chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discomfort, Limb discomfort, Rash pruritic, Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 75-year-old male patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. Concomitant products included CRESTOR, FLONASE Nasal Spray, LINZESS and ZETIA. On 25th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th July 2018, less than a day after receiving SHINGRIX, the patient experienced itchy rash, arm discomfort, blistery rash and raised rash. On an unknown date, the outcome of the itchy rash, arm discomfort, blistery rash and raised rash were not recovered/not resolved. It was unknown if the reporter considered the itchy rash, arm discomfort, blistery rash and raised rash to be related to SHINGRIX. Additional information was reported as follows: The patient experienced a rash with blisters that were raised and weeping, itchy and also experienced discomfort on both arms from his upper arm to his elbow. The pharmacist reported that the patient followed-up with the physician on 8th August 2018. The pharmacist reported that he reported this to VAERS.
Sex: F
Vaccine: MMRV, MMR, MMRV, VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 5 year old female child patient. There was no information about concurrent condition, concomitant medication and historical medication. On 01-AUG-2018, the patient was vaccinated with expired doses of PROQUAD lot # N001488, expiration date: 12-JUL-2018, VARIVAX (Lot number unknown) and M-M-R II (lot number unknown) for prophylaxis. Concomitant therapies included sterile diluent. No adverse event was reported.
Sex: F
Vaccine: MMRV, MMR, MMRV, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 5 year old female child patient. There was no information about concurrent condition, concomitant medication and historical medication. On 01-AUG-2018, the patient was vaccinated with expired doses of PROQUAD lot # N001488, expiration date: 12-JUL-2018, VARIVAX (Lot number unknown) and M-M-R II (lot number unknown) for prophylaxis. Concomitant therapies included sterile diluent. No adverse event was reported.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 58-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included shingles. On 6th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th August 2018, less than a day after receiving SHINGRIX, the patient experienced joint pain and injection site pain. In August 2018, the patient experienced sleeplessness, feeling hot and facial flushing. On an unknown date, the patient experienced influenza-like symptoms. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, sleeplessness, joint pain and injection site pain were recovering/resolving and the outcome of the feeling hot and facial flushing were recovered/resolved.  The reporter considered the influenza-like symptoms, sleeplessness, joint pain, injection site pain, feeling hot and facial flushing to be related to SHINGRIX. Additional details were reported as follows: The patient was fine prior to vaccination. At around 3 pm, the patient was vaccinated with SHINGRIX vaccine in right arm at local pharmacy. The patient reported that, within 4 to 5 hours after receiving SHINGRIX vaccine, arm hurt at injection site and felt joint paint all over her body that intensified during the night. The patient reported that, she also felt feverish and facial flushing in the middle of the night (latency several hours). These symptoms caused inability to sleep. The patient took  Tylenol for pain and facial flushing, which resolved afterwards. However, aching in joints remains and arm was still hurting. These symptoms were directly related to SHINGRIX vaccine as she felt fine prior. Lot number and expiry date was not available. No further information was provided. The patient had denied permission to contact primary care physician.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Feeling hot, Flushing, Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 58-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included shingles. On 6th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th August 2018, less than a day after receiving SHINGRIX, the patient experienced joint pain and injection site pain. In August 2018, the patient experienced sleeplessness, feeling hot and facial flushing. On an unknown date, the patient experienced influenza-like symptoms. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, sleeplessness, joint pain and injection site pain were recovering/resolving and the outcome of the feeling hot and facial flushing were recovered/resolved.  The reporter considered the influenza-like symptoms, sleeplessness, joint pain, injection site pain, feeling hot and facial flushing to be related to SHINGRIX. Additional details were reported as follows: The patient was fine prior to vaccination. At around 3 pm, the patient was vaccinated with SHINGRIX vaccine in right arm at local pharmacy. The patient reported that, within 4 to 5 hours after receiving SHINGRIX vaccine, arm hurt at injection site and felt joint paint all over her body that intensified during the night. The patient reported that, she also felt feverish and facial flushing in the middle of the night (latency several hours). These symptoms caused inability to sleep. The patient took  Tylenol for pain and facial flushing, which resolved afterwards. However, aching in joints remains and arm was still hurting. These symptoms were directly related to SHINGRIX vaccine as she felt fine prior. Lot number and expiry date was not available. No further information was provided. The patient had denied permission to contact primary care physician.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 58-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included shingles. On 6th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th August 2018, less than a day after receiving SHINGRIX, the patient experienced joint pain and injection site pain. In August 2018, the patient experienced sleeplessness, feeling hot and facial flushing. On an unknown date, the patient experienced influenza-like symptoms. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, sleeplessness, joint pain and injection site pain were recovering/resolving and the outcome of the feeling hot and facial flushing were recovered/resolved.  The reporter considered the influenza-like symptoms, sleeplessness, joint pain, injection site pain, feeling hot and facial flushing to be related to SHINGRIX. Additional details were reported as follows: The patient was fine prior to vaccination. At around 3 pm, the patient was vaccinated with SHINGRIX vaccine in right arm at local pharmacy. The patient reported that, within 4 to 5 hours after receiving SHINGRIX vaccine, arm hurt at injection site and felt joint paint all over her body that intensified during the night. The patient reported that, she also felt feverish and facial flushing in the middle of the night (latency several hours). These symptoms caused inability to sleep. The patient took  Tylenol for pain and facial flushing, which resolved afterwards. However, aching in joints remains and arm was still hurting. These symptoms were directly related to SHINGRIX vaccine as she felt fine prior. Lot number and expiry date was not available. No further information was provided. The patient had denied permission to contact primary care physician.
Age: 68.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 68 years old patient (gender unknown) who experienced left deltoid injection site bled a little bit and a raised marble sized lump developed quickly, while received vaccine FLUZONE HIGH DOSE. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. Notes: patient is on low dose daily aspirin therapy. On 14-Aug-2018, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI977AB, expiry date 09 Mar 2019 via unknown route in the left deltoid. On 14-Aug-2018, the patient developed a non-serious left deltoid injection site bled a little bit (vaccination site haemorrhage) same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 14-Aug-2018, the patient developed a non-serious a raised marble sized lump developed quickly (vaccination site mass) same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data was not provided. Final diagnosis was a raised marble sized lump developed quickly and left deltoid injection site bled a little bit. No corrective treatment was received. Applied pressure with sterily gauzed and pressure. The patient outcome is reported as Unknown for left deltoid injection site bled a little bit and as Unknown for a raised marble sized lump developed quickly. List of documents held by sender- none.
Age: 68.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Injection site haemorrhage, Injection site mass
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 68 years old patient (gender unknown) who experienced left deltoid injection site bled a little bit and a raised marble sized lump developed quickly, while received vaccine FLUZONE HIGH DOSE. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. Notes: patient is on low dose daily aspirin therapy. On 14-Aug-2018, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI977AB, expiry date 09 Mar 2019 via unknown route in the left deltoid. On 14-Aug-2018, the patient developed a non-serious left deltoid injection site bled a little bit (vaccination site haemorrhage) same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 14-Aug-2018, the patient developed a non-serious a raised marble sized lump developed quickly (vaccination site mass) same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data was not provided. Final diagnosis was a raised marble sized lump developed quickly and left deltoid injection site bled a little bit. No corrective treatment was received. Applied pressure with sterily gauzed and pressure. The patient outcome is reported as Unknown for left deltoid injection site bled a little bit and as Unknown for a raised marble sized lump developed quickly. List of documents held by sender- none.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash macular, Rash pruritic
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of tenderness in a female patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced tenderness, erythema and welts. On an unknown date, the outcome of the tenderness, erythema and welts were unknown. It was unknown if the reporter considered the tenderness, erythema and welts to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient via AHVM. The age at vaccination was not reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Tenderness, Urticaria
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of tenderness in a female patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced tenderness, erythema and welts. On an unknown date, the outcome of the tenderness, erythema and welts were unknown. It was unknown if the reporter considered the tenderness, erythema and welts to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient via AHVM. The age at vaccination was not reported.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Back pain, Discomfort, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Fatigue, malaise, site redness, warmth and swelling, fever, painful trapezius muscle, jaw locked up.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site warmth, Neck pain, Pain, Pain in jaw, Pyrexia
Clinical narrative: Fatigue, malaise, site redness, warmth and swelling, fever, painful trapezius muscle, jaw locked up.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Fatigue, malaise, site redness, warmth and swelling, fever, painful trapezius muscle, jaw locked up.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Myalgia, Pyrexia, Trismus
Clinical narrative: Fatigue, malaise, site redness, warmth and swelling, fever, painful trapezius muscle, jaw locked up.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Decreased appetite, Headache, Injection site pain, Pain
Clinical narrative: Experienced fever, chills, drowsiness, vomiting, red rash on face and rest of body, body ache, lack of appetite, headache, and soreness of arm that received injection.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rash, Rash erythematous, Rash generalised, Somnolence
Clinical narrative: Experienced fever, chills, drowsiness, vomiting, red rash on face and rest of body, body ache, lack of appetite, headache, and soreness of arm that received injection.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Experienced fever, chills, drowsiness, vomiting, red rash on face and rest of body, body ache, lack of appetite, headache, and soreness of arm that received injection.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site bruising, Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Fever, chills, very large red and hard bruise at injection site covering upper arm.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Blood glucose increased, Chest X-ray, Diabetes mellitus, Disorientation, Full blood count
Clinical narrative: After administration of both vaccines patient exhaled loudly and went unresponsive. Pale. Safely transferred from chair to floor. Remained unresponsive despite tactile and verbal stimulation. EPIPEN injected 0.3 mg left thigh at 1024. Responsive immediately after EPIPEN, however unsure of surroundings. Transferred to emergency room.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Glycosylated haemoglobin increased, Metabolic function test, Pallor, Unresponsive to stimuli
Clinical narrative: After administration of both vaccines patient exhaled loudly and went unresponsive. Pale. Safely transferred from chair to floor. Remained unresponsive despite tactile and verbal stimulation. EPIPEN injected 0.3 mg left thigh at 1024. Responsive immediately after EPIPEN, however unsure of surroundings. Transferred to emergency room.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report has been received from a female physician office manager who was also the patient, via a field representative, concerning herself. The patient's medical history, concurrent conditions, drug allergies and concomitant therapies were not reported. On an unknown date (reported as "years ago"), the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, route of administration, anatomical location, lot number and expiration date were not provided), for prophylaxis. On an unknown date, the patient experienced injection site swelling. She did not recall any additional details about this event. At the time of reporting, the patient's outcome for injection site swelling and the causal relationship between ZOSTAVAX and the event were unknown. This is one of two reports regarding the same patient.; Sender's Comments: US-009507513-1808USA007656:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous prospective pregnancy report was received from a medical assistant refers to a 18 year old female patient. The medical history, concurrent conditions and concomitant medications were not reported. On 18-AUG-2017, the patient was vaccinated with GARDASIL 9 lot # N000326, 14-OCT-2019, intramuscular, dose 1 for prophylaxis. On 14-FEB-2018, the patient was vaccinated with GARDASIL 9,intramuscular, lot # N021572, 01-MAY-2020 dose 2 for prophylaxis. On 13-JUL-2018, the patient was vaccinated with GARDASIL 9 intramuscular, lot # N023828, 25-JUN-2020 dose 3 for prophylaxis. Other suspect therapies included BEXSERO on 13-JUL-2018. The patient's mother reported that patient was 7 months pregnant. The pregnancy was discovered a few weeks ago and the patient had seen an unspecified gynecologist. The ultrasound of the patient was performed and it did not show any fetal abnormalities. The approximated LMP (last menstrual period) was 06-JAN-2018, Estimated date of delivery is on 13-OCT-2018. Date of conception was 20-JAN-2018. There was no treatment rendered for the event. The patient sought medical attention.
Sex: F
Vaccine: MMR
Symptoms: Eye irrigation, No adverse event, Syringe issue
Clinical narrative: Information has been received from a nurse referring to another female nurse of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 09-AUG-2018, the nurse administrated M-M-R II (rHA) (lot# N013866, expiration date 04-MAY-2019) which reconstituted by sterile diluent (MERCK) (route, strength, dose, frequency, batch/lot # and expiration date were not reported) to a patient. The vaccine sprayed out of the syringe, and may have gotten in the nurse's (unspecified) eye. The nurse used sterile eye wash immediately after potentially being exposed to M-M-R II in her eye. No adverse effect was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1808USA004956: US-009507513-1808USA004703.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from an office manager regarding a patient of unknown age and gender. Information on medical history, current conditions and concomitant therapies was not reported. On 16-AUG-2018, 10-MAY-2018 and 03-JUL-2018 the patient was vaccinated with 1st, 2nd and 3rd dose VARIVAX for prophylaxis (strength, anatomical location, route, lot# and expiry date not reported) (inappropriate schedule of drug administration). It was also reported that the patient did not had any adverse event. No product complaint involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent. On 10-AUG-2018, the patient was vaccinated with an improperly stored VARIVAX (lot: R009409; expiry date: 29-MAR-2020) (dose and route were not reported) that was reconstituted with properly stored sterile diluent (lot: N029880, expiry date: 15-MAY-2020). The vaccine VARIVAX was exposed to 47 degree F to 77 degree F for 7 days. There was a previous temperature excursion when it was exposed to 15 degree F to 46 degree F for 7 days. The call was because of a data logger. No adverse events reported.
Sex: M
Vaccine: HPV9
Symptoms: Crohn's disease
Clinical narrative: Information has been received from a physician via a company representative, referring to an adolescent male patient of unknown age (reported as "14 or 15 years old"). The patient's medical history, concurrent conditions and concomitant therapies were not reported. As medical history was reported that the patient received unspecified vaccines. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis. The reporting physician stated that the patient was diagnosed with Crohn's disease an unknown amount of time after receiving his first and only dose of GARDASIL 9. However, other physician (the physician who diagnosed the patient) suspected that the patient had had Crohn's disease since an unknown date prior to receiving GARDASIL 9, as every time the patient had received any (unspecified) vaccine, (including but not limited to GARDASIL 9), the patient experienced an increase in unspecified Crohn's disease symptoms. As a result of the event, patient has decided not to complete the GARDASIL 9 series. The outcome of the Crohn's disease was unknown and the causality between this and the vaccination with GARDASIL 9 was not reported. Upon internal review, the event of Crohn's disease was considered as medically significant.
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a currently 4 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA, (which had a lot # of N020686 and an expiration date of 22-OCT-2018; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA007361: US-009507513-1808USA007362: US-009507513-1808USA007363: US-009507513-1808USA007364: US-009507513-1808USA007365: US-009507513-1808USA007366: US-009507513-1808USA007367: US-009507513-1808USA007368: US-009507513-1808USA007369: US-009507513-1808USA007370: US-009507513-1808USA007371: US-009507513-1808USA007372: US-009507513-1808USA007373: US-009507513-1808USA007374: US-009507513-1808USA007375: US-009507513-1808USA007376: US-009507513-1808USA007360.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from Registered Nurse, referring to a 19 year old male patient. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On 17-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose and administration route were not reported) lot number N007931 and expiration date on 17-NOV-2019, for prophylaxis. On 17-AUG-2018, the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose and administration route were not reported) lot number N015087 and expiration date on 20-OCT-2019, for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: FLUX, MEA, PPV
Symptoms: Blood immunoglobulin A increased, Blood immunoglobulin G normal, Blood immunoglobulin M decreased, Immunoglobulin therapy, Vaccination failure
Clinical narrative: Information has been received from the authors in a published literature article and refers to a 12 year old male patient. The patients' concurrent conditions included Common variable immune deficiency (CVID), low immunoglobulin M (IgM), elevated immunoglobulin A (IgA), and normal immunoglobulin G (IgG). On an unspecified date, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, anatomical location, lot number and expiration date were not reported) and with unspecified influenza and measles vaccines,  but he showed poor response to the vaccines (Vaccination failure). Thereafter, the patient was placed on treatment with intravenous (IV) Immunoglobulin therapy due to low immunoglobulin M (IgM), elevated immunoglobulin A (IgA), and normal immunoglobulin G (IgG) but poor response to the vaccines. The outcome of vaccination failure was unknown at the time of the report.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber referring to a 17 weeks old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-AUG-2018, at age 17 weeks old, the patient was vaccinated with ROTATEQ (Lot: N029670; expiry date: 03-SEP-2019) (Drug administered to patient of inappropriate age). No adverse effects reported.
Sex: F
Vaccine: HPV9
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a Medical Assistant via company representative concerning a 14 year old female patient. Information on the patient's concomitant medications, pertinent medical history and drug reactions or allergies was unknown. In approximately December 2017 (reported as "8 months ago"), the patient was vaccinated with the first dose of GARDASIL 9, intramuscular for prophylaxis (dosing details, lot# and expiry date not reported). On an unknown date, the patient experienced an unspecified systemic adverse reaction (adverse event). It was reported that the patient had made appointments to see an unspecified number of unspecified physicians at an unspecified facility for diagnosis and treatment. It was unknown if the patient had received treatment for the event. No product quality complaint (PQC) was involved. Outcome of the event was unknown. The reporter's causality assessment was not provided.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assitant and refers to a 3 month old patient of unknown gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 15-AUG-2018, the patient was vaccinated with an expired ROTATEQ lot # M040271 with expiration date on 30-APR-2018, oral for prophylaxis (dose was not reported). However, no adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. In August 2015, the patient was vaccinated with the first dose of VARIVAX and M-M-R (measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)) (manufacturer unknown). On 09-AUG-2018, the patient was vaccinated inadvertently with PROQUAD lot # N020010 with expiration date on 13-JAN-2019, by intramuscular route for prophylaxis. However, no adverse effects were reported.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Biopsy skin, Rash generalised
Clinical narrative: This spontaneous report was received from the patient's mother referring to a 19-year old female patient. The patient did not have any medical history, concurrent conditions and concomitant medications. On 11-MAY-2018, the patient received her first GARDASIL 9 0.5 ml (route, lot and expiry date not reported) for the prevention of Human papilloma virus. It was reported that one to two days later (approximately 12-MAY-2018), the patient broke out in a full body rash (rash generalized). The patient saw physician for the event and unspecified treatment was provided. Biopsy was performed and results were not reported. Outcome of the event was not recovered. Causality of the event was not reported.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assitant, refers to a currently 14 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9,  (which had a lot # of N022728 and an expiration date of 31-MAY-2020; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA006354:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assitant, refers to a currently 12 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9, (which had a lot # of N022728 and an expiration date of 31-MAY-2020; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA006354:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assitant, refers to a currently 11 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9,  (which had a lot # of N022728 and an expiration date of 31-MAY-2020; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA006354:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a currently 14 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9, which had a lot # of N022728 and an expiration date of 31-MAY-2020; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006354.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assitant, refers to a currently 5 months old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ per oral, (which had a lot # of N030366 and an expiration date of 13-MAR-2019; however, dosage number was not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA006354:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assitant, refers to a currently 4 month old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ per oral, (which had a lot # of N030366 and an expiration date of 13-MAR-2019; however, dosage number was not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA006354:
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assitant, refers to a currently 5 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored M-M-R II, (which had a lot # of N014486 and an expiration date of 10-MAY-2019; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006354.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assitant, refers to a currently 1 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored M-M-R II, (which had a lot # of N014486 and an expiration date of 10-MAY-2019; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA006354:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assitant, refers to a currently 4 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored M-M-R II, (which had a lot # of N014486 and an expiration date of 10-MAY-2019; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA006354:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the intended purpose of long-term prevention of shingles and zoster related injuries (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-AUG-2016, the patient was treated by a physician for herpes zoster or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.  In 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy, for routine adult health maintenance and for the intended purpose of long-term prevention of shingles and zoster related injuries. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2013, the patient was treated by a physician/MD, for Herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX vaccine for the long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 16-AUG-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician at a medical center for routine adult health maintenance and the intended purpose of long-term prevention of shingles and zoster-related injuries. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-FEB-2013, the patient was treated by a physician at a medical center for herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-DEC-2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the intended purpose of long-term prevention of shingles and zoster related injuries (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In or about December 2015, the patient was treated at a physician office and Emergency Room for herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: This spontaneous report has been received from a female physician office manager who was also the patient, via a field representative, concerning herself. The patient's medical history, concurrent conditions, drug allergies and concomitant therapies were not reported. On 16-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 with lot # N022303 and expiration date on 01-MAR-2019 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis. On an unknown date in 2018 (reported as "shortly after receiving PNEUMOVAX 23"), the patient experienced injection site swelling which included swelling of the majority of her arm. The patient did not seek medical attention. It was reported that she took TYLENOL for this swelling and it resolved on an unknown date in 2018 (reported as "after several days"). At the time of reporting, the causal relationship between injection site swelling and peripheral swelling, and PNEUMOVAX 23 was unknown. This is one of two reports regarding the same patient. Sender's Comments: US-009507513-1807USA012213.
Sex: U
Vaccine: HPV9, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 4 year old patient of unknown gender. The patient's concomitant therapy, historical therapy and concurrent condition were not reported. On 16-AUG-2018, the unspecified 4 years old patient was inadvertently vaccinated with GARDASIL 9 (strength, dose, unit, route was not reported) (lot # N026814, expiration date was 15-JUL-2020) for prophylaxis (drug administered to patient of inappropriate age). It was also reported that the patient was administered with BOOSTRIX and MENACTRA on the same day. No adverse effects reported. Information regarding treatment given, lab diagnostics/studies performed, sought medical attention were not applicable.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Initial Report Received: 14-Jun-2018 Patient is a 31-year-old woman (race not provided) who was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  The patient reported that she developed the non-serious events of rash on both arms, rash on head and chest, rash on neck, red rash, and itchy rash. Relevant medical history and concomitant medications were not provided. The patient received the first injection of HEPLISAV-B (Lot # 1033384, expiration 06-Apr-2019) on 17-Apr-2018. The patient experienced no symptoms. The patient received the second injection of HEPLISAV-B (same lot #/expiration as first dose) on 18-May-2018. In May-2018, 1 to 2 days after the second administration of HEPLISAV-B, the patient developed a rash with small red bumps. The rash gradually presented on both arms, chest, head, and neck, and was red and itchy.  The rash worsened over the week and the patient visited her dermatologist.  She was treated with Elidel cream (pimecrolimus) and oral Xyzal antihistamine (levoceterizine).  No other information was provided. At the time of the report, the outcome of the events were unknown. The reporter did not provide a seriousness assessment for the events. Company comment:  The company assessed all events as non-serious. The events of rash, rash erythematous and rash pruritic are unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed all events as non-serious. The events of rash, rash erythematous and rash pruritic are unlisted per HEPLISAV-B USPI.