chrisvoncsefalvay/vaers-outcomes huggingface dataset:
positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; stomach issue; This is a spontaneous report from a contactable consumer (patient). A male patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced stomach issues on an unknown date. He was scheduled for an scope on the esophagus and had a COVID test "on Sunday" which came back with a positive result. The patient has no symptoms and had a 96.5 temperature. He was scheduled for his second dose "today".  The clinical outcome of the event positive COVID-19 test with no symptoms and abdominal discomfort was unknown.   The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
after receiving immunization patient felt hot and dizzy. She then fainted and lost conciousness for about 10 seconds.
flu-like symptoms for a day; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received last year prior to the reporting date, refer case US2022001255).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's husband. The age at vaccination was not reported. The reporter stated that the patient received dose of Shingrix last year and experienced flu-like symptoms for a day. The reporter did not consent to follow-up. This is 1 of 4 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022001254:Same reporter US-GLAXOSMITHKLINE-US2022001252:Same reporter US-GLAXOSMITHKLINE-US2022001255:Different dose, same patient
Within 3 minutes of the vaccination, he felt disoriented with sounds, cold sweat and nausea. Progressed to vomiting.
This spontaneous report as received from a nurse refers to her healthcare colleague, a female patient of unknown age. Initially the case was reported by a pharmacy representative. No information regarding the patient's medical history was provided. On 05-SEP-2012 the patient was vaccinated with RECOMBIVAX HB dose 1. She received the second dose on 02-OCT-2012 and the third dose on 04-MAR-2013. Route was not reported. No concomitant medication was reported. On an unknown date after completion of the three dose series, the patient had a negative titer test for Hepatitis B, also reported as the patient failed to seroconvert. No other adverse events were reported. No outcome was reported. No causality assessment was provided. Additional information has been requested.
This spontaneous report was received from a nurse refers to a 26 year old female patient. The patient's allergies included: drug allergies to penicillin (manufacturer unknown). Medical history included: abnormal menstrual bleeding which was treated DEPO PROVERA prior to start of GARDASIL series. On 24-MAR-2014 the patient was vaccinated with first dose of GARDASIL. On 19-MAY-2014 the patient was vaccinated with second dose of GARDASIL in her right arm. On 27-MAY-2014, the patient developed weakness and pain in her right arm. No tingling or lack of sensation was present in right arm. The patient stated to physician that she felt disabled because she could not use her arm fully (disability). The physician directed to administer ibuprofen (manufacturer unknown) and apply ice to the site. The patient had no relief and contacted the physician's office on 02-JUN-2014. There was no product quality complaint involved. The outcome of disabled because she could not use her arm fully, pain in her right arm and weakness was unknown. The relatedness of the events with GARDASIL was unknown. Additional information has been requested.
arrative: 50yo male patient died in hospital from liver cirrhosis on 12/25/2021. Pt was at hospital. Pt's active problem list prior to death: Active Problems: High antibody titer (SCT 441781003) Cirrhosis of liver (SCT 19943007) High risk drug monitoring status (SCT 24Chronic ethmoiditis (SCT 73237007) Erectile dysfunction (SCT 397803000) Lipoma (SCT 93163002) Solitary nodule of lung (SCT 427359005) Other Unspecified Counseling (ICD-9- CM V65.40) Abdominal Pain, Generalized (ICD-9-CM 78Ileitis (ICD-9-CM 558.9) Impotence of organic origin (ICD-9-CM 60Tennis Elbow (ICD-9-CM 726.32) Essential hypertension (SCT 59621000) Skin Abscess (ICD-9-CM 682.9) Health Maintenance (ICD-9-CM V65.9) Pain in joint involving shoulder region (ICD-9-CM 719.41) Lipoma (ICD-9-CM 214.9) Psoriatic arthritis (SCT 156370009) Psoriasis (SCT 9014002) Fatigue Syndrome, Chronic (ICD-9-CM 780.71) Type 2 diabetes mellitus without complicCarpal Tunnel Syndrome (ICD-9-CM 354.0) Elevated Liver Function Tests (ICD-9-CM Hyperlipidemia (SCT 55822004) Sleep apnea (SCT 73430006) Tobacco Use (ICD-9-CM 305.1) Obesity (ICD-9-CM 278.00) Psoriasis (ICD-9-CM 696.1) LBP (ICD-9-CM 724.2) Pt had received a covid vaccine on 7/7/21 (J&j). This death is not related to the covid vaccine.
Swollen/ tingly feeling in lips, tongue and cheeks as well as tingling in legs and arms, started about 1 minute after injection.  Was monitored on site by EMT for 45 minutes.  It did not seem to get much worse so, went home and took Benedryl.  About 1 hour later symptoms started to subside.  Next day, sore arm and still have a strange feeling in my tongue and lips.  Teeth feel a little numb or swollen.  Feels like I have lost some of my sense of taste on my tongue.
Patient described headache at night for multiple days in a row. Most recently on 2/17/21 patient reported felt headaches at night every night since date of vaccination.
Developed a high fever; A spontaneous report was received from a consumer concerning a 43-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a high fever.  The patient's medical history included COVID-19 that ended up with pneumonia. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient developed a high fever.   No treatment information was provided. However, the reporter wanted to know if could alternate between the use of Tylenol and Ibuprofen.  Action taken with mRNA-1273 in response to the event was not reported.   At the time of this report, the outcome of the event, developed a high fever was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of pyrexia, a causal relationship cannot be excluded.
Huge rash all over neck that has yet to go away. Roof of mouth is also aching.
High fever (100 degrees) on the evening of 9/10/08, which returned to normal by morning. Also on the evening of 9-10-08, my fingertips on my right hand began to hurt (numbness, burning, aching) and have continued to hurt (worse at night). Now being treated with prednisone.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) (batch number FG2D4, expiry date 19th September 2021) for prophylaxis.   On 11th June 2019, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's wife. The reporter only provided her first name.
Patient began complaining of shakiness, mild nausea and transient flushing approximately 3 hours after receiving rabies vaccine and rabies immune globulin.
Within two days, eczema appeared on the skin of both cheeks and within a week the skin of both cheeks was raw and weeping. Pediatrician initially could not diagnose, but an immunologist diagnosed as eczema. Treatment was eventually successful over the course of several months.
Pt was given a Moderna vaccine for his second dose of COVID -19 vaccine. Pt should have recieved  Pfizer .
This spontaneous report has been received from a physician referring to a 15 month old patient of unknown gender. The physician reported that on 12/09/2016 a fifteen month old was inadvertently administered the VARIVAX and PROQUAD instead of the VARIVAX and M-M-R II vaccines. No adverse effects were reported. Additional information has been requested.
Initial report received from a nurse practitioner on 23 July 2010. A 41-year-old female patient, who has no known drug allergies, asthma, and COPD (chronic obstructive pulmonary disease) had received an intramuscular left deltoid injection of TYPHIM Vi (lot number E0214-1), and a left deltoid dose of HAVRIX (manufacturer GlaxoSmithKline, lot number AHAVB387AA) on 04 May 2010. Immediately post-vaccination the patient experienced a 5 second metallic taste in her mouth and a sore arm that lasted 2 days. The patient required medical attention; however it was not reported whether the patient received any treatments. At the time of this report, the patient had recovered. Follow-up information received from a health care professional on 16 August 2010 clarified that the patient did not have COPD. The patient's medical history confirmed she had asthma and also included Crohn's disease. The patient used the concomitant medications of fluticasone and ADVAIR and VENTOLIN inhalers as needed (PRN). The patient did not received medical attention and none was given. The outcome for the event remained recovered. Documents held by sender: None.
VACCINATION  WAS GIVEN 22 HOURS AFTER VIAL PUNCTURE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccination was given 22 hours after vial puncture. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccination was given 22 hours after vial puncture was not reported. This report was non-serious.
Red painful swollen hard bump on left thigh that was dime sized. By 6/6/2014 bump was quarter sized hot swollen hard painful.  Cold compressed area and gave Tylenol at 3am.  At 9:30am called peds office.  Had 11:15am appt & child examined.  Fnp advised cellulitis & to give Benadryl & Tylenol & to monitor infection.  If spreading occurred further antibiotic would be administered.  Fnp not sure which injection caused infection.  Pneumoccocal or hib or hep.
Patient felt ringing in ear and fainted within a couple of minutes of vaccination.  Patient felt better after resting and was released to home.
This spontaneous report as received from a Nurse practitioner concerning a patient of unknown age and gender. Neither concurrent nor historical conditions were reported. On 10-APR-2015, the patient was vaccinated with the first dose of GARDASIL 9 (route, dose and lot number were not reported). On 10-AUG-2015, the patient was vaccinated with the second dose of GARDASIL 9 (route, dose and lot number were not reported) (inappropriate schedule of drug administration). No adverse event was informed. Additional information has been requested.
Vaccine site red, swollen, hard, and hot to the touch. Received shot on Tuesday and reaction started Wednesday morning. Redness spread all day Wednesday. Treat with MOTRIN and warm compresses.
Right underarm soreness and some swelling (same arm vaccine was given in), low-grade fever, muscle aches, mild headache.
My vision disappeared in my right eye; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 29Mar2021 at approximately 10 o' clock (Lot Number: ER8727) as 2nd dose, single for COVID-19 immunisation. Medical history included High Blood Pressure and Blood cholesterol abnormal, both from an unknown date. Concomitant medications included unspecified medication for High Blood Pressure, cholesterol, and a blood thinner. The patient previously received the first dose of bnt162b2 for COVID-19 immunization at the age of 74-year-old on 08Mar2021. Lot Number of the first shot was reported as "EN it looks like 6205". The patient stated he had an adverse reaction to the vaccine. The patient got the second shot at approximately 10 o' clock in the morning of 29Mar2021 and at 10 o' clock at night his vision disappeared in his right eye. The patient was in hospital for 3 days. The patient was told that his right eye was not going to work anymore, it was absolutely the same. The patient received treatment and stated they told him to go to an ophthalmologist and get the services and he told him that his right eye was gone. The patient underwent lab tests and procedures which included lab work was done with unknown results on unknown date.  The outcome of events was not recovered.  Follow-up attempts are needed. Further information is expected.
Patient returned to the pharmacy today 10/19/2019 to report pain, swelling, redness in most of right arm for about 4 days after vaccination.  Pt denied any itching/hives or calor.  All symptoms have resolved.  Pt did not seek any medical treatment.  She simply wished to report what had happened and ask if it were normal.
Patient (Female, DOB 07/09/1972) received Janssen COVID vaccine (Lot #1808980) on 04/29/2021. On 07/06/2021, patient reporting to vaccine station. RN looked patient up, issued mobile device to see if patient received dose of COVID vaccine. On first inspection, patient did not appear to have her first dose of COVID-19 vaccine. Patient received Janssen vaccine (Lot #205A21A Exp 8/7/2021) at 11:10 am by RN. RN recognized patient from previous outreach events and notified RN that patient had been vaccinated previously. RN looked up patient in and noted additional record at bottom that could only be found on larger mobile screen. RN instructed patient to stay in observation for full 30 minutes. Patient denies shortness of breath. Patient alert and oriented x4, able to answer questions. RN instructed patient to not received any additional COVID-19 vaccines. RN provided patient with education related to when to seek medical care. Patient completed full 30 minutes of observation. Patient remained at focused outreach event, walking around with steady and balanced gait.
frozen shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (frozen shoulder) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 039K20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: shingles (in her right arm) in February 2021. Past adverse reactions to the above products included Frozen shoulder with shingles. Concurrent medical conditions included Frozen shoulder since February 2021.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-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 PERIARTHRITIS (frozen shoulder). At the time of the report, PERIARTHRITIS (frozen shoulder) was resolving.            Concomitant medication of the patient was not reported.  The patient still neither reach front or back nor reach up or behind. At the time of reporting the patient had two bad arms. The patient was recommended by her doctor to get the booster or third dose vaccine in her glute muscle, not on the same arm.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-319769 (Patient Link).
Individual states that she was interested in getting the Moderna vaccine after she had been been administered the Janssen vaccine.  Reports that she had researched the Moderna vaccine and become comfortable with receiving that particular vaccine instead of the Janssen.  There have been no reactions to this point.
Rash on face & head about 15 minuts post vaccination. No urticaria or wheezing. Observed in clinic for 1 hour with fading of macular rash. Left in good condition
Local allergic reaction, treated with 7 days of KEFLEX to cover the possibility of infection.
Severe shaking started at 11 PM and continued for over an hour. Including teeth shattering. Had a low grade fever also.
pt recv vax 16JUL96 & 3 days later pt reportedly devel a rash in unusual places, behind the knee & inside the mouth;pt was treated w/unspecified steroid med;
Significant pain; Muscular problems through my arm, back and upper leg, on the right side which is where I had the injection# it's hard to move; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Mar2021 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (about approximately I guess 3 weeks earlier I had the first shot, first shot EL1284), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Significant pain"; MYALGIA (non-serious), outcome "unknown", described as "Muscular problems through my arm, back and upper leg, on the right side which is where I had the injection# it's hard to move".  No follow-up attempts are possible. No further information is expected.
Pulled a muscle; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE STRAIN (Pulled a muscle) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced MUSCLE STRAIN (Pulled a muscle). At the time of the report, MUSCLE STRAIN (Pulled a muscle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. No laboratory provided by reporter Treatment medications prescribed by HCP included pain pills and muscle relaxers. The reporter wanted to know if the patient can take them .
No additional AE reported; a dose of VAQTA expired on 16JAN2023 and was administered on 02FEB2023; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The information about the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 02-FEB-2023 the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) lot # W007375, expiry date 16-JAN-2023 (dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event (AE) reported (no adverse event).
Information has been received from a nurse concerning a 21 year old female, who "several months ago" , was vaccinated with the first dose of GARDASIL, and was fine in the office. When she got home, developed flu-like symptoms. The patient did received a second dose of GARDASIL and was fine. It was unknown if the patient sought medial attention. Additional information has been requested.
Developed a rash four days post vaccine. Continued to spread for at least the next week until it covered entire body. Pt reports being extremely uncomfortable. treated with multiple doses of steroids (oral, IV, IM) and antihistamines
pain at injection site up through neck area and down into forearm chills headache body aches fatigue
HA, fever, pain in L arm axilla. Erythema with streaking/(+) lymphangitis/(+) adenopathy. Tx: Tylenol prn.
Sore arm; Body ache; Fever; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), FATIGUE (Fatigue) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (From November). Concurrent medical conditions included Taste absent (From November). Concomitant products included METOPROLOL, ROSUVASTATIN CALCIUM (CRESTOR), SPIRONOLACTONE and GABAPENTIN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), FATIGUE (Fatigue) and CHILLS (Chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
rash on chest primarily, some on thigh and arm mentioned by patient on a routine visit, relates rash started about a week after the 2nd vaccine, has been applying over the counter cortisone with improvement but not complete resolution so is asking for a prescription steroid cream
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  HCP reported that there was a confusion between the expiration date printed in the carton and the expiration date when the quick response (QR) code scanned. On 18-OCT- 2021, vial was stored in the refrigerator. No temperature excursions was noted. No adverse events were noted.  No treatment medication was provided.