chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial misuse report received from a nurse on 10 December 2013. A 4-year-old child patient had received FLUZONE 0.25 ml instead of 0.5 ml. No adverse event was reported. List of documents held by sender: none.
arm pain radiating to shoulder;no local rxn;pain not severe;treated w/PT for 1month & NSAID w/o improvement;has limited range of motion;no sensory deficit;1FEB95 f/u MRI can 24JAN95 showed localized rxn in bone @ inj site;
Patient received his Tdap vaccination and within 5-10 minutes had a seizure. Mother witnessed the seizure and feels it lasted about 1 minute. Patient has no history of seizure activity, but Mother's sister has a seizure disorder. Patient was examined at the emergency room that evening (CAT scan and bloodwork were unremarkable) and has a follow up appointment with a neurologist on 4-22-08. Patient attended school the following day.
Fever, nausea, vomiting with left upper arm cellulitis about 10 cm x 6 cm. The area was erythematous, warm and very tender.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 17Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: The patient received vaccine. No other medication in 2 weeks. The patient received antiviral product Paxlovid for COVID 19 Treatment started from 07Jul2022 to 10Jul2022. No known allergies and other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
lt thigh w/large red swelling, t102.4 ax treated @ home w/APAP & cooling baths for irrtiability, twitching & fever & had grand mal @ home; prob febrile seizure;
Patient reported urticaria (hives) and pruritus several days after vaccination. No site irritation, inflammation, or swelling was observed when pt came in for consultation.
Patient apparently received the Pfizer vaccine on 9/31/2021 in Clinic. He is now in a Rehab facility where we went to vaccinate. He mentioned that he had received his first dose in Sept, 2021 but did not have his vaccination card nor did he remember which vaccine he received. Upon inquiry, he stated that "it was probably Moderna". So we went ahead and gave him the Moderna vaccine, which is the only vaccine we have. He did well with no immediate reaction noted during the 15 mins he waited. Later while entering his data in the website we realized the error and are reporting the same. Please let us know if patient will need a second Moderna dose or if he is considered fully vaccinated. Thank you.
On 2/7/21 developed fever to 102, severe headache and fatigue. Fever resolved over 1 day. Headaches resolved  over next week. On 2/15/21 (11 days after vaccine) he developed maculopapular blanching rash over torso. Had stopped his medications a few days prior to see if would help headache. Denies any new exposures, medications, supplements, etc.   Seen by me 2/18/21.  Was tested for COVID w/ PCR test on  I treated him with Medrol dose pak after checking labs. CBC wnl. ESR/crp pending. Still very fatigued. No LN's on exam.
Stromg muscle aches in legs and somewhat in back after one fose, pain in upper thigh; Strong muscle aches in legs.upper thigh area and somewhat in back; Some shortness of breath,slight shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Stromg muscle aches in legs and somewhat in back after one fose, pain in upper thigh), BACK PAIN (Strong muscle aches in legs.upper thigh area and somewhat in back) and DYSPNOEA (Some shortness of breath,slight shortness of breath) 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.    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 PAIN IN EXTREMITY (Stromg muscle aches in legs and somewhat in back after one fose, pain in upper thigh), BACK PAIN (Strong muscle aches in legs.upper thigh area and somewhat in back) and DYSPNOEA (Some shortness of breath,slight shortness of breath). At the time of the report, PAIN IN EXTREMITY (Stromg muscle aches in legs and somewhat in back after one fose, pain in upper thigh), BACK PAIN (Strong muscle aches in legs.upper thigh area and somewhat in back) and DYSPNOEA (Some shortness of breath,slight shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Swelling, itching, painful, redness at injection site for 2 weeks and has not subsided. Reported to clinic 11/1/04. Referred to PMD and was placed on antibiotics.
Hypersensitive tactile sensation. Any part of my body that was in contact with anything felt like it wasn't part of my body.; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021 at 07:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), diabetes and obesity. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021 at 20:00, the patient experienced hypersensitive tactile sensation. Any part of patient body that was in contact with anything felt like it was not part of patient body. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hypersensitive tactile sensation. Any part of patient body that was in contact with anything felt like it was not part of patient body was recovered on unspecified date of Mar2021.   No follow-up attempts are needed. No further information is expected.
increased heart rate; pain in jaw; shoulder pain; Vaccination site swelling; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (increased heart rate), PAIN IN JAW (pain in jaw), ARTHRALGIA (shoulder pain), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (vaccination site pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0421L20A) for COVID-19 vaccination.    Co-suspect product included non-company product NAPROXEN SODIUM (ALEVE) for an unknown indication.    Concurrent medical conditions included Diabetes and Hypertension.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and NAPROXEN SODIUM (ALEVE) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (vaccination site pain). On 18-Feb-2021, the patient experienced TACHYCARDIA (increased heart rate), PAIN IN JAW (pain in jaw) and ARTHRALGIA (shoulder pain). On 19-Feb-2021, TACHYCARDIA (increased heart rate), PAIN IN JAW (pain in jaw), ARTHRALGIA (shoulder pain), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (vaccination site pain) had resolved.             Action taken with mRNA-1273 in response to the drug was not applicable.Concomitant medications included unspecified Diabetic and High Blood Pressure medications.  On 18-Feb-2021, the patient expressed concern for having a heart attack however the symptoms had resolved the next day.
Ten minutes after receiving the first vaccine I started to develop a headache.  The headache developed into a moderate headache.  It lasteed for 18 hours and although Tyenol was taken it barely lessened the headache.  It was gone by the next day
site pain abdomen pain chills low energy feel like vomiting headache  uneasiness in chest
He became lethargic, legs & head hurt, within 2 hours fever 102? 5 hours after injection.
Some amount of the vaccine has leaked from the syringe; Some amount of the vaccine has leaked from the syringe; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Some amount of the vaccine has leaked from the syringe) and DEVICE CONNECTION ISSUE (Some amount of the vaccine has leaked from the syringe) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (Some amount of the vaccine has leaked from the syringe) and DEVICE CONNECTION ISSUE (Some amount of the vaccine has leaked from the syringe). At the time of the report, UNDERDOSE (Some amount of the vaccine has leaked from the syringe) and DEVICE CONNECTION ISSUE (Some amount of the vaccine has leaked from the syringe) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
SIDE EFFECTS; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The patient experienced side effects after receiving the Shingrix vaccine.
COVID-19 positive; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) and SARS-COV-2 TEST POSITIVE (COVID-19 positive) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RHINORRHOEA (Runny nose). On 11-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 positive). At the time of the report, RHINORRHOEA (Runny nose) and SARS-COV-2 TEST POSITIVE (COVID-19 positive) outcome was unknown. Not Provided      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.   No relevant concomitant medications were reported Treatment details included Infusion.   This case was linked to MOD21-027991 (E2B Linked Report).; Sender's Comments:  MOD21-027991:
Bloodshot right eye; This is a spontaneous report from a contactable physician. A 41-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 10May2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included fibroadenoma of right breast. It was unknown if the patient was pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient did not receive any medications within two weeks prior to the COVID-19 vaccination. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccination. On 11May2021, the patient experienced a bloodshot right eye. The event did not result in doctor or other health care professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, it was unknown if the patient has been tested for COVID-19. The clinical outcome of the event bloodshot right eye was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from an other health professional referred to a patient of unknown age and gender. The call was originally placed by a healthcare worker, but the adverse event information was provided by another healthcare worker   who reported that ZOSTAVAX vial (lot #, dose, route and frequency unspecified) that underwent a temperature excursion was administered to the patient on 15-AUG-2014. No adverse effect reported. Additional information has been requested.
Mom called 3/16/01 and stated child has temperature 101F and broke out with chickenpox with about 15, total.
Pt reported running a high fever and rash after receiving vax. Also complained of aching and joint pain. Recovering, fever resolved but achiness remains. Pt still has a rash on arm.
swelling at injection site; Headache; dizziness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On 17-SEP-2023, the patient received the 2nd dose of Shingles vaccine. On 17-SEP-2023, less than a day after receiving Shingles vaccine, the patient experienced injection site swelling (Verbatim: swelling at injection site), headache (Verbatim: Headache) and dizziness (Verbatim: dizziness).  The outcome of the injection site swelling, headache and dizziness were not resolved.   It was unknown if the reporter considered the injection site swelling, headache and dizziness to be related to Shingles vaccine.     It was unknown if the company considered the injection site swelling, headache and dizziness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-Sept-2023 and 18-Sept-2023 The case was received from the patient via interactive digital media. The patient got the second shot on the day of reporting and had some swelling at injection site, headache and dizziness. The physician stated that the patient will never get shingles again and they will see.
Patient presented on 9/27/2021 to emergency room with fever, malaise, myalgia, headache, fatigue, productive cough, and shortness of breath. Patient was found to be COVID-19 positive on 9/25/2021. Patient was treated with supplemental oxygen, dexamethasone, and remdesivir.  Patient was discharged home on 10/2/2021 with home oxygen.
Myalgia fatigue Narrative: Per nursing report: "Took second [sic: first] dose vaccine yesterday[9/2]. C/o severe body aches and fatigue. States did not come to work today [9/3] due to not feeling well.
Awoke with left arm pain and discomfort, stiffness to left side of neck. At 1700 same day noted redness to shoulder with swelling to last two fingers of left hand. Self treated with Motrin on both days and Benadryl on 1 Oct 2015.
Information has been received from an unspecified reporter on an article, via a company representative, referring to a 20 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (strength, administration route, anatomical location, lot number and expiration date were not reported) for prophylaxis (also reported as "vaccine for human papillomavirus (HPV)"). On an unspecified date one week after receiving the first dose, the patient developed severe abdominal pain. It was reported that the patient also experienced nausea. On an unknown date, the patient continued to receive the second dose of GARDASIL (strength, administration route, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unspecified date ten days after receiving the second dose, the patient had unspecified lab done which results revealed significantly elevated pancreatic enzymes (values and units not provided), then he was diagnosed with acute pancreatitis. The outcome of the severe abdominal pain, the nausea and the acute pancreatitis was unknown and the causality between the vaccination with GARDASIL and the aforementioned events was not reported. Upon internal review, the acute pancreatitis was considered as a medically significant event.
Mild to moderate headache beginning at around 6pm; fatigue; This is a spontaneous report from non-contactable consumer (patient).   A 31-years-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Feb2021 (Batch/Lot Number: EL3247) at the age of 31-year-old, as single dose for covid-19 immunisation.   The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), administered in Arm Left on 20Jan2021 02:00 PM.  Medical history included, asthma from an unknown date and unknown if ongoing. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; salbutamol (VENTOLIN [SALBUTAMOL]) taken for an unspecified indication, start and stop date were not reported.   The patient previously took, ciprofloxacin and experienced drug hypersensitivity.   The patient experienced mild to moderate headache beginning at around 6pm (non-serious) on 10Feb2021 18:00 with outcome of recovering, fatigue (non-serious) on 10Feb2021 18:00 with outcome of recovering.    No follow up attempts are possible. No further information is expected.
Approx 17hrs after receiving shot I started feeling a mild headache and trouble concentrating. I felt physically weaker and mild stomach ache with my eyes sensitive to light. The following morning I felt almost back to normal. The following evening 2 days after receiving shot I felt a lot of Upper back and shoulder pain. I felt like throwing up but did not. I only slept  3 hours that night and was physically soar. I ate only a can of chicken noodle soup and drank a can of ginger ale Sunday 7/25/21. I slept well last night but still feel tired and a little brain fog. I ate a good breakfast this AM and believe now three days after my second shot I will likely be almost back to normal.
She was fussy for at least 72 hours after her vaccines. She then woke up with a slight rash covering her entire torso, face, and slight in diaper area. I called the doctor and they said it was from her chicken pox vaccine. That is would pass in a week or so. It continued to worsen, and she continued to be fussy, not running a fever though. This later for a full 14 days an was what appeared to be a chicken pox rash without the pus. Raised red bumps covering body.
- vaccinated on 9/17/19 around 5 pm - Side effects became noticeable on 9/18/19 and are still there today on 9/18/19. Symptoms stay the same, not getting worse.  -2" x 2" inflamed area about 3 - 4" below injection site.  - Recommended pt to go to urgent care for evaluation
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8732), on 20Apr2021 as dose 2, single (Lot number: EW0161), on 27Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 31May2022 as dose 4 (booster), single (Lot number: FM0173), in left arm for covid-19 immunisation. The patient's relevant medical history included: "A-fib" (unspecified if ongoing); "controlled high blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "venous insufficiency" (unspecified if ongoing); "peripheral neuropathy" (unspecified if ongoing); "treated ocular melanoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a 17 year old female patient reporting on herself. There was no concurrent conditions, medical history or concomitant medications. On 22-JUN-2016, the patient was vaccinated with a dose of GARDASIL (Dose, route, anatomical location, lot number and batch number were not provided). The consumer stated that in 2016, she was experiencing burning sensation and soreness at the site of GARDASIL injection. At the time of the report, the patient was not recovered/not resolved from the events. On 16-DEC-2016, the patient experienced burning sensation and soreness at the site of the insertion while was on NEXPLANON (MARRS:1701USA000855). The causality between burning sensation and soreness at the site of injection and GARDASIL was not provided. There was no product quality complaint issue involved. Additional information has been requested. Sender's Comments: US-009507513-1701USA000855.