chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
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. No relevant medical history was provided. Since 12-MAR-2015 these patients were vaccinate with 12 doses of PROQUAD (Merck) (dose and route not reported) which were improperly stored. No adverse events were reported. This is one two cases received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 month old patient of unknown gender. On 30-MAR-2015 the patient accidentally received a dose of ZOSTAVAX (route and lot # not reported, dose 0.65 ml) instead of VARIVAX (Merck). The patient also received, on an unspecified date, M-M-R II, PEDVAXHIB and HAVRIX. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. Since 26-JAN-2015, doses of PEDVAXHIB (lot#, expiry date, dose, route and dose number were not provided), which were exposed to temperatures outside of the recommended range, had been administered to the unspecified patients (dates unspecified). No adverse effect had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a pharmacist via field representative refers to a male patient of unknown age. Patient's pertinent medical history and drug reactions/allergies were unspecified. On an unspecified date in 2015 (reported as earlier this week) the patient received ZOSTAVAX, .65 ml (therapy route, lot # and expiry date unspecified). Concomitant medications were unspecified. Reporting pharmacist stated that the patient experienced an adverse reaction to ZOSTAVAX earlier this week and further explained the adverse reaction as a total body rash. There were no other symptoms reported. Patient sought medical attention of an unspecified type. No treatment was given for the adverse event. Lab diagnostic studies were unspecified. Outcome of the event, rash generalized was reported as recovering. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. Since 26-JAN-2015, doses of GARDASIL (lot#, expiry date, dose, route and dose number were not provided), which were exposed to temperatures outside of the recommended range, had been administered to the unspecified patients  (dates unspecified). No adverse effect had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This patient had the PNEUMOVAX injection 2 hours after having a HUMIRA injection. Later that night she reported severe aching in her arm and could not move her arm until the next morning. She was told to consult with her physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown demographics. On 23-MAR-2015 the patient was inadvertently administered with improperly stored M-M-R II (lot # J014873, expiry date: 21-NOV-2015), .5 ml, subcutaneous. No adverse effects were reported. Outcome of the event was unknown. Reporting health professional considered the event to be not related to M-M-R II. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received via Pfizer from a pharmacist refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (strength, dose, route of administration, indication, lot# and expiry date unspecified). No concomitant medications were reported. On an unknown date, the patient presented to clinic with a complaint of rash around the injection site following a PNEUMOVAX 23 vaccination. No other symptoms were reported. The outcome of the event was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. The reporter enquired if there was any literature regarding the use of PREVNAR 13 following this type of reaction from PNEUMOVAX 23. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 76-year-old female patient with no drug reactions or allergies and with no medical history. On 07-NOV-2011, the patient was vaccinated with a dose of ZOSTAVAX injection (lot # 669745/0759AA with expiry date: 18-NOV-2011; strength, dose and route of administration unspecified). Concomitant therapies included fish oil, baby aspirin, OS-CAL, vitamin D and atenolol. The nurse reported that the patient developed shingles twice since the vaccination. The first episode of shingles occurred on an unspecified date, the patient received unspecified treatment and recovered on an unspecified date. Then, the patient was seen in the physician's office on 31-MAR-2015 (reported as: yesterday), she sought medical attention due to second episode of shingles. No laboratory tests were performed. The patient was prescribed acyclovir 800 mg, 5 times daily for the next 7 days, along with TYLENOL and ibuprofen (unspecified doses as needed). The nurse reported that the patient had not recovered from the second episode of shingles. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. Since 26-JAN-2015, doses of RECOMBIVAX HB (lot#, expiry date, dose, route and dose number were not provided), which were exposed to temperatures outside of the recommended range, had been administered to the unspecified patients (dates unspecified). No adverse effect had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Nausea, Vomiting
Clinical narrative: Nausea, vomiting and clammy.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 3/12/13 Call taken by PSA and info given to this RN. Called patient back at given number. Patient states getting his Pneumonia injection yesterday and today his lt arm started to swell from the shoulder to the elbow. Also states the area is red and warm and tender to touch. Informed patient of system recommendation of 12 to 24 hours. Patient to be seen tomorrow. 69 yo wm who received PNEUMOVAX 3/11. Developed some swelling and redness at the site. Was sore. No fever or chills. Today the redness/swelling has tracked down past the left antecubital fossa. Only minimal warmth. No more pain. Getting better. Medication changes: OTC BENADRYL 25 mg Q 6 prn.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: 3/12/13 Call taken by PSA and info given to this RN. Called patient back at given number. Patient states getting his Pneumonia injection yesterday and today his lt arm started to swell from the shoulder to the elbow. Also states the area is red and warm and tender to touch. Informed patient of system recommendation of 12 to 24 hours. Patient to be seen tomorrow. 69 yo wm who received PNEUMOVAX 3/11. Developed some swelling and redness at the site. Was sore. No fever or chills. Today the redness/swelling has tracked down past the left antecubital fossa. Only minimal warmth. No more pain. Getting better. Medication changes: OTC BENADRYL 25 mg Q 6 prn.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Right arm erythema, swelling and tenderness.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to unspecified patients of unknown demographics. On an unknown date the patients received impropelry stoerd GARDASIL (incorrect product storage). No adverse effects were reported. Outcome of the event, incorrect product storage was unknown. Reporting health professional considered product the event to be not related to GARDASIL. This is one of several reports from the same reporter (MARRS # 1504USA004227 and MARRS # 1504USA004228). Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Broke out in hives from neck on down.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Faecal incontinence, Lumbar puncture, Myelitis transverse, Nuclear magnetic resonance imaging, Paralysis
Clinical narrative: Couldn't bear weight on his legs and was losing bowel and bladder control. He was paralyzed from the waist down over night.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Urinary incontinence, Weight bearing difficulty
Clinical narrative: Couldn't bear weight on his legs and was losing bowel and bladder control. He was paralyzed from the waist down over night.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Erythema, Oedema, Pain
Clinical narrative: Redness pain & swelling occurred few hours after injection. Within 26 hours redness & swelling increased from shoulder to elbow, area became really hot. Patient also had fever, chills & body aches. Patient went to ER aprox 6PM 4/7/15.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia, Skin warm, Swelling
Clinical narrative: Redness pain & swelling occurred few hours after injection. Within 26 hours redness & swelling increased from shoulder to elbow, area became really hot. Patient also had fever, chills & body aches. Patient went to ER aprox 6PM 4/7/15.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: 21 cm itchy red area on upper arm treated with clobetasol cream followed in 3 days by cephalexin oral.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: VIIth nerve paralysis
Clinical narrative: Patient states she developed Bell's Palsy 9 days after vaccination.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed herpes zoster approximately 24 hours after being immunized with ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding to an unspecified number of patients of unknown ages and gender. The patients medical history or concurrent conditions were not provided. On an unspecified date, the patients were vaccinated with a dose of improperly stored ZOSTAVAX (dose, route, lot number and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 16-MAR-2015 the patient was vaccinated with VARIVAX (Merck) which was administered via intramuscular (dose and lot # were not reported). It was reported that the patient received VARIVAX (Merck) instead of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Age: 97.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 20 cm area of red itchy skin on left upper arm. Cool compress and loratadine.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: 10 cm erythema right upper arm.
Age: 10.0
Sex: M
Vaccine: HEPA, HPV4, TDAP
Symptoms: Disorientation, Loss of consciousness, Posture abnormal
Clinical narrative: Administered Tdap, Hep A, and HPV vaccines. Patient slumped over in chair with nurse still in  the room. Nurse lowered him to the floor. Patient was unconscious for about 20 seconds. He then was alert and responsive but disoriented for approximately another 20 seconds. Nurse instructed him to stay lying down. Gave cold bottled water and saltine crackers and provided a cool gel pack for head and neck. Allowed him to slowly sit up with back against the wall. Nurse continued to monitor for fifteen minutes. Patient stated he felt better and nurse observed improved condition. Left ambulatory with mother.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Headache, Injection site inflammation, Injection site pain
Clinical narrative: Light fever, sore throat, tiredness, headache, sore and inflamed injection spot, joint pain.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Light fever, sore throat, tiredness, headache, sore and inflamed injection spot, joint pain.
Age: 1.37
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Local swelling, erythema and pruritis over area of 7x6cm.  No shortness of breath, vomiting or changes in mental status.
Age: 1.16
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Autopsy, Blood test, Decreased appetite, Diet refusal, Fatigue
Clinical narrative: Irritability, fatigue, loss of appetite, fever, refusing to drink.
Age: 1.16
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Toxicologic test
Clinical narrative: Irritability, fatigue, loss of appetite, fever, refusing to drink.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Asthenia, Rash
Clinical narrative: At first he complained of being very weak. For three days he kept complaining of being weak and just layed around. On the third day he started developing some sort of rash/bumps on his jaw line. It took 3 weeks for it to clear up. I didn't realize he had a reaction until about a week after the vaccine, by this time his symptoms were starting to clear up, so I decided not to contact his Dr.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient received a Zostavax vaccine from me on 4/7/15 under the immunization protocol for physician.  She called the pharmacy on 4/9/15 at approximately 2:00-2:15pm complaining of a site reaction and an acute illness that began this morning.  She informed me that she had on the back side of her left arm at the injection site a silver-dollar sized, red, firm and irregularly shaped area that was painful which she had noticed this morning.  She also said that she had felt fine until this morning when she began to have vertigo, stiffness at the back of her neck, stomach upset and vomited all brown liquid one time.  She said her stomach was still a little upset and that she had 4 large, loose bowel movements already today. She said that she was still feeling light-headed and had taken her temperature today and that it was 98.1F. She said she had taken some of her usual medications this morning including her allergy medication.  She had already called her primary care doctor and informed them of her symptoms. She wanted to know if this was related to the vaccine she had received and I told her that it was possible but that I would like to call her back after I spoke with the protocol physician regarding the situation. I informed her that I was going to call the protocol physician immediately.  She said that was okay and gave me a phone number to call her back.  I called the protocol physician's office at approximately 2:30pm to let them know that a potential adverse reaction may have occurred and the receptionist informed me that unless she was actually a patient of doctor, there was nothing they would be able to do.  I then called the patient's primary care physician, and spoke with someone at approximately 2:35pm.  I informed her that I was aware of what the patient had called them regarding and that she had called me as well.  She said she would give the information to doctor and took the number of the pharmacy for him to call.  I called the patient back at approximately 3:00pm on 4/9/15 and she informed me that she was feeling better but her stomach still felt a little upset and she was still light headed.  She also noted that the site reaction seemed to be improving and was not as red, raised and painful as it had been earlier. She described it as being more like a bruise now but still being a little tender.  I advised her to apply ice to the site reaction to help with pain, redness and swelling.  I also advised her to make sure she was drinking plenty of fluids due to the bowel movements and the vomiting.  I informed her that the symptoms she was experiencing could have been due to the vaccine (headache, diarrhea, nausea, flu-like symptoms, injection site reaction).  My source for confirming this information was Facts and Comparisons.  I also informed the patient that should her symptoms worsen or persist beyond 1-2 days she should again call doctor's office.  As of 8:15pm on 4/9/15 I have not received any reply from doctor's office.  Both pharmacy supervisor and immunization coordinator had also been notified by 3:15pm on 4/9/15.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral, (lot numbers and expiration dates were not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender who on 06-APR-2015 was vaccinated with an improperly stored dose of M-M-R II (lot # K001230, expiration date 27-JAN-2016), 0.5 ml, subcutaneous. No adverse effects reported. It was unknown if the patient sought medical attention. This is one of several reports from the same source. 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 Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (administration route, lot numbers and expiration dates were not provided). No concomitant therapies were reported, neither was any adverse event. This is one of several reports 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 as received from a nurse practitioner refers to two patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 19-MAR-2015, the patients were vaccinated with a dose of RECOMBIVAX HB intramuscular, which underwent a supported temperature excursion. Dose, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. No adverse effects 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 registered nurse, refers to an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL (strength, dosage, route, and lot# were not reported). None symptoms were reported. This is one of several reports received from the same reporter. 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 register nurse, refers to an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ, oral, (strength, dosage and lot# were not reported). None symptoms were reported. This is one of several reports received 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 as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. The nurse reported that on an unknown dates, the unspecified number of patients received doses of RECOMBIVAX HB (dose, route, lot number and expiration date not reported) that were improperly stored. No adverse experiences reported. No concomitant medications were reported. No further information was provided. This is one of the several reports of the same source. 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 register nurse, refers to an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored VAQTA, (strength, dosage, route, and lot# were not reported). None symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unkonwn date the patient was vaccinated with GARDASIL, intramuscular, (strength, dosage, frequency, lot# were not reported). Concomitant therapy was not reported. The nurse practitioner informed that on an unknown date, the patient inadvertently received four doses of GARDASIL. No adverse effects were reported. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse, refers to an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored PEDVAXHIB, (strength, dosage, route, and lot# were not reported). None symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Heart rate increased, Hypotension, Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old female patient. The patient's medical history and concurrent conditions were not reported. On 10-MAR-2015, the patient was vaccinated with GARDASIL lot # K009482, expiration date: 06-MAR-2017, 0.5 ml, intramuscularly. No concomitant therapies were reported. Following vaccination, the patient experienced 3 syncope episodes (each one lasted about 20 seconds, and occurred within a short period of time), her heart rate increased and she developed hypotension. The physician stated that the patient did not received any treatment, but was monitored in the office for about an hour and 45 minutes, until the patient felt better, and then the physician let her go. The outcome of heart rate increased, syncope and hypotension was reported as recovered on 10-MAR-2015. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. The nurse reported that an unknown dates, the unspecified number of unspecified patients received doses of ROTATEQ (dose, lot number and expiration date not reported) oral, that were improperly stored. No adverse experiences reported. No concomitant medications were reported. No further information was provided. This is one of the several reports of the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient with no known medical history, nor drug reaction/allergies. On 15-JAN-2015, the patient was vaccinated with PNEUMOVAX23 lot # K009107, expiration date 21-JAN-2016 (dose and route were not reported). No co-suspect and concomitant therapies were reported. On an unknown date in 2015, the patient experienced injection site pain reported as soreness and tenderness at the site of injection. The outcome of injection site pain was reported as not recovered. No treatment was given for adverse events. The patient did not seek medical attention. The causality was not reported. 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 Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (administration route, lot numbers and expiration dates were not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several 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 as received from a medical assistant refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. On 31-MAR-2015, the patient was vaccinated with VARIVAX (Merck) (dose, strength, route and lot number were not reported), that was improperly stored. No adverse effects were reported. No product quality complaint was 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 Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (administration route, lot numbers and expiration dates were not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Lymphadenopathy, Neck pain, Tongue disorder
Clinical narrative: This spontaneous report was received from the mother of a 17 year old female patient with allergy to yeast who on 17-MAR-2015, was vaccinated with a dose of GARDASIL or GARDASIL 9 (lot number and route of administration not reported) (reported as "does not know if the daughter received GARDASIL or GARDASIL 9"). Concomitant medication included an "unspecified birth control" medication. On 18-MAR-2015, the patient experienced lymphadenopathy and neck pain. On 24-MAR-2015 the patient developed red bumps on the back of her tongue. The patient was a student away at college and went to seek medical attention from school nurse practitioner. On an unknown date "unspecified bloodwork" was performed (not results provided). At the time of the report the patient had not recovered from neck pain, lymphadenopathy and tongue disorder. Relationship between neck pain, lymphadenopathy, tongue disorder and vaccination with GARDASIL or GARDASIL 9 was not reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Local swelling, Lymphadenopathy, Neck pain, Tongue discolouration
Clinical narrative: This spontaneous report was received from the mother of a 17 year old female patient with allergy to yeast who on 17-MAR-2015, was vaccinated with a dose of GARDASIL or GARDASIL 9 (lot number and route of administration not reported) (reported as "does not know if the daughter received GARDASIL or GARDASIL 9"). Concomitant medication included an "unspecified birth control" medication. On 18-MAR-2015, the patient experienced lymphadenopathy and neck pain. On 24-MAR-2015 the patient developed red bumps on the back of her tongue. The patient was a student away at college and went to seek medical attention from school nurse practitioner. On an unknown date "unspecified bloodwork" was performed (not results provided). At the time of the report the patient had not recovered from neck pain, lymphadenopathy and tongue disorder. Relationship between neck pain, lymphadenopathy, tongue disorder and vaccination with GARDASIL or GARDASIL 9 was not reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tongue disorder
Clinical narrative: This spontaneous report was received from the mother of a 17 year old female patient with allergy to yeast who on 17-MAR-2015, was vaccinated with a dose of GARDASIL or GARDASIL 9 (lot number and route of administration not reported) (reported as "does not know if the daughter received GARDASIL or GARDASIL 9"). Concomitant medication included an "unspecified birth control" medication. On 18-MAR-2015, the patient experienced lymphadenopathy and neck pain. On 24-MAR-2015 the patient developed red bumps on the back of her tongue. The patient was a student away at college and went to seek medical attention from school nurse practitioner. On an unknown date "unspecified bloodwork" was performed (not results provided). At the time of the report the patient had not recovered from neck pain, lymphadenopathy and tongue disorder. Relationship between neck pain, lymphadenopathy, tongue disorder and vaccination with GARDASIL or GARDASIL 9 was not reported. 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 physician refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 05-APR-2015, the patient was vaccinated with an expired dose of ZOSTAVAX lot # J014566, expiration date 18-FEB-2015, 0.65 ml, subcutaneous. No co-suspect and concomitant therapies were reported. No symptoms reported. Additional information has been requested.
Age: 0.66
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 7 month old male patient. Medical history and concurrent conditions were not provided. On 31-MAR-2015 reported as "today", the patient was vaccinated with a expired second dose of ROTATEQ oral by mouth, 2 ml, lot number J012522, expiry date 31-JAN-2015. No adverse effects reported at this time. There was no concomitant medication provided. 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 register nurse, refers to an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB, (strength, dosage, route, and lot# were not reported). None symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 month old patient of unknown gender. Concurrent conditions and medical history were not reported. The physician informed that on 08-APR-2015, the patient was inadvertently vaccinated with the first dose of ROTATEQ series, route defaulted to oral (batch/lot # and expiration date not reported). No adverse effect was reported. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5, RV5
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 month old patient of unknown gender. Concurrent conditions and medical history were not reported. The physician informed that on 08-APR-2015, the patient was inadvertently vaccinated with the first dose of ROTATEQ series, route defaulted to oral (batch/lot # and expiration date not reported). No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash
Clinical narrative: Patient was given PREVNAR 13 right deltoid IM on 04-02-15, on 04-06-15 her arm developed a rash with redness, swelling and itching. She was evaluated for it on 04-09-15.
Age: 39.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Big red lump hot to the touch in area where vaccine was administered-size of softball.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Paraesthesia, Pruritus
Clinical narrative: Tingling/itching on left arm, left neck and face. Paresthesias severe and radiate to neck and scalp. Difficulty sleeping secondary symptoms.
Age: 9.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Fall, Fear
Clinical narrative: 0900 after injection pt. c/o dizziness, slumped to floor. Pt. remained awake, scared. P. 72 O2 Sat 97%. 0910 - skin W/D. No complaints. Assisted to w/c. Sat for 15 minutes, ready to go home, with mother at 0930.
Age: 9.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: 0900 after injection pt. c/o dizziness, slumped to floor. Pt. remained awake, scared. P. 72 O2 Sat 97%. 0910 - skin W/D. No complaints. Assisted to w/c. Sat for 15 minutes, ready to go home, with mother at 0930.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Feeling abnormal, Injection site erythema, Night sweats, Sensory disturbance, Vaccination site nodule
Clinical narrative: Severe pulsation type feeling in his head, unlike a usual headache, associated with "brain fog" and night sweats. Denied fever. Sx persisted for 3 days. Similar symptoms with AVA # 1 admin on 07 Feb 15, but those sx were mild in comparison to this episode. Vaccination site tender with a small red knot.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Vaccination site pain
Clinical narrative: Severe pulsation type feeling in his head, unlike a usual headache, associated with "brain fog" and night sweats. Denied fever. Sx persisted for 3 days. Similar symptoms with AVA # 1 admin on 07 Feb 15, but those sx were mild in comparison to this episode. Vaccination site tender with a small red knot.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash generalised
Clinical narrative: Rash all over body.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site pain, Muscle spasms, Muscular weakness
Clinical narrative: Patient experienced severe muscle pain at injection with trouble moving arm.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nuclear magnetic resonance imaging, X-ray limb
Clinical narrative: Patient experienced severe muscle pain at injection with trouble moving arm.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site reaction, Mobility decreased, Myalgia, Nuclear magnetic resonance imaging
Clinical narrative: Patient experienced severe muscle pain at injection with trouble moving arm.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Erythema, Headache, Macule, Rash pustular
Clinical narrative: Patient is a 24 yo male who received small pox vaccine 10 days ago as part of CBRNE. The patient sought medical evaluation today with generalized exanthem to extremities, and trunk. He has a severe headache 6 or 7/10 yesterday, now 3.10. He had had mild myalgias, but no fever, arthralgias no chills or vomiting. He has no history of eczema or immunocompromise. The lesions are discrete and mildly pruritis, but not painful. A/P: -I requested photographs ASAP and once received reviewed them with dr. I telephoned dr., the patient was also present: The patients clinical history and photographic exam most consistent with non-viral pustulosis following the vaccinia vaccine-these lesions tend to be pruritic and appear around 7-14 days post-vaccination -these lesions are considered non-infections and have been shown in previous studies to be negative by PCR for an vaccinia virus -typically, lesions resolve in about 1 week -lesions are consistent with auto-inoculation or generalized vaccine and do not appear consistent with other viral lesions such as HSV or VZV -I also recommended supportive care with antihistamines and TYLENOL or ibuprofen as needed.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Arthralgia, Headache, Myalgia, Pruritus, Rash generalised
Clinical narrative: Patient is a 24 yo male who received small pox vaccine 10 days ago as part of CBRNE. The patient sought medical evaluation today with generalized exanthem to extremities, and trunk. He has a severe headache 6 or 7/10 yesterday, now 3.10. He had had mild myalgias, but no fever, arthralgias no chills or vomiting. He has no history of eczema or immunocompromise. The lesions are discrete and mildly pruritis, but not painful. A/P: -I requested photographs ASAP and once received reviewed them with dr. I telephoned dr., the patient was also present: The patients clinical history and photographic exam most consistent with non-viral pustulosis following the vaccinia vaccine-these lesions tend to be pruritic and appear around 7-14 days post-vaccination -these lesions are considered non-infections and have been shown in previous studies to be negative by PCR for an vaccinia virus -typically, lesions resolve in about 1 week -lesions are consistent with auto-inoculation or generalized vaccine and do not appear consistent with other viral lesions such as HSV or VZV -I also recommended supportive care with antihistamines and TYLENOL or ibuprofen as needed.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Skin lesion
Clinical narrative: Patient is a 24 yo male who received small pox vaccine 10 days ago as part of CBRNE. The patient sought medical evaluation today with generalized exanthem to extremities, and trunk. He has a severe headache 6 or 7/10 yesterday, now 3.10. He had had mild myalgias, but no fever, arthralgias no chills or vomiting. He has no history of eczema or immunocompromise. The lesions are discrete and mildly pruritis, but not painful. A/P: -I requested photographs ASAP and once received reviewed them with dr. I telephoned dr., the patient was also present: The patients clinical history and photographic exam most consistent with non-viral pustulosis following the vaccinia vaccine-these lesions tend to be pruritic and appear around 7-14 days post-vaccination -these lesions are considered non-infections and have been shown in previous studies to be negative by PCR for an vaccinia virus -typically, lesions resolve in about 1 week -lesions are consistent with auto-inoculation or generalized vaccine and do not appear consistent with other viral lesions such as HSV or VZV -I also recommended supportive care with antihistamines and TYLENOL or ibuprofen as needed.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. On an unknown date and in August 2013, the patient was vaccinated with the first and second dose of GARDASIL, (lot number, expiry date, dose and route were not reported). By the reporting time of 31-MAR-2015, the third dose had not been received. The physician asked whether the 3rd dose should be administered or repeated the series. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: This spontaneous report as received from a female patient of unknown age reporting on herself. On 29-MAR-2015, the patient was vaccinated with ZOSTAVAX (dose, lot number, expiration date, route of administration were not reported). On unspecified date in 2015, the patient experienced redness, warmth and a hard lump on her arm where she received ZOSTAVAX. The patient sought medical attention: called a health care professional (unspecified, on an unknown date). The outcome of the events was not reported. Relatedness between the events and vaccination with ZOSTAVAX was not reported. Additional information is not expected as there is no contact information available.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients. The reporter stated unspecified patients had received GARDASIL 9 (dose, route unknown), as a booster dose, after receiving GARDASIL (dose, route unknown). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: Information has been received from a pharmacist via field employee referring to a female patient of unknown age. The patient had no pertinent medical history and no drug reactions/allergies. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dose and lot# unknown). No concomitant medications. The patient developed a burning sensation throughout her entire back soon after the administration. No treatment and no lab given to the event. The patient did not seek medical attention. The outcome of burning sensation was unknown. No PQC (product quality issue) involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a nurse practitioner referring to an unspecified number of patient of unknown ages and gender. On an unknown dates the patients were vaccinated with GARDASIL (strength, lot#, dosage, frequency and route unspecified) and still ended up getting the HPV infection. The outcome of the event was unknown. Additional information is not expected because the reporter did not want to be contacted.
Sex: F
Vaccine: PPV
Symptoms: Hypoglycaemia
Clinical narrative: Information has been received from a female patient of unknown age via email referring to herself. The patient had a carbohydrate digestive disorder that had as one of its symptoms, hypoglycemia. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 injection, (lot number, expiry date, dose and route were not reported). Within ten minutes of receiving this injection, the patient began having a hypoglycemic reaction. The outcome of the event was unknown. The patient wanted to know what sugars were involved in the polysaccharide of the vaccine to help her better understanding the triggers to her carbohydrate disorder. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13
Symptoms: Contusion, Immune thrombocytopenic purpura, Irritability, Platelet count decreased, Pyrexia
Clinical narrative: Low grade fever in the 99 range, a little fussy, showed bruises days after vaccines within the week was diagnosed with ITP, been almost a year now. No treatment.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Chills, Erythema, Lethargy, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for 5 patients. This is 4th of 5 report (3 different lot #'s appear to be involved). An adult patient of unspecified age (60 years or older) of unspecified age, ethnicity and gender started to receive PREVNAR 13 via an unspecified route of administration on an unspecified date in 2015. The patient medical history and concomitant medications were not reported. On an unspecified date in 2015, the patient experienced cellulitis, swelling, redness, chills, and lethargy. The outcome of the events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Chills, Erythema, Lethargy, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for 5 patients. This is 5th of 5 report (3 different lot #'s appear to be involved). An adult patient of unspecified age (60 years or older), ethnicity and gender started to receive PREVNAR 13 via an unspecified route of administration on an unspecified date in 2015. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2015 the patient experienced cellulitis, swelling, redness, chills, and lethargy. The outcome of the events was unknown.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information about patient's medical history was not provided. On an unknown date, the patient was vaccinated with a dose of PROQUAD (Merck) (0.5 ml, subcutaneously, dose number, frequency and indication were not specified) (lot # K008185, expiration date: 05-DEC-2015) that was improperly stored. Concomitant medication was not reported. No adverse experience was reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (operations manager) referring to unknown number of patients. On unknown dates, the patients were administered improperly stored GARDASIL, lot # K005881, expiry date: 14-JAN-2017, (route, dose and frequency were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain, Arthralgia, Asthenia, Back pain, Grip strength decreased
Clinical narrative: On or about December 1, 2014, I began to experience severe hip and back pain. Pain was especially noticable during sleep making it painful to get out of bed. Pain began in hip area and began shooting into my legs & groin. Went to the Urgent Care Center for examination (incl x-rays). Followed recommendation to take Advil or Tylenol and mederated use of hip.  Condition improved somewhat but not completely. Subsequently, in February-March timeframe began to experience severe back pain, not as focused on the hip but more in lower and middle back area.  Pain also developed in the abdomen and shoulders. In both instances, I also experienced a significant decrease in muscular strength...abilty to pick up, lift and hold objects.