chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with doses of VAQTA (route, lot number and expiration date were not reported). On unknown dates, there was an incorrect product storage as the multiple unspecified patients were administered improperly stored VAQTA. No adverse events were reported. It was unknown if the patients sought medical attention. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Patint had flushing/sweating, light headed. Patient stable, released from vaccination site.
Pt received vaccination on Friday.  On Friday evening she started to run a fever, but Sat am she reports temp of 102, chills, body aches, sore/red vaccination site.  Presented to ER.  Rapid COVID test negative.  Determined to be vaccination reaction.
My normal temp is 97.3. Thursday evening I felt slightly chilled, Friday morning I woke up to a temp of 99.9 a very sore arm, and a slight headache. After taking care of my cats and calling in to take off work, I went back to bed then woke up to a temp of 102. I also had body chills, aches (to the point they were worse than the pain in my arm, and a headache. I took some Tylenol which brought it down to 101.7 I also rubbed peppermint essential oil on my forehead. which brought it down into the 100 range. I was able to sleep some more and when I woke up when the Tylenol had worn off and my temp was 102.4.  Took more Tylenol and used more peppermint oil. By 9 pm temp was 100.7 and I was sweating. At some point during the day, I had switched from water to drinking cranberry juice. Saturday my temp stayed in the 99 range for most of the day and I slept most of the day because of the fatigue. I also started to get a rash on my arm that I had received the shot. Saturday evening my temp started to go up again so I took more Tylenol. Sunday fever free, just tired and when standing for periods of time I'd get dizzy. Monday I had a headache but felt much better,.
Sore arm; chills for a short period of time; hard lump on gum below left bottom tooth; swollen lymph node and sore throat on right side of neck.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 10-FEB-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to product.
post vaccination  pt. reports " sharp pain to right side of chest "  on a scale of1-10 discomfort was a "6" initially but is now a "4" continues to originate from mid sternum radiating to right side  pt. denies any nausea or shortness of breath   Pt. does admit having "anxiety " at times and has had this "pain before" his primary care physician has cleared him for cardiac event in the past After a 15 minute observation period  pt. reported chest discomfort was first a "1" then soon after a "0" Pt. was released and continues to have 0 pain upon ambulating
her arm was killing her; swollen real bad, with a red spot at the injection site and a big knot; felt dizzy; felt nauseated; and had body aches; big knot in; itches; States she had most all the side effects except fever; she had a headache; This is a spontaneous report received from a contactable consumer or other non hcp. A 68-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9810) via an unspecified route of administration in Arm Left on 21Mar2021 12:20 (age at vaccination 68years old) as single dose for covid-19 immunisation. The patient had a historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9810) via an unspecified route of administration in Arm Left on 01Mar2021 12:20 (age at vaccination 68years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced big knot in, itches, states she had most all the side effects except fever on 22Mar2021, her arm was killing her, swollen real bad, with a red spot at the injection site and a big knot on an unspecified date, she had a headache on 21Mar2021, felt dizzy, felt nauseated, and had body aches on 23Mar2021. Clinical course was reported as she received the first dose of the Pfizer COVID 19 vaccine on 01Mar2021 at 12:20PM in the left arm. She didn't have any side effects except a sore arm. Adds she had the second shot on Monday 21Mar2021 at 1220PM in the left arm. She had most all the side effects except fever. Her arm was killing her, swollen real bad, with a red spot at the injection site and a big knot; she had a headache; felt dizzy; felt nauseated; and had body aches. She is most concerned about the knot which is a red raised place the size of half dollar and it itches. The clinical outcome of the events fever, headache, felt dizzy, felt nauseated was recovered on 23Mar2021, and other event had body aches was recovering and big knot in event was not recovered and other events was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. ON an unknown date, the patients were vaccinated with ROTATEQ Route, lot # and expiration date were not provided). On an unknown date, the patients were administered ROTATEQ that had been improperly stored in the same temperature excursion as the M-M-R II previously reported. No adverse effects were reported. IT was unknown if the patient's sought medical attention. At the time of the report, the patient's status was unknown. This is one of several reports received from the same source. Additional information has been requested.
faulty needle and syringe that caused leakage to occur; Not the entire quantity was injected into the patient; incomplete dose administered; A Spontaneous report was received from a pharmacist concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a faulty needle and syringe that caused leakage to occur and not the entire quantity was injected into the patient.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received a dose of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, it was reported that a faulty needle and syringe caused leakage to occur and the patient did not receive the entire quantity of the vaccine. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.  The events of faulty needle and syringe that caused leakage to occur and not the entire quantity was injected into the patient was considered resolved on an unspecified date.; Reporter's Comments: This report refers to a case of a patient of unknown age and gender who experienced non-serious unexpected event of faulty needle and syringe that caused leakage to occur and not the entire quantity was injected into the patient (device connection issue, incomplete dose administered) for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of device connection issue and incomplete dose administered
having night sweats; waking up in the middle of the night drenched; fatigued; fever of 104 degrees; A spontaneous report was received from a consumer concerning a 37-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever of 104 degrees, having night sweats, waking up in the middle of the night drenched, fatigued.  The patient's medical history was not provided. Concomitant medications reported were Topamax, Paxil for drug use for unknown indication.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unkown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the events fever of 104 degrees. On an unknown date, the patient experienced the events having night sweats, waking up in the middle of the night drenched, fatigued.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, fever of 104 degrees, having night sweats, waking up in the middle of the night drenched, fatigued was unknown.
Patient stated, "I had Part 2 of the Pneumo vaccine @ 10:30 am on Tuesday, June 26, 2018. The injection site burned a bit, but as the day wore on my left arm became more and more painful as well as swollen. By 6pm that night I could not even push my car door open and even having clothing brush across the upper arm area was painful. The upper arm area was swollen and red from the injection site down to my elbow joint. I was only able to sleep on my back or right side Tuesday night. Wednesday, the 27th was no better, still painful and more swollen. By the end of the day Wednesday, the arm tissue was so swollen that the swollen area extended out over the elbow joint and the skin area was reddened. My right upper arm measured 10 inches in circumference and the swollen left upper arm measured 11 inches. I developed chills and went to bed about 10:30 pm. I took a plain (not PM) ALEVE gelcapsule. If the symptoms did not dissipate by Thursday morning when I got up, I planned to go to Urgent Care to make sure there was nothing else going on. On Thursday morning, the pain had subsided, but the swelling was still quite apparent as was the redness, all in the area from the injection site down to the elbow joint. At 8pm on Thursday night, the swelling and redness continued."
Mother states pt developed diffused pain July 5 was taken to ED of possible leg strain 2 fall, July 10 got bone scan was normal, done for persistent pan in Le leg pain resolved shortly thereafter.
It looks like bullous pemphigoid; he developed an erythematous rash on his extremities which has begun to blister.; he developed an erythematous rash on his extremities which has begun to blister.; This is a spontaneous report from a contactable physician via a sales representative. A 69-year-old male patient received second dose of bnt162b2 (bnt162b2), via an unspecified route of administration from on an unspecified date at SINGLE DOSE for covid-19 immunisation. Medical history included diabetes and parkinson's disease. The patient's concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunisation on an unknown date. After received r the second dose of the bnt162b2, two days post doe the patient developed an erythematous rash on his extremities which had begun to blister. It looked like bullous pemphigoid. The event outcome was unknown.; Sender's Comments: Based on the available information and on a reportedly close temporal association,  causality cannot be excluded between the events and the administration of the suspect product BNT162B2 (COVID-19 MRNA VACCINE BIONTECH). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
1st dose in 2020, 2nd dose in 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received first dose in 2020).   On 8th November 2022, the patient received the 2nd dose of Shingrix. On 8th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 8-Nov-2022 Reporter's comment: No other information reported to the agent by the patient. The reporter did not consent to follow-up. Additional supportive information: The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Both hands shaking uncontrollably for over 2 hours; extreme chills, hands would not stop even when held; completely out of control; started 34-36 hrs after shot.
Right arm wheal measures 17cm x 14cm at deltoid/upper arm. Prescribed oral steroids.
Information has been received from a male concerning his 4 year old son who in January 2007, was vaccinated with PROQUAD. His son was diagnosed with autism after the vaccination. The reporter stated that he thought his son received two, 0.25 ml dose of PROQUAD. The reporter feels his son's autism diagnosis was related to PROQUAD. Upon internal review, autism was considered to be an other important medical event. No further information is available.
Chest pain intermittent. Onset of menses 1 wk early (on OC's).
Large indurated erythematous area around inject site measured 7x11 cm (rt thigh);
Vertigo.  It comes and goes but has been worse since the second shot.  Also my daughter knows of 5 women who have miscarried a week after receiving their shots.  My daughter is now not willing to get vaccinated due to this fact.
Information has been received from a physician concerning a 17 year old female who on 09-APR-2008 was vaccinated with her first dose of GARDASIL (Lot #, route and site were not reported).  Concomitant therapy included ALESSE.  On 30-APR-2008 the patient experienced redness, soreness and swelling of the labia.  The patient sought unspecified medical attention with an office visit.  At the time of this report, the patient was recovering from redness, soreness and swelling of the labia.  No additional information was provided.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/13/2008.  Initial and follow-up information has been received from a physician concerning a 17 year old female who on 09-APR-2008 was vaccinated with her first dose of GARDASIL (Lot #, route and site were not reported).  Concomitant therapy included ALESSE.  On 30-APR-2008 the patient experienced redness, soreness and swelling of the labia, later reported as pain and burning in the vaginal area.  Patient's vaginal culture was negative.  The patient sought unspecified medical attention with an office visit.  At the time of this report, the patient was recovering from redness, soreness and swelling of the labia.  No additional information was provided.  Additional information has been requested.
PATIENT STARTED TO EXPERIENCE TREMORS ,SYNCOPE  AND PROFUSE SWEATING ABOUT 10 MINUTES AFTER RECEIVING VACCINE. HE LOST CONSCIOUSNESS FOR ABOUT 1 MINUTE. HE WAS ATTENDED TO BY PARAMEDICS FOR ABOUT 15 MINUTES THEN LEFT ON HIS OWN.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired ZOSTAVAX (lot #670980/0731AA, expire date 17-AUG-2012) (vaccination site unknown) on 20-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
This spontaneous prospective pregnancy report was received from a registered nurse via company representative regarding a female patient of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with GARDASIL 9. No concomitant medication was reported. It was reported that the patient was recently found to be pregnant on an unspecified date. The LMP (Last Menstrual Period) and EDD (Estimated date of delivery) was unknown. The patient visited physician office to seek medical attention. The outcome of the event was unknown. Additional information has been requested.
Initial solicited report received from an investigator in a trial on 02 March 2017. A 26 year-old male subject with no significant medical history. The subject received concomitant medication with Influenza Vaccine on 29 January 2016. The subject received a dose of ACAM2000, (lot number and route, site of administration not reported) on 01 February 2016. On 24 February 2016, 23 days after vaccination the subject was diagnosed with myocarditis, unspecified. The lab data included on 24 February 2016, the Troponin I was normal, on 25 February 2016, ECG was abnormal, on 26 February 2016, Echocardiogram was normal, MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 26-year-old male subject who had unspecified myocardtis with favorable temporal association post vaccination with ACAM2000. Myocarditis is a listed adverse events that may occur following vaccination with live vaccinia virus smallpox vaccine. Based on data available, role of study vaccine can not be ruled out.
Swollen lymph node in neck; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 22Mar2021 at 15:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos disease and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), metformin hydrochloride (METFORMIN XR) and magnesium (MANUFACTURER UNKNOWN) supplement; all for unknown indications from unknown dates and unknown if ongoing. On 31Mar2021 at 07:00, the patient experienced swollen lymph node in neck and sore throat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph node in neck and sore throat was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Received 2nd dose at 10:30 am at Hospital.   I went to work as usual at 1:45 pm though 10:00 pm. without any issues.  Came home, had 2 glasses of wine, as usual, at 1:00 a.m. feeling body aches and headache continued sleeping, woke up at 9:00 a.m. with dry heaves with phlegm with small streaks of blood, rapid heart rate, fatigue with body aches, pain in location of injection, occasional headache, loss of appetite.  The body aches, fatigue continued the following day,  appetite returned slightly.   Thankful these were my scheduled days off from work.   Third day after injection body aches dissipating able to go out of the house to do errands.
Employee was given vaccine during monitoring period within 10 mins employee stated felt as though she was going to pass out. Employee remained conscious and was able to tell us she was able to breathe fine and just felt dizzy. MRT was called MD and staff arrived. Employee began to have a rash on chest, back and neck, Stated tongue was tingling. At this time MD gave verbal order for EPI 0.3 via epi pen on hand to be administered was administered to right thigh by employee health nurse. Employee vss and was taken via wheel chair to ER with MRT staff Was taken to the ER where Benydryl, Pepcid, and Solumedrol given IV and patient was monitored.
hypotonic-hyporesponsive collapse 2 mins p/inject; pt became respnsive p/40 seconds;
Pt reported dizziness approx 10 mins after vaccination. Vital signs were stable. Pt was brought to medical tent and allowed to drink water and lay down and her sx resolved in 20-25 mins
Leg was very sore, he came down with a fever 101 deg that night. Leg was swollen and red and he limped when walking. Motrin and Tylenol helped.
This spontaneous report as received from a healthcare professional refers to unspecified patients of unknown age and gender. Patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, patients were vaccinated with the improperly stored doses of (Oka/Merck) VARIVAX (lot number L000453 and expiration date 06-JAN-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
arm still hurts deep down in the muscle where I got both of those shots; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (arm still hurts deep down in the muscle where I got both of those shots) 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.   In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm still hurts deep down in the muscle where I got both of those shots). At the time of the report, VACCINATION SITE PAIN (arm still hurts deep down in the muscle where I got both of those shots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.
Rash developed on legs, arms and trunk 24- 36 hours after administration of vaccines.
Pt with residual "knot" after shot which later swollen area and circumferential redness, tenderness. Tx'd with abx for ? cellulitis with improvement.
pt originally adm 28NOV92 w/syncope, chronic atrial fibrillation, hypoxemia secondary to pneumonia & edema; mitral regurgitation; resp failure; alkalosis; acid-base disorder; paradoxical vent tachycardia; acute infect polyneuritis; poss GBS
High fever 103.00.  Blinding headache.  Body aches.  Flu like symptoms.