chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 26-JUL-2016, the patient was vaccinated with improperly stored MMR II lot # L029266, therapy type (dose, strength, route of administration and expiry date were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients. The patients concurrent conditions and medical history were not reported. On an unspecified dates, an unspecified number of patients received an improperly stored dose of M-M-R II (dose, route of administration, lot number and expiration date were not reported). No concomitant medications were reported. No adverse effect was reported. No further details were provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unknown number of patients of unknown age and gender. Medical histories, concomitant medications, laboratory data and drug histories were all unknown. On an unknown date, the patients were vaccinated with GARDASIL 9 (dose, frequency, route of administration were not reported, lot # M004116 with expiration date: 12-OCT-2017, as routine vaccination). The doses of GARDASIL 9 were involved in a temperature excursion. No adverse events were reported. At the time of the report, it was unknown it these patients would continue GARDASIL 9 for the possible off label indication of routine vaccination and the outcomes of these patients being exposed to GARDASIL 9 that was involved in a temperature excursion was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 31-AUG-2016, the patient was vaccinated with ZOSTAVAX injection lot # K009769, expiration date 9-OCT-2015 (dose, strength, route of administration were not provided). There were no concomitant medications provided. No adverse effects were reported and product quality complain was not involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L027733, expiration date 13-SEP-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 28.4 degrees Fahrenheit for 2 days, 21 hours, 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a certificated medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 23-AUG-2016, the patient was inadvertently administered expired M-M-R II injection (dose unknown, lot# K011317, expired on 13-AUG-2016, recombinant human albumin (rHA)) subcutaneously. No adverse effect was reported. Additional information is not expected as there is no consent for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 20-AUG-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L046893, expiration date 23-FEB-2017; dose and route were unknown). No adverse effect was reported. The vaccine was exposure under 27 Fahrenheit degree for 12 hours. There was no previous temperature excursion. Data logger was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L024993, expiration date 17-OCT-2017; lot # L043214, expiration date 30-AUG-2017 (dose and route of administration were not reported). Administered doses of vaccine experienced the temperature excursion of 34 degrees Fahrenheit for 3 hours. Data logger was not involved. There were no previous excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the multiple patients were vaccinated with improperly stored doses of VARIVAX lot # M005971, expiration date 02-FEB-2018, (Concentration, dose and route were not reported). The multiple patients' concomitant therapy was not reported. No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 1.17
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Aspiration, Chest X-ray abnormal, Choking, Dyskinesia, Hypotonia
Clinical narrative: the patient is a 15 month old female who presents for evaluation following an "episode." Around 645, the patients mother went to check on her to wake her up from a nap. She is sleeping on her stomach, but doing well. Approximately 10 minutes later, father went to get her up, and found her on her back, with glazed eyes. When he tried to pick her up, he found her to be completely floppy. He called down to his wife, who came upstairs and noticed that her lips were purple (dad is colorblind). That time they decide to call 911. Mother initially states that patient was not breathing, however after further questioning it seems that she was making gurgling, choking, "aspiration" noises. During this time, the patient did bite down on her father's finger, but they are under the impression that it was more of a reflex than a purposeful behavior. the episode lasted approximately 5-8 minutes, suddenly the patient took a big breath like a sigh, and came back around. Her breathing pattern normalized. After that, mother and father state that she is not acting her normal self, that she is slightly fussier than normal. EMS arrived and checked her glucose (118), recommended transport, but mother and father decided to bring her via private vehicle. She does have a history of developmental delay, but otherwise does not have any chronic medical problems. Last year, she was having some jerking episodes which was thought potentially to the due to seizures, however were found not to be the case. She does have a fever here. Mother and father state that she had not been exhibiting any signs or symptoms of infection. No coughing, congestion, runny nose. She often pulls at her ears and does have ear tubes in place. No nausea, vomiting, or diarrhea. No rashes.
Age: 1.17
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Increased upper airway secretion, Lip discolouration, Respiratory arrest, Staring
Clinical narrative: the patient is a 15 month old female who presents for evaluation following an "episode." Around 645, the patients mother went to check on her to wake her up from a nap. She is sleeping on her stomach, but doing well. Approximately 10 minutes later, father went to get her up, and found her on her back, with glazed eyes. When he tried to pick her up, he found her to be completely floppy. He called down to his wife, who came upstairs and noticed that her lips were purple (dad is colorblind). That time they decide to call 911. Mother initially states that patient was not breathing, however after further questioning it seems that she was making gurgling, choking, "aspiration" noises. During this time, the patient did bite down on her father's finger, but they are under the impression that it was more of a reflex than a purposeful behavior. the episode lasted approximately 5-8 minutes, suddenly the patient took a big breath like a sigh, and came back around. Her breathing pattern normalized. After that, mother and father state that she is not acting her normal self, that she is slightly fussier than normal. EMS arrived and checked her glucose (118), recommended transport, but mother and father decided to bring her via private vehicle. She does have a history of developmental delay, but otherwise does not have any chronic medical problems. Last year, she was having some jerking episodes which was thought potentially to the due to seizures, however were found not to be the case. She does have a fever here. Mother and father state that she had not been exhibiting any signs or symptoms of infection. No coughing, congestion, runny nose. She often pulls at her ears and does have ear tubes in place. No nausea, vomiting, or diarrhea. No rashes.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Injection site nodule
Clinical narrative: 1000 AM patient said started to develop redness and hard know approximately silver dollar size.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Hydrocele, Scrotal swelling, Ultrasound testes
Clinical narrative: New acute onset hydrocele presenting with (L) scrotal swelling on 8-24-16 seen in ED with subsequent ultrasound on 8-25 and visit 8-26.
Sex: F
Vaccine: HPVX
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This prospective report was received from a 24 years old female patient  reporting on herself via company representative. The patient's medical history and concurrent conditions were not reported. The primary reporter stated that she was administered her first dose of GARDASIL 9 injection or GARDASIL ( strength, dose , lot number, expiration date, route of administration were not provided). There were no concomitant medications reported. The patient was subsequently determined to be pregnant on unspecified date(vaccine exposure before pregnancy), the last menstrual period(LMP), estimated date of conception(DOC) and estimated date of delivery (EDD)were not reported. No product quality complain was involved. The outcome of the vaccine exposure during pregnancy was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L042258, expiration date 18-AUG-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 28.4 degrees Fahrenheit for 2 days, 21 hours, 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to "about 15" unspecified patients of unknown age and gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Concentration, dose and route of administration were not reported), lot # L005299, expiration date 17-FEB-2017. Patient's concomitant medication was no reported. No adverse effects were reported. A product complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # L024993, expiration date 17-OCT-2017; lot # L043214, expiration date 30-AUG-2017 (therapy type, dose and route of administration were not reported). Administered doses of vaccine experienced the temperature excursion of 34 degrees Fahrenheit for 3 hours. Data logger was not involved. There was no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 3 month old female patient. The patient had not relevant medical history, concomitant medications and drug history. On 28-JUL-2016, the patient was vaccinated once with a 0.5 ml dose of PEDVAXHIB, which was involved in a temperature excursion (lot # J016188, expiration date 01-OCT-2016) by unknown route. Concomitant medication was not reported. The reporter explained that no adverse events had been relayed to him thus far after the patient received this vaccination. The patient had no relevant laboratory data. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning 2 unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On 09-AUG-2016, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M006726, expiration date 08-FEB-2018; strength, dose and frequency were unknown), subcutaneously, which was exposed to temperature excursion of 11.5 degrees Fahrenheit for 1 hour and 52 minutes. Previous temperature excursion was 13.1 degrees Fahrenheit for 48 hours. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 11 month old (also reported as "five days before 12 months") patient of unknown gender. No information on patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 28-JUN-2001, five days before 12 months of age, the patient was vaccinated with the first dose of VARIVAX, lot number reported as 0231L, valid for number 638492/0231L, expiration date: 14-AUG-2002. Next, on 07-APR-2008, the patient was vaccinated with the second dose of VARIVAX, lot number reported as 1848U, valid for number 660037/1848U, expiration date: 15-NOV-2009, both vaccination administered subcutaneously (doses not reported). No adverse effects were reported. 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 vaccine coordinator refers to multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L016429, expiration date 09-AUG-2017 (dose and route of administration were not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 28.4 degrees Fahrenheit for 2 days, 21 hours, 30 minutes. Data logger was involved. There was no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly doses of GARDASIL 9 (lot # L043214, expiration date 30-AUG-2017, exact doses and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 17-JUN-2014, the patient inadvertently received a dose of either VAQTA (dose, route of administration, lot #, expiration date not reported) or HAVRIX (dose, route of administration, lot #, expiration date not reported). They received another dose on 14-NOV-2014. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 22-JUL-2016, the patient was vaccinated with improperly stored M-M-R II lot # L029266, therapy type (albumin status) rHA, (dose, strength, route of administration and expiry date were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. From 01-JUN-2016 to 23-AUG-2016 the patients were vaccinated with improperly stored GARDASIL 9 (lot # M007764, Exp 30-JAN-2018, dose and route unknown), which was exposed at 47 Fahrenheit for 2016 hours and 34 Fahrenheit for 2016 hours. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Eosinophil count increased, Full blood count, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 years old male patient. The patient's pertinent medical history included asthma. The patient had unspecified allergy reaction to penicillin and had no concomitant medications. On 19-AUG-2016, the patient was vaccinated with the first dose of M-M-R II injection, albumin status of recombinant human albumin (rHA), 0.5 ml, subcutaneously in the right arm, lot # M002418, expiry date 12-JAN-2018 and the first dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, 0.5 ml, intramuscularly in the same right arm, lot # U5315AA, expiry date 29-APR-2018 for initial vaccination. On an unknown date in August 2016 (reported as "sometime afterwards"), the patient experienced bad reaction and sought medical attention in the emergency room at the hospital on 22-AUG-2016. The nurse described the bad reaction as "the right shoulder, more than halfway down the arm, was red, swollen, lumpy, painful, and swelling up towards neck and the neck was stiff". The nurse reported that, the physician prescribed treatment with prednisone (manufacturer unknown), albuterol breathing treatment, BENADRYL and epinephrine. The patient had lab diagnostic studies performed which included a complete metabolic panel and a complete blood count. The results showed elevated monocytes and eosinophils and also the lymphocytes were low. The patient was not admitted to the hospital and was sent home. At the time of this report, the patient was still recovering and was not in distress. The reporter did not provide the causality assessment between the events and M-M-R II and other suspect vaccine. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Injection site swelling, Local swelling, Lymphocyte count decreased, Monocyte count increased, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 years old male patient. The patient's pertinent medical history included asthma. The patient had unspecified allergy reaction to penicillin and had no concomitant medications. On 19-AUG-2016, the patient was vaccinated with the first dose of M-M-R II injection, albumin status of recombinant human albumin (rHA), 0.5 ml, subcutaneously in the right arm, lot # M002418, expiry date 12-JAN-2018 and the first dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, 0.5 ml, intramuscularly in the same right arm, lot # U5315AA, expiry date 29-APR-2018 for initial vaccination. On an unknown date in August 2016 (reported as "sometime afterwards"), the patient experienced bad reaction and sought medical attention in the emergency room at the hospital on 22-AUG-2016. The nurse described the bad reaction as "the right shoulder, more than halfway down the arm, was red, swollen, lumpy, painful, and swelling up towards neck and the neck was stiff". The nurse reported that, the physician prescribed treatment with prednisone (manufacturer unknown), albuterol breathing treatment, BENADRYL and epinephrine. The patient had lab diagnostic studies performed which included a complete metabolic panel and a complete blood count. The results showed elevated monocytes and eosinophils and also the lymphocytes were low. The patient was not admitted to the hospital and was sent home. At the time of this report, the patient was still recovering and was not in distress. The reporter did not provide the causality assessment between the events and M-M-R II and other suspect vaccine. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. From 01-JUN-2016 to 23-AUG-2016 the patients were vaccinated with improperly stored ROTATEQ (lot # M005733, Exp 01-OCT-2017, dose unknown) orally, which was exposed at 47 Fahrenheit for 2106 hours and 34 Fahrenheit for 2016 hours. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. From 01-JUN-2016 to 23-AUG-2016 the patients were vaccinated with improperly stored (wistar ra 27-3) M-M-R II ( lot # L041457, Exp 22-OCT-2017, dose and route unknown), which was exposed at 47 Fahrenheit for 2016 hours and 34 Fahrenheit for 2016 hours. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a male patient of unknown age who had not eaten. In August 2016, "last week", the patient was vaccinated with a dose of GARDASIL 9 (dose, route and lot # not reported). Concomitant therapies included MENVEO. The nurse reported that in August 2016, the patient seemed fine when waiting after the vaccine, but then stood up and passed out. The patient did not receive any type of medical treatment or hospitalization and recovered right away. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 25-JUL-2016, the patient was vaccinated with improperly stored M-M-R II lot # L029266, therapy type (albumin status) rHA, (dose, strength, route of administration and expiry date were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Dizzy and lightheaded for 3 minutes.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Patient developed rash on shoulder after receiving PREVNAR 13. Rash was still present 2 weeks later. Patient saw PCP and received a steroid shot.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: She developed a rash with blisters on her Right arm, Down her back and buttocks. Within the 1st 2 weeks of getting the shot. Went to Dr on 8-26-16 - Acyclovir 400 mg 2T PO 5 times every day times 7days - 8-26-16.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Persistent induration and erythema surrounding injection site on right thigh.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Had started on the evening vaccine was given then a large , red welt formed at the site of injection on Sunday after vaccine. Reports site is also itchy.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Cough, Rash, Swelling
Clinical narrative: 1.5 hours after getting vaccines patient broke out with a rash, swelling of ears. Rash to abdomen, hands, face, ears, bottom. Started with cough. Mom gave pt TYLENOL after onset of symptoms. Rash started resolving about 2 hours after onset.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fever to 103 degrees, fatigue, lethargy.  First call to nurse advice at 8:37 pm; actual start time not documented in notes, but fever started same day as vaccine.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Borrelia test negative, Fatigue, Lethargy, Pyrexia
Clinical narrative: Fever to 103 degrees, fatigue, lethargy.  First call to nurse advice at 8:37 pm; actual start time not documented in notes, but fever started same day as vaccine.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Staphylococcal infection
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 70 year old male patient with no pertinent medical history or drug reactions. The patient's historical drug included a dose of PREVNAR in 2015. On 21-AUG-2016, the patient was vaccinated with PNEUMOVAX 23 with lot # L022262 Expiration date: 05-NOV-2016, 0.5 ml, once, subcutaneous (indication reported as: age and previous administration of PREVNAR 1 year ago). Other suspect therapies included FLUZONE HD (Lot No. UI636AB Expiration date: 27-MAR-2017). Concomitant medications reported as "nothing new in his current medication therapy". On an unspecified date in 2016, the patient experienced "a red swollen arm" following the administration of PNEUMOVAX 23 and FLUZONE HD. The pharmacist reported that the patient was seen by a nurse practitioner at the physician's office on an unknown date in 2016. The pharmacist reported that the patient stated that the "nurse practitioner thought that it might be a Staph Cellulitis infection (cellulitis staphylococcal), but was some kind of bacterial infection that the patient received unspecified antibiotic shots for". The pharmacist reported that "the patient was not recovered and currently "is red and swollen down to his wrist". No Product Quality Complaint (PQC) was involved. Upon internal review the cellulitis staphylococcal was considered a medically significant event. The causality between PNEUMOVAX 23, FLUZONE HD and the event was not reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Bacterial infection, Cellulitis staphylococcal, Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 70 year old male patient with no pertinent medical history or drug reactions. The patient's historical drug included a dose of PREVNAR in 2015. On 21-AUG-2016, the patient was vaccinated with PNEUMOVAX 23 with lot # L022262 Expiration date: 05-NOV-2016, 0.5 ml, once, subcutaneous (indication reported as: age and previous administration of PREVNAR 1 year ago). Other suspect therapies included FLUZONE HD (Lot No. UI636AB Expiration date: 27-MAR-2017). Concomitant medications reported as "nothing new in his current medication therapy". On an unspecified date in 2016, the patient experienced "a red swollen arm" following the administration of PNEUMOVAX 23 and FLUZONE HD. The pharmacist reported that the patient was seen by a nurse practitioner at the physician's office on an unknown date in 2016. The pharmacist reported that the patient stated that the "nurse practitioner thought that it might be a Staph Cellulitis infection (cellulitis staphylococcal), but was some kind of bacterial infection that the patient received unspecified antibiotic shots for". The pharmacist reported that "the patient was not recovered and currently "is red and swollen down to his wrist". No Product Quality Complaint (PQC) was involved. Upon internal review the cellulitis staphylococcal was considered a medically significant event. The causality between PNEUMOVAX 23, FLUZONE HD and the event was not reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Bacterial infection, Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 70 year old male patient with no pertinent medical history or drug reactions. The patient's historical drug included a dose of PREVNAR in 2015. On 21-AUG-2016, the patient was vaccinated with PNEUMOVAX 23 with lot # L022262 Expiration date: 05-NOV-2016, 0.5 ml, once, subcutaneous (indication reported as: age and previous administration of PREVNAR 1 year ago). Other suspect therapies included FLUZONE HD (Lot No. UI636AB Expiration date: 27-MAR-2017). Concomitant medications reported as "nothing new in his current medication therapy". On an unspecified date in 2016, the patient experienced "a red swollen arm" following the administration of PNEUMOVAX 23 and FLUZONE HD. The pharmacist reported that the patient was seen by a nurse practitioner at the physician's office on an unknown date in 2016. The pharmacist reported that the patient stated that the "nurse practitioner thought that it might be a Staph Cellulitis infection (cellulitis staphylococcal), but was some kind of bacterial infection that the patient received unspecified antibiotic shots for". The pharmacist reported that "the patient was not recovered and currently "is red and swollen down to his wrist". No Product Quality Complaint (PQC) was involved. Upon internal review the cellulitis staphylococcal was considered a medically significant event. The causality between PNEUMOVAX 23, FLUZONE HD and the event was not reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Initial unsolicited report received from a non-healthcare person on 29 Aug 2016. This case involves a 50 years old female patient who was vaccinated with FLUZONE QUADRIVALENT (batch number: UT5629JA, expiry date: 30 Jun 2016, dose and dose in series not reported) via intramuscularly in right arm on 22 Aug 2016 at 05:00 PM. The patient previously had heart issues in the past with a quadruple bypass. It was also reported that patient had no illness at the time of vaccination. The patient concomitant medications include levothyroxine 112 mcg, Atorvastatin 40 mg, Lisinopril 10 mg and Metoprolol Tart 25 mg. On 22 Aug 2016 at 05:15 PM, 15-minute after vaccination the patient experienced arm with injection was painful and has persisted with numbness and tingling for greater than one week. (Symptoms come and go throughout the day). Laboratory investigations and corrective treatment were not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus
Clinical narrative: A hard knot  the size of a lime with a mild bruise in the middle developed with itchy red welts in an arc under the knot. The area was hot to the touch. While very itchy, it did not hurt. This knot and rash was at the location the shot was administered.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site rash, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: A hard knot  the size of a lime with a mild bruise in the middle developed with itchy red welts in an arc under the knot. The area was hot to the touch. While very itchy, it did not hurt. This knot and rash was at the location the shot was administered.
Age: 1.67
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis of male external genital organ, Ultrasound scan
Clinical narrative: Scrotal cellulitis and prescribed amoxicillin.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Abasia, Abdominal pain upper, Arthralgia, Asthenia, Chills
Clinical narrative: On 9/5/16 beginning at 2 pm patient was unable to walk and experienced a fever, headache, tiredness, muffled hearing, nausea, vomiting, stomach ache, chills, sore joints, body aches, rash, dizziness, weakness, fever blister. The following day she experienced diarrhea.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Hypoacusis
Clinical narrative: On 9/5/16 beginning at 2 pm patient was unable to walk and experienced a fever, headache, tiredness, muffled hearing, nausea, vomiting, stomach ache, chills, sore joints, body aches, rash, dizziness, weakness, fever blister. The following day she experienced diarrhea.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Oral herpes, Pain, Pyrexia, Rash
Clinical narrative: On 9/5/16 beginning at 2 pm patient was unable to walk and experienced a fever, headache, tiredness, muffled hearing, nausea, vomiting, stomach ache, chills, sore joints, body aches, rash, dizziness, weakness, fever blister. The following day she experienced diarrhea.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: On 9/5/16 beginning at 2 pm patient was unable to walk and experienced a fever, headache, tiredness, muffled hearing, nausea, vomiting, stomach ache, chills, sore joints, body aches, rash, dizziness, weakness, fever blister. The following day she experienced diarrhea.
Age: 1.08
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Apraxia, Autism, Central auditory processing disorder, Cerebral palsy, Developmental delay
Clinical narrative: Immediate onset after vaccination. Inconsolable screaming. Could not settle him. Drove home with him screaming, which stopped abruptly after 10 minutes or so. Took him from car seat, did not wake up. Put down for nap at 10am (when usually would wait till afternoon). At 12 noon, I tried to wake him up, could not stir him. Pulled up blind, turned on lights, made noise, still no response. At 3pm, he finally was able to respond and sit up, but then eyes rolled back and collapsed on his side. By 5 pm, he was more cognizant of his surroundings. I believe he was experiencing seizures. He subsequently stopped calling for me in the mornings, stopped word approximations, development slowed. He should have been in the hospital on the day of immunization, but it was my second child and I thought it would be better to wait it out at home rather than have 2 small children in the emergency room. Other subsequent diagnoses are epilepsy, autism, central auditory processing disorder, visual processing disorder, apraxia. His right side of his body presents more like a person with cerebral palsy, than autism.
Age: 1.08
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Emotional distress, Epilepsy, Eye movement disorder, Illusion, Immediate post-injection reaction
Clinical narrative: Immediate onset after vaccination. Inconsolable screaming. Could not settle him. Drove home with him screaming, which stopped abruptly after 10 minutes or so. Took him from car seat, did not wake up. Put down for nap at 10am (when usually would wait till afternoon). At 12 noon, I tried to wake him up, could not stir him. Pulled up blind, turned on lights, made noise, still no response. At 3pm, he finally was able to respond and sit up, but then eyes rolled back and collapsed on his side. By 5 pm, he was more cognizant of his surroundings. I believe he was experiencing seizures. He subsequently stopped calling for me in the mornings, stopped word approximations, development slowed. He should have been in the hospital on the day of immunization, but it was my second child and I thought it would be better to wait it out at home rather than have 2 small children in the emergency room. Other subsequent diagnoses are epilepsy, autism, central auditory processing disorder, visual processing disorder, apraxia. His right side of his body presents more like a person with cerebral palsy, than autism.
Age: 1.08
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Screaming, Seizure, Sensory processing disorder, Somnolence, Speech disorder
Clinical narrative: Immediate onset after vaccination. Inconsolable screaming. Could not settle him. Drove home with him screaming, which stopped abruptly after 10 minutes or so. Took him from car seat, did not wake up. Put down for nap at 10am (when usually would wait till afternoon). At 12 noon, I tried to wake him up, could not stir him. Pulled up blind, turned on lights, made noise, still no response. At 3pm, he finally was able to respond and sit up, but then eyes rolled back and collapsed on his side. By 5 pm, he was more cognizant of his surroundings. I believe he was experiencing seizures. He subsequently stopped calling for me in the mornings, stopped word approximations, development slowed. He should have been in the hospital on the day of immunization, but it was my second child and I thought it would be better to wait it out at home rather than have 2 small children in the emergency room. Other subsequent diagnoses are epilepsy, autism, central auditory processing disorder, visual processing disorder, apraxia. His right side of his body presents more like a person with cerebral palsy, than autism.
Age: 1.08
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Immediate onset after vaccination. Inconsolable screaming. Could not settle him. Drove home with him screaming, which stopped abruptly after 10 minutes or so. Took him from car seat, did not wake up. Put down for nap at 10am (when usually would wait till afternoon). At 12 noon, I tried to wake him up, could not stir him. Pulled up blind, turned on lights, made noise, still no response. At 3pm, he finally was able to respond and sit up, but then eyes rolled back and collapsed on his side. By 5 pm, he was more cognizant of his surroundings. I believe he was experiencing seizures. He subsequently stopped calling for me in the mornings, stopped word approximations, development slowed. He should have been in the hospital on the day of immunization, but it was my second child and I thought it would be better to wait it out at home rather than have 2 small children in the emergency room. Other subsequent diagnoses are epilepsy, autism, central auditory processing disorder, visual processing disorder, apraxia. His right side of his body presents more like a person with cerebral palsy, than autism.
Age: 30.0
Sex: M
Vaccine: DTAP
Symptoms: Dizziness, Eyelid injury, Lip injury, Syncope
Clinical narrative: Patient sat for a few minutes.  Felt fine.  Stood in line for a couple minutes and stated he felt dizzy and fainted where impact of floor caused gashes above eye and he bite through his lip.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Dizziness, Headache, Pain in extremity, Pain in jaw
Clinical narrative: Reported HA and dizziness with 1st dose, too. For Post-2nd dose: @10 minutes, patient reported headache (7/10) and dizziness. @15 minutes reported additional pain (slight) in the left wrist (same side as vaccine) but still felt "ok". @20 minutes reported pain in the jaw and a slight throat tickle. @25 minutes, no change. @30 minutes no change. @35 minutes, headache (8/10) but did not want to go to the ER. @40 minutes, felt a little better. @45 minutes, felt better. Still has headache and pain in arm but did not want to stay any longer. Recommended to go to ER if symptoms worsen or do not resolve.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Throat irritation
Clinical narrative: Reported HA and dizziness with 1st dose, too. For Post-2nd dose: @10 minutes, patient reported headache (7/10) and dizziness. @15 minutes reported additional pain (slight) in the left wrist (same side as vaccine) but still felt "ok". @20 minutes reported pain in the jaw and a slight throat tickle. @25 minutes, no change. @30 minutes no change. @35 minutes, headache (8/10) but did not want to go to the ER. @40 minutes, felt a little better. @45 minutes, felt better. Still has headache and pain in arm but did not want to stay any longer. Recommended to go to ER if symptoms worsen or do not resolve.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Blindness unilateral, Nuclear magnetic resonance imaging, Ophthalmological examination, Vision blurred, Visual impairment
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 29 August 2016. This case involves a 55-year-old female (reported as 56 year old) patients who was vaccinated with a dose of ADACEL (batch number- U5279AA, expiry date: 18 March 2018) intramuscularly in the right deltoid on 10 June 2016. Patient's illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions included: no known allergies, none. Concomitant medications were not reported. On 11 June 2016, one day following the vaccination, the patient experienced vision in right eye became blurry and 48 hours later, patient could not see from right eye. The patient received IV steroids for 3 days as corrective treatment and vision returned partially, then one week later began to diminish, treated with oral prednisone, with partial return of vision, on prednisone until last month in july 2016. The patient was seen by neurologist and referred to opthalmal neurologist for late September. The patient was seen by ophthalmologist (ophtlamologist) MRI and eye exam. The outcome of the events was reported as not recovered. Upon internal review the case was considered as serious because of important medical event: could not see from right eye. List of documents held by sender: none.; Sender's Comments: Could not see from right eye is unlisted with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Time to onset is compatible with the role of the vaccine. This is poorly documented case. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Right upper arm from forearm to shoulder red, hard, and swollen. Child taken to Emergency Room at 5:30 PM and given oral Benadryl, and continued daily Benadryl through Sunday 9-4-16.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Peripheral swelling
Clinical narrative: Right upper arm from forearm to shoulder red, hard, and swollen. Child taken to Emergency Room at 5:30 PM and given oral Benadryl, and continued daily Benadryl through Sunday 9-4-16.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Vulvar dysplasia
Clinical narrative: This spontaneous report as received from a physician, via a company representative, refers to a currently 26-year-old female patient. The patient's medical history, drug reactions or allergies were not reported. In approximately 2006 (reported as 10 years ago), at approximately 16 years old the patient was vaccinated with a dose of GARDASIL (lot #, dose, route and site of administration were not reported). Concomitant medications were not reported. On an unknown date, the patient developed vulvar dysplasia (also reported as bulbar dysplasia) and had 4 unspecified procedures for her condition. The outcome of vulvar dysplasia was reported as not recovered at the time of the report. The relatedness between the event and GARDASIL was not reported.  Upon internal review, the event of vulvar dysplasia was considered to be medically significant. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Head injury, Immediate post-injection reaction, Inappropriate schedule of drug administration, Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an 18 year old male patient with no pertinent medical history. The patient's drug reactions or allergies were not reported. On 20-SEP-2012 and 23-SEP-2013, the patient was vaccinated with the first and the second dose of GARDASIL 9 (dose, route, lot # and expiry date were not reported), respectively. On 01-SEP-2016, he was vaccinated intramuscularly with the third 0.5 ml  dose of GARDASIL 9 (lot # M018810, expiry date 28-MAY-2018).  Concomitant therapies included tuberculin purified protein derivative (PPD) and unspecified medication reported as "Mendeo". On 01-SEP-2016, immediately after getting the third dose of GARDASIL 9, the patient fainted, "fell head first from the table" and hit his head. Right after this event, in the office, they tried to wake up the patient by administering him oxygen and ammonia. The patient's blood pressure was measured twice in the office with the first result of 107/58 (unit not provided) and the second result of 117/68 (unit not provided). The office called the emergency number and the patient was sent to hospital on the same day. At the time of report, the patient was still in the hospital and he did not recover. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested