chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 12 year old female patient. The patients' medical history, concurrent conditions, and concomitant medications were not reported. On 02-OCT-2018, the patient was vaccinated with improperly stored second dose of GARDASIL 9 (dose and frequency were not reported) (lot # R011628, expiry date: 11-DEC-2020) intramuscularly in the left deltoid for prophylaxis. The reporter spoke with company representative and refrigeration temperature was too low. Vaccine was not active need to be revaccinated. The reporter spoke with patient's mother and explained this to her. No reaction to vaccine except some soreness at injection site (vaccination site pain), on 02-OCT-2018. The outcome of event, vaccination site pain was reported as recovered/resolved. The relationship between the event, vaccination site pain and GARDASIL 9 was not provided. The vaccines were exposed to a temperature below 32 degree Fahrenheit (F): 31.1 F for 8 hours and 57 minutes and 31.9 F for 9 hours and 57 minutes; exposed to temperature above 32 F: 35.0 F for 31 minutes; and exposed to temperature in range of 47F to 77F (48. 9F) for 1 hour and 42 minutes. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA002051: Original Case: 1810USA002051.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pain, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 25 months old female patient. The patients' medical history, concurrent conditions, and concomitant medications were not reported. On 31-AUG-2017 the patient was vaccinated with FLUZONE 25 (lot # UT6262MA) intramuscularly into the right thigh for prophylaxis. On 04-OCT-2017, the patient was vaccinated with first dose of VAQTA and FLUZONE 25 (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. On 03-OCT-2018, the patient was vaccinated with improperly stored second dose of VAQTA from lot # R010954, expiry date: 27-MAY-2019 (dose and frequency were not reported) intramuscularly in the left vastus lateralis for prophylaxis. The reporter spoke with company representative and refrigeration temperature was too low. Vaccine was not active need to be revaccinated. The reporter spoke with patient's mother and explained this to her. No reaction to vaccine except some soreness at injection site (vaccination site pain), on 03-OCT-2018. The outcome of event, vaccination site pain was not reported. The relationship between the event, vaccination site pain and VAQTA was not provided. The VAQTA was exposed to a temperature below 32 degree Fahrenheit (F): 31.1 F for 8 hours and 57 minutes and 31.9 F for 9 hours and 57 minutes; exposed to temperature above 32 F: 35.0 F for 31 minutes; and exposed to temperature in range of 47F to 77F (48. 9F) for 1 hour and 42 minutes. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA002051: Original Case: 1810USA002051.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 18-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions and allergies were not reported. On 16-OCT-2018, the patient was vaccinated with PROQUAD subcutaneously, lot# R012413, expiration date: 28-OCT-2019 (exact dose, site of administration and frequency were not reported) for prophylaxis. No adverse effects were reported.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Alopecia areata
Clinical narrative: This spontaneous report was received from a consumer via a company representative and refers to a 16-year-old male patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies. On an unknown date in June 2018, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (site of administration, lot# and expiration date were not reported) for human papillomavirus "HPV" prophylaxis. A few weeks after the vaccination, the patient developed alopecia areata. On an unknown date in August 2018, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly (site of administration, lot# and expiration date were not reported) for HPV prophylaxis. The event of alopecia areata continued to progress after an unspecified amount of time after the second dose of GARDASIL 9. No lab diagnostic tests were performed. The patient was referred to an unspecified dermatologist. The outcome of the event was reported as not recovered. The relatedness between the event and GARDASIL 9 was not provided.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Dysgeusia, Headache, Hypoaesthesia oral, Vision blurred
Clinical narrative: This spontaneous report was received from a 79-year-old female patient. The patient's concurrent conditions included allergic reactions to DOXAFIN, hydrochloride (unspecified), doxycycline, latex, LEVAQUIN, TESSALON, ZITHROMAX, candicidin, methylchloroisothiazolinone and methylisothiazolinone. In the past, on an unspecified date, the patient took penicillin and could taste it on the tip of her tongue. Concomitant therapies included SYNTHROID. On 17-OCT-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # was not provided), 0.5 milliliter, intramuscularly to prevent pneumococcal disease. The patient stated that within a second after vaccine administration, she could taste the vaccine on her tongue, and that after a while, her tongue started to feel numb. The patient began to feel dizzy and developed a severe headache. She mentioned that she was unable to read writing because the letters were fussy. The patient received unspecified treatments for her experience, however, no laboratory diagnostics were performed and did not seek for medical attention. At the time of the report, the outcome of dysgeusia, visual impairment, headache, dizziness and hypoesthesia oral was reported as recovering. No causality assessment was provided.
Sex: F
Vaccine: HPV9
Symptoms: Death
Clinical narrative: This spontaneous report was received from an unspecified reporter referring to unknown number of female patients of unknown ages. Information about concomitant medication, pertinent medical history and drug reactions was not provided. On an unknown date the patients were vaccinated with GARDASIL 9 for prophylaxis (strength, dose, frequency, route, lot # and expiration date were not reported). The reporter stated the patients all over were being devastated by GARDASIL 9, and that the GARDASIL 9 was killing as many people as it wanted (death). The reporter considered death to be related to GARDASIL 9. It was unknown if autopsy was done. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1810USA010304:
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-OCT-2017 the patient was vaccinated with 2nd dose of VAQTA 25/0.5 intramuscularly for prophylaxis 5 days too early (inappropriate schedule of drug administration). No adverse effects reported.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Croup infectious
Clinical narrative: This spontaneous report was received from a physician referring to a 5 year old male patient.The patient had no concomitant medications, pertinent medical history or drug reaction. On 25-SEP-2018 the patient was vaccinated with PROQUAD (therapy type: rHA (recombinant Human albumin), lot #:N023001, Expire date: 19-FEB-2019, dose and frequency was not provided) subcutaneously for prophylaxis. On 19-OCT-2018, the patient returned to the office and was discovered that he had developed "case of croup". The patient was prescribed an unspecified dose of prednisone for treatment. The outcome of croup infectious was reported as not recovered/not resolved. No lab diagnostics/studies were performed. The causality assessment was not provided. Upon internal review, croup was determined to be medically significant.
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a female patient of unknown age. The patient historical drug included KEFLEX. The patient's concurrent conditions included multiple sclerosis, allergy for latex and KEFLEX. On 16-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R018735, expiration date and dosage regiment were not reported) for prophylaxis. After vaccination, in October 2018 (reported as 11 hours later), the patient reported waking up due to intense arm pain that radiated to the whole body. The patient reported that her arm was very red and swollen and extends 6-7 inches from her elbow to mid arm. The patient was speaking with her unspecified neurologist on an unspecified date who told her to take ibuprofen 600 mg three times a day for 6 days and ice the arm. The laboratory diagnostics were not performed. At the time of the report, the patient reported that she felt a little better, less pain and less swelling but had not recovered. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported.
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Headache, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a female patient of unknown age. The patient historical drug included KEFLEX. The patient's concurrent conditions included multiple sclerosis, allergy for latex and KEFLEX. On 16-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R018735, expiration date and dosage regiment were not reported) for prophylaxis. After vaccination, in October 2018 (reported as 11 hours later), the patient reported waking up due to intense arm pain that radiated to the whole body. The patient reported that her arm was very red and swollen and extends 6-7 inches from her elbow to mid arm. The patient was speaking with her unspecified neurologist on an unspecified date who told her to take ibuprofen 600 mg three times a day for 6 days and ice the arm. The laboratory diagnostics were not performed. At the time of the report, the patient reported that she felt a little better, less pain and less swelling but had not recovered. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported.
Sex: F
Vaccine: PPV, PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a female patient of unknown age. The patient historical drug included KEFLEX. The patient's concurrent conditions included multiple sclerosis, allergy for latex and KEFLEX. On 16-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R018735, expiration date and dosage regiment were not reported) for prophylaxis. After vaccination, in October 2018 (reported as 11 hours later), the patient reported waking up due to intense arm pain that radiated to the whole body. The patient reported that her arm was very red and swollen and extends 6-7 inches from her elbow to mid arm. The patient was speaking with her unspecified neurologist on an unspecified date who told her to take ibuprofen 600 mg three times a day for 6 days and ice the arm. The laboratory diagnostics were not performed. At the time of the report, the patient reported that she felt a little better, less pain and less swelling but had not recovered. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Severe reaction to PNEUMOVAX 23 vaccine. Arm swollen to size of SML. grapefruit with extreme pain in arm, forehead and back of head; pain radiating over entire body; arm red from elbow to mid arm.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Headache, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Severe reaction to PNEUMOVAX 23 vaccine. Arm swollen to size of SML. grapefruit with extreme pain in arm, forehead and back of head; pain radiating over entire body; arm red from elbow to mid arm.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Vaccination complication
Clinical narrative: Severe reaction to PNEUMOVAX 23 vaccine. Arm swollen to size of SML. grapefruit with extreme pain in arm, forehead and back of head; pain radiating over entire body; arm red from elbow to mid arm.
Sex: F
Vaccine: MMR
Symptoms: Immunisation, Seroconversion test negative
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 35 year old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with M-M-R II, subcutaneous, for prevention of measles, mumps and rubella (dose, lot # and expiration date were not reported). The patient was asking for revaccination with M-M-R II, due to positive titers only for mumps and rubella. It was reported, that measles failed to seroconvert. The outcome of the events was reported as not recovered/not resolved. The causality assessment was not provided.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Basedow's disease, Laboratory test, Systemic lupus erythematosus, Thyroidectomy, Urticaria
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) and refers to her 17-year-old non-pregnant female daughter. The patient had no pertinent medical history. She did not have any known drug reactions or allergies. The patient's concomitant medications were not reported. On an unknown date in 2009 (reported as sometime in 2009), the patient was vaccinated with a dose of GARDASIL (dose, lot# and expiry date were not reported), via intramuscular route of administration for prevention of human papilloma virus (HPV). On an unknown date, the patient received second dose of GARDASIL. On an unknown date in 2009 (reported as sometime in 2009), the patient developed graves disease, lupus, had removal of her thyroids and developed hives after receiving GARDASIL. She saw multiple physicians and the events required multiple visits at the hospital. The patient received unspecified treatment for the events and multiple unspecified tests were performed. The outcome of the events was reported as not recovered. The relatedness between the events and vaccine was not provided. Upon internal review, the events of graves disease, lupus and removal of her thyroids were considered to be medically significant. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1810USA009407:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On 17-OCT-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R018143 for prophylaxis (dose, strength, route of administration, and frequency were unknown). No adverse effects were reported. On an unknown date, the VARIVAX vaccines suffered from a temperature excursion of -9°C to 8°C during 2 Hours and 10 Minutes. No previous temperature excursions were reported. Digital data logger was involved.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a physician refers to a 2 week old patient. On 21-OCT-2018 the patient was vaccinated with M-M-R II for prophylaxis. On 21-OCT-2018, 1 day after onset of therapy the patient experienced drug administered to patient of inappropriate age. On an unknown date the patient experienced no adverse event. The outcome of drug administered to patient of inappropriate age and no adverse event is unknown. The reporter considered drug administered to patient of inappropriate age and no adverse event to be not assessed to M-M-R II.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 22-OCT-2018 the patient was vaccinated with ZOSTAVAX lot # N021172, intramuscular for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced incorrect route of drug administration and no adverse event. The outcome of incorrect route of drug administration and no adverse event is unknown.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 67 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 15-OCT-2017, the patient received vaccination with first dose of PNEUMOVAX 23, one dose for prophylaxis (route, lot # and expiry date unknown). On 15-OCT-2018, the patient was vaccinated with second dose of PNEUMOVAX 23, one dose from lot # N023651, expiry date: 20-MAY-2019. No adverse effects were reported. Product quality complaint was not involved.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Inflammation, Injection site inflammation, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 57 year old female patient.  No patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were reported. On 18-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R018732, expiry date: 27-FEB-2020, for prophylaxis (strength, dose, dosage schedule and anatomical location were not provided). On 20-OCT-2018, the patient experienced Injection site arm and hand inflammation and fever. The patient was treated on the same date with unspecified ibuprofen. The outcome of injection site inflammation, pyrexia, feeling hot and injection site warmth was reported as resolved. The reporter's causality assessment between PNEUMOVAX 23 with injection site inflammation, fever, feeling hot and injection site warmth was not reported.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a patient of 13 or 14 year old of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. In August 2017 (reported as "about 14 months ago, when the patient was 12 years old"), the patient received the first dose of GARDASIL 9. On 23-OCT-2018, the patient was in the office to receive the second dose of GARDASIL 9 (dose, route, lot number and expiration date were not reported) (inappropriate schedule of drug administration). No adverse effects reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 23-OCT-2018 the patient was inadvertently administered with VARIVAX (lot # N008077, expiration date: 09-MAR-2019, route: intramuscular, dose detail were unknown) and M-M-R II (lot #, expiration date and dose detail were unknown, route: intramuscular) for prophylaxis(subcutaneous injection formulation administered by other route). No adverse effects were reported.
Age: 81.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a currently 87 year old patient regarding him/herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient had no known drug allergies. On 05-DEC-2012 the patient was vaccinated with ZOSTAVAX (lot, expiry date and dose were not reported) subcutaneously for prophylaxis. Approximately on an unknown date of 2018 (also reported as now), the patient suffering from shingles. The outcome of herpes zoster was reported as not recovered. The causality assessment was not provided by the reporter.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 23-OCT-2018 the patient was vaccinated with expired VAQTA (lot # N016805 with expiration date 04-SEP-2018) for prophylaxis. The VAQTA did not have any temperature excursions prior to administration. No adverse symptoms were reported.
Sex: M
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: This spontaneous report has received from a nurse referring to a male patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was administered M-M-R II (strength, dose, rout, frequency, lot# and expiration date were not provided) for prophylaxis. At the same time, the patient moved while being administered his M-M-R II, booster shot and the needle came out of the patient's arm because he moved, and "only 75%" of the dose was administered. The patient's parents didn't want to have the patient receive another injection to administer the rest of the dose (Incomplete dose administered).
Sex: U
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a teacher of children with autism and refers to an unspecified number of children. The patients' pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. The teacher reported that on an unknown date, the patients were vaccinated with M-M-R II injection (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. She stated that she had seen children "before and after getting M-M-R II" and some of these children have developed autism on an unspecified dates. The primary reporter did not clarify if she was referring to some of her individual students or if she was referring to cases she has heard about or read about. The outcome of the event was not reported. Causality assessment was not provided. Upon internal review, the event of autism was considered to be medically significant.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse, concerning a 15 year old patient of unknown gender. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications. On 22-FEB-2018, the patient received the first dose of the vaccination series of GARDASIL 9, lot # N026814 and expiration date on 15-JUL-2020, for prophylaxis (route of administration and anatomical location were not reported). The second dose of the vaccine was administered to the patient on 01-OCT-2018 and the third one on 22-OCT-2018 (inappropriate schedule of drug administration). No adverse effects were reported.
Sex: U
Vaccine: HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring an unspecified number of patient of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL 9 lot # N032284 expiration date 22-SEP-2020 (dose, strength and anatomical route were not reported) and with the therapy ROTATEQ lot # R012957 expiration date 11-JUN-2019 (dose, strength and anatomical route were not reported) both medications indicated for prophylaxis. Temperature below 32 Fahrenheit, time frame 48 hours no previous temperature excursion, the call was due to a data logger. On an unspecified date, the physician reported that on multiple unspecified patients were administered improperly stored doses of. No adverse effect reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not provided. On 22-OCT-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # R012416, expiry date: 28-OCT-2019) which was reconstituted with properly stored sterile diluent, via subcutaneous route for prophylaxis. Concomitant therapies included sterile diluent. Nurse reported that the vaccine was exposed to -9 to 8 degree Celsius (6.3 C) for 3 hours and 37 minutes. Data Logger was involved. There was no previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Injection site pain, Product storage error
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reaction and concomitant medication were unknown. On an unspecified date, the patient was administered improperly stored VARIVAX (REFRIGERATOR STABLE) (lot number lot # N012131, expiration date 17-APR-2019, dosage schedule and route unknown) and M-M-R II (lot number M045393, expiration date 14-NOV-2018, dosage schedule and route unknown), both for prophylaxis. The M-M-R II was stored between 47 degrees Fahrenheit (F) to 77F (56.3F) for 2 hours and 52 minutes, and VARIVAX (REFRIGERATOR STABLE) between 15 F to 46F (24.7F) for 3 hours and 42 minutes. There was no previous temperature excursion. The sterile diluent used to reconstitute the vaccines was properly stored. The patient was complaining of injection site pain two days post injection. No treatment was given. The outcome of the injection site pain was unknown. The causal relationship between the event injection site pain and the therapies was not provided.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history was not reported. In 2015, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscular for prophylaxis. On 24-OCT-2018, the patient received another dose of PNEUMOVAX 23 lot # R012976, expiration date 25-JAN-2020 intramuscular for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 14-SEP-2018, the patient received improperly stored (-14 Celsius (C) degree to -10 C degree for 5 hours; there was no previous temperature excursion) VARIVAX (lot # R017636, expiration date auto-generated as 20-JUN-2020, also reported as 30-JUN-2018; strength, dose, frequency and route were not reported) for prophylaxis and was also reconstituted with sterile diluent (MERCK) (lot # R001089, expiration date 18-SEP-2020; strength, dose, frequency and route were not reported). No adverse effect was reported. It was not because of a data logger. Sender's Comments: US-009507513-1810USA003203: US-009507513-1810USA011661.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date, the patient was vaccinated with improperly stored VARIVAX, lot # R002054 and expiration date on 22-JAN-2018, for prophylaxis (route of administration and anatomical location were not reported). It was reported that the vaccine was reconstituted with properly stored sterile diluent. The administered dose of the vaccine experienced a temperature excursion of -9 to 8 degrees Celsius for 2 hours and 47 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA012270: US-009507513-1810USA012268: US-009507513-1810USA012269.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On 25-OCT-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # N005096 and expiration date 22-OCT-2018, for prophylaxis (dose strength, frequency, and route of administration were unknown). The patient experienced no adverse events. The outcome of expired product administered was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date, the patient was vaccinated with improperly stored VARIVAX, lot # R002054 and expiration date on 22-JAN-2018, for prophylaxis (route of administration and anatomical location were not reported). It was reported that the vaccine was reconstituted with properly stored sterile diluent. The administered dose of the vaccine experienced a temperature excursion of -9 to 8 degrees Celsius for 2 hours and 47 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA012082: US-009507513-1810USA012270: US-009507513-1810USA012269.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date, the patient was vaccinated with improperly stored VARIVAX, lot # R002054 and expiration date on 22-JAN-2018, for prophylaxis (route of administration and anatomical location were not reported). It was reported that the vaccine was reconstituted with properly stored sterile diluent. The administered dose of the vaccine experienced a temperature excursion of -9 to 8 degrees Celsius for 2 hours and 47 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1810USA012270: US-009507513-1810USA012268: US-009507513-1810USA012082:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date, the patient was vaccinated with improperly stored VARIVAX, lot # R002054 and expiration date on 22-JAN-2018, for prophylaxis (route of administration and anatomical location were not reported). It was reported that the vaccine was reconstituted with properly stored sterile diluent. The administered dose of the vaccine experienced a temperature excursion of -9 to 8 degrees Celsius for 2 hours and 47 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA012082; US-009507513-1810USA012268; US-009507513-1810USA012269.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a non-Merck clinical site coordinator and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported. On 05-OCT-2018, the patient was vaccinated with improperly stored ROTATEQ, orally (exact dose was not provided), lot # N030364, expiration date: 06-MAR-2019, for prophylaxis. The vaccine was stored at 11 Celsius degrees (C) for 1 hour 20 minutes and 8.7 C for 7 minutes. There were no other previous temperature excursions noted. No adverse effects were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1810USA012274: US-009507513-1810USA005531.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a non-Merck clinical site coordinator and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported. On 08-OCT-2018, the patient was vaccinated with improperly stored ROTATEQ, orally (exact dose was not provided), lot # N030364, expiration date: 06-MAR-2019, for prophylaxis. The vaccine was stored at 11 Celsius degrees (C) for 1 hour 20 minutes and 8.7 C for 7 minutes. There were no other previous temperature excursions noted. No adverse effects were reported. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1810USA005531: US-009507513-1810USA012273:
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site warmth, Peripheral swelling
Clinical narrative: Information has been received from a medical assistant referring to a 68 year old female patient. The patient had no concomitant therapy, pertinent medical history or drug reactions/allergies. On 15-OCT-2018 the patient was vaccinated with PNEUMOVAX 23 (lot # R018735, expiration date: 06-APR-2020, dose and frequency were unknown) intramuscularly in the left arm for prophylaxis. On 16-OCT-2018 the patient experienced redness and swelling which extended from the left inner arm to the elbow and the injection site area was hot to touch. The patient notified physician's office of reaction on 16-OCT-2018 and was told to observe the reaction site area and to call back if symptoms worsened. No treatment was given for the events. No lab diagnostics or studies were performed for the events. The outcome of the events was recovered. The causality assessment was not provided by the reporter.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Dermatitis, Injection site erythema, Injection site pain, Injection site warmth, Skin infection
Clinical narrative: Skin: 2.5-in x 3-in circular area of erythema on left deltoid, warm to the touch, minimal tenderness, no induration.          Assessment    1. Local skin infection  2. Skin inflammation  3. Adverse effect of influenza vaccine, initial encounter            Plan     1. Skin inflammation 2. Local skin infection 3. Adverse reaction to influenza vaccine, initial encounter - Inflammatory reaction vs infection due to flu vaccine - Advised mom to mark the area with a pen/marker and monitor for worsening - If no improvement or if redness spreads over the next 1-2 days, start antibiotics - cephalexin (KEFLEX) 250 mg/5 mL suspension; Take 8.5 mLs (425 mg per dose) by mouth 2 (two) times daily for 7 days.  Dispense: 119 mL; Refill: 0
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: Skin: 2.5-in x 3-in circular area of erythema on left deltoid, warm to the touch, minimal tenderness, no induration.          Assessment    1. Local skin infection  2. Skin inflammation  3. Adverse effect of influenza vaccine, initial encounter            Plan     1. Skin inflammation 2. Local skin infection 3. Adverse reaction to influenza vaccine, initial encounter - Inflammatory reaction vs infection due to flu vaccine - Advised mom to mark the area with a pen/marker and monitor for worsening - If no improvement or if redness spreads over the next 1-2 days, start antibiotics - cephalexin (KEFLEX) 250 mg/5 mL suspension; Take 8.5 mLs (425 mg per dose) by mouth 2 (two) times daily for 7 days.  Dispense: 119 mL; Refill: 0
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Cough, Eye pruritus, Immediate post-injection reaction, Injection site pain, Oropharyngeal pain
Clinical narrative: Immediate pain in the injection site and down the affected arm. Tingling in the left arm, face, tongue, nose, top of the head and upper left leg. Sensation difference between the left and right side of the body. Experienced a mild cough, sore throat and itchy eyes on day after the Flu shot through the weekend. Cough and sensation differences remain past the third day post injection.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity, Paraesthesia, Paraesthesia oral, Sensory disturbance
Clinical narrative: Immediate pain in the injection site and down the affected arm. Tingling in the left arm, face, tongue, nose, top of the head and upper left leg. Sensation difference between the left and right side of the body. Experienced a mild cough, sore throat and itchy eyes on day after the Flu shot through the weekend. Cough and sensation differences remain past the third day post injection.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site bruising, Injection site pain, Injection site paraesthesia, Paraesthesia
Clinical narrative: Immediate pain in the injection site and down the affected arm. Tingling in the left arm, face, tongue, nose, top of the head and upper left leg. Sensation difference between the left and right side of the body. Experienced a mild cough, sore throat and itchy eyes on day after the Flu shot through the weekend. Cough and sensation differences remain past the third day post injection.
Age: 28.0
Sex: F
Vaccine: FLUX, HEP
Symptoms: Disability, Influenza, Malaise, Psoriatic arthropathy, Pyrexia
Clinical narrative: Health Nurse requested me to take Flu Shot and I was concerned that with my poor immune system I would get the Flu. Health Nurse swore I would not get the Flu, and that since I worked as a MH/SA Emergency Clinician in the county jail I was at high risk of catching the Flu. That night I was terribly sick with fever of 107.5 (for the second time in my life.) I had the Flu and called my Doctor about fever and he didn't really give me advice so I had roommate put ice in a cold bath to try to break the fever. I only remember waking up the next day with a severe Flu. The day before vaccinations was my last healthy day. Dr. diagnosed me with SLE Lupus, Psoriatic Arthritis, etc. Disabled 04/07/1997.
Age: 28.0
Sex: F
Vaccine: FLUX, HEP
Symptoms: Systemic lupus erythematosus
Clinical narrative: Health Nurse requested me to take Flu Shot and I was concerned that with my poor immune system I would get the Flu. Health Nurse swore I would not get the Flu, and that since I worked as a MH/SA Emergency Clinician in the county jail I was at high risk of catching the Flu. That night I was terribly sick with fever of 107.5 (for the second time in my life.) I had the Flu and called my Doctor about fever and he didn't really give me advice so I had roommate put ice in a cold bath to try to break the fever. I only remember waking up the next day with a severe Flu. The day before vaccinations was my last healthy day. Dr. diagnosed me with SLE Lupus, Psoriatic Arthritis, etc. Disabled 04/07/1997.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right thigh swollen and red, Child was seen in the ER and was placed on ABX however seen in the office 1 day after the ER and told to DC ABX.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Fever, pain, lymph node swelling, aches.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Knot developed in the arm at site of injection, swollen, hard, warm to touch.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Cough, Disturbance in attention, Dyspnoea
Clinical narrative: Flu like symptoms started evening of 10/10/2018 and included body aches, joint pain, rib pain, fatigue, shortness of breath, dry cough, headache. Denies fever at that time. Flu like symptoms resolved within about 5 days. Back pain started on 10/20/18 at approximately 2:00 a.m. and became more severe evening of 10/21/2018. 4 clustered lesions detected on back, below shoulder, at that time. 10/22/2018 was seen at Urgent Care and physician diagnosed with shingles. Patient prescribed 1 gram of Valacyclovir three times per day. Along with 500 mg of Naproxen two times aily. Flexoril 3 times per day. Patient unable to take Valacylovir as prescribed, she states she took 3 first 24 hours but found it made her experience occular migraine and felt unable to concentrate and fatigued.  After these events she took only one per day.  She was also unable to take Flexoril due to fatigue/sedation. Switched Naproxen to Ibuprofen because she continued to feel fatigued and attributed this to the medication. 10/29/18 Patient states she is having twinges of pain "under shoulder blade but it is not the noticeable". Lesions are dry.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Herpes zoster, Influenza like illness, Migraine
Clinical narrative: Flu like symptoms started evening of 10/10/2018 and included body aches, joint pain, rib pain, fatigue, shortness of breath, dry cough, headache. Denies fever at that time. Flu like symptoms resolved within about 5 days. Back pain started on 10/20/18 at approximately 2:00 a.m. and became more severe evening of 10/21/2018. 4 clustered lesions detected on back, below shoulder, at that time. 10/22/2018 was seen at Urgent Care and physician diagnosed with shingles. Patient prescribed 1 gram of Valacyclovir three times per day. Along with 500 mg of Naproxen two times aily. Flexoril 3 times per day. Patient unable to take Valacylovir as prescribed, she states she took 3 first 24 hours but found it made her experience occular migraine and felt unable to concentrate and fatigued.  After these events she took only one per day.  She was also unable to take Flexoril due to fatigue/sedation. Switched Naproxen to Ibuprofen because she continued to feel fatigued and attributed this to the medication. 10/29/18 Patient states she is having twinges of pain "under shoulder blade but it is not the noticeable". Lesions are dry.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal chest pain, Pain, Skin lesion
Clinical narrative: Flu like symptoms started evening of 10/10/2018 and included body aches, joint pain, rib pain, fatigue, shortness of breath, dry cough, headache. Denies fever at that time. Flu like symptoms resolved within about 5 days. Back pain started on 10/20/18 at approximately 2:00 a.m. and became more severe evening of 10/21/2018. 4 clustered lesions detected on back, below shoulder, at that time. 10/22/2018 was seen at Urgent Care and physician diagnosed with shingles. Patient prescribed 1 gram of Valacyclovir three times per day. Along with 500 mg of Naproxen two times aily. Flexoril 3 times per day. Patient unable to take Valacylovir as prescribed, she states she took 3 first 24 hours but found it made her experience occular migraine and felt unable to concentrate and fatigued.  After these events she took only one per day.  She was also unable to take Flexoril due to fatigue/sedation. Switched Naproxen to Ibuprofen because she continued to feel fatigued and attributed this to the medication. 10/29/18 Patient states she is having twinges of pain "under shoulder blade but it is not the noticeable". Lesions are dry.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site discolouration, Injection site reaction, Injection site swelling, Skin exfoliation
Clinical narrative: Patient reports that she had swelling and discoloration from top of left arm to elbow, which her primary provider described as a cellulitis. Also her smallpox vaccination site became gray and scaly. 2 months duration. Seen and evaluated by primary provider, no medication treatment.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right shoulder: She exhibits decreased range of motion (on abduction of shoulder) and swelling. She exhibits no bony tenderness, no effusion, no deformity, normal pulse and normal strength. Right elbow: Normal. Lymphadenopathy: She has no cervical adenopathy. Neurological: She is alert. Skin: Skin is warm and dry. Capillary refill takes less than 2 seconds. No rash noted. There is erythema (circumferential erythema extending from right shoulder to elbow with moderate amount of swelling, warmth and tenderness). Vitals reviewed. Cellulitis of right upper arm - BENADRYL 12.5 mg/5 mL liquid; Give 10 mL by mouth three times daily for 2 days then every 6-8 hours as needed.  Dispense: 118 mL; Refill: 0 - KEFLEX 250 mg/5 mL suspension; Take 6.3 mLs (315 mg per dose) by mouth 2 (two) times daily for 10 days.  Dispense: 126 mL; Refill: 0 - Cool compresses PRN - Advised mom report will be made to VAERS to which she is in agreement - F/u in 2 days for recheck or sooner for worsening sx. Advised mom to mark area of erythema and strict f/u for worsening erythema or swelling - Educated re: dx etiology, mgmt, and f/u.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: Right shoulder: She exhibits decreased range of motion (on abduction of shoulder) and swelling. She exhibits no bony tenderness, no effusion, no deformity, normal pulse and normal strength. Right elbow: Normal. Lymphadenopathy: She has no cervical adenopathy. Neurological: She is alert. Skin: Skin is warm and dry. Capillary refill takes less than 2 seconds. No rash noted. There is erythema (circumferential erythema extending from right shoulder to elbow with moderate amount of swelling, warmth and tenderness). Vitals reviewed. Cellulitis of right upper arm - BENADRYL 12.5 mg/5 mL liquid; Give 10 mL by mouth three times daily for 2 days then every 6-8 hours as needed.  Dispense: 118 mL; Refill: 0 - KEFLEX 250 mg/5 mL suspension; Take 6.3 mLs (315 mg per dose) by mouth 2 (two) times daily for 10 days.  Dispense: 126 mL; Refill: 0 - Cool compresses PRN - Advised mom report will be made to VAERS to which she is in agreement - F/u in 2 days for recheck or sooner for worsening sx. Advised mom to mark area of erythema and strict f/u for worsening erythema or swelling - Educated re: dx etiology, mgmt, and f/u.