chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, drug reactions, allergies and concurrent conditions were not reported. On unknown day in June 2016, (reported as "one day this week on an unspecified date") the patient was vaccinated with a one dose of improperly stored VARIVAX lot # L046888, expiration date: 23-NOV-2017, (route of administration, anatomical location and dose were not reported). Concomitant therapies were 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 nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 06-MAY-2016, the patient was vaccinated with GARDASIL 9 (lot # L043213, expiry date: 23-AUG-2017) that was improperly stored. The vaccine was stored in refrigerator at a temperature of 14.2UC for 8 hours 30 minutes and at 1.5 UC for 26 hours 30 minutes and in freezer at a temperature of -12UC for 8 hours 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report was received from a nurse refers to an currently 72 year old female patient of an unknown age. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 04-NOV-2009, the patient was vaccinated with PNEUMOVAX 23 injection (lot number and dosage not reported). On an unknown date, the patient developed a large, local, red and itchy rash at the injection site. The outcome of all the events was unknown. The reporter did not provide any causality assessment between events and PNEUMOVAX 23. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Large red rash around injection site that became itchy within 24 hours of injection. Reported back to pharmacy on 6/28 where pharmacist directed patient to apply Benadryl cream topically 2-3 times daily until resolved. Rash reduced to quarter size and less itchy upon follow-up on 7/1.
Age: 66.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint stiffness, Lymphadenopathy
Clinical narrative: Patient reports joint pain and stiffness as well as swelling of glands.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a health care student concerning a patient of unknown age. On 01-JAN-2013, the patient was vaccinated with ZOSTAVAX (dose, frequency, lot number and expiry date unspecified), subcutaneously. On 10-JUN-2016, the patient was inadvertently vaccinated with a second dose of ZOSTAVAX lot # L034726, expiry date: 09-DEC-2016. No adverse effects reported. No further details provided. 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 licensed practical nurse refers to multiple patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies provided. On multiple unspecified dates, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (lot# L000610 with expiration date 31-JAN-2017, dose, anatomical location and route of administration were not reported). It was also reported that the first improperly stored doses were administered on 15-JUL-2015. The reporting nurse stated that the products were exposed to a low temperature of 33 Fahrenheit for an unknown amount of time. On an unknown dates, there were multiple excursions for these product encompassing various lot numbers (some of which were exhausted). No adverse effects were reported. This is one of several reported received from the same reporter. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies provided. On multiple unspecified dates, the patients were vaccinated with an improperly stored doses of GARDASIL (lot# K007264 with expiration date 02-MAR-2017, dose, anatomical location and route of administration were not reported). It was also reported that the first improperly stored doses were administered on 12-DEC-2014. The reporting nurse stated that the products were exposed to a low temperature of 33 Fahrenheit for an unknown amount of time. there were multiple excursions for these product encompassing various lot numbers (some of which were exhausted). No adverse effects were reported. This is one of several reported received from the same reporter. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies provided. On multiple unspecified dates, the patients were vaccinated with an improperly stored doses of ROTATEQ (lot # L033545 with expiration date 30-MAY-2017, dose was not reported, orally). It was also reported that the first improperly stored doses were administered on 04-DEC-2014. The reporting nurse stated that the products were exposed to a low temperature of 33 Fahrenheit for an unknown amount of time. On an unknown dates, there were multiple excursions for these product encompassing various lot numbers (some of which were exhausted). No adverse effects were reported. This is one of several reported received from the same reporter.  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 as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 04-MAY-2016, the patient was vaccinated with GARDASIL 9 (lot # L043213, expiry date: 23-AUG-2017) that was improperly stored. The vaccine was stored in refrigerator at a temperature of 14.2UC for 8 hours 30 minutes and at 1.5 UC for 26 hours 30 minutes and in freezer at a temperature of -12UC for 8 hours 30 minutes. There was  no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PROQUAD (lot # M007965, therapy type rHA, expiration date 15-AUG-2017, and lot # L031603, therapy type rHA, expiration date 18-FEB-2018, strength, dose, frequency and route were not reported). The vaccine has been stored under temperature of -10.6 degree for 30 hours. Data logger had been involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Hypoaesthesia, Muscle spasms, Pain in extremity
Clinical narrative: Numbness of vaccinated arm about 5 minutes after, convulsing of the bicep and/or tricep muscle for about 10 minutes, then distinct soreness for approximately two hours and mild soreness for 24 hours.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Symptoms included redness and swelling at site of administration. Sharp pain radiated from site to elbow. General chills followed.  It was warm on contact.  Currently redness is decreased and site is getting better.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Carotid pulse abnormal, Computerised tomogram head normal, Disorientation, Dizziness, Dyspnoea
Clinical narrative: Immediately after HPV9 vaccine. Pt reported "I'm going to pass out". Helped pt to lie down on bed and had mom call for help. Pt body became rigid, lost consciousness, labored, shallow breathing, strong carotid pulse. Urinated on bedding. LOC for apprx 1 min. When regained consciousness very tearful, disoriented, sleepy. Pt taken to hospital via ambulance.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Electroencephalogram normal, Fibrin D dimer, Full blood count, Hypopnoea, Immediate post-injection reaction
Clinical narrative: Immediately after HPV9 vaccine. Pt reported "I'm going to pass out". Helped pt to lie down on bed and had mom call for help. Pt body became rigid, lost consciousness, labored, shallow breathing, strong carotid pulse. Urinated on bedding. LOC for apprx 1 min. When regained consciousness very tearful, disoriented, sleepy. Pt taken to hospital via ambulance.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Metabolic function test, Muscle rigidity, Somnolence, Tearfulness
Clinical narrative: Immediately after HPV9 vaccine. Pt reported "I'm going to pass out". Helped pt to lie down on bed and had mom call for help. Pt body became rigid, lost consciousness, labored, shallow breathing, strong carotid pulse. Urinated on bedding. LOC for apprx 1 min. When regained consciousness very tearful, disoriented, sleepy. Pt taken to hospital via ambulance.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Urinary incontinence, Urine analysis
Clinical narrative: Immediately after HPV9 vaccine. Pt reported "I'm going to pass out". Helped pt to lie down on bed and had mom call for help. Pt body became rigid, lost consciousness, labored, shallow breathing, strong carotid pulse. Urinated on bedding. LOC for apprx 1 min. When regained consciousness very tearful, disoriented, sleepy. Pt taken to hospital via ambulance.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Erythema, Swelling
Clinical narrative: Minimal redness and swelling.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Fall, Headache, Hyperhidrosis, Pallor, Presyncope
Clinical narrative: After receiving HPV vaccination having a near syncopal episode and fall while checking out of the office. She initially complained of a headache but denied any neck pain. She was raised to a seated position a wheelchair and brought into an examination room. After receiving HPV vaccine #2 she was pale, diaphoretic, with a weak pulse. She was brought to a reclined position with improvement in color and strength in pulse. Water intake has been low on the 90° day. Patient observed for 15 minutes. She was placed in a supine position with elevation of her legs with resolution of her symptoms. She drank apple juice with complete return to normal baseline. Headache symptoms resolved. No cardiac findings on exam or neurologic findings. She is released to home and will monitor for any further symptoms. Recommend increasing fluid intake.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Pulse abnormal
Clinical narrative: After receiving HPV vaccination having a near syncopal episode and fall while checking out of the office. She initially complained of a headache but denied any neck pain. She was raised to a seated position a wheelchair and brought into an examination room. After receiving HPV vaccine #2 she was pale, diaphoretic, with a weak pulse. She was brought to a reclined position with improvement in color and strength in pulse. Water intake has been low on the 90° day. Patient observed for 15 minutes. She was placed in a supine position with elevation of her legs with resolution of her symptoms. She drank apple juice with complete return to normal baseline. Headache symptoms resolved. No cardiac findings on exam or neurologic findings. She is released to home and will monitor for any further symptoms. Recommend increasing fluid intake.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Antinuclear antibody negative, Arthralgia, Back pain, Erythema nodosum, Full blood count normal
Clinical narrative: Developed Erythema nodosum rash on the legs, with joint pain leading to back pain.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Metabolic function test normal, Rash, Red blood cell sedimentation rate increased
Clinical narrative: Developed Erythema nodosum rash on the legs, with joint pain leading to back pain.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient presented to ED on 7/2 or 2 days following vaccination reporting of fever and tenderness in the area over the last couple of days.  Fever reached a high of 103.  Patient was seen and given fluids, Tylenol and ceftriaxone 1 gram injection.  Patient was sent home with antibiotic course consisting of cephalexin and Bactrim DS for a 10 day course.  Patient returned to ED on Monday July 4th with increased pain, ongoing fevers, pronounced swelling and redness that had spread.  Patient was discharged on clindamycin for treatment.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 60 years old female patient. The patient's concurrent condition, historical condition and drug reactions/allergies were not reported. On 18-JUN-2016 the patient was vaccinated with a dose of ZOSTAVAX (lot # M010486, expiration date 25-MAY-2017, dose not reported) subcutaneously. Concomitant therapy was not provided. On unknown dates in 2016 the patient experienced redness and swelling at the injection site. The patient did not seek any medical attention. No treatment was given for both events. The patient had not recovered from both events at the time of reporting. The pharmacist declined the varicella zoster virus (VZV) packet. Reporter's causality was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician via a company representative and refers to a 17 year old female patient. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 08-APR-2016, the patient was vaccinated with the third dose of GARDASIL 9 (lot #, expiration date, exact dose and route of administration were not reported). Dates of the first and the second dose of vaccine were not provided. On an unspecified date in June 2016, the patient called the physician's office to report that she was pregnant. The last menstrual period (LMP) date was 20-APR-2016 and estimated date of delivery (EDD) was 25-JAN-2017. Pregnancy gestation was unspecified. The pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to 60 patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L040458, expiration date: 04-FEB-2018; dose and route were not provided). No adverse symptoms were reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 20-JUN-2016 the patient was vaccinated with GARDASIL lot # K023432 expiration date 18-JUN-2016, intramuscular. Dose and frequency were not reported. No other suspect or concomitant therapy was reported. No adverse events were reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9, MEN, MENB, TDAP
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 14 year old female patient. No information about the patient's pertinent medical history, concomitant medications and drug reaction or allergies was reported. On an unknown date, the patient was vaccinated with her first dose of GARDASIL 9 injection, intramuscularly (dose, anatomical location, lot # and expiry date were not specified).  Other suspect therapies included TRUMENBA, TDAP (manufacturer unknown) and meningococcal vaccine (unspecified) (manufacturer unknown) administered on the same office visit. It was reported that, after the vaccination, the patient felt woozy, like she was about to faint but did not. The physician let the patient site and wait until the feeling subsided and no treatment was given. The outcome of the event was not reported. The reporter did not provide the causality assessment. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This solicited report has been received from a consumer (also reported as "mother"), as part of a marketing research program, referring to a friend's daughter, a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient passed out after vaccinated with the third dose of GARDASIL (lot #, expiration date, dose and route were not reported). The outcome of the event was unknown. Additional information is not expected as the reporter did not consent for further follow up.
Sex: M
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This solicited report received from a consumer (mother), as part of a market research program and referred to a now approximately 8 year old male patient. The patient's concurrent conditions, medical history and allergies, as well as, concomitant therapies were not reported. On unknown date, the patient was vaccinated with GARDASIL (strength, dosage schedule, route, lot number and expiration were not reported). On unknown date, the patient experienced rash (details unspecified). The reporter stated that the side effects seemed unpleasant for her child. The outcome of the event was unknown. The reporter did not provide causality relationship between the event and study therapy. Additional information is not expected because the reporter refused to be contacted.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-MAY-2016, the patient was vaccinated with M-M-R II (lot # L024268, expiry date: 18-JUL-2017) (route of administration: subcutaneous) and VARIVAX (lot # L048467, expiry date: 02-DEC-2017) (route of administration: subcutaneous) that were improperly stored. The vaccines were stored in refrigerator at a temperature of 14.2UC for 8 hours 30 minutes and at 1.5 UC for 26 hours 30 minutes and in freezer at a temperature of -12UC for 8 hours 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 02-MAY-2016, the patient was vaccinated with PEDVAXHIB (lot # L038502, expiry date: 07-AUG-2018) (route of administration: intramuscular) and ROTATEQ (lot # L027070, expiry date: 07-MAR-2017) (route of administration: oral) that were improperly stored. The vaccines were stored in refrigerator at a temperature of 14.2UC for 8 hours 30 minutes and at 1.5 UC for 26 hours 30 minutes and in freezer at a temperature of -12UC for 8 hours 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 23-JUN-2016, the patient was vaccinated with ZOSTAVAX intramuscularly rather than subcutaneously (dose, lot number and expiration date were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Received vaccines 07/05/2016. Mom called 07/06/16 evening and stated that patient's arm is red and hot to touch where she received her shots. Spoke with ER dime sized, no fever or streaking. Just monitor. Call if any changes.
Age: 1.52
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: VARIVAX give 6/17/2016 - rash started 6/22/2016. Anytime varicella vaccine given-family members break out with rash.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: (R) arm localized swelling, redness 8 x 7 cm no treatment given. Recommend TYLENOL/Advil for pain.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown ages and genders. None of their pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with GARDASIL 9 (which had a lot# as L013429 with an expiration date of 21-JUL-2017; however, the dosage numbers, doses, anatomical locations and routes of administration were unknown). The vaccine experienced a temperature excursion of 10.3 C for a time frame of 15 minutes. In addition to this, there was a previous temperature excursion of 11 C for a time frame of 1 hour. The former excursion was called out due to a data logger and the temperature, at the time of reporting, was back in range. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Abdominal pain, Paraesthesia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of numbness of upper extremities in a 21-year-old female patient who received RABAVERT (batch number 586011AA, expiry date January 2019). On 17th June 2016, the patient received RABAVERT 1 ml. In June 2016, less than a month after receiving RABAVERT, the patient experienced numbness of upper extremities, tingling of extremity, abdominal pain and burning sensation. On an unknown date, the outcome of the numbness of upper extremities, tingling of extremity, abdominal pain and burning sensation were not recovered/not resolved. It was unknown if the reporter considered the numbness of upper extremities, tingling of extremities, abdominal pain and burning sensation to be related to RABAVERT. Additional details were provided as follows: This case was previously reported to a doctor.  The coordinator reported that, the patient experienced numbness and tingling in bilateral arms with abdominal pain and burning in bilateral hands and feet after receiving RABAVERT vaccine. This case has been linked with case US2016094169, reported by the same reporter.
Age: 21.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Abdominal pain, Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of numbness of upper extremities in a 21-year-old female patient who received RABAVERT (batch number 586011AA, expiry date January 2019). On 17th June 2016, the patient received RABAVERT 1 ml. In June 2016, less than a month after receiving RABAVERT, the patient experienced numbness of upper extremities, tingling of extremity, abdominal pain and burning sensation. On an unknown date, the outcome of the numbness of upper extremities, tingling of extremity, abdominal pain and burning sensation were not recovered/not resolved. It was unknown if the reporter considered the numbness of upper extremities, tingling of extremities, abdominal pain and burning sensation to be related to RABAVERT. Additional details were provided as follows: This case was previously reported to a doctor.  The coordinator reported that, the patient experienced numbness and tingling in bilateral arms with abdominal pain and burning in bilateral hands and feet after receiving RABAVERT vaccine. This case has been linked with case US2016094169, reported by the same reporter.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Oedema, Pain, Rash
Clinical narrative: Initial unsolicited report received from a nurse on 20 October 2015. This case is linked with 2015SA169848, 2015SA169857, 2015SA169859 and 2015SA169870. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (single dose) (batch number: U5321BA, expiration date: 30 June 2016, dose, dose number, route and site of administration were not reported) on 13 October 2015. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient had developed rash and localized reaction. Laboratory investigation and corrective treatment were not reported. The outcome of the events was not reported. Follow up information received from nurse on 30 December 2015. The patient's age was reported as 64 years at the time of event. Patient had medical history of menopause, hypertension, vitamin D deficiency, diabetes mellitus type 2, gastroesophageal reflux disease. The patient had tiredness, light headed, heart pounding and racing when she had not taken the ZIAC for two days in October 2014. Patient had sinus pressure, drainage and cough in March 2015. Patient also had history of left otitis media with effusion on unknown date. Allergies to drugs, food or chemical were reported as none. Patient reported that diabetes was under control. Patient did not have any reaction to previous vaccinations. Family history reported that patient's mother had diabetes and sister and father had cancer and nephew had diabetes and cancer. Concomitant medication included ZIAC 10-6.25 mg tablet advised to take 0.5 tablet by mouth daily, dispersion, Rfl:, PRINIVIL 20 mg tablet advised to take 1 tablet by mouth daily, dispersion: 30 tablets Rfl:5, GLUCOPHAGE 500 mg tablet advised take 1 tablet by mouth daily with breakfast, dispersion Rfl:, PREMARIN 0.9 mg tablet advised to take 1 tablet by mouth every day, dispersion:30 tablet Rfl: 11, ZANTAC 150 mg tablet advised to take 1 tablet by mouth 2 times daily, dispersion: 60 tablets Rfl:, 5 Blood-glucose meter (RELION PRIME), for use with twice daily glucose testing Dx:250.00, dispersion: 1 each, Rfl:0, Blood sugar diagnostic (RELION PRIME) strip, for twice daily glucose testing Dx:250.00 Dispersion:100 strip, Rfl:1, Cholecalciferol, vitamin D3,(VITAMIN D3) 5,000 unit oral tablets advised to take 1 tablet by mouth daily, dispersion 100 tablet Rfl:0, OS-CAL-500 plus D 500 mg(1250 mg)-200 unit oral tablet advised to take 2 tabs by mouth daily,Dispersion, rfl, centrum and biotin. Patient was given 0.5 ml of FLUZONE QIV intramuscularly in left deltoid. On 13 October 2015, same day following vaccination patient experienced left frontoanterior pain, left frontoanterior edema, minimal and was warm to touch and red. Laboratory investigations and corrective treatments were not reported. Follow up information received from nurse on 20 May 2016. No additional information has been provided. List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Initial unsolicited report received from a nurse on 20 October 2015. This case is linked with 2015SA169848, 2015SA169857, 2015SA169859 and 2015SA169870. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (single dose) (batch number: U5321BA, expiration date: 30 June 2016, dose, dose number, route and site of administration were not reported) on 13 October 2015. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient had developed rash and localized reaction. Laboratory investigation and corrective treatment were not reported. The outcome of the events was not reported. Follow up information received from nurse on 30 December 2015. The patient's age was reported as 64 years at the time of event. Patient had medical history of menopause, hypertension, vitamin D deficiency, diabetes mellitus type 2, gastroesophageal reflux disease. The patient had tiredness, light headed, heart pounding and racing when she had not taken the ZIAC for two days in October 2014. Patient had sinus pressure, drainage and cough in March 2015. Patient also had history of left otitis media with effusion on unknown date. Allergies to drugs, food or chemical were reported as none. Patient reported that diabetes was under control. Patient did not have any reaction to previous vaccinations. Family history reported that patient's mother had diabetes and sister and father had cancer and nephew had diabetes and cancer. Concomitant medication included ZIAC 10-6.25 mg tablet advised to take 0.5 tablet by mouth daily, dispersion, Rfl:, PRINIVIL 20 mg tablet advised to take 1 tablet by mouth daily, dispersion: 30 tablets Rfl:5, GLUCOPHAGE 500 mg tablet advised take 1 tablet by mouth daily with breakfast, dispersion Rfl:, PREMARIN 0.9 mg tablet advised to take 1 tablet by mouth every day, dispersion:30 tablet Rfl: 11, ZANTAC 150 mg tablet advised to take 1 tablet by mouth 2 times daily, dispersion: 60 tablets Rfl:, 5 Blood-glucose meter (RELION PRIME), for use with twice daily glucose testing Dx:250.00, dispersion: 1 each, Rfl:0, Blood sugar diagnostic (RELION PRIME) strip, for twice daily glucose testing Dx:250.00 Dispersion:100 strip, Rfl:1, Cholecalciferol, vitamin D3,(VITAMIN D3) 5,000 unit oral tablets advised to take 1 tablet by mouth daily, dispersion 100 tablet Rfl:0, OS-CAL-500 plus D 500 mg(1250 mg)-200 unit oral tablet advised to take 2 tabs by mouth daily,Dispersion, rfl, centrum and biotin. Patient was given 0.5 ml of FLUZONE QIV intramuscularly in left deltoid. On 13 October 2015, same day following vaccination patient experienced left frontoanterior pain, left frontoanterior edema, minimal and was warm to touch and red. Laboratory investigations and corrective treatments were not reported. Follow up information received from nurse on 20 May 2016. No additional information has been provided. List of documents held by sender: none.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown ages and genders. None of their pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with ROTATEQ (which had lot numbers as L035276 and L039298 with expiration dates of 09-JUN-2017 and 27-JUN-2017, respectively; however, the dosage numbers, doses and anatomical locations were unknown), orally. The vaccine experienced a temperature excursion of 10.3 C for a time frame of 15 minutes. In addition to this, there was a previous temperature excursion of 11 C for a time frame of 1 hour. The former excursion was called out due to a data logger and the temperature, at the time of reporting, was back in range. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, MEN, VARCEL
Symptoms: Peripheral swelling, Rash
Clinical narrative: Swelling and rash on the back of my left arm.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 7/6/16 Patient in for nurse visit to receive MMR vaccine. (MMR titer was neg) MMR Vaccine given. When charting MMR - I noted patient received on 6/29/16 VARICELLA vaccine - (MMR given to soon) MD aware and follow up with Primary MD.
Age: 0.4
Sex: M
Vaccine: DTAP, HPV4, IPV, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt cannot receive HIB dose for minimum of 28 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Mom called on 07/03 stating that she got both vaccines in the same leg on  06/30 and now has a red 1 in spot where they were given.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Sensory disturbance, X-ray
Clinical narrative: Since the shingle shot administration in Feb 2016. Pt has had tingling and buzzing sensation of left arm.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia, Joint swelling, Nausea, Pain, Pain in extremity
Clinical narrative: Swelling in face and hands starting about 6-8 hrs after vaccine. Body aches, swelling in knees as well. Nausea and some symptoms persisted for a week, including insomnia on 6/1/15, given Prednisone 20mg BID X 5 days; Improved (Pain (L) arm and jaw, palpitations as well).
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in jaw, Palpitations, Peripheral swelling, Swelling face
Clinical narrative: Swelling in face and hands starting about 6-8 hrs after vaccine. Body aches, swelling in knees as well. Nausea and some symptoms persisted for a week, including insomnia on 6/1/15, given Prednisone 20mg BID X 5 days; Improved (Pain (L) arm and jaw, palpitations as well).
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: NO ADVERSE EVENT BUT FOUND OUT PREGNANT THE DAY AFTER RECEIVING MMR.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash covering body.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMR
Symptoms: Lymphadenopathy
Clinical narrative: Noticed to have 2 enlarged lymph nodes in right groin area; MMR vaccine was given in that leg.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ, VARCEL
Symptoms: Diarrhoea, Headache, Nausea, Pain, Pyrexia
Clinical narrative: FEVER, RASH, HEADACHE, NAUSEAS, VOMITING, DIAHRREA, BODY PAIN.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ, VARCEL
Symptoms: Rash, Vomiting
Clinical narrative: FEVER, RASH, HEADACHE, NAUSEAS, VOMITING, DIAHRREA, BODY PAIN.
Age: 14.0
Sex: M
Vaccine: HPV9, MEN
Symptoms: Full blood count, Peripheral swelling, Pyrexia, Rash generalised
Clinical narrative: Patient has rash in entire body, fever, swelling on the left forearm.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown ages and genders. None of their pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with M-M-R II (which had lot numbers as K024825 and L028274 with expiration dates of 02-DEC-2016 and 28-JUL-2017, respectively; however, the dosage numbers, doses, anatomical locations and routes of administration were unknown). The vaccine experienced a temperature excursion of 10.3 degrees C for a time frame of 15 minutes. In addition to this, there was a previous temperature excursion of 11 degrees C for a time frame of 1 hour. The former excursion was called out due to a data logger and the temperature, at the time of reporting, was back in range. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Local swelling, Pyrexia, Rash erythematous, Swelling face
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 20-year-old female patient who received BEXSERO (batch number 151401, expiry date unknown). On 23rd June 2016, the patient received BEXSERO. On 23rd June 2016, several hours after receiving BEXSERO, the patient experienced fever, local swelling and facial swelling. In June 2016, the outcome of the fever, local swelling and facial swelling were recovered/resolved. It was unknown if the reporter considered the fever, local swelling and facial swelling to be related to BEXSERO. Additional details were provided as follows: On 23rd June 2016, at 11:30 am, the patient received a dose of BEXSERO and in the evening the patient began to experience a fever of 100.3 degrees F, swelling in the face mostly under her eyes and red bumps on her legs, hand and abdomen, which lasted for 3 to 4 days. At the time of the reporting, no additional information was available but might be available upon follow up.
Age: 16.0
Sex: M
Vaccine: HPV4, MENB, MNQ
Symptoms: Dizziness, Fall, Pallor, Syncope
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pallor facial in a 16-year-old male patient who received BEXSERO. Concomitant products included GARDASIL and MENACTRA. On 26th May 2016, the patient received BEXSERO .5mll. On 26th May 2016, less than a day after receiving BEXSERO, the patient experienced pallor facial, dizziness, syncope vasovagal and fall. On an unknown date, the outcome of the pallor facial, dizziness, syncope vasovagal and fall were recovered/resolved. It was unknown if the reporter considered the pallor facial, dizziness, syncope vasovagal and fall to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. The field representative mentioned that the doctor reported that, the patient experienced pale face with dizziness, vasovagal syncope and fall to the floor after receiving a dose of BEXSERO vaccine.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dermatitis acneiform, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of rash in a 2-month-old female patient who received PEDIARIX (batch number A4H53, expiry date 6th November 2017). Co-suspect products included ROTARIX lyophilized formulation (batch number A41CB544A, expiry date 20th February 2017), PEDIARIX (batch A4H53, expiry date 6th November 2017) and ROTARIX lyophilized formulation (batch number A41CB563A, expiry date 27th August 2017). Concomitant products included HIB Vaccine, PCV 13 vaccine, HIB vaccine, and PCV 13 vaccine. On 2nd March 2016, the patient received the 1st dose of PEDIARIX and the 1st dose of ROTARIX lyophilized formulation (oral). On 26th April, 2016, the patient received the 2nd dose of PEDIARIX and the 2nd dose of ROTARIX lyophilized formulation (oral). On 3rd March 2016, 1 days after receiving PEDIARIX, ROTARIX lyophilized formulation and PEDIARIX, not applicable after receiving PEDIARIX and ROTARIX lyophilized formulation and not applicable after receiving PEDIARIX and ROTARIX lyophilized formulation, the patient experienced rash and hives. On 27th April 2016, the patient experienced rash and hives. On an unknown date, the outcome of the rash, hives, rash and hives were unknown. It was unknown if the reporter considered the rash, hives, rash and hives to be related to PEDIARIX, ROTARIX lyophilized formulation, PEDIARIX and ROTARIX lyophilized formulation. Additional details were provided as follows: On 2nd March 2016, the patient received 1st dose of PCV13 and HIB vaccines. About 24 hours later after receiving the ROTARIX lyophilized formulation and PEDIARIX, the patient experienced a rash and hives on both legs. On 26th April 2016, the patient received 2nd dose of PCV13 and HIB vaccines. About 24 hours later after receiving ROTARIX lyophilized formulation and PEDIARIX, again the patient experienced a rash and hives on both legs. The HIB vaccine was non GSK vaccine and the brand was HIB vaccine.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown ages and genders. The patients' medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (which had the lot # of L027067, expiration date 06-APR-2017) (dose, strength and anatomical site of vaccination were not informed) orally. Information regarding concomitant medication was not reported. Additionally, no adverse effects were reported. There was not a product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Areflexia, Asthenia, Blood creatinine increased, Blood thyroid stimulating hormone normal, Borrelia test negative
Clinical narrative: Case number PHHY2016US092226 is an initial literature report received on 09 Jun 2016. The author discussed about a Guillain Barre Syndrome (GBS) case following influenza vaccination in an elderly patient with antecedent Salmonella infection. This report refers to a 77 year old female patient. Her medical history was not reported. Her current conditions included Salmonella infection, chronic kidney disease stage III and hypothyroidism. Her concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) four weeks ago. She was presented with falls from general weakness in the setting of a diarrheal illness. She endorsed non-bloody watery diarrhea twice a day for the past 9 days without vomiting, pain or fever. She developed lower extremities (LE) weakness and numbness 1 day prior to presentation and upper extremities (UE) weakness and difficulty with silverware on the day of presentation. Examination revealed normal vital signs, non tender abdomen, decreased extremity sensation, decreased strength (plantar flexion R 3/5, L 2/5; dorsiflexion R 1/5, L 0/5, straight leg raise both 2-3/5, hand grip both 2-3/5, triceps both 2/5 and biceps both 3/5) and areflexia. Laboratory results showed leukocytes 6.4000/muL , hemoglobin 10.3 g/dL, platelets: 475,000/muL, creatinine: 1.23 mg/dL and normal thyroid stimulating hormone (TSH), B12 and Lyme reflex. Stool cultures grew Salmonella group D. Spine magnetic resonance imaging showed degenerative changes without compression. Lumbar puncture was performed given suspicion for Guillain-Barre Syndrome (GBS) and the cerebral spinal fluid (CSF) analysis revealed normal results with protein 36 mg/dL and nucleated cells 1/muL. Antibiotics were held as diarrhea resolved shortly after admission. Five days of empiric intravenous immunoglobulin (IVIG) treatment led to improvement in neurologic exam (3/5 in LE, 4/5 in UE). CSF eventually returned positive for oligoclonal bands consistent with GBS. Nerve conduction studies (NCS) were scheduled as an outpatient. The outcome of GBS, areflexia, general weakness, fall, numbness and hemoglobin decreased was not reported. The seriousness of hemoglobin decreased was not reported. The causality of events to influenza vaccine was not reported. The author concluded the article stating that the trigger for this patient's GBS was likely her antecedent Salmonella infection.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: CSF cell count normal, CSF oligoclonal band present, CSF protein normal, Culture stool positive, Diarrhoea
Clinical narrative: Case number PHHY2016US092226 is an initial literature report received on 09 Jun 2016. The author discussed about a Guillain Barre Syndrome (GBS) case following influenza vaccination in an elderly patient with antecedent Salmonella infection. This report refers to a 77 year old female patient. Her medical history was not reported. Her current conditions included Salmonella infection, chronic kidney disease stage III and hypothyroidism. Her concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) four weeks ago. She was presented with falls from general weakness in the setting of a diarrheal illness. She endorsed non-bloody watery diarrhea twice a day for the past 9 days without vomiting, pain or fever. She developed lower extremities (LE) weakness and numbness 1 day prior to presentation and upper extremities (UE) weakness and difficulty with silverware on the day of presentation. Examination revealed normal vital signs, non tender abdomen, decreased extremity sensation, decreased strength (plantar flexion R 3/5, L 2/5; dorsiflexion R 1/5, L 0/5, straight leg raise both 2-3/5, hand grip both 2-3/5, triceps both 2/5 and biceps both 3/5) and areflexia. Laboratory results showed leukocytes 6.4000/muL , hemoglobin 10.3 g/dL, platelets: 475,000/muL, creatinine: 1.23 mg/dL and normal thyroid stimulating hormone (TSH), B12 and Lyme reflex. Stool cultures grew Salmonella group D. Spine magnetic resonance imaging showed degenerative changes without compression. Lumbar puncture was performed given suspicion for Guillain-Barre Syndrome (GBS) and the cerebral spinal fluid (CSF) analysis revealed normal results with protein 36 mg/dL and nucleated cells 1/muL. Antibiotics were held as diarrhea resolved shortly after admission. Five days of empiric intravenous immunoglobulin (IVIG) treatment led to improvement in neurologic exam (3/5 in LE, 4/5 in UE). CSF eventually returned positive for oligoclonal bands consistent with GBS. Nerve conduction studies (NCS) were scheduled as an outpatient. The outcome of GBS, areflexia, general weakness, fall, numbness and hemoglobin decreased was not reported. The seriousness of hemoglobin decreased was not reported. The causality of events to influenza vaccine was not reported. The author concluded the article stating that the trigger for this patient's GBS was likely her antecedent Salmonella infection.