chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Abdominal discomfort, Dysgeusia, Headache, Influenza like illness, Injection site inflammation
Clinical narrative: Started as taste sensation,,,,,,,,,,continued with flu like symptoms (body/nerve pain, fever (101.9) headache, stomach issues. Site inflammation.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Neuralgia, Pruritus generalised, Pyrexia
Clinical narrative: Started as taste sensation,,,,,,,,,,continued with flu like symptoms (body/nerve pain, fever (101.9) headache, stomach issues. Site inflammation.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-06-14.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Adverse event
Clinical narrative: Advrs effect of pertuss vaccine, inc combin w pertuss, init on 2016-03-03.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Vaccine given in left thigh. Swelling in thigh and lower leg the night that vaccine was given. Injection site warm and red. Painful to touch.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Shoulder pain when I lift my arm.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: On 9-5-2016 he developed slight temp highest was 101.9 on 9-7-2016.On 9-8-16 he had fine red rash mainly on trunk. Rash went away until 9-15-16 when bright red rash returned and covers entire body. Appetite decreased. No Temp.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: Swelling and hard knot @ injection site. Lasted about 7 days. This was an injection for
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2016-02-18.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. No patients' concurrent conditions or medical history were provided. On an unknown date, these patients were vaccinated with improperly stored doses of ROTATEQ oral injection (lot # L047185 with expiry date: 17-SEP-2017; strength, dose and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 30 degrees Fahrenheit for 30 days. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 29-APR-2016, the patient was vaccinated with an incorrectly stored PROQUAD (lot # L050909, an expiration date 14-JUN-2017 (reported as 20107), dose, dose number, anatomical location and route of administration were not provided). It was reported that the refrigerator was out of range. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant via Sanofi referring to an unspecified number of patients of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. The reporter learned a delivery of vaccines including ROTATEQ was shipped on 11-AUG-2016 and received on 15-AUG-2016 which was too long in transit (outside PI storage). The reporter stated that 14 doses of ROTATEQ (lot # was reported as M004544, expiration date 18-OCT-2017 had been administered to patients orally since 15-AUG-2016. There was no further transport information, namely temperature. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M014927, expiry date 18-FEB-2019) or (lot# M010440, expiry date 09-DEC-2018) (dose and route not reported). The vaccine was exposed to temperature of 32 Fahrenheit for 9650 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This case was cross referenced with #1609USA000170 (same reporter link). Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 11-APR-2016, the patient was vaccinated with an incorrectly stored dose of PROQUAD (therapy type: rHA, lot # L031601, an expiration date 18-FEB-2017, dose, dose number, anatomical location and route of administration were not provided). It was reported that the refrigerator was out of range. This is one of several reports received from the same reporter. Additional information is not expected as all data was already obtained.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.), referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 13-SEP-2016, the patient was vaccinated with GARDASIL 9 (lot# reported as L040054, expiration date 26-DEC-2017, intramuscular; dose and dose number were not reported) which had been exposed to a temperature excursion (25 Fahrenheit, 1 hour, on 12-SEP-2016) (incorrect product storage). No known adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Seizure
Clinical narrative: This spontaneous report received from a physician via a company representative regarding a 11 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in August 2016 (reported as last month), patient received GARDASIL 9 injection (dose, dose #, route, lot number and expiry date were not reported). On an unknown date in August 2016, the patient had a seizure immediately after receiving an unspecified dose of GARDASIL 9. No treatment was provided for the event. It was not specified how long the seizure had lasted in the patient. The physician recommended her to visit a neurologist due to the seizure. It was unknown if the patient was seen by the neurologist yet. The outcome of seizure was unknown. Causality assessment was not provided by the reporter. Upon internal review, seizure was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients may have been vaccinated with unknown number of improperly stored VARIVAX of lot # M012990, expiry: 14-MAR-2018 after temperature excursion of 7 hours, 48 minutes to a maximum of 20.9 Fahrenheit (F). This vaccine lot had no previous excursions. In addition the reporter stated that on an unknown date, the patients may have been vaccinated with improperly stored doses of VARIVAX of lot#: L050956, expiry: 17-DEC-2017 for which excursion occurred for 7 hours, 48 minutes to a maximum of 20.9 Fahrenheit (F). Multiple prior excursion for unspecified vaccine were reported of 3 hours 49 minutes to a maximum of 7.9 F, 28F for 4.5 hours, 9.9 F for 8 hours 47 minutes, 12.4 F for 17 hours 40 minutes, 16.2 F for 17 hours 33 minutes and 14.8 F for 10 hours and 14 minutes. There were no adverse effects reported. No additional information available. This is one of two reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician referring to a 12 year old male patient with asthma. The patient had no drug reactions/allergies or concomitant medication. On 21-JUL-2015, the patient was vaccinated with his first dose of GARDASIL 9 (lot # K026246 with expiration date 28-JAN-2017; route was not reported). On 09-SEP-2016, the patient was vaccinated with his second dose of GARDASIL 9 (lot # M020103 with expiration date 15-FEB-2018; route was not reported) (inappropriate schedule of drug administration). On the same day, the patient experienced an adverse effect of headache "ever since the second dose". The patient's mother sought medical attention by calling the physician on an unspecified date in 2016, and a treatment of an unspecified dose of "TYLENOL or ibuprofen" was ingested, which improved the headache temporarily. There was no lab diagnostics studies performed. The causality was not 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 registered nurse refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2016 (reported as after a temperature excursion on 09-AUG-2016 and prior to excursion on 09-SEP-2016), the patient was vaccinated with an improperly stored dose of PROQUAD lot # M011661 with expiration date: 08-SEP-2017 (dose and route of administration were not reported). Administered dose of PROQUAD underwent temperature excursions at 58 Fahrenheit degrees for 5 hours. Data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L041206 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse via a company representative referring to a 9 years old patient of unknown gender. The patient's concurrent condition, medical history, and concomitant medication were not provided. On unknown dates, the patient was vaccinated with two doses of VARIVAX (strength, dose, frequency, route, lot number and expiration date were unknown). In August 2016 (reported as last week), the patient was diagnosed with chicken pox. The patient had sought unspecified medical attention. The outcome of the chicken pox was not reported. The causal relationship between chicken pox and VARIVAX was unknown. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 12-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L026602, expiration date: 19-OCT-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent 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 the data was already obtained.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Pt stated 2 days after admin, she developed hives/itchy all over body.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient had a rash on body (back and belly) near arm where shot was. Pt. took BENADRYL and was getting better.
Age: 72.0
Sex: U
Vaccine: FLU3, TDAP
Symptoms: Injection site inflammation, Injection site warmth, Pain
Clinical narrative: Inflammation of the skin in the site of injection. Pain, after 3 days of vaccine BOOSTRIX and FLUZONE HD. She didn't use any care for the reaction, Not used of Ice or analgesics. The site is warmth.
Age: 33.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Worsening, not improving pain like she was "punched in the arm". Arm pain and weakness continuing without improvement > 2 weeks.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Dyskinesia, Injection site pruritus, Pain, Pruritus
Clinical narrative: Body aches, fever of 102 degree F. Itching on both arms and injection site. Coughing and difficulty closing jaw.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Body aches, fever of 102 degree F. Itching on both arms and injection site. Coughing and difficulty closing jaw.
Age: 14.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Diarrhoea, Nervousness
Clinical narrative: Patient started with upset stomach and shaky around 1:45 pm. When pt got home from school had diarrhea and upset stomach. The shaking did stop at home. She rested and drank fluids. Sx improved the next day 9/16/16.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Tonic clonic movements
Clinical narrative: While patient was seated on exam table 2nd dose GARDASIL 9 given (L) deltoid. Approx. 2 min later pt slumped onto table and as he was being placed in supine position he began having tonic clonic movements which lasted approx. less than 5 seconds then stopped. Pt was responsive but tired. Kept in supine position for 15 to 20 min after event. Pt felt fine afterwards. Was D/C home. Vitals stable.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction
Clinical narrative: Patient came at pharmacy and asked for PMEUMOVAX 23 and flu shot, she filled vaccination forms and were asked questions, and she got PNEUMOVAX 23 and FLUZONE High-Dose. 4 days later patient came at our pharmacy saying that she remembered that she had pneumonia shot at a different pharmacy, and she is complaining of injection site reactions.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Headache, sweating, chest tightness, dizziness day after shot given. Saw MD 4 days later and given steroids po.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Influenza, Injection site pain, Pain
Clinical narrative: Case PHEH2016US23188, is an initial spontaneous case received from a consumer on 12 Sep 2016. This report refers to an adult female patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown date (reported as 2012 to 2013). The patient stated that, after she received the 2012 to 2013 vaccine she had a bad reaction to the shot, for 6 months. She also stated that, she experienced flu, fatigue, body aches and pain, weakness, pain where the shot was given from an unknown date. She experienced heart palpitations on an unknown date. After 6 months, all the symptoms were stopped and the patient did not experience any further problems and the patient got her strength back. The outcome of events was reported as complete recovery after 6 months. The seriousness and causality of the events was not reported. The seriousness assessment of all the events (medically significant) was upgraded based on information available in the source document. The case is lost to follow up at initial.
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Vaccination complication
Clinical narrative: Case PHEH2016US23188, is an initial spontaneous case received from a consumer on 12 Sep 2016. This report refers to an adult female patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown date (reported as 2012 to 2013). The patient stated that, after she received the 2012 to 2013 vaccine she had a bad reaction to the shot, for 6 months. She also stated that, she experienced flu, fatigue, body aches and pain, weakness, pain where the shot was given from an unknown date. She experienced heart palpitations on an unknown date. After 6 months, all the symptoms were stopped and the patient did not experience any further problems and the patient got her strength back. The outcome of events was reported as complete recovery after 6 months. The seriousness and causality of the events was not reported. The seriousness assessment of all the events (medically significant) was upgraded based on information available in the source document. The case is lost to follow up at initial.
Sex: M
Vaccine: HEP
Symptoms: Alopecia, Connective tissue disorder, Emotional distress, Joint injury, Multiple sclerosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of multiple sclerosis in a male patient who received ENGERIX B. On an unknown date, the patient received the 3rd dose of ENGERIX B. On an unknown date, less than a month after receiving ENGERIX B, the patient experienced multiple sclerosis (serious criteria GSK medically significant), muscle twitching, mental distress, itchy legs, hair loss, joint injury and connective tissue disorder. On an unknown date, the outcome of the multiple sclerosis, muscle twitching, mental distress, itchy legs, hair loss and joint injury were unknown and the outcome of the connective tissue disorder was not recovered/not resolved. It was unknown if the reporter considered the multiple sclerosis, muscle twitching and mental distress to be related to ENGERIX B. The reporter considered the itchy legs, hair loss, joint injury and connective tissue disorder to be related to ENGERIX B. Additional details were provided as follows: The patient refused to provide his name and demographics. He stated he had already reported these issues to Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), Vaccine Adverse Event Reporting System (VAERS) and his physician. The age at vaccination was not reported. The patient had received all 3 doses of the vaccine in his left arm and had experienced muscle twitching in his left arm since then. The patient stated that he experienced these issues along with others (not named) within a month of the 3rd vaccine and he has been suffering for more than 3 years at the time of reporting. The patient stated that his physician might have reported it to GlaxoSmithKline also, as his physician contacted GlaxoSmithKline himself. The patient noted but was not able to confirm a possible Human leukocyte antigen (HLA) B27 gene marker, as he was investigating these symptoms and possible multiple sclerosis. The patient noted that he had been researching this for the last 12 months. He stated he was upset that GlaxoSmithKline was not doing anything to help him, as the vaccine had harmed him and the burden of proof was on him to determine the causality of his injuries and the vaccine. The patient stated that he has been told by his physician to consult another physician and that his physician was only offered the product information (PI) from GlaxoSmithKline when he called. He noted that he was pursuing the Vaccine Injury court for seeking legal advice and was advised not to provide any additional information to GlaxoSmithKline. The patient refused to provide his physician's name or contact information. He did not provide his phone number but called from some other number, if able to correlate to a possible previous report.
Sex: M
Vaccine: HEP
Symptoms: Muscle twitching, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of multiple sclerosis in a male patient who received ENGERIX B. On an unknown date, the patient received the 3rd dose of ENGERIX B. On an unknown date, less than a month after receiving ENGERIX B, the patient experienced multiple sclerosis (serious criteria GSK medically significant), muscle twitching, mental distress, itchy legs, hair loss, joint injury and connective tissue disorder. On an unknown date, the outcome of the multiple sclerosis, muscle twitching, mental distress, itchy legs, hair loss and joint injury were unknown and the outcome of the connective tissue disorder was not recovered/not resolved. It was unknown if the reporter considered the multiple sclerosis, muscle twitching and mental distress to be related to ENGERIX B. The reporter considered the itchy legs, hair loss, joint injury and connective tissue disorder to be related to ENGERIX B. Additional details were provided as follows: The patient refused to provide his name and demographics. He stated he had already reported these issues to Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), Vaccine Adverse Event Reporting System (VAERS) and his physician. The age at vaccination was not reported. The patient had received all 3 doses of the vaccine in his left arm and had experienced muscle twitching in his left arm since then. The patient stated that he experienced these issues along with others (not named) within a month of the 3rd vaccine and he has been suffering for more than 3 years at the time of reporting. The patient stated that his physician might have reported it to GlaxoSmithKline also, as his physician contacted GlaxoSmithKline himself. The patient noted but was not able to confirm a possible Human leukocyte antigen (HLA) B27 gene marker, as he was investigating these symptoms and possible multiple sclerosis. The patient noted that he had been researching this for the last 12 months. He stated he was upset that GlaxoSmithKline was not doing anything to help him, as the vaccine had harmed him and the burden of proof was on him to determine the causality of his injuries and the vaccine. The patient stated that he has been told by his physician to consult another physician and that his physician was only offered the product information (PI) from GlaxoSmithKline when he called. He noted that he was pursuing the Vaccine Injury court for seeking legal advice and was advised not to provide any additional information to GlaxoSmithKline. The patient refused to provide his physician's name or contact information. He did not provide his phone number but called from some other number, if able to correlate to a possible previous report.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt developed shingles (mild). Pt then prescribed Valacyclovir via MD
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (Lot # L041457, expiry 22-OCT-2017 and Lot # L009544, expiry 19-MAR-2017). The temperature and time frame that the M-M-R II was exposed to were as follows, Temperature: 14.9F, Time frame: 1 hour. There were no previous temperature excursions. Data Logger was involved. The medical assistant confirmed that the improperly stored vaccines were administered. No adverse effect was reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to patients of unknown demographics. On unknown dates the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M013377, expiry date 25-MAY-2017). The temperature and timeframe that the ZOSTAVAX was exposed to were as follows, Temperature: 14.9F, Time frame: 1 hour. There were no previous temperature excursions. Data Logger was involved. The medical assistant confirmed that the improperly stored vaccines were administered. No adverse effect was reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M001152 (dose, expiration date and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 14-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # M003434, expiry date, therapy type, dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office administrator, concerning multiple unspecified patients (unknown age and gender). No relevant medical history or concurrent conditions were reported. Starting from an unspecified date in 2015, these patients were vaccinated with improperly stored VARIVAX (lot numbers, expiration dates, dose numbers, doses and routes were not reported; temperature/time frame: 30 Fahrenheit/312 hours, call not because of data logger). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to one unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant therapies were not reported. On 24-AUG-2016, the patient received a dose of improperly stored PROQUAD (lot # L033698, expiration date: 28-AUG-2017) (dose and route of administration were not provided). There were no adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered pharmacist via a company representative referring to a 65 year old female patient. The patient's medical history, concomitant medication or drug allergies/drug reactions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route unknown). On an unknown date, an unspecified amount of time after the dose was administered, the patient was diagnosed with shingles. It was unknown if any medical attention was sought. The outcome of shingles was reported as not resolved. The causality assessment was not provided. 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 medical assistant refers to multiple patients of unknown demographics. On unknown dates the patients received improperly stored doses of VAQTA (lot # M015290 with expiry date: 20-SEP-2017). The temperature and timeframe that the VAQTA was exposed to were as follows: Temperature 50.4F. Timeframe: 19.5 hours total cumulative. The medical assistant reported that the patients received doses of improperly stored VAQTA but lot numbers and expiry dates of those specific vaccines that were administered was unknown. No adverse effects reported. Medical assistant also reported that the vaccines were not yet back in range. Data logger was involved. There were no previous excursions. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
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. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 02-SEP-2016 the patient was vaccinated with improperly stored PROQUAD (subcutaneous, lot# M018636, expiration date 11-OCT-2017, strength and dose were unspecified) and VARIVAX (subcutaneous, lot# L032391, expiration date 26-AUG-2017, strength and dose were unspecified). The vaccines were exposed to 5.2 F for 10 minutes and then were back to range. There was no previous temperature excursion. Data logger issue was involved. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 10-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot# L045953; dose, route of administration and expiry date were not reported). There were no concomitant therapies reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number patients of unknown age and gender. On an unknown dates the patients may have been vaccinated with unknown number of improperly stored PROQUAD of lot # M0155698, expiry: 26-SEP-2017 after temperature excursion of 26 hours, 48 minutes to a maximum of 13.5 Fahrenheit (F). This lot had no previous excursions. In addition the reporter stated that on an unknown date, the patients may have been vaccinated with improperly stored doses of PROQUAD of lot#: M004889, expiry: 25-JUL-2017 and lot#: M009746 expiry: 23-AUG-2017 for which excursion occurred for 26 hours, 48 minutes to a maximum temperature of 13.5 F. Multiple Prior excursion for unspecified vaccine were reported of 3 hours 49 minutes to a maximum of 7.9 F, 28 F for 4.5 hours, 9.9 F for 8 hours 47 minutes, 12.4 F for 17 hours 40 minutes, 16.2 F for 17 hours 33 minutes and 14.8 F for 10 hours and 14 minutes. There were no adverse effects reported.  No additional information available. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients received an improperly stored dose of PROQUAD (lot# M015695, expiration date 26-SEP-2017, recombinant human albumin (rHA); lot# L051098, expiration date 17-JUN-2017, rHA; lot# M006102, expiration date 01-AUG-2017, rHA, dose and route were unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Post vaccination syndrome, Pyrexia
Clinical narrative: Postvaccination fever on 2016-04-30.
Age: 1.08
Sex: M
Vaccine: HIBV, MMRV, PNC13
Symptoms: Post vaccination syndrome, Pyrexia
Clinical narrative: Postvaccination fever on 2016-06-12.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2016-06-11.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2016-06-22.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: Oth complications following immunization, NEC, init on 2016-07-06.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2016-07-08.
Age: 1.67
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2016-07-13.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest X-ray normal, Injection site inflammation, Nausea, Pyrexia, Shift to the left
Clinical narrative: Patient reported fever, nausea, vomiting, and inflammation at site of injection of PNEUMOVAX. Symptom onset occured later in the evening of 9/13/2016. Patient went to the emergency room on 9/14/2016 and was treated with IV fluids, ciprofloxacin 500mg twice daily for 14 days, and metoclopramide 10mg as needed for 6 days.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urine analysis normal, Vomiting, White blood cell count increased
Clinical narrative: Patient reported fever, nausea, vomiting, and inflammation at site of injection of PNEUMOVAX. Symptom onset occured later in the evening of 9/13/2016. Patient went to the emergency room on 9/14/2016 and was treated with IV fluids, ciprofloxacin 500mg twice daily for 14 days, and metoclopramide 10mg as needed for 6 days.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Seizure like phenomena, Tremor
Clinical narrative: Patient stated experienced shakes from head to feet for 40 minutes, it felt like a seizure, then it was gone.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Fibromyalgia
Clinical narrative: Fibromyalgia symptoms.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Aphasia, Mobility decreased, Syncope
Clinical narrative: Syncope and unable to speak, move legs or arms for 2 hours.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Electroencephalogram, Neurological examination, Tremor
Clinical narrative: Tremor in both hands happening at various times of day in all different environments; at rest and exercise.
Age: 26.0
Sex: F
Vaccine: YF
Symptoms: Cough, Dyspnoea, Nasal congestion, Sneezing, Urticaria
Clinical narrative: I was monitored for 15 minutes after my vaccination and was fine. During my 30 min drive home I slowly developed symptoms, first sneezing/ stuffiness, then coughing, then hives, and wheezing and difficulty breathing. I took an epi-pen which helped with the breathing. My hives returned about an hour after my epi-pen dose.
Age: 26.0
Sex: F
Vaccine: YF
Symptoms: Wheezing
Clinical narrative: I was monitored for 15 minutes after my vaccination and was fine. During my 30 min drive home I slowly developed symptoms, first sneezing/ stuffiness, then coughing, then hives, and wheezing and difficulty breathing. I took an epi-pen which helped with the breathing. My hives returned about an hour after my epi-pen dose.
Sex: U
Vaccine: HEP
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 who on 27-JUN-2016 was incorrectly stored dose of Hepatitis B Vaccine (Recombinant) Lot#M006708 or M006708, maximum temperature excursion 22.7C for 3 h 48min, minimum temperature excursion 0.2C for 7 h 36 min. Additional information has been requested.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.), referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 13-SEP-2016, the patient was vaccinated with ROTATEQ (lot # L046320, expiration date 29-SEP-2017, oral; dose and dose number were not reported) and PEDVAXHIB (M014925, expiration date 16-FEB-2019, intramuscular; dose and dose number were not reported), both of which had been exposed to a temperature excursion (25.0 Fahrenheit for 1 hour) on 12-SEP-2016. No known adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history concurrent conditions and concomitant medications were not reported. On 06-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M001152 (dose, expiration date and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number 2016409613 for PREVNAR 13. This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, dose and route unknown). On an unknown date, the patient experienced allergic reaction to PNEUMOVAX 23. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 07-SEP-2016, the patient was inadvertently administered an improperly stored dose of VARIVAX lot # M023384, expiration date 11-MAY-2018, subcutaneous. No adverse effects were reported. Additional information is not expected as no consent was given for further contact.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 63-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. ON 31-MAR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L035283, expiration date 15-DEC-2016 (dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 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 the data was already obtained.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 64-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-JAN-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L029484, expiration date 06-NOV-2016 (dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 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 the data was already obtained.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M0011452 (dose, expiration date and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dizziness, Dry mouth, Erythema, Hypotension, Laboratory test
Clinical narrative: Swelling, redness, pain in left arm. Dizzy, dry mouth, vomited, fainted, low B/P.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Swelling, Syncope, Vomiting, X-ray
Clinical narrative: Swelling, redness, pain in left arm. Dizzy, dry mouth, vomited, fainted, low B/P.
Age: 18.0
Sex: F
Vaccine: FLU4, HEPA, HPV4, MENB
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: Headache, fever, body aches, generalized malaise.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Cardiac ablation, Cardioversion, Cough, Nuclear magnetic resonance imaging abnormal, Pneumonia
Clinical narrative: Cough, fever three days after immunizations - persisted and turned into pneumonia, treated for pneumonia. On 7/19/15 had a VT which cardioverted. Placed on TOPROL XL 50mg. Had RVOT VT in Aug 2015 - received ablation, March 2016, another VT had repeat ablation, July 2016 - wide complex tach. converted. Still with cardiac problems most recent ablation 9/13/16.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pyrexia, Ventricular tachycardia
Clinical narrative: Cough, fever three days after immunizations - persisted and turned into pneumonia, treated for pneumonia. On 7/19/15 had a VT which cardioverted. Placed on TOPROL XL 50mg. Had RVOT VT in Aug 2015 - received ablation, March 2016, another VT had repeat ablation, July 2016 - wide complex tach. converted. Still with cardiac problems most recent ablation 9/13/16.
Age: 38.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Diarrhoea, Feeling abnormal, Nausea, Vomiting
Clinical narrative: Nausea/vomiting/diarrhea, weakness, "feeling foggy" approx 8hrs post vaccine admin. S/s improving 48hrs post vaccine.
Age: 37.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Nausea
Clinical narrative: Patient started to feel some nausea after the vaccine was given, patient sitting down, vitals obtained, ice pack applied.
Age: 37.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Chest discomfort, Cough, Dyspnoea, Nausea, Pruritus
Clinical narrative: Patient started to feel some nausea after the vaccine was given, patient sitting down, vitals obtained, ice pack applied.
Age: 37.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Vomiting
Clinical narrative: Patient started to feel some nausea after the vaccine was given, patient sitting down, vitals obtained, ice pack applied.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Altered state of consciousness, Arthralgia, Back pain, Dizziness, Ear pain
Clinical narrative: Patient reports her arm started to swell and get what looked like a rash day of vaccination.  By the next morning, patient states entire upper arm was red, HOT, swollen, and still had a rash. Patient reports additional symptoms of severe exhaustion, inability to sit up for longer than a few minutes without extreme dizziness, fever, achy and painful joints, back pain, ear pain, headache, nausea, feeling like she was going to pass out, severe arm pain. These symptoms lasted for 4 days and the most severe day was the day after the vaccines were administered.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Erythema, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Patient reports her arm started to swell and get what looked like a rash day of vaccination.  By the next morning, patient states entire upper arm was red, HOT, swollen, and still had a rash. Patient reports additional symptoms of severe exhaustion, inability to sit up for longer than a few minutes without extreme dizziness, fever, achy and painful joints, back pain, ear pain, headache, nausea, feeling like she was going to pass out, severe arm pain. These symptoms lasted for 4 days and the most severe day was the day after the vaccines were administered.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Peripheral swelling, Pyrexia, Rash, Skin warm
Clinical narrative: Patient reports her arm started to swell and get what looked like a rash day of vaccination.  By the next morning, patient states entire upper arm was red, HOT, swollen, and still had a rash. Patient reports additional symptoms of severe exhaustion, inability to sit up for longer than a few minutes without extreme dizziness, fever, achy and painful joints, back pain, ear pain, headache, nausea, feeling like she was going to pass out, severe arm pain. These symptoms lasted for 4 days and the most severe day was the day after the vaccines were administered.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Dizziness, Ear pain, Fatigue, Injection site swelling, Myalgia
Clinical narrative: Patient reports her arm started to swell and get what looked like a rash day of vaccination.  By the next morning, patient states entire upper arm was red, HOT, swollen, and still had a rash. Patient reports additional symptoms of severe exhaustion, inability to sit up for longer than a few minutes without extreme dizziness, fever, achy and painful joints, back pain, ear pain, headache, nausea, feeling like she was going to pass out, severe arm pain. These symptoms lasted for 4 days and the most severe day was the day after the vaccines were administered.