chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Violent chills/teeth chattering; Blue lips; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the right arm on 08Jul2021 at 13:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included XYZAL for unknown indication from unknown date and unknown if ongoing. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the right arm on 17Jun2021 at 14:00 (at the age of 45 year old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 10Jul2021 at 01:15, the patient experienced violent chills/teeth chattering with blue lips. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events violent chills/teeth chattering and blue lips was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
about 1 wk p/vax pt exp vomiting low grade fever 100, pain in the hips & back; stayed in bed & was better in 2 days;
Patient received 2nd dose Moderna COVID-19 vaccine on 07/26/2021. During  the billing process, insurance reported patient received 1st dose Pfizer COVID-19 vaccine. WAIIS was checked and  pharmacy was contacted to confirm 1st dose Pfizer vaccination. Her vaccination card portrayed 1st dose Moderna COVID-19 vaccine. Patient received 1st dose Pfizer from  Pharmacy in  on 06/10/2021 per  RPh (confirmed 7/28/21 via phone) and image of consent form (via fax same day). Patient was contacted and counseled to watch for any unusual symptoms and answered any other concerns patient had.
Patient came in to receive the covid bivalent pfizer vaccine but instead was given the covid 19 pfizer gray cap (not bivalent).
Night mares that wouldn't stop. Big time pain at shot location. Restlessness big time . Stayed in bed all day.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date those patients were vaccinated with an improperly stored M-M-R II (therapy type, dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
developed an itching burning rash as the sight of where injection was given; developed an itching burning rash as the sight of where injection was given; developed an itching burning rash as the sight of where injection was given/ uncomfortable rash; tiredness; muscle discomfort; joint/ muscle discomfort; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE DISCOMFORT (muscle discomfort), MUSCULOSKELETAL DISCOMFORT (joint/ muscle discomfort), VACCINATION SITE PRURITUS (developed an itching burning rash as the sight of where injection was given), FATIGUE (tiredness) and VACCINATION SITE PAIN (developed an itching burning rash as the sight of where injection was given) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced MUSCLE DISCOMFORT (muscle discomfort), MUSCULOSKELETAL DISCOMFORT (joint/ muscle discomfort) and FATIGUE (tiredness). On 27-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VACCINATION SITE PRURITUS (developed an itching burning rash as the sight of where injection was given), VACCINATION SITE PAIN (developed an itching burning rash as the sight of where injection was given) and VACCINATION SITE RASH (developed an itching burning rash as the sight of where injection was given/ uncomfortable rash). In October 2023, MUSCLE DISCOMFORT (muscle discomfort), MUSCULOSKELETAL DISCOMFORT (joint/ muscle discomfort) and FATIGUE (tiredness) had resolved. At the time of the report, VACCINATION SITE PRURITUS (developed an itching burning rash as the sight of where injection was given), VACCINATION SITE PAIN (developed an itching burning rash as the sight of where injection was given) and VACCINATION SITE RASH (developed an itching burning rash as the sight of where injection was given/ uncomfortable rash) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medications were not reported.  It was reported that for 4 days patient had joint/ muscle discomfort and tiredness.  No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2023: Live follow-up received. AE reference number added.
Patient reports moderate swelling to left clavicle area starting around 03/10/2019, then having severe pain in left deltoid area on 03/15/2019 preventing her from being able to lift her left arm above her head.
Heavy menstrual bleeding for weeks at a time. On and off for the past 3 months. Off for a couple days, then back right away.  Extreme fatigue.  Dizzy Vertigo Achy joints Headaches
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 29-AUG-2014 the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscularly, lot # J009827, that had expired on 10-AUG-2014. No adverse effects were reported. Additional information is not expected as there was no consent for follow-up.
Patient was injected with an expired dose of Covid-19 injection(Moderna). The vaccine expired on 06/28/22 at 8:40PM. Vaccine was administered on 06/29/2022 at 3:01PM. No symptoms were present at the time of vaccination.
Red Hives appeared on back, neck, and face. Experienced an itching sensation. Contacted after care hours and was instructed to administer Benadryl, or place loose clothing on child, place child in tub of cold water that was comfortable for child, or place child in front of fan and to keep her cool.  I as the parent decided to administer Benadryl in a less than teaspoon dosage. Symptoms resided. Symptoms reappeared on 11/22 and 11/24.
a patient was inadvertently administered the Shingrix diluent component only without the lyophilized powder; a patient was inadvertently administered the Shingrix diluent component only without the lyophilized powder; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number K2YA4, expiry date 25th January 2024) for prophylaxis.   On 23rd December 2022, the patient received Shingrix. On 23rd December 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 30-DEC-2022 Reporters comment: The pharmacy intern called and reported that a patient was inadvertently administered the Shingrix diluent component only without the lyophilized powder. The reporter asked for any recommendation for this. Intern declined safety follow-up and to provide any patient details. The reporter did not consent to follow up. Additional Supportive information: The patient was inadvertently administered the Shingrix diluent component only without the lyophilized powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Patient walked away with dad to walk around store for 15 minute observation period. She started feeling lightheaded within 90 seconds fell on the floor and hit her head on the ground about 10 feet from the pharmacy. Pharmacy called 911 immediately and they arrived within 5 minutes. Patient became more conscious after a few minutes, but started to lose consciousness again so they transported her to the hospital.
itching  1  week  after  vaccination., then (redness) in site of injection about one inch in surrounding areas.Patient  reports  no itching or pain but a feeling  of warmth and a dull headache.  Advised patient to  consult with her physician about getting the second dose
Loose stool; Rash on mouth; Off balance woosy; Fatigue worsen; Pain in injection site right arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose stool), ORAL MUCOSAL ERUPTION (Rash on mouth), VERTIGO (Off balance woosy), FATIGUE (Fatigue worsen) and VACCINATION SITE PAIN (Pain in injection site right arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (Headache). On 15-Mar-2021, the patient experienced DIARRHOEA (Loose stool), ORAL MUCOSAL ERUPTION (Rash on mouth), VERTIGO (Off balance woosy), FATIGUE (Fatigue worsen) and VACCINATION SITE PAIN (Pain in injection site right arm). At the time of the report, DIARRHOEA (Loose stool), ORAL MUCOSAL ERUPTION (Rash on mouth), VERTIGO (Off balance woosy), FATIGUE (Fatigue worsen), VACCINATION SITE PAIN (Pain in injection site right arm) and HEADACHE (Headache) outcome was unknown.            No treatment information were reported.   This case was linked to MOD-2021-072987 (E2B Linked Report).; Sender's Comments:  MOD-2021-072987:2nd dose
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a multiple unspecified patients of unknown demographics. On an unknown dates, the patients received improperly stored GARDASIL 9 lot # L014198 with expiration  date: 05-SEP-2017; lot # L016428 with expiration date: 30-JUL-2017, (strength, dose number and dose was not reported). concomitant medication was not reported. No adverse effects was reported. PQC was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a Registered Nurse refers to a female patient of unknown age. The nurse reported that the patient, who was pregnant (unspecified gestation) (Last Menstrual Period (LMP) and expected date of delivery (EDD) were unknown), was administered the first dose of GARDASIL (Lot# unspecified), dose and location unspecified on 20-NOV-2013. No adverse effected reported. The outcome of pregnant was unknown. Additional information has been requested.
Had a flare of herpes Keratitis on day 19 after SPV. Was taking acyclovir prophylactically at 800 mg/day. Last flare 10/02. Before that in 1997. Opthalmology states condition is not autoinoculation of vaccine.
no additional AE; that a patient was inadvertently administered a dose of PROQU AD on 10/26/2021 with a labeled expiry of 10/17/2021; Patient age: 13 years; This spontaneous report was received from a registered nurse, who was also a nursing manager and refers to a 13-year-old patient of unknown gender. There was no information regarding their medical history, concurrent condition nor concomitant therapies provided.  On 26-OCT-2021, the patient was inadvertently administered an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) 0.5 mL, lot # T013539, expiration date 17-OCT-2021 (route of administration and anatomical location were not provided) for prophylaxis (expired product administered, product administered to patient of inappropriate age). The registered nurse stated the patient reported no adverse event (AE) after the administration.
Developed hives after receiving 4 mo vaccines. Have persisted for about 3 days.
Mixed Covid 19; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Mixed Covid 19) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Penicillin allergy.   On 27-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Mixed Covid 19). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Mixed Covid 19) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient went over the side effects for Moderna. Reporter scheduled his second shot no knowing until today that he already had received the Pfizer IMZ for his first dose. Reporter called that patient to inform him that according to the CDD he is finished with his COVID IMZs now and he will cancel his second Moder IMZ. He was fine.  No concomitant medication information was provided. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received on 14-JUN-2021. Reporter phone number has been updated. Patient details has been updated. Penicillin allergy has been updated. Additional suspect drug Pfizer IMZ has been updated.
11:47 AM received vaccine; on 11;53 AM, the patient noticed blotching on the antecubital both arms and hands, no itch, no SOB.   p 90/60, ox sat 95%, 64 HR , regular;  Patient refused benadryl; by 12 noon, just the hands had redness.  (Patient reported a similar reaction after the first dose of Moderna).
had fever; threw up; This is a spontaneous report from a contactable consumer (patients mother).   A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number and Expiration date were not provided), via an unspecified route of administration in Arm Left on 05Aug2021 13:00 (age at vaccination13-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient healthy before vaccination. The patient's concomitant medications were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number and Expiration date were not provided), via an unspecified route of administration in Arm Right on 15Jul2021 as dose 1, single for COVID-19 immunization. States her son just had his 2nd dose of the Pfizer COVID shot 05Aug2021 (yesterday) and at 20:00 had fever and all these things she knows are part of some of the side effects after the 2nd dose; states she does not think it was anything serious for her son and was not an allergy but he had a temperature and threw up and in the packet they gave her it said some of the side effects could occur and she is not worried.  States the patient's first dose was administered 15Jul2021 and she has no lots, expiry dates or NDC numbers to provide for the patient's Pfizer COVID doses of the vaccine. States the first dose was administered to the patient's right arm and the 2nd dose to his withheld and the symptoms began yesterday around 20:00pm and he had the shot at 13:00pm; states the last time he threw up was at 11:00am today and she was giving him Tylenol every 4 hours of 30mL and the temperature is under control and it was regular strength Tylenol; states she has no lots, expiry dates or UPC numbers for the Tylenol. The outcome of the events was unknown.    No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received form a registered nurse concerning an elderly patient who last week,on an unspecified date in approximately July 2003, was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent. The patient developed local swelling, redness and warmth. The registered nurse reported the patient was not hospitalized although treatment was required. It was noted that the patient was previously immunized with a dose of pneumococcal vaccine 23 polyvalent "about 5 years ago". The registered nurse expressed concern about the lot of pneumococcal vaccine 23 polyvalent , and she requested a lot check. No additional information was provided. Unspecified medical treatment was sought. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. The reporter also mentioned another patient who had similar experiences following vaccination with pneumococcal vaccine 23 polyvalent (WAES 0307USA00760).
She was given Regeneron infusion on 8/24/21 and in that evening she developed SOB and desaturation. Transferred to Hospital from outside hospital on 8/26/21. Tested COVID19 positive on 8/21/21 and transferred due to acute on chronic hypoxic respiratory failure and COVID 19 pneumonia. On admission she was on 6L NC. At baseline she is on 3L. Patient received remdesivir, dexamethasone, albuterol, doxycycline and ceftriaxone. Patient was having some palpitation on 9/5/21 evening and  EKG troponin unremarkable. Increase Propanol dose to 20 mg. Repeat x-ray not change compared to previous  X-ray, Physical therapy evaluate recommend skilled nursing facility, O2 req improving to baseline . Patient completed 10 days of Remdesivir, Decadron, Rocephin and doxycycline. Transfer to swing bed. Discharged on 9/16/21
Breakthrough case admission after 5 vaccines  Pfizer 3/5/21 lot# EN6199;  Pfizer 3/25/21 lot# ER8732;  Pfizer 10/13/21 lot# FE3590;  Pfizer 5/20/22 lot# FM7553;  Pfizer 10/11/22 lot# GH9693
Presented to ED just following third vaccine admin.  States within 10 min she started feeling warm, lightheaded, and like her throat was closing up.  She was given 0.3 epi IM at the vaccination site.  On EMS evaluation she was still feeling short of breath with wheezing and was given an additional 0.5 IM epi, one DuoNeb, 50 mg IV Benadryl, and 8 mg Zofran with improvement in symptoms. discharged home with rx for prednisone 20mg - take 60mg daily x 5 days.   Went back to ED on 10/16/21 with arm pain (RUE mild swelling with overlying erythema). US found Superficial thrombophlebitis of the cephalic vein of the upper arm (right). CTA negative for PE. discharged home on Eliquis.
Early menstrual cycle by 2 weeks. Heavy flow with cramping and bloating, during ovulation time. Normally have regular periods. Not on birth control. Flow started 12 days after 2nd dose.
Information has been received from a physician concerning a 25 year old female patient with no known drug allergies and hyperthyroidism who was vaccinated SC with a first 0.5ml dose of VARIVAX (Merck) on 22-MAR-2002 and a second 0.5ml dose on 7-JUN-2002 (lot # 639778/0981L). Concomitant therapy included thyroid medication. On 08-AUG-2009, laboratory test revealed that varicella titer level was 1.07. The patient did not have protective titer levels after vaccination. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Dizziness, Myalgia, HYPERtension, Syncope, Tachycardia, shaky legs Narrative: Employee reports having multiple episodes of dizziness, feeling like passing out even after the initial episode Employee was able to been seen by their PCP who placed them on blood pressure medications for high blood pressure.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2016, 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, also known as shingles and other complications. On or about 01-AUG-2016, The patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. As a direct and proximate result of the ZOSTAVAX, 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 direct and proximate result of these malfunctions, 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. Upon internal review severe varicella pneumonia was considered a medically significant event. Additional information has been requested.
Patient had Tdap injection LT arm on 12-28-08. C/o pain movement area below injection site, red swollen. PR saw PMD and was started on prednisone and antibiotic. Improving
hot to the touch; itchy; rash; red area on their arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE RASH (rash) and VACCINATION SITE ERYTHEMA (red area on their arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE RASH (rash) and VACCINATION SITE ERYTHEMA (red area on their arm). At the time of the report, VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE RASH (rash) and VACCINATION SITE ERYTHEMA (red area on their arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.