical history who on 08/13/2004 was vaccinated in the left arm with a first dose of Varicella virus vaccine live.  Concomitant therapy that day included a dose in the left arm (different location) of tetanus toxoid.  There were no other concomitant medications.  On 08/21/2004 the patient developed soreness with shooting pain, itchiness, warmth and induration in the left arm at the site of administration.  The patient was seen in the office on 08/25/2004.  On 09/15/2004 the patient received a second dose of varicella virus vaccine live.  It was reported that the patient developed similar symptoms after both doses.  The symptoms which developed after the second injection were more centralized than the first episode and were approximately the size of a .50 cent piece.  The physician diagnosed these symptoms as Cellulitis.  The date of onset after the second dose was not known.  The patient was treated with diphenhydramine hcl and cefprozil after both episodes.  The patient is currently considered no recovered.  No product quality complaint was involved.  No additional information was provided.  Additional information has been requested.
Constant fatigue; joint pain; shortness of breath when I try to excersise; Sleeping a minimum of 12-14 hours a day; dose number 1, 25Mar2021, dose number 2, 11Apr2021; This is a spontaneous report from a contactable consumer (patient) reported for himself that:  A 57 years old male patient  received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm right on 11Apr2021 10:00 (Batch/Lot Number: EW0162) as DOSE 2, SINGLE for covid-19 immunisation .Age at vaccination 57 years. Hitorical vaccine included: first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) administered on 25Mar2021 at 09:00 AM on left arm Lot# ER8730.Medical history included Abdominal aortic aneurysm (AAA)  from 2015 to an unknown date Concomitant medication(s) included labetalol taken for an unspecified indication, start and stop date were not reported; amlodipine besilate (NORVASC) taken for an unspecified indication, start and stop date were not reported; benazepril (BENAZEPRIL) taken for an unspecified indication, start and stop date were not reported; duloxetine (DULOXETINE) taken for an unspecified indication, start and stop date were not reported.  On 01Jul2021 the  patient reported Constant fatigue and joint pain, shortness of breath when I try to exercise. Sleeping a minimum of 12-14 hours a day.The outcome of the event dose number 1, 25Mar2021, dose number 2, 11Apr2021 was unknown. The outcome of the other events was not recovered.Additional information:Facility where the most recent COVID-19 vaccine was administered: School or Student Health Clinic,No other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, no diagnosis with COVID-19.Since the vaccination, the patient hasn't  been tested for COVID-19  Follow-up attempts are completed. No further information is expected.
Feverish, aching muscles - particularly arm, back and neck; weak. Red, swollen, sore upper arm where shots given. Could only sleep for 24-48 hours.
R09.02 HYPOXIA 1/10/2022 HYPERTHYROIDISM
Spoke with patient on 8/14/13 and she said she was fine first couple days after pneumonia shot then left arm got very hot and it burned all the way down under left breast for a week. Had to take her pain medication (SOMA) to be able to work. Could barely move her arm the whole time.
Initial report received from a healthcare professional on 22 March 2013. A 26-year-old female patient, had received an intramuscular dose of ADACEL (lot number: U4586AA and site of administration was not reported) on 21 March 2013. The patient's health during pregnancy, specific risk factors (e.g. alcohol, tobacco or recreational drugs) and treatment for infertility were reported as "Not Applicable". Concomitant medications were not reported. The patient's menstrual period was 03 July 2012 and estimated date of delivery was reported as 09 April 2013. As per reporter the patient had not experienced any adverse event. Documents held by sender: None.
dose left arm 06/09, left sided headache 06/13; headache worsening 06/14, took 650 Tylenol x2 that day, more intense headache 06/15, called PCP office to report headache & questioning  RN re side effect of shingrex shot, wasn't able to R/O but to monitor & call back if worse; 06/17 noticed 'pink' cheek, tenderness under left eyebrow & pressure left sinus area & thought maybe I was having a dental/sinus issue > exam & xrays  by dentist proved negative to the symptoms I was describing but he gave me amoxicillin 500mg po tid: if pain was better then it was probably an underlying dental problem but if pain persists then recall PCP. 06/17 nite I had terrific headache & pain left forehead which necessitated tylenol/ibuprofen doses + ice pack to affected area. I 'knew' 06/18 AM that I had shingles ? 'bumpy' painful left forehead, swelling under  brow, & lesions thru-ought scalp; went to local Urgent Care where PA diagnosed me with Shingles & prescribed Acyclovir 1GM tid x7days. Within 36 hrs relief was felt.
Initial report received from Healthcare professional on 16 October 2014. This case is linked to case number 2014SA14350 and 2014SA143085. A 34-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE QIV (Batch number UI212AA, expiry date and dose number was not reported) in to the deltoid right on 13 October 2014. The patient had experienced arthralgia in right hand, can't grip the steering wheel, pain in right arm and hand and numbness on 13 October 2014. Lab investigations and corrective treatment were not reported. The patient illness at the time of vaccination was not reported, and pre-existing diagnosed allergies and birth defects were reported as none. At the time of this report, the outcome of the event was not resolved. List of documents held by sender: none. Follow up information received from a health care professional on 16 March 2015. It was reported as not my patient by the physician.
Itching and slightly rough skin 3 inch diameter around injection site starting 2/9/2021 (8 days post vaccination). Continued itching and slightly rough skin on 2/10/2021 with addition of redness.
I RECEIVED MY FIRST ANTHRAX VACCINE DOSE ON 14 MAY 2004, SAME DAY AS MY SMALLPOX VACCINATION.  THE SECOND DOSE OF THE ANTHRAX VACCINE WAS GIVEN ON 18 JUN 2004 AT THE EMEDS ALONG WITH HEPATITIS B VACCINATION.  THE THIRD DOSE WAS GIVEN ON 3 JULY 2004 ALSO.  APPROXIMATELY THE MIDDLE OF SEPTEMBER WHEN I RETURNED HOME, I BEGAN EXPERIENCING HIVES AND ITCHINESS AT THE SITE OF THE 1ST AND 3RD DOSE (RIGHT ARM).  IT WOULD LAST FOR APPROXIMATELY 1-2 DAYS AND THEN DISAPPEAR, BUT CONTINUED TO RETURN OFF AND ON.  I INFORMED MY DOCTOR OF THIS AND HE SIMPLY SAID THAT AS LONG AS IT DOESN'T SPREAD, I WOULD BE OK, BUT THAT IT MAY ONLY GET WORSE AFTER THE NEXT DOSE.  NO TREATMENT.  AROUND THE MONTHS OF MARCH AND APRIL, I BEGAN EXPERIENCING HIVES AND ITCHINESS ON MY LEFT ARM, THE SITE OF THE 2ND INJECTION.  NOT ONLY THERE BUT ALSO PARTS OF MY FACE: UNDER MY EYE ONE DAY, ON MY EYEBROW ANOTHER DAY, SOMETIMES ON THE CHEEKS, SOMETIMES AROUND THE LIPS.  THERE HAS BEEN NO CHANGE TO MY FACIAL CARE.  SINCE APRIL, IT HAS BEEN ON AND OFF, SPORADIC.  IN NOV 2004, BUMPS BEGAN TO FORM CLOSE TO MY ANAL AREA.  IT WAS LATER DIAGNOSED AS ACTINIC KERATOSIS, IN AN AREA OF MY BODY WHERE THE SUN HAS NEVER HIT.  IN DEC 2004, I WAS TAKEN TO THE HOSPITAL FOR A KIDNEY INFECTION AND TREATED WITH ANTIBIOTICS.  I ALSO HAVE A HISTORY OF LOW GRADE CERVICAL DYSPLASIA (LGSIL OR CIN 1), WITH TREATMENT SUCH AS COLPOSCOPY AND A LEEP.  THE BEGINNING MONTHS OF 2005 FOLLOWING THE DEPLOYMENT, A COLPOSCOPY WAS CONDUCTED WITH A DIAGNOSIS OF MILD TO MODERATE CERVICAL DYSPLASIA (HGSIL OR CIN 1-2) WITH A TREATMENT OF A LEEP AND AN EVALUATION: ERODED CERVIX.  THE HIVES AND ITCHINESS STILL CONTINUE.
Erythema multiforme starting 1 wk post vaccine and persisting over 4 weeks.
GARDASIL 9 underwent a temperature excursion 8/6/2020 and was administered on 8/11/2020.; No additional AE reported; This spontaneous report has been received from a vaccine coordinator, regarding to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 06-AUG-2020, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection vaccine underwent a temperature excursion (product storage error), and was administered to the patient on 11-AUG-2020, at a dose of 5 milliliter (mL) (route of administration, vaccine scheme and anatomical location were not provided; lot number was S005524 and expiration date was on 29-SEP-2021), as prophylaxis. No additional adverse event (AE) was reported.  There was a temperature of 14.5 degree Celsius (C), with a time frame of 45 minutes. There was not a previous temperature excursion. In addition, a digital data logger was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S005524; expirationdate: 29-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
feels like she has shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 5 times).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-NOV-2022 Reporter's Comment: The case was self reported by the patient. The patient received a dose of Shingrix a couple weeks ago and now felt like she had shingles again. The patient had shingles five times and her doctor recommended to get Shingrix.
friend got shingle shot, got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient got the shingles shot and got the shingles again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
My upper arm swelled. The site turned red and I now have a hardened, red area about the size of an egg. I also developed severe chills, fatigue, insomnia, diarrhea about 12 hours after receiving the injection. The symptoms improved after approximately 24 hours. I am still fatigued and my arm is no longer swollen other than the area the size of an egg.
sinus issues; stuffy nose; cough; hoarseness; soreness in both arms; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in right arm on 08Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Vaccination facility type was Clinic. Medical history included Parkinson's from an unknown date and unknown if ongoing. The patient's concomitant medications were none. The patient previously took the first dose of BNT162B2 via intramuscular administration administered in left arm on 18Mar2021 for COVID-19 immunisation and experienced sore arm, and took a Flu shot probably 25 years ago. The patient experienced cough on 09Apr2021 with outcome of recovering, hoarseness on 09Apr2021 with outcome of recovering, sinus issues on 09Apr2021 with outcome of recovering, soreness in both arms on 08Apr2021 with outcome of recovering, stuffy nose on 09Apr2021 with outcome of recovering. Patient had sinus drainage on 09Apr2021. AEs did not require a visit to Emergency Room and Physician Office. Clincial course reported as follow: Patient stated that it may be obvious by the sound of her voice that after the second dose of COVID vaccine on 08Apr2021, by the time patient woke up on 09Apr2021, she had developed a cough. The cough was getting better but her voice was very hoarse, and has also had sinus issues with it, stuffy nose and sinus drainage. Patient stated that the cough was worse last night and her husband was concerned because she had Parkinson's. Patient believed her height was 4'10" or 4'11" and her weight 80-85 pounds right now, she had Parkinson's and for that reason she carried a low weight. Patient stated that with the second COVID vaccine, it was weird because she could feel the pain in her left arm even though she got the dose of COVID vaccine in the right arm so both arms hurt after the second dose. The hoarseness, sinus issues, cough all started 09Apr2021 in the morning when patient woke up. She stated that those symptoms were improving. The pain in both arms after second dose was improved, the pain started on 08Apr2021 and that the pain started right when she was giving me the vaccine. Patient stated that after a flu shot that was probably 25 years ago. Patient stated that within 3 minutes of getting that flu shot her left sinus blocked up and stayed blocked up for 3 weeks (no treatment). When she told her doctor, the doctor recommended not getting any other flu shots.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
13 year old patient received age 5-11 COVID vaccine instead of 12+. No harm identified.
has not felt good; headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (has not felt good) and HEADACHE (headaches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (has not felt good) and HEADACHE (headaches). At the time of the report, FEELING ABNORMAL (has not felt good) and HEADACHE (headaches) outcome was unknown.            No concomitant product information was reported.  No treatment information was reported.  Action taken with mRNA-1273 in response to events was not applicable.