chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 Minutes after injection started feeling adverse effects: Light headed, dizzy, severe headache, mild swelling of ankles and hands, tingling lips, BP 173/98, HR 96, applied cold compress, gave Acetaminophen 500mg upon patient request,Laid patient down, propped up feet.  Started feeling better...remained laying down until confident to sit up.Placed patient in chair....started experiencing generalized itching.  Gave 50mg liquid diphenhydramine. Medical personnel in building advised calling EMS.  Patient refused.  Husband may bring to her to hospital (less than a mile away).Total time from injection to leaving facility: 90 minutes
Parent state, after both DTaP injections, pt stopped babbling, cooing for 4 weeks.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 32-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment at this time. It was reported that no adverse reactions were reported by any patients.
A report has been received from a Health Professional concerning a patient of unknown gender and age. The patient's medical history included sore throat. Concomitant medications were not reported. It was reported that the patient was given a once/single dose of FLUMIST Quadrivalent on 29-Sep-2015. The patient had a sore throat and the physician thought it would be okay for the patient to get a dose of FLUMIST. Mother had returned with the patient who had flu like symptoms experienced on 30-Sep-2015. Action taken with FLUMIST Quadrivalent was none. The outcome of the event of flu like symptoms was unknown. The report was considered to be non-serious by the company physician.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 17-JAN-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742.
Felt okay until around 6:30pm that evening when I began to feel achy, fatigued, as well as pins and needles all over my limbs.  I was extremely tired and the aches had significantly increased so I went to bed at about 8:00pm. When I couldn?t sleep around 9:30pm I took 1000 mg of acetaminophen. I woke up at around 11:00pm and felt extremely feverish (shivering, entire body extremely soar. My joints hurt so badly that I couldn?t get comfortable) and nauseous. I then had 4 or 5 episodes of violent vomiting throughout the night every 2 or so hours.  After, I would be drenched in sweat.  When I got up *crawled to trash can next to my bed* at around 2:30/3:00AM I took 200mg ibprofin. Felt fatigued and no appetite the next day then was fine
45 sec. episode of rolling of eyeballs. Taken to hospital. Flickering movements of both eyes lasting approx. 15 min. Discharged home on Phenobarbital.
First two shots, I fell and had hard time getting up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: EL9264) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: FALL (non-serious), outcome "unknown", described as "First two shots, I fell and had hard time getting up". Therapeutic measures were not taken as a result of fall.  Additional information: Consumer stated, first two shots, he fell and had hard time getting up. He had taken blood pressure medicine at that time, and he found out later on, he should not take it as it can drop your blood pressure. And then on the other ones, afterwards, couple of hours later, he got sick to his stomach and was throwing up and those were not given as any of the side effects. Sender's Comments: Linked Report(s) : PFIZER INC-202201375626 same patient/reporter, different vaccine dose; PFIZER INC-202201375627 same patient/reporter, different vaccine dose; PFIZER INC-202201375625 same patient/reporter, different vaccine dose; PFIZER INC-202201375628 same reporter/patient, different vaccine dose;
This spontaneous report as received from a nurse practitioner refers to a 61 year old female patient. On 26-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported). On 26-AUG-2015, the patient experienced herpes zoster. The patient sought medical attention via seeing nurse practitioner. The nurse practitioner reported that the patient experienced prodromal symptoms, prior to receiving ZOSTAVAX. The outcome of the herpes zoster was unknown. Relatedness between the herpes zoster and the therapy with ZOSTAVAX was not reported. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was instructed to sit down after the vaccine in our waiting room. The patient got up without her knowledge and walked away. The nurse went to check on the patient, and found he looked pale. The nurse, helped the patient to the ground and got me, the NP. The patient was helped to a laying position with legs bent. patient instructed to lie in this position for a few minutes and provided gatorade juice. Patient assisted to sitting, drank juice and recovered.
patient became diaphoretic, pale, had nausea. (Vasovagal reaction)
Slight loss of hearing, vision completely whited out, blood pressure dropped to 60/40.  I felt very sleepy. This started about 2 or 3 minutes after the vaccine was injected.  Medics started me on oxygen and elevated my feet. Attempted to start an IV (not successful because I have hard to find veins), checked blood sugar (normal) and did EKG (normal). After about 15 minutes my blood pressure returned to normal and I felt fine except for a headache. They wanted to send me to the hospital but I refused. My primary care physician advises me to not take the second dose of this vaccine.
Muscle twitches in arms and legs, hot heavy sensation in arms and legs, diarrhea.
No adverse event; expired dose of VARIVAX was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concurrent conditions were not reported. Concomitant medication included sterile diluent (lot# T009242 with expiration date: 15-OCT-2022).   On 24-JUN-2022, the patient was vaccinated an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter/once, lot #T020652 with expiration date: 16-JUN-2022, administered for prophylaxis (route of administration was not provided) (Expired product administered). The varicella virus vaccine live (oka/merck) (VARIVAX) had no history of temperature excursions. Dose was supported by post-expiry memo. The patient did not have any adverse effects or symptoms from administration of this dose (no adverse event). No other adverse event was reported.
Patient called Monday and stated she had knots under her neck and on side of head.  They were present on same side of body as shot was given and were painful. I advised her to call physician. She was seen in clinic and admitted to hospital for IV antibiotics and steroids.  I talked with her on 4/29.  She is currently in hospital, but states doing much better.
Anxious, hyper, I cannot sit still; Anxious, hyper, I cannot sit still; I could not sit still; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Lot number: ER8734) at the age of 71 years as dose 2, single and administration date 17Mar2021 (Lot number: EN6207) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYMBICORT. The following information was reported: PSYCHOMOTOR HYPERACTIVITY (non-serious), ANXIETY (non-serious), outcome "recovered" and all described as "Anxious, hyper, I cannot sit still"; RESTLESSNESS (non-serious), outcome "recovered", described as "I could not sit still". Therapeutic measures were taken as a result of psychomotor hyperactivity, anxiety, restlessness.  Additional Information: Patient stated, when she got the first dose on the 17Mar2021 she felt the same symptoms and then it went away after a couple of days. She took Tylenol as treatment. Then she got the second dose yesterday and she was more anxious yesterday and today than 3 weeks prior. Patient stated, she do take Symbicort periodically. she do not use that every day. Patient stated, she wanted to tell a symptom that she had and it is not on the list of receipt. She did not have any of the symptoms that was in the hand out sheet, no fever, no chills, no joint pains, did not even feel it her my arm. But she felt, she do not know you how you say it where you are, she know you are not from this country. she call it high (incomplete sentence). She experienced it the date she  got it 4/7 April the 7th and April the 8th it lasted 2 days it was very high anxiety; I was anxious hyper. she could not sit still, do you understand how hyper it is, but that is not one of the side effects. And the copy was of Dec2020 that one that I was handed. she know people who are getting this, they can have other health issues. But she do not have, but she could not sit still, that was her reaction and no one that she have spoken to have heard reaction from the Pfizer vaccine.  No follow-up attempts are possible. No further information is expected.
Flu: Initial information received on 31-Oct-2021 regarding an unsolicited valid social media non-serious case received from a consumer via Regulatory Authority.    This case involves (Adult and unknown gender) patient who experienced flu(influenza) while receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number, expiry date not reported) via unknown route in unknown administration site for Prophylactic vaccination.   On an unknown date the patient experienced a non-serious flu (influenza) (latency unknown) following the administration of INFLUENZA VACCINE.  It was reported" No way lady. Got the flue shot and got the flu. Never again".  It was not reported if the patient received a corrective treatment for the event (flu).  It is unknown if the patient experienced any additional symptoms/ events.   No laboratory details were reported.   It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the reported event was unknown.  There will be no information on the batch number for this case.
Headache and vomiting for several days following immunizations vaccines were administered on 08/27/16.
First 2 weeks no symptoms at all. After about 2 weeks I noticed 4 small bruises on my L forearm. About a week later I noticed a huge black bruise on my L  hip with a knot in the middle of it - it is still there but much lighter. Some days later I noticed a bruise on my R knee. Today I noticed a bruise on my R forearm. I do take a low does aspirin every day. I did get a little dizzy a couple of times and when I look up I get vertigo - not sure if that is related.
This spontaneous report as received from a other health professional refers to multiple patients of unknown age and gender. On unknown dates, those patients were vaccinated with improperly stored M-M-R II lot # N008365 for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1708USA005938: US-009507513-1708USA005937: US-009507513-1708USA005935: US-009507513-1708USA005936.
A serious spontaneous report of asthma attack has been received from a health professional concerning a male child, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither medical history nor concomitant medication was reported for this patient. On an unknown date in Dec-2010, the patient received FLUMIST. On 21-Dec-2010, two weeks after FLUMIST vaccination, the patient experienced an asthma attack that caused him to go to the hospital. The outcome of the event asthma attack was unknown.
ventricular tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR TACHYCARDIA (ventricular tachycardia) in a 55-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VENTRICULAR TACHYCARDIA (ventricular tachycardia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 21-Dec-2021 due to VENTRICULAR TACHYCARDIA. The patient was treated with Surgery (Cardiac ablation) for Ventricular tachycardia. At the time of the report, VENTRICULAR TACHYCARDIA (ventricular tachycardia) outcome was unknown.            Patient had no prior Heart condition. Had several tests and procedures done along with a cardiac ablation which still did not fix the issue and currently on a heart event monitor awaiting the next step. Case did not met requirements for PQC. No concomitant medication information was provided. No treatment medication was provided.  Company comment:This is a case concerning a 55-year-old female patient with no medical history, who experienced the unexpected serious  AESI event of Ventricular tachycardia (seriousness criterion hospitalization and medically significant) which occurred on unknown date after to the second dose of mRNA1273 vaccine. Patient had no prior Heart condition. Had several tests and procedures done along with a cardiac ablation which still did not fix the issue and currently on a heart event monitor awaiting the next step. The event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2022: Non-significant follow up.; Sender's Comments: This is a case concerning a 55-year-old female patient with no medical history, who experienced the unexpected serious  AESI event of Ventricular tachycardia (seriousness criterion hospitalization and medically significant) which occurred on unknown date after to the second dose of mRNA1273 vaccine. Patient had no prior Heart condition. Had several tests and procedures done along with a cardiac ablation which still did not fix the issue and currently on a heart event monitor awaiting the next step. The event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
High fever treated with Tylenol and ice pack. Took steroids to treat migraine and cluster headaches. Injections in the head and neck to elevate the headache. Took Nurtec to try to abort the headaches. Rash all down my trunk.
2 hours after vaccine frontal lobe H/A, nauseated and dizzy, never reacted in past from vaccine.
on 25 July 2022 I developed a rash on my left pectoral, left back and left underarm which I went to the hospital for on 26 July 2022.  They diagnosed it as shingles and covid.  So I got shingles  WHEN I got covid and I don't think is normal, I believe it is an aftereffect of the vaccine.
This case was reported by a nurse and described the occurrence of injection site induration in a 12-year-old male patient who received MENVEO (batch number X15099, expiry date unknown). On 9th June 2016, the patient received the 1st dose of MENVEO. On an unknown date, less than a year after receiving MENVEO, the patient experienced injection site induration and injection site redness. On an unknown date, the outcome of the injection site induration and injection site redness were recovered/resolved. It was unknown if the reporter considered the injection site induration and injection site redness to be related to MENVEO. Additional details were provided as follows: In the morning of reporting date, the sales representative called the office nurse and at this visit they discussed that there were a high number of patients with severe local reactions to the MENVEO and BEXSERO vaccines. These patients were returning to reporter's office with very large, reddened, swollen, hardened, warm induration at the injection site and the surrounding area, many times measuring 6 inches or more from the injection site. The physician had prescribed oral antibiotics for most of these patients. The patient concerned in this case had experienced 8 mm induration and redness at injection site after MENVEO vaccination, which had lasted for 5 days. He was monitored by his parents. The reporter had tried several different methods of mixing the vaccine (letting it sit, administering it immediately, etc) but none had proved effective in reducing reaction rates. The reporter requested for suggestions on how they could possibly reduce the potential for a local reactions. Also, they inquired if there had been any problems with certain lot numbers of the vaccine, so that they could compare those numbers to the vaccines which they administered to their patients. This case has been linked to 4 other cases (MENVEO vaccine), reported by the same reporter.
Information has been received from a Licensed Practical Nurse (L.P.N.) for a GARDASIL, a Pregnancy Registry product, concerning a 22 year old pregnant female patient with asthma, amenorrhoea and hyperlipidemia and none drug allergies who on 23-SEP-2011, and 29-NOV-2011, was vaccinated with a first dose of GARDASIL (route, expiration date and Lot # unspecified) and the second dose of GARDASIL, 0.5 ml, intramuscular (Lot # 668985/0690AA) (expiration date 30-JUL-2013). Concomitant therapy included prenatal vitamins (unspecified), gemfibrozil 600mg, montelukast sodium and ADVAIR. It was also reported expiration date that the nurse was not sure if the patient was still taking these medications or if they were discontinued when the patient discovered that she was pregnant. Subsequently, in approximately October 2011 the patient became pregnant (an urine pregnancy test, hcg beta quantitative). On an unspecified date, the patient experienced some spotting. No treatments was given for the events. The patient had sought medical attention during second prenatal office visits. At the time of report patient spotting was resolved. Follow-up information has been received from a Licensed Practical Nurse (L.P.N.) for a GARDASIL, a Pregnancy Registry product, concerning a 22 year old female patient with hyperlipidemia, no illness at the time of vaccination, with a history of irregular menstruation, who on 26-NOV-2011, (previously reported 29-NOV-2011), received the second dose of GARDASIL, 0.5 ml, IM, in the right deltoid region (Lot # 668985/0690AA). It was reported that the patient was still pregnant. Her last menstrual period was on approximately 19-OCT-2011 and her estimated delivery date was 25-JUL-2012 (previously reported as 07-JUL-2012). The reporter stated that on 01-DEC-2011, the patient experienced vaginal spotting. On an unknown date, the patient recovered from vaginal spotting. Follow up information received. The nurse was called who stated that she would look into the information to see if she could find anything and that if she could would call back but have not been heard from her. The case is lost to follow up. Additional information is not expected.
This spontaneous report was received from a registered nurse via company representative refers to a female patient of unknown age. No concurrent condition or medical history was reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL. Concomitant medication was not reported. On an unknown date, the patient experienced seizure, a couple of minutes after receiving the vaccine. Approximately on an unknown date in May 2015 (reported as seen recently and now), the patient was seen at the medical office and was now experiencing vasovagal syncope. The outcome of vasovagal syncope and seizure was unknown. No product quality complaint was reported. Upon internal review, the event seizure was determined as medically significant. Additional information is not expected.
Systemic: Abdominal Pain-Severe, Additional Details: patient states he had muscle cramping in his lower legs, shins and abdominal 1-2 hours after receiving shot. Patient states it lasted an 1-1.5 hours for pain/cramps to stop.
The pt received the injection on 11:30 and woke from nap at 3:00 pm. The pt was crying, had a temp of 103 1 hour after Tylenol was given. The pt was cranky, clingy, feverish through the rest of the day. The pt vomited, woke in the AM was cooler and appeared more comfortable.