chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hep B titers showed no antibodies after a needle stick; 1st dose on 20Nov2001, 3rd on 01Jul2002; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 8-month-old female patient who received HBV (Engerix B 10 mcg) for prophylaxis.   Co-suspect products included HBV (Engerix B 10 mcg) for prophylaxis and HBV (Engerix B 10 mcg) for prophylaxis.   On 1st July 2002, the patient received the 3rd dose of Engerix B 10 mcg. On 20th December 2001, the patient received the 2nd dose of Engerix B 10 mcg. On 20th November 2001, the patient received the 1st dose of Engerix B 10 mcg. On 1st July 2002, unknown after receiving Engerix B 10 mcg, not applicable after receiving Engerix B 10 mcg and Engerix B 10 mcg and not applicable after receiving Engerix B 10 mcg and Engerix B 10 mcg, the patient experienced drug dose administration interval too long. In October 2022, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too long were unknown.   Additional Information: GSK receipt date: 17-Oct-2022 Reporter's comment: A pharmacist reported that patient completed an Engerix-B series years ago from reporting. The patient recently had a needle stick and went to Urgent Care last week from reporting (unsure of day) for blood work and her Hepatitis B titers showed no antibodies. The reporter consented to follow up. Additional supportive information: The patient received 3rd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule.
Initial case was received from health care professional on 07 January 2013. This case concerns 9-yr-old child whose medical history and concomitant medication was not reported received FLUZONE ID. The safety and immunogenicity of FLUOZONE Intradermal vaccine have not been established in persons <15 or 65 and over years of age. If FLUZONE Intradermal vaccine has been administered inadvertently to an individual whose age falls outside the product indication, consider re-immunizing the person with influenza vaccine appropriate for the persons age/underlying condition(s).
I had to wait 30 mins after vaccine due to allergic to Celebrex. After I left on the way home I started to feel weird left jaw felt numb. Upon me walking in to my home call the number provided. I was informed to come to ER might be having allergic reaction. In the ER took Vitals, check Ear was administered 2 Benadryl. I still was exp the swelling and numbness of my jaw. I have contacted my PCP was prescribed steriod pack last time taken 12/26.The hospital where I worked is following up with me to have CT scan of my jaw scheduled.
Pt devel a rash following vax w/Hep B vax; No further details were provided;
ADACEL was administered mistakenly to the patient, with no reported adverse event; ADACEL was administered mistakenly to the patient to 7 year old child, with no reported adverse event; Initial information was received on 22-Aug-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 7 years old male patient to whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administered mistakenly 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 hepatitis a vaccine, measles vaccine, mumps vaccine, rubella vaccine (MMR), polio vaccine (polio) and varicella zoster vaccine (varicella vaccine) for Prophylactic vaccination.  On 25-Jul-2023, the patient received a 0.5 ml , once (Dose 1) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: U7549AA, expiry date: 04-Nov-2024, strength: standard) via unknown route in the right thigh for Prophylactic vaccination (Immunisation) and was mistakenly administered Adacel, with no reported adverse event (wrong product administered) and (product administered to patient of inappropriate age) (Latency: same day).  It was reported " Physician said he's calling to confirm if it will not count for tetanus vaccine or is it counted as a tetanus dose? He also said that ADACEL was administered mistakenly to the patient, since they thought DTaP can't be given after 7 years of age. Physician said that the patient was supposed to get his DTaP but he never got his DTaP at age 5 so he received Tdap at 7 years old as the 5th dose in his DTaP series."  At time of reporting, the outcome was Unknown for the event.  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.
This spontaneous report as received from a medical assistant concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, concomitant medications or drug allergies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Lot # L004655, Expiry date : 11-FEB-2017, NDC# 0006-4827-00) (Strength, dose and route of administration were not reported) for prophylaxis (incorrect product storage). Other suspect therapies included sterile diluent(MERCK STERILE DILUENT) as prophylaxis. There was previous temperature excursions on 23-FEB-2016 to 24-FEB-2016, 27-FEB-2016 to 29-FEB-2016, 01-MAR-2016 to 04-MAR-2016, 08-MAR-2016 to 09-MAR-2016, 15-MAR-2016 to 20-MAR-2016, 23-MAR-2016 to 26-MAR-2016, 30-MAR-2016, 02-APR-201 to 04-APR-2016, 19-APR-2016 to 21-APR-2016 and 23-APR-2016 to 24-APR-2016 for 24 hours each. Data logger was involved. On 27-APR-2016,12-MAY-2016, 24-OCT-2016, 13-NOV-2016, 06-DEC-2016 and 04-APR-2017 there was temperature excursions of -0.12, -0.46, -0.14, -0.24, +9 and -20.18 to +14 degree Celsius for 1 hour 15 minutes, 1 hour, 30 minutes, 45 minutes, 1 hour and 3 hours 30 minutes respectively. There was no product quality complaint involved. No adverse effects were reported. This is 1 of 6 reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA007802:
soreness; little knot around the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness) and VACCINATION SITE LYMPHADENOPATHY (little knot around the site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness) and VACCINATION SITE LYMPHADENOPATHY (little knot around the site). At the time of the report, VACCINATION SITE PAIN (soreness) and VACCINATION SITE LYMPHADENOPATHY (little knot around the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment information was not provided.
Shortly after receiving the vaccine my left shoulder was aching. I didn't think much of it at the time as that was expected. However the next day I felt achy in my knees, hips, shoulders and hands. Kind of like the flu. Again not really concerned as this sometimes is a mild side affect. As the days wore on my joints started aching more and more. It does not feel like it is in the joint per say but the muscles and connective tissue (ligaments and tendons). I am concerned now as it has been almost 3 month and the pain has gotten to the point that it is often hard for me to walk or lift anything.
Information has been received from a physician concerning a 3 year old patient who on 07/01/1995 was vaccinated with a dose of varicella virus vaccine live.  On 01/02/1998 the patient experienced a case of breakthrough varicella.  There were less than 50 lesions.  Unspecified medical attention was sought, but there was no treatment and no hospitalization.  The patient recovered.  No product quality complaint was involved.  This is one patient out of 40 reported.  Thirty nine other cases experienced breakthrough varicella after vaccination with varicella virus vaccine live.  Additional information is not expected.
This spontaneous report as received from a 61 year old female patient with hypothyroidism and no drug reactions or allergies refers to herself. No information regarding the patient's medical history was provided. On an unknown date in approximately August 2015 (reported as "some time in August"), the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, (dose, injection site, lot number and expiration date were not reported). The patient's concomitant therapies included SYNTHROID. On approximately 18-DEC-2015 (date estimated based on "about 4 days ago"), the patient began to experience redness and irritation with blisters that she thought was sun poisoning. The patient sought medical attention via visiting a local clinic where the doctor confirmed it was actually a severe case of shingles. No laboratory diagnostic studies were performed. The patient was given acyclovir 800 mg and an unspecified corticosteroid cream for the treatment of the event. At the time of the report, the patient did not recover from the event. The relatedness between a severe case of shingles and ZOSTAVAX was not reported. Additional information is not expected as no contact details to healthcare professional were provided.
Information has been received from a health professional concerning a 22 year old female who on approximately 25-MAR-2008 was vaccinated intramuscularly with her first dose of GARDASIL vaccine (lot# not reported). On approximately 27-MAR-2008 the patient experienced pain in her shoulder and disabled range of motion in her arm. She was seen in the doctors office, but her outcome was not reported. Additional information has been requested. 02/18/2010 She does have problems with abduction and putting her hand behind her head. The patient received Ibuprofen and was told to follow up with personal care provider and the problem resolved on its own.  Additional information has been requested.
Prolonged crying, developed rash on chest/stomach, and stared blankly when he was not crying. I called the nurse line and they said he would be fine and did not need to go to the hospital. His legs were swollen, and it took him almost 2 weeks to recover. The symptoms began after a few hours of receiving the shots.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 69-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 11-Sep-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804091 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Number (SEQ18-04086) was updated in the additional information tab. No changes were made to the narrative.
Pt. reported after 2 hours her arm felt almost paralyzed and extremely painful, more than regular injection site RXN.
Felt warm, poor appetite, crying for 3hrs p/shots; requested to be seen by MD on call but declined;
This spontaneous report was received from a pharmacist regarding a 81 year old male patient. There was no information on pertinent medical history and drug reactions or allergies. On 05-SEP-2014, the patient was vaccinated with expired dose of PNEUMOVAX 23 dose 0.5 ml (millilitre), product lot # J004747, expiry date: 20-JUL-2014 intramuscularly. There was no information on concomitant therapy. Potency of dose supported. No adverse effects was experienced by patient. The patient did not seek any medical attention. There was no product quality complaint involved. The outcome was unknown. Additional information has been requested.
Pt has a history of vasovagal syncope and actually required transport to the hospital for a prolonged hypotensive episode after her first dose of Moderna last month. Shortly after vaccination, pt had a syncopal event. Initial BP was in the 60s systolic. HR 52, and SP0298%. After an extended observation period, she became more alert and BP was noted to be 90/60. Repeat HR was 62. Symptoms were mostly resolved when the pt elected to go home with a family member.
BODY PAIN; JOINTS IN HANDS AND BACK STARTED FEELING SWOLLEN; JOINTS OF HAND AND BACK STARTED FEELING LOSSE; 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 concurrent conditions included Hypermobile Ehlers Danlos Syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 08-APR-2021, the subject experienced body pain. On 08-APR-2021, the subject experienced joints in hands and back started feeling swollen. On 08-APR-2021, the subject experienced joints in hands and back started feeling very loose. Treatment medications included: magnesium chloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, and the outcome of joints in hands and back started feeling swollen and joints in hands and back started feeling very loose was not reported. This report was non-serious.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 28-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. The reporter stated that because their facility has not been able to download the digital data logger, they have been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the State was made.  There had been no power outages that would have impacted the Moderna vaccine. However, she reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion.  Reporter stated that no adverse reactions were reported by any patients. No treatment medication were provided.
No further AE.; patient given PNEUMOVAX23 expiration 8/18/2023; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 12-SEP-2023, the patient was vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, one time, lot #U035117, expiration date: 18-AUG-2023, administered for prophylaxis (anatomical location, and route of administration were not provided) (expired product administered). There were no adverse events reported (no adverse event).
heart palpitations; severe vertigo; Headaches; nauseous; dizzy; did not have fever but was a bit more elevated than usual; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations), BODY TEMPERATURE INCREASED (did not have fever but was a bit more elevated than usual), VERTIGO (severe vertigo), DIZZINESS (dizzy) and HEADACHE (Headaches) in a 68-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 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced BODY TEMPERATURE INCREASED (did not have fever but was a bit more elevated than usual). On 19-Feb-2021, the patient experienced DIZZINESS (dizzy) and NAUSEA (nauseous). On an unknown date, the patient experienced PALPITATIONS (heart palpitations), VERTIGO (severe vertigo) and HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 18-Feb-2021, BODY TEMPERATURE INCREASED (did not have fever but was a bit more elevated than usual) had resolved. At the time of the report, PALPITATIONS (heart palpitations), VERTIGO (severe vertigo), DIZZINESS (dizzy), HEADACHE (Headaches) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: 12 blood counts (Low) a drop in 12 blood counts.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant FU added as reporter email response : new event updated and event outcome for Body temperature elevated and lab data information also updated.
Day after vaccination infant had a generalized tonic-clonic seizure.  Recovered spontaneously and completely. Had another generalized seizure 4/12/08 and admitted for further evaluation. CT, LP, chemistries normal. Evaluation proceeds; is still hosptialized.  4/22/2008 ER record received for DOS 3/28/2008 with DX: Seizure, presenting to ER post-ictal.  Infant found in crib staring with arms and legs shaking.  Unresponsive to parent.  Shaking continued 5-10 minutes.  PE WNL except T=100.1'F.  5/12/2008 MR received for DOS 4/13-15/2008 with Final DX: Seizure. Infant presented to ER with 2nd generalized seizure in 3 weeks. Admitted for w/u.  PE (+) for somnolence alternating with irritability, otherwise WNL. Pt had no subsequent seizures and remained afebrile. Follow-up: Continues to have a seizure disorder. Neurodevelopmental status, otherwise, appears to be normal.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic pain" (unspecified if ongoing); "depression" (unspecified if ongoing); "endometriosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2022) positive, notes: Rebound- developed COVID-19 symptoms again and tested positive today (05Aug); only took paxlovid for 2 days due to severe vomiting. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The employee had COVID test on 12/28 that as positive and was asymptomatic. Subsequent COVID testing on 12/29 and 12/31 were negative. He was tested as part of routing surveillance
SHARP PAIN IN BACK; ARM PIT HURT; NO ENERGY TOO; HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, once a total administered, start therapy date not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced headaches, back pain, arm pit hurt, and no energy. The action taken with covid-19 vaccine was not applicable. The outcome of the headaches, back pain, arm pit hurt and no energy was not reported. This report was non-serious.