chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional AE's; an 18 year old patient who was administered a dose of PROQUAD.; This spontaneous report was received from a registered nurse and refers to an 18-year-old patient of unknown gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 04-MAY-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #W012729, expiration date: 16-OCT-2023, administered subcutaneously for prophylaxis (strength was not provided) while being 18 years old (Product administered to patient of inappropriate age). No additional adverse events details or product quality complaints were reported (no adverse event).
Redness and swollen on injection area.  Also, itchiness and warm to the touch.  Pt had pain for 2 days.
Within less than six hours, 103 degree Fahrenheit fever and chills. High fever persisted from 2pm EST - 2am (11/3); 103 temp taken at 6pm when home from school; residual low temp continued through 12noon EST (11/3). Treated with 400 mg ibuprofen at 6pm, regular strength tylenol at 9pm, 400 mg ibuprofen at 12am, and tylenol at 8am (11/3). Used ice packs in arm pits and bilateral groin to break the 103 temp. No other adverse symptoms observed (no rash, coughing, vomitting, etc). Back to normal (expect a little tired from the night before) late Friday afternoon (for the prior year, child had not missed a single day of school due to illness).
FULL BODY RASH, PREDNISONE, TRIAMCINOLONE CREAM,ATATRAX
bilateral foot/ankle edema; bilateral foot/ankle edema; constipation; lowered sodium levels; This is a spontaneous report from a contactable consumer, the patient, based on information received by Pfizer from Eisai (manufacturer control number: EC-2021-089103). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE: Lot number: not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization; and lenvatinib mesilate (LENVIMA) from 26Feb2021 to 04Mar2021, via an unspecified route of administration, at 14 mg daily for differentiated thyroid cancer. Medical history included differentiated thyroid cancer and hypertension, both from an unspecified date. Concomitant medications were not reported. On an unspecified date, the patient experienced bilateral foot/ankle edema, constipation, lowered sodium levels. The cardiologist increased the patient's hydrochlorothiazide from 25 mg once daily to 50 mg once daily for the foot/ankle edema. The patient was not sure if the events were related to lenvatinib mesilate or the vaccine. The patient was advised to temporarily hold lenvatinib mesilate therapy until 05Apr2021, starting 05Mar2021 and continuing for one week after receiving the second vaccination on 29Mar2021, pending no side effects from the second vaccination. At that time, the patient will resume lenvatinib mesilate 10 mg daily. The action taken in response to the events for lenvatinib mesilate was unknown. The clinical outcome of bilateral foot/ankle edema, constipation, lowered sodium levels was unknown.  Information about lot/batch number has been requested.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 31-MAR-2015, the patient was vaccinated with a dose of ROTATEQ (lot # K011663) (expiration date and dose were not provided). There was a 72 hours excursion for this vaccine. No adverse events have been reported. This is one of several reports from the same reporter. Additional information has been requested.
Family noticed multiple red spots all over child's body with swelling and itching. Mom gave oral OTC Benadryl and topical Allerest cream when she got home from work that day.  Child's rash is lessening next day (7/11/14).
stomach ache; first shot put me in bed for a week and a half; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), VACCINATION COMPLICATION (first shot put me in bed for a week and a half) and HEADACHE (headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included GABAPENTIN, BUPROPION HYDROCHLORIDE (WELLBUTRIN), DIAZEPAM, CEFIXIME (FLEXERIL [CEFIXIME]), OXYCODONE and HYDROCODONE for an unknown indication.   On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), VACCINATION COMPLICATION (first shot put me in bed for a week and a half) and HEADACHE (headache). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), VACCINATION COMPLICATION (first shot put me in bed for a week and a half) and HEADACHE (headache) outcome was unknown.            No treatment medication were reported.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-089545 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089545:Second dose
24 hrs post inject-redness 3.5x4.5 induration, heat, itching, lasted 72 hrs. Resolved completely.
This spontaneous report was received from a registered nurse who refers to a female patient of unknown age. It was reported that on 05-SEP-2013 the patient was vaccinated intramuscular with a second 0.5 ml dose of GARDASIL (lot number was not reported), four year after she received her first dose of GARDASIL (lot number, route and dose not reported) on an unknown date in September 2009 (four years ago). No adverse effects reported. Additional information is not expected.
First covid vaccine, standard Side effects (headache, fatigue, worsening of muscle aches and pains, rash), second vaccine (same side effects, may better tolerated although I started a RA flare shortly afterwards and eventually had to start low dose presdnisone).  Booster shot, --covid #3, tolerated fine at first, although at this time was on prednisone for RA flare, that had greatly improved. 4 days later while at home, no stress went outside to garden (nice weather) walked back into house, and instantly started sweated and felt extreme tireness, lightheadness and got extreme heart palpitations. since I was alone I called my husband and told hime my heart was pounding so hard I thought it was going to come out of my chest. I do not have cardiac problems. I took my BP, it was normal, my HR was 157. I relaxed and stayed calm and repeated my BP and HR every 15 mins as we monitored it. After 1 hour the Hr went down to 92. I thought maybe I was have a hot flash and almost went to ER. but things calmed down. I had another episode of heart rate resting up to 122 a few days later, since my RA got worse again after the 3rd shot, I had to bump up prednisone. I see DR next week. I have not had an issue since and as of today, by RA flare seems to be better. I will be f/u wit dr soon
Individual expressed they get migraines or headaches sometimes believed due to lack of hydration.; Individual expressed they get migraines or headaches sometimes believed due to lack of hydration.; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP).  An adult female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) (Lot number: unknown) as dose 1, single and also received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) (Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported MIGRAINE (non-serious), HEADACHE (non-serious) all with outcome unknown.   The reporter did not believe this is AE but was reporting out of caution. The reporter did not know the vaccination date or vaccine and reported that patient was in early 20s.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a nurse referring to a 21 patient of unknown age and gender. Medical history and current conditions were not reported. On an unknown date, the patient were subcutaneously vaccinated with improperly stored doses of VARIVAX (Merck) (dose, frequency, indication were not reported, lot # L033138; expiration date : 31-AUG-2017 and lot: L015048; expiration: 29-APR-2017). It was unspecified which patients received which lot. No known adverse effects. Additional information has been requested.
Boostrix - Tdap instead of Dtap; Boostrix - Tdap instead of Dtap; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 03-NOV-2024) for prophylaxis.   On 15-JUN-2023, the patient received Boostrix. On 15-JUN-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Boostrix - Tdap instead of Dtap) and inappropriate age at vaccine administration (Verbatim: Boostrix - Tdap instead of Dtap). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUN-2023 The reporter was a medical assistant. The healthcare professional asked for any adverse reaction expected. During the call permission for follow up was not requested. The reporter reported that the administration of a Tdap (Boostrix) instead of Infanrix (Dtap) to a 16 month-old patient, which led to wrong vaccine administered and inappropriate age at vaccine administration.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 02-FEB-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Several hours after administration, patient reported that her arm was red, warm and seemed swollen and hard in area around injections site. In the first 24 hours this reaction continued extending to area near elbow. In the first 24 hours it seemed the worst, sensitive to pressure, and hot to touch. Began to resolve after 24 hours, but continued thru 48 hours.
pc from pts mom stating pt was adm to hosp 28JUL94 w/t104, neck stiffness, legs stiffness; pt remains in hosp today 29JUL94; check w/hosp nurse who stated pt was doing better & fever had dec; hyperpyrexia
This spontaneous report as received from a healthcare worker refers to a 45 year old patient of unknown gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On 16-JAN-2016 the patient was vaccinated with PROQUAD (lot number, dose and route were unknown), instead of M-M-R II. No adverse effects reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
This spontaneous report as received from a health worker refers to an unspecified amount of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of RECOMBIVAX HB (lot#, dose, route, indication not reported) that underwent a temperature excursion on an unknown date. Concomitant therapy was not reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt stated she experienced pain following the vaccination which worsened over time and her arm gradually swelled from the shoulder to the elbow and was hot to the touch.  She stated she could only move that arm using the other arm. She called the pharmacy about 8:00 pm asking what to do and if she should go to the ER.  The RPh on duty advised the pt to take Advil 600 mg every 6 hrs and take Benadryl if itching or hives developed.  She recommended going to the ER if the pt's condition worsened. I spoke to the pt at 9:45 AM on 9/8/11. She stated that the swelling was going down and she could use her arm more.  I told her to keep taking the Advil and to use and ice pack and elevate her arm.
Left abdominal/flank pain, later hyperpigmented rash, appeared like post-herpetic neuralgia though not seen at time of initial rash.
fatigue; headache; body aches; This is a spontaneous report from a contactable healthcare professional reporting for a 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 0142), intramuscular on 04Jan2021 15:30 in left arm at single dose for COVID-19 immunization. Medical history included COVID-19, type 1 diabetes and penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included insulin.  The patient experienced fatigue, headache and body aches on 05Jan2021 10:00. No treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremities)-Medium, Systemic: Pain in her hand. Swelling started with her fingers. The swelling and pain keeps moving up her hand to her wrist. It is affecting her ability to move her hands as before/affecting her daily activities. Severe, Systemic: Joint Pain-Medium.
quite a redness - at the injection site and around it, about 3inches across and 2 inches wide; large area that looks swollen - at the injection site and around it, about 3 inches across; arm hurt; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (arm hurt), VACCINATION SITE ERYTHEMA (quite a redness - at the injection site and around it, about 3inches across and 2 inches wide) and VACCINATION SITE SWELLING (large area that looks swollen - at the injection site and around it, about 3 inches across) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Sjogren's syndrome in 1995 and Interstitial lung disease in 2006. Concurrent medical conditions included Hypertension since 1997 and Hyperlipidemia since 2002. Concomitant products included ALLOPURINOL for Gout, POTASSIUM CHLORIDE for Hyperkalemia, ROSUVASTATIN CALCIUM (CRESTOR) for Hyperlipidemia, IRBESARTAN (AVAPRO), HYDROCHLOROTHIAZIDE and DILTIAZEM HYDROCHLORIDE (CARDIZEM CD) for Hypertension, FAMCICLOVIR (FAMVIR [FAMCICLOVIR]) and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) for Infection, MULTIVITAMIN [VITAMINS NOS] and COLECALCIFEROL (VITAMINE D) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced MYALGIA (arm hurt). On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (quite a redness - at the injection site and around it, about 3inches across and 2 inches wide) and VACCINATION SITE SWELLING (large area that looks swollen - at the injection site and around it, about 3 inches across). At the time of the report, MYALGIA (arm hurt), VACCINATION SITE ERYTHEMA (quite a redness - at the injection site and around it, about 3inches across and 2 inches wide) and VACCINATION SITE SWELLING (large area that looks swollen - at the injection site and around it, about 3 inches across) had resolved. Not Provided          Patient had allergy to Adhesive Patient stopped taking Mycophenolate 1500mg BID which he is taking from 2009 he stopped  before 3 days of vaccination and then restarted it after 3 days of vaccination. Patient stated Redness at the injection has spread after a few hours through next two days ,then started to get bigger at day 7 and after few days it subsided Patient wants to know if this is normal, and can he get second dose   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Follow up is significant , there is addition of Medical history, Updating Suspect product dosage ,concomitant medications ,Updating of Event outcome, Addition of causality
AFTER VACCINATION, PATIENT SAT AT THE WAITING ROOM. WITHIN A FEW MINUTES HE BECAME PALE WITH COLD CLAMMY SKIN, THROAT SWELLING, SLOW THREADY PULSE, SEIZURE LIKE SYMPTOM, BARELY RESPONDING WHEN WE TRIED TALK TO HIM.   911 WAS CALLED IMMEDIATELY AND EPIPEN WAS GIVEN WITH DADS PERMISSION. AFTER A FEW SECONDS, PT BECAME ALERT AND CAN RESPOND WITH US. I MONITORED HIS RESPIRATION AND PULSE RATE WHILE WAITING FOR EMS.  EMS TOOK  OVER APPROX.  WITHIN 10 MINUTES AND TOOK THE PATIENT TO THE EMERGENCY ROOM.
Starting 1 day after the administration, patient started experiencing left arm pain and swelling. Patient had also received a flu vaccine in the other arm during the same visit. Patient reported her symptoms in the left arm got progressively worse and included heat, pain, itching and the appearance of a rash which the patient described as "bumps". 2 days later, the patient developed a low grade intermittent fever and chills. About 4 days ago from the date of this report, patient started developing a rash on her left side which extended to her stomach. Patient visited her PCP who concluded that it may be shingles but did not prescribe any treatments.
Swelling progressive; no tenderness; no grip. Confluent urticarial dimed edema; no abnormal area of fluctuance, no area of defined induration.
About 5 hours after shots, became pale and lethargic. Parents described as dusky; not cyanotic. No seizure. Admitted overnight for observation to the hospital. EEG was normal. Appetite returned as well as normal activity by the next morning. 9/9/05 Review of d/c summary indicates final diagnosis of immunization reaction, cyanotic episode, and apnea episode.
very itchy; injection site is red; chills; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE ERYTHEMA (injection site is red) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling at injection site) and CHILLS (chills). On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (injection site is red). At the time of the report, VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (injection site is red) outcome was unknown and VACCINATION SITE SWELLING (swelling at injection site) and CHILLS (chills) had resolved.        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.   Concomitant medications were not reported.   Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional information include contains non significant information.Email updated On 07-Jul-2021: Additional information include patient initials got updated. On 12-Jul-2021: Additional information include patient initial corrected as per query response.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Headache, Myalgia, Arthralgia, NauseaVomiting, chills Narrative:  Other Relevant History:
Mild headache at noon on 4/9/21 Worsening headache, fatigue, loss of appetite at 9 pm Took 600mg of ibuprofen at 11:30pm Body aches and chills at 2:00am on 4/10/21 Vomiting and migraine, fever of 101 at 5:30am Took 1000mg acetaminophen at 5:30am Fatigue and headache continued Took 1000mg acetaminophen at 11:40am Fever at 99.4 at 2:00pm Appetite returned some at 2:30pm Fatigue and headache continued Took ibuprofen at 5:30pm Appetite returned to normal at 6:30pm Fatigue reduced considerably by 10pm Took acetaminophen 5:00am on 4/11/21 Mild headache still at 11:45am on 4/11/21.
Patient c/o pain and pressure in her left shoulder joint immediately after the vaccine injection. She came to me for evaluation on 11/08/2018 initially. She rated her left shoulder/arm pain 5-6 /10 aching, annoying, sore. She c/o decreased ROM. She was unable to lift 5# with LUE. I saw her again on 11/15/18 for a follow up visit and she reported limited improvement in the left shoulder. I am sending her for an orthopedic consult 11/19/18. She is taking OTC remedies for the pain and applying ice prn.
Muscle aches, fatigue. Rash on back - Taking Benadryl.