chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Eye pruritus, Throat irritation
Clinical narrative: This initial spontaneous case, was received on 09-Aug-2017, from the reported by other non-health professional via health authority (VAERS ID: 696700) concerning a 21-year-old, adult female patient. The patient had no problem with food/egg or insects and other immunizations. On 01-Oct-2014, the patient received INN flu vaccine seasonal and within one to two hours of vaccination, the patient noticed red, watery, itchy eyes and throat. These symptoms lasted for one day and cleared on its own without medical attention or medication. On an unspecified date in 2015, the patient received influenza virus vaccine polyvalent (dose (reported as 0), route of administration, anatomical site, batch number, expiry date, trade name, manufacturer and indication was not reported). On the same day, within one hour after vaccination, the patient noticed mild itchy eyes without any discharge or redness and had mild itchy throat. No swelling or rashes were observed. The symptoms lasted for a day, cleared on its own without any medication attention or medication. On an unspecified date in 2015, the patient completely recovered from the events (eye pruritus, throat irritation). The health authority assessed the events (eye pruritus, throat irritation) as non-serious.
Age: 21.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Throat irritation
Clinical narrative: This initial spontaneous case, was received on 09-Aug-2017, from the reported by other non-health professional via health authority (VAERS ID: 696700) concerning a 21-year-old, adult female patient. The patient had no problem with food/egg or insects and other immunizations. On 01-Oct-2014, the patient received INN flu vaccine seasonal and within one to two hours of vaccination, the patient noticed red, watery, itchy eyes and throat. These symptoms lasted for one day and cleared on its own without medical attention or medication. On an unspecified date in 2015, the patient received influenza virus vaccine polyvalent (dose (reported as 0), route of administration, anatomical site, batch number, expiry date, trade name, manufacturer and indication was not reported). On the same day, within one hour after vaccination, the patient noticed mild itchy eyes without any discharge or redness and had mild itchy throat. No swelling or rashes were observed. The symptoms lasted for a day, cleared on its own without any medication attention or medication. On an unspecified date in 2015, the patient completely recovered from the events (eye pruritus, throat irritation). The health authority assessed the events (eye pruritus, throat irritation) as non-serious.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Eye pruritus, Lacrimation increased, Ocular hyperaemia, Throat irritation
Clinical narrative: This initial spontaneous case was received on 09-Aug-2017, from the reported by other non-health professional via health authority (VAERS ID: 696700) concerning a 21-year-old, adult, female patient. The patient had no problem with food/egg or insects, and other immunizations. On 01-Oct-2014, the patient received INN flu vaccine seasonal and within one to two hours of vaccination, the patient noticed red, watery, itchy eyes and throat. These symptoms lasted for one day and cleared on its own without medical attention or medication. On an unspecified date in 2015, the patient received INN flu vaccine seasonal and within one hour had mild itchy eyes and mild itchy throat. On an unspecified date in Oct-2016, the patient received influenza vaccine (dose (reported as 0), route of administration, anatomical site, batch number, expiry date, trade name, manufacturer and indication was not reported). After vaccination, the patient had an itchy throat which was milder than the previous episodes of vaccination (01-Oct-2014 and unspecified date in 2015). No problem in eyes, swelling or rashes were not observed. This symptom persisted for one day. The patient did not receive any medical attention or medication. It was reported that, the patient completely recovered from the event (throat irritation). The health authority assessed the event (throat irritation) as non-serious.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Eye pruritus, Throat irritation
Clinical narrative: This initial spontaneous case was received on 09-Aug-2017, from the reported by other non-health professional via health authority (VAERS ID: 696700) concerning a 21-year-old, adult, female patient. The patient had no problem with food/egg or insects, and other immunizations. On 01-Oct-2014, the patient received INN flu vaccine seasonal and within one to two hours of vaccination, the patient noticed red, watery, itchy eyes and throat. These symptoms lasted for one day and cleared on its own without medical attention or medication. On an unspecified date in 2015, the patient received INN flu vaccine seasonal and within one hour had mild itchy eyes and mild itchy throat. On an unspecified date in Oct-2016, the patient received influenza vaccine (dose (reported as 0), route of administration, anatomical site, batch number, expiry date, trade name, manufacturer and indication was not reported). After vaccination, the patient had an itchy throat which was milder than the previous episodes of vaccination (01-Oct-2014 and unspecified date in 2015). No problem in eyes, swelling or rashes were not observed. This symptom persisted for one day. The patient did not receive any medical attention or medication. It was reported that, the patient completely recovered from the event (throat irritation). The health authority assessed the event (throat irritation) as non-serious.
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Throat irritation
Clinical narrative: This initial spontaneous case was received on 09-Aug-2017, from the reported by other non-health professional via health authority (VAERS ID: 696700) concerning a 21-year-old, adult, female patient. The patient had no problem with food/egg or insects, and other immunizations. On 01-Oct-2014, the patient received INN flu vaccine seasonal and within one to two hours of vaccination, the patient noticed red, watery, itchy eyes and throat. These symptoms lasted for one day and cleared on its own without medical attention or medication. On an unspecified date in 2015, the patient received INN flu vaccine seasonal and within one hour had mild itchy eyes and mild itchy throat. On an unspecified date in Oct-2016, the patient received influenza vaccine (dose (reported as 0), route of administration, anatomical site, batch number, expiry date, trade name, manufacturer and indication was not reported). After vaccination, the patient had an itchy throat which was milder than the previous episodes of vaccination (01-Oct-2014 and unspecified date in 2015). No problem in eyes, swelling or rashes were not observed. This symptom persisted for one day. The patient did not receive any medical attention or medication. It was reported that, the patient completely recovered from the event (throat irritation). The health authority assessed the event (throat irritation) as non-serious.
Sex: U
Vaccine: FLUX, MENB, FLUX, MENB
Symptoms: Back pain, Pyrexia
Clinical narrative: This initial serious spontaneous case was received on 09-Aug-2017 from physician via health authority (VAERS ID: 697131) and concerns a patient of unspecified age and gender. The patient's medical history and concomitant medication were not reported. On an unspecified date, the patient was administered with Influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient was also administered with TRUMENBA (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified dates, after vaccination the patient experienced fever at 104 Fahrenheit and back pain and went to the emergency room (ER). On an unspecified date, the patient lab test included body temperature which resulted 104 Fahrenheit. The outcome of the events was not reported. The health authority assessed this case as non-serious.
Age: 14.0
Sex: M
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Malaise, Mental impairment
Clinical narrative: This initial spontaneous case, was received on 09-Aug2017, from other non-health professional via health authority (VAERS ID: 698117) concerning a 14-year-old, adolescent, male patient. The patient was allergic to cat/dog dander, dust mites, peanuts and oysters. On 21-Oct-2011, the patient was administered with influenza virus vaccine polyvalent, dose, route of administration, SYR (as reported), anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day (at same time: as reported), the patient was administered with Gardasil (co-suspect, dose, route of administration, anatomical location, batch number, expiry date: not reported). On 27-Dec-2011, after 2 months 7 days of vaccination, the patient experienced fatigue, unrestful sleep and chronic fatigue. The patient had trouble in concentrating, thinking and had brain fog. The patient felt unwell and rested. The outcome of the events was not reported. The health authority assessed the events as non-serious. Significant follow-up received on 24-Aug-2017: The listedness of the events fatigue and mental impairment were corrected.
Age: 14.0
Sex: M
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Poor quality sleep, Restlessness
Clinical narrative: This initial spontaneous case, was received on 09-Aug2017, from other non-health professional via health authority (VAERS ID: 698117) concerning a 14-year-old, adolescent, male patient. The patient was allergic to cat/dog dander, dust mites, peanuts and oysters. On 21-Oct-2011, the patient was administered with influenza virus vaccine polyvalent, dose, route of administration, SYR (as reported), anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day (at same time: as reported), the patient was administered with Gardasil (co-suspect, dose, route of administration, anatomical location, batch number, expiry date: not reported). On 27-Dec-2011, after 2 months 7 days of vaccination, the patient experienced fatigue, unrestful sleep and chronic fatigue. The patient had trouble in concentrating, thinking and had brain fog. The patient felt unwell and rested. The outcome of the events was not reported. The health authority assessed the events as non-serious. Significant follow-up received on 24-Aug-2017: The listedness of the events fatigue and mental impairment were corrected.
Age: 14.0
Sex: M
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Poor quality sleep
Clinical narrative: This initial spontaneous case, was received on 09-Aug2017, from other non-health professional via health authority (VAERS ID: 698117) concerning a 14-year-old, adolescent, male patient. The patient was allergic to cat/dog dander, dust mites, peanuts and oysters. On 21-Oct-2011, the patient was administered with influenza virus vaccine polyvalent, dose, route of administration, SYR (as reported), anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day (at same time: as reported), the patient was administered with Gardasil (co-suspect, dose, route of administration, anatomical location, batch number, expiry date: not reported). On 27-Dec-2011, after 2 months 7 days of vaccination, the patient experienced fatigue, unrestful sleep and chronic fatigue. The patient had trouble in concentrating, thinking and had brain fog. The patient felt unwell and rested. The outcome of the events was not reported. The health authority assessed the events as non-serious. Significant follow-up received on 24-Aug-2017: The listedness of the events fatigue and mental impairment were corrected.
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Bronchitis, Diarrhoea, Laboratory test, Nausea, Urticaria
Clinical narrative: This initial serious spontaneous case was received on 08-Aug-2017, via health authority (VAERS ID: 698623) by other non-health professional, concerning a 77-year-old, elderly, female patient. The patient's current condition included diabetes. Current illness of the patient was not reported. The patient's concomitant medication included Aspirin, estradiol, LEVEMIR, NOVOLOG, lisinopril, metoprolol, Vitamin D3, RETAINE and simvastatin. On 30-Sep-2016, FLUAD (TIV) was administered (Dose: 0.5ml (1 as reported) batch number: 4699522103, anatomical location: left arm, route of administration, expiry date and indication was not reported). On 16-Nov-2016, 1 month 18 days after vaccination, the patient experienced acute bronchitis which lasted till 10-Dec-2016, for which she was treated with Z-PAK. On 16-Feb-2017, the patient had flu with symptoms of diarrhoea and nausea for which the patient was hospitalised on the same day and was discharged on the following day. A second episode of acute bronchitis was experienced on 07-Apr-2017, which lasted till 28-May-2017. The patient was treated again with Z-PAK. On 03-May-2017, the patient developed hives, 8 large hives on arms, hands, elbows and neck, which lasted till 12-May-2017, for which the patient was treated with diphenhydramine. On 21-May-2017, the patient developed a second episode of hives, 5 small hives on hands and right arm, which lasted till 26-May-2017. At the time of this report, the patient had not recovered from the event flu. The health authority considered the events as serious (hospitalisation).
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Bronchitis, Diarrhoea, Influenza, Nausea, Urticaria
Clinical narrative: This initial serious spontaneous case was received on 08-Aug-2017, via health authority (VAERS ID: 698623) by other non-health professional, concerning a 77-year-old, elderly, female patient. The patient's current condition included diabetes. Current illness of the patient was not reported. The patient's concomitant medication included Aspirin, estradiol, LEVEMIR, NOVOLOG, lisinopril, metoprolol, Vitamin D3, RETAINE and simvastatin. On 30-Sep-2016, FLUAD (TIV) was administered (Dose: 0.5ml (1 as reported) batch number: 4699522103, anatomical location: left arm, route of administration, expiry date and indication was not reported). On 16-Nov-2016, 1 month 18 days after vaccination, the patient experienced acute bronchitis which lasted till 10-Dec-2016, for which she was treated with Z-PAK. On 16-Feb-2017, the patient had flu with symptoms of diarrhoea and nausea for which the patient was hospitalised on the same day and was discharged on the following day. A second episode of acute bronchitis was experienced on 07-Apr-2017, which lasted till 28-May-2017. The patient was treated again with Z-PAK. On 03-May-2017, the patient developed hives, 8 large hives on arms, hands, elbows and neck, which lasted till 12-May-2017, for which the patient was treated with diphenhydramine. On 21-May-2017, the patient developed a second episode of hives, 5 small hives on hands and right arm, which lasted till 26-May-2017. At the time of this report, the patient had not recovered from the event flu. The health authority considered the events as serious (hospitalisation).
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This initial spontaneous case was received from other non-health professional via health authority (VAERS ID: 698972 on 09-Aug-2017, concerning a 62-year-old, adult, male patient. It was reported that, the patient did not have any medical history or illness. On 08-Jun-2017, the patient was administered with INN Flu Vaccine Seasonal (route of administration: SYR (as reported), anatomical location: right arm, dose, batch number, manufacturer, trade name: not reported). On the following day, i.e., 1 day after vaccination, the patient experienced burning, redness and swelling of 8 inches from the injection site. The outcome of the events was not reported. The health authority assessed the report as non-serious.
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3
Symptoms: Myalgia, Pyrexia, Tinnitus
Clinical narrative: This initial non-serious spontaneous case, was received on 16-Aug-2017, reported by a pharmacist and concerns a 65-year-old male patient. Patient's medical history was not reported. The patient's concomitant medication included meloxicam. On 14-Aug-2017, the patient received FLUAD (dose: 0.5ml, batch number: 178303, expiry date: Apr-2018, route of administration, anatomical location was not reported). On 14-Aug-2017, after administration of FLUAD, the patient went out for shopping after immunisation in the afternoon. On 15-Aug-2017, in a follow-up to the patient by the HCP (health care professional), it was reported that the patient experienced low grade fever, slight headache and local soreness at injection site. However, tinnitus which started on the same day was still ongoing. It was stated that, ringing in ears was not mentioned in the prescribing information under the adverse event section. Outcome of the events low grade fever, slight headache and local soreness at injection site was recovered and tinnitus was not recovered. The reporter assessed the event as non-serious.
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3
Symptoms: Tinnitus
Clinical narrative: This initial non-serious spontaneous case, was received on 16-Aug-2017, reported by a pharmacist and concerns a 65-year-old male patient. Patient's medical history was not reported. The patient's concomitant medication included meloxicam. On 14-Aug-2017, the patient received FLUAD (dose: 0.5ml, batch number: 178303, expiry date: Apr-2018, route of administration, anatomical location was not reported). On 14-Aug-2017, after administration of FLUAD, the patient went out for shopping after immunisation in the afternoon. On 15-Aug-2017, in a follow-up to the patient by the HCP (health care professional), it was reported that the patient experienced low grade fever, slight headache and local soreness at injection site. However, tinnitus which started on the same day was still ongoing. It was stated that, ringing in ears was not mentioned in the prescribing information under the adverse event section. Outcome of the events low grade fever, slight headache and local soreness at injection site was recovered and tinnitus was not recovered. The reporter assessed the event as non-serious.
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3
Symptoms: Headache, Injection site pain, Pyrexia, Tinnitus
Clinical narrative: This initial non-serious spontaneous case, was received on 16-Aug-2017, reported by a pharmacist and concerns a 65-year-old male patient. Patient's medical history was not reported. The patient's concomitant medication included meloxicam. On 14-Aug-2017, the patient received FLUAD (dose: 0.5ml, batch number: 178303, expiry date: Apr-2018, route of administration, anatomical location was not reported). On 14-Aug-2017, after administration of FLUAD, the patient went out for shopping after immunisation in the afternoon. On 15-Aug-2017, in a follow-up to the patient by the HCP (health care professional), it was reported that the patient experienced low grade fever, slight headache and local soreness at injection site. However, tinnitus which started on the same day was still ongoing. It was stated that, ringing in ears was not mentioned in the prescribing information under the adverse event section. Outcome of the events low grade fever, slight headache and local soreness at injection site was recovered and tinnitus was not recovered. The reporter assessed the event as non-serious.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Rash erythematous, Skin warm, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 81 year old female patient with hypertension and heart failure. The patient's medical history included a myocardial infarction. Concomitant therapies included carvedilol, spironolactone, hydralazine, warfarin, isosorbide, atorvastatin, oxybutynin, and digoxin. On 10-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly in the left upper arm for prophylaxis, lot number: N010106, expiration date: 15-NOV-2018 (also reported as 07-NOV-2018); and FLUZONE HD, lot number: UI808AB, expiration date: 28-FEB-2018, in the same arm as pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (route of administration and indication were not reported). In September 2017, the patient began experiencing pain, swelling, redness and warmness at PNEUMOVAX 23 injection site,which were reported as "the size of a small egg". The pharmacist reported that the patient was seen at an unspecified urgent care on 12-SEP-2017 and was diagnosed with "cellulitis" (vaccination site cellulitis). The patient was prescribed clindamycin and mupirocin ointment as treatment. At the reporting time, the patient had no recovered form the event of vaccination site cellulitis. Causality assessment was not provided. The pharmacist requested a lot check on PNEUMOVAX 23 (N010106, 07-NOV-2018). This is one of two cases from the same source.; Sender's Comments: US-009507513-1709USA011514:
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Vaccination site cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 81 year old female patient with hypertension and heart failure. The patient's medical history included a myocardial infarction. Concomitant therapies included carvedilol, spironolactone, hydralazine, warfarin, isosorbide, atorvastatin, oxybutynin, and digoxin. On 10-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly in the left upper arm for prophylaxis, lot number: N010106, expiration date: 15-NOV-2018 (also reported as 07-NOV-2018); and FLUZONE HD, lot number: UI808AB, expiration date: 28-FEB-2018, in the same arm as pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (route of administration and indication were not reported). In September 2017, the patient began experiencing pain, swelling, redness and warmness at PNEUMOVAX 23 injection site,which were reported as "the size of a small egg". The pharmacist reported that the patient was seen at an unspecified urgent care on 12-SEP-2017 and was diagnosed with "cellulitis" (vaccination site cellulitis). The patient was prescribed clindamycin and mupirocin ointment as treatment. At the reporting time, the patient had no recovered form the event of vaccination site cellulitis. Causality assessment was not provided. The pharmacist requested a lot check on PNEUMOVAX 23 (N010106, 07-NOV-2018). This is one of two cases from the same source.; Sender's Comments: US-009507513-1709USA011514:
Age: 37.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Drug administered at inappropriate site, Erythema, Injection site pain, Pain in extremity, Skin infection
Clinical narrative: Vaccine was administered in the inappropriate site (1/3 from the elbow). As a result patient got cellulitis.  This resulted to redness, tenderness, pain, inflammation, and warmth to the injection site. I advice pt to go to the urgent care to get a second opinion and she was diagnosed with cellulitis secondary to vaccine administration.
Age: 37.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Skin warm
Clinical narrative: Vaccine was administered in the inappropriate site (1/3 from the elbow). As a result patient got cellulitis.  This resulted to redness, tenderness, pain, inflammation, and warmth to the injection site. I advice pt to go to the urgent care to get a second opinion and she was diagnosed with cellulitis secondary to vaccine administration.
Age: 37.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Cellulitis, Drug administered at inappropriate site, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Vaccine was administered in the inappropriate site (1/3 from the elbow). As a result patient got cellulitis.  This resulted to redness, tenderness, pain, inflammation, and warmth to the injection site. I advice pt to go to the urgent care to get a second opinion and she was diagnosed with cellulitis secondary to vaccine administration.
Age: 37.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injection site warmth
Clinical narrative: Vaccine was administered in the inappropriate site (1/3 from the elbow). As a result patient got cellulitis.  This resulted to redness, tenderness, pain, inflammation, and warmth to the injection site. I advice pt to go to the urgent care to get a second opinion and she was diagnosed with cellulitis secondary to vaccine administration.
Age: 70.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 70 year old female patient with sulfa allergy. On 19-SEP-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # N000463 exp date 19-OCT-2018) intramuscularly (also reported as subcutaneously) in the right arm. Concomitant therapies included influenza virus vaccine (unspecified). The pharmacist reported that on 20-SEP-2017, the patient experienced pain at the injection site, redness from the shoulder to the elbow and the arm was war to the touch. The patient went to the doctor on 21-SEP-2017 and the doctor stated that the reaction was possibly due to the PNEUMOVAX 23 being administered subcutaneously instead of intramuscularly. The patient was treated with a steroid injection and pain medication. At the time of the report, the patient had not recovered.
Age: 70.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Sleep disorder
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 70 year old female patient with sulfa allergy. On 19-SEP-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # N000463 exp date 19-OCT-2018) intramuscularly (also reported as subcutaneously) in the right arm. Concomitant therapies included influenza virus vaccine (unspecified). The pharmacist reported that on 20-SEP-2017, the patient experienced pain at the injection site, redness from the shoulder to the elbow and the arm was war to the touch. The patient went to the doctor on 21-SEP-2017 and the doctor stated that the reaction was possibly due to the PNEUMOVAX 23 being administered subcutaneously instead of intramuscularly. The patient was treated with a steroid injection and pain medication. At the time of the report, the patient had not recovered.
Age: 70.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 70 year old female patient with sulfa allergy. On 19-SEP-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # N000463 exp date 19-OCT-2018) intramuscularly (also reported as subcutaneously) in the right arm. Concomitant therapies included influenza virus vaccine (unspecified). The pharmacist reported that on 20-SEP-2017, the patient experienced pain at the injection site, redness from the shoulder to the elbow and the arm was war to the touch. The patient went to the doctor on 21-SEP-2017 and the doctor stated that the reaction was possibly due to the PNEUMOVAX 23 being administered subcutaneously instead of intramuscularly. The patient was treated with a steroid injection and pain medication. At the time of the report, the patient had not recovered.
Age: 35.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: I'm not sure what kind of flu shot I got. I got it Friday and that night I started getting severe numbness and tingling worse in my R hand than left. It went away but has returned the last 3 nights and tonight it is now both hands and R foot. I didn't think at all about relating it to my flu shot until my husband started asking me when it started. Then I started rethinking my day.....I made an appointment with the first available for my primary care doctor which is Thursday. I will call the employee health clinic that gave me the shot tomorrow.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Shoulder joint pain appeared about two hours after flu vaccine and continues as of today, 9/25/17.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Adverse event, Chest X-ray, Full blood count, Neurological examination normal
Clinical narrative: Per Doctor, Normal neuro exam other than facial nerve testing. Flu shot Friday afternoon and symptoms started Sunday AM, possible correlation. Also very possible that this is viral. He is probably grade 3 on House-Brackmann scale, will go ahead and tx with steroid burst, VALTREX- advised of possible SE. Advised of importance of keeping eye lubricated and sun protection. Also discussed with optometry, no need for f/u from their perspective at this point. Will check labs and CXR considering airway exam. Pt will f/u Friday for re-eval. He was instructed to f/u sooner with any worsening or concerns or go to ED. Pt verbalized understanding and agreement with POC.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Injection site swelling, Syncope
Clinical narrative: PT has some swelling around the injection site, and fainted. Tender to palpation around the site with a raised area around injection site.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, 26 improperly stored doses of GARDASIL 9 Lot # N000326 expiration date 14-OCT-2019 and Lot #N004799 expiration date 15-NOV-2019 (strength, dose and route were not reported) were administered to multiple unspecified patients for prophylaxis. The doses were improperly stored at a temperature between 47°F to 77°F and 32°F to 35°F during a time frame of 10 minutes and 120 minutes, respectively. There were no previous temperature excursions and the call was due of a data logger. No adverse effects were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 year old patient of unknown gender. Medical history and current conditions were not reported. On 13-JUL-2017, the patient was vaccinated with improperly stored PROQUAD (lot # M043306, expiry date: 24-APR-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiry unknown). The vaccine was stored between -14 Celsius degrees (C) to -10 C with timeframe 6 hours 31 minutes. During previous temperature excursion vaccine was exposed to a temperature range of -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. No product quality complaint was reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA001467: US-009507513-708USA001338: US-009507513-1709USA005542: US-009507513-1709USA006807: US-009507513-1709USA006809: US-009507513-1709USA006813: US-009507513-1709USA006815: US-009507513-1709USA006816: US-009507513-1709USA006819: US-009507513-1709USA006820.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 year old patient of unknown gender. Medical history and current conditions were not reported. On 26-JUL-2017, the patient was vaccinated with improperly stored PROQUAD (lot # M043306, expiry date: 24-APR-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiry unknown). The vaccine was stored between -14 Celsius degrees (C) to -10 C with timeframe 6 hours 31 minutes. During previous temperature excursion vaccine was exposed to a temperature range of -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. No product quality complaint was reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA001467: US-009507513-708USA001338: US-009507513-1709USA005542: US-009507513-1709USA006809: US-009507513-1709USA006806: US-009507513-1709USA006807: US-009507513-1709USA006813: US-009507513-1709USA006815: US-009507513-1709USA006819: US-009507513-1709USA006820.
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 12 month old male patient. The patient did not have medical history or drug reaction or allergies. Information regarding the patient's concurrent conditions were not reported. Historical drug included 3 doses of RECOMBIVAX HB on unknown dates. Concomitant therapies included M-M-R II and VARIVAX. On 05-SEP-2017, the patient was inadvertently vaccinated with a 4th dose of RECOMBIVAX HB lot # M042322, expiration date 21-FEB-2019, by intramuscular route in the right arm for prophylaxis.  Other suspect therapies included VAQTA. It was reported that the nurse who administered RECOMBIVAX HB "thought she grabbed VAQTA and it was not until after the dose of RECOMBIVAX HB was administered she realized she grabbed the wrong vial". On an unknown date the patient's mother was contacted, but she did not provide any information regarding adverse events. None laboratory studies were performed.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse referring to a 20 patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 23-AUG-2017, 20 unknown patients were administered a dose of improperly stored VARIVAX Lot # M048203 expiration date 07-DEC-2018 for prophylaxis (strength and route were not reported) reconstituted with a properly stored sterile diluent (manufacturer unknown). The vaccines were stored at a temperature between -14°C to -10°C (-10.4°C) during a time frame of 13.15 hours (795 minutes). There were no previous temperature excursions and the call was no because of a data logger. No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an administrator refers to unspecified patients of unknown demographics. The patients medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored dose of LIQUID PEDVAX (Strength, dose, frequency, route and anatomical location were not reported) of lot # M014925 with an expiry date of February 2019 for prophylaxis. There were no concomitant therapies reported. The vaccine was exposed to 9 to 25 Celsius degree (C) (8.7 C) for 7 hours and 11 minutes, 9 to 25 Celsius degree (C) (9.2 C) for 11 hours and 43 minutes, 9 to 25 Celsius degree (C) (11.3 C) for 21 hours and 19 minutes, 9 to 25 Celsius degree (C) (9.2 C) for 9 hours and 34 minutes and 9 to 25 Celsius degree (C) (9.5 C) for 4 hours and 44 minutes. Digital data logger was involved. There was no previous temperature excursion involved. There were no adverse symptoms reported. There was no product quality complaint involved. The health care worker stated that no additional information was available at the time of the call. She additionally reported that the office had no means to gather the requested data, including patient identifiers and date of vaccination. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005276:
Age: 0.25
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant concerning a 3 month old patient of unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 19-SEP-2017 the patient was vaccinated with PROQUAD with lot number M044719 and expiration date on 07-MAY-2018, for prophylaxis (dose, dose number and route of administration were not provided). Concomitant therapies included the sterile diluent. No adverse effects were reported.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain, Diarrhoea, Headache, Vomiting
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 14-year-old male patient. The patient had no pertinent medical history and no concomitant medications. On 25-NOV-2014, the patient received the first shot of GARDASIL (lot number K006191) and the second shot on 02-FEB-2015 (lot number K006191), both intramuscularly. The patient never received a third dose of GARDASIL. On 23-MAY-2015, the patient began experiencing vomiting and headaches and he was taken to the emergency room of an unspecified hospital. He was not admitted. In April 2016, the patient was admitted to an unspecified hospital due to vomiting and headaches and was released on an unspecified date. On 19-MAY-2017, the patient went to the emergency room of an unspecified hospital because of experiencing abdominal pain and diarrhea. The patient sought medical attention and was treated. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA010511.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with M-M-R II (lot # L003855, expiration date: 05-FEB-2017; lot # L041456, expiration date: 22-OCT-2017; and lot # L010488, expiration date: 26-MAR-2017) for prophylaxis. According to the reporter, the vaccine was exposed to temperatures between 42 degrees fahrenheit (F) to 77 F for 57 hours, and between 32 F to 35 F for 166 hours. No adverse symptoms were reported. A digital data logger was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA010755: US-009507513-1709USA010753: US-009507513-1709USA010754:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 20-SEP-2017, the patient was vaccinated with an expired dose of PROQUAD lot # M007960 and expiration date of 15-AUG-2017, (route of administration and anatomical location were not reported), reconstituted with sterile diluent (MERCK) (lot # unknown) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # N003701, expiration date 01-NOV-2019 and lot # N003536, expiration date 02-NOV-2019 (dose and route of administration were not reported). There was no adverse effect reported. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA011847:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates (reported as on unspecified dates or after 05-JUN-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # M046133, expiration date 26-SEP-2019 and lot # M047666, expiration date 24-OCT-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 32 to 35 degrees Fahrenheit for 8 hours. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA011726:
Age: 17.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has received from a medical assistant referring to multiple unspecified patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug and allergy history. On multiple unspecified dates, the patients were vaccinated with improperly stored doses VARIVAX lot # N017396, expiration date 07-JUN-2019, for prophylaxis. Concomitant therapies included sterile diluent (STERILE MRK). The doses of VARIVAX were exposed to a temperature excursion of 15°Fahrenheit (°F) to 46°F during a time frame of 1 hour and 23 minutes, which was detected by the data logger. There was a previous temperature excursion of 6°F to 14°F for 1 hour and 16 minutes. No adverse effects were reported.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Hypersomnia, Vomiting
Clinical narrative: Information has been received from a medical assistant, referring to a 4 month old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-SEP-2017, the patient was vaccinated with a dose of ROTATEQ lot # M032643 with expiration date on 04-MAR-2018, orally (strength and dose were not reported) for prophylaxis. On 18-SEP-2017, the patient proceeded to "sleep for 14-16 hours" (sleep disorder) and on 20-SEP-2017, she experienced vomiting. The outcome of the vomiting and the sleep disorder was reported as not recovered/not resolved and the causality between the vaccination with ROTATEQ and the aforementioned events was unknown.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in early July 2017, the patients were vaccinated an improperly stored doses of with GARDASIL 9 0.5 ml, injection, lot number N013276, expiration date 21-JAN-2020 (route of administration was not reported) for prophylaxis. The temperature of excursion with GARDASIL 9 was 47 to 77 Fahrenheit degrees during 5 minutes. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA011511: US-009507513-1709USA011512.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 20-SEP-2017, the patient may had received an improperly stored dose of VARIVAX lot # M045205 and expiration date on 11-NOV-2018 (dose and route of administration were not reported) for prophylaxis. The doses of VARIVAX were exposed to a temperature excursion of -14 degrees Celsius (°C) to -10°C during a time frame of 3 hours and 42 minutes, which was detected by the data logger. There was no prior temperature excursion and neither adverse events nor product quality complaints were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 21-SEP-2017, the patient was vaccinated with a properly stored expired dose of RECOMBIVAX HB lot # M007763 (expiration date: 15-SEP-2017), intramuscularly (frequency was not reported) for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to 29 unspecified patients of unknown age and gender. The patients' pertinent medical history or concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # N014368, expiration date: 09-MAY-2017 (dose, frequency and route of administration were unspecified) for prophylaxis, reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. The temperature excursion was as follows: Temperature: 17.9 Fahrenheit degrees Time frame: 1 Hour and 33 Minutes Previous temperature excursion? No Was call because of a "data logger"? No.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant concerning unspecified number of patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. From 18-SEP-2017 to 21-SEP-2017 the patients were vaccinated with improperly stored doses of ROTATEQ with lot number N005617 and expiration date on 03-OCT-2018 (dose and dose number were not provided), oral for prophylaxis.    It was reported that on an unspecified date, the vaccines were exposed to a temperature between 32 Fahrenheit degrees and 35 Fahrenheit degrees for 2 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT) that was properly stored. On 20-SEP-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # N009777, expiration date on 04-MAR-2018 (strenght, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccine had a temperature excursion of 78 Fahrenheit (F) during a time frame of 3 days. It was reported that no previous temperature excursions ocurred and a digital data logger was involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with dose of GARDASIL 9 for prophylaxis (strength, dose, route, frequency, lot/batch # and expiration date were not reported). No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of 31°F (degrees Fahrenheit) for 10 minutes. No previous temperature excursion was done. The call was not because of a "data logger".