chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787 US-009507513-1805USA009900:Original Case : 1805USA006787 US-009507513-1805USA009901:Original Case : 1805USA006787 US-009507513-1805USA009902:Original Case : 1805USA006787 US-009507513-1805USA009903:Original Case : 1805USA006787 US-009507513-1805USA009904:Original Case : 1805USA006787 US-009507513-1805USA009905:Original Case : 1805USA006787 US-009507513-1805USA009906:Original Case : 1805USA006787 US-009507513-1805USA006787:Original Case : 1805USA006787 US-009507513-1805USA009908:Original Case : 1805USA006787 US-009507513-1805USA009909:Original Case : 1805USA006787 US-009507513-1805USA009910:Original Case : 1805USA006787 US-009507513-1805USA009911:Original Case : 1805USA006787 US-009507513-1805USA009912:Original Case : 1805USA006787 US-009507513-1805USA009913:Original Case : 1805USA006787 US-009507513-1805USA009914:Original Case : 1805USA006787 US-009507513-1805USA009915:Original Case : 1805USA006787 US-009507513-1805USA009916:Original Case : 1805USA006787 US-009507513-1805USA009917:Original Case : 1805USA006787 US-009507513-1805USA009918:Original Case : 1805USA006787 US-009507513-1805USA009919:Original Case : 1805USA006787 US-009507513-1805USA009920:Original Case : 1805USA006787 US-009507513-1805USA009921:Original Case : 1805USA006787 US-009507513-1805USA009922:Original Case : 1805USA006787 US-009507513-1805USA009923:Original Case : 1805USA006787 US-009507513-1805USA009924:Original Case : 1805USA006787 US-009507513-1805USA009925:Original Case : 1805USA006787 US-009507513-1805USA009926:Original Case : 1805USA006787 US-009507513-1805USA009927:Original Case : 1805USA006787 US-009507513-1805USA009928:Original Case : 1805USA006787 US-009507513-1805USA009929:Original Case : 1805USA006787 US-009507513-1805USA009930:Original Case : 1805USA006787 US-009507513-1805USA009931:Original Case : 1805USA006787 US-009507513-1805USA009932:Original Case : 1805USA006787 US-009507513-1805USA009933.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787 US-009507513-1805USA009900:Original Case : 1805USA006787 US-009507513-1805USA009901:Original Case : 1805USA006787 US-009507513-1805USA009902:Original Case : 1805USA006787 US-009507513-1805USA009903:Original Case : 1805USA006787 US-009507513-1805USA009904:Original Case : 1805USA006787 US-009507513-1805USA009905:Original Case : 1805USA006787 US-009507513-1805USA009906:Original Case : 1805USA006787 US-009507513-1805USA009907:Original Case : 1805USA006787 US-009507513-1805USA006787:Original Case : 1805USA006787 US-009507513-1805USA009909:Original Case : 1805USA006787 US-009507513-1805USA009910:Original Case : 1805USA006787 US-009507513-1805USA009911:Original Case : 1805USA006787 US-009507513-1805USA009912:Original Case : 1805USA006787 US-009507513-1805USA009913:Original Case : 1805USA006787 US-009507513-1805USA009914:Original Case : 1805USA006787 US-009507513-1805USA009915:Original Case : 1805USA006787 US-009507513-1805USA009916:Original Case : 1805USA006787 US-009507513-1805USA009917:Original Case : 1805USA006787 US-009507513-1805USA009918:Original Case : 1805USA006787 US-009507513-1805USA009919:Original Case : 1805USA006787 US-009507513-1805USA009920:Original Case : 1805USA006787 US-009507513-1805USA009921:Original Case : 1805USA006787 US-009507513-1805USA009922:Original Case : 1805USA006787 US-009507513-1805USA009923:Original Case : 1805USA006787 US-009507513-1805USA009924:Original Case : 1805USA006787 US-009507513-1805USA009925:Original Case : 1805USA006787 US-009507513-1805USA009926:Original Case : 1805USA006787 US-009507513-1805USA009927:Original Case : 1805USA006787 US-009507513-1805USA009928:Original Case : 1805USA006787 US-009507513-1805USA009929:Original Case : 1805USA006787 US-009507513-1805USA009930:Original Case : 1805USA006787 US-009507513-1805USA009931:Original Case : 1805USA006787 US-009507513-1805USA009932:Original Case : 1805USA006787 US-009507513-1805USA009933.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source.  Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787 US-009507513-1805USA009900:Original Case : 1805USA006787 US-009507513-1805USA009901:Original Case : 1805USA006787 US-009507513-1805USA009902:Original Case : 1805USA006787 US-009507513-1805USA009903:Original Case : 1805USA006787 US-009507513-1805USA009904:Original Case : 1805USA006787 US-009507513-1805USA009905:Original Case : 1805USA006787 US-009507513-1805USA009906:Original Case : 1805USA006787 US-009507513-1805USA009907:Original Case : 1805USA006787 US-009507513-1805USA009908:Original Case : 1805USA006787 US-009507513-1805USA006787:Original Case : 1805USA006787 US-009507513-1805USA009910:Original Case : 1805USA006787 US-009507513-1805USA009911:Original Case : 1805USA006787 US-009507513-1805USA009912:Original Case : 1805USA006787 US-009507513-1805USA009913:Original Case : 1805USA006787 US-009507513-1805USA009914:Original Case : 1805USA006787 US-009507513-1805USA009915:Original Case : 1805USA006787 US-009507513-1805USA009916:Original Case : 1805USA006787 US-009507513-1805USA009917:Original Case : 1805USA006787 US-009507513-1805USA009918:Original Case : 1805USA006787 US-009507513-1805USA009919:Original Case : 1805USA006787 US-009507513-1805USA009920:Original Case : 1805USA006787 US-009507513-1805USA009921:Original Case : 1805USA006787 US-009507513-1805USA009922:Original Case : 1805USA006787 US-009507513-1805USA009923:Original Case : 1805USA006787 US-009507513-1805USA009924:Original Case : 1805USA006787 US-009507513-1805USA009925:Original Case : 1805USA006787 US-009507513-1805USA009926:Original Case : 1805USA006787 US-009507513-1805USA009927:Original Case : 1805USA006787 US-009507513-1805USA009928:Original Case : 1805USA006787 US-009507513-1805USA009929:Original Case : 1805USA006787 US-009507513-1805USA009930:Original Case : 1805USA006787 US-009507513-1805USA009931:Original Case : 1805USA006787 US-009507513-1805USA009932:Original Case : 1805USA006787 US-009507513-1805USA009933.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot #: N021728, Exp Date: 06-FEB-2019) (Lot#: N022972, Exp Date: 19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899: Original Case: 1805USA006787; US-009507513-1805USA009900: Original Case: 1805USA006787; US-009507513-1805USA009901: Original Case: 1805USA006787; US-009507513-1805USA009902: Original Case: 1805USA006787; US-009507513-1805USA009903: Original Case: 1805USA006787; US-009507513-1805USA009904: Original Case: 1805USA006787; US-009507513-1805USA009905: Original Case: 1805USA006787; US-009507513-1805USA009906: Original Case: 1805USA006787; US-009507513-1805USA009907: Original Case: 1805USA006787; US-009507513-1805USA009908: Original Case: 1805USA006787; US-009507513-1805USA009909: Original Case: 1805USA006787; US-009507513-1805USA006787: Original Case: 1805USA006787; US-009507513-1805USA009911: Original Case: 1805USA006787; US-009507513-1805USA009912: Original Case: 1805USA006787; US-009507513-1805USA009913: Original Case: 1805USA006787; US-009507513-1805USA009914: Original Case: 1805USA006787; US-009507513-1805USA009915: Original Case: 1805USA006787; US-009507513-1805USA009916: Original Case: 1805USA006787; US-009507513-1805USA009917: Original Case: 1805USA006787; US-009507513-1805USA009918: Original Case: 1805USA006787; US-009507513-1805USA009919: Original Case: 1805USA006787; US-009507513-1805USA009920: Original Case: 1805USA006787; US-009507513-1805USA009921: Original Case: 1805USA006787; US-009507513-1805USA009922: Original Case: 1805USA006787; US-009507513-1805USA009923: Original Case: 1805USA006787; US-009507513-1805USA009924: Original Case: 1805USA006787; US-009507513-1805USA009925: Original Case: 1805USA006787; US-009507513-1805USA009926: Original Case: 1805USA006787; US-009507513-1805USA009927: Original Case: 1805USA006787; US-009507513-1805USA009928: Original Case: 1805USA006787; US-009507513-1805USA009929: Original Case: 1805USA006787; US-009507513-1805USA009930: Original Case: 1805USA006787; US-009507513-1805USA009931: Original Case: 1805USA006787; US-009507513-1805USA009932: Original Case: 1805USA006787; US-009507513-1805USA009933.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of  PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929 , Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. ; Sender's Comments:  1805USA009899:Original Case : 1805USA006787 1805USA009900:Original Case : 1805USA006787 1805USA009901:Original Case : 1805USA006787 1805USA009902:Original Case : 1805USA006787 1805USA009903:Original Case : 1805USA006787 1805USA009904:Original Case : 1805USA006787 1805USA009905:Original Case : 1805USA006787 1805USA009906:Original Case : 1805USA006787 1805USA009907:Original Case : 1805USA006787 1805USA009908:Original Case : 1805USA006787 1805USA009909:Original Case : 1805USA006787 1805USA009910:Original Case : 1805USA006787 1805USA006787:Original Case : 1805USA006787 1805USA009912:Original Case : 1805USA006787 1805USA009913:Original Case : 1805USA006787 1805USA009914:Original Case : 1805USA006787 1805USA009915:Original Case : 1805USA006787 1805USA009916:Original Case : 1805USA006787 1805USA009917:Original Case : 1805USA006787 1805USA009918:Original Case : 1805USA006787 1805USA009919:Original Case : 1805USA006787 1805USA009920:Original Case : 1805USA006787 1805USA009921:Original Case : 1805USA006787 1805USA009922:Original Case : 1805USA006787 1805USA009923:Original Case : 1805USA006787 1805USA009924:Original Case : 1805USA006787 1805USA009925:Original Case : 1805USA006787 1805USA009926:Original Case : 1805USA006787 1805USA009927:Original Case : 1805USA006787 1805USA009928:Original Case : 1805USA006787 1805USA009929:Original Case : 1805USA006787 1805USA009930:Original Case : 1805USA006787 1805USA009931:Original Case : 1805USA006787 1805USA009932:Original Case : 1805USA006787 1805USA009933:Original Case : 1805USA006787 1805USA009934:Original Case : 1805USA006787 1805USA009935:Original Case : 1805USA006787 1805USA009898:Original Case : 1805USA006787
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: 1805USA009899:Original Case : 1805USA006787; 1805USA009900:Original Case : 1805USA006787; 1805USA009901:Original Case : 1805USA006787; 1805USA009902:Original Case : 1805USA006787; 1805USA009903:Original Case : 1805USA006787; 1805USA009904:Original Case : 1805USA006787; 1805USA009905:Original Case : 1805USA006787; 1805USA009906:Original Case : 1805USA006787; 1805USA009907:Original Case : 1805USA006787; 1805USA009908:Original Case : 1805USA006787; 1805USA009909:Original Case : 1805USA006787; 1805USA009910:Original Case : 1805USA006787; 1805USA009911:Original Case : 1805USA006787; 1805USA006787:Original Case : 1805USA006787; 1805USA009913:Original Case : 1805USA006787; 1805USA009914:Original Case : 1805USA006787; 1805USA009915:Original Case : 1805USA006787; 1805USA009916:Original Case : 1805USA006787; 1805USA009917:Original Case : 1805USA006787; 1805USA009918:Original Case : 1805USA006787; 1805USA009919:Original Case : 1805USA006787; 1805USA009920:Original Case : 1805USA006787; 1805USA009921:Original Case : 1805USA006787; 1805USA009922:Original Case : 1805USA006787; 1805USA009923:Original Case : 1805USA006787; 1805USA009924:Original Case : 1805USA006787; 1805USA009925:Original Case : 1805USA006787; 1805USA009926:Original Case : 1805USA006787; 1805USA009927:Original Case : 1805USA006787; 1805USA009928:Original Case : 1805USA006787; 1805USA009929:Original Case : 1805USA006787; 1805USA009930:Original Case : 1805USA006787; 1805USA009931:Original Case : 1805USA006787; 1805USA009932:Original Case : 1805USA006787; 1805USA009933:Original Case : 1805USA006787; 1805USA009934:Original Case : 1805USA006787; 1805USA009935:Original Case : 1805USA006787; 1805USA009898:Original Case : 1805USA006787.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot #: N021728, Exp Date: 06-FEB-2019) (Lot#: N022972, Exp Date: 19-FEB-2019) , (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787 US-009507513-1805USA009900:Original Case : 1805USA006787 US-009507513-1805USA009901:Original Case : 1805USA006787 US-009507513-1805USA009902:Original Case : 1805USA006787 US-009507513-1805USA009903:Original Case : 1805USA006787 US-009507513-1805USA009904:Original Case : 1805USA006787 US-009507513-1805USA009905:Original Case : 1805USA006787 US-009507513-1805USA009906:Original Case : 1805USA006787 US-009507513-1805USA009907:Original Case : 1805USA006787 US-009507513-1805USA009908:Original Case : 1805USA006787 US-009507513-1805USA009909:Original Case : 1805USA006787 US-009507513-1805USA009910:Original Case : 1805USA006787 US-009507513-1805USA009911:Original Case : 1805USA006787 US-009507513-1805USA009912:Original Case : 1805USA006787 US-009507513-1805USA006787:Original Case : 1805USA006787 US-009507513-1805USA009914:Original Case : 1805USA006787 US-009507513-1805USA009915:Original Case : 1805USA006787 US-009507513-1805USA009916:Original Case : 1805USA006787 US-009507513-1805USA009917:Original Case : 1805USA006787 US-009507513-1805USA009918:Original Case : 1805USA006787 US-009507513-1805USA009919:Original Case : 1805USA006787 US-009507513-1805USA009920:Original Case : 1805USA006787 US-009507513-1805USA009921:Original Case : 1805USA006787 US-009507513-1805USA009922:Original Case : 1805USA006787 US-009507513-1805USA009923:Original Case : 1805USA006787 US-009507513-1805USA009924:Original Case : 1805USA006787 US-009507513-1805USA009925:Original Case : 1805USA006787 US-009507513-1805USA009926:Original Case : 1805USA006787 US-009507513-1805USA009927:Original Case : 1805USA006787 US-009507513-1805USA009928:Original Case : 1805USA006787 US-009507513-1805USA009929:Original Case : 1805USA006787 US-009507513-1805USA009930:Original Case : 1805USA006787 US-009507513-1805USA009931:Original Case : 1805USA006787 US-009507513-1805USA009932:Original Case : 1805USA006787 US-009507513-1805USA009933.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications. On an unknown date, the patient was vaccinated with M-M-R II by intramuscular route (strength, dose, anatomical location, lot number and expiration date were not reported) for prophylaxis (incorrect route of drug administration).  No adverse symptoms were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not reported. On 22-MAY-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX23 injection, lot # R002354, expiry date: 17-DEC-2018, intramuscularly for prophylaxis (strength, dose and dosage schedule were not provided). No adverse effects were reported. The temperature excursion and time frame for PNEUMOVAX23 were 10.9°C during 1 hour and 15 minutes. No previous temperature excursion was reported. Data logger was reported.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 12 months old male patient. No information was provided regarding medical history, concurrent conditions or concomitant medications of the patients. On 20-NOV-2017, the patient was vaccinated with improperly stored doses of VAQTA (lot # N014945, expiry date 31-AUG-2018) for prophylaxis (dose and route of administration were not reported). The VAQTA was stored in temperature of 32 degree Fahrenheit (°F) to 35 °F for 4 hours. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 22-MAY-2018, the patient was vaccinated with ZOSTAVAX lot # M041087 with expiration date of 03-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). This was supported as per the expiry memo. No adverse effects reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, 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 or about 13-MAY-2011, the patient was inoculated with 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. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 27-JUL-2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe shingles. On or about 28-JUL-2015, the patient sought subsequent treatment from a physician for continued and worsening blistering outbreaks that were further diagnosed as shingles. The patient was prescribed acyclovir, morphine, and famciclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for the 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, Pain, 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 or about 21-JUL-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. On or about 27-JUN-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster. The patient was prescribed valacyclovir HCL (VALTREX) and acetaminophen (+) hydrocodone bitartrate (NORCO) for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for the 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 is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 24-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route administered at a pharmacy as recommended for routine adult health maintenance and for the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. During July 2016, the patient was treated at a medical group for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the pt 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: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to two male boy patients of unknown age. The patients' medical history, concurrent condition and other concomitant medication were not reported. On 03-APR-2018, the two patients were vaccinated with improperly stored VARIVAX (dose, route unknown, lot # N015475 with expiration date 18-MAY-2019) for prophylaxis. The sterile diluent (manufacturer unknown) (unknown lot number and expiration date) used for reconstitution was properly stored. The vaccine was exposed to temperature excursion of -14 degree Celsius to -10 degree Celsius for a time frame of 2 hours. There were no previous temperature excursions. Data logger was involved. No product quality complaint (PQC) was involved in this case. No adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA011819: US-009507513-1805USA011820: US-009507513-1805USA011821: US-009507513-1805USA011822: US-009507513-1710USA004084.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a female girl patient of unknown age. The patient's medical history, concurrent condition and other concomitant medication were not reported. On 03-APR-2018, the patient was vaccinated with improperly stored VARIVAX (dose, route unknown, lot # N015475 with expiration date 18-MAY-2019)  for prophylaxis. The sterile diluent (manufacturer unknown) (unknown lot number and expiration date) used for reconstitution was properly stored. The vaccine was exposed to temperature excursion of -14 degree Celsius to -10 degree Celsius for a time frame of 2 hours. There were no previous temperature excursions.  Data logger was involved. No product quality complaint (PQC) was involved in this case. No adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1805USA011818: US-009507513-1805USA011820: US-009507513-1805USA011821: US-009507513-1805USA011822: US-009507513-1710USA004084:
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a girl patient of unknown age. The patient's medical history, concurrent condition and other concomitant medication were not reported. On 07-MAR-2018, the patient was vaccinated with improperly stored VARIVAX (dose, route unknown, lot # N015475 with expiration date 18-MAY-2019) for prophylaxis. The sterile diluent (manufacturer unknown) (unknown lot number and expiration date) used for reconstitution was properly stored. The vaccine was exposed to temperature excursion of -14 degree Celsius to -10 degree Celsius for a time frame of 2 hours. There were no previous temperature excursions. Data logger was involved. No product quality complaint (PQC) was involved in this case. No adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA011819: US-009507513-1805USA011818: US-009507513-1805USA011821: US-009507513-1805USA011822: US-009507513-1710USA004084.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to two boy patients of unknown age. The patients' medical history, concurrent condition and other concomitant medication were not reported. On 20-MAR-2018, the two patients were vaccinated with improperly stored VARIVAX (dose, route unknown, lot # N017396 with expiration date 07-JUN-2019) for prophylaxis. The sterile diluent (manufacturer unknown) (unknown lot number and expiration date) used for reconstitution was properly stored. The vaccine was exposed to temperature excursion of -14 degree Celsius to -10 degree Celsius for a time frame of 2 hours. There were no previous temperature excursions. Data logger was involved. No product quality complaint (PQC) was involved in this case. No adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA011818: US-009507513-1805USA011819: US-009507513-1805USA011820: US-009507513-1710USA004084: US-009507513-1805USA011822.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a boy patient of unknown age. The patient's medical history, concurrent condition and other concomitant medication were not reported.  On 28-FEB-2018, the patient was vaccinated with improperly stored VARIVAX (dose, route unknown, lot # N017396 with expiration date 07-JUN-2019) for prophylaxis. The sterile diluent (manufacturer unknown) (unknown lot number and expiration date) used for reconstitution was properly stored. The vaccine was exposed to temperature excursion of -14 degree Celsius to -10 degree Celsius for a time frame of 2 hours. There were no previous temperature excursions. Data logger was involved. No product quality complaint (PQC) was involved in this case. No adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA011818: US-009507513-1805USA011819: US-009507513-1805USA011820: US-009507513-1805USA011821: US-009507513-1710USA004084:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Redness, soreness, swelling, bruising at injection site, significant from day one to about day ten, minor from about day ten through day 21; general body aches days two to three.
Age: 81.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood test, Breast pain, Erythema, Eye pain, Injection site pain
Clinical narrative: Vaccination very painful; it hurt like someone hit her with a hammer. By 11pm there was swelling in left arm and shoulder. Applied ice but did not help; did not take any medicine. Next day, arm was more swollen and really hot at site of vaccination. Patient also reports that it hurt to move eyes and felt nausea. By night problems continued, took ALEVE and called pharmacist. Pharmacist recommended applying heat. Patient could sleep with heat treatment and medicine. Patient developed blotches in entire bodyfeels like under the skin. Also left breast is really sore. Today went to doctor and did blood work. Doctor recommended to take ALEVE and liquid BENADRYL.  Today doing better but arm is really red from shoulder to elbow.
Age: 81.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea, Peripheral swelling, Rash macular, Swelling, Vaccination site warmth
Clinical narrative: Vaccination very painful; it hurt like someone hit her with a hammer. By 11pm there was swelling in left arm and shoulder. Applied ice but did not help; did not take any medicine. Next day, arm was more swollen and really hot at site of vaccination. Patient also reports that it hurt to move eyes and felt nausea. By night problems continued, took ALEVE and called pharmacist. Pharmacist recommended applying heat. Patient could sleep with heat treatment and medicine. Patient developed blotches in entire bodyfeels like under the skin. Also left breast is really sore. Today went to doctor and did blood work. Doctor recommended to take ALEVE and liquid BENADRYL.  Today doing better but arm is really red from shoulder to elbow.
Age: 81.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Full blood count normal, Injection site bruising, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Vaccination very painful; it hurt like someone hit her with a hammer. By 11pm there was swelling in left arm and shoulder. Applied ice but did not help; did not take any medicine. Next day, arm was more swollen and really hot at site of vaccination. Patient also reports that it hurt to move eyes and felt nausea. By night problems continued, took ALEVE and called pharmacist. Pharmacist recommended applying heat. Patient could sleep with heat treatment and medicine. Patient developed blotches in entire bodyfeels like under the skin. Also left breast is really sore. Today went to doctor and did blood work. Doctor recommended to take ALEVE and liquid BENADRYL.  Today doing better but arm is really red from shoulder to elbow.
Age: 81.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Petechiae
Clinical narrative: Vaccination very painful; it hurt like someone hit her with a hammer. By 11pm there was swelling in left arm and shoulder. Applied ice but did not help; did not take any medicine. Next day, arm was more swollen and really hot at site of vaccination. Patient also reports that it hurt to move eyes and felt nausea. By night problems continued, took ALEVE and called pharmacist. Pharmacist recommended applying heat. Patient could sleep with heat treatment and medicine. Patient developed blotches in entire bodyfeels like under the skin. Also left breast is really sore. Today went to doctor and did blood work. Doctor recommended to take ALEVE and liquid BENADRYL.  Today doing better but arm is really red from shoulder to elbow.
Age: 81.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood test, Breast pain, Erythema, Eye pain, Injection site pain
Clinical narrative: Petechial type, non-pruritic rash on both arms, abdomen, back, and both thighs. Upper left arm (site of injection), erythema, warmth, and edema from top of shoulder to brachial area; mild bruising noted at injection site. No treatment initiated; CBC drawn-WNL. Rash improving on 4th day.
Age: 81.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea, Peripheral swelling, Rash macular, Swelling, Vaccination site warmth
Clinical narrative: Petechial type, non-pruritic rash on both arms, abdomen, back, and both thighs. Upper left arm (site of injection), erythema, warmth, and edema from top of shoulder to brachial area; mild bruising noted at injection site. No treatment initiated; CBC drawn-WNL. Rash improving on 4th day.
Age: 81.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Full blood count normal, Injection site bruising, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Petechial type, non-pruritic rash on both arms, abdomen, back, and both thighs. Upper left arm (site of injection), erythema, warmth, and edema from top of shoulder to brachial area; mild bruising noted at injection site. No treatment initiated; CBC drawn-WNL. Rash improving on 4th day.
Age: 81.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Petechiae
Clinical narrative: Petechial type, non-pruritic rash on both arms, abdomen, back, and both thighs. Upper left arm (site of injection), erythema, warmth, and edema from top of shoulder to brachial area; mild bruising noted at injection site. No treatment initiated; CBC drawn-WNL. Rash improving on 4th day.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Injection site pain, redness, swelling, low grade fever, chills.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Disturbance in attention, Fatigue, Feeling abnormal
Clinical narrative: Next day, patient had local swelling and redness at site of vaccination. Next day woke up feeling chills, myalgia, muscle ache and weakness, real malaise and fatigue. Patient did not have fever, did not have headache or nausea. Profound fatigue, brain fog and trouble concentrating/focusing lasting for about 5 days. By third day developed acidic stomach that has not resolved yet; patient had acidic reflux in past but has been off for many years successfully. On 4/23, started to feel earlier symptoms again that had resolved already; this time there was a low grade fever 102. It has been very debilitating. Took Motrin/Advil to help with symptoms seems to help with myalgia--taken as needed. Doctor appointment scheduled for 5/1 at Hospital Internal Medicine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Gastric disorder, Injection site erythema, Malaise, Muscular weakness, Myalgia
Clinical narrative: Next day, patient had local swelling and redness at site of vaccination. Next day woke up feeling chills, myalgia, muscle ache and weakness, real malaise and fatigue. Patient did not have fever, did not have headache or nausea. Profound fatigue, brain fog and trouble concentrating/focusing lasting for about 5 days. By third day developed acidic stomach that has not resolved yet; patient had acidic reflux in past but has been off for many years successfully. On 4/23, started to feel earlier symptoms again that had resolved already; this time there was a low grade fever 102. It has been very debilitating. Took Motrin/Advil to help with symptoms seems to help with myalgia--taken as needed. Doctor appointment scheduled for 5/1 at Hospital Internal Medicine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: Next day, patient had local swelling and redness at site of vaccination. Next day woke up feeling chills, myalgia, muscle ache and weakness, real malaise and fatigue. Patient did not have fever, did not have headache or nausea. Profound fatigue, brain fog and trouble concentrating/focusing lasting for about 5 days. By third day developed acidic stomach that has not resolved yet; patient had acidic reflux in past but has been off for many years successfully. On 4/23, started to feel earlier symptoms again that had resolved already; this time there was a low grade fever 102. It has been very debilitating. Took Motrin/Advil to help with symptoms seems to help with myalgia--taken as needed. Doctor appointment scheduled for 5/1 at Hospital Internal Medicine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: LARGE LOCAL REACTION - REDNESS AND SWELLING.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Hyperhidrosis, Middle insomnia
Clinical narrative: Approximately 10 hours (4 am) after injection I woke up cold so put on sweats and tried to go back to sleep. Woke up around 6 am feeling very tired and still cold. One hour later felt a severe tingling sensation over my entire body, then started shivering and very cold. Shivers lasted an hour as I was wrapped up in several  blankets. Temperature of 101-102 remained for 10-12 hours. Fever broke and I sweated through my clothes 2-3 times for the next 6 hours. 24 hours after my initial reaction I feel normal, but tired.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Approximately 10 hours (4 am) after injection I woke up cold so put on sweats and tried to go back to sleep. Woke up around 6 am feeling very tired and still cold. One hour later felt a severe tingling sensation over my entire body, then started shivering and very cold. Shivers lasted an hour as I was wrapped up in several  blankets. Temperature of 101-102 remained for 10-12 hours. Fever broke and I sweated through my clothes 2-3 times for the next 6 hours. 24 hours after my initial reaction I feel normal, but tired.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Nausea dizzy faint chills fever pain in the arm.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Nausea dizzy faint chills fever pain in the arm.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events 1 month after MMR vaccine 5/23/18.
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-APR-2018, the patient was vaccinated with VARIVAX. Other suspect therapies included sterile diluent. On an unknown date in April 2018, the patient experienced rash pruritic. The outcome of rash pruritic was reported as recovering/resolving. The reporter considered rash pruritic to be related to sterile diluent and VARIVAX.
Age: 79.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and the patient's daughter refers to a 79 years old female patient. The patient's concurrent conditions and concomitant medications were not reported. The patient had undergone an unspecified surgery long time ago. The patient's drug reactions and allergies were not reported. On 13-OCT-2017, the patient was vaccinated with PNEUMOVAX 23(dose, units and frequency not reported) (lot # N012127 and expiration date: 20-JAN-2019) intramuscularly on right upper arm (deltoid). Co-suspect medication included influenza virus vaccine (flu shot) taken at the same time at the opposite side. On an unknown date in October 2017, patient experienced extreme pain in the arm and could not able to lift arm or get dressed. The patient wanted to go to emergency room but did not. The patient took 7 days to be able to function (injected limb mobility decreased) and 7 to 10 days for pain to go away. Outcome of the events was recovered. The reporter did not provide the causal relationship for the events with suspect therapy PNEUMOVAX 23. This is one of the 4 cases received from the same reporter. Sender's Comments: US-009507513-1710USA009526: US-009507513-1805USA007661: US-009507513-1805USA007662.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities, Pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old male patient. The patient's concurrent conditions were not reported. The patient's drug reactions, allergies and concomitant medications were not reported. On 17-OCT-2017, the patient was vaccinated with PNEUMOVAX23 (dose, units and frequency not reported) (lot # N012127 and expiration date: 20-JAN-2019) intramuscularly on right upper arm. It was reported that the patient had Flu shots before, at the same time, on the opposite side. The patient went to emergency room. On an unknown date in October 2017, patient experienced excruciating pain, the patient could not event shake hand or put clothes on, patient could not get dressed (injected limb mobility decreased). It was reported that the patient could not sleep. The patient was treated with ice and Tylenol for the event injected limb mobility decreased. The patient took 7 days to be able to function (injected limb mobility decreased) and 10 days for pain to go away (injection site pain). The outcome of the event insomnia was unknown and other events had resolved. The reporter did not provide the causal relationship for the events with suspect therapy PNEUMOVAX23. This is one of the 4 cases received from the same reporter. Sender's Comments: US-009507513-1710USA009526: US-009507513-1805USA007660.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old male patient. The patient's concurrent conditions were not reported. The patient's drug reactions, allergies and concomitant medications were not reported. On 17-OCT-2017, the patient was vaccinated with PNEUMOVAX23 (dose, units and frequency not reported) (lot # N012127 and expiration date: 20-JAN-2019) intramuscularly on right upper arm. It was reported that the patient had Flu shots before, at the same time, on the opposite side. The patient went to emergency room. On an unknown date in October 2017, patient experienced excruciating pain, the patient could not event shake hand or put clothes on, patient could not get dressed (injected limb mobility decreased). It was reported that the patient could not sleep. The patient was treated with ice and Tylenol for the event injected limb mobility decreased. The patient took 7 days to be able to function (injected limb mobility decreased) and 10 days for pain to go away (injection site pain). The outcome of the event insomnia was unknown and other events had resolved. The reporter did not provide the causal relationship for the events with suspect therapy PNEUMOVAX23. This is one of the 4 cases received from the same reporter. Sender's Comments: US-009507513-1710USA009526: US-009507513-1805USA007660.