chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 29-Jul-2021 from a Other health care professional via Medical Information (MI) (Reference number- 00702929) and transmitted to Sanofi on 29-Jul-2021.  This case involves a patient (unknown gender) reported that patient administered expired HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  It was reported that, "The medical assistant declined to provide her e-mail address. She states that she is calling from a doctor's office because she administered Act-Hib that expired two days ago. When she was asked to provide additional AE information she declined and said not at this time. This is all the information she provided at the time of her call".  At the time of reporting, patient had no adverse event.  There will be no information available on the batch number for this case.  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 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.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of IPOL, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Agency (Reference number-00704258) and transmitted to Sanofi on 30-Jul-2021.  This case involves patient of unknown demographics who received an expired dose of IPV (VERO) [IPOL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Information on concomitant medications was not reported.  On an unknown date, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot number: P1F541M; expiry date: 12-Jul-2020) via unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to expired vaccine used (latency: same day).  It was reported, "caller stated a patient received an expired IPOL vaccine and wanted to know what to do from here. The caller reported that this vaccine was from the state supplied vaccines that he does not monitor at this time and that patient Information, complete event Information, and Administering physician are unknown to the caller."  No adverse events were reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: we do not have the lot numbers for her vaccinations available.  She was advised to e-mail a copy of her COVID vaccination card to primary care provider's office.   she developed a runny nose on 8/3/2021 and tested positive for COVID that same day
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Computerised tomogram thorax abnormal, Dyspnoea, Echocardiogram abnormal
Clinical narrative: Shortness of breath, bilateral leg swelling, chest pain, fever 103, saturation?s in low 80s lead be to the ER and ultimately admission into the hospital. Elevated WBC, d-dimer, LFTs, CT showed bilateral lung infiltrates, ECHO showed dilated right atrium and pulmonary hypertension
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Liver function test, Lung infiltration, Oxygen saturation decreased, Peripheral swelling
Clinical narrative: Shortness of breath, bilateral leg swelling, chest pain, fever 103, saturation?s in low 80s lead be to the ER and ultimately admission into the hospital. Elevated WBC, d-dimer, LFTs, CT showed bilateral lung infiltrates, ECHO showed dilated right atrium and pulmonary hypertension
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary hypertension, Pyrexia, Right atrial dilatation, White blood cell count increased
Clinical narrative: Shortness of breath, bilateral leg swelling, chest pain, fever 103, saturation?s in low 80s lead be to the ER and ultimately admission into the hospital. Elevated WBC, d-dimer, LFTs, CT showed bilateral lung infiltrates, ECHO showed dilated right atrium and pulmonary hypertension
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Arthralgia, Back pain, Blood test normal, Cardiac stress test normal
Clinical narrative: Pericarditis - resulting in symptoms: dry cough, muscle weakness, extreme fatigue, shortness of breath, pain (chest, back, shoulder), joint aches, tingling arms/hands, restless legs, confusion/lack of concentration, dizziness, nausea, anxiety, low heart rate (36 - 70 bpm).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Confusional state, Cough, Disturbance in attention, Dizziness
Clinical narrative: Pericarditis - resulting in symptoms: dry cough, muscle weakness, extreme fatigue, shortness of breath, pain (chest, back, shoulder), joint aches, tingling arms/hands, restless legs, confusion/lack of concentration, dizziness, nausea, anxiety, low heart rate (36 - 70 bpm).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram abnormal, Fatigue, Fluid overload, Heart rate decreased
Clinical narrative: Pericarditis - resulting in symptoms: dry cough, muscle weakness, extreme fatigue, shortness of breath, pain (chest, back, shoulder), joint aches, tingling arms/hands, restless legs, confusion/lack of concentration, dizziness, nausea, anxiety, low heart rate (36 - 70 bpm).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Muscular weakness, Nausea, Paraesthesia, Pericarditis
Clinical narrative: Pericarditis - resulting in symptoms: dry cough, muscle weakness, extreme fatigue, shortness of breath, pain (chest, back, shoulder), joint aches, tingling arms/hands, restless legs, confusion/lack of concentration, dizziness, nausea, anxiety, low heart rate (36 - 70 bpm).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Restless legs syndrome
Clinical narrative: Pericarditis - resulting in symptoms: dry cough, muscle weakness, extreme fatigue, shortness of breath, pain (chest, back, shoulder), joint aches, tingling arms/hands, restless legs, confusion/lack of concentration, dizziness, nausea, anxiety, low heart rate (36 - 70 bpm).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: Body aches, headache, cold chills, fatigue, upset stomach
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches, headache, cold chills, fatigue, upset stomach
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Minor chest pain. I normally walk 4 to 5 miles per day. I have never had chest pain, but I did yesterday. It feels like it's at the top of my heart.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Have shooting sharp pains in arm and leg both left. Happens intermittently since I got 1st shot
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received improperly stored vaccine/ Temperature excursion 48.4F; No further information  is available; This spontaneous report was received from a physician concerning an unspecified age and gender patient. The patient's pertinent medical history, concomitant medications, drug reactions, or allergies were not reported.  On 28-JUN-2021, the patient was vaccinated with one improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe as prophylaxis (lot number T035379, expiration date 31-MAY-2022, which were determined to be valid) (route and anatomical location of administration were not reported).   The involved vaccine was exposed to a temperature excursion of 48.4 grades Fahrenheit (F) for 25 hours and 29 minutes, as recorded by a data logger (product storage error) (unspecified date). There was not a previous temperature excursion. No further information was available (no adverse event). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella, Varicella virus test positive
Clinical narrative: CHICKENPOX lesions (>25) on the extremities, trunk, feet and groin/ Tested positive for varicella zoster using the PCR test; This spontaneous report was received from a lab manager concerning a 2-year-old female patient.   The patient had a healthy past medical history however it was reported that she was allergic to spinach. Information regarding the patient's historical drug was not provided. Concomitant therapies included daily vitamins with fluoride.  On 27-JUN-2021, the patient was exposed to shingles because of her grandmother for an unknown timeframe.  On 28-JUN-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters on the left arm, lot number T035398 expiration date 16-OCT-2022 (route of administration was not provided) as prophylaxis.  On 08-JUL-2021, the patient presented chickenpox lesions (>25) on the extremities, trunk, feet and groin; the patient tested positive for varicella zoster via Polymerase chain reaction (PCR) test.   The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine strain. On 12-JUL-2021, a sample was obtained from a skin lesion (papule). It was unknown if the patient was on antiviral therapy; results from the PCR test were still pending.  At the time of the report the rash was still present. The causal relationship between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the chickenpox was not reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported at this time; HCP called in to report a temperature excursion. Caller reported MMR II had been administered to two patients; This spontaneous report was received from an office manager/physician and refers to a 12-month-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 19-JUL-2021, the patient was vaccinated with improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dosage regimen was not reported), lot # T001211 rHA and expiration date 12-JAN-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion above 46 degree fahrenheit (°F) (47.5) for 6 minutes on an unknown date; previous temperature excursions were the following: 46.8°F for 3 minutes and 47.8 for 5 minutes.  No adverse symptoms were reported.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-2107USA007018:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX was administered after undergoing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 15-JUL-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported), lot # T035400 and expiration date 16-OCT-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 0.4 degree celsius (°C) for 13 hours and 10 minutes on an unspecified date); no previous temperature excursions were reported.   The call was made due to a digital data logger.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2107USA006957: US-009507513-2107USA006887: US-009507513-2107USA007004: US-009507513-2107USA007007: US-009507513-2107USA007009:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX was administered after undergoing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 19-JUL-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported), lot # T028310 and expiration date 20-AUG-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 0.4 degree celsius (°C) for 13 hours and 10 minutes on an unspecified date); no previous temperature excursions were reported.   The call was made due to a digital data logger.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2107USA006887: US-009507513-2107USA006957: US-009507513-2107USA007000: US-009507513-2107USA007007: US-009507513-2107USA007007:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX was administered after undergoing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 19-JUL-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported), lot # T035400 and expiration date 16-OCT-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 0.4 degree celsius (°C) for 13 hours and 10 minutes on an unspecified date; no previous temperature excursions were reported.   The call was made due to a digital data logger.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2107USA006887: US-009507513-2107USA006957: US-009507513-2107USA007000: US-009507513-2107USA007004: US-009507513-2107USA007009:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX was administered after undergoing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 15-JUL-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported), lot # T028310 and expiration date 20-AUG-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 0.4 degree celsius (°C) for 13 hours and 10 minutes on an unspecified date; no previous temperature excursions were reported.   The call was made due to a digital data logger.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2107USA006957: US-009507513-2107USA006887: US-009507513-2107USA007000: US-009507513-2107USA007004: US-009507513-2107USA007007:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In or about November 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) as prescribed and/or administered by a healthcare provider at the physician's office for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I have the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient had a shingle shot some years ago and thought he or she was protected. The patient had shingles. The patient further stated that better get the updated shot. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot...still got shingles/Suspected Vaccination failure; got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient got the shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. This case has been linked with the case US2021AMR138261, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR138261:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: suspected vaccination failure; received both shots / had 2 severe attacks since injections / Shingles pain is DEEP; pain / Shingles pain is DEEP / nothing they did stopped the pain; shingles pain is deep with topical rash; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and rash. The patient was treated with antiinflammatory/antirheumatic products (Anti Inflammatory Drug (Nos)) and opioids {nos} (Opioid). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received both the Shingles shots and they did not work and had 2 severe attacks of shingles since injections. The patient also had shingles pain which was deep with topical rash. The pain was excruciating, and the patient was given anti-inflammatory drugs, which did not help. Even opioid pain drugs had no effects. The patient found no drug or treatment that reduced the pain. The patient went to emergency outpatient clinic both times and nothing they did could stop the pain. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot and got shingles twice/Suspected vaccination failure; Got shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Rechallenge with Shingles vaccine was negative. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had shingles shot and got shingles twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Product storage error
Clinical narrative: after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 9-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number mk944, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th July 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.    his 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: The physician reported that, the patient was administrated with Pediarix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 29 linked cases,reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164800:
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Product storage error
Clinical narrative: after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa-HBV-IPV (Pediarix) (batch number mk944, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th July 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that, the patient was administrated with Pediarix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 29 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164786: US-GLAXOSMITHKLINE-US2021164787: US-GLAXOSMITHKLINE-US2021164789: US-GLAXOSMITHKLINE-US2021164791: US-GLAXOSMITHKLINE-US2021164792: US-GLAXOSMITHKLINE-US2021164793: US-GLAXOSMITHKLINE-US2021164794: US-GLAXOSMITHKLINE-US2021164795: US-GLAXOSMITHKLINE-US2021164797: US-GLAXOSMITHKLINE-US2021164798: US-GLAXOSMITHKLINE-US2021164799: US-GLAXOSMITHKLINE-US2021164800: US-GLAXOSMITHKLINE-US2021164801: US-GLAXOSMITHKLINE-US2021164802: US-GLAXOSMITHKLINE-US2021164803: US-GLAXOSMITHKLINE-US2021164804: US-GLAXOSMITHKLINE-US2021164805: US-GLAXOSMITHKLINE-US2021164806: US-GLAXOSMITHKLINE-US2021164808: US-GLAXOSMITHKLINE-US2021164801: US-GLAXOSMITHKLINE-US2021164802:
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Product storage error
Clinical narrative: after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number mk944, expiry date 3rd May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th July 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The physician reported that, the patient was administrated with Pediarix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 29 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164795:Same reporter. US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164799:Same reporter. US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164797:Same reporter. US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Product storage error
Clinical narrative: administrated with Pediarix after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 9x3t5, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th July 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The physician reported that, the patient was administrated with Pediarix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 29 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164784: US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Product storage error
Clinical narrative: administrated with Pediarix after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 9x3t5, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th July 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The physician reported that, the patient was administrated with Pediarix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 29 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter
Age: 0.92
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: below freezing temperature excursion; administrated with Havrix/ 11 month old patient; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old female patient who received HAV (Havrix) (batch number yl532, expiry date 9th September 2022) for prophylaxis.   On 2nd July 2021, the patient received Havrix. On 2nd July 2021, unknown after receiving Havrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the inappropriate age at vaccine administration and incorrect storage of drug were unknown.  Additional details were provided as follows: The physician reported that a 11 months patient was administrated with Havrix after a below freezing temperature excursion, which led to inappropriate age at vaccine administration and incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case is one of 28 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164779: US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164784:
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Product storage error
Clinical narrative: administrated with Bexsero after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 21st March 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th July 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were provided as follows: Physician reported that the patient was administrated with Bexsero after a below freezing temperature excursion which led to incorrect storage of drug.  No adverse event was reported. The reporter consented to follow up. This case was 1 of 28 case reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: administrated with Bexsero after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number abxb35aa, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th July 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The physician reported that the patient was administrated with Bexsero after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 28 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter