chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received her Moderna booster on 02/01/22. Her husband called this morning 02/02/22 to report that patient was experiencing low grade fever, body aches, mild swelling/soreness at the injection site, and one episode of vomiting. She was concerned because she only had a sore arm with the first and second doses of Moderna. After discussing her symptoms in detail, she thinks the vomiting episode was because she choked on her coffee and she is reporting no nausea. She is not reporting any itching, rash, or any sign of allergic reaction. I told her to take Tylenol and drink plenty of fluids and rest for 24 hours. I also recommended that if she does not feel any better in the next 24 hours to reach out to her physician to make sure they don't want to see her. I told her to reach out if there are any new symptoms or questions and I also told her I was going to report her symptoms to VAERS and encouraged her to use the VSAFE platform to report directly to CDC.
swelling, redness, itching and mild edema induration at site. large. Benadryl po; Ice
Tingling in mouth, lightheaded, dizzy within 15 minutes of vaccine. Went back to pharmacist told her of symptoms, she said these were normal and go away in couple days. About one hour later very fatigued, cough, slight headache. Did not seek further counsel. Later that night heart racing, was gone by morning. Next day still very fatigued, cough.
Pfizer dose #1 administered 3/17/21 Lot EN6208, Dose 2 administered 4/13/21. Patient presented to Hospital 5/21/21, hospitalized, and ultimately diagnosed with pericarditis and discharged on NSAID. During this hospitalization, an echocardiogram revealed a reduced ejection fraction of 45-50% and a small pericardial effusion thought to be secondary to Pericarditis. He was readmitted 6/1/21 after presenting with progressive shortness of breath and edema. He was found, at that time, to have a large compromising pericardial effusion with cardiac tamponade requiring pericardiocentesis for 1200 ml.
Improperly stored ROTATEQ; No adverse event; This spontaneous report was received from a registered nurse, refers to an unspecified patient of unknown gender and age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 17-FEB-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dose, which had Lot number 1660112, with expiry date on 18-OCT-2020 (strength and route were not reported) for prophylaxis, however no adverse effects reported.   It was reported that the vaccines were exposed to temperature Mmltiple excursions: below 2 grade centigrade range for a time frame of 2 hours and 30 hours. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved.  This is one of the several reports received from the same reporter.
Approximately 16 hours after vaccine was given pt noted lip tingling and vomiting lasted several minutes then resolved spontaneously
Ringing in ears/ringing sound like white noise; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears/ringing sound like white noise) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced TINNITUS (Ringing in ears/ringing sound like white noise). At the time of the report, TINNITUS (Ringing in ears/ringing sound like white noise) had not resolved. Not Provided          Patient experienced a ringing sound like white noise in his ears that doesn't seem to be going away. He has not taken any treatments for his symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Significant followup
Initial report received from a healthcare professional on 12 December 2012. A 66-year-old female patient, had received an intramuscular dose of FLUZONE vaccine (lot number: UH734AA) on the right deltoid on 10 December 2012. The patient's pre-existing allergies, birth defects and medical conditions were unknown. The patient's concomitant medications were not reported. The patient had no illness at the time of vaccination. The patient had received many doses of FLUZONE vaccine previously on unspecified dates. On 11 December 2012, the patient experienced bolus eruption on right deltoid (4x4mm) debrided with hypopigmentation. The patient had also developed bulla sep (1x1mm) which was intact. There was no erythema and tenderness. Laboratory data was not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: None. Follow-up information received from a healthcare professional on 08 April 2013: The reporter states that the roof of the larger lesion had ruptured and peeled away resulting in an area of hypopigmentation. No additional tests were done. The roof of the larger lesion had been ruptured and peeled away had not recovered.
This spontaneous report was received from a medical assistant, referring to multiple unspecified patients, from unknown ages and genders. Medical history or concurrent conditions were not reported. On an unknown date, improperly stored doses of M-M-R II (lot # K000174, expiration date: 08-JAN-2016, K011317, expiration date: 13-AUG-2016, L009213, expiration date: 17-MAR-2017, K022284, expiration date: 12-NOV-2016) (strength, dose and route were not reported), were administered to multiple unspecified patients. Concomitant medication was not provided. No adverse effects were reported. It was also reported that the temperature was 10.3 degrees C, time frame was 4 hours, it was no previous temperature excursion and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information is not expected because the reporter did not allow further contact.
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 26-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided   This case was linked to MOD-2021-370324 (Patient Link).
83-year-old Caucasian female, initially seen in the emergency department with symptoms of cough, palpitations, body aches and fever. Patient had multiple family members positive COVID-19 in which she was in close contact. In the emergency department, patient required supplemental oxygen to keep O2 saturations above 88%. Patient also discovered to be atrial fibrillation with RVR. Patient was admitted to the hospitalist service, patient was started on COVID-19 protocol and isolation airborne precautions. Given dexamethasone 6 mg daily for 10 days and remdesivir for 5 days. Patient was started on therapeutic Lovenox. Cardiology was consulted for atrial fibrillation RVR, patient was to continue home amiodarone and started on a Cardizem drip. 21 September pulmonology is consulted with recommendations to keep potassium greater than 4 and magnesium greater than 2 in regards to atrial fibrillation. Treat hypoxia increasing O2 requirement to heated high-flow starting at 60 L at 100% FiO2. Patient's oxygen requirements continue to become problematic patient eventually was transferred to the ICU and placed on noninvasive ventilation. Atrial fibrillation and heart rate remained to be problematic with rate into the 130 to 140s at times. 29 September patient expressed to family members that she was tired and was ready to die, code status changed to DNR patient was transition to comfort measures and expired 1917Hr
Patient already received a dose of Pfizer Bivalent in Sept 2022 but was unaware when she came in to get a dose today. She did not have her vaccine card with her. It was realized after she left through system that patient had already completed the Pfizer series. So today she received an extra dose of Pfizer Bivalent.
Information has been received from a pharmacist concerning an 89 year old female patient with no drug reactions or allergies who on 07-JUL-2012 was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX (Merck) (lot# 669692/0615AA; expiration date 02-JUL-2012). The patient noticed redness and swelling at her injection site starting on Saturday, 09-JUN-2012. The patient called the pharmacy on Saturday, 09-JUN-2012, and stated that the site did not hurt or itch, nor was warm to the touch. The patient visited the pharmacy on 11-JUN-2012, and she asked another pharmacist to look at her injection site. No treatment was given for the events. The pharmacist told the reporting pharmacist that the site of redness and swelling was "about a couple of inches in diameter" and that the patient reported that the redness and swelling was improving. Additional information has been requested.
Fever 102; Chills; Extreme weakness; Horrible headache; Sick to stomach; This is a spontaneous report from a contactable consumer, the patient. A 88-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 13:15 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to penicillin and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. On an unknown date in Apr2021, the patient experienced fever 102, chills, extreme weakness, horrible headache, sick to her stomach. On an unknown date in Apr2021, the patient underwent body temperature test and the result was found to be 102 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 102, chills, extreme weakness, horrible headache, sick to her stomach was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Received FLUZONE high dose vaccine, 2 hours later had severe coughing, an hour later became nauseated then had diarrhea, chills, then became very hot and began having heavy sweating, muscle aches followed by bad headache. Also became very weak and dizzy so bad I had to lay down. I have a flu shot every year and have never had any reaction.
Narrative: 71 YOF tested positive for COVID19 after receiving 2 doses of vaccine.
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 35-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.  Reporter stated that no adverse reactions were reported by any patients.  No treatment medications were reported.
blood pressure elevated  10-20 points on a consistent bases  putting me in a condition that i my need to take meditation to help control it it has been aprox three weeks  just received my 2nd dose will be tracking my b/p
Tenderness in left armpit started on 11/17/17. Noted tennis ball sized swelling and tenderness under the left armpit the next morning.
swollen hand/forearm; pain in right elbow and now left elbow; nodules in right elbow and now left elbow; pain and nodules in right elbow and left elbow; This spontaneous case was reported by an other and describes the occurrence of PERIPHERAL SWELLING (swollen hand/forearm), PAIN IN EXTREMITY (pain in right elbow and now left elbow), NODULE (nodules in right elbow and now left elbow) and VACCINATION SITE PAIN (pain and nodules in right elbow and left elbow) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK duration, citrate free. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen hand/forearm), PAIN IN EXTREMITY (pain in right elbow and now left elbow), NODULE (nodules in right elbow and now left elbow) and VACCINATION SITE PAIN (pain and nodules in right elbow and left elbow). At the time of the report, PERIPHERAL SWELLING (swollen hand/forearm), PAIN IN EXTREMITY (pain in right elbow and now left elbow) and NODULE (nodules in right elbow and now left elbow) was resolving and VACCINATION SITE PAIN (pain and nodules in right elbow and left elbow) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products reported  No treatment products reported
Shortly after vaccination patient developed throat pain, dysphagia, dizziness, felt throat was swollen. Evaluated by EMS BP 125.91; HR 68, RR 16; Oxygen saturation 99%. Received IM benadryl and IM Epi and transported to hospital
myalgias, vomiting, diarrhea, prolonged and heavier menstrual bleeding
CDC reports: 9 mo infant developed fever, pain at inject site & screaming episode, duration of illness 2 days.
Patient reported his throat was 'itchy' and possibly swelling approximately 10 minutes post injection. He sat there 25 more minutes with us checking on him regularly and said it appeared to get better. He had throat swelling in the past to kiwi and bananas.
First I felt a soreness in my right arm, which spread to my neck and down my arm in the next few hours after the vaccine. Later that evening (around 7pm) I became sore and achy in my muscles and joints all over my body. I also alternated between feeling feverish and having chills.  My temperature was 99.8F. The next day I awoke with all the same symptoms and also a severe headache. My temperature that morning was 100.9F. I felt so tired and fatigued that I couldn't move my body or stay awake for too long. I stayed in bed all day and didn't have much of an appetite. I took NSAIDS and Acetaminophen to reduce the headache pain and control the fever. The following day (today) I woke up with fewer symptoms. I still had a severe headache, was overly tired,  and had a mild fever (99.8F). I remained in bed most of the day (napping), and have had a slightly improved appetite. I took Aleve this morning for the headache, but haven't needed it since (at 8:30pm). It seems that the side effects are subsiding. My right arm is still tender surrounding the injection site and I still have a faint headache, but it is now tolerable.
1 day p/vax pt devel a fever of 102, stomach ache, loss of appetite, & an inj site rxn characterized by swelling & tenderness;tx w/keflex & recovered p/4 days;
Sore Arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included BP Pills for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included Tylenol, Ibuprofen and concomitant drugs
Admit for COVID and AKI. Vaccine completed Feb 2021. Treated w/ steroids, O2, vit-c, vit-D, zinc, Rocephin, cefepime, Vanc, no remdesivir d/t AKI. Still admitted at time of review 7/29; condition deteriorating to septic shock.
100° temp; headache; muscle aches; loss of energy; Balance off kilter; swollen and very sore site of injection; still swollen and arm muscle after 3 days.
Slight sore arm and tiredness beginning 24 hrs after vaccination; Slight sore arm and tiredness beginning 24 hrs after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 19Oct2023 at 17:30 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 19Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 immunization; Covid-19 vaccine (DOSE 2), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER)), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious) all with onset 20Oct2023 at 16:30, outcome "recovered" and all described as "Slight sore arm and tiredness beginning 24 hrs after vaccination". Therapeutic measures were not taken as a result of pain in extremity, fatigue. Additional information: the patient had no known allergies. The patient was not covid tested post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Covid-19 breakthrough. First vaccination 2/1/21. Patient admitted 1/5/2022 with low hemoglobin 6.2. Patient has history of DM, HTN, HLD, PVD, Schizophrenia, multi foot ulcers. Admitted from local rehab for treatment of foot ulcers and IV ABX. He's been at facility since end of December.
asthma sx reported later that evening p/vax;no upper airway edema or chest pain;recv proventil via HHN @ walk in clinic that evening;the next day 4NOV98 stated asthma fine today;
Stroke with right side hand and mouth paralysis. Patient was treated with plavix for 30 days
My doctor says there is a good chance the Moderna vaccination trigged a polymyalgia rheumatica reaction.  I am currently being treated with Prednisone.
This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 79-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included levodopa for an unknown indication and carbidopa for an unknown indication. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient started levodopa at an unknown dose and frequency and carbidopa at an unknown dose and frequency. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was recovering/resolving. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she developed rash across her back that that was itchy. The patient did not think it was shingles occurrence due to lack of pain. The patient thought that it might be related to carbidopa or levodopa that she recently began taking. The reporter did not wish to have follow-up regarding the report and asked that her address be anonymous. The reporter was unable to provide full demographics for the pharmacy or her physician. However, she did provide contact details of her physician.
Elevted blood pressure, headaches, nausea, vomiting and hot flashes leading to cold flashes. . INcrease blood pressure meds to keep blood pressure at a normal range. 12/14/21 md office visit to comfirm blood pressures out of range with take prescribed meds.
6:20pm pt was noted following injection to experience a short 10-15 sec of tonic stiffening and unresponsiveness following reporting he did not feel well. Patient was hypotensive BP 110/58 improved with laying down over the course of 15 min. Given juice to drink during recovery time.
Fever, rash , vomiting, loss of motor skills, diarrhea, brain lesson.
A SLIGHT BRUISE AT INJECTION SITE; SORE ARM; This spontaneous report received from a patient concerned a 76 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced a slight bruise at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from a slight bruise at injection site, and the outcome of sore arm was not reported. This report was non-serious.
Information has been received from a physician concerning a 10 year old female patient who was vaccinated with the second dose of VARIVAX. Subsequently the patient experienced a localized rash around the injection site. The patient had saw physician for medical attention. Additional information has been requested.