chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hyperlipidemia; Hypertension; Impaired fasting glucose; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERLIPIDAEMIA (Hyperlipidemia), IMPAIRED FASTING GLUCOSE (Impaired fasting glucose) and HYPERTENSION (Hypertension) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 009C21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Impotence since 07-Nov-2013 and Carpal tunnel syndrome since 13-Nov-2015.   On 27-Jul-2021 at 10:02 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Aug-2021 at 9:44 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-Jan-2022, the patient experienced IMPAIRED FASTING GLUCOSE (Impaired fasting glucose). On 21-Jan-2022, the patient experienced HYPERLIPIDAEMIA (Hyperlipidemia) and HYPERTENSION (Hypertension). The patient was treated with AMLODIPINE (oral) ongoing from 21-Jan-2022 for Hypertension, at a dose of 5 milligram once a day. At the time of the report, HYPERLIPIDAEMIA (Hyperlipidemia) and IMPAIRED FASTING GLUCOSE (Impaired fasting glucose) outcome was unknown and HYPERTENSION (Hypertension) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that it is unknown that the patient has ever been diagnosed with or tested positive for COVID-19.   This case was linked to MOD-2022-607808 (Patient Link).
I started experiencing chest pain when I woke up. Also, right foot and arm were tingling. This is from the second dose of the Pzifer Vaccine.
48 hours later red & swollen 3 1/4 x 2 1/2 inches around DTaP injection site. Treatment Motrin & Benadryl left thigh.
ACUTE MYOCARDIAL INFARCTION; THROMBOCYTOPENIA; This solicited report received from a physician concerned a 47 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose series number:1) (suspension for injection, batch number was not reported, expiry date: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced acute myocardial infarction (AMI) 11 days post JNJ vaccine and was diagnosed with thrombocytopenia at same time by labs (not specified). The patient was treated with aspirin, heparin drip and statins. It was reported that the patient survived. The physician suspected the events to be linked to JNJ vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute myocardial infarction and thrombocytopenia was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and acute myocardial infarction, and thrombocytopenia as related. Company causality between covid-19 vaccine ad26.cov2.s, and acute myocardial infarction, and thrombocytopenia was related. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220114454 and 20220114483.; Sender's Comments: V0: 20220114526 -covid-19 vaccine ad26.cov2.s- acute myocardial infarction, thrombocytopenia. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Episode of altered mental status, confusion, and tremor like movements arms/legs. Started about 3hrs after MENVEO, lasted about 2 hrs, resovled. Seen in E.D.
Information has been received from a consumer concerning a male with no past medical history and no known allergies who on 6/16/95 was vaccinated with the 1st dose of MMRII (lot 0906W provided, is invalid for this product). The 2nd dose of MMRII (lot 0830 provided, is invalid for this product) was given on 6/22/98. There was no concomitant medications. Subsequently, the pt developed autism. The pt sought medical attention. Upon internal review, autism was determined to be an "Other Important Medical Event". Additional information has been requested.
Tasted very bad, appeared oily; Not able to swallow full dose; Not able to swallow full dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 8-week-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 17-APR-2023, the patient received Rotarix lyophilized formulation. On 17-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: Not able to swallow full dose) and accidental underdose (Verbatim: Not able to swallow full dose). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Tasted very bad, appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2023 and 25-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023060947:Same reporter. FU1 - deleted US-GSK-US2023AMR058971:Same reporter
Initial unsolicited report received from a consumer on 22-Nov-2016. This case involves a male patient (age not reported) who was vaccinated with Fluzone HD via intramuscular route (batch number, dose, expiration date was not reported) at right deltoid on 03-Nov-2016. Illness at time of vaccination was reported as unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions were also reported as unknown. Concomitant medications were not reported. On 04-Nov-2016, one day following vaccination, patient experienced soreness on injection site and had difficulty to bend the right arm. Lab data and corrective treatment were not reported. Outcome of the events were reported as not recovered. List of documents held by sender: none.
Sore arm, aches - 24 hours Posterior neck stiffness with pain on flexion and limited range of motion - 72 hours
On 12/24/2022, I began to feel sicker and sicker. I had a sore throat and felt feverish. I had been testing myself with home antigen tests, because my husband had tested positive on 12/20/2022. I took another test on 12/24/2022, and the result was negative. On 12/25/2022, I tested positive. I contacted my medical provider, and I was prescribed Paxlovid, a cough medicine, and an albuterol inhaler. I started taking the Paxlovid and began feeling better pretty quickly. I had a fever for about three days, but I gradually got better. Around 1/1/2023, I tested negative on a home antigen test. I then felt like I was coming down with a sore throat, and then I tested positive again. This time, I had major sinus congestion and a fever. I also had body aches and tiredness, but the main symptom was the head congestion. I contacted my doctor, because I thought I had a sinus infection. My doctor told me I didn't have an infection and that it was just a rebound, but she did prescribe me an antibiotic. I felt sick for about five or six days, and I felt a bit worse than I did during the first round. It then took another five days or so afterwards before I tested negative again.  During my second round of COVID-19, I developed soreness in my right foot. It's on the lateral side of the foot under the ankle bone. The pain is intermittent, but ever since I had COVID-19, I have continued to have issues with it.
Starting one day after the vaccine, I developed a headache which turned into a migraine within 24 hours. The migraine became debilitating on Sunday, January 3, 2021. I had vomiting, nausea and dizziness as well. I was unable to work on Monday, January 4, 2021 because I still had the migraine.  I take Ubrelvy (prn) and it did not work. I attempted to return to work Tuesday afternoon as the migraine subsided, but it returned shortly after I made it to work. Our treatment nurse took my blood pressure, it was high. My blood sugar was high. I was dehydrated and the migraine was back. My nurse practitioner treated me with an IV of saline solution, pain relieving injection for the migraine and Zofran for the nausea.
Tinnitus which seemed to be at a minimal level before got much louder sometime around getting vaccine.Started visit to an ENT dr. but they didn't see anything majorly wrong
Developed period like cramps for a whole month; Being light-headed frequently; In addition her cycle became irregular resulting in 5 months of missed period, this was not normal due to having regular cycles, to this day Sep2021 she still had missing and or skipping months of periods; This is a spontaneous report from a contactable other healthcare professional, the patient. A 25-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on an unknown date in Jan2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. 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 vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 31Dec2020 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Mar2021, after second dose of vaccination, the patient developed period like cramps for a whole month. Then she was being light headed frequently. In addition, her cycle became irregular resulting in 5 months of missed period. This was not normal due to having regular cycles. It was reported that, to this day Sep2021 the patient was still missing and or skipping months of periods. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included lab tests with ultrasound and blood work on an unknown date in 2021 and results were unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events developed period like cramps for a whole month and being light headed frequently was unknown; whereas for event and cycle became irregular resulting in 5 months of missed period, this was not normal due to having regular cycles, to this day Sep2021 she still had missing and or skipping months of periods was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA267265, 2018SA267274, 2018SA267305, 2018SA267294, 2018SA267282, 2018SA267253, 2018SA267282, 2018SA267283, 2018SA267294, 2018SA267293 and 2018SA267304 same reporter. This case involves a 60 years old male patient who received a 0.5 ml dose of suspect vaccine FLUZONE QUADRIVALENT, lot UI815AA, expiry date 30-Jun-2018 via intramuscular route in the left deltoid on 17-Sep-2018. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. It was an actual medication error due to expired vaccine used. It was reported that patient was administered FLUZONE QUADRIVALENT vaccine on 17-Sep-2018, which was expired on 30-Jun-2018. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender - none.
The next day, the patient had a migraine, sore muscles, high fever, and dizziness. Effects lasted all day until it called down around 10:00 pm.
Redness around the injection site; Tender to the touch injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tender to the touch injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Tender to the touch injection site). On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, VACCINATION SITE PAIN (Tender to the touch injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: TCR: Outcome of events updated
can only see out of one eye now; I can only see out of one eye now and one ear; I got the shot and then the flu; put on 40 lbs; Initial information received on 21-Dec-2022 regarding an unsolicited valid  non-serious Social media case received via consumer/non-hcp.  This case involves Adult and unknown gender patient who was diagnosed with can only see out of one eye now, i can only see out of one eye now and one ear, i got the shot and then the flu and put on 40 lbs after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect influenza vaccine produced (manufacturer, dose, strength, frequency, formulation, batch number, expiry date, route, administration site: unknown) for prophylactic vaccination (immunization).  On an unknown date the patient diagnosed with non-serious events of can only see out of one eye now (visual impairment), serious i can only see out of one eye now and one ear (Ear disorder) , serious i got the shot and then the flu (influenza), put on 40 lbs (weight increased) (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all events.
Felt faint. Felt faint, slumped over in chair, within 5 minutes of vaccination, brought to cot via wheelchair to lie down. Upon lygin down stated "I feel better, alert and oriented x 3, Took vitals, stable throughout. States no breakfast or lunch today and nothing to drink. No difficulty breathing, no acute distress. Final disposition, feeling better, to home, driven by friends, encouraged fluids and rest.
headache; muscle ache; fatigue; nonstop terrible pain; blood pressure was very low; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (nonstop terrible pain), HYPOTENSION (blood pressure was very low), HEADACHE (headache), MYALGIA (muscle ache) and FATIGUE (fatigue) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (cashew).   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced PAIN (nonstop terrible pain), HYPOTENSION (blood pressure was very low), MYALGIA (muscle ache) and FATIGUE (fatigue). On 09-May-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 500 mg. On 14-May-2021, PAIN (nonstop terrible pain), HYPOTENSION (blood pressure was very low), MYALGIA (muscle ache) and FATIGUE (fatigue) had resolved. At the time of the report, HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported.
Information has been received from a nurse referring to a female patient of unknown age. Concurrent conditions and medical history of the patient were not reported. On 14-MAR-2016 (reported as "nine days ago"), the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route unspecified) (also reported as the patient received PREVNAR 13), but we have limited information due to the call was ended abruptly. On 23-MAR-2016 (reported as "now") the patient's arm was red and swollen. The outcome of the events was unknown. Additional information has been requested.
Arm at injection became sore and tender. Noticed four red areas around injection sight. Warm to touch. Patient applied ice packs and OTC ointment per self. Symptoms improved.
12/29/21 presents to ED for "intermittent falls and worsening confusion". PMHx of "HTN, HLD NIDDM"
Patient reports shortness of breath, nonproductive cough, fevers and chills. Treated with duonebs, dexamethasone, remdesivir and oxygen by discharged home when stable.
Fever 103.8, shaking chills, severe headache, body?s aches, burning eyes, dizziness
had a severe allergies to something in the second dose of Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of multiple allergies in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced multiple allergies. On an unknown date, the outcome of the multiple allergies was unknown.   It was unknown if the reporter considered the multiple allergies to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient stated that he/she had severe allergies to something in the 2nd dose of Shingrix, The patient wanted to know if he/she should get COVID vaccine.
Information has been received from a physician concerning a 14 year old male who on 09-Nov-1996 was vaccinated with the first dose of MMR II, on 18-Nov-2000 was vaccinated with the second dose of MMR II, on 13-NOV-2009 the patient experienced mumps, on 02-Dec-2009 was vaccinated with the third dose of MMR II (LOT # 664886/0776Y).  On 12-NOV-2009 the patient experienced mumps.  Diagnose on 15-DEC-2009 revealed the patient had parotitis and the patient was afebrile.  Follow-up information was received which reported that on 15-NOV-2009 the patient experienced mumps.  Diagnose on 17-NOV-2009 revealed the patient had parotitis R and the patient was afebrile.  Laboratory tests on 20-NOV-2009 included IgM negative, IgG 6.09 and serum amylase 340.  Additional information has been requested.
Per d/c summary of 4/24/06 mother reported child gasping and spitting a few hours after shots.  Then dropped his head and was unconscious for 40 minutes with mild jerking and low grade fever.  Did not take him to ER for another 40 minutes.  On ride to ER child responded more.  In ER he vomited and had fever of up to 102.7F.  After the initial febrile eval in ER became afebrile and stayed afebrile for the hospital stay.  Tx with IV Claforan. DC report for 5 day confinement and 23 page Medical Records to include ED report received from Murray=Calloway County Hospital. Prior to admission mother stated baby had epdisode of irregular breathing, eyes rolled back and decreased responsiveness. DC diagnoses included:Fever, leukocytosis, presumed sepsis and probable febrile seizure. On admission to ED temp 102.7 vomiting,   Admitted RX with IV Claforan.  During course of hospitalization frequent episodes of vomiting and very loose stools. 2nd day WBC 28,900 on 4/20/06 with 46 segs and 40 lymphs. No seizure activities, apneic episodes or choking spells were noted during hositalization and episodes of choking resolved. DC on Cefzil 125mg and Enfamil AR
Jansen J & J Vaccine- Intermittent Dizziness & Vertigo. I have been out for work for 1 week which recommended by Dr. I still experience dizziness up until now on and off.
Three days after the first dose around 09:00pm small dime size at clavicle lymph node about a week later it was a quarter size and was moveable and I made an appointment but I do not remember the time.  Dr. thought it may be related to breast cancer.  In my family we have a history of Breast cancer. She thought it was more like a breast cancer.   2-6 week it did not go away. It did get smaller and stop being moveable. I have a pea size lymph node is still present. The left is swelling up and moving around.
FEVER UP TO 102, MYALGIAS, MALAISE INJECTION SITE REDNESS.