chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: FLUC3
Symptoms: Hepatobiliary scan normal, Laboratory test normal, Legionella test, Mycoplasma test negative, Pyrexia
Clinical narrative: Case number PHHY2016US023697, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 616040) on 19 Feb 2016. This report refers to a 72 years old female patient. Medical history included associated decreased sodium and fever which abated after 2 weeks. Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 174084) intramuscularly on 02 Nov 2015. On 04 Nov 2015 the patient developed febrile illness (temperature between 100 and greater than or equal to 104 degrees F) which required hospitalization for 13 days. The patient had no response to broad antibiotics. The patient underwent blood culture test, legionella test, chest x-ray, mycoplasma test, urine analysis, rickettsia test, HIDA (hepatobiliary scan), computerized tomogram of abdomen/pelvis and the results of the tests were negative. Outcome of the events was unknown. The causality of the events was not reported.
Age: 72.0
Sex: F
Vaccine: FLUC3
Symptoms: Typhus rickettsia test, Urine analysis normal
Clinical narrative: Case number PHHY2016US023697, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 616040) on 19 Feb 2016. This report refers to a 72 years old female patient. Medical history included associated decreased sodium and fever which abated after 2 weeks. Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 174084) intramuscularly on 02 Nov 2015. On 04 Nov 2015 the patient developed febrile illness (temperature between 100 and greater than or equal to 104 degrees F) which required hospitalization for 13 days. The patient had no response to broad antibiotics. The patient underwent blood culture test, legionella test, chest x-ray, mycoplasma test, urine analysis, rickettsia test, HIDA (hepatobiliary scan), computerized tomogram of abdomen/pelvis and the results of the tests were negative. Outcome of the events was unknown. The causality of the events was not reported.
Age: 59.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site discomfort, Injection site pain, Muscular weakness
Clinical narrative: Case number PHHY2016US030586, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 616905) website on 29 Feb 2016. This report refers to a 59 years old female patient. Past medical history was not reported. Historical drugs included as penicillin, doxycycline and clindamycin. Concomitant medications was not reported. The patient was vaccinated with FLUCELVAX (batch number: not reported) into left arm, intramuscularly on 06 Oct 2015. It was reported that, injection was given in top of shoulder. On 06 Oct 2015, the patient felt like balloon was expanding in shoulder, increase in pain and decrease in range of motion and strength in left arm over the weeks to follow. The patient X ray had been done on an unknown date and magnetic resonance imaging (MRI) scan is scheduled on 09 Jan 2016. The patient visited to the emergency room. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of injected limb mobility decreased was upgraded to medically significant based on the information available in the source document.
Age: 59.0
Sex: F
Vaccine: FLUC3
Symptoms: X-ray
Clinical narrative: Case number PHHY2016US030586, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 616905) website on 29 Feb 2016. This report refers to a 59 years old female patient. Past medical history was not reported. Historical drugs included as penicillin, doxycycline and clindamycin. Concomitant medications was not reported. The patient was vaccinated with FLUCELVAX (batch number: not reported) into left arm, intramuscularly on 06 Oct 2015. It was reported that, injection was given in top of shoulder. On 06 Oct 2015, the patient felt like balloon was expanding in shoulder, increase in pain and decrease in range of motion and strength in left arm over the weeks to follow. The patient X ray had been done on an unknown date and magnetic resonance imaging (MRI) scan is scheduled on 09 Jan 2016. The patient visited to the emergency room. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of injected limb mobility decreased was upgraded to medically significant based on the information available in the source document.
Age: 60.0
Sex: F
Vaccine: FLUC3
Symptoms: Pruritus, Rash pruritic
Clinical narrative: Case number PHHY2016US029501, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 616911) website on 29 Feb 2016. This report refers to a 60 years old female patient. Medical history was not reported. Vaccination history included administration of first dose of FLUCELVAX (batch number: not reported) when the patient was 59 years old which caused rash on legs (see case: PHHY2016US029543). Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX (batch number: 173252) intramuscularly into gluteus on 29 Oct 2015. On 30 Oct 2015 after vaccination, the patient experienced itchy rash around hairline, forehead, it spread to the back, both lower legs, both knees, shoulders, chest over the next several days, with intense itching. The patient was prescribed 07 days of steroids (manufacturer unknown), antihistamine ZYRTEC and PEPCID. The patient had no relief or change with the medications. It was reported as the rash moved around to different areas of body and did not start to clear until 28 Dec 2015. The patient visited the emergency room on an unknown date. The final outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality not reported. Seriousness of the events rash generalized and pruritus generalised was upgraded based on information available in the source document.
Age: 64.0
Sex: F
Vaccine: FLUC3, VARZOS
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2016US033387, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 617739) website on 08 Mar 2016. This report refers to a 64-years-old female patient. Past medical history included atrioventricular nodal reentrant tachycardia (AVNRT), vision impairment. The patient experienced nausea and vomiting on Cephalexin (manufacturer unknown) and rash on ibuprofen (manufacturer unknown). Concomitant medications included tramadol (manufacturer unknown), trazodone (manufacturer unknown), paroxetine (manufacturer unknown), Albuterol, cyanocobalamin (manufacturer unknown), estrogens conjugated (manufacturer unknown), oxybutynin (manufacturer unknown), omeprazole (manufacturer unknown) and simvastatin (manufacturer unknown). The patient was vaccinated with FLUCELVAX (batch number: 174278) intramuscularly in left deltoid and ZOSTAVAX (other manufacturer, batch number: L021609) subcutaneously in left arm both received on 20 Nov 2015. Erythema started 3 hours after injection and suggested more of reaction than an infection. On 22 Nov 2015, the patient experienced progressive redness, tenderness and warmth around injection site (reported as likely Zoster site). The symptoms were mostly local around injection site. The patient experienced itchy palms and itchy throat that concerned more of systemic hypersensitivity reaction (reported as no stridor, wheezing, fevers or other mucosal involvement experienced by the patient). The patient was treated with BENADRYL, SOLU-MEDROL, ranitidine ER (manufacturer unknown) in the emergency room and responded well to the treatment. The patient also treated with diphenhydramine (manufacturer unknown) 25 mg once and methylprednisolone (manufacturer unknown) 125 mg once and ranitidine (manufacturer unknown) 50 mg once. Outcome of the events was reported as complete recovery on an unknown date. Seriousness of the events was reported as non serious. Symptoms mostly locally around injection site considered to be likely with zoster vaccine, but could not rule out reaction to influenza. Seriousness of the event hypersensitivity was upgraded to medically significant based on the information available in the source document.
Age: 64.0
Sex: F
Vaccine: FLUC3, VARZOS
Symptoms: Local reaction, Pruritus, Throat irritation
Clinical narrative: Case number PHHY2016US033387, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 617739) website on 08 Mar 2016. This report refers to a 64-years-old female patient. Past medical history included atrioventricular nodal reentrant tachycardia (AVNRT), vision impairment. The patient experienced nausea and vomiting on Cephalexin (manufacturer unknown) and rash on ibuprofen (manufacturer unknown). Concomitant medications included tramadol (manufacturer unknown), trazodone (manufacturer unknown), paroxetine (manufacturer unknown), Albuterol, cyanocobalamin (manufacturer unknown), estrogens conjugated (manufacturer unknown), oxybutynin (manufacturer unknown), omeprazole (manufacturer unknown) and simvastatin (manufacturer unknown). The patient was vaccinated with FLUCELVAX (batch number: 174278) intramuscularly in left deltoid and ZOSTAVAX (other manufacturer, batch number: L021609) subcutaneously in left arm both received on 20 Nov 2015. Erythema started 3 hours after injection and suggested more of reaction than an infection. On 22 Nov 2015, the patient experienced progressive redness, tenderness and warmth around injection site (reported as likely Zoster site). The symptoms were mostly local around injection site. The patient experienced itchy palms and itchy throat that concerned more of systemic hypersensitivity reaction (reported as no stridor, wheezing, fevers or other mucosal involvement experienced by the patient). The patient was treated with BENADRYL, SOLU-MEDROL, ranitidine ER (manufacturer unknown) in the emergency room and responded well to the treatment. The patient also treated with diphenhydramine (manufacturer unknown) 25 mg once and methylprednisolone (manufacturer unknown) 125 mg once and ranitidine (manufacturer unknown) 50 mg once. Outcome of the events was reported as complete recovery on an unknown date. Seriousness of the events was reported as non serious. Symptoms mostly locally around injection site considered to be likely with zoster vaccine, but could not rule out reaction to influenza. Seriousness of the event hypersensitivity was upgraded to medically significant based on the information available in the source document.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Wheezing
Clinical narrative: Case number PHEH2015US020224 spontaneous report received from a physician on 08 Oct 2015. This report refers to a 60 years old female patient. The patient had no history of illness. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer: Novartis, batch number: not reported) intramuscularly on 08 Oct 2015. On the same day after vaccination the patient showed signs of moderate to severe bronchitis like reaction (wheezing). The chest X-ray performed indicated negative result. The physician saw the patient on 08 Oct 2015 and further did not follow-up with her. The outcome of event was recovered. Seriousness and causality of the event was not reported. Seriousness assessment of wheezing was upgraded based on information in the source document. Follow-up information received from a physician on 08 Dec 2015: Outcome of the event (recovered) updated. Non significant follow up report from Vaccine Adverse Event Reporting System (VAERS reference number: 621292) received on 18 Mar 2016: Updated VAERS ID only.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Case number PHHY2016US037999 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 622088) and via Baxalta on 18 Mar 2016. This report refers to a female patient whose age was not reported. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unspecified date, the patient experienced influenza due to vaccination failure. The time to onset for the influenza and lab test confirmation of the strain was unknown. The outcome of the events was reported as unknown. The seriousness of the events was not reported, but the events were considered as medically significant based on the information available in the source documents. It was unknown if the reporter considered vaccination failure and influenza to be related to seasonal influenza vaccine administration. The patient gave consent to contact her for follow up.
Age: 41.0
Sex: M
Vaccine: FLUC3, PPV
Symptoms: Administration site pain, Ultrasound scan, X-ray
Clinical narrative: Case number PHHY2016US057345, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 622948) on 27 Apr 2016. This report refers to a 41 years old male patient. Medical history was not reported. Concurrent condition included diabetes. Concomitant medication were unknown. The patient was vaccinated FLUCELVAX (batch number: 173906) and PNEUMOVAX (batch number: L014458, other manufacturer); both intramuscularly into left arm on 06 Feb 2016. On the same day after vaccinations the patient experienced pain at administration site. The pain got worse and the patient sought treatment. The patient underwent x-ray and ultrasound (results not reported). The patient was treated with an unknown antibiotic and naproxen. The patient was given an injection of "lidocaine/cortisone" and was instructed to follow up in two weeks. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "pain at administration site" was upgraded based on information in the source document.
Sex: M
Vaccine: FLUX
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: Case number PHHY2016US051634, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 625642) on 18 Apr 2016. This report refers to a male patient of an unknown age. Past medical history and concomitant medication were not reported. He was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on an unknown date. Following vaccination, on an unknown date, the patient developed Guillain Barre syndrome from which he died. It was unknown if an autopsy was performed. The causality of the event was not reported.
Age: 81.0
Sex: M
Vaccine: FLUC3
Symptoms: Inflammation, Rash, Rash erythematous
Clinical narrative: Case number PHHY2016US053594 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 625982) on 18 Apr 2016. This report refers to an 81 year old male patient. His current conditions included nasal congestion with dairy products and rash with adhesive tape. He was vaccinated with FLUCELVAX (batch number: 174277) in the left arm on 24 Nov 2015. It was reported that the patient tolerated the vaccine well and the nurse did not note any signs or symptoms of adverse reaction at that time of vaccination. Approximately 2 days after vaccination, the patient developed a rash on both arms going to his back. It started with small red spots, and then became bigger, inflamed and bumpy. He took methylprednisolone by mouth as directed. The events outcome was reported as complete recovery. The seriousness of the events was not reported, but the events were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 91.0
Sex: M
Vaccine: FLUC3
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site urticaria, Injection site warmth
Clinical narrative: Case number PHHY2016US058007, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 626574) website on 27 Apr 2016. This report refers to a 91 years old male patient. Historical conditions included basal cell carcinoma/squamous cell carcinoma (BCC/SCC), edema, chronic low back pain, hyperuricemia, arthritis gouty, renal cyst bilateral, thyroid nodule left thyroid lobe hypodensity or nodule, other disease of lung right lower lobe pleural based 6mm nodule, fatty liver, anemia, chronic kidney disease unspecified, hypertrophy (benign) of prostate and hip pain. The patient had stable computerized tomography (CT) of thorax on an unknown date since 2008 and follow up computerized tomography (CT) of chest in Nov 2009. Current conditions included infection due to pseudomonas aeruginosa, infection due to enterococcus, actinic keratosis, hyperglycemia, osteoarthritis, degenerative joint disease (DJD), hypertension and infected skin graft in leg. Concomitant medication included minocycline (manufacturer unknown). The patient was vaccinated with FLUCELVAX (batch number: 174277) in to left deltoid on 26 Jan 2016. On same day after vaccination, the patient experienced itching all over body that very night after taking the flu shot. His face became very red and did not scratching his face. He experienced hives, redness, and induration and warm in left deltoid (where the shot was given). The patient denied having a fever, chills, nausea, shortness of breath, cough, urine problem and hematic urine. The patient was treated with amoxicillin (manufacturer unknown), diphenhydramine (manufacturer unknown) 25 mg BID and prednisone (manufacturer unknown) 21 dosepak. The patient was visited to emergency room on an unknown date. The final outcome of the events was reported as unknown. The seriousness and causality of the events was not reported. Seriousness of the events pruritus generalized were upgraded based on information available in the source document.
Age: 91.0
Sex: M
Vaccine: FLUC3
Symptoms: Pruritus generalised
Clinical narrative: Case number PHHY2016US058007, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 626574) website on 27 Apr 2016. This report refers to a 91 years old male patient. Historical conditions included basal cell carcinoma/squamous cell carcinoma (BCC/SCC), edema, chronic low back pain, hyperuricemia, arthritis gouty, renal cyst bilateral, thyroid nodule left thyroid lobe hypodensity or nodule, other disease of lung right lower lobe pleural based 6mm nodule, fatty liver, anemia, chronic kidney disease unspecified, hypertrophy (benign) of prostate and hip pain. The patient had stable computerized tomography (CT) of thorax on an unknown date since 2008 and follow up computerized tomography (CT) of chest in Nov 2009. Current conditions included infection due to pseudomonas aeruginosa, infection due to enterococcus, actinic keratosis, hyperglycemia, osteoarthritis, degenerative joint disease (DJD), hypertension and infected skin graft in leg. Concomitant medication included minocycline (manufacturer unknown). The patient was vaccinated with FLUCELVAX (batch number: 174277) in to left deltoid on 26 Jan 2016. On same day after vaccination, the patient experienced itching all over body that very night after taking the flu shot. His face became very red and did not scratching his face. He experienced hives, redness, and induration and warm in left deltoid (where the shot was given). The patient denied having a fever, chills, nausea, shortness of breath, cough, urine problem and hematic urine. The patient was treated with amoxicillin (manufacturer unknown), diphenhydramine (manufacturer unknown) 25 mg BID and prednisone (manufacturer unknown) 21 dosepak. The patient was visited to emergency room on an unknown date. The final outcome of the events was reported as unknown. The seriousness and causality of the events was not reported. Seriousness of the events pruritus generalized were upgraded based on information available in the source document.
Age: 58.0
Sex: F
Vaccine: FLUC3
Symptoms: Anxiety, Pruritus, Urticaria
Clinical narrative: Case number PHHY2016US068588, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 627730) on 17 May 2016. This report refers to a 58 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 174277) into left arm on 16 Nov 2015. On the same day after vaccination the patient developed urticaria, pruritus and anxiety. The patient was treated with epinephrine 0.3 mg once. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "urticaria" was upgraded based on information in the source document.
Age: 19.0
Sex: M
Vaccine: FLUC3
Symptoms: Feeling abnormal, Influenza, Influenza like illness, Vaccination failure
Clinical narrative: Case number PHEH2016US008149, is an initial spontaneous report received from a health care professional on 31 Mar 2016. This report also associated with product quality complaint (QA reference number: 1013962). This report refers to a 20 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173906) intramuscular on an unknown date in Sep 2015. The patient caregiver stated he had been feeling bad for about a month with flu like symptoms and was recently diagnosed with influenza. The seriousness, outcome and causality of the events were not reported. The seriousness assessment of influenza, vaccination failure and influenza like illness were upgraded based on information in the source document. Non significant follow up report from Vaccine Adverse Event Reporting System (VAERS reference number: 630513) received on 17 May 2016: Updated VAERS ID only.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Vaccination site abscess, Vaccination site discolouration, Vaccination site induration
Clinical narrative: This spontaneous report was received from a 23-year-old female pharmacy student, who was reporting on herself. The patient's pertinent medical history included having warts on her hand at an unspecified time in the youth (which were removed by unspecified means). The patient had no drug reactions or allergies. No information regarding the patient's concurrent conditions was provided. On 14-NOV-2016, the patient received the first dose of GARDASIL 9 injection, at the dose of 0.5 ml, frequency reported as "once", intramuscularly in gluteal muscle (lot # and expiration date were not reported) for human papilloma virus (HPV) protection. Concomitant therapies included LINZESS and MINASTRIN. On an unknown date, after receiving the dose of  GARDASIL 9, the patient experienced induration, hardness, redness and heat at the vaccination site. The patient sought medical attention (office visit) and received treatment with KEFLEX at the dose of 500 mg, twice per day, for 7 days. However, the patient stated that the symptoms did not improve. The vaccination area was "black and blue" and when she palpated the area, it felt like an abscess. She also reported that it stung like a shard of glass and burned if touched. There were no laboratory diagnostics studies performed. The patient did not recover from aforementioned events at the time of the report. The reporter did not provide causal relationship between the events and the GARDASIL 9. Upon internal review, the events of induration, hardness, redness and heat at the vaccination site, as well as, the event of "black and blue" vaccination area were considered to be medically significant since the patient may require medical intervention and further treatment to prevent other complications. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: This spontaneous report was received from a 23-year-old female pharmacy student, who was reporting on herself. The patient's pertinent medical history included having warts on her hand at an unspecified time in the youth (which were removed by unspecified means). The patient had no drug reactions or allergies. No information regarding the patient's concurrent conditions was provided. On 14-NOV-2016, the patient received the first dose of GARDASIL 9 injection, at the dose of 0.5 ml, frequency reported as "once", intramuscularly in gluteal muscle (lot # and expiration date were not reported) for human papilloma virus (HPV) protection. Concomitant therapies included LINZESS and MINASTRIN. On an unknown date, after receiving the dose of  GARDASIL 9, the patient experienced induration, hardness, redness and heat at the vaccination site. The patient sought medical attention (office visit) and received treatment with KEFLEX at the dose of 500 mg, twice per day, for 7 days. However, the patient stated that the symptoms did not improve. The vaccination area was "black and blue" and when she palpated the area, it felt like an abscess. She also reported that it stung like a shard of glass and burned if touched. There were no laboratory diagnostics studies performed. The patient did not recover from aforementioned events at the time of the report. The reporter did not provide causal relationship between the events and the GARDASIL 9. Upon internal review, the events of induration, hardness, redness and heat at the vaccination site, as well as, the event of "black and blue" vaccination area were considered to be medically significant since the patient may require medical intervention and further treatment to prevent other complications. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Blister, Headache, Pruritus, Rash erythematous
Clinical narrative: Red rash, blisters, itching, headache.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Pallor, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: Pale, unresponsive and not breathing.
Age: 0.92
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Blood test, Electrocardiogram, Electroencephalogram, Joint stiffness
Clinical narrative: Clenched fists, stiff legs, stiff ankles, general weakness and drowsiness.
Age: 0.92
Sex: M
Vaccine: FLU4
Symptoms: Muscle contractions involuntary, Musculoskeletal stiffness, Somnolence
Clinical narrative: Clenched fists, stiff legs, stiff ankles, general weakness and drowsiness.
Sex: U
Vaccine: HEPA
Symptoms: Hepatitis A, Hepatitis A virus test positive
Clinical narrative: .This literature marketed report has been received from the authors of the published literature article, describing a pediatric transplant recipient patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (manufacturer unknown) (dose, lot # and expiration date were not reported). On an unknown date, the patient had detectable Hepatitis A (HAV) ribonucleic acid (RNA) in specimen, which confirmed that the child was infected with HAV. Further investigation to ascertain how the patient acquired HAV was under way. The authors considered hepatitis A to be related to hepatitis a vaccine, inactivated (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-APR-2015, the patient was vaccinated with the first dose of GARDASIL injection, lot# L001442 and expiration date 30-NOV-2016; exact dose and route of administration were not reported. On 30-JUN-2015, the patient received a second dose of GARDASIL injection (lot reported as L007495 and expiration date: 28-FEB-2017; exact dose and route of administration were not reported). On 03-NOV-2015, the patient received the first dose of GARDASIL 9 injection (lot# L019286 and expiration date: 30-SEP-2017; exact dose and route of administration were not reported). On 04-JAN-2016, the patient received the second dose of GARDASIL 9 injection (lot reported as  L077282 and expiration date: 30-SEP-2017; exact dose and route of administration were not reported). On 05-DEC-2016, the patient received the third dose of GARDASIL 9 injection (lot# M031557 and expiration date: 30-APR-2019; exact dose and route of administration were not reported). No adverse effects were reported. The reporter provided GARDASIL with lot# L004795, which was not valid for GARDASIL. However, lot# L007495 is valid for GARDASIL 9. Lot number L077282 is an invalid lot number for GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # L039094, expiration date 08-JAN-2017 (dose and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information is not expected as there is no information available.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a pharmacy intern concerning an 11 or 12 years old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 13-JAN-2015, the patient was vaccinated with the first dose in the Human Papillomavirus (HPV) series with GARDASIL (strength, dose, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unspecified date in December 2016, the patient was vaccinated with the second dose in the HPV series with GARDASIL 9 (strength, dose, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 16-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX injection, lot # M028552, expiry date 07-JUN-2018 (dose, route of administration and anatomical location were not specified) for prophylaxis. The administered dose underwent a temperature excursion between 14 Fahrenheit degrees and 46 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, and refers to a patient of unknown age and gender. The patient's medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that, on an unspecified date, the patient may have received an improperly stored dose of VARIVAX, lot # M033904, expiration date 20-JUL-2018, or a dose of PROQUAD, lot # M022401, expiration date 30-NOV-2017, for prophylaxis (dose number and route were unspecified). No adverse effect reported. The vaccines underwent a temperature excursion between -15 Celsius degrees and -10 Celsius degrees during 1 hour. No data logger was involved. The reporter stated that they were not sure which of the vaccines the patient received. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, Loss of consciousness
Clinical narrative: This spontaneous report was received from a physician via field employee refers to a patient of unknown demographics. Information on pertinent medical history and allergies were reported as unknown. On an unknown date, physician reported that the patient was vaccinated with first dose of GARDASIL 9, intramuscular injection (dose was not reported) for prophylaxis. On an unknown date, patient received second dose and the patient passed out. The patient's mother (demographics unknown) refused the third dose. The outcome of passed out was reported as unknown. Upon internal review, the event of loss of consciousness was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Pertinent medical history, current condition and concomitant medications were not reported. On 19-JAN-2017, the patient was vaccinated with ZOSTAVAX (dosage regimen were not reported), subcutaneous and already had received dose of ZOSTAVAX (lot number, expiry unknown by reporter) on an unknown date in May 2016 (extra dose administered). No side effects were reported (no adverse event). No further information available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse via a field representative referring to a female patient of unknown age. Information about concomitant therapy, concurrent condition, drug reactions/allergies and medical history was unknown. On unknown dates, the patient was subsequently vaccinated with 3 doses of GARDASIL (dose, frequency, route, lot # and expiration date were unknown) for prophylaxis. The feild representative confirm that it was GARDASIL and not GARDASIL 9). On an unknown date, the patient performed papanicolaou smear (Pap) test which showed positive for cervical cancer after receiving the third dose of GARDASIL. The patient sought medical attention. The outcome of cervical cancer was unknown. The causality assessment between the event and GARDASIL was unknown. Upon internal review, cervical cancer was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 61 year old female patient concerning herself. The patient did not have pertinent medical history and drug reaction/allergies. The patient had concomitant medications, but she refused to answer the name of medications. In around February 2016, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, lot# and expiration date were unknown) (route reported "vaccine") for "prevent the shingles". On 12-JAN-2017(reported as 8 days ago), the patient experienced a mild case of the shingles. The treatment was given for the shingles. The outcome of the event and the causality between ZOSTAVAX and the event were unknown. Additional information is not expected since there was no consent to contact the physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date after 07-OCT-2016, the patient was vaccinated with improperly stored PROQUAD (rHA, lot # M007963, expiration date 24-DEC-2017, 0.5 ml, subcutaneous) for prophylaxis. No adverse effects were reported. The excursion temperature included higher than 5 Fahrenheit degree but lower than 14 Fahrenheit degree for 8 hours and 30 minutes and higher than 14 Fahrenheit degree but lower than 46 Fahrenheit degree for 30 minutes. There was no previous excursion. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA003754.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date after 07-OCT-2016, the patient was vaccinated with improperly stored PROQUAD (rHA, lot # M031567, expiration date 24-DEC-2017, 0.5 ml, subcutaneous) for prophylaxis. No adverse effects were reported. The excursion temperature included higher than 5 Fahrenheit degree but lower than 14 Fahrenheit degree for 8 hours and 30 minutes and higher than 14 Fahrenheit degree but lower than 46 Fahrenheit degree for 30 minutes. There was no previous excursion. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA003754.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date after 07-OCT-2016, the patient was vaccinated with improperly stored PROQUAD (rHA, lot # M007963, expiration date 15-AUG-2017, 0.5 ml, subcutaneous) for prophylaxis. No adverse effects were reported. The excursion temperature included higher than 5 Fahrenheit degree but lower than 14 Fahrenheit degree for 8 hours and 30 minutes and higher than 14 Fahrenheit degree but lower than 46 Fahrenheit degree for 30 minutes. There was no previous excursion. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA003754.
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site nodule
Clinical narrative: Initial unsolicited report received from a medical assistant on 13 January 2017. This Case Is Linked With 2017SA007206, 2017SA007210. This case involves a 4-years-old female patient who was vaccinated with dose of DAPTACEL (batch number: C5117AA, expiry date: 19 January 2019, dose and dose in series were not reported) and HEPATITIS A VACCINE (HEP A) (batch number: M032492, expiry date, dose and dose in series were not reported) via intramuscularly in the thigh site on 12 January 2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination was reported as none per reporter. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 13 January 2017, one day of following the vaccination, the patient had developed a knot at the injection site. The patient required emergency room (ER) or doctor visit on an unknown date. The patient's Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as unknown. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt. called to report erythema, redness, pain, swelling at injection site R deltoid injection site, tennis ball size. (Call to office approx. 4:45pm). Advised BENADRYL, ice to area and ER if no improvement or worsening sx.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dyspnoea, Hypersomnia
Clinical narrative: Pt. brought to MC via EMS on 1/18/17 at 13:27 for difficulty breathing and sleeping more since shots.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal discomfort, Anaphylactic reaction, Angioedema, Asthma, Chest discomfort
Clinical narrative: Case number PHEH2016US021633, is an initial spontaneous report received from a physician on 25 Aug 2016. This report refers to a 7 year old female patient. Medical history and concomitant medications were not reported. The patient received FLUCELVAX QUADRIVALENT (batch number: 185286) at a dose of 0.5 ml intramuscularly on 24 Aug 2016. On the same day approximately 15 minutes after receiving vaccination, the patient experienced upset stomach, tachypnea, wheezing and angioedema (the physician reported it as anaphylactic reaction to vaccine). The physician reported that, the patient experienced asthma, dyspnea, chest discomfort, sneezing, erythema, flushing, urticaria, rash, edema/swelling of eye, eyelids and skin. The physician reported that symptoms have resolved except patient was still coughing. The physician stated that steroids, albuterol and BENADRYL would be required as a treatment. The outcome of the events GI upset and cough was reported as complete recovery on 24 Aug 2016, of the event angioedema was reported as complete recovery on 25 Aug 2016, of the event wheezing reported as complete recovery on 26 Aug 2016 and outcome of other events was not reported. Seriousness of the events was not reported. The physician assessed the causality between the events and FLUCELVAX QUADRIVALENT as suspected. Seriousness of the event anaphylactic reaction was upgraded based on Novartis important medical event (NVS IME) list. Follow up report received from a physician on 10 Oct 2016: Added events (asthma, dyspnea, chest discomfort, sneezing, erythema, flushing, urticaria, rash, edema/swelling of eye, eyelids and skin). Updated event information (event end dates of the events angioedema, wheezing, GI upset and cough and outcome of event cough) and treatment information and updated the narrative accordingly.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Dyspnoea, Erythema, Eye oedema, Eye swelling
Clinical narrative: Case number PHEH2016US021633, is an initial spontaneous report received from a physician on 25 Aug 2016. This report refers to a 7 year old female patient. Medical history and concomitant medications were not reported. The patient received FLUCELVAX QUADRIVALENT (batch number: 185286) at a dose of 0.5 ml intramuscularly on 24 Aug 2016. On the same day approximately 15 minutes after receiving vaccination, the patient experienced upset stomach, tachypnea, wheezing and angioedema (the physician reported it as anaphylactic reaction to vaccine). The physician reported that, the patient experienced asthma, dyspnea, chest discomfort, sneezing, erythema, flushing, urticaria, rash, edema/swelling of eye, eyelids and skin. The physician reported that symptoms have resolved except patient was still coughing. The physician stated that steroids, albuterol and BENADRYL would be required as a treatment. The outcome of the events GI upset and cough was reported as complete recovery on 24 Aug 2016, of the event angioedema was reported as complete recovery on 25 Aug 2016, of the event wheezing reported as complete recovery on 26 Aug 2016 and outcome of other events was not reported. Seriousness of the events was not reported. The physician assessed the causality between the events and FLUCELVAX QUADRIVALENT as suspected. Seriousness of the event anaphylactic reaction was upgraded based on Novartis important medical event (NVS IME) list. Follow up report received from a physician on 10 Oct 2016: Added events (asthma, dyspnea, chest discomfort, sneezing, erythema, flushing, urticaria, rash, edema/swelling of eye, eyelids and skin). Updated event information (event end dates of the events angioedema, wheezing, GI upset and cough and outcome of event cough) and treatment information and updated the narrative accordingly.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Eyelid oedema, Flushing, Rash, Skin oedema, Skin swelling
Clinical narrative: Case number PHEH2016US021633, is an initial spontaneous report received from a physician on 25 Aug 2016. This report refers to a 7 year old female patient. Medical history and concomitant medications were not reported. The patient received FLUCELVAX QUADRIVALENT (batch number: 185286) at a dose of 0.5 ml intramuscularly on 24 Aug 2016. On the same day approximately 15 minutes after receiving vaccination, the patient experienced upset stomach, tachypnea, wheezing and angioedema (the physician reported it as anaphylactic reaction to vaccine). The physician reported that, the patient experienced asthma, dyspnea, chest discomfort, sneezing, erythema, flushing, urticaria, rash, edema/swelling of eye, eyelids and skin. The physician reported that symptoms have resolved except patient was still coughing. The physician stated that steroids, albuterol and BENADRYL would be required as a treatment. The outcome of the events GI upset and cough was reported as complete recovery on 24 Aug 2016, of the event angioedema was reported as complete recovery on 25 Aug 2016, of the event wheezing reported as complete recovery on 26 Aug 2016 and outcome of other events was not reported. Seriousness of the events was not reported. The physician assessed the causality between the events and FLUCELVAX QUADRIVALENT as suspected. Seriousness of the event anaphylactic reaction was upgraded based on Novartis important medical event (NVS IME) list. Follow up report received from a physician on 10 Oct 2016: Added events (asthma, dyspnea, chest discomfort, sneezing, erythema, flushing, urticaria, rash, edema/swelling of eye, eyelids and skin). Updated event information (event end dates of the events angioedema, wheezing, GI upset and cough and outcome of event cough) and treatment information and updated the narrative accordingly.