chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Antibody test positive, Blood immunoglobulin G, Confusional state, Encephalitis california, Fatigue
Clinical narrative: Sx started 7/16/17 with Fever, Rash, Headache, Fatigue or malaise, Stiff neck, Altered mental status, Seizures, drowsiness and confusion. Pt was hospitalized at Hospital 6/19/17-6/23/17 and was diagnosed with LaCrosse Encephalitis and Jamestown Canyon Virus disease.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Malaise, Mental status changes, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Sx started 7/16/17 with Fever, Rash, Headache, Fatigue or malaise, Stiff neck, Altered mental status, Seizures, drowsiness and confusion. Pt was hospitalized at Hospital 6/19/17-6/23/17 and was diagnosed with LaCrosse Encephalitis and Jamestown Canyon Virus disease.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Seizure, Somnolence, Viral infection
Clinical narrative: Sx started 7/16/17 with Fever, Rash, Headache, Fatigue or malaise, Stiff neck, Altered mental status, Seizures, drowsiness and confusion. Pt was hospitalized at Hospital 6/19/17-6/23/17 and was diagnosed with LaCrosse Encephalitis and Jamestown Canyon Virus disease.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Erythema
Clinical narrative: Patient has erythema 1.5 cm x 1 in on left arm, since 07/21/2017. No other symptoms related.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site pain, Insomnia
Clinical narrative: Received the smallpox vaccination on 11 July. Last night my temp was 103.0, I had a HA, nausea and vomited once. I took Tylenol and fever went down to 101.0. The headache now hurts so bad that I cannot sleep. Two hours ago my temp was 101.0, so I took ibuprofen 800 mg. The nausea is gone and I have not vomited again. I can drink fluids well, 3 canteens so far today. No blurry vision, neck stiffness or pain. The SPV site has erythema extending about an inch around it and tender. Axillary nodes tender, not enlarged. I called our family practice clinic and they have no appts. They said to call back if my vision got blurry or my neck got stiff. Seen at ED. Temp came down to 101.2 after taking ibuprofen. Dx cellulitis---given Bactrim.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Lymph node pain, Nausea, Pyrexia, Vomiting
Clinical narrative: Received the smallpox vaccination on 11 July. Last night my temp was 103.0, I had a HA, nausea and vomited once. I took Tylenol and fever went down to 101.0. The headache now hurts so bad that I cannot sleep. Two hours ago my temp was 101.0, so I took ibuprofen 800 mg. The nausea is gone and I have not vomited again. I can drink fluids well, 3 canteens so far today. No blurry vision, neck stiffness or pain. The SPV site has erythema extending about an inch around it and tender. Axillary nodes tender, not enlarged. I called our family practice clinic and they have no appts. They said to call back if my vision got blurry or my neck got stiff. Seen at ED. Temp came down to 101.2 after taking ibuprofen. Dx cellulitis---given Bactrim.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Patient received dose 3 in series too early. No reported adverse reaction to receiving this dose too early.  Dose 1--3/1/17 Dose 2--6/14/17 Dose 3--due 8/9/17, given 7/21/17.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling at injection site  headache, body aches, diarrhea, itching  and still red and swollen at injection site warm to touch this is now 72 hrs.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Redness, swelling at injection site  headache, body aches, diarrhea, itching  and still red and swollen at injection site warm to touch this is now 72 hrs.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling at injection site  headache, body aches, diarrhea, itching  and still red and swollen at injection site warm to touch this is now 72 hrs.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Decreased appetite, Nausea, Somnolence, Urine analysis normal
Clinical narrative: History per MOC. My daughter went in for her 4 yo check up and received her 4 yo shots---DTaP, IPV, MMRV. That was 0900. We ran around all day, got home and she went to sleep at 1530 until 1830. Now that she is up her temp is 102.2, nausea with no vomiting, drowsy. She won?t eat, not even her birthday cake from yesterday. I just gave her some Tylenol that she took without a problem. PMH:  chronic kidney disease; chromosome duplication disorder; recent diagnosis of autism.  She is often sick and has been hospitalized several times. Rec that they encourage sips of clear fluids and go to ED. I could well be the vaccinations that caused these symptoms, but with her PMH she may respond differently than other children. Concern esp because she has more than one symptoms. It may be another condition causing the problem. FOC called back 4 hours later---waiting in a very busy ED. He called again on 21 July---they waited 3 hrs and went home, but back to their own pediatrician on the 21st.  She was fine then, negative u/a.
Age: 25.0
Sex: F
Vaccine: HEPA, IPV, MNQ, TDAP
Symptoms: Eye pain, Head discomfort, Headache, Photophobia
Clinical narrative: 24 days after receiving vaccines, 25 yo female c/o headaches with eye pain. Pt referred to Ophthalmology c/o left eye pain with light sensitivity, temporal pressure radiating to back of head.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Breath sounds abnormal, Chest X-ray abnormal, Chest pain, Muscle spasms
Clinical narrative: The patient received the BEXSERO vaccine in the morning. Later that same day he was at rest standing and had an abrupt onset of severe chest and upper mid back pain. He went to his school's medical center and was told he had a muscle spasm. His symptoms were not improving so he went to the PCP's office two days later (7/16). At the office visit the physician had a concern for differential breath sounds and sent the patient to the local ED. At the ED a chest x-ray showed a large pneumothorax. A chest tube was placed in the ED and the patient was admitted to the hospital for management.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pneumothorax, Thoracostomy
Clinical narrative: The patient received the BEXSERO vaccine in the morning. Later that same day he was at rest standing and had an abrupt onset of severe chest and upper mid back pain. He went to his school's medical center and was told he had a muscle spasm. His symptoms were not improving so he went to the PCP's office two days later (7/16). At the office visit the physician had a concern for differential breath sounds and sent the patient to the local ED. At the ED a chest x-ray showed a large pneumothorax. A chest tube was placed in the ED and the patient was admitted to the hospital for management.
Sex: F
Vaccine: HBHEPB
Symptoms: Hepatitis B surface antibody negative, No adverse event
Clinical narrative: Information was received on 14-JUL-2017 from a medical assistant who reported that a 16 year old female patient had received the three dose series of COMVAX (dosage and lot#/expiration not reported) on the following dates (20-JUL-2001, 13-OCT-2001, 27-AUG-2002). Medical assistant reported that patient had "lab work drawn" on 13-JUL-2017 and that "titers for Hep B came back negative". No adverse reactions reported. No further information reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 14-JUL-2017 from a nurse who reported that on an unspecified date, an unspecified patient received an improperly stored dose of VARIVAX (lot# M048200, expiration 07-DEC-2018) reconstituted with properly stored sterile water diluent (lot#/expiration not reported). Temperature was -14 degrees C to -10 degrees C for 170 hours and 26 minutes; -9 degrees C to 8 degrees C for 8 hours and 26 minutes. There was a previous temperature excursion. No adverse effects reported. No further details provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received on 30-JUN-2017 from a nurse refers to a patient of unknown age and gender. Medical history and concomitant medication not provided. The nurse reported that a patient received an expired dose of VARIVAX (dose and frequency not reported) on 29-JUN-2017 subcutaneous for prophylaxis. The nurse reported the lot # J0144107 and expiration date 13-NOV-2015 for VARIVAX. No side effects were noted. The outcome of expired product administered is unknown. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 11-JUL-2017 from a medical assistant regarding multiple unspecified patients (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were administered improperly stored vaccines including VAQTA (lot # M047658, exp 28-OCT-2017), RECOMBIVAX (lot # M026309, exp 11-NOV-2018), GARDASIL 9 (lot # M032650, exp 31-MAR-2019), and ROTATEQ (lot # M029251, exp 14-MAR-2018) (doses, route, site of administration for all not reported).  The reporter was unable to provide the lot # and exp date for the properly stored sterile diluent that was used to reconstitute the vaccines. No adverse effects were reported. Temperature 47 degrees Fahrenheit to 77 degrees Fahrenheit. Time frame 56 minutes. Previous temperature excursion? No. Was call because of a data logger? Yes. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients. The patients' medical history, concomitant medications, concurrent conditions, drug and allergy history were not provided. It was reported that on unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot number M037770, expiration date 01-JUN-2019 (dose, frequency and administration route were not reported) for prophylaxis. Temperatures and time frames registered in the data logger, were: 0°Centigrades (C) to 1°C (0.8°C) for 34 hours; 9°C to 25°C (8.7°C) for 27 hours and 26°C or warmer (26.2°C) for 27 hours. No adverse effects were reported. This is one of of several reports from the same reporter. Sender's Comments: US-009507513-1707USA005547: US-009507513-1707USA005548: US-009507513-1707USA005549: US-009507513-1707USA005550: US-009507513-1707USA005551.
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a 12-month-old male patient (reported also as approximately 12-month-old). There was no information about the patient's medical history, concurrent conditions and concomitant therapies provided. On an unknown date, the patient was inadvertently vaccinated with a dose of GARDASIL 9 (dose, strength, route of administration, anatomical location, lot # and expiration date were not reported). A misuse adverse event was also reported. No adverse reaction was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # reported as M034837, expiration date on 18-JUL-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit for 70 minutes. Data logger was involved in recording of the temperature excursions. 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-009507513-1707USA009093: US-009507513-1707USA009094: US-009507513-1707USA009095: US-009507513-1707USA009096.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 73 year old male consumer with no known allergies referring to himself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. "In approximately 2009" (reported as 7 or 8 years ago), the patient was vaccinated with ZOSTAVAX, 0.65 ml., once for prophylaxis (lot # and expiration date were not reported).  "In approximately 2010" (reported as 6 or 7 years ago), the patient developed shingles a year after being vaccinated with ZOSTAVAX. The patient reported that he was currently "on the tail end" of recovering from his shingles. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients. The patients' medical history, concomitant medications, concurrent conditions, drug and allergy history were not provided. It was reported that on unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II, lot number M036544, expiration date 15-AUG-2018 or lot number M016234, expiration date 31-MAR-2018 (dose and administration route were not reported) for prophylaxis. Temperatures and time frames registered in the data logger, were: 0°Centigrades (C) to 1°C (0.8°C) for 34 hours; 9°C to 25°C (8.7°C) for 27 hours and 26°C or warmer (26.2°C) for 27 hours. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA004510: US-009507513-1707USA005548: US-009507513-1707USA005549: US-009507513-1707USA005550: US-009507513-1707USA005551.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 05-JUL-2017 from a pharmacist who was reporting on a patient of unknown age and gender. No medical history or concomitant medications were reported. The pharmacist reported that on an unknown date, the patient was vaccinated with a dose of VARIVAX (lot and expiration were not reported) (dose and site not reported) vaccine received for prophylaxis was expired (date unknown) and sterile diluent (dose, lot and expiration not reported). The pharmacist reported that the vaccine had been expired by "one month". The pharmacist stated she had no additional information but would call back with lot number and expiration date. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The nurse stated that the patient started human papillomavirus (HPV) series with GARDASIL 9 administered on an unknown date for prophylaxis (dose, route of administration and anatomical location were not provided). Then, on an unknown date in 2017, the patient was inadvertently vaccinated, as second dose of GARDASIL 9, with an expired dose of GARDASIL with lot number K010215 and expiration date on 17-JAN-2016 (also reported as 05-MAY-2017) (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history or concomitant medications were not reported. The nurse reported that on an unknown date, the patient was vaccinated with a expired dose of ZOSTAVAX lot # M015926 expiration date on 28-JUN-2017 for prophylaxis. At the reporting time no adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly doses of GARDASIL 9 lot # M028323 expiration date: 26-SEP-2018. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit (53.4F) for 54 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA009211: US-009507513-1707USA009212.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information had been received on 19-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 26-MAR-2013 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 02-APR-2016, the patient was treated at a medical center for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 25-MAY-2016, the patient was treated by a physician at a clinic for continuing and worsening symptoms, which was then diagnosed as post herpetic neuralgia, a chronic condition of residual nerve damage and pain secondary to shingles. The patient was prescribed gabapentin and oxycodone to help curb her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a  further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 26-JUN-2016, the patient was vaccinated with GARDASIL 9 (lot#, expiry date and dosing details were unknown) dose 1 for prophylaxis. On 18-NOV-2016, the patient was vaccinated with second dose in vaccination series of GARDASIL 9 (lot#, expiry date and dosing details were unknown) (inappropriate schedule of drug administration). No adverse effects were reported.  The outcome of the events was unknown. There were no product quality complaints.
Sex: U
Vaccine: HIBV, HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date, the patient may have received an improperly stored dose of one of the following vaccines: PEDVAXHIB lot # M047666, expiration date 24-OCT-2019, GARDASIL 9 lot # M041990, expiration date 28-JUN-2019 or ROTATEQ lot #M018957 with expiration date 22-NOV-2017 or lot #M040269 with expiration date 28-APR-2018. The nurse was not sure which of the vaccines the unspecified patient received. No adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 2 hours. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M041394, expiration date: 23-MAY-2018. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion 34.3 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reactions or allergies was provided. On unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot# N010105 with expiration date: 15-NOV-2018 (dose and route of administration were not reported) as prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly (lot# and expiration date not reported). The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 18 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006289: US-009507513-1707USA009050: US-009507513-1707USA009051: US-009507513-1707USA009052: US-009507513-1707USA009054: US-009507513-1707USA009055: US-009507513-1707USA009056: US-009507513-1707USA009057.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reactions or allergies was provided. On unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot# M041513 with expiration date: 11-OCT-2018, lot# N002203 with expiration date: 19-JAN-2019 and lot# M033906 with expiration date 20-JAN-2018 (dose and route of administration were not reported) as prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly (lot# and expiration date not reported). The doses of vaccine were stored between 6 degrees Fahrenheit (F) to 14F for 54 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006289: US-009507513-1707USA009050: US-009507513-1707USA009051: US-009507513-1707USA009052: US-009507513-1707USA009053: US-009507513-1707USA009054: US-009507513-1707USA009056: US-009507513-1707USA009057.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 20-JUL-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N000336, expiry date 03-JUL-2018 (dose and route of administration were not reported) as prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 15 to 46 degrees Fahrenheit (F) for 1 hour and 30 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown demographics. 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 PEDVAXHIB lot # M007762, expiration date on 07-DEC-2018, lot # M036057, expiration date on 18-MAY-2017, lot # M045207, expiration date on 30-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit for 70 minutes. Data logger was involved in recording of the temperature excursions. 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-009507513-1707USA005091.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown demographics. 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 VAQTA lot # M033611, expiration date on 02-MAR-2018, lot # M039202, expiration date on 11-MAR-2018 and lot # L015460, expiration date on 20-JUL-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit for 70 minutes. Data logger was involved in recording of the temperature excursions. 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-009507513-1707USA005091.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M038227, expiration date 06-MAR-2018 and lot # M011661, expiration date 08-SEP-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 6-14 degrees Fahrenheit for 9 hours and 15 minutes. Data logger was involved in recording of the temperature excursions. 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-009507513-1707USA005091.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M010480, expiration date 01-MAR-2018 and lot # M009766, expiration date 23-FEB-2018, (dose and route of administration were not reported) reconstituted with doses of properly stored sterile diluent (MERCK) (dose, lot number and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 6-14 degrees Fahrenheit for 9 hours and 15 minutes. Data logger was involved in recording of the temperature excursions. 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-009507513-1707USA005091.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly doses of M-M-R II Lot M022407, expiration date: 02-MAY-2018. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit (53.4F) for 54 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA007194: US-009507513-1707USA009212.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly doses of RECOMBIVAX HB Lot M046373, expiration date 04-NOV-2018. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit (53.4F) for 54 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA007194: US-009507513-1707USA009211.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Body temperature increased, Injection site erythema, Injection site rash, Injection site swelling, Irritability
Clinical narrative: Swelling, red skin, white bumps at injection site. White bumps turned to red bumps after about 4 hours. My daughter was extremely  cranky and not her self the remainder of the day. She had a mild temperature (99.2 degrees, at the appointment prior to vaccines it was 98.3).
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Rash erythematous
Clinical narrative: Swelling, red skin, white bumps at injection site. White bumps turned to red bumps after about 4 hours. My daughter was extremely  cranky and not her self the remainder of the day. She had a mild temperature (99.2 degrees, at the appointment prior to vaccines it was 98.3).
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Has experienced persistent left mid deltoid pain since injection. Symptoms increase with shoulder abduction.
Age: 11.0
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Pediatric patient was given a BOOSTRIX vaccine on 4/20/17 that expired 4/18/17. Patient and parent notified.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash appeared on 7/8/17. Itching.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Redness and inflammation around site of injection.
Age: 75.0
Sex: U
Vaccine: PNC13, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient previously received PCV13 on 10/20/16. She came into the office on 1/27/17. Orders were to administer Tdap and RMA administered PCV13 in error.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Wrong drug administered
Clinical narrative: Patient came in for her "6 month" immunizations. Chart was prepped incorrectly saying patient needed PEDIARIX, PREVNAR, Rotavirus and Hib. Our facility uses PEDVAX HIB and a dose at 6 months is not appropriate. Patient received dose at 6 months which is an error at the 10/24/16 office visit.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Product preparation error
Clinical narrative: Possible misadministration of PENTACEL vaccine. Vaccine inventory audit discovered 1 remaining vial of the PENTACEL diluent (DTaP/ Polio solution portion) so it is assumed that an incorrect diluent was used to mix with the Hib powder portion of the vaccine rendering the vaccine not valid. It is unclear which child in the month of June received the invalid dose, so all families are being notified of the possible error and offered revaccination.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Product preparation error
Clinical narrative: Possible misadministration of PENTACEL vaccine. Vaccine inventory audit discovered 1 remaining vial of the PENTACEEL diluent (DTaP/ Polio solution portion) so it is assumed that an incorrect diluent was used to mix with the Hib powder portion of the vaccine rendering the vaccine not valid. It is unclear which child in the month of June received the invalid dose, so all families are being notified of the possible error and offered re-vaccination.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product preparation error
Clinical narrative: Possible misadministration of PENTACEL vaccine. Vaccine inventory audit discovered 1 remaining vial of the PENTACEL diluent (DTaP/ Polio solution portion) so it is assumed that an incorrect diluent was used to mix with the Hib powder portion of the vaccine rendering the vaccine not valid. It is unclear which child in the month of June received the invalid dose, so all families are being notified of the possible error and offered re-vaccination.
Age: 69.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site swelling, Swelling face
Clinical narrative: PATIENT STATED HER FACE WAS SWOLLEN AND HER ARM WHERE PREVNAR WAS GIVEN WAS ALSO SWOLLEN.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Hypersensitivity, Local reaction, Vaccination complication
Clinical narrative: Allergic reaction, initial encounter -- vital signs stable, afebrile, O2 sat at 100% -- likely localized allergic reaction to vaccine, although cellulitis is also part of my differential -- will treat with prednisone burst for 5 days -- counseled to ice arm, take over the counter Benadryl -- if redness spreads or if patient develops fever/chills, she should start taking antibiotic prescribed for possible cellulitis -- return precautions given - prednISONE 10mg Tab; Take 3 Tabs by mouth daily for 5 days  Dispense: 15 Tab; Refill: 0 - cephalexin (KEFLEX) 500mg Cap; Take 1 Cap by mouth four times daily for 10 days  Dispense: 40 Cap; Refill: 0.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Product preparation error
Clinical narrative: Possible misadministration of PENTACEL vaccine. Vaccine inventory audit discovered 1 remaining vial of the PENTACEL diluent (DTaP/ Polio solution portion) so it is assumed that an incorrect diluent was used to mix with the Hib powder portion of the vaccine rendering the vaccine not valid. It is unclear which child in the month of June received the invalid dose, so all families are being notified of the possible error and offered revaccination.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received on 29-JUN-2017 from a registered nurse referred to a patient of unknown age and gender. Medical history, concurrent conditions, concurrent medications, and allergies were not reported. The registered nurse reported that on an unknown date, the unspecified patient was given an expired dose of GARDASIL injection (dose, dose number, route, site of administration, Lot number and expiration date were not reported) for prophylaxis. It had been confirmed that the product was GARDASIL. No further adverse experience information to report. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 32 Fahrenheit degrees (°F) to 35 Fahrenheit degrees (°F) for 1 hour. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported)  for prophylaxis. The vaccine was exposed from 32 Fahrenheit degrees (°F) to 35 Fahrenheit degrees (°F) for 1 hour. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017,  the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported)  for prophylaxis. The vaccine was exposed from 32 Fahrenheit degrees (°F) to 35 Fahrenheit degrees (°F) for 1 hour. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 21-JUL-2017 the patient was vaccinated with GARDASIL lot # L012190 for prophylaxis. On 21-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to GARDASIL.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an immunization official referring to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB lot # L040458 with expiration date of 04-FEB-2018, for prophylaxis (dose, route, anatomical location and frequency were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 13.5 hours. No previous temperature excursion was performed. The call was because of a "data logger". Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On July 2015, the patient was vaccinated with a dose of GARDASIL 9 (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. On 21-JUL-2017 (reported as today), the patient was at the office for his second dose of GARDASIL 9 (inappropriate schedule of drug administration). No adverse effect was reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 61 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 20-MAY-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque forming units, lot # M037013, expiration date: 22-NOV-2017, as prophylaxis (Dose and route were not reported), which experienced a temperature excursion of 15 to 46 Fahrenheit degrees for 12 hours. There were no previous temperature excursions and a digital data logger was involved. No adverse effects were reported. The patient's concomitant medications included sterile diluent. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1707USA009292: US-009507513-1707USA009293: US-009507513-1707USA009294.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 66  year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 16-APR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque forming units, lot # M037013, expiration date: 22-NOV-2017, as prophylaxis (Dose and route were not reported), which experienced a temperature excursion of 15 to 46 Fahrenheit degrees for 12 hours. There were no previous temperature excursions and a digital data logger was involved. No adverse effects were reported. The patient's concomitant medications included sterile diluent. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1707USA009283: US-009507513-1707USA009293: US-009507513-1707USA009294.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 16-APR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque forming units, lot # M037013, expiration date: 22-NOV-2017, as prophylaxis (Dose and route were not reported), which experienced a temperature excursion of 15 to 46 Fahrenheit degrees for 12 hours. There were no previous temperature excursions and a digital data logger was involved. No adverse effects were reported. The patient's concomitant medications included sterile diluent. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1707USA009283: US-009507513-1707USA009292: US-009507513-1707USA009294.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 04-APR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque forming units, lot # M037013, expiration date: 22-NOV-2017, as prophylaxis (Dose and route were not reported), which experienced a temperature excursion of 15 to 46 Fahrenheit degrees for 12 hours. There were no previous temperature excursions and a digital data logger was involved. No adverse effects were reported. The patient's concomitant medications included sterile diluent. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1707USA009283: US-009507513-1707USA009292: US-009507513-1707USA009293.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered
Clinical narrative: Patient was given both PEDIARIX and IPV at same visit (7/20/17).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Eye swelling, Rash, Rash erythematous, Swelling face
Clinical narrative: After 10 min of vaccines being administered, patient's face, eyes began swelling, red rash on cheeks -pt was given BENADRYL, prednisolone and EIP PEN was administered per Dr. -VS- 86/SS, HR103, Resp 28 w/in 10 mins.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: 7/20/17 Site red, warm, swelling around 8pm. 7/21/17 increased redness, swelling, itching. Reported to Employee Health.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Patient presented to the pharmacy approx. 12 days after receiving PREVNAR 13 shot on 6/13/17, complaining of her arm being red and hot to the touch from the injection site to her elbow. She was advised to put ice on it and contact her PCP. Pt returned approximately 1 month later, still not having seen PCP. Her arm is still red but also has a rash all over injection site to elbow.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Three days after injection, patient developed red, warm, raised area 14 cm x 14 cm on/below L deltoid - reports stinging; used ice at home.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Visit to emergency room per mother 2 days after administration of vaccines. Redness with swelling and warm to touch. Instructed by ED physical to apply cool compress.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Patient received vaccinations on 04/24/2017 and within 24 hours patient developed a red lump on her left thigh. This lump lasted for 2 weeks and only subsided with a course of cephalexin.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Fall, Hyperhidrosis, Lethargy, Pallor, Syncope
Clinical narrative: Patient fainted approximately 5 minutes after vaccine was given. She fell to the floor but was immediately conscious and able to answer questions. She was able to get up and sit in a chair. EMS was called and responded, patient declined transport to hospital. Vitals stable. She reports having fainted once after a blood draw. She was sweating, lethargic, and pale, but remained at the pharmacy for about 30 minutes, at which time she was feeling and looking much better.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient was given 1st dose of HPV then approximately 5 minutes later while patient was standing in exam room she started to faint. Mother assisted patient to a laying position on the couch in the exam room. Patient was examined by Dr. and given an ice pack and a glass of water. Patient stayed laying for 15 minutes then sat up for 15 minutes prior to leaving clinic to ensure safety.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.