chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 15 month old patient unknown gender. The patients' medical history, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin)rHA(M-M-R II)  lot # N024696, expiration date 07-APR-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA009336: US-009507513-1809USA009329: US-009507513-1809USA009336: US-009507513-1809USA009345: US-009507513-1809USA009344: US-009507513-1809USA009343: US-009507513-1809USA009342: US-009507513-1809USA009341: US-009507513-1809USA009340: US-009507513-1809USA009339: US-009507513-1809USA009338: US-009507513-1809USA009337: US-009507513-1809USA009346: US-009507513-1809USA009335: US-009507513-1809USA009334: US-009507513-1809USA009333: US-009507513-1809USA009332: US-009507513-1809USA009331: US-009507513-1809USA009330.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist refers to a currently 33 year old female patient. Information on pertinent medical history and concomitant medications were not reported. The patient was allergic to Penicillin. On an unknown date in 2016, the patient was vaccinated with M-M-R II injection 0.5 ml once subcutaneously (lot # L024267 and expiry date: 01-JUL-2017) for fertility (product use in unapproved indication). On an unknown date, the patient underwent a "blood test" by an unknown healthcare professional (not further clarified) and her titer results were negative for measles, mumps, and rubella. It could not be further determined if the patient received any prior doses of M-M-R II as part of routine vaccination. No treatment was given to treat the adverse events. The outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was reported as not recovered/not resolved. The causality assessment was not reported. There was no product quality complaint (PQC) reported.
Age: 0.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 3 month old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 01-MAR-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB, lot # N012921 (expiry date: 28-FEB-2020) for prophylaxis (incorrect product storage). The vaccine was concomitantly reconstituted with properly stored sterile diluent (MERCK). The vaccine underwent a temperature excursion of 34.70 F for 0.25 hours. No adverse effects were reported. The call was because of a data logger. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA000815: US-009507513-1809USA002917: US-009507513-1809USA002918: US-009507513-1809USA002919: US-009507513-1809USA002920: US-009507513-1809USA002921: US-009507513-1809USA002922: US-009507513-1809USA002923.
Age: 1.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 14 month old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 01-MAR-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB, lot # N012921 (expiry date: 28-FEB-2020) for prophylaxis (incorrect product storage). The vaccine was concomitantly reconstituted with properly stored sterile diluent (MERCK). The vaccine underwent a temperature excursion of 34.70 F for 0.25 hours. No adverse effects were reported. The call was because of a data logger. On 01-MAR-2018, the patient was vaccinated with other dose of LIQUID PEDVAXHIB for prophylaxis (lot#, expiry date and dosage not reported). No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA000815: US-009507513-1809USA002916: US-009507513-1809USA002918: US-009507513-1809USA002919: US-009507513-1809USA002920: US-009507513-1809USA002921: US-009507513-1809USA002922: US-009507513-1809USA002923: US-009507513-1804USA000815.
Age: 1.25
Sex: U
Vaccine: HIBV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 15 month old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 29-MAR-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB, lot # N012921 (expiry date: 28-FEB-2020) and M-M-R II, (therapy type: rHA), lot #N010495, (expiry date: 31-MAR-2019) for prophylaxis (incorrect product storage). The vaccines were concomitantly reconstituted with properly stored sterile diluent (MERCK). The LIQUID PEDVAXHIB underwent a temperature excursion of 34.70 F for 0.25 hours and the M-M-R II underwent a temperature excursion of 35.00 F for 0.25 hours. No adverse effects were reported. The call was because of a data logger. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA000815: US-009507513-1809USA002916: US-009507513-1809USA002917: US-009507513-1809USA002919: US-009507513-1809USA002920: US-009507513-1809USA002921: US-009507513-1809USA002922: US-009507513-1809USA002923: US-009507513-1804USA000815.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 13 year old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 18-JAN-2018, the patient was vaccinated with improperly stored GARDASIL 9 lot # N013276 (expiry date: 21-JAN-2020) for prophylaxis (dose not reported). The vaccine was concomitantly reconstituted with properly stored sterile diluent (MERCK). The vaccine underwent a temperature excursion of 35.80 F for 0.25 hours. No adverse effects were reported. The call was because of a data logger. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA000815: US-009507513-1809USA002916: US-009507513-1809USA002917: US-009507513-1809USA002918: US-009507513-1809USA002920: US-009507513-1809USA002921: US-009507513-1809USA002922: US-009507513-1809USA002923.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 16 year old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 18-JAN-2018, the patient was vaccinated with improperly stored GARDASIL 9, lot # N017686 (expiry date: 02-FEB-2020) for prophylaxis (incorrect product storage) (dose not reported). The vaccine was concomitantly reconstituted with properly stored sterile diluent. The vaccine underwent a temperature excursion of 35.30 F for 0.25 hours. No adverse effects were reported. The call was because of a data logger. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA000815: US-009507513-1809USA002916: US-009507513-1809USA002917: US-009507513-1809USA002918: US-009507513-1809USA002919: US-009507513-1809USA002921: US-009507513-1809USA002922: US-009507513-1809USA002923.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 17 year old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 22-MAR-2018, the patient was vaccinated with improperly stored GARDASIL 9, lot # N017686 (expiry date: 02-FEB-2020) for prophylaxis (incorrect product storage) (dose not reported). The vaccine was concomitantly reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). The vaccine underwent a temperature excursion of 35.30 F for 0.25 hours. No adverse effects were reported. The call was because of a data logger. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA000815: US-009507513-1809USA002916: US-009507513-1809USA002917: US-009507513-1809USA002918: US-009507513-1809USA002919: US-009507513-1809USA002920: US-009507513-1809USA002922: US-009507513-1809USA002923:
Age: 0.42
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 5 month old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 08-MAR-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB, lot # N012921 (expiry date: 28-FEB-2020) for prophylaxis (incorrect product storage) (dose not reported). The vaccine was concomitantly reconstituted with properly stored sterile diluent (MERCK). The vaccine underwent a temperature excursion of 34.70 F for 0.25 hours. No adverse effects were reported. The call was because of a data logger. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA000815: US-009507513-1809USA002916: US-009507513-1809USA002917: US-009507513-1809USA002918: US-009507513-1809USA002919: US-009507513-1809USA002920: US-009507513-1809USA002921: US-009507513-1809USA002923.
Age: 1.08
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 13 month old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 24-JAN-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB, lot # N012921 (expiry date: 28-FEB-2020) for prophylaxis (incorrect product storage) (dose not reported). The vaccine was concomitantly reconstituted with properly stored sterile diluent (MERCK). The vaccine underwent a temperature excursion of 34.70 F for 0.25 hours. No adverse effects were reported. The call was because of a data logger. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA000815: US-009507513-1809USA002916: US-009507513-1809USA002917: US-009507513-1809USA002918: US-009507513-1809USA002919: US-009507513-1809USA002920: US-009507513-1809USA002921: US-009507513-1809USA002922.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 38 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-AUG-2018, the patient was vaccinated with a dose of M-M-R II injection, lot # N023146, expiration date 24-AUG-2019, (frequency was not reported), that was administered intramuscularly, for prophylaxis. No adverse effects were reported. The vaccine was administered along with a sterile diluent.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
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 20-FEB-2015, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of the ZOSTAVAX, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a shingles outbreak until 20-FEB-2017. As a direct result of the ZOSTAVAX, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX.  The outcome of shingles outbreak was unknown. Shingles outbreak was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 18-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and indication not provided). 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. On or about 20-NOV-2016, the patient was treated at a medical office for a blistering vesicular outbreak that was diagnosed as a herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, 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 direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a physician, via company representative, referring to a female child of unknown age. Information regarding the patient's medical history, concurrent conditions or concomitant medications was unknown. On an unknown date, the patient was vaccinated with GARDASIL 9, intramuscularly as prevention of human papillomavirus (HPV) (dose, anatomical location, lot number and expiration date were not reported). On an unknown date, after receiving GARDASIL 9 the patient experienced seizures. Furthermore, the patient visited the neurologist and received treatment to the aforementioned event. It was unknown if any laboratory diagnostic was performed. At the time of the report, the outcome of seizure was unknown. The reporter did not provide causality assessment between the event and vaccination with GARDASIL 9.  Upon internal review the event seizures was determined to be medically significant.
Sex: U
Vaccine: HIBV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 1 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II lot # N025894,expiration date 19-SEP-2019, lot#N025898, expiration date 19-SEP-2019 (dose and route of administration were not reported) for prophylaxis and LIQUID PEDVAXHIB lot#R005116, expiration date 28-NOV-2020, lot#R004963, expiration date 21-NOV-2020 (dose and route of administration were not reported). There was no adverse effect reported. It was unknown, which lot# was administered to the patient. The doses of vaccines experienced the temperature excursion of 47.12 degrees Fahrenheit for 40 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA010336:Original Case : 1809USA008636, US-009507513-1809USA010334:Original Case : 1809USA008636, US-009507513-1809USA010333:Original Case : 1809USA008636, US-009507513-1809USA010335:Original Case : 1809USA008636.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a nurse prescriber via a company representative and refers to a 18-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unspecified day in September 2018 (reported as within the last week), the patient was vaccinated concomitantly with GARDASIL 9 and hepatitis A vaccine (manufacturer unknown) (lot #, expiration date, dose, site and route of administration were not reported for both vaccines) for prophylaxis. On the same date (reported as ''at the time of injection''), the patient ''passed out''. It was reported, the patient recovered ''quickly'' from the event on an unspecified day in September 2018. The patient did not receive treatment for the event and did not seek medical attention. The causality assessment between the event and GARDASIL 9 and hepatitis A vaccine (manufacturer unknown) was not provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. Beginning on 28-MAY-2018, the patients were vaccinated with improperly stored doses of VAQTA lot # N026997 (expiration date: 10-NOV-2018, additional dosage information was not reported) for prophylaxis. No adverse effects were reported. The vaccines were exposed to a temperature of 9-25 Celsius degrees for a timeframe of 1 hour and to a temperature below to 0 Celsius degrees for 19 hours. There was no previous excursion. No digital data logger was involved.
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Antinuclear antibody positive, Borrelia test, Immunology test, Joint swelling, Nuclear magnetic resonance imaging normal
Clinical narrative: This spontaneous report was received from a consumer referring to a 13 year old female patient with no pertinent medical history or drug reaction or allergies. Concomitant therapies included meningococcal vaccine and diphtheria toxoid, pertussis acellular vaccine. On 18-JUL-2018, the patient was vaccinated with the first dose of GARDASIL 9 lot # R003557 (expiration date 20-NOV-2018) intramuscularly in the right arm for prophylaxis. On approximately 25-JUL-2018 (reported as one week after vaccination), the patient developed a swollen knee. Since this reaction developed, the patient underwent two MRI tat confirmed that there was no tissue or ligament damage. Only fluid could be seen on the patient's knee. It was also stated that the patient had a low positive ANA (antinuclear antibody) marker. The patient has gone to 5 weeks of physical therapy and was on naproxen. Other laboratories performed were a full CDC infection diseases test, an autoimmune panel and a test for Lyme disease, however, no results were provided. At the time of the report, the outcome of joint swelling and antinuclear antibody positive was reported as not recovered. No relatedness assessment was provided.
Age: 6.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 6 years old patient unknown gender. The patients' medical history, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of M-M-R II  lot # N024696, expiration date 07-APR-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA000142:
Age: 1.33
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 16 month old patient unknown gender. The patients' medical history, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of M-M-R II  lot # N024696, expiration date 07-APR-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 9 to 25  (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA000142:
Age: 1.92
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 23 Months old patient unknown gender. The patients' medical history, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of M-M-R II  lot # N013868, expiration date 04-MAY-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA000142:
Age: 1.67
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 20 Months old patient unknown gender. The patients' medical history, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of M-M-R II  lot # N013868, expiration date 04-MAY-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA000142:
Age: 1.83
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 22 Months old patient unknown gender. The patients' medical history, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of M-M-R II  lot # N013868, expiration date 04-MAY-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA000142:
Age: 1.33
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 16 Months old patient unknown gender. The patients' medical history, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of M-M-R II  lot # N024696, expiration date 07-APR-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA000142:
Age: 1.33
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 16 Months old patient unknown gender. The patients' medical history, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of M-M-R II lot # N024696, expiration date 07-APR-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA000142.
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 13 Months old patient unknown gender. The patients' medical history, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of M-M-R II lot # N024696, expiration date 07-APR-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA000142.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 20 year old patient of unknown gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On an unknown date, the 20 year old patient was vaccinated with PROQUAD (strength, dose, frequency, routed, lot# and expiration date were unknown) for prophylaxis. No adverse symptoms were reported.
Sex: U
Vaccine: HIBV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 1 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II lot # N025894,expiration date 19-SEP-2019, lot#N025898, expiration date 19-SEP-2019 (dose and route of administration were not reported) for prophylaxis and LIQUID PEDVAXHIB lot#R005116, expiration date 28-NOV-2020, lot#R004963, expiration date 21-NOV-2020 (dose and route of administration were not reported). There was no adverse effect reported. It was unknown, which lot# was administered to the patient. The doses of vaccines experienced the temperature excursion of 47.12 degrees Fahrenheit for 40 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA008636:Original Case : 1809USA008636, US-009507513-1809USA010336:Original Case : 1809USA008636, US-009507513-1809USA010335:Original Case : 1809USA008636, US-009507513-1809USA010334:Original Case : 1809USA008636.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 4 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II lot # N025894,expiration date 19-SEP-2019, lot#N025898, expiration date 19-SEP-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. It was unknown, which lot# of vaccine were administered to the patient. The doses of vaccines experienced the temperature excursion of 47.12 degrees Fahrenheit for 40 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA010333:Original Case : 1809USA008636, US-009507513-1809USA010335:Original Case : 1809USA008636, US-009507513-1809USA008636:Original Case : 1809USA008636, US-009507513-1809USA010336:Original Case : 1809USA008636.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 5 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II lot # N025894, expiration date 19-SEP-2019, lot#N025898, expiration date 19-SEP-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. It was unknown, which lot# was administered to the patient. The doses of vaccines experienced the temperature excursion of 47.12 degrees Fahrenheit for 40 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA010333:Original Case : 1809USA008636, US-009507513-1809USA010334:Original Case : 1809USA008636, US-009507513-1809USA010336:Original Case : 1809USA008636, US-009507513-1809USA008636:Original Case : 1809USA008636.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 7 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II lot # N025894,expiration date 19-SEP-2019, lot#N025898, expiration date 19-SEP-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. It was unknown, which lot# was administered to the patient. The doses of vaccines experienced the temperature excursion of 47.12 degrees Fahrenheit for 40 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA010333:Original Case : 1809USA008636, US-009507513-1809USA010334: US-009507513-1809USA010335:US-009507513-1809USA008636.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Herpes zoster, Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, generalized aching, teeth chattering, feeling cold, burning skin and pruritus. The patient was treated with Valacyclovir. On an unknown date, the outcome of the influenza-like symptoms, generalized aching, teeth chattering, feeling cold, burning skin and pruritus were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, generalized aching, teeth chattering, feeling cold, burning skin and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller (patient) stated that she had dose SHINGRIX vaccine in early June 2018 in the left arm. The patient sated that she experienced flu like symptoms about 24 hours after receiving the vaccine. The patient felt achy all over, her teeth were chattering, felt cold, and ended up laying in bed for the rest of the day. The patient's symptoms resolved about 6 hours later. The patient started experiencing prodromal symptoms of a shingles outbreak about 10 months (discrepant data, however no clarification could be obtained) after dose of the SHINGRIX. The patient started experiencing burning and itching along her dermatone which prompted her to go to urgent care. The patient was given a 7 day cycle of Valacyclovir and her prodromal symptoms relieved in the first day. The patient was hesitant to receive the 2nd dose of medication as she worries about the side effects. No further information were provided.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin burning sensation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, generalized aching, teeth chattering, feeling cold, burning skin and pruritus. The patient was treated with Valacyclovir. On an unknown date, the outcome of the influenza-like symptoms, generalized aching, teeth chattering, feeling cold, burning skin and pruritus were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, generalized aching, teeth chattering, feeling cold, burning skin and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller (patient) stated that she had dose SHINGRIX vaccine in early June 2018 in the left arm. The patient sated that she experienced flu like symptoms about 24 hours after receiving the vaccine. The patient felt achy all over, her teeth were chattering, felt cold, and ended up laying in bed for the rest of the day. The patient's symptoms resolved about 6 hours later. The patient started experiencing prodromal symptoms of a shingles outbreak about 10 months (discrepant data, however no clarification could be obtained) after dose of the SHINGRIX. The patient started experiencing burning and itching along her dermatone which prompted her to go to urgent care. The patient was given a 7 day cycle of Valacyclovir and her prodromal symptoms relieved in the first day. The patient was hesitant to receive the 2nd dose of medication as she worries about the side effects. No further information were provided.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 73-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fall (collapse due to stress and infection and was on respirator). Concurrent medical conditions included rotator cuff tear and carpal tunnel syndrome (causes numbness in hands and fingers). On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than 3 months after receiving SHINGRIX, the patient experienced fatigue, disorientation, feeling abnormal and influenza-like symptoms. On an unknown date, the outcome of the fatigue, disorientation and feeling abnormal were recovered/resolved and the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the fatigue, disorientation, feeling abnormal and influenza-like symptoms to be related to SHINGRIX. Additional information was reported as follows: After vaccination with SHINGRIX the patient felt what she called mild flu like symptoms of fatigue, feeling out of sorts and slight disorientation. The events experienced by the patient were mostly resolved. This case was linked with case US2018GSK170183 (2nd dose), reported by the same reporter for the same patient.
Age: 67.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Anxiety, Disturbance in attention, Feeling abnormal, Irritability, Personality change
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of concentration loss in a 67-year-old female patient who received FLULAVAL TETRA (batch number 972F3, expiry date 13th June 2019) for prophylaxis. Concomitant products included ZOLOFT. On 6th September 2018, the patient received FLULAVAL TETRA (intramuscular) .5 ml. On an unknown date, 1 day after receiving FLULAVAL TETRA, the patient experienced concentration loss, personality change, feeling abnormal, anxiety and irritability. On an unknown date, the outcome of the concentration loss, personality change, feeling abnormal, anxiety and irritability were not recovered/not resolved. It was unknown if the reporter considered the concentration loss, personality change, feeling abnormal, anxiety and irritability to be related to FLULAVAL TETRA. Additional details were provided as follows: The healthcare professional reported the case for herself. The patient developed lack of focus, anxiety, crankiness, out of sorts feeling, and a personality shift. The health care professional stated her adverse events are feeling a little better but they had not gone away. The health care professional was taking ZOLOFT and health care professional was concerned about potential drug interaction between ZOLOFT and the FLULAVAL. This case is linked to case US2018165445 and US2018165450 reported by the same reporter.
Sex: U
Vaccine: FLU4, FLUX
Symptoms: Anxiety, Disturbance in attention, Feeling abnormal, Irritability, Personality change
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of concentration loss in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2017-2018 season) (batch number unknown, expiry date 13th June 2019) for prophylaxis. Concomitant products included sertraline hydrochloride (Zoloft). On an unknown date, the patient received Influenza vaccine Quadrivalent 2017-2018 season (intramuscular). On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced concentration loss, personality change, feeling abnormal, anxiety and irritability. On an unknown date, the outcome of the concentration loss, personality change, feeling abnormal, anxiety and irritability were not recovered/not resolved. It was unknown if the reporter considered the concentration loss, personality change, feeling abnormal, anxiety and irritability to be related to Influenza vaccine Quadrivalent 2017-2018 season. Additional details were provided as follows: The healthcare professional reported the case for herself. The age at vaccination was not reported. The patient developed lack of focus, anxiety, crankiness, out of sorts feeling, and a personality shift. The health care professional stated her adverse events are feeling a little better but they had not gone away. The health care professional was taking Zoloft and health care professional was concerned about potential drug interaction between Zoloft and the FLULAVAL. This case is linked to case US2018165442 and US2018165445 reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Nervous system disorder, Neurological symptom, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included gluten sensitivity (that caused neurological symptoms). On 10th September 2018 19:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th September 2018, 1 days after receiving SHINGRIX, the patient experienced headache, sleepiness, foggy feeling in head, neurological symptom and nervous system disorder. On an unknown date, the outcome of the headache, sleepiness, foggy feeling in head, neurological symptom and nervous system disorder were unknown. It was unknown if the reporter considered the headache, sleepiness, foggy feeling in head, neurological symptom and nervous system disorder to be related to SHINGRIX. Additional details were provided as follows: The reporter was husband of the patient. The patient received dose of SHINGRIX in the left arm in the evening, a day before the date of reporting. On 11th September 2018, in the morning, the patient woke up and felt like she had been exposed to gluten and with a bad headache and she had trouble waking up and staying awake and she was in a fog. It felt like her nervous system was not working right. These were symptoms very characteristic of her reactions to gluten. The reporter was concerned that the patient was exposed to gluten from the SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site vesicles
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received SHINGRIX for prophylaxis. On 7th July 2018, the patient received the 2nd dose of SHINGRIX. On 7th July 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 1st August 2018, the patient experienced injection site vesicles. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site vesicles was unknown. It was unknown if the reporter considered the injection site pain and injection site vesicles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 73 or 74 years old. The patient received SHINGRIX on right arm. In 2018, the patient had soreness and pain at the injection when he received the vaccine. The pain did not go away until four days later and he said the pain came back about the first of August and seemed to get worse. The patient stated that, it started back slowly and intermittently and he believed that the weather, temperatures in the 90's or above, might had affected the change in the pain which had gotten worse. The patient stated that in his mind, it seemed a bubble was coming in where he received the shot. He thought that the liquid from the injection might have bubbled under the skin but was not certain. The patient did not see any bubbles under the skin. The pain aggravated at the site in which he could forget about it then it hurt when he paid attention to it and then he said that it should be considered an ache instead of a pain. The patient did mention this to a physician initially, only casually after discussion of other issues. The physician did not seem concerned by it experience. The patient did speak with the pharmacy where he received the injection just to let them know of his experience. The patient gave information about the physician that he spoke to and the pharmacy. The patient also spoke with the vaccine administrator who was a fill in pharmacist on the day the vaccine was given.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Fatigue, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 82-year-old female patient who received SHINGRIX for prophylaxis. On 5th September 2018, the patient received the 2nd dose of SHINGRIX. On 6th September 2018, 1 days after receiving SHINGRIX, the patient experienced erythema of extremities, upset stomach and pruritus. On 9th September 2018, the patient experienced tiredness. On 9th September 2018, the outcome of the erythema of extremities was recovered/resolved. On an unknown date, the outcome of the upset stomach and pruritus were recovered/resolved and the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, upset stomach, tiredness and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The arm redness resolved a couple of days before the time of reporting and the tiredness developed about that time.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site bruising, Injection site haemorrhage, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 22nd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced shivering and injection site bruising. On 22nd August 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, swelling arm, muscle pain and injection site hemorrhage. On an unknown date, the outcome of the shivering, fatigue, swelling arm, injection site bruising, muscle pain and injection site hemorrhage were recovered/resolved. It was unknown if the reporter considered the shivering, fatigue, swelling arm, injection site bruising, muscle pain and injection site hemorrhage to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The patient received SHINGRIX in the left deltoid. She stated that the pharmacist must have hit a blood vessel because there was blood on the BAND-AID and noticed a bruise at the injection site about 3 or 4 days later that lasted about a week. Within 12 hours, she experienced muscle pain (resolved over 3 or 4 days), fatigue (resolved after 36 hours) and swelling in the arm. She also had shivering, but it was very short lived. She felt better 48 hours after receiving the vaccine and stated that the side effects were not bad enough to where she would not get the 2nd vaccine.