chrisvoncsefalvay/vaers-outcomes huggingface dataset:
starting around 8 pm 2/12, patient experienced sharp pain around the liver and gallbladder. by the time she went to bed, she was experiencing extreme bloating and gas, and developed diarrhea soon after. on saturday 2/13, the patient's arm began to swell and a rash developed on several parts of the body (trunk, arms, legs). swelling and hives went away after patient took benadryl, diarhhea and bloating have lessened, by are still present as of monday 2/15
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 19-APR-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 669646/1703Z, expiry date 09-DEC-2012) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Vaccine exp date on syringe 10/15/22 and on box 10/2022; exp check on box administered when charted in computer exp 10/15/22 noted and adverse event found.
Felt like CoVid.  I had CoVid about 6 months ago.  Fever (104 F)  Chills Total body ache
RAPID HEART RATE >100 FOR 5 HOURS, SHORTNESS OF BREATH, HEADACHE, MUSCLE ACHES, SEVERE ARM PAIN "IT'S GOING TO FALL OFF".
ACUTE NON ST ELEVATION MI 4/27/2023 ATHEROSCLEROSIS OF AORTA ACUTE NON ST ELEVATION MI 4/27/2023 ACUTE NON ST ELEVATION MI
Patient experienced severe gastrointestinal symptoms after Gardasil injections. Injections 6/12/07 and 8/14/2007 followed by emergency room visits 8/25/07 and 11/1/07, third injection 12/20/07 followed by emergency room visit and extended hospitalization 2/08.  Severe abdominal pain and vomiting occured each time which would not stop without emergency medical and drug intervention. Multiple diagnostic and lab tests indicated possibility of gall bladder involvement.  Gall bladder was removed 12/5/07. The final Gardasil injection was after gall bladder surgery and another gastrointestinal episode with emergency treatment and a 5 day hospitalization occured after this.  Patient had no history of gall bladder or gastrointestinal symptoms before beginning series of Gardasil injections.  No underlying cause has been clearly established for these conditions, symptoms or multiple episodes by either primary physician, surgeon, gynecologists or gastroenterologist. Tests indicated slow gall bladder emptying, slow gastric emptying and slight gastritis concurrent with these multiple episodes, but patient had no symptoms indicating slow stomach or gallbladder functioning prior to beginning Gardasil. All other tests and screens were negative for anything unusual. Patient has had no recurrence of the symptoms since 2/08, but she is on continuing drug treatment for the gastrointestinal issues.  We are reporting this to assist in identifying any trends related to similar gastrointestinal symptoms, since these conditions are not typical for a 15/16 year old female and the timing of the three injections and the repeated recurrence of these unusual and previously nonexistent symptoms seems a bit more than coincidental.  7/23/08 MR received for several OVs beginning in 11/2007 through 3/2008. Seen 11/7/2007 with c/o 3 episodes of nausea, vomiting and abdominal pain. One episode required IV fluids for dehydration. Pt reports early satiety, weight loss, decreased appetite, fatigue, stress, indigestion, constipation, abdominal bloating, cramping and epigastric pain as well as above.  PE (+) for epigastric and RUQ tenderness otherwise WNL. Endoscopy scheduled. (+) for antritis.  Impression:  Antritis. Pt had Lap chole 12/5/07. Hospital Consult dated 2/7/08 for persistant nausea and vomiting.  Impression:  Persistant nausea and vomiting-etiology unclear.  Abdominal pain, epigastric and LUQ, etiology unclear. Hx antritis. F/U 2/20/08 Impression:  Gastroparesis.  9/8/2008 MR received for multiple Er visits and admission DOS 2/6-11/2008 with D/C DX:  1) Gastric motility disorder. 2) Prolonged vomiting. 3) Dehydration 2' to #2. Hypokalemia 2' to #2.  Pt presented with onset of nausea, vomiting and diarrhea x 3 days. Seen at both PCP office and ER several times prior to admission.   1/25/2010 Follow up: continuing digestive/gastrointestinal problems.
I cannot move them without difficulty; I have been having severe pain in my shoulders and my neck; I have been having severe pain in my shoulders and my neck; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (I cannot move them without difficulty), NECK PAIN (I have been having severe pain in my shoulders and my neck) and ARTHRALGIA (I have been having severe pain in my shoulders and my neck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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, the patient experienced MUSCULOSKELETAL STIFFNESS (I cannot move them without difficulty), NECK PAIN (I have been having severe pain in my shoulders and my neck) and ARTHRALGIA (I have been having severe pain in my shoulders and my neck). At the time of the report, MUSCULOSKELETAL STIFFNESS (I cannot move them without difficulty), NECK PAIN (I have been having severe pain in my shoulders and my neck) and ARTHRALGIA (I have been having severe pain in my shoulders and my neck) outcome was unknown.            Concomitant medications were not provide. Treatment medication were not provided.   Reporter did not allow further contact
Kinrix was administered to a child L deltoid-Age 2yr 4 mo-DTaP and IPV should have been given in separate doses-Kinrix to be administered as booster dose @ 4 y.o and older-The dose is considered valid and does not require repeating-PHN has reviewed information and voices understanding
On 3/26/10 pt presented with a rash that looked like urticaria. He was on Amoxicillin and it was stopped. Pt returned on 3/07/10 with blue hands and feet and erythema multiforme rash. Over the next week the rash faded away but intermittently came and went. Mom concerned this was due to Varicella shot. I thought it was more likely due to Amoxicillin.
Localized reaction to injection site, approximately 2 x 4 inches in size. Painful.  Redness noted and hot to touch.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 55-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperature in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 08-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804080 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
COVID-19 Treatment/Retested & this time it was positive.; COVID-19 Treatment/Retested & this time it was positive.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 at 14:30 as dose 1, single (Lot number: EK9231), in right arm, on 01Feb2021 at 14:30 as dose 2, single (Lot number: EL3299), in right arm and on 29Sep2021 at 11:00 as dose 3 (booster), single (Lot number: FC3180) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 31Dec1999.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19 Treatment/Retested & this time it was positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (28May2022) negative, notes: On 6th day self-tested for Covid. Test was negative; (01Jun2022) Positive, notes: Retested & this time it was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- Took Paxlovid for 5 days. On 6th day self-tested for Covid. Test was negative. 4 days later- started to feel crappy again. Retested & this time it was positive. The patient had no known allergy. The patient  received vaccine and took other medication in 2weeks.  No follow-up attempts are needed. No further information is expected.
Hives on face, limbs, torso; lasting 2 weeks. Treated with Benadryl X 2 days prior to vaccinations given. Continue Benadryl.
Starting Friday night, 5/28/21, after she received the vaccine, patient started feeling shortness of breath and heart fluttering. She noted that she was coming off of a UTI and that her doctor was also in the process of adjusting her thyroid medicine.
"Covid Arm" symptoms...redness, soreness, hot to touch, muscle tight at injection site after one week from initial injection.
Chills began around 9:30pm which lead to a high fever of 104F at 11pm. Fever subsided within 30min of taking 400mg ibuprofen.
Dizziness & HYPERtension Narrative: went to ER only b/c employee health office was not open
Small black dot on left thigh, warm, raised area across with blotchy edges, mildly tender approx. 2 1/2"  in diameter. Prescribed Keflex for seven days.
Phone call 11/1/07 from pt. to report left arm swollen from shot site to elbow over entire top of upper arm, stiff and painful, some redness noted. Noticed at 3:00 am, Now better by 4:30 pm - less swelling, redness and pain now. Will notify MD if no improvement or worse.
Myocarditis and was admitted in hospital for chest pain with notably elevated troponin after getting a booster/3rd dose of Moderna vaccine
sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Renal cell carcinoma (lost a kidney, due to renal cell carcinoma) and Blood pressure high.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.            Concomitant medications included was non-specified blood pressure medicine. She saw a cardiologist a week, or so, after the emergency room visit. He changed her blood pressure medicine. Her Dr changed her blood pressure medicine back to the original one.  Treatment medication was not provided by the reporter.  This case concerns an 88 year-old female patient with no reported relevant medical history who experienced the unexpected serious event of vaccination site pain. The event occurred approximately 1 day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per reporter, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.   This case was linked to MOD-2021-370170 (Patient Link). Sender's Comments: This case concerns an 88 year-old female patient with no reported relevant medical history who experienced the unexpected serious event of vaccination site pain. The event occurred approximately 1 day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per reporter, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.
Swollen, painful red arm that is still swollen at the time of our meeting at 9 AM this morning; two episodes of vomiting at approx. 3 AM last night.
redness, swelling, discomfort @ inj site radiating to elbow-wrist area;ice, DPH, Ibuprophen;
Guillain-Barre syndrome. Week after flu shot developed fever/sore throat which lasted about week then developed numbness in fingertips - progressed to neuromuscular weakness, respiratory SOB.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 26-SEP-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Swelling sensation in middle-ear (both ears). Slight tinnitus. Slightly muffled hearing.
Post-vaccination, patient began trembling and stated she had the chills (shivering).  She took 2 tablets of her own personal oral Benadryl.  Blood pressure and heart rate per checked; BP 168/90 HR 123.  When checked 15 minutes later, BP was the same and HR was 118.  Patient stated she was anxious and did not take her fluoxetine that morning.  EMS was called and patient was transported.
became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; nauseous; light headed; chills; flu like symptoms; arm felt sore/arm at site of injection remains sore; at site of injection remains sore and itchy; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (lot number: ER8733) first dose on 30Mar2021 12:30 PM on left arm at single dose for COVID-19 immunisation. Medical history included IDDM (Type 1 diabetes mellitus) and MS (Multiple sclerosis). Patient is not pregnant. No other vaccine in four weeks. No known allergies. Concomitant medications in two weeks included Insulin for IDDM, dimethyl fumarate (TECFIDERA) for MS. Had vaccine at 12:30pm. At 3am (31Mar2021), arm felt sore and felt both nauseous and light headed as well as having chills and flu like symptoms. Went to bathroom and on way back to bed, became faint and passed out onto the floor. Patient hit chin and jaw so hard it was bleeding and obviously very sore and swollen. It's been nearly a week since that incident and arm at site of injection remains sore and itchy. She still feel nauseous at times and her face is still swollen from falling onto the floor and passing out. She was now fearful of having the second dose on 20Apr2021 as due since her reaction to 1st dose was so severe. The outcome of the events was recovering. No treatment for the events. No Covid tested post vaccination.
severe case of egpa; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A 59 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 Immunization. The following information was reported: EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS (medically significant), outcome "unknown", described as "severe case of egpa". The event "severe case of egpa" was evaluated at the physician office visit. Therapeutic measures were taken as a result of eosinophilic granulomatosis with polyangiitis. Additional information: The patient is presently being treated with Rituxan and prednisone. Prior to the vaccine, the patient had no asthma, no muscle problems and was a very health 59-year-old man. No weight issues, no diabetes, exercised daily, and was exceptionally healthy.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Swelling and redness, Rt thigh injection site, 6x12 area.
flu like symptoms; headache; muscle ache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on 16Aug2021 (Batch/Lot Number: FA7485) as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The Patient reported that he and his wife got vaccinated yesterday (on 16Aug2021), and are experiencing some flu like symptoms. He was wondering if there was any reason they could not take Tylenol or Ibuprofen. He and his wife decided to get a 3rd vaccination; that it had been over 6 months and they are over 65, not immunocompromised. Patient stated now the symptoms are very mild just got some muscle ache and headache. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
Patient experienced a syncopal event.  Patient was lowered to the floor, legs were elevated, and vital signs were monitored. Provided ice packs and fluids. Patient returned to a sitting position, and then standing position. Patient was monitored for an additional 30 minutes after event, before stating he "felt better" and was ready to return to his room.
patient got very sick every time patient took a flu shot; Initial information was received on 20-Nov-2020 regarding an unsolicited valid non-serious case from a non-health care professional/consumer (patient) via social media.  This case involves a patient of unknown age who got very sick every time patient took a flu shot (illness), while patient was treated with influenza vaccine.  Vaccination(s) included influenza vaccine with patient had the flu twice before the vaccines came and was sicker with the shots.  Medical history, medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got very sick every time patient took a flu shot (illness).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Patient developed shortness of breath 3 days post injection. Death due to COVID-19 pneumonia 4/27/21
Three days after receiving the vaccination, I woke up and my heart rate was racing. It was around 160-170 BPM's. My blood pressure was up to 210/116. I wasn't even able to walk around my house. I went to the hospital and they performed an EKG and blood work. All of my tests came back normal. My event lasted about a week before I started to feel better. I was given some blood pressure meds until everything went back to normal.
Date of start of drug: 25Jan2021, Dose Number: 1; Date of start of drug: 18Mar2021, Dose Number: 2; Miscarriage; This is a spontaneous report from a contactable consumer (patient) reported herself. A 26-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 18Mar2021 01:00 PM (Batch/Lot Number: EN6203) as 2ND DOSE, SINGLE for covid-19 immunisation, at the age at vaccination date of 26 years old.  Patient was not pregnant. Medical history reported as no. The patient's concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. No known allergies. Historical vaccine included first dose of BNT162B2 (lot number: En6203) on  25Jan2021 01:00 PM at left arm.  The patient experienced miscarriage (medically significant) on 26Apr2021 with outcome of recovered, date of start of drug: 25jan2021, dose number: 1; date of start of drug: 18mar2021, dose number: 2 (non-serious) on an unspecified date with outcome of unknown. The event miscarriage resulted in Doctor or other healthcare professional office/clinic visit. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19/ Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts completed. No further information expected.
My son had a seizure which lasted around 10 minutes. He was stiff, non responsive, stopped breathing. Had no fever at the time of seizure.