chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dad brought son in -left arm arcular swollen area approximately 70 cm circumference. Mild warmth and raised. "little sore', no systemic symptoms-no rash, no spreading, no hive, no difficulty breathing, no fever. Enc. Tylenol if needed alternate arm paces-watch for temp, problems with respiration
tested positive for COVID-19 after second booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (tested positive for COVID-19 after second booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 COVID-19 (tested positive for COVID-19 after second booster). At the time of the report, COVID-19 (tested positive for COVID-19 after second booster) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive continues to test positive for COVID (unknown length of time)..         No concomitant medication was reported. Reported reported that her sister caught Covid-19 after her 2nd booster. Reported could not confirm if her sister received the Moderna COVID-19 vaccine for any of her doses including the second booster.   No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 (reported as tested positive for COVID-19 after second booster) which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 (reported as tested positive for COVID-19 after second booster) which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Swelling, pain, redness, hot to touch at injection site 4 days after vaccine.
Patient with h/a, dizziness, and weakness requiring multiple trips to the ER and Urgent Care.  SE following second dose which was on 3/18/21
the adjuvant was not mixed with the lyophilized powder; the adjuvant was not mixed with the lyophilized powder; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 72A32, expiry date 8th July 2023) for prophylaxis.   On 18th May 2022, the patient received Shingrix. On 18th May 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 18-May-2022 Reporter's comment: Pharmacist reported that the patient was administered Shingrix adjuvant only, the adjuvant was not mixed with the lyophilized powder. The reporter consented to follow-up. Additional Supportive Information: The patient only received Shingrix adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Serious case of oral thrush, treated with Nystantin prescribed by Urgent Care Herpes outbreak (genital) Sacral Herpes lesions on stomach 5 total , three seriously infected
Case number PHEH2014US010188, is an initial spontaneous report received from a nurse on 15 May 2014 with a follow-up received on 24 June 2014. This report refers to 13 year old male patient. He was not taking any concomitant medications. He was vaccinated with initial application of MENVEO (batch number: A12094) intramuscularly in to the right deltoid at 5:00 pm on 08 May 2014. Seven days later the vaccine was noted to have been stored out of temperature range for a 2.5 hour period prior to administration. Temperature maximum of 21 degree Celsius was reached. No adverse event was reported following this mal administration (incorrect storage of drug). Follow-up received from the nurse on 24 June 2014: Updated patient demographics, site and time of application, vaccination history and comment from reporter.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical histories, drug reactions or allergies, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # M025565, expiration date 08-NOV-2017 (dose was not reported). There were no adverse effects reported. Administered doses of ROTATEQ were exposed to temperature excursion of 31.3 degrees Fahrenheit for 87 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009271.
STROKE; SORE ARM; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included: stroke (transient ischemic attack), and concurrent conditions included: hypertension, tylenol and ibuprofen allergy (one was rash and the other one made him edgy) and he did not know which was which, marijuana drug abuse, patient had used a pot (marijuana) in the past and he still uses but not that frequently and not for pleasure, non alcohol user, and cigarette smoker. Patient used cigarettes as a teen and had used it off and on since then but after his stroke in 2016 he stopped smoking and now sometimes smokes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 13-MAY-2021 in left arm for prophylactic vaccination. Concomitant medications included clopidogrel bisulfate, and lisinopril.  On 13-MAY-2021, the patient experienced sore arm and he mentioned that he could not recall any adverse events except a sore arm. The caller stated that 30 to 37 days later (not sure about the exact date) on 12-JUN-2021, patient had a stroke, patient got up up in the morning and felt crappy, Later he called ambulance and was transferred to the hospital, where they did computerized tomography (CT scan) and Magnetic resonance imaging (MRI) and patient diagnosed with stroke. On 12-JUN-2021 patient was hospitalized and he was there for 2 days and was transferred to the other center and he was there for 19 days. Patient still feels numb and weak, nothing like a sharp pain in the chest but his sensation was odd feeling like his skin was being in somebody else's body. He mentioned it felt like his body went to sleep. His leg had been numb (he used cane at the beginning but not anymore) but not to the degree that cannot walk but it was not easy to walk. Patient reported that he will see a neurologist and a cardiologist in future. It was notable that the patient could not recall the specific dates of hospitalization or other incidences. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and outcome of stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0; 20210912862-Covid-19 vaccine ad26.cov2. s- stroke. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: Medical History
I woke up in the middle of night and I couldn't lift my arm and it was painful, I had a fever, chills, and my heart was racing heart. Subsided after about 15 hours. Then for the next 8-10 days I still had extreme brain fog, couldn't concentrate, and I could barely do my job. Loss of appetite, headache, taste and smell. It finally subsided after about 3 days.
This is a spontaneous report from a contactable pharmacist (patient). A patient, of unspecified age and gender, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on Mar 10, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Patient experienced headache, mild fever, head congestion  (Mar 11, 2021); SOB/shortness of breath (Mar 14, 2021); fatigue (Mar 15, 2021); cough, chest tightness, neck aches, fever and headache (Mar 16, 2021). The outcome of headache, mild fever, head congestion resolved on Mar 11, 2021; SOB (shortness of breath), fatigue, cough, chest tightness, neck aches, fever and headache: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a patient who on 12/5/03 was vaccinated with a dose of varicella virus vaccine live. It was reported that on 12/1/03 the patient experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought, but there was no treatment and no hospitalization. The patient recovered. No product quality complaint was involved. This is one patient out of 40 reported. Thirty nine other cases (WAES0407USA01446, 0409USA01855 through 0409USA01864, 0409USA01866 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additional information is not expected.
Breakthrough case after full vaccination. Patient developed symptoms 7/19/21 including fever, chest tightness, cough, SOA, nausea, loss of taste/smell, nasal burning, head congestion, sneezing, and rash to trunk
3FEB94 pt stated since vax was recvd exp dizziness, diarrhea & now numbness in lt arm; 15FEB94 pt did see MD who thought sx more viral then vax related; lab work done; nausea & occasional diarrhea cont; 28FEB94 pt fine;
Our healthcare facility was performing a public service by providing vaccines at our local school.  During this time, the vaccine recipients parent completed our COVID-19 vaccine consent form with inaccurate information.  The date of birth provided on the consent form was incorrect.  This lead our vaccinator to believe the patient was 12 years old, but the patient is actually 11 years old.  The patient received the vaccine and was monitored for 15 minutes with no adverse effects.  Later, this writer was contacted by the Regulatory authority to notify us that we had vaccinated a person under the age of 12.  This writer called the patient's parent to inquire whether she was harmed at all or had any adverse effects from the vaccine dose.  The parent confirmed that the recipient had no adverse effects.  Furthermore, the parent admitted that the patient was not 12, and that the parent still would like for the patient to receive the second dose of the series.  This author replied that it is not recommended for the patient's age and that we would not willfully vaccinate a child under the age of 12.
Pain swelling redness at injection site.  Dizziness, Body Aches.  headache  stomach  distress, tiredness
Patient was not present for 2nd dose clinic today.  Manager of facility reported that patient died in his sleep on 4/6/21
with my 1st shot, i got a severe headache within 10 minutes; Shot site soreness.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 59-year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Sep2021 14:30 (Lot number: FC3184) at the age of 59 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Fibromyalgia", start date: 13Mar2017 (ongoing), notes: Pertinent Details: Chronic pain; "Neuropathy", start date: 13Mar2017 (ongoing), notes: Pertinent Details: Chronic-entire body neck down; "Hypothyroid", start date: 1976 (ongoing), notes: Pertinent Details: Hashimotos- allergic to thyroid replacement. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 07Sep2021 14:35, outcome "recovered" (Sep2021), described as "with my 1st shot, i got a severe headache within 10 minutes"; VACCINATION SITE PAIN (non-serious) with onset 07Sep2021 14:35, outcome "recovered" (Sep2021), described as "Shot site soreness.". Therapeutic measures were taken as a result of headache, vaccination site pain  Additional information: Vaccination facility type: Pharmacy or Drug store. With 1st shot, I got a severe headache within 10 minutes, that lasted for 5 days. And shot site soreness. Just thought you should keep track of side effects. Patient was treated with NSAIDS for headache and vaccination site pain. Patient did not receive any other vaccines within 4 weeks of vaccination.  Follow-up attempts completed. No further information expected.
SARS-CoV-2 N gene Resp Ql NAA+probe~SARS-COV-2 (COVID-19) - COLLECT KIT OR EXTERNAL KIT performed on 7/23/21 at 13:45. Test came back positive. Case investigation interview with patient has not been conducted as of the time of this note.
pt was administered Hep B vax 12APR92 & 14APR93 c/o generalized urticaria & wheals & itching; took DPH; advised to call family MD & if further sx occur go to ER immediately;
Vaccine booster given on 11/1/2021. Muscle aching noted the next day.  The days following I began to become winded doing things as simple as normal walking.  The feeling of being winded continued and worsened by the day until I went to the Emergency Room during the early morning hours of 11/9/2021.  I was transferred by ambulance from there to the  Medical Center in Emergency Room to see cardiology.  I had flown from 11/4 to 11/8.   I was diagnosed by cardiology as having pericarditis.  I was sent to the cardiac cath lab to remove the fluid.  1075 cc's of fluid was removed from my heart.  My cardiologist said that my heart had gone into cardiac tamponade during the procedure.  I was moved to the ICU after the procedure and then discharged home the next day.  I was placed on preventative meds on discharge.  In follow-up chest imaging, it was determined that I also had a small pulmonary embolus that showed in my right lung.  The cardiologist said it appeared to be older and likely from when the pericarditis was.
w/in 2 hr of vax throat started swelling & could not swallow; was seen in ER & given DPH IVs & ATB;
Patient experienced tingling in tongue, and in left arm, vitals are normal.  Complained of "weird feeling" in the chest, no experienced pain. Administered 25mg of Benadryl orally.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 26May2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medication in 2 weeks. Paxlovid was taken for treatment from 29May2022 to 02Jun2022. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial misuse report received from a healthcare professional on 21 March 2013. A 61-year-old patient received a dose of MENACTRA instead of MENOMUNE. No adverse event was reported. List of documents held by sender: none.
Initial unsolicited report received from a nurse on 18 May 2018. This case involves a six year old patient (gender was not reported) who was vaccinated with of ADACEL (batch number, expiry date, route and site of administration were not reported) as the fourth dose of ADACEL on an unspecified date. It was a case of actual medication error due as product use in unapproved population, Inappropriate age at vaccine administration and Wrong vaccine administered. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
A report has been received from a health professional concerning an 8 year old, subject of unknown gender, who had been receiving nasal FLUMIST started on an unknown date. The nurse reported that they inadvertently administered expired FLUMIST to the patient, which started on 14-JAN-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
I received my second Moderna booster for COVID-19 on 5/19/2022. On the morning of 7/22/2022, I had a severe headache and severe fatigue. I also had a bit of brain fog and a slight fever. I had runny eyes and a runny nose with sinus congestion and pain. I took 2 home tests for COVID-19 that day, and they both yielded positive results. I called the doctor's office and requested a prescription for Paxlovid, which I got and started taking that evening. The fever reached 103 on 7/23/2022, and I took an OTC medicine for migraines to treat it, and the medicine seemed to treat about 10-20% of the pain. The fever lasted only 24 hours, though. I was really tired that day, so I spent most of the day sleeping. On 7/24/2022, the temperature and the headache began to abate. I had a low-grade fever, and the fatigue worsened. I drank plenty of water, though I didn't eat much, as I had lost my appetite. I also had a bad taste in my mouth, which was caused by the Paxlovid. On 7/25/2022, I started to feel relief. The symptoms became manageable. I still had fatigue, but it was less intense, so I was able to move around and get food. On 7/26/2022, the symptoms were 95% gone. I took another home test for COVID-19 on 7/26/2022, and the result was positive, though the line was faint. On 7/27/2022 and 7/28/2022, I took more home tests, both of which yielded a negative result. On 7/28/2022, I called the doctor's office and told them that I thought I had recovered. They advised me to wear a mask for the following 5 days and to let them know if the symptoms returned. I did as I was instructed, and the symptoms did not return. For a couple of days during my illness, I lost more hair than usual, and other people noticed it. Also, my sense of taste was altered. Not only did the Paxlovid leave a bad taste in my mouth, but chocolate and other sweets tasted different. My sense of taste finally returned to normal about 8/1/2022.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 45-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of COVID-19 vaccine (manufacturer unknown), for immunisation. The patient developed urticaria (hives all over body), with outcome of unknown. Additional information: No product complaint associated with this case. Life-threatening: no. Intervention/Medically important: no. Death: no. No prolonged hospitalization. Disabling/incapacitating: no. Congenital anomaly/Birth defect: no. Hospitalization required: no. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Pt vaccinated with TD/OPV pt's arm was swollen from shoulder to midway between the elbow and wrist; red, hot, very firm to touch, severe pain by 5NOV90 had a few welt-like areas;
induration lt lateral thigh 2cm x 2cm site of DTP vax IM;
Facial rash/hives, facial swelling about 48 hours after vaccine was administered. Roughly 80 hours after vaccine, she experienced vomiting (about 5 times in 6 hours).  Scheduled an appt with PA 89 hours after vaccine was administered. PA said it could be a virus, or it could be the vaccine. She advised to watch patient's two other siblings for viral symptoms alighting with patient's. No one else at home or school was exhibiting viral symptoms before, during or after patient's symptoms. PA advised to follow up if patient was dehydrated. Patient laid around and was very sluggish with no appetite until Monday, 2/21/22 when she seemed to regain some energy. Patient vomited several more times throughout the weekend at random points. We are still treating her rash/hives with Aquaphor.
no adverse events, patient inadvertently received Quadracel. I followed up, no harm to patient, mother made aware. Patient was here for Tdap requirement. He and his brother were in the same room and brother was receiving Quadrcel with his vaccines.
Mother of baby reports 2 months later that approx 15-20 minutes after vaccinations, baby was lethargic, listless, and hard to awaken. This went on for 24 hours. She reported to baby's pediatrician who parent states was unconcerned. SN requested she take baby to pediatrician for 4 month vaccines but insurance won't cover. Received order from Dr. to administer 4 mo vaccines here at health dept.
I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/31/2023 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Felt the vaccine into the left hemisphere of head immediately . Within 30 mins tasted the vaccine draining from left sinus and sinus cavity vasodilated. Headache began next then on only left side - did not respond to OTC pain relievers. Left ear pain began and the left check lost sensation. The cheek sensation has not returned 100%; it?s about 95%. I experienced a mild fever - 101-102 degrees - for three days. I also experienced fatigue, nausea and muscle and joint pain.
Several days post vax, the pt complained of myalgias, bilateral chest wall as well as lower extremity muscle weakness.