chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the Moderna Covid 19 vaccine after temperature excursion; Patient received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). On 28-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after 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.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen. Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively. The vaccines suffered 2 temperature excursions since April, both lasted less than one minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed.  No treatment information was reported.
sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient was sick for 4 days.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concomitant medications, concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On unknown dates, the patients might have received doses of improperly stored VARIVAX injection, lot # M041513 with expiration date on 11-OCT-2018 and lot # M046004 with expiration date on 18-NOV-2018 (doses and route of administration were not reported). The administered doses of vaccines were reconstituted with sterile diluent (lot # and expiration date were reported as unknown). Administered doses of vaccines experienced a temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 1 hour 10 minutes and an excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit, which lasted for 4 hours 40 minutes. Administered doses of VARIVAX lot # M041513 with expiration date on 11-OCT-2018 underwent previous temperature excursions: an excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 2 hours and an excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 1 hour 30 minutes. A digital data logger was involved in recording the excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the reporter. Sender's Comments: US-009507513-1706USA011480: US-009507513-1706USA011481.
Red, swollen, bruised index finger; Red, swollen, bruised index finger; Red, swollen, bruised index finger; Something stuck under the skin which cause an infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Red, swollen, bruised index finger), SWELLING (Red, swollen, bruised index finger), CONTUSION (Red, swollen, bruised index finger) and INFECTION (Something stuck under the skin which cause an infection) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced ERYTHEMA (Red, swollen, bruised index finger), SWELLING (Red, swollen, bruised index finger), CONTUSION (Red, swollen, bruised index finger) and INFECTION (Something stuck under the skin which cause an infection). At the time of the report, ERYTHEMA (Red, swollen, bruised index finger), SWELLING (Red, swollen, bruised index finger), CONTUSION (Red, swollen, bruised index finger) and INFECTION (Something stuck under the skin which cause an infection) had resolved. Not Provided          Concomitant product use was not provided by the reporter.  The patient was doing okay and does not have any symptoms now. Everything had resolved. The patient stated the reported AE index finger was bruised, red, and swollen was not related to the vaccine. The patient went to the urgent care and the provider there believed she got something stuck under the skin which cause an infection.  Treatment information included antibiotic for 5 days for infection. Action taken with mRNA -123 is not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-131955 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Outcome of the events were updated from unknown to recovered, additional event and narrative were updated.Second dose information added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-131955:Second dose
According to receipt documents the vaccines beyond use of 14 days frozen and 31 days of refridgeration was exceeded by 1 day
felt agitated; Fast heart beat 111 pulse; felt the eyes were burning; Had cold-hot flashes all day; Felt like she had a flu; Her eyes were blurry; Felt weak; Very tired; Her neck muscles were in pain; had nauseas; her arm was red below the injection site.; Itchiness at the injection site; 30 before the shot experienced Right arm hurting; Swollen arm,; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like she had a flu), VISION BLURRED (Her eyes were blurry), AGITATION (felt agitated), TACHYCARDIA (Fast heart beat 111 pulse) and EYE IRRITATION (felt the eyes were burning) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN, VITAMINS NOS and ESCITALOPRAM for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm,), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE PAIN (30 before the shot experienced Right arm hurting). On 27-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had a flu), VISION BLURRED (Her eyes were blurry), TACHYCARDIA (Fast heart beat 111 pulse), EYE IRRITATION (felt the eyes were burning), HOT FLUSH (Had cold-hot flashes all day), ASTHENIA (Felt weak), FATIGUE (Very tired), MYALGIA (Her neck muscles were in pain), NAUSEA (had nauseas) and VACCINATION SITE ERYTHEMA (her arm was red below the injection site.). On 28-Jan-2021, the patient experienced AGITATION (felt agitated). The patient was treated with PARACETAMOL (TYLENOL) on 26-Jan-2021 for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Felt like she had a flu), VISION BLURRED (Her eyes were blurry), AGITATION (felt agitated), TACHYCARDIA (Fast heart beat 111 pulse), EYE IRRITATION (felt the eyes were burning), HOT FLUSH (Had cold-hot flashes all day), PERIPHERAL SWELLING (Swollen arm,), ASTHENIA (Felt weak), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE PAIN (30 before the shot experienced Right arm hurting), FATIGUE (Very tired), MYALGIA (Her neck muscles were in pain), NAUSEA (had nauseas) and VACCINATION SITE ERYTHEMA (her arm was red below the injection site.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 92.7f (Inconclusive) 92.7F. On an unknown date, Tachycardia: 111 (Inconclusive) 111.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications simvastatin,  vitamins, Escitalopram.    Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No specific follow-up information recorded.
By the evening on the day of the shot I noticed my arm getting red and swollen. It continued swelling until I went to the doctor today June 4th. He said I was having an allergic reaction and to take Benadryl. Started Benadryl at 4:45 this evening.
10 days after Booster shot hives started on body and would come and go in different places and were extremely itchy and red. Lasted approximately 1-2 weeks before contacting allergist and symptoms are still showing but have lessened.
During vaccinations, all of the medicine dispensed at the neck of the syringe,   Gave second vaccine with EMT approval and patient approval.
Interchange of vaccine products; positive for Covid; positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in 2022 as dose 5 (booster), single (Batch/Lot number: unknown) and in 2023 as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: she has asthma, is overweight and is 66 years old.; "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13May2023, outcome "unknown" and all described as "positive for Covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The event "positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) between 5'0'' and 5'1''; SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative before the social events all week; (unspecified date) Unknown Results; (unspecified date) Unknown Results; (13May2023) Positive, notes: tested positive for covid on Saturday; Weight: (unspecified date) around 260. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 13May2023). Clinical course: She has had 4 of the Pfizer covid vaccines which the first dose was in the beginning of Mar2021 and then had two Moderna booster doses - the last one was 2 weeks ago and the other was 6 months prior to that. Tested positive for covid on Saturday. She had 6 covid vaccines total. She woke up Saturday morning with a "weird scratchy thing", which she has a lot because her apartment is old and dry. She had social events all week and tested negative before the social events all week. However, she was on the way to graduation and there were two lines and she has tested twice since then and she has Covid. She was prescribed Paxlovid from her doctor. She has a runny nose and constant sneezing, feels like a bad cold.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Profound weakness the day following the shot, slide to floor unable to get up due to weakness, profound rhabdomyolysis with acute kidney injury
9/7/21 pt tested positive for COVID in assisted living home where he resides; sx:  cough, SOB, runny nose; per death certificate, pt died in the assisted living home; no other information available to this nurse
Information has been received from a health professional concerning a 6 year old male who on 06-AUG-2007 was vaccinated with a second SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 658056/0835U) in the left arm. On 06-AUG-2007 the patient's arm became red and swollen to an area of 2"x3". No medical attention was sought. The patient's recovery status was unknown. Additional information has been requested.
gave bivalent for first covid of series. should have been monovalent.  Pt getting monovalent for 2nd dose of series tonight.  will follow up in 60 days for her bivalent booster per cdc guidelines.  Pt had no adverse rxns to the bivalent vaccine (dose 1)
1 day post vax, the pt experienced fever, nausea, sore throat was dx 1 week post vax with sinus infection.
brainf fog; The second shot the back pain was worse and traveled down to legs, hips, and calves. Also pain in neck that moved down to shoulders.  Can't turn head all the way right and left; can hardly walk , can't get out of bed, has a hard time getting off the toilet.; fatigue; chills; fever; back pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (can hardly walk , can't get out of bed, has a hard time getting off the toilet.), BACK PAIN, FEELING ABNORMAL (brains fog), MYALGIA (The second shot the back pain was worse and traveled down to legs, hips, and calves. Also pain in neck that moved down to shoulders.  Can't turn head all the way right and left) and FATIGUE (fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE SODIUM (CYTOMEL), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), Flax Seed Oil, POTASSIUM, MAGNESIUM, ESTRADIOL and PROGESTERONE for an unknown indication.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced BACK PAIN (back pain). On 25-Mar-2021, the patient experienced FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced GAIT DISTURBANCE (can hardly walk , can't get out of bed, has a hard time getting off the toilet.), FEELING ABNORMAL (brainf fog) and MYALGIA (The second shot the back pain was worse and traveled down to legs, hips, and calves. Also pain in neck that moved down to shoulders.  Can't turn head all the way right and left). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. On 27-Mar-2021, FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, GAIT DISTURBANCE (can hardly walk , can't get out of bed, has a hard time getting off the toilet.), BACK PAIN (back pain), FEELING ABNORMAL (brainf fog) and MYALGIA (The second shot the back pain was worse and traveled down to legs, hips, and calves. Also pain in neck that moved down to shoulders.  Can't turn head all the way right and left) 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-2021-090649 (Patient Link).
Patient was experiencing same feeling in my throat that I had when I ate shrimp and found out I was allergic to it. Benadryl IM administered. Lung sounds clear bilaterally. No relief from Benadryl. Adrenaline SC. Lung sounds remains clear. Experienced shaky feeling, headache and high blood pressure over next hour. Went from 180/110 to 200/90 to 140/60 with a constant pulse of 100. Went home with friend and told to contact a911 if any symptoms reappeared.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In January 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 07-JUL-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
He started having difficulty breathing and was breathing rapidly, taking lots of fast short breaths. It lasted 4 hours long.
Mild reactions after 1st booster dose; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Mild reactions after 1st booster dose) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Deep vein thrombosis (10 years ago patient had deep vein thrombosis which was resolved).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Mild reactions after 1st booster dose). At the time of the report, IMMUNISATION REACTION (Mild reactions after 1st booster dose) outcome was unknown.            It was reported that the patient's age was over age of 65. Patient did not take any blood thinner anymore. No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2022-588869, MOD-2022-588876 (Patient Link).   Reporter did not allow further contact
Patient was in his usual state of health until 3 weeks after the covid vaccine, when he played basketball for 3 hours on 6/22. He had been inactive prior to 6/22 and it was hot day. He developed leg pain that evening and was diagnosed with rhabdomyolysis with a CK of 21,980. Patient was hospitalized for IV fluids and since then his CK has been down trending and his leg pain has now resolved.
In November 2022 my symptoms for the COVID-19 were body aches and runny nose.  I started Paxlovid on November 24, 2022.  The first day I felt good was December 9, 2022.  In addition, beginning January 18th until April 26th, 2023, I have had diarrhea every day.  I have visited the doctor and eventually I did have a 26th I had a colonoscopy, and I was diagnosed with colitis.  I am now begin treated with Budesonide.
From the very beginning, 4-6 hours after the vaccine I was running a fever of 100.3-100.4 for 30 hours, feeling nauseated, and sweat.  About 5 weeks ago, I started developing  a bad cough and drainage in my sinus. Not a whole lot of fever but a lot of breathing problems such as shortness of breath. I got spray and shots of steroids (First and last week of June). I got hyper something in my lung where I got issues with breathing and pneumonia. I have an albuterol inhaler and I also got a mammograms along with ultrasounds. Nothing was found but I thought I would report that as well.
pt recv vax in 1983 & devel a fever & a rash assoc w/vax;no further details were provided;
Fever, localized reaction at vaccine site observed treated with BENADRYL. Diffuse macular, papular with vesicles appeared 5 days after varicella vaccine being treated with BENADRYL. She was also diagnosed with conjunctivitis currently tx'd with GARAMYCIN and sinusitis completing a course of ZITHROMAX.
Swelling, pain, itching or right deltoid.  With redness (6 x 7 cm)