chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Similar symptoms to pericarditis, with debilitating pain that was exasperated while lying down; Heart palpitations; left armpit with pain radiating to entire left shoulder through the middle of the neck; low grade fever; severe fatigue; slightly dry cough; This is a spontaneous report from a contactable consumer reporting for himself. A 27-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EV8732/expiration date: not provided), via an unspecified route of administration, on 07Apr2021 at 13:45 (at the age of 27 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included COVID-19 on an unspecified date. The patient did not have any known allergies to medications, food, or other products. Concomitant medication (other medications taken in two weeks) were none.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Apr2021 at 22:00, the patient experienced similar symptoms to pericarditis, with debilitating pain that was exasperated while lying down, Heart palpitations, left armpit with pain radiating to entire left shoulder through the middle of the neck, low grade fever, severe fatigue and slightly dry cough. The events required a physician's office visit. The patient received treatment for these events. The clinical course of the events was as follows: Heart palpitations originating under left armpit with pain radiating to entire left shoulder through the middle of the neck. Similar symptoms to pericarditis, with debilitating pain that was exasperated while lying down, low grade fever, severe fatigue, and slightly dry cough. Lasted about 30 hours. Discomfort relief, like pericarditis, was only felt when sitting up and propping myself up by my arms leaning forward. Onset was rapid, occurring 13 days after the first dose of the vaccine over a period of 8 hours (palpitations came first, followed by shoulder and neck pain in the morning). Treated with Aspirin at first (low effectiveness) followed by NSAID Advil 7 hours later (high effectiveness, symptom relief was about 50%). High strength Advil recommended by MD. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
While sitting @ table pt suddenly leaped like out of chair to floor; shook a little, stiff, color ashen gray; happened about 1/2 hr post inject; no fever; Seen @ ER by MD;
Patient reported swelling of upper lips at 1030, no swelling visible immediately, 1039  patient reported swelling felt like it had decreased, no problems with breathing, v/s stable, O2Sat 99, and R 15, at 1040 patient reported swelling was still there and that is when lips appeared pink and epi pen #1 was administered. Patient tx with epi pen x 2. Left alert and oriented x 3 via gurney with EMS transported to hospital for observation.
Chronic Hives - red, raised skin. Itchy and burning feeling. Shows up in random spots throughout the day. Hands are affected the worst - turn red and burn.
Shortness of breath; chest tightness; stated that she got the first shot in her left hip; soreness to left hip; burning at her left hip; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received BNT162B2 first dose (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on 14Jan2021 at 16:20 (Batch/Lot Number: EL3249) as single dose, then via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included rotator cuff injury from 2020, unknown injury from 2018 to 2019 and repeated injuries to her shoulder (occurred before the vaccine) from an unknown date and unknown if ongoing. The concomitant medication was not reported. The reporter stated that she is a healthcare worker with repeated injuries to her shoulder that occurred before the vaccine. Stated that she had rotator cuff surgery in 2020 and the another injury 1-2 years prior to that one. Stated that the first booster that she received was three weeks ago in her hip on 14Jan2021 16:20. Stated that she went to get the second dose today in her thigh. Stated that she was told that it was being given in her thigh because it was conclusive to being effective. Stated that she was told that the first dose may not be effective. Wanted to know the current information where it should be administered. Wanted to know if she should get first dose again. Clarified that the booster is for the Pfizer Covid 19 vaccine. Stated that she got the first one on 14Jan2021. Stated that she gets repeat vaccines every year and had a declination to IM sites to the shoulder/arm area due to her injuries. No further details provided. Later clarified first booster was to her left hip. The reporter stated that with the first shot that she had soreness to left hip and burning at her left hip on 14Jan2021 16:20. Stated four days after the vaccine that she did a lot of cardio and had chest tightness and shortness of breath on 17Jan2021 16:00 within 10 minutes after that lasted for an hour. Stated burning only lasted 15 minutes. The outcome of the events the first dose may not be effective due to being given in her left hip was reported as unknown. The outcome of the events stated that she got the first shot in her left hip and burning at her left hip reported as recovered 14Jan2021. The outcome of the events soreness to left hip, Shortness of breath and chest tightness was reported as recovered 17Jan2021.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 11-APR-2014, the patient was inadvertently administered RECOMBIVAX HB that had expired, (lot number unknown and expiration date 06-APR-2014, thimerosal status was not provided), (dose number and anatomical location unspecified), 1 ml, intramuscular for an unspecified indication. Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Mom reported child had vaccine in 4-6 pm clinic 1-17-02 and was fine until he woke @ 5:30 am 1/19/02 and had a headache, dizziness and fever. LD-site was ok. Headache lasted a couple days. Dizziness was for 1 day. Fever was 101.8-102.5 with ear thermometer and lasted through 1/19 and 1/20. This was controlled with Motrin (Tylenol was ineffective). Child is fine now.
Large Red Circle on Left Elbow/red circle appeared in her elbow; Left elbow began to feel sore/experienced pain in her elbow; This is a spontaneous report from a contactable consumer(patient) via information team. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ENC6203, Expiry Date, NDC number: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 at 09:15 (at the age of 73-years-old) as dose 1, single for Age and didn't want to catch virus and pre-existing conditions. Medical history included ongoing cardiac disorder, ongoing hypertension. There were no concomitant medications. The patient had no Family Medical History Relevant to adverse events. Vaccine was administered at Vaccination Facility, there were no additional vaccines administered on same date of the Pfizer Suspect, the patient had no Prior Vaccinations (within 4 weeks). The patient stated that she had the shot, the Pfizer vaccine, on 04Mar2021 and it was her first shot and she had it in her left arm, in the evening (04Mar2021, started 12 hours after vaccine; 21:30-22:00) experienced pain in her elbow and also a red circle appeared in her elbow, her elbow began to feel sore, had a large red circle. and the following day it disappeared. She asked, would she have a worse reaction with the second shot, she was interesting because she read online that most people have a reaction 8 days after and she had 12 hours after, she has a heart condition and high blood pressure but does not feel that it was relevant and does not want to go into further details regarding it. She further stated that most people have this redness 12 days after receiving the Moderna vaccine and it happened to her 12 hours after getting the Pfizer-BioNTech Covid-19 vaccine, she had no redness at the injection site. The patient had no adverse event following prior vaccinations. The adverse events did not require patient to visit Emergency Room, Physician Office (She didn't even think of it as a cause from the vaccine; it was only when she saw the online news that she saw that was one of the reactions). The patient underwent lab test and procedure which included Weight: 140lbs or 139lbs on an unspecified date. The outcome of events was recovered on 05Mar2021.  No follow up attempts were possible. No further information was expected.
One large red welt continuing to grow; two red spots below injection site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (One large red welt continuing to grow) and VACCINATION SITE ERYTHEMA (two red spots below injection site) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 URTICARIA (One large red welt continuing to grow) and VACCINATION SITE ERYTHEMA (two red spots below injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (One large red welt continuing to grow) and VACCINATION SITE ERYTHEMA (two red spots below injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication included.   Reporter did not allow further contact
Warm to touch; Injection site itching; Red; Rasied; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Rasied) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No medical history reported.     On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Rasied). The patient was treated with HYDROXYZINE HCL at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Rasied) outcome was unknown.        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 products reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: An additional document received on 15 Apr 2021 included no new information
Patient passed away unrelated to covid vaccine Narrative: The patient had with a history of ischemic cardiomyopathy and multiple PCI's, CABG history of acute renal failure and hypokalemia and decompensated heart failure. Patient received his first dose of Pfizer dose on 2/18. Patient passed away on 3/8 due to cardiac arrest upon arrival to ER. Cause of death is not related to COVID-19 vaccination.
Information has been received from a medical assistant referring to a 8 year old female patient. The patient was not pregnant. The patient's pertinent medical history and drug reactions/allergies were not provided. Concomitant therapies included losartan (manufacturer unknown), amlodipine (reported as amlodidine) and oxybutynin. On 31-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # L017265, expiration date 10-FEB-2017, subcutaneous, once; dose was unknown). On the same day, 3 hours after the vaccination (reported as "3 hours ago"), the patient's arm was very painful with no swelling and no redness, ice was applied to the arm. The outcome of the event was unknown. The causality assessment was not provided. Additional information has been requested.
Varicella like rash appeared on torso, arms, legs @18 hours after recieving vaccine.   Patient's mother denied possibility of insect bites.   Child was afebrile and in otherwise good health.
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:54 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 31.10 . Concomitant products were not provided. On 15-Apr-2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021 and vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021. On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
2hr p/vax started vomiting repeatedly;became lethargic;mom called paramedics who took pt hosp;pt given fluid boluses IV;WBC count 25,600, electrolytes showed a C02=14;pt transferred to another hosp hydration cont electrolytes corrected;
The issue that I had  was a fever and then I began to have extreme knee pain and couldn't walk on it. It went on for six weeks before I went to my doctor he did an x-ray and it showed significant loss of cartilage and I was put on Ibuprofen and I was given a shot of cortisone. It helped with the pain but its still bothersome here and there. The last time I had knee pain was about 3 years ago.
Site at varicella injection site became red, warm to touch, and raised the day after injection.  Diameter size as big as approx. 3 inches.
A LITTLE DISCOMFORT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced a little discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a little discomfort was not reported. This report was non-serious.
10 days, post vax, pt had a seizure and went to ER. The seizure lasted approx. 30 seconds. On the 11th day, post vax, she had 3 more and was hospitalized for the weekend. Seizures under control for a few days and then started again. They increased in frequency to 12+ a day. Hospitalized the weekend of 6/2/00 and went into status on 6/13/00 and was hospitalized for 35 days, starting 6/14/00. Still has multiple seizures daily. 60 day follow-up states the pt has developmental delays. F/U 5/21/01: Dx: Developmental delay, severe and difficult to control seizures of undetermined etiology. Treat with Ketogenic diet, Dilantin and Depakote. Depakote stopped and started on Topamax. She was also given ACTH 40 units q d starting in 7/00 and ? Now, she has been put on zonisamide 50mg bid, Valium 2mg hs prn and Prilosec 5mg qd.
Severe constant headache that has been lasting for 5 days so far along with nausea. Low body temperature in a range 94.5-97 degrees F.  There has been unstable blood pressure.
3 days had the hot, pink, itching localized symptoms at site of injection. Fluzone administered on Dec 13 2006. Client waited till Dec 15 2006 to report condition.
This spontaneous report as received from a pharmacist refers to a 64 years old female patient with none pertinent medical history and none drug reactions/allergies, who was vaccinated with a dose of ZOSTAVAX (lot# reported as 0242AE, Expiration date 01-APR-2013) (dose not reported) SQ in the left arm on 21-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 23-AUG-2012 the patient experienced rash at the injection site, 3 days after onset of therapy. The patient sought medical attention, she came to pharmacy. No treatment was given. No lab diagnostics studies were performed. The outcome of rash at the injection site was reported as not recovered/not resolved. The relatedness for rash at the injection site was not reported for ZOSTAVAX. Additional information is not expected.
Information has been received from a health professional concerning a 31 year old female with a history of asthma who on 07-JAN-2008 was vaccinated IM in the left deltoid with the first dose of pneumococcal 23v polysaccharide vaccine (654977/0888F). Concomitant therapy included influenza virus vaccine (unspecified) IM in the right deltoid. On approximately 07-JAN-2008 the patient experienced injection site reaction and came back to the employee health department on 09-JAN-2008. Per the reporter, the injection site reaction was very painful, warm and red. Swelling at the injection site was 11cm wide and 7 cm long. The patient sought unspecified medical attention. Subsequently, the patient recovered from injection site reaction. The patient had been treating self with BENADRYL. Additional information has been requested.
Started feeling weak around 9AM, tired, ache all over. At 7 AM my husband noticed my (R) arm where I had my shot was red and swallon, and hot. Took 2 Tynols 1-Benadryl. was sick up until 10/26 - still takening Tynol & uped Benadryl to 2 every 6 hrs. Got vacc. in my (R) arm - sick next day felt like a rag doll, weak, achy couldn't think I could walk so tired, Then my husband noticed rash, red, swallen & hot on my arm. Took Tyneol & Benadryl for several days - I took care of myself - most of it was once the weekend. I did call a 24hr nurse# & they suggest to go to a care center. I felt better Sunday after then my arm with rash, hot & red & swallon. So I kept up with Tynole & Benadryle. This was my 2nd vacc. for Shingles - same 1st one I had - 8/21/20 from pharmacy Didn't have a reaction then - Hope this helps - I don't have internet so I had to do it this way.
Patient was scheduled for second dose on 4/14/21.  Wife called that morning to say that patient passed away on 4/6/21.  Wife stated he saw the neurologist on 4/1/21.  On 4/6 he was doing very well in the am and pm.  She put him to bed, he woke up and called to her, gasped and passed away.  She reports he tolerated the 3/17 vaccination well. I called the doctor on 4/16/21 for more information but he has not returned my call as of yet.
Patient had Johnson and Johnson on 03/23/2021, and per Dr. it was appropriate for patient to receive Moderna Booster.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On an unknown date an unspecified number of patients might have been vaccinated with improperly stored dose of RECOMBIVAX HB. Dose, lot and expiry date were unspecified. No adverse effects were reported. This is 1 of several cases from same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M018810 with expiration date on 18-MAY-2018; lot # M024261 with expiration date on 30-JUL-2018; lot # M016193 with expiration date on 24-APR-2018; lot # M023169 with expiration date on 13-JUN-2018; lot # M028323 with expiration date on 26-SEP-2018; lot # M030380 with expiration date on 01-FEB-2019; lot # L036301 with expiration date on 20-DEC-2017; dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009358: US-009507513-1701USA005323: US-009507513-1701USA009357.
This was the 2nd shot of the 2-shot MODERNA regimen.  I received the expected headache and sore arm within a few hours after the injection, they were expected.  What began happening about 24 hours after the injection was this:  I could literally feel the vaccine move through my kidneys, then my lungs, then down my spine over the course of about 8 hours with inflammation and a fever.  What happened next was frightening, it felt as if 10,000 knives were being thrust in to my chest and back.  Breathing was difficult and painful.  This went on for a few hours.  I was unable to find my phone to call anyone or emergency help.  Over the course of 48 hours during all this I lost 8 pounds from sweating.  It was after about 48 hours that the fever broke and all pain subsided.
This spontaneous report was received from a certified medical assistant, and refers to a patient of unknown age and gender. Concurrent conditions, medical history, historical or concomitant drugs were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ Oral liquid, orally, lot # N034401, expiration date 09-MAY-2019, for prophylaxis (strength and dose were not reported). The reporter stated that this dose was stored at 47.3 F during 30 minutes, without a previous temperature excursion. No adverse symptoms reported. This call was made because of a data logger.