chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Nurse Practitioner who refers to a 18 year old unspecified patient. The patient's medical history and/or concurrent conditions were not provided. On an unknown date the patient was vaccinated with RECOMBIVAX HB dose 1, 10/1.0 mcrg/ml, intramuscular (lot # and expiration date not provided). Concomitant medication was not provided. The Nurse Practitioner reported that on an unspecified date, an unspecified 18 year old patient received RECOMBIVAX HB adult dose. No adverse effect reported. A PQC was not involved. No further information was provided. Follow up information was received on 24-OCT-2016 from a nurse. The nurse stated that the unknown patient was serologically tested on an unknown date for hepatitis B immunity, and tested seronegative for hepatitis B immunity on an unknown date. No further information was provided. Additional information has been requested.
Pt had a syncopal event 2mins after vaccination.  BP 104/70, HR 99, RR 17 -- > 98/55, 73, 18.  Pt recovered.  Pt stable and released from the vaccination site.
7th patient administered expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7th patient administered expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (7th patient administered expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7th patient administered expired Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that the vaccine did not undergo temperature excursion. Treatment medications were not reported.  The patient did not report any other adverse events.
vaccine administration error regarding Pfizer lot # GL0087 EXP: 02/29/2024 administered on 06/05/2023 with beyond use date of 02/17/2023 with recommendation to get booster at local pharmacy
After pt received injection, he was standing with friend. His teacher noticed he was pale and dull-eyed. Extremely tired and weak. C/O seeing two of everything, felt like he was on a cruise ship and lightheaded. Rested for a while. Felt better, went on bus back to his school. Felt sick. Cont seeing double, went home. Slept for 6 1/2 hrs till 630pm. At 9pm blinked and stated he felt like himself again. Later that night. Temp 100.4 but afebrile next am. As of 12/7 doing well per mom.
Information has been received from a healthcare worker referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates these patients were vaccinated with improperly stored doses of ROTATEQ (lot # K015816 with expiration 29-MAY-2016; dose and frequency were not reported) orally. No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
This spontaneous report received from a registered nurse refers to unspecified number of patients with unknown demographics. No medical history was reported. It was reported that since 09-DEC-2015, unspecified number of patients had been vaccinated with improperly stored ROTATEQ (dose, route, frequency: unknown). No adverse effects was reported. The excursion temperature was reported as 29.8 degrees Fahrenheit (F) for 24 hours. Outcome of excursion was reported as "not supported" and it was also reported that there was no previous temperature excursion. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Five days after my first COVID vaccine shot I began experiencing an intense feeling of my heart beating out of my chest. The feeling was more noticeable when laying down and prevented me from sleeping soundly most nights. I also experienced unusual breaths where I felt like I had to continually breath deep but was prevented from taking a full breath. Finally, my blood pressure has been at a constant elevated level (135/80) even though I've never had signs of high blood pressure before.
Injection site pain; Tiredness; Headache; Muscle pain; Joint pain; Minor nausea; Feeling unwell; Arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0182) via an unspecified route of administration in left arm on 13Jun2021 10:00 as 2nd dose, single for COVID-19 immunization. Patient medical history included high BP, migraines and known allergies to Compazine. The concomitant medications included estradiol, amitriptyline, propranolol HCL ER. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0178) via an unspecified route of administration in left arm on 23May2021 10:00 as 1st dose, single for COVID-19 immunization. Vaccine facility type was reported as Pharmacy or Drug Store. Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Patient was 52-years-old and was not pregnant at the time of vaccination. On 14Jun2021 at 05:00, patient experienced injection site pain, tiredness, headache, muscle pain, joint pain, minor nausea, feeling unwell, arm pain.  Patient did not receive any treatment for the adverse events. The outcome of the events was not resolved.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 10-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Administration error, not AE.  Vaccinator injected patients arm with no vaccine in the syringe, patient and vaccinator recognized the error and patient was given anonther injection with the correct amount of vaccine.  No AE were reported by the patient.
BODY ACHES; SHOULDER PAIN/FELT SYMPTOMS OF SORE JOINTS; FELT FATIGUE/EXTREMELY TIRED; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's past medical history included exercise induced asthma, and concurrent conditions included occasional alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient was previously treated with salbutamol for exercise induced asthma.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced shoulder pain/felt symptoms of sore joints. On 01-APR-2021, the subject experienced felt fatigue/extremely tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, shoulder pain/felt symptoms of sore joints, and felt fatigue/extremely tired on 03-APR-2021. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history and current conditions were not provided. On an unknown date the patient was vaccinated with an expired dose of ZOSTAVAX (dose and route were not reported) lot # J008435, expiration date 11-OCT-2014, 19400 PFU. No concomitant medications were reported. No adverse effects were noted. Additional information has been requested.
Vaccine administered 7 days early.  Patient was due on for second vaccine on December 7, 2022  Provider and patient informed.  No adverse effects noted
"Titer 5" After 2 Doses 1 Month Apart; Patient Received 3 Doses of Heplisav-B; Initial Report Received on 06-Oct-2022  This is a spontaneous report, received from a nurse regarding a patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On an unknown date, dose 3 of HEPLISAV B (Lot # unknown, expiration date unknown, NDC # unknown), route and site not specified, was administered for hepatitis B immunisation.   The patient that had received 2 doses of HEPLISAV B a month apart did not convert and their titer was 5 so a 3rd dose was given.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
low grade fever; tiredness; severe injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th August 2019, the patient received Shingrix (intramuscular). On 9th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and tiredness. On 10th August 2019, the patient experienced low grade fever. On 10th August 2019, the outcome of the low grade fever and tiredness were recovered/resolved. In August 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain, low grade fever and tiredness to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The reporter did not give permission to follow up. In the document outcome of events was reported as unknown, but in date of end of reaction/event was reported, so events outcome was captured as recovered/resolved.
Patient is fully vaccinated. COVID positive 12/31/2021 at ED visit.  Patient complaining of intermittent chest pain. Patient presents to the ED secondary to reported 2 day history of dry nonproductive cough, shortness of breath, intermittent chest discomfort. Denies any nausea or vomiting. No diarrhea. Reporting fatigue, weakness and general malaise. Positive for headaches and congestion.BP 140/77  | Pulse 86  | Temp 98.2 °F (36.8 °C)  | Resp 16  | Ht 175.3 cm (5' 9")  | Wt 102 kg (225 lb)  | SpO2 100%  | BMI 33.23 kg/m² EKG normal SR, no infaction, no arrythmia.  CXR: no evidence of an acute process. Labs good.Discharged home.
No adverse event; HCP stated they accidentally administered 3 doses to children after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses to children after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     The patient medical history/conditions, allergy, concomitant diseases and risk factor was unknown.     On 03-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses to children after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses to children after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses to children after the expiration date).    The patient was 7 months and 2 weeks old.  No concomitant medications were reported.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient did not experienced any adverse events .  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716538, US-MODERNATX, INC.-MOD-2023-716545 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716538:same reporter US-MODERNATX, INC.-MOD-2023-716545:same reporter
COUGH CHILLS, INJECTION SITE PAINS, BODYACHES Narrative:
pain in my shoulder got worse; pain in my shoulder got worse; had range of motion issues; Other transient join pain followed/joint issue; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself (patient). A 75-years-old female non-pregnant patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 16:00 (at the age of 75-years-old) as dose 2, single for covid-19 immunization at Hospital. Patient's medical history included pre-diabetes and mild high blood pressure from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medication(s) included lisinopril, metformin, alprazolam (XANAX) and ibuprofen start and stop date were not reported. Patient's historical vaccine included first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: not reported; expiration date: not reported) administered via unknown route in left arm on 26Jan2021 at 16:00 (at the age of 74-years-old) as dose 1, single for COVID-19 immunization and experienced pain in my left arm and shoulder on 26Jan2021 at 17:00. No other vaccines received within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On an unknown date in Feb2016, the patient experienced pain in my shoulder got worse, had range of motion issues, other transient join pain followed/joint issue. The sudden onset of shoulder and joint issues occurred at exactly the same time as the vaccine dose. Patient reported that she will see a rheumatologist. No therapeutic measures were taken in response to the events. The patient underwent lab tests and procedures which included antinuclear antibody: 1:160 on an unknown date. The reporter reporting events as non-serious. The outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021318923 Same reporter/product/patient, different dose and similar events
Fever Began violent headbanging.  This lasted intermittently for several months.  Child caused himself a mild concussion and black eyes.
pt recv vax & reporter heard sound & found pt on floor p/fell on infection waste;appeared to be fainted given ammonia inhaler;c/o pain lt site of head;
40 patients administered with vaccines that have undergone temperature excursion; patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported It was reported that only lot number: 059H21A was affected and it was first thawed on 28-Jan-2022 It was reported Maximum or minimum temperatures reached as applicable (specify temp is in C or F) on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours. No Treatments were reported   This case was linked to MOD-2022-540806.
8/2/01 leg sore, Tylenol given. Won't take bottle. Isn't drinking. Referred to Md. 8-3-01 child ok. Seen Md -ok. As of 10-05-01 child ok.
Fever 101, Chills, joint pain, body aches, fatigue, and kidney pain (lower back pain).  injection site pain, swelling, redness, and heat.
high fever-hoarsenss-weak-pale-pain/redness at injection site-headache-chill~ongoing as of 2/28/07-only treatment ibuprofen   Child was taken to his pediatrician's office and seen by a nurse practicioner who thought he had the flu.
First noticed this AM. Raised slightly red swollen site Left Deltoid region. Warm to the touch. No rash to the body, no shortness of breath, no fever. No other complaint noted. Advised parent to continue to watch, apply cold pack, continue to give Ibuprofen drops as necessary. Call PCP or go to ER if condition worsens.
Patient was given Meningococcal vaccine by mistake. Correct vaccine should have been Pneumococcal . Per Nurse team and provider patient presents no side effect or symptoms as of today.
Moderna COVID-19 Pain in my armpit on same side as vaccination started yesterday 3/6/21. When I woke up today (3/7/21), I have pain and swelling in my armpit. Swelling is slightly smaller than a ping pong ball, not hot to the touch. I don't have any other pain and no fever. I am slightly fatigued.
Injection site [red and] hot to the touch; Injection site went tall and swollen; Injection site red [and hot to the touch]; Injection site sore/the area is also tender to the touch and very painful; This spontaneous case, initially received from other healthcare professional (nurse) on 28-Sep-2018, concerns a 50-year-old, adult, male patient.  The patient had no historical conditions. The patient was not taking any concomitant medications at the time of vaccination.  On 26-Sep-2018, the patient was administered Afluria (QIV) [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 02444611A and expiry date: 06-Jun-2019] for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.  On 27-Sep-2018, one day after vaccination, the patient's injection site went tall (as reported) and swollen, bigger than half a dollar. It was red, hot and tender to touch and was very painful. The patient's treatment measure included ice.  On an unspecified date in 2018, the patient had recovered from the events within one week after administration of the vaccine. The patient felt better.  The reporter assessed this case as non-serious.  This case 201804183 was cross-linked with the original case 201804181 due to same reporter.  Follow up received on 26-Oct-2018: The expiry date of the suspect product was updated as 06-Jun-2019 in the product tab. The outcome for all the events was changed from not recovered to recovered in the event tab. It was reported that, the patient felt better. The narrative was amended accordingly.; Reporter's Comments: A 50-year-old male patient experienced injection site warmth, pain, swelling and redness, one day after the administration of suspect vaccine Afluria (QIV). The company assessed the causality of the events as related due to plausible temporal relationship between vaccination to event onset and localized events of the injected limb.
Patient here for urgent care on 11/17/2015, reported rash with pain on upper left arm after receiving PREVNAR 13 shot recently. Skin comment: (L) deltoid = erythema, warm patch irreg 4x 5 cm. Mild soft tissue swelling. Non tender.
Fever, coughing, body ache, head ache, congestion, chest pain, death
Vomiting and watery diarrhea shortly after receiving shots. Instructed to increase fluids, monitor for signs of dehydration, F/U in clinic or ER if worsens.