chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an 18 year old male who on 22-APR-1993 and 08-OCT-1997 was vaccinated with the first and second doses of MMR II.  On 09-NOV-2009 the patient experienced mumps.  On 16-NOV-2009 the patient was diagnosed with mumps.  On 16-NOV-2009 the patient had the first blood work, serum immunoglobulin G is 2.05, serum immunoglobulin M<1:10, serum amylase is 63.  The patient did not have a fever.  The patient did experience symptoms of cough and congestion.  At the time of this report the patient status was unknown.  Follow up information has been received from a physician reported that on 15-DEC-2009 the patient experienced mumps.  On 18-DEC-2009 the patient was diagnosed with mumps.  The patient developed right parotitis and a temperature of 100 degrees F.  On 08-DEC-2009 the patient had the first blood work, serum immunoglobulin G is 2.14, serum immunoglobulin M<1:10, serum amylase is 39.  Additional information has been requested.
I had a sore throat, a headache, fatigue, cough and tightness in my chest.
Patient developed a rash and bumps on his arms and reported a burning sensation in his feet.  He saw his primary care doctor, and they referred him to dermatology.  He will be following up with them in June or July.
This spontaneous report was received from a nurse regarding patient of unknown age and gender. Information on patient's concurrent conditions, medical history, drug allergies and concomitant medications were not reported. On 25-NOV-2018, the patient was inadvertently vaccinated with expired dose of VAQTA (strength and dose were not reported) (lot#  N020951 and expiry 15-OCT-2018) intramuscularly for prophylaxis (expired product administered). No adverse effects was reported. The outcome of the event was unknown. No Product Quality Complaint was involved.
Pain in leg right; Pain in right leg from hip to knee; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in leg right) and ARTHRALGIA (Pain in right leg from hip to knee) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (Father is on High Blood pressure medications  (unspecified)).    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 PAIN IN EXTREMITY (Pain in leg right) and ARTHRALGIA (Pain in right leg from hip to knee). The patient was treated with PARACETAMOL (TYLENOL) for Pain in hip and Pain in leg, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in leg right) and ARTHRALGIA (Pain in right leg from hip to knee) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment for the Pain included Tylenol.   It was reported that patients mother had loss of taste just in evening of the day of vaccination and she felt sleepy. She was sleeping for 3/4 hours, and when she woke up she was feeling okay.
FEVER, HA, ST, RN, CONGESTION, FATIGUE, NAUSEA, DIARRHEA, MUSCLE PAIN
Janssen COVID-19 Vaccine EUA slight headache, fatigue, a few aches
patients received a FLUZONE QIV HD dose earlier in October, and inadvertently received another during their visit today. with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an 86-year-old female patient who had received a INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] dose earlier in October, and inadvertently received another during their visit today. with no reported adverse.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, the patient received 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation: unknown) (lot number: UJ926AD and expiry date:  30-Jun-2023) via intramuscular route in unknown administration site. On 28-Oct-2022 she also received 0.7ml dose of the same vaccine lot UJ926AD via intramuscular route in the right deltoid for Immunization.  On 28-Oct-2022, a non-serious event occurred, patient received a fluzone qiv hd dose earlier in October, and inadvertently received another during their visit today. with no reported adverse event (extra dose administered) (latency: 21 days).  It was reported, They are asking what needs to be done in the case of an extra dose such as this?.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Child received 0.25 mL dose instead of a full 0.5 mL; This case was reported by a nurse via call center representative and described the occurrence of underdose in a child patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, the 1st dose of FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced underdose. On an unknown date, the outcome of the underdose was 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: 7-Dec-2022 Reporter's comment: The nurse reported that there was a possibility a child might had received 0.25 ml dose of FluLaval QIV instead of a full 0.5 ml dose for their first and second doses of influenza vaccine.   At the time of reporting, the nurse did not had any verified information including date of administration, lot number of the dose administered, or any patient information. The reporter consented to follow-up. This is 2 of 2 linked case, reported by same reporter. Additional supportive information: The patient received might had received 0.25 ml dose of Flulaval QIV instead of a full 0.5ml  dose, which led to underdose.; Sender's Comments:  US-GSK-US2022183616:Same reporter
I had some site soreness for several days...nothing too bad. Took some Tylenol for it. Two days after injection I got pretty bad diarrhea that lasted several days. I also got the chills/shakes the second night. Then I got a pretty bad Eczema flare...on my breasts. It continues at week two. My left armpit HURT terribly for almost a week. Tylenol did not relieve it at all. I also had quite sore Lymph nodes across my chest/side of neck.
Information has been received from a medical assistant via a company representative referring to an 11 years old male patient. The patient's concomitant medication, medical history and drug reactions/allergies were unknown. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 (3 dose series; lot #, expiration date dose were unknown; intramuscular). It was reported that the patient had a small red circle at injection site when given the second dose. The patient was flushed and ice pack was given to site of injection. Then the patient was kept lying down until he was ok. No lab diagnostics studies were performed. The dose series was continued. At the reporting time, the patient had recovered from the events. The causality was not reported. Additional information has been requested.
11/29/07:  15-20 minutes after vaccines were given patient left health department and went across the street to the store and complained of feeling feverish with shortness of breath; also complained of reflux, flushing of the skin lasting about 15 minutes; Feeling somewhat better she drove home but complained of some abdominal cramps and nausea lasting another 15 minutes.  Patient says she felt fine when she arrived home and went jogging.  Pt called to report this on 11/30/07 and said she feels fine today but wanted to report what happened.  Pt denies any other adverse events.
Resident was getting the boost, the dose on the vial stated maximum doses of 11 of 0.5ml  which was given and the booster injection was suppose to be 0.25ml. No adverse reactions noted to patient
I started with fatigue, fever, body aches and nausea. Pain also occurred at the injection site.
Serve lip swelling and lip pain; Fever of 104; Chills; Aches; 3 days
pt woke up the following day with red bump on dorsum of R hand, + itchy, swelling , during the course of the day redness and bumps increased. Mom applied ice to area and gave Benadryl with rash resolving.  Denies any new foods, changes in foods, meds or creams. soaps used per parental report  Injection site clear.  no other body parts affected
Systemic: orange urine-Mild, Additional Details: patient reports orange urine 30 minutes after receiving vaccine
This is in follow-up to report (s) previously submitted on 9/24/2007. Information has been received from a registered nurse (R.N.) concerning a female "over 60 years of age" who was vaccinated with a subcutaneous injection of Zostavax (Oka/Merck). Subsequently, on an unspecified date, the patient experienced "injection site swelling which was severely inflated and enormous." The patient visited the physicians office for follow-up where they treated her with steroids to keep inflammation down. The outcome is not reported. No product quality complaint was involved. Additional information received indicates that the patient is a 74-year-old female with allergies to sulfa, tape, and amoxicillin, and concurrent medical conditions IBS, GERD, mirgraines and hypothyroidism. On 16-Jul-2007 at 11:30, the patient received an intramusclar dose in the left deltoid of PNEUMOVAX 23 (LOT# 655592/0662F) (previously reported as zoster vaccine live (Oka/Merck)). Concomitant medications included FIORICET TABLETS, ALLERGRA, PREVACID, LEVOXYL, TIGAN, PROVIGIL, montelukast sodium (MSD), LORAZEPAN, "onlan" and "suspar". There was no illness at the time of vaccination. On 18-Jul-2007, the patient developed redness, welts and pain at the injectio site. The area below the injection site was moderately swollen. No laboratory or diagnostic test were performed. The patient was given 60 milligrams intramuscularly or KENALOG, and oral prednisone. On 23-Jul-2007, the patient recovered. The reporter considered the adverse events to be other important medical events that required medical attention. Additional information is not expected.
Severe headache, body aches, nausea, cold sweats. Vital signs stable, afebrile.
On 11/02/2000, the patient presented with numerous large lesions and pustules on his body, number unknown, that were 7 to 9 cm, without papules with decentral vesiculation. He was diagnosed with early varicella. He also had positive cold symptoms. No tests were performed. He was treated with oral acyclovir for 5 days. The outcome was not provided. No further information is available. Per F/U 6/17/02: he was also treated with acyclovir (600mg po 4 times a day for 5 days). It was reported that the pt recovered on 11/8/00. No further info is available.
pt had a positive COVID test on 1/24/22 as an out patient; 1/30/22 pt was brought to ED with worsening SOB, generalized weakness, productive cough that's worsened over past 2-3 days; O2 supplementation; tested positive again for COVID; chest x-ray shows COVID pneumonia; given Decadron and Remdesivir; ABX; O2 needs increased; transferred to MICU; pt required intubation with mechanical ventilation, requiring a paralytic; ran fever; EKG showed LBBB and Sinus Tachycardia; worsening kidney function; pt became a DNR and transitioned to comfort care; he passed away in the hospital
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) and on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: NYQUIL, start date: 10Jul2023, stop date: 12Jul2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was given from 12Jul2023 to 16Jul2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pfizer bivalent vaccine expired on 12/2/22, per manufacturer storage and stability guidelines.  Vaccine was administered on 12/3/22.  Pharmacist called parent, explained how expiration date was determined per manufacturer, and recommended to return for re-vaccination as there is no efficacy date past 10 weeks.  Parent was agreeable to come in for re-vaccination at a later unspecified date.
Resident passed away 2 days after receiving the vaccine. oxygen level has decreased shortly 1 day after receiving the vaccine.
PT EXPERIENCED BEING COLD, VIOLENT SHAKING, AND RED/SORE ARM WITHIN 4 HOURS
Patient reports sharp pain in temple within 2.5 hours of vaccine administration with feeling cold, having chills, and shaking.  Patient has facial swelling on 4th day after vaccination and sent home from work with Benadryl, acetaminophen, and ibuprofen.
Swollen lymph nodes under my arm.  It started Sunday March 28th and is still swollen as of today March 31st but the swelling has gone down.  Today I woke to a rash /allergic reaction on the injection site
redness, warmth, itching, pain starting 7 days after injection. yellow sebum from area.
Breakthrough case: I developed symptoms from COVID-19 on 09/06/2021. My symptoms included tightness/congestion of my chest, and I had a bad sinus headache. I took Advil and these symptoms cleared up within hours. I still continued to take Advil the next few days.
After receiving 2nd dose, patient stated her tongue was swelling, throat closing, difficulty breathing and felt warm to touch.
Areas of injection 1 cm below injection site with area of induration around 2 cm x1.5 cm
recommended diluent added to vial.    Patient infromed of possible increased concentration and possible increased side effects.  Information regarding patient education came from Pfizer and CDC'd "Interim Clinical Considerations for use of mRNA COVID-19 vaccines.  Patient reported no increase in symptoms or other issues.
itching all over body; rash all over body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching all over body) and RASH (rash all over body) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy (allergy to oysters ). Concomitant products included DOCUSATE SODIUM (STOOL SOFTENER), VALPROATE SEMISODIUM (DIVALPROEX SODIUM DISPENSING SOLUTIONS), DULOXETINE HYDROCHLORIDE (CYMBALTA), LEVETIRACETAM, VITAMIN D [VITAMIN D NOS], NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]), ALBUTEROL [SALBUTAMOL], PERAMPANEL (FYCOMPA) and NIFEDIPINE (NICARDIA) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PRURITUS (itching all over body) and RASH (rash all over body). At the time of the report, PRURITUS (itching all over body) and RASH (rash all over body) had not resolved. Not Provided          The concomitant medications also included unspecified Blood Pressure pill 12.5 MG and 10 MG. No laboratory investigations were provided. The Treatment information was included (Diphenhydramine) Benadryl Oatmeal Bath "lotion".  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
SWELLING UNDER BOTH ARMPITS; RUNNY NOSE; NASAL STUFFINESS; RED THROAT; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included environmental allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced runny nose. On 10-MAR-2021, the subject experienced nasal stuffiness. On 10-MAR-2021, the subject experienced red throat. On 12-MAR-2021, the subject experienced swelling under both armpits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling under both armpits, and runny nose, and the outcome of nasal stuffiness and red throat was not reported. This report was non-serious.
I have had a sinus infection. I determined it was a sinus infection - it was very bad cold symptoms, head congestion, headache, and cough. Started on October 26th, in the afternoon. Those lasted for about 6-7 days. And then I felt better for a few days and now I have similar symptoms reoccurring again. Particularly, head congestion and fluid on my ears. Home remedies and mover the counter cold medicine. I noticed post vaccine, ringing in my ears and that has been off and on since having the vaccine. I still don't feel 100%.
Severe Chest pain; This is a spontaneous report from a Non-contactable consumer (patient).   A 49-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Oct2021 11:30 (Batch/Lot Number: EF8839) as single dose (at the age of 49) for covid-19 immunisation. Medical history was none. No known allergies. The patient's concomitant medications were not reported. The patient experienced severe chest pain on 01Nov2021 19:00. Patient was treated with Mobic for pain. The outcome was unknown.    No follow-up attempts are possible. No further information is expected
Approximately 1 hour post-vaccination, experienced dizziness, rapid heart-beat, and mental fogginess. Approximately 2 days post vaccination, experience chest pain that radiated from right shoulder, shooting to the left (across the front of chest) and also pain in between shoulder blades. This occurred after both Moderna dose 1 and Moderna Dose 2 vaccinations. The chest pain was on and off for approximately two weeks.
15cm x 9.5cm red, sore, warm (L) arm. Temp 100.9. Cool compresses. ADVIL 400 BID.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced hives and trouble breathing when treated with Augmentin (amoxicillin/clavulanic acid).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 06-AUG-2021 for prophylactic vaccination. The dose number in series was 1. No concomitant medications were reported.  On 06-DEC-2021, the patient started experiencing sneezing. On 07-DEC-2021, the patient got tested with rapid home Covid-19 test which resulted positive (suspected covid-19 infection, suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20211217553-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report was received from a medical assistant and refers to a 19 year old patient. The patient's pertinent medical history and concurrent conditions were not provided. On 21-APR-2016, the patient was vaccinated with a dose of PROQUAD (route, lot number and expiration date were not provided). Concomitant therapies included a pediatric dose of ENGERIX-B also administered on the same date. On 21-APR-2016, there was an inappropriate schedule of drug administration as the patient who was 19 years of age was inadvertently administered PROQUAD. There was no adverse event. At the time of the report, the patient's status was unknown. Additional information has been requested.
Initial information received on 11-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 10 days old male patient who was inadvertently received 0.25 ml dose of vaccine FLUZONE QUADRIVALENT (lot number: UT6315RA, expiry date: 30-JUN-2019) via intramuscular route in left arm on 11-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history was not reported. Concomitant medications were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. No symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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. Documents held by sender: none.