chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HBP calling to report a patient received their first dose of GARDASIL 9 at the age of 9 years old.  The office just administered  the second dose to the patient at the age of 19 on 9/11/2023.  NO symptoms or side effects reported.  No other AE and no; No adverse event; Information has been received from a pharmacist student referred to a child patient of unknown age and gender. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.     On an unknown date in 2013 (also reported as "at the age of 9-years-old"), the patient was vaccinated with her/his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, dose number, frequency, route, anatomical location, lot number and expiratoion date were not reported), as prophylaxis.   On 11-SEP-2023 (also reported as "at the age of 19-years-old"), the patient was vaccinated with her/his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, dose number, frequency, route, anatomical location, lot number and expiratoion date were not reported), as prophylaxis (inappropriate schedule of product administration). No adverse event.
4/12/21 Patient presented to the emergency room with left side intermittent chest pain x1 week.  Patient reports "feels like heart beating out of chest" yesterday.  Workup was consistent with pulmonary embolism.  Patient was admitted and Lovenox for pulmonary embolism treatment was started.  Pain controlled, hypertension controlled.
Patient described a pain that shot down her arm during injection. It has been 2 weeks since the dose and patient describes pain that starts at the site and shoots down here arm throughout the day when she moves. There is no swelling or other outward signs.
Lethargy/extreme fatigue; Terrible headache; Nausea; Severe sick to stomach; Chills; Body aches; Left arm extremely red and huge egg shaped mark down to elbow; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Severe sick to stomach), LETHARGY (Lethargy/extreme fatigue), CHILLS (Chills), MYALGIA (Body aches) and VACCINATION SITE ERYTHEMA (Left arm extremely red and huge egg shaped mark down to elbow) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010AZ1A and 042C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history information was reported.  Concomitant products included ETANERCEPT (ENBREL) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Severe sick to stomach), CHILLS (Chills), MYALGIA (Body aches) and VACCINATION SITE ERYTHEMA (Left arm extremely red and huge egg shaped mark down to elbow). On 10-Mar-2021, the patient experienced LETHARGY (Lethargy/extreme fatigue), HEADACHE (Terrible headache) and NAUSEA (Nausea). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, ABDOMINAL PAIN UPPER (Severe sick to stomach), LETHARGY (Lethargy/extreme fatigue), CHILLS (Chills), MYALGIA (Body aches), VACCINATION SITE ERYTHEMA (Left arm extremely red and huge egg shaped mark down to elbow), HEADACHE (Terrible headache) and NAUSEA (Nausea) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments     Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received on 06-Jul-2021 contains no new information.
Patient complained of nausea and dizziness while in the observation area. Vital signs stable. Patient felt like her heart rate was fast. Patient was given 4 mg Zofran. Vitals taken again, stable, symptoms resolved 10 minutes after Zofran. Patient ambulated well. She was discharged.
This spontaneous report was received from a pharmacist regarding an approximately 61 years old female patient. On 13-JAN-2014 the patient was vaccinated with ZOSTAVAX lot # (J011338, expiry date: 19-DEC-2014) dose; 0.65 ml, subcutaneous in the left arm for vaccination. No concomitant medications were reported. Approximately on an unknown date in January 2014 the patient experienced redness at the injection site of the left arm. Patient sought medical attention: came into pharmacy. No other effects reported. Pharmacist states client will take over the counter BENADRYL if needed. There was no product quality complaint (PQC) involved. The outcome of redness at the injection site of the left arm was reported as not resolved. Causality assessment was not provided. Additional information is not expected.
Sick; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves 70-years-old patient (unknown demographics) who got sick (sickness), when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (sickness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received any corrective treatment.  The event outcome was unknown for sickness.  There will be no information available on the batch number for this case.
Headache, lethargy, fever, chills and sore injection site from about 6 hours post injection to about 60 hours post injection
This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, an unspecified patients were vaccinated with a dose of improperly stored VAQTA (dose, route, lot number and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a certified medical assistant concerning a patient who on an unknown date, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On an unknown date, an unspecified adverse event occurred. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
From initial information received on 11/03/03 from a consumer, regarding an adverse event occurring in the USA, it was reported that the 70 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1069AA, administered intramuscularly in the right deltoid on 10/22/03. Within one hour of vaccination, the patient noticed soreness underneath her arm. She reported that the pain was fairly close to the axillary area. The patient denied any redness, lumps, numbness or tingling. She stated that she had no limitations in mobility. The patient recovered from this event on an unspecified date.
This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not had past history of similar event. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced swelling to right leg, spasms to right leg, and spasms to abdominal area. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling to right leg, spasms to right leg, and spasms to abdominal area. This report was non-serious. This report was associated with product quality complaint: 90000216050.
pt recv vax 16AUG96 & pt exp nausea & fatigue;
A female consumer with no known allergies reported that on 27-MAR-2008 she was vaccinated with zoster vaccine live (Oka/Merck), (dose was not reported). The patient developed a clear runny nose since she was given the vaccine. The consumer also reported that she transported the vaccine from the pharmacy to the physician's office over a 30 minute time span. She reports that she was given this vaccine, but does not report any other adverse reactions. The patient's clear runny nose persisted. The consumer contacted the physician. Additional information was requested. Additional information was received from the physician who reported that this 69-year-old female developed appendicitis on 16-Apr-2008. Concomitant therapy included MICARDIS. The reporting physician felt that appendicitis was not related to zoster vaccine live (Oka/Merck). The lot number 1286U was reported as not valid for this product.
Frequent urination for two days following vaccinations.; Stabbing pain in right leg from knee to mid-shin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single and administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Clinical depression" (unspecified if ongoing); "Kidney absent" (unspecified if ongoing), notes: Missing left Kidney. Concomitant medication(s) included: VENLAFAXINE HCL; BUPROPION HCL. The following information was reported: POLLAKIURIA (non-serious) with onset 22Apr2021, outcome "recovering", described as "Frequent urination for two days following vaccinations."; PAIN IN EXTREMITY (non-serious) with onset 22Apr2021, outcome "recovering", described as "Stabbing pain in right leg from knee to mid-shin". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pollakiuria, pain in extremity.  Additional information: 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 vaccine within four weeks prior to vaccination. The events did not result in doctor or other healthcare professional office/clinic, emergency room/ department or urgent care. Since the vaccination, the patient had been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
nausea; pain in her stomach she describes as 'stomach cramps; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. On an unspecified date, on the 1st day of 2nd dose, patient experienced nausea and 3 days later had a pain in her stomach she described it as 'stomach cramps, terrible'. Outcome for the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
sore arm; feeling a little beat up the next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for COVID-19 immunization, reaction(s): "feeling a little beat up the next day", "sore arm"; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for COVID-19 immunization, reaction(s): "feeling a little beat up the next day", "sore arm"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE; Lot number: unknown), for Covid-19 Immunization, reaction(s): "feeling a little beat up the next day", "sore arm"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE; Lot number: unknown), for Covid-19 Immunization, reaction(s): "feeling a little beat up the next day", "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MALAISE (non-serious), outcome "unknown", described as "feeling a little beat up the next day".  Additional information: The patient had no side effects but only had minor side effects like a sore arm and feeling a little beat up the next day. He had 6 shots of the Pfizer Covid vaccine, two of the initial and 4 boosters.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289406 Same patient/vaccine, different dose, similar event;
Swollen left arm. Sent to OHSU per taxi. Soft ice pack wrapped and applied to arm. Given 2 tsp Benadryl 12.5/5 given now (14:35).
No additional AE reported.; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion.; This spontaneous report was received from a Certified medical assistant regarding a 15-month-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-DEC-2022, an improperly stored vaccine of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) underwent a temperature excursion of 47.9 degrees Fahrenheit (F) (storage in clinical practice) for 47 minutes.   On 29-DEC-2022, the patient was vaccinated with the improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly in the right thigh, for prophylaxis (strength was not provided) (Product storage error). Digital data logger was involved. No adverse event was reported. The vaccine was available for return/evaluation and it was used according to the instruction leaflet.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009943:
Vaccine Reaction- FLU-After approximately 4 day of the vaccines was administered to the patient, he starts developing short of breath, facial flushing, and a generalized rash with some hives.
Information has been received from a physician concerning a 12 year old male on 16-FEB-1999 and 05-FEB-2001 was vaccinated with the first and second dose of MMR II, respectively (route, site, and lot number not reported). On 24-DEC-2009 the patient experienced mumps (the date diagnosed was reported as 30-NOV-2009). The patient also experienced parotitis and a fever of 100.6 degree F. On 30-NOV-2009, the first blood work was done which revealed serum IgM 13.29, serum IgG 0.26, and serum amylase 183. The outcome for mumps was not reported. Follow up information has been received from a physician concerning a 12 year old (also reported as 10 year old) male patient who on 12-DEC-2009 (date diagnosed was reported as 13-DEC-2009) experienced left parotitis. The patient was afebrile. On 14-DEC-2009 laboratories test revealed: serum immunoglobulin M test: < 1:10, serum immunoglobulin G test: 5.02 and serum amylase test: 111. The outcome for mumps was not reported. No further information is available.
Began to feel hot, hearing disturbance, loss of consciousness.  BP 105/70, HR 102  History of vasovagal reactions with past vaccinations and ear piercing; fasting for Ramadan
Information has been received from a registered nurse concerning a 20 year old female who was vaccinated with Gardasil.  Subsequently the patient experienced pain around the injection site for 10 days.  Medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Around 30 hours after MMR = 101 degrees fever, very cranky (lasted 3 days); 5 days after MMR = measles like rash all over chest and back of neck (lasted 24 hours); 13 days after MMR. Severe rash all over neck and chest, very irritable (lasted 5 days). Tested for measles. Came back negative.
cellulitis with antibiotics... first appeared early the day after the shot and within 24 hours the swelling, heat, etc had at least doubled in size to the size of a cantalope
Day 1  (12 hrs after vaccine through about 8am the next day). Chills, fever (102), body aches, headache, nausea Day 2 ( headache, feeling exhausted) Symptoms would come and go Day 3  (headache, feeling winded when walking or exerting self)
When I got home after the Vaccine. i began to have a headache. Then I had muscle soreness. Finally I feal fatigued and went to sleep. I also fealt a bit dizzy that night and a little in the morning. I took another nap and then i felt normal.
LIVER FUNCTION TEST ABNORMAL; ASPARTATE AMINOTRANSFERASE INCREASED. Information has been received from a dentist concerning himself, a 35 year old male with an allergy to penicillin, and no other medical history who in 1987, was vaccinated with an initial three dose series of hepatitis b  virus vaccine rHBsAg (yeast)(lot numbers not available). Concomitant therapy included atenolol (TENORMIN) (dates, dose, indication not reported). He reported that when he had the initial three dose series of hepatitis b virus vaccine rHBsAg (yeast) in 1987, he experienced an elevation in liver enzymes, which eventually returned to normal. He also mentioned that he received a booster dose of hepatitis b virus vaccine rHBsAg (yeast) in February 2003. Subsequently, three months later (approximately May 2003), after the booster dose a routine screening was conductd and he was found to have an elevated aspartate aminotransferase (AST). His AST was 54 (normal 0-40). There was no additional information provided. Unspecified medical attention was sought. Additional information has been requested.
This study case was received on 18 and 21 March 2013 from the investigator in a trial. A male subject (age reported as 21 on an EKG dated 01 November 2012) with no relevant past medical history, developed possible myopericarditis 2 days after he received the following vaccine: an injection of ACAM2000 in the right arm. He reported body aches and cold sweats the day of the vaccination, and experienced dizziness the following day that was somewhat alleviated by rest. Two days post vaccination on 27 October 2012 the subject developed chest pain/pressure (1 on a scale of 5) and shortness of breath that was associated with exercise, the episodes lasted 1-45 minutes. The symptoms were reduced but not eliminated with rest; and they interfered with his work. The subject was evaluated by a physician on 30 October 2012 and was prescribed ibuprofen 400 mg every morning for chest pain/pressure. On 01 November 2012 a rapid Troponin test was normal and an EKG was completed that was borderline, but results were pending. The subject was referred for medical follow-up, action taken was unknown at the time of this report. The investigator considered the event to be an "other important medical event". The subject has not recovered. According to the investigator the event was possibly related. Documents held by sender: EKG.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy (Number of fetuses -1) since 01-Nov-2020. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Vitamin supplementation.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 01-Oct-2020 and the estimated date of delivery was 08-Jul-2021. On 19-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 19-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2020, Pregnancy test positive: Positive. On an unknown date, Ultrasound uterus: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment mentioned
arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Had overwhelming fatigue and fever to 101 and myalgias. Fever went to 102 and lasted until 10/14/03. Also had severe pruritis. Labs showed LFT's elevated, fever to 103.7 on 10/18. Admitted to hospital. Labs have all returned to normal presently.