chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child given .25mg flu vaccine (appropriate for age) by time parents got to check-out child c/o throat hurting and covered in hive-like rash. Epinipherine .5mg/ 1000 given SC 911 called. Sent to ER. Given Benadryl orally and prednisone x 3 days. F/U 3 days later child had cold/ cough and had been seen by PMD.
Site: Pain at Injection Site-Medium, Additional Details: Upon R.N. administering Pfizer age 5-11 dose number two, pt. jerked arm and needle came out of arm.  There was 0.1ml of vaccine left in syringe after first administering so that remaider was injected IM.  Pt jerked again and needle made superficial scratch on pt.'s arm and it started bleeding from scratch.  Mother was concerned pt. didn't receive all vaccine.  RN sure pt. did receive all vaccine.
Did not feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old male patient received BNT162B2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 26Mar2021, outcome "recovered" (29Mar2021), described as "Did not feel well". Additional information: The patient did not feel well for 3 days after getting the 1st dose. He asked if he will be experiencing more side effects on the 2nd dose. He was schedule to get the 2nd dose on 14Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Atrial Fibrulatio/ Tachycardia weakness fever dizzyness shortness of breath sore throat
After 1st injection, left shoulder was tender and did not go away. Received 2nd injection in the same arm and tenderness increased.  In April, started to have some decreased mobility in arm. The beginning of May pain increased and continued to increase over the month. Made appointment with Orthopedic Dr specializing in shoulders, but could not be seen until 6/23. Took over the counter analgesics to try to relieve pain. Unable to complete simple daily tasks without assistance. Very painful. Saw physician 6/23 and had x-rays. Diagnosed with Adhesive capsulitis (Frozen Shoulder) Physical Therapy prescribed for 6 weeks. Still in severe pain.
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. No treatment information was provided.   Reporter did not allow further contact
A report has been received from a Pharmacist concerning a 55 year old, female subject, who had been receiving FLUMIST. Concomitant medications included Tolterodine L-Tartrate, Alprazolam, Acyclovir and Sertraline. FLUMIST started on 06-Oct-2013. It was reported that the FLUMIST was administered to a 55 year old on 06-Oct-2013. FLUMIST was discontinued on 06-Oct-2013. The outcome of the event of we administered FLUMIST to a 55 year old is unknown. The report was considered to be non-serious.
Only one incidence of severe dizziness for 10 minutes or so. Very tired for that day and following day.
This spontaneous report as received from a nurse refers to a 63 year old patient. Medical history and concurrent conditions were not reported. On 14-FEB-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis relapse (Ulcerative colitis flare up) since 2021.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose once a week. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine used).    No concomitant medicine were reported.
Patient received MMR, varicella, HIB, and  PCV.  She suffered a febrile seizure that lasted 3 minutes.
I63.512 ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 1/3/2023 HYPOTHYROIDISM
Colitis was then unstable needing even remicade IVs and being hospitalized with IV infusions not working; Colitis was then unstable needing even remicade IVs and being hospitalized with IV infusions not working; Ended up with toxic megacolon and had entire colon removed within 4-5 days because they couldn't save; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing), notes: ulcerative colitis for 20 years that was treated with very little medicine and GF diet. The patient's concomitant medications were not reported. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as unknown. Any other medications the patient received within 2 weeks of vaccination was reported as unknown. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as unknown. Since the vaccination, has the patient been tested for COVID-19 was reported as unknown. The following information was reported: COLITIS ULCERATIVE (hospitalization, disability, medically significant), CONDITION AGGRAVATED (hospitalization, disability), outcome "not recovered" and all described as "Colitis was then unstable needing even remicade IVs and being hospitalized with IV infusions not working"; MEGACOLON (hospitalization, disability, medically significant), outcome "unknown", described as "Ended up with toxic megacolon and had entire colon removed within 4-5 days because they couldn't save". Therapeutic measures were taken as a result of colitis ulcerative, condition aggravated, megacolon. It was reported that, received word of a 40-year-old with ulcerative colitis for 20 years that was treated with very little medicine and GF diet. Stated that, the individual got vaxxed. Stated that, colitis was then unstable needing even remicade IVs and being hospitalized with IV infusions not working. Stated that, ended up with toxic megacolon and had entire colon removed within 4-5 days because they couldn't save. Stated that, at the time of adverse event report, it was not known whether this was Pfizer or Moderna. Hospitalization prolonged was reported as no.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Dizziness; Weakness; Difficulty Communicating; Fast Heartbeat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), COMMUNICATION DISORDER (Difficulty Communicating) and HEART RATE INCREASED (Fast Heartbeat) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), COMMUNICATION DISORDER (Difficulty Communicating) and HEART RATE INCREASED (Fast Heartbeat). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), COMMUNICATION DISORDER (Difficulty Communicating) and HEART RATE INCREASED (Fast Heartbeat) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 127/70 normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication use was provided by the reporter. No treatment medication were reported.  Reporter does not consent for further contact   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: TCR is attached as follow-up document on 04-MAY-2021 where is mentioned that patient is fine now and not interest in FU.
Swollen left leg noticed on 3-19-2021 as a result of blood clots identified by ultra sound on 03-31-2021
COVID arm; Patient experienced injection site reaction including swelling.; Patient experienced injection site reaction including redness; Patient experienced injection site reaction including soreness.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (COVID arm), VACCINATION SITE SWELLING (Patient experienced injection site reaction including swelling.), VACCINATION SITE ERYTHEMA (Patient experienced injection site reaction including redness) and VACCINATION SITE PAIN (Patient experienced injection site reaction including soreness.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.   It was reported allergies of patient was unknown.  It was reported acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.  It was unknown whether patient has diagnosed/tested positive for COVID-19.  Concurrent medical conditions included Diverticulitis (Worsening for the last 5 years). Concomitant products included CALCIUM for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Patient experienced injection site reaction including swelling.), VACCINATION SITE ERYTHEMA (Patient experienced injection site reaction including redness) and VACCINATION SITE PAIN (Patient experienced injection site reaction including soreness.). On 05-Feb-2021, the patient experienced IMMUNISATION REACTION (COVID arm). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination adverse reaction, at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (COVID arm) outcome was unknown and VACCINATION SITE SWELLING (Patient experienced injection site reaction including swelling.), VACCINATION SITE ERYTHEMA (Patient experienced injection site reaction including redness) and VACCINATION SITE PAIN (Patient experienced injection site reaction including soreness.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient received no other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Patient stated that patient experienced wild reactions.  The patient did not experienced similar events in the past.   This case was linked to MOD-2022-628837, MOD-2022-628840 (Patient Link).
I was sweating profusely and lost 2 pounds over night. I got my thyroid levels checked 3 days later and it was indicated that I no longer needed my thyroid medication for my hypothyroidism.
This spontaneous report as received from a immunization official refers to multiple patients of unknown age and gender. No information regarding the patients pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown dates, multiple patients were vaccinated with improperly stored doses of PROQUAD lot # M044022, expiration 01-MAY-2018; VARIVAX Lot #M045204, exp 11-NOV-2018 and M034583 exp 27-JUL-2018; and ZOSTAVAX lot# M042504, exp 30-NOV-2017. Properly stored Sterile diluent lot# not reported. No adverse events were reported. Temperature 1-4 degrees Celsius to -10 degrees Celsius for 2 hours. Previous temperature excursion PROQUAD -14 degrees Celsius to -10 degrees Celsius for 1 hour and 30 minutes; VARIVAX -14 degrees Celsius to -10 for 15 hours and 30 minutes and ZOSTAVAX -14 degrees Celsius to -10 for 15 hours and 30 minutes A digital data logger was involved. Additional information has been requested.
Client reported feeling nauseous at first and then feeling a rush to huis head and shoulders. He felt cold, clammy, sweaty Client reported he had not ate anything for breakfast. Denies any health problems, daily needs or allergies. Client reported these symptoms happened 1 year ago with an antibiotic injection and did not know the name of antibiotics. Symptoms lasted 5 minutes he stayed total 3 minutes and felt better before he left ,
Patient had severe autoimmune response. Symptoms paralleled rheumatoid arthritis. Patient described pain as uncontrollable and unmanageable. The symptoms began in the hands, with tight and stiff joints, as well as swelling to the extreme that hands could not be closed. These symptoms spread to the shoulders, ankles, and all the joints in the feet. Walking was unbearable, which did not lessen with any OTC pain medications or topical treatments. The patient's toes began to show the same symptoms as the hands, extreme swelling which prohibited walking. These pains lasted longer than 8 weeks.
body aches; fever with chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (fever with chills) and PYREXIA (fever) 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 (body aches), CHILLS (fever with chills) and PYREXIA (fever). At the time of the report, PAIN (body aches), CHILLS (fever with chills) and PYREXIA (fever) outcome was unknown.            No concomitant information was reported.   No treatment information was reported.   Reporter did not allow further contact
Janssen COVID-19 Vaccine EUA chill, fever, headache, nausea over 24 hour period followed by exhaustion for the next 24 hours
Appx 30 min after receiving flu shot, PT started to feel throat tightness, however; was able to maintain her airway. She was still able to swallow and speak. Pt self-admitted into the Emergency room since she was in the vicinity when her symptoms started. In ED, Pt received two doses of epinephrine IM,  Benadryl IVP, and respiratory treatments. Pts throat swelling subsided. Patient never lost her airway or went into respiratory distress.
Flushed and sweaty after 20 minutes. Heart started beating fast and irregular. Went by ambulance to ER where given complete smattering of tests, 2 EKG's Chest xrays, Chest CAT scan, blood work and observation. Heart and BP continued to be elevated during stay. PB 168/85 down to 148/74. Heart rate 110 to 85 ish.  Discharged from hospital. Bed at 10:15 feeling ok. During the night fever, chills, swollen glands, nausea, severe body aches, headache. fast heart rate, heavy breathing, general malaise, sleeplessness, painful injection site. Took tylenol at 5:00 AM and slept a few hours. Woke at 10 AM  with body aches, but heart rate was down to 76 and BP down to 112/74. Continuing the tylenol and wiped out.
Pt. nervous about receiving vaccines. (Shots) Pt needed six total vaccines. After receiving three vaccines, pt c/o nausea. I stopped giving vaccine to give Pt a moment to recover, then Pt began to perspire and became pale and fainted. RN used 0.3 ml Ammonia inhalant for respiratory stimulate Pt. Pt regained consciousness. Laid pt down. Took vital signs. B/P 118/78 Pulse 78 Resp. 16. Pt A&O x 4. Dr. attended pt and was OK'd to leave with parent.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: Ew0151), in left arm, on 21Apr2021 as dose 2, single (Lot number: Ew0165), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: Ff2587), in left arm and on 11Apr2022 as dose 4 (booster), single (Lot number: Fj4989) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension. Concomitant medication(s) included: AMLODIPINE; LISOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: It was reported that, patient took Paxlovid from 14Jun2022 to 18Jun2022 for COVID 19 Treatment. Adverse event reported as Rebound of Covid symptoms after taking Paxlovid on 26Jun2022 at 12:00 PM and the events were recovering and no treatment for AE. Patient had no known allergies.
Information has been received from a physician concerning a 17-year-old patient who on 19-MAR-1991 and 13-SEP-1993 was vaccinated with their first and second 0.5 ml doses of MMR II. On 06-NOV-2006 the patient underwent IGG titers and experienced rubella IGG titers less then 10. At the time of this report, the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
I went in for a CT scan because I am a smoker and I wanted to make sure everything was ok, and they diagnosed me with lung Cancer. They were 100 percent sure it was Cancer after the CT scan, so they did a PET Scan, and they were able to identify it as Cancer. I am now Cancer Free.
This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included muscle pain. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site muscle pain, injection site bruising and injection site swelling. In May 2018, the outcome of the injection site bruising and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site muscle pain was recovering/resolving. It was unknown if the reporter considered the injection site muscle pain, injection site bruising and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in early May 2018. Within 24 hours after receiving the SHINGRIX, the patient developed significant pain, swelling and bruising at the injection site which lasted over 2 weeks. The pain was significant enough that she could not sleep on that side. The patient showed the reaction to the pharmacist around on 10th day. The swelling and bruising have resolved, but she had some muscular pain, though it had improved. The patient had a history of muscular pain, so she was not sure if the pain she experienced was related to the SHINGRIX or not. The patient denied permission to contact their physician.