chrisvoncsefalvay/vaers-outcomes huggingface dataset:
THERE WAS NO REACTION AS OF THE TIME OF THIS REPORTING. PATIENT WAS GIVEN A 0.2ML DOSE OF NON-DILUTED PEDIATRIC DOSE COVID VACCINE.
Patient presents with chest tightness/SOB. Arm at injection site is red and slightly swollen.  Injection given at 10:10; reaction noted 10:15; oral diphenhydramine 25 mg administered @ 10:19. Patient reports improved symptoms at 10:35. At 10:40, pt reports additional tightness.  Discussed options with patient and patient mom - can administer dose of epinephrine, call ambulance. Could also administer additional dose of benadryl and pt go to ED. Patient and patient mom elect for additional dose of benadryl and report immediately to ED (ambulance declined).  Patient got additional dose of diphenhydramine 25 mg and departs with mom to emergency department.
Sore lips; Tingling; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9X1LLQGH1GU6RL) via an unspecified route of administration in the left arm on 21Apr2021 at 14:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took tetracycline and experienced allergy to the medication. On 29Apr2021, the patient experienced sore lips and tingling. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore lips and tingling was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE HYPOXIA
tested positive (April 1) to Covid19; This is spontaneous report from Pfizer-sponsored program. The contactable consumer reported that, the male patient (reporter's son) of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection) via an unspecified route of administration on 27Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 01Apr2021 patient tested positive to COVID-19 . The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected
Rash all over body. It got worse every time it showed up. It was the worst on his face.   Given Benadryl and prednisone prescription for 5 days.
Measles, degenerative joint and disc disease for earlier than the normal. I am disabled from it, no treatment, discovered joint and disc disease at 48. Morphine low. Totally disabled. The follow up received on 8/1/03 states "I have arthritis and degenerative joint disease and disc dehydrations and nervousness. I do not know if the vacines I received are the reason or not. I had around 12 vaccines. I am currently being healed."
The pt developed myalgia, arthralgia, headache, photophobia, fever, local swelling, local erythema and chills, post vax.
Immediately: Achy Sore Itchy Hot to touch Day 2 and Day 7: Flu like symptoms Day 5: Symptoms were worse: Redness, hard, and extremely itchy Day 7: redness measured 5.08cm Day 9 (today): Redness measures 11.5cm x 9cm and still growing Still itchy, not as sore but still warm to touch.
Patient reports that he had a massive gout attack. He said it happened in both legs, and 1 arm. Patient was unable to walk for 2 months. Patient believes the vaccine caused the gout attack.
Soreness in mouth and jaw with some swelling. Lasted from midnight to about 4-5 AM. Woke up patient in pain.
pt recv vax 11OCT97 & 30min later swelling was noted of fingers on both hands which lasted 2 days;had trouble removing rings;had a temp of 100 that noc;
Case was vaccinate and boosted against Covid, and was  hospitalized for Covid care  4 months later.  Hospitalized at: Hospital.  ONset 1/31/22 with weakness, confusion, hypoxia and cough. Discharged to home to complete Decadron there.
Ulcerative Colitis, Hypocalcemia, Midline removed while in hospital and discovered lumps. Ultrasound ordered and found blood clots. Xarelto prescribed and still ongoing issue.
Next day: Fever Chills Dizziness  Nausea Vomiting  Body aches  Drowsiness 2 days after: Congestion  Phlem Coughing  Sneezing  Loss of appetite 3 days after: Loss of smell Tightness in chest  Increased heart rate
I started having a severe headache. I felt a lot of sinus pressure. It was constant and not relieved by anything. I was given a shot of Sumatriptan to see if that would help. I had adverse reaction to that med. I had a CT scan of sinuses and an MRI of my brain. I saw a neurologist. I had several sessions of acupuncture. I finally went to an acupuncture session where the headache went away after having the headache for a month. That was the end of that headache.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 19-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Pt recvd 2 doses of Engerix-B 9MAY91, 13JUN91 & on 11NOV01 pt exp burning while inject was given that cont for a few hrs;
Patient said 1 hour after vaccine given had redness and swelling at the site. 2 hours post vaccine patient said she had behavioral changes such as mood swings and a fever of 102 degrees F. She said she also had vomiting and nausea from 4/12/13-4/15/13. She said symptoms resolved on 4/16/13. Other symptoms were hives on legs/arms/face/back and resolved on 4/15/13.
Fever, rash (diffuse, morbilliform), cervical adenopathy; t39C 29NOV; rash 1DEC resolved spontaneously;
Heartbeats skipped; Palpitations of the heart, heart being accelerated heart being accelerated; Little pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of EXTRASYSTOLES (Heartbeats skipped), PALPITATIONS (Palpitations of the heart, heart being accelerated heart being accelerated) and VACCINATION SITE PAIN (Little pain at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 42L20E) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Blood pressure high.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced EXTRASYSTOLES (Heartbeats skipped), PALPITATIONS (Palpitations of the heart, heart being accelerated heart being accelerated) and VACCINATION SITE PAIN (Little pain at the injection site). At the time of the report, EXTRASYSTOLES (Heartbeats skipped) outcome was unknown and PALPITATIONS (Palpitations of the heart, heart being accelerated heart being accelerated) and VACCINATION SITE PAIN (Little pain at the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took cholesterol medication. No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: TCR is attached on 26-Jun-2021 Updated outcome for the events (palpitations and vaccination site pain) from unknow to recovered. On 16-Jul-2021: Follow-up received on 16-JUL-2021 contains non significant information. Verbatim of the event palpitation updated, patient initials updated.
Began not feeling well with 1-2 hours after receiving vaccine. Within 6-7 hours, I felt worse with a low grade fever, chills, nausea, muscle pain/aches. Within 7-8 hours I felt worse. That night I work every 1-2 hours with muscle aches/pain and spasms all over including my back. I tried taking Tylenol, stretching, ice pack(s), heating pad, massage pad and nothing worked. I went to the ER where they gave me something for anxiety which did help.
neuropathy feeling near her eye / left side of her face and scalp and the top front corner around her eye; bad headaches / back of the head; it brought her to tears; didn't go in for 2nd because of pandemic; shingles; pain on the back of the neck, base of neck; This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included muscle spasm (around age 10, the patient was taken to the hospital for a brain infection).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 7th June 2020, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced neuropathy (serious criteria GSK medically significant), headache, neck pain, crying and social problem. The patient was treated with prednisone and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the neuropathy, shingles, headache, crying and social problem were unknown and the outcome of the neck pain was recovered/resolved.   It was unknown if the reporter considered the neuropathy, shingles, headache, neck pain and crying to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 1st dose in fall of 2019, she did not remember if it was given intramuscularly.  The patient did not go for 2nd dose because of pandemic. On 6th July 2020, the patient experienced mild case of shingles. The patient stated that her case of shingles was not that bad. She described her shingles symptoms as bad headaches and extreme pain on the back of the neck, base of neck to the back of the head which only lasted for a minute and happened several times but it brought her to tears. She said that it was pretty much resolved but that she would still have some neuropathy feeling near her eye and on the left side of her face and scalp and the top front corner around her eye. She was prescribed prednisone and an unspecified antiviral medication. The reporter consented to follow up.
Infection, inside lower eyelid, left eye.  Treated with Ciprofloxacin 0.3% eye drops.
Patient received Shingrix vaccine on 9/06/19. And three days later, on 9/09/19, she noticed of small and painful lump forming on her left lower side of the neck. Patient was advised to contact the PCP and monitor for any worsening of symptoms
Initial misuse report received from a healthcare professional on 28 March 2013. A new born patient was administered ADACEL. No adverse event was performed. List of documents held by sender: none.
Bleeding after the injection; Hematoma that lasted 12 days; Left arm was also sore; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding after the injection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced HAEMORRHAGE (Bleeding after the injection) (seriousness criterion medically significant), HAEMATOMA (Hematoma that lasted 12 days) and PAIN IN EXTREMITY (Left arm was also sore). At the time of the report, HAEMORRHAGE (Bleeding after the injection), HAEMATOMA (Hematoma that lasted 12 days) and PAIN IN EXTREMITY (Left arm was also sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications use was not provided. Treatment information was not provided by the reporter.  The patient is scheduled to receive the second dose of the Moderna COVID-19 vaccine on 03-May-2021.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received: Contain non significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received the 12+ dose of the Pfizer-BioNTech vaccine for the second dose in his primary series, He received the appropriate 5-11 year dose for his first immunization on 2/25/22
hives; swollen injection site; fever; chills; muscle tension; muscle spasms; nausea; headache; metallic taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 10:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. Concomitant medications included venlafaxine hydrochloride (VENLAFAXINE) and omeprazole (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date, unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 10:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 23:30, 13hours post vaccination, the patient experienced hives, swollen injection site, fever, chills, muscle tension and spasms, nausea, headache and metallic taste in mouth. 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. The clinical outcome of the events of hives, swollen injection site, fever, chills, muscle tension and spasms, nausea, headache and metallic taste in mouth were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Right arm and leg noted with continuous uncontrollable jerking movements of involuntary nature that are still persisting.
Deathly Ill; Sore Throat; Headache; Nausea; fever; couldn't talk because he hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Deathly Ill), OROPHARYNGEAL PAIN (Sore Throat), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (fever) in a 49-year-old male patient 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 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Deathly Ill), OROPHARYNGEAL PAIN (Sore Throat), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (fever) and MYALGIA (couldn't talk because he hurts). At the time of the report, VACCINATION COMPLICATION (Deathly Ill), OROPHARYNGEAL PAIN (Sore Throat), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (fever) and MYALGIA (couldn't talk because he hurts) outcome was unknown. Not applicable          No concomitant and treatment drugs were reported.
RESTLESSNESS; FEVER; ACHY THROUGHOUT THE BODY; HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pre-diabetic, hypertensive, and rheumatoid arthritis, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced achy throughout the body. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced restlessness. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from restlessness on 10-APR-2021, and fever on 12-APR-2021, was recovering from headache, and had not recovered from fatigue, and achy throughout the body. This report was non-serious.
After a day and half, she started with shooting pain with pressure in her tempo on her head by left side of eyes; She started with pain in her left shoulder next day after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (She started with pain in her left shoulder next day after receiving 2nd dose) and PAIN (After a day and half, she started with shooting pain with pressure in her tempo on her head by left side of eyes) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ARTHRALGIA (She started with pain in her left shoulder next day after receiving 2nd dose). On an unknown date, the patient experienced PAIN (After a day and half, she started with shooting pain with pressure in her tempo on her head by left side of eyes). At the time of the report, ARTHRALGIA (She started with pain in her left shoulder next day after receiving 2nd dose) and PAIN (After a day and half, she started with shooting pain with pressure in her tempo on her head by left side of eyes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
PATIENT HAS LARGE RED AREA EXTENDING FROM INJECTION SITE TO A COUPLE INCHES ABOVE THE ELBOW.  SHE SAID IT WAS SWOLLEN BUT IS NOT ANY LONGER.  IT IS NOT PAINFUL OR ITCHY, JUST RED.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Feb-2021 at 11:46 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 11:46 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 49.46. No concomitant medications were reported. Batch number 031L20A administered on 13-Feb-2021 had  temperature 32 at 09:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported
10/30/2022 Cough and stuffy nose started.  Cough got worse over the course of the evening.  10/31 Saw the doctor.  Doctor ran a PCR COVID-19 test.  Tested positive on an at home COVID-19 test.  Fever of 100 on 10/31 and 11/1 in the evening.  Symptoms tapered off until I felt better on 11/2.  By 11/4 I was fully recovered.  There was a bloody nose on 11/4.