chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Differential white blood cell count normal, Ehrlichia test, Immunology test normal, Infection, Laboratory test normal
Clinical narrative: Case number PHHO2015US004372, is an initial report received on 16 Mar 2015, from clinical study. This 18-year-old male subject was enrolled in a study. The subject's medical history included asthma. Concomitant medications were not reported. On 06 Sep 2014 at 09:33, the subject received the study vaccine MenB. It was reported that the subject had just returned from a 5-day camping trip with other college students. Approximately at 18:50 hrs the subject was taken to the ER room due to fever, myalgia, malaise and mild neck stiffness. In the emergency room, the subject recovered from the event neck stiffness. The subject was noted with temperature of 101-102 F. ER physician suspected possible meningitis. On the same day lumbar puncture was performed and CSF analysis was not consistent with meningitis. CSF showed WBC-1, glucose was normal, protein was normal and culture showed no growth. On the same day the subject was admitted to the hospital for overnight observation. The other investigations included WBC: normal with normal differential, platelets: normal, ALT was 71, AST was 46 (mildly elevated), blood culture showed no growth, urine analysis was normal, Lyme disease antibody titre was negative, Wright's stain for Ehrlichia showed negative, Ehrlichia IgG antibody titre was <1:64, blood smear showed normal and West Nile virus IgG and IgM antibodies showed negative. On 07 Sep 2014, the subject was discharged from the hospital with a diagnosis of likely tick borne illness and was prescribed with doxycycline as a treatment. On 07 Nov 2014, a follow up serology for tick-borne illness was performed (considering subject's history of a recent camping trip), which included Lyme EIA test which returned negative, Rickettsia rickettsii IgG showed negative, Ehrlichia chaffeensis IgG showed negative, Anaplasma phagocytophilum IgG was negative and Babesia microti AB IFA was negative. It was reported that these negative antibody results, 8 weeks following symptom onset argue against the earlier presumptive diagnosis of a tick-borne illness and hence the symptoms myalgia, malaise and fever were considered as serious (hospitalization). The event mild neck stiffness was considered as non-serious. It was reported that as per the hospital admission notes that the neck stiffness had resolved in the emergency room and it was not included in the treating physician's assessment as an important factor in the clinical decision making and was not indicated as a reason for the hospital admission. The investigator did suspect a causal relationship between the events and study vaccine. Investigator stated that since all antibody tests for tick-borne illness were negative, this suggests that the subject's symptoms were possibly related to rMenB vaccine based on the timing of onset and the absence of an identified alternative cause. Follow up received on 23 Mar 2015, prior to the circulation of previous report: Clinical information related to the seriousness of the event neck stiffness was updated.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Malaise, Musculoskeletal stiffness, Myalgia, Parasitic blood test negative, Platelet count normal
Clinical narrative: Case number PHHO2015US004372, is an initial report received on 16 Mar 2015, from clinical study. This 18-year-old male subject was enrolled in a study. The subject's medical history included asthma. Concomitant medications were not reported. On 06 Sep 2014 at 09:33, the subject received the study vaccine MenB. It was reported that the subject had just returned from a 5-day camping trip with other college students. Approximately at 18:50 hrs the subject was taken to the ER room due to fever, myalgia, malaise and mild neck stiffness. In the emergency room, the subject recovered from the event neck stiffness. The subject was noted with temperature of 101-102 F. ER physician suspected possible meningitis. On the same day lumbar puncture was performed and CSF analysis was not consistent with meningitis. CSF showed WBC-1, glucose was normal, protein was normal and culture showed no growth. On the same day the subject was admitted to the hospital for overnight observation. The other investigations included WBC: normal with normal differential, platelets: normal, ALT was 71, AST was 46 (mildly elevated), blood culture showed no growth, urine analysis was normal, Lyme disease antibody titre was negative, Wright's stain for Ehrlichia showed negative, Ehrlichia IgG antibody titre was <1:64, blood smear showed normal and West Nile virus IgG and IgM antibodies showed negative. On 07 Sep 2014, the subject was discharged from the hospital with a diagnosis of likely tick borne illness and was prescribed with doxycycline as a treatment. On 07 Nov 2014, a follow up serology for tick-borne illness was performed (considering subject's history of a recent camping trip), which included Lyme EIA test which returned negative, Rickettsia rickettsii IgG showed negative, Ehrlichia chaffeensis IgG showed negative, Anaplasma phagocytophilum IgG was negative and Babesia microti AB IFA was negative. It was reported that these negative antibody results, 8 weeks following symptom onset argue against the earlier presumptive diagnosis of a tick-borne illness and hence the symptoms myalgia, malaise and fever were considered as serious (hospitalization). The event mild neck stiffness was considered as non-serious. It was reported that as per the hospital admission notes that the neck stiffness had resolved in the emergency room and it was not included in the treating physician's assessment as an important factor in the clinical decision making and was not indicated as a reason for the hospital admission. The investigator did suspect a causal relationship between the events and study vaccine. Investigator stated that since all antibody tests for tick-borne illness were negative, this suggests that the subject's symptoms were possibly related to rMenB vaccine based on the timing of onset and the absence of an identified alternative cause. Follow up received on 23 Mar 2015, prior to the circulation of previous report: Clinical information related to the seriousness of the event neck stiffness was updated.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Typhus rickettsia test, Urine analysis normal, West Nile virus test negative, White blood cell count normal
Clinical narrative: Case number PHHO2015US004372, is an initial report received on 16 Mar 2015, from clinical study. This 18-year-old male subject was enrolled in a study. The subject's medical history included asthma. Concomitant medications were not reported. On 06 Sep 2014 at 09:33, the subject received the study vaccine MenB. It was reported that the subject had just returned from a 5-day camping trip with other college students. Approximately at 18:50 hrs the subject was taken to the ER room due to fever, myalgia, malaise and mild neck stiffness. In the emergency room, the subject recovered from the event neck stiffness. The subject was noted with temperature of 101-102 F. ER physician suspected possible meningitis. On the same day lumbar puncture was performed and CSF analysis was not consistent with meningitis. CSF showed WBC-1, glucose was normal, protein was normal and culture showed no growth. On the same day the subject was admitted to the hospital for overnight observation. The other investigations included WBC: normal with normal differential, platelets: normal, ALT was 71, AST was 46 (mildly elevated), blood culture showed no growth, urine analysis was normal, Lyme disease antibody titre was negative, Wright's stain for Ehrlichia showed negative, Ehrlichia IgG antibody titre was <1:64, blood smear showed normal and West Nile virus IgG and IgM antibodies showed negative. On 07 Sep 2014, the subject was discharged from the hospital with a diagnosis of likely tick borne illness and was prescribed with doxycycline as a treatment. On 07 Nov 2014, a follow up serology for tick-borne illness was performed (considering subject's history of a recent camping trip), which included Lyme EIA test which returned negative, Rickettsia rickettsii IgG showed negative, Ehrlichia chaffeensis IgG showed negative, Anaplasma phagocytophilum IgG was negative and Babesia microti AB IFA was negative. It was reported that these negative antibody results, 8 weeks following symptom onset argue against the earlier presumptive diagnosis of a tick-borne illness and hence the symptoms myalgia, malaise and fever were considered as serious (hospitalization). The event mild neck stiffness was considered as non-serious. It was reported that as per the hospital admission notes that the neck stiffness had resolved in the emergency room and it was not included in the treating physician's assessment as an important factor in the clinical decision making and was not indicated as a reason for the hospital admission. The investigator did suspect a causal relationship between the events and study vaccine. Investigator stated that since all antibody tests for tick-borne illness were negative, this suggests that the subject's symptoms were possibly related to rMenB vaccine based on the timing of onset and the absence of an identified alternative cause. Follow up received on 23 Mar 2015, prior to the circulation of previous report: Clinical information related to the seriousness of the event neck stiffness was updated.
Age: 1.36
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. mother brought child back to clinic a day after vaccination. Reaction on left thigh red raised and warm to touch covered from upper thigh to knee.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 2 month vaccines were adminsitered to 1 month old baby - no reaction.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle injury, Tendon injury
Clinical narrative: Patient received a flu shot incorrectly. The pharmacist was standing facing her and gave the shot in her shoulder. She poked her once took the needle out and poked her again. The patient called 2 days later to see if it was supposed to hurt. The patient has been in physical therapy since administration due to damage to her supraspinatus muscle and tendon.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information  has been received from a pharmacist referring to a patient of unknown age and gender. The patient received two dose of ZOSTAVAX (subcutaneous, 0.65ml, lot# was unknown) in February 2014 and February 2015 (extra dose administered), respectively. There was no adverse experience reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On 10-SEP-2014 the patient was vaccinated with one dose of VAQTA (lot number reported as 5B23A, dose and route were unknown) which underwent an unsupported temperature excursion. No adverse effects reported. The lot number 5B23A is an invalid lot number for VAQTA. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Crying, Discomfort, Injection site pain
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of unspecified patients of unknown age and gender. On unknown dates these patients were vaccinated with GARDASIL (dose, route and lot# were not reported). On unknown dates these patients experienced injection site pain after receiving GARDASIL. The reporter felt this because GARDASIL was "irritating to the muscle." The reporter also reported that all of these unspecified patients cried after receiving GARDASIL because the injections were so "uncomfortable." No treatment was given for these adverse events. No lab diagnostics studies were performed. The outcome of these events was reported as recovered/resolved. The reporter considered injection site pain, injection site discomfort and injection site irritation were related to GARDASIL and the relationship between other events and GARDASIL was not reported. This is one of several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 17 month old patient of unknown gender. In November 2014, the patient was vaccinated with the first dose of MMR II and (Oka/Merck) VARIVAX (lot#, dose and route for both products were not reported). On 23-MAR-2015, the patient was vaccinated with MMR II and (Oka/Merck) VARIVAX again. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients. On an unknown date unspecified number of unspecified patients were vaccinated with doses of improperly stored ZOSTAVAX, subcutaneously. No adverse effect reported. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPIPV, FLU3, HIBV, RV1
Symptoms: Dehydration, Diarrhoea, Vomiting
Clinical narrative: On 3/23/15 mom noticed very loose diarrhea and vomiting at about 1 pm, then two hours later it happened again and diarrhea stopped 2 days after he was hospitalized. Was given IV fluids to hydrate after very bad dehydration. Was discharged 3/30/15.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness
Clinical narrative: Pt states after vaccine she developed dizziness throughout the day, 3 days straight and again on Sunday 3/26/15. She's concern the length of dizziness may interfere with her daily functions.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness postural
Clinical narrative: Pt states after vaccine she developed dizziness throughout the day, 3 days straight and again on Sunday 3/26/15. She's concern the length of dizziness may interfere with her daily functions.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unkonwn age and gender. The medical assistant reported that, on an unknown date, an unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ routes of administration default to oral (lot numbers, expiration dates and doses 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: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous reprot as received from a pharmacist refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. On 17-MAR-2015, the patient was vaccinated with PNEUMOVAX23 lot # J009689, expiration date 29-JAN-2015 (dose, strength and route were not reported). Secondary suspects and concomitant therapies were not reported. The pharmacist reported that the patient received an expired dose of PNEUMOVAX23. No adverse effects were reported. No product quality complaint was reported. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Low grade fever, minimal swelling at injection site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a unkonwn number of patients of unknown demographics. On 27-JAN-2015 the patients were inadvertently administered VARIVAX (Merck) (dose, route and lot # not reported) that had been improperly stored. No adverse effects were reported. Follow up information has been received from the reporting medical assistant, during a phone call on 23-MAR-2015. The medical assistant reproted that VARIVAX (Merck) lot# involved was K010337, expiration date was not provided. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Urticaria
Clinical narrative: 2 urticarial lesions 10 and 20 minutes after vaccine. (R) preauricular and (L) forearm. No other symptoms. Known allergies to milk, egg, peanut, tomato and wheat.
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a nurse referring to a 61 year old male patient. The patient had no drug reactions/allergies. The patient was vaccinated with RECOMBIVAX HB (dose and route unspecified), dose 1 on 22-JUN-2012 (lot # was reported as 152AA, expiry date unknown), dose 2 on 14-AUG-2012 (lot # 0021AE, expiry date unknown) and dose 3 on 14-JAN-2013 (lot # and expiry date unknown), for prevention of Hepatitis B. After administration of the 3 doses of RECOMBIVAX HB, the patient "had titers drawn (on an unspecified date of 2013) which did not register", therefore the patient was also administered 2 booster doses of RECOMBIVAX HB (dose 4 on 09-APR-2013 (lot # H018691, expiry date unknown) and dose 5 on 24-APR-2013 (lot # 0021AE, expiry date unknown), but when his titers were drawn again, recently (in approximately 2015), on an unspecified date, "his titers still did not register." The outcome of the events was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On 03-DEC-2014 the patient was vaccinated with a improperly stored dose of VAQTA (lot number J015882, expiration date 22-OCT-2015, dose and route were unknown). No adverse effects reported. This is one of several reports received from same source. 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 healthcare worker concerning a patient of unknown age. No medical history and current conditions were reported. On an unknown date the patient was vaccinated with GARDASIL (lot # K005881, Expiry: 14-JAN-2017, 0.5 ml, intramuscular), which was improperly stored. No adverse events were reported. No product quality complaint was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product 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, concurrent  conditions and concomitant medications were not reported. On 26-MAR-2015, the patient was inadvertently vaccinated with expired VARIVAX (Merck), vial 1350 U, 0.5 milliliter (ml), subcutaneously, lot # H013477, expiry date 11-JUL-2014. No adverse effects were reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inflammation, Injection site inflammation
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 2 unspecified patients of unknown age and gender. No medical history and current conditions were reported. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (lot # K004542, Expiry: 19-AUG-2015, intramuscular) (dose unknown) for vaccination. No concomitant medications were reported, On an unknown date the 2 unspecified patients experienced severe inflammation in their arms, an unspecified amount of time after receiving doses from the same lot of PNEUMOVAX 23. The inflammation was described as originating at the injection site in the upper arm and spreading down through the fingers. The outcome of the event severe inflammation in their arms was unknown. The reporter causality was not provided. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. No medical history and current conditions were reported. On an unknown date the patient was vaccinated with GARDASIL (dose, lot number was unknown) after the age of 26 years old. No adverse effects were reported. No product quality complaint was involved. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Hypoaesthesia, Pain in extremity, Skin warm
Clinical narrative: Left arm approx. 2 1/2 x 1 1/2 in blister type reaction surrounded by redness measuring 5 in x 6 in. Warm to touch, painful with numbness in fingertips.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from healthcare worker refers to unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with doses of PROQUAD (Merck), (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with doses of VARIVAX (Merck), (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness, fever, chills, swelling at injection site
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Upper arm felt warm and swollen 15 mins after administration of vaccine. Gave BENADRYL 50mg PO in clinic.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema
Clinical narrative: 1 cm x 1 cm ecchymotic region on left deltoid 1 yr after 3rd HPV injection.
Sex: U
Vaccine: HEPA
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 unspecified dates these patients were administered with unspecified doses of VAQTA (lot # and expiry date unspecified) which were improperly stored throughout March 2015. No adverse effects were reported. Outcome of the event was unknown. Reporting health professional considered the event to be not related to VAQTA. This is one of several reports from the same reporter (MARRS # WAES1503USA013938, MARRS # WAES1503USA014261, MARRS # WAES1503USA014262, MARRS # WAES1503USA014263, MARRS # WAES1503USA014264 and MARRS # WAES1503USA014265).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 13-MAR-2015 the patient was vaccinated with an expired dose of PROQUAD (Lot Number: J006569-Expiration date: 30-NOV-2014) with route of administration and dose unspecified, and no adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed practical nurse (LPN) regarding unspecified patients of unknown demographics. All patient information including concurrent condition, medical history and past drug history were unknown. On an unknown date, the patient was vaccinated with LIQUID PEDVAXHIB, lot number- K015463, expiration date- 09-JUL-2017. No concurrent condition was reported. On an unknown dates, the HIB was exposed to temperatures up to 11.6 degrees Celsius for a total of 63 hours and were given to an unknown number of patients. The outcome of receiving the HIB vaccine that had undergone a temperature excursion was unknown. 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 concerning unspecified number of patients of unknown age and gender. On unknown dates the patient received GARDASIL (lot#, expiration date, dose and route not reported), after being improperly stored for one month. No adverse effects were reported. Follow up information has been received from the medical assistant on 16-MAR-2015. On unknown date the patients received GARDASIL (lot# J006236, expiration date:25-FEB-2016), which was improperly stored. No adverse events following administration of the vaccinations. It was reported that the reporter does not have patient identification information readily available at the time of the call. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender with unknown concurrent conditions or medical history. The nurse stated that the unspecified numbers of patients, on unknown dates were vaccinated with VARIVAX (Merck) (dose, route, frequency, lot number not provided) that were improperly stored. No adverse events were reported due to the incorrect product storage. At the time of this report, the outcome of the patients was unkonwn. 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 health care professional refers to an unspecified number of patients who were vaccinated on unknown dates with unspecified doses of VAQTA that were improperly stored. No adverse effects reported. No further information 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 health care professional refers to an unspecified number of patients who were vaccinated on unknown dates with unspecified doses of RECOMBIVAX HB that were improperly stored. No adverse effects reported. No further information provided. 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 health care professional refers to an unspecified number of patients who were vaccinated on unknown dates with unspecified doses of MMR II that were improperly stored. No adverse effects reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This report as received from a health care professional refers to an unspecified number of patients who were vaccinated on unknown dates with unspecified doses of GARDASIL that were improperly stored. No adverse effects reported. No further information provided. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Adverse event, Anaphylactoid reaction, Pain, Pain in extremity
Clinical narrative: Information has been received from Pfizer, Inc (MFR # 2015079472) on 27-MAR-2015. This spontaneous report as received from a physician refers to a female patient of unknown age who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (dose, lot #, expiration date and route were not reported). On an unknown date, the patient experienced anaphylactic like symptoms, also she had severe pain in her left side, severe pain when move around and painful arm (pain) and finally she had unspecified associated symptoms (adverse event). At the time of the report, the outcome of anaphylactic reaction, pain and adverse event was unknown. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Hypoaesthesia, Nasopharyngitis, Oropharyngeal pain, Pain in extremity
Clinical narrative: Patient states within 24-48 hours she developed a fever, arm became very sore, facial cheeks turned red, sore throat, numbness in toes and other cold like symptoms. No medical treatment occurred.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Patient states within 24-48 hours she developed a fever, arm became very sore, facial cheeks turned red, sore throat, numbness in toes and other cold like symptoms. No medical treatment occurred.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. The patient relevant medical history, concomitant medications and past drug therapy were unknown. On 17-MAR-2015, the patient was vaccinated with PNEUMOVAX 23 (lot # J009689 and expiration date 29-JAN-2015) unknown dose, vial right deltoid injection for an unknown indication which was expired on 29-JAN-2015. No adverse event was reported. It was unknown if there was any relevant laboratory data. As of 17-MAR-2015, it was unknown if the patient will receive another PNEUMOVAX 23 injection. Action taken was not applicable. The outcome of receiving an expired vaccine was unknown. Causality was not assessed by the reporter. Comments: The pharmacist did not feel comfortable providing detailed information regarding the patient due to HIPAA, limited information available. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Syncope
Clinical narrative: Patient had syncopal episode the next morning.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Night sweats, Pyrexia
Clinical narrative: 4 days after vaccination fever 100.1, (Sat 3/28/15) night sweats the following evening. Fever resolved the following evening (Sunday 3/29/15).
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The medical assistant reported that, on an unknown date, an unspecified number of patients were vaccinated with improperly stored dose of M-M-R II (lot numbers, expiration dates, doses and routes of administration 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: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The medical assistant reported that, on an unknown date, an unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (lot numbers, expiration dates, doses and routes of administration 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: 0.8
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 9 month old female patient. The patient's medical history, concomitant medications were not reported. On 26-MAR-2015 the patient was inadvertently vaccinated with GARDASIL (dose number, dose volume, route of administration, lot number were not reported). No adverse events were reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Night sweats, Pyrexia
Clinical narrative: Had PPSV on 3-11-15 with adverse reaction on 3-14, 3-15, 3-16, 3-17 with fever of 102 degrees, coughing spells constantly. Unable to leave house. Brought fever down with TYLENOL but would go up each night with night sweats.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: GARDASIL vaccine administered on 3/3/315. Site became red and warm to touch on day of injection and increased in size and redness on day 2. No fever. Treated with KEFLEX TID and CLARITIN daily for 1 week.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. Information about the patients' relevant medical history, co-suspect or concomitant medications was not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (dose, route, lot# and expiration date were not reported). No symptoms were reported. No PQC (product quality complaint) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 1.51
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Developed a half dollar sized lump with a softball sized area of redness around injection site 4 days after varicella vaccine. No tx-only phone call.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus
Clinical narrative: Pt. received vaccine 3/16 (PREVNAR 13) and stated no s/s. (PM) 3/20 states started itching in left arm area where vaccine received. 3/21 states started itching with redness at vaccine site. Purchased and used BENADRYL cream without relief of s/s. 3/22 s/s worsened. Was seen at clinic (AM) Dx with cellulitis Rx given: Prednisone 10mg Doxycycline 100mg BID.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: MENACTRA vaccine administered on 3/19/15. Injection site started to get red on day of injection, increased to size of fist. On day 2, redness increased to size of whole hand. Warm to touch. Due to hx of cellulitis, treated with OMNICEF 600 mg x 10 days.
Sex: U
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a registered nurse via field representative refers to 40 patients of unknown age and gender. The patients were relocated. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date (also reported as a while ago), the patients were vaccinated with M-M-R II, (dose, frequency, route of administration and indication were not provided). On an unknown date, 40 patients broke out in rashes and fevers, but did not get the measles. The outcome of broke out in rashes and fevers was unknown. Causality was not provided. No further adverse event information was given. This is one of two reports received from same reporter (linked with MARRS# 1503USA013899). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles post vaccine
Clinical narrative: This spontaneous report as received from a registered nurse via field representative refers to a patient of unknown age and gender. Patient was relocated. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date (also reported as a while ago), the patient was vaccinated with M-M-R II, intramuscularly, (dose and frequency were not provided). On an unknown date, later patient developed the measles for an unspecified amount of time. Nurse stated that adverse experience happened "a while ago" she did not know much information. No product quality complaint (PQC) was involved. The outcome of measles was unknown. Causality was not provided. No further adverse event information was given. This is one of two reports received from same reporter (linked with MARRS# 1503USA014690). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Decreased appetite, Dizziness, Fatigue, Gastritis
Clinical narrative: This spontaneous report as received from a physician via Pfizer (Mfr control # 2015038893) refers to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 08-DEC-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 dose, route, lot# and expiration date were not reported. On an unknown date, the patient experienced dizziness, chronic abdominal pain, headache, terrible gastritis, flu, tiredness, loss of appetite and her arm was really really sore, it hardly reached up. The outcome of the events was not reported. The relatedness between the events: dizziness, headache, terrible gastritis, flu, tiredness, loss of appetite and 'her arm was really reallly sore, it hardly reached up' and PNEUMOVAX 23. The patient considered chronic abdominal pain to be not related to PNEUMOVAX 23. Additional information is not expected, because the reporter did not wish to be contacted.
Sex: F
Vaccine: PPV
Symptoms: Headache, Influenza, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician via Pfizer (Mfr control # 2015038893) refers to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 08-DEC-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 dose, route, lot# and expiration date were not reported. On an unknown date, the patient experienced dizziness, chronic abdominal pain, headache, terrible gastritis, flu, tiredness, loss of appetite and her arm was really really sore, it hardly reached up. The outcome of the events was not reported. The relatedness between the events: dizziness, headache, terrible gastritis, flu, tiredness, loss of appetite and 'her arm was really reallly sore, it hardly reached up' and PNEUMOVAX 23. The patient considered chronic abdominal pain to be not related to PNEUMOVAX 23. Additional information is not expected, because the reporter did not wish to be contacted.
Sex: U
Vaccine: PPV
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. The patient's medical history and current conditions were not provided. On 25-MAR-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (expiration date not provided) lot # K004930, 0.5 ml, intramuscular. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS, FLUX
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who was also a physician, regarding herself. The patient's concurrent conditions included scabies, for which the patient was treated with STROMECTOL (detailed in MARRS number 1502USA009858). The patient also had several drug reactions, which included ciprofloxacin that caused shoulder tendonopathy, MEPHAQUINE that caused migraine, tachycardia, chest pain and irregular heart rate, BACTRIM that caused extreme facial swelling, low heart rate and difficulty breathing, unspecified flu and yellow fever vaccines which caused unspecified hives, and metformin that caused her fingers to turn blue, numb and tingly. On an unknown date the patient was vaccinated with zoster vaccine (manufacturer unknown) (reported as unspecified shingles vaccine). On an unknown date, the patient experienced unspecified hives. The outcome of the hives was unknown. Causality assessment was not provided. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. The nurse reported that on 27-MAR-2015, the patient was vaccinated with PNEUMOVAX23, .5 milliliter (ml), product lot#J010654, intramuscularly that expired on 17-OCT-2014. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 30-SEP-2014 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not provided) and then with the second dose on 30-MAR-2015. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The registered nurse reported that, on unknown dates, an unspecified number of improperly stored PROQUAD (Merck) (Lot # reported as K025760 and expiry date 8-JUN-2016) doses had been administered to these patients (dose, lot numbers and routes were not provided). No adverse effects were reported. Product quality complaint was not reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report as received from a consumer refers to her family members. No demographics were provided for the patients. The reporter stated that her family had a history of unspecified allergic reaction to M-M-R II (dose, frequency, lot #, route of administration and indication were not specified). No product quality complaint (PQC) was involved. The outcome of allergy to vaccine was unknown. The reporter considered allergy to vaccine to be related to M-M-R II. Additional information is not expected, as no contact details were provided.
Age: 1.07
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Instantly red and whelped at injection sites. Watched for 10 min. 2" whelps at injection sites. Given BENADRYL.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Injection site swelling, Peripheral swelling, Tenderness
Clinical narrative: Arm erythemic, swollen 5cm around vaccine site, extending past elbow, tender. Rx: BENADRYL 25mg 1-2 PO Q 6 hours prn, return prn.
Age: 57.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Pain in extremity
Clinical narrative: Two days after injection noted aching pain in left arm. Seems to be positional, worse as the day progresses. No redness or swelling. Advised to use heat to area and take ibuprofen.
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a multiple unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date and before their first birthday, the multiple patients were vaccinated with doses of VARIVAX (Merck) (dose, route, lot number and expiry date were not reported). No adverse effects reported. 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 certified medical assistant refers to an unspecified number of patients of unknown age and gender. The medical assistant reported that, on an unknown date, an unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot numbers, expiration dates, doses and routes of administration 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: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager, refers to a patient (who is also a physician) of unknown age and gender. It was reported, that on 25-MAR-2015, the patient was vaccinated with a third dose of improperly stored RECOMBIVAX HB dose and route were not reported (lot # K012649, expiration date: 14-APR-2016). The temperature excursion for the RECOMBIVAX HB was found to be supported by in-house stability data. It was not known, when the patient received the first and second dose of the vaccine. No adverse symptoms reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Skin warm, Swelling
Clinical narrative: Extreme redness to below elbow, swelling; never reacted to any vaccine before this; also inflamed area hot to touch; lasted 4-5 days.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On 26-MAR-2015 the patient was vaccinated with a dose of improperly stored GARDASIL lot # K006191, exp. Date: 02-FEB-2017, dose/frequency: 0.5 ml/1 dose, intramuscularly. Concomitant therapy was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. The patient had no pertinent medical history and no known drug reactions/allergies. On 29-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K009199, expiration date 16-MAY-2015, dose and route not reported). There was no concomitant medication. The patient received ZOSTAVAX and experienced redness, itchiness, and a "knot" forming at the injection site. Patient sought medical attention via seeing the pharmacist. No lab diagnostics studies were performed. No treatment was given. At the time of the report, the patient's itchiness and the knot at the injection site went away but the redness was still there. Additional information  has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Contraindication to vaccination
Clinical narrative: Information has been received from a female patient of unknown age with rheumatoid arthritis referring to herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (strength, lot#, dosage and route unspecified). Additional information is not expected because there was no available contact information.