chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: did not work- Covid vaccines; did not work- Covid vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EN9581), on 02Mar2021 as dose 2, single (Lot number: EN6206), on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 19Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 69 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN, stop date: 24Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jul2022, outcome "not recovered" and all described as "did not work- Covid vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Positive, notes: she tested positive on Sunday 24Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Caller stated she had Covid, stated she was miserable, got two booster vaccine did not work. She tested positive on Sunday 24Jul2022, the same day she started taking Paxlovid. Caller stated she took a ton of medication, told her to stop taking the statin so she did, she was taking rosuvastatin, stopped taking it on Sunday night 24Jul2022. She was instructed too but she knew she needed to because she saw that another patient (withheld) was taking a statin and was prescribed Paxlovid and had to pause his statin medication.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chest discomfort, Dizziness, Headache
Clinical narrative: Headache all day everyday since vaccinated; abdominal pain for nine days following vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 12Jul2022 at 16:30 as dose 1, single (Lot number: FN2908) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Stage II Rectal Cancer 2007", start date: 2007 (unspecified if ongoing), notes: Stage II Rectal Cancer 2007; "Stage IV Rectal Cancer" (unspecified if ongoing), notes: Stage IV Rectal Cancer; "Metastasized to the Liver 2011", start date: 2011 (unspecified if ongoing), notes: Metastasized to the Liver 2011; "If COVID prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 12Jul2022 at 16:45, outcome "not recovered", described as "Headache all day everyday since vaccinated"; ABDOMINAL PAIN (non-serious) with onset 12Jul2022 at 16:45, outcome "not recovered", described as "abdominal pain for nine days following vaccination". Therapeutic measures were not taken as a result of headache, abdominal pain.  Additional information: The patient did not receive any other medications in two weeks. The patient did not receive other vaccine in four weeks. The patient had no known allergies. The patient has not been tested for COVID-19 post vaccination. Device timestamp: 25Jul2022. The reporter assessed the case as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. AE resulted in none of the above.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Headache
Clinical narrative: Headache all day everyday since vaccinated; abdominal pain for nine days following vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 12Jul2022 at 16:30 as dose 1, single (Lot number: FN2908) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Stage II Rectal Cancer 2007", start date: 2007 (unspecified if ongoing), notes: Stage II Rectal Cancer 2007; "Stage IV Rectal Cancer" (unspecified if ongoing), notes: Stage IV Rectal Cancer; "Metastasized to the Liver 2011", start date: 2011 (unspecified if ongoing), notes: Metastasized to the Liver 2011; "If COVID prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 12Jul2022 at 16:45, outcome "not recovered", described as "Headache all day everyday since vaccinated"; ABDOMINAL PAIN (non-serious) with onset 12Jul2022 at 16:45, outcome "not recovered", described as "abdominal pain for nine days following vaccination". Therapeutic measures were not taken as a result of headache, abdominal pain.  Additional information: The patient did not receive any other medications in two weeks. The patient did not receive other vaccine in four weeks. The patient had no known allergies. The patient has not been tested for COVID-19 post vaccination. Device timestamp: 25Jul2022. The reporter assessed the case as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. AE resulted in none of the above.
Age: 11.0
Sex: M
Vaccine: COVID19, MMR, COVID19, MMR
Symptoms: Product preparation error
Clinical narrative: she did not dilute the Pfizer COVID-19 vaccine orange cap when she gave the vaccine to the patient; she did not dilute the Pfizer COVID-19 vaccine orange cap when she gave the vaccine to the patient; only side effect was that he was very sleepy that day, otherwise the was fine; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  An 11-year-old male patient received BNT162b2 (BNT162B2), on 06Jul2022 as dose 1 (orange cap), single (Batch/Lot number: unknown) at the age of 11 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious) with onset 06Jul2022, outcome "unknown", described as "only side effect was that he was very sleepy that day, otherwise the child was fine"; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 06Jul2022, outcome "unknown" and all described as "she did not dilute the Pfizer COVID-19 vaccine orange cap when she gave the vaccine to the patient".  Additional Information: Patient went to get the second dose of the Pfizer COVID-19 vaccine orange cap. Patient got the undiluted dose before.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 11.0
Sex: M
Vaccine: COVID19, MMR, COVID19, MMR
Symptoms: Overdose, Product preparation error, Somnolence
Clinical narrative: she did not dilute the Pfizer COVID-19 vaccine orange cap when she gave the vaccine to the patient; she did not dilute the Pfizer COVID-19 vaccine orange cap when she gave the vaccine to the patient; only side effect was that he was very sleepy that day, otherwise the was fine; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  An 11-year-old male patient received BNT162b2 (BNT162B2), on 06Jul2022 as dose 1 (orange cap), single (Batch/Lot number: unknown) at the age of 11 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious) with onset 06Jul2022, outcome "unknown", described as "only side effect was that he was very sleepy that day, otherwise the child was fine"; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 06Jul2022, outcome "unknown" and all described as "she did not dilute the Pfizer COVID-19 vaccine orange cap when she gave the vaccine to the patient".  Additional Information: Patient went to get the second dose of the Pfizer COVID-19 vaccine orange cap. Patient got the undiluted dose before.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 11.0
Sex: M
Vaccine: COVID19, MMR, COVID19, MMR
Symptoms: Unevaluable event
Clinical narrative: she did not dilute the Pfizer COVID-19 vaccine orange cap when she gave the vaccine to the patient; she did not dilute the Pfizer COVID-19 vaccine orange cap when she gave the vaccine to the patient; only side effect was that he was very sleepy that day, otherwise the was fine; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  An 11-year-old male patient received BNT162b2 (BNT162B2), on 06Jul2022 as dose 1 (orange cap), single (Batch/Lot number: unknown) at the age of 11 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious) with onset 06Jul2022, outcome "unknown", described as "only side effect was that he was very sleepy that day, otherwise the child was fine"; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 06Jul2022, outcome "unknown" and all described as "she did not dilute the Pfizer COVID-19 vaccine orange cap when she gave the vaccine to the patient".  Additional Information: Patient went to get the second dose of the Pfizer COVID-19 vaccine orange cap. Patient got the undiluted dose before.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Fatigue, Pain in extremity, SARS-CoV-2 test, Thirst
Clinical narrative: I randomly tested myself for covid after 5 days of the increased loudness of tinnitus and was positive; I randomly tested myself for covid after 5 days of the increased loudness of tinnitus and was positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 03Mar2021 at 07:30 as dose 1, single (Lot number: EN6205), in left deltoid and on 26Mar2021 as dose 2, single (Lot number: ER8730) at the age of 46 years, in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism", start date: 1995 (ongoing); "Vitamin D deficiency", start date: 2018 (ongoing); "Allergies" (ongoing); "Suspected COVID-19", start date: Mar2019 (unspecified if ongoing), notes: Patient believe had covid prior to this in Mar2019. Concomitant medication(s) included: LEVOTHYROXINE oral taken for thyroid disorder, start date: 1995 (ongoing); VITAMIN D NOS oral taken for vitamin d deficiency, start date: 2018 (ongoing); CLARITIN oral taken for hypersensitivity, start date: 2017 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "I randomly tested myself for covid after 5 days of the increased loudness of tinnitus and was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: I randomly tested myself for covid after 5 days of the increased loudness of tinnitus and was positive.  Clinical Course: Vaccination Facility Type was reported as Hospital. Patient had no prior vaccination (within four week). Specific relevant test for thromboembolic events with thrombocytopenia: None. Patient randomly tested for covid after 5 days of the increased loudness of tinnitus and was positive. Patient reported as I believe I had covid prior to this in Mar2019 after caring for a sick patient who had just returned from (city withheld) but we were not testing yet at that time.
Age: 46.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: I randomly tested myself for covid after 5 days of the increased loudness of tinnitus and was positive; I randomly tested myself for covid after 5 days of the increased loudness of tinnitus and was positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 03Mar2021 at 07:30 as dose 1, single (Lot number: EN6205), in left deltoid and on 26Mar2021 as dose 2, single (Lot number: ER8730) at the age of 46 years, in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism", start date: 1995 (ongoing); "Vitamin D deficiency", start date: 2018 (ongoing); "Allergies" (ongoing); "Suspected COVID-19", start date: Mar2019 (unspecified if ongoing), notes: Patient believe had covid prior to this in Mar2019. Concomitant medication(s) included: LEVOTHYROXINE oral taken for thyroid disorder, start date: 1995 (ongoing); VITAMIN D NOS oral taken for vitamin d deficiency, start date: 2018 (ongoing); CLARITIN oral taken for hypersensitivity, start date: 2017 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "I randomly tested myself for covid after 5 days of the increased loudness of tinnitus and was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: I randomly tested myself for covid after 5 days of the increased loudness of tinnitus and was positive.  Clinical Course: Vaccination Facility Type was reported as Hospital. Patient had no prior vaccination (within four week). Specific relevant test for thromboembolic events with thrombocytopenia: None. Patient randomly tested for covid after 5 days of the increased loudness of tinnitus and was positive. Patient reported as I believe I had covid prior to this in Mar2019 after caring for a sick patient who had just returned from (city withheld) but we were not testing yet at that time.
Age: 46.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I randomly tested myself for covid after 5 days of the increased loudness of tinnitus and was positive; I randomly tested myself for covid after 5 days of the increased loudness of tinnitus and was positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 03Mar2021 at 07:30 as dose 1, single (Lot number: EN6205), in left deltoid and on 26Mar2021 as dose 2, single (Lot number: ER8730) at the age of 46 years, in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism", start date: 1995 (ongoing); "Vitamin D deficiency", start date: 2018 (ongoing); "Allergies" (ongoing); "Suspected COVID-19", start date: Mar2019 (unspecified if ongoing), notes: Patient believe had covid prior to this in Mar2019. Concomitant medication(s) included: LEVOTHYROXINE oral taken for thyroid disorder, start date: 1995 (ongoing); VITAMIN D NOS oral taken for vitamin d deficiency, start date: 2018 (ongoing); CLARITIN oral taken for hypersensitivity, start date: 2017 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "I randomly tested myself for covid after 5 days of the increased loudness of tinnitus and was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: I randomly tested myself for covid after 5 days of the increased loudness of tinnitus and was positive.  Clinical Course: Vaccination Facility Type was reported as Hospital. Patient had no prior vaccination (within four week). Specific relevant test for thromboembolic events with thrombocytopenia: None. Patient randomly tested for covid after 5 days of the increased loudness of tinnitus and was positive. Patient reported as I believe I had covid prior to this in Mar2019 after caring for a sick patient who had just returned from (city withheld) but we were not testing yet at that time.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Arm soreness, fever, chills
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Palpitations
Clinical narrative: Sudden and persistent heart palpitations (heart flutters)
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Eczema
Clinical narrative: Spongiotic dermatitis, eczema. No previous history of eczema.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient received infant Moderna dose (6 month to 5 years). He was 5 years + 10 days. No adverse reaction happened.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Skin discolouration, Tinnitus
Clinical narrative: From the start of the shots, I developed this rash that I am still dealing with.  After closer examination, I believe it to possibly be monkey pox.  The way that people react to seeing it is also very apparent.  I am also suffering with tinnitus that was attempted to be treated with hearing aids, which have done absolutely nothing!  I have photos that I have taken of my skin after every injection!  And after the initial outbreak, the rash turns dark!  I've been trying to find creams to try to clear my skin and it's still discolored!  If this is monkey pox, Moderna is responsible for me having it!
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: NO ADVERSE REACTION REPORTED. A PFIZER VACCINE WAS ADMISNISTERED TO A PATIENT AFTER BUD OF 7/22/22. PATIENT, RECIEVED A PFIZER BOOSTER SHOT 6 DAYS AFTER BUD. The medical/safety team at Pfizer WAS CONTACTED AND indicated THE DISCOVERING PHARMACIST they do have stability but not efficacy data on the adult Pfizer vaccine beyond 72 days when stored in a refrigerator. They recommended that our rph contacts the CDC and inquires about repeating doses for these patients. Speaking with the CDC employees, our rph was given the same information as above and referred to the immunization division at the DOH.  Our rph contacted the DOH in the state, but she was asked to confer with either pharmacy's Medical Doctor or the standing order physician. Our rph was able to interact with the latter, and she was given the guidance of re-vaccinating . In the context of the guidance from the standing order physician, the patient will need to repeat the dose. Regular schedules for series completion/booster doses will be observed if/when warranted.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: NO ADVERSE REACTION REPORTED. A PFIZER VACCINE WAS ADMISNISTERED TO A PATIENT AFTER BUD OF 7/22/22. PATIENT RECIEVED A PFIZER BOOSTER SHOT 5 DAYS AFTER BUD. The medical/safety team at Pfizer WAS CONTACTED AND indicated THE DISCOVERING PHARMACIST they do have stability but not efficacy data on the adult Pfizer vaccine beyond 72 days when stored in a refrigerator. They recommended that our rph contacts the CDC and inquires about repeating doses for these patients. Speaking with the CDC employees, our rph was given the same information as above and referred to the immunization division.  Our rph contacted the in the state, but she was asked to confer with either pharmacy's Medical Doctor or the standing order physician. Our rph was able to interact with the latter, and she was given the guidance of re-vaccinating . In the context of the guidance from the standing order physician, the patient will need to repeat the dose. Regular schedules for series completion/booster doses will be observed if/when warranted.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: NO ADVERSE REACTION REPORTED. A PFIZER VACCINE WAS ADMISNISTERED TO A PATIENT AFTER BUD OF 7/22/22. PATIENT, RECIEVED A PFIZER BOOSTER SHOT 5 DAYS AFTER BUD. The medical/safety team at Pfizer WAS CONTACTED AND indicated THE DISCOVERING PHARMACIST they do have stability but not efficacy data on the adult Pfizer vaccine beyond 72 days when stored in a refrigerator. They recommended that our rph contacts the CDC and inquires about repeating doses for these patients. Speaking with the CDC employees, our rph was given the same information as above and referred to the immunization division at the DOH.  Our rph contacted the DOH in the state, but she was asked to confer with either Medical Doctor or the standing order physician. Our rph was able to interact with the latter, and she was given the guidance of re-vaccinating . In the context of the guidance from the standing order physician, the patient will need to repeat the dose. Regular schedules for series completion/booster doses will be observed if/when warranted.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: NO ADVERSE REACTION REPORTED. A PFIZER VACCINE WAS ADMISNISTERED TO A PATIENT AFTER BUD OF 7/22/22. PATIENT, RECIEVED A PFIZER BOOSTER SHOT 5 DAYS AFTER BUD. The medical/safety team at Pfizer WAS CONTACTED AND indicated THE DISCOVERING PHARMACIST they do have stability but not efficacy data on the adult Pfizer vaccine beyond 72 days when stored in a refrigerator. They recommended that our rph contacts the CDC and inquires about repeating doses for these patients. Speaking with the CDC employees, our rph was given the same information as above and referred to the immunization division at the DOH.  Our rph contacted the DOH in the state, but she was asked to confer with either Medical Doctor or the standing order physician. Our rph was able to interact with the latter, and she was given the guidance of re-vaccinating . In the context of the guidance from the standing order physician, the patient will need to repeat the dose. Regular schedules for series completion/booster doses will be observed if/when warranted.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: NO ADVERSE REACTION REPORTED. A PFIZER VACCINE WAS ADMISNISTERED TO A PATIENT AFTER BUD OF 7/22/22. PATIENT, RECIEVED A PFIZER BOOSTER SHOT 5 DAYS AFTER BUD. The medical/safety team at Pfizer WAS CONTACTED AND indicated THE DISCOVERING PHARMACIST they do have stability but not efficacy data on the adult Pfizer vaccine beyond 72 days when stored in a refrigerator. They recommended that our rph contacts the CDC and inquires about repeating doses for these patients. Speaking with the CDC employees, our rph was given the same information as above and referred to the immunization division.  Our rph contacted the DOH in the state, but she was asked to confer with either Medical Doctor or the standing order physician. Our rph was able to interact with the latter, and she was given the guidance of re-vaccinating . In the context of the guidance from the standing order physician, the patient will need to repeat the dose. Regular schedules for series completion/booster doses will be observed if/when warranted.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: NO ADVERSE REACTION REPORTED. A PFIZER VACCINE WAS ADMISNISTERED TO A PATIENT AFTER BUD OF 7/22/22. PATIENT RECIEVED A PFIZER BOOSTER SHOT 5 DAYS AFTER BUD. The medical/safety team at Pfizer WAS CONTACTED AND indicated THE DISCOVERING PHARMACIST they do have stability but not efficacy data on the adult Pfizer vaccine beyond 72 days when stored in a refrigerator. They recommended that our rph contacts the CDC and inquires about repeating doses for these patients. Speaking with the CDC employees, our rph was given the same information as above and referred to the immunization division at the DOH.  Our rph contacted the DOH in the state, but she was asked to confer with either the pharmacy Medical Doctor or the standing order physician. Our rph was able to interact with the latter, and she was given the guidance of re-vaccinating . In the context of the guidance from the standing order physician, the patient will need to repeat the dose. Regular schedules for series completion/booster doses will be observed if/when warranted.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received 2nd booster dose 3 days after 30-day use by date, administer  the second Booster vaccine after the 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received 2nd booster dose 3 days after 30-day use by date, administer  the second Booster vaccine after the 30 day use by date) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 939909, 008C21A and 003b21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received 2nd booster dose 3 days after 30-day use by date, administer  the second Booster vaccine after the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received 2nd booster dose 3 days after 30-day use by date, administer  the second Booster vaccine after the 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. The vial was initially stored in the refrigerator on 24Jun2022. It was unknown that the patient had any allergies to medications, food and other products. No other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine. No treatment information were provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Added patient DOB , Batch / Lot numbers and Narrative  updated.
Sex: F
Vaccine: RV1
Symptoms: Expired product administered, No adverse event
Clinical narrative: maldaministration, one week after expiry date; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a infant female patient who received Rota (Rotarix lyophilized formulation) (batch number AB445, expiry date unknown) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK receipt date: 26-JUL-2022 Reporter's comment: The patient's age was reported as 4 month 1 day old at the time of the event. The date was not provided but maldaministration occured one week after expiry date. The one week after product expiry date, no adverse events had been reported to the clinic. The reporter thinks it was a mistake by the vaccine clinic personel. The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Rotarix, which led to expired vaccine used. There was discrepancy in reported patient's age as partial and its age was lesser than 4 months hence not captured in patient tab.
Age: 60.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired dose of MMRII had been administered to a patient; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-JUN-2022 (reported as 22-JUN-2023 - future date), the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, expiration date: 02-JUN-2022, administered for prophylaxis (strength, dose, lot #, anatomical location, and route of administration were not provided) (expired product administered). No additional adverse event reported (no adverse event).  Follow-up information was received from a nurse practitioner on 27-JUL-2022 via a telephone call referring to an unknown gender 60-year-old patient. The primary diagnosis of the patient was anxiety, cognitive impairment, headache and status post motor vehicle accident (all diagnosis were from 2015) and prior to receiving this vaccine series. The patient was allergic to penicillin and codeine. The patient's only medication was salbutamol (ALBUTEROL) as need. On 22-JUN-2022, the patient received a single dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status recombinant Human albumin (rHA) on left arm (lot # T018892, expiration date: 02-JUN-2022). On 26-JUL-2022, she was revaccinated to the left arm with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (lot number was T029550 expiration date was 01-SEP-2022) for prophylaxis (strength, dose and route of administration were not provided). No adverse effects and no concerns.  This case became valid due to known patient's identifier.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test abnormal
Clinical narrative: The patient stated that she received VARIVAX sometime in 1996 and when she got a titer done this week for work, it came back as "low" so she just received another dose of VARIVAX.; This spontaneous report has been received from a female consumer of unknown age concerning herself. Her concomitant medications, pertinent medical history, and drug reactions/allergies therapies were not reported.  On an unspecified date in 1996, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX). On an unspecified date in June 2022 (reported as this week), she got a titer done for work, and it came back as "low". So, the patient just received another dose of varicella virus vaccine live (Oka/Merck) (VARIVAX). The outcome of the event antibody test abnormal was unknown. The patient did not want to continue with additional information for adverse event (AE).  The causality between the event antibody test abnormal and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, Product preparation error
Clinical narrative: No additional AEs; HCP calling to report that MMR II and VARIVAX were reconstituted with sodium chloride and administered to same patient on 07/15/2022.; Inappropriate schedule of vaccine HCP calling to report that MMR II and VARIVAX were reconstituted with sodium chloride and administered to same patient on 07/15/2022. No adverse reactions reported at this time. No additional AEs, no PQCs reported.; This spontaneous report has been received from a registered nurse, referring a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 15-JUL-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, 1 dose, and measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live, 0.5 milliliter, 1 dose, (strengths, routes of administration, anatomical location, lot numbers and expiration dates were not provided) indicated as prophylaxis (inappropriate schedule of product administration), both vaccines were reconstituted with sodium chloride (product preparation error).  No additional adverse event were reported.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received PNEUMOVAX 23 1st dose on 6/15/2017 and 2nd dose on 6/8/2018; This spontaneous report has been received from a medical student and refers to a patient of an unknown age and gender.  The patient's medical history, current conditions, concomitant therapies, and previous drugs reactions or allergies were not reported.  On 15-JUN-2017, the patient wqas vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), on 08-JUN-2019 the patient received a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (doses, lot #s, expiry dates, and routes of administration were not provided) (product use issue).
Age: 14.0
Sex: U
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AEs were reported; A nurse reported that a 14 year old patient inadvertently received PEDVAX HIB on 7/18/2022; This spontaneous report has been received from a nurse referring to a 14-year-old patient of unknown gender. Their pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 18-JUL-2022, the patient was vaccinated with a dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) as prophylaxis (dose regimen and route of administration were not provided). Lot# U014484, expiration date; 15-SEP-2023.   The nurse reported that the patient received inadvertently a dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (Product administered to patient of inappropriate age).
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 27-JUN-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs were reported.; Physician reported that a patient received the first dose of ROTATEQ later than recommended. The patient received the first dose of ROTATEQ today 7/26/2022 and the patient was 6 month old.; This spontaneous report was received from a physician and refers to a 6-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 26-JUL-2022, the 6-month-old patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose, lot # reported as: U021367 upon internal validation was confirmed as valid, expiration date was reported: 07-MAR-2023 and was confirmed as valid (exact dose, strength, formulation and route of administration were not provided) for prophylaxis (product administered to patient of inappropriate age). There was no additional adverse event reported.
Age: 28.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs were reported; Pharmacist reported that on 7/26/2022, a 28 year old patient received PROQUAD that was reconstituted with a diluent.   No additional AEs were reported.  No further information provided.; This spontaneous report has been received from a pharmacist and refers to a 28-year-old patient.  The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 26-JUL-2022, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live  (rHA)(PROQUAD), lot number W004029, expiration date: 02-AUG-2023 as prophylaxis (dose description, vaccination scheme and route of administration were not provided); reconstituted with a sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion, lot number u008044, expiration date: 06-JUL-2023, as prophylaxis (strength, and route of administration were not provided) (Inappropriate age at vaccine administration). No additional adverse event were reported.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No adverse effects reported; a patient received their first dose of GARDASIL 9 at 14 years of age. The patient came back to the office and received a second dose of GARDASIL 9 at 16 years old.; This spontaneous report was received from a registered nurse referring to a 16-year-old female patient. Her pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.   On an unspecified date in 2019  and in 2021 (reported as "at 14 and 16 years of age respectively"), the patient was vaccinated with the first and second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), administered as prophylaxis (dose regimen, route of administration, lot number and expiration date were not reported) (Inappropriate schedule of product administration)..
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 18-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 15-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 14-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 12-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 27-JUN-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 28-JUN-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 29-JUN-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 01-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.