chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eye stroke was due to the COVID Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension; AMLODIPINE taken for hypertension. The following information was reported: OCULAR VASCULAR DISORDER (medically significant) with onset 2021, outcome "unknown", described as "Eye stroke was due to the COVID Vaccine". The event "eye stroke was due to the covid vaccine" required physician office visit. Additional information: The patient stated "Well, I had an eye stroke two weeks after I had an my first Pfizer COVID-19 Shot and I did not connect with my first COVID Pfizer until recently when I am reading report about it and now I am convenience that eye stroke was due to the COVID-19 Vaccine. Yeah I got that was a year ago. I guess I was 83 years (not sure) "."Consumer's weight, consumer stated, my weight then and now I think 125 pounds (not sure). The patient did not have any lab work done when she had this eye stroke. "I went to the eye doctor several times." Consumer stated, "The date I got the vaccination, I do not know since I lost the record, it was Feb two years. "   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a nurse via a company representative referring to a female patient of unknown age. Patient's current conditions and pertinent medical history were not provided. "Last week", on an unspecified date of 2015, the patient was vaccinated with her first dose of GARDASIL (injection, lot # K005881, dose, route and expiry date were not provided). Concomitant therapies included MENACTRA. While receiving the vaccination in the physician's office, the patient experienced fainting. The treatment given to the patient was allowing the patient to lie down after the fainting episode. The reporter stated that the patient had not eaten a meal in approximately four hours when receiving the injection of GARDASIL. The reporter also stated that the patient's blood pressure was measured at 109/71 and pulse rate at 91 BPM (date unspecified, in approximately 2015). The outcome of the event was not provided. The reporter stated that the adverse event is pertaining to GARDASIL containing four strains and not GARDASIL 9. Additional information has been requested.
Initial report received from the nurse on 15 Dec 2009. The infant received FLUVIRIN 0.25 ml on 13 Dec 2009. No further information reported at the time of the report.
Common cold symptoms began 10/11/21 then chest pains began on 10/14/21. On 10/19 I took the patient to urgent care who prescribed Motrin. The pain became more severe so I took the patient to Hospital Emergency Room where he was admitted. Troponin was a 9 and patient was diagnosed with Myocarditis.  He was given Motrin for pain and inflammation. Doctors treated with IVIG once the troponin levels continued to stay at a 7. He stayed in the hospital for 12 days and was released on steroids and a heart monitor. Also during this time his heart rate became irregular.
pt recv vax & had some redness & warmth @ the inj site p/15-20min;advised to used cool compresses & anti-inflammatory product for 24hr;mom reports some tightness in throat;
Syncope and dizziness, BP 125/75, HR73, RR16. Patient experienced syncope and fell to floor from chair. Regained consciousness after ~3 seconds. Vital signs stable, released in stable condition
Shot one: Fever above 100°, extreme diarrhea, body aches for four days.   Second shot was as if I had Covid19 w/o drop in O2.  Extreme weakness. Symptoms  enduring 5 days. Since second shot persistent lack of energy and feeling bruised all over body.
Vision blurred, severe headache, began spotting (menstrual), severe back pain, and dizziness.
Leaking at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site leaking in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site leaking. On an unknown date, the outcome of the injection site leaking was unknown.   It was unknown if the reporter considered the injection site leaking to be related to Shingrix.  Additional details were provided as follows: The health care professional called in to inquire any information on this type of leakage. The patient received the Shingrix vaccine and fluid leaked out and when health care professional went to put a band aid on more fluid leaked out. More leaked later when patient went home. The health care professional stated the injection went fine and they think this might be sebaceous fluid.  The patient's information was gathered.
RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FEVER
STROKE; BLOOD CLOT IN LEG; This spontaneous report received from a consumer concerned a 51 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was healthy with no health issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that on an unspecified date in 2021, the patient started with symptoms after 13 days of vaccination. The patient woke with leg pain That morning, he got in the vehicle to go to work and pulled over due to heaviness in his left arm and slurred speech. An ambulance was called and they took him to the emergency room. From there he was life flighted to another hospital and was continued with laboratory tests. Laboratory data included: doppler ultrasound (NR: not provided) not reported, MRI (magnetic resonance imaging) (NR: not provided) not reported, scan (NR: not provided) not reported and other tests. It was due to the blood clot in his leg that caused him to suffer a stroke. He spent days in the hospital and had to wear a heart monitor for two weeks. He was  on blood thinners until further notice to prevent this from happening again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in leg and stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This case concerns a 51 year-old male with no prior medical issues who was hospitalized for a stroke and blood clot in his leg 13 days after receiving the Janssen Covid-19 vaccine. Concomitant medications, family history, and social history were not reported. Thirteen days post-vaccination, the patient awoke with leg pain. While driving to work, he experienced heaviness in his left arm and slurred speech and pulled his car over. An ambulance took him to a local hospital and from there, he was air-lifted to another hospital where doppler ultrasound, MRI, and other unspecified tests were performed.  He spent an unspecified number of days in the hospital and wore a heart monitor for 2 weeks. He was treated with blood thinners. Per the reporter (patient's daughter), the blood clot caused the stroke. Outcome was not reported. Based on the available information, the relationship with Janssen Covid-19 vaccine is considered indeterminant. More information (e.g. platelet count, D-dimer, fibrinogen, anti-platelet factor 4 antibodies, medical records) is being sought.
(L) Upper arm red, swollen, itchy, low grade FVR yesterday, none today, still using arm/treated with cephalexin.
20 minutes after vaccination, severe itching of scalp. Three hours after vaccination started a dry cough, within a few minutes difficulty breathing and tightening in chest. Heart rate increased  to 125 & blood pressure dropped significantly low and digestive issues. Took 2 Benadryl & Epipen when no relief from Benadryl.  Four minutes after injections chest & throat tightness began to decline.
myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment drugs were reported.  Company Comment: This spontaneous case concerns a patient with unknown age and gender with no medical history reported, who experienced Serious ( medically significant ) , expected event of myocarditis which occurred on an unknown  date with an unknown dose number of mRNA-1273 vaccine ( Moderna covid 19 vaccine ) , date of vaccination is also unknown. Details re:  laboratories , diagnostics and treatment for this event was not reported. The re-challenge for this case is not applicable since the dose details was not reported and the outcome of the event is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient with unknown age and gender with no medical history reported, who experienced Serious ( medically significant ) , expected event of myocarditis which occurred on an unknown  date with an unknown dose number of mRNA-1273 vaccine ( Moderna covid 19 vaccine ) , date of vaccination is also unknown. Details re:  laboratories , diagnostics and treatment for this event was not reported. The re-challenge for this case is not applicable since the dose details was not reported and the outcome of the event is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to a patient after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis. No Medical History information was reported. On 23-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to a patient after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to a patient after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to a patient after manufacturer date of expiry). Concomitant product use was not provided by the reporter. The vial was initially stored in the refrigerator on 15-Aug-2022. The vial did not undergo any temperature excursions. The pharmacy buyer stated that they gave a first booster dose of the Moderna COVID-19 vaccine to a patient from a vial after the manufacturer's expiry date. Treatment information was not provided.
I had an active shingles case from February 2018 until April 2021. The two Moderna regular  shots only gave me a soreness in the shoulder. The booster shot delivered on 11.16/2021 was the only one that bothered. Approximately 12 hours after receiving the shot, I experienced extreme heart burn which lasted some 4 hours  and soreness in shoulder the next day. By this report, I only want to highlight the reactivation of the shingles big time, lots of festering and bleeding. That occurred over the next two weeks and is still progressing. Also,, a very similar spot between my thumb and index finger on the right hand has shown up. The original shingles was at my tail bone, mostly on the right side.
(R) leg swollen, itchy at injection site. Measures approx 6 cm diam. No fever.
Fever; Chills; Headache; Nausea; Excessive urination at night; This is a spontaneous report from a non-contactable consumer, the patient. A 48-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 05Apr2021 at 10:00 (at the age of 48-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was 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 4 weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 15Mar2021 at 09:45, as a single dose for COVID-19 immunisation. On 05Apr2021 at 21:00, the patient experienced fever, chills, headache, nausea and excessive urination at night. The patient did not receive any treatment for the events. The adverse events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events fever, chills, headache, nausea and excessive urination at night was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Country select in patient tab. 2. Vaccination Facility Country select. 3. 'The patient did not receive any medication within two weeks of vaccination' deleted in narrative since not reported. 4. Narrative 'The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination' update as 'The patient did not receive any other vaccines within 4 weeks prior to the vaccination'.
This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a 70-year-old female patient who received SHIGNRIX. In April 2018, the patient received SHINGRIX (intramuscular) .5 ml. In April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site pain. The patient was treated with NSAID's (NOS). On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were recovering/resolving. The reporter considered the injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The physician reported to a GlaxoSmithKline field representative at the SHINGRIX booth at a national convention that his wife who was the consumer had a reaction. The patient's concomitant medication included antidepressant and cholesterol medication. The patient received the vaccine either on Monday 16th April 2018 or on Tuesday 17th April 2018 at a retail pharmacy by a pharmacy intern. The injection site was the left deltoid of the upper arm. The symptoms all started within 24 hours of the vaccination. The symptoms were currently resolving, and the patient had been using a nonsteroidal anti-inflammatory medication of unknown name for the symptoms. There was no prescription ordered or required for the patient to have the SHINGRIX vaccination. The reporter advised the patient to go to the pharmacy and have the vaccination. No further details were provided during the call. The reporter was an internal medicine MD and granted permission to be contacted via phone with further related questions. The exact mailing address for the pharmacy could not be provided nor the exact names of the cholesterol and antidepressant therapies.
Client reported to EMTs pain on her left side around her ribs that she described as "pulsating." Vitals obtained at 2:08PM were as follows: BP 130/76, HR 75, and O2 98%. The client denied any SOB, chest pressure, or throat tightness. The client reports a history of a similar pain on her left side of unknown origin. The client was alert and oriented to person, place, time, and events. The client rated the pain at a 3-4 on a scale of 10. The client has a history of hypertension, which is controlled with Lisinopril. Repeat vitals obtained at 2:20PM were as follows: BP 138/76, HR 67, and O2 98%. The client stated, "I'm okay I can walk." The client stated her symptoms were unchanged. The client elected to leave the vaccination site. Client ambulated away from the observation area unassisted with a steady gait at 2:23PM.
Shortness of breathe and chest pain: went to the ER twice between 4/2-4/16.   Ringing in ear and blurred vision. Constant ringing in ear, went to urgent care on 4/29 because it?s unbearable. Seeing white spots and minor headaches
cherry color pin point papules v.s. one time x 24 hr O2 sat
A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided). The patient's past and current medical history included flu (2017).  No concomitant products were reported. The patient received FLUMIST QUADRIVALENT (intranasal) unknown, via nasal route, for nr on an unknown date. On an unknown date, the patient experienced got the flu. It is unknown if any action was taken with FLUMIST QUADRIVALENT (intranasal). The outcome of the event was unknown. The event was considered non-serious.
Heavy breathing and pulling at ears the night before carrying her to the ER, some cough. In the ED, T to 40.2 on the evening of 04/27/01. Normally uses 0.5 L prn O2 at home, in ED pulse ox 94% on R.A. coffee ground material from G-tube. Initially hemoccult neg, but later when rechecked was hemoccult positive. Initially tachycardia, became SVT after albuterol, developed diminished respiratory effort, cardiac arrest and death at 9:10 PM. Autopsy report states cause of death as medical complications of prematurity: dehydration, bronchopulmonary dysplasia and edema, s/p Nissen fundoplasty for esophageal reflux, gliosis and extensive neuronal necrosis of the brain (brain atrophy) , small subdural hemorrhage (manner of death - natural). Cause of death-medical complications of prematurity.
Had shortness of breath, chills, and fever up to 102 for the first day and half. On Sunday it came back to normal finally.  Night sweats that are still continuing.  Just during the day and get hot flashes.  Flushing, upper body clamminess and then goes away and then has chills.  His breathing has improved but is still not real steady on his feet.  He is about 80-85% on his balance, 95% on his breathing.  His biggest problem at this point is the hot flashes and the chills. He also has had loss of appetite and has had weight loss.
This spontaneous report as received from a nurse refers to a 2 year old female patient. Patient did not have any pertinent medical history. Also reported that patient was allergic to latex. On an unknown date, at the age of 12 months patient was vaccinated with first dose of VARIVAX (Merck) (dosing details were not reported) subcutaneously. On 09-SEP-2015, at 2 years of age, patient received second dose of vaccinated VARIVAX (Merck) (dosing details were not reported) (lot # L017997 with an expiry date of 19-MAY-2017) subcutaneously. On 10-SEP-2015 the patient developed a "localized rash" at the injection site. Patient did not receive any treatment for the event. The event "localized rash" was resolved within two to three days. The reporter did not provide the causality between the event and the suspect therapy. There was no product quality complaint. Additional information has been requested.
CLIENT WAS ADMINISTERED INCORRECT VACCINE PRODUCT FOR AGE. NO REPORTED ABNORMAL OUTCOME FOLLOWING VACCINATION.
Had a lot of pain in left armpit for about 5 days after the booster.  It was so uncomfortable I called my doctor to make sure it was a normal reaction.  I also had a lot of swelling there.  It was painful to lift my arm and to touch that area.  It was not something I experienced with my first two Moderna vaccines, which is why I called the doctor.    I also experienced the common symptoms of fever, chills, muscle aches overnight the first night after the vaccine and up to about 28 hours after the vaccine.  Then the fever and chills went away but the body aches continued and then I got a headache.  The headache lasted on and off for about 4 days after the vaccine.
?Pfizer-BioNTech COVID-19 Vaccine EUA?.  We are reporting a vaccine administration error, NOT an adverse drug reaction. There was no harm to the patient (KW) as a result of the error. The error occurred on 1/11/2021 during the hospital?s vaccination of co-workers for COVID-19. The co-worker in this report was vaccinated with a syringe containing air only and no actual vaccine. How the error occurred - a first-time volunteer from critical care transport was assisting at the hospital?s vaccine clinic with vaccine preparation and was observed correctly drawing up doses from the first vial. Error occurred when the volunteer drew up doses from the second vial (and was not being observed). The volunteer drew up air only and no vaccine. How the error was discovered - administrator thought the syringe felt ?strange? and did not contain any vaccine. The error was discovered at that point. Investigation found that the volunteer had drawn up a total of 6 doses that contained air instead of vaccine and were dispensed for administration. Four vaccine syringes containing only air (and no vaccine) were recovered unused. Two vaccine syringes containing air (and no vaccine) had reached patients. This patient (KW) received one of the affected syringes, was still at vaccine clinic when the error was discovered and was immediately re-vaccinated with a correctly prepared syringe. Action ? the vaccine clinic is taking greater care and additional time to confirm the skillset of the individuals who are first time volunteers at the vaccine clinic.
Immediately after administration, client became pale and sweaty and had laid down on the floor.  Did not become unresponsive and felt better after 20 minutes.
Patient's arm became swollen and red at injection site. Monitored in the office for 15 minutes at which time swelling lessened. FNP checked arm and advised patient's father to go home and give BENADRYL. He was also advised to call our office tomorrow if any sign of redness or swelling returns.
Ileocecal Intussusception with perforation during barium enema and open surgery for repair.