chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MENB, MENB
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age and gender received TRUMENBA via an unspecified route of administration on 11Jun2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of meningococcal group b rlp2086 on an unspecified date and experienced pain. On 11Jun2018, the patient experienced pain immediately after shot. The next day, on 12Jun2018, the patient experienced red and swollen below injection site with pain, and unable to lift arm above head. The patient stated that the pain experienced was much different than when had gotten the first dose of meningococcal group b rlp2086. The patient had to take MOTRIN that helped with the pain. Clinical outcome of the events pain immediately after shot/ Pain lasted up to 4 days/ pain experiencing was much different than when had gotten the first dose of meningococcal group b rlp2086 and unable to lift arm above head was unknown. The event red below injection site with pain/still slightly red below injection site was not recovered while the event swollen below injection site recovered on an unspecified date. It was reported that the pain lasted up to 4 days (morning of office visit) and was still slightly red below injection site. No swelling noted at time of office visit on 14Jun2018. Information on batch number has been requested.
Sex: U
Vaccine: MENB, MENB
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age and gender received TRUMENBA via an unspecified route of administration on 11Jun2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of meningococcal group b rlp2086 on an unspecified date and experienced pain. On 11Jun2018, the patient experienced pain immediately after shot. The next day, on 12Jun2018, the patient experienced red and swollen below injection site with pain, and unable to lift arm above head. The patient stated that the pain experienced was much different than when had gotten the first dose of meningococcal group b rlp2086. The patient had to take MOTRIN that helped with the pain. Clinical outcome of the events pain immediately after shot/ Pain lasted up to 4 days/ pain experiencing was much different than when had gotten the first dose of meningococcal group b rlp2086 and unable to lift arm above head was unknown. The event red below injection site with pain/still slightly red below injection site was not recovered while the event swollen below injection site recovered on an unspecified date. It was reported that the pain lasted up to 4 days (morning of office visit) and was still slightly red below injection site. No swelling noted at time of office visit on 14Jun2018. Information on batch number has been requested.
Sex: U
Vaccine: MENB, MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age and gender received TRUMENBA via an unspecified route of administration on 11Jun2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of meningococcal group b rlp2086 on an unspecified date and experienced pain. On 11Jun2018, the patient experienced pain immediately after shot. The next day, on 12Jun2018, the patient experienced red and swollen below injection site with pain, and unable to lift arm above head. The patient stated that the pain experienced was much different than when had gotten the first dose of meningococcal group b rlp2086. The patient had to take MOTRIN that helped with the pain. Clinical outcome of the events pain immediately after shot/ Pain lasted up to 4 days/ pain experiencing was much different than when had gotten the first dose of meningococcal group b rlp2086 and unable to lift arm above head was unknown. The event red below injection site with pain/still slightly red below injection site was not recovered while the event swollen below injection site recovered on an unspecified date. It was reported that the pain lasted up to 4 days (morning of office visit) and was still slightly red below injection site. No swelling noted at time of office visit on 14Jun2018. Information on batch number has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pain in extremity
Clinical narrative: Pain at injection site upon administration. Sore arm, unable to lay on arm for a few days. Redness (6x4inch area) and itching around injection site 4 days post injection.
Age: 3.0
Sex: F
Vaccine: YF
Symptoms: Myalgia, Pyrexia
Clinical narrative: Patient received the YF-Vaccine on 15 Jun 2018 around 1100 with no immediate adverse event. However, later in the day, the patient began to develop a fever and generalized muscle aches, especially of her bilateral ankles. She has had intermittent fevers over the last 3 days but rising as high as 104 by a forehead thermometer at home. Clinic has treated with alternating TYLENOL and Ibuprofen. No other systemic symptoms. No generalized rash or hives. No lip swelling, tongue swelling. Throat tightness, shortness of breath, wheezing or chest pains. Patient currently denies any myalgia. Clinic notes patient more reserved than usual and does not eat or drink as usual but has voided today.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspepsia, Herpes zoster, Mobility decreased, Nausea
Clinical narrative: At 8:30 pm, around bedtime on the day of the vaccine, I experienced severe heartburn, followed by debilitating nausea (was not able to even sit up). By the next day, I began to break out in shingles, first on my hands and arms, and eventually on my legs, feet, trunk, and back. These have continued until today (3 weeks later) and still continue.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash
Clinical narrative: ADVERSE EVENT 19JUN18: VACCINE ADMINISTERED AT 1020. ONSET OF RASH ON RIGHT ARM AT 1700, RASH SPREAD TOWARDS FACE AND INCREASED ERYTHEMA SINCE ONSET. TREATMENT 20JUN18: PREDNISOLONE 15MG/ML AND BENADRYL ORAL SUSP. 12.5MG/5ML OUTCOME: TBD.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient developed dime sized red circular bumps that became warm all around the injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Arm soreness with swelling, terrible headache, shivering all through the night, weakness.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site pruritus, Nausea, Pyrexia
Clinical narrative: Pt complains of redness and itching at site, nausea, and fever. Pt did not check how high the fever got. Reports feeling terrible.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Only liquid component of the vaccine given the lyophilized form not given.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Pain
Clinical narrative: Ached all over but that was in the list temperature of 100.4 after taking 2 TYLENOL 500 mg each. Did not take temp before that.
Sex: U
Vaccine: HIBV, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report was received from a nurse and refers to a unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in October 2017 (reported that from 10-OCT-2017 to 12-OCT-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018, lot # M046133, expiration date: 26-SEP-2019), PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) and GARDASIL 9 (lot # L036301 expiration date: 20-DEC-2017, lot # M028323, expiration date: 26-SEP-2018 and lot # N017686, expiration date: 2-FEB-2020) (for all vaccines doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius (C) to 25C (11.4C) for 1 hours. Data logger was involved. Follow-up information has been received from the nurse on 11-JUN-2018. She provided that the temperature excursion took place on 10-OCT-2017. The patient identification information was not readily available. Follow-up information has been received from the nurse on 11-JUN-2018 concerning a patient of unknown age and gender. The patient was vaccinated with PEDVAXHIB (lot # M046133, expiration date: 26-SEP-2019) of temperature excursion which took place on 10-OCT-2017 from 16:32 until 19:02 (maximum temperature 11.4C). No adverse effects were reported. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is valid because the patient's identifier was received. Sender's Comments: US-009507513-1806USA008455: US-009507513-1806USA008456: US-009507513-1806USA008457: US-009507513-1806USA008458: US-009507513-1806USA008459: US-009507513-1806USA008460: US-009507513-1806USA008461: US-009507513-1806USA008462: US-009507513-1806USA008463: US-009507513-1806USA008464: US-009507513-1806USA008465: US-009507513-1806USA008466: US-009507513-1806USA008467: US-009507513-1806USA008468: US-009507513-1806USA008469: US-009507513-1806USA008470: US-009507513-1806USA008471: US-009507513-1806USA008472: US-009507513-1806USA008473: US-009507513-1806USA008474: US-009507513-1806USA008475: US-009507513-1806USA008476: US-009507513-1806USA008477: US-009507513-1806USA008478: US-009507513-1806USA008479: US-009507513-1806USA008480: US-009507513-1806USA008481: US-009507513-1806USA008482: US-009507513-1806USA008483: US-009507513-1806USA008484: US-009507513-1806USA008485: US-009507513-1806USA008486: US-009507513-1806USA008487: US-009507513-1806USA008488: US-009507513-1806USA008489: US-009507513-1806USA008490: US-009507513-1806USA008491.
Sex: U
Vaccine: HIBV, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report was received from a nurse and refers to a unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in October 2017 (reported that from 10-OCT-2017 to 12-OCT-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018, lot # M046133, expiration date: 26-SEP-2019), PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) and GARDASIL 9 (lot # L036301 expiration date: 20-DEC-2017, lot # M028323, expiration date: 26-SEP-2018 and lot # N017686, expiration date: 2-FEB-2020) (for all vaccines doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius (C) to 25C (11.4C) for 1 hours. Data logger was involved. Follow-up information has been received from the nurse on 11-JUN-2018. She provided that the temperature excursion took place on 10-OCT-2017. The patient identification information was not readily available. Follow-up information has been received from the nurse on 11-JUN-2018 concerning a patient of unknown age and gender. The patient was vaccinated with GARDASIL 9 (lot # N017686, expiration date: 02-FEB-2020) of temperature excursion which took place on 10-OCT-2017 from 16:32 until 19:02 (maximum temperature 11.4C). No adverse effects were reported. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is valid because the patient's identifier was received. Sender's Comments: US-009507513-1710USA007686.
Sex: U
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 70-year-old patient on unknown gender. The patient's medical history, concurrent condition and drug reactions or allergies were not reported. On 05-JUN-2018, the patient was inadvertently given a dose of PROQUAD subcutaneously, lot# N025719, expiration date: 17-MAR-2019 (frequency was not reported) instead of ZOSTAVAX, for prophylaxis.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-JUN-2018, the patient was vaccinated with an expired dose of M-M-R II lot # M017346, expiration date 06-APR-2018 (formulation, strength, dose, frequency, route of administration, indication, were not reported) for prophylaxis. The outcome of expired product administered is unknown.
Age: 0.42
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 5 month old patient of unknown age. Concurrent conditions, medical history, historical and concomitant drugs were not reported. The pharmacist informed that on 09-JUN-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 Injection, for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported) instead of PREVNAR 13. No adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with the ZOSTAVAX vaccine at a hospital as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2015, she was treated at a hospital for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-JUL-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2015, the patient was treated at an urgent care center for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report was received from a nurse and refers to a unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in October 2017 (reported that from 10-OCT-2017 to 12-OCT-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018, lot # M046133, expiration date: 26-SEP-2019), PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) and GARDASIL 9 (lot # L036301 expiration date: 20-DEC-2017, lot # M028323, expiration date: 26-SEP-2018 and lot # N017686, expiration date: 2-FEB-2020) (for all vaccines doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius (C) to 25C (11.4C) for 1 hours. Data logger was involved. Follow-up information has been received from the nurse on 11-JUN-2018. She provided that the temperature excursion took place on 10-OCT-2017. The patient identification information was not readily available. Follow-up information has been received from the nurse on 11-JUN-2018 concerning a patient of unknown age and gender. The patient was vaccinated with PEDVAXHIB (lot # M046133, expiration date: 26-SEP-2019) of temperature excursion which took place on 10-OCT-2017 from 16:32 until 19:02 (maximum temperature 11.4C). No adverse effects were reported. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is now valid because the patient's identifier was received. Sender's Comments: US-009507513-1710USA007686.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report was received from a nurse and refers to a unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in October 2017 (reported that from 10-OCT-2017 to 12-OCT-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018, lot # M046133, expiration date: 26-SEP-2019), PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) and GARDASIL 9 (lot # L036301 expiration date: 20-DEC-2017, lot # M028323, expiration date: 26-SEP-2018 and lot # N017686, expiration date: 2-FEB-2020) (for all vaccines doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius (C) to 25C (11.4C) for 1 hours. Data logger was involved. Follow-up information has been received from the nurse on 11-JUN-2018. She provided that the temperature excursion took place on 10-OCT-2017. The patient identification information was not readily available. Follow-up information has been received from the nurse on 11-JUN-2018 concerning a patient of unknown age and gender. The patient was vaccinated with PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018) of temperature excursion which took place on 10-OCT-2017 from 16:32 until 19:02 (maximum temperature 11.4C). No adverse effects were reported. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is now valid because the patient's identifier was received. Sender's Comments: US-009507513-1710USA007686.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report was received from a nurse and refers to a unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in October 2017 (reported that from 10-OCT-2017 to 12-OCT-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018, lot # M046133, expiration date: 26-SEP-2019), PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) and GARDASIL 9 (lot # L036301 expiration date: 20-DEC-2017, lot # M028323, expiration date: 26-SEP-2018 and lot # N017686, expiration date: 2-FEB-2020) (for all vaccines doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius (C) to 25C (11.4C) for 1 hours. Data logger was involved. Follow-up information has been received from the nurse on 11-JUN-2018. She provided that the temperature excursion took place on 10-OCT-2017. The patient identification information was not readily available. Follow-up information has been received from the nurse on 11-JUN-2018 concerning a patient of unknown age and gender. The patient was vaccinated with GARDASIL 9 (lot # M028323, expiration date: 26-SEP-2018) of temperature excursion which took place on 10-OCT-2017 from 16:32 until 19:02 (maximum temperature 11.4C). No adverse effects were reported. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is now valid because the patient's identifier was received. Sender's Comments: US-009507513-1710USA007686.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report was received from a nurse and refers to a unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in October 2017 (reported that from 10-OCT-2017 to 12-OCT-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018, lot # M046133, expiration date: 26-SEP-2019), PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) and GARDASIL 9 (lot # L036301 expiration date: 20-DEC-2017, lot # M028323, expiration date: 26-SEP-2018 and lot # N017686, expiration date: 2-FEB-2020) (for all vaccines doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius (C) to 25C (11.4C) for 1 hours. Data logger was involved. Follow-up information has been received from the nurse on 11-JUN-2018. She provided that the temperature excursion took place on 10-OCT-2017. The patient identification information was not readily available. Follow-up information has been received from the nurse on 11-JUN-2018 concerning a patient of unknown age and gender. The patient was vaccinated with GARDASIL 9 (lot # M028323, expiration date: 26-SEP-2018) of temperature excursion which took place on 10-OCT-2017 from 16:32 until 19:02 (maximum temperature 11.4C). No adverse effects were reported. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is now valid because the patient's identifier was received. Sender's Comments: US-009507513-1710USA007686.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report was received from a nurse and refers to a unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in October 2017 (reported that from 10-OCT-2017 to 12-OCT-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018, lot # M046133, expiration date: 26-SEP-2019), PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) and GARDASIL 9 (lot # L036301 expiration date: 20-DEC-2017, lot # M028323, expiration date: 26-SEP-2018 and lot # N017686, expiration date: 2-FEB-2020) (for all vaccines doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius (C) to 25C (11.4C) for 1 hours. Data logger was involved. Follow-up information has been received from the nurse on 11-JUN-2018. She provided that the temperature excursion took place on 10-OCT-2017. The patient identification information was not readily available. Follow-up information has been received from the nurse on 11-JUN-2018 concerning a patient of unknown age and gender. The patient was vaccinated with PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) of temperature excursion which took place on 10-OCT-2017 from 16:32 until 19:02 (maximum temperature 11.4C). No adverse effects were reported. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is now valid because the patient's identifier was received. Sender's Comments: US-009507513-1710USA007686.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report was received from a nurse and refers to a unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in October 2017 (reported that from 10-OCT-2017 to 12-OCT-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018, lot # M046133, expiration date: 26-SEP-2019), PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) and GARDASIL 9 (lot # L036301 expiration date: 20-DEC-2017, lot # M028323, expiration date: 26-SEP-2018 and lot # N017686, expiration date: 2-FEB-2020) (for all vaccines doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius (C) to 25C (11.4C) for 1 hours. Data logger was involved. Follow-up information has been received from the nurse on 11-JUN-2018. She provided that the temperature excursion took place on 10-OCT-2017. The patient identification information was not readily available. Follow-up information has been received from the nurse on 11-JUN-2018 concerning a patient of unknown age and gender. The patient was vaccinated with GARDASIL 9 (lot # N017686, expiration date: 02-FEB-2020) of temperature excursion which took place on 10-OCT-2017 from 16:32 until 19:02 (maximum temperature 11.4C). No adverse effects were reported. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is valid because the patient's identifier was received. Sender's Comments: US-009507513-1710USA007686.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse pre scriber concerning a 13-year-old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (also reported as GARDASIL) injection, lot # N007931 with expiration date 17-NOV-2019 for prophylaxis (dose # and route of administration were unknown). The vaccine experienced a temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for 1 hour. The digital data logger was involved in recording the temperature excursion details. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1801USA004687.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 35 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 30-APR-2018 the patient was vaccinated with M-M-R II (lot # N013279, expiry date: 28-APR-2019) (dose, strength and frequency were unknown) intramuscularly instead of the recommended subcutaneous route for prophylaxis. M-M-R II reconstituted with sterile diluent (MRK) (lot# N015479, expiry date: 23-JUL-2019). No adverse effects were reported. No product quality complaint was involved. It was reported that, no prescription drug treatment was required for the event. This is one of two reports received from the same reporter.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 11-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (age and gender was not reported) who experienced "one of 4 patients, cannot determine which one, got only ACTHIB reconstituted with sterile water/no AE reported", while he/she received vaccine PENTACEL Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to inappropriate reconstitution technique because patient got only ACTHIB reconstituted with sterile water. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 12-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse (LPN).This case involves a patient (age and gender was not reported), who experienced one patient, received expired dose/ no ae reported, while he/she received vaccine PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to expired vaccine used. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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. Documents held by sender: none.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Musculoskeletal pain, Pain in extremity
Clinical narrative: Injection site erythema, arm pain, shoulder pain.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Patient called on 6/19/18 and reported that the injection site was very itchy and experience hives around the site. She applied BENADRYL cream and took an oral BENADRYL. No shortness of breath reported. She reported that she felt better after using the BENADRYL.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site swelling, Nausea, Neck pain
Clinical narrative: Swelling at site of injection, fatigue, nausea, fever, pain at site of injection, neck pain.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Swelling at site of injection, fatigue, nausea, fever, pain at site of injection, neck pain.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Hep A vaccine dose number 2 given 11 days too early.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Full blood count, Rash
Clinical narrative: Red eruption on head, face, chest, shoulders, back shoulders, ears, arms.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Hep A vaccine dose #2 given 11 days too early.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abnormal loss of weight, Amylase normal, Blood thyroid stimulating hormone normal, Cytomegalovirus test, Cytomegalovirus test negative
Clinical narrative: Anorexia, nausea, malaise x 1 mo. 20 # unintentional wt loss.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Full blood count normal, Laboratory test normal, Lipase normal, Liver function test normal
Clinical narrative: Anorexia, nausea, malaise x 1 mo. 20 # unintentional wt loss.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Red blood cell sedimentation rate normal
Clinical narrative: Anorexia, nausea, malaise x 1 mo. 20 # unintentional wt loss.
Age: 52.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Hep A vaccine dose 2 given 11 days too early.
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Hep A vaccine dose #2 given 11 days too early.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Injection site pain, Injection site warmth, Pallor
Clinical narrative: Warmth tender induration approximately 2cm at site; blanches.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: The patient called and reported that several days after receiving the first dose of SHINGRIX he had pain/tingling and weakness in his extremities. This weakness was extreme on exertion. The patient also reported pain in his arm and bruising at the injection site. I advised the patient to seek medical attention because he had been feeling these side effects longer than 1 week. He received a steroid shot from his PCP and visited the pharmacy stating he was feeling better. I noticed the bruise on his arm was not on the deltoid but towards the back of his arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: Dose was 0.5mL. Next morning and all that day: dizziness, low grade fever, nausea, chills, headache and fatigue. Off and on the next 2 days then fine the 4th day (Tuesday 19th). At vaccine site in arm:  swelling, redness and itching intensely for 3 days, at a lower level days 4 and 5 (currently at day 5).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Nausea, Pyrexia, Vaccination site swelling
Clinical narrative: Dose was 0.5mL. Next morning and all that day: dizziness, low grade fever, nausea, chills, headache and fatigue. Off and on the next 2 days then fine the 4th day (Tuesday 19th). At vaccine site in arm:  swelling, redness and itching intensely for 3 days, at a lower level days 4 and 5 (currently at day 5).
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Chills, Dyspnoea, Hyperhidrosis, Myalgia
Clinical narrative: Started on 6/18/2018 at about 5 pm with a mild fever (99.8) and aches. Treated with TYLENOL. Continued with fever, aches, chills, sweats, joint pain, nausea, difficulty breathing the following morning. Continued to treat with TYLENOL but added MOTRIN on 6/19/18. around 5 pm on 6/19/18 nausea set it in for 4 hours and treated with MAALOX. On 6/20/2018 aches and nausea gone but soreness in muscles still felt.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Started on 6/18/2018 at about 5 pm with a mild fever (99.8) and aches. Treated with TYLENOL. Continued with fever, aches, chills, sweats, joint pain, nausea, difficulty breathing the following morning. Continued to treat with TYLENOL but added MOTRIN on 6/19/18. around 5 pm on 6/19/18 nausea set it in for 4 hours and treated with MAALOX. On 6/20/2018 aches and nausea gone but soreness in muscles still felt.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Contusion, Dizziness, Fatigue, Headache
Clinical narrative: After an hour of the vaccine I had pain and bruising pain in my left arm. After a poor night's sleep with pain throughout the night I woke feeling headache, nausea, dizziness, tired, chills as well as the arm pain. With ibuprofen some symptoms have eased but I had to stay in bed for the whole morning. Almost recovered 24 hours after vaccination but it was brutal.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Middle insomnia, Nausea, Pain in extremity, Poor quality sleep
Clinical narrative: After an hour of the vaccine I had pain and bruising pain in my left arm. After a poor night's sleep with pain throughout the night I woke feeling headache, nausea, dizziness, tired, chills as well as the arm pain. With ibuprofen some symptoms have eased but I had to stay in bed for the whole morning. Almost recovered 24 hours after vaccination but it was brutal.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Nausea, Pain in extremity
Clinical narrative: After an hour of the vaccine I had pain and bruising pain in my left arm. After a poor night's sleep with pain throughout the night I woke feeling headache, nausea, dizziness, tired, chills as well as the arm pain. With ibuprofen some symptoms have eased but I had to stay in bed for the whole morning. Almost recovered 24 hours after vaccination but it was brutal.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Blood urine present, Mental status changes, Myalgia
Clinical narrative: Extreme muscle pain, extreme  weakness, mental changes, blood in the urine. patient has been to Dr. and blood work, but unaware of results. Patient is just now starting to feel better.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: Nausea, chills, fever, headache, severe muscle aches, stomach distress, followed by diarrhea the next morning.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Nausea, chills, fever, headache, severe muscle aches, stomach distress, followed by diarrhea the next morning.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Cough, Injection site pain, Myalgia, Nausea
Clinical narrative: Cough, nausea, abdominal pain, muscle ache - on site and generalized.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Injection site pain, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient states that "a couple hours after the injection she started running a fever and for the next couple of days had vomiting and pain at injection site". She said that even now, 20 days after injection she still has nausea and has not been able to eat a full meal.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Herpes zoster, Injected limb mobility decreased, Ophthalmic herpes zoster
Clinical narrative: Three days after injection, unable to raise arm for a couple days. A week after injection, came down with shingles on left-side of face, affecting left eye.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Itching on day one (6/19) then she woke up this morning with extreme swelling in the right deltoid and hot to the touch, still really itchy also.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: She came in and showed me a 3 to 4 inch in diameter bright red circular injection site reaction.  She stated it was itchy and somewhat hot. It was 3 days post vaccination. Was given 06/16 patient did not report until 06/19. Recommended patient to call MD, take BENADRYL and place ice pack on arm. I tried calling patient provider but they are only open on Thursday and Fridays (left message).
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient reports that within 3 hours she had tingling in arms progressing to pain in arms and legs and body aches. She reported that 48 hours post injection that the symptoms were much better, mostly resolved except for soreness at injection site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersensitivity, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Swelling and redness at injection site. Headache started - general malise. Lymph node swelling. Went to Dr to check - no injection issue but classified as allergy.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Swelling and redness at injection site. Headache started - general malise. Lymph node swelling. Went to Dr to check - no injection issue but classified as allergy.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chills, Dizziness, Immediate post-injection reaction, Pyrexia
Clinical narrative: Directly after the vaccine, I felt weak, drained and dizzy. A few hours later I got chills and a fever and have had a high fever ever since. It is now Wednesday, 5 days later, and I still have a high fever and hives, even after going to the emergency room and being flushed with an IV.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria, White blood cell count decreased
Clinical narrative: Directly after the vaccine, I felt weak, drained and dizzy. A few hours later I got chills and a fever and have had a high fever ever since. It is now Wednesday, 5 days later, and I still have a high fever and hives, even after going to the emergency room and being flushed with an IV.
Age: 69.0
Sex: M
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Computerised tomogram head normal, Corneal abrasion, Electrocardiogram normal, Facial paralysis, Lacrimation disorder
Clinical narrative: Patient developed right-sided Bell's Palsy (facial and tongue paralysis, lacrimation, tinnitus) starting 5/23/2018. Required ED visit to rule out stroke, and was given antiviral and prednisone. Also had corneal abrasion at that time due to inability to close eye. Symptoms are still present though has shown mild improvement since onset.
Age: 69.0
Sex: M
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Tinnitus, Tongue paralysis
Clinical narrative: Patient developed right-sided Bell's Palsy (facial and tongue paralysis, lacrimation, tinnitus) starting 5/23/2018. Required ED visit to rule out stroke, and was given antiviral and prednisone. Also had corneal abrasion at that time due to inability to close eye. Symptoms are still present though has shown mild improvement since onset.
Age: 69.0
Sex: M
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Facial paralysis
Clinical narrative: Patient developed right-sided Bell's Palsy (facial and tongue paralysis, lacrimation, tinnitus) starting 5/23/2018. Required ED visit to rule out stroke, and was given antiviral and prednisone. Also had corneal abrasion at that time due to inability to close eye. Symptoms are still present though has shown mild improvement since onset.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Patient was given vaccine in right deltoid, this is his 3rd in the series of 3. After sitting for about 2 minutes I asked the patient how he felt, patient states dizzy. I then proceeded to call help and the provider PA-C and LPN came and we placed patient supine in the floor. His vitals was taken. His blood pressure was 100/54, pulse was 58, respiration was 18 and no pain.  The patient was then given some water, a cold rag and a cookie. Patient rested in the floor for about 10 minutes, then we got him to lie on the bed for another 30 minutes, patient pulse was 70 before he left. I got patient to stand about 5 minutes before he left.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Patient is experiencing severe pain in left arm (where injection was administered). She states it is hard to move her arm and very painful. It has been 2 weeks since the patient received the SHINGRIX vaccine.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient is experiencing severe pain in left arm (where injection was administered). She states it is hard to move her arm and very painful. It has been 2 weeks since the patient received the SHINGRIX vaccine.