chrisvoncsefalvay/vaers-outcomes huggingface dataset:
light headed; feels like fighting a cold; sore throat; a rashby my left elbow; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 10:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, and blood pressure high. The patient had no known allergies. Concomitant medications included metformin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN, amlodipine (MANUFACTURER UNKNOWN), and insulin (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, the patient experienced a sore throat, rash by left elbow, fatigue. On 07Apr2021 at 07:00, the patient experienced when turned head to look in a different direction became light headed, body felt like fighting a cold. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore throat, rash by left elbow, fatigue, light headed, body felt like fighting a cold was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No additional AEs; patient has received 4 GARDASIL 9 vaccines; 2 of those vaccines were administered subcutaneous. (3rd dose); 3rd dose was administered only 2 months after 2nd dose; 2 of those vaccines were administered subcutaneous. (1st dose); This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies was not reported.  On 10-JUN-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered subcutaneously (dose, lot #, and expiry date were not provided) (incorrect route of product administration) for prophylaxis.   On 12-JUL-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, lot #, and expiry date and route of administration were not provided) administered for prophylaxis.   On 14-SEP-2022, the patient received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered subcutaneously (dose, lot #, and expiry date were not provided) (incorrect route of product administration) for prophylaxis. It was also noted that the 3rd dose was administered only 2 months after 2nd dose (inappropriate schedule of product administration). When the patient was asked about how he/she had known the injections were subcutaneous, the patient stated "One was too low and the other was too high."  Additionally, on 17-JAN-2023, the patient received a fourth dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (dose, lot #, and expiry date and route of administration were not provided) administered for prophylaxis (extra dose administered).   No additional adverse event was reported.
he received the Pfizer covid vaccine in triceps muscle instead of the Deltoid./it was not administered on his deltoid, it was injected to another site on his lower arm/ tricep; sore arm; anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 18Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "he received the Pfizer covid vaccine in triceps muscle instead of the Deltoid./it was not administered on his deltoid, it was injected to another site on his lower arm/ tricep"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; ANXIETY (non-serious), outcome "unknown", described as "anxiety".  Additional information: Caller stated he received the Pfizer covid vaccine in triceps muscle instead of the Deltoid. Caller wanted to know would that effect the efficacy of the vaccine. He said has sore arm and some anxiety as his injection was not given in the deltoid muscle. He wants to report that it was not administered on his deltoid, it was injected to another site on his lower arm/ tricep. Caller wanted to know should he be concerned. Asked if there will be an issue with regards to the efficacy of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 as dose number unkown, single (Lot number: 330268D) and on 28Apr2022 as dose number unkown, single (Lot number: FJ4989), in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 09Apr2021 as dose number unkown, single (Lot number: 1805018), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer history" (unspecified if ongoing), notes: Cancer history, but normal mammograms since; "known allergies: Penicillin, oral" (unspecified if ongoing), notes: known allergies: Penicillin, oral. Concomitant medication(s) included: GABAPENTIN, start date: Jun2018; ALENDRONATE, start date: Nov2020; CALCIUM, start date: Nov2020; IBUPROFEN, start date: Jan1983; PROPRANOLOL, start date: Jan2003; SUMATRIPTAN, start date: Jan2000; ESTRADIOL, start date: Jan2017; REFRESH OPTIVE, start date: Jan2003; ACETAMINOPHEN, start date: Jan1960; FEXOFENADINE HYDROCHLORIDE, start date: Jan1974; LANSOPRAZOLE, start date: Jan2003.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive; (20Jul2022) Positive. Therapeutic measures were taken as a result of covid-19.  clinical course: In last 2 week patient took several other medication like Multi for her,(Nature made nutritional products; start date=Jan1985; lot number=2457281)  rest of additional info given was already captured in linked case  202201021866same patient and reporter, different drug and event.  No follow-up attempts are possible. No further information is expected.
NO ADVERSE EFFECT; one improperly stored dose of V AQTA was administered; This spontaneous report was received from a medical assistant and refers to a 13 month old patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 11-MAY-2020, the patient was vaccinated with one improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # S025993, expiration date 17-OCT-2020 (upon internal validation) for prophylaxis.  The administered vaccine experimented temperature o  68.58 degrees Fahrenheit for 9 hours 41 minutes with previous temperature excursión of 46.1 degrees Fahrenheit for 7 minutes. Digital data logger was not involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025993; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This case was reported by a pharmacist via call center representative and described the occurrence of myalgia in a 78-year-old female patient who received SHINGRIX (batch number P57AA, expiry date 5th July 2021) for prophylaxis. Concurrent medical conditions included neurological disorder nos (the patient did indicate having a nerve condition disorder). On 12th March 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced myalgia, nerve pain, feelings of weakness and walking difficulty. On an unknown date, the outcome of the myalgia, nerve pain, feelings of weakness and walking difficulty were not recovered/not resolved. It was unknown if the reporter considered the myalgia, nerve pain, feelings of weakness and walking difficulty to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experience myalgia and nerve pain. The patient visited her physician and was informed that the symptoms would subside, however the symptoms have persisted for nearly a month. The patient did report a small amount of improvement with her symptoms but also reports she still feels weak and was having difficulty walking. The pharmacist reported that the patient did indicate having a nerve condition disorder. The exact condition was not known by the reporter. The patient did not report having taken any medications to alleviate her symptoms since receiving the vaccine. The onset of the symptoms after the vaccine was administered was unknown by the reporter.
Started right after the MMRV w/ cold sx and fever. Sx of URI started to resolve a few days later then the shot site swelled up and a diffuse rash started. LG fever on and off, spiking. Completely resolved within 2 weeks.
Period irregularity, sharp pains randomly in ovaries, Random sharp pains throughout my body (chest a lot)
Sx onset 7/14/21 cough, sore throat, muscle aches, headache, fatigue, loss of smell & loss of taste.
pt recv vax 28APR99 & 1-2hr later devel severe h/a splitting h/a accompanied by vomiting;no  family member w/same dx;no fever, no rash, no hives, no itching;
Headache, Sedation, Myalgia, Arthralgia, Fever, Diarrhea,  Chills, pain at the injection site
The shot was on the other side and it was a lymph thing.; Soreness in left armpit; Tiredness; Left arm soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 09:55 (Lot number: EN6208) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM taken for arthritis. The following information was reported: FATIGUE (non-serious) with onset 17Mar2021 12:00, outcome "recovering", described as "Tiredness"; VACCINATION SITE PAIN (non-serious) with onset 16Mar2021 10:15, outcome "not recovered", described as "Left arm soreness at injection site"; AXILLARY PAIN (non-serious) with onset 18Mar2021 04:00, outcome "not recovered", described as "Soreness in left armpit"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "The shot was on the other side and it was a lymph thing.".  Additional information: They did the shot way up in the arm just below the shoulder. She heard about blood clots and it worried her.  No follow-up attempts are possible. No further information is expected.
40 years old received Pediarix; administered Pediarix instead a Tdap vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 40-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number ZK4XF, expiry date 11-APR-2025) for prophylaxis.   On 30-OCT-2023, the patient received Pediarix. On 30-OCT-2023, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: 40 years old received Pediarix) and wrong vaccine administered (Verbatim: administered Pediarix instead a Tdap vaccine). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-OCT-2023 The nurse reported 40 year old male was supposed to receive a Tdap vaccine but a Medical Assistant administered Pediarix instead which led to inappropriate age at vaccine administered and wrong vaccine administered. At the time of reporting, no additional dosing had occurred. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter.
Within 12 hours flue-like symptons of muscle ache, headache, chills, fatigue, cough, loss of appetite. In general, myalgia. Persisted with gradual improvement over 7 days. Shot given about 2PM on Nov. 4, 2006.
lost my sense of taste; I feel so sick; lost my sense of smell; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost my sense of taste), MALAISE (I feel so sick), ANOSMIA (lost my sense of smell) and FATIGUE (fatigued) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced AGEUSIA (lost my sense of taste), MALAISE (I feel so sick), ANOSMIA (lost my sense of smell) and FATIGUE (fatigued). At the time of the report, AGEUSIA (lost my sense of taste), MALAISE (I feel so sick), ANOSMIA (lost my sense of smell) and FATIGUE (fatigued) outcome was unknown.            No concomitant medications were reported. No treatment was reported.   This case was linked to MOD21-079739, MODERNATX, INC.-MOD-2021-083099 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20-May-2021 and contains non-significant Information.; Sender's Comments:  MOD21-079739: MODERNATX, INC.-MOD-2021-083099:
bad shingles right after their boosters; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 27-Feb-2023 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter asked that mRNA jab. The reporter knew that the patient got bad shingles right after the boosters. Additional supportive information: The follow-up could not be possible as no contact details were available. As per reported information it seems that reporter was reporting about the 2nd dose of Shingles vaccine which was considered as booster of shingles vaccine, therefore single suspect was coded with dose number 2 with immediate time to onset for shingles. This 1 of 3 linked cases reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR036625:Same reporter US-GSK-US2023AMR036631:Same reporter
Approximately one month ago, Patient experienced blindness 24 to 48 hours after injection/she went blind within 24-48 hours after vaccine; This serious case was reported by a consumer via sales rep and described the occurrence of blind in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced blind (Verbatim: Approximately one month ago, Patient experienced blindness 24 to 48 hours after injection/she went blind within 24-48 hours after vaccine) (serious criteria GSK medically significant).  The outcome of the blind was unknown.   It was unknown if the reporter considered the blind to be related to Shingrix.     It was unknown if the company considered the blind to be related to Shingrix.   Additional Information: GSK Receipt date: 01-SEP-2023 The reporter was sales representative and said that fell free to call her at any time. The reporter called and reported that approximately 1 month ago, patient went to first physician who provided Shingrix injection and reported to the second physician the patient followed up with that she went blind within 24 to 48 hours after vaccine. The reporter gathered information from second physician during visit and said she had to report this adverse event. Neither physician wanted their names mentioned and the first one did not want to report it, and the second physician was not a fan of Shingrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
arm is very sore after receiving the shot; A spontaneous report was received from a non healthcare professional concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm is very sore after receiving the shot.   Medical history was not reported.  Concomitant medication was not reported.  On 21-Jan-2021, prior to the onset of the event arm is very sore after receiving the shot, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) via intramuscular route in right arm shoulder deltoid condition for prophylaxis of COVID-19 infection.  On 21-Jan-2021, the patient experienced arm is very sore after receiving the shot.  Laboratory details was not provided.  Treatment medication was not provided.  Action taken with mRNA-1273 in response to the event arm is very sore after receiving the shot was not provided.  The outcome of the event arm is very sore after receiving the shot was not recovered.  The reporter did not provide the assessment of the event arm is very sore after receiving the shot to study drug.
Patient was here for the 2nd dose of his Moderna Covid Vaccine when it was noticed that the patient was out of age range for this vaccine (16 years old).  The DOB of the patient that was given to the pharmacy during the 1st dose was entered dishonestly by a parent filling out the online patient consent form.  Patient did not have any reactions to first dose given.
RN administered Tdap Vaccination Boostrix with Lot #:7535X and Expiration date of 2/15/2015. RN administered vaccine after vaccine expiration date. RN notified patient and patient was revaccinated on 03/16/2015 with Tdap vaccine Lot #: U5030AA and Exp.: 05/01/2017 by RN.
Hospital RN administered influenza vaccination Fluvirin o.5ml - states that she almost immediately developed hives which progressed, with pruritis - reported to Employee Health approx 1 hour later - escorted to Emergency Dept, received epinephrine, steroids, and pepcid - responded well, discharged several hours later to home.
I woke up just freezing; one of them chills or just being very cold; This is a spontaneous report from a contactable consumer. This contactable consumer (patient) reported that: A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration, on unspecified date as a dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient stated that patient woke up just freezing and one of them chills or just being very cold. Patient stated that, "About a reaction possibly, patient had a shot about 7:09 here where patient located. Patient probably had it about 3 o'clock this afternoon so it was been 16 hours and patient woke up just freezing like never had been just cold patients entire life and live-in world's wintertime and understand side effects and patient was looking in this was got a bunch of side effects was that one of them were chills or just being very cold. Patient queried if Is that a side effect to that. Patient was informed about Pfizer Medical Information Department, Patient just wanted to know that was a side effect this time. Because patient had never been this cold in life. Patient stated that patient was sure, it was a side effect. The outcome of the event was unknown.
Cold, nausea (terribly nausea), sweating, fever, aching, pain, chills all over body, fatigue (can't move her body), apathy. (the next morning)-> Take TYLENOL 650 mg -Z tablets Q8H. She feels the same way, in bed for 3 day already.
Case number PHEH2044US004296 is an initial spontaneous report from the consumer received on 28 FEB 2014. This report refers to a 12-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number not reported) intramuscularly on 20 FEB 2014. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).  Following an internal review on 18 AUG 2014 of the data received on 28 FEB 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
patient got a flu shot yesterday and wasn't feeling very good last night. Had the chills for a little while; Initial information was received on 31-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case is linked to case 2020SA307599, 2020SA307615, 2020SA307606, 2020SA307607, 2020SA307613, 2020SA307609, 2020SA307610, 2020SA307611, 2020SA307612 and 2020SA307608.  This case involves a patient of unknown age who got a flu shot yesterday and wasn't feeling very good last night. had the chills for a little while (chills), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient got a flu shot yesterday and wasn't feeling very good last night. had the chills for a little while (chills).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Fatigue that has not gone away. Large bumps on my left hand.  Mental health is declining.
I have a strange bruise on my arm from the vaccines that were administered, I have a terrible sickness, my mouth feels swollen, I can't taste my food since Sunday, I can't breathe during my sleep, and, I'm losing sleep because of it. I never felt this sick until after those shots on Tuesday at my doctors office.