chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 14 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K011562, expiration date 08-APR-2017 (strength, dose and route of administration were not provided). There were no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported.  On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L014415, expiration date 25-JUL-2017, strength, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 13 year old patient of unknown gender. There was no information about the patient's concomitant medications and pertinent medical history reported. On 06-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot# K023432, expiration date 18-JUN-2016) (strength, dose, route and site of administration were not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 74 year old female patient regarding herself. The patient's concurrent conditions included diabetes mellitus, thyroid disorder and hypertension. She was allergic to an unspecified generic medication for high blood pressure. Approximately in 2013 (reported as about 2 years ago) the patient was vaccinated with ZOSTAVAX, subcutaneously. The patient was also on a lot of unspecified concomitant medications. On unspecified date in April 2015 the patient experienced herpes zoster. The patient sought medical attention for the same. No laboratory tests were conducted. No product quality complaint was involved. On unspecified date in May 2015 the patient recovered from the event. The causality assessment was not provided. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: A ZOSTAVAX vaccine was given 12-1-15 by IM route instead of subcutaneous route. Patient is fine. We consulted with vaccine manufacturer and was told there is no need to revaccinate-effective and less side effects than subq.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 2 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 22-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010511, expiry date 17-JAN-2016; dose and route were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. The nurse reported that 8 doses of improperly stored PROQUAD (Merck) (dose and route not reported, lot # K011312 with expiration date 14-FEB-2016) had been administered to the patients on unspecified dates. No adverse effects were 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 nurse referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, these patients were vaccinated with an unspecified number of improperly stored doses of VAQTA (lot # L023232 with expiration 25-FEB-2017; lot # L009445 with expiration 01-JUN-2017; lot # was reported as L02375 with expiration 12-JAN-2017; dose, frequency and route were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history was not reported. On an unknown date in 2012 (reported as 3 years ago), the patient was vaccinated with ZOSTAVAX (dose, route and lot number was not reported). Concomitant medications was not reported. On an unknown date, the patient was inadvertently vaccinated with second dose of ZOSTAVAX (dose, route and lot number was not reported). No adverse effects was reported. No further details provided. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Vaginal haemorrhage
Clinical narrative: Information has been received from a nurse practitioner via a field representative concerning a 24 year old female patient. The patient did not have any allergies or medical history. On 24-SEP-2015, the patient was vaccinated with a first dose of GARDASIL 9, lot # L019286, expiration date 14-SEP-2017 (dose unspecified), intramuscularly. The patient did not take any concomitant medications. On an unspecified date in 2015, after receiving her first dose of vaccine, the patient experienced light vaginal bleeding which lasted 7 days and after those 7 days, she had her regular menstrual cycle. The patient reported that her last regular menstrual cycle was on 14-OCT-2015. On 02-NOV-2015, the patient received the second dose of GARDASIL 9 (lot # L019286, expiration date 14-SEP-2017, intramuscular, dose unspecified). After the patient received her second dose of the vaccine, she started to experience light vaginal bleeding on 04-NOV-2015, which lasted until 08-NOV-2015. The patient visited doctor office to seek medical attention. No treatment was given for vaginal bleeding. No lab diagnostics were performed. Therapy with GARDASIL 9 was also reported not discontinued. The causality of vaginal bleeding and GARDASIL 9 was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 31-JUL-2012, the patient was vaccinated with the first dose of M-M-R II (lot #, expiration date, dose, and route unspecified). On 20-AUG-2012, the patient received the first dose of VARIVAX (Merck) (lot #, expiration date and route unspecified). Then, on 31-AUG-2012, the patient was administered the second dose of M-M-R II (lot #, expiration date, dose and route unspecified). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # J007948, expiration date 24-MAR-2016, strength, dose, frequency and route were unknown). No adverse effect 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 pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot# L016284, expiration date 07-AUG-2016, dose and route were unknown). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of VAQTA (dose and route were not reported, lot # K018181, expiration date 04-JUN-2017). There were no adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of VAQTA (lot # K000943, expiration date 24-SEP-2016, strength, dose, frequency and route were unknown). No adverse effect reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 06-NOV-2015, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L016428, expiration date 30-JUL-2017, strength, dose, frequency and route were unknown). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified multiple patients of unknown age and gender. There was no concurrent condition or medical history reported. The nurse reported that improperly stored ROTATEQ (Lot # L008054, expiration date 30-NOV-2016; lot # K023534, expiration date 22-MAY-2016; lot # K023537, expiration date 22-JUN-2016) (dosage, strength and route not reported) were administered to the unspecified multiple patients on unknown dates. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) (strength, dose, frequency and route were not reported) lot # L009207 with an expiry date of 17-SEP-2016 and lot # L030589 with expiry date of 10-FEB-2017. No concomitant medications were reported. Patient did not seek any medical attention. No adverse effects were reported. There was no product quality complaint. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (strength, dose, frequency and route were not reported) lot # K021933 with an expiry date of 17-SEP-2016 and lot # L004649 with an expiry date of 11-FEB-2017. No concomitant medications were reported. Patient did not seek any medical attention. No adverse effects were reported. There was no product quality complaint. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored M-M-R II (strength, dose, frequency and route were not reported) lot # L009214 with an expiry date of 17-MAR-2017. No concomitant medications were reported. Patients did not seek any medical attention. No adverse effects were reported. There was no product quality complaint. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 9 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K011562, expiration date 08-APR-2017 (strength, dose and route of administration were not provided). On 30-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L011846, expiration date 16-JUN-2017 (strength, dose and route of administration were not provided). There were no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K012432, expiration date 18-JUN-2016 (strength, dose and route of administration were not provided). There were no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. On unspecified dates the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K018963, expiry: 15-OCT-2016). No adverse symptoms reported. The outcome was unknown. No product quality complaint was involved. This case is also related to MARRS# 1512USA000626 (same reporter link). Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: FLU3, FLU(H1N1)
Symptoms: Dysgeusia, Hemiplegia, Pain in jaw, Tinnitus, VIIth nerve paralysis
Clinical narrative: Guillain-Barre - permanent - toxic encephalopathy - still 6 yrs later.
Age: 39.0
Sex: M
Vaccine: FLU3, FLU(H1N1)
Symptoms: Asthenia, Cognitive disorder, Grip strength decreased, Guillain-Barre syndrome, Neurological examination abnormal
Clinical narrative: Guillain-Barre - permanent - toxic encephalopathy - still 6 yrs later.
Age: 39.0
Sex: M
Vaccine: FLU3, FLU(H1N1)
Symptoms: Pain, Romberg test positive, Toxic encephalopathy, Winged scapula
Clinical narrative: Guillain-Barre - permanent - toxic encephalopathy - still 6 yrs later.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Body temperature increased
Clinical narrative: Case number PHHY2015US141674, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 581571) website on 23 Oct 2015. This report refers to a 19 year old female patient. Medical history was reported as none and there was no current illness. Concomitant medication included SUDAFED 120 mg. The patient was vaccinated with BEXSERO (batch number: 146101) and GARDASIL (other manufacturer, batch number: L006549) both intramuscularly into the left arm on 08 Jun 2015. On the same day after vaccination, the patient developed an increase in the body temperature to 102.9 (units not mentioned). The patient had to visit emergency room. Outcome of the event was reported as complete recovery. The event was reported as non-serious. Causality was not reported.
Age: 13.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Headache, Injection site pain, Pain, Pyrexia, Syncope
Clinical narrative: Case number PHHY2015US141677, is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number: 585704) website on 23 Oct 2015. This report refers to a 13 year old male patient. Medical history and concomitant medication was not reported. On 07 Jul 2015, the patient was vaccinated with BEXSERO (batch number: 146801) into right arm and MENACTRA (batch number: U4799BA) into left arm. On 08 Jul 2015, the patient experienced headache, bilateral injection site pain in arms and body aches. On 09 Jul 2015 the patient had syncopal episodes and fever. The patient went to the emergency room. Outcome of the events was recovered. The events were reported as non-serious. Causality assessment was not reported. Seriousness of the event syncope was upgraded based on information available in source document.
Age: 11.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Retinal depigmentation
Clinical narrative: Case number PHHY2015US139435, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 586779) on 23 Oct 2015. This report refers to an 11 year old female patient. Medical history, concomitant medication and current illness were reported as none. The patient was vaccinated with BEXSERO (batch number: 146101) intramuscularly into the left leg on 01 Jul 2015. On 07 Jul 2015, the patient was taken to eye specialist where a change was noticed in the retinal pigmentation of the eye. Outcome of the events was reported as condition unchanged. This event was reported as non-serious. Causality was not reported.
Age: 11.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Retinal pigmentation
Clinical narrative: Case number PHHY2015US139435, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 586779) on 23 Oct 2015. This report refers to an 11 year old female patient. Medical history, concomitant medication and current illness were reported as none. The patient was vaccinated with BEXSERO (batch number: 146101) intramuscularly into the left leg on 01 Jul 2015. On 07 Jul 2015, the patient was taken to eye specialist where a change was noticed in the retinal pigmentation of the eye. Outcome of the events was reported as condition unchanged. This event was reported as non-serious. Causality was not reported.
Age: 25.0
Sex: U
Vaccine: FLUX, FLU4
Symptoms: Asthenia, Injected limb mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Extreme arm pain within 1st week of injection on 8/10/15 lasting 3 weeks plus.
Age: 25.0
Sex: U
Vaccine: FLUX, FLU4
Symptoms: Pain in extremity
Clinical narrative: Extreme arm pain within 1st week of injection on 8/10/15 lasting 3 weeks plus.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain
Clinical narrative: This spontaneous consumer report (initial receipt 17-Nov-2015) concerns a 66 year old female patient. Her concomitant medication included omeprazole. On 20-Oct-2015, the patient received a flu shot (influenza virus vaccine, manufacturer and batch number not reported) in the right arm and a booster Pneumovax 23 vaccine (pneumococcal vaccine, batch number: K010464) in her left arm for prevention. On 20-Oct-2015, the patient's left arm began to hurt. On 21-Oct-2015, The patient could not lift her arm above her waistline. On 22-Oct-2015, The patient stated she was now able to lift her arm but there was redness at the injection site that travelled throughout to her left elbow, the same day, and then to her left forearm. On 23-Oct-2015, the patient went to an unspecified physician who informed her that he had "an infection". The physician prescribed her treatment with cefadorxil (500 mg, 2 times a day for 10 days). The patient reported that the redness was getting worse and she was not feeling well. On 25-Oct-2015, she went to the hospital (at which she was not admitted) and was instructed to stop taking cefadroxil. The patient underwent unspecified blood tests and was told that her body was not fighting the infection. At the hospital, the patient was prescribed amoxicillin and clavulanate (875 mg, twice a day for a week) and sulfamethoxazole/trimethoprim (2 times a day for a week). She was also administered an unspecified dose of intravenous piperacillin/tazobactam. On 25-Oct-2014, the patient started taking acidophilus for her stomach. The outcome was reported as not recovered. Reporter's Comments: N/A||Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information all events, except injection site erythema and malaise, are unlisted. Causality: Unrelated. In the background of the infection that affected the Pneumovax vaccinated limb, it is a reasonable assumption that the events are not related to the flu vaccine. Malaise is also deemed unrelated for this case as it is more likely that the events are attributable to the ongoing infection. It is unlikely that the influenza vaccination caused decreased immune response, and the appropriate antibiotic regimen was requuired to address this type and severity of infection.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous consumer report (initial receipt 17-Nov-2015) concerns a 66 year old female patient. Her concomitant medication included omeprazole. On 20-Oct-2015, the patient received a flu shot (influenza virus vaccine, manufacturer and batch number not reported) in the right arm and a booster Pneumovax 23 vaccine (pneumococcal vaccine, batch number: K010464) in her left arm for prevention. On 20-Oct-2015, the patient's left arm began to hurt. On 21-Oct-2015, The patient could not lift her arm above her waistline. On 22-Oct-2015, The patient stated she was now able to lift her arm but there was redness at the injection site that travelled throughout to her left elbow, the same day, and then to her left forearm. On 23-Oct-2015, the patient went to an unspecified physician who informed her that he had "an infection". The physician prescribed her treatment with cefadorxil (500 mg, 2 times a day for 10 days). The patient reported that the redness was getting worse and she was not feeling well. On 25-Oct-2015, she went to the hospital (at which she was not admitted) and was instructed to stop taking cefadroxil. The patient underwent unspecified blood tests and was told that her body was not fighting the infection. At the hospital, the patient was prescribed amoxicillin and clavulanate (875 mg, twice a day for a week) and sulfamethoxazole/trimethoprim (2 times a day for a week). She was also administered an unspecified dose of intravenous piperacillin/tazobactam. On 25-Oct-2014, the patient started taking acidophilus for her stomach. The outcome was reported as not recovered. Reporter's Comments: N/A||Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information all events, except injection site erythema and malaise, are unlisted. Causality: Unrelated. In the background of the infection that affected the Pneumovax vaccinated limb, it is a reasonable assumption that the events are not related to the flu vaccine. Malaise is also deemed unrelated for this case as it is more likely that the events are attributable to the ongoing infection. It is unlikely that the influenza vaccination caused decreased immune response, and the appropriate antibiotic regimen was requuired to address this type and severity of infection.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Blood test, Erythema, Injection site erythema, Injection site infection, Malaise
Clinical narrative: This spontaneous consumer report (initial receipt 17-Nov-2015) concerns a 66 year old female patient. Her concomitant medication included omeprazole. On 20-Oct-2015, the patient received a flu shot (influenza virus vaccine, manufacturer and batch number not reported) in the right arm and a booster Pneumovax 23 vaccine (pneumococcal vaccine, batch number: K010464) in her left arm for prevention. On 20-Oct-2015, the patient's left arm began to hurt. On 21-Oct-2015, The patient could not lift her arm above her waistline. On 22-Oct-2015, The patient stated she was now able to lift her arm but there was redness at the injection site that travelled throughout to her left elbow, the same day, and then to her left forearm. On 23-Oct-2015, the patient went to an unspecified physician who informed her that he had "an infection". The physician prescribed her treatment with cefadorxil (500 mg, 2 times a day for 10 days). The patient reported that the redness was getting worse and she was not feeling well. On 25-Oct-2015, she went to the hospital (at which she was not admitted) and was instructed to stop taking cefadroxil. The patient underwent unspecified blood tests and was told that her body was not fighting the infection. At the hospital, the patient was prescribed amoxicillin and clavulanate (875 mg, twice a day for a week) and sulfamethoxazole/trimethoprim (2 times a day for a week). She was also administered an unspecified dose of intravenous piperacillin/tazobactam. On 25-Oct-2014, the patient started taking acidophilus for her stomach. The outcome was reported as not recovered. Reporter's Comments: N/A||Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information all events, except injection site erythema and malaise, are unlisted. Causality: Unrelated. In the background of the infection that affected the Pneumovax vaccinated limb, it is a reasonable assumption that the events are not related to the flu vaccine. Malaise is also deemed unrelated for this case as it is more likely that the events are attributable to the ongoing infection. It is unlikely that the influenza vaccination caused decreased immune response, and the appropriate antibiotic regimen was requuired to address this type and severity of infection.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous consumer report (initial receipt 17-Nov-2015) concerns a 66 year old female patient. Her concomitant medication included omeprazole. On 20-Oct-2015, the patient received a flu shot (influenza virus vaccine, manufacturer and batch number not reported) in the right arm and a booster Pneumovax 23 vaccine (pneumococcal vaccine, batch number: K010464) in her left arm for prevention. On 20-Oct-2015, the patient's left arm began to hurt. On 21-Oct-2015, The patient could not lift her arm above her waistline. On 22-Oct-2015, The patient stated she was now able to lift her arm but there was redness at the injection site that travelled throughout to her left elbow, the same day, and then to her left forearm. On 23-Oct-2015, the patient went to an unspecified physician who informed her that he had "an infection". The physician prescribed her treatment with cefadorxil (500 mg, 2 times a day for 10 days). The patient reported that the redness was getting worse and she was not feeling well. On 25-Oct-2015, she went to the hospital (at which she was not admitted) and was instructed to stop taking cefadroxil. The patient underwent unspecified blood tests and was told that her body was not fighting the infection. At the hospital, the patient was prescribed amoxicillin and clavulanate (875 mg, twice a day for a week) and sulfamethoxazole/trimethoprim (2 times a day for a week). She was also administered an unspecified dose of intravenous piperacillin/tazobactam. On 25-Oct-2014, the patient started taking acidophilus for her stomach. The outcome was reported as not recovered. Reporter's Comments: N/A||Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information all events, except injection site erythema and malaise, are unlisted. Causality: Unrelated. In the background of the infection that affected the Pneumovax vaccinated limb, it is a reasonable assumption that the events are not related to the flu vaccine. Malaise is also deemed unrelated for this case as it is more likely that the events are attributable to the ongoing infection. It is unlikely that the influenza vaccination caused decreased immune response, and the appropriate antibiotic regimen was requuired to address this type and severity of infection.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Blood test, Erythema, Infection, Injection site erythema, Malaise
Clinical narrative: This spontaneous consumer report (initial receipt 17-Nov-2015) concerns a 66 year old female patient. Her concomitant medication included omeprazole. On 20-Oct-2015, the patient received a flu shot (influenza virus vaccine, manufacturer and batch number not reported) in the right arm and a booster Pneumovax 23 vaccine (pneumococcal vaccine, batch number: K010464) in her left arm for prevention. On 20-Oct-2015, the patient's left arm began to hurt. On 21-Oct-2015, The patient could not lift her arm above her waistline. On 22-Oct-2015, The patient stated she was now able to lift her arm but there was redness at the injection site that travelled throughout to her left elbow, the same day, and then to her left forearm. On 23-Oct-2015, the patient went to an unspecified physician who informed her that he had "an infection". The physician prescribed her treatment with cefadorxil (500 mg, 2 times a day for 10 days). The patient reported that the redness was getting worse and she was not feeling well. On 25-Oct-2015, she went to the hospital (at which she was not admitted) and was instructed to stop taking cefadroxil. The patient underwent unspecified blood tests and was told that her body was not fighting the infection. At the hospital, the patient was prescribed amoxicillin and clavulanate (875 mg, twice a day for a week) and sulfamethoxazole/trimethoprim (2 times a day for a week). She was also administered an unspecified dose of intravenous piperacillin/tazobactam. On 25-Oct-2014, the patient started taking acidophilus for her stomach. The outcome was reported as not recovered. Reporter's Comments: N/A||Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information all events, except injection site erythema and malaise, are unlisted. Causality: Unrelated. In the background of the infection that affected the Pneumovax vaccinated limb, it is a reasonable assumption that the events are not related to the flu vaccine. Malaise is also deemed unrelated for this case as it is more likely that the events are attributable to the ongoing infection. It is unlikely that the influenza vaccination caused decreased immune response, and the appropriate antibiotic regimen was requuired to address this type and severity of infection.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This medically confirmed spontaneous report (initial receipt 17-Nov-2015) concerns a 15 year-old female patient. On 19-Oct-2015, the patient received the flu shot (Influenza virus vaccine, manufacturer and batch number not provided). On the same day, the patient also received Gardasil (human papillomavirus vaccine, batch number K010215) 1 shot on the other arm for the prevention of HPV (human papillomavirus). On 19-Oct-2015, the patient passed out 15 seconds after getting the shot while using Gardasil. The outcome was recovered on 19-Oct-2015. Reporter's Comments: N/A. Sender's Comments: Company comments: Seriousness: Serious. IME (Important Medical Event). Listedness: Unlisted. Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, the event is unlisted. Causality: Possible. Event is a possible autonomic response to the administration of the vaccine. Patient also received HPV vaccine on same day and is co-suspect.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Loss of consciousness
Clinical narrative: This medically confirmed spontaneous report (initial receipt 17-Nov-2015) concerns a 15 year-old female patient. On 19-Oct-2015, the patient received the flu shot (Influenza virus vaccine, manufacturer and batch number not provided). On the same day, the patient also received Gardasil (human papillomavirus vaccine, batch number K010215) 1 shot on the other arm for the prevention of HPV (human papillomavirus). On 19-Oct-2015, the patient passed out 15 seconds after getting the shot while using Gardasil. The outcome was recovered on 19-Oct-2015. Reporter's Comments: N/A. Sender's Comments: Company comments: Seriousness: Serious. IME (Important Medical Event). Listedness: Unlisted. Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, the event is unlisted. Causality: Possible. Event is a possible autonomic response to the administration of the vaccine. Patient also received HPV vaccine on same day and is co-suspect.
Age: 15.0
Sex: M
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This medically confirmed spontaneous report (initial receipt 17-Nov-2015) concerns a 15 year-old male patient. On 26-Oct-2015, the patient received the flu shot (Influenza virus vaccine, manufacturer and batch number not provided). On the same day, the patient also received Gardasil injection (human papillomavirus vaccine, batch number K010215) 1 shot on the other arm for the prevention of HPV (human papillomavirus). On 26-Oct-2015, the patient passed out after getting the shot while using Gardasil. The outcome was recovered on 26-Oct-2015. Reporter's Comments: N/A. Sender's Comments: Company comments: Seriousness: Serious. IME (Important Medical Event). Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria US Product Information, the event is unlisted. Causality: Possible. Event is a possible autonomic response to the administration of the vaccine. Patient also received HPV vaccine on same day and is co-suspect.
Age: 15.0
Sex: M
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Loss of consciousness
Clinical narrative: This medically confirmed spontaneous report (initial receipt 17-Nov-2015) concerns a 15 year-old male patient. On 26-Oct-2015, the patient received the flu shot (Influenza virus vaccine, manufacturer and batch number not provided). On the same day, the patient also received Gardasil injection (human papillomavirus vaccine, batch number K010215) 1 shot on the other arm for the prevention of HPV (human papillomavirus). On 26-Oct-2015, the patient passed out after getting the shot while using Gardasil. The outcome was recovered on 26-Oct-2015. Reporter's Comments: N/A. Sender's Comments: Company comments: Seriousness: Serious. IME (Important Medical Event). Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria US Product Information, the event is unlisted. Causality: Possible. Event is a possible autonomic response to the administration of the vaccine. Patient also received HPV vaccine on same day and is co-suspect.
Age: 49.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Atrophy, Burning sensation, Injection site pain, Injection site reaction, Muscle atrophy
Clinical narrative: For the first week notice a lump the size of a golf ball on left deltoid.  Week 2 lump absorbed. Week 3 a gap approx 3 inches wide noticed on left deltoid. Was seen by MD.
Age: 49.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Nerve conduction studies, Nodule, Nuclear magnetic resonance imaging, Pain in extremity, Shock
Clinical narrative: For the first week notice a lump the size of a golf ball on left deltoid.  Week 2 lump absorbed. Week 3 a gap approx 3 inches wide noticed on left deltoid. Was seen by MD.
Age: 49.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: X-ray
Clinical narrative: For the first week notice a lump the size of a golf ball on left deltoid.  Week 2 lump absorbed. Week 3 a gap approx 3 inches wide noticed on left deltoid. Was seen by MD.
Age: 49.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injection site mass
Clinical narrative: For the first week notice a lump the size of a golf ball on left deltoid.  Week 2 lump absorbed. Week 3 a gap approx 3 inches wide noticed on left deltoid. Was seen by MD.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Musculoskeletal stiffness, Polymyalgia rheumatica
Clinical narrative: Initial unsolicited report received from the consumer on 20 November 2015. This case involves a 73-year-old female patient who was vaccinated with a dose of FLUZONE HD (dose, dose in series, route and site of administration, batch number not reported) on 8 October 2015. The patient denies of having any illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and prior vaccination within 4 weeks of vaccination. The patient's concomitant medication was not provided. On 10 October 2015, 2 days following the vaccination, the patient experienced pain in hip flexors (at 10.10 hours) and then patient had difficulty in bending and then spread up to shoulder. The patient was diagnosed with Polymyalgia Rheumatica. The patient required ER doctor visit. The patient's laboratory data was not provided. The patient received Prednisone as corrective treatment. The outcome of the event was unknown. Upon internal review the case was considered as serious because of important medical events Polymyalgia Rheumatica, pain in hip flexors, pain on bending, pain spread to shoulders. List of documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal pain, Pain, Polymyalgia rheumatica
Clinical narrative: Initial unsolicited report received from the consumer on 20 November 2015. This case involves a 73-year-old female patient who was vaccinated with a dose of FLUZONE HD (dose, dose in series, route and site of administration, batch number not reported) on 8 October 2015. The patient denies of having any illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and prior vaccination within 4 weeks of vaccination. The patient's concomitant medication was not provided. On 10 October 2015, 2 days following the vaccination, the patient experienced pain in hip flexors (at 10.10 hours) and then patient had difficulty in bending and then spread up to shoulder. The patient was diagnosed with Polymyalgia Rheumatica. The patient required ER doctor visit. The patient's laboratory data was not provided. The patient received Prednisone as corrective treatment. The outcome of the event was unknown. Upon internal review the case was considered as serious because of important medical events Polymyalgia Rheumatica, pain in hip flexors, pain on bending, pain spread to shoulders. List of documents held by sender: none.
Age: 1.61
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Lethargy, Polymerase chain reaction, Rash generalised, Scab, Skin lesion
Clinical narrative: Developed fever on the evening of 11/26/2015. Awoke 11/27/2015 with extremely itchy rash. Dx with Herpetic infection, also had eczema and lesions were distributed in these areas. Treated with oral acyclovir.   11/28/2015 returned for follow up; much worse; admit to hospital for IV acyclovir x 48 hours. Improved. Both siblings developed same lesions within 48 hours.
Age: 1.61
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Varicella post vaccine, Varicella virus test
Clinical narrative: Developed fever on the evening of 11/26/2015. Awoke 11/27/2015 with extremely itchy rash. Dx with Herpetic infection, also had eczema and lesions were distributed in these areas. Treated with oral acyclovir.   11/28/2015 returned for follow up; much worse; admit to hospital for IV acyclovir x 48 hours. Improved. Both siblings developed same lesions within 48 hours.
Age: 1.61
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Eczema, Herpes virus infection, Polymerase chain reaction, Pyrexia, Rash pruritic
Clinical narrative: Developed fever on the evening of 11/26/2015. Awoke 11/27/2015 with extremely itchy rash. Dx with Herpetic infection, also had eczema and lesions were distributed in these areas. Treated with oral acyclovir.   11/28/2015 returned for follow up; much worse; admit to hospital for IV acyclovir x 48 hours. Improved. Both siblings developed same lesions within 48 hours.
Age: 1.61
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Simplex virus test positive, Skin lesion
Clinical narrative: Developed fever on the evening of 11/26/2015. Awoke 11/27/2015 with extremely itchy rash. Dx with Herpetic infection, also had eczema and lesions were distributed in these areas. Treated with oral acyclovir.   11/28/2015 returned for follow up; much worse; admit to hospital for IV acyclovir x 48 hours. Improved. Both siblings developed same lesions within 48 hours.
Age: 1.61
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Blister, Injection site reaction, Lethargy, Pyrexia, Scab
Clinical narrative: Developed fever on the evening of 11/26/2015. Awoke 11/27/2015 with extremely itchy rash. Dx with Herpetic infection, also had eczema and lesions were distributed in these areas. Treated with oral acyclovir.   11/28/2015 returned for follow up; much worse; admit to hospital for IV acyclovir x 48 hours. Improved. Both siblings developed same lesions within 48 hours.
Age: 1.61
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Developed fever on the evening of 11/26/2015. Awoke 11/27/2015 with extremely itchy rash. Dx with Herpetic infection, also had eczema and lesions were distributed in these areas. Treated with oral acyclovir.   11/28/2015 returned for follow up; much worse; admit to hospital for IV acyclovir x 48 hours. Improved. Both siblings developed same lesions within 48 hours.
Age: 1.61
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Injection site reaction, Lethargy, Pyrexia, Rash vesicular, Scab
Clinical narrative: Developed fever on the evening of 11/26/2015. Awoke 11/27/2015 with extremely itchy rash. Dx with Herpetic infection, also had eczema and lesions were distributed in these areas. Treated with oral acyclovir.   11/28/2015 returned for follow up; much worse; admit to hospital for IV acyclovir x 48 hours. Improved. Both siblings developed same lesions within 48 hours.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Extreme pain at time of injection. I have had flu shots every year for more than 20 years and it never has hurt this much.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache, Malaise, Vomiting
Clinical narrative: Severe headache vomiting malaise.
Age: 0.51
Sex: M
Vaccine: DTPHEP, RVX, UNK
Symptoms: Asocial behaviour, Decreased eye contact, Hypotonia, Mobility decreased, Muscular weakness
Clinical narrative: Patient's legs were weak, like floppy not just sore but barely moving. The next morning he was not responding to anything.  He couldn't move his arms or legs. His legs would flop to the side like frog legs. He would try to pick up his head and it would just drop.  We couldn't get him to smile like he always does or coo or interact with anything. His social skills as a 6-month old were gone and he was looking through us.  As if he didn't even see us. This went on for almost 2-hours.
Age: 0.51
Sex: M
Vaccine: DTPHEP, RVX, UNK
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient's legs were weak, like floppy not just sore but barely moving. The next morning he was not responding to anything.  He couldn't move his arms or legs. His legs would flop to the side like frog legs. He would try to pick up his head and it would just drop.  We couldn't get him to smile like he always does or coo or interact with anything. His social skills as a 6-month old were gone and he was looking through us.  As if he didn't even see us. This went on for almost 2-hours.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain in extremity, Tenderness
Clinical narrative: Employee complained of arm hurting, tender to touch, red at vaccination site, approximatly 2.5 inches.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Feeling hot, Pain, Pruritus
Clinical narrative: Very large red welt with large lighter red ring circling.  Approximately 8"L x 6" W.  Hot, sore, itchy.  Felt like coming down with something. Took Benadryl and iced area.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Very large red welt with large lighter red ring circling.  Approximately 8"L x 6" W.  Hot, sore, itchy.  Felt like coming down with something. Took Benadryl and iced area.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Arm was painful, slightly swollen, feverish and had a reddish color and lasted for four days.  There was some relief when the patient took a Benadryl on the third day.
Age: 4.0
Sex: M
Vaccine: FLUN4, HEPA, MMR, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Pt was given extra dose of Hep A, instead of KINRIX as ordered by provider at well child visit.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Hypoaesthesia
Clinical narrative: Appoximately 30 minutes after receiveing vaccine, employee developed numbness that spread over body, difficulty breathing that required medical treatment.  Received Benadryl and steroid injection at physician office for emergency care.