chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Name of Drug as Reported: Pfizer / BioNTech, Patient Drug Start date: 29Apr2023; Name of Drug as Reported: Moderna Bivalent, Patient Drug Start date: 10Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Apr2023 at 14:00 as dose 6 (booster), single (Lot number: GL2042) at the age of 66 years for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 10Sep2022 as dose 5 (booster), single (Lot number: A57143C) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Apr2021 as dose 1, single (Lot number: 016B21A), on 30Apr2021 as dose 2, single (Lot number: 04bA21A), on 30Aug2021 as dose 3 (booster), single (Lot number: 025C21A) and on 06Apr2022 as dose 4 (booster), single (Lot number: 066K21A) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE, start date: 01Jan2009, stop date: 22Jul2023; ENBREL, start date: Jan2017, stop date: 23Jul2023. Past drug history included: Humira, start date: Jan2010, stop date: Dec2016. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Apr2023 at 14:00, outcome "unknown", described as "Name of Drug as Reported: Pfizer / BioNTech, Patient Drug Start date: 29Apr2023; Name of Drug as Reported: Moderna Bivalent, Patient Drug Start date: 10Sep2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Pyrexia: (07Aug2023) 99-100 Fahrenheit, notes: 99-100  degree Fahrenheit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated for COVID with Paxlovid from 29Jul2023 to 02Aug2023 and experienced rebound of symptoms; mild fever (99-100 degree Fahrenheit), sinus congestion, occasional clearing cough on 07Aug2023.
Hives, swelling lips and eyes, dermatographia, acid reflux, joint paint, chest tightness  all came  about 10 days after my vaccinations  The day of my vaccine, I had a bad headache, shivering and sore arm
Shortly after receiving the vaccine my tongue started to swell and almost felt hairy. My chest became tight, I had a metallic taste in my mouth, I was light headed and dizzy. The next two days after I was extremely lethargic. I could bravely stay awake for more that 20 minutes at a time for the first two days. I was also extremely hungry but still had the metallic taste in my mouth. Until day 3 I would still feel like my tongue felt hairy when the benedryl would wear off.On day 3 I became nauseous and broke out in hives on my hands and neck. I did not fully feel like I had my energy back and was like ?myself? until 4 days after receiving the vaccine
This case was reported by a physician to a sales representative and described the occurrence of seizure in an adult pt who received Engerix-B. On 9/16/04, the pt received a dose of Engerix-B. On an unspecified date in 9/04, at an unspecified time following the administration of Engerix-B, the pt experienced a seizure and was hospitalized. Outcome was not reported. The reporting physician considered the event to possibly be related to vaccination with Engerix-B.
Mild symptoms of Covid; Mild symptoms of Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 7-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29May2022, outcome "recovering" and all described as "Mild symptoms of Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) positive, notes: Nasal Swab. The patient had mild symptoms of Covid: fever, congestion. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions, medical histories and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (Lot # M006105, expiration date 01-AUG-2017) dose, route, anatomical location and frequency were unknown. Temperature excursions and times were reported as follows: -9.6C for 2 hours and 11 minutes, -6.6C for 5 hours and 33 minutes and -4.3C for 8 hours and 30 minutes. Data logger was reported as yes. No adverse effects were reported. Additional information has been requested.
11-12-06 Cardiac Arrest 3/26/07 Received Death Certificate which reveals COD as cardiac dysrhythymia & myocardial infarction with contributing factor of diabetes.
Swelling to shoulder and down  mid arm. Red in uneven circular area around vaccine site, hot to touch, itchy going on 52+ hours. migraine for 24 hours past.
I had an episode of SVT which required an emergency room visit and adenosine to "reset" my heart rhythm. I received my second dose of Shingrix at ~9:00 am on Oct. 13.  I started having heart palpitations after dinner that evening around 5:30 pm.  I take Atenolol daily to prevent SVT episodes. I have not had an episode that required an emergency room visit for over 12 years until Oct. 13, 2021. I took an extra Atenolol pill and tried several methods to break the SVT at home.  After ~3.5 hours, my husband & I drove to the hospital. They did an EKG and had me try to blow into a syringe. Eventually, they used adenosine to reset my heart rhythm.
In the middle of May I developed a lump in my breast that I got confirmed to be benign. In June I experienced two kidney stones. Both of these new events were abnormal for myself and my family history.
Right after injection, patient started wheezing and difficulty breathing.  I had Epipen available for immediate use. Offered to call 911 and pt refused.  Since pt has history of Asthma, filled her Albuterol inhaler right away and pt tried 2 puffs to see if gets better.  Mom came in to pharmacy. Pt did not want to get Epipen. Mom said will drive home and if needed will take her to ER. Pt went to ER and got treated.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from quality. The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 at 10:00 as dose 1, single (Lot number: ER8727), in right arm, on 11Apr2021 at 10:00 as dose 2, single (Lot number: EW0153), in right arm and on 04Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FH8020) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history Asthma; "Known allergies Penicillin" (unspecified if ongoing), notes: Known allergies Penicillin. Concomitant medication(s) included: OMEPRAZOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid used for treatment of COVID-19. Other medication in 2 weeks reported as yes Omeprazole.
Covid Pneumonia; High fevers; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (Covid Pneumonia) in a 78-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.     Concurrent medical conditions included Leukemia.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced COVID-19 PNEUMONIA (Covid Pneumonia) (seriousness criteria hospitalization and medically significant) and PYREXIA (High fevers). At the time of the report, COVID-19 PNEUMONIA (Covid Pneumonia) and PYREXIA (High fevers) outcome was unknown.            Hospitalization- treatment with remdesivir x 2 courses and other unknown monoclonal antibodies. Is on oxygen.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
Mother called to report pt having the following side effects: fever 102.5, whole body muscle aches, headache, anxiety and shortness of breath.  She stated she went to bed around 10:30pm on 7/12/21 with not issues and when she awoke about 2am her daughter was on the couch crying and in pain from the body aches and headache.  Mother calling to report event and questions about seeking medical treatment. Advised to go for evaluation or call emergency services if pt is having difficulty breathing or is short of breath.
11/19/21 presents to ED for "headache". PMHx of "ESRD on HD MWF, HTN, HEP C, bipolar".
My 12 year old slept for 20+ hours, could not stand up straight without falling over, she had tol hold the wall in order to walk, fever of 102.9 that was increasing, blood pressure of 111/52, uncontrollable vomiting, and had trouble breathing.  I took her to the ER on 12/21/21 when her symptoms got worse.  It's been years and her symptoms haven't gotten any better. Since the day of her first vaccine she's hd migranes, trouble concentrating, and light and sounds seems to trigger migranes.
Information was received on 14-JUL-2017 from a pharmacist regarding a 78 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 03-JAN-2012 the patient was vaccinated with ZOSTAVAX, lot # 1599AA expiration 13-JAN-203, 1 DF, subcutaneous for the prevention of shingles. Concomitant therapies included sterile diluent (lot # and expiration unknown.) The pharmacist reported that the patient has had three cases of shingles since receiving the vaccine. The patient has developed a painful rash each time the shingles occurred. The shingles episodes occurred on 25-JAN-2012, September 2014 and 30-JUN-2017. On 25-JAN-2012, the patient was treated with VALTREX 500 mg by mouth three times a day for 2 weeks. In September 2014, the patient was treated with VALTREX by mouth three times a day for 2 weeks. On 25-JUN-2017 (also reported as 30-JUN-2017), the patient was treated with VALTREX twice daily for 2 weeks and Prednisone 10mg once a day for 2 weeks. The pharmacist reported the patient saw the doctor each time she had shingles. The pharmacist reported that the patient did not have significant disability or incapacity but was very uncomfortable. The patient was not hospitalized. The outcome of herpes zoster is unknown. No additional information was available. Additional information has been requested.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 30-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S002506 and expiration date 04-APR-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Woke up with malaise and pain in left (surgical) breast. Malaise progressed to brain fog, fatigue, and muscle aches over a 5-6 day period. Left breast swelled and turned red. Saw primary physician on 10/8/21 and was prescribed antibiotics and an emergency visit was scheduled with Dr. and PA, at Breast Center on 10/11/21.  At 4:00 am 10/11/21, woke with massive spontaneous drainage of left breast. Dr. diagnosed radiation recall vs lymphedema of the breast. An ultrasound was performed. A wick was inserted into the open wound to allow for additional drainage. The wick was replaced several times before finally fallilng out on 10/30/21. The spontaneous wound subsequently closed up. The breast then became concave on the left side at the site of the lumpectomy cavity/ surgical scar area. The initial erythema had subsided somewhat but the area around the scar remained red. Dr. gave a referral to another Dr for evaluation of left breast lymphedema. Dr. indicated this was the third case she had seen of breast lymphedema following Covid vaccine injections. She again prescribed antibiotics plus physical therapy to enhance range of motion and release scar tissue that has formed in the surgical area. The indentation from the collapsed seroma cavity will not go away and the breast will remain smaller than the other breast and possibly require plastic surgery in the future. This is permanent disfigurement and has rightfully caused quite a bit of distress to the patient.
Pt had react to MMR of face & eye swelling, w/difficulty breathing & sinus congestion; anaphalatic react;
Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A, 15H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Lot: 015H22A - 4 doses Administered on 19Dec2022 to 4 patients. (BUD 16Dec2022) **HCP consents to providing initials & DOB of recipients via email pending approval from superiors.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022).    No concomitant medication information was provided.  It was reported that Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022 & 20Dec2022 Lot: 019H22A - Administered on 20Dec2022 to 3 patients (BUD 17Dec2022) , Lot: 015H22A - 4 doses Administered on 19Dec2022 to 4 patients. (BUD 16Dec2022)    No treatment medications were provided
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 11:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 11:48 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 73.30.  Concomitant products were not provided.  On 28-Feb-2021, At excursion time 09:00 AM, temperature was 27, total doses given for the day was 152 and at 01:00 PM, temperature was 26, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  Vial was stored on cooler 1, on 28-Feb-2021, Excursion duration At 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 PM: 46, 1PM: 26, 2 PM : 37, 3 PM: 43 and 4 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Approximately 1 hour after receiving the vaccine had facial tingling on the right side of face.  Was driving when it happened.  One of the physicians were available at vaccine site, was told it was probably neuralgia, possible Bell's palsy, to continue to monitoring it, and to report back if symptoms got worse.  If the symptoms were severe enough they will give steroids.  She updated him 30 minutes prior to this, it has not gotten any worse, but her right eye is not closing right, advised to get wetting drops like tears, and if she had trouble swallowing, breathing, or any worsening to go to the ER.  Told her to report to him in the morning.  Works in the same office with the doctor and will see them and continue to have it monitored.  Will let them know if she could report to work.  Checked with employee health who cleared her for work, but to check in the morning if the symptoms progressed.
Arm was sore and hard immediately after injection. Night of the injection, chills and body aches. No other symptoms noticed until 1/7/2021. It was noticed that my arm was swollen, with welt like redness. It felt hard and itchy, which went away by 1/11/2021.
Patient was given a 1mL dose instead of a 0.5mL dose, resulting in a sore arm.  Pt was informed to seek medical advice in case of adverse effects.
past due for his second Moderna Covid-19 shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (past due for his second Moderna Covid-19 shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (past due for his second Moderna Covid-19 shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (past due for his second Moderna Covid-19 shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information and treatment details provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: TCR
Information has been received from a physician concerning a female who in April 2008, was vaccinated with the third and final dose of GARDASIL. In this year 2009, the patient had been experiencing malaise. Unspecified medical attention had been sought and the the patient had not recovered. Additional information has been requested.
PT states 8 hrs post vax, he developed a part of his lower lip swelled. He had redness and burning. Lasted 48 hrs. No other swelling occurred. No swelling at vax site. He was not seen by reporter (vax provider) at the time, but reporter withheld next dose.
Pain in left breast near armpit; Suspect swollen lymph nodes; This is a spontaneous report received from a contactable consumer. An 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206, Dose number: 2) via unknown route of administration on the left arm on 16Mar2021 at 11:15 hours as a single first dose for COVID-19 immunisation. The patient's past drug history included  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW6198) via an unspecified route of administration on 24Feb2021 at 15:15 hours as single first dose for COVID-19 immunisation. Medical history included arthritis. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ZYRTEC, Rousuvastatin (MANUFACTURER UNKNOWN), Vitamin D (MANUFACTURER UNKNOWN), XHANCE for an unknown indication since an unspecified date and was unknown if ongoing. On 17Mar2021 at 7:00 hours, the patient experienced pain in left breast near armpit. The pain was still present 2 days after the vaccine. The patient suspected it was swollen lymph nodes but the patient was concerned about another cause and was concerned it would persist. The clinical outcome of the events pain in left breast near armpit and suspect swollen lymph nodes was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
on 08/20/2021 that night pain in the injection site, The next day I had fever, cold chills, achiness. bad headaches Fever and chills ended on 08/22/2021 but the bad headaches continued 6 days and I went to urgent care on  08/27/2021, was given a shot for headaches that did not help, and script for Cetirizine. The next day the headache improved. 09/08/2021 started getting congested in the head and nose. 09/09/2021 seen my neurologist, he gave me prednisone and Perphenazine.
Headache, Myalgia, Fever, NauseVomiting, chills Narrative: