chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-FEB-2016, the patient was inadvertently vaccinated with VAQTA 25/0.5 (units not reported), intramuscularly (dose, lot # and expiration date were not reported). There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In February 2016 (reported as starting on or after 14-FEB-2016), the patients were vaccinated with the improperly stored doses of PROQUAD (Merck) (lot # L006390, expiration date 25-AUG-2016; dose and route of administration were not reported). No adverse effects were reported. The vaccines were stored in -14 degrees of Celsius for 12 hours and 45 minutes and in -14 degrees of Celsius for 17 hours on unknown dates. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Condition aggravated, Fatigue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue aggravated in a 39-year-old male patient who received BOOSTRIX (batch number FB942, expiry date 2nd November 2017). Concurrent medical conditions included Crohn's disease and fatigue. Concomitant products included HUMIRA. On 31st December 2015, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced fatigue aggravated. On an unknown date, the outcome of the fatigue aggravated was unknown. It was unknown if the reporter considered the fatigue aggravated to be related to BOOSTRIX. Additional details were received as follows: The reporter stated that, after receiving a dose of BOOSTRIX the patient complaining of fatigue. The patient had fatigue prior to the vaccination but he felt that it was worse since getting the BOOSTRIX. The reporter did not have a specific time when patient felt the fatigue got worse. The batch number reported for BOOSTRIX (FB948), did not exist and was updated to be FB942, as per sales database.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-JAN-2016, the patient was vaccinated with incorrect stored oral, ROTATEQ (dose, lot number and expiry date were not reported). Concomitant therapy was not reported. It was reported that, temperature was 34F for 18 hours. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports 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 Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent condition and concomitant medications were provided.  On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # reported as L035637, expiration date: 08-JUN-2017, dose was not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. 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 registered nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. Since 14-DEC-2015, the patients were vaccinated with an improperly stored doses of (Oka-Merck) PROQUAD (dose and route were not reported, lot # L042817, expiration date 26-APR-2017). There was no adverse event reported. This is one of several reports received from the same source. 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 refers to a multiple concurrent conditions and medical history were not provided. On multiple unspecified dates, the patients were "possibly" vaccinated with improperly stored doses of GARDASIL, lot# K007828 and expiration date 02-MAR-2017, lot # L039066 and expiration date 19-MAR-2017 and lot# L035105 and expiration date 14-MAY-2017 as reported (dose, route of administration and anatomical location were not reported). There were no concomitant medication provided. The GARDASIL vaccines were exposure to 34F for 295.75 hours. There was no previous excursion and no data logger issue. No adverse effects reported. No product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient who had allergy to "sulfa antibiotics". The patient had no pertinent medical history. On 23-FEB-2016 the patient was vaccinated with ZOSTAVAX (lot # reported as L034727, expiration date 09-DEC-2016, subcutaneous, 0.65 ml). Concomitant therapies included LIPITOR, lisinopril (manufacturer unknown) (reported as "lisinipril"), FLONASE and trazodone (manufacturer unknown). On 24-FEB-2016, the patient began to experience "pain, warmth, redness, and swelling the size of a golf ball" at the injection site. On the same day, the patient called the pharmacy for medical attention and the pharmacist instructed the patient to "ice the area" as treatment. No lab diagnostics studies were performed. On 25-FEB-2016 (the reporting day), the pharmacy spoke with the patient and the symptoms had not improved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 16-FEB-2016, 17-FEB-2016 or 18-FEB-2016, the patients were vaccinated with GARDASIL 9 lot # L016429, expiration date 09-AUG-2017 (dose and route were not provided). Concomitant therapy information was not provided. On 16-FEB-2016, 17-FEB-2016 or 18-FEB-2016, there was an incorrect product storage as multiple unspecified patients received GARDASIL 9 that were improperly stored. No adverse events were reported. The highest temperature for the reported excursion was 48.32 F and it was during the timeframe of 25 minutes. There was no previous temperature excursion. The call to report this information was because of a data logger. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a consumer referring to an unknown number of 30 to 40 year old patients of unknown gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with ZOSTAVAX (dosage, strength and lot # unknown) (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 19-year-old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the 19-year-old patient was vaccinated with two doses of VAQTA 0.5 ml, intramuscularly, lot# L004439, expiration date: 15-FEB-2016 and L034381, expiration date: 21-DEC-2016. There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On 16-FEB-2016, 17-FEB-2016 or 18-FEB-2016, the patients were vaccinated with RECOMBIVAX HB lot # L019298, expiration date 22-JUN-2017 (dose and route were not provided). Concomitant therapy information was not provided. On 16-FEB-2016, 17-FEB-2016 or 18-FEB-2016, there was an incorrect product storage as multiple unspecified patients received RECOMBIVAX HB that were improperly stored. No adverse events were reported. The highest temperature for the reported excursion as 48.32 F and it was during the time frame of 25 minutes. There was no previous temperature excursion. The call to report this information was because of a data logger. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-JUL-2015, patient was administered a dose of GARDASIL (lot #, expiry date, dose, frequency and route of administration not reported). Then was subsequently administered a dose of GARDASIL 9 on 21-DEC-2015. This was outside the labeled recommendations in both the GARDASIL and GARDASIL 9 prescribing information. No adverse effect reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a 4 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On 03-FEB-2016, the 4 year old patient was inadvertently vaccinated with GARDASIL 9 lot # L020015, expiration date 16-AUG-2017. No adverse event was reported. The outcome of the event was unknown. No PQC was involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site warmth, Rash erythematous
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old female immunocompetent patient. The patient had no pertinent medical history or drug reactions/allergies. History vaccine included PREVNAR 13 vaccinated on 21-DEC-2015. On 18-FEB-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # L022795 with expiration date of 05-NOV-2016, dose, strength and route unknown). There was no concomitant medication. On an unspecified date "over the weekend" after 18-FEB-2016, the patient developed a "red rash" and horrible pain with heat at the injection site of PNEUMOVAX 23. No treatment was given for the events. The patient was recovering from the events. Causality was not provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old female immunocompetent patient. The patient had no pertinent medical history or drug reactions/allergies. History vaccine included PREVNAR 13 vaccinated on 21-DEC-2015. On 18-FEB-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # L022795 with expiration date of 05-NOV-2016, dose, strength and route unknown). There was no concomitant medication. On an unspecified date "over the weekend" after 18-FEB-2016, the patient developed a "red rash" and horrible pain with heat at the injection site of PNEUMOVAX 23. No treatment was given for the events. The patient was recovering from the events. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. Since 14-DEC-2015, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose and route were not reported, lot # K011077, expiration date 30-MAR-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 16-FEB-2016 the patient was vaccinated with an improperly stored (at 9.4 Centigrade for 1 hour) dose of ROTATEQ (lot # L013202, expiration date 27-JAN-2017, dose unknown) orally (incorrect product storage). No adverse effect was reported. There were no temperature excursion issues previously. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to an unknown number of unspecified patients of unknown gender who were under the age of 50 years. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients were vaccinated with the dose of ZOSTAVAX injection (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug allergies were not reported. On unknown dates the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K026386 with expiration date of 15-DEC-2016, lot# L011084 with expiration date of 01-APR-2017, dose, strength and route unknown). This is one of several cases reported from the same reporter. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 17-FEB-2016 the patient was vaccinated with an improperly stored (at 9.4 Centigrade for 1 hour) dose of ROTATEQ (lot # L013202, expiration date 27-JAN-2017, dose unknown) orally (incorrect product storage). No adverse effect was reported. There were no temperature excursion issues previously. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug allergies were not reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot # L011846 with expiration date of 16-JUN-2016, lot # L018351 with expiration date of 11-AUG-2017, dose, strength and route unknown. This is one of several cases reported from the same reporter. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site pain, Injection site reaction, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Information has been received from a 68 year old male patient referring to himself. The patient had no pertinent medical history and drug reactions or allergies. On an unknown date (reported as "recently"), the patient stated he was given an unspecified influenza virus vaccine inactivated. The patient also had received a zoster vaccine live (reported as "a shingles vaccine") during the summer of 2015. On 10-FEB-2016 the patient was vaccinated with PNEUMOVAX 23 (0.5 ml, once, intramuscular, lot # not reported, expiry date: 09-FEB-2017). Concomitant therapies included loxapine, ACCUPRIL, atorvastatin and a thyroid medication. On 10-FEB-2016, the patient had been experiencing injection site pain, fatigue, stiffness at the injection site and he felt feverish. There was no treatment given for the events. No diagnostics studies were performed. The patient didn't provide his doctor's name because he had not seen his current doctor yet. The patient had spoken with his pharmacist for medical attention. The outcome of the events was reported as recovering. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Cardiomyopathy, Ejection fraction decreased, Endocarditis
Clinical narrative: Information has been received from a published literature article. Introduction: Occult hepatitis B virus (HBV) was defined by the presence of HBV DNA in patient sera in the absence of hepatitis B surface antigen (HBsAg). Occult HBV had been associated with hepatocellular carcinoma, reactivation during immune suppression, and transmission to others. While the hepatitis B vaccine was very effective at preventing chronic HBV infection, recent studies indicated it was less effective at preventing occult HBV following infant vaccination. No studies, however, had examined the efficacy of adult HBV vaccination at preventing occult HBV. Here, it was presented the first report of occult HBV following adult vaccination. Case presentation: In November 2012, a 21-year old woman was admitted to a medical center with tricuspid valve endocarditis secondary to methicillin-susceptible Staphylococcus aureus which was complicated by non-ischemic cardiomyopathy (ejection fraction 15%). She reported active use of intravenous drugs. The patient tested positive for antibodies to the hepatitis C virus (HCV), with initially undetectable HCV RNA and subsequent low-level viremia. The patient was anti-HBs positive, anti-HBc negative, and HBsAg negative consistent with her reported history of prior vaccination with HBV vaccine (detail information unknown) as part of a nursing training program several years prior to her hospital admission. Despite a persistently negative HBsAg, HBeAg was positive, and HBV DNA was detectable in three separate serum samples. During the course of the hospitalization, the patient seroconverted to become anti-HBc positive. She received no antiviral medications and, at follow-up six months later, she was found to be HBeAg negative and anti-HBe positive, and no longer had detectable HBV DNA, indicating that her occult HBV infection had resolved. Conclusions: HBV vaccination in infancy was effective at preventing chronic HBV infection but was less effective at preventing occult HBV infection. Similar studies examining the efficacy of adult HBV vaccination in preventing occult HBV had not been performed. This case highlighted the importance of carefully determining the HBV status of high-risk individuals, as vaccination history and the presence of antiHBs might not be adequate to rule out HBV infection, even in the absence of HBsAg. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B core antibody positive, Hepatitis B e antibody positive, Hepatitis B e antigen positive, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative
Clinical narrative: Information has been received from a published literature article. Introduction: Occult hepatitis B virus (HBV) was defined by the presence of HBV DNA in patient sera in the absence of hepatitis B surface antigen (HBsAg). Occult HBV had been associated with hepatocellular carcinoma, reactivation during immune suppression, and transmission to others. While the hepatitis B vaccine was very effective at preventing chronic HBV infection, recent studies indicated it was less effective at preventing occult HBV following infant vaccination. No studies, however, had examined the efficacy of adult HBV vaccination at preventing occult HBV. Here, it was presented the first report of occult HBV following adult vaccination. Case presentation: In November 2012, a 21-year old woman was admitted to a medical center with tricuspid valve endocarditis secondary to methicillin-susceptible Staphylococcus aureus which was complicated by non-ischemic cardiomyopathy (ejection fraction 15%). She reported active use of intravenous drugs. The patient tested positive for antibodies to the hepatitis C virus (HCV), with initially undetectable HCV RNA and subsequent low-level viremia. The patient was anti-HBs positive, anti-HBc negative, and HBsAg negative consistent with her reported history of prior vaccination with HBV vaccine (detail information unknown) as part of a nursing training program several years prior to her hospital admission. Despite a persistently negative HBsAg, HBeAg was positive, and HBV DNA was detectable in three separate serum samples. During the course of the hospitalization, the patient seroconverted to become anti-HBc positive. She received no antiviral medications and, at follow-up six months later, she was found to be HBeAg negative and anti-HBe positive, and no longer had detectable HBV DNA, indicating that her occult HBV infection had resolved. Conclusions: HBV vaccination in infancy was effective at preventing chronic HBV infection but was less effective at preventing occult HBV infection. Similar studies examining the efficacy of adult HBV vaccination in preventing occult HBV had not been performed. This case highlighted the importance of carefully determining the HBV status of high-risk individuals, as vaccination history and the presence of antiHBs might not be adequate to rule out HBV infection, even in the absence of HBsAg. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis C RNA increased, Hepatitis C antibody positive, Staphylococcal infection, Viral load increased
Clinical narrative: Information has been received from a published literature article. Introduction: Occult hepatitis B virus (HBV) was defined by the presence of HBV DNA in patient sera in the absence of hepatitis B surface antigen (HBsAg). Occult HBV had been associated with hepatocellular carcinoma, reactivation during immune suppression, and transmission to others. While the hepatitis B vaccine was very effective at preventing chronic HBV infection, recent studies indicated it was less effective at preventing occult HBV following infant vaccination. No studies, however, had examined the efficacy of adult HBV vaccination at preventing occult HBV. Here, it was presented the first report of occult HBV following adult vaccination. Case presentation: In November 2012, a 21-year old woman was admitted to a medical center with tricuspid valve endocarditis secondary to methicillin-susceptible Staphylococcus aureus which was complicated by non-ischemic cardiomyopathy (ejection fraction 15%). She reported active use of intravenous drugs. The patient tested positive for antibodies to the hepatitis C virus (HCV), with initially undetectable HCV RNA and subsequent low-level viremia. The patient was anti-HBs positive, anti-HBc negative, and HBsAg negative consistent with her reported history of prior vaccination with HBV vaccine (detail information unknown) as part of a nursing training program several years prior to her hospital admission. Despite a persistently negative HBsAg, HBeAg was positive, and HBV DNA was detectable in three separate serum samples. During the course of the hospitalization, the patient seroconverted to become anti-HBc positive. She received no antiviral medications and, at follow-up six months later, she was found to be HBeAg negative and anti-HBe positive, and no longer had detectable HBV DNA, indicating that her occult HBV infection had resolved. Conclusions: HBV vaccination in infancy was effective at preventing chronic HBV infection but was less effective at preventing occult HBV infection. Similar studies examining the efficacy of adult HBV vaccination in preventing occult HBV had not been performed. This case highlighted the importance of carefully determining the HBV status of high-risk individuals, as vaccination history and the presence of antiHBs might not be adequate to rule out HBV infection, even in the absence of HBsAg. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: Patient stated she felt fuzzy in her head, numbness running down left arm where injection was given, had a headache within about 15 min of receiving injection. Brought pt to a room. Pt declined treatment, she stated she just wanted to go home. Monitored, pt until her head felt better. Vitals normal.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus, Pyrexia
Clinical narrative: This spontaneous report was received from a 62 year old female patient, referring on herself. The patient was allergic to codeine, sulfur and iodine. The patient did not have any medical history. On 23-FEB-2016, the patient was vaccinated with a dose of ZOSTAVAX one time (dose, frequency, route (reported as vaccine), lot # and expiration date were not reported) (reported as shingles). Concomitant therapies included clonidine (reported as clonadine), BENICAR (reported as BENACAR) and hydrochlorothiazide. On an unknown date in February 2016 (reported as 12-15 hours after receiving the ZOSTAVAX), the patient started experiencing redness on injection site, itchy and fever. No treatment was given to the patient. No laboratory diagnostic studies were performed. The patient did not seek any medical attention. No product quality complaint was involved. At the time of the report, the outcome of injection site erythema, pyrexia and injection site pruritus was unknown. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Pruritus, Swollen tongue
Clinical narrative: Pt received PREVNAR 13 at aprx 2pm. At aprx 3am, pt woke up with tongue swelling, entire arm redness, itching and pain.
Age: 22.0
Sex: U
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: Redness.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased
Clinical narrative: Vaccine given 2/24/16, left arm - deltoid. Pt seen 2/25/16 unable/unwilling to move arm. No swelling noted. Seen 2/29/16 sx much improved.
Age: 21.0
Sex: F
Vaccine: HPV9, MENB, MNQ, TD
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blood pressure increased, Cough, Hordeolum, Nasal discharge discolouration, Rhinorrhoea
Clinical narrative: Within 2 hrs had runny nose, a week later had stye, then a few days later vaginal infection. Following started the week of vaccine and is now resolving. Same with cough. Still has runny nose and never struggles with that before. B/P is up lately. Green nasal discharge.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Vaginal infection
Clinical narrative: Within 2 hrs had runny nose, a week later had stye, then a few days later vaginal infection. Following started the week of vaccine and is now resolving. Same with cough. Still has runny nose and never struggles with that before. B/P is up lately. Green nasal discharge.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen slightly/red. Warm to touch.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: Significant redness and swelling, rash warm to the touch.
Age: 0.77
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Chest X-ray, Full blood count, Pyrexia, White blood cell count increased
Clinical narrative: Mother noticed patient to have a fever on 2/21/16 at 10:00 AM axillary temp of 101 and then highest temp was 103.5 until this morning temp of 106.0 core temp.
Age: 69.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Peripheral swelling
Clinical narrative: Itchiness, redness, pain in left arm injection site, swelling left arm.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chills, Headache, Pain, Pyrexia, Viral infection
Clinical narrative: In health dept. on 02/19/16. Received MCV and Tdap vaccine at approx. 11:30 am. Mom presents today, states child started w/fever 02/19/16 between 5-6 pm. Was in ER on Saturday 02/20/16. Shows us papers with diagnosis of fever and viral syndrome. Symptoms included fever, h/a, chills, body aches. Was released home same day and has follow up appt. with MD.
Age: 11.0
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot, swollen area left deltoid s/p TRUMENBA (Men-B) vaccine. Ice. BENADRYL.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: "Dime sized" bump under skin in area where shot #3 was administered. Site is tender to touch.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Breast swelling, Gynaecomastia, Nipple pain
Clinical narrative: Swollen/enlarged breasts. Sore/tender nipples x approximately 2 weeks.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Paraesthesia, Pruritus
Clinical narrative: About 24 hours after HPV #2 given in (L) deltoid she developed pins and needles feeling w/itching and pain over entire low back area, most noticeable laying down at bedtime.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Body temperature increased, Irritability
Clinical narrative: 103 degree and unconsolable irritability approximately 2 hours post PEDIARIX and PREVNAR administration. Treated with ibuprofen. No local reaction.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Pain in extremity, Rash, Skin warm
Clinical narrative: Pt received PREVNAR vaccine on Monday and broke out with a rash 3" x 3" on arm - warm to touch and somewhat painful on Tuesday 2/16/16. Also had a headache.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Decreased activity, Hypophagia, Pharyngitis, Pyrexia, Viral upper respiratory tract infection
Clinical narrative: Child developed fever, decreased activity, decreased oral intake. Office visit: (+) viral URI, pharyngitis.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Ear infection, Exposure during pregnancy, Upper respiratory tract infection
Clinical narrative: This spontaneous report retrospective pregnancy report was received and from a nurse practitioner concerning her daughter, a 14 year old female patient via company representative. The patient's current conditions included scoliosis. The patient did not have previous pregnancies. On an unknown date in 2007, the patient was vaccinated with the first dose of GARDASIL 0.5 ml intramuscularly (IM) when she was 17 weeks pregnant. On 25-JUL-2007, the patient was vaccinated with the second dose of GARDASIL (lot # 656050/0245U and expiry date 26-SEP-2009). Concomitant vaccines on 25-JUL-2007 included DTaP and meningococcal vaccine (unspecified). The male baby was born healthy on 04-JAN-2008. There were no congenital anomalies or other complications. The baby weighed 7 pounds, 3.8 ounces and was 21 inches long. APGAR scores were 9/9. The patient sought medical attention. It was reported that the patient had included vaginal delivery with no complications. The child's events (birthmark on the child's left lower leg, mild declarations and child may be experiencing unspecified developmental issues/child's unspecified issues) were reported in MARRS # 0807USA03843. The baby developed rash after receiving ROTATEQ, experienced upper respiratory infection and ear infection (reported in MARRS# 0903USA03600). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: Information has been received from a nurse practitioner (N.P.) for GARDASIL, Pregnancy Registry product, concerning a 17 year old female patient with none pertinent medical history and none drug reactions/allergies. On 04-APR-2001, the patient was vaccinated with the first dose of VARIVAX (Merck) (lot#, dose and route not reported). On 25-APR-2012 the patient received the second dose of VARIVAX (Merck) (lot#, dose and route not reported) and the first dose of GARDASIL (lot#, dose and route not reported), and then she discovered to be pregnant with her last menstrual period on 23-MAR-2012 and estimate delivery date on 28-DEC-2012. Outcome of pregnancy was unknown. Urine pregnancy test was performed on 25-APR-2012 with positive result. The patient did not seek medical attention. No adverse event reported. Information has been received from an office manager on 01-FEB-2016 via a VARIVAX pregnancy registry follow up phone call. The reporter stated the patient's visit was the first and last visit to their office. No additional information for this patient and her pregnancy was available. No further information is available. Reporter, patient, product event and narrative were updated.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Death
Clinical narrative: Death.
Age: 36.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Abasia, Coordination abnormal
Clinical narrative: Initial unsolicited report received from a non-health care professional (office staff) on 17 February 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of Fluzone QIV (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced pain, dizziness and weakness. It was reported that two weeks later patient was hospitalized. Lab data and corrective treatments were not reported. Outcome of events were not reported. List of documents held by sender: none. Sender's Comments: Pain is unlisted with INFLUENZA QUADRIVAL A-B VACCINE but weakness and dizziness are listed. This case is very poorly documented medically not confirmed case to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 36.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Dizziness, Pain
Clinical narrative: Initial unsolicited report received from a non-health care professional (office staff) on 17 February 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of Fluzone QIV (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced pain, dizziness and weakness. It was reported that two weeks later patient was hospitalized. Lab data and corrective treatments were not reported. Outcome of events were not reported. List of documents held by sender: none. Sender's Comments: Pain is unlisted with INFLUENZA QUADRIVAL A-B VACCINE but weakness and dizziness are listed. This case is very poorly documented medically not confirmed case to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abasia, Blood test, Electromyogram, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Muscle weakness resulting in the inability to walk or control speech or bladder. Guillain-Barre Syndrome.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Speech disorder, Urinary incontinence
Clinical narrative: Muscle weakness resulting in the inability to walk or control speech or bladder. Guillain-Barre Syndrome.
Age: 67.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Seizure, Specialist consultation
Clinical narrative: Patient found unresponsive post-seizure 3 days after vaccine administration. Hospitalized for 24 plus hours, given full cardiac and neurological workup, with no underlying.
Age: 67.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cardiac function test normal, Neurological examination normal, Seizure, Unresponsive to stimuli
Clinical narrative: Patient found unresponsive post-seizure 3 days after vaccine administration. Hospitalized for 24 plus hours, given full cardiac and neurological workup, with no underlying.
Age: 1.04
Sex: M
Vaccine: DTPIHI, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Blood culture, Body temperature increased, Febrile convulsion, Full blood count, Influenza A virus test
Clinical narrative: Mom states that child received immunizations at 11 AM.  Stated he started developing fever that evening.  At approximately 8:30 PM the child had a seizure.  Child was taken to ER via ambulance.  Temperature was 104.7. rectally.  Testing performed in the ER was either negative or within normal limits.  Mother says she was advised to contact the Health Department.  Mother states he is better now and his temperature is 101 Rectally.   4:30 PM 3/1/2016 called mother.  Mom state the temp is down to 98.7.  Baby is fine but sill has runny nose and sniffle.  Advised mom to f/u with the baby's pediatrician and follow directions of ER.  Upon record review, the ER record confirmed the baby was received in the ER with "Febrile Seizure".  Temp was 101.4 F.  WBC 13.2.  CBC Lymphocytes 3.49, Monocytes 1.38.  Immmature Granulocytes 0.05.  Mycoplasma Screen Negative; Rapid Flu Negative.  Called Infection Control Nurse who stated that the Quality Assurance Nurse usually calls the patient past ER visit for f/o and they usually encourage patients to f/u with their primary doctor.
Age: 1.04
Sex: M
Vaccine: DTPIHI, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Influenza B virus test, Metabolic function test, Mycoplasma test
Clinical narrative: Mom states that child received immunizations at 11 AM.  Stated he started developing fever that evening.  At approximately 8:30 PM the child had a seizure.  Child was taken to ER via ambulance.  Temperature was 104.7. rectally.  Testing performed in the ER was either negative or within normal limits.  Mother says she was advised to contact the Health Department.  Mother states he is better now and his temperature is 101 Rectally.   4:30 PM 3/1/2016 called mother.  Mom state the temp is down to 98.7.  Baby is fine but sill has runny nose and sniffle.  Advised mom to f/u with the baby's pediatrician and follow directions of ER.  Upon record review, the ER record confirmed the baby was received in the ER with "Febrile Seizure".  Temp was 101.4 F.  WBC 13.2.  CBC Lymphocytes 3.49, Monocytes 1.38.  Immmature Granulocytes 0.05.  Mycoplasma Screen Negative; Rapid Flu Negative.  Called Infection Control Nurse who stated that the Quality Assurance Nurse usually calls the patient past ER visit for f/o and they usually encourage patients to f/u with their primary doctor.
Age: 1.04
Sex: M
Vaccine: DTPIHI, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Culture, Febrile convulsion, Granulocyte count, Influenza virus test negative, Laboratory test normal
Clinical narrative: Mom states that child received immunizations at 11 AM.  Stated he started developing fever that evening.  At approximately 8:30 PM the child had a seizure.  Child was taken to ER via ambulance.  Temperature was 104.7. rectally.  Testing performed in the ER was either negative or within normal limits.  Mother says she was advised to contact the Health Department.  Mother states he is better now and his temperature is 101 Rectally.   4:30 PM 3/1/2016 called mother.  Mom state the temp is down to 98.7.  Baby is fine but sill has runny nose and sniffle.  Advised mom to f/u with the baby's pediatrician and follow directions of ER.  Upon record review, the ER record confirmed the baby was received in the ER with "Febrile Seizure".  Temp was 101.4 F.  WBC 13.2.  CBC Lymphocytes 3.49, Monocytes 1.38.  Immmature Granulocytes 0.05.  Mycoplasma Screen Negative; Rapid Flu Negative.  Called Infection Control Nurse who stated that the Quality Assurance Nurse usually calls the patient past ER visit for f/o and they usually encourage patients to f/u with their primary doctor.
Age: 1.04
Sex: M
Vaccine: DTPIHI, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Lymphocyte count normal, Monocyte count increased, Mycoplasma test, Pyrexia, Seizure
Clinical narrative: Mom states that child received immunizations at 11 AM.  Stated he started developing fever that evening.  At approximately 8:30 PM the child had a seizure.  Child was taken to ER via ambulance.  Temperature was 104.7. rectally.  Testing performed in the ER was either negative or within normal limits.  Mother says she was advised to contact the Health Department.  Mother states he is better now and his temperature is 101 Rectally.   4:30 PM 3/1/2016 called mother.  Mom state the temp is down to 98.7.  Baby is fine but sill has runny nose and sniffle.  Advised mom to f/u with the baby's pediatrician and follow directions of ER.  Upon record review, the ER record confirmed the baby was received in the ER with "Febrile Seizure".  Temp was 101.4 F.  WBC 13.2.  CBC Lymphocytes 3.49, Monocytes 1.38.  Immmature Granulocytes 0.05.  Mycoplasma Screen Negative; Rapid Flu Negative.  Called Infection Control Nurse who stated that the Quality Assurance Nurse usually calls the patient past ER visit for f/o and they usually encourage patients to f/u with their primary doctor.
Age: 1.04
Sex: M
Vaccine: DTPIHI, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: White blood cell count normal
Clinical narrative: Mom states that child received immunizations at 11 AM.  Stated he started developing fever that evening.  At approximately 8:30 PM the child had a seizure.  Child was taken to ER via ambulance.  Temperature was 104.7. rectally.  Testing performed in the ER was either negative or within normal limits.  Mother says she was advised to contact the Health Department.  Mother states he is better now and his temperature is 101 Rectally.   4:30 PM 3/1/2016 called mother.  Mom state the temp is down to 98.7.  Baby is fine but sill has runny nose and sniffle.  Advised mom to f/u with the baby's pediatrician and follow directions of ER.  Upon record review, the ER record confirmed the baby was received in the ER with "Febrile Seizure".  Temp was 101.4 F.  WBC 13.2.  CBC Lymphocytes 3.49, Monocytes 1.38.  Immmature Granulocytes 0.05.  Mycoplasma Screen Negative; Rapid Flu Negative.  Called Infection Control Nurse who stated that the Quality Assurance Nurse usually calls the patient past ER visit for f/o and they usually encourage patients to f/u with their primary doctor.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Hypoaesthesia, Vision blurred
Clinical narrative: Once the HPV vaccine was administered the patient started to feel dizzy, said that his vision has become blurry and that he felt numbness through his whole body. Blood pressure was taken at the time and it was 84/82. It was recommended to the patient to remain seated and after a few minutes the patient said he was feeling better.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 20-Jan-2016. This case involves a 40-year-old male patient, who was vaccinated with Fluzone (batch number: unknown, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On 16-Jan-2016 at 5:00 P.M, unspecified time after vaccination, patient found positive for influenza A virus test. It was reported that the patient required emergency room/doctor visit. Laboratory investigations and corrective treatments were not reported. At the time of this report patient was not recovered from the event. Documents held by sender: none. Follow up information received from the non-healthcare professional on 19 February 2016. The patient received a dose of FLUZONE (batch number U5321FA, expiration date 30 Jun 2016) on 22 October 2016. It was reported that the patient did not receive any previous vaccine. The patient did not have any known drug allergy and patient had tonsillectomy in 2001. Upon internal review this case considered as serious due to important medical events: Influenza A virus infection and vaccination failure. On 16 January 2016, two month after vaccination, the patient found positive for influenza A virus and it was a vaccination failure case. Sender's Comments: As with any vaccine, vaccination with INFLUENZA QUADRIVAL A-B VACCINE may not protect 100% of susceptible individuals. In the current case, the patient was tested positive for influenza group A 86 days post vaccination. Additional information regarding infectious work-up results, patient's immune status at the time of vaccination (medical history, concomitant medication), exact chronology with symptoms as well as confirmatory investigation results (details of test method used to confirm specific influenza A strain, e.g. PCR) are needed for complete assessment. Based on the available information, a possible vaccination failure cannot be ruled out.
Sex: M
Vaccine: PPV
Symptoms: Abasia, Asthenia, Decreased appetite, Pyrexia
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 12-FEB-2016, the patient was vaccinated with the first dose of PNEUMOVAX 23 injection (lot # I024132, expiration date, anatomical location and route of administration were not reported) 0.5 ml, one time injection. On 13-FEB-2016, the patient experienced a high fever, loss of appetite and he did not have the strength to walk. On the same day, he went to an unspecified hospital for unspecified treatment. The patient was at the hospital for an unspecified amount of time. On 17-FEB-2016, he saw the reporting physician and had unspecified treatment. The outcome of the events was not reported. The patient sought medical attention by contacting the physician. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has not been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Nausea, Pallor, Pruritus, Urticaria
Clinical narrative: LIGHT HEADED, PALE AND QUEASY.  NEXT DAY DEVELOPED RASH THAT LOOKED LIKE HIVES, RAISED BUMPS, ITCHY.