chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient received a 0.25 ml (25 mcg) dose as booster dose only presentation vial instead of 0.5 ml (50 mcg); This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml (25 mcg) dose as booster dose only presentation vial instead of 0.5 ml (50 mcg)) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml (25 mcg) dose as booster dose only presentation vial instead of 0.5 ml (50 mcg)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml (25 mcg) dose as booster dose only presentation vial instead of 0.5 ml (50 mcg)) 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 INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml (25 mcg) dose as booster dose only presentation vial instead of 0.5 ml (50 mcg)).    The concomitant medications were not provided.   Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022. It was reported that the patient had received 0.25 ml (25 mcg) instead of 0.5 ml (50 mcg) as a booster dose.  It was unknown if patient experienced any symptoms after getting the vaccine.  Treatment details were not provided.
PATIENT STOPPED AT THE CLINIC FOR NURSE TO LOOK AT HER ARM.  STATES HAD A FLU SHOT AND AREA IS RED.  FLU SHOT WAS A HIGH DOSE FLU SHOT GIVEN 09/09/2011, TODAY, 11/03/2011 PATIENT HAS A 1 1/2" BY 1 1/2" REDDENED AREA, IRREGULAR BORDER, RASHY LOOKING, NON RAISED AND NOT BRIGHT RED.  SAYS IT HAS HURT SINCE THE DAY OF THE VACCINE BUT THE RASH STARTED 11/2, ALONG WITH MORE SORENESS UP HER ARM DOWN TO HER ELBOW.  RELATES A LOT OF GENERALIZED MALAISE.
Within a day after the vaccine, pain and ecchymosis of the outer aspect of the L shoulder at the site of the vaccine. I thought the pain  would resolve but over the next 3 months the pain persists in the L shoulder and I am unable to lift my arm fully due to pain and stiffness in the upper arm and joint. Unable to sleep on the L shoulder at night due to pain. Motrin 600 mg does not relieve the pain in the shoulder and upper arm.
The first adverse event was a sharp pain in my left shoulder as I reached to turn off a lamp. Over time, the pain became more frequent with certain ranges of motion. Then the range of motion in my left shoulder decreased immensely. I currently experience 24/7 chronic pain in my left shoulder, arm, and wrist, as well as limited range of motion. I received PT three times a week.
Caller received 1st shot and went in for a routine physical. they ran blood work and found no antibodies.; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received first dose of bnt162b2 (Solution for injection), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced caller received 1st shot and went in for a routine physical, they ran blood work and found no antibodies. Caller received 1st shot and went in for a routine physical. they ran blood work and found no antibodies. she wants to know what is going on. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative. The patient did not receive any treatment for the event. The clinical outcome of the caller received 1st shot and went in for a routine physical, they ran blood work and found no antibodies was unknown. Information about lot number has been requested.
No adverse events reported. Pt was given a flu shot 2 weeks earlier at a different pharmacy per report after the event. Pharmacist at the time was not aware of this fact. Accidentally the second shot was administered. Both flu shots are inactivated.
Tinnitus I have suffering from the first Pfizer shot which I received on 5/3/2021 and got worse after the second shot which I received on 6/3/2021I have been suffering from June 25 2021 still suffer from Tinnitus . There is no treatment for Tinnitus
Information has been received form a pharmacist referring to a 39 year old male patient. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with pediatric dose of RECOMBIVAX HB (lot # L029631, expiration date 14-AUG-2017, strength unknown) intramuscularly (unapproved dose of administration). No adverse effect was reported. Additional information has been requested.
This spontaneous report was received from a consumer (patient's mother) and refers to a currently 18-year-old, non-pregnant female patient. The patient's concurrent conditions was not reported. The patient did not have drug reactions or allergies. On an unknown day, reported as "sometime in either 2011 or 2012", the patient was vaccinated with GARDASIL, 1 dose, intramuscularly, for prevention of HPV (lot# and expiration date were not reported). Concomitant therapies included TEGRETOL. On an unknown date, reported as "approximately one to two weeks after receiving the vaccine", the patient experienced seizure. On an unknown date, reported as "after began to have seizures", the patient was diagnosed with epilepsy. The patient's mother reported that her daughter at the day of the reporting was 18 years old and since she had received the GARDASIL and had experienced the seizures, her daughter was mentality of a 6 to 10 year old. The reporter reported that the GARDASIL caused her to become mentally retarded. On an unknown dates the patient was hospitalized due to epilepsy. On 05-JAN-2018, the patient experienced seizures which caused stomach pain, sore muscles and knocked her braces out of her mouth. On an unknown date, the patient had performed developmental testing which confirmed that the patient was mentally retarded. On an unknown date in December 2017, reported as "approximately two weeks ago", the patient had an electroencephalography (EEG) which showed that patient had active seizures. The outcome of the events was reported as not recovered. The relatedness between the seizure, mentally retarded and GARDASIL was reported as related.
Subsequent to receiving one dose of varicella virus vaccine live on 1/15/97, the pt experienced chickenpox with 23 spots on 4/26/99. By two days later she had developed 98 spots. At the time of this report the pt had not recovered. Additional information has been requested.
Hospitalization on 9/5/2021 due to COVID19. Reported per Janssen COVID vaccine EUA.
Patient received full contents of one vaccine vial (5 doses).  Patient was sent to ED for evaluation but was asymptomatic.  Patient reported fever (Tmax of 102) and low blood pressure overnight on day of event.  Has been followed by Primary Care and Hematology since event.  On 9/24, patient presented with malaise, mild back pain, headache, and bruise on hip.  BP and vitals were normal.  Labs, including CBC and coagulation panel, have remained normal throughout.  Lung examination on 10/4 was normal.  On 10/11, patient reported some numbness and drooping on right side for 5-6 minutes (no slurred speech or numbness down arm).  Patient planned to be discharged from Hematology service after 10/18 appointment, if all remains the same.
received / first dose of hepatitis B vaccine /in 2016 /now/ need a 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 17-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B (1st dose received in 2016).   On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient's parent. The age at vaccination was not applicable for this report. The member of public reported his daughter received her first dose of hepatitis B vaccine (brand unknown) elsewhere in 2016. They reside here now and need a 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Hepatitis B, which led to incomplete course of vaccination. No other details were available. The reporter consented to follow up.
experienced a sore shoulder at the injection site; mild body aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 24Mar2021 11:40 (Lot number: EK5730) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunisation.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Mar2021, outcome "recovered", described as "experienced a sore shoulder at the injection site"; PAIN (non-serious) with onset 25Mar2021, outcome "recovered", described as "mild body aches"; FATIGUE (non-serious) with onset 25Mar2021, outcome "recovered", described as "fatigue". Therapeutic measures were taken as a result of vaccination site pain, pain, fatigue.  No follow-up attempts are possible. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 13th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, 1 day after receiving SHINGRIX, the patient experienced rash, pain and neuralgia. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the pain and neuralgia were recovering/resolving. It was unknown if the reporter considered the rash, pain and neuralgia to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that 24 to 72 hours after receiving SHINGRIX, the patient experienced slight rash and mild case of neuralgia. The patient still had lingering pain, at the time of reporting. The health care professional stated that the vaccine was not administered at his pharmacy so he did not have any vaccine information. The health care professional did not know when exactly the rash and neuralgia started but was sure it was within 24 to 72 hours.
Left arm red, swollen, painful decreased range of motion, TX Tylenol, Benadryl PO. Return to office PRN. Assume he recovered.
Toward the end of January I thought I had gotten a sinus infection. I finally went into the doctor and had been on doxycycline for the sinus infection. I was having the bad sinus headache, I had drainage in the back of my throat in the mornings and in the evening which made me cough but otherwise I did not have a cough. When I went into the doctor on the 9th I was tested for COVID-19 and it was positive, other than symptoms related to the sinus infection I did not have other COVID-19 symptoms.
Tested positive for Covid; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the event of positive for SARS-CoV-2, are assessed as unlikely related. Further information has been requested.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the event of positive for SARS-CoV-2, are assessed as unlikely related. Further information has been requested.
Chest pain, lung heaviness, pressure behind eyes and in head, weakness, fatigue, joint pain, dry mouth, feeling of passing out.
sore arm next day. severe leg pain several days later. shaking / tremor a week after.  trouble writing, using cellphone credit card machines. unable to carry a cup of coffee to table. went to DR on 2/26/2021.  Blood pressure high (not usual). Bloodwork done-all negative for any issues.  Blood pressure recheck on 3/12/2021 - still high. Now taking Atenolol for it.  I have an appointment to see a neurologist in May.  The tremors have decreased little by little.  April 12 was a good day (first time since getting these problems) and now , this week have felt much better.   9(((
11/17/20 J&J Ad26.CoV2.S  vaccination.  The next morning patient began mild achiness & fatigue that lasted 48 hours and mild arm pain that lasted 72 hours. severity: Gr 1 1/5/21 Pfizer #1. Sudden onset at 10 hours of shaking chills, temperature 103+, severe myalgias and malaise. Severe for 36 hours. 80% better at 48 hrs; at baseline by 72 hours. 1/26/21 Pfizer #2. 10 hours later again noted shaking chills, temperature >103, severe myalgias and malaise. 1/27 could not work. Worked 1/29 & 1/29 at half capability.  1/30 & 1/31 felt worse with temperature >103 both days. 2/1 had to leave work early; noted multiple aphthous ulcers on palate and tongue. Continued to have myalgias and temperature 102-3 through 2/3; tempera
Covid 19 vaccination administered on 9/20/22.  discovered that the lot number used for that dose expired Aug 31st when product removed from freezer, 10 week exp was assigned to the bag containing the vials. however, the vials themselves expired aug 31st
The patient was brought to the ED by EMS on 3/5/23 for evaluation of dizziness, generalized weakness, and a headache. A COVID-19 PCR test performed in the ED resulted positive. Ultimately he was admitted 3/4/23 - 3/7/23. Discharge diagnoses included COVID-19 infection. Of note, the patient has received the primary COVID vaccine series and three boosters.
Symptoms-extreme swelling at injection site, redness. Patient sought treatment at hospital ER.
Fever Fatigue Narrative:  Patient reported fatigue and fever 100.4 and going down  Other Relevant History:
Information has been received from a Licensed Practical Nurse 1 concerning a male patient who was vaccinated With a dose of PNEUMOVAX. Concomitant therapy included DTaP (manufacturer unknown) and MENACTRA. Patient received two injections in each arm. The reporter reported that patient experienced fever, redness and soreness after the vaccination. the outcome was unknown. Additional information has been requested.
Immediately after give shot, patient became nauseated, fainting slumping down and totally lost consciousness for 10 seconds and in and out of consciousness for 5mins. 911 was call, oxygen administered, V/S taken B/P 120/60 Pulse 74 Resp 20. Patient was kept under observation until paramedic arrive.
Had rash, felt like she was having hot flashes and passed out on her dialysis unit and was taken to the ED.
pt presented x 2 days post vax w/swelling & redness @ site of DTAP;sl bruising, T100ax spiking to 103;warmth & swelling of lt anterior thigh;dx allerg rxn;
Tonic clonic seizures lasting 8-10 minutes (Status Epiletius). Treated with Dilantin 1100 mg IV, KCl elixir 20 mg eq po, Valium 5 mg IM, left hip, Valium 5 mg IM right hip, Valium 10 mg IV, Valium 5 mg IV, Tylenol 650 mg supp, KU 20 mEg IV at 50 cc 1 hr; Transferred to Lubbock Univ Med Ctr.
dime size hard but mobile red on end lump under left arm pit. Hard to touch, somewhat tender, reduced in size as of Sunday but still remained; This is a spontaneous report from a contactable consumer (patient). This 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EM9810) via an unspecified route of administration in the left arm on 02Feb2021 at 15:45 at single dose for COVID-19 immunisation. Relevant medical history included sulfa allergy, diabetes mellitus and high blood pressure. Concomitant medications included metformin and metoprolol. On 04Feb2021 at 16:00, the patient noticed dime size hard but mobile red on end lump under left arm pit. Hard to touch, somewhat tender, reduced in size as of Sunday 07Feb2021 but still remained. The patient did not receive corrective treatments. The patient did not have COVID-19 prior to vaccination, and she was not tested for COVID-19 post vaccination. The patient had not recovered from the event.
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient regained consciousness within one minute. Her blood pressure was 107/78 mmHg and heart rate was 62 bpm. She was fully recovered and left the pharmacy after 30 minutes. I follow-up with the patient on 05/08/2021. Patient said she was fine after she left the pharmacy and only had soreness at the right arm.
This spontaneous report as received from a physician via company representative refers to four patients of unspecified demographics. Patients medical history, drug allergies and reactions were unspecified. On an unknown date in 2008 (reported as sometimes in 2008), the patients were vaccinated with VARIVAX injection (dose, frequency, lot number and expiry date were unspecified) for prevention of chicken pox. It was reported that age of all four patients was appropriate to receive VARIVAX vaccine. Concomitant therapy was unspecified. On an unknown ate, all four patients developed mild chickenpox. All four patients sought medical attention, they visited physicians office. No product quality complaint was involved. The outcome of event milk chickenpox was reported as recovered (on an unspecified date). The reporters causality assessment for the event mild chickenpox with the therapy of VARIVAX was not reported. Additional information is not expected.
Vaccine received at 4pm on 2/21. Nausea started the next morning, followed later by fever (highest at 101.8), body aches, chills, headache, and mild arm soreness. All symptoms resolved within 24 hours, except mild arm soreness. Arm soreness continued for 5 days, and a red, itchy, and painful area was noted approximately 2 inches away from injection site during this time. All symptoms resolved on own.
This spontaneous report as received from a medical assistant also reported as healthcare worker refers to an unspecified group of patients of unknown demographics. Patient's medical history were not provided. In approximately 2014 also reported as "on an unspecified dates since 02-NOV-2014", the patients were vaccinated with doses of VAQTA(dose, frequency, route of administration and lot # were not reported) which were exposed to an unsupported temperature excursion. Concomitant medication was not reported. The reporting medical assistant was not aware of any adverse effects. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
5.5 cm diameter indurated, warm lesion over Rt deltoid. Slight fever of 100 degrees.
ACHING JOINTS; COUGHING; STOMACH SWOLLEN UP; DIARRHEA; ARM SORENESS; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, smoker, and blood pressure, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 07-JUN-2021, the patient experienced arm soreness. On 20-AUG-2021, the patient experienced coughing. On 20-AUG-2021, the patient experienced stomach swollen up. On 20-AUG-2021, the patient experienced diarrhea. On 21-AUG-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) positive for Covid-19 antibodies. On 22-AUG-2021, the patient experienced aching joints. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughing, stomach swollen up, diarrhea, and aching joints on AUG-2021, and arm soreness on 08-JUN-2021. This report was non-serious.
tested positive for Covid-19; asymptomatic; tested positive for Covid-19; asymptomatic; Back pain; Cold; This is a spontaneous report from a contactable nurse (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 29Dec2020 at single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient informed that she received the first dose of the Covid-19 vaccine on 29Dec2020 and her second dose was scheduled on 19Jan2021, but she was tested positive for Covid-19 on unspecified date. The patient informed that she was asymptomatic and only has back pain and cold. The patient wanted to know if she can receive the second dose of the vaccine. The outcome of the events tested positive for Covid-19; asymptomatic, back pain, cold was unknown.  Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Based on the time association, the lack of efficacy cannot be excluded for vaccine BNT162B2.
truncal red exanthem w/in 1hr of vax;no fever;no fussiness; lt leg swelling w/o erythema-this has persisted x4hr
16JUL92 pt recvd 1st dose of Engerix-B & devel h/a for 1 1/2 - 2 days which was unrelieved by APAP; devel muscle weakness 1 1/2 wks p/inject; 1-2 wks later had trouble w/rt leg/hip; 4 days prior devel arthritis in lt wrist;
This spontaneous report as received from a Community Nursing Service refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route not reported) lot # J003727, expiry 07-NOV-2015. Outcome of the event was not reported. Additional information has been requested.