chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 66 year old female consumer with blood pressure, cholesterol and betacarotene allergy who on 10-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck, Lot # and expiration date not reported). Concomitant therapy included lisinopril (manufacturer unspecified) and CRESTOR. Consumer reported that on 13-MAR-2011, she started experiencing fever. She mentioned that she also noticed that at the injection site it was warm and swollen and it was red with a rash. Patient sought medical attention by pharmacist.. No labs were performed. At the time of reporting patient's outcome was unknown. Follow up information been received from a medical assistant who stated that her office did not administer the injection to the patient, nor was patient seen by physician after the reported incident. She stated that physician's office had no information to offer regarding this adverse event. No further information is available.
Pt recvd vax 3SEP92 & early in the morning on 6SEP92 pt awoke w/chills, severe muscle aches, & felt feverish; took ASA, & the sx resolved w/in a few hrs; no further details were provided;
Ongoing  hospitalization began 9/19/2021 with fever, chills, malaise, hypernatremia, treated with remdesivir, decadron, Vit C ,Zinc, 2 L oxygen nasal cannula. thrombocytopenia
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: gj3277) at the age of 71 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Pt recv vax on 1/4/99; 24 hr post vax pt exp induration/ erythema, hard nodule/ heat rxn to elbow & right axilla lymph node
I experienced a fever, chills, body aches. I do have a history of lupus and it felt like a had a lupus attack.   I received treatment  and blood work.
At routine annual well visit, routine EKG abnormal, change from previous year, ST depression.
This initial report was received from a office manager concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX, lot number was reported as M027348 with expiration date 27-JUL-2017 (dose, strength and route of administration were not provided). The temperature excursion lasted 4 hours at -10 Celsius and had a previous excursion that lasted 16 hours at -3.8 Celsius. No adverse effects were reported and no data logger was involved. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Jan2023 as dose 6 (booster), single (Lot number: 6L0446) at the age of 57 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid was administered from 27Sep2023 to 01Oct2023.
Hospitalization: 11/16/2022 - 11/19/2022 (3 days) Presentation to the ED: shortness of breath COVID + date: 11/16/22. Treatment: broad-spectrum IV antibiotic therapy, remdesivir, IV dexamethasone, DuoNeb therapy and oxygen therapy as needed. Discharge to: Home.   Moderna Lot# 031L20A 2/4/2021 Moderna Lot# 027A21A 3/8/2021 Moderna Lot# 013F21A 11/9/2021
Patient developed tactile fever and decreased energy on 2/22/2020 per mother. Overnight, around 2 AM on 2/23/2020 mother heard grunting sound over baby monitor so she went to check on him. She found him with back arched and eyes rolling back. Episode lasted less than 30 seconds, and infant was "out of it" for a few minutes after the event. Parents took infant to Medical Center, where he was tested for flu, RSV (both negative) and monitored for additional seizures. He was discharged after about 4 hours. Infant came to pediatrician office on 2/24/2020 for follow up--still febrile (temperatures around 101 per report), parents using both tylenol and motrin at appropriate doses to control fever. No significant findings on exam.
Red blotches all over. Sick to stomach, throwing up, fever. Itched terribly.
Day 1-2: fever,  chills, body ache, fatigue headache Day 3-8: persistent headache and fatigue
This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-MAR-2017, the patient was vaccinated with a dose of VARIVAX (dose, route of administration, lot # and expiration date were not reported). On the same day, the patient was also concomitantly vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) instead of receiving M-M-R II. No adverse effects were reported. The physician reported that the medical assistant who administered the vaccines did not confuse ZOSTAVAX with M-M-R II, but inadvertently selected the incorrect vaccine from the supply and did not double-check before administration. No dose of M-M-R II was administered. Additional information has been requested.
Information has been received from a Registered Nurse (R.N.) concerning a 26 year old female with sulfonamide allergy and penicillin allergy who on 12-FEB-2007 was vaccinated IM with a first dose of Gardasil, lot #654702/0011U and in APR, 2007 received the second dose of Gardasil. Concomitant therapy included escitalopram oxalate (LEXAPRO) and TRI-NASAL (therapy unspecified). The patient reported a painful burning feeling at the injection site after both dose one and dose two. The patient also reported that the injection site was sore for about two weeks after the first injection. Patient sought unspecified medical attention. The patient was reported as recovering at the time of this report. Additional information has been requested.
In June 2021, a routine blood test revealed a low white blood cell count and I was diagnosed with leukopenia.  The blood test was repeated in August and white blood cell count remained slightly below the standard range.  I was referred to a hemotologist who repeated the test in September when the white blood cell count returned to the standard range.  I am being monitored for a follow up blood test in November, but the issue has been resolved for now.
Junctional bradycardia. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
ODD, SEARING, SHARP, SPORADIC SUDDEN HEADACHE THAT STARTED ON 02/27/21 AT APPROX. 4PM. SPORADIC, MILD, SUDDEN ONSET OF NAUSEA STARTING APPROX. 4PM ON 02/27/21 BOTH SYMPTOMS BEGAN TO DECREASE IN SEVERITY AND FREQUENCY ON 02/28/21 AROUND 4PM. MODERATE LETHARGY AT 9PM ON 02/27/21. ONLY TREATED THE HEADACHE WITH IBUPROPHEN  AT 11PM ON 02/27/21.
2 hours after vaccine I had a headache, high blood pressure, lightheaded and, dizzy the day after I was sore all day. In addition ligament pain with lots of muscle pain.
Petechia appeared from knees down (bilateral) and persist to date, starting the day after vaccination.
First seizure was 1min30 sec and required ambulatory services to ER pediatric unit, Second seizure occurred on 4/12/2017 at 5:20 PM and required a return to ER followed by an overnight visit.
Case number PHEH2014US024950, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to an 89 year old male patient. Medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree f 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursion lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
This spontaneous report as received from a licensed practitioner nurse refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with GARDASIL (dose, frequency, route and lot # were not reported) which was improperly stored. No adverse effects were reported. No product quality complaint was reported for GARDASIL. This case is linked to case # 1502USA000442 (same reporter link). Additional information has been requested.
About 24 hours after the first dose, I started feeling pain in my chest. This pain has never been preset before. It went away after about 3 days. About 36 hours after the second dose, the pain returned and was worse than the first time. I assumed it would go away on its own, but it did not. On 9/21/2021 I went to the urgent care. They performed an EKG, told me it was normal, and then told me to go to the nearest ER if the pain got worse. I did not go to the ER as I did not feel as though the pain was bad enough. On 11/17/2021 I went to the cardiovascular medicine provider. They also performed an EKG, gave the same results as the urgent care, but also instructed me to get a blood test to check for inflammation. On 12/1/2021 I got a blood test. The results show an average "risk for future cardiovascular event" according to the data sheet. These results were sent to the medical center. I called them to find out their interpretation of the results. They informed me that there is no risk and to go to the ER if the pain continues. I did not go to the ER due to the high expense. The pain is continuing.
Immediate pulse increase, chest pain, rash/hives, fever, nausea, weakness.
This spontaneous report was received from a medical assistant referring to a 14 year old male patient. It was no reported any patient's pertinent medical history, concurrent conditions, drug reactions/allergies or concomitant medications. On 15-JUL-2004, the patient received the first dose of VARIVAX (dose, route of administration, Lot # and expiration date were not reported). Then, on 19-MAY-2008, he received the second dose of VARIVAX (dose, route of administration, Lot # and expiration date were not reported), both for prophylaxis. On 28-JAN-2017, the patient developed "lesions all over his body". On 31-JAN-2017, the patient was seen by the physician and was diagnosed with chickenpox (varicella). There was no treatment given for the condition and it was unknown if laboratory studies were performed. The patient was not hospitalized. At the time of the report, the patient's present status was not recovered. There was no product quality complaint involved. Additional information has been requested.
The patient is a 15yo male who received Moderna for his first dose of the covid vaccine on 01/08/2022.  The patient's mother reported that her son had no adverse reactions and  "specifically requested that her son get the Moderna vaccine instead."
Cellulitis of left anterior thigh (9cm X 5cm); developed on 5/16/01 with treatment on 5/17/01 with Augmentin X 10 days.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a 17 years old female patient who was vaccinated with a 0.5 ml dose of FLUBLOK QIV (batch number R013859 and expiration date 14-JUN-2019) via unknown route in the right deltoid on 20-Sep-2018. The patient's medical history and concomitant medications were not reported. No concomitant vaccines were given. It was an actual medication error due to inappropriate age at vaccine administration. No information reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Patient became very dizzy, pale, and jittery before fainting for maybe a minute.  Our NP also came out, we had her lie flat, took her BP (115/75).  Blood started to return to face and patient came to.
Minimal 1 cm without color, induration, fever. Some itching on upper arm. Urticaria, Pruritus and erythema.
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021 at 2:28 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 2:28 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 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 63.11. Concomitant products were not reported. On 08-Feb-2021, Excursion time was 10 AM, temperature was 29, at 11 AM temperature was 35, total doses given for the day were 30, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 02-Feb-2021, vial was moved to clinic on 08-Feb-2021. 03 vials were sent to clinic. Vaccine BUD date was 04-Mar-2021.  Vial was stored on cooler 1, on 08-Feb-2021, Excursion duration 9 AM: 36, 10 AM: 29, 11 AM: 35, 12 AM: 38, 1PM: 43, 2 PM: 42, 3 PM: 42 and 4 PM: 42.   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. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  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.
No second dose of Moderna COVID-19 Vaccine; Woke up with swollen upper lip and chin and neck; Teeny tiny blisters upper lip, chin and neck; Hot, red, itchy, swollen areas of the face; Woke up with swollen upper lip and chin and neck; woke up with swollen upper lip and chin and neck/swollen areas of the face; itchy face; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (No second dose of Moderna COVID-19 Vaccine), SWELLING (Woke up with swollen upper lip and chin and neck), BLISTER (Teeny tiny blisters upper lip, chin and neck), ERYTHEMA (Hot, red, itchy, swollen areas of the face) and LIP SWELLING (Woke up with swollen upper lip and chin and neck) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) 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 CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced SWELLING (Woke up with swollen upper lip and chin and neck), BLISTER (Teeny tiny blisters upper lip, chin and neck), ERYTHEMA (Hot, red, itchy, swollen areas of the face), LIP SWELLING (Woke up with swollen upper lip and chin and neck), SWELLING FACE (woke up with swollen upper lip and chin and neck/swollen areas of the face) and PRURITUS (itchy face). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (No second dose of Moderna COVID-19 Vaccine). The patient was treated with CYCLOSPORINE at a dose of 200 mg once a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, INTENTIONAL PRODUCT USE ISSUE (No second dose of Moderna COVID-19 Vaccine), SWELLING (Woke up with swollen upper lip and chin and neck), BLISTER (Teeny tiny blisters upper lip, chin and neck), ERYTHEMA (Hot, red, itchy, swollen areas of the face), LIP SWELLING (Woke up with swollen upper lip and chin and neck), SWELLING FACE (woke up with swollen upper lip and chin and neck/swollen areas of the face) and PRURITUS (itchy face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other relevant concomitant included fish oil and hormone replacement pill.  Treatment details included prednisone dose packs at different dosages and lengths.
Patient had neck spasms which progressed to lower back spasms with blood pressure elevating to 190/90.  After approximately 10 minutes of resting, spasms ceased and blood pressure decreased to 160s.  Follow up with patient at 8pm and patient stated that she had no symptoms and the blood pressure had returned to 120s as tested on home blood pressure monitor.
Received all 4 vaccines at 11:30AM, by 6pm the same night she had a fever of 101, then increased to 103 deg F. She has 2- 1 minute seizures. She was stabilized in clinic- given ibuprofen and improved.
Had chills and hot flashes. Fever got up to 101.4. I couldn't keep any food or liquid down for 48 hours. This all began 12 hours after getting the shot. A week later my face began breaking out. It's either pimples or rosacea.
Pt reports feeling flushed, heart beating heavily and weak. Pt noted to have a pale skin. Initially followed commands but later became unable to respond. Eyes open. Pulse palpable. Pt breathing. This last for a few seconds. Pt returned to baseline after water and fans. The office AC was not working at the time. Very warm in office.
Patient reports onset of migraine headache approximately 5 hours after injection received. Migraine became increasingly worse and patient took OTC naproxen sodium with minimal relief. Patient reports migraine became debilitating and patient began bedrest. Patient remained in bed for 2-3 days with migraine headache pain. Treated with repeated doses of OTC naproxen sodium. Patient also reports night sweats but is currently menopausal. Patient sought medical treatment from primary care provider as a follow-up a few days later with no further issues.
patient received Shingrix injection 04/24/19 in right arm, and the next day had pain and redness in area of injection. Right side of back had burning sensation and poking pain, then on 04/26/19 developed a rash in back and front. on 04/27/19 started having muscle pain, joint pain & headaches and saw blisters.
Patient presented to community mobile team on 11/10/22 to receive Pfizer COVID Bivalent Booster dose at 1030AM. Previously, the patient had received two full doses for Pfizer COVID vaccine primary series 03/30/21 Lot #EN6203 and 04/24/21 Lot # EW0179 and a Pfizer COVID vaccine booster on 11/9/21 Lot# 301358A. The patient was currently taking Allopurinol 200mg BID for gout and Propanolol TID for migraines. The patient was allergic to ampicillin which causes hives and IV contrast dye which results in hives as well. She reported having a history of gout, migraines and a nephrectomy. Patient answered no to all the pre-screening questions, reported she has done well with vaccines in the past and no history of fainting. The patient received a Pfizer Bivalent booster vaccine (0.3 ml dose) Lot#GJ6665 in the left arm by RN at 10:36 AM. At 10:42 AM patient reported feeling dizzy while sitting in the observation area. RN advised patient to sit in gravity chair and lay down while taking vitals. Vitals were taken at 10:42 AM BP 100/60, HR 62 SpO2 97. Patient sat in gravity chair for ten minutes and reported feeling better. Vitals were taken again at 10:51 AM BP 100/62 ,HR 56, SpO2 96. Patient reported only having soup this morning and was given water and ate nutrigrain bar. She returned to her seat and a third set of vitals were taken. Vitals at 11:00 AM BP 98/62 ,HR 63, SpO2 96. Patient reported feeling better, no other side effects and left in a steady gait.
Mother indicated on registration/consent form that child's date of birth was .  When data entry staff checked the   Registry to confirm spelling of name child's date of birth was listed .  Telephone call to mother to confirm year of birth and she indicated correct date of birth making child only 11 years of age at time of first dose of vaccine.