chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart attack; three strokes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "three strokes". Clinical course: Caller is a male patient. States that he has been trying to get the booster dose and he can not find anybody to give him the shot. Mentions that he had visited # and they do not have appointments until 14:00. Says that if we could send him the vaccine, as he is a diabetic, he could administer it to both his daughter and himself. He states that he has had a heart attack and three strokes and he is aware that he should give this information to the vaccine provider so they can vaccine them expeditely but no one wants to hear him. He asks for information on where can he get an appointment for the booster shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Had very mild pain in left arm; 16 year old daughter injected with Moderna vaccine; A spontaneous report was received from a consumer, concerning a 16-year-old female patient, who received Moderna's COVID-19 vaccine, where 16-year-old daughter injected with Moderna vaccine had very mild pain in left arm.   The patient's medical history reported included severe asthma.  Concomitant product use was not provided by the reporter.  On 28 JAN 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28 JAN 2021, a 16-year-old patient was injected with vaccine and had no reactions of fever or any other adverse events. Later, on an unspecified date in 2021, she also experienced very mild pain in her left arm where she was vaccinated. The patient was under asthma medications twice a day for her asthma.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the event, 16-year-old daughter injected with Moderna vaccine was considered resolved on 28 JAN 2021. The outcome of the event had very mild pain in left arm was considered unknown at the time of this report.; Reporter's Comments: The events developed on same day after first dose of mRNA-1372. Based on the current available information and temporal association between the use of the product and the start date of the event of vaccination site pain, a causal relationship cannot be excluded.
Fatigue, extreme chills (teeth chattering), vomitting, dry heaves, aches, headache, fever 100.2. Not able to eat much for days.  Low grade fever continued  for 4 days. Woke up on March 28th with extreme dizziness - even before sitting up in bed. which I have never experienced before. Went to Doctor/Nurse Practioner March 30, 2021. Continued feeling ill - nausea, loss of appetite, and vertigo until Monday, April 5th.
Approximately 10 minutes after vaccine I began to feel weird. About a few days after I had terrible stomach pains.  I started to have chest pain. I went to the ER, and they did an x-ray and ultrasound, and my heart was enlarged. I went back to the hospital, and I did a stress test. I pasted that stress test. For the most part the symptoms have improved but I still get fatigued. They are continuing to monitor it.
Initial report received from a medical assistant on 11 Mar 2011: This patient was vaccinated with MENVEO (batch number unknown) 0.5 ml intramuscularly on 04 Mar 2011. While administering vaccine, some of the dose leaked out and ran down the patient's arm. No adverse event occurred following this administration.
7 Month old  Female brought in by mother presenting with a fever, cough, diarrhea and vomiting x 2 days ago status post receiving vaccination shots. Patient was given Tylenol to relieve symptoms. Mother of patient was informed to return immediately if symptoms worsen/persist.
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 36 year-old female patient. On 08-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL for the prevention of influenza. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion as 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
SLUGGISH; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sluggish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sluggish was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported). On an unknown date the patient experienced shingles after receiving ZOSTAVAX. The patient sought medical attention. The outcome of the event was unknown. Relatedness between the event and the ZOSTAVAX was not reported. Additional information has been requested.
Headache, fever (101°), extreme body aches, insomnia - lasting 24 hours   Irritation at injection site (bump, rash, itching, bruising) - lasting 1 week
Side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Pregnant; Sore arm; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and PAIN IN EXTREMITY (Sore arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and PAIN IN EXTREMITY (Sore arm). On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 29-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Internal review on 20-Jul-2021 resulted in updates to the pregnancy details.
10-21-2022 Pt was administered Moderna bivalent vaccine in the right deltoid. Patient was monitored for 15 min with no signs of adverse reaction.  10-24-22 15:18 Patient called and reported redness and warmth to the right deltoid injection site. She also reported firmness under the injection site on the right deltoid.
Headache, Myalgia & Fever Narrative: Fever 101.0 , body aches, severe headache, GI issues, hurt to walk. Those have since resolved, but continues to have significant arm pain.
Information has been received from a licensed practical nurse (LPN), concerning a 20 year old female patient, who on 13-JUL-2007, was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot # not reported). There was no concomitant medication. On 13-JUL-2007, in the evening following the vaccination, the patient experienced flu-like symptoms, with fever, fatigue and nausea. On 17-JUL-2007, the nurse spoke with the patient, who confirmed the symptoms continued, and also reported she currently had "congestion" (unspecified) and a sore throat. At the time of this report, the patient had not recovered from the events. The patient sought unspecified medical attention. Additional information has been requested.
This spontaneous report was received from a female patient (who was also a healthcare worker) of unknown age refers to herself. The patient's pertinent medical history included diabetes and the patient's drug allergies were unspecified. On 30-DEC-2014 the patient was vaccinated with PNEUMOVAX 23 (dose, frequency and lot # were not reported). Concomitant medications were none. The patient reported that she had diabetes that was very well controlled by diet and she had a fantastic fasting glucose and A1C. On 30-DEC-2014, when the patient got home and blood glucose reading done by her at home and glucose read in the high 200's. The patient stated that she did not take any treatment, and that it was coming down slowly and was currently at 160. The outcome of glucose read in the high 200s was unknown, The causality of the events was not reported. No product quality complaint (PQC) was reported for PNEUMOVAX 23. Additional information has been requested.
Rhonchi, frothy sputum, low grade temp, elevated HR,   12/30 MD assessed 1:00PM and increased prednisone and added Cefdinir.  Sent to hospital 12/30 at approximately 6:30PM with worsening symptoms
Soreness and swelling at injection site beginning next day after shot Day 3 a  redness and itching began on left arm wear injection was given. Each day the redness, and itchiness increase in area. Day 6 ( today) I woke to see that it had advanced down to just above the inside of the elbow and around slightly to back of arm. Went to Emergent Care.  The doctor prescribes prednisone RX plus said to apply hydrocortisone cream twice daily.
PATIENT RECEIVED MODERNA VACCINE ON 3/26/23 AFTER BUD OF 3/14/23.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 18-FEB-2014 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # J011272, expiration date 21-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Brachycardia, discovered at yearly DR Visit. HR 38bpm on EKG. Sent to ER. Admitted for 72 hours. Diagnosed with AV Wenkebach Block 2:1. Released with no restrictions. Asymptomatic at time of admission other than slow HR.  After discharge, mild shortness of breath and shaky legs when HR is low  Follow up Dr visit determined a pacemaker is needed, to be scheduled.
sz fever 104.5;pt went limp did not breath for a second;went pale, shaking, bumps all over body, fussiness;mom states vax caused sz;pt is not self;
feels hot; no appetite; whole body aches; fever at 100.9F; dizziness; left middle finger joint hurts a little; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), JOINT SWELLING (left middle finger joint hurts a little), FEELING HOT (feels hot), DECREASED APPETITE (no appetite) and PAIN (whole body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced JOINT SWELLING (left middle finger joint hurts a little). On an unknown date, the patient experienced DIZZINESS (dizziness), FEELING HOT (feels hot), DECREASED APPETITE (no appetite), PAIN (whole body aches) and PYREXIA (fever at 100.9F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), JOINT SWELLING (left middle finger joint hurts a little), FEELING HOT (feels hot), DECREASED APPETITE (no appetite), PAIN (whole body aches) and PYREXIA (fever at 100.9F) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were reported. Treatment medication also includes Warm press, and Alcohol.
retinal infarct; optic neuropathy of the right eye; loss of vision; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and for routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered retinal infarct (retinal infarction), optic neuropathy of the right eye, and loss of vision (blindness). As a result of those symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related. All the events were considered as disabling by the reporter.   Upon internal review, the events retinal infarction, optic neuropathy, and blindness were determined to be medically significant.
inadvertently administered a dose of pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees with no adverse event reported; inadvertently administered a dose of pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees with no adverse event reported; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old male patient who inadvertently received a dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel (Vero)] that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees with no adverse event reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine and Rotavirus vaccine for Prophylactic vaccination.  On 09-Feb-2023, the patient who received a dose 1 of 0.5 ml with frequency 1X (once) of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel (Vero)] that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees with no adverse event reported (poor quality product administered) (latency: same day) (lot: UJ682AAA, expiry date: unknown) of form: Suspension for injection, via intramuscular route in left leg with unknown strength for Immunization.  On an unknown date the patient received a dose of pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees with no adverse event reported (product storage error) (unknown latency).  Action taken: not applicable.  Outcome: Unknown.  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 the 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.
Shoulder swelled to the size of a grapefruit. Severe pain with movement. Unable to raise affected arm over my head without assistance from other arm. Unable to sleep because of pain.  Soaks, heating pad, cold applied. Massage and exercise to add absorption of vaccine. Pain medication, Advil 800mg every 4 hours. Progressed to hydroco/apap 7.5-500 tab at night only to be able to sleep. 12/10/12 Pain continues to a lesser degree, neuralgia down my arm to my wrist and up my clavicle through my neck.
Right arm is sore the following day. When i got home from work (1/13/21) took a shower and i was feeling the area where i got the shot and when i raise my right arm i notice under my armpit is swollen.
Swollen eyes; Edema on top and bottom of eyes & cheeks; edema on top and bottom of eyes & cheeks; This is a spontaneous report from a non-contactable consumer. A 63-year old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Left Arm on 25Feb2021 at 08:00PM as Dose number Unknown, Single for COVID-19 immunization. The patient's medical history included food allergy to msg, nuts and melons. The patient previously took cefalexin monohydrate (KEFLEX) and experienced allergy. The patient's Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication. On 16Mar2021 at 03:00PM, the patient experienced swollen eyes, edema on top and bottom of eyes & cheeks. Therapeutic measures were taken as a result of this with cortisone shot and prednisone tapered dosage. The outcome for the events was recovering.     Information on Lot/Batch number was available. Additional information has been requested.
Red arm; Itchy arm; Looks like a bullseye at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE SWELLING (Looks like a bullseye at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE SWELLING (Looks like a bullseye at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE SWELLING (Looks like a bullseye at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Itching/hives on chest, arms, and neck 3 hours after injection. Took one Benadryl at 3.5 hours post injection (present time).
Patient's husband called and told me that her wife has headache, pain in site of injection and heat palpitation following  the yesterdays' 2nd Moderna covid 19 vaccine immunization. I told him pain with immunization is a usual side effect of vaccine ,  however for heart palpitation, she may may need see a Doctor , and if necessary need to visit Emergency room.
Dry itchy eyes, itchy rash all over hand and face, headache, body ache
Less than one month subsequent to receiving vax the pt developed approximately 50 varicella lesions and was place in isolation. The rash was described as papules vesicle located mainly on his face, chest, abdomen, rectal area, and legs. In addition he developed a fever of 102.1 (taken rectally), however the pt is known to have poor thermoregulatory control. The reporter expressed concern with the vaccine lot administered to the pt. The pt recovered. No further information is available.
Red rash, fussiness, cough, conjunctivitis, coryza 5 days before presentation. fever 102.8 two days before presentation. Seen in urgent care twice in those 5 days. Rash in office: brownish-red, raised, blanchable, coalescing in some areas. Present on trunk, legs down to feet, arms down to hands, neck.