chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reporting having administered a dose of ActHIB and then realizing the diluent portion was expired/ no AE; Initial information received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from the nurse.  This case involves a 47 year old female patient who was vaccinated with an 0.5 mL dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number of Act-HIB: UI955AA and expiry date: 08Jun2020 and of box: U6111AA and expiry date: 24Jan2020, frequency once) via an intramuscular route in the left deltoid for prophylactic vaccination on 06-Feb-2020. The diluent was expired (expired product administered).  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  It is a case of actual medication error due to expired product administered. It was reported that the patient was administered a dose of Act-HIB and then realizing the diluent portion was expired due to the diluent having a different expiration and their vaccines are input by a state run program that has placed the expiration date of the Act-HIB portion in the system and not the diluent.  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 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.
throbbing in right ear; He was due for his second dose today on11-MAY-2021 but rescheduled it for next week; tinnitus increased / throbbing in his right ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus increased / throbbing in his right ear), EAR PAIN (throbbing in right ear) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He was due for his second dose today on11-MAY-2021 but rescheduled it for next week) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included Tinnitus.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced TINNITUS (tinnitus increased / throbbing in his right ear). On an unknown date, the patient experienced EAR PAIN (throbbing in right ear) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He was due for his second dose today on11-MAY-2021 but rescheduled it for next week). At the time of the report, TINNITUS (tinnitus increased / throbbing in his right ear) had not resolved, EAR PAIN (throbbing in right ear) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He was due for his second dose today on11-MAY-2021 but rescheduled it for next week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was worried about getting the second shot because the ringing was difficult to manage.The patient had consulted with his doctor who told him there was no treatment for tinnitus. No concomitant medications were reported. No treatment provided.
he only got some pain on his arm where he got the injection; he only got some pain on his arm where he got the injection and it was a little red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old male patient received bnt162b2 (COMIRNATY), administration date 01May2021 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "smoker" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset May2021, outcome "recovered" (May2021), described as "he only got some pain on his arm where he got the injection"; VACCINATION SITE ERYTHEMA (non-serious) with onset May2021, outcome "recovered" (May2021), described as "he only got some pain on his arm where he got the injection and it was a little red". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
soreness around injection site later in the evening; fingers were a little stiff for about an hour after vaccination; Tingling sensation passed through arm down to fingers within 15 minutes of dosing; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm at the age of 51-year-old on 07Apr2021 13:00 (Batch/Lot Number: ER8734) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history included hypertension, asthma, dust allergy, mold allergy, pollens allergy, Environmental allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant. Concomitant medications included lisinopril; salbutamol (ALBUTEROL HFA); budesonide, formoterol fumarate (SYMBICORT); fexofenadine hydrochloride (ALLEGRA); ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS); fish oil. Tingling sensation passed through arm down to fingers within 15 minutes of dosing on 07Apr2021 13:15; fingers were a little stiff for about an hour after vaccination on 07Apr2021 14:00; soreness around injection site later in the evening (7 pm) on 07Apr2021 19:00; mostly resolved by next morning. Therapeutic measures were taken as a result of events (Took Excedrin night of vaccination prior to sleeping). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was reported as recovering.   No follow up attempts are needed. No further information is expected.
Right after the vaccine: sore arm, fatigue and a fever and nausea (and they lasted a day or so) and I experienced loss of sensitive in my right leg; I could feel pressure but I could not feel pain. Started at my toes and went to my hips. It lasted about two weeks. It resolved with the toes first and then worked its way up to the hips. After that, I started experiencing new mixed up signal sensations in my torso: burning or wetness in leg (when it's not there). I had an MRI a couple of weeks ago. It showed I developed two lesions in my cervical spine. My doctor thought that my meds that I had been on for 7 years didn't help with what the vaccine produced it. Treatment: 5 days of IV solumedrol followed by Medrol Dospak taper and I'm going to be switching medications from Tecfadera to another one.  Most of my symptoms have gone away but the warm and burning sensation in my torso has returned but is much less than before.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 14-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (strength, dose and frequency were not reported) lot # L007224, expiration date 03-MAR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pink ring the size of a nickle; Rash at the injection site that extends to the elbow; Bump at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Pink ring the size of a nickle), VACCINATION SITE INDURATION (Bump at the site of the injection) and VACCINATION SITE RASH (Rash at the injection site that extends to the elbow) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023N20A and 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE and HYDROCORTISONE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE INDURATION (Bump at the site of the injection). On 24-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Pink ring the size of a nickle) and VACCINATION SITE RASH (Rash at the injection site that extends to the elbow). At the time of the report, RASH ERYTHEMATOUS (Pink ring the size of a nickle), VACCINATION SITE INDURATION (Bump at the site of the injection) and VACCINATION SITE RASH (Rash at the injection site that extends to the elbow) outcome was unknown.            No treatment information was specified   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: ollow-up information received)   contains non-significant information
No adverse effect.  However, the child was supposed to receive Prevnar and was given Pneumovax instead.  I was advised to report.
PATIENT HAD INJECTION ADMINISTERED. APPROXIMATELY 2 MINUTES AFTER INJECTION PATIENT BECAME UNRESPONSIVE, SQUATTING JUST ABOVE THE CHAIR HE HAD BEEN SITTING IN AND UNABLE TO RESPOND TO VOICE COMMAND. ATTEMPTED TO ADDRESS PATIENT 3 TIMES TO NO RESPONSE. PATIENTS SHOULDER WAS GENTLY TOUCHED AND THE PATIENT RESPONDED, SAT DOWN IN THE CHAIR AND COMPLAINED THAT HIS HEAD WAS "GOING A MILLION MILES AN HOUR" AND "COULDN'T THINK STRAIGHT". PATIENT THEN COMPLAINED OF A NEED OF THIRST, COLD WATER WAS GIVEN TO THE PATIENT WHO DRANK MINIMAL SIPS BEFORE COMPLAINING OF INABILITY TO AMBULATE WITHOUT EXTREME FATIGUE. AT THIS TIME PATIENT'S FACE BEGAN TO LOSE COLOR AS DID HIS EXTREMETIES AS WELL AS VISIBLE PERSPERATION, PATIENT WAS AT THIS TIME ABLE TO COMMUNICATE AND RESPOND TO QUESTIONS. PATIENT SLOWLY BEGAN TO RECOVER ABILITIES OVER THE COURSE OF 15-20 MINUTES POST INJECTION. PARAMEDICS WERE CALLED APPROXIMATELY 5 MINUTES POST INJECTION AND EVALUATED PATIENT UPON ARRIVAL APPROXIMATELY 30 MINUTES AFTER INJECTION. PATIENT DECLINED TO GO TO THE ED WITH PARAMEDICS AND OPTED TO BE DRIVEN THERE BY FAMILY.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX, lot#:0610AE, dose route and frequency unknown. On 04-JUN-2013, the patient was vaccinated with improperly stored Oka/Merck) VARIVAX lot # 0610AE, dose 2. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
This study case was received from the investigator in the trial on 05 July 2013. An 21 year-old male subject whose past medical history included chest pain and headaches was found to have encephalitis following immunization procedures 10 days after the subject had received the following vaccines on 09 June 2009: an injection of ACAM2000, (lot number, route and site of administration not reported), TYPHIM Vi (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Hep A - Adult 1 (manufacturer, lot number, route and site of administration not reported). A Troponin I, ECG, Echocardiogram, Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
7/5/05 Received message from parent, patient experiencing abdominal cramping. Taken dose 1 and 2. Parent stopping 3 and 4. Started morning after dose 1.
when I woke up the next day my skin was itching and I had red hives on my arks legs and scalp. it still persist, doctor appointment scheduled to seek treatment.
Noticed red rash (2"x3") at the injection site after shower. Does not itch, but seems to have a flat lump underneath the skin. No treatment. Have not reported to my doctor.
Patient is 12 years old.   For her 2nd dose - she was administered the wrong drug = given the Pfizer PEDS COVID vaccine (0.2 mL) instead of the correct Adolescent/Adult COVID vaccine product (should have been 0.3 mL of this product).  Wrong drug product.  Wrong dose.
I developed high blood pressure 8-10 days after taking the first vaccine. I had never had high blood pressure before. Thy put me on Metoprolol Succinate on Feb 9, 2021 and am still taking it.
Patient felt very bad; Patient felt very achy; Patient experienced fever of 101°F/Patient experienced fever of up to 105°F during the nights; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Patient felt very bad), MYALGIA (Patient felt very achy) and PYREXIA (Patient experienced fever of 101°F/Patient experienced fever of up to 105°F during the nights) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Patient stated got 2 first shots of Pfizer vaccine (did not remember dates of vaccination).) in 2021 and Pfizer vaccine (Patient stated got 2 first shots of Pfizer vaccine (did not remember dates of vaccination).) in 2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 26-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced FEELING ABNORMAL (Patient felt very bad), MYALGIA (Patient felt very achy) and PYREXIA (Patient experienced fever of 101°F/Patient experienced fever of up to 105°F during the nights). The patient was treated with SECUKINUMAB (COSENTYX) ongoing since an unknown date for Arthritis, at an unspecified dose and frequency; IRBESARTAN ongoing since an unknown date for Blood pressure, at an unspecified dose and frequency; ROSUVASTATIN ongoing since an unknown date for Blood cholesterol abnormal, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 28-Jan-2022, FEELING ABNORMAL (Patient felt very bad), MYALGIA (Patient felt very achy) and PYREXIA (Patient experienced fever of 101°F/Patient experienced fever of up to 105°F during the nights) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: 105°f (High) Fever.         On 27-Jan-2022 patient felt very bad, very achy, and experienced fever of 101°F. For almost one week caller felt fine throughout the day, but experienced fever of up to 105°F during the nights. Patient took Tylenol and symptoms finally gone away. Patient was under treatment with Cosentyx injections for arthritis, Irbesartan for blood pressure, and Rosuvastatin for cholesterol. No concomitant medication reported.
Tiredness; Headache; Nauseated; Dizziness; Doesn't feel well; Feels like it is warm in here; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 09:15 (Lot number: EP7534, Expiration Date: Jul2021) at the age of 57 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 31Mar2021 01:30, outcome "recovering", described as "Tiredness"; HEADACHE (non-serious) with onset 31Mar2021 01:30, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 31Mar2021 01:30, outcome "recovering", described as "Nauseated"; DIZZINESS (non-serious) with onset 31Mar2021 01:30, outcome "recovering", described as "Dizziness"; MALAISE (non-serious) with onset 31Mar2021 01:30, outcome "not recovered", described as "Doesn't feel well"; FEELING HOT (non-serious) with onset 31Mar2021 01:30, outcome "not recovered", described as "Feels like it is warm in here". Therapeutic measures were not taken as a result of fatigue, headache, nausea, dizziness, malaise, feeling hot.  Additional information: The events did not result to ER or Physician office visit. The patient had not received any other vaccines within 4 weeks prior vaccination.  No follow-up attempts are possible. No further information is expected.
Maternal exposure during pregnancy; Maternal exposure during pregnancy; Maternal exposure during pregnancy; Muscle and joint aches in legs; Muscle and joint aches in legs; Shivering; fatigue; This is a spontaneous report from a contactable nurse.  A 30-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:ek9231), intramuscular on 15Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included colitis ulcerative and hypersensitivity to sulfa drugs, tomato, nuts from an unknown date and unknown if ongoing.  Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), diphenhydramine hydrochloride (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]), colecalciferol (VITAMIN D [COLECALCIFEROL]). On 15Jan2021 22:00, the muscle and joint aches in legs, shivering and fatigue. The patient was 35 Weeks pregnant at the onset of the event. The patient was due to deliver on 26Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021 covid test result of Negative. The outcome of the eventsmuscle and joint aches in legs, shivering and fatigue was recovering.
I first noticed that I had an irritated feeling in my nose. I had been having a sensation in my nose for a few weeks before. About four days later I got a Petechia rash on my lower calf It was about 5 inches big. Later that day my husband started coughing. We were on vacation with a group staying in the same house. People started to having symptoms all of a sudden, and everyone had been vaccinated. We isolated away from those showing symptoms. I got a sore throat, headache and coughing. I got a blister rash on the corner of my mouth. I then got a fever and a very bad headache. My fever was 102 which was very high for me. I had dizziness, sweating and chills as well as loss of appetite. I experienced Brain fog and lost my sense of taste and smell about a week after the onset. The loss of taste and smell lasted for about 5 days. When it returned it seemed like smells were unpleasant for two days. My sense of taste returned after that but now even seven weeks later I still have times when I can't taste anything salty. About five days after onset on 08/17/2021 I had Tachycardia and I was out of breath. The coughing was constant. My Oxygen was low and I was hospitalized on 08/21/2021 and I got Monoclonal Antibodies on 09/23/2021. The day after I got the Regeneron antibodies I started to feel better and two days later my brain started to feel less foggy. It has been seven weeks and I still having a little trouble with brain fog, forgetful and disorganized.
She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had body aches. Swelling in arm pits. Tightness in right chest and back. She did a lot of driving and arm went numb, but gone now she is home. Swelling in arm still there.
INFANRIX administered to a pregnant patient; INFANRIX administered to a pregnant patientadministration; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included iron and minerals nos + vitamins nos (Prenatal Vitamins).   On 15th March 2022, the patient received Infanrix (intramuscular) and Infanrix Pre-Filled Syringe Device. The patient's last menstrual period was on 3rd September 2021 and estimated date of delivery was 10th June 2022. The patient received Infanrix at week 27 of the pregnancy. On 15th March 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown. The pregnancy was ongoing.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Nurse called to report that Infanrix vaccine was administered to a pregnant patient in her right arm, by mistake which led to vaccine exposure during pregnancy and inappropriate age at vaccine administration. The reporter would like to know if there were any contraindications and what she should do.  They representative spoke from content and package insert (PI). The warm transferred call to medical information and provided telephone number for future reference.
It was reported that a female pt received a Fluzone SV 2000-2001 vaccination on 10/23/2000. Reportedly that same day the pt experienced hives and itching which were treated with antihistamines. The experience is resolving. Further information is being requested. From additional correspondence received on 02/02/2001, it was reported that the pt recovered from this experience. Additional vaccine pt and reporter information was also provided.
This patient is 16.5 years old, and under the guidance of the physician the Moderna vaccination was administered.  The patient had no adverse effects from the vaccine.
Pt. C/O feeling dizzy and light headed, was taken to cot area to lie down, had vital signs assessed and seemed reassured when all were normal. Pt.'s complaints resolved without treatment other than reassurance
Became lethargic, GERD, and developed jaundice. Jaundice lasted total of twelve weeks. Exculsively breast fed. Is now Five months of age and still has episodes of GERD.
Received vaccination on 11/8/07 at 1:30pm and felt symptoms on 11/9/07 at 8:30pm.  Had stomach ache, which led to vomiting off and on for 6 hours.  Had diarrhea for 24 hours and a fever 2 degrees above normal.  Only lasted for 24 hours.  Drank pedialite & water, took advil, and had light foods.  Recovered quickly from most symptoms - still had slight fever second day.
Within 24 hours of vaccine administration , PT's DTaP site became very red and painful-Swelling increased to max size of approximately 8 X 5 cm. Indurated- Resolved over 3 days to less red but induration persisted.