chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2022 as dose 2 (initial pfizer dose), single (Lot number: EL9262) at the age of 38 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Nov2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "vaccine brand other=Moderna, vaccine dose number=1; vaccine brand=Pfizer / BioNTech, vaccine dose number=2" (unspecified if ongoing), notes: Moderna dose number: 1, Pfizer dose number: 2. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient received Paxlovid for the treatment of COVID-19 (treatment start date: 06Jun2022 and treatment stop date:11Jun2022). Other medication details: other medication in 2weeks: product: Dicloxicillin, other medication in 2weeks start date: 05Jun2022, other medication in 2weeks stop date: 15Jun2022), (other medication in 2weeks product: Zyrtec. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Reported Event: Rebound COVID- runny nose, congestion, sore throat, sinus pressure, adverse event start date: 15Jun2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective cannot be ruled out.
Most recent flu shot was FLUCELVAX-IIV-4 (0.5 mL). Shortly after receiving the flu shot prior to this one, I began to have a number of symptoms I had never had before, including vertigo (hospitalized twice for - after much testing, no cause found), fatigue, muscle weakness not improved by exercise, increased need for sleep (7 hrs/night was norm, became 10 -12), low motivation, general malaise, foggy brain...Then when I had this injection, symptoms worsened considerably and I resigned from work December 8, 2017. Filed for and received disability January 2018.
Within 1 hour after vaccine administered developed a burning sensation in neck and across chest. Also developed tingling of both hands. Felt somewhat lightheaded, fatigued.
I developed pericarditis after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6205) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: PERICARDITIS (medically significant) with onset 04Mar2021, outcome "not recovered", described as "I developed pericarditis after receiving the vaccine". The event "i developed pericarditis after receiving the vaccine" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Diagnostic tests: Unknown results, notes: Diagnostic tests; SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of pericarditis with Diagnostic tests and colchicine medication.  Clinical Course: Product- COVID 19, Brand: Pfizer, Lot number: EP7534, administration date: 18Mar2021, Dose number: 2. Patient had not taken other vaccine in four weeks. Patient did not have covid prior vaccination. Patient had covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Feb2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Tramadol, reaction(s): "known allergies", notes: known allergies: codeine and all derivitives, tramadol; Codeine and all derivitives, reaction(s): "known allergies", notes: known allergies: codeine and all derivitives, tramadol. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Treatment of COVID-19; (04Jun2022) Positive, notes: testing positive still for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received any other medication within 2 weeks of vaccination. Treatment includes Anti-viral COVID 19 Treatment, brand Paxlovid, treatment start date 30May2022 to 03Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was mistakenly given an extra bivalent dose by a medical assistant on this date after receiving a first bivalent booster on 9/28/2022.  I called patient afterward upon discovering the error, confirmed she was feeling normally. Made patient aware she had received an extra bivalent dose.
Patient was seated and alert at time of vaccination. After receiving the first dose, patient began to ask questions about side effects of vaccines after discussing prior to vaccine. Pharmacy intern notified patient to wait for 15 minutes to be observed for reactions. After approximately 2 minutes, patient's husband came to find the pharmacist and alert that the patient was complaining of dizziness and lightheadedness. Patient's blood pressure was checked by the pharmacist, which reported 80/60 mmHg and patient was lowered with feet elevated. Paramedics were called and blood pressure returned to a normal reading of 116/74 mmHg, by the time the paramedics arrived. Paramedics also check the patient's blood glucose and reported a normal reading.
The patient, mom and dad indicated that the patient didn't have any reactions to any vaccinations previously that required medical attention, just had a fear of needles.  He had a history of passing out once with the sight of blood before.   He was using his ear buds and watching a video on his phone as a distraction as well as holding onto his mom's hand during the vaccination.  The patient tolerated the preparation, insertion, injection and removal of the needle without incident.  After disposal of the used needle and placement of the bandage, the patient didn't respond to a joke that I was telling him and became limp, his eyes rolled back in his head and then proceeded to slouch in the chair.  The mom was holding the right side of the patient and I was holding the patient on the left with my right hand supporting his neck and head and my left arm supporting his left arm and shoulder.  He started to become flush and rigid for a brief second and then come to and respond to his mom.  This entire reaction lasted for approximately 10 seconds.  He said that he was feeling dizzy and wanted some water.  He put his head between his knees with both his mom and I ensuring that he was safe.  I offered the family and the patient to contact EMS if they wanted to have him evaluated further and the family and patient declined.  He rested for approximately 15 minutes before feeling well enough to go home.
Vaccine was given on Friday 3/26 around 3:30 pm.  Did not have any strong reactions and after I took off the bandaid on Saturday skin looked normal.  Noticed bright redness on Sunday evening around 7 pm after taking off a hoodie.  Did not see it any earlier as I was wearing a hoodie with long sleeves.    Initially was only red and not itchy.  Saw a doctor in the afternoon & he confirmed it was a reaction and not an infection.  Drew a line around the red area to check if redness spreads beyond the line.  Redness started spreading beyond the line and was more itchy.  Took 1/2 zyrtec tablet at bedtime.  Woke up Tuesday & itchiness was more pronounced.  Redness appeared to be more improved...not as dark as before.  Used cold compress for itchiness but did not really help.  Took Bendaryl tablet & decided to see dermatologist.
pain in her arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Feb-2021 and was forwarded to Moderna on 03-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain in her arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No medical history reported.). Concomitant products included BISOPROLOL FUMARATE (ZEBETA) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced INJECTION SITE PAIN (pain in her arm). On 14-Jan-2021, INJECTION SITE PAIN (pain in her arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, COVID-19: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
swelling on her arm; Welts on her arms; Pain in areas she has injured in the past; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on her arm), URTICARIA (Welts on her arms), PAIN (Pain in areas she has injured in the past), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included AMLODIPINE BESILATE (NORVASC) and MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling on her arm), URTICARIA (Welts on her arms), PAIN (Pain in areas she has injured in the past), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). At the time of the report, PERIPHERAL SWELLING (swelling on her arm), URTICARIA (Welts on her arms), PAIN (Pain in areas she has injured in the past), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.            the action taken with response to the drug is not applicable
Dizziness (inability to drive), Migraine, Tingling, Tremors, Involuntary head nodding, and Fatigue.
Cold; Chills all night; Fatigue; Redness; Swelling of any arthritic joints; swelling and pain for 4 days; swelling and pain for 4 days; Lack of appetite; Brain fog- ongoing; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17May2021 at 12:00 (at the age of 52-years-old) as a DOSE 2, SINGLE for COVID-19 immunisation. The patients medical history and concomitant medications was not reported. The patient had no known allergies to medications, food or other products. Patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unspecified date as a single dose for COVID-19 immunisation. On an unknown date in May2021, the patient experienced a cold within 2 hours, chills all night, fatigue. The patient reported that she could not go to work due to the chills and fatigue. On an unknown date in May2021, the patient also experienced redness, swelling of any arthritic joints, swelling and pain for 4 days, redness for days, lack of appetite and brain fog-ongoing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events cold within 2 hours, chills all night, fatigue, redness, swelling of any arthritic joints, swelling for four days, pain for four days, redness for days and lack of appetite was recovered with lasting effects. The clinical outcome of the event brain fog was ongoing not recovered at the time of this report.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
COVID vaccination given 03/15/2021 and 04/15/2021.  Pt onset of COVID s/s on 06/29/2021, tested positive by PCR 7/2/2021, hospitalized 07/06/2021-07/09/2021 due to COVID.   Adverse event reported due to vaccination breakthrough with hospitalization.
mouth bleeding; nose bleeding; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH HAEMORRHAGE (mouth bleeding) and EPISTAXIS (nose bleeding) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced MOUTH HAEMORRHAGE (mouth bleeding) and EPISTAXIS (nose bleeding). On 02-Feb-2021, MOUTH HAEMORRHAGE (mouth bleeding) and EPISTAXIS (nose bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Local reaction 2d after vaccine given. Redness, swelling, and warmth at site.
Numbness/tingling right arm since vaccine. Sweaty palms since vaccine. Chest pain starting 18MAY, shortness of breath associated with it 20MAY, continued chest pain with relief when leaning forward- concern for pericarditis
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 01-Jun-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were provided No treatment were provided; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
pt recv vax 15OCT96 & pt became ill & seen @ hosp w/sore throat, fever up to 103 & rash on EEG & neck;illness cont to intensify & eventually required mechanical intervention -respirator;dx 26MAR97 is systemic juvenile rheumatoid arthritis
Vaccine was expired for 7  days. Given inadvertently due to confusion in extended dates. vaccine stored in refrigerator and not ultra-cold. Used ultra-cold extended date instead of 10 week expiration date.
Influenza vaccine administered instead of Tdap. This was the second influenza immunization given to patient in 2022.
she was very weak & still had chest pain.; On wednesday morning 3:30am she tried again to go to bathroom & this time was on floor for two hours with paralyzed legs, chills & pains in her chest; Pains in her Chest; Her legs became paralyzed; She become violently ill; She attempted to get out of bed to go to the bathroom & fell on the floor.; This is a spontaneous report from contactable consumers. A female patient of an unspecified age received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 23Mar2021 11:00 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Tuesday 23Mar2021 my wife and I took our second Pfizer vaccine at 11:00am. At 7:00pm 23Mar2021 she become violently ill. She attempted to get out of bed to go to the bathroom & fell on the floor. Her both legs became paralyzed. She stayed on the floor until I was able to maneuver her back on the bed. On Wednesday (24Mar2021) morning 3:30am she tried again to go the bathroom & this time was on the floor for two hours with paralyzed legs, chills, & pains in her chest. I wanted to call an ambulance both times she refused. By Friday morning 26Mar2021, her legs were no longer paralyzed but she was very weak & still had chest pain. She started to feel much better one month later. Just wondering if this particular vaccine was tainted in any way. Event outcome of legs became paralyzed was recovered on 26Mar2021, of the remaining events were recovering.  Follow up attempts are needed. Further information has been requested.
This spontaneous report as received from a nurse practitioner refers to a multiple unspecified patients of unknown age and genders. Patients' medical histories, concurrent conditions and drug reactions or allergies were not reported. On an unknown date, the patients were administered intramuscularly doses of GARDASIL (dose: 0.5 ml, frequencies and lot # were not reported) which underwent multiple, unspecified temperature excursions. The stability of the administered doses have not been evaluated for stability at this time due to lack of information. Product quality complaint (PQC) was not involved. No adverse experiences were reported. Additional information has been requested.
Less than 3 months after the second shot, I have been diagnosed with shingles. I am incredibly healthy with no underlying health issues. I am 36 years old.
PNEUMOVAX23 and SHlNGRIX were mixed in the same syringe/PNEUMOVAX23 was inadvertently used as diluent; PNEUMOVAX23 and SHlNGRIX were mixed in the same syringe/PNEUMOVAX23 was inadvertently used as diluent; PNEUMOVAX23 was inadvertently used as diluent; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.  On 26-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(one dose; route, lot number and expiration date were not reported) for prophylaxis. It was stated pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and zoster rge vaccine (mammalian)(SHINGRIX) were mixed in the same syringe and administered to the patient. Pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was inadvertently used as diluent (wrong product administered, product preparation error and product confusion).
ear infection a week after the first dose; Fever for 2 days after the vaccination; 8 Month old baby received a first dose from a vial intended for 12-17 year old patients; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EAR INFECTION (ear infection a week after the first dose), PYREXIA (Fever for 2 days after the vaccination) and INCORRECT DOSE ADMINISTERED (8 Month old baby received a first dose from a vial intended for 12-17 year old patients) in an 8-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2022, the patient experienced PYREXIA (Fever for 2 days after the vaccination) and INCORRECT DOSE ADMINISTERED (8 Month old baby received a first dose from a vial intended for 12-17 year old patients). On 16-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EAR INFECTION (ear infection a week after the first dose). On 11-Aug-2022, PYREXIA (Fever for 2 days after the vaccination) had resolved. At the time of the report, EAR INFECTION (ear infection a week after the first dose) and INCORRECT DOSE ADMINISTERED (8 Month old baby received a first dose from a vial intended for 12-17 year old patients) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs was reported. Patient's mother called to report that she was notified by a pediatrician that her 8-month-old son received a first dose of Moderna COVID-19 vaccine from the wrong vial on 09Aug2022.  The vial was intended for 12- 17-year-old.MI agent searched the system and did not find the doctor's name or phone number within the database.Patient's mother reported that the pediatrician's office told her that they called Moderna and Pfizer and they suggested to revaccinate with Pfizer. The patient had not been re-vaccinated yet. No Treatment medications were reported.
Began having chest pains on the morning of 4/27. I was taken to the ER at 7pm. An EKG was ran and came back normal. Blood tests showed my Trop level was high. I was taken to another hospital via ambulance. My trop levels were taken 2 more times that night, both coming high at 3.49 and 4.19. They took two more EKGs that night. On the morning of 4/28, they conducted an echocardiogram that came back normal. On 4/29, they performed an angiogram at 1:45pm that came back with no blockages. I was discharged on 4/29 at 6pm with the diagnosis of myocarditis.