chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 10-JAN-2017 from a nurse regarding a 6 month old female patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 09-JAN-2017 the patient was vaccinated with a dose of ROTATEQ, lot number M029681 expiration 22-JAN-2018, unknown route for prophylaxis that was improperly stored. No adverse effects reported. No further information was reported. Additional information has been requested. Lot number M029681 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent.
Age: 0.08
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy intern and refers to a 5 weeks old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 24-JAN-2017, the patient was vaccinated with 0.5 ml of 1 ml adult dose of RECOMBIVAX HB (route of administration, lot # and expiry date were not reported). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the improperly stored (in the temperature of above 14F but less than 46F, for 50 hours) dose of ROTATEQ (orally, lot # M019708, expiration date 25-OCT-2017; dose was not reported) for prophylaxis. No adverse effect and no previous excursion were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (strength, dose, lot number, expiration date, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. The vaccines had a temperature excursion of 0.7 (1 Celsius (C)) for 180 hours with no previous temperature excursions. Also it was reported that a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA002225:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative referring to a 67 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2015, the patient received a dose of ZOSTAVAX vial, 1 dose (dose, route of administration, anatomical location, lot number and expiration date were not provided) for prevention of shingles. On an unknown date, reported as after receiving ZOSTAVAX, the patient developed shingles. It was unknown whether a treatment was given for the adverse event. At the time of the report, the patient was recovered from shingles. The causal relationship between ZOSTAVAX and shingles was not reported. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA001824.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-JAN-2017, the patient received a dose of improperly stored VARIVAX lot number M008171, expiration date 16-FEB-2018 (dose and route of administration were not provided) for prophylaxis. There was no adverse effect reported. No further information was provided. Administered dose of VARIVAX was exposed to a temperature excursion of >5°F but <14°F for 10 minutes. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA001825: US-009507513-1702USA001826: US-009507513-1702USA001827: US-009507513-1702USA001828.
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a Medical Assistant via a company representative, referring to a male patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions and known allergies was not reported. The patient's concomitant vaccinations included influenza virus vaccine inactivated (unspecified). On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (anatomical route of vaccination, lot number and expiration date were not provided) as immunization for the prevention of pneumococcal disease (prophylaxis). On an unknown date, the patient developed severe redness (injection site erythema) and swelling (injection site swelling) at the injection site after being vaccinated with PNEUMOVAX 23. It was also reported that, it was not specified if the patient received the flu shot in the same arm as the PNEUMOVAX 23. Furthermore, the patient was advised by the physician to go to an urgent care for the above reported symptoms, but it was unknown if the patient went to an urgent care. No product quality issue was involved. At the time of the report, the outcome of injection site erythema and injection site swelling was unknown. Additionally, the reporter did not provide for causality between the adverse events and vaccination with PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative referring to a 62 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2015, the patient received a dose of ZOSTAVAX vial, 1 dose (dose, route of administration, anatomical location, lot number and expiration date were not provided) for prevention of shingles. On an unknown date, reported as after receiving ZOSTAVAX, the patient developed shingles (herpes zoster). It was unknown whether a treatment was given for the adverse event. At the time of the report, the patient was recovered from shingles. The causal relationship between ZOSTAVAX and shingles was not reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012202:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-JAN-2017, the patient received a dose of improperly stored VARIVAX lot number M008171, expiration date 16-FEB-2018 (dose and route of administration were not provided) for prophylaxis. There was no adverse effect reported. No further information was provided. Administered dose of VARIVAX was exposed to a temperature excursion of >5°F but <14°F for 10 minutes. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012278: US-009507513-1702USA001826: US-009507513-1702USA001827: US-009507513-1702USA001828.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-JAN-2017, the patient received a dose of improperly stored VARIVAX lot number M024683, expiration date 18-MAY-2018 (dose and route of administration were not provided) for prophylaxis. There was no adverse effect reported. No further information was provided. Administered dose of VARIVAX was exposed to a temperature excursion of >5°F but <14°F for 10 minutes. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012278: US-009507513-1702USA001825: US-009507513-1702USA001827: US-009507513-1702USA001828.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-JAN-2017, the patient received a dose of improperly stored VARIVAX lot number M024683, expiration date 18-MAY-2018 (dose and route of administration were not provided) for prophylaxis. There was no adverse effect reported. No further information was provided. Administered dose of VARIVAX was exposed to a temperature excursion of >5°F but <14°F for 10 minutes. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA012278: US-009507513-1702USA001825: US-009507513-1702USA001826: US-009507513-1702USA001828.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-JAN-2017, the patient received a dose of improperly stored ZOSTAVAX vial 19400 PFU; lot number M032360, expiration date 18-AUG-2017 (dose and route of administration were not provided) for prophylaxis. There was no adverse effect reported. No further information was provided. Administered dose of ZOSTAVAX was exposed to a temperature excursion of >5°F but <14°F for 10 minutes. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012278: US-009507513-1702USA001825: US-009507513-1702USA001826: US-009507513-1702USA001827:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of ROTATEQ administered orally (strength, dose, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported. The vaccines had a temperature excursion of 0.7 (1 Celsius (C)) for 180 hours with no previous temperature excursions. Also it was reported that a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA012186:
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paralysis
Clinical narrative: Initial unsolicited report received from other non-healthcare professional on 24-Jan-2017. This case involves a female patient (age was reported as 25 or 26-year-old) was vaccinated with a dose of Fluzone QIV (batch number: UI669AD, expiry date: 30-Jun-2017, dose, dose in series, route and site of administration was not reported) on 29-Sep-2016. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, a medical condition was reported as unknown. Concomitant medication was not reported. On an unknown day, following the vaccination, patient experienced numbness of left side and paralysis. The patient required emergency visit. It was also reported that the patient was hospitalized several different times from 29-Sep-2016 to 24-Jan-2017. Lab data and corrective treatment were not reported. Outcome of events reported as not recovered. List of documents held by sender: none. Sender's Comments: Experienced numbness of left side and paralysis are unlisted with FLUZONE QIV. This is very poorly documented case. However patient's immune status, medical history, concomitant medication etc. is require to further assess this case.
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2015149558) on 18-Jan-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (TETANUS TOXOID) (batch number, expiry date, dose and dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, patient had developed allergy. Laboratory investigations and corrective treatments were not reported.  The outcome of the event was unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site mass
Clinical narrative: Initial unsolicited case received from a pharmacist via other company Novartis (under the case ID: PUS2016US185481) on 16 Jan 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE (Batch number, expiry date, dose, route and site of administration was not reported) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date after the vaccination the patient experienced difficulty moving arm and lump in arm, she had trouble lifting her arm, she also has a lump in her arm in the area where the vaccine was received. The patient lab tests and corrective treatment was not reported. The outcome of the events were not reported. List of documents held by sender: none.
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Chills, Erythema, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: He had chills, fever, and left arm from site of injection to elbow, and inner fore arm had redness and some swelling 1+ which was reported as being worse prior to being seen in Employee Health & Safety.
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Swelling
Clinical narrative: He had chills, fever, and left arm from site of injection to elbow, and inner fore arm had redness and some swelling 1+ which was reported as being worse prior to being seen in Employee Health & Safety.
Age: 29.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Altered state of consciousness, Dizziness
Clinical narrative: After receiving the Anthrax vaccination, felt light headed and almost past out. Felt light headed for about five minutes.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Local swelling, Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient experienced a stiff neck with swelling and pain.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to "possible few hundred of patients" of unknown age and gender. The patients' concurrent conditions, drug allergies or reactions, pertinent medical history and concomitant therapies were not reported. Since approximately 2013 (reported as for about 3 to 3 1/2 years) the patients had been receiving ZOSTAVAX (19400 PFU) intramuscularly (dose, lot # and expiration date were not reported). The physician also reported that there have been no additional Adverse Events reported regarding "the efficacy of administering ZOSTAVAX (19400 PFU) intramuscularly with these patients." No treatment was given. The patients did not seek medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 09-JAN-2017 from an other health professional regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was accidentally vaccinated with PROQUAD, lot number M025690 (expiration date not reported) unknown route for prophylaxis that was improperly stored. The vaccine had been stored in the refrigerator for over a week before being administered to the patient. No adverse reaction was reported. No further information was reported. This is one of two reports received from the same reporter. Lot number M025690 is an invalid lot number for measles, mumps, rubella (oka-merck) virus vaccine live. Additional information has been requested.; Sender's Comments: US-009507513-1701USA004688:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to 9 patients of unknown age and gender. The patients' concurrent conditions or medical history were not reported. On unspecified dates since 11-JAN-2017, improperly stored doses of VAQTA (lot # M033611, expiration date 02-MAR-2018; dose, route and site of administration were not reported) were administered to the patients. The vaccine was stored over 46 degrees Fahrenheit but under 77 degrees Fahrenheit for 1 hour and 6 minutes. There was previous temperature excursion of over 46 degrees Fahrenheit but under 77 degrees Fahrenheit for 1 hour and 30 minutes. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007854: US-009507513-1701USA007856: US-009507513-1701USA007841.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to 16 patients of unknown age and gender. The patients' concurrent conditions or medical history were not reported. On unspecified dates since 11-JAN-2017, improperly stored doses of PEDVAXHIB (lot # M032150, expiration date 21-APR-2019; dose, site and route of administration were not reported) were administered to the patients. The vaccine was stored over 46 degrees Fahrenheit but under 77 degrees Fahrenheit for 1 hour and 6 minutes. There was previous temperature excursion of over 46 degrees Fahrenheit but under 77 degrees Fahrenheit for 1 hour and 30 minutes. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007854: US-009507513-1701USA007841: US-009507513-1701USA007855.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L015460, expiration date: 20-JUL-2017; lot# M018644, expiration date: September 2017; lot# M022556, expiration date: 26-MAY-2017; lot# M002268, expiration date: 20-SEP-2017) (dose and route of administration were not provided). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion above 46 degrees Fahrenheit and less than 77 degrees Fahrenheit (the highest temperature: 46.81 degrees Fahrenheit) for 90 minutes. Data logger was involved. There were no previous excursions reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA002226: US-009507513-1702USA002227: US-009507513-1702USA002228.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of PEDVAXHIB lot # M027884 and expiration date on 19-APR-2019 (Strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. On 20-JAN-2017, the vaccines had an unspecified temperature excursion (reported as "> 8 Celsius (C) but < 25 C) for 1 hour and 26 minutes. Also it was reported that the vaccines had six previous temperature excursions of unspecified temperatures (all reported as "> 8 Celsius (C) but < 25 C) for 1 hour and 9 minutes; 22 minutes; 25 minutes; 24 minutes; 1 hour and 12 minutes and 26 minutes, on 30-NOV-2016; 22-DEC-2016; 27-DEC-2016; 06-JAN-2017; 12-JAN-2017 and 14-JAN-2017 respectively. It was confirmed that a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA002235: US-009507513-1702USA002234.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-JAN-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX, subcutaneously for prophylaxis, with lot # M035694 and expiration date 07-NOV-2017 (strength 19400 PFU, dose not reported). The administered dose of the vaccine experienced a temperature excursion that was greater than -15 degrees Celsius but less than -10 degrees Celsius for 17 minutes. Another temperature excursion in the same temperature ranges was reported for 3 minutes. There was no adverse effect reported. No product quality complaint was involved. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012982: Original Case : 1701USA012977.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-JAN-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX, subcutaneously for prophylaxis, with lot # M035694 and expiration date 07-NOV-2017 (strength 19400 PFU, dose not reported). The administered dose of the vaccine experienced a temperature excursion that was greater than -15 degrees Celsius but less than -10 degrees Celsius for 17 minutes. Another temperature excursion in the same temperature ranges was reported for 3 minutes. There was no adverse effect reported. No product quality complaint was involved. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012977: Original Case : 1701USA012977
Sex: M
Vaccine: FLUX, HPV9
Symptoms: Apgar score abnormal, Foetal exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report was received from a physician and refers to a 1-day-old male neonate. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The patient's mother medical history included 1 prior pregnancy with one full term delivery and allergy to CECLOR. On an unknown date, the patient was exposed transplacentally to the dose of GARDASIL 9 administered to his 29-year-old mother on 19-OCT-2016 at 11:30, first dose, 0.5 ml, lot# reported as M021407 with an expiration date 30-APR-2018 in the left deltoid for prophylaxis. The patient's mother received also other suspect medications included PRENATE (since 05-JUL-2016, tablet daily, orally for pregnancy), MACROBID (since 14-SEP-2016, for urinary tract infection (UTI)), DICLEGIS (since 22-06-2016, tablet in am, tablet in the afternoon, 2 tablets at bed time (HS) orally), TYLENOL (325 mg, as need (pm) for headaches) and was vaccinated with a dose of influenza virus vaccine (unspecified), on 19-OCT-2016. On 31-MAY-2016, the patient's mother had ultrasound examination performed. The pregnancy was confirmed with last menstrual period (LMP) on 13-APR-2016, estimated date of conception on 26-APR-2016 and estimated date of delivery (EDD) at 19-JAN-2017 (it was a twin pregnancy). The patient's mother was exposed to the therapy with GARDASIL 9 in the third trimester of pregnancy (27 weeks and 1 day). The earliest exposition of the other suspect therapies was in the first trimester of pregnancy (all captured in MARRS# 1611USA003674). On 30-DEC-2016, the patient was born at the 37 weeks of gestation (type of delivery was not reported). The baby's weight was 6 lbs and 3 oz (length was not provided). The infant was born normal, no congenital anomaly was reported. The APGAR score assessment was reported as 4 in a 9 grade scale. The outcome of the APGAR score 4 in the 9 grade scale was unknown. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review the event of APGAR score 4 in the 9 grade scale was determined to be medically significant. Additional information has been requested. Sender's Comments: US-009507513-1611USA003674.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a male patient of unknown age. There was no information about the patient's medical history, concurrent conditions or concomitant therapies reported. On 30-JAN-2016, the patient was vaccinated with an improperly stored ZOSTAVAX lot number M036643 with expiration date of 19-NOV-2017 (strength, dose, dosage schedule, anatomical location and route of administration were not provided) for prophylaxis, and the administered dose was exposed to a temperature higher than 8°C but lower than 25°C for 20 hours (digital data logger) without any previous temperature excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000434.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M006708, expiration date: 02-JUN-2018; lot# M013639, expiration date: 15-SEP-2017, lot# L033343; expiration date: 13-SEP-2017) (dose and route of administration were not provided). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion above 46 degrees Fahrenheit and less than 77 degrees Fahrenheit (the highest temperature: 46.81 degrees Fahrenheit) for 90 minutes. Data logger was involved. There were no previous excursions reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA002227: US-009507513-1702USA002228: US-009507513-1701USA010895.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L026602, expiration date: 19-OCT-2017 and lot# L040054, expiration date: 26-DEC-2017) (dose and route of administration were not provided). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion above 46 degrees Fahrenheit and less than 77 degrees Fahrenheit (the highest temperature: 46.81 degrees Fahrenheit) for 90 minutes. Data logger was involved. There were no previous excursions reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA010895: US-009507513-1702USA002226: US-009507513-1702USA002228.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported.  an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL 9 lot # M013636 and expiration date on 15-FEB-2018 (Strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. On 20-JAN-2017, the vaccines had an unspecified temperature excursion (reported as "> 8 Celsius (C) but < 25 C) for 1 hour and 26 minutes. Also it was reported that the vaccines had six previous temperature excursions of unspecified temperatures (all reported as "> 8 Celsius (C) but < 25 C) for 1 hour and 9 minutes; 22 minutes; 25 minutes; 24 minutes; 1 hour and 12 minutes and 26 minutes, on 30-NOV-2016; 22-DEC-2016; 27-DEC-2016; 06-JAN-2017; 12-JAN-2017 and 14-JAN-2017 respectively. It was confirmed that a digital data logger was involved. No product quality complaint (PQC) was involved.      This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA012268: US-009507513-1702USA002235:
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # L030162 and expiration date on 11-AUG-2017 (Strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. It was reported that the vaccine had six previous temperature excursions of unspecified temperatures (all reported as "> 8 Celsius (C) but < 25 C) for 1 hour and 9 minutes; 22 minutes; 25 minutes; 24 minutes; 1 hour and 12 minutes and 26 minutes, on 30-NOV-2016; 22-DEC-2016; 27-DEC-2016; 06-JAN-2017; 12-JAN-2017 and 14-JAN-2017 respectively. It was confirmed that a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA002234: US-009507513-1701USA012268:
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 78-year-old female patient received PREVNAR 13 (lot N34936, expiry date 31Oct2017, NDC number 0005-1971-02) intramuscular, in left deltoid, on 26Oct2016, at about 17:00, at 0.5 ml single, for pneumonia prevention. The patient medical history was not reported. The patient's concomitant medications were not reported. Since an unspecified date in Oct2016, after vaccination, the patient experienced diarrhea, extreme tiredness, weakness, loss of appetite, sore dull pain in her arm, froggy throat.  The patient mentioned these side effects to her doctor but felt they were not significant. The events had not yet resolved at the time of report.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Throat irritation
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 78-year-old female patient received PREVNAR 13 (lot N34936, expiry date 31Oct2017, NDC number 0005-1971-02) intramuscular, in left deltoid, on 26Oct2016, at about 17:00, at 0.5 ml single, for pneumonia prevention. The patient medical history was not reported. The patient's concomitant medications were not reported. Since an unspecified date in Oct2016, after vaccination, the patient experienced diarrhea, extreme tiredness, weakness, loss of appetite, sore dull pain in her arm, froggy throat.  The patient mentioned these side effects to her doctor but felt they were not significant. The events had not yet resolved at the time of report.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Initial solicited report received on 18 January 2017 from an investigator participating in the below-mentioned study. This is a prospective pregnancy registry case. This case involves a female subject (age not reported) who had vaccine exposure during pregnancy. The date of LMP was not reported. The estimated date of delivery was not reported. The mother and father's health status was not reported. The father's age was not reported. The current pregnancy history was not reported. Previous pregnancy details were not reported. The subject's maternal drug exposure details were not reported. The subject received a dose of FLUZONE QIV on an unknown date (route and site of administration and batch number not reported). The subject's treatment for infertility, family history of congenital abnormality details was not reported. The subject had serious adverse event miscarriage. Pregnancy complications were not reported. Prenatal testing details were not reported. The pregnancy outcome was reported as the subject had miscarriage. The outcome of the event miscarriage was not reported. List of documents held by sender: none. Sender's Comments: A pregnant female subject received a dose of study vaccine (information regarding LMP, date of conception, EDD or USG findings were unknown). The subject had a miscarriage (unknown latency) after receiving the study product. Based on limited available information, the sponsor assesses the event as not related to study product or trial procedure.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Child got a small rash on the right side of his trunk up near the breast and armpit. The rash didn't appear to effect him in anyway however by 2/4/2017 the rash began to spread over the rest of his trunk, extremities, and face. The original site of the rash also appeared to become itchy.
Age: 48.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Significant right arm pain, limited mobility.
Age: 73.0
Sex: F
Vaccine: DTAP, PNC13, VARZOS
Symptoms: Dyspnoea, Migraine, Palpitations
Clinical narrative: Patient stated she could not breathe good, migraines worsened, and heart was racing. She stated she took a bath, washed with antiseptic soap, and dressed in silky clothing and this helped. Her son later gave her BENADRYL.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Biopsy skin, Cutaneous vasculitis
Clinical narrative: Cutaneous vasculitis, BUE and BLE. sparing trunk and face.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Depression, Mental disorder, Suicidal ideation
Clinical narrative: Mental disturbances, extreme feelings of depression and despondency and suicidal ideation without intent, lasting approx. 12-18 hours; with no previous diagnosis or history of depression.  Did not seek medical care.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Shoulder pain and limited shoulder mobility. Started within hours of flu shot. Per doctor took ibuprofen and alternated cold and heat. Symptoms have persisted. Now entering physical therapy.
Age: 1.08
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Chills, Myoclonus
Clinical narrative: myoclonus vs rigors.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: RASH AROUND 3 INCHES LONG BY 2 INCHES WIDE AND ITCHING AROUND THE INJECTION SITE.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Patient stated she began to get nerve pain down her back, hip, and leg about 20 days after receiving the vaccine. She was given one day of valacyclovir treatment as well as gabapentin.
Age: 61.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cellulitis, Glycosylated haemoglobin, Hyperkeratosis, Hypotonia, Localised infection
Clinical narrative: Initial unsolicited report received consumer via other company on 23-Jan-2017. Manufacture control number: 16K-163-18015522-00. This case involves a 54-year-old male patient who was vaccinated with a dose of QUADRACEL and received 40 milligram dose of HUMIRA (form: solution for injection in prefilled pen) subcutaneously (Batch number, expiry date and site of administration was not reported) on an unspecified date in 2016. Patient's medical history included, in summer 2010 patient had cellulitis. In 2015 patient had double hernia for which he had laparoscopic surgery. Discovered bowel was twisted but it untwisted itself in summer of 2015. In summer of 2015 patient had cellulitis in legs and volvulus of bowel. On an unspecified date in 2015, double hernia, cellulitis in legs and bowel was twisted and cellulitis was resolved. Concomitant medication was not reported. On an unspecified date in 2016, following vaccination patient got infection in both feet which went septic and hospitalized in late November 2016 and cellulitis septic it was healing on right foot other foot might have to have a small part of the left foot cut off; it was a size of a half dollar, it was a callus with infection and lost nearly 100 pounds with this down to 199 pounds and lost most of muscle tone in calfs and arms. Patient was diagnosed as cellulitis. On 13 Dec 2016 patient would see his dermatologist. Lab test includes Glycohemoglobin, results not reported. On an unspecified date, patient received antibiotics intravenously, Betamethasone Dipropionate and clotrimazole as a corrective treatment. Patient was recovering from foot callus, infection in feet, cellulitis, sepsis and muscle tone in calfs and arms and outcome of other event was unknown. Case was reported as serious by reporter. List of documents held by sender: none. Sender's Comments: A 54 years old male had history of Double hernia, cellulitis in leg, and bowel was twisted, who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE and experienced Hyperkeratosis, Infection in both feet/cellulitis, Sepsis, Weight decreased and Hypotonia. Hypotonia is listed with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE however Hyperkeratosis, Infection in both feet/cellulitis, Sepsis, Weight decreased are not listed with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. Time to onset is unknown. Details regarding relevant medical history, concurrent condition, concomitant medication, vaccination history and its tolerance are needed to complete assessment of the case.
Age: 61.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Sepsis, Weight decreased
Clinical narrative: Initial unsolicited report received consumer via other company on 23-Jan-2017. Manufacture control number: 16K-163-18015522-00. This case involves a 54-year-old male patient who was vaccinated with a dose of QUADRACEL and received 40 milligram dose of HUMIRA (form: solution for injection in prefilled pen) subcutaneously (Batch number, expiry date and site of administration was not reported) on an unspecified date in 2016. Patient's medical history included, in summer 2010 patient had cellulitis. In 2015 patient had double hernia for which he had laparoscopic surgery. Discovered bowel was twisted but it untwisted itself in summer of 2015. In summer of 2015 patient had cellulitis in legs and volvulus of bowel. On an unspecified date in 2015, double hernia, cellulitis in legs and bowel was twisted and cellulitis was resolved. Concomitant medication was not reported. On an unspecified date in 2016, following vaccination patient got infection in both feet which went septic and hospitalized in late November 2016 and cellulitis septic it was healing on right foot other foot might have to have a small part of the left foot cut off; it was a size of a half dollar, it was a callus with infection and lost nearly 100 pounds with this down to 199 pounds and lost most of muscle tone in calfs and arms. Patient was diagnosed as cellulitis. On 13 Dec 2016 patient would see his dermatologist. Lab test includes Glycohemoglobin, results not reported. On an unspecified date, patient received antibiotics intravenously, Betamethasone Dipropionate and clotrimazole as a corrective treatment. Patient was recovering from foot callus, infection in feet, cellulitis, sepsis and muscle tone in calfs and arms and outcome of other event was unknown. Case was reported as serious by reporter. List of documents held by sender: none. Sender's Comments: A 54 years old male had history of Double hernia, cellulitis in leg, and bowel was twisted, who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE and experienced Hyperkeratosis, Infection in both feet/cellulitis, Sepsis, Weight decreased and Hypotonia. Hypotonia is listed with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE however Hyperkeratosis, Infection in both feet/cellulitis, Sepsis, Weight decreased are not listed with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. Time to onset is unknown. Details regarding relevant medical history, concurrent condition, concomitant medication, vaccination history and its tolerance are needed to complete assessment of the case.
Age: 65.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Chills, Computerised tomogram, Nausea
Clinical narrative: Abdominal pain, nausea, chills. Chills lasted until 10 PM. Abdominal pain increased to very significant on January 29 and 30. Went to ER early Jan 31. Abdominal pain only ended on Feb 2.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Pain, Pharyngeal oedema, Pyrexia, Vomiting
Clinical narrative: Ran fever all night, body aches, vomit, diarrhea, swollen throat.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Chest discomfort, Chills, Pain
Clinical narrative: PATIENT STATED SHE WAS HAVING CHILLS WITH NO FEVER, ACHES AND PAINS, AS WELL AS SHE FELT PRESSURE IN HER CHEST.
Age: 29.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Nausea, Pruritus, Rash, Swollen tongue
Clinical narrative: PT REPORTED SWOLLEN TONGUE NAUSEA THAT LASTED 4-5 DAYS WITH RANDOM DIZZINESS AND RASH/HIVES THAT COME AND GO WITH LOTS OF ITCHING.
Age: 29.0
Sex: F
Vaccine: HEPAB
Symptoms: Urticaria
Clinical narrative: PT REPORTED SWOLLEN TONGUE NAUSEA THAT LASTED 4-5 DAYS WITH RANDOM DIZZINESS AND RASH/HIVES THAT COME AND GO WITH LOTS OF ITCHING.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient received vaccine on Friday afternoon. Developed injection site redness, swelling, warmth. Later that day she had a fever of 102F at home. Called the after-hours hotline and was referred to the ED.  She went to the ED on 2/4 with localized band-like erythema (about 4 cm wide) across upper arm around site of injection, swelling, warmth. Prescribed hydroxyzine 50mg four times daily, cool compresses, and tylenol as needed.  Symptoms improved and upon re-evaluation in AM clinic on 2/6, redness and swelling resolved with post-inflammatory light hyperpigmentation present.
Age: 23.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Severe left shoulder pain (arm of injection). Range of motion limited due to pain. Last 4 weeks. Only improved after 7 day oral steroid treatment.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Swelling, Red, very sore, itching.
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a pharmacist concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not informed. On an unknown date, the patient was vaccinated with ZOSTAVAX) (lot #, expiration date, dosage and therapy route were not provided), for prophylaxis. On an unspecified date, the patient developed chickenpox. The outcome of chickenpox was unknown at the time of the report. The causal relationship between chickenpox and ZOSTAVAX was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old male patient. The patient's pertinent medical history was not informed. Concurrent conditions included hypothyroidism, chronic obstructive pulmonary disease (COPD) and diabetes. Concomitant therapies included levothyroxine, tamsulosin, montelukast (manufacturer unknown), paroxetine, glipizide, lorazepam (ATIVAN), albuterol sulfate, ipratropium bromide (DUONEB), fluticasone propionate, salmeterol xinafoate (ADVAIR), brimonidine and loxatine. On an unknown date in 2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # and expiration date were not reported), administered per subcutaneous route to prevent shingles. On an unspecified date in the summer of 2016, the patient developed shingles. On an unknown date, during the summer of 2016 the patient recovered. Then, on 25-JAN-2017, the patient received another dose of ZOSTAVAX lot # L046896, expiration date 23-FEB-2017. The causal relationship between shingles and ZOSTAVAX was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: HEP, HEPA, HIBV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 2.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Anaphylactic reaction, Dyspnoea, Musculoskeletal stiffness, Skin discolouration
Clinical narrative: Anaphylaxis, labored breathing/shortness of breath, color change and body stiffness.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient complained of severe pain and redness in right shoulder.