chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On September parent brought child in for four year old immunization for school. Parent was holding child securely for immunization child received the first three vaccine Dtap, IPV, and HepA. Shortly after child started to pass out. I called for emergency assistance from staff members. Administered  ammonia inhaler and elevated legs child started coming around. During the episode the client urinate on self and floor. Vital signs monitored as follows 12:05 100/64 92,12:10 100/64 92,12:15 99 /65 95.12:18 114/58 95. Applied warm blanket client vital signs stable was able to drink some fluids and eat crackers. Client was later released per parent with escort.
Patient reported waking on 11/24/2021 approximately 0800 with severe fatigue/malaise, headache, body aches.  Pt spouse later entered and stated pt appeared to be having allergic reaction. Pt spouse noticed welps on skin and generalized redness across face and chest. Pt took Benadryl 50mg PO and symptoms resolved. Pt states that on 11/25/2021, he felt better with minimal fatigue remaining.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 19-MAR-2015, the patient was inadvertently vaccinated with a single dose of ZOSTAVAX lot # J011882 (subcutaneously, dose and anatomical location were not reported) that expired in 04-JAN-2015. No concomitant therapy was reported. No adverse effects were reported. Additional information is not expected, the reporter does not wish to be contacted.
Fever earaches, fatigue Narrative: Per nursing report: "c/o took Moderna vaccine on Thursday March 25th,2021. C/o started having temp-101.8, chills, hot and cold through Saturday [3/27]. C/o bilateral ear aching also. States also still feels week today."
Hospitalization for COVID-19 Reported per Pfizer COVID-19 Vaccine EUA (3rd dose)
Patient developed an area of swelling  and erythema surrounding injection site on L deltoid. The affected area measured approximately 5 cm x 3 cm when examined 08/10/22. Patient complained of tenderness to palpation of the area.
after I got the shot my right thum went num; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (after I got the shot my right thum went num) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (after I got the shot my right thum went num). At the time of the report, HYPOAESTHESIA (after I got the shot my right thum went num) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported.   Reporter did not allow further contact
at approximately 910am this writer responded to a code blue paged to room 212B. Upon arrival resident was being assisted to the floor from bed. Resident unresponsive without pulse or respirations. Color pale in appearance. 911 Activated. MD/Family were notified. CPR initiated at 912am. AED applied. 3 cycles of CPR was completed upon arrival of EMS at approximately 919am. EMS assumed care. at 934am EMS called and ordered to terminate code. NP on scene aware. Call placed to family and updated.
VAXELIS administered to a patient post excursion. Refrigerator malfunction Max/Low Temperature reached: 28 F; This spontaneous safety report, with reference number 2023SA220996, was received by a partner on 19-JUL-2023 and forwarded to company on 20-JUL-2023, from an other-HCP.  The causal relationship between Vaxelis and the reported event "VAXELIS administered to a patient post excursion. Refrigerator malfunction Max/Low Temperature reached: 28 F." was assessed as not applicable due to the nature of the event.  Further information is expected.
This spontaneous report as received from a registered nurse refers to a 61 years old patient. On 18-DEC-2012 the patient was vaccinated with 0.5ml VARIVAX (merck) (subcutaneous, dose and lot number were not reported) instead of a dose of ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
Arm was tender; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tenderness.  The patient's medical history was not provided. C oncomitant medications were Tylenol and aspirin for unknown indications.  On 22 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011-J20A) intramuscularly in the Left arm for prophylaxis of COVID-19 infection.  On unknown date, the patient experienced arm tenderness.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.   At the time of this report, the outcome of the event arm tenderness was unknown.; Reporter's Comments: This case concerns a female patient,  who experienced non-serious expected event of injection site pain left arm after vaccination on that arm .The event of injection site pain left arm occurred after the first dose of mRNA-1273, COVID -19 Vaccine. Based on the current available information and temporal association between the use of the product and onset of the event ,  a causal relationship cannot be excluded.
Shots were administered, 10/13/17 at 3:55 PM. Pt began experiencing adverse reactions at 9 AM 10/14/2017 including: redness, warmth and swelling beginning 3-4 inches below injection site, running the length of the arm and total circumference of the arm and ending at the elbow. Pt also experienced total body aches and fever beginning 9 AM 10/14/17. Symptoms continued until this date and time with some improvement of all symptoms. Pt has been treating symptoms with ibuprofen and ALEVE. Pt was instructed to continue to monitor symptoms and reach out to PCP via phone to update records and discuss additional treatment. Will follow-up with pt tomorrow.
Patient reported a strange "chemical scent" in her nostrils shortly after FLUBLOK was administered, also reported a tickle/tightness in her throat after vaccine was administered. She used her rescue inhaler and took one 25mg diphenhydramine while still at the pharmacy.
Information has been received from Pregnancy Registry for GARDASIL vaccine from a Registered Nurse (R.N.) concerning a female patient who was vaccinated with a third dose of GARDASIL vaccine (lot # unknown).  The nurse reported that the patient received her third injection when she was pregnant but did not know it.  It was unknown if medical attention was sought by the patient.  The data of last menstrual period and estimated date of delivery is unknown.  The outcome was unknown.  Follow up information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 17 year old Caucasian female patient with no previous pregnancy history and no pertinent medical history who on 09-OCT-2007 was vaccinated with the first dose of GARDASIL (lot # not provided).  Subsequently the patient was pregnant (LMP was 13-NOV-2007 and EDD was 20-AUG-2008).  On 10-DEC-2007 she received the second dose of GARDASIL (lot # not provided) when she did not realize she was pregnant (previously reported the third dose).  Concomitant therapy included allergy injection every other week for treatment of allergies.  Other medications used during pregnancy included prenatal vitamin qd taken for December 2007 to August 2008.  In October 2007, the patient experienced anxiety and ZOLOFT 50 mg qd was started.  On 14-JAN-2008 ultrasound was performed for bleeding and cramping with the result of within normal limits.  On 24-MAR-2008 routine ultrasound was performed again with the result of within normal limits.  On 06-AUG-2008 (from LMP 37 weeks 6 days) the patient delivered a normal, healthy male baby weighting 8 pounds 10 ounces with no congenital anomalies.  The Apgar score was 8/9.  There was not complication during pregnancy and labor/delivery, and not infections or illness during pregnancy for the patient. Additional information is not expected.
pt brought to ED with c/o increasing SOB and weakness; found to be hypoxic and positive for COVID; O2 supplementation via NC; admitted; given remdesivir and Decadron; O2 needs continued to increase requiring BiPAP; DNR; pt's condition worsened; pt passed away in the hospital
Breakthrough Case, two weeks after dose 4 of vaccine. Started off with a fever and constantly sneezing. Took a few home tests and they came back negative, after 4 days finally tested positive on  4/19/2022. I called my Dr's office, and we decided not to take any medications, and just wait it out.
Left side of face went numb 2-4 hours after vaccination, eventually involved entire left side of body. Aprox 6-8 hours after vaccination just the left face, mouth, throat, and tongue affected. 2+ months later no change.
PT VACCINATED WITH MMR DEVELOPED SWOLLEN EYES WHEEZES ALL LUNG FIELDS. 1HR AFTER INJECTION DEVELOPED WHEEZING, SOB, SWELLNG FACE,SNEEZING.
I started feeling nauseated about 8 hours after I got the shot. around 10-11 hours after the shot I started having extreme and violent chills that came on every minute or 2. I had fever. I was dizzy and I was hallucinating. I felt like my brain was in 2 parts trying to do many different things. I couldn't get up to go to the bathroom and found that I had wet myself. I was alone but didn't know where my phone was so I didn't call for help.
No additional AE details available; vaccines were administered after experiencing temperature excursion; This spontaneous report as received from a Medical Assistant refers to a 15-month-old-patient of unknown gender.      The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 29-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (Lot # T032317, expiration date 22-SEP-2022) (dose, route of administration, and anantomical location were not reported) for prophylaxis.       The vaccine was administered after experiencing temperature excursion (product storage error). Temperature 6°F to 14°F (8.5F) for 0 hours 18 minutes 0 seconds; 6°F to 14°F (11.9F) for 1 hour 0 minutes 0 seconds. Time frame: Cumulative Timeframe: 1 hour and 18 minutes. There was no previous temperature excursion. No additional adverse events (AE) details available. No PQC was reported.
8hr p/vax devel 10x15cm of erythema, swelling & low grade fever;
9PM t100.5 (pt had been on APAP 4 hrs since 1Pm); 1130PM, t102.6, onset of rash on feet, hands, stomach & neck, diarrhea watery; mom took pt to hosp ER where MD prescribed Pedialyte & Pediaprofen;
Patient reported about 5 minutes after vaccine at that she felt nauseous like she would throw up, checked bp 105/80 and Pulse 97, gave water and crackers, nausea resolved in about 10 minutes. at 11:35 checked bp 118/93 pulse 88. Patient didn't know what her normal bp and pulse are. FU call on 3/13 pt stated she only had coffee that morning, no food. she felt better after she left the store.
Worst bone pain after second shot/Bones hurt after second shot; Does not feel good after second shot/, I am not happy; Can not bend fingers after second shot; I am angry; Worst joint pain after second shot; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Worst bone pain after second shot/Bones hurt after second shot), VACCINATION COMPLICATION (Does not feel good after second shot/, I am not happy), MUSCULOSKELETAL STIFFNESS (Can not bend fingers after second shot), ANGER (I am angry) and ARTHRALGIA (Worst joint pain after second shot) 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 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 BONE PAIN (Worst bone pain after second shot/Bones hurt after second shot), VACCINATION COMPLICATION (Does not feel good after second shot/, I am not happy), MUSCULOSKELETAL STIFFNESS (Can not bend fingers after second shot), ANGER (I am angry) and ARTHRALGIA (Worst joint pain after second shot). At the time of the report, BONE PAIN (Worst bone pain after second shot/Bones hurt after second shot), VACCINATION COMPLICATION (Does not feel good after second shot/, I am not happy), MUSCULOSKELETAL STIFFNESS (Can not bend fingers after second shot), ANGER (I am angry) and ARTHRALGIA (Worst joint pain after second shot) outcome was unknown.            No Treatment informations were reported.   This case was linked to MOD-2021-345934 (Patient Link).
High fever, onset evening of the day child was vaccinated. Fever of 104F and left leg swelling with stiffness.
DKA; My son was diagnosed as type 1 diabetes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 3-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose; vaccination site: thigh), administration date: 2022, for COVID-19 Immunization; Bnt162b2 (2nd dose), administration date: 2022, for COVID-19 Immunization. The following information was reported: DIABETIC KETOACIDOSIS (hospitalization, disability, life threatening) with onset 14Nov2022, outcome "recovered with sequelae", described as "DKA"; TYPE 1 DIABETES MELLITUS (hospitalization, disability, life threatening) with onset 14Nov2022, outcome "recovered with sequelae", described as "My son was diagnosed as type 1 diabetes". The patient was hospitalized for diabetic ketoacidosis, type 1 diabetes mellitus (hospitalization duration: 4 day(s)). The events "dka" and "my son was diagnosed as type 1 diabetes" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of diabetic ketoacidosis, type 1 diabetes mellitus. The clinical course was reported as follows: My 03-year-old son was hospitalized due to DKA and diagnosed as type 1 diabetes on 14Nov2022. He had 3 doses COVID vaccines. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201340824 same reporter/patient, different event/dose;
This spontaneous report was received from a pharmacist referred to a 48 year old female patient. The patient's pertinent medical history included Legionnaires disease and allergy to sulfa drugs. She was taking unspecified medications. On 19-SEP-2016, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscularly in the right arm. Lot # M027552 with expiration date: 04-FEB-2018. The patient received concomitantly influenza virus vaccine (unspecified) (reported as flu vaccine) in the left arm. It was reported that "within the past 24 hours" after vaccination, the patient developed an unspecified rash at the right armpit with a size reported of "two inches". The pharmacist reported that the patient was scheduled to see her unspecified physician on 21-SEP-2016 regarding the event. The patient did not receive treatment for the event and laboratory diagnostic studies were not performed. There was not a product quality complaint involved. At the time of reporting the outcome of the event was reported as not recovered. The causality assessment between the event and the suspect therapy was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
03/27/01, came home from school complaining of extreme tiredness (unusual for her) and a slight headache and a sore arm. At 17:30 gave Tylenol for headache and sore throat. The next morning complained of being hot during the night. Temperature in AM was 98.6F (usually 97F), complained of back hurting and sore muscles. Too tired to go to school. Took to clinic for strep test and it was negative. Felt better in the afternoon but still tired and wiped out to go to school. The next morning was fine.
ER for restricted airway after 3 hours. Muscle pain, joint pain, extreme dizziness, sore throat, headache, cold hot sweats, fatigue, for 5 days. dizziness, sore throat, still after 6 days
Systemic: Weakness-Mild, Additional Details: Patient felt dizziness and just fell down and recover right away . I pharmacist gave some water and check vital and she was fine and made her sit down for 30 min. then send her home
Extreme headache (24 hours); stomach cramping pain (12 hours); projectile vomiting (ongoing for about an hour); postmenopausal bleeding. Within 5 days of the second Moderna shot, I got my period after 2 years without it!
After receiving the first dose of Pfizer within the same week I felt some discomfort in my vaginal area. I made an appointment 9/20/2021 to figure out what was wrong and was tested.  When visiting the doctors office I was tested for STDs/STIs, blood was drawn and swabs of the lesions were taken.  As the week progressed the pain got worse and more intense, I then had lesions on my vagina. Results of everything came back negative. No specific diagnosis was given but to use cool compresses. The first incidence happened in September and lasted about 2-3 weeks. Since September, every time I have a menstrual cycle I get the same vaginal lesions. This has been consistent to this day with no treatment or anything that helps with relief of the pain and discomfort.
Headache; Fever; Chills; Sweating all night; This is a spontaneous report received from a contactable consumer (patient's parent). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6202), on 04Mar2021 (at the age of 27-year-old) as unknown, single dose for COVID-19 immunisation. Vaccine facility type was reported as workplace clinic. The patient's medical history included known allergies: seasonal allergies, mold, dust, and mites. No COVID prior vaccination was reported. No concomitant medications in two weeks were reported. Patient did not receive other vaccines in four weeks. On 05Mar2021 the patient had headache, fever, chills and sweating all night. Patient was treated due to the events with paracetamol (TYLENOL). Patient was not tested for COVID post vaccination. The outcome of the events was recovered with sequel (reported as recovered with lasting effect).  No follow-up attempts are needed. No further information is expected.
w/in 48 hrs p/shot given; pt had seizure lasting 20-30 secs; had 2 more that were witnessed w/in 2 wks p/pt was brought to neurologist; EEG was given & other testing didn't find anything so related to DTP;
low grade fever; heart rate was elevated; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), HEART RATE INCREASED (heart rate was elevated) and NAUSEA (nauseous) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020A21A and 025B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PYREXIA (low grade fever), HEART RATE INCREASED (heart rate was elevated) and NAUSEA (nauseous). At the time of the report, PYREXIA (low grade fever), HEART RATE INCREASED (heart rate was elevated) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Heart rate: 90 (High) heart rate elevated at 90+bpm. and 83 (High) HR is currently 83bpm.. On 05-Apr-2021, Pyrexia: 99.1-100.4 (High) a low grade fever be 99.1 F and 100.4 F.         No concomitant medication was reported. The treatment medication was Tylenol. Action taken with mRNA-1273 in response to the events were not applicable.
administered a flu shot to a consumer twice/no AE; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 63-year-old male patient who was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] twice (extra dose administered).  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On 14-Sep-2020, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE prefilled syringe (lot number expiry date not reported) via unknown route at an unknown administration site and on 17-Nov-2020 he received 0.5 ml of second dose of the same vaccine (extra dose administered) (latency same day) (lot UT7115NA, expiry date-30-Jun-2020) via intramuscular route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to (extra dose administered).  At the time of report, no adverse event was reported.  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 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.
3/13/03 Cellulitis of left leg. She developed fever (Temp max 103), redness and welling after receiving HIB and pneumovax on 3/11/03. On presentation, erythema was approximately 4cmx2cm with underlying swelling measuring approximately 5cmx5cm. By 3/14/03 the erythema increased area 10cmx3cm and swelling increased with an area of induration.
Body ache; had a fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Body ache) and PYREXIA (had a 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 MYALGIA (Body ache) and PYREXIA (had a fever). At the time of the report, MYALGIA (Body ache) and PYREXIA (had a fever) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.
devel generalized erythema, pruritus; no cardioresp; time course consistent w/immed hypersensitivity; treated w/SQ epi, po DPH;