chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 3-decade-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). The reported cause of death was Heart attack. It is unknown if an autopsy was performed.            No concomitant and treatment medication was reported by patient.   This case was linked to MOD-2022-438341, MOD-2022-438342, MOD-2022-438339, MOD-2022-438336, MOD-2022-438340 (Patient Link).; Reported Cause(s) of Death: Heart attack
Then the swelling got worse and worse; Itchy; Swelling under my armpit; It was very painful; Couldn't 'sleep; I was scared; This is a spontaneous report from a contactable consumer (patient, self-reported). A 48-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0167 and expiry date was not reported), via an unspecified route of administration, in Deltoid Left, on 14Jun2021 (age at vaccination: 48 year), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Deltoid Left, on 24May2021 (age at vaccination: 48 year), as a single dose for COVID-19 immunization and no reaction. The patient reported that the patient was calling to report that the patient had an adverse reaction to the Pfizer Vaccine for COVID-19 virus. The patient got the second shot on Monday. On an unspecified date in Jun2021, it felt itchy and that was okay but when the patient got home, the patient started having some swelling under my armpit. So, each day since Monday it got worse. Today, the patient had to go to the doctor so that they could see, you know patient was scared. The patient did not know if it was breast cancer or a tumor or what. The patient would like to know if it was just a reaction to the vaccination. The patient stated, Monday, 14Jun2021, that was when it started and then it accelerated and then the swelling got worse and worse. The patient went to see the doctor because patient couldn't 'sleep' and it was very painful. The doctor prescribed some pain medicines like Ibuprofen, 800 mg, one every 8 hours. The doctor told the patient to put a warm comfort on it. Outcome of the event I was scared was reported as unknown and for all other events, it was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
"still a red hole in my arm in that area; arm turned red; arm was also hot and warm; sore arm which went away eventually; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (sore arm which went away eventually), ERYTHEMA (arm turned red), VACCINATION SITE WARMTH (arm was also hot and warm) and VACCINATION SITE INDURATION ("still a red hole in my arm in that area) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced TENDERNESS (sore arm which went away eventually). On 13-Feb-2021, the patient experienced ERYTHEMA (arm turned red) and VACCINATION SITE WARMTH (arm was also hot and warm). On 23-Feb-2021, the patient experienced VACCINATION SITE INDURATION ("still a red hole in my arm in that area). At the time of the report, TENDERNESS (sore arm which went away eventually) had resolved and ERYTHEMA (arm turned red), VACCINATION SITE WARMTH (arm was also hot and warm) and VACCINATION SITE INDURATION ("still a red hole in my arm in that area) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
heat sensation in my right arm from my wrist to my elbow; sore arm; unusual feeling; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9264, expiry date not reported), via an unspecified route of administration, administered in right arm on 01Feb2021 05:15 (at the age of 69 years old) as dose 1, single for covid-19 immunisation. Medical history included primary adrenal insufficiency from an unknown date and unknown if ongoing, and hypothyroidism from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination and of the report. Concomitant medications included hydrocortisone, fludrocortisone, levothyroxine sodium, vitamin c [ascorbic acid], colecalciferol (VITAMIN D), calcium citrate, cetirizine hydrochloride (ZYRTEC), and fish oil, all taken for an unspecified indication, start and stop date were not reported. The patient previously took cefatrizine propyleneglycolate (CEFTIN) and cefaclor (CECLOR), and experienced known allergies to them.  The patient had no other vaccine in four weeks. On 03Feb2021 at 11:30 AM, the patient had heat sensation in right arm from wrist to elbow, and a sore arm and no other symptoms with either dose 1 or 2, except with dose 1, at day 3. It was on and off for 4 days. It was an unusual feeling since 03Feb2021 at 11:30 AM, but patient didn't require pain meds. The patient did not require any treatments in response to the events. The patient had no covid prior vaccination and was not tested for covid post vaccination. It was mentioned that the patient had the second dose of BNT162B2 (lot EL6202) on 23Feb2021 as covid 19 immunisation administered in the right arm. The outcome of the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
20 seconds later, felt tight throat and "funny" feeling, had left pharmacy Rx. 30 seconds - arm sore, felt anxious. 45 seconds - had to clear throat often, took ALLEGRA allergy pill. Called Dr. told if got worse go to ER. 1 hour later, also felt tingling up arm (L) and down (L) leg. Felt better after 2 hours. Large red mark at injection site.
has eczema around her eyes/eczema flare around her eyes, up to her eyebrows and forehead; Left eye lid swelled, and right eye was swelled up in a 2 inch round red spot; Left eye lid swelled, and right eye was swelled up in a 2 inch round red spot; Left eye lid swelled, and right eye was swelled up in a 2 inch round red spot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ECZEMA (non-serious) with onset 2021, outcome "unknown", described as "has eczema around her eyes/eczema flare around her eyes, up to her eyebrows and forehead"; SWELLING OF EYELID (non-serious), EYE SWELLING (non-serious) all with onset 2021, outcome "unknown" and all described as "Left eye lid swelled, and right eye was swelled up in a 2 inch round red spot"; RASH MACULAR (non-serious) with onset 2021, outcome "unknown", described as "Left eye lid swelled, and right eye was swelled up in a 2 inch round red spot.". Therapeutic measures were taken as a result of eczema, swelling of eyelid, eye swelling, rash macular.  Additional information: Reporter seriousness for Eczema flared up around eyes: around her eyes, up to her eyebrows and forehead, Left eye lid swelled, and right eye was swelled up in a 2 inch round red spot was unspecified. Reporter seriousness for She is supposed to go for her second shot today and is uneasy was Unspecified. The patient stated that she now has eczema around her eyes, she got the shot, 3 weeks ago today, and after a few days, her eczema flared up around her eyes, her left eye lid swelled up, her right eye was swelled up in a 2 inch round red spot. The patient had an eczema flare around her eyes, up to her eyebrows and forehead. The patient has been using a steroid ointment that her doctor gave her last year. she used it on the third day after the shot and has been using it for 10 days.The medication is IC-Desonide 0.5% ointment, and patient stated that it was helping her. The patient stated that she was supposed to go for her second shot today and was uneasy. Caller wanted to know if anyone else with skin issues had flared up.  \No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; Vaccines administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date).    This case contains information for the 08th of 13 patients described by the reporter.  No concomitant medications were reported.   As per the provider the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures at max. was -24C and min. was -23C.  On 27-Dec-2020, Moderna COVID-19 vaccine was received with expiration date as 28-Mar-2022.  On 11-Apr-2022, 13 doses were administered.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728240 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Follow-up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728240:Master Case (Patient 1)
Patient came in to receive 2nd dose of moderna.  We no longer have moderna 2nd doses.  Pfizer dose given.  Patient made aware.  No complaints.
Information has been received from a health professional concerning a 7-8 year old male who, "when he was 15 months old", in approximately 1998, was vaccinated once with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 12/13/2005, the patient came into the office with breakthrough varicella with less than 50 lesions. The patient had no fever and no treatment was given. At the time of the report the patient was recovering. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. No other information was provided. Additional information has been request.
Suspected vaccination failure/had the shot and also had shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: Age at vaccination was not reported. The patient had a shot of Shingles vaccine and had shingles sometimes afterwards. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.
Felt very Sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt very Sick) in a 71-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced MALAISE (Felt very Sick). On 04-Feb-2021, MALAISE (Felt very Sick) had resolved.            concomitant medicines was not reported by reporter   treatment information was not provided  The action taken with mRNA-1273 with the events was considered as not applicable  For mRNA-1273 (Moderna COVID-19 Vaccine) (intramascular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-014267 (Patient Link).   Reporter did not allow further contact
1/14/2021 evening left arm started to itch, slightly annoying. Went to bed woke up 1/15/21  covered with itchy bumps and irritated skin. by noon it had spread to my legs and feet. 1/17/21 rash still present. feels like irritation from fiberglass, appearance blotches ,tiny bumps and welts around armpits and joints.
No adverse reaction to the vaccine, the vaccine is administered after the deadline of April 1, 2022. Vaccine is not expired.
No adverse effect reported; Inadvertently administered an improperly stored dose of PROQUAD; This spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 10-JUN-2019, an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot No R020814, expiration date on 16-JAN-2020) was inadvertently administered to the patient for prophylaxis (strength, dose number, anatomical location and route of administration were not reported). The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (PROQUAD) was reconstituted with properly stored sterile diluent. There was no adverse effect reported.  The storage temperature was of 12.5 degrees Fahrenheit (°F) for a time frame of 2 hours 4 minutes without a previous temperature excursion and was called because a digital data logger
Angular cheilitis; Canker sore in mouth; Loss of sour taste for over 3 months; Peeling; Swollen lips; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8934) via an unspecified route of administration in the left arm on 28Mar2021 at 10:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient received unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 07Mar2021 at 10:15 as a single dose for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 12Apr2021, the patient experienced angular cheilitis, canker sore in mouth, loss of sour taste for over 3 months, peeling and swollen lips. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures taken as a result of the events which included treatment with unspecified oral antibiotics, antifungal cream and acyclovir (MANUFACTURER UNKNOWN). The clinical outcome of the event loss of sour taste for over 3 months was recovered on an unknown date in 2021 while that of events angular cheilitis, canker sore in mouth, peeling and swollen lips were recovering at the time of report.
m.d. rpt that after pt recv vax JUL98 pt devel inject site swelling, redness, induration 1-2cm in diam & pain. no fever present
Headaches Nausea Heart Palpitations Anxiety  Insomnia Nerve Pain Body Aches Fatigue/Weakness  Brain Fog Difficulty with concentration Issues with memory/memory loss Difficulty with speech/cognitive dysfunction Heaviness of feet, legs, arms and hands Weakness of feet, legs, arms and hands Tingling of feet, legs, arms, hands and face Numbness of feet, legs, arms, hands and face Pain in the feet, legs, arms, hands , knees and ankles Difficulty walking Tremors/Trembling Back Pain/Burning Burning Pain of the base of skull/back of head Neck pain/stiffness Neck Tics/Twitching Blurred Vision Pupil Dysregulation Inability to focus pupils in response to light/stimuli Light Sensitivity Body Temperature Dysregulation Cracking/popping of bones and joints Tinnitus Pain/pressure in ears Hair Loss Food sensitivities and allergies (gluten, wheat, dairy) Mold allergy POTS Cant stand for long periods of time Easily out of breath Faintness  Chronic Fatigue Pelvic Pain Depression
all the tumor masses in her body were painful; all the tumor masses in her body were painful and uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of TUMOUR PAIN (all the tumor masses in her body were painful) and DISCOMFORT (all the tumor masses in her body were painful and uncomfortable) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Neurofibromatosis (Elephant man disease.). Concomitant products included MORPHINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TUMOUR PAIN (all the tumor masses in her body were painful) (seriousness criterion medically significant) and DISCOMFORT (all the tumor masses in her body were painful and uncomfortable) (seriousness criterion medically significant). At the time of the report, TUMOUR PAIN (all the tumor masses in her body were painful) and DISCOMFORT (all the tumor masses in her body were painful and uncomfortable) outcome was unknown. Not Provided    Treatment of these events included the patient's concomitant use of morphine.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Rapid heartbeat accompanied by Bp of 195/90, bleeding under skin in huge area at vaccine site arm pain. Bp was treated by increased dosage of Vasotec over a period of 2 weeks where it returned to normal. Bruise diminished slowly over 3 week period. Also after 8 day a skin rash appeared on the left arm, first as splotches that increased to a large area about 2 inches below vaccine site in a rectangular are for most of upper arm. It was red, itchy and burning. Only thing that released it was cortisone cream. It lasted several weeks. And only occurred for this first vaccine dose.
Shaking; The taste in her mouth was different; Pain all over body; Fever; Vomiting; Pain injection site; A spontaneous report was received from a consumer concerning a 43 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had a fever 102f, vomiting, shaking, the taste in her mouth was different. and she had pain all over the body.  The patient's medical history was COVID-19 provided by the reporter. Concomitant medication was not reported.  On 23 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031M20A) via intramuscular route in her right arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the events had a fever 102f, vomiting, shaking, the taste in her mouth was different. and she had pain all over the body. Treatment included advil and Tylenol were provided by the reporter.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, had a fever 102f, vomiting, shaking, the taste in her mouth was different. and she had pain all over the body were unknown at the time of this report.