chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old patient of an unknown gender. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (dose, lot # and route of administration were not reported) when they were indicated for ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles post vaccine, Vaccination failure
Clinical narrative: From 09-DEC-1983 to 13-JAN-1984, 21 cases of measles occurred. The outbreak involved 16 high school students, all of whom had histories of measles vaccination after 15 months of age. The affected high school had 276 students and was in the same building as the junior high school with 135 students. A review of health records in the high school showed that all 411 students had documentation of measles vaccination on or after the first birthday, in accordance with the law. This outbreak demonstrated that transmission of measles can occur within a school population with a documented immunization level of 100%. During 2006, a total of 6584 confirmed and probable cases of mumps were reported to the Centers for Disease Control and Prevention, college campuses with mumps outbreaks included ones with 77 percent to 97 percent of students having had 2 dosage of mumps vaccine. On an unknown date unknown patients were vaccinated with M-M-R II (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patients experienced infectious disease outbreaks despite high vaccination coverage (vaccination failure). The action taken with the therapy with vaccination failure was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with M-M-R II was related. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia areata, Laboratory test normal, Viral test negative
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 23 year old female patient with none pertinent medical history, drug reactions or allergies. The patient's concurrent conditions were not reported. In approximately July 2015 (reported as 4 months ago), the patient was vaccinated by another healthcare provider with one dose of GARDASIL 9, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. In approximately 2015 (reported as approximately 2 weeks post vaccination), the patient developed alopecia areata. The patient had been seen many specialists, dermatologist, rheumatologist and has had all types of testing, including DNA test on an unspecified date which the result was negative. It was reported that the patient spent thousands and thousands of dollars to resolve the issue. The patient was treated with an unspecified steroid injection to the head. The patient sought medical attention by contacting the nurse practitioner. The reporter nurse could not confirm if the patient was vaccinated with GARDASIL 9 or GARDASIL. At the time of the report, the outcome of the alopecia areata was recovering described as the patient's hair was starting to grow back (recovering). The reporter considered alopecia areata to be related to GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Licensed Practical Nurse concerning an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On 27-OCT-2015, the patients received doses of improperly stored ROTATEQ, (Lot # K009745, exp. date on 17-FEB-2016), (strength and dose were not reported). There was no concomitant medication reported. No adverse effects reported. 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 was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an unspecified improperly stored dose of VAQTA lot # L028666 and expiration date 04-NOV-2016, (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects were reported. There was no product quality issue involved. This is one of several cases from the same reporter. 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 licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an unspecified improperly stored dose of RECOMBIVAX HB, injection, lot # L025738 and expiration date 14-AUG-2017, as reported, (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects were reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Rash
Clinical narrative: Skin rash. Loratadine 10 mg every day.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 62 year old male patient. No relevant medical history or concurrent conditions were reported. On 27-AUG-2015 the patient was vaccinated with improperly stored PNEUMOVAX23 (lot # K009876, expiration date 19-MAR-2016; dose and route not reported) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a consumer referring to her son, a male patient of unknown age. The patient's pertinent medical history and drug reactions/allergies were not reported. On 19-JUN-2015 the patient was vaccinated with his first dose of GARDASIL (dose, route and lot# were not reported). The patient did not receive his second dose at the recommended two month interval, and as of the date of this report had still not received it (inappropriate schedule of drug administration). No adverse effect was reported. Additional information is not expected as there was no any contact information provided.
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of an unknown age. The patient's concurrent conditions and medical history were not reported. On 02-NOV-2015, the patient was vaccinated with ZOSTAVAX (unknown route and strength) was reconstituted with a dose of FLUZONE quadrivalent (manufactured by Sanofi Pasteur) rather than sterile diluent. No adverse effect was reported. There was no product quality complaint involved. Aditional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare work referring to a 51 year old female patient. No relevant medical history or concurrent conditions were reported. On 17-AUG-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # K009876, expiration date 19-MAR-2016; dose and route not reported). No adverse effects were reported. This is one of 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 registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. Te registered nurse reported that on 02-NOV-2015, the patient was vaccinated inadvertently with a dose of both MMR II and a dose of PROQUAD (route, dose, lot # and expiry date were not provided). No adverse effects were reported. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 42 year old female patient. No relevant medical history or concurrent conditions were reported. On 24-AUG-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # K009876, expiration date 19-MAR-2016; dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patients mother noticed slight swelling after administration of flu vaccine.  On 11-3-15 patients right arm was red and swollen from shoulder to elbow. Warm to touch. No pain, no fever, no breathing difficulties.  Moves arm well.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm, Tenderness
Clinical narrative: Patient said that the arm starting to swell up bigger and bigger starting a couple hours after vaccination. She said she iced it to make it feel better. The shoulder started to develop a big bump, was warm to the touch, red, itchy, and hurt when pressed.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Transient global amnesia
Clinical narrative: Patient did not recognize her own dog, then didn't know who she was.  Taken by husband to ER and was admitted for transient global amnesia.  Symptoms resolved by the next day and she was discharged.  All testing reported negative by patient, but I do not have any hospital records at this time. Of note, patient did have her initial dose of Augmentin 875 mg and Sudafed 30 mg at 3:00 PM that day, 1 hour prior to onset of symptoms.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Body temperature increased, Chills, Nausea, Tremor
Clinical narrative: Started with a lower backache.  By 2:15 PM I had mild shaking in my upper body; by 2:30 PM I had severe, uncontrollable shaking, teeth chattering.  Slightly elevated temp.  Called facility and was advised to take 2 Tylenol.   Fell asleep about 4:00 PM, awoke after 5:00 PM and shaking was gone.  Felt slightly nauseous throughout the reaction.  Felt fine in the morning of 11/4/15.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Rash
Clinical narrative: Pt reported severe pain in right shoulder muscle and rash.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates the unspecified patients was vaccinated with doses of improperly stored GARDASIL 9 (lot # L013429, expiration date 21-JUL-2017) (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dizziness, Expired product administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient's concurrent conditions included pectoralis excavatum. On 01-NOV-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # K006681, expiration date 21-OCT-2015 (route and site of administration not reported). On the same day, she concomitantly received an unspecified influenza virus vaccine. Later on 01-NOV-2015, after the vaccines had been administered, the patient become woozy. She used cold compresses and laid down for 15 minutes. The outcome of becoming woozy was reported as recovered/resolved on 01-NOV-2015. The reported did not assess the causal relationship between the event "become woozy" and vaccination with PNEUMOVAX 23. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient reports "red baseball-size rash" at injection site, starting 4 days after vaccine. She is worried it will blister and turn into shingles rash.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Large reddened area 6 inches x 4 inches, hot to touch, swollen.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest discomfort, Dizziness, Dyspnoea, Erythema
Clinical narrative: Case number PHEH2015US021921, is an initial spontaneous report from a consumer received on 26 Oct 2015. This report refers to a 38-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 157003) intramuscularly on 19 Oct 2015. On the same day after vaccination, the patient experienced immediate local reactions to heat, swelling and itching at the injection site. On 20 Oct 2015, the patient experienced chest tightness, shortness of breath, dizziness, headache, hot flash, the patient's heart felt heavy and feet were tingly. The patient took BENADRYL. On 21 Oct 2015, the patient blood pressure went up and she went to emergency room after the patient spoke to a nurse. The patient blood pressure was through the roof and it set the alarm off on the machine. On 22 Oct 2015, the patient was pretty much tired and anything the patient did left the patient winded. The patient used Albuterol inhaler to help with tightness. On 23 Oct 2015, the patient had to leave work due to dizziness that lasted for hours. Itching, swelling and redness went away on 24 Oct 2015. The site flared up on 26 Oct 2015. It was reported that over the weekend the patient was still winded and fatigued and outcome of other events was unknown. Seriousness of the events and causality was not reported. Seriousness of the events was upgraded based on information available in the source document.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Hot flush, Immediate post-injection reaction, Impaired work ability
Clinical narrative: Case number PHEH2015US021921, is an initial spontaneous report from a consumer received on 26 Oct 2015. This report refers to a 38-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 157003) intramuscularly on 19 Oct 2015. On the same day after vaccination, the patient experienced immediate local reactions to heat, swelling and itching at the injection site. On 20 Oct 2015, the patient experienced chest tightness, shortness of breath, dizziness, headache, hot flash, the patient's heart felt heavy and feet were tingly. The patient took BENADRYL. On 21 Oct 2015, the patient blood pressure went up and she went to emergency room after the patient spoke to a nurse. The patient blood pressure was through the roof and it set the alarm off on the machine. On 22 Oct 2015, the patient was pretty much tired and anything the patient did left the patient winded. The patient used Albuterol inhaler to help with tightness. On 23 Oct 2015, the patient had to leave work due to dizziness that lasted for hours. Itching, swelling and redness went away on 24 Oct 2015. The site flared up on 26 Oct 2015. It was reported that over the weekend the patient was still winded and fatigued and outcome of other events was unknown. Seriousness of the events and causality was not reported. Seriousness of the events was upgraded based on information available in the source document.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction, Paraesthesia
Clinical narrative: Case number PHEH2015US021921, is an initial spontaneous report from a consumer received on 26 Oct 2015. This report refers to a 38-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 157003) intramuscularly on 19 Oct 2015. On the same day after vaccination, the patient experienced immediate local reactions to heat, swelling and itching at the injection site. On 20 Oct 2015, the patient experienced chest tightness, shortness of breath, dizziness, headache, hot flash, the patient's heart felt heavy and feet were tingly. The patient took BENADRYL. On 21 Oct 2015, the patient blood pressure went up and she went to emergency room after the patient spoke to a nurse. The patient blood pressure was through the roof and it set the alarm off on the machine. On 22 Oct 2015, the patient was pretty much tired and anything the patient did left the patient winded. The patient used Albuterol inhaler to help with tightness. On 23 Oct 2015, the patient had to leave work due to dizziness that lasted for hours. Itching, swelling and redness went away on 24 Oct 2015. The site flared up on 26 Oct 2015. It was reported that over the weekend the patient was still winded and fatigued and outcome of other events was unknown. Seriousness of the events and causality was not reported. Seriousness of the events was upgraded based on information available in the source document.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient was given an immunization with AFLURIA at pharmacy by pharmacist 9/11/15. On Tues Oct 13, 2015, pt called pharmacy and spoke to reporter. Patient said she had been having deep muscle pain at the injection site since getting the injection. Not everyday or event when exercising but when she lies down in bed or resting when pressure on that arm. I called her physician to tell them. As of last week there was still deep muscle soreness. She said this didn't happen previous year but did happen 3 yrs ago from another pharmacy vaccination.
Age: 0.96
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a Nurse Practitioner referring to an 11 month old patient of unknown gender. There was no medical history or drug reaction/allergies reported. On 01-DEC-2010, the patient was vaccinated with the first dose of M-M-R II (dose, route and lot# were unknown) (inappropriate schedule of drug administration). The second dose of M-M-R II was administered on an unspecified date after the patient's 4th year birthday (inappropriate schedule of drug administration). No concomitant medication was provided. No adverse effect was reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule, Swelling
Clinical narrative: Arm developed a knot approx 12 hours post immun. and then began to develop swelling pt took BENADRYL and APAP.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored ROTATEQ, lot# L008996, expiration date- 01-DEC-2016 and lot # K011948, expiration date- 07-JUN-2016. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLUR3
Symptoms: Pruritus, Rash
Clinical narrative: This is an initial report of an Adverse Event, received on 26Oct2015, for Protein Sciences FLUBLOK. The female subject, received FLUBLOK Intramuscular on an unknown date. On an unknown date after receiving FLUBLOK, the subject called to ask Are you aware of any side effects with bumps and intense itching 24 hours after receiving the injection and continuing for up to 72 hours? Mainly on legs, arms and spots on face?" At the time of the report, the outcome for the events was unknown. Concomitant medications were not reported. The company's assessment of the causal relationship between bumps and FLUBLOK and intense itching and FLUBLOK is a possible relationship in light of the safety profile information that pruritic rash is an expected event. In summary, this case report does not change the known safety profile of FLUBLOK.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction reported. On unknown dates the patients were vaccinated with 4 doses of improperly stored ROTATEQ (lot # K010325 with expired date 10-MAY-2016, oral, dose was unknown). No concomitant therapy was provided. No adverse event was 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 regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L006383, expiration date 25-FEB-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information had been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare work referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 24-AUG-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # K009876, expiration date 19-MAR-2016; dose and route not reported). No adverse effects were reported. 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 regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored PROQUAD, lot number-L032761, expiration date- 24-FEB-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Erythematous area with slight swelling and warmth. Initial redness 5 3/4 cm x 5 cm at 8 AM on Tues. Nov 3rd. By 8 AM on Wed. Nov 4th the area of redness was 6 1/2 cm x 8 1/2 cm. No other rash or breathing difficulty.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored MMR II, lot # L012479, expiration date 15-APR-2017, and lot # L002873, expiration date 27-JAN-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 61 year old male patient. The patient had no medical history or drug reaction. On 27-OCT-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expired date were unknown). No concomitant medication was taken. On 29-OCT-2015, the patient called the reporter and stated that she experienced an injection site reaction of swelling, redness, and a "lump". No treatment was given. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker who worked at a state immunization program referring to multiple unspecified patients of unknown age and gender. On multiple unspecified dates these patients were vaccinated with doses of improperly stored MMR II (lot # K016154 with expiration 24-SEP-2016, dose and route were not reported). No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (lot # K004205 with expired date 12-JAN-2017, dose and route were unknown). No concomitant therapy was provided. No adverse effect was 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 Licensed Practical Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9, lot# L007560, expiration date- 15-JUN-2017, Lot # L01642, expiration date- 30-JUL-2017 and lot # K026246, expiration date-28-JAN-2017, (incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist via a field representative referring to a male patient in his seventies. Information about about medial history, concurrent condition and concomitant medication was not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (strength, dosage, frequency and route unspecified). On an unspecified date in 2015 (reported as "within the last few weeks") the patient received an unspecified flu vaccine. On an unknown date, six days after receiving PNEUMOVAX23, the patient had unspecified redness and swelling at the injection site. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VAQTA lot # K012456, expiration date: 28-APR-2017 (dose and route of administration were not reported). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician referring to a 23 year old patient of unknown gender. No pertinent or historical conditions were reported. On an unknown date, the patient was vaccinated with MMR II (strength, dose, route, lot number and expiration date unknown). On an unknown date, the patient had titers drawn twice to check for MMR II immunity, and both times the results were negative. The outcome of the event was unknown. Causality between the event and MMR II was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # K024553, expiration date: 15-APR-2017 (dose and route of administration were not reported. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored GARDASIL lot # K014191, expiration date: 10-MAY-2017 (dose and route of administration were not reported). No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored oral, ROTATEQ lot t# K010325, expiration date: 10-MAY-2015 and lot # K023537, expiration date: 22-JUN-2016 (dose and route of administration were not reported). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 49 year old male patient. No relevant medical history or concurrent conditions were reported. On 26-AUG-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # K009876, expiration date 19-MAR-2016; dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from an unknown age, male consumer, reporting on himself. Medical history and concurrent conditions were not reported. On 10-OCT-2014 the patient was vaccinated with the first dose of RECOMBIVAX HB 10 mcg/ml, lot #K006682, expiration date 17-DEC-2015, (dosage and route were not provided), subsequently on 07-NOV-2014, he received the second dose of RECOMBIVAX HB lot# J013394, (dosage and route were not provided), and on 10-MAY-2015, he received the third dose of RECOMBIVAX HB lot # K010535, expiration date not reported, (dosage and route were not provided). The patient reported that on an unknown date in approximately 2015, he experienced an Anti-HBs antibody negative, reported as "his immune system did not respond to the vaccination". It was unknown if the patient sought medical attention. The outcome of the Anti-HBs antibody negative was unknown at the time of this report. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a pharmacist concerning unspecified patients (age and gender not provided). On unknown dates, improperly stored dose of PNEUMOVAX 23 (lot # K019561, expiration date 20-APR-2016; and lot# L027732, expiration date 23-FEB-2017) were administered to an unspecified number of unspecified patients (dosages and routes of administration not provided). It was not confirmed by the pharmacist which does were administered from which lot number of PNEUMOVAX 23. No adverse effects were reported. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Lymphadenopathy, Secretion discharge, Skin disorder
Clinical narrative: Patient reports enlarged lymphnodes in left and right axilla, and left groin. The patient described his lymph nodes "exploding" creating a break in skin with drainage. Patient also reports two places on head with broken skin and drainage, and right shoulder pain.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Certified Medical Assistant concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. The primary reporter stated that as of 13-OCT-2015, when temperature excursion was recorded, an unspecified number of patients were administered on unspecified dates, improperly stored doses of GARDASIL 9 (lot # L014198, exp. date on 05-SEP-2017), (strength, route of administration and dose were not provided). No adverse effects were reported. 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 has been received from a Certified Medical Assistant concerning an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. The primary reporter stated that ton 13-OCT-2015, when temperature excursion was recorded, an unspecified number of patients were administered on an unspecified dates improperly stored dose of VAQTA, (lot # K012457, exp. date on 04-JUN-2017), (strength, route of administration and dose were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This initial spontaneous report was received from a Registered Nurse male patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23. Medical history and concomitant medications were not provided. The nurse stated that the patient got at least two doses of PNEUMOVAX 23 five years apart. She was unsure if he received a dose before that, making it three doses administered if previously given. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Certified Medical Assistant concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. The primary reporter stated that as of 13-OCT-2015, when temperature excursion was recorded, an unspecified number of patients were administered on unspecified dates, improperly stored dose of RECOMBIVAX HB (lot # K022265, exp. date on 22-OCT-2016), (strength, route of administration and dose were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: Frequent headaches.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Gave PREVNAR 10/28/15 approximately 5 days later 7 cm x 9 cm erythema and induration about injection site.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Impaired work ability, Injection site pain, Pain
Clinical narrative: The patient is a healthy 44-year-old female who noted localized pain after receipt of influenza vaccine IIV (manufacturer SmithKline lot # 7AJ5J) to her left deltoid. She reports she noted no initial or immediate pain. She reports she noted mild local pain at the injection area the next day. She states she didn't particularly pay attention that approximately 2 weeks later she noted worsening shoulder pain at the subacromion was initially severe enough she left work. She states the pain is continued. It affects ADLs such as dressing. She notes it mostly with extension especially above shoulder level. The pain is currently 2/10. She has been taking ibuprofen or NAPROSYN one to times a day. She did try a topical diclofenac patch which was not effective. She continues her routine exercise program which is ballet dance approximately 5 days per week. She states she likely would not have noted it is related to vaccine receipt except the injection was very high in the deltoid. She has no weakness or restricted ROM. She denies prior injury to her shoulder. She reports she took ibuprofen, likely 400 mg, prior to vaccine receipt to mitigate adverse effects and routinely following the vaccine. She denies immediate reaction after vaccine receipt consistent with IgE allergy including no urticaria, dyspnea, oral facial throat swelling. She denies systemic reaction of fever chills malaise, cough, headache, arthralgias or myalgias. She denies local site reaction of erythema edema, warmth or induration.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability
Clinical narrative: Extreme fussiness - after child's nap - returned to office.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Certified Medical Assistant concerning an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. The primary reporter stated that as of 13-OCT-2015, when temperature excursion was recorded, an unspecified number of patients were administered on unspecified dates, improperly stored doses of PNEUMOVAX 23 (lot # L022262, exp. date on 05-NOV-2016), (strength, route of administration and dose were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Diaphragmalgia, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever. Chills. Muscle strength. Pain in diaphragm and right arm. Chattering teeth. Head ache (excruciating). BENADRYL helped.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: RED, RASH, SWOLLEN, WARM TO TOUCH. TREATED WITH ANTIBIOTICS AND STEROIDS.
Age: 0.33
Sex: M
Vaccine: PNC13, RV5
Symptoms: Incorrect product formulation administered
Clinical narrative: Pentacel, Dtap, HIB, IPV- Dtap-IPV component of Pentacel was given alone, without the reconstitution agent.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Muscular weakness, Pain
Clinical narrative: All over body aches 10/10.  Upper and lower extremity weakness. Inability to perform ADLs without assist.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Patient presented with arm soreness and red hot rash around the injection site of the Prevnar 13 injection. The rash measured 7cm X 9cm on right upper deltoid area with Erythema but without induration.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Pain, Wheezing
Clinical narrative: Wheezing, chest tightness, achiness, weakness.
Age: 3.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Eye pruritus, Eye swelling, Vomiting, Wheezing
Clinical narrative: Child returned to clinic within 30 minutes with wheezing, L eye swelling, and pruritis. Albuterol and Benadryl administered, with complete resolution of symptoms. No hypotension, vomiting associated. Child monitored for 30 min prior to discharge and at baseline when left clinic.
Age: 46.0
Sex: M
Vaccine: VARZOS
Symptoms: Antibody test negative, Wrong drug administered
Clinical narrative: VARICELLA TITER NEGATIVE SO VARIVAX WAS SUPPOSED TO BE ADMINISTERED BUT ZOSTAVAX WAS ADMINISTERED.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Headache, Rhinorrhoea
Clinical narrative: Onset commenced approximately one week after flu shot was given.  Reported headaches (crown, occiput - Frontal); runny nose; however, no fever.  No treatment provided and no OTC medicines taken.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: Flu type symptoms.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling at vaccination site; started to swell about 1 hour after vaccination, then continued to get more red and swollen until 2 days later his entire upper arm was red and swollen with extension to upper back.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Chills, Nausea
Clinical narrative: Patient states stomach upset, nausea, chills the evening after Prevnar 13 injection. She states upset stomach and nausea continued 4 days.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warm to touch at site.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Ear congestion, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient c/o "numbness and tingling in right lower forearm and right ear feels like it's clogged."  Patient stated the "numbness and tingling started to occur in left lower forearm."  There were no s/s of respiratory distress or swelling noted on or around face or neck or at vaccination site.  Referred patient to Emergency Room.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Injection site vesicles, Injection site warmth, Skin lesion
Clinical narrative: Redness and heat circumferentially from just below his left shoulder to just above his left elbow/ hand with good perfusion// blistered lesion where he got the shot.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Painful arm and hand 6 hrs after vaccinated. Lasted overnight into the following day. Itching started 11/2 and went away wt time. I did take ADVIL 10/30 pm.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient received ZOSTAVAX from pharmacy on 10/21/15. She noticed a rash on 10/23/15. She visited her doctor on 10/23/15 and her doctor told her that although it is rare that he believes patient developed shingles after receiving the vaccine. Pt is still currently breaking out with rash although they are breaking out further apart.
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On an unknown date the patients were vaccinated with oral, ROTATEQ (lot # K016261, expiration date 23-JUN-2016) (dosage, strength and route of administration not reported). There was no concomitant medication reported. At the time of the report, no adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: Information was received from a registered nurse concerning a 35 year old female patient, who received 2 doses of MMR II (each doses on a separate unspecified date in 2009) (albumin status, dosage, and route of administration not provided). On 04-JUN-2015, the patient had MMR titers drawn and the titers showed that the patient was negative rubella. The patient received a dose of MMR II (lot #K011188, expiration date 12-AUG-2016) on 16-JUN-2015, and an additional dose of MMR II (lot #L003856, expiration date 05-FEB-2017) (albumin status, dosages and route of administration not provided) on 15-SEP-2015, because of the negative rubella titer. The outcome of the negative rubella titer and the causality was not reported. No further information was provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Furuncle, Injection site rash, Injection site swelling, Pain, Pruritus generalised
Clinical narrative: Swelling and rash at injection site. Boil on arm and chin after injection. Itching and pain all over.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Patient continues to have pain and difficulty in motion of arm. Range of motion is effected. Having pain at night and intermittently on motion.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Rash pruritic, Sinusitis
Clinical narrative: Started with severe cough, went to sinus infection, treated for 9 days with Antibiotic, sinus infection cleared up developed itching rash. Still have rash as of today 11/04/2015.
Age: 13.0
Sex: M
Vaccine: FLUN4, PPV
Symptoms: Chills, Headache, Local reaction, Myalgia, Pyrexia
Clinical narrative: Initial localized reaction lt arm then progressed to generalized rxn with fever, headache, chills and myalgia.  Begun on prednisone burst and taper 10/19/15 and resolved by 10/26/2015.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain extending entire length of arm for extended period of time.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site for approximately 2 weeks.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Chills, Dizziness, Headache
Clinical narrative: Patient started experiencing chills at approximately 9:00pm. By 11:00pm, she started also experiencing a headache, lightheadedness, and a temperature of 104F.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Arthralgia, Gait disturbance, Groin pain, Injected limb mobility decreased, Neck pain
Clinical narrative: Started with left arm sore and not able to move very well, moved to right arm, then to neck. States he just felt pain. Mom gave Tylenol. Started to complain on Saturday that legs/knees were very painful and was not able to get around very well, then moved to groin area.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Pain in extremity
Clinical narrative: Started with left arm sore and not able to move very well, moved to right arm, then to neck. States he just felt pain. Mom gave Tylenol. Started to complain on Saturday that legs/knees were very painful and was not able to get around very well, then moved to groin area.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: PT STATES THERE WAS INITIAL SORENESS AT THE TIME OF ADMINISTRATION. PT STATES THAT BRUISING DEVELOPED AROUND THE ADMINISTRATION SITE. FOLLOWING DAY THERE WAS REDNESS AND ELEVATED BUMPS BELOW THE BRUISING AND THERE WAS SOME WARMTH FELT AROUND THE AREA.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Pruritus
Clinical narrative: BLISTERS AND ITCHING TO THE ARM.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Computerised tomogram abdomen, Computerised tomogram pelvis, Culture stool, Full blood count, Intussusception
Clinical narrative: Intussusception.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Metabolic function test, Occult blood, Rotavirus test, Ultrasound scan
Clinical narrative: Intussusception.