chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.07
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 12 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 20-AUG-2015, the patient was vaccinated with improperly stored doses of MMR II (lot # J010208, expiration date 23-AUG-2015, exact dose and route of administration were not reported) and VARIVAX (lot # J009987, expiration date 12-AUG-2015, exact dose and route of administration were not reported). The dose of VARIVAX was expired. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.34
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 16 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 10-SEP-2015, the patient was vaccinated with improperly stored doses of MMR II (lot # J010208, expiration date 23-AUG-2015, exact dose and route of administration were not reported) and VARIVAX (lot # K002046, expiration date 10-FEB-2016, exact dose and route of administration were not reported). The dose of MMR II was expired. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.68
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 20 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 30-JUL-2015, the patient was vaccinated with improperly stored doses of M-M-R II (lot # J010208, expiration date 23-AUG-2015, exact dose and route of administration were not reported) and VARIVAX (Merck) (lot # J009987, expiration date 12-AUG-2015, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, Injury associated with device, Scratch
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 years and 9 months old male patient. The patient's pertinent medical history included allergic rhinitis. Concomitant therapies included cetirizine hydrochloride and ibuprofen. The patient did not have any drug reactions or allergies. On 20-NOV-2015, while attempting to administer a dose of VARIVAX (dose and route were not reported, lot # reported as L023549, expiration date: 26-JUN-2017), the child "pulled away" causing the needle to scratch their skin and resulting in a partial dose administered. It was unspecified how much vaccine, if any, was administered. The outcome of scratch was reported as recovering. There was no treatment given for the events. No laboratory tests were performed. The relatedness between scratch and VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication. On 04-NOV-2015, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # J008799, with expiration date of 16-APR-2015; strength, dosage, frequency and route unspecified). No adverse effects were reported. Additional information is not expected as the reporter did not want to be contacted.
Age: 46.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 46 year old female patient. On 06-NOV-2015 the patient was vaccinated with a dose of GARDASIL. No adverse effect reported. Additional information has been requested.
Age: 1.68
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 20 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 30-JUL-2015, the patient was vaccinated with improperly stored doses of M-M-R II (lot # J010208, expiration date 23-AUG-2015, exact dose and route of administration were not reported) and VARIVAX (Merck) (lot # J009987, expiration date 12-AUG-2015, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.04
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 12 month old patient of unknown gender. No information regarding the patient's medical, concurrent conditions and concomitant therapies was provided. On 23-JUL-2015, the patient was vaccinated with improperly stored doses of M-M-R II (lot # J010208, expiration date 23-AUG-2015, exact dose and route of administration were not reported) and VARIVAX (Merck) (lot # J009987, expiration date 12-AUG-2015, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# L013429, expiration date: 21-JUL-2017 or lot# reported as L020015, expiration date: 16-AUG-2017 or lot# L025737, expiration date: 28-JUL-2017) (dose and route of administration were not reported). No adverse effect was reported. There was no product quality complaint. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 20-NOV-2015, the patient was vaccinated with improperly stored pediatric dose of VAQTA (lot # L015460, expiration date: 20-JUL-2017 or lot # K018181, expiration date: 04-JUN-2017 or lot # L018499, expiration date: 25-FEB-2017) (dose and route of administration were not reported). No adverse effect was reported. There was no product quality complaint. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 20-NOV-2015, the patient was vaccinated with improperly stored adult dose of VAQTA (lot # reported as L027735, expiration date: 12-JAN-2017) (dose and route of administration were not reported) and improperly stored dose of GARDASIL 9 (lot# L013429, expiration date: 21-JUL-2017 or lot# reported as L020015, expiration date: 16-AUG-2017 or lot# L0257373, expiration date: 28-JUL-2017) (dose and route of administration were not reported). No adverse effect was reported. There was no product quality complaint. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. On an unknown dates in 2015, starting on or after 28-OCT-2015, an unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (route of administration and dose number were not reported, lot number: J007296 (verified as not valid), expiry date: 05-FEB-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 20-NOV-2015, the patient was vaccinated with improperly stored adult dose of VAQTA (lot # reported as L027735, expiration date: 12-JAN-2017) (dose and route of administration were not reported). No adverse effect was reported. There was no product quality complaint. 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: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. On an unknown dates in 2015, starting on or after 28-OCT-2015, an unspecified number of patients were vaccinated with improperly stored doses of GARDASIL 9 (route of administration and dose number were not reported, lot number: L013429 and expiry date: 21-JUL-2017). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 34.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 34 year old patient of unknown gender. On 17-NOV-2015, the patient was vaccinated with first dose of RECOMBIBAX HB 0.5 ml. The reporter stated that the patient received the pediatric dose of RECOMBIVAX HB on 17-NOV-2015. No symptoms were reported. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect therapy. This case is linked to the case 1511USA014539 and 1511USA011479 (same reporter link). 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 licensed practical nurse and refers to approximately 20 patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored M-M-R II lot # K014833, expiry date: 14-SEP-2016, lot# L005290 expiry date: 17-FEB-2016 and lot # K018990 with expiry date: 15-OCT-2015. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. The registered nurse provided that on 24-NOV-2015, the patient tested positive via a urine screening that she was pregnant. The last menstrual period (LMP) date and estimated date of delivery (EDD) were not known. On 24-NOV-2015, the patient was also inadvertently vaccinated with a dose of GARDASIL 9 (lot # L017407, expiration date 15-AUG-2017; dose and route of administration were not reported). The pregnancy outcome was outcome pending. The foetal outcome was unknown. Additional information has been requested.
Age: 28.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 28 year old patient of unknown gender. On 17-NOV-2015, the patient was vaccinated with first dose of RECOMBIVAX HB 0.5 ml. The reporter stated that the patient received the pediatric dose of RECOMBIVAX HB on 17-NOV-2015. No symptoms were reported. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect therapy. This case is linked to case 1511USA014540 and 1511USA011479 (same reporter link). Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 25 year old patient of unknown gender. On 17-NOV-2015, the patient was vaccinated with first dose of RECOMBIVAX HB 0.5 ml. The reporter stated that the patient received the pediatric dose of RECOMBIVAX HB on 17-NOV-2015. No symptoms were reported. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (unknown route and strength) Lot # J013431 with expiry date of 24-OCT-2015. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a unspecified patients of unknown age. On an unknown date, the patients were vaccinated with GARDASIL 9 which was outside the recommended administration intervals. No adverse effects were 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 licensed practical nurse and refers to approximately 20 patients of unknown age and gender. Patient's demographics, concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA lot # K005958 and L018499 expiry date 09-FEB-2017 and 25-FEB-2017. No adverse effects were reported. This was one of several reports received from the same source. 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 practical nurse and refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # L011846, expiry date 16-JUN-2017. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Irritability, Ultrasound scan normal, VIth nerve paralysis
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company on 17-Nov-2015. Manufacturer number was reported as: 2015288028. This case involves a three-month-old female patient, who was vaccinated with second dose of 0.5 ml PENTACEL (batch number: C4772AA/C4855AA expiry date 18-Jul-2016) via intramuscular route in right vastus lateralis; second dose of 0.5 ml PREVENAR (manufacturer: Wyeth, Batch number: L62072 expiry date 16-Nov-2015) via intramuscular route in left vastus lateralis and second dose of 2 ml ROTATEQ (manufacturer: Merck, Batch number: K020183 expiry date 25-JUN-2016) orally all on 12-May-2015. Patient had no illness at the time of vaccination and had history of esotropia pseudostrabismus hyperopia on 02-Jun-2015. Patient had not taken any concomitant medication. It was reported that patient had two siblings. On 12-May-2015, same day few hours after vaccination, the patient experienced sixth nerve palsy, fussiness and bulging fontanelle. Laboratory investigations and corrective treatment were not reported. On an unspecified date, patient recovered from events sixth nerve palsy, fussiness and bulging fontanelle. Upon internal review, the case was considered as serious due to important medical event sixth nerve palsy. Documents held by sender: none.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Agitation, Fontanelle bulging, Inappropriate schedule of drug administration, Pyrexia, Ultrasound scan
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company on 17-Nov-2015. Manufacturer number was reported as: 2015288028. This case involves a three-month-old female patient, who was vaccinated with second dose of 0.5 ml PENTACEL (batch number: C4772AA/C4855AA expiry date 18-Jul-2016) via intramuscular route in right vastus lateralis; second dose of 0.5 ml PREVENAR (manufacturer: Wyeth, Batch number: L62072 expiry date 16-Nov-2015) via intramuscular route in left vastus lateralis and second dose of 2 ml ROTATEQ (manufacturer: Merck, Batch number: K020183 expiry date 25-JUN-2016) orally all on 12-May-2015. Patient had no illness at the time of vaccination and had history of esotropia pseudostrabismus hyperopia on 02-Jun-2015. Patient had not taken any concomitant medication. It was reported that patient had two siblings. On 12-May-2015, same day few hours after vaccination, the patient experienced sixth nerve palsy, fussiness and bulging fontanelle. Laboratory investigations and corrective treatment were not reported. On an unspecified date, patient recovered from events sixth nerve palsy, fussiness and bulging fontanelle. Upon internal review, the case was considered as serious due to important medical event sixth nerve palsy. Documents held by sender: none.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: VIth nerve paralysis
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company on 17-Nov-2015. Manufacturer number was reported as: 2015288028. This case involves a three-month-old female patient, who was vaccinated with second dose of 0.5 ml PENTACEL (batch number: C4772AA/C4855AA expiry date 18-Jul-2016) via intramuscular route in right vastus lateralis; second dose of 0.5 ml PREVENAR (manufacturer: Wyeth, Batch number: L62072 expiry date 16-Nov-2015) via intramuscular route in left vastus lateralis and second dose of 2 ml ROTATEQ (manufacturer: Merck, Batch number: K020183 expiry date 25-JUN-2016) orally all on 12-May-2015. Patient had no illness at the time of vaccination and had history of esotropia pseudostrabismus hyperopia on 02-Jun-2015. Patient had not taken any concomitant medication. It was reported that patient had two siblings. On 12-May-2015, same day few hours after vaccination, the patient experienced sixth nerve palsy, fussiness and bulging fontanelle. Laboratory investigations and corrective treatment were not reported. On an unspecified date, patient recovered from events sixth nerve palsy, fussiness and bulging fontanelle. Upon internal review, the case was considered as serious due to important medical event sixth nerve palsy. Documents held by sender: none.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Pyrexia, Ultrasound skull abnormal, VIth nerve paralysis
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company on 17-Nov-2015. Manufacturer number was reported as: 2015288028. This case involves a three-month-old female patient, who was vaccinated with second dose of 0.5 ml PENTACEL (batch number: C4772AA/C4855AA expiry date 18-Jul-2016) via intramuscular route in right vastus lateralis; second dose of 0.5 ml PREVENAR (manufacturer: Wyeth, Batch number: L62072 expiry date 16-Nov-2015) via intramuscular route in left vastus lateralis and second dose of 2 ml ROTATEQ (manufacturer: Merck, Batch number: K020183 expiry date 25-JUN-2016) orally all on 12-May-2015. Patient had no illness at the time of vaccination and had history of esotropia pseudostrabismus hyperopia on 02-Jun-2015. Patient had not taken any concomitant medication. It was reported that patient had two siblings. On 12-May-2015, same day few hours after vaccination, the patient experienced sixth nerve palsy, fussiness and bulging fontanelle. Laboratory investigations and corrective treatment were not reported. On an unspecified date, patient recovered from events sixth nerve palsy, fussiness and bulging fontanelle. Upon internal review, the case was considered as serious due to important medical event sixth nerve palsy. Documents held by sender: none.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Hypermetropia, Irritability, Pseudostrabismus, Strabismus
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company on 17-Nov-2015. Manufacturer number was reported as: 2015288028. This case involves a three-month-old female patient, who was vaccinated with second dose of 0.5 ml PENTACEL (batch number: C4772AA/C4855AA expiry date 18-Jul-2016) via intramuscular route in right vastus lateralis; second dose of 0.5 ml PREVENAR (manufacturer: Wyeth, Batch number: L62072 expiry date 16-Nov-2015) via intramuscular route in left vastus lateralis and second dose of 2 ml ROTATEQ (manufacturer: Merck, Batch number: K020183 expiry date 25-JUN-2016) orally all on 12-May-2015. Patient had no illness at the time of vaccination and had history of esotropia pseudostrabismus hyperopia on 02-Jun-2015. Patient had not taken any concomitant medication. It was reported that patient had two siblings. On 12-May-2015, same day few hours after vaccination, the patient experienced sixth nerve palsy, fussiness and bulging fontanelle. Laboratory investigations and corrective treatment were not reported. On an unspecified date, patient recovered from events sixth nerve palsy, fussiness and bulging fontanelle. Upon internal review, the case was considered as serious due to important medical event sixth nerve palsy. Documents held by sender: none.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Irritability, VIth nerve paralysis
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company on 17-Nov-2015. Manufacturer number was reported as: 2015288028. This case involves a three-month-old female patient, who was vaccinated with second dose of 0.5 ml PENTACEL (batch number: C4772AA/C4855AA expiry date 18-Jul-2016) via intramuscular route in right vastus lateralis; second dose of 0.5 ml PREVENAR (manufacturer: Wyeth, Batch number: L62072 expiry date 16-Nov-2015) via intramuscular route in left vastus lateralis and second dose of 2 ml ROTATEQ (manufacturer: Merck, Batch number: K020183 expiry date 25-JUN-2016) orally all on 12-May-2015. Patient had no illness at the time of vaccination and had history of esotropia pseudostrabismus hyperopia on 02-Jun-2015. Patient had not taken any concomitant medication. It was reported that patient had two siblings. On 12-May-2015, same day few hours after vaccination, the patient experienced sixth nerve palsy, fussiness and bulging fontanelle. Laboratory investigations and corrective treatment were not reported. On an unspecified date, patient recovered from events sixth nerve palsy, fussiness and bulging fontanelle. Upon internal review, the case was considered as serious due to important medical event sixth nerve palsy. Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose normal, Dizziness, Loss of consciousness, Vision blurred, Vomiting
Clinical narrative: Fainting (non-responsive for less than 1 minute). Vomiting.
Age: 23.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Fainting (non-responsive for less than 1 minute). Vomiting.
Age: 21.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Beta haemolytic streptococcal infection, Caesarean section, Exposure during pregnancy, Oropharyngeal pain, Polymerase chain reaction positive
Clinical narrative: Initial unsolicited pregnancy report received from literature on 19 November 2015. This case is linked to 2015SA192114 (same literature). Abstract: Given the illness and deaths caused by respiratory syncytial virus (RSV) infection during the first year of life, preventing infant RSV infections through maternal vaccination is intriguing. However, little is known about the extent and maternal effects of RSV infection during pregnancy. We describe 3 cases of maternal RSV infection diagnosed at a center during winter 2014. Case-patient 1 (26 years old, week 33 of gestation) received a diagnosis of RSV infection and required mechanical ventilation. Case-patient 2 (27 years old, week 34 of gestation) received a diagnosis of infection with influenza A (H1N1) virus and RSV and required mechanical ventilation. Case-patient 3 (21 years old, week 32 of gestation) received a diagnosis of group A streptococcus pharyngitis and RSV infection and was monitored as an outpatient. Clarifying the effects of maternal RSV infection could yield valuable insights into potential maternal and fetal benefits of an effective RSV vaccination program. This case involves a 21-year-old female patient who was vaccinated with Influenza Vaccine (batch number, site of administration were not reported) on unspecified date during pregnancy. It was reported that at the time of vaccination the patient was 32 weeks pregnant (primagravida), LMP not reported. Hence, it was a case of drug exposure during pregnancy. The patient's medical history was complicated by mild aortic coarctation and a cognitive delay. She had no history of asthma or smoking and concomitant medications were not reported. On an unspecified date after vaccination, patient presented to outpatient department with a three day history of sore throat, congestion and fever. At initial visit, the patient was afebrile with stable vital signs and was therefore sent home on oral medications. Later the patient was diagnosed with group A streptococcal pharyngitis and RSV (Respiratory syncytial virus infection). Laboratory investigations included throat culture specimen and nasopharyngeal aspirate by viral PCR both of which were positive for type A streptococcus and RSV respectively. The patient was treated with empiric oseltamivir initially and then treated with penicillin (500 mg, twice a day, for 10 days) for the group A streptococcus infection without any further complications. The outcome of the events was not reported. At 39 weeks of gestation, the patient underwent an uncomplicated primary cesarean delivery of a (birth weight 2.855 grams) female infant with Apgar scores of 9 at 1 and 5 minutes. The infant was admitted to the newborn nursery and discharged home with the mother on postoperative day 4. Upon internal review, the case was assessed as serious due to important medical event group A streptococcus pharyngitis, RSV infection. Documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pyrexia, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Respiratory tract congestion, Streptococcus test positive
Clinical narrative: Initial unsolicited pregnancy report received from literature on 19 November 2015. This case is linked to 2015SA192114 (same literature). Abstract: Given the illness and deaths caused by respiratory syncytial virus (RSV) infection during the first year of life, preventing infant RSV infections through maternal vaccination is intriguing. However, little is known about the extent and maternal effects of RSV infection during pregnancy. We describe 3 cases of maternal RSV infection diagnosed at a center during winter 2014. Case-patient 1 (26 years old, week 33 of gestation) received a diagnosis of RSV infection and required mechanical ventilation. Case-patient 2 (27 years old, week 34 of gestation) received a diagnosis of infection with influenza A (H1N1) virus and RSV and required mechanical ventilation. Case-patient 3 (21 years old, week 32 of gestation) received a diagnosis of group A streptococcus pharyngitis and RSV infection and was monitored as an outpatient. Clarifying the effects of maternal RSV infection could yield valuable insights into potential maternal and fetal benefits of an effective RSV vaccination program. This case involves a 21-year-old female patient who was vaccinated with Influenza Vaccine (batch number, site of administration were not reported) on unspecified date during pregnancy. It was reported that at the time of vaccination the patient was 32 weeks pregnant (primagravida), LMP not reported. Hence, it was a case of drug exposure during pregnancy. The patient's medical history was complicated by mild aortic coarctation and a cognitive delay. She had no history of asthma or smoking and concomitant medications were not reported. On an unspecified date after vaccination, patient presented to outpatient department with a three day history of sore throat, congestion and fever. At initial visit, the patient was afebrile with stable vital signs and was therefore sent home on oral medications. Later the patient was diagnosed with group A streptococcal pharyngitis and RSV (Respiratory syncytial virus infection). Laboratory investigations included throat culture specimen and nasopharyngeal aspirate by viral PCR both of which were positive for type A streptococcus and RSV respectively. The patient was treated with empiric oseltamivir initially and then treated with penicillin (500 mg, twice a day, for 10 days) for the group A streptococcus infection without any further complications. The outcome of the events was not reported. At 39 weeks of gestation, the patient underwent an uncomplicated primary cesarean delivery of a (birth weight 2.855 grams) female infant with Apgar scores of 9 at 1 and 5 minutes. The infant was admitted to the newborn nursery and discharged home with the mother on postoperative day 4. Upon internal review, the case was assessed as serious due to important medical event group A streptococcus pharyngitis, RSV infection. Documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Caesarean section, Culture throat positive, Exposure during pregnancy, Oropharyngeal pain, Pharyngitis streptococcal
Clinical narrative: Initial unsolicited pregnancy report received from literature on 19 November 2015. This case is linked to 2015SA192114 (same literature). Abstract: Given the illness and deaths caused by respiratory syncytial virus (RSV) infection during the first year of life, preventing infant RSV infections through maternal vaccination is intriguing. However, little is known about the extent and maternal effects of RSV infection during pregnancy. We describe 3 cases of maternal RSV infection diagnosed at a center during winter 2014. Case-patient 1 (26 years old, week 33 of gestation) received a diagnosis of RSV infection and required mechanical ventilation. Case-patient 2 (27 years old, week 34 of gestation) received a diagnosis of infection with influenza A (H1N1) virus and RSV and required mechanical ventilation. Case-patient 3 (21 years old, week 32 of gestation) received a diagnosis of group A streptococcus pharyngitis and RSV infection and was monitored as an outpatient. Clarifying the effects of maternal RSV infection could yield valuable insights into potential maternal and fetal benefits of an effective RSV vaccination program. This case involves a 21-year-old female patient who was vaccinated with Influenza Vaccine (batch number, site of administration were not reported) on unspecified date during pregnancy. It was reported that at the time of vaccination the patient was 32 weeks pregnant (primagravida), LMP not reported. Hence, it was a case of drug exposure during pregnancy. The patient's medical history was complicated by mild aortic coarctation and a cognitive delay. She had no history of asthma or smoking and concomitant medications were not reported. On an unspecified date after vaccination, patient presented to outpatient department with a three day history of sore throat, congestion and fever. At initial visit, the patient was afebrile with stable vital signs and was therefore sent home on oral medications. Later the patient was diagnosed with group A streptococcal pharyngitis and RSV (Respiratory syncytial virus infection). Laboratory investigations included throat culture specimen and nasopharyngeal aspirate by viral PCR both of which were positive for type A streptococcus and RSV respectively. The patient was treated with empiric oseltamivir initially and then treated with penicillin (500 mg, twice a day, for 10 days) for the group A streptococcus infection without any further complications. The outcome of the events was not reported. At 39 weeks of gestation, the patient underwent an uncomplicated primary cesarean delivery of a (birth weight 2.855 grams) female infant with Apgar scores of 9 at 1 and 5 minutes. The infant was admitted to the newborn nursery and discharged home with the mother on postoperative day 4. Upon internal review, the case was assessed as serious due to important medical event group A streptococcus pharyngitis, RSV infection. Documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Polymerase chain reaction positive, Pyrexia, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Respiratory tract congestion
Clinical narrative: Initial unsolicited pregnancy report received from literature on 19 November 2015. This case is linked to 2015SA192114 (same literature). Abstract: Given the illness and deaths caused by respiratory syncytial virus (RSV) infection during the first year of life, preventing infant RSV infections through maternal vaccination is intriguing. However, little is known about the extent and maternal effects of RSV infection during pregnancy. We describe 3 cases of maternal RSV infection diagnosed at a center during winter 2014. Case-patient 1 (26 years old, week 33 of gestation) received a diagnosis of RSV infection and required mechanical ventilation. Case-patient 2 (27 years old, week 34 of gestation) received a diagnosis of infection with influenza A (H1N1) virus and RSV and required mechanical ventilation. Case-patient 3 (21 years old, week 32 of gestation) received a diagnosis of group A streptococcus pharyngitis and RSV infection and was monitored as an outpatient. Clarifying the effects of maternal RSV infection could yield valuable insights into potential maternal and fetal benefits of an effective RSV vaccination program. This case involves a 21-year-old female patient who was vaccinated with Influenza Vaccine (batch number, site of administration were not reported) on unspecified date during pregnancy. It was reported that at the time of vaccination the patient was 32 weeks pregnant (primagravida), LMP not reported. Hence, it was a case of drug exposure during pregnancy. The patient's medical history was complicated by mild aortic coarctation and a cognitive delay. She had no history of asthma or smoking and concomitant medications were not reported. On an unspecified date after vaccination, patient presented to outpatient department with a three day history of sore throat, congestion and fever. At initial visit, the patient was afebrile with stable vital signs and was therefore sent home on oral medications. Later the patient was diagnosed with group A streptococcal pharyngitis and RSV (Respiratory syncytial virus infection). Laboratory investigations included throat culture specimen and nasopharyngeal aspirate by viral PCR both of which were positive for type A streptococcus and RSV respectively. The patient was treated with empiric oseltamivir initially and then treated with penicillin (500 mg, twice a day, for 10 days) for the group A streptococcus infection without any further complications. The outcome of the events was not reported. At 39 weeks of gestation, the patient underwent an uncomplicated primary cesarean delivery of a (birth weight 2.855 grams) female infant with Apgar scores of 9 at 1 and 5 minutes. The infant was admitted to the newborn nursery and discharged home with the mother on postoperative day 4. Upon internal review, the case was assessed as serious due to important medical event group A streptococcus pharyngitis, RSV infection. Documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Streptococcus test positive
Clinical narrative: Initial unsolicited pregnancy report received from literature on 19 November 2015. This case is linked to 2015SA192114 (same literature). Abstract: Given the illness and deaths caused by respiratory syncytial virus (RSV) infection during the first year of life, preventing infant RSV infections through maternal vaccination is intriguing. However, little is known about the extent and maternal effects of RSV infection during pregnancy. We describe 3 cases of maternal RSV infection diagnosed at a center during winter 2014. Case-patient 1 (26 years old, week 33 of gestation) received a diagnosis of RSV infection and required mechanical ventilation. Case-patient 2 (27 years old, week 34 of gestation) received a diagnosis of infection with influenza A (H1N1) virus and RSV and required mechanical ventilation. Case-patient 3 (21 years old, week 32 of gestation) received a diagnosis of group A streptococcus pharyngitis and RSV infection and was monitored as an outpatient. Clarifying the effects of maternal RSV infection could yield valuable insights into potential maternal and fetal benefits of an effective RSV vaccination program. This case involves a 21-year-old female patient who was vaccinated with Influenza Vaccine (batch number, site of administration were not reported) on unspecified date during pregnancy. It was reported that at the time of vaccination the patient was 32 weeks pregnant (primagravida), LMP not reported. Hence, it was a case of drug exposure during pregnancy. The patient's medical history was complicated by mild aortic coarctation and a cognitive delay. She had no history of asthma or smoking and concomitant medications were not reported. On an unspecified date after vaccination, patient presented to outpatient department with a three day history of sore throat, congestion and fever. At initial visit, the patient was afebrile with stable vital signs and was therefore sent home on oral medications. Later the patient was diagnosed with group A streptococcal pharyngitis and RSV (Respiratory syncytial virus infection). Laboratory investigations included throat culture specimen and nasopharyngeal aspirate by viral PCR both of which were positive for type A streptococcus and RSV respectively. The patient was treated with empiric oseltamivir initially and then treated with penicillin (500 mg, twice a day, for 10 days) for the group A streptococcus infection without any further complications. The outcome of the events was not reported. At 39 weeks of gestation, the patient underwent an uncomplicated primary cesarean delivery of a (birth weight 2.855 grams) female infant with Apgar scores of 9 at 1 and 5 minutes. The infant was admitted to the newborn nursery and discharged home with the mother on postoperative day 4. Upon internal review, the case was assessed as serious due to important medical event group A streptococcus pharyngitis, RSV infection. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a 54 year old female patient reporting on herself. The patient's pertinent medical history included Crohn's disease. The patient did not have any drug reactions or allergies. The patient's concomitant medications included unspecified flu shot. On 20-NOV-2015, the patient was vaccinated with PNEUMOVAX 23 (dose, lot # and expiration date were not reported, once, subcutaneously). On 21-NOV-2015, the patient began experiencing flu-like symptoms and also developed a red rash close to the injection site on her arm. The rash was very painful and tender to touch. On an unspecified date in November 2015, the patient went to the hospital, was given a computerized tomogram (CAT-scan) and told that she developed cellulitis (it was also reported that no laboratory tests were performed). The patient was hospitalized on an unspecified date in November 2015 (duration unknown). On 23-NOV-2015 (reported as today), the rash got slightly larger but the pain subsided. The patient was to go to the doctor on 25-NOV-2015 for further evaluation. The outcome of the events was reported as not recovered. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information is not expected as the patient did not consent to contact her physician.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Cellulitis, Computerised tomogram abnormal, Influenza like illness, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report was received from a 54 year old female patient reporting on herself. The patient's pertinent medical history included Crohn's disease. The patient did not have any drug reactions or allergies. The patient's concomitant medications included unspecified flu shot. On 20-NOV-2015, the patient was vaccinated with PNEUMOVAX 23 (dose, lot # and expiration date were not reported, once, subcutaneously). On 21-NOV-2015, the patient began experiencing flu-like symptoms and also developed a red rash close to the injection site on her arm. The rash was very painful and tender to touch. On an unspecified date in November 2015, the patient went to the hospital, was given a computerized tomogram (CAT-scan) and told that she developed cellulitis (it was also reported that no laboratory tests were performed). The patient was hospitalized on an unspecified date in November 2015 (duration unknown). On 23-NOV-2015 (reported as today), the rash got slightly larger but the pain subsided. The patient was to go to the doctor on 25-NOV-2015 for further evaluation. The outcome of the events was reported as not recovered. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information is not expected as the patient did not consent to contact her physician.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a 54 year old female patient reporting on herself. The patient's pertinent medical history included Crohn's disease. The patient did not have any drug reactions or allergies. The patient's concomitant medications included unspecified flu shot. On 20-NOV-2015, the patient was vaccinated with PNEUMOVAX 23 (dose, lot # and expiration date were not reported, once, subcutaneously). On 21-NOV-2015, the patient began experiencing flu-like symptoms and also developed a red rash close to the injection site on her arm. The rash was very painful and tender to touch. On an unspecified date in November 2015, the patient went to the hospital, was given a computerized tomogram (CAT-scan) and told that she developed cellulitis (it was also reported that no laboratory tests were performed). The patient was hospitalized on an unspecified date in November 2015 (duration unknown). On 23-NOV-2015 (reported as today), the rash got slightly larger but the pain subsided. The patient was to go to the doctor on 25-NOV-2015 for further evaluation. The outcome of the events was reported as not recovered. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information is not expected as the patient did not consent to contact her physician.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Tachycardia
Clinical narrative: Initial unsolicited report received from a consumer on 12 November 2015. This case involves an 81-year-old female patient, who was vaccinated with a dose of FLUZONE HD (batch number: unknown, dose, dose in series, route and site of administration was not reported) on 04 November 2015 at 10:00 AM. The patient denied illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. On 04 November 2015, same day of vaccination, patient experienced shortness of breath and tachycardia in the evening. On 05 November 2015, patient presented to Emergency room in the morning and was admitted for three days (discharge date was not reported). Laboratory investigations was not reported and patient was treated with Metoprolol 25 mg daily. The outcome of the events was reported as unknown. Documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Had a temperature of 100.1 F, pain in left deltoid, left deltoid area swelling, difficulty to lift her left arm.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Myalgia, Nausea, Paraesthesia
Clinical narrative: Tingly head, nausea, headache, muscle aches.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Body temperature increased, Diarrhoea, Feeding disorder, Headache, Mobility decreased
Clinical narrative: Tingly head, nausea, headache, muscle aches.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myalgia, Nausea, Pain
Clinical narrative: Tingly head, nausea, headache, muscle aches.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site rash, Peripheral swelling, Rash
Clinical narrative: Injection site rash.  Arm was swollen, raised, and red.  Rash to the face also occurred.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: During hospital public flu clinic, patient was noted to have a red spot after receiving flu vaccine. Pt was sent to the ED.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Developed a 10 cm ring of pink skin on the upper left arm centered at vaccine site, slightly tender and warm, was still present at office visit 11/25/2015.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Bells Palsy developed within 24 hours of vaccination for influenza.