chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported to the pharmacy and said she's experiencing a reaction from her tetanus shot from 4/12.  She developed some localized pain/swelling shortly after receiving the injection.  She rubbed her arm continuously in hopes of relieving the reaction.  She started to experience itching on Saturday.  Present day, the area has about a 2 1/2 inch, raised whelp that was slightly red.  No other symptoms since the injection.  I advised the patient to take oral benadryl and to see her dr if it does not resolve.
Clinical Summary Patient is a 86 y.o. male with a history of CAD, HFpEF, CKD-4, recently dx with COVID 12/17/22, who presented to hospital 12/22/22 with progressive dyspnea, weight gain, generalized weakness and abdominal/lower extremity edema. Found to have acute CHF. Hospital course complicated by worsening CKD started on HD, pneumonia and dispo/goals of care. After GOC discussions plan was to transition to inpatient hospice.    1. Acute on Chronic HFpEF: S/p PPM, with pHTN. Follows with Dr. TTE 12/14/22 with EF 57%, pHTN. Admit ProBNP 31K. Started on IV diuresis then switched to Lasix gtt, now on dialysis. Meds completed for CC.  2. AKI on CKD-4: Follows Dr. (nephrology). Baseline Cr recently ~3 but on admission Cr >4. Nephrology began trial of CRT 12/30/22. IR placed line 12/30/22. Pt already has outpt chair set up for T-R-S, however family requested twice a week given weakness - Nephro following labs. Patient declined HD and transitioned to hospice.  3. COVID-19: Symptom onset 12/16/22. Tested positive 12/17/22. Had persistent hypoxia, so obtained CT Chest 12/24/22, showed multifocal PNA. Completed decadron and Azithromycin 1/2/22. Resolved.  4. Acute Resp Failure: used to be on O2 at baseline, but last few months has not used it. Required 3L on admit, titrate for comfort.  5. DM-2: by hx. Insulin completed.  6. CAD: Follows with Dr. (cardiology). CABG 1992 and also stent. ASA and statin completed.  7. History of Heart Block: Complete heart block s/p PPM implant with generator change during hospitalization 12/2021. Recent device interrogation almost 100% RV pacing without significant arrhythmia 8. Dysphagia: new problem noted 1/1/22- recommended regular solids, thin liquids 9. Sacral pressure injury stage 2: wound care completed.
A report has been received from a study investigator concerning a 37 year old, female subject, weight: 173.0 pounds, enrolled in study. The patient had amniocentesis and amino level was normal on 11-Feb-2014. The patient did not receive any concomitant medications. The study therapy was started on 31-Oct-2013 for influenza. The date of last menstrual period was 23-Oct-2013. The first test was done on 11-Dec-2013 by using ultrasound which was positive. The second test was done on 20-Dec-2013 using ultrasound and was found positive. The patient experienced pregnancy which was started on unknown date. The estimated conception date was 06-Nov-2013. The estimated date of delivery was 30-Jul-2014. The outcome of the pregnancy was reported to be a healthy baby. The baby was male, weighed 3.35 kg, height 51.5 cm. The number of weeks at outcome of pregnancy was 38. There were no complications during delivery or pregnancy and the delivery was normal (vaginal type). The report was considered to be non-serious. The study investigator considered that there was no causal relationship between pregnancy and study therapy.
Initial report received from a consumer on 27 September 2011. A 61-year-old male patient with no reported medical history had received a dose of IMOVAX (lot number unknown) on 23 September 2011, and 3 days later, on 26 September 2011, she received a dose of RABAVERT (manufacturer Novartis, lot number unknown). Following the RABAVERT vaccination the patient experienced chest pressure and throat tightness that was continued at the time of this report. The patient did not receive medical evaluation. No indication for the vaccinations were provided. The patient has not recovered. The reporter declined to give further information; and no other contact information was provided. No further information is expected. Documents held by sender: None.
pt recv vax & devel a rash on abd, chest, naval, sides, under axilla & on back; also exp some itchiness;
This spontaneous report as received from a other health professional refers to a patient of unknown age. On NOV-2015 the patient was vaccinated with GARDASIL dose 1, 1 DF for prophylaxis. Other suspect therapies included GARDASIL 9. On 05-SEP-2017 the patient experienced inappropriate schedule of drug administration and interchange of vaccine products. The outcome of inappropriate schedule of drug administration and interchange of vaccine products is unknown. The reporter considered inappropriate schedule of drug administration and interchange of vaccine products to be not related to GARDASIL 9 and GARDASIL. Additional information has been requested.
4-18-13 noticed red raised area on right upper arm. Area warm and tender. Childrens Ibuprofen given per weight recommendations. Vomiting and diarrhea episodes started 4-18-13 night. 7 1/2 cm wide 8 cm long.
This case was reported by a pharmacist and described the occurrence of brain swelling in a 24-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), (non-gsk) FLUZONE. The subject's medical history included Cesarean delivery, live birth and pregnancy. Concurrent medical conditions included endometriosis. Concurrent medications included Prenatal vitamin, TORADOL and PERCOCET. On 16 November 2011 at 11:30 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left arm). On 16 November 2011 the subject received a dose of FLUZONE (unknown route). On 4 December 2011, 18 days after vaccination with BOOSTRIX and FLUZONE, the subject experienced brain swelling, vision disturbance including "could not see side of face", and cloudy vision. The pharmacist reported that on 14 November 2011, prior to the administration of the vaccines, the subject gave birth to a baby by Cesarean delivery. The subject was hospitalized for 7 days due to the events and the pharmacist considered the events were disabling and clinically significant (or requiring intervention). The pharmacist explained that the subject was hospitalized at another facility for the adverse events. Relevant test results included nuclear magnetic resonance imaging that showed brain swelling and a lumbar puncture that was negative. The subject was treated with Corticosteroids. At the time of reporting the events were improved.
Patient presented to COVID-19 vaccination clinic for Moderna dose 1. When checking in at registration, patient was asked if this was for his first or second dose and patient stated he was here for the second dose.  When checked in at vaccination station, the first nurse asked patient screening questions.  When asked if he had received any immunizations within the past two weeks, patient stated no. When documenting the vaccine, the nurse received a EMR alert for vaccine duplication. When reviewing the chart further, nurse did not see additional vaccines administered that would contraindicate dose and asked another nurse to confirm. The second nurse also did not see vaccine contraindications in the chart. During this time a third nurse screened the patient again and the patient denied having received any vaccinations in the past two weeks. Patient was vaccinated with Moderna dose #1.  In the meantime, the clinic site manager reviewed the outside records in the patients chart, it was noted that the patient received the J&J COVID-19 vaccine on 3/11. The patient was asked if he had received the vaccine and he said yes and that he had looked at the research and he wanted to get the Moderna vaccine as that what was recommended.  Patient has now received one dose of J&J vaccine on 3/11 and one dose of Moderna vaccine 11 days later on 3/22. No adverse reactions identified during clinic observation period. Manufacturer consulted about data regarding mixed vaccine administration and stated there is no current data to support mixed vaccinations, however, referred to CDC recommendations regarding administration of any subsequent COVID-19 vaccine.
sore right injection sight arm; headache; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore right injection sight arm) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic, Blood pressure high and Sickle cell trait. Concomitant products included METFORMIN, ATENOLOL, CHLORTALIDONE (ATENOLOL/CHLORTHALIDONE), AMLODIPINE and LEVOTHYROXINE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore right injection sight arm) and HEADACHE (headache). On 04-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PAIN (sore right injection sight arm) outcome was unknown.            No Treatment information were provided by the reporter.  Patient received her second Moderna Covid-19 vaccine on 30MAR2021. The patient reported that had no adverse reactions. Lot number for the second Moderna Covid-19 vaccine 018B21A expiration date was not provided. The patient received both vaccinations in her right arm shoulder deltoid muscle.
Numbness on left side of body starting Oct 2, diagnosed with Multiple Sclerosis Oct 9. No prior medical or symptom history consistent with Multiple Sclerosis.
Cold sores in mouth have appeared; Flare ups on face; Eczema flares, have been in a cycle of clearing and rebounding; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Eczema flares, have been in a cycle of clearing and rebounding), DERMATITIS ATOPIC (Flare ups on face) and ORAL HERPES (Cold sores in mouth have appeared) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concomitant products included FLUCONAZOLE for an unknown indication.   In December 2020, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced ECZEMA (Eczema flares, have been in a cycle of clearing and rebounding). In May 2021, the patient experienced DERMATITIS ATOPIC (Flare ups on face). On an unknown date, the patient experienced ORAL HERPES (Cold sores in mouth have appeared). The patient was treated with KETOCONAZOLE (topical) for Dermatitis atopic, at an unspecified dose and frequency; PREDNISONE for Eczema, at an unspecified dose and frequency; ACYCLOVIR [ACICLOVIR] for Cold sore mouth, at a dose of 5 days and FLUCONAZOLE for Eczema, at a dose of UNK, qwk. At the time of the report, ECZEMA (Eczema flares, have been in a cycle of clearing and rebounding) and DERMATITIS ATOPIC (Flare ups on face) outcome was unknown and ORAL HERPES (Cold sores in mouth have appeared) was resolving.            Patient's dermatologist told her to put ketoconazole shampoo over the face which did not help much. Last month the patient was prescribed fluconazole once a week. Patient states the flare ups are not as bad as what her condition was prior to beginning dupixent.  Other treatment medications included Protopics, antifungals,but none were tolerable. Cold sores in mouth have appeared about a month ago. Was treated with 5 days of acyclovir, helped but total remission was not achieved.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623823 (Patient Link).
In bed all day; Didnt have an appetite; few chills; Fatigue; Moderate headache enough to bother me; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (In bed all day), DECREASED APPETITE (Didnt have an appetite), HEADACHE (Moderate headache enough to bother me), CHILLS (few chills) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (Moderate headache enough to bother me). On 13-Feb-2021, the patient experienced BEDRIDDEN (In bed all day), DECREASED APPETITE (Didnt have an appetite), CHILLS (few chills) and FATIGUE (Fatigue). At the time of the report, BEDRIDDEN (In bed all day), DECREASED APPETITE (Didnt have an appetite), HEADACHE (Moderate headache enough to bother me), CHILLS (few chills) and FATIGUE (Fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 100.2 (High) fever-100.2. On 18-Feb-2021, Body temperature: 98 (High) fever-98.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications  were not reported  Treatment was not specified
pt recv vax & devel granuloma @ the inj site;pt was advised to apply warm packs, move the legs a lot & massage;The granuloma lasted for one to four weeks;
Received TDAP 10/13/10. And on 10/18/10 presented to hospital with 100 mm x 100 mm area of redness, swelling and fever at site left deltoid area.
Client reports vaccine was administered on 2/22/11 at 17:00. Reports began feeling chest palpitations and experiencing dizziness at 1800. Ct reports she fell down at this time. Did not seek medical attention. Arrived at clinic on 2/23/11 at 1000. No further dizziness/palpitations reported. Encouraged to go to emergency room for further medical evaluation at this time.
Some local reaction left arm- redness, swelling, tender x3 days. No systemic symptoms.
dizziness; nausea; sore all over; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), NAUSEA (nausea), MYALGIA (sore all over) and HEADACHE (headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Schizophrenia. Concomitant products included FLUPHENAZINE DECANOATE (PROLIXIN [FLUPHENAZINE DECANOATE]) for Schizophrenia.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), NAUSEA (nausea), MYALGIA (sore all over) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), NAUSEA (nausea), MYALGIA (sore all over) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
There was no reaction until twelve hours later.  I became hyperactive and could not sleep.  I went to urinate 16 times.  My heart started racing (piles 111) and I had irregular heartbeat.  Six hours later, I got diarrhea.  The heart racing slowly went away and I was able to rest.  By noon, the next day my heart returned to normal, in fact the hypertension I had for months before was GONE!  I am completely normal, with normal heart readings and I slept well last night.
Rash on my neck; Rash on my face after first dose; Sore arm after first dose that lasted four days; Fever; Lost my voice; I am with cough. At night I cough, cough, cough; Next day I started to feel lumps in my clavicle; Feel lumps below my arm; Feel lumps in my throat; My throat hurts when I swallow; Feel decay, without strength; Cant swallow; Couldn't go to work until yesterday; Very sore arm after second shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on my neck), RASH (Rash on my face after first dose), PAIN IN EXTREMITY (Sore arm after first dose that lasted four days), PYREXIA (Fever) and DYSPHONIA (Lost my voice) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B221A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 29-Apr-2021, the patient experienced PAIN IN EXTREMITY (Very sore arm after second shot). On 30-Apr-2021, the patient experienced DYSPHONIA (Lost my voice), COUGH (I am with cough. At night I cough, cough, cough), PERIPHERAL SWELLING (Next day I started to feel lumps in my clavicle), PERIPHERAL SWELLING (Feel lumps below my arm), SENSATION OF FOREIGN BODY (Feel lumps in my throat), ODYNOPHAGIA (My throat hurts when I swallow), ASTHENIA (Feel decay, without strength), DYSPHAGIA (Cant swallow) and GAIT DISTURBANCE (Couldn't go to work until yesterday). On an unknown date, the patient experienced RASH (Rash on my neck), RASH (Rash on my face after first dose), PAIN IN EXTREMITY (Sore arm after first dose that lasted four days) and PYREXIA (Fever). The patient was treated with CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL SKIN ALLERGY RELIEF) at an unspecified dose and frequency; IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and AZITHROMYCIN at an unspecified dose and frequency. On 11-May-2021, DYSPHONIA (Lost my voice) outcome was unknown, GAIT DISTURBANCE (Couldn't go to work until yesterday) had resolved. At the time of the report, RASH (Rash on my neck), RASH (Rash on my face after first dose), PAIN IN EXTREMITY (Sore arm after first dose that lasted four days), PYREXIA (Fever), COUGH (I am with cough. At night I cough, cough, cough), PAIN IN EXTREMITY (Very sore arm after second shot), PERIPHERAL SWELLING (Next day I started to feel lumps in my clavicle), PERIPHERAL SWELLING (Feel lumps below my arm), SENSATION OF FOREIGN BODY (Feel lumps in my throat), ODYNOPHAGIA (My throat hurts when I swallow), ASTHENIA (Feel decay, without strength) and DYSPHAGIA (Cant swallow) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-122568 (Patient Link).
5 doses administered more than 12 hours after 1st puncture of the vials; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021 at 8:59 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reported stated that dose was administered after 12 hours post puncture, number of doses/vials: 1 doses/1 vials, , Date the vial was initially stored in the refrigerator: 22Sep2021. On 30-Sep-2021 at 10:17 am the vial was first punctured. The vial was stored in fridge post puncture. The vial did not go under any temperature excursions. The total amount of time the vial was exposed to room temperature range was 15 minutes.  No concomitant drugs were reported. No treatment drugs were reported.
swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node) 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.    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 LYMPHADENOPATHY (swollen lymph node). At the time of the report, LYMPHADENOPATHY (swollen lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
This spontaneous report as received from a nurse refers to an unknown number of patient. On an unknown date the patient was vaccinated with VARIVAX (dose, route and frequency were not reported, lot# reported as M030138, EXP 15-JUN-2018).   The nurse reported the vaccine was exposure at 4.5 Celsius for 3 hours and 15minutes and then 5 Celsius for 4 hours and 5 minutes before administration. No adverse effect was reported. This is one of the reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008060: US-009507513-1612USA008061: US-009507513-1612USA001370:
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 20-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 medications were reported. The reporter stated that, there had been no power outages that would have impacted the Moderna vaccine. It was also reported that, 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.  The reporter stated that no adverse reactions were reported by any patients. No treatment medications were reported.