chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has asthma (unclear of timeline); This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal vaccine (PNEUMOVAX 23 [PNEUMOCOCCAL VACCINE]), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pneumovax 23, administration date: 2012, for IMMUNIZATION. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "has asthma (unclear of timeline)".  Additional information: Patient recently had pneumovax 23 about 9 months ago which was she thinks the 3rd time she would have received it in her lifetime (2012 and 2022). States she had prevnar 13, 7 years. She was 76 yrs of age and has asthma (unclear of timeline). She discussed it with her hcp who thought maybe should have pcv 20.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse refers to a 11 year old female patient. The patient's medical history included supraventricular tachycardia cardiac. Patient had no drug reactions/allergies. On 23-DEC-2003 the patient was vaccinated with VARIVAX dose 1 (dosing information, route of administration and lot # were not provided). On 23-DEC-2013 the patient was vaccinated with VARIVAX lot # J006161 (expiry date 20-MAY-2015) dose 2, 0.5 ml, subcutaneous. No concomitant medication was used. The patient's parents reported that the next day (24-DEC-2103) "18 hours later" a large vesicle was formed over the injections site. The physician documented that the vesicle was 4 cm in diameter and was full of clear fluid. The patient was recommended (Ibuprofen) and "compresses" for comfort. It was also reported that no treatment was given. The patient was seen in the office for a follow up visit on 27-dec-2013. And the vesicle was draining clear liquid and was beginning to crust. The nurse stated that the lesion "looked exactly like a chickenpox lesion". The outcome of the event was reported as recovering/resolving. Additional information has been requested.
p/ pt recv vax approx 7 days later pt exp 2 varicella-like lesions at inject site on rt leg.
approximately 15 minutes after receiving both vaccines patient c/o dizziness. Pt was laid  on exam table, feet were elevated. After approximately 5 minutes  patient was able to drink a cup of water but still c/o dizziness. Blood pressure was taken and was normal. After approximately 10-15 minutes later patient stated he felt better.
pt recv vax 24OCT95 & w/in 12-24 hrs devel an inj site rxn characterized as red, swollen, & warm;f/u info was recv 7MAR96;sx lasted 2-3 days & resolved
I was informed by the Department of Health during an audit that we administered Moderna vaccine lot # 041C21A on dates of service 11/2-11/08/21 that were expired. The date of expiration was 11/01/21 unknown to my knowledge.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I was informed by the Department of Health during an audit that we administered Moderna vaccine lot # 041C21A on dates of service 11/2-11/08/21 that were expired. The date of expiration was 11/01/21 unknown to my knowledge.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (I was informed by the Department of Health during an audit that we administered Moderna vaccine lot # 041C21A on dates of service 11/2-11/08/21 that were expired. The date of expiration was 11/01/21 unknown to my knowledge.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I was informed by the Department of Health during an audit that we administered Moderna vaccine lot # 041C21A on dates of service 11/2-11/08/21 that were expired. The date of expiration was 11/01/21 unknown to my knowledge.) 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 (I was informed by the Department of Health during an audit that we administered Moderna vaccine lot # 041C21A on dates of service 11/2-11/08/21 that were expired. The date of expiration was 11/01/21 unknown to my knowledge.).    No concomitant medication details was reported. No treatment medication details was reported.
Swelling and redness at injection site, nausea, diarrhea, joint and muscle soreness, tiredness, headaches, shooting pain up and down injected arm, neck pain.
Red and swollen around injection site bruise was about 3 inches long and 4 inches wide.
My first time I started getting laryngitis on 12/27/2022 after visiting my daughter and family for the holidays. I tested positive from a rapid antigen COVID-19 test on 12/29/2022. I contacted my doctor via online portal who prescribed me PAXLOVID 5-day prescription for recovery. Months following, I started experiencing mild symptoms of runny nose and congestion/cough. I didn't have any fever or high temperature. We were out of the country, and we did a COVID-19 test before flying home 03/16/2023 when I tested positive. I contacted my doctor who again prescribed me PAXLOVID for this second round of COVID-19. As of now, I'm feeling fine from my symptoms and just feeling jetlagged from my travels.
First day, HA and extreme fatigue, then next day cough, runny nose, achy joints ( mild, mostly arms), and fatigue, by day 4 after vaccine, just cough and headache with mild fatigue, by day 6, mostly resolved
Vision dim; This is a spontaneous report from a contactable patient. A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER613; UNKNOWN DOSE, SINGLE DOSE), via an unspecified route of administration in the left arm on 17Mar2021 at 04:45 PM (at the age of 56-years-old) for COVID-19 vaccination. The patients medical history includes type 1 diabetes mellitus. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to food, medications or other. The patients past drug history was unknown. The patients concomitant medication includes insulin. On 17Mar2021, the patients Vision affected by flashing lights. There seemed to be a delay in images reaching her brain instead. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive treatment for adverse event. The clinical outcome of the event was found to be recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Went into the er because I was shaking like I was having a seizure and I was delirious. During the testing they found a blood clot in my lung. I am being treated with anti biotics and blood thinners
The injection site started to ache and swell about 4 hours after administration. Patient took Benadryl and Ibuprofen over the counter and also iced the area. The swelling started to subside. She came by the pharmacy 6/3015 around 12pm and her arm was still swollen but the swelling was decreasing per patient.
ANAPLASTIC THYROID CANCER; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 60 year old or unspecified ethnic origin male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-MAR-2021, the patient experienced sore throat and flu like symptoms which were not severe and was not associated with temperature, however the patient had difficulty in drinking water which lasted for 2 to 3 weeks. The patient visited his primary care physician for the same and was prescribe antibiotics. The patient's physician noticed a small spot near the collar bone and planned for further investigation. On 30-APR-2021, the patient underwent a sonogram for the same which was negative. The patient then visited an Ear, Nose and Throat (ENT) physician who performed an examination and advised that nothing was wrong with patient neck and also prescribed second course of antibiotics for a period of 10 days. The bulge in the patient neck grew bigger with in period of 4 to 5 days. The patient visited a hospital and got CT-scan done along with the consultation with an oncologist. On 21-MAY-2021, the patient was diagnosed with anaplastic thyroid cancer with 20% chance in one year. The biopsy was planned but was not conducted due to the position of the bulge. On MAY-2021, Laboratory data included: CAT scan (NR: not provided) Cancer was not presence anywhere else in body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anaplastic thyroid cancer, and the outcome of flu like symptoms was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210556602-COVID-19 VACCINE AD26.COV2.S-Anaplastic thyroid cancer. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
14 days p/vax pt devel fever of 106.4 & a rash;
severe allergic reaction; felt very weak\weakness; very dizzy; sweated; the vein in her leg felt strange and swollen, under her groin; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (very dizzy), HYPERHIDROSIS (sweated), VASODILATATION (the vein in her leg felt strange and swollen, under her groin), ASTHENIA (felt very weak\weakness) and HYPERSENSITIVITY (severe allergic reaction) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (very dizzy), HYPERHIDROSIS (sweated) and VASODILATATION (the vein in her leg felt strange and swollen, under her groin). On 29-Apr-2021, the patient experienced ASTHENIA (felt very weak\weakness). On an unknown date, the patient experienced HYPERSENSITIVITY (severe allergic reaction). On 14-Apr-2021, DIZZINESS (very dizzy), HYPERHIDROSIS (sweated) and VASODILATATION (the vein in her leg felt strange and swollen, under her groin) had resolved. On 30-Apr-2021, ASTHENIA (felt very weak\weakness) had resolved. At the time of the report, HYPERSENSITIVITY (severe allergic reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Blood pressure measurement: 70/40 decreased. On 29-Apr-2021, Oxygen saturation decreased: 90 oxygen was low, reaching 90.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. The patient indicates that she does not take medications. Treatment medications provided by the reporter included apple juice and rest
pt recv vax;p/ 2nd dose,exp pain in lt arm;sweating & fatigue;w/ 3rd dose,lab tests showed anti HBs<10;c/o pain, sweats & fatigue;MD felt exp not related to vax but pt felt sx related to vax;pt refused booster dose;by dec94 recovered;
Patient received dose # 1 of Pfizer vaccine in left arm.  He developed swelling under the arm after receiving injection.  He states that he waited an extra week in between doses due to the swelling which had improved, but was not resolved prior to 2nd dose.  He received dose # 2 in right arm and developed swelling under the right arm as well.  Swelling is again improved, but is still significant under both arms.  Patient did receive a positive covid test on 11/29/2020.  The patient is also a physician.
Extremely sore and swollen shoulder the day after, 3/25/21. 8 out of 10 on personal pain scale. Took ibuprofen to relieve pain. As of 3/26/21,  swelling has gone down and pain has reduced to a 3 out of 10 on a personal pain scale.
First Dose 29Apr2021, second dose 02May2021; First Dose 29Apr2021, second dose 02May2021; felt tired; Cough; Runny nose; Osteoarthritis getting bad in knuckles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4155792-00 (Company).  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 02May2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Drug: Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran), Unknown, Daily Dose: First Dose (1 in 1 Once) , Route of Administration: Intra-muscular, Therapy Dates(From/To): 29Apr2021-29Apr2021), administration date: 29Apr2021, when the patient was 65 years old, for COVID-19 Immunization, reaction(s): "Osteoarthritis aggravated".  The following information was reported: OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 02May2021, outcome "unknown" and all described as "First Dose 29Apr2021, second dose 02May2021"; FATIGUE (non-serious) with onset 02May2021, outcome "recovered" (May2021), described as "felt tired"; COUGH (non-serious) with onset 2021, outcome "recovered" (2021), described as "Cough"; RHINORRHOEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Runny nose"; OSTEOARTHRITIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Osteoarthritis getting bad in knuckles". The action taken for adalimumab was unknown.  Additional information: Drug: Pfizer BioNTech covid-19 vaccine (tozinameran) (tozinameran),unknown, unknown, unknown Daily dose: 1) first Dose (1 in 1 once) 2) Second Dose (1 in 1 Once) 3)-Third Dose (1 in 1 Once) Route of Admin:  1) Intra-muscular 2) Intra-muscular 3) Intra-muscular Therapy Dates/Duration 1)09Apr2021- 09Apr2021 2) 09May2021-09May2021 3) 23Dec2021- 23Dec2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial report received from a health care professional on 19 April 2011. A 21-year-old female patient whose medical history was not reported, had received the morning of 18 April 2011 a first intramuscular left deltoid injection of MENACTRA (lot number U3510AA), an intramuscular right deltoid injection of a TDAP vaccine (trade name and manufacturer unknown, lot number, route and site of administration not reported) and a TB (tuberculin) test (trade name, manufacturer name, lot number, route and site of administration not reported). The same day, the patient called the health department to report that she had blacked out for 1 minute, and that her left arm was sore and swollen up to her shoulder. The patient required a doctor visit, however the results of that visit were not provided. The reported did not have the patient's record at time of reporting, but will provide further information in follow-up. At the time of this report, the patient had not recovered. Additional information has been requested. Documents held by sender: None.
patient called 11/14/19 and reported she had to go to ER 10/10/19 for cellulitis
Severe arm pain, stiff neck, fever that occurred within 24 hours of administration and lasted for 1 day.
This child had a fever of 103 on 07/07/98. A temperature of 105 - 106 rectal at home on 07/08/98. A temperature of 103 axillary in office  on 07/09/98, bilateral otitis media ; treated with Acetaminiphen, Ibuprofen, Trimethoprim / Sulfa antibiotic; Nystatin oral suspension for thrush. On 07/10 Cefirraxone IM. The patient had viral exanthem rash from 07/11 to 07/15 pink, macular, irritable. The patient is now irritable, delayed, and has autistic features.
Developed bilateral  leg  weakness within few hours  after vaccine administration, Within 24 hours developed bilateral leg tingling and  Noted weakness with walking and numbness after sitting.
Received telephone call from client. Reports pain in left shoulder srea which radiates to neck area. Reports pain began after Td injection and continues x 4wks. Reports no redness or swelling. Plans to see private MD
ZOSTAVAX administered 3-10-16 at 4:10 pm. She stated she noticed a red, raised area on the back of her (R) arm after work on Fri, March 11, 2016 at approximately PM. She stated it started itching Saturday. She has only used plain lotion at site. The site measures 1 inch x 1 inch (L x W) today (3-14-16) at 4:10 pm, it is red and raised, but not itchy. There is a discolored area and I also measured this discolored area and the red area together (2 inches x 1 1/2 inches) (L x W).
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, TIZANIDINE HCL and EZETIMIBE for an unknown indication.    On an unknown date, 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 (sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-320984, MOD-2021-307848 (Patient Link).
translator used, patient verified this was his 2nd dose, therefore 2nd dose was given.. Wife later showed card which indicated that patient has received two doses of Sinovac in another country and one dose here 11/2021. Through translator patient was educated that he had received 4th dose and patient verbalized understanding
Patient suddently moved her arm during vaccine administration of Pfizer booster and received only a small portion of the booster and the rest of the vaccine came out of syringe and squirted out.  Unable to determine how much of booster dose she actually received.  She became extremely anxious during and after administration.  I immediately called my supervisor, RN, at the DOH and informed her what occurred.  She advised me to readminister vaccine if spouse consents.  Option given to spouse.   She has end stage dementia and does not go out at all and only sees himself, her two aides and hospice nurses.  He declined to have her readministered with booster.
Had shakes and Temp of 102 degrees-2 red spots size of 2 eggs-rash dry and scaly down to elbow-okay the next AM.
ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS ACUTE DVT OF RIGHT CALF, UNSPECIFIED VEIN HYPOTENSION HYPOXEMIA
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 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 11:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 11:58 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 72.09.  Concomitant products were not provided.  For Lot no : 026C21A on 25-May-2021, excursion time was 8 AM and 9 AM and temperature was 35 and 35 respectively, total doses given for the day was 39, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 18-May-2021 and was moved to clinic on  24-May-2021. 3 vials was sent to clinic. Vaccine BUD date was 06-Jun-2021.  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 brand traceable 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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported
was inadvertently administered a dose of Tenivac lot#U6091AA lot#12Oct2020 today with no AE; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient of unknown age who was inadvertently administered a dose of Tenivac lot#U6091AA lot#12Oct2020 (Expired product administered) while she received vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] at a dose of 0.5 ml daily (batch number: :U6091AA and expiration date: 12-Oct-2020) via intramuscular route in unknown administration site for prophylactic vaccination.   Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   This was an actual medication error case due to the event incorrect product storage (latency: unknown).   At the time of reporting, no adverse event was reported.   No laboratory data was reported.   Disclaimer: 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