chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered expired DAPTACEL with no reported adverse event; Initial information received on 10-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old male patient who was administered with expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (Mmr) and Varicella Zoster Vaccine (VARICELLA VACC.) for Prophylactic Vaccination (Immunisation).  On 06-Apr-2023, the patient received 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: C5828AA, Expiry date: 30-MAR-2023) (Strength: Standard, Frequency: once) via intramuscular route in the right thigh for Prophylactic Vaccination (Immunisation).  On 06-Apr-2023, the patient was administered with expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no reported adverse event (expired product administered) (latency: same day).  It was reported, This is reported as a medication error due to the inappropriate administration of an expired product to a patient.   Action taken: not applicable.  Outcome: 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.
Red, blotchy rash all over stomach, legs and back-no itching, lasted 2 days.
postive COVID results; postive COVID results; loss of taste & smell; loss of taste & smell; severe head congestion; fatigue; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955) intramuscularly, administered in left arm on 26Mar2021 11:30 (at the age of 51-year-old) as dose 2, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248) intramuscularly, administered in left arm on 05Mar2021 11:30 as dose 1, single for covid-19 immunisation. Patient had known allergies to sulfa. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient's concomitant medications were not reported. On 29Aug2021 the patient had positive covid results, loss of taste & smell, severe head congestion, fatigue. The case is serious and patient visited to doctor or other healthcare professional office/clinic. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab) result was positive on 31Aug2021. No treatment received for the events. Outcome of the events were resolving.  The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3248 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3248, fill lot EL3231, and the formulated drug product lot EL3224. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EP6955 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts possible. No further information expected.
Mother called and stated that yesterday evening 7/31/2019 at around 7:00pm, he developed hives from head to toe on his body. Mother states he is out of town at this time and is not sure if this is from the vaccines that he received on 7/22/2019.
Second dose 7 days post 1st dose; Excruciating muscle pain her left leg; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 7 days post 1st dose) and MYALGIA (Excruciating muscle pain her left leg) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 7 days post 1st dose). 13-Apr-2021, the patient experienced MYALGIA (Excruciating muscle pain her left leg). On 13-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 7 days post 1st dose) had resolved. At the time of the report, MYALGIA (Excruciating muscle pain her left leg) outcome was unknown.
I had abnormal blood work on 8/26/22. My doctor decided to have more blood work done on 11/22/22 and my Thyroid Stimulating Hormone was still high. In the weeks leading up to this, I noticed some split fingernails and was having depression. I was not able to lose weight and had some sensitivity to cold. I am still dealing with this and just started taking an increased dose for depression.
Severe headache, fever 101, nausea and vomiting lasting from 7:00 am until 8:00 pm the day following the vaccine
no adverse event; expired vaccine administered; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions and allergies and concomitant medications were not provided.  On 24-JAN-2022, the patient started therapy with expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, dose 0.5 milliliter, lot #T002842, expiration date: 23-JAN-2022, administered for prophylaxis (strength and route of administration were not provided). The vaccine was reconstituted with sterile diluent (STERILE DILUENT)(dose 0,5 ml; lot # T014299, valid expiry date 28-NOV-2022) administered on the same day.  There was no previous temperature excursion. No adverse effects were reported.
After the first shot on 12/26/20 I had dizziness, facial flushing, elevated blood pressure, and tachycardia within minutes. It lasted about an hour. I had no issues after that. I received the 2nd shot on  1/15/21, I had the exact same reaction however it only lasted 20 min. I then went to my car and started driving home, about 10 minutes later and while on the freeway I had dizziness, flushing, tachycardia, , shakiness, and facial numbness. I took an exit and was able to pull over in a parking lot. It lasted about 20 minutes. Since that time I have had frequent episodes of dizziness, facial flushing, tremulousness,  facial numbness/tingling, and presyncope. The worst episodes were on 2/1/21 and 2/3/21. I was unable to work because of these symptoms.
Presented to ER on 12/27/21. presents to the emergency room for generalized weakness and fall x2 yesterday.  Patient states that her husband is having COVID like symptoms at home with loss of taste or smell.  She decided that she needed to come to the hospital after she had her 2nd fall.  She states she just injured her right foot in the fall.  Upon arriving into the emergency room her initial workup revealed a temperature of 99.5°, a pulse of 77, respirations of 20, blood pressure 132/81, she is oxygenating on room air 98%.  She had a normal chest x-ray.  Patient tested positive for COVID.  Received pfizer on 01/06/21, 01/27/21, and 09/01/21. Hemoglobin hematocrit of 11.4 and 34.4.  Reacting of 1.8.   Hospitalist was called for admission in this patient with generalized weakness and being COVID positive.  Appears patient will need skilled nursing facility placement. Was on room air the whole time. Discharged on 12/31/21
Presented on 8/25/05 with c/o myalgia, dizziness, and emesis. Lt. Axillary lymphadenopathy noted. Amoxicillin and Motrin ordered. Placed on quarters for 24 hours and No P.T. for 5 days. Returned on 8/26/05 with c/o chest pain and memory loss. MD evaluated and noted patient to be alert and in no acute distress. Mental status was normal (AOx3) Placed on quarters for an additional 24 hours. No further c/o have been noted.
This spontaneous report was received from a pharmacist and refers to a 24 -year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-DEC-2016, the patient was vaccinated with the first dose of GARDASIL for prophylaxis (dose, route of administration, lot# and expiration date were not reported). On 02-MAR-02017, the patient was vaccinated with GARDASIL 9 for prophylaxis as her second dose (dose, route of administration, lot# and expiration date were not reported). No adverse effect were reported. Product quality complaint (PQC) was not reported. Additional information has been requested.
She was given the vaccine intramuscularly in her glute; A spontaneous report was received from a consumer concerning a 79-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was given the vaccine intramuscularly in her glute.  The patient's medical history included breast cancer. There was no concomitant medication provided.  On 23-feb-2021, approximately prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 022M20A) intramuscularly in the glute for prophylaxis of COVID-19 infection.   On 23-Feb-2021, due to her medical history of breast cancer she was unable to receive the vaccine in either of he arm. The patient was given the vaccine intramuscularly in her glute. There was no treatment information provided.    Action taken with mRNA-1273 in response to the events was not reported.   The events, She was given the vaccine intramuscularly in her glute were considered as recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # 022M20A) with no associated AEs reported.
6/25/03 at 2am body puffy, dizzy, nausea, vomited, then found in fetal position and had a seizure, unconscious for 20 seconds felt fine for 2 days then there was nausea, dizziness, blurry vision. Visited neurologist still have tingling/numbness on hands, feet shin, calf. Now being sent to allergist. Follow up on 10/28/2003: "Vaccine recipient did not recover from adverse events.  Numbness/tingling; weakness; Fatigue; Demyelination (brain)."
suffer on his death bed for almost a year after taking a flu vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was recovering/resolving.   It was unknown if the reporter considered the near death experience to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at the vaccination was not reported. The reporter watched her husband suffer on his death bed for almost a year after taking a flu vaccine. The patient was better now.
Patient, 10 days after vaccines given, developed febrile seizure, and fever for seven days.
bruising from shoulder down to the elbow and across the injection site on the inside of the arm, area is yellow now; Initial information received on 22-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 84-years-old male patient who experienced bruising from shoulder down to the elbow across the injection site on the inside of the arm (contusion), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment and family history were not provided.   No other vaccination were used.  On 17-Sep-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength: Fluzone High Dose, lot number: UJ484AB, expiry date: 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious bruising from shoulder down to the elbow and across the injection site on the inside of the arm (contusion) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Event details: Two days later the area of bruising was yellow at the time of reporting.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The patient was recovering from bruising at the time of reporting (two days later and the area of bruising was yellow).
Fell; Weakness in legs; got so weak; His legs just continued to get worse/He could not get up without help; He could not walk; This is a spontaneous report from a contactable nurse reported for her father.  An 87-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, intramuscular on left arm on 13Jan2021 (Time the vaccination was given: 13:00-13:15) at the age of  87-years-old at single dose for prevention because of age group.  Medical history included covid-19 in Jun2020, forgetful from an unknown date, he got a little forgetful sometimes, so he may have forgotten to tell her.  This occurred prior to getting the vaccine.  The patient's concomitant medications were not reported.  Prior Vaccinations (within 4 weeks) was none. Family medical history was none. The patient got the Pfizer COVID vaccine last week on 13Jan2021, he was really sick in Jan2021. The patient had weak legs anyway, but he got so weak.  Weakness in legs started at night on 13Jan2021, around 20:00. No emergency room (ER) or physician's office required. He never complained of any symptoms and did not know if there were other symptoms, because he did not complain.  He fell on Thursday night on 14Jan2021. He got the vaccine around 1:00-1:15pm, and got so weak, that he went to the bathroom and he fell in the floor.  His legs just continued to get worse.  It started on Wednesday night on 13Jan2021.  He could not walk in Jan2021.  Thursday was the worst. By Friday, it started to get better.  He did not get hospitalized.  He could not get up without help. The patient had Covid 19 in Jun2020. He had a lot of symptoms after receiving the first dose of the vaccine. The reporter reported her father fell in the bathroom while brushing his teeth and her brother had to come over to get him up. The reporter was starting to wonder if he should take the second dose. The outcome of the events Weakness in legs and fell was resolving and of the other events was unknown. The reporter considered event Weakness in legs was serious due to medically significant and disabling; considered event fall was serious due to medically significant.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of the events muscular weakness, fall and gait disturbance cannot be excluded. The events are confounded by the elderly patient's underlying conditions. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
The patient is a resident at a skilled nursing facility.  The facility filled out the paper work with consent from the patient & family that makes medical decisions.  We were under the impression this would be the first shot the patient would receive, but upon entering it into GRITS, found out it is the third shot.  The patient got two doses prior; on 1/14/21 & 2/2/21.  The patient has had no adverse effects from this third dose.
Breakthrough case admission after three vaccines Pfizer x3; Pfizer 2/19/21 Lot# En620;  Pfizer 3/12/21 Lot# EN6199;  Pfizer 12/9/21 Lot# 330308D
swelling of all the digits on both right and left hand and facial rash 3 days after receiving the 2nd COVID vaccine  (Pfizer)
Pain, swelling in arm where shot was given, then pain and swelling continued in other joints all over her body, couldn't sleep, couldn't walk, couldn't dress herself - was told by doctor's office to take ADVIL and BENADRYL but this didn't help much. Went back to Doctor and made several calls to doctor. Pain and swelling continued. Was referred to a Rheumatologist and this doctor said vaccine could have brought this out in her. Diagnosed her with Rheumatoid Arthritis. Nodules formed on her lymph nodes and had to go through series of tests to see what it was. Also had to stay in the hospital overnight. Now is getting infusions every six months to help with the arthritis. Was never sick before having this vaccine, and now feels bad most of the time. Has never been the same since having this vaccine.
Fatigue; Headache; Muscle ache/ muscle pain; Nausea; Vomiting; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache/ muscle pain), NAUSEA (Nausea) and VOMITING (Vomiting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Feb-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache/ muscle pain), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced PAIN (body aches). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache/ muscle pain), NAUSEA (Nausea), VOMITING (Vomiting) and PAIN (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
10/09/06 c/o left arm pain since Tdap injection 10/04/06, pain radiates up to neck and scupular region. Day of injection temp 101. Pain is improving. Continuing using Ibuprofen and Benadryl and heat.
Pain right shoulder, ice applied, moderate redness, swelling increasing with time, malaise, temperature 100, Naproxen BID.
Fainted about 5 minutes after receiving vaccine (fell, hit head) - vagal response per paramedic Able to get up and leave, feeling better about 35 minutes after event.
Patient received only a partial dose as she lose some volume from the syringe during administration; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a elderly male patient who received Herpes zoster (Shingrix) (batch number FAN5A, expiry date 28th July 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 08-AUG-2022.  Reporter's Comments: The patient received only a partial dose of Shingrix vaccine as she loses some volume from the syringe during administration.  The consent to follow up was granted. Additional Supportive Information: As patient received only a partial dose of Shingrix, which led to incomplete dose administered.
Booster was given approximately a month early. Patient experience known side effects of the vaccine like fatigue and muscle aches.
I had a really sore throat, headache, low grade temperature, joint pain, mild cough. I got PAXLOVID on 12/30/22. I'm still testing positive today and still with sore throat.
Painful swelling of lymph node in left armpit.  3 days and still happening.   Swelling to the point of stretch marks in my armpit.
Sinus was mess up; Soreness at injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Sinus was mess up), INJECTION SITE PAIN (Soreness at injection site) and CHILLS (Chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Asthma.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced SINUS HEADACHE (Sinus was mess up), INJECTION SITE PAIN (Soreness at injection site) and CHILLS (Chills). At the time of the report, SINUS HEADACHE (Sinus was mess up), INJECTION SITE PAIN (Soreness at injection site) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is currently on muscle relaxant, pain medication, asthma and oxygen machine.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were reported. No treatment information was reported. This case was linked to MOD-2021-395985 (Patient Link).