chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Flushing, Lethargy, Nausea
Clinical narrative: The first symptom was that I was extremely flushed in chest and face areas and extremely lethargic. The next day, extremely lethargic, nausea and diarrhea, that night, fever and chills, the next day diarrhea, nausea, swollen and tender armpit on the arm where I received the injection. On the next day, the nausea is lessened, no more diarrhea, but still have a very tender armpit and it is still swollen. Very lethargic.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Swelling, Tenderness
Clinical narrative: The first symptom was that I was extremely flushed in chest and face areas and extremely lethargic. The next day, extremely lethargic, nausea and diarrhea, that night, fever and chills, the next day diarrhea, nausea, swollen and tender armpit on the arm where I received the injection. On the next day, the nausea is lessened, no more diarrhea, but still have a very tender armpit and it is still swollen. Very lethargic.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Redness at injection site, hard lump, soreness, lasted 5 days.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Dry mouth, Dysphonia, Headache
Clinical narrative: Symptoms began with headache (very rare for this patient) then he noticed low grade fever, sore throat (hoarseness) and dry mouth. Sunday morning woke feeling weak, dizzy, sweating, syncopal, but did not lose consciousness. Ran temperature of 99.8F on Sunday, about 2 degrees above his baseline. Remained in bed all day. As of Monday he began feeling much better, temperature normal, but with residual soreness and aches.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Oropharyngeal pain, Pain, Pyrexia, Syncope
Clinical narrative: Symptoms began with headache (very rare for this patient) then he noticed low grade fever, sore throat (hoarseness) and dry mouth. Sunday morning woke feeling weak, dizzy, sweating, syncopal, but did not lose consciousness. Ran temperature of 99.8F on Sunday, about 2 degrees above his baseline. Remained in bed all day. As of Monday he began feeling much better, temperature normal, but with residual soreness and aches.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pruritus, Urticaria, Wheezing
Clinical narrative: Employee reported reddness, itchy where shot was given. Developed hives; 2 hours after immunization, developed wheezing. She went home, took Benadryl.
Age: 25.0
Sex: F
Vaccine: JEV1, TYP, JEV1, TYP
Symptoms: Blood creatine phosphokinase increased, Neck pain, Pain in extremity
Clinical narrative: Left arm pain and neck pain worsening over the 9th of August to where she did not want to move her arm.
Age: 25.0
Sex: F
Vaccine: JEV1, TYP, JEV1, TYP
Symptoms: Malaise, Pain in extremity, Peripheral swelling, Rhabdomyolysis
Clinical narrative: Left arm pain and neck pain worsening over the 9th of August to where she did not want to move her arm.
Sex: U
Vaccine: MMR
Symptoms: Parotitis, Salivary gland pain
Clinical narrative: This spontaneous report as received from a physician 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 an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella virus vaccine (manufacturer unknown) (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patient was hospitalized (date unspecified) for parotitis pain management. The outcome of the event was unknown. The relatedness between vaccination with measles, mumps, and rubella virus vaccine (manufacturer unknown) and the event was not reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no contact details to the physician.
Sex: U
Vaccine: MMR
Symptoms: Meningitis
Clinical narrative: This spontaneous report as received from a physician 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 an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella virus vaccine (manufacturer unknown) (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patient was hospitalized to rule out meningitis. the outcome of the event was unknown. the relatedness between vaccination with measles, mumps, and rubella virus vaccine, (manufacturer unknown) and the event was not reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no contact details to the physician.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report obtained from a contactable health care professional. A 18 year old female patient received, on 30Jul2016 at 13:15, meningococcal group b rlp2086 (Lot. M74091, Expiration date: Jun2017, NDC number: 0005-0100-01) intramuscular, in the right arm, at 0.5 ml, single dose. Relevant medical history was unknown. Concomitant medication included MENACTRA (Lot. U5410AA), received on 30Jul2016, intramuscular, in the left arm, at 1 DF, single dose. The vaccines was administered at the private doctor's office and was purchased with private funds. Illness at time of vaccination were none. On 30Jul2016, the patient passed out after receiving meningococcal group b rlp2086. The patient recovered on 30Jul2016, she was out for about a minute. The patient felt fine when she left the doctor's office.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-JUN-2016 the patient was vaccinated with improperly stored PROQUAD (lot # L032761, expiry date 24-FEB-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Decreased eye contact, Dyskinesia, Language disorder, Motor dysfunction
Clinical narrative: Loss of language Hand flapping loss of eye contact loss of motor skills etc.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant 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 05-SEP-2012, the patient was vaccinated with a dose of M-M-R II (injection, lot # reported as 1641Z, expiration date: 24-NOV-2012)(exact dose, dose number, therapy type and route of administration were not provided). On 29-SEP-2012 (less than 1 month apart), the patient was vaccinated with a dose of VARIVAX (lot # H011232, expiration date: 06-JUN-2014 (exact dose and route of administration were not provided). There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-JUL-2016, the patient was vaccinated with improperly stored dose of VARIVAX (dose, route of administration and injection site were not provided) (lot # M009765, expiration date: 25-FEB-2018). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On an unspecified date, the patients were vaccinated with GARDASIL (dose, route of administration, lot# and expiration date were not reported). No concomitant therapies were reported. On an unknown date, the patients were off-schedule receiving second and/or third doses of GARDASIL or GARDASIL 9. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. on 02-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017 dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular, Stress
Clinical narrative: This spontaneous report was received from a Nurse Practitioner (NP) via a filed representative concerning her daughter who was between the ages of 13 and 17. Medical history and concomitant medications were not provided. On an unspecified date but "within the last year", the female patient (pt) completed GARDASIL series. The pt experienced irregular menstruation after completing the series. She had a follow-up visit with the OB/GYB who did an "extensive work-up" but the doctor could not determine the root cause of the pt's adverse experience. The NP did mention that her daughter had been under a lot of stress which may have contributed to the irregular menstruation. The event resolved. Additional information is not expected as there was no contact information available.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-MAY-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L032761, expiry date 24-FEB-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-MAY-2016 the patient was vaccinated with improperly stored PROQUAD (lot # L032761, expiry date 24-FEB-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, refers to an unspecified patient of unknown of gender. On an unknown date, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # reported as M001814, expiration date 15-OCT-2018), 0.5 ml and dose of ROTATEQ (lot # L033694, expiration date 16-JUN-2017), 2 ml orally. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Meningitis
Clinical narrative: This spontaneous report as received from a physician 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 an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patient was hospitalized for meningitis treatment. The outcome of meningitis was unknown. The relatedness between vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and meningitis was not reported. This is one of several reports received from the same reporter. Upon internal review the event of meningitis was determined to be medically significant. Additional information is not expected because there was no contact details to the physician.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 5 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-MAY-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L032761, expiry date 24-FEB-2017) dosing regiment unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-JUL-2016, the patient was vaccinated with improperly stored dose of PROQUAD (dose, route of administration and injection site were not provided) (lot # M004892, expiration date: 25-JUL-2017). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, Drug reactions or allergies and concomitant therapies was provided. On 29-JUL-2016, the patient was vaccinated with improperly stored dose of PROQUAD (dose, route of administration and injection site were not provided) (lot # M004892, expiration date: 25-JUL-2017). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Drug ineffective
Clinical narrative: Initial solicited report received from a consumer (online market research respondent) in the study on 04 December 2015. The subject (gender and age were not reported) received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE on an unspecified date, (site and route of administration and batch number were not reported). The medical history and concomitant therapy details were not reported. During a prompted discussion the subject reported that, the subject received the vaccine last season and had found it ineffective. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Blister, Hypersensitivity, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Initial unsolicited report received from a nurse on 23 December 2015. This case involves a three year old male patient who was vaccinated with a fifth dose of FLUZONE QIV (batch number UI516AB, expiry date 30 June 2016, route of administration were not reported) in left deltoid on 21 December 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was mild (excema) eczema. Patient had no other vaccinations within 4 weeks of vaccinations. On 22 December 2015, one following the vaccination patient's left arm had swelling from shoulder to below elbow with little blisters, vesicles on it and it was red and hot and allergic reaction. Patient required emergency room (ER)/doctor visit. Patient had no laboratory investigation. Corrective treatment was not reported. The outcome of event was not recovered. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: Initial unsolicited report received from a nurse on 23 December 2015. This case involves a three year old male patient who was vaccinated with a fifth dose of FLUZONE QIV (batch number UI516AB, expiry date 30 June 2016, route of administration were not reported) in left deltoid on 21 December 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was mild (excema) eczema. Patient had no other vaccinations within 4 weeks of vaccinations. On 22 December 2015, one following the vaccination patient's left arm had swelling from shoulder to below elbow with little blisters, vesicles on it and it was red and hot and allergic reaction. Patient required emergency room (ER)/doctor visit. Patient had no laboratory investigation. Corrective treatment was not reported. The outcome of event was not recovered. List of documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Local swelling, Pharyngeal oedema
Clinical narrative: Swelling of neck started several hours after vaccine then progressively worsen to swelling of throat. Shortness of breath.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, Injection site irritation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2015, reported as "sometime last year", the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, route and lot# were not reported). On 29-JUL-2016, the patient was inadvertently administered a second dose of PNEUMOVAX23 (dose, route and lot# were not reported). On the same day, 29-JUL-2016, the patient experienced normal "local irritation" at the injection site after this second injection. The outcome of injection site irritation was not reported. The relatedness between vaccination of PNEUMOVAX23 and normal "local irritation" at the injection site was not reported. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain, Vomiting
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO. On 29th July 2016, the patient received BEXSERO./5 ml. On 30th July 2016, 1 days after receiving BEXSERO, the patient experienced injection site pain and vomiting. On an unknown date, the outcome of the injection site pain and vomiting were unknown. The reporter considered the injection site pain and vomiting to be probably related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. The age at vaccination was not reported. The field representative reported that doctor's unknown patient experienced pain at injection site and vomiting after receiving BEXSERO vaccine. The patients details were unknown and limited event details were available. The doctor requested safety report to be mailed to office manager.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office administrator and a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot # reported as L040053, expiration date 10-MAY-2017 or lot # reported as M018624, expiration date 28-MAY-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced a temperature excursion of 72.5 degrees Fahrenheit for 5 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office administrator and a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M011116, expiration date 17-JUN-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced a temperature excursion of 72.5 degrees Fahrenheit for 5 hours. There were no previous excursions. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received f rom a nurse practitioner via a company representative referring to a 4 year old patient of unknown gendere. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 29-JUL-2016, the patient was inadvertently administered a dose of ZOSTAVAX (lot #, expiration date, dose and route were unknown (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-JUL-2016, the patient was vaccinated with an expired dose of PNEUMOVAX23 (injection, lot # K009874, expiry date 19-MAR-2016)(dose, frequency and therapy route were not reported). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist via a company representative, referring to a 75 year old female patient. On 09-JUL-2016 the patient was vaccinated with ZOSTAVAX. On approximately 12-JUL-2016, three to four days following the administration of vaccine, the patient experienced itching and a swollen area (size of an egg) that was localized at the injection site. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unknown patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On unknown dates, the patients' were vaccinated with improperly stored doses PNEUMOVAX23 which had lot # L012042, expiry date: 18-NOV-2016, (route and dose not reported). The vaccines were exposed to temperature of 9 degree Celsius for 3 hours (also reported as 50 degree Fahrenheit for 4 hours). No previous temperature excursion was reported. The temperature excursion was detected by a data logger. Additionally, no adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unknown patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On unknown dates, the patient's were vaccinated with improperly stored doses of RECOMBIVAX HB), (strength: 5/0.5 mcg/ml which has a lot # L016427, expiry date: 12-APR-2017)(route and dose not reported). The vaccines were exposed to temperature of 9 degree Celsius for 3 hours (also reported as 50 degree Fahrenheit for 4 hours). No previous temperature excursion was reported. The temperature excursion was detected by a data logger. Additionally , no adverse effects were reported and no quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On unknown date, the patients were vaccinated with a combination of GARDASIL (dose, route of administration, lot# and expiration date were not reported) and Gardasil 9 (dose, route of administration, lot# and expiration date were not reported) to complete a three dose series. No concomitant therapy was reported. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-JUL-2016, the patient was vaccinated with improperly stored dose of VARIVAX (dose, route of administration and injection site were not provided)(lot # M009765, expiration date: 25-FEB-2018). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical  nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-JUL-2016, the patient was vaccinated with improperly stored dose of VARIVAX (dose, route of administration and injection site were not provided)(lot # M009765, expiration date: 25-FEB-2018). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician regarding a 67 year old female patient. Previously patient had PNEUMOVAX23 vaccination with no reaction. Drug allergies and reactions were unknown. On 06-JUL-2016, the patient was vaccinated with PNEUMOVAX23 (lot # L035687/expiration date 16-FEB-2017, 0.5 ml/one time, intramuscular in the left arm (also reported-Pheunomia). Concomitant therapies included Lambisil AT, calcium, PREVENTOL G-D, levothyroxine sodium (manufacturer unknown) SINGULAIR, probiotics, albuterol and vitamin d. On an unknown date in JULY 2016, the patient experienced inflammation and swelling at injection site. Treatment was given for the adverse event. No laboratory diagnostic tests were performed. Patient sought medical attention. No PQC (product quality complaint) was involved. Action taken with PNEUMOVAX23 was reported as discontinued. The outcome of inflammation and swelling at injection site was reported as resolved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # K007974, expiry date: 03-JUN-2016) (incorrect product storage). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reaction/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # K011314, expiry date: 14-FEB-2016) (incorrect product storage). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Medication error
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and refers to a 22 year old female patient. The patient did not have pertinent medical history and drug reaction or allergies. The patient did not take any concomitant medication. On 01-AUG-2016, the patient was inadvertently vaccinated with a dose of VARIVAX subcutaneous, lot # L010146, expiration date 24-MAR-2017 (anatomical location and dose were not provided). At the time of vaccination the patient was 16 weeks pregnant. The patient's last menstrual period (LMP) was estimated as 11-APR-2016, date of conception as 25-APR-2016 and estimated date of delivery as 16-JAN-2017. The pregnancy outcome at the time of the report was pending. The fetal outcome was unknown. The patient did not receive any treatment, did not have any lab diagnostic studies performed and did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-JUL-2016, the patient was vaccinated with improperly stored dose of VARIVAX (dose, route of administration and injection site were not provided) (lot # M009765, expiration date: 25-FEB-2018). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. The patient's medical history was not reported. On 21-JUL-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K008079, expiration date 03-SEP-2015)(dose, route and site of administration were not reported). Concomitant medications were not reported. No adverse symptoms were reported. 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 Nurse refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection, lot # L020015 (expiry date: 16-Aug-2017). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report concerning a female patient of an unknown age was received from a pharmacist. The patient's concurrent condition and medical history were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU), (lot and expiration date were not provided) subcutaneously. There were no concomitant medications reported. On an unknown date, reported as about three days following the vaccination, the patient experienced a "reddened itchy" area that looked like a rash, however, the reporter stated that it was not a rash, but an injection site reaction that looked like a rash. In addition, it was stated that the patient sought medical attention (reported as "seen at the pharmacy"). No product quality complaint was involved. At the time of reporting, the outcome of infusion site reaction was unknown. The causality between ZOSTAVAX and the event of injection site reaction was not assessed. The reporter did not considered the event of injection site reaction life threatening or medically significant. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. Pertinent medical history, concurrent conditions and drug reactions were unknown by the reporter. On 15-AUG-2011, the patient was vaccinated with a dose of M-M-R II, 0.5 ml, subcutaneously, lot number 0155AA, expiration date 01-FEB-2013, (Anatomical location was not provided). No other suspect or concomitant medication were reported. On an unknown date after receiving M-M-R II, the patients titers came back negative (antibody test negative). The patient sought medical attention by contacting a medical office an stated "she needs another shot". The outcome of the event and the causality between the therapy with M-M-R II and the event were unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Scar
Clinical narrative: Red bumps, pt thinks it looks like case of chickenpox, not itchy, scarred areas from prior outbreaks.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Muscle contractions involuntary, Nail discolouration, Nausea, Tremor
Clinical narrative: 29yof presented to ED with nausea and shaking which was happened on and off throughout the past day after receiving Tdap vaccination the day before.  Patient was prescribed hydroxyzine 25mg tablet bid prn. Patient described their symptoms to include soreness at injection site, muscle contractions but their body was not doing anything and discoloration to nail beds which were documented to have been blue.  Patient was instructed to follow up with their primary care physician.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Bronchiolitis, Computerised tomogram thorax abnormal, Fatigue, Pain
Clinical narrative: That evening developed all over body aches, weakness, fatigue, hacking mildly productive cough and developed a fever of 100F(oral). Subsequently admitted to hospital 7/5/16 with pneumonia/bronchiolitis.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia, Productive cough, Pyrexia
Clinical narrative: That evening developed all over body aches, weakness, fatigue, hacking mildly productive cough and developed a fever of 100F(oral). Subsequently admitted to hospital 7/5/16 with pneumonia/bronchiolitis.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Local reaction to immunization(s) - right thigh- swelling, redness, sore Lump at site of injections. BENADRYL, Hydrocortisone cream.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is on of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant (C.M.A.) referring to a patient of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant therapies were not reported. On 03-AUG-2016, the patient was vaccinated with M-M-R II lot # K020188, expiration date: 22-OCT-2016 (albumin status unknown) and PROQUAD lot # L009210, expiration date: 17-SEP-2016. Dose, route, frequency and anatomical location were not reported. The Medical Assistant stated that the patient did not experienced adverse effects. There was not a product quality complaint involved. Addition information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Blindness, Malaise, Pain, Prostate cancer, Pyrexia
Clinical narrative: Lose of eyesight ringing in the ears and other system fever/pain. Father have to return to medical on Aug 21. I am patient's daughter. I'm filing this due to my father behalf because he is in prison he sick due to the vaccine shot they gave him he has prostate cancer. It make him sick this will be the second time to the hospital or their facility Aug 21, 2016 because of the vaccine that was given. Please feel to contact me.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Tinnitus
Clinical narrative: Lose of eyesight ringing in the ears and other system fever/pain. Father have to return to medical on Aug 21. I am patient's daughter. I'm filing this due to my father behalf because he is in prison he sick due to the vaccine shot they gave him he has prostate cancer. It make him sick this will be the second time to the hospital or their facility Aug 21, 2016 because of the vaccine that was given. Please feel to contact me.
Age: 1.33
Sex: F
Vaccine: HIBV, MMR
Symptoms: Ataxia, C-reactive protein, Full blood count, Metabolic function test, Rash papular
Clinical narrative: Ataxia, 10 erythematous papules on chest and back.
Age: 1.33
Sex: F
Vaccine: HIBV, MMR
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Ataxia, 10 erythematous papules on chest and back.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a Doctor of Pharmacy via company representative concerning a 76 year old female patient with allergy to penicillin. The patient's historical conditions were not provided. On 27-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU, lot # L046896 (expiry date: 23-FEB-2017) (dose and route were not provided). Concomitant medications were not reported. On 01-AUG-2016, the patient called to the pharmacy to report that she was experiencing redness, itching, and swelling at the injection site since on an unknown date in 2016. Additionally, no rash was reported. The reporter advised the patient to apply ice to the site as a treatment. At the time of the reporting, the patient's outcome concerning redness, itching, and swelling at the injection site was reported as not recovered/not resolved. The causality was not stated. Additional information has been requested.
Age: 0.43
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Cough, Irritability, Pyrexia
Clinical narrative: Fever, fussy, and cough.
Age: 26.0
Sex: U
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative concerns a female patient of unknown age, who on an unknown date, was vaccinated with ZOSTAVAX "one shot/ once" (dosage and lot number not provided) by subcutaneous injection. No information was provided regarding concomitant medications or the patient's medical history. On an unknown date, after getting the ZOSTAVAX), the patient experienced a rash which was diagnosed as shingles. The shingles were on her shoulders and chest. It was unknown if the patient received any treatment. The outcome of the rash which was diagnosed as shingles is unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Dysphonia, Erythema, Injection site pruritus
Clinical narrative: Pt received MENACTRA vaccine on 8-5-2016 and had facial redness, dizziness, hoarseness and itching at site on the following day 8-6-2016. Pt took BENADRYL and issue resolved.
Age: 1.02
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Pt received MMR, varicella and PREVNAR 13 vaccines on 7/13/16. Mom returned to clinic on 7/28/16 for reddened area centered on injection site of varicella about 1 cm in diameter. No pain, rash, or induration noted. Reassured localized reaction is not dangerous indicates strong immune reaction to vaccine. May use topical creams or TYLENOL for symptomatic relief. Re-check if worse. Current reaction not problem for future vaccines.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, MMRV
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Child given MMR and MMRV vaccines, should have received MMR and varicella vaccines. Spoke with father by phone, states child had no reactions from vaccines.
Age: 18.0
Sex: F
Vaccine: MENB, TD
Symptoms: Chills, Dizziness, Injection site pain, Nausea, Pyrexia
Clinical narrative: Slight fever (100.5 F), chills, slight, nausea, dizziness, soreness at inj. site, duration approx. 2 days. No treatment necessary.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test positive, Nodule
Clinical narrative: Large subcutaneous nodule over the right upper bicep muscle that has persisted for almost a year since the vaccine; nonindurated, nonerythematous, nonpainful, nonpruritic; It is clearly visible just looking at her arm. It was not present prior to receiving the "high dose flu shot" last year.
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Dyskinesia, Myopia, Visual impairment
Clinical narrative: Increased jerking at night as dozing off to sleep and then a few months later with single jerking, especially in the legs, while awake which persists.  Some vision changes in the Lt eye with increased myopia.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Syncope
Clinical narrative: Syncope after receiving immunizaions. Pt. placed in supine position with legs elevated.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Decreased appetite, Injection site erythema, Injection site swelling, Pyrexia, Somnolence
Clinical narrative: Fever of 100 degrees, redness and swelling at one injection site on thigh, decreased appetite, vomiting, sleepy but refusal to sleep.  Called doctor's office, still waiting on a call back.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Vomiting
Clinical narrative: Fever of 100 degrees, redness and swelling at one injection site on thigh, decreased appetite, vomiting, sleepy but refusal to sleep.  Called doctor's office, still waiting on a call back.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Rash
Clinical narrative: Extensive rash and cellulitis of upper arm.