chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial literature report received on 17 Jan 2011: This adolescent had no history of hereditary disease or allergy. Pure tone audiometry performed four years earlier had shown normal hearing in both ears. The adolescent was vaccinated with H1N1 (manufacturer unknown, batch number not reported) on an unspecified date. Fourteen hours after the H1N1 vaccination, the adolescent developed bilateral sudden hearing loss and also experienced mild dizziness, nausea, and bilateral tinnitus, but did not have vertigo, vomiting or any other symptoms. Pure tone audiometry performed on an unspecified date revealed moderate hearing impairment in both ears. Auditory brainstem response revealed 55 decibels (dB) hearing loss in both ears, with normal waveforms at 90 dB sound pressure level. The tympanogram showed normal tympanic membrane compliance in both ears. Brain magnetic resonance imaging did not reveal any pathological findings. On an unknown date, the adolescent underwent blood examinations for syphilis, antibody against antinuclear antigen, herpesvirus-I, herpesvirus-II, cytomegalovirus, hepatitis B virus, and hepatitis C virus were also performed. The blood sample was also analyzed for T3, T4, thyroid-stimulating hormone, cholesterol, and triglycerides. All these blood examinations yielded normal results. The adolescent was administered prednisolone (1 mg/kg/d), dextran (100 mL/hr, 500 mL/d), and vitamin B complex. After six days of therapy, the patients hearing ability improved. After one month on an unknown date, pure tone audiometry showed hearing threshold of 30 dB in both ears.
No adverse reaction to report, However pt was given an additional dose of MMRV and DtaP:IPV. Pt has just received them on 7/28/21, and received them again.
A 59-year-old female patient had received an injection (route/site and lot number not reported) of FLUZONE SV 2007-2008, and on the day of vaccination, she complained of pain in her shoulder that persisted for approximately four months.  She was diagnosed approximately four months later with a torn rotator cuff which she had surgically corrected.  Past medical history included osteoarthritis and menopausal symptoms.  No further information was provided.
was cold; Diarrhea; Sleepy; Threw up once; was cold, mentioned that she she would sit on couch and shake; Mild fever; Rash at injection around site 2/ 3 inches; Nausea/ thought of eating was nauseating; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (was cold), DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepy), VACCINATION SITE RASH (Rash at injection around site 2/ 3 inches) and NAUSEA (Nausea/ thought of eating was nauseating) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE RASH (Rash at injection around site 2/ 3 inches) and NAUSEA (Nausea/ thought of eating was nauseating). On an unknown date, the patient experienced FEELING COLD (was cold), DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepy), VOMITING (Threw up once), CHILLS (was cold, mentioned that she she would sit on couch and shake) and PYREXIA (Mild fever). At the time of the report, FEELING COLD (was cold), DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepy), VACCINATION SITE RASH (Rash at injection around site 2/ 3 inches), NAUSEA (Nausea/ thought of eating was nauseating), VOMITING (Threw up once), CHILLS (was cold, mentioned that she she would sit on couch and shake) and PYREXIA (Mild fever) outcome was unknown.            Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.      Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non significant follow up appended.
ACUTE ST ELEVATION MI, INFERIOR WALL  10/18/2022 --  RECURRENCE OF SAME SYMPTOMS
08/19/10 soreness/redness at site with nausea/dizziness until 08/24/10, diffuse urticaria with pruritis to ER.  Tx'd with ALLEGRA, BENADRYL, ZYRTEC, PREDNISONE.
Pale Skin and Losing color in skin approx. 10 minutes after vaccination. Pediatrician screened patient. emergency kit at the ready if needed.
Within hours: 102 degrees fever; chills; headache; body aches lasted 3 days; very severe arm pain (a) injection site - entire arm warm hours
Pt brought back to clinic about 2.5 hours after below named vaccines given. Pt with pruritic hives to left side of face, left upper arm. No shortness of breath. Refused any treatment. Parents advised to give child Benadryl and start Prelone syrup at home. To return in 24 hours or sooner to ER if symptoms progress.
Headache, Myalgia, HYPOtension, Tachycardia, felt like glands were swollen, fatigue Narrative: Had drop in BP and elevated HR. She measured her BP in her unit because she as feeling light-headed. BP was 100/60. HR was 108 at the highest. This resolved in about 1 hour. The following day around noon is when she developed body aches and headache. Felt like her glands were swollen. Felt very tired. On 1/8 she felt better but still tired. On 1/9 she felt totally normal again. On 1/12 at night around 12:30 am, she woke from sleep feeling like her heart was beating fast. She measured her heart rate on her pulse oximeter and it was 150 bpm. This lasted for about 5 min and then was in the 90's. She does not have a history of heart problems, palpitations, or tachycardia. Advised to f/u with her PCP if her tachycardia recurs.
This spontaneous report as received from a consumer refers to her 11 years old daughter with penicillin allergy and no pertinent medical history. The patient was vaccinated with a dose of VAQTA. No other co-suspects were reported. No concomitant medications were reported. The consumer reported that while on VAQTA, her daughter's behaviour toward her siblings changed. Her hair became dry. Her hair was still dry. She cannot tolerate flashing or bright light in her eyes. She lost some hair on her head and began pulling hair out around her ear. She visited the doctor for medical attention. No treatment was given for the events. No lab diagnostics studied were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Pt recvd hep B vax on 19DEC89,19JAN90 & 02JUL90.Fever blisters occurred p/ 2nd vax.14AUG90 test results showed pt did not convert p/ vax.Addt'l dose given;results for HBSAB again neg.
The patient received the immunization in the early afternoon of 03-07-2018. The patient had pain in his arm that night. On Friday 03-09-2018 the patient presented back to the complaining of L arm/shoulder pain yet the RN was not available that day. The patient called on 03/13/18 in the am to report the pain. The patient states the pain is worse at night. The patient has been taking 400 mg of ibuprofen at night. The patient has been doing gentle stretching exercises which seem to help. The patient has a history of arthritis. RN advised the patient to increase the dose of ibuprofen as tolerated taking 400 mg in the morning and 400 mg at night with food to prevent stomach upset. The RN advised the patient to call back on Friday 3/16/18 so RN could check for improvement. RN advised the patient to call PMD for an appointment if the pain does not improve.
On the second evening post injection I experienced tightening, fullness and heaviness in my throat, air hunger, chest tightness/heaviness,  chest pain and palpitations/irregular heart beats, anxiety, increase thirst and urination from 8pm to 3:30 am. The symptoms resolved enough by 3:30 so that I could fall asleep. I have an epi pen with me left from when I used to have severe allergies regularly (a condition I have healed form over the last 1.5 years following removing myself from the mold exposure). I considered going to the ER but waited. On day 3 I began taking antihistamines for 7 days - Claratin which helped take the edge off the 3rd and 4th night. I am now taking half a claratin but still experiencing slight symptoms at night, airway, chest tightness, insomnia. Mast cells have a circadian rhythm which I think is why it's worse at night. I truly hope it fades because I have made tremendous progress on my health and this feels like a set back.
Increased fussiness, not wanting to breast feed, "large knots in legs." was taken to the ER
sore arm; This is a spontaneous report from a contactable physician (the patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The caller stated last Thursday she received the vaccine and only had a sore arm but she was worried because she did not check her temperature prior to the vaccine. She stated she did not have symptoms but asked if she should have checked it.  Information about lot/batch has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
A consumer report has been received. The report concerns a 1 year old, female consumer, who had been receiving nasal FLUMIST. FLUMIST started on 15-AUG-2013. The patient experienced sore throat which started on 19-AUG-2013, fever and fatigue which started on 16-AUG-2013 and burning sensation in her nose which started on 15-AUG-2013. FLUMIST was discontinued on 15-AUG-2013. At the time of reporting, the event of burning sensation in her nose, fever, sore throat and fatigue was ongoing. The report was considered to be non-serious.
Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion); Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) in a 41-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment at this time. It was reported that no adverse reactions were reported by any patients. No treatment medication was provided.
Patient was seated for 5 minutes after injection and then fell on floor.  She immediately sat up.  She experienced nausea and dry heaving but no vomiting.   She walked out of the store under her own power about 20 minutes after the event.
Flare up of atopic dermatitis. Became very painful and red the day after receiving the vaccine. Occurrence of severe joint pain in left foot big toe (perhaps gouty arthritis).
Patient received her flu shot and left the area. Her mother brought her back a few minutes later saying that the patient stated she was feeling sick to her stomach. The patient was pale. She was offered to lie down but refused and was seated. She said her jaw was feeling stiff on the right side and Her mother said her forehead was "clammy". An ice pack was offered and used. The patient's mother sat by her for another 10-15 minutes and said she was feeling good enough to leave. On a follow up phone call at 6:00pm the mother stated that she had recovered rather quickly after leaving the pharmacy.
Woke up with a bad cramp up the front of my left leg (ankle to shin). Got up and went to the bathroom. Sat on the commode. Blacked out. Woke up on the floor. Got up went back to bedroom. My legs were like rubber. Fell again in bedroom but didn't black out again. Got up again went to kitchen and drank tonic water for leg cramp and began to feel better. Saw my family doctor on Jan 2. He examined me and recommended that I not get the second SHINGRIX shot. His opinion was that I had a reaction to the first injection. The result of the black out was a small cut under my right eye, large bruise on my left shoulder, bruise on my left side, bruise on my upper left arm, sore ribs on the left side and a skinned left knee. Other than being sore from the fall I continued with my normal activities.
Became unresponsive and hypotonic - no fever or S.O.B. or sweating. Lasted about 1 hr.
Extreme pain and swelling in lymph under right arm; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Apr2021 at 14:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included seasonal allergy, asthma and osteoarthritis. The patient was allergic to iodine dye. Concomitant medications included ranitidine hydrochloride (ZANTAC), omeprazole (PRILOSEC), bupropion hydrochloride (WELLBUTRIN), desvenlafaxine succinate monohydrate (PRISTIQ) and gabapentin (MANUFACTURER UNKNOWN), all taken from unknown dates for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Mar2021 at 14:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. On 03Apr2021 at 09:00, the patient experienced extreme pain and swelling in lymph under right arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event experienced. The clinical outcome of the event extreme pain and swelling in lymph under right arm was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
0909, 10/21/09: Received seasonal flu shot left arm, 0.5ml Afluria CSL Biotherapies; Lot#01949211A, exp 6/9/10. Took 500mg TYLENOL. No allergies, no issues with flu shots before. 0945 10/21/09: Sharp pain/pressure left arm; itchy, hot nauseated. 1051, 10/21/09: To employee health left arm very swollen shoulder to elbow, hot, painful. Tongue "feels thick". No respiratory distress. Skin warm and dry. To E.D.
Pt c/o rash with vesicles in three spots on face (R forehead, upper cheek, and lower cheek) Pt state he had the J&J vaccine on Tuesday and on Thursday the rash started to appear.
Moderna COVID-19 Vaccine EUA  01.08.2021 - SLIGHT HEADACHE SEVERAL HOURS POST VACCINE  01.09.2021 - SEVERE HEADACHE - DESCRIBED AS "LITTLE SHOCKS".  HOME SELF-CARE MOTRIN AND ALEVE.    01.10.2021 - WOKE UP SUNDAY MORNING AND HUSBAND COMMENTED HER MOUTH "LOOKED WEIRD", AND HER EYE LOOKED LIKE IT WAS "LEANING"  01.11.2021 - REPORTED TO OCCUPATIONAL HEALTH CLINIC.  REFERRED TO HER PRIMARY CARE PHYSICIAN FOR EVALUATION.  ADVISED TO COMPLETE V-SAFE REGISTRATION.  01.11.2021 - EMPLOYEE SEEN BY LOCAL URGENT CARE.  TREATED WITH 80 MG OF PREDNISONE ON SITE,  PRESCRIPTION FOR 40MG PREDNISONE X 7 DAYS, PRESCRIPTION FOR VALTREZ.  RELEASED.  PLACED OFF WORK TILL 01.13.2021.
Shortness of breath; elevated pulse rate of 90 to 120 for over 4 hours,; elevated blood pressure as high as 152/83; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 at 13:45 as dose 1, single (Lot number: HD9876), in left arm for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Elevated cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Covid-19 vaccine (DOSE 5, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 24Oct2023 at 01:30, outcome "recovering", described as "Shortness of breath"; HYPERTENSION (non-serious) with onset 24Oct2023 at 01:30, outcome "recovering", described as "elevated blood pressure as high as 152/83"; HEART RATE INCREASED (non-serious) with onset 24Oct2023 at 01:30, outcome "recovering", described as "elevated pulse rate of 90 to 120 for over 4 hours,". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, heart rate increased, hypertension.  Additional information: other medications in two weeks included multivitamin, D, glucosamine, calcium. The patient reported shortness of breath, elevated pulse rate of 90 to 120 for over 4 hours, elevated blood pressure as high as 152/83. His normal resting bp is typically 125/80 with a pulse rate in the low 70s or high 60s. His resting pulse remains high at 83 bpm, 24 hours after receipt of vaccine. The patient had no known allergies.
First Booster: Had Soreness on injection site and tenderness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 25Oct2021 at 12:01 as dose 3 (booster), single (Lot number: 30155BA1) at the age of 71 years, in left top arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia", start date: 1993 (unspecified if ongoing), notes: Fibromyalgia; "Angina attack" (unspecified if ongoing), notes: Angina attack; "Rheumatoid arthritis" (unspecified if ongoing), notes: Rheumatoid arthritis, Diagnosed with years ago.; "Mild stroke TIA" (unspecified if ongoing); "Mild stroke TIA" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT NUMBER: EN6199, Route of administration: Left top arm, Time the Vaccination Was Given: 13:23, Vaccine Administered at Facility? No), administration date: 12Mar2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, LOT NUMBER: EW0164, Route of administration: left top arm, Time the Vaccination Was Given: 12:57, Vaccine Administered at Facility? no), administration date: 24Apr2021, when the patient was 71-year-old, for COVID-19 Immunization, reaction(s): "First dose: 12Mar2021, Second dose: 24Apr2021". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Oct2021, outcome "unknown", described as "First Booster: Had Soreness on injection site and tenderness". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: First Booster: Had Soreness on injection site and tenderness: The caller clarifies the caller did have soreness on injection site and tenderness after receiving the first booster Unknown Pfizer Vaccine. The caller had soreness on injection site and tenderness for the first few hours after receiving the first booster Unknown Pfizer Vaccine and not that much. The caller tries to maintain pain from Rheumatoid Arthritis with Tylenol. No additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect.Prior Vaccinations (within 4 weeks) If applicable, no list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).  No follow-up attempts are possible. No further information is expected.
Patient called complaining of stiffness in the arm [upper] radiating to underarm. Started 1 week after shot and increasingly worst after approx. 2 wks.
This spontaneous report as received from a registered nurse refers to approximately 8 week old female infant patient. The pertinent medical history included child abuse and poor weight gain. No drug allergies/reactions were reported. On 07-NOV-2014 the patient was vaccinated with first dose in ROTATEQ series (Lot # K005394; Expiry date: 23-FEB-2016) 2 milliliter (ml) orally. On 07-NOV-2014, patient's mother called up the physician's office and stated that the patient began to vomit and have diarrhea. Approximately on an unknown date in November 2014, the patient recovered from vomiting. On 13-NOV-2014, the patient sought medical attention in the hospital and was admitted with a diagnosis of abnormal weight loss, diarrhea and failure to thrive. The patient was dehydrated. Patient's weight was reported as 8.9 pounds during admission into the hospital. On 14-NOV-2014, stool test was positive for rotavirus and other laboratory tests (unspecified) were normal. The patient was treated with intravenous hydration. On 16-NOV-2014, patient was discharged from the hospital. The patient was scheduled for follow-up on 16-NOV-2014 and 19-NOV-2014. The patient recovered on 19-NOV-2014 (described as that patient gaining weight and no longer vomiting and no diarrhea). The causality of the reported events with respect to suspect drug was unknown. Additional information has been requested.
Jittery, nausea, no vomiting, felt warm (face). Site of injection: hot to touch to 1/2 length of arm, tender and sore.