chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA, FLU4, HEPA
Symptoms: Upper respiratory tract infection, Viral upper respiratory tract infection, Weight bearing difficulty
Clinical narrative: A few days after receiving his vaccine, patient began to show signs of head cold/ upper respiratory infection. 20 days post vaccine, patient woke up unable to walk or put any weight on his legs & was admitted to Hospital. The illness spread wakening upper body muscles, facial muscles, and shutting down his bladder functions. Patient was treated with IGIV & steroids. He was diagnosed with Guillain Barre Syndrome. As of Dec. 2015 he is in inpatient rehab, still unable to sit up or use his legs at all.
Age: 1.67
Sex: M
Vaccine: FLU4, HEPA, FLUX, HEPA, FLU4, HEPA
Symptoms: Autopsy, Death, Unresponsive to stimuli
Clinical narrative: Initial unsolicited report received from a physician on 28-MAR-2017. This case involves a 20-month-old male patient who was vaccinated with a dose of FLUZONE QIV and a dose of HEPATITIS A VACCINE (HEP A VACCINE) (for both the vaccines batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, day after the vaccination, the patient passed away. Lab data and corrective treatment were not reported. Autopsy details was not reported. List of documents held by sender: none.; Sender's Comments: 20 month old child was vaccinated with FLUZONE QIV and HEP A VACCINE following which patient passed away next day. Time to onset is compatible, but additional information regarding patient medical history, past vaccination history and concomitant medication are unknown. Results of laboratory analysis and autopsy report are not provided. Additional information is required to fully assess role of the vaccine in reported event.; Reported Cause(s) of Death: passed away.
Age: 1.67
Sex: M
Vaccine: FLU4, HEPA, FLUX, HEPA, FLU4, HEPA
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: Initial unsolicited report received from a physician on 28-MAR-2017. This case involves a 20-month-old male patient who was vaccinated with a dose of FLUZONE QIV and a dose of HEPATITIS A VACCINE (HEP A VACCINE) (for both the vaccines batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, day after the vaccination, the patient passed away. Lab data and corrective treatment were not reported. Autopsy details was not reported. List of documents held by sender: none.; Sender's Comments: 20 month old child was vaccinated with FLUZONE QIV and HEP A VACCINE following which patient passed away next day. Time to onset is compatible, but additional information regarding patient medical history, past vaccination history and concomitant medication are unknown. Results of laboratory analysis and autopsy report are not provided. Additional information is required to fully assess role of the vaccine in reported event.; Reported Cause(s) of Death: passed away.
Age: 1.67
Sex: M
Vaccine: FLU4, HEPA, FLUX, HEPA, FLU4, HEPA
Symptoms: Autopsy, Death, Laboratory test
Clinical narrative: Initial unsolicited report received from a physician on 28-MAR-2017. This case involves a 20-month-old male patient who was vaccinated with a dose of FLUZONE QIV and a dose of HEPATITIS A VACCINE (HEP A VACCINE) (for both the vaccines batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, day after the vaccination, the patient passed away. Lab data and corrective treatment were not reported. Autopsy details was not reported. List of documents held by sender: none.; Sender's Comments: 20 month old child was vaccinated with FLUZONE QIV and HEP A VACCINE following which patient passed away next day. Time to onset is compatible, but additional information regarding patient medical history, past vaccination history and concomitant medication are unknown. Results of laboratory analysis and autopsy report are not provided. Additional information is required to fully assess role of the vaccine in reported event.; Reported Cause(s) of Death: passed away.
Age: 1.42
Sex: F
Vaccine: HIBV
Symptoms: Blood test, Heart rate increased, Injection site swelling, Pyrexia, Rash
Clinical narrative: Site reaction/swelling, increased heart rate, increased respiration, rash along legs, belly, chest, neck, face, and ears. Fever of 99-100.3.
Age: 1.42
Sex: F
Vaccine: HIBV
Symptoms: Respiratory rate increased
Clinical narrative: Site reaction/swelling, increased heart rate, increased respiration, rash along legs, belly, chest, neck, face, and ears. Fever of 99-100.3.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Exposure during pregnancy, Injection site erythema, Injection site pain
Clinical narrative: I revived the Tdap vaccines and immediately developed significant pain at injection site. About 15 minutes later I developed redness, swelling, hives - all local to the affected arm. About 10 hours later developed low grade temps, chills, muscle aches. About 5 hours after the above symptoms developed vomiting.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site urticaria, Myalgia, Vomiting
Clinical narrative: I revived the Tdap vaccines and immediately developed significant pain at injection site. About 15 minutes later I developed redness, swelling, hives - all local to the affected arm. About 10 hours later developed low grade temps, chills, muscle aches. About 5 hours after the above symptoms developed vomiting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. 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 with a dose of ZOSTAVAX via an unspecified route (anatomical location, lot number and expiration date were not reported) for prevention of shingles. On an unknown date, after receiving the ZOSTAVAX, the patient experienced shingles.  The outcome of shingles was not reported.  The relatedness between the event and zoster vaccine live (ZOSTAVAX) was not reported.   Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and an administrator refers to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M031807, expiration date 02-APR-2018; dose and frequency were not reported), orally, for prophylaxis. The vaccine data logger measure a temperature range from 32°F to 35°F (0°C to 1°C) for a total time frame of 1 hours (1 cycle) on 24-JAN-2017, 3 hours (3 cycles) on 25-JAN-2017 and 4 hours (4 cycles) on 26-JAN-2017 for a total of 8 hours (8 cycles). The medical assistant mentioned that the vaccine was exposed only for 1 hour and 30 minutes at a temperature as low as 33.1°F, the other cumulative hours were at 34°F. There was no previous temperature excursion. No adverse effects were reported, and a product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001785: US-009507513-1704USA001786: US-009507513-1704USA001784:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from  a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 23-MAR-2017 (also reported as 24-MAR-2017), the patient was vaccinated  with a dose of M-M-R II lot # M028130 and expiration date of 06-JUN-2018 (strength and dose were unknown) for prophylaxis and with a dose of VARIVAX lot # M036272 and expiration date of 17-AUG-2018  (strength and dose were unknown) for the same indication. Both vaccines were administered intramuscularly rather than subcutaneously. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date in August 2014, the patient was vaccinated with a first dose of GARDASIL (dosage schedule, route of administration, anatomical location, lot# and expiration date were not provided), for prophylaxis. On an unknown date in March 2016, the patient was vaccinated with a second dose of GARDASIL (lot # L039066 with expiration date 19-MAR-2017). No adverse effects were reported. Additional information is not expected as there is no consent to contact the reporter.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Herpes zoster, Hypoaesthesia, Koebner phenomenon, Local swelling
Clinical narrative: This spontaneous report was received via a company representative from an unspecified healthcare worker and refers to a 65-year-old male patient. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 17-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX vial, 0.65 ml (one dose), lot # L028282 (expiry date was not reported, route of administration unknown, reported as injection) to prevent Shingles, together with diluent (dose, frequency, lot #, expiry date and indication were not reported) and left for out of town. On an unknown date in 2015, the patient developed a "bad rash" and went to an unspecified emergency room (date not provided). There, he was diagnosed with chickenpox. Afterwards, in December 2015, the patient developed "numbing of the face". He went to an emergency room and was admitted to an unspecified hospital (dates of hospitalization were not provided). The patient was diagnosed with Bell's palsy (reported as belspalcy), caused by the chicken pox. Subsequently, in February 2016, the patient visited dermatologist due to the "lesions on his torso". The dermatologist first diagnosed the patient with eczema and attempted to burn off the lesions as a treatment. As the procedure was ineffective, the dermatologist changed their diagnosis to psoriasis and Koebner syndrome. Then, in March 2017, the patient experienced swelling behind the ear and behind the neck and went back to dermatologist, who diagnosed the patient with Shingles. The outcome of the events was reported as not recovered at the time of the report. The causality between ZOSTAVAX, diluent and the events was not reported. Upon internal review, the event of Bell's palsy was considered to be medically significant. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Psoriasis, Rash, Skin lesion, Swelling, Varicella
Clinical narrative: This spontaneous report was received via a company representative from an unspecified healthcare worker and refers to a 65-year-old male patient. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 17-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX vial, 0.65 ml (one dose), lot # L028282 (expiry date was not reported, route of administration unknown, reported as injection) to prevent Shingles, together with diluent (dose, frequency, lot #, expiry date and indication were not reported) and left for out of town. On an unknown date in 2015, the patient developed a "bad rash" and went to an unspecified emergency room (date not provided). There, he was diagnosed with chickenpox. Afterwards, in December 2015, the patient developed "numbing of the face". He went to an emergency room and was admitted to an unspecified hospital (dates of hospitalization were not provided). The patient was diagnosed with Bell's palsy (reported as belspalcy), caused by the chicken pox. Subsequently, in February 2016, the patient visited dermatologist due to the "lesions on his torso". The dermatologist first diagnosed the patient with eczema and attempted to burn off the lesions as a treatment. As the procedure was ineffective, the dermatologist changed their diagnosis to psoriasis and Koebner syndrome. Then, in March 2017, the patient experienced swelling behind the ear and behind the neck and went back to dermatologist, who diagnosed the patient with Shingles. The outcome of the events was reported as not recovered at the time of the report. The causality between ZOSTAVAX, diluent and the events was not reported. Upon internal review, the event of Bell's palsy was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse 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 (dose and route of administration were not provided; lot # M014304, expiration date: 22-SEP-2017, albumin status:rHA; lot# M037012, expiration date: 21-FEB-2017, albumin status:rHA). The reporting nurse stated, that sterile diluent (manufacturer unknown) (lot# and expiration date were not provided) used to reconstitute the vaccines was properly stored. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 25.7 degrees Fahrenheit for 1.5 hours and 8.8 Fahrenheit for 1 hour. Digital data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1704USA002617.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from  a physician and a healthcare worker, refers to a female patient of currently 34 years old. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patient was vaccinated with an unspecified number of doses of an unspecified measles vaccine (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis. It was reported that, on an unknown date, a "blood work" was performed to the patient and the results showed  that she had a low measles titer (measles antibody negative). The patient sought medical attention by visiting the physician's office. On 28-MAR-2017, the patient was vaccinated with a dose of M-M-R II (strength, dose, route of administration, lot number and expiration date were unknown) for prophylaxis because of the event. The outcome of measles antibody negative was unknown. The causality between  the unspecified measles vaccine (manufacturer unknown) and the event was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from nurse and refers to an unspecified adult patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 29-MAR-2017, the patient was vaccinated with an expired dose of M-M-R II (dose, route, and anatomical location were not reported) (lot # L009545 and expiration date 19-MAR-2017) for prophylaxis. It was reported that the vaccine was properly stored. No adverse effects were reported. Additional information is not expected because the reporter refused additional contact.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This information has been received from a nurse concerning a 71 year old male patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 31-MAR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 with lot number L024132 and expiration date on 21-JAN-2017 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis. The reporter stated that the vaccine was stored properly. No product quality complained was involved. No adverse effect was reported. Additional information is not expected as there was no consent to contact the reporter.
Sex: M
Vaccine: PPV
Symptoms: Cardiac disorder
Clinical narrative: This solicited report has been received from a 45 years old male patient, who was enrolled in a marketed research, concerning himself. The patient's medical history, concurrent conditions and concomitant therapies were unknown. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route, frequency, site administration, lot# and expiration date were not reported.) for prophylaxis. On an unknown date the patient had heart problems. The patient was also informed that if a person never had the vaccine before, that they were likely to contract the disease. The outcome of the event was unknown. Causality between to PNEUMOVAX23 and the event was not provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and an administrator and refers to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # M036056, expiration date 18-MAY-2019; dose, route of administration, and frequency were not reported), for prophylaxis. The vaccine data logger measured a temperature range from 32°F to 35°F (0°C to 1°C) for a total time frame of 1 hour (1 cycle) on 24-JAN-2017, 3 hours (3 cycles) on 25-JAN-2017 and 4 hours (4 cycles) on 26-JAN-2017 for a total of 8 hours (8 cycles). The medical assistant mentioned that the vaccine was exposed only for 1 hour and 30 minutes at a temperature as low as 33.1°F, the other cumulative hours were at 34°F.. There was no previous temperature excursion. No adverse effects were reported, and a product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001785: US-009507513-1704USA001786: US-009507513-1703USA008107:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and an administrator and refers to an unspecified 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 unspecified dates, an unspecified number of patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M036059, expiration date 03-JUN-2019; dose, route of administration, and frequency were not reported), for prophylaxis. The vaccine data logger measure on 24-JAN-2017 a temperature range, the same temperature frame for 3 hours (3 cycles), on 26-JAN-2017, for 4 hours (4 cycles) at the same temperature frame for a total of 8 hours. The medical assistant mentioned that the vaccine was exposed only for 1 hour and 30 minutes at a temperature as low as 33.1 °F, the other cumulative hours were at 34 °F. There was no previous temperature excursion. No adverse effects were reported, and product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA008107: US-009507513-1704USA001786: US-009507513-1704USA001784.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and an administrator and refers to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The reporters stated that on unspecified dates, an unspecified number of patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot # M036728, expiration date 20-MAY-2018; dose, route of administration, and frequency were not reported), for prophylaxis. The vaccine data logger measure on 24-JAN-2017 a temperature range from 32°F to 35°F (0°C to 1°C) for a total time frame of 1 hours (1 cycle), on 25-JAN-2017, the same temperature frame for 3 hours (3 cycles), on 26-JAN-2017, for 4 hours (4 cycles) at the same temperature frame for a total of 8 hours. The medical assistant mentioned that the vaccine were exposed only for 1 hour and 30 minutes at a temperature as low as 33.1 °F, the other cumulative hours were at 34°F.  There was no previous temperature excursion. No adverse effects were reported, and product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001785: US-009507513-1703USA008107: US-009507513-1704USA001784:
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse refers to currently a 23 years old female patient of unknown age. She did not have past medical history and pregnancies. On 27-MAR-2017, the patient was vaccinated with third dose of GARDASIL 9 from lot # M041990 (dose, route and anatomical location not reported), for prophylaxis (also indicated GARDASIL). Concomitant medication included PRENATAL. On 29-MAR-2017, the patient had an ultrasound showed the patient was pregnant, singleton. The last menstrual period (LMP) and estimated date of delivery (EDD) were reported to be 16-JAN-2017 and 23-OCT-2017, respectively. Outcome of pregnancy was pending. 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 nurse 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 (dose and route of administration were not provided; lot # L046884, expiration date: 23-NOV-2017; lot# M025865, expiration date: 24-MAY-2018). The reporting nurse stated, that sterile diluent (manufacturer unknown) (lot# and expiration date were not provided) used to reconstitute the vaccines was properly stored. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 25.7 degrees Fahrenheit for 1.5 hours and 8.8 Fahrenheit for 1 hour. Digital data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013690.
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This is a spontaneous report from a contactable medical assistant. A male patient of unspecified age and race/ethnicity received on 31Mar2017 a single dose of TRUMENBA for immunization. Medical history and concomitant medications were not reported. On unspecified date in 2017, the patient experienced a local reaction described as red and swelling at the injection site, with a red ring like a circle around the injection site that felt hot to the touch. As of 03Apr2017, outcome was not recovered.
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: Initial unsolicited report received from non-healthcare professional (family friend) on 21-Mar-2017. This case involves an 11-year-female patient who was vaccinated with a first dose of ADACEL (Batch number, expiry date, dose, and dose in series, route and site of administration were not reported) on an unknown date in allergist office. Patient's illness at time of vaccination was reported as none. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions included milk allergy. Concomitant medications were not reported. It was unknown if the patient was vaccinated with any other vaccine within four weeks. On an unknown date, after vaccination, patient was anaphylactic. The patient was required ER/doctor visit. Laboratory investigations were reported as none. Corrective treatments were not reported. Patient was recovered from the event. Upon internal review the company decided to consider the case serious because of important medical event anaphylactic reaction. List of documents held by sender: none. Sender's Comments: Anaphylactic reaction is listed with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Although the patient is allergic to milk and from this is poorly documented case it is difficult to assess the role of the vaccine. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Feeling hot, Headache, Influenza A virus test positive, Pain, Vomiting
Clinical narrative: Pt/mother report pt awoke feeling hot, achy, headache, vomited x 1, came to school and temperature checked by school RN 102.5.
Age: 29.0
Sex: M
Vaccine: ANTH, PPV, TYP
Symptoms: Injection site swelling, Pain
Clinical narrative: Sore during the day of the vaccinations. Woke up the next morning to swelling in the upper right arm.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: This spontaneous report was received from a male patient (age unknown) referring to himself. There was no information provided about the patient's concurrent conditions, medical history or concomitant medication. On 08-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX vials for prophylaxis (strength, dose, frequency, route of administration, anatomical location, indication, lot # and expiration date were not reported). The reporter stated that, on 13-MAR-2017, the joints of his left ring finger were very sore when he closed his hand (arthralgia). The outcome of the event and the relatedness between the event and ZOSTAVAX were not reported. Additional information has been requested.
Sex: F
Vaccine: HPV9, MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and refers to a female patient of unknown age. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 21-FEB-2017, the patient was confirmed to be pregnant via an urine pregnancy test. Her last menstrual period (LMP) and estimated delivery date (EDD) were not provided. On the same day, the patient was inadvertently vaccinated with a dose of M-M-R II (albumin status: recombinant human albumin (rHA)) injection, lot # M017347 with expiry date 06-APR-2018 (route of administration was not reported), a dose of VARIVAX (exact dose, route of administration, lot # and expiry date were not provided) and a dose of GARDASIL 9 (exact dose, route of administration, lot # and expiry date were not provided). The patient was seen by the reporter on 28-MAR-2017 (reported as yesterday) and was still pregnant at that time. No adverse effects were reported. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Erythema, Induration, Injection site cellulitis, Irritability, Pyrexia
Clinical narrative: Mother states that on the day after vaccination the area was red, hard, and warm. The infant had fever and was irritable.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Skin warm
Clinical narrative: Mother states that on the day after vaccination the area was red, hard, and warm. The infant had fever and was irritable.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Peripheral swelling, Pruritus, Pyrexia, Syncope
Clinical narrative: Arm itching and swollen, took benadryl, thought would help, got shaky, went to bed. Felt nauseous during night, syncope episode twice. Fever 101F. Arm does not itch this morning, still swollen, still has fever and shakes.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Arm itching and swollen, took benadryl, thought would help, got shaky, went to bed. Felt nauseous during night, syncope episode twice. Fever 101F. Arm does not itch this morning, still swollen, still has fever and shakes.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Swelling near the injection site, large, bruised-looking, raised area the size of a palm. I don't usually have any bruising from needle sticks (I have regular IV's and blood draws due to medical condition). Swelling was extremely painful.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pyrexia
Clinical narrative: Felt like shoulder had been kicked by a mule, 2 degrees of fever by 9 PM.  I'd had the first two pneumonia shots with no adversity.
Sex: U
Vaccine: HIBV, HPV9, MMR, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information had been received on 10-MAR-2017 from a nurse who reported that improperly stored doses of ROTATEQ, GARDASIL 9, PEDVAXHIB and M-M-R II were administered to unspecified patients from 01-FEB-2017 to 28-FEB-2017. Temperature of vaccines ranged from 47 degrees Fahrenheit to 77 degrees Fahrenheit for a time frame of two hours. There was no previous temperature excursion. Call was because of a "data logger". No adverse effects. No further information to report. Names of vaccines involved: ROTATEQ (lot# M033337, expiration 13-APR-2018), (lot# M042822, expiration 19-JUN-2018), (lot# M042171, expiration 07-JUN-2018), (lot# M039067, expiration 18-APR-2018). PEDVAXHIB (lot# M036058, expiration 19-MAY-2019), (lot# M046133, expiration 26-SEP-2019), (lot# M046134, expiration 27-SEP-2019). GARDASIL 9 (lot# M028323, expiration 26-SEP-2018), (lot# M017983, expiration 30-MAY-2018), (lot# M041212, expiration 21-JUN-2019), (lot# M041990, expiration 28-JUN-2019). M-M-R II (lot# M029230, expiration 08-JUN-2018), (lot# M008588, expiration 16-FEB-2018), (lot# M035935, expiration 09-AUG-2018), (lot# M037096, expiration 23-AUG-2018). Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Oral pain, Pain in jaw
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date in 2017 (reported as "earlier this year"), the patient received a first dose of GARDASIL 9 injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) for human papilloma virus (HPV) prevention. On an unknown date in 2017 (reported as "day or so" after the administration of the first dose of GARDASIL 9, the patient had developed some jaw and mouth pain. The patient sought medical attention (doctor's appointment) and she was given an unspecified treatment for the adverse events. On an unknown date in 2017, the patient recovered from the events of jaw and mouth pain (also reported as "adverse events improved"). At the time of the report (provided as "at that time"), the patient's mother did not feel that her daughter would continue the vaccination series schedule (which was also reported as "vaccination was not reintroduced"). The causality assessment between the events of jaw and mouth pain and the vaccination with GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses (32 doses in total) of VARIVAX injection, lot # L035127 with expiry date 14-SEP-2017 (2 doses) and lot # M035142 with expiry date 03-AUG-2018 (30 doses) (exact dose, route of administration and anatomical location were not specified) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). On an unknown date, the administered doses of VARIVAX underwent a temperature excursion under 6 Fahrenheit degrees to 14 Fahrenheit degrees for 14 hours. It was reported that there were previous temperature excursions: between 6 Fahrenheit degrees and 14 Fahrenheit degrees for 1 hour and 15 Fahrenheit degrees to 46 Fahrenheit degrees for 6 hours. Product quality complaint (PQC) was not involved. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician and from a nurse practitioner via a company representative and refers to a 2 patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and drug reactions or allergies was provided. On unknown dates (reported as "over 2 years ago"), the patients were vaccinated with single dose of ZOSTAVAX injection, dose reported as ".065", subcutaneously (lot# and expiration date were not reported) for prevention of shingles. No information about the concomitant therapies was provided. On unknown dates, the patients experienced a mild case of shingles. The outcome of the event and the causality between the event and ZOSTAVAX were not reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies or concomitant therapies was provided. On unknown dates reported as "over the past 3 months", the patients were vaccinated with improperly stored doses of vaccine, VAQTA lot # M032492, expiration date: 02-MAR-2018 (dose, route and site of administration were not reported). No adverse experience was reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 21 hours cumulatively over "3 months," on unspecified dates. Data logger was not involved. There were no previous excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA014473: US-009507513-1703USA014471: US-009507513-1703USA014472: US-009507513-1703USA014469: US-009507513-1703USA007914.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates reported as "over the past 3 months", the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lots #: M037771 with expiration date: 21-FEB-2019, M023718 with expiration date: 09-SEP-2018 and M008551 with expiration date: 02-JUN-2018 (dose, route and site of administration were not reported). No adverse experience was reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 21 hours cumulatively over "3 months," on unspecified dates. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA014473: US-009507513-1703USA014471: US-009507513-1703USA014470: US-009507513-1703USA014469: US-009507513-1703USA007914:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 03-FEB-2017 at 15:45, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 17-JAN-2017 at 10:41, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 09-JAN-2017 at 16:10, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Granuloma annulare, Rash
Clinical narrative: This spontaneous report was received from a physician via a company employee and refers to a 11 year old female patient. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a first dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) for prevention of human papillomavirus (HPV). Concomitant therapies included ADACEL and MENACTRA vaccines. On an unknown date, after receiving GARDASIL 9, the patient developed a rash around her ankles and feet. The reporter stated that the rash looked like Granuloma Annulare, however it was not confirmed. The outcome of the event of rash looked like a Granuloma Annulare was reported as recovered on an unknown date (also reported as the rash lasted for "a few weeks" before the patient recovered). The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Therapeutic response unexpected
Clinical narrative: This case involves a 77 years old female subjects who had therapeutic response unexpected after receiving the vaccine. No information was provided regarding previous therapies, premedication and concomitant medication, or if the subject presented events on previous vaccination. On an unspecified date, (latency unknown) after receiving a dose of FLUZONE HD (batch number, expiry date, dose, dose in series, route and site of administration were not reported) the subjects had therapeutic response unexpected after vaccination. It was reported that the subject have had the senior version and reacted poorly. No information regarding lab data and corrective treatment were reported. The outcome of the events was not reported. The event relation to the study vaccine or trial procedures: not reported. Relationship to investigational product according to Company: not associated. List of documents held by sender: none.