chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gave dose to a pediatric patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave dose to a pediatric patient) in a 17-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave dose to a pediatric patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave dose to a pediatric patient) 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.   Concomitant medications were not reported.  Treatment information was not provided.
Patient experienced chest tightness and itching/splotching on  right forearm. She was given 50 mg of oral liquid diphenhydramine.
PATIENT RECEIVED THE JANSSEN SHOT IN MARCH. GOT THE MODERNA IN JUNE BECAUSE THOUGHT THE JANSSEN WASN'T GOOD ENOUGH
I had body aches, chills, no temperature, soreness of my arm lasted 24 hours. Then I got COVID 6 months later experienced sore throat, chills, fever (5 days), headache, congestion and cough. My cough lasted for about three weeks. Although I had symptoms first two COVID home tests results was negative and then took Rapid (results positive). My doctor prescribed Pavlovic for 5 days.
When trying to bill the insurance for the vaccine given by our pharmacy, it was then notified that the patient had previously received a flu shot a few months earlier at a clinic in town.  The patient is located in a nursing home locally and indicated that they had not received the flu shot and asked to get it.  There were no known adverse events.
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 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 10:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 10:58 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). In 2021, 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. On 17-Feb-2021, Excursion time was 08 AM, temperature was 20, total doses given for the day was 62, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 17-Feb-2021. 1 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021. On 17-Feb-2021, Excursion time was 09 AM, temperature was 22, total doses given for the day was 62, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 11-Feb-2021, vial was moved to clinic on 17-Feb-2021. 5 vials were sent to clinic. Vaccine BUD date was 13-Mar-2021. 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 Fisherbrand 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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
This spontaneous report was received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with MMR II (lot# L009213 and expiration date 17-MAR-2017) (dose and route were not reported) that had been improperly stored. No concomitant therapies were reported. No adverse effects reported. No Product Quality Complaint (PQC0 was involved. This is one of the several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
2 days after adult Td, developed soreness, swelling, bruise, warmth.  Involving left shoulder and lateral upper arm.
red rash going into his armpit; red patch; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash going into his armpit) and RASH MACULAR (red patch) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced RASH ERYTHEMATOUS (red rash going into his armpit) and RASH MACULAR (red patch). At the time of the report, RASH ERYTHEMATOUS (red rash going into his armpit) and RASH MACULAR (red patch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications were reported.  Symptoms: It was reported that the patient had experienced a red line which was going into his armpit.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were unknown. It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Inside sales team took information from the health care professional, medical information never spoke to him and he did not want to be called back. The health care professional was the patient. Everything inside sales was reported but very limited information was available.
On the eighth day after receiving the first dose of the Moderna Covid vaccine, I developed a 4x5" red itchy rash just below where I got the shot on my arm. It continues to persist three days afterwards, and that arm and elbow ache as well.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On 24-SEP-2015 the patient was vaccinated with a dose of TWINRIX (lot number, expiration date, dose and route were not reported). Five years later, on 29-SEP-2015 the patient was vaccinated with a dose of RECOMBIVAX HB (dose and route not reported, lot # reported as L019299 with expiration date 15-APR-2017)). No adverse experience was reported. Additional information has been requested.
The patient was given 2 flu shots. The first on sept. 13, 2023, and the second on Nov. 16, 2023
patient was administered dose and went to the waiting area. patient loss consciousness for about 20 seconds. patients mother supported her in chair. after lightly shaking patient and call patients name she regained consciousness. patient was clammy and diaphoretic and pale. she was given water to drink and was back to normal in about 5 minutes
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. An elderly female patient received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: FL3197) for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "IVP DYE" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. 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: Blood pressure measurement: 220/110; Blood test: Normal; Chest X-ray: Normal; Electrocardiogram: Normal; Urine analysis: Normal. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: On the completion of day 2 of Paxlovid, 4 doses totally B/P went up to 220/110. Consumer went to the ED and it was felt it was due to the Paxlovid, all her tests were normal-EKG, chest films and blood work and urinalysis. Anti-viral details included Paxlovid for COVID-19 Treatment, started on 16May2022 and ended on 18May2022. Anti-viral details included Paxlovid for COVID-19 Treatment, started on 16May2022 and ended on 18May2022.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), RHINORRHOEA (Running nose), INFLUENZA LIKE ILLNESS (Flulike symptoms), MYALGIA (Muscle pain) and CHILLS (Chills) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Artificial cardiac pacemaker user and Immune disorder (NOS). Concomitant products included ESCITALOPRAM and AMITRIPTYLINE for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in arm), RHINORRHOEA (Running nose), INFLUENZA LIKE ILLNESS (Flulike symptoms), MYALGIA (Muscle pain), CHILLS (Chills) and PYREXIA (temperature of 102). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm), RHINORRHOEA (Running nose), INFLUENZA LIKE ILLNESS (Flulike symptoms), MYALGIA (Muscle pain), CHILLS (Chills) and PYREXIA (temperature of 102) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included Tylenol This case was linked to MOD-2021-041081 (E2B Linked Report).; Sender's Comments:  MOD-2021-041081:
Nausea; Head is very fuzzy and it's hurting; Body ache; He had a fever of 100.5; Head is very fuzzy and it's hurting; Feeling unwell; This is a spontaneous report from a contactable consumer (reporter's father) from a Pfizer sponsored program. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205 and expiration date was not reported), via an unspecified route of administration on 25Mar2021 (at the age of 62-years-old) at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. After vaccination patient felt a little unwell on 26Mar2021 but overall okay just kind of started up side effects probably. He was just fine on 27Mar2021 but when he woke up on 28Mar2021, he had nausea in the morning and then when he came home from  work, he said that his head was very fuzzy and it was hurting, he was not feeling well and he had some like body ache and when he took his temperature. He had a fever of 100.5 and the package that was given when he got the vaccine, had all of those side effects. But it says it should go away after a couple of days and they were just wondering because reporter's dad does have to work out with the public. No treatment was given for the events. The outcome of the events was unknown. .  No follow-up attempts are needed. No further information is expected.
In January 2022 I began to have a headache on and off again. Also, in general, my body became very sensitive to things like face creams and some foods cause digestive issues now and they did not before the booster. This also happened when I got my 1st and 2nd dose of the vaccine. In addition, my blood pressure increased, possibly because of another medication I took. I've never had issue with blood pressure before. I believe the booster caused me to not be able to bounce back as easily as before from increased blood pressure.
pt called office on 10FEB93 & reported recent 5 day hospitalization in local hosp; dx GBS like synd w/paralysis; weakness of face & lower extremities which were resolving; MD expected recovery;
This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018) (dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) (60.33 °F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Moderns Civid-19 vaccine EUA Approx 7.5 hrs after vaccine fever began to go up and hard chills began. The chills continued continually for about 6 hours. My team peaked at 103.6 . fever lasted about 13 hours. Severe pain continued with extreme fatigue another two days. Some diarrhea accompanied. This was my second vaccine . I had very similar symptoms after the first vaccine but they started about 24 hours later in this process. I had a bad case of covid-19 in mid October. I am still enduring side effects from that.
pt got 2nd covid shot yesterday woke up with full body ache and pain at shot sight LT arm. H/A pt states N/v vomited 4 times today denies diarrhea. afibrile ,lt arm swollen at injection sight , ttp some redness at injection sight.  CHIEF COMPLAINT & HPI:  28 yo F had covid vaccine #2 yesterday and today is having bodyaches, chills, headache, nausea, and vomiting.  no fever.  no cp/sob.  no abd pain.  no dysuria/hematuria.  also redness around the site of the injections.
7 pediatric pts were given Covid 12+ monovalent as a booster dose after 8/31/22
Severe pain and soreness in injection site area for 36+ hrs. Severe aching in feet, hands and overall body aches. Hips starting hurting. Sniffles. Sharp stabbing pain in stomach. Headache.  Body aches felt like someone had trodden on me.
Patient called the pharmacy on 8/21/19 to report a serious reaction to the Shingrix vaccine she received on 8/16/19. Patient went to her MD today and they said patient should report her reaction to the pharmacy so we could submit to VAERS. Patient reported feeling warm liquid going through left side of her brain, breathing issues, knot in the throat, and an off balance feeling beginning within 5 minutes of receiving vaccine. Patient reports improvement of all symptoms since the event but still having some balance issues.
Pt is a 74 year old male who had his 1st dose of Pfizer today. Approximately 20 minutes after having his vaccination he was sitting in a chair getting ready to leave observation when he complained of heart burn with no other associated symptoms.   Patient was assesed and released via the AMA process.  Patient had symptoms decrease in severity during assesment.  Additionally a full set of vital signs including a 12 lead were obtained. 12 lead was negative for any signs of a cardiac event.  Pt refused transportation to the emergency room via ambulance. Patient was assited to the back of Fire Paramedic Ambulance for further evaluation. Refer to patient care report.
Developed rash after receiving immunizations.  Possible post vaccination VZ vs. step rash.  Treated with Duricef 200mg twice daily for 5 days and Benadryl.
PT DEVELOPED A MACULAR/PAPULAR ERYTHEMATOUS BLANCHING RASH STARTING APPROX 2-3 DAYS AFTER IMMUNIZATION, WAS EVAL 14 MAR 2003 FOR THIS. RASH AFFECTED PRIMARILY FACE (PRIMARILY AT SCALP LINE AND RASH AT THIS AREA WAS DEEPLY ERYTHEMATOUS), AND MILDLY TO BILATERAL UPPER EXTREMITIES (R>L, MILDLY ERYTHEMATOUS). WAS SEEN BY DERMATOLOGY WHO FELT RASH WAS MOST LIKELY DUE TO AN IMMUNE RESPONSE TO THE VACCINATION. PT OTHERWISE HEALTHY, C/O MILD FATIGUE SINCE INJECTION. NO OTHER C/O. POSITIVE TAKE TO VACCINE.
After I gave her the shot, she left and came back in about 30 seconds saying she couldn't breathe. I gave her an epinephrine shot in the thigh. She started breathing easier. She said she felt better. We gave her diphenhydramine 25mg and called 911. The paramedics came and talked to her and checked her oxygen levels and blood pressure, which was high. They said that was probably due to the epinephrine. She does not have high blood pressure normally. They said her lungs sounded fine. She said she felt light headed and her hands were shaking a little, but her breathing was fine. They called an ambulance because they wanted her to go to the hospital because of her blood pressure being high. She said she would go, but not in an ambulance. Her partner would take her. Her partner arrived and then the ambulance arrived. They checked her blood pressure again and it seemed to be going down a little. They said it didn't look like an anaphylactic reaction. The patient said she was going right to  Hospital (about 15 minutes away).
PASSED OUT 11 HOURS FROM THE TIME OF VACCINATION; This spontaneous report received from a patient concerned a 27 year old male with unknown race and ethnicity. 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: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date patient passed out 11 hours from the time of vaccination. Patient had slept two hours with his head elevated. Near the end of his pee he passed out in the bathroom. He had another person with him, helping him stay hydrated. Temperature was staying below 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of passed out 11 hours from the time of vaccination was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210502538-covid-19 vaccine ad26.cov2.s-Passed out 11 hours from the time of vaccination . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
BIG PAUSE BETWEEN HEARTBEATS (HEAR RATE WITH A 3/4THS PAUSE BETWEEN AFIB (ATRIAL FIBRILLATION) AND DEFIB DE-FIBRILLATION)); SHORTNESS OF BREATH; HURTS TO BREATHE; PAIN IN THE AORTA; VOMITING; COLD WITH SHAKING; FEELING UNWELL; 10 SEVERE HEADACHE (8 OUT OF 10, WITH BEING WORST); NAUSEA; COUGHING; This spontaneous report received from a patient concerned a 24 year old male. The patient's height, and weight were not reported. The patient's past medical history included smoker, and concurrent conditions included alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use. the patient had no past medical history of cardiac problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 02-AUG-2021 17:11 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the subject experienced coughing. On 02-AUG-2021, the subject experienced nausea. On 03-AUG-2021, the subject experienced big pause between heartbeats (hear rate with a 3/4ths pause between afib (atrial fibrillation) and defib de-fibrillation) ). On 03-AUG-2021, the subject experienced shortness of breath. On 03-AUG-2021, the subject experienced hurts to breathe. On 03-AUG-2021, the subject experienced pain in the aorta. On 03-AUG-2021, the subject experienced vomiting. On 03-AUG-2021, the subject experienced cold with shaking. On 03-AUG-2021, the subject experienced feeling unwell. On 03-AUG-2021, the subject experienced 10 severe headache (8 out of 10, with being worst). Laboratory data included: Heart rate (NR: not provided) 3/4ths pause between afib and defib. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cold with shaking, and had not recovered from coughing, big pause between heartbeats (hear rate with a 3/4ths pause between afib (atrial fibrillation) and defib de-fibrillation)), 10 severe headache (8 out of 10, with being worst), vomiting, pain in the aorta, shortness of breath, hurts to breathe, nausea, and feeling unwell. This report was non-serious.
Developed soreness at injection site, followed by swelling and large red patch extending from just above elbow to just below armpit and nearly wrapping around bicep. Severe headache began next morning as well as extreme sensitivity and itching around injection site.  Ran low grade fever. Took ibuprofen (200 mg x 4) for soreness, fever and headache and Claritin for itching. No relief. Reported to doctor's office on 11/26/14. Advised to go to ER if temp reached 101.3.