chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"I have a 32-year-old patient who received 2 doses of GARDASIL, 10 plus years ago."; No other AE reported; This spontaneous report as received from a pharmacist refers to a currently 32-year-old female patient. The patient's concurrent condition, concomitant medication and medical history were not provided.  On an unknown dates, (reported as "10 plus years ago"), the patient was vaccinated with two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. Therefore the patient experienced inappropriate schedule of product administration. No adverse events were reported. The reporting pharmacist wanted to know if she could give her the third dose "even if it has been 10 plus years ago".
Client was current on Depo Provera Contraceptive and due her next injection.  Previous injection was given on 6/5/19.  As was due, Depo Provera was given on  9/4/19, as well as an MMR. A pregnancy test was done on 9/4/19 with a negative result.   Client presented on 10/18/19 with a positive pregnancy test.  Per ultrasound, client conceived 9/4/19 and has an EDC of 5/30/2020.  She is now G3P2.  This report is being filed due to a Depo Provera Contraceptive Failure which led to an MMR being inadvertently given to a client who is now pregnant.
Temp spike at approximately 32 hours post vaccination. Mild flu-like  symptoms that resolved 72-80 hours post vaccination
This spontaneous case was reported by a medical assistant and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator after puncture), EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis. No Medical History information was reported. On 19-Aug-2022 at 9:18 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2022 at 9:18 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator after puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator after puncture), EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator after puncture) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 12 hours post puncture). No concomitant medications were reported. Number of doses/vials includes 2 doses from 1 vial. Date the vial was initially stored in the refrigerator was reported as 04-Aug-2022. Date and time vial was first punctured was reported as 18-Aug-2022 at 10:30 AM. Vial was stored in fridge post puncture. Vial did not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius which was 46 degree to 77 degree Fahrenheit) was total of 30 minutes. Vial was not exposed to room temperature for more than 24 hours. No treatment medications were reported.
patient had a red, hot, swollen arm for 2 days 2 weeks after his shot.
went to ER 14OCT98 approx 6PM; d/t edema, rash, pain, edema of rt arm where vax given;edema & redness almost to elbow;no c/o n/v, diff breathing;
Inadvertently administered Kinrix to sibling patients/but noticed the recommended age after; 3rd dose of DTAP and 3rd dose of IPV; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 16-OCT-2023, the patient received Kinrix. On 16-OCT-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inadvertently administered Kinrix to sibling patients/but noticed the recommended age after) and inappropriate schedule of vaccine administered (Verbatim: 3rd dose of DTAP and 3rd dose of IPV). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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: 18-OCT-2023 The reporter was a medical assistant. The reporter reported that they inadvertently administered Kinrix vaccine to patient. The reporter mentioned that patient need to receive both DTAP and IPV and Kinrix had both but noticed the recommended age.  The reporter stated that it was the 3rd dose of DTAP and 3rd dose of IPV for the patient. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. This US2023144287 case has been linked to the case reported by the same reporter. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2023144287:Same reporter,2nd patient
not feeling too good at the moment; had a very unpleasant reaction/all basically what's listed as side effects; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling too good at the moment), VACCINATION COMPLICATION (had a very unpleasant reaction/all basically what's listed as side effects), HEADACHE (headache) and NAUSEA (nausea) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (not feeling too good at the moment), VACCINATION COMPLICATION (had a very unpleasant reaction/all basically what's listed as side effects), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, FEELING ABNORMAL (not feeling too good at the moment), VACCINATION COMPLICATION (had a very unpleasant reaction/all basically what's listed as side effects), HEADACHE (headache) and NAUSEA (nausea) was resolving.            No concomitant medication was mentioned. No treatment medication was mentioned. The reporter stated that the patient, was in his 70, and was slowly improving & had no side effects with the 1st two doses.
Swelling, pain, hot to touch, chills, fever, kept awake at night, hard at injection site.
itching after injection, some redness. The following morning the patient noticed swelling and induration around the injection site. the swelling. there was continued significant swelling, redness, itching, hardness, and pain.
Pt states extreme tenderness at injection site and pt states he is struggling to move his left arm. Pt also stated tingling of left fingers
Lightheadedness, tachycardia   Pt with heart racing and feeling lightheaded a few minutes after vaccination. Initial VS 133 with BP of 173/97. Quickly improved to 131/91 with HR 76 after bottle of water. Pt denies cp, sob, rash, nausea, or trouble swallowing.
an expired Menactra dose was administered inadvertently to a consumer, no AE; Initial information received on 24-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 years old female patient who received an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (first dose 0.5 mL, lot U6152AA, expiry date: 19-Mar-2020) inadvertently via intramuscular route in the left deltoid on 24-Mar-2020 for prophylactic vaccination.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
1. Allergic urticaria (L50.0). 2. Adverse effect of other viral vaccines, initial Attention not to aggravate. No formal restrictions.. first aid only encounter.
knots on both sides of her neck underneath her chin; two knots on neck under chin on either side was reported as worsened; This is a spontaneous report from a contactable consumer or other non hcp.   A 87-years-old female patient received BNT162B2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 (Batch/Lot Number: EL8982) as 1st dose, single for covid-19 immunisation.  Medical history included a lung problem, and a pacemaker, diagnosed a good while ago, no details provided. Has had pacemaker for about 8 or 9 years. There were no concomitant medications. On 29Jan2021, the patient experienced knots on both sides of her neck underneath her chin, two knots on neck under chin on either side was reported as worsened. The patient stated that "she can press on the knots and they can push down". Caller stated she had the Covid shot on 22Jan2021, stated that on Friday she started to get these knots on both sides underneath her chin on her neck, they are like good sized knots, wondered if that could have anything to do with the vaccine. States she tried to get to her regular doctor today but it snowed and they were closed today. Caller was encouraged to reach out to them when they are open. States she can press on the knots and they can push down. She stated that she read the vaccine could cause swollen lymph nodes.The events were considered as non serious. The outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
The patient's Doctor ordered routine vaccinations of DTap, HIB (ACT HIB), and PCV-13 (Prevnar) for said child. A newly employed medical assistant administered PENTACEL (DTap, IPV,HIB), HIB (ACTHIB), and PVC-13 (PREVNAR) in error. This resulted in the patient receiving a double dose of the HIB vaccination and an unnecessary dose of IPV. The vaccine co-ordinator of the office spoke with the immunization epidemiologist nurse at the Department of Health and inquired about risks or reactions to be looking for. The nurse felt that HIB is a "benign" vaccination and did not suspect that there would be any serious adverse reactions. Told us to have mother keep a look out for any side effects that may be more pronounced with the double dosage. The patient's Doctor spoke with the child's mother on 7/18/2018 at approx. 10:30 AM to inform her of error that occurred,  the patient's mother reported that as of that time, patient did not exhibit any adverse reactions. Was told to call if any concerns arose. Procedures were put in place for more training of said employee.
Pt did not have reaction until about 25  min after shot administered. He began feeling dizzy, had headache and double vision once he got to his vehicle. Also had disorientation of location and who was with him. Once brought back the clinic he was given juice and snack. Vitals and glucose taken. Medicine given for headache. Provider in room to assess pt. Monitored for about an hour until recovery. Pt double vision resolved along with headache and dizziness.
HYPOTENSION 1/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Couldn?t lift arm for a week after the shot. Was very sore. A couple of months after first shot, eyes became blurry, needed to see eye doctor. Still received the booster. One day he was found laying on the floor incapacitated and was rushed to the hospital.  His organs were failing, body was ?malnourished? according to the hospital. I strongly believe it was related to the vaccine, but the vaccine was not discussed at the time due to stigma around such a discussion. He eventually died at the hospital.
Rt deltoid became swollen, inflamed, hot to touch, tender to touch. Affected area measures 30mm x 25 mm rt deltoid to intracubital space. Temp 99.
This serious spontaneous case, initially received on 27-Mar-2018, from a 30-year-old, adult, female pregnant patient. The patient was pregnant twice in the past and had no history of still birth/miscarriage or birth defect/congenital anomaly. The patient had no significant medical history, no paternal/maternal history and no family history of miscarriages. The patient's concomitant medication was not reported. The patient had no stress recently. The patient's last menstrual period was 10-Oct-2017 (estimated date of delivery reported as 29-Jul-2018). Reportedly, the patient was not aware of the pregnancy before the vaccination. On 20-Oct-2017, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, anatomical location: arm, batch number: 195227, expiry date: 31-May-2018, dose: not reported) (explicitly coded as vaccine exposure during pregnancy). On an unspecified date, the patient underwent ultrasound (results not reported, before miscarriage). On 25-Nov-2017, after 1 month 6 days of vaccination, the patient experienced spontaneous abortion, associated with heavy bleeding. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious. Follow-up information received on 20-Apr-2018: It was reported that, the patient had no history of recent stresses or no family history of miscarriages. An ultrasound was done to the patient prior to the miscarriage. Narrative was amended accordingly.
Tinnitus; Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 13:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease, discoid lupus erythematosus, allergy to gluten and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included colestipol (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12), vitamin d not other specified (VITAMIN D), cetirizine hydrochloride (ZYRTEC) and multivitamin (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown dates and unknown if ongoing. On 24Mar2021 at 06:00, the patient experienced tinnitus and vertigo. The events resulted in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. Therapeutic measures were taken as a result of the reported events and included an ongoing treatment still with steroids. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tinnitus and vertigo was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
VOMITED; COVID 19 (SMELLS AND TASTES WAS ALTERED); NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020,  expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination on Left Deltoid. No concomitant medications were reported. On 09-DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On an unspecified date, the subject experienced vomited, covid 19 (smells and tastes was altered), feels like getting worse everyday, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, vomited, and covid 19 (smells and tastes was altered), and the outcome of feels like getting worse everyday was not reported. This report was non-serious.
This spontaneous report as received from a patient's mother refers to her daughter of unknown age. The patient was mistakenly given the first dose of GARDASIL (route, dose and lot # were unknown) at an office visit in March 2010 and had not elected to receive the second or third dose of GARDASIL. No adverse effect reported. Additional information is not expected.
get winded much more easily; blood oxygen numbers were below 95; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and loss of smell, and other pre-existing medical conditions included: Patient did not have a history of lung issues, allergies, or known comorbidities outlined in the patient or prescriber package inserts. Patient was a healthy and athletic person whose blood oxygen numbers hovered in the 97-100 range prior to received the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-NOV-2021, the patient experienced blood oxygen numbers were below 95. Laboratory data included: Oxygen saturation (NR: not provided) 94 %, 93 %, 83 %, 75 %. On an unspecified date, the patient experienced get winded much more easily. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) 94 %, 78 %. Treatment medications (dates unspecified) included: salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood oxygen numbers were below 95 and get winded much more easily was not reported. This report was non-serious.
A 72 year old female came in to the clinic to and stated that has some discomfort to right arm where she was given a shot. Also stated she noticed bruising on 2 areas of the right arm. (1 in the injection site, 1 just right above the elbow).  I observed the right arm and noted approximately a 1cm size bruise at the injection site and a 50cent coin piece just right above the elbow.  Patient stated did not apply any cold or warm compresses to injection site. Referred to physician if she continues to have discomfort to right arm.
Patient was inadvertently given dose #2 of Pfizer (pediatric) outside of the recommended 21-day interval.  According to ASIIS, dose #1 was administered on 12/27/21 and dose #2 was administered 1/3/22.
Pt had a headache and fainted after shot. The following day, she had paralysis of left side of face. Treatment was to lay down; take antiviral medicines for 5 days and steroid medicines for 10 days.
Patient became unconscious and fell down on 2/18 after feeling extreme exhaustion and dizziness, cold sweat, nausea, head confusion, swollen arm on 2/17.
Crying for more than 3hrs. Not eating. Swelling at injection site ((R) thigh). Tx: TYLENOL & cool compress.
Gave patient 2nd Hep A shot at 2:00pm (6/16/08).  Patient complained of numbness in left arm and tingling in left fingers.  Observations of injection site showed localized reaction with hot, red areas.  Dr interviewed patient and released patient with instructions to call if symptoms worsened.  Vital signs were taken and were normal.
Information has been received from a registered nurse concerning an 18 month old male with underweight who on 08-DEC-2009 morning was vaccinated with a dose of ROTATEQ (dose, route, and lot # not reported). No adverse effects reported. The patient sought medical attention through an office visit. Follow up information has been received from a registered nurse concerning an 18 month old male patient with no illness at the time of the vaccination who on 08-DEC-2009, at 9:30 am was vaccinated orally with first dose of ROTATEQ (lot# 664588/0613Y). Concomitant vaccination at the same time included a dose of PENTACEL (lot# C339SAA) (Sanofi Pasteur) in right deltoid, a dose of PREVNAR (lot# D93212) (Wyeth) in left deltoid, and a dose of FLUZONE (lot# U3260BA) (Sanofi Pasteur) in left deltoid. No adverse event reported. Additional information is not expected.
patient states he felt fine the day he received the vaccine, but at 0500 on 1/15/2021 he was woken out of his sleep having difficulty breathing. He estimates this episode lasted 30 seconds- 1 minute. he drank a sip of water thinking that would help. He then had a second more severe episode that lasted about 2 minutes. "I could not breathe, it felt like I was under water". H stated that after the episodes he felt jittery and very fatigued the rest of the day.  He stated that the second episode was the worst he had ever had and thought he was going to pass out. He is a nonsmoker with NKDA. He does have asthma. He is on an inhaler and has a rescue inhaler. He stated that his last episode was 3-4 months ago, but these episodes were different. " It was a bigger fight to breathe".  On 1/18/2021  at 2100  He had another episode that lasted 1-2 minutes. He used his inhaler, and improved. He was weak and dizzy after this episode and was unable to go to work.
I woke up the next day but it felt like my entire body was on fire. My skin was sensitive to touch. I was sweaty and I felt like I was going to have panic attack but I didn't but I had elevated heart rate and tunnel vision. I was confused as whether if it was a fibromyalgia or vaccine reaction. I called Pediatrics on 03/23/2021 and they told me to wait it out that it was most likely the vaccine but call them back if it didn't subside in 48hrs. Later that day I also felt like I was going to vomit but didn't. I was extremely fatigued. That was the extent of it. All the symptoms did subside later that evening on 03/23/2021