chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse reaction were noted; Expired VAQTA adminsitered; This spontaneous report has been received from a health care professional regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, drug allergies or reaction were not provided.   On 16-NOV-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 mL (anatomical location of vaccine and route of administration were not reported), lot # S018772, expiration date reported 11-JUL-2020, but upon internal validation was established as 07-JUL-2020, for prophylaxis. No adverse reaction were noted to the patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S018772; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Received booster shot on 9/20/2022,Felt ok 9/21/2022,started to feel bad on the 22nd, really felt bad on the 23rd, took a at home test, and tested positive for Covid. Have know idea how I got it or where it came from. On the 26th I started the 5 day treatment of paxovid. I don't seem to have any long term effects. I did have a dry cough,body aches,very tired.
Had an adverse reaction; Itching; Severe allergic reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had an adverse reaction), PRURITUS (Itching) and HYPERSENSITIVITY (Severe allergic reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had an adverse reaction), PRURITUS (Itching) and HYPERSENSITIVITY (Severe allergic reaction). At the time of the report, VACCINATION COMPLICATION (Had an adverse reaction), PRURITUS (Itching) and HYPERSENSITIVITY (Severe allergic reaction) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medications was reported.  No treatment drug details was reported.
Per client:  As vaccine went in arm went numb, then felt light headed as walking to chair, while sitting vision went blurry and hearing went muffled; feels a little shaky; EMT checked BP 95/66;   At 1427 vision and hearing better; BP range 101/68; Client reports her usually BP is "average"; at 1433 BP per EMT 102/72 while sitting; at 1436 BP per EMT while 93/68 standing; client continues to feel lightheaded; EMT discussed treatment options with client to transport her to the free standing emergency department (FSED) or call husband to pick her up.   Client decided to call husband to come and pick her up; EMT recommends her to go to FSED.
Injection site was warm/hot to touch, touch tender, pt. febrile and chills, oral temp 99.8 after chills. Fever started 29 hours after injection - remained febrile for 60 hours. Normal temp. 97.8. No nausea, no diarrhea. R injection site itches and warm 3/12. No spleen.
Rash on chest, neck and arms  Nausea, loss of appetite Severe Headache Extreme Fatigue
4.6x3.0 cm area of erythema . Warm to touch surrounding injection site.
generalized itching; This is a spontaneous report from a contactable consumer (patient) via . This 68-year-old patient of unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6207) via an unspecified route of administration in the right arm on 15Mar2021 at 16:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, obesity and hypertension, all from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had no concomitant medications and had not received any other vaccines in the four weeks prior to the COVID vaccine. The patient reported that 24 hours after injection they developed generalized itching; no hives just itching head to toe. The patient reported taking diphenhydramine hydrochloride (BENADRYL) every 6 hours. The patient reported receiving the second dose of BNT162B2 (lot number EN8731) on 12Apr2021.The clinical outcome of generalized itching was unknown. It was also reported that since vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
About 10 min following  vaccination, patient's father yelled for help. Patient was sitting on a chair and pale looking. He said his vision turned black, felt dizzy. His breathing was normal, but blood pressure dropped. During the 2 min observation time, his breathing was fast at some point. He said he wasn't nauseous. He asked for water. I gave him some warm water. He finished the whole cup of 6 oz of water.  We continued to monitor his blood pressure every 2-3 min. His blood pressure was going up every time we checked. He continued to ask for water, and he drank another cup of warm water. After about 10 min, he felt better and able to walk without dizziness.
The patient had no immediate reactions to the second dose of the vaccine, except for arm soreness which resolved in 24 hours. One to two  week later, the patient developed a global widespread swollen red patches all over the body. The whole body would itch aggressively including head scalp. The red patches will keep appearing at any random location. Clinic detected eczema like symptoms and recommended antihistamine  cetirizine (ZyrTEC) , white petroleum mineral oil (vaseline) and steroid ointments (hydrocortisone). Patient applied for few days. The symptoms would go away and reappear next day. After few days its reappearing every two days. Patient is taking ZyrTEC and feels good for 2 days and have to take recurring medicine. Patient has no history of allergy, side effects  or any health conditions. This has become chronic.
Myalgia, Fever, CoughWheeze, SORE THROAT, FEVER 99-102.4F, CHILLS Narrative:
Patient was give her 1st Moderna shot on 7/20/21 with no issues or side effects. On 8/17/21 she received her 2nd Moderna shot @ 6:00pm. She is a healthy young female with no known allergies, health conditions, and not on any medications or OTC supplements. After the Second dose I advised patient to sit for 15 minutes in our waiting area to be monitored and what to look out for in case of a reaction. Around 6:10 pm her friend signaled to me that the patient was not feeling well. I immediately went out to check on her. She stated that she could see black/dark color in her eyes, was having hearing loss, syncope, felt ice cold internally, but was hot and clammy outside to the touch. I sat her down and called 911 for EMT to come evaluate her. She was feeling much better about 10 minutes after this @ about 6:20-6:30 pm.  EMT and fire department evaluated patient and we all advised her to stay with family for the night to be monitored. She did not go to the ER. They felt she was ok to go home and rest. 8/18/21
ACUTE ONSET OF DIURNAL ENURESIS AND ENCOPRESIS. EXACT TIME OF ONSET UNKNOWN. MOM STATES "SEVERAL DAYS AFTER IMMUNIZATION".
This spontaneous report was received from a licensed practical nurse referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 05-JUN-2017,  the patient was vaccinated with an expired dose of M-M-R II lot # L020189 with expiration date of 03-JUN-2017, status albumin: RHA, (strength, dose, frequency, route of administration, were not provided) for prophylaxis. No adverse effects reported. No further details were available. Follow up information has been received from the licensed practical nurse on 02-AUG-2017, referring to the 14 months old male patient with 3 siblings. The patient's did not have illness at time of vaccination, and neither any pre-existing allergies, birth defects and/or medical conditions. The patient's concomitant therapies included VARIVAX, PREVNAR 13, HAVRIX A, PEDVAXHIB and INFANRIX DTPA-IPV+HIB. This is one of two reports received from the same source. Sender's Comments: US-009507513-1706USA002819.
1st dose in Mar2022, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in March 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comments: The patient got his first shingrix shot and never got the second dose. No further information was reported to the agent by the patient. Did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Client in clinic for Family Planning - vaccines offered & client agreed to update tetanus with Tdap/client's Mo. phone 03/21/11 about 1pm reporting it "hurt at the time and conts to hurt from [injection site] to below - elbow to fingertips numb. Note: never came in for PPD reading 03/17 appt. - PC resched. for 03/18 - no show.
pressure fullness on the chest; heart rate  speeding up; after hours it got better than couple of hours it did the same thing; blood pressure /it was really 'high'; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (non-serious) with onset Nov2022, outcome "not recovered", described as "blood pressure /it was really 'high'"; HEART RATE INCREASED (non-serious) with onset Nov2022, outcome "not recovered", described as "heart rate  speeding up; after hours it got better than couple of hours it did the same thing". The events "heart rate  speeding up; after hours it got better than couple of hours it did the same thing" and "blood pressure /it was really 'high'" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Patient went through again EKG and then went and had hormone check. Patient asking if anybody else has this kind of side effect for the heart rate speeding up and had pressure fullness on the chest. It got better and didn't then patient went to emergency room and after hours it got better than couple of hours it did the same thing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning an 18 year old female with a history of condyloma diagnosed prior to all three doses of GARDASIL in 2007 who in 2007 was vaccinated with three doses of GARDASIL injection. When the patient's physician performed a Pap test and result showed that she had a "high risk for HPV". The physician did not remember the dates for the individual doses for GARDASIL but the patient finished all three doses in 2007. The patient sought unspecified medical attention. Follow-up information has been received from the physician and medical records concerning the 18 year old female cashier with no known drug allergies and no illness at time of vaccination who on 24-JUL-2007 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot # 0469U) in her left arm, the second dose of GARDASIL (lot # 0530U) in her left arm on 24-SEP-2007, and the third dose of GARDASIL (lot # 655327/1287U) in her left arm. It was noted on cytology report of 14-JUL-2008 that the patient on 2007-07-24 had a pap that was HPV+. On 12-AUG-2009, the patient experienced high risk for HPV. On 14-JUL-2008, gynecological cytology test was performed and the result was negative for intraepithelial lesion or malignancy. Base on the cytology result, reflex high risk HPV DNA testing was not performed. On 12-AUG-2009, gynecological cytology test was performed and the result was atypical squamous cells of undetermined significance. As requested, sample was submitted for high risk HPV DNA testing. The result was cervical high risk HPV, DNA test positive. On 22-SEP-2009, microscopic diagnosis was performed. The patient underwent cervical biopsy and endocervix curettage. Clinical information was that the biopsy of the cervix revealed benign endocervical tissue with no evidence of dysplasia. The endocervix curettage revealed benign endocervical glandular fragments with no evidence of dysplasia. At the time of report, the patient's outcome was unknown. Additional information is not expected.
Extreme fatigue, sleeplessness, body aches, sore arm where vaccination given. Lasted three days so far.  Some relief with Tylenol
Patient came in for Moderna Booster shot (0.25 mL). She received a full dose (0.5 mL).
No local effects beyond slight soreness Headache and extreme muscle ache had to take tylenol to be able to fall asleep Did not check for fever
Passed out in the shower; Could not taste; Could not smell; Fever; Chills; Very ill for 28 hours; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out in the shower) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (Very ill for 28 hours). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out in the shower) (seriousness criterion medically significant), AGEUSIA (Could not taste), ANOSMIA (Could not smell), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out in the shower), AGEUSIA (Could not taste), ANOSMIA (Could not smell), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown and MALAISE (Very ill for 28 hours) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.    Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Pt recvd booster on 27APR92; Noted swelling & erythema @ site on 29APR92; LUE started proximal 1/3 extending to elbow along lateral aspect; c/o pain w/flexion or extention;
Kidney stones; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via unspecified route of administration on 23Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller mentioned that after her first shot on 23Feb2021 she developed kidney stones and has been taking pain medications. Her second dose is due tomorrow and would like to know if it is okay for her to take the second dose. Outcome of the events was unknow.  Information on the lot/batch number has been requested.
The patient is a 19 yo male with pmh of anxiety d/o on clonazepam, who is also afraid of needles. He presented with his father to the site of vaccination and was very worried about the phobia to needles. He was nervous, about 4 minutes after vaccination he experienced lightheadness and near syncope, he was lie down flat on the floor and had legs elevated about 90 degrees, at this time the father was looking for water and when he came back he noticed that we were assising his son.  He stayed for 15 mins there, VS: were stable 120/75 HR: 80  taken by the nurse. Denied any headaches, no palpitations and felt better, he just landed from California.  Pt and dad refused EMS and wanted to leave home. Patient was stable a
As I was giving the vaccine I put the needle in the right deltoid before I was able to push the plunger to administer the dose the patient's brother pulled out the needle from the arm before I could stop him. As a result I alerted the team lead and wasted a dose. The patient was unharmed and we were able to successfully administer another dose.
36 hours after vaccination, broke out in hives on each arm and torso.  Measuring 5-8mm, round, raised, red and itchy.; This is a spontaneous report from a contactable Nurse reporting for himself. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO142), intramuscular on 23Dec2020 12:15 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included coronary artery disease (CAD), prior myocardial infarction (MI), asthma and hypertension (HTN). There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 36 hours after vaccination, broke out in hives on each arm and torso. Measuring 5-8mm, round, raised, red and itchy on 24Dec2020 23:45. No treatment received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event was not recovered.
2 days after 2nd vaccine, vaginal bleeding (period is consistently 30+ days (31,36,30,31) , after vaccine a 27 days cycle
Rash on hip and forearm; allergic reaction to the vaccine; Pain at injection site; Fatigue; Feeling sick; This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 36-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 53BF4, expiry date 14th August 2021) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number N754X, expiry date 11th November 2021) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Boostrix (intramuscular) and the 3rd dose of Engerix B (intramuscular). On 12th September 2019, 3 days after receiving Boostrix and Engerix B, the patient experienced allergic reaction, injection site pain, fatigue and feeling unwell. On 23rd September 2019, the patient experienced localized rash. On an unknown date, the outcome of the allergic reaction, injection site pain, fatigue, feeling unwell and localized rash were unknown.   It was unknown if the reporter considered the allergic reaction, injection site pain, fatigue, feeling unwell and localized rash to be related to Boostrix and Engerix B.  Additional details were provided as follows: The patient received both Boostrix and Engerix B in her left deltoid. On 12th September 2019, the patient reported to his employer that, he was experiencing fatigue, pain at injection site and feeling sick.  On 23rd September 2019, the patient again reported to his employer that, he had a rash on hip and forearm and he was wondering if he was having an allergic reaction to the vaccines.  The reporter consented to follow up. The reporter stated that, further details were not known to her and she could only relay what the patient's employer reported to her.
PRETTY SEVERE DISCOMFORT ALONG THE SPINE BETWEEN THE SCAPULA; CHILLS; DULL HEADACHE; BURNING IN CHEST; BURNING IN SHOULDER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the subject experienced burning in chest. On 07-MAR-2021, the subject experienced burning in shoulder. On 08-MAR-2021, the subject experienced pretty severe discomfort along the spine between the scapula. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced dull headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning in chest on 07-MAR-2021, and chills, was recovering from burning in shoulder, and had not recovered from pretty severe discomfort along the spine between the scapula, and dull headache. This report was non-serious.
PCT developed syncope, tonic and clonic achirhesl/seizures lost consciousness approximately 40-50 seconds. Treatment oxygen mask, Benadryl IM 50mg.