chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-OCT-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-OCT-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse refers to a female patient of unknown age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not reported. The patient was reported as pregnant. Her LMP and EDD were unknown. On 29-DEC-2015, the patient was vaccinated with dose 1 of GARDASIL 9. The patient required medical attention on an unknown date and she walked into the reporter's office to get vaccinated with her second dose of GARDASIL 9. Reporting nurse stated that since the patient looked like she was 7 months pregnant, second vaccine dose was not administered to her. Nurse stated that she was unknown why the first vaccine dose was given to the patient, since it was documented that the patient was pregnant. Nurse also mentioned that the patient complained of injection site soreness at an unspecified site. Outcome of the events were unknown. The pregnancy outcome was outcome pending. No other complaints were reported. Reporter did not assessed the causality of event, injection site soreness with respect to therapy with GARDASIL 9. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: Information has been received from the authors of the literature article. The aim of this study was to evaluate persistence of varicella (VZV) specific antibodies after vaccination with 1 or 2 doses of VZV vaccine (manufacturer unknown) and to identify determinants of varicella seropositivity in a large cohort of children and adolescents with PHIV and also in perinatally HIV-exposed but uninfected (PHEU) children. The Adolescent Master Protocol (AMP), a component of the Pediatric HIV/AIDS Cohort Study, is an ongoing prospective cohort study designed to evaluate long-term effects of HIV infection and antiretroviral therapy (ART) among children with PHIV. It enrolled 451 children with PHIV and 227 PHEU children aged 7-16 years from March 2007 to November 2009 at 15 sites. Participants were required to have complete medical history of ART use, plasma HIV RNA concentrations, and lymphocyte subset measurements since birth. There were 653 subjects (432 PHIV and 211 PHEU) whose birth years ranged from 1991 to 2002. Compared with PHEU subjects, more subjects with PHIV were living in poverty. At the time their specimens were obtained for testing, subjects with PHIV were older and had a lower BMI z score than PHEU subjects. Overall, fewer subjects with PHIV compared with PHEU subjects received the VZV vaccine, with 38% vs 18% unvaccinated, 26% vs 25% having received 1 dose, and 34% vs 55% having received 2 doses, respectively (P< .001). Subjects with PHIV were older than PHEU subjects at the time of their vaccine (median: 4.7 vs 1.5 years; P < .001), had a shorter interval between first and second vaccinations (median: 3.9 vs 6.1 years; P < .001), and had more documented HZ episodes (10% vs 0%; P < .001). The median interval from last vaccine dose to sample collection was longer for subjects with PHIV than PHEU subjects (4.2 vs 3.5 years: P< .05). Of the 653 subjects tested, 84 (24.8%) tested negative by wcELISA. Among those testing negative, 78 (11.9% of all subjects) then tested positive by gpELISA. Overall, 87% of the cohort was seropositive to varicella, with a seroprevalence among subjects with PHIV of 82% (95% CI, 78%-86%), significantly lower than among PHEU subjects (97%; 95% CI, 94%-99%). This case concerns of 4 patients who received two doses of VZV vaccine (manufacturer unknown) in the PHIV cohort, and were seronegative. This is one of several reports from the same literature source (linked to MARRS # 1602USA004824 and 1602USA004825). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: Information has been received from the authors of the literature article. The aim of this study was to evaluate persistence of varicella (VZV) specific antibodies after vaccination with 1 or 2 doses of VZV vaccine (manufacturer unknown) and to identify determinants of varicella seropositivity in a large cohort of children and adolescents with PHIV and also in perinatally HIV-exposed but uninfected (PHEU) children. The Adolescent Master Protocol (AMP), a component of the Pediatric HIV/AIDS Cohort Study, is an ongoing prospective cohort study designed to evaluate long-term effects of HIV infection and antiretroviral therapy (ART) among children with PHIV, It enrolled 451 children with PHIV and 227 PHEU children aged 7-16 years from March 2007 to November 2009 at 15 sites. Participants were required to have  complete medical history of ART use, plasma HIV RNA concentrations, and lymphocyte subset measurements since birth. There were 653 subjects (432 PHIV and 221 PHEU) whose birth years ranged from 1991 to 2002. Compared with PHEU subjects, more subjects with PHIV were living in poverty. At the time their specimens were obtained for testing, subjects with PHIV were older and had a lower BMI z score than PHEU subjects. Overall, fewer subjects with PHIV compared with PHEU subjects received VZV vaccine, with 38% vs 18% unvaccinated, 26% vs 25% having received 1 dose, and 34% vs 55% having received 2 doses, respectively (P<.001). Subjects  with PHIV were older than PHEU subjects at the time of their first vaccine (median: 4.7 vs 1.5 years; P < .001), had a shorter interval between first and second vaccinations (median: 3.9 vs 6.1 years; P < .001), and had more documented HZ episodes (10% vs 0%; P < .001). The median interval from last vaccine dose to sample collection was longer for subjects with PHIV than PHEU subjects (4.2 vs 3.5 years; P< .05). Of the 653 subjects tested, 84 (24.8%) tested negative by wcELISA. Among those testing negative, 78 (11.9% of all subjects) then tested positive by gpELISA. Overall, 87% of the cohort was seropositive to varicella, with a seroprevalence among subjects with PHIV of 82% (95% Cl, 78%-86%), significantly lower than among PHEU subjects (97%; 95%Cl, 94%-99%). This case concerns of 2 patient who received >/= 3 doses of VZV vaccine (manufacturer unknown) in the PHIV cohort, and were seronegative. This is one of several reports from the same literature source (linked to MARRS # 1602USA002825 and 1602USA004825). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: Information has been received from the authors of the literature article. The aim of this study was to evaluate persistence of varicella (VZV) specific antibodies after vaccination with 1 or 2 doses of VZV vaccine (manufacturer unknown) and to identify determinants of varicella seropositivity in a large cohort of children and adolescents with PHIV and also in perinatally HIV-exposed but uninfected (PHEU) children. The Adolescent Master Protocol (AMP), a component of the Pediatric HIV/AIDS Cohort Study, is an ongoing prospective cohort study designed to evaluate long-term effects of HIV infection and antiretroviral therapy (ART) among children with PHIV. It enrolled 451 children with PHIV and 227 PHEU children aged 7-16 years from March 2007 to November 2009 at 15 sites. Participants were required to have complete medical history of ART use, plasma HIV RNA concentrations, and lymphocyte subset measurements since birth. There were 653 subjects (432 PHIV and 211 PHEU) whose birth years ranged from 1991 to 2002. Compared with PHEU subjects, more subjects with PHIV were living in poverty. At the time their specimens were obtained for testing, subjects with PHIV were older and had a lower BMI z score than PHEU subjects. Overall, fewer subjects with PHIV compared with PHEU subjects received the VZV vaccine, with 38% vs 18% unvaccinated, 26% vs 25% having received 1 dose, and 34% vs 55% having received 2 doses, respectively (P< .001). Subjects with PHIV were older than PHEU subjects at the time of their vaccine (median: 4.7 vs 1.5 years; P < .001), had a shorter interval between first and second vaccinations (median: 3.9 vs 6.1 years; P < .001), and had more documented HZ episodes (10% vs 0%; P < .001). The median interval from last vaccine dose to sample collection was longer for subjects with PHIV than PHEU subjects (4.2 vs 3.5 years: P< .05). Of the 653 subjects tested, 84 (24.8%) tested negative by wcELISA. Among those testing negative, 78 (11.9% of all subjects) then tested positive by gpELISA. Overall, 87% of the cohort was seropositive to varicella, with a seroprevalence among subjects with PHIV of 82% (95% CI, 78%-86%), significantly lower than among PHEU subjects (97%; 95% CI, 94%-99%). This case concerns of 1 patient who received >/=3 doses of VZV vaccine (manufacturer unknown) in the PHEU cohort, and was seronegative. This is one of several reports from the same literature source (linked to MARRS # 1602USA002825 and 1602USA004824). Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bursitis, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 87 year old female patient concerning on herself. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (route of administration, anatomical location, lot number and expiration date were not reported). There were no concomitant medications reported. On an unknown date, the patient experienced swelling and pain in her arm and the pain eventually moved into her shoulders. The patient mentioned that she went to see her physician (unknown date) and the doctor thought she had bursitis. At the time of the report, the outcome of bursitis, peripheral swelling and pain in extremity was unknown. The reporter did not assess the relatedness of bursitis, peripheral swelling and pain in extremity with PNEUMOVAX 23. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Musculoskeletal pain, Swelling
Clinical narrative: This spontaneous report was received from a 87 year old female patient concerning on herself. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (route of administration, anatomical location, lot number and expiration date were not reported). There were no concomitant medications reported. On an unknown date, the patient experienced swelling and pain in her arm and the pain eventually moved into her shoulders. The patient mentioned that she went to see her physician (unknown date) and the doctor thought she had bursitis. At the time of the report, the outcome of bursitis, peripheral swelling and pain in extremity was unknown. The reporter did not assess the relatedness of bursitis, peripheral swelling and pain in extremity with PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and concerns an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (having lot # as L019297 and expiration date as 18-AUG-2017) (dose number, dosage and route of administration were not reported). No concomitant therapies were reported. No previous excursions had occurred. This temperature excursion occurred at 50 F for a time frame of one hour. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients' were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L013063 expiration date 14-APR-2017 (dose and route of administration were not reported). The temperature excursion was 6.8 degrees F but time frame was undetermined at the time of the report. No previous excursions were reported. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) concerning a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL lot # K010215 (dose, and route not reported) which was improperly stored. Concomitant medications were not provided. It was reported that the vaccine was exposed to 34.3F for 360 hours and there was no previous temperature excursion. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 05-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent condition and concomitant medication was not reported. On unknown dates in 2016 (reported as since 01-JAN-2016), the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route of administration were not reported, lot# L038917, expiration date 20-FEB-2018). No adverse effects had been reported. The GARDASIL 9 vaccines underwent the temperature excursion of -3 Celsius degrees for 19 hours. No product quality complaint was involved. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-OCT-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Information regarding the patients's medical history, concurrent condition and concomitant medication was not reported. On unknown dates in 2016 (reported as since 01-JAN-2016), the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 prefilled syringes (dose and route were not reported, lot# reported as L040181, expiration date 08-AUG-2017). No adverse effects had been reported. The PNEUMOVAX 23 vaccines underwent the temperature excursion of -3 Celsius degrees for 19 hours. No product quality complaint was involved. 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 medical assistant (M.A.) refers to patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-OCT-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. 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 was received from a pharmacist, referring to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 21-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # J01537, expiration date: 09-APR-2016) (dose, route and strength were not provided). Concomitant medication was not provided. No adverse effects were reported. It was also reported that temperature was -0.1 degrees C, time frame was 15 minutes and it was not previous temperature excursion. This is one of several cases 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 was received from a registered nurse referring to a unspecified number of patients of unknown ages and genders. The patient's concurrent conditions and medical histories were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (routes, doses, frequency and anatomical place of vaccinations were not provided), lot # K016311, expiration date 26-MAY-2016. The doses of the vaccine were exposed to 47.6 degrees F for 85 minutes before been administered. Concomitant therapies were not provided. No adverse effects reported. There was not product quality complain involved. This is one of several reports from the same source. Additional information has been requested. -
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. Patient's pertinent medical history and drug reactions/allergies were not reported. Pharmacist stated that a physician's practice informed her that they may have administered a dose of PROQUAD (Merck) to a patient on 05-FEB-2016 (reported as "today") that expired on 05-DEC-2015 (lot number unspecified) (expired product administered). The outcome was unknown. The pharmacist was not in the location where the expired dose was administered, so she did not have access to any other details surrounding this event. She was not aware of any adverse effects. No product quality complaint was involved. Additional information has been requested.
Age: 1.38
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a 1 year old patient of an unknown gender. The patient's medical history, concurrent conditions or drug reactions were not reported. On 01-FEB-2016 the patient was vaccinated with PROQUAD (Merck) 0.5 ml, subcutaneous in the leg, lot # L023112; expiration date 24-DEC-2016, concomitantly with the first dose of VARIVAX (Merck) 0.5 ml, subcutaneous in the other leg, lot # L035124; expiration date 14-SEP-2017. Concomitant therapies were not provided. No adverse effect was reported. Product quality complaint was not filed. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reporter. On 19-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient who was current condition and medical history was not provided. She did not have any drug allergies. On an unknown date, reported as 7 years ago, the patient was vaccinated with ZOSTAVAX. The patient was on multiple unspecified concomitant medications. On an unknown date, 2 years after the vaccination, the patient experienced chicken pox. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. The causality assessment was not provided. 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 medical assistant (M.A) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571m expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Case number PHHY2014US153168, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 540074) website on 13 Nov 2014. This report refers to a 64-year-old male patient. Historical conditions were not reported. This polymedicated patient received FLUVIRIN (batch number: 145002) along with ZOSTAVAX (batch number: K000727) into the right arm on 14 Aug 2014. On 16 Aug 2014, the patient developed localized, pyramid shaped rash around the injection site. The injection site was tender to touch. The outcome of the events was not reported. The events were reported as non-serious; Causality was not reported.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Case number PHHY2014US153204, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 540205) website on 13 Nov 2014. This report refers to a 66 year old female patient. Her medical history and concomitant medication were not reported. She had no current illness. She was vaccinated with FLUVIRIN (batch number: 1452050 and PNEMOVAX (other manufacturer, batch number: K007821) both intramuscularly in left arm on 15 Aug 2014. On the same day after vaccination, the patient experienced pain, redness and swelling of the arm at the site of injections and fever. Final outcome was not reported. The events were reported as non-serious. Causality was not reported.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Case number PHHY2014US153291 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System on 13 Nov 2014. This report refers to a 59 year old female patient. Her past medical history and concomitant medications were not reported. On 08 Aug 2014, she was vaccinated with FLUVIRIN (batch number: 145001) into her left arm. On the same day after vaccination, her left arm, at the injection site was very painful and it hurt to lift the arm. The reporter informed the patient to ice the site of injection and take APAP for pain. She was also informed to follow up with her physician in a day or two. The outcome of the events was not reported. The events were reported as non serious and the causality of the events was not reported.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Case number PHHY2014US153199, is an initial spontaneous report received from the Vaccine Adverse Event Reporting Systems (VAERS, reference number: 540818) website on 13 Nov 2014. This report refers to a 20 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145203) intramuscularly on 19 Aug 2014. On the same day after vaccination, she developed injection site reaction, described as large heated erythematous muscular pain at shoulder. Final outcome was condition unchanged. Events were reported as non-serious. Causality was not reported.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chills, Injected limb mobility decreased, Local reaction, Malaise
Clinical narrative: Case number PHHY2014US153786 is an initial spontaneous report received the Vaccine Adverse Event Reporting System (VAERS reference number: 540934) website on 13 Nov 2014. This report refers to a 55 years old female patient. Her medical history was not reported. Her concomitant medications included Naproxen. She was vaccinated with FLUVIRIN (batch number: 1411001) and PNEUMOVAX (other manufacturer, batch number: J013555); both vaccines administered intramuscularly in the right arm on 20 Aug 2014. On 21 Aug 2014, she experienced low grade fever of 100 degrees for 3 days, aches in hips and knees, chills, malaise and local reaction at vaccination site resulting in difficulty of lifting right arm. The outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vaccination site reaction
Clinical narrative: Case number PHHY2014US153786 is an initial spontaneous report received the Vaccine Adverse Event Reporting System (VAERS reference number: 540934) website on 13 Nov 2014. This report refers to a 55 years old female patient. Her medical history was not reported. Her concomitant medications included Naproxen. She was vaccinated with FLUVIRIN (batch number: 1411001) and PNEUMOVAX (other manufacturer, batch number: J013555); both vaccines administered intramuscularly in the right arm on 20 Aug 2014. On 21 Aug 2014, she experienced low grade fever of 100 degrees for 3 days, aches in hips and knees, chills, malaise and local reaction at vaccination site resulting in difficulty of lifting right arm. The outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Case number PHHY2014US154955 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 541017) website on 13 Nov 2014. This report refers to a 58 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145001 and PNEUMOVAX (batch number: J004196); both vaccines administered in the right arm on 12 Aug 2014, her right arm was red down to about the elbow and it was little swollen at site. She also had fever overnight. The outcome was reported as complete as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Nausea, Vomiting
Clinical narrative: Case number PHHY2014US153700, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 541030) website on 13 Nov 2014. This report refers to an 18 year old female patient. Medical history included seizures. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1411001) in left arm on 12 Aug 2014. On the same day after vaccination, she became tired and experienced vomiting, nausea and arm pain at injection site. Final outcome was complete recovery. These events were reported as non-serious. Causality was not reported.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hyperhidrosis, Injection site pain, Malaise, Pain
Clinical narrative: Case number PHHY2014US154132, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 541647) website on 13 Nov 2014. This report refers to a 66-year-old female patient. On 24 Aug 2014, she was vaccinated with FLUVIRIN (batch number: 145221) along with PNEUMOVAX (batch number: K009107), both intramuscularly in the left arm. On 24 Aug 2014, she fell sick, experienced sweating, aches and pain at injection site. The patient visited the emergency room. The outcome of the events reported as recovered. The events reported as non serious. The causality of the events was not reported.
Age: 54.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Hypersensitivity, Rash macular
Clinical narrative: Case number PHHY2014US150377, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 541888) website on 13 Nov 2014. This report refers to a 54-year-old female patient. Historical conditions were not reported. Current illness was none. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 145205), along with TENIVAC (batch number: V8453AA) intramuscularly on 18 Aug 2014. On 21 Aug 2014, she developed spotty rash on the immunization arm and had an allergic reaction. She was taking diphenhydramine to help with the allergic reaction. The outcome of the events was unknown. The events were reported as non-serious; Causality was not reported.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Case number PHHY2014US154219, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 541900) website on 13 Nov 2014. This report refers to a 56-year-old female patient. Her current condition included hypertension which was treated with losartan. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in the right arm on 30 Aug 2014. On the same date, after vaccination she experienced 101.2 F fever, headache, nausea, chills and shivering. The outcome of the events reported as recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2014US0150787, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 541948) website on 13 Nov 2014. This report refers to a 37-year-old female patient. Medical history included asplenia. Concomitant medications included trazodone, venlafaxine, topiramate, levothyroxine and alprazolam. She was vaccinated with FLUVIRIN (batch number: 145225) into the left arm, along with PNEUMOVAX (batch number: J004387) into the left arm on 25 Aug 2014. On 26 Aug 2014, the patient site of PNEUMOVAX (both vaccines administered in left arm, route not reported) became red, swollen and painful. The patient went to ER. The MD was unsure if it was either cellulitis or allergic reaction (reaction was definitely around PNEUMOVAX site). The outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2014US154249, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 541953) website on 13 Nov 2014. This report refers to a 23 year-old female patient. She was vaccinated with FLUVIRIN (batch number: 145402) intramuscularly in the left arm on 27 Aug 2014 (at 06:54 pm). On 28 Aug 2014 (at approximately 01:00 pm), she felt nauseous and vomited at around 01:30 pm and again at 04:00 pm. She ran a low grade temperature. She took TYLENOL on 29 Aug 2014 at 10:00 am and again at 02:00 pm, as the low grade temperature came back. She took ginger ale to replenish fluids (Gator Aide/water/tea). The outcome of the events reported as not recovered. The events reported as non serious. The causality of the events was not reported.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pruritus generalised
Clinical narrative: Case number PHHY2014US150626, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 541972) website on 13 Nov 2014. This report refers to a 49-year-old female patient. Historical conditions were not reported. Concomitant medications included LIDODERM, OXYCONTIN, warfarin and hydromorphone. She was vaccinated with FLUVIRIN (batch number: 145202) intramuscularly on 25 Aug 2014. On the same day after vaccination, she experiencing itching all over the body and was about to vomit. The patient went to see a doctor. She got prednisone for treatment on 28 Aug 2014. The outcome of the events was complete recovery. The events were reported as non-serious; Causality was not reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US150581, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 541996) website on 13 Nov 2014. This refers to a 36-year-old female patient. Medical history was not reported. Concurrent conditions included allergy to penicillin. No concomitant medications was reported. She was vaccinated with FLUVIRIN (batch number: 1411101) intramuscularly on 01 Aug 2014. On 02 Aug 2014, she developed redness, warm and swelling at injection site. She experienced flu-like symptoms. She went to urgent care and was told to watch for 48 hours. She was asked to return if she was not better. She was better, but the MD said it was an allergic reaction. The outcome of the events was complete recovery. The events were reported as non-serious; Causality was not reported.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site paraesthesia, Injection site swelling, Paraesthesia
Clinical narrative: Case number PHHY2014US155355 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 542129) website on 13 Nov 2014. This report refers to an 30 year old male patient. His past medical history and concomitant medications were not reported. On 01 Sep 2014, he was vaccinated with FLUVIRIN (batch number: 1411001) intramuscularly into his left arm. On the same day, approximately six hours after the vaccination, he had tingling in arm from the injection site to his fingers and swelling of his arm at the injection site and surrounding areas. On 03 Sep 2014, the tingling sensation was only till his wrist and not his fingers. The outcome of swelling at injection site and surrounding areas was condition improving and the outcome of tingling sensation was condition unchanged. The events were reported as non serious and causality of the events was not reported.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Case number PHHY2014US153518, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542138) website on 13 Nov 2014. This report refers to a 27 year old female patient. Her medical history was not reported. Concomitant medications included lamotrigine and ADDERALL XR. She was vaccinated with FLUVIRIN (batch number: 145203) into left arm on 01 Sep 2014. On an unspecified date post vaccination she experienced rashes around collar bone and partially on right shoulder. She also developed intensive itch on left side of collar bone. Outcome of the event was condition unchanged. Events were reported as non-serious. Causality assessment was not reported.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Case number PHHY2014US154206, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542327) website on 13 Nov 2014. This report refers to a 74 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 145205) intramuscular into right arm on 03 Sep 2014. On the same day patient was feeling fine until she took a shower and at about 4 PM then she felt dizzy. She went to the emergency room and consulted a doctor who prescribed meclizine for dizziness. Outcome of the event was completely recovered. Events were reported as non-serious. Causality assessment was not reported.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US153750, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542386) website on 13 Nov 2014. This report refers to a 45-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145204) intramuscularly on 01 Sep 2014. On 02 Sep 2014, her injection site became red, enlarged and warm. She took ZYRTEC and BENADRYL with no improvement as of 03 Sep 2014 and hence consulted doctor. The doctor told her it was an injection site reaction and continue BENADRYL. Final outcome of the event was reported as recovered. There events were reported as non-serious. Causality of the events was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Case number PHHY2014US154077, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542532) website on 13 Nov 2014. This report refers to a 60-year-old female patient. Concurrent conditions included allergy to egg whites, orange, chocolate, mold, ragweed and penicillin. Concomitant medications included TOPROL XL, fosinopril and omeprazole. She was vaccinated with FLUVIRIN (batch number: 1411001) intramuscularly into left arm on 01 Sep 2014. On the same day, she was also vaccinated with BOOSTRIX (batch number: 3T549, other manufacturer) intramuscularly into right arm and ZOSTAVAX (batch number: J016258) subcutaneously into left arm. On the same day, after vaccinations, she experienced pain, itching, rash, redness, swelling and hot at the injection site. Swelling and redness extended to a patch approximately 4 inches by 8 inches on arm. She visited pharmacy 54 hours after vaccine administered to determine next action. She was told to take BENADRYL and use cold compresses. After another 24 hours, symptoms still persist. Final outcome of the events was reported as condition unchanged. These events were reported as non-serious. Causality of the events was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Injection site warmth
Clinical narrative: Case number PHHY2014US154077, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542532) website on 13 Nov 2014. This report refers to a 60-year-old female patient. Concurrent conditions included allergy to egg whites, orange, chocolate, mold, ragweed and penicillin. Concomitant medications included TOPROL XL, fosinopril and omeprazole. She was vaccinated with FLUVIRIN (batch number: 1411001) intramuscularly into left arm on 01 Sep 2014. On the same day, she was also vaccinated with BOOSTRIX (batch number: 3T549, other manufacturer) intramuscularly into right arm and ZOSTAVAX (batch number: J016258) subcutaneously into left arm. On the same day, after vaccinations, she experienced pain, itching, rash, redness, swelling and hot at the injection site. Swelling and redness extended to a patch approximately 4 inches by 8 inches on arm. She visited pharmacy 54 hours after vaccine administered to determine next action. She was told to take BENADRYL and use cold compresses. After another 24 hours, symptoms still persist. Final outcome of the events was reported as condition unchanged. These events were reported as non-serious. Causality of the events was not reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Case number PHHY2014US155219, is an initial spontaneous report received from the vaccine adverse events reporting system (VAERS reference number: 542705) on 13 Nov 2014. This report refers to a 55 years old female patient. Her medical history was not reported. Her concomitant medications included topiramate at a dose of 25 mg and 100 mg and sumatriptan 6 mg/0.5 ml injection. She was vaccinated with FLUVIRIN (batch number: 1411301) intramuscularly in right arm on 03 Sep 2014. It was reported that ton 04 Sep 2014, she experienced red oval shape 2 inch rash on right arm below injection site which was warm to touch. She visited emergency room on 04 Sep 2014 in evening. The outcome of the events was reported as unknown. The health authority reported that the events were non-serious and causality of the events was not reported.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Case number PHHY2014US154424, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 542707) website on 13 NOV 2014. This report refers to a 66 year old male patient. His historical condition and concomitant medication were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number 145205) intramuscularly in right arm and PNEUMOVAX (other manufacturer, batch number: J004332) intramuscularly in left arm both on 02 SEP 2014. On 04 SEP 2014, he developed rash on chest. Final outcome was complete recovery. The event was reported as non-serious. Causality was not reported.