chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7 days after vaccination had flare-up of MS symptoms which were stable for years. Neurologist stated that there is no way to know if this is vaccine related. Flare-up consisted of incoordination, numbness L side and loss of taste. By the next week, more loss of strength and coordination, deep fatigue, limping. At time of report symptoms improved but not back to baseline. Patient talked to neurology clinic to discuss symptoms and COVID-19 vaccine dose 2. Patient did not have a fever or headache after vaccination--did have some arm soreness at injection site for first few days.
No additional adverse events reported; M-M-R II and PROQUAD underwent a temperature excursion were administered; This spontaneous report was received from an office manager referring to a patient of unknown age an gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknonw date between 11-AUG-2021 and 12-AUG-2021, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # T018892 with an expiration date on 02-JUN-2022) for prophylaxis  (strength, dose, frequency, and route of administration were not reported) that underwent a temperatura excursión of above 9°C Celsius degrees (18.9°C) for  18 hours, 0 minutes and 0 seconds (product storage error).    No previous temperatura excursions were reported.  No additional adverse effect were reported.  This is one of five Reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003904:Original Case : 2108USA003819 US-009507513-2108USA003903:Original Case : 2108USA003819 US-009507513-2108USA003902:Original Case : 2108USA003819 US-009507513-2108USA003905:Original Case : 2108USA003819
Immediately following vaccination, patient began to feel lightheaded.  He was guided to the floor then lost consciousness  Smelling salts were administered.  LOC approx 30 sec.  Pt was brought back to Med Obs 1 via liter, given water and crackers.   Vitals 10:44 HR 82, Resp 16, BP 147/67  O2 100, Vitals 1050 HR 80 Resp 16 BP 134/64 O2 100 Pt discharged to home himself h/o LOC with vaccines as child
sore arm; feel weak; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ASTHENIA (feel weak) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and ASTHENIA (feel weak). At the time of the report, PAIN IN EXTREMITY (sore arm) and ASTHENIA (feel weak) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
pain @ inj site that evening;has now spread to entire upper arm, burning pain-constant-unrelieved by APAP-hot & cold compresses-went to ER told it would be OK 2-3 days p/shot;3wk now & no relief;
This spontaneous report was received from a female patient of unknown age. The patient historical drug included KEFLEX. The patient's concurrent conditions included multiple sclerosis, allergy for latex and KEFLEX. On 16-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R018735, expiration date and dosage regiment were not reported) for prophylaxis. After vaccination, in October 2018 (reported as 11 hours later), the patient reported waking up due to intense arm pain that radiated to the whole body. The patient reported that her arm was very red and swollen and extends 6-7 inches from her elbow to mid arm. The patient was speaking with her unspecified neurologist on an unspecified date who told her to take ibuprofen 600 mg three times a day for 6 days and ice the arm. The laboratory diagnostics were not performed. At the time of the report, the patient reported that she felt a little better, less pain and less swelling but had not recovered. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported.
No adverse events have been reported as of yet. Patient received a 3rd dose of a 2 dose series vaccine.
Bivalent booster given to patient after beyond use date. BUD was 02/28/2023
Severe anaphylaxis, requiring epinephrine drip and stay in ICU, now resolved.
Chills, arm pain at injection site,  mild fever of 99.9,  muscle aches, headache, nausea, racing resting heart rate, lack of appetite, vomiting.  Took Advil and  Excedrin, and  rested.  Better after 24 hours, but nausea lasted four days.
This case was reported by a healthcare professional, daughter of the subject, and described the occurrence of pruritus all over body in a 67-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medications included Tuberculin and PREMARIN. On 26 May 2011 the subject received 1st dose of ENGERIX B (unknown route, right arm). On unknown date in 2011 the same year after vaccination with ENGERIX B, the subject experienced pruritus all over body and raised rash. The subject did contact her physician about the events. The healthcare professional considered the events were disabling. The subject was treated with steroid injections to help with the itching. At the time of the report, allergy testing has been pursued, but no results have been received yet. The subject subsequently received second and third doses of ENGERIX B on 26 October 2011 and 10 November 2011. The healthcare professional suspected the ENGERIX B as causing the events, but did not describe a flare up after the second and third doses of ENGERIX B, more than the events had not gone away since the first dose. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with ENGERIX B.
Severe headache and neck ache. Started the evening of 3/19/2021 when the vaccine was administered. Was even worse the next day 3/20/2021 and lasted all of that day. Was better the following day on 3/21/2021 but still have a dull aching headache.
Pt vax w/ hepta B; exp possible endocarditis.  DX is unconfirmed.
rash all over body;itchy;pt recv vax 11AUG97 & next day 5Pm had broken out;
Patient said she woke up on 10/13/22 with a rash about 6 inches below the injection site of the shot. She said it was itchy, warm, circular and slightly raised on her arm. She treated herself with anti-itch cream and was counseled to take benadryl if the itching continued. She was also told that if it looked like it was getting worse or infected to go to her regular provider or an urgent care to get immediate attention.
This spontaneous report was received from a nurse and refers to an unknown number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of M-M-R II lot number reported as N004433, expiration date 07-FEB-2019 (strength, dose, frequency, route of administration, and anatomical location were not reported), were administered to an unknown number of patients on an unknown date for prophylaxis. The vaccine was exposed to a temperature of 48 Fahrenheit degrees for 5 minutes. There was no previous temperature excursion and the call was not because of a "data logger". No adverse reactions reported. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. This week, approximately on 28-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. The next day, approximately on 29-OCT-2013, the patient had a headache and felt lightheaded. On 01-NOV-2013, the patient's blood pressure was 150/84. Patient's outcome was unknown. The patient sought medical attention by calling the reporting pharmacist. Additional information has been requested.
pt found deceased at home on 7/27/2021, "apparent natural death" but noted "prior COVID 19, COPD" under the "chain of events that directly caused the death" on the death certificate from Dr.; PMH:  CHF, CVA, COPD, DM, lung CA; Dr. also reports pt had a positive COVID test on 12/16/2020; no other medical information available at this time
Immediately post vax in right lateral thigh, mother noticed red area at site of injection with a small white wheal. Right thigh redness grew to approximately 4cm X 2cm. Pt also developed 10 small hives over trunk and neck. Benadryl 1/2 teaspoon given in office. Pt waited one hour in office before going home and will continue Benadryl every 6 hours for a 24 hour period.
This case was reported by a nurse and described the occurrence of a systemic yeast infection in a 39 yr old female pt who received hep B vaccine recombinant (Engerix B). The pt's past medical history included a prior history of yeast sensitivity, but it had been under control prior to Engerix B admin. On 22Aug97, the pt received the first dose of Engerix B. On 19Sep97, the pt received the second dose of Engerix B. On 01Feb98, the pt received the third dose of Engerix B (lot ENG2930A2). Approx one year after the third dose of Engerix B, on an unspecified date in 1999, the pt experienced recurrent systemic yeast infections. The event was unresolved.
Hot burning sensation; Chills; Fever 0f 104F; Nausea; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Hot burning sensation), CHILLS (Chills), PYREXIA (Fever 0f 104F), NAUSEA (Nausea) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced SKIN BURNING SENSATION (Hot burning sensation), CHILLS (Chills), PYREXIA (Fever 0f 104F), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SKIN BURNING SENSATION (Hot burning sensation), CHILLS (Chills), PYREXIA (Fever 0f 104F), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: (High) Fever of 104 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
pt recv vax & same day 220PM exp arthritic pain in joints, dizziness, flushing, drowsiness, upper torso rash, arm discomfort (inj site);ER or MD visit was required;all sx dissipated w/in 1hr while waiting in MD office x/sluggish feeling;
Approximately 3-4 weeks after  getting Shingrix vaccine in right arm, got  horrible itching from mid forearm to just above elbow. Tried Capsacin patches, acupuncture. Ice was the only thing to "calm" it down.  After getting both Moderna COVID  vaccines in between, on  4/9/2021 I got the second Shingrix shot in the left arm. Approx. 3-4 weeks later got severe itching in that arm. This time I now have stinging along the nerves in both arms. Nothing is helping.   At my wits end!!! Would an antiviral possibly help?
Information has been received from a licensed practical nurse referring to an adult patient of unknown age and gender. Information about concurrent condition, medical history and concomitant therapy was not reported. On 09-FEB-2016 the patient was inadvertently vaccinated with a pediatric dose of unspecified hepatitis b vaccine (recombinant) (manufacturer unknown, dose 1, lot# reported as ZT59G, expiration date: 14-FEB-2016 and route not reported) (vaccine underdose). Then on 15-MAR-2016, the patient was vaccinated with another dose of RECOMBIVAX HB (dose 2, lot# K023310, expiration date: 15-APR-2017 and route not reported) (interchange of vaccine products). No adverse effect was reported. It was unspecified if the patient sought for medical attention. Lot number ZT59G is an invalid lot number for hepatitis b vaccine (recombinant). Additional information has been requested.
Patient received fluarix and pneumovax 23 on 1/6/22 @ 6:59am. The following morning at 9am 1/7/22, patient experienced adverse effects of fever, chills, body aches, dizziness, inflammation at site of injections, redness at site of injections. Patient saw Dr. on1-10-22 and was diagnosed with cellulitis at injection sites. Patient was given a course of oral cephalexin antibiotics, and was counseled to monitor for 24 to 48 hours for improvement. Symptoms continues to time of report on 1-10-22.
Episode of syncope x 30-40 seconds immediately after vaccination with H1N1 vaccine.  Patient was nervous and has a history of a previous fainting spell while watching blood being drawn from a family pet. Placed supine with feet elevated. Given po fluids/food as she had not eaten dinner prior to clinic. EMS summoned to monitor vital signs. Recovered and sent home with parent 45 minutes after event.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age an gender. On 08-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported). which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Normal weak; Headaches for 24 hours; Severe diarrhea; Stomach pain; Body pain all over; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included paroxetine hydrochloride (PAXIL), atorvastatin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), celecoxib (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL A); all were for an unknown indication from an unknown date and unknown if ongoing. On 11Apr2021, the patient experienced normal weak and headaches for 24 hours. On an unknown date in 2021, almost 2 weeks later, the patient experienced severe diarrhea, stomach pain and body pain all over. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events normal weak and headaches for 24 hours was resolved on 12Apr2021, after the duration of 24 hours; while that of events severe diarrhea, stomach pain and body pain all over was not resolved at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 08:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 2 hours, post vax, I began to have a reaction. My lips first started to swell, then the area just above my lips, below my nose. Then the right side of my tongue began to swell. All this within a 4 hour period from start until I went to ER where they gave me an injection to counteract the reaction. Please refer to my ER record and a visit to my physician, 2 weeks later.
Approx 7 hours after receiving the vaccine client says he heard a loud roar and lost consciousness. Wife called EMSA and they met her and was transported to Hospital with seizure like activity for approx. 3 minutes. He has never had a seizure before. They were not sure if the seizure was R/T his stroke or the vaccine.
Client received Pfizer 12+ dose of 0.3 ML instead of the 0.2ML of pediatric pfizer dose.
Hot flashes have gotten worse; Sore and red rash; red; rash an inch below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes have gotten worse), PAIN (Sore and red rash), ERYTHEMA (red) and VACCINATION SITE RASH (rash an inch below the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced HOT FLUSH (Hot flashes have gotten worse), PAIN (Sore and red rash), ERYTHEMA (red) and VACCINATION SITE RASH (rash an inch below the injection site). At the time of the report, HOT FLUSH (Hot flashes have gotten worse), PAIN (Sore and red rash), ERYTHEMA (red) and VACCINATION SITE RASH (rash an inch below the injection site) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was reported.
Patient was seen 3 weeks prior for routine vaccinations which she received. Patient had another visit in which the same routine vaccines were pended, ordered and given again by RN. Inapproporate interval of vaccines given too close together which will require the patient to be revaccinated again at the proper interval. Vaccines- Dtap, Hep B, Polio, Prevnar 13, Hib, Rotavirus
taste buds were not working; felt bloated; muscle aches' all muscles ached real bad (especially muscles in the leg); difficulty sleeping; shoulders and neck are stiff; "bad pain like I've been beaten"; shoulders and neck are stiff; "bad pain like I've been beaten"; can barely move; fatigue; "can't keep my eyes open", "no energy; chills; "cold from inside of the body"; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine last 2APR2021, In Apr2021, patient had after leaving the vaccination site, Caller mentioned that his taste buds were not working (persistent; it has been 10 days); felt bloated; couldn't feel anymore; muscle aches' all muscles ached real bad (especially muscles in the leg); difficulty sleeping - shoulders and neck are stiff; "bad pain like I've been beaten"; can barely move; fatigue; "can't keep my eyes open", "no energy" chills; "cold from inside of the body" The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 22-MAY-2017 (also reported as prior 25-MAY-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # K016964, expiration date 16-JUL-2017 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion between 32 to 35 degrees Fahrenheit for 13 hours (also reported as on 22-MAY-2017 of 35 degrees Fahrenheit for between 45 - 60 minutes) and no previous excursions were reported. Digital data logger was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1705USA013714: US-009507513-1706USA008771: US-009507513-1706USA008773.
This patient came in today for her second dose of Moderna.  She received convalescent plasma 84 days ago.  Patient had their first dose on March 6th and was not hard stopped for the screening question.  She had no symptoms after first dose, so we completed the series with the second dose today 4/3/21.
Hives; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received second dose of bnt162b2 (BNT162B2, lot number: EL3249), via an unspecified route of administration on 16Jan2021 07:00 on Left upper Arm at SINGLE DOSE for covid-19 immunisation. Medical history included Blood pressure, High cholesterol, Asthma. Concomitant medication included losartan for high cholesterol, montelukast for asthma, valsartan for blood pressure. The patient woke-up at 5 AM with hives on 17Jan2021. The event was treated with Benadryl and have the hydrocortisone cream that went away and came back, that went away and came back and came back again in the morning of reporting date, so the consumer didn't know it's related. Investigation Assessment: No. The event outcome was not recovered.
Screaming non stop, lack of eating, stiffening his body while screaming and grabbing at his face and pulling, and lack of sleeping.
Information has been received from the mother of a 21 year old female consumer with pertinent medical history and drug reactions/allergies reported as none, who on September 2007, was vaccinated with a dose of Gardasil vaccine, injection (form), 0.5 mL. Concomitant therapy included vitamins (unspecified). Subsequently on an unspecified date, the patient experienced elevated liver enzymes (AST & ALT) and fatigue. On an unspecified date, a blood test was performed with results not reported. Unspecified medical attention was sought. The patient's elevated liver enzymes (AST & ALT) and fatigue persisted. No product quality complaint was involved. Additional information has been requested.
Heavy fatigue, typical arm pain, the night of and into the following morning developed severe fever that went between 103 and 104, but would break from over the counter cold meds,  and then return in full force when they wore off. Intense nausea, no appetite, intense sweating and cold shakes, fingers and toes got blue at one point from cold. This covers from Monday when I got the boost to Wednesday when my fever broke, things seemed better, just aches and moans but felt better, then Wednesday night the fever went low grade, 95 to 96 with intense sweating and "fever dream" state, hard to describe. My girlfriend who was watching over me in my delirium said she thought I needed a doctor at a few points cause I was so out of it, but from my perspective it was very bad sick, but not detrimental. I just don't know if I experienced covid, or what to me seemed like very severe reactions.
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient were not reported. On 03-DEC-2014 the patient was vaccinated with one dose of VAQTA (lot number J015882, expiration date 22-OCT-2015, dose and route were unknown) which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.