chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician. A 69 year-old male patient received on 26Feb2015 PREVNAR 13 (lot number J67646, expiry date 31Mar2016) intramuscular at 0.5 ml single. Relevant medical history included diabetes, hypertension and hyperlipidemia. Concomitant medications included duloxetine (manufacturer unknown) at 30 mg three times a day, LIBRIUM at 5 mg twice a day, losartan (manufacturer unknown) at 25 mg twice a day, amlodipine (manufacturer unknown) at 5 mg two times a day and metformin (manufacturer unknown) at 500 mg three times a day. The patient experienced aspiration pneumonia on an unspecified date in Jun2015, myasthenia gravis and respiratory failure on unknown date. The primary infection site of pneumonia was lungs. The serotyping was not done for that and she did not know the specific organism. The patient underwent lab data which included: blood culture performed before the vaccination on 18Jun2013 that was negative. Chest X ray on an unspecified date in 2014 with unknown result. Urine culture on 26May2015 showed Coagulase negative staphylococcus. The patient underwent blood work on 05Mar2015, 06Mar2015, 31Mar2015, 21Apr2015, 07May2015, 08May2015, 09May2015, 10May2015, 11May2015, 12May2015, 18May2015, 26May2015, 06Jun2015, 10Jun2015, 25Aug2015, 26Aug2015 and on 27Aug2015 all with unknown results. The patient had recovered from the pneumonia but he was still experiencing myasthenia gravis and the patient was receiving treatment for Myasthenia gravis that was currently stabilized. The outcome of respiratory failure was unknown. The physician did not know the predisposing factors for infection but it occurred at the same time the patient had the respiratory failure secondary to Myasthenia gravis. The doctor when asked if the failure of treatment thought to be due to the development of a resistance to the product stated no and further added that she did not think that the pneumonia was connected with it, the patient concern was that he developed the Myasthenia gravis. The physician stated that it was unknown if there was a reasonable possibility that the myasthenia gravis and aspiration pneumonia were related to the vaccine.
Fever 105.5F per mom, at ER, and apnea. Was admitted to the hospital for 2 days. Post immunization reaction.
moderate redness, moderate swelling from shoulder to almost the elbow, mild tenderness, moderate itching, moderate burning, lump the size of a tennis ball.
Swelling down left arm to elbow. Area was red & itchy w/rash 10 days after injection.
Pt states that several of her toes are numb now and they were not previous to vaccine.
The needle came off syringe and the patient did not receive a full dose; A spontaneous report was received from a pharmacist concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced the non-serious event the needle came off syringe and the patient did not receive a full dose.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Dec 2020, the pharmacist reported that while administering the vaccine to the patient, the needle came off the syringe, and the patient did not receive a full dose. The patient had already left the office, and the pharmacist currently had no patient identifiers at the time. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, the needle came off syringe and the patient did not receive a full dose, was considered resolved on 22 Dec 2020.  The reporter did not provide an assessment for the event, the needle came off syringe and the patient did not receive a full dose.; Reporter's Comments: This case concerns a patient of unreported age and sex, who experienced an unexpected event of the needle coming off syringe and the patient did not receive a full dose.  The event occurred on 22 Dec 2020 during the administration of the first dose of the study medication. The sponsor considered the event as related  to the mRNA-1273.
This case was reported by a consumer and described the occurrence of allergic reaction in a 60-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of hypersensitivity (and other events after receiving 1st dose on 16th April 2018, refer case US2018143007). On 31st July 2018, the patient received the 2nd dose of SHINGRIX. On 4th August 2018, 4 days after receiving SHINGRIX, the patient experienced mouth ulcer, sore mouth and eating disorder. On an unknown date, the patient experienced allergic reaction, injection site erythema, injection site swelling, injection site itching, injection site pain, influenza-like symptoms, rash, muscle pain, movement disorder, feels awful, shivering and fever. The patient was treated with BENADRYL and ALEVE. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the allergic reaction, injection site itching, injection site pain, influenza-like symptoms, rash, muscle pain, movement disorder, feels awful, mouth ulcer, sore mouth, eating disorder, shivering and fever were recovering/resolving and the outcome of the injection site erythema and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the allergic reaction, injection site erythema, injection site swelling, injection site itching, injection site pain, influenza-like symptoms, rash, muscle pain, movement disorder, feels awful, mouth ulcer, sore mouth, eating disorder, shivering and fever to be related to SHINGRIX. Additional information was reported as follows: The patient received vaccine on the right arm. The patient experienced similar adverse events with the 2nd dose as that after receiving the 1st dose, with some additional events. The patient stated that she could hardly move, felt terrible, hard to even get out of her bed. The patient experienced ulcers in the mouth, where one was at the roof and the other at the back behind the molars. The patient also stated that it was difficult for her to eat with the ulcers. The patient experienced itchiness after vaccination with both the doses. The patient took BENADRYL for itching and for the other events she took ALEVE. At the time of reporting, the patient stated that the events were better but not completely resolved. The patient also stated that, the patient had redness and swelling at the injection site 6 days after the shot.
Patient attended clinic to receive Flu and HPV-9 dose #2. Mom stated that when received first HPV dose 7/30/2015 patient had nausea and dizziness. Denied any allergies or health problems. Mom stated patient ate lunch before coming to clinic and a juice box was provided prior to vaccine administration. At 1:55pm Flu was administered IM to right deltoid and HPV-9 IM to left deltoid. Immediately after administration patient stated felt "ok". Patient was told to remain seated. Five (5) minutes after vaccine administration patient lost consciousness and fell out of chair and hit head and right elbow on floor. Patient regained consciousness in less than 30 seconds. Called for assistance and RNs entered room to assist. Patient legs were elevated. Affirmed after questioning that could breathe without difficulty but that right elbow and head "hurt". EMS was called at 2:05pm. Ice pack was provided for patient to place on head. EMS arrived at 2:14pm. Upon patient assessment EMS was concerned patient stated he had blurred vision and was having a hard time staying upright in the chair. Patient was transported by EMS to Hospital for futher evaluation at 2:25pm. Mom remained in clinic with other three children and flu shots were administered to her and two other children. Confirmed phone number and told her will call to follow-up tomorrow, 10/16/15.
tightness of chest; wheezing; fast heart rate; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness of chest), WHEEZING (wheezing), HEART RATE INCREASED (fast heart rate) and DYSPNOEA (shortness of breath) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced CHEST DISCOMFORT (tightness of chest), WHEEZING (wheezing), HEART RATE INCREASED (fast heart rate) and DYSPNOEA (shortness of breath). At the time of the report, CHEST DISCOMFORT (tightness of chest), WHEEZING (wheezing), HEART RATE INCREASED (fast heart rate) and DYSPNOEA (shortness of breath) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 05-Mar-2021: No specific follow-up information recorded.
This spontaneous report was received from a physician, and refers to a 20 year old female patient. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 16-MAR-2017, the patient was vaccinated with the first dose of GARDASIL 9, subsequently on 15-MAY-2017, the patient received the second dose of GARDASIL 9. Since 16-JAN-2018, 10 months 1 day after onset of therapy the patient experienced Inappropriate schedule of vaccine administered, as she presented to the reporter's office to received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (Lot # N025428, Exp: 19-JUN-2020) on 22-MAY-2018. No adverse effect reported.
Chronic lower back pain since 12/98, soreness & tingling in both hands since 12/98;c/o similar problems w/both knees 12/98;
Patient report that she has stiffness in her arm to where she cant lift her arm or move it away from her body...
Totally unrelated to my vaccine, I think! But on the morning of July 12, 2021, I awoke with somewhat severe abdominal pain. It continued to get worse so I went to the ER. I was diagnosed with a kidney stone. It did not pass for a week and I continued to experience severe pain which interfered with my ability to work and other life activities. The pain subsided/ended about a week later.
Ongoing PVCs continuous ongoing all day every day 10 days after booster since 11/11/2021 .  Have been trying beta blockers which have helped cut down by half.  Very disturbing.
Sever body aches, fever , vomiting, facial swelling of eyes and lips.
This spontaneous reports as received from a registered nurse refers to patient of unknown age and gender. No information about medical history, concurrent conditions and concomitant medications were reported. On an unknown date, the patient was vaccinated with (Oka-Merck) PROQUAD (dose number, dose, lot # was not reported) that was improperly stored and which had been exposed to temperature as high as 8.5 F. No adverse effects were reported. The reporter was unable to locate lots numbers and expiration date of (Oka-Merck) PROQUAD that experienced a temperature excursions. The outcome of the events reported is unknown. This case is linked to the cases 1405USA010623, 1405USA008131, 1405USA010621 via same reporter link. Additional information has been requested.
Maculopapular rash with pruritis from ears to calves covering entire body and only sparing the hands and feet.   Especially dense rash in the antecubital fossa bilateral and symmetric.
Massive increase in migraines from 6 a year to 3-6 a week. Also dizzy all the time and struggling with vertigo (neither were present before); Massive increase in migraines from 6 a year to 3-6 a week. Also dizzy all the time and struggling with vertigo (neither were present before); Massive increase in migraines from 6 a year to 3-6 a week. Also dizzy all the time and struggling with vertigo (neither were present before); This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in right arm on 09Apr2021 13:00 (at the age of 56-year-old) (Batch/Lot Number: EW0158) as dose 2, single for covid-19 immunisation. Medical history included migraines, Seizure Disorder, and Penicillin Allergy. The patient was not pregnant. Concomitant medications were not reported but patient had other medications in two weeks. The patient had no other vaccine in four weeks. The patient received first dose of bnt162b2 for covid-19 immunisation on 19Mar2021 (at the age of 56-year-old). On 23Apr2021, the patient experienced massive increase in migraines from 6 a year to 3-6 a week and also was dizzy all the time and struggling with vertigo (neither were present before). The events resulted in doctor or other healthcare professional office/clinic visit, and disability or permanent damage. There were no therapy for the events. The patient had no covid prior vaccination and patient was not covid tested post vaccination. Outcome of events was not recovered.
Four days after the second dose, my throat was swollen almost completely shut.  I choked repeatedly just trying to swallow saliva.
This spontaneous report as received from a physician refers to a 19 year old female patient with allergy to sulfa. The patient's medical history included intermittent abdominal and back pain. On 12-JUL-2014 the patient was vaccinated with a dose of GARDASIL lot # J010395, expiration date: 29-Apr-2016, 0.5 ml, intramuscular. There was no concomitant medication. On 12-JUL-2014, after receiving a dose of GARDASIL the patient immediately felt kind of weird. The physician stated the patient was monitored in her office, for an unspecified amount of time, and "eventually" felt better and left the office. The physician stated the patient called in to the office on the reporting date, 17-JUL-2014, stating she had developed a "lima bean size" induration at the injection site and was experiencing fatigue, nausea, light headedness that was "on and off" and pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago". No lab tests were performed. No treatment was received. The outcome of pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago", light headedness that was "on and off", nausea, fatigue and a "lima bean size" induration at the injection site was unknown. Additional information has been requested.
Case PHEH2016US024547, is an initial spontaneous report received from a pharmacist on 21 Sep 2016. This report refers to a 33 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated wit FLUVIIRN (unknown whether seasonal or pandemic, batch number: 1618701) at an unknown dose on an unknown date. On 21 Sep 2016, the pharmacist stated that when administering FLUVIRIN vaccine needle retracted and splashed back in eye. The pharmacist splashed water in patient eye. The eye seemed irritated. The outcome of the event was unknown. The seriousness of the event was reported as non serious. The causality of the event was not reported.
In Study got first shot in Aug was diagnosed the same day with COVID was Asymptomatic; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (In Study got first shot in Aug was diagnosed the same day with COVID was Asymptomatic) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In August 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2020, the patient experienced ASYMPTOMATIC COVID-19 (In Study got first shot in Aug was diagnosed the same day with COVID was Asymptomatic). At the time of the report, ASYMPTOMATIC COVID-19 (In Study got first shot in Aug was diagnosed the same day with COVID was Asymptomatic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: abnormal (abnormal) have no antibodies.         No concomitant medications were reported.  No reactions to shot. In January the study was unblinded and She was given the second shot. She got tested two times in 2021 and have no antibodies  Treatment information was not provided.
pain to injection site; chills; dministered Moderna Vaccine 2 weeks early/COVID Vaccine 2 administered; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dministered Moderna Vaccine 2 weeks early/COVID Vaccine 2 administered), INJECTION SITE PAIN (pain to injection site) and CHILLS (chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 048C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes since 09-Apr-2019 and Hypertension since 21-Jul-2021.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dministered Moderna Vaccine 2 weeks early/COVID Vaccine 2 administered). On 22-Jul-2021, the patient experienced INJECTION SITE PAIN (pain to injection site) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Injection site pain and Chills, at an unspecified dose and frequency. On 21-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dministered Moderna Vaccine 2 weeks early/COVID Vaccine 2 administered) had resolved. At the time of the report, INJECTION SITE PAIN (pain to injection site) and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up information added -Medical History, Patient information,  Events Provided, Facility detail added
Pain all over his body; Arthritis Pain as if he was a 60 years old  (After 2nd Dose); Pain starts at his Neck and Cervical, then moves down to all joints  (After 2nd Dose); Joint Pain; High Fever (After 2nd Dose); Chills (After 2nd Dose); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARTHRITIS (Arthritis Pain as if he was a 60 years old  (After 2nd Dose)), NECK PAIN (Pain starts at his Neck and Cervical, then moves down to all joints  (After 2nd Dose)), ARTHRALGIA (Joint Pain (After 2nd Dose)), MYALGIA (Pain all over his body) and PYREXIA (High Fever (After 2nd Dose)) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.     On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 06-Apr-2021, the patient experienced PYREXIA (High Fever (After 2nd Dose)) and CHILLS (Chills (After 2nd Dose)). On 11-Apr-2021, the patient experienced ARTHRITIS (Arthritis Pain as if he was a 60 years old  (After 2nd Dose)), NECK PAIN (Pain starts at his Neck and Cervical, then moves down to all joints  (After 2nd Dose)) and ARTHRALGIA (Joint Pain (After 2nd Dose)). On an unknown date, the patient experienced MYALGIA (Pain all over his body). On 08-Apr-2021, PYREXIA (High Fever (After 2nd Dose)) and CHILLS (Chills (After 2nd Dose)) had resolved. At the time of the report, ARTHRITIS (Arthritis Pain as if he was a 60 years old  (After 2nd Dose)), NECK PAIN (Pain starts at his Neck and Cervical, then moves down to all joints  (After 2nd Dose)), ARTHRALGIA (Joint Pain (After 2nd Dose)) and MYALGIA (Pain all over his body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: unknown (normal) normal. In April 2021, Magnetic resonance imaging: unknown (normal) normal.         No treatment information provided by the reporter. No other concomitant medical  provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.
Pt recvd immun 6JAN92 & had normal exam @ that time; 3 days later was cranky & had some diarrhea later that afternoon was found in crib by babysitter unresponsive; paramedics called & pt taken to local hosp; resusitative efforts unsuccessfu
pt recvd vax 430PM on 28SEP94 & then next morning 29SEP pt lt thigh was red & swollen; swollen area was 2x1.5; 30SEP the swollen area was red & hard & had inc in size to 4x3; inflammation started to dec on 2OCT & by 3OCT there was no inflam