chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had a syncope episode along with urinary incomitance shortly after receiving the Janssen vaccine. Pt was sitting in the medical monitor area when the event happened. Pt was unconscious for less than a minute and EMS was called. EMS evaluated pt, he was pale but fully verbal and functioning.  vitals were stable,  BP 110/69, HR 74,  02 97. Pt refused transport but was monitored at the site by doctor for an hr before being released. Pt was instructed to go to UC/ER if he had another episode or new s/s and follow up with his primary care provider. The following day, the patient's primary care provider tried multiple times to reach out and follow up with pt. Pt did not respond to his PCP.
Pain in heart; Pain in left arm; Pain in left shoulder; This is a spontaneous report received from a contactable consumer (patient). This 64-year-old female patient (non-pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 10Mar2021 at 14:45 PM (Lot number: EN6199) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included hypertension; lower lumbar stenosis; right renal artery stenosis; known allergies to latex. No covid prior vaccination. Concomitant medication included amlodipine besylate. None other vaccine same date. No other vaccine in four weeks. The patient previously took dicloxacillin and experienced drug hypersensitivity. On 26Mar2021 at 07:00 AM, the patient experienced pain in heart, left shoulder and left arm. Lab data included VitalAxis Covid19 (nasal swab) was negative on 10Jun2021. Treatment received for events including 81 mg Aspirin. Outcome of events was recovered on unspecified date in 2021. This report was assessed by the reporting consumer as non-serious.   Information on Lot/Batch number was available. Additional information has been requested.
chills; fever; skin abscess and had to have an incision and drainage performed; This case was reported by a consumer via other manufacturer and described the occurrence of chills in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included decreased appetite, weight loss (lost 15 lbs), abscesses of skin, loss of energy, diarrhea and constipation. Previously administered products included Shingles vaccine. Concomitant products included lenvatinib mesilate (Lenvima).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, fever and skin abscess drainage. On an unknown date, the outcome of the chills, fever and skin abscess drainage were unknown.   It was unknown if the reporter considered the chills, fever and skin abscess drainage to be related to Shingrix.  Additional details were received as follows: The patient's spouse reported that patient received the lenvima 20 mg in past on 14th October 2020 for differentiated thyroid cancer. Patient had past history of skin abscesses. On unknown date patient received the shingles vaccine. Patient had lab tests in end of November such as CT scan which showed a reduction of 46 percent  in the size of his tumors. Patient's blood pressure was measured and it was going up a little bit but currently normal. Patient received the welcome kit and has been checking his blood pressure daily (diastolic usually in 80s, occasionally in 70s and twice at 90) Patient's appetite was decreased and he has lost 15 lbs since starting on Lenvima. On October 2020 patient had nutrition consult,also patient experienced overall lack of energy, diarrhea a couple of times, but mostly experienced constipation. On unknown date patient received the dose of Shingrix and on December 2020 patient experienced chills and fever with skin abscess and which had to have an incision and drainage performed along with Antibiotics. The reporter consented to follow up.
I started to have a tickle in throat on September 8th, by September 10th I also had a cough. I went to the local urgent care to get a covid test. Got my positive result on September 11th around 7am. I was 12 weeks pregnant at that time. I was advised by my OB-GYN to only take my prenatal vitamin. However for my cough I took a natural kids cough medicine to help lessen the cough. I was sick for about 15 days. Over that time I had alot of mucus, cough, sneezing very hard where I lost control of my bladder sometimes and also had some bone pain mostly in my fore arms and neck/shoulder area. During my sickness my husband whom is also vaccinated, and 2 children who where not all got sick with positive covid-19 results.
Have been really feeling the side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Have been really feeling the side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Have been really feeling the side effects). At the time of the report, VACCINATION COMPLICATION (Have been really feeling the side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Information has been received from a healthcare worker, for VARIVAX (merck), a Pregnancy Registry product, concerning an approximately 45 years old female patient with no pertinent medical history and drug reactions or allergies. On 25-SEP-2012 the patient was vaccinated with a dose of VARIVAX (merck) (lot # 671027/1067AA, exp. date: 05-JUL-2013). Concomitant medications included prenatal vitamins and BENADRYL. It was reported that the patient was found to be 5 weeks pregnant. Reporter mentioned the patient's LMP was 07-FEB-2012 and the date does not match her gestation date. The reporter clarified the patient was currently 5 weeks pregnant and the patient was nursing in February 2012. The estimated EDD was 28-MAY-2013. The patient was exposed to VARIVAX (Merck) during trimester 1. Reporter stated the patient recently got pregnant through in vitro fertilization. No treatment information was reported. No lab diagnostics studies performed. The outcome of the pregnant was unknown. Follow-up information has been received from a physician. The patient miscarriaged (medically significant upon internal review). Additional information is not expected.
diluting fluzone qiv t and administering,with no reported adverse event; diluting fluzone qiv t and administering,with no reported adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/ gender patient who reported diluting INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and administering,with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 31-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE once (strength, dose, formulation, route, lot number not reported via unknown route in unknown administration site for immunizaton.  On 31-OCT-2022 the patient developed a non-serious events diluting fluzone qiv t and administering,with no reported adverse event (product preparation error) and (incorrect product formulation administered)following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.  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 the 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.
11/16/2018 Patient started some odd behaviors. Shaking in arms and legs while lying on the floor around 6:15 pm. 11/17/2018 shaking arms and legs, eye staring increased and rapid heart beating. Lasted about 10 minutes 12 noon. 11/18/2018 same symptoms occurred shaking arms and legs, staring and increased heartbeat. Lasting 15 minutes. 11/19/2018 to 11/20/2018 same symptoms lasting 3-5 minutes. Wednesday 11/21/2018 called the Dr and they told me to take to ER. From then we went to Hospital, prescribed Topiramate 1.8 ML twice daily after being discharged still have seizure like activity. 11/24/2018 to 11/25/2018 small seizure like symptoms lasting a few minutes. 11/25/2018 seizure symptoms lasting 30 minutes went to Hospital was told to increase medicine to 3.5 ml twice a day. Came home about 6:30 pm he was given his medicine and 6:45 -7:30 seizure activity called ambulance took to ER told us to contact neurology.
weakness, headache, body aches, soreness at the injection site, warm injection site, dizziness, loss of appetite
took 3 steps and just blacked out and passed out; coughing; black eye; didn't remember losing her consciousness; When she sneezes or cough her chest hurts; can't turn over while sleeping at night; she has not gotton back to normal; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (took 3 steps and just blacked out and passed out) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history.).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (took 3 steps and just blacked out and passed out) (seriousness criterion medically significant), COUGH (coughing), EYE CONTUSION (black eye), MEMORY IMPAIRMENT (didn't remember losing her consciousness), CHEST PAIN (When she sneezes or cough her chest hurts), MOVEMENT DISORDER (can't turn over while sleeping at night) and FEELING ABNORMAL (she has not gotton back to normal). At the time of the report, LOSS OF CONSCIOUSNESS (took 3 steps and just blacked out and passed out), COUGH (coughing), EYE CONTUSION (black eye), MEMORY IMPAIRMENT (didn't remember losing her consciousness), CHEST PAIN (When she sneezes or cough her chest hurts), MOVEMENT DISORDER (can't turn over while sleeping at night) and FEELING ABNORMAL (she has not gotten back to normal) had not resolved. Not Provided  Treatment information was provided as tylenol. No concomitant information was provided. Patient mentioned she is a vegan no meat, diary, does not take pills. Woke up next morning, she had a black eye, her reading glasses were broken, didn't remember loosing her consciousness.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-076632 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
sore arm; It is itchy; really red; she is having a bad rash over her body.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), RASH PRURITIC (It is itchy), RASH ERYTHEMATOUS (really red) and RASH (she is having a bad rash over her body.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-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 PAIN IN EXTREMITY (sore arm), RASH PRURITIC (It is itchy), RASH ERYTHEMATOUS (really red) and RASH (she is having a bad rash over her body.). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown and RASH PRURITIC (It is itchy), RASH ERYTHEMATOUS (really red) and RASH (she is having a bad rash over her body.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment medications were reported   This case was linked to MOD-2021-036085, MOD-2021-036525, MOD-2021-036525 (Patient Link).
Information has been received from a licensed practical nurse concerning a female patient who in approximately August 2001 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number unknown). There were no concomitant vaccinations, but it was unknown if there were concomitant drug therapies. Subsequently, the patient presented to the physician's office twice with severe arm pain in the entire arm, "pitting edema" from her biceps to her elbow and injection site induration 3-6 inches wide. It was reported that the swelling spread into the underlying tissue 3 inches in all directions from the injection site. It was noted that the patient was afebrile. The patient was treated with cold packs and acetaminiphen (TYLENOL). It was reported that the patient recovered from her experience. Follow up information indicated that the reporter felt that the patient's severe arm pain in the entire arm, "pitting edema" from her biceps to her elbow, injection site induration 3-6 inches wide and injection site swelling were not related to therapy with pneumococcal vaccine 23 polyvalent, but rather due to improper technique administering the shot. No further information is available.
started having brownish vaginal discharge; started having irregular vaginal bleeding; Heavy fatigue; brain fog; hot flashes; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 34-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Ew0178) via an unspecified route of administration, in arm left on 15May2021 at 15:45 (at the age of 34-years-old) as dose 2, single, for COVID-19 immunization. The patient medical history was not reported. The patient had known allergies to Sulfer and penicillin. The concomitant medications of the patient included ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0161), via an unspecified route of administration in arm left on 23Apr2021 at 03:30 PM (at the age of 34-years-old) as dose 1, single, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 16May2021 at 08:00 AM, the patient started having brownish vaginal discharge and started having irregular vaginal bleeding. The patient reported that she finished her period a week before her second vaccine; so this was not normal. She also had heavy fatigue, brain fog and hot flashes as well. No treatment was given for the adverse events. The outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
Information has been received from an unspecified reporter concerning a 60 year old male with "numerous allergies/reaction" and a history of "inflammatory spinal condition", who on 16-JUL-2010 was an "injection" of vaccinated with ZOSTAVAX (Merck). On 20-JUL-2010 the patient experienced slight joint pain and muscle pain. He stated that he read this may occur with ZOSTAVAX (Merck) and wanted to find out how long it would last. The patient did not have medical attention. The patient's slight joint pain and muscle pain persisted. No further information is available.
After 2 hours patient arm got swollen & had a fever. The next day he got like a flu like symptoms in which he end up going to the emergency room and was in ICU 8/26 - 9/9/2012.
Large area (circular area about 3? in diameter) of swelling, redness, tenderness and bruising on the front of the shoulder, about 4 inches from the injection site. Red streaks developed and extended from the swollen area.
Swollen lymph glands; fatigue; soreness behind her eyes; light sensitive; Arm pain; chills; headache; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 0.3 ml injection, Lot#: EW0162, Expiration Date: 31Jul2021) at single dose on 18Apr2021 12:50 in left upper arm muscle for COVID-19 immunization. The first dose was on 28Mar2021 (Expiry Date: 31Jul2021) at 1400 or 1500, and experienced shingles, arm pain, headache, fatigue and some chills. Medical history included shingles in the past, with the second vaccine patient had just cleared up from the shingles. Patient clarified shingles was pretty cleared up, it was not active and doctor said she could get the second vaccine. There was on other products taken. Prior vaccinations (within 4 weeks) was no. Patient experienced swollen lymph glands on 20Apr2021; arm pain, chills and headache on 18Apr2021; fatigue and soreness behind her eyes on 19Apr2021. Days later she got the second vaccine, patient was having regular side effects of arm pain, fatigue, and swollen lymph glands. She had gotten shingles before, and sometimes it popped up at different times. She didn't have other underlying condition like some people who had immunodeficiencies or arthritis. The arm pain after first and the second vaccine started the day of the vaccine. That arm pain from the second vaccine woke her up at 3am, it was so bad. It seemed to subside more quickly. Today it's still there, but not as bad. It was almost not noticeable. Patient felt more fatigue after the second vaccine today and yesterday. She felt more fatigued today and clarified it was persisting as of now. The lymph glands felt tender in her neck, which started today and was ongoing. Patient also had chills after the second vaccine, but was improving. Patient also had a headache after the second vaccine, which resolved today. It also felt sore behind her eyes. Patient stated it had to happen with her in the past as a flu symptoms. They were light sensitive, and if she moved them to the right and left she had soreness behind her eyes. This started yesterday and was ongoing. She did not have the soreness behind her eyes with first dose. She was not sure if it's associate with the headache. The outcome of events arm pain and chills was recovering. The outcome of event headache was recovered on 20Apr2021. The outcome of rest events was not recovered.  No follow up attempts are needed. No further information is expected.
Sore arm; Night sweats; Local reactions; Other side effects; Fatigue; Chills/Shaking chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NIGHT SWEATS (Night sweats), VACCINATION SITE REACTION (Local reactions), VACCINATION COMPLICATION (Other side effects) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), NIGHT SWEATS (Night sweats), VACCINATION SITE REACTION (Local reactions), VACCINATION COMPLICATION (Other side effects), FATIGUE (Fatigue) and CHILLS (Chills/Shaking chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), NIGHT SWEATS (Night sweats), VACCINATION SITE REACTION (Local reactions), VACCINATION COMPLICATION (Other side effects), FATIGUE (Fatigue) and CHILLS (Chills/Shaking chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was not provided.
Information was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. The patient's healthcare provider (unspecified healthcare professional), recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 29-NOV-2012, a healthcare provider (unspecified healthcare professional) at the medical center, administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On 10-DEC-2012, the patient was treated by a healthcare provider (not further specified if physician or other health care professional) at a medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.