chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately after shot: I felt some pain & burning at injection sight. In general felt a little off, but nothing significant. After observation period, on the drive home, I began to "taste" the shot, as did my husband who received vaccine right after me. Then, my face felt a little funny, and my jaw felt tight, but no visible swelling. Then I felt a rush of burning sensation throughout my chest and abdominal region. After arriving home, 20 minutes later, I felt a little nauseated, but not bad. An hour later, I was unable to eat dinner, as I felt ill. I felt like I had a mild fever and I was shivering with chills. While trying to sleep, the chills continued. I then experienced unusual frequent urination, every 2 to 3 hours. I had no consumed abnormal amounts of liquid, but my urine was nearly clear, which was odd. After returning to bed after the first time urinating, my heart rate became very fast and I felt like I had a hard time finding my pulse in my neck, which is unusual for me.   The day after the vaccination I experience headache, a lot of tenderness around injection sight and arm muscle pain making it very painful to make certain movement, like putting on my top and reaching for objects. That evening I experience some muscle aches.   These symptoms have improved now that it is day three after the vaccination. I still have a mild headache and pain at injection sight.
No additional AE's; Temperature excursion that ocurred on VARIVAX / was administered; This spontaneous report as received from a medical assitant, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 27-MAY-2021, the patient was vaccinated with an incorrect stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T028305, expiration date reported as 20-AUG-2022, for prophylaxis (strength, dose, route and frequency were not reported).  The temperature excursion was of -58 Fahrenheit degrees (°F) to 5 (°F) (15.2°F), during 2 hours 15 minutes 0 seconds.Aprevious temperature excursion was not reported. A digital data logger was involved. No adverse events were reported.
I had the delivery of my first child.  During the delivery I was fine at first, but then I experienced an uterine inversion. I had to have an emergency surgery. My baby was 7 lbs. 14 oz. During the pregnancy I had no complications. I was prescribed pain killers after the surgery. I also had a mastitis and endometriosis infection. I was prescribed antibiotics for that.
Fever 100.2 Discrete erythematous vesicular papular lesions Dx: varicella Tx:: Atarax
This spontaneous report as received from a other health professional refers to a patient of unknown age. The patient received CERVARIX in 2011 (exact date unspecified, CERVARIX was provided at another unspecified provider). On 20-FEB-2013 the patient was vaccinated with GARDASIL (lot # unspecified). No adverse event reported. The outcome of the event was unknown. Additional information is not expected.
reddening of the area around the injection approx 3"x5" in size, warm& tender to touch, lasted about 5 days
neck seem to swollen; had a pain on their throat as if had something stucked; pain in the arm increasde up to the point that they could not move it; pain in the arm increasde up to the point that they could not move it; little pain on their arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little pain on their arm), PAIN (pain in the arm increasde up to the point that they could not move it), MOBILITY DECREASED (pain in the arm increasde up to the point that they could not move it), OROPHARYNGEAL PAIN (had a pain on their throat as if had something stucked) and SWELLING (neck seem to swollen) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (little pain on their arm). On 17-Feb-2021, the patient experienced PAIN (pain in the arm increasde up to the point that they could not move it) and MOBILITY DECREASED (pain in the arm increasde up to the point that they could not move it). On 18-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (had a pain on their throat as if had something stucked). On 19-Feb-2021, the patient experienced SWELLING (neck seem to swollen). On 19-Feb-2021, PAIN IN EXTREMITY (little pain on their arm), PAIN (pain in the arm increasde up to the point that they could not move it) and MOBILITY DECREASED (pain in the arm increasde up to the point that they could not move it) had resolved. At the time of the report, OROPHARYNGEAL PAIN (had a pain on their throat as if had something stucked) and SWELLING (neck seem to swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications included thyroid and blood pressure medications Treatment details included none
Sexual dysfunction, frequent strong headaches, loss of vision, occasional dizzy spells, small masses in different parts of the body. Erectile dysfunction and masses in the scrotum.
Rash/hive on trunk of body. No rash/hives around site of injection. Itchy. Have been appearing in batches since injection.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
flushed;dizziness;BP 120/72, P85, SP 98%;
No adverse event; Administered with monovalent vaccine instead of bivalent as booster, administered with 0.5 ml of red cap vaccine as booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administered with monovalent vaccine instead of bivalent as booster, administered with 0.5 ml of red cap vaccine as booster) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057A22A, 939905 and 0038A22A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Administered with monovalent vaccine instead of bivalent as booster, administered with 0.5 ml of red cap vaccine as booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administered with monovalent vaccine instead of bivalent as booster, administered with 0.5 ml of red cap vaccine as booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administered with monovalent vaccine instead of bivalent as booster, administered with 0.5 ml of red cap vaccine as booster).    The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Pt explained having a giant hive on back of left arm (injection site) that reached from elbow to shoulder. Also said had itching of the throat. Pt saw her physician and Dr reported as moderate adverse reaction.
Booster; Yearly lung scan that is normally clear now shows spot all over; whole body rash and itching; whole body rash and itching; Allergy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Sep2021 12:00 (Lot number: 30145BA) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9263, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 29Jan2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "After the second dose itchy skin that did not go away"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL1283, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 08Jan2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Sep2021 12:00, outcome "unknown", described as "Booster"; PULMONARY MASS (non-serious) with onset 2021, outcome "unknown", described as "Yearly lung scan that is normally clear now shows spot all over"; RASH (non-serious), PRURITUS (non-serious) all with onset 2021, outcome "not recovered" and all described as "whole body rash and itching"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "not recovered", described as "Allergy". The events "yearly lung scan that is normally clear now shows spot all over", "whole body rash and itching", "whole body rash and itching" and "allergy" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, pruritus, hypersensitivity. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 18-OCT-2012 12:07, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician, concerning a 32 year old female patient with attention deficit disorder, migraines and irregular menstruation, and a history (02-OCT-2007) of vaccination with Pneumovax 23 vaccine (lot #657626/1084U) while hospitalized with bilateral pneumonitis which required intubation. On 04-JAN-2008 the patient was again vaccinated in the right shoulder, with a dose of Pneumovax 23 (lot # not reported). Concomitant vaccine therapy included a dose in the left shoulder, of influenza virus vaccine (STRATTERA), desogestrel/ethinyl estradiol (DESOGEN), estradiol (ESTRACE), hyoscyamineSO4 (LEVSIN) and rizatriptan benzoate (MSD). On 05-JAN-2008, 24 hours after vaccination, the patient developed a fever of 102 F, myalgia, photophobia, pain and swelling at the injection site in right shoulder, and leukocytosis. She was hospitalized, and treatment included ertapenem (INVANZ), administered twice, ibuprofen and intravenous fluids. Diagnostic labs were obtained (not specified), as well as a chest x-ray (results not provided). On 07-JAN-2007, the patient was afebrile, but had continued leukocytosis. The physician stated the patient was recovering from the events. The physician considered the events to be serious as an other important medical event. Additional information has been requested.
No additional AE; was inadvertently administered an expired dose of ROTATEQ; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.  On 02-DEC-2020, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 milliliters (ml) by oral route lot # 1660951, with an expiration date on 11-NOV-2020 for prophylaxis (strength was not reported).   No additional adverse event was reported.
patient diaphoretic, pale, c/o dizziness and nausea. no LOC, no falls, no vomiting.  no other adverse reactions. BP low but stable throughout:  12:07 91/62, O2 sat 98%, P 78. Drank water, apple juice, cold pack applied to neck/forehead. Patient recovered within a few minutes. MD Stat was called. Dr.  examined patient.  MD in Covid Clinic  also examined patient. Patient able to sit in chair during this reaction, and was stable to do orthostatic VS. VS 12:55 pm BP 103/64, O2 sat 96%, P 80. Patient called a family friend, felt well, was stable and ambulated to car and was driven home. last VS prior to leaving Covid clinic at 1:30 were BP 112/62, O2 Sat 97% P 85.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Tachycardia-Mild, Additional Details: Patient reported feeling dizzy and heart was racing. She says she suffers from anxiety and it was probably that.  She took Clonazepam prescribed by her doctor and wanted rescue called. Rescue arrived and said it was anxiety. She reported feeling better and left with her dad
Nausea, vomiting within minutes. Respiratory distress within 3 - 4 hours. Rash onset within 4 hours.
This spontaneous report received from a patient concerned a 30-year-old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JAN-2022, the patient experienced severe cough, body pain, vomiting from coughing, and headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from severe cough, body pain, vomiting from coughing, and headache. This report was non-serious. This report was associated with a product quality complaint: 90000210540 The suspected product quality complaint has been confirmed to be voided (did not meet RA criteria as reported complaints were adverse events, and there was no report of a covid infection or statement indicating the vaccine did not work) based on the RA evaluation/investigation performed.
Patient states that apporximately 12 hours after the vaccine he felt like a piece of food was stuck in his throat.  He tried making himself vomit, without results.  The feeling of something in his throat continued and felt it was getting worse for 2-3 days.  He took Ibuprofen which seemed to help.  After 4-5 days the smptom resolved.  Patient did not seek any medical attention.
Rash, mottled in appearance, appeared on R arm on mid-arm between elbow and shoulder about 3 inches below deltoid.  Flat, no pustules, dark pigmented, itchy.. Not accompanied by fever, chills or other rashes or symptoms.  Sore arm x 24 hrs.
can not describe the symptoms, can not explain the adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (can not describe the symptoms, can not explain the adverse event) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cirrhosis liver (as a pre-existing condition).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced ADVERSE DRUG REACTION (can not describe the symptoms, can not explain the adverse event). At the time of the report, ADVERSE DRUG REACTION (can not describe the symptoms, can not explain the adverse event) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had treatment for Cirrhosis in the Liver.    This case was linked toMOD-2021-068314 (E2B Linked Report).; Sender's Comments:  MOD-2021-068314:Cross-linked
2 days after vaccination, pt presents to clinic with hot, swollen area to left tricep with some ecchymosis.  denies much pain.  Advised cool compress 4 times daily and anti-inflammatory.  Also advised to return to clinic or call if no improvement in 1-2 days with advised treatment.
felt those were similar to the second shot reaction; increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction; night sweating/We felt those were similar to the second shot reaction; Joint pain/We felt those were similar to the second shot reaction; aching everywhere/We felt those were similar to the second shot reaction; Fever/We felt those were similar to the second shot reaction; chills/We felt those were similar to the second shot reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction) and MYALGIA (aching everywhere/We felt those were similar to the second shot reaction) in a female patient of an unknown age 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction), MYALGIA (aching everywhere/We felt those were similar to the second shot reaction), PYREXIA (Fever/We felt those were similar to the second shot reaction) and CHILLS (chills/We felt those were similar to the second shot reaction). At the time of the report, VACCINATION COMPLICATION (felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction), MYALGIA (aching everywhere/We felt those were similar to the second shot reaction), PYREXIA (Fever/We felt those were similar to the second shot reaction) and CHILLS (chills/We felt those were similar to the second shot reaction) outcome was unknown. Not Provided          no concomitant medications were reported.  no treatment medications were reported.   This case was linked to MOD-2021-317608 (Patient Link).
consumer missed dose for VARIVAX; consumer missed dose for VARIVAX; No additional AE reported; This spontaneous report was received from the patient's mother referring to her relative, a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date many years ago, the patient was vaccinated with  a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, anatomical location, route of administration, lot #, and expiration date were not reported) for prophylaxis but never completed the dosing schedule (inappropriate schedule of product administration) and therefore missed a dose of the vaccine.      No additional adverse events were reported.
queasy stomach; This is a spontaneous report received from a contactable consumer (patient). An adult female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, (lot number was not reported), as unknown, single dose, for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included tofacitinib citrate (XELJANZ XR) taken for an unspecified indication, start and stop date were not reported. On an unspecified, the patient experienced queasy stomach and had health problems (unspecified, pending clarification). The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported.  It was reported that the administrations were done mostly for booster shots.  No side effects were reported.  No treatment medications were reported.