chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AFIB; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8730), via an unspecified route of administration, administered in the left arm on 25Mar2021 17:45 as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing , atrial fibrillation (AFIB) from an unknown date and unknown if ongoing, surgery from an unknown date and unknown if ongoing, ablasion completed in 15Apr for AFIB. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (ASPRIN) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (CARTIA [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; ubidecarenone (COQ10 [UBIDECARENONE]) taken for an unspecified indication, start and stop date were not reported; omega-3-acid ethyl ester (LOVAZA) taken for an unspecified indication, start and stop date were not reported; ramipril (RAMIPRIL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. The patient had an ablasion completed in 15Apr2021 for AFIB and had no symptoms since. On 02Apr2021, he had a routine electrocardiogram (EKG) and it showed AFIB was back. He had no symptoms prior. The onset date of afib was reported as 02Apr2021 at 09:00. There was an emergency room (ER) or physician office visits. The patient underwent lab tests and procedures which included electrocardiogram: afib was back on 02Apr2021. Therapeutic measures taken as a result of afib included dronedarone hydrochloride. The outcome of afib. was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
This case was reported by a other health professional via call center representative and described the occurrence of nausea in a 60-year-old female patient who received SHINGRIX (batch number P539L, expiry date 30th January 2020). On 15th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced nausea, pain, neck mass and vomiting. On an unknown date, the outcome of the nausea, pain, neck mass and vomiting were not recovered/not resolved. The reporter considered the nausea, pain, neck mass and vomiting to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy student. On 15th February 2018 at 9:21, the patient received SHINGRIX on left arm. The patient experienced a lump around the thyroid area of their neck. The reporter was unable to provide additional information. The reporter's call was transferred to Medical Information.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 10-year-old patient who received Hepatitis A vaccine (batch number 3397T) for prophylaxis.   On 20-FEB-2023, the patient received the 2nd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
atient is a 52-year-old male with history of type 2 diabetes, anxiety, depression, lipidemia, atrial fibrillation on metoprolol and Eliquis and obesity presenting to the emergency department for feeling palpitations and like his heart is racing.  Patient has a history of this, he states he recently had a cardiac ablation on 2/2 at hospital by Dr.  He states today he was sitting in his kitchen eating some eggs when he felt his heart began to race, he states he checked his heart rate and states it was up to 250, so he came to the ER for evaluation.  He denies chest pain or shortness of breath, he just feels the uncomfortable sensation of his heart beating fast.  He was seen at our facility on 2/6 for a similar complaint and was successfully cardioverted with Cardizem. Associated Symptoms: dizziness, palpitations
20 x 12 cm erythematous area surrounding vaccination sight. Pt reports itching and numbness/ tingling from shoulder to elbow.
Very painful at the moment of injection. Onset of headache approximately three hours after injection - with intermittent headache for three days. Three nights of intense night sweats & inability to rest. Unable to raise left arm above shoulder without a great deal of pain for 2+ days. Body aches and fatigue for three days. Intermittent nausea and some spatial disorientation. Treated with ibuprofen to little effect.  This stuff had better work.
Patient received a J&J vaccine but had received one dose of Pfizer at an earlier time.
Very lightheaded and dizzy. Became extremely pale and hot.  Felt like I was going to pass out.  Hard to stand or talk and could not focus. Heart felt like it was pounding and I remember when I made it home and got in bed I was breathing really hard and fast right before I fell asleep.  That was around 4 PM.  Slept for most of the evening and was feeling much better the next morning.  My coworkers kept telling me how pale I was.  And I remember feeling very hot and sick to my stomach if I tried to talk or listen to someone talk.
The pt experienced a possible febrile seizure post vax. The pt was seen at a hospital.
Began itching "1 day after shot" - continued to 4 days has raised dots on chest with the rash. Treated with BENADRYL 50mg every  4 hours as needed for this. Prednisone treatment offered patient refused.
This spontaneous report was received form a medical assistant and refers to a patient of unknown age and gender. On 03-JUN-2015, the patient was vaccinated with improperly stored M-M-R II (route of administration and dose were not reported) (lot number reported as: K016152, expiry date: 24-SEP-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
PATIENT CAME BACK 2 DAYS LATER COMPLIANT OF ITCHY SWELLING EYE, RASH ITCH ON TUMMY WHERE SKIN FOLD.
I had shoulder surgery in February 03, 2021 so I was healing from that. I was due to return to work on 03/16/2021. I was also doing physical therapy because of my surgery. Like 2-4 days after having the vaccine I was feeling scared, anxious, I did not want to get out of the house, I did not want to go back to work. I started feeling very anxious. Overly anxious. I was working as a teacher and I could not take it. Some of my family members had to stay home with me so I did not have to stay by myself. I saw my doctor on 03/22/2021, it was a video visit. She could see that I was not myself. On 04/09/2021 I had to be admitted to Hospital because I was out of control. They gave me another medication and change the dosages.  I came home on 04/16/2021. I did not go back to my work. I decided to resign and stay home. My doctor also suggested me to do it.
Approx. 2 weeks after first dose of Moderna, I experienced pain in my left calf.  The pain became  more intense over time radiating down into my ankle  and top of my foot. The pain  was rated 10 out of 10. I could not reposition myself in bed because I could not put any pressure on my left leg.  Walking was very difficult requiring me to use a cane and then a walker.  There was no injury or accident that would cause such pain. The only thing that occurred was the Moderna vaccination. It is nearly 4 months later and still use the cane and walker. I take both OTC and prescription pain meds to be functional.
As soon as getting the shot got a headache right afterwards, Getting one every day. On May 6th got numbness in lips and down arm, could not write of move arm. Same thing happened later that day, went to the hospital the night and got admitted until later the next evening having had 11 seizures. Having 6 strokes and no control over right arm and left leg. Feels like wearing a helmet everyday that is to tight on head. Lost a lot of vision in eyes
This medically confirmed spontaneous report (initial receipt 14-Nov-2014) concerns a 40 year-old male patient who had an allergy to haloperidol and sulfonamides. He received flu vaccines in 2010, 2012 and 2013 without any issues. Concomitant medications included carbamazepine, citalopram, simvastatin and omeprazole. On 08-Nov-2014, the patient received AFLURIA vaccine (batch number T53509). On 08-Nov-2014, sometime in the morning following the administration of the AFLURIA vaccine, the patient experienced swelling and some leakage of the penis. He also had small rash-like eruptions on the cheeks and forehead. The patient took diphenhydramine 50mg once. The patient's doctor was aware of these events and prescribed diphenhydramine 25mg three times daily. The symptoms resolved over two days. Outcome was recovered on 10-Nov-2014. Reporter comments: The reporter was not aware that the patient had any other skin issues.
Fever after first booster shot; Chills after first booster shot; Felt tired after  first booster shot; Sore arm after first booster shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after first booster shot), CHILLS (Chills after first booster shot), FATIGUE (Felt tired after  first booster shot) and VACCINATION SITE PAIN (Sore arm after first booster shot) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination.     The patient's past medical history included Gastrointestinal disorder NOS (GI problems), Abdominal cramps and Diarrhea.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced PYREXIA (Fever after first booster shot), CHILLS (Chills after first booster shot), FATIGUE (Felt tired after  first booster shot) and VACCINATION SITE PAIN (Sore arm after first booster shot). On 29-Oct-2021, PYREXIA (Fever after first booster shot), CHILLS (Chills after first booster shot), FATIGUE (Felt tired after  first booster shot) and VACCINATION SITE PAIN (Sore arm after first booster shot) had resolved.            On 27-Oct-2021, patient received first booster dose. No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-547078, MOD-2022-547107, MOD-2022-547110 (Patient Link).
12MAR93 returned to clinic approx 2 hrs p/vax & stated pt had fever, had been shaking & c/o legs hurting; t103.1; MD instruced to given APAP; fever cont off & on; seen by MD; admitted to hosp;
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 09-MAR-2016, the patients was vaccinated orally with a dose of oral ROTATEQ lot # L026740, expiry date 16-APR-2017 (dose was not specified). The administered dose of oral ROTATEQ underwent temperature excursion at 11 Celsius degrees for 15.5 hours. No previous temperature excursions were reported. No adverse events were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Fever after her 1st dose that only lasted 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after her 1st dose that only lasted 24 hours) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. Concurrent medical conditions included Fibrillation (For 10 years and her doctor told her in September that she is now in a fib all the time). On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever after her 1st dose that only lasted 24 hours). At the time of the report, PYREXIA (Fever after her 1st dose that only lasted 24 hours) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No Concomitant medication was reported. No treatment medications were reported. This case was linked to MOD-2021-385873 (Patient Link).
21JAN93 1145AM exp blurred vision & dizziness, nausea & a flushed feeling; the blurred vision subsided in about an hr & then nausea & h/a lasted into the evening; that evening noticed welt @ inject site & rash on hives;
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
accidentally received Adacel injections from prefilled syringes that expired on 5/2/2019/ No AE; Initial information received on 17-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 11 years old female patient who received 0.5 mL dose of expired vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U5656AA, expiry date: 02-May-2019 via intramuscular route in the arm NOS on 16-Jul-2019  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Expired vaccine used.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
A non-serious spontaneous report administered expired FLUMIST was received from a nurse concerning a four-year-old male. The patient received FLUMIST on 02-Dec-2008. The patient was given FLUMIST that expired in December 2007. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1 customers not discarding product from the previous season and 2 product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 09-APR-2009: product complaint investigation results.
Very sensitive area on the right arm (like needles poking the skin). Painful when touching vein in right wrist.
I received my 2nd covid shot on 10/25/2021 in am, around 11 am t started to have heart palpations, they came and went all day.  On 10/26/2021, the palpitations came and stayed. I was short of breath and color was gray, My heart hurt and it radiated up into my jaw, My nursing supervisor wanted me to go home and rest or go to the ER, I stated if I am going to die it will be here, I am not going to ER for another covid event. I did message my cardiologist at 12:09 because I could not get into a regular rhythm myself, at 12:23 they sent a script for diltiazem to the pharmacy, my supervisor went and picked it up, it took two doses to get the heart regulated. I have since had palpitation on and off again. I messaged MD today and am being placed on a medication to regulate heart again.
Immediate swelling at injection site. Patient received  25mg po diphenhydramine and cold compress to injection site.
Extreme arm pain in the shoulder. Interferes with sleep, showering, cleaning etc. Pain since vaccination. Went to doctor and was prescribed Naproxen (2 refills). Suggested that I go to orthopedic surgeon or get X-ray but did not pursue do to finances.
Initial report was received 06 April 2012 from another manufacturer (Service Request Number: 1-5049831690), who received the report from the patient's grandmother. A male child (age not reported) who had a history of egg allergy, had received an injection of DTP vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and an unspecified amount of time later, he stopped speaking completely. At two years of age, he was prescribed occupational and speech therapy by a holistic physician. After almost two years of therapy, he is now speaking. Outcome was not reported. The reporter for this case is the same as for case number 2012-03772. Documents held by sender: None.
c/o soreness 9MAY97-10MAY97 congested w/sore throat;also noted whelp on arm approx size quarter, warm to touch;applied alternating cold & warm compresses 11MAY97;erythematous inc, induration inc size fifty cent piece 12MAY97;pruritic;
never went for the second dose; Had a cough; Gave birth 2 months ago / breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (never went for the second dose), COUGH (Had a cough) and MATERNAL EXPOSURE DURING BREAST FEEDING (Gave birth 2 months ago / breastfeeding) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (never went for the second dose), COUGH (Had a cough) and MATERNAL EXPOSURE DURING BREAST FEEDING (Gave birth 2 months ago / breastfeeding). At the time of the report, PRODUCT DOSE OMISSION ISSUE (never went for the second dose) had resolved and COUGH (Had a cough) and MATERNAL EXPOSURE DURING BREAST FEEDING (Gave birth 2 months ago / breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.  This is a case of product omission issue for this 25-year-old, female patient with no known medical history, who experienced the unexpected events of maternal exposure during breastfeeding and cough. It is unknown when events occurred after first dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-326863 (Parent-Child Link).   See case MOD-2021-326863 for details regarding the child case.; Sender's Comments: This is a case of product omission issue for this 25-year-old, female patient with no known medical history, who experienced the unexpected events of maternal exposure during breastfeeding and cough. It is unknown when events occurred after first dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
I came down with bells palsy which runs in the family; i started getting uncoordinated; double vision; This is a spontaneous report from a contactable consumer (patient). This 38-year-old male patient received dose 2 of BNT162B2 via an unspecified route of administration on 17Feb2021 (at the age of 38-years-old) as a single dose for COVID-19 immunization. Medical history included family history of Bell's palsy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on 26Jan2021 as a single dose for COVID-19 immunization. On 01Mar2021 the patient came down with Bell's palsy which runs in the family so he ignored that. That went away and he started getting uncoordinated which turned into double vision. The patient visited an emergency room/department of urgent care for the events. The patient was hospitalized for 5 days for the events. The patient received treatment with steroids for the events. The outcomes of Bell's palsy, uncoordinated, and double vision were recovered with lasting effects. It was also reported that since the vaccination the patient was tested with a nasal swab for COVID-19 on 11May2021 with result of negative.   The lot number for BNT162B2 was not provided and will be requested during follow-up.
Pt developed redness, swelling and warmth around injection site approximately 16 hrs after injection. Pt went to primary care who confirmed allergic reaction. Pt was prescribed BACTRIM for cellulitis prophylaxis.
Patient developed a 102+ fever and complained her throat hurt. The pediatrician informed us pt.'s glands in her throat were swollen.
2-3 days post vaccination, at the site, were somewhat tender and indurated initially, but quickly became intensely pruritic while expanding; 2-3 days post vaccination, at the site, were somewhat tender and indurated initially, but quickly became intensely pruritic while expanding; Initial information received on 21-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 49 years old and unknown gender patient for whom 2-3 days post vaccination, at the site, were somewhat tender and indurated initially, but quickly became intensely pruritic while expanding after receiving yellow fever vaccine [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect yellow fever vaccine. Solution for injection (lot number, strength, dosage, expiry date- not reported) via subcutaneous route in unknown administration site for Prophylactic vaccination. Information on the batch number was requested  On an unknown date, the patient developed a non-serious event of 2-3 days post vaccination, at the site, were somewhat tender and indurated initially, but quickly became intensely pruritic while expanding (vaccination site pain) (vaccination site pruritus) (latency: 2-3 days approximately) following the administration of yellow fever vaccine. No significant systemic reactions noted.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events  At time of reporting, the outcome was Unknown for both the events.; Sender's Comments:  US-SA-2023SA129044: