chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of VAQTA with lot # M027879 and expiration date of 24-JAN-2018 and lot # M036458 with expiration date on 02-MAR-2018 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccines were exposed to temperature of 12 Centigrade degrees (°C) range for a time frame of 24 hours. The temperature excursion was recorded by a data logger and the previous excursions were reported as 9°C to 25°C for 9 hours for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA007701: US-009507513-1704USA014374: US-009507513-1704USA014372.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB with lot # M020926 and expiration date of 11-AUG-2018 and lot # M037248 with expiration date on 21-FEB-2019 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccines were exposed to temperature of 12 Centigrade degrees (°C) range for a time frame of 24 hours. The temperature excursion was recorded by a data logger and the previous excursions were reported as 9°C to 25°C for 9 hours for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014373: US-009507513-1704USA007701: US-009507513-1704USA014372.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. Pertinent medical histories and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored PROQUAD lot # M006104 and expiry date 01-AUG-2017 for prophylaxis (incorrect product storage) which was reconstituted with sterile diluent (manufacturer unknown). No adverse effects reported (no adverse event). This is one of the two case from the same reported. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014690: Original Case : 1704USA014450.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. Pertinent medical histories and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored PROQUAD lot # M006104 and expiry date 01-AUG-2017 for prophylaxis (incorrect product storage) which was reconstituted with sterile diluent (manufacturer unknown). No adverse effects reported (no adverse event). This is one of the two case from the same reported. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014450: Original Case : 1704USA014450.
Sex: U
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: A spontaneous report has been received from a Pharmacist concerning a patient. There were no reported medical history, concurrent diseases and concomitant medications. The patient received nasal FLUMIST QUADRIVALENT (intranasal) on an unknown date. On an unknown date, the patient experienced nausea and stomach pain. The outcome of the events of nausea and stomach pain was unknown. The company physician considered the events of nausea and stomach pain to be non-serious.
Sex: F
Vaccine: PNC13
Symptoms: Appetite disorder, Arthritis, Blood test, Chills, Diarrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 75-year-old female patient of other race received PREVNAR 13, via an unspecified route of administration in the right arm, on an unspecified date, at single dose, for immunisation. The patient was vaccinated at physician's office. Medical history included diphtheria (when she was a child). The patient was basically healthy. There were no concomitant medications. On an unspecified date the patient had all the signs of lupus with outcome of unknown, extreme tiredness with outcome of unknown, arms swollen/arm next morning was swollen and red like crazy with outcome of unknown, rash with outcome of recovered, fever with outcome of recovered, couldn't move with outcome of unknown, eyes were watering with outcome of unknown, ears were running with outcome of unknown, diarrhoea with outcome of unknown, appetite was like her whole eating system was just messed up with outcome of unknown, symptoms of arthritis with outcome of unknown, feeling unwell with outcome of unknown, arm next morning was swollen and red like crazy with outcome of unknown, had a fever and chill with outcome of unknown, couldn't lift arms with outcome of unknown, white blood cells highly elevated with outcome of unknown, whole body lock down with outcome of unknown, every joint in the body was stiff with outcome of unknown, her muscles were sore with outcome of unknown, blood pressure high with outcome of unknown, weight loss with outcome of unknown. The patient underwent lab tests and procedures which included blood test on an unspecified date (unknown results). Therapeutic measures were taken as a result of rash.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Fatigue, Hypertension, Joint stiffness, Lacrimation increased
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 75-year-old female patient of other race received PREVNAR 13, via an unspecified route of administration in the right arm, on an unspecified date, at single dose, for immunisation. The patient was vaccinated at physician's office. Medical history included diphtheria (when she was a child). The patient was basically healthy. There were no concomitant medications. On an unspecified date the patient had all the signs of lupus with outcome of unknown, extreme tiredness with outcome of unknown, arms swollen/arm next morning was swollen and red like crazy with outcome of unknown, rash with outcome of recovered, fever with outcome of recovered, couldn't move with outcome of unknown, eyes were watering with outcome of unknown, ears were running with outcome of unknown, diarrhoea with outcome of unknown, appetite was like her whole eating system was just messed up with outcome of unknown, symptoms of arthritis with outcome of unknown, feeling unwell with outcome of unknown, arm next morning was swollen and red like crazy with outcome of unknown, had a fever and chill with outcome of unknown, couldn't lift arms with outcome of unknown, white blood cells highly elevated with outcome of unknown, whole body lock down with outcome of unknown, every joint in the body was stiff with outcome of unknown, her muscles were sore with outcome of unknown, blood pressure high with outcome of unknown, weight loss with outcome of unknown. The patient underwent lab tests and procedures which included blood test on an unspecified date (unknown results). Therapeutic measures were taken as a result of rash.
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Mobility decreased, Myalgia, Otorrhoea, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 75-year-old female patient of other race received PREVNAR 13, via an unspecified route of administration in the right arm, on an unspecified date, at single dose, for immunisation. The patient was vaccinated at physician's office. Medical history included diphtheria (when she was a child). The patient was basically healthy. There were no concomitant medications. On an unspecified date the patient had all the signs of lupus with outcome of unknown, extreme tiredness with outcome of unknown, arms swollen/arm next morning was swollen and red like crazy with outcome of unknown, rash with outcome of recovered, fever with outcome of recovered, couldn't move with outcome of unknown, eyes were watering with outcome of unknown, ears were running with outcome of unknown, diarrhoea with outcome of unknown, appetite was like her whole eating system was just messed up with outcome of unknown, symptoms of arthritis with outcome of unknown, feeling unwell with outcome of unknown, arm next morning was swollen and red like crazy with outcome of unknown, had a fever and chill with outcome of unknown, couldn't lift arms with outcome of unknown, white blood cells highly elevated with outcome of unknown, whole body lock down with outcome of unknown, every joint in the body was stiff with outcome of unknown, her muscles were sore with outcome of unknown, blood pressure high with outcome of unknown, weight loss with outcome of unknown. The patient underwent lab tests and procedures which included blood test on an unspecified date (unknown results). Therapeutic measures were taken as a result of rash.
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Rash, Systemic lupus erythematosus, Weight decreased, White blood cell count increased
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 75-year-old female patient of other race received PREVNAR 13, via an unspecified route of administration in the right arm, on an unspecified date, at single dose, for immunisation. The patient was vaccinated at physician's office. Medical history included diphtheria (when she was a child). The patient was basically healthy. There were no concomitant medications. On an unspecified date the patient had all the signs of lupus with outcome of unknown, extreme tiredness with outcome of unknown, arms swollen/arm next morning was swollen and red like crazy with outcome of unknown, rash with outcome of recovered, fever with outcome of recovered, couldn't move with outcome of unknown, eyes were watering with outcome of unknown, ears were running with outcome of unknown, diarrhoea with outcome of unknown, appetite was like her whole eating system was just messed up with outcome of unknown, symptoms of arthritis with outcome of unknown, feeling unwell with outcome of unknown, arm next morning was swollen and red like crazy with outcome of unknown, had a fever and chill with outcome of unknown, couldn't lift arms with outcome of unknown, white blood cells highly elevated with outcome of unknown, whole body lock down with outcome of unknown, every joint in the body was stiff with outcome of unknown, her muscles were sore with outcome of unknown, blood pressure high with outcome of unknown, weight loss with outcome of unknown. The patient underwent lab tests and procedures which included blood test on an unspecified date (unknown results). Therapeutic measures were taken as a result of rash.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Hypoaesthesia, Musculoskeletal pain, Nerve compression, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. An 80 year-old male patient received PREVNAR 13 (lot R48403, expiration date Apr2018, NDC 0005197102) via an unspecified route of administration on 17Mar2017 at 0.5 ml single for immunization. Medical history included ongoing benign prostatic hyperplasia, concomitant medications included finasteride at 5 mg once a day and tamsulosin at 0.4 mg once a day, both oral ongoing for benign prostatic hyperplasia. On 17Mar2017 the patient had some soreness for the first couple of days, the pain then on an unspecified day in Mar2017 was radiating to the back of the arm and the shoulder (pain was not in joint, but just below it) and the patient also had numbness and tingling that radiated to the fingers. The patient noticed it more when he laid on the side where he received the injection. No relevant tests were performed. Outcome of soreness was unknown, the patient was not recovered from the other reported events. The reporter did not believe it was the vaccine that was causing the patient's symptoms and said that it sounded more like a pinched nerve. Causality for events pain radiating to the back of the arm and the shoulder and numbness and tingling that radiated  to the fingers was reported as unrelated to pneumococcal 13-val conj vac (dipht crm197 protein).; Sender's Comments: Based on the information currently available, the events pain radiating to the back of the arm and the shoulder and numbness and tingling that radiated to the fingers are not related to the vaccination with PREVENAR 13 but more likely represent intercurrent medical conditions of nerves pinched.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. An 80 year-old male patient received PREVNAR 13 (lot R48403, expiration date Apr2018, NDC 0005197102) via an unspecified route of administration on 17Mar2017 at 0.5 ml single for immunization. Medical history included ongoing benign prostatic hyperplasia, concomitant medications included finasteride at 5 mg once a day and tamsulosin at 0.4 mg once a day, both oral ongoing for benign prostatic hyperplasia. On 17Mar2017 the patient had some soreness for the first couple of days, the pain then on an unspecified day in Mar2017 was radiating to the back of the arm and the shoulder (pain was not in joint, but just below it) and the patient also had numbness and tingling that radiated to the fingers. The patient noticed it more when he laid on the side where he received the injection. No relevant tests were performed. Outcome of soreness was unknown, the patient was not recovered from the other reported events. The reporter did not believe it was the vaccine that was causing the patient's symptoms and said that it sounded more like a pinched nerve. Causality for events pain radiating to the back of the arm and the shoulder and numbness and tingling that radiated  to the fingers was reported as unrelated to pneumococcal 13-val conj vac (dipht crm197 protein).; Sender's Comments: Based on the information currently available, the events pain radiating to the back of the arm and the shoulder and numbness and tingling that radiated to the fingers are not related to the vaccination with PREVENAR 13 but more likely represent intercurrent medical conditions of nerves pinched.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site bruising, Pain in extremity, Ultrasound scan, X-ray
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 68-year-old female patient received PREVNAR 13 via an unspecified route of administration at single dose on 05Jan2017 for immunisation. The patient medical history was not reported. Concomitant medication included hydrochlorothiazide, losartan. The patient experienced pain in arms started probably about a week after vaccination in Jan2017. The pain started probably about a week after she got vaccinated, it was mild in the beginning and she just figured it was just going to go away and then each week it was getting worse all the time. Then one day in Jan2017 she felt like her arm was just about to burst with all this pain with outcome not recovered. She experienced red face in Mar2017 with outcome not recovered, bruising around where they gave the shot on an unspecified date and it lasted almost 2 months with outcome of unknown. She went to her doctor 2 weeks before and he could not find anything, he sent her to hospital to get X-ray and an ultrasound to make sure that she did not have blood clot and in order to find out what is going on.
Age: 1.75
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, DTAPIPVHIB, HEP, PNC13
Symptoms: Pain in extremity, Screaming
Clinical narrative: This is a spontaneous report from a contactable nurse. A 21-month-old female patient received PREVNAR 13 (Lot# R49358, Exp date Apr2018, NDC# 0005197102), via an unspecified route of administration, on 12Apr2017, at 0.5 ml single, for immunisation. The patient's medical history was not reported. Concomitant medications included PENTACEL and hepatitis b vaccine (unspecified trade name) both for immunisation. The patient experienced grabbing her foot or her hand and stopping what she was doing and screaming out loud on 13Apr2017 with outcome of not recovered, possible joint pain on an unspecified date with outcome of unknown.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Injected limb mobility decreased, Injection site pain, Peripheral swelling
Clinical narrative: The night of my vaccination, I had a lot of pain in my right bicep into the front part of my shoulder, which was difficult to move. Days 2-4 after the pain and movement improved but my arm became red in a mottled like pattern and swollen. By Day 5 post vaccine, the redness and pain have mostly resolved.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Skin discolouration
Clinical narrative: The night of my vaccination, I had a lot of pain in my right bicep into the front part of my shoulder, which was difficult to move. Days 2-4 after the pain and movement improved but my arm became red in a mottled like pattern and swollen. By Day 5 post vaccine, the redness and pain have mostly resolved.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Low-grade fever for several hours, thigh where injection was administered red, swollen, puffy, hot to the touch. Not tender. Area of redness and swelling extended from the top of the thigh to the inner thigh.
Age: 1.33
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 04-APR-2017 from a medical assistant regarding 7 patients of unknown ages and gender. The patients' concurrent conditions, medical histories and concomitant medications were not reported. The medical assistant reported that on unknown dates, 7 unspecified patients may have been vaccinated with PEDVAXHIB, (lot number N000236, expiration 24-OCT-2019), intramuscular for prophylaxis during or after a temperature excursion occurred. No adverse events were reported. The vaccines were stored at 52 degrees Fahrenheit for 2 hours. There was no previous temperature excursion. The call was made due to a data logger. No additional information was provided. Additional information has been requested. Lot number N000236 has been verified to be a valid lot number for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate.)
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant 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 PROQUAD lot # M043306, expiration date 24-APR-2018 (albumin status, dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced temperature excursions of -14 degrees Celsius to -10 degrees Celsius for 105 hours 50 minutes and -14.1 degrees Celsius for 6 hours 26 minutes. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014640.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of VARIVAX (lot number M006731, expiration date: 09-FEB-2018 and lot number M012990, expiration date: 14-MAR-2018) (dose, route of administration and anatomical location were unknown) for prophylaxis. The vaccine was stored at temperature more than 6 Fahrenheit degrees (F) to less than 14 F for 10 minutes. Previous temperature excursion was more than 6F to 14F for 10 minutes. The temperature excursions were detected by a data logger. The improperly stored vaccines were reconstituted with a properly stored sterile diluent (manufacturer unknown). No adverse effects were reported. This is one of two reports from the same source (MARRS# 1704USA009381). Additional information has been requested. Sender's Comments: US-009507513-1704USA009381.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurses (LPN) and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 15-APR-2017, the patient was vaccinated with a improperly stored dose of GARDASIL 9 (lot # L037554, expiry date: 25-DEC-2017) (dose and route of administration were not reported). No adverse event was reported. Temperature excursion and time frame were 31.3F for 2 hours and 39 minutes; 32F for 3 hours and 36 minutes; 52.5F for 2 hours and 17 minutes. The was no previous temperature excursion. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant 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 VARIVAX lot # M032493, expiration date 06-JUL-2018 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced temperature excursions of -14 degrees Celsius to -10 degrees Celsius for 105 hours 50 minutes and -14.1 degrees Celsius for 6 hours 26 minutes. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA006420.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from radiology technician and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. From 30-MAR-2017 to 18-APR-2017, the patients were vaccinated with the improperly stored doses of PROQUAD (dose, route and anatomical location were not reported) (lot # M039448 and expiration date 20-MAR-2018) for prophylaxis. The reporter stated that the sterile diluent (DILUENT MRK) used to reconstitute the vaccine was not improperly stored. There were no adverse effects reported. The administered doses of vaccine experienced a previously temperature excursion of 9 to 8 degrees Celsius for 1 hour and 5 minutes. The last temperature excursion was reported between 9 to 8 degrees Celsius for 1 hour and 2 minutes. Data logger was involved. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA009851.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: DTaP and IPV administered too soon.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness, pain, swelling and itching in arm where vaccination administered.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On 27-MAR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot number: L017406, expiration date 26-FEB-2017 (strength, anatomical location, dose, frequency, and route of administration were not provided) for prophylaxis. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Pyrexia
Clinical narrative: This spontaneous report was received from a medical assistant (and the mother of the patient) via a company representative and refers to a 11 your old female patient. The patient's medical history, concomitant therapies and concurrent conditions were not reported. On an unknown date, the patient received her first dose of prophylactic vaccine against human papillomavirus (HPV) reported as GARDASIL. It was not specified which vaccine was administered, therefore the suspect therapies included both: GARDASIL and GARDASIL 9 (dose, route of administration, anatomical location, lot# and expiration date were not reported). After receiving the vaccination, the patient experienced fever and general malaise. The outcome of the adverse events was reported as recovered (on an unknown date). The relatedness between the suspect therapies and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot# M005732, expiration date 19-OCT-2017) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 9 and 25 degrees Celsius (also reported as "10.2 C") for 2 hours; and a previous temperature excursion between 9 and 25 degrees Celsius (also reported as "10.4 C") for 1 hour and 50 minutes in two different time frames. Moreover, it was reported that a digital data logger was involved. No adverse effects were reported. There was no product quality complaint (PQC) 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 licensed practical nurse, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored VARIVAX (lot # M033214 expiration date: 13-JUL-2018 and lot # M009769 expiration date: 25-FEB-2018). The vaccines were exposed to 32 to 35 Fahrenheit degree for 2 hours. No previous excursions. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004034: US-009507513-1704USA004040: US-009507513-1704USA004042:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers a female patient of unknown age. There was no information about the patient's concurrent conditions, medical history, any known allergies, reactions or concomitant medications. On 10-APR-2017, the patient was vaccinated with an expired dose of PROQUAD (lot # L039269; expiration date 05-APR-2017), intramuscularly, for prophylaxis (dose and frequency not reported) reconstituted with sterile diluent injection (DILUENT MRK) (unknown lot # and unknown expiration date). No adverse effects were reported. No further information was available. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. No information about the patients' medical history, concurrent conditions or concomitant medications was provided. On unknown dates, the patients were vaccinated with multiple improperly stored doses of PROQUAD (with lot # M038227, expiration date 06-MAR-2018; lot # M039447, expiration date 20-MAR-2018 and lot # M041084, expiration date 22-APR-2018), for prophylaxis (dose, frequency and route were not provided), the doses underwent a temperature excursion of 6 degrees Fahrenheit during 15 hours with no data logger involved and no previous temperature excursion. The vaccines were reconstituted with properly stored sterile diluent. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004645.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. No information about the patients' medical history, concurrent conditions or concomitant medications was provided. On unknown dates, the patients were vaccinated with multiple improperly stored doses of VARIVAX (with lot # M024702, expiration date 18-MAY-2018; lot # M028553, expiration date 07-JUN-2018; lot # M033211, expiration date 13-JUL-2018 and lot # M037642, expiration date 01-SEP-2018 ), for prophylaxis (dose, frequency and route were not provided), the doses underwent a temperature excursion of 6 degrees Fahrenheit during 15 hours with no data logger involved and no previous temperature excursion. The vaccines were reconstituted with properly stored sterile diluent.  No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA004632:
Age: 78.0
Sex: U
Vaccine: VARZOS
Symptoms: Blood test normal, Computerised tomogram normal, Dyspnoea
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 78 year old patient. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 16-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, lot number an expiration date were not reported). On 17-FEB-2017 (reported as the day after receiving ZOSTAVAX, also reported as 17-FEB-2016), the patient experienced difficulty in breathing. He sought medical attention by contacting the physician and was treated for the event with an unspecified medication. The patient had an unspecified blood test and computed tomography scan performed, all tests had normal results. The outcome of the event was unknown at the time of the report. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative 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 an unknown date, the patient was vaccinated in error with a dose of RECOMBIVAX HB (also reported as "adult version of RECOMBIVAX" and "RECOMBIVAX HB INJ 40") injection, lot # M001579 (dose, route and site of administration and expiry date were not reported). No adverse reactions were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding patient's concurrent conditions, medical history and concomitant therapies was reported. On 13-APR-2017, the patient was vaccinated with improperly stored ZOSTAVAX (dose and route of administration were not provided) lot # M035692, expiration date: 07-NOV-2017) for prophylaxis. A sterile diluent (STERILE DILUENT) (lot# and expiration date were not reported) was used to reconstitute the vaccine. No adverse effects were reported. The ZOSTAVAX was stored for 2 months in 70 degrees Fahrenheit. There was no previous temperature excursions. It was not a case of a "data logger". Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple, unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M024261, expiration date 30-JUL-2018 (dose and route of administration were not reported). No adverse effects were reported. The temperature excursion lasted for 5 minutes and ranged from 47 to 77 (also reported as 48.8) degrees Fahrenheit. There was no previous temperature excursion. Digital data logger was not used. The product quality complaint was not involved.        Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received on 18-APR-2017 from a physician refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-APR-2017, the patient was vaccinated with PNEUMOVAX23 lot # L035686 expiration 15-FEB-2017. The physician reported that the patient was inadvertently administered an expired dose of PNEUMOVAX23 and no adverse event reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to an unknown number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The medical assistant reported that on unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of PROQUAD (lot # M036159, expiration date 12-FEB-2018; doses, routes of administration, and frequencies were not reported) for prophylaxis which were reconstituted with an sterile water diluent (manufacturer unknown) (lot numbers and expiration dates were not reported). The vaccines were exposed to a temperature excursion range from 47°F to 77°F for a total time frame of 30 minutes. There were no previous temperature excursion or data logger involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA009554: US-009507513-1704USA009553:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to an unknown number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The medical assistant reported that on unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of VARIVAX (lot # L017145, expiration date 03-MAY-2017; doses, routes of administration, and frequencies were not reported) for prophylaxis which were reconstituted with an sterile water diluent (manufacturer unknown) (lot numbers and expiration dates were not reported). The vaccines were exposed to a temperature excursion range from 47°F to 77°F for a total time frame of 30 minutes. There were no previous temperature excursion or data logger involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA008587: US-009507513-1704USA009554:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to an unknown number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The medical assistant reported that on unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # reported as M344370, expiration date 13-FEB-2019; doses, routes of administration, and frequencies were not reported) for prophylaxis. The vaccines were exposed to a temperature excursion range from 47°F to 77°F for a total time frame of 30 minutes. There were no previous temperature excursion or data logger involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA008587: US-009507513-1704USA009553:
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 45-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reaction or allergies were not reported. On 17-FEB-2017, the patient received a dose of GARDASIL 9 injected intramuscularly (dose, anatomical location, lot # and expiration date were not reported) for prophylaxis. There were not known any adverse effects. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Polymerase chain reaction positive, Rash, Skin lesion, Varicella virus test positive
Clinical narrative: This spontaneous report was received from a physician referring to a 24 year old male patient with chronic neutropenia as concurrent condition. The patient had none drug reactions or allergies. On 17-MAR-2017, the patient was vaccinated with VARIVAX (lot#, dose, frequency and route of administration were unspecified) for prophylaxis with sterile diluent (manufacturer unknown). After vaccination, the patient developed rash approximately in March 2017. Then, the patient underwent a polymerase chain reaction (PCR) on the skin lesion which resulted positive and was hospitalized on 21-APR-2017. It was reported that the patient was responding to acyclovir. It was also reported that the adverse events were not significant disability, incapacity or life threatening. At the time of the report, the outcome of varicella virus test positive and rash was unknown. Additionally, it was stated that the patient remained hospitalized. The relatedness assessment of the aforementioned adverse events with VARIVAX and sterile diluent (manufacturer unknown) was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner 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 RECOMBIVAX HB lot # L048236, expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 58 degrees Fahrenheit for 3 hours. Data logger was involved. There was previous excursion of 63 degrees Fahrenheit for 2.5 hours reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA015042: US-009507513-1704USA015043: US-009507513-1704USA015044:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner 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 GARDASIL 9 lot # reported as M011840, expiration date 01-FEB-2018, lot # M030380, expiration date 01-FEB-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 58 degrees Fahrenheit for 3 hours. Data logger was involved. There was previous excursion of 63 degrees Fahrenheit for 2.5 hours reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014982: US-009507513-1704USA015043: US-009507513-1704USA015044:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner 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 M-M-R II lot # M034856, expiration date 27-JUL-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 58 degrees Fahrenheit for 3 hours. Data logger was involved. There was previous excursion of 63 degrees Fahrenheit for 2.5 hours reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014982: US-009507513-1704USA015044: US-009507513-1704USA015042:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner 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 PNEUMOVAX23 lot # L031459, expiration date 30-APR-2017, lot # M043424, expiration date 06-JUN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 58 degrees Fahrenheit for 3 hours. Data logger was involved. There was previous excursion of 63 degrees Fahrenheit for 2.5 hours reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014982: US-009507513-1704USA015042: US-009507513-1704USA015043:
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Allergy to tetanus; Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer report number: 2017147386) on 19-Apr-2017. This case involves a female patient (onset age not reported) who was vaccinated with a dose of TETANUS VACCINE AND TOXOID (Tetanus Toxoid) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's relevant medical history and concomitant medications were not reported. On an unspecified date following vaccination (Latency unknown), the patient experienced allergy to tetanus vaccines and toxoid. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: TYP
Symptoms: Typhoid fever, Vaccination failure
Clinical narrative: Initial unsolicited report received from a pharmacist on 20-Apr-2017. This case involves 17-year-old male patients, who was vaccinated with a dose of TYPHIM VI intramuscularly (Batch number, expiration date, dose in series and site of administration were not reported) on 02-May-2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions were unknown. Illness at the time of vaccination was none. Patient's concomitant medication were not reported. On an unknown date, following the vaccination, the patient contracted typhoid disease while travelling. It was unknown what strain of typhoid the patient was diagnosed with. It was also a case of vaccination failure. Patient required emergency room/ doctor visit. Patient's lab data was reported as: CDC testing for typhoid disease was done. Patient's corrective treatments was not reported. On an unknown date patient recovered from event. Case was considered serious for the important medical events: contracted typhoid disease and Vaccination failure. List of documents held by sender: none.; Sender's Comments: Based on the information patient received TYPHOID VI POLYSACCHARIDE VACCINE and experienced typhoid (Exact time to onset was not specified) however diagnosis was not confirmed. Considering that the patient received TYPHOID VI POLYSACCHARIDE VACCINE, the patient should have been protected against typhoid. This case is therefore a suspected vaccination failure. It was reported that the reporter that typhoid was confirmed with recent CDC testing however strain of typhoid is unknown. More details regarding relevant medical history, exact time to onset, date of vaccination investigation reports confirming the diagnosis, patient immune statues at the time of vaccination are needed for complete assessment of the case.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Swelling and redness and erythema at injection site and above, headache. Nausea at first but has subsided.
Age: 48.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, warmth, hardness, itching, tender. No treatment.  Lasted for about 2 days.
Age: 48.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Tenderness
Clinical narrative: Redness, swelling, warmth, hardness, itching, tender. No treatment.  Lasted for about 2 days.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Feeling abnormal, Seizure
Clinical narrative: Seizure, not herself.