chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-JAN-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L016429, expiration date: 09-AUG-2017; dose and route of administration were not provided). The vaccine underwent a temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Sex: F
Vaccine: HPV4, UNK
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report was received from a nurse and refers to a female patient of unknown age. There was no information regarding the patient's pertinent medical history and drug reactions or allergies provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date and dose were not reported), intramuscularly in the dorsogluteal region. The nurse explained that the patient received 3 other unspecified vaccines at the same time and there was nowhere to put them all. No adverse symptoms were reported. Additional information is not expected as there was no consent for follow-up.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certificated medical assistant and refers to 2 patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On 29-AUG-2016, the patients were vaccinated with an improperly stored dose of GARDASIL 9 lot # L038503, expiration date 18-DEC-2017 (dose, frequency, route of administration were not reported). The patients' concomitant therapy was not reported. The administered dose of vaccine was exposed to a temperature of 12.2 degree Celsius, for 1 hour 49 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of the 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 certificated medical assistant and refers to patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 31-AUG-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L038503, expiration date 18-DEC-2017 (dose, frequency, route of administration were not reported). The patient's concomitant therapy was not reported. The administered dose of vaccine was exposed to a temperature of 12.2 degree Celsius, for 1 hour 49 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an 18-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-JAN-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L016429, expiration date: 09-AUG-2017; dose and route of administration were not provided). The vaccine underwent a temperature excursion of either +1 or -1 degrees Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Heart rate increased, Hypersensitivity
Clinical narrative: Patient experienced shortness of breath and increased heart way hours after recieving the flu vaccination. She went to the emergency room and was treated appropriately. She was told that these symptoms were an allergic reaction to the flu vaccination that she had received earlier that day.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 17-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-FEB-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L027282, expiration date: 21-SEP-2017; dose and route of administration were not provided). The vaccine underwent a temperature excursion of either +1 or -1 degrees Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-FEB-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L027282, expiration date: 21-SEP-2017; dose and route of administration were not provided). The vaccine underwent a temperature excursion of either +1 or -1 degrees Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 15-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-FEB-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L027282, expiration date: 21-SEP-2017; dose and route of administration were not provided). The vaccine underwent a temperature excursion of either +1 or -1 degrees Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several hours received from the same reporter. Additional information is not expected, as all required information has been received.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 11-SEP-2016, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 injection, lot # K012424, expiration date: 05-JUN-2016, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. On the same date, the patient also experienced "soreness" at the injection site. The outcome of injection site pain was unknown at the time of the report. The relatedness between the event and PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
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 medical history, concurrent condition and concomitant therapy were not reported. On 14-AUG-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # L049744, expiration date 12-OCT-2017, dose and route not reported). The vaccine was improperly stored at 55 degree Fahrenheit (F) for 16 days, 47.8 F for 13 hours, 50 F for 32 hours and then 47.8 F for 4 hours. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an administrator refers to a patient of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On an unknown date the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (lot# 1018503 and expiration date 16-APR-2017)(dosing regimen and frequency unknown). No adverse effect reported. No product quality complaint (PQC) filed. 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 certificated medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 26-AUG-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L038503, expiration date 18-DEC-2017 (dose, frequency, route of administration were not reported). The administered dose of vaccine was exposed to a temperature of 12.2 degree Celsius, for 1 hour 49 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (patient's grandmother) refers to a 4 month old patient of unknown gender. On 01-SEP-2016 the patient was vaccinated with two doses of PEDVAXHIB. No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 29-JUL-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L008057, expiration date 01-DEC-2016, dose and route were unknown). The vaccine was stored under 0.4 degree centigrade for 18 hours. It was called because of a data logger. There was no previous temperature excursion. No adverse effect was reported. No PQC was involved. This is one of three reports received 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 certified medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # L039092, expiry date 06-OCT-2017, lot # L043622, expiry date 03-NOV-2017, lot # M004326, expiry date 25-JAN-2018 (dose, route and site of administration were not reported). There were no known adverse effects. The vaccines experienced temperature excursion of -5.2 degrees Celsius for 50 hours 17 minutes. This is one of several reports received from the same source. Follow up information has been received from the registered nurse on 07-SEP-2016. Patients' identifiers and dates of vaccination were unavailable at the time of the call. The nurse reported that there was no patient who had reported issues following GARDASIL 9 administration. This report refers to a patient of unknown age and gender. On 24-MAY-2016, the patient was vaccinated with improperly stored dose of VAQTA lot # K008333 or M011116. On 23-JUN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ orally, lot# L035511, K022993 or L029618 (dose was not reported). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous repro was received from a certificated medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 26-AUG-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # M012495, expiration date 09-OCT-2017 (dose, frequency, route of administration were not reported). The patient's concomitant therapy was not reported. The administered dose of vaccine was exposed to a temperature of 12.2 degree Celsius, for 1 hour 49 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
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 medical history, concurrent condition and concomitant therapy were not reported. On 15-AUG-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # L049744, expiration date 12-OCT-2017, dose and route not reported). The vaccine was improperly stored at 55 degree Fahrenheit (F) for 16 days, 47.8 F for 13 hours, 50 F for 32 hours and then 47.8 F for 4 hours. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old male patient with no drug reactions or allergies. The patient's pertinent medical history included diabetes type 2. On 27-AUG-2016 (also reported as "Saturday"), the patient was vaccinated with a dose of ZOSTAVAX (19400 plaque-forming units, PFU) (lot # L040445, expiration date: 15-JAN-2017) injected subcutaneously in the right arm. The patient was taking VICTOZA and metformin concomitantly. On 28-AUG-2016 (also reported as "Sunday"), the patient noticed that his right arm appeared to be sunburned "from the elbow down to his hand". On 29-AUG-2016 (also reported as "Monday"), the patient began to experience itching on his right arm. He reported that he applied triamcinolone cream on the affected area, but he did not specify whether or not he experienced any relief from the triamcinolone cream. There were no laboratory diagnostic studies performed. The reporting pharmacist stated that there was no rash present. The patient was not experiencing fever and he had not recovered at the time of the report. The reporter did not provide causal relationship between aforementioned events and the vaccination with ZOSTAVAX. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 31-AUG-2016, the patient was vaccinated with an improperly stored dose of VAQTA lot # M017982, expiration date 13-SEP-2017 (dose, frequency, route of administration were not reported). The patient's concomitant therapy was not reported. The administered dose of vaccine of exposed to a temperature of 12.2 degree Celsius, for 1 hour 49 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This spontaneous report as received from a physician refers to a 62 year old female patient. Her pertinent medical history included hypothyroidism and gastritis. She was allergic to cholestatin. On 01-AUG-2016, the patient was vaccinated with ZOSTAVAX (dose not reported) lot # L032184, subcutaneous. Concomitant therapies included SYNTHROID and ZANTAC. On 01-AUG-2016, the patient experienced myalgia and muscle pain. The patient sought medical attention. Treatment was given for the event (details were not reported). It was reported that the patient still has symptoms since the injection. The causal relationship between the event and the drug was not reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 68 year old female patient reporting on herself. The patient's medical history included two hip replacements of her left hip. The patient's concurrent conditions included allergies to shellfish, bees and wasps. Concomitant therapies included LIDODERM, VALTREX and biotin. On 03-DEC-2010, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, lot # and expiration date were not reported). On 06-SEP-2016 (reported as today), the patient called to report that, on an unknown date, she developed shingles again. She stated this would be 7th time she had had shingles since taking the ZOSTAVAX, but she reported it for the first time. The patient got shingles in the same area each time - in her left hip and left buttock area. The patient's physician confirmed that the first seven episodes of shingles was on 28-JUN-2012 and stated that the patient's constant recurrence of shingles was a mild version. There was a treatment for the adverse event given. The patient sought medical attention. There was no laboratory tests performed. The outcome of shingles was not reported. The relatedness between the ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, 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 history, drug reactions/allergies and concomitant medication were not provided. On an unknown date, the patient received ZOSTAVAX (lot #, expiration date and dose were unknown) intramuscularly rather then subcutaneously. No adverse effects were reported. Additional information has been requested.
Age: 21.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 21-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-MAY-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L026602, expiration date: 19-OCT-2017; dose and route of administration were not provided). The vaccine underwent a temperature excursion of either +1 or -1 degrees Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from same reporter. Additional information is not expected, as all required information has been received.
Age: 38.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 38-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-APR-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L026602, expiration date: 19-OCT-2017; dose and route of administration were not provided). The vaccine underwent a temperature excursion of either +1 or -1 degrees Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 31-AUG-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot # L016284 with an expiration date on 07-AUG-2016; dose and route of administration were not provided). There was no adverse effect reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site burning in an unspecified number of patient who received FLUARIX TETRA. On an unknown date, the patients received FLUARIX TETRA at an unknown dose. On an unknown, immediately after receiving FLUARIX TETRA, the patients experienced injection site burning. On an unknown date, the outcome of the injection site burning was unknown. The reporter considered the injection site burning to be related to FLUARIX TETRA. Additional details were provided as follows: The age at vaccination for the patients was not reported. The reporter had noticed a high percentage of patients who had received the FLUARIX QUADRIVALENT vaccine via the prefilled syringes for the 2016-2017 season and had experienced local injection site reactions including itching, burning, redness, swelling and hot feeling (refer case US2016132082). The patients concerned in this case had experienced only burning as the vaccine was being administered. The field representative was unable to provide any further details at the time of the call. The field representative was unable to provide any further details at the time of the call. The field representative was unable to provide any further details at the time of the call. The field representative indicated that this practice was a new user of the FLUARIX QUADRIVALENT product and had only been using the product for approximately two weeks before the time of reporting. He was also going to contact Medical Information.
Age: 0.8
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a 10 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 25-FEB-2014, the patient was vaccinated with a booster dose of PEDVAXHIB (lot # reported as j011964 with expiration date 19-JUN-2016; dose and route were not reported) at 10 months of age (inappropriate schedule of drug administration). No adverse reactions were reported. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 12-SEP-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M013636, expiration date 15-FEB-2018, dose and route were unknown). The vaccine was stored under 0.4 degree Centigrade for 18 hours. It was called because of a data logger. There was no previous temperature excursion. No adverse effect was reported. No PQC was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. Approximately on 04-SEP-2016 (reported as "5 days ago"), the patient was vaccinated with ZOSTAVAX (lot #, expiry date, dose, strength, dose number, vaccination site, route not provided). It was reported that, approximately in September 2016, the patient was prescribed with unspecified antibiotics and unspecified steroids after vaccination of ZOSTAVAX for an unknown reason (Adverse event). The outcome of adverse event was unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M011117, expiration date 07-DEC-2017 (dose and route of administration were not reported). There were no symptoms reported. Administered dose of vaccine experienced the temperature excursion of 47.7 degrees Fahrenheit for 36 minutes. Data logger was involved. There were previous excursions of 46.7 degrees Fahrenheit for 19 minutes and of 63 degrees Fahrenheit for 5 hours and 15 minutes. Additional information has been requested.
Sex: U
Vaccine: HEPA, RV5, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients or unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # L039092, expiry date 06-OCT-2017, lot # L043622, expiry date 03-NOV-2017, lot # M004326, expiry date 25-JAN-2018 (dose, route and site of administration were not reported). There were no known adverse effects. The vaccines experienced temperature excursion of -5.2 degrees Celsius for 50 hours 17 minutes. This is one of several reports received from the same source. Follow up information has been received from the registered nurse on 07-SET-2016. Patients' identifiers and dates of vaccination were unavailable at the time of the call. The nurse reported that there was no patient who had reported issues following GARDASIL 9 administration. This report refers to a patient of unknown age and gender. On 23-JUN-2016 the patient was vaccinated with improperly stored doses of VARIVAX lot # L039092 or L043622 or M004326, VAQTA Lot# M011116 or K008333 and ROTATEQ orally Lot#L035511, K022993 or L029618 (doses were not reported). Additional information has been requested.
Age: 1.17
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Eye swelling, Irritability, Rhinorrhoea
Clinical narrative: Received 15mo vaccines on 9/16. Mom called our office 9/17/16 patient cranky, eyes swollen, clear nasal drainage, no cough. Mom reported same symptoms occurred last time vaccines given. Mom did not call at that time. All symptoms improved on 9/18-9/19.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Prolonged Fever, Tmax 104.9 for 5 days after vaccination. (Doing well this morning 9/20/16).
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site vesicles
Clinical narrative: Blisters at injection site.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Initial unsolicited report received from a consumer on 10-SEP-2016. This case involves a 76-year-old female patient who was vaccinated with a dose of FLUZONE HD batch number: UI636AA, expiration date: 27-MAR-2017, intramuscularly, in the right deltoid on 09-SEP-2016. Patient received a previous dose of FLUZONE HD on an unspecified date in 2015 any adverse event with the vaccination was not reported. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as denied to provide. Concomitant medications were not reported. On 10-SEP-2016, one day following the vaccination, the patient had a 2 inch area of redness 6 inches below the injection site. It was reported that there is nothing at the injection site itself. Lab data and corrective treatment were not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Migraine, Nausea, Salivary hypersecretion
Clinical narrative: Employee stated she started to feel dizzy, nauseated, severe migraine and salivating 15 minutes after her injection. Blood pressure was 131/87 pulse 67. Employee was transported EMS.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Fever, swelling to right arm, heat to right arm, pain to right arm.
Age: 18.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: Patient suffered two seizures. No history of seizures in the past. Spent 3 days in the hospital. Now has to take medication for two years.
Age: 18.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Patient suffered two seizures. No history of seizures in the past. Spent 3 days in the hospital. Now has to take medication for two years.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Severe arm soreness then the next day she noted increased redness, swelling that extended lower in the upper arm and around the back.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Computerised tomogram normal, Decreased eye contact, Dyskinesia, Opisthotonus, Seizure
Clinical narrative: Pt. mother states on 9/15/16 9:30AM pt. right side of face, head, fists seized hard and shook. No fever, short episode. 9/16/16 mother states pt had the same episode and flailing backward, no eye contact; tongue going back and forth in and out of mouth. Went to ER had a CAT scan. Later 9/16/16 at night lips curling over teeth and tongue at top of mouth. Tongue muscle was noted to wave. Multiple events, longer up to 30 mins. Stomach muscle has a wave.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Tongue movement disturbance, Tremor
Clinical narrative: Pt. mother states on 9/15/16 9:30AM pt. right side of face, head, fists seized hard and shook. No fever, short episode. 9/16/16 mother states pt had the same episode and flailing backward, no eye contact; tongue going back and forth in and out of mouth. Went to ER had a CAT scan. Later 9/16/16 at night lips curling over teeth and tongue at top of mouth. Tongue muscle was noted to wave. Multiple events, longer up to 30 mins. Stomach muscle has a wave.
Age: 27.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Sore, hot, red, swollen area of upper outer right arm. 60x60 mm at the widest/longest sections of the irregular area where varicella vaccine given.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Headache, Malaise, Swollen tongue
Clinical narrative: 10 minutes after administering her flu shot she reported not feeling well. She stated to she felt sick and I had her sit down. After 20 minutes she stated that her head was severely aching and that her tongue felt like it was swelling. She then stated that she was having difficulty breathing. Her face looked red and at that point I gave her an EPIPEN injection and called 911.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to unspecified number of patients of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored (temperature 33F for 90 days) doses of VAQTA strength: 25/0.5 (units not involved), lot # L015460 with expiry date 20-JUL-2017 (dose, strength, route, vaccination site unspecified). Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a 4 year old female patient with no known drug allergy. The patient had no illness at time of vaccination. The patient's birth weight was 6 lb and has two siblings. Concomitant therapies included VARIVAX and KINRIX. On 25-MAY-2016 at 09:08, the patient was vaccinated with M-M-R II lot # reported as L0428218 dose 2, subcutaneously in the right thigh. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Patient got a rash on the arm that the injections were given. Started as a small red spot then began to spread to the entire upper arm. She states it itches and hurts. Arm was still red at time of this report.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Chest X-ray abnormal, Chills, Computerised tomogram, Computerised tomogram thorax abnormal
Clinical narrative: On Aug. 16, 2016 I went to see my Primary Doctor - for my Diabetic check-up. My appointment was at 11:00 A.M. She was pleased with all my lab results, checked my feet, heart, lungs, Blood Pressure (a little high), temperature, etc. Everything was good and before she left the room, Doctor said she was giving me a new pneumonia shot, (PCV 13). Nothing was discussed, as to what reaction, if any I could have, so I thought is was a regular pneumonia shot. The Doctor left and her asst. (she was new to me and I can't remember her name) came in and gave me the PCV 13 shot in my left arm, handed me my papers and said to see Dr. in 6 months. My sister, was with me and we left the office a little before 12:00 p.m. We went to lunch and within an hour, I was feeling cold, tired and not very hungry. By the time (4:00 P.M.) I arrived home I had the chills and was very sleepy. The next day, Aug 17th, early morning hours, I started coughing, was hot and cold and ran a fever (102-103 degrees) and I only ate to take my diabetic meds. I think it was on Aug 19th that I called and reported my symptoms to my Dr. Doctor never called me back and I wasn't getting any better, in fact I was having trouble breathing. I called and got an appointment to see a Nurse Practitioner on Aug 30th 10:40 A.M. She sent me to the emergency room right away. They did an X-Ray and CAT Scan of my lungs, blood work, urine test and put me on oxygen. They told me I had right lung pneumonia and transported me to medical center on Aug 30th, 2016. I was discharged, on 9-4-16 around 12:00 P.M. and the discharge papers said I had pneumonia of right middle lobe due to infectious organism. Since I am never sick, I don't even get a cold and have never ran a reaction to any shot I was given (I get a flu shot every year and even got the swine flu shot, years ago). This reaction has really thrown me for a loop. I still have a cough and feel run down. I have an appointment with Dr. on Tue. 9-27-16 at 11:20 A.M. I hope I am feeling better. I know in my heart this shot made me sick, since I am never sick and within 4 hours of getting this shot, I was ill. I just wonder how many other cases there have been. I hope I will make a full recovery.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Decreased appetite, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: On Aug. 16, 2016 I went to see my Primary Doctor - for my Diabetic check-up. My appointment was at 11:00 A.M. She was pleased with all my lab results, checked my feet, heart, lungs, Blood Pressure (a little high), temperature, etc. Everything was good and before she left the room, Doctor said she was giving me a new pneumonia shot, (PCV 13). Nothing was discussed, as to what reaction, if any I could have, so I thought is was a regular pneumonia shot. The Doctor left and her asst. (she was new to me and I can't remember her name) came in and gave me the PCV 13 shot in my left arm, handed me my papers and said to see Dr. in 6 months. My sister, was with me and we left the office a little before 12:00 p.m. We went to lunch and within an hour, I was feeling cold, tired and not very hungry. By the time (4:00 P.M.) I arrived home I had the chills and was very sleepy. The next day, Aug 17th, early morning hours, I started coughing, was hot and cold and ran a fever (102-103 degrees) and I only ate to take my diabetic meds. I think it was on Aug 19th that I called and reported my symptoms to my Dr. Doctor never called me back and I wasn't getting any better, in fact I was having trouble breathing. I called and got an appointment to see a Nurse Practitioner on Aug 30th 10:40 A.M. She sent me to the emergency room right away. They did an X-Ray and CAT Scan of my lungs, blood work, urine test and put me on oxygen. They told me I had right lung pneumonia and transported me to medical center on Aug 30th, 2016. I was discharged, on 9-4-16 around 12:00 P.M. and the discharge papers said I had pneumonia of right middle lobe due to infectious organism. Since I am never sick, I don't even get a cold and have never ran a reaction to any shot I was given (I get a flu shot every year and even got the swine flu shot, years ago). This reaction has really thrown me for a loop. I still have a cough and feel run down. I have an appointment with Dr. on Tue. 9-27-16 at 11:20 A.M. I hope I am feeling better. I know in my heart this shot made me sick, since I am never sick and within 4 hours of getting this shot, I was ill. I just wonder how many other cases there have been. I hope I will make a full recovery.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling cold, Feeling of body temperature change, Pneumonia, Pyrexia, Somnolence
Clinical narrative: On Aug. 16, 2016 I went to see my Primary Doctor - for my Diabetic check-up. My appointment was at 11:00 A.M. She was pleased with all my lab results, checked my feet, heart, lungs, Blood Pressure (a little high), temperature, etc. Everything was good and before she left the room, Doctor said she was giving me a new pneumonia shot, (PCV 13). Nothing was discussed, as to what reaction, if any I could have, so I thought is was a regular pneumonia shot. The Doctor left and her asst. (she was new to me and I can't remember her name) came in and gave me the PCV 13 shot in my left arm, handed me my papers and said to see Dr. in 6 months. My sister, was with me and we left the office a little before 12:00 p.m. We went to lunch and within an hour, I was feeling cold, tired and not very hungry. By the time (4:00 P.M.) I arrived home I had the chills and was very sleepy. The next day, Aug 17th, early morning hours, I started coughing, was hot and cold and ran a fever (102-103 degrees) and I only ate to take my diabetic meds. I think it was on Aug 19th that I called and reported my symptoms to my Dr. Doctor never called me back and I wasn't getting any better, in fact I was having trouble breathing. I called and got an appointment to see a Nurse Practitioner on Aug 30th 10:40 A.M. She sent me to the emergency room right away. They did an X-Ray and CAT Scan of my lungs, blood work, urine test and put me on oxygen. They told me I had right lung pneumonia and transported me to medical center on Aug 30th, 2016. I was discharged, on 9-4-16 around 12:00 P.M. and the discharge papers said I had pneumonia of right middle lobe due to infectious organism. Since I am never sick, I don't even get a cold and have never ran a reaction to any shot I was given (I get a flu shot every year and even got the swine flu shot, years ago). This reaction has really thrown me for a loop. I still have a cough and feel run down. I have an appointment with Dr. on Tue. 9-27-16 at 11:20 A.M. I hope I am feeling better. I know in my heart this shot made me sick, since I am never sick and within 4 hours of getting this shot, I was ill. I just wonder how many other cases there have been. I hope I will make a full recovery.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Urine analysis
Clinical narrative: On Aug. 16, 2016 I went to see my Primary Doctor - for my Diabetic check-up. My appointment was at 11:00 A.M. She was pleased with all my lab results, checked my feet, heart, lungs, Blood Pressure (a little high), temperature, etc. Everything was good and before she left the room, Doctor said she was giving me a new pneumonia shot, (PCV 13). Nothing was discussed, as to what reaction, if any I could have, so I thought is was a regular pneumonia shot. The Doctor left and her asst. (she was new to me and I can't remember her name) came in and gave me the PCV 13 shot in my left arm, handed me my papers and said to see Dr. in 6 months. My sister, was with me and we left the office a little before 12:00 p.m. We went to lunch and within an hour, I was feeling cold, tired and not very hungry. By the time (4:00 P.M.) I arrived home I had the chills and was very sleepy. The next day, Aug 17th, early morning hours, I started coughing, was hot and cold and ran a fever (102-103 degrees) and I only ate to take my diabetic meds. I think it was on Aug 19th that I called and reported my symptoms to my Dr. Doctor never called me back and I wasn't getting any better, in fact I was having trouble breathing. I called and got an appointment to see a Nurse Practitioner on Aug 30th 10:40 A.M. She sent me to the emergency room right away. They did an X-Ray and CAT Scan of my lungs, blood work, urine test and put me on oxygen. They told me I had right lung pneumonia and transported me to medical center on Aug 30th, 2016. I was discharged, on 9-4-16 around 12:00 P.M. and the discharge papers said I had pneumonia of right middle lobe due to infectious organism. Since I am never sick, I don't even get a cold and have never ran a reaction to any shot I was given (I get a flu shot every year and even got the swine flu shot, years ago). This reaction has really thrown me for a loop. I still have a cough and feel run down. I have an appointment with Dr. on Tue. 9-27-16 at 11:20 A.M. I hope I am feeling better. I know in my heart this shot made me sick, since I am never sick and within 4 hours of getting this shot, I was ill. I just wonder how many other cases there have been. I hope I will make a full recovery.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to unspecified number of patients of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored (temperature 33F for 90 days) doses of ROTATEQ of lot # L039638 with expiry date 23-AUG-2017 (dose, strength, route, vaccination site unspecified). Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to unspecified number of patients of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored (temperature 33F for 90 days) doses of RECOMBIVAX HB of lot # M000442 with expiry date 31-MAR-2018 (dose, strength, route, vaccination site unspecified). Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to 2 patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On 26-AUG-2016, the patients were vaccinated with an improperly stored dose of VAQTA lot # M017982, expiration date 13-SEP-2017 (dose, frequency, route of administration were not reported). The patients' concomitant therapy was not reported. The administered dose of vaccine was exposed to a temperature of 12.2 degree Celsius, for 1 hour 49 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to 4 patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On 31-AUG-2016, the patients were vaccinated with an improperly stored dose of ROTATEQ lot # M012495, expiration date 09-OCT-2017, route of administration defaulted to oral (dose and frequency were not reported). The patients' concomitant therapy was not reported. The administrated dose of vaccine was exposed to a temperature of 12.2 degree Celsius, for 1 hour 49 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of the 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 an office manager refers to unspecified number of patients of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored (temperature 33F for 90 days) doses of GARDASIL 9 of lot # L026602 with expiry date 19-OCT-2017 (dose, strength, route, vaccination site unspecified). Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.