chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from the patient's wife, referring to her husband a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unspecified date in 2009, the patient was vaccinated with the first dose of ZOSTAVAX (dose, route, lot number and expiration date not reported) for prophylaxis. The reporter stated that the patient inadvertently received a second ZOSTAVAX injection on 11-JUL-2017. No adverse event reported.
Patient feels as though someone is repeatedly punching his arm. It started last night at around 10:00pm. Currently, the injection site is red, appears bruised, and is painful to the touch at the injection site. Patient has taken 800mg of ibuprofen and 250mg of acetaminophen, which he claims has not helped. He has also applied ice to the area, which seemed to help. He does not have shortness of breath, a fever, or trouble breathing.
Information has been received from a medical assistant concerning a 17 weeks old male patient with no pertinent medical history and no known allergies who on 02-FEB-2009 was vaccinated orally with the first dose of ROTATEQ (lot # 660550/0616X) and on 17-APR-2009 received orally the second dose of ROTATEQ (LOT # 663142/1462X).  There was no concomitant medication.  On 17-APR-2009, 5 to 10 minutes after receiving his second dose of ROTATEQ, the patient vomited.  It was reported that the patient was seen for an office visit.  On 17-APR-2009 the patient recovered.  Follow-up information has been received from a physician concerning the infant patient.  It was reported that on 17-APR-2009 the patient concomitantly received a dose of PENTACEL and a dose of PREVNAR.  There was no illness present at the time of vaccination.  It was reported that the patient promptly vomited ROTATEQ after it was given.  The physician office contacted a company representative to see if the patient should be given another dose of ROTATEQ and she told them not to.  There were no problems the patient experienced after this event.  No laboratory or diagnostic tests were performed.  On 15-JUN-2009 the patient received the third dose of ROTATEQ without problem.  No further information is available.
A 10 year old was not flagged when entering the clinic and was given the Pfizer vaccine.  Mom was notified that the second dose could not be given until it is approved for that age.  No adverse effects or side effects were noted.
itching; slight little pain when the needle went in; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and VACCINATION SITE PAIN (slight little pain when the needle went in) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PRURITUS (itching) and VACCINATION SITE PAIN (slight little pain when the needle went in). On 05-Mar-2021, PRURITUS (itching) had resolved. At the time of the report, VACCINATION SITE PAIN (slight little pain when the needle went in) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided. Patient did not experienced any side effects after the booster dose.   This case was linked to MOD-2021-391901.
Reports receipt of vaccines on 7/23/08 (both vaccines in left arm). Early a.m. on 7/25/08 awoke with fever (temp 102.4), shaking, and chills.  Later on 7/25/08, she noted her arm was red, swollen, tender and there was streaking between injection sites and elbow.  She also noted headache, fatigue, and generalized body aches.  She went to ER on Saturday and was diagnosed with "cellulitis" and started on Z-PACK.  On 7/28/08, vaccine site and surrounding area still tender, but streaking, redness and swelling significantly decreased.  She was afebrile and denied systemic symptoms.  Evaluation on 7/29/08 noted induration at vaccine site about 30 x 50 cm.  Minimal redness.  Afebrile.
24 hours after vaccine admin, pt experienced erythema, induration, warm to touch around admin site.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 9:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:48 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 53.10. Concomitant products were not provided. On 03-Apr-2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021 and vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Patient given COVID-19 vaccine (Pfizer) as first dose at previous vaccine clinic on April 6th 2021. Patient given second dose of COVID-19 (Moderna) on April 29th 2021. Patient made aware of incident. Pharmacist, MD and site lead RN notified about incident. All of them spoke with patient. Patient observed on-site for 30 minutes. Patient had no adverse reaction while on-site and tolerated vaccine well. Patient left site and was given clinic contact information to follow-up if needed. Patient verbalized understanding and had no further concerns at that time.
Was administering vaccine and the screw tip of syringe and needle made a popped sound. After the "pop" the rest of the medication ran down the patients arm. I don't know how much the patient received. Patient stated he felt the liquid go in his arm and knows he got it.
10mins post vaccination pt c/o flushing/sweating and dizziness. Vitals 16:25 103/52, 70, 20, SpO2 100% -- > 16:35 109/55, 63, 20, 100% -- > 16:43 113/69, 55, 20, 100% Pt stable and released from vaccination site at 16:43.  Pt refused wheelchair.
Patient came back a month after receiving the vaccine stating that this vaccine has given him muscle soreness that has still not gone away. It is only around the site of the immunization.
Evening of second day following 3rd Injection only ( no reactions at all to 1st & 2nd dose): nausea/vomiting, diarrhea, 3 episodes over next 7 days; chills for 3 days, severe on 3rd day after injection;  insomnia for these 3 nights, severe ankle and foot pain 1 night,  same period of time;  starting 2nd day after injection also had fatigue, headache, body aches for 8 days totaled; generally I did not feel well until 11/7/2021, but never felt like a medical appt. would help me.
This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No symptoms were reported. This is one of the several reports from the same source. Additional information has been requested.
On Friday, May 20, I woke up at 6:00 am with cough, headache, and lethargy.  I took home covid  test and tested positive.  I called my primary care physician who prescribed paxlovid, histamine, and albuterol.  The symptoms  eased after two days but I completed the full regimen as directed. I tested positive through Wednesday, May 25 and then negative on Thursday, May 26.
Patient felt dizzy. when she lowered her head she felt slightly better, but then felt dizzy again and fainted for ca 30 sec. then regained conciousness. We let he lie down. She felt better after a while, but when she sat up she felt dizzy again and lied down again. We called 911 and EMT came to check. They left withou reporting back to me. The patient left at the same time
This spontaneous report was received from a Office Manager refers to a 04 year old male patient. The patient's relevant medical history and concurrent condition were not reported. On 09-APR-2018, the patient was vaccinated with a dose of expired PROQUAD injection lot # M041083 (expired date: 04-APR-2018), 0.5 ml once for prophylaxis (expired vaccine used). Concomitant therapy included sterile diluent (DILUENT MRK INJ) which was used to reconstitute. No adverse effect reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1804USA005644:
excruciating back pain, 10/10,  Pt went to ER for treatment and got ketorolac.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-OCT-2015 16:11, the patient was vaccinated with improperly stored RECOMBIX HB with lot number: L016427, expiry date: 13-APR-2017 9dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 10.0 (1hour 26mins) and 1.2 (3hours 55mins) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 66 year old female who on 27-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (route not reported, lot# 665300/1314Y). On 27-SEP-2010 the patient experienced injection site became warm, painful and swollen that night. She stated that the reaction cleared in three days. She did not seek medical attention and she was fully recovered at the time of this report. The nurse stated that the pharmacy that administered the vaccine had a standing order from the listed physician and that the patient was not examined prior to receiving the vaccine. This is one of several reports received from the same source. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jun2022 at 19:00 as dose 4 (booster), single (Lot number: FNZ908) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had initial symptoms, positive COVID test on 10Sep2022, and Start Paxlovid 14Sep2022 end Paxlovid 15Sep2022.
received the Moderna booster on 1/19. He had a fever the day following the vaccine and felt fatigued. He developed pruritis and rash this past Saturday (1/29). He has taken benadryl for the itching. Reports some relief after soaking in a hot bath with epsom salt. He denies fever, sob, chest tightness.
swollen lymph nodes bilaterally in abdomen and groin, abdominal pain on left side, pain in abdomen, nausea, cyst present on liver
FEELING HEAVY; NECK IS STIFF; SLIGHT DRAINAGE; FEELING WEAK; FEVER OF 100.4; HEADACHE; SPREADING COLD THEN TURNS TO SPREADING HOT OVER WHOLE BODY; SINUS PRESSURE; THROAT IS DRY AND THROBBING; VERY COLD; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and antibody infusion, and concurrent conditions included sulfa allergy, and myosin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced spreading cold then turns to spreading hot over whole body. On 03-JUN-2021, the subject experienced sinus pressure. On 03-JUN-2021, the subject experienced throat is dry and throbbing. On 03-JUN-2021, the subject experienced very cold. On 03-JUN-2021, the subject experienced fever of 100.4. On 03-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.4. On 04-JUN-2021, the subject experienced feeling heavy. On 04-JUN-2021, the subject experienced neck is stiff. On 04-JUN-2021, the subject experienced slight drainage. On 04-JUN-2021, the subject experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very cold, spreading cold then turns to spreading hot over whole body, sinus pressure, feeling heavy, neck is stiff, slight drainage, headache, and feeling weak, and the outcome of throat is dry and throbbing and fever of 100.4 was not reported. This report was non-serious.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 02-JUN-2017, the patient was vaccinated with PROQUAD (lot # reported as M049123, expiry date: 13-JUN-2018), (route: subcutaneous) reconstituted with properly stored diluent MRK (lot #N002578, expiry date: 05-AUG-2019). No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 03-FEB-2014, a healthcare provider at a family practice administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2017, the patient was treated by a healthcare provider at an express care facility for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Loss of use of entire left-side of body, nausea, low-grade temperature, slurred speech and rapid pulse. Went to ER. CAT scan, EKG, blood and urine tests and chest x-ray. All results came back negative. ER doctor diagnosed as possible reaction to third dose of Pfizer vaccine. Patient had a hemorrhagic stroke on 08/25/2020 with entire left-side paralysis. Therapy for a year and regained back to 75% of normalcy. Patient received the first dose of Pfizer vaccine on 02/12/2021 with no side effects at all. On 03/05/2021 received second dose of Pfizer vaccine.
Shngrix injection really hurt; This case was reported by a pharmacist and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The patient complained that the Shingrix injection really hurt. The reporter consented to follow up.
Very tired for one week; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Very tired for one week) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 02-Jun-2021, the patient experienced FATIGUE (Very tired for one week). On 09-Jun-2021, FATIGUE (Very tired for one week) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment drugs were provided.
High pitched wailing. Dragging leg (right). General crankiness. Rash (lasted 2 1/2 days). Fever 102 degrees F.
Pt reported muscle aches (primarily neck/ back/ arm pain), headache, low grade fever (<101.0) 1-2 days after vaccination.   Reports tachycardia & chest pain 1 week after vaccination, had gone to school nurse.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 10-Dec-2011, the patient inadvertently received expired FLUMIST. The product expired on 05-Dec-2011. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 30-Mar-2012 and incorporated into the narrative. No late occurring adverse event.
Rash started on 04/13/19 on back.  Itchy rash continued to spread to abdomen and to other areas on the body.  Clinically diagnosed with varicella rash related to vaccine on 04/23/19.
Per NP hive on lower extremities spreading to abdomen, following immunizations, reported change in color of extremities, not observed by provider following Benadryl hives resolving, infant sleeping advised to monitor and wake in 3 hours to feed. Will refer to allergist to determine a plan for the following set of shots.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 17-JUL-2017 the patient was vaccinated with PROQUAD, (lot# and expiration date not reported) for prophylaxis and also vaccinated with VARIVAX (lot# and expiration date not reported) for prophylaxis. No adverse events reported.  No additional information provided. Additional information has been requested.
brain issue; Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and CEREBRAL DISORDER (brain issue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included Barrett's esophagus on 15-Apr-2021. Concurrent medical conditions included Hypothyroidism since 01-Mar-2009 and Hypertension since 01-Mar-2006. Concomitant products included OMEPRAZOLE from 2012 to an unknown date for Gastroesophageal reflux, LISINOPRIL from 2006 to an unknown date for Hypertension, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 2009 to an unknown date for Hypothyroidism.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced TINNITUS (Tinnitus). On an unknown date, the patient experienced CEREBRAL DISORDER (brain issue). At the time of the report, TINNITUS (Tinnitus) and CEREBRAL DISORDER (brain issue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Significant follow up appended: Reporter address was added. The patient demography updated. Medical History included Hypothyroidism, Hypertension and Barrett's Esophagus were added. Suspected 2nd dose updated. Concomitant medications LEVOTHYROXIN, LISINOPRIL, OMEPRAZOLE were added. Event Tinnitis start date and outcome was updated and additional event brain issue was added.