chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 45 year old patient of unknown gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On 16-JAN-2016 the patient was vaccinated with PROQUAD (lot number, dose and route were unknown), instead of M-M-R II. No adverse effects reported. There were no product quality complaints (PQC) involved. 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 nurse refers to unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On unspecified dates, the patients were vaccinated with an improperly stored dose of PEDVAXHIB (lot # L030872, expiry date: 11-JUN-2018). The temperature excursion details for vaccine were as follows: temperature 27.4 F, time frame 37.36 hours. The nurse reported a temperature excursion for the following products: GARDASIL 9 (Lot # L013429, expiry date: 29-JUL-2017; Lot # L017407, expiry date: 15-AUG-2017), M-M-R II (Lot # L012480, expiry date: 10-APR-2017) and PEDVAXHIB (lot # L030872, expiry date: 11-JUN-2018), however only PEDVAXHIB dose was administered. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 03-JAN-2016, it was reported that the patient received an improperly stored dose of MMR II (lot # L023385, exp date on 25-JUN-2017). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Only 3 doses of MMR II were administered. The registered nurse also reported temperature excursion. High temperature excursion: Temperature: 14C Time frame: 11 hours. Low temperature excursions: Temperature IC Time frame: 11 hours. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 06-JAN-2016, it was reported that the patient received an improperly stored dose of M-M-R II, lot # L015282, exp date on 30-APR-2017). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Only 3 doses of MMR II were administered. The registered nurse also reported temperature excursion. High temperature excursion: Temperature: 14C Time frame: 11 hours. Low temperature excursion:; Temperature: 1C Time frame: 11 hours. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, 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 medical history, drug reactions or allergies and concurrent conditions were not reported. On 22-JAN-2016, the patient was inadvertently vaccinated with a dose of an expired PROQUAD (Merck), lot number reported as L010209, expiration date 17-JAN-2016 (dose, route anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 05-JAN-2016, it was reported that the patient received an improperly stored dose of M-M-R II, lot # L015282, exp date on 30-APR-2017. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Only 3 doses of MMR II were administered. The registered nurse also reported temperature excursion. High temperature excursion: Temperature: 14C Time frame: 11 hours. Low temperature excursion: Temperature: IC Time frame: 11 hours. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Musculoskeletal discomfort, Skin warm
Clinical narrative: 1-23-16 developed headache, shoulder, neck, muscle discomfort: resolved by Sat night. 1-24-16 3 red area near site of injection 12 x 10 cm red/warm to touch.
Age: 9.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm, red raised area at site of injection. Denies itching, Area affected was approx. 3 x 5 inches.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Memory impairment, Pain, Pyrexia
Clinical narrative: Fever, body aches, forgetfulness for over 3 weeks. Shingles re occurred.
Age: 1.78
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Pt given PPV23 instead of PCV13, pt received influenza (Fluzone) 3+ years rather than 6 months +, and pt received Pediarix rather than polio.
Age: 1.68
Sex: M
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Vomiting 6 times in 4 hours.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Fatigue, Peripheral swelling, Pyrexia
Clinical narrative: Pt reported joint pain all over & fever for 2 days, tired for several days, and rxn on arm still present - redness, swelling, and warmth.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Pt reported joint pain all over & fever for 2 days, tired for several days, and rxn on arm still present - redness, swelling, and warmth.
Age: 44.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Headache, Nausea, Pyrexia, Vertigo
Clinical narrative: Developed a fever that ran as high as 103.0. Felt nauseated and head was spinning H/A. Symptoms began at 6:30pm on day that vaccine was given 1/22/16 and resolved by 8:30pm the following day 1/23/16.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Joint range of motion decreased, Pain in extremity, Periarthritis, Skin warm
Clinical narrative: Deep ache in left arm along with heat, progressed to severe pain, loss of feeling in hand, extreme swelling and loss of range of motion.  Loss of range of motion continued to current frozen shoulder.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling, X-ray limb
Clinical narrative: Deep ache in left arm along with heat, progressed to severe pain, loss of feeling in hand, extreme swelling and loss of range of motion.  Loss of range of motion continued to current frozen shoulder.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Abnormal faeces, Aphasia, Autism, Candida nappy rash
Clinical narrative: He developed a fever and full body rash/hives on 9/29/2013 and the rash/hives lasted for over 10 days Then his health and immune system quickly deteriorated. On 10/15/13 he developed candida diaper rash and impetigo. On 11/11/13 he developed a sleep disorder and feeding problems. On 12/17/13 he developed his first ear infection, on 1/9/14 he contracted the flu, on 2/21/14 he developed a second ear infection, and on 3/12/14 he developed a third ear infection. On 3/17/14 his stool changed. On 3/24/14 he developed a fourth ear infection and on 3/25/14 a fever.  In March and early April of 2014 he lost his eye contact, stopped responding to his name and stopped saying all the words he knew at the time including (Mama and Daddy). He started developing ritualistic and exclusive behavior likes lining up his cars and tuning out everyone around him. On 5/3/13 he developed a fifth ear infection, on 5/7/13 he had vomiting, on 5/15/13 he contracted hand, foot and mouth disease, and on 5/17/13 he had sores in mouth and difficulty swallowing. He continues to have a weakened immune system and in Dec. 2014 was diagnosed with Autism after 9 months of waiting for appointments for an evaluation and diagnosis of his condition.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Decreased eye contact, Dysphagia, Ear infection, Feeding disorder of infancy or early childhood, Hand-foot-and-mouth disease
Clinical narrative: He developed a fever and full body rash/hives on 9/29/2013 and the rash/hives lasted for over 10 days Then his health and immune system quickly deteriorated. On 10/15/13 he developed candida diaper rash and impetigo. On 11/11/13 he developed a sleep disorder and feeding problems. On 12/17/13 he developed his first ear infection, on 1/9/14 he contracted the flu, on 2/21/14 he developed a second ear infection, and on 3/12/14 he developed a third ear infection. On 3/17/14 his stool changed. On 3/24/14 he developed a fourth ear infection and on 3/25/14 a fever.  In March and early April of 2014 he lost his eye contact, stopped responding to his name and stopped saying all the words he knew at the time including (Mama and Daddy). He started developing ritualistic and exclusive behavior likes lining up his cars and tuning out everyone around him. On 5/3/13 he developed a fifth ear infection, on 5/7/13 he had vomiting, on 5/15/13 he contracted hand, foot and mouth disease, and on 5/17/13 he had sores in mouth and difficulty swallowing. He continues to have a weakened immune system and in Dec. 2014 was diagnosed with Autism after 9 months of waiting for appointments for an evaluation and diagnosis of his condition.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Immune system disorder, Impetigo, Influenza, Pyrexia, Rash generalised
Clinical narrative: He developed a fever and full body rash/hives on 9/29/2013 and the rash/hives lasted for over 10 days Then his health and immune system quickly deteriorated. On 10/15/13 he developed candida diaper rash and impetigo. On 11/11/13 he developed a sleep disorder and feeding problems. On 12/17/13 he developed his first ear infection, on 1/9/14 he contracted the flu, on 2/21/14 he developed a second ear infection, and on 3/12/14 he developed a third ear infection. On 3/17/14 his stool changed. On 3/24/14 he developed a fourth ear infection and on 3/25/14 a fever.  In March and early April of 2014 he lost his eye contact, stopped responding to his name and stopped saying all the words he knew at the time including (Mama and Daddy). He started developing ritualistic and exclusive behavior likes lining up his cars and tuning out everyone around him. On 5/3/13 he developed a fifth ear infection, on 5/7/13 he had vomiting, on 5/15/13 he contracted hand, foot and mouth disease, and on 5/17/13 he had sores in mouth and difficulty swallowing. He continues to have a weakened immune system and in Dec. 2014 was diagnosed with Autism after 9 months of waiting for appointments for an evaluation and diagnosis of his condition.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Sleep disorder, Stomatitis, Unresponsive to stimuli, Urticaria, Vomiting
Clinical narrative: He developed a fever and full body rash/hives on 9/29/2013 and the rash/hives lasted for over 10 days Then his health and immune system quickly deteriorated. On 10/15/13 he developed candida diaper rash and impetigo. On 11/11/13 he developed a sleep disorder and feeding problems. On 12/17/13 he developed his first ear infection, on 1/9/14 he contracted the flu, on 2/21/14 he developed a second ear infection, and on 3/12/14 he developed a third ear infection. On 3/17/14 his stool changed. On 3/24/14 he developed a fourth ear infection and on 3/25/14 a fever.  In March and early April of 2014 he lost his eye contact, stopped responding to his name and stopped saying all the words he knew at the time including (Mama and Daddy). He started developing ritualistic and exclusive behavior likes lining up his cars and tuning out everyone around him. On 5/3/13 he developed a fifth ear infection, on 5/7/13 he had vomiting, on 5/15/13 he contracted hand, foot and mouth disease, and on 5/17/13 he had sores in mouth and difficulty swallowing. He continues to have a weakened immune system and in Dec. 2014 was diagnosed with Autism after 9 months of waiting for appointments for an evaluation and diagnosis of his condition.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal oedema, Rash, Swollen tongue
Clinical narrative: Tongue and throat started swelling. Taken to ER, IV with 3 medicines, rash on face started while at ER and continued for 3 days.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Mobility decreased, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Severe arm pain as such I could not raise it without help to get dressed. Lots of swelling. Fevers for days.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Antibody test negative, Asthenia, Balance disorder, Electromyogram, Fatigue
Clinical narrative: 10/2/2015 - Received influenza vaccination. 10/5/2015 - Extreme fatigue and weakness, loss of balance, left deltoid numbness, left thumb numbness. 10/25/2015 - Abnormal gait, worsening fatigue, difficulty lifting. 12/21/2015 Diagnosed with Transverse Myelitis.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Hypoaesthesia, Injection site hypoaesthesia, Laboratory test normal, Mobility decreased
Clinical narrative: 10/2/2015 - Received influenza vaccination. 10/5/2015 - Extreme fatigue and weakness, loss of balance, left deltoid numbness, left thumb numbness. 10/25/2015 - Abnormal gait, worsening fatigue, difficulty lifting. 12/21/2015 Diagnosed with Transverse Myelitis.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Myelitis transverse, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: 10/2/2015 - Received influenza vaccination. 10/5/2015 - Extreme fatigue and weakness, loss of balance, left deltoid numbness, left thumb numbness. 10/25/2015 - Abnormal gait, worsening fatigue, difficulty lifting. 12/21/2015 Diagnosed with Transverse Myelitis.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Chest discomfort, Cold sweat, Hallucination, Heart rate increased, Pain
Clinical narrative: Pt stated today (01/25/16 at 1430) that after his Tdap administration on 01/21/16 at 1500, he went home and at about 1900 that evening he started having cold sweats, body aches, pressure in his chest, and hallucinations. Pt didn't go to the ER, urgent care and came into the clinic this afternoon for blood draw and to report reaction. Pt also had rapid heart beat.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age. On an unknown date, the patients may have been vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K026666, 22-OCT-2016, L016427 13-APR-2017. No adverse effects reported. Temperature 1.7 degree Centigrade, time frame 19 minutes. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a male patient of unknown age, referring on himself. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. Subsequently a week later (on an unspecified date), the patient got a case of shingles. At the time of the report, the outcome of shingles was unknown. The relatedness between the shingles and ZOSTAVAX was not provided. No product quality complaint was involved. Additional information is not expected as no reporter's contact details were provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of unspecified patients. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (Lot#: K010215, expiry date: 05-MAY-2017; K011562, expiry date: 08-APR-2017). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient returned and was evaluated by Dr. on 1/21/16. Large (approx. 5"0), swollen, red reaction in right arm. Some antihistamines and localized care at present. Dr. recommends no future HPV or MCV4 shots (BENADRYL Cream and TYLENOL).
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Patient received pediatric dose of Hep B instead of adult dose.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: Throat and tongue started swelling administered epinephrine (EPIPEN) 0.3 mg and diphenhydramine 25 mg.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of unspecified patients. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (Lot#: K015970, expiry date: 23-SEP-2016, exposure on 22 F for 183 hours from 15-MAR-2015 to 16-JUN-2015; K021487, expiry date: 03-NOV-2016, exposure of 22 F for 183 hours from 15-MAR-2015 to 16-JUN-2015; L002871, expiry date: 27-JAN-2017, exposure on 22 F for 136 hours from 08-MAY-2015 to 13-JUL-2015; L005301, expiry date: 17-FEB-2017, exposure on 21 F for 109 hours from 14-JUN-2015 to 17-AUG-2015; L016127, expiry date: 06-MAY-2017, exposure on 21 F for 70 hours from 16-AUG-2015 to 27-SEP-2015; L019124, expiry date: 27-MAY-2017, exposure on 22 F for 134 hours from 23-SEP-2015 to 15-NOV-2015; L023588, expiry date: 26-JUN-2017, exposure on 22 F for 117 hours from 07-OCT-2015 to 15-NOV-2015). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of unspecified patients. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ oral liquid (Lot#: K009900, expiry date: 04-MAY-2016, exposure on 58 F for 12.75 hours from 28-MAR-2015 to 27-APR-2015; K010222, expiry date: 12-MAY-2016, exposure on 58 F for 12.75 hours from 28-MAR-2015 to 27-APR-2015; K011948, expiry date: 07-JUN-2016, exposure on 57 F for 29.75 hours from 14-AUG-2015 to 25-AUG-2015; K016275, expiry date: 20-APR-2016, exposure on 50 F for 1.5 hours on 28-MAR-2015; K020181, expiry date: 24-JUN-2016, exposure on 57 F for 48 hours from 14-AUG-2015 to 27-SEP-2015; K024700, expiry date: 30-JUL-2016, exposure on 57 F for 77.53 hours from 14-AUG-2015 to 29-NOV-2015; L001316, expiry date: 10-NOV-2016; L008057, expiry date: 01-DEC-2016; L013192, expiry date: 19-JAN-2017). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect product storage, No adverse event, Product packaging confusion
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse which reported that on 13-JAN-2015, dose of packed PROQUAD (Merck) was inadvertently placed into refrigerator rather than the freezer (dose, frequency, and lot number were not reported), the was due to the similarity in packaging of the M-M-R II (dose, frequency and lot number were not reported). No adverse effects noted and no product quality complaint was involved. This case must be VOID because it was not mentioned a patient was vaccinated. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist referring to two patients of unknown age (demographics not provided). The patient's concurrent conditions and medical histories were not reported. On 20-OCT-2015, the patients were vaccinated with ZOSTAVAX (lot # L028279, expiration date on 28-OCT-2016) (dose, frequency, route and concentration were not provided). On 21-OCT-2015, the patients experienced injection site reaction. The outcome of injection site reaction was unknown. The primary reporter did not provide the causality between ZOSTAVAX and injection site reaction. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, since 08-DEC-2015, the patients were vaccinated with unspecified number of improperly stored doses of oral, ROTATEQ (lot # L008057, expiration date 01-DEC-2016) (strength was not reported) by oral route. There was no concomitant medication reported. The reporter stated that the oral, ROTATEQ, were exposed at 32 degrees F (also reported as 31 degrees F) during 2 hours 30 minutes. No adverse effect was reported and no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a 79 year old female consumer concerning herself. No pertinent medical history was reported. The patient's drug reaction or allergies included allergy to Sulfa drugs and "Vythroman". On 26-MAR-2008 the patient was vaccinated with ZOSTAVAX (dose, route and frequency: unknown). Other concomitant therapies included valacyclovir hydrochloride (1 gm, three times a day) and gabapentin. On 21-DEC-2015, 2827 days after onset of therapy the patient experienced shingles on her left arm and back, she also had bumps and a breaking out rash. The patient had sought medical attention and treatment was received for the adverse events. The action taken was not applicable. The outcome of the adverse events was reported as recovering/resolving. The causality of the adverse events was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practice nurse refers to multiple patients of unknown age. On an unknown date, the patients may have been vaccinated with an improperly stored doses of GARDASIL. No adverse effects reported. Temperature 1.7 degree centigrade, time frame 19 minutes. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, since 08-DEC-2015, the patients were vaccinated with unspecified number of improperly stored doses of GARDASIL (lot # K011562, expiration date 08-APR-2017) (strength, route of administration and anatomical location were not reported). There was no concomitant medication reported. The reporter stated that the GARDASIL vaccines, were exposed at 32 degrees F (also reported as 31 degrees F) during 2 hours 30 minutes. No adverse effect was reported and no product quality complain was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning multiple unspecified patients. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the multiple unspecified patients received doses of improperly stored M-M-R II subcutaneous Injection (dose and frequency not reported) (lot # J006140 with expire date of April 2017). The conditions storage was 13.1 C Celsius degree for 15 hours. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of unspecified patients. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (Lot#: L013429, expiry date: 21-JUL-2017, exposure to 55 F for 48.25 hours from 16-SEP-2015 to 29-NOV-2015; L007560, expiry date: 15-JUN-2017; L014415, expiry date: 25-JUL-2017; L020015, expiry date: 16-AUG-2017). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of unspecified patients. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (Lot#: J013394, expiry date: 25-AUG-2016; K010535, expiry date: 27-AUG-2016; K014548, expiry date: 27-AUG-2016; K018180, expiry date: 17-SEP-2016, exposure on 58 F for 13 hours from 28-MAR-2015 to 27-APR-2015; K026666, expiry date: 22-OCT-2016; L004754, expiry date: 10-NOV-2016, exposure to 57 F for 77.53 hours from 14-AUG-2015 to 29-NOV-2015; L016427, expiry date: 13-APR-2017; L018501, expiry date: 22-JUN-2017; L025738, expiry date: 14-AUG-2017, exposure on 55 F for 10.75 hours from 28-NOV-2015 to 29-NOV-2015). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of unspecified patients. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II (Lot#: K006141, expiry date: 29-APR-2016; K014833, expiry date: 14-SEP-2016; K016153, expiry date: 24-SEP-2016, exposure on 58 F for 7.75 hours from 22-APR-2015 to 27-APR-2015; K024035, expiry date: 26-NOV-2016; L000459, expiry date: 06-JAN-2017; L005291, expiry date: 17-FEB-2017; L012479, expiry date: 10-APR-2017; Lot# L012482, expiry date: 10-APR-2017). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with improperly stored doses of GARDASIL, 1 DF, lot # K011562, expiration date 08-APR-2017 (strength, dose number, route and anatomical location were not reported), and ROTATEQ, 1 DF, lot # L008996, expiration date 01-DEC-2016, (strength and dose number were not reported). No adverse effects reported. The reporter stated that the vaccines were exposed to a temperature of 34F during 12 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHHY2015US164806 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 596411) on 14 Dec 2015. This report refers to a 62 year old male patient. His medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157405, expiry date: 31 May 2016) in the left arm and PNEUMOVAX (other manufacturer, batch number: K008927) in the right arm; both vaccines administered on 09 Sep 2015. On 10 Sep 2015, he developed cellulitis at both sites of injection. He went to emergency room and was treated at hospital with antibiotics and steroids. The events outcome was unknown. The events were reported as non-serious, but the event was upgraded as medically significant based on the NVS IME list. The causality of the events was not reported. Based on the documents review, it was concluded that FLUVIRIN batch 157405 was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non significant follow up received via quality assurance department (QA reference number: 1010324) on 16 Dec 2015: QA number updated. Follow up received via quality assurance department on 15 Jan 2016: Batch summary updated.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain in extremity
Clinical narrative: Case number PHHY2015US164809 is a spontaneous report initially received from the Vaccine Adverse Event Reporting system (VAERS reference number: 601812) website on 14 Dec 2015. This report refers to a 50 years old female patient. Medical history and concurrent illness were none. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 15732P) intramuscularly into left arm along with PNEUMOVAX (batch number: K010466, other manufacturer) intramuscularly into right arm on 07 Oct 2015. On 08 Oct 2015 the patient complained of sore arm. On 10 Oct 2015 the patient showed with her arm all red and was diagnosed with cellulitis. The patient went to emergency room due to these events. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "cellulitis" was upgraded based on the NVS-IMS list. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 15732P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from quality assurance department (QA reference nr. 1010328) on 16 Dec 2015: Updated QA reference number only. Follow-up information received from quality assurance department on 21 Jan 2016: Updated batch review report.
Age: 50.0
Sex: F
Vaccine: FLU3, HEPAB, TDAP
Symptoms: Chest pain, Cough, Dyspnoea, Oropharyngeal spasm
Clinical narrative: Dyspnea, cough, "throat spasm", chest ache onset approx. 1730, lasting until approx. H.S. (2200). Patient did not seek treatment.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Condition aggravated, Herpes zoster, Intensive care, Ultrasound kidney
Clinical narrative: This spontaneous report was received from a 78 year old female patient reporting on herself. The patient's medical history included shingles from which she recovered from in 2010 and stroke. The patient had an allergy to penicillin. On an unknown date in 2011, the patient was vaccinated with ZOSTAVAX injection, subcutaneously, 1 shot (exact dose, lot #, expiration date and anatomical location were not reported). The patient had no concomitant medications. On an unspecified date in 2015, the patient experienced a second case of shingles. On an unknown date in December 2015, the patient experienced a stroke and was hospitalized for 5 days in the intensive care unit (ICU) and 10 days in rehabilitation. The patient sought medical attention and received six unspecified medications including one painkiller, as a treatment. On an unknown date, sonogram of liver and kidneys was performed (details and results were not reported). The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not provided. The reporter considered stroke to be disabling. Upon internal review, stroke was considered to be medically significant. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound liver
Clinical narrative: This spontaneous report was received from a 78 year old female patient reporting on herself. The patient's medical history included shingles from which she recovered from in 2010 and stroke. The patient had an allergy to penicillin. On an unknown date in 2011, the patient was vaccinated with ZOSTAVAX injection, subcutaneously, 1 shot (exact dose, lot #, expiration date and anatomical location were not reported). The patient had no concomitant medications. On an unspecified date in 2015, the patient experienced a second case of shingles. On an unknown date in December 2015, the patient experienced a stroke and was hospitalized for 5 days in the intensive care unit (ICU) and 10 days in rehabilitation. The patient sought medical attention and received six unspecified medications including one painkiller, as a treatment. On an unknown date, sonogram of liver and kidneys was performed (details and results were not reported). The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not provided. The reporter considered stroke to be disabling. Upon internal review, stroke was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding multiple, unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with GARDASIL lot # K010215 expiration date- 05-MAY-2017 and lot # L018286, expiration date- 13-APR-2017 (incorrect product storage). No adverse event was reported. No concomitant medication was reported. The outcome of event was unknown. It was reported that the Temperature: 54F, Time frame: 12 hours, Back in range- Yes, Previous temperature excursion- No and Was call because of a data logger- Yes. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous reporter was received from a consumer regarding herself a 59 year old female patient. The patient's pertinent medical history included shingles years ago from which she recovered. Patient had no drug allergies or reactions. On 12-JAN-2016, the patient was vaccinated with ZOSTAVAX, 19400 PFU(DF), 0.65 ML, subcutaneous. Patient was on none concomitant medication. On 15-JAN-2016, the patient in the morning woke up with an itching at the injection site. Later in the day it became red, achy, hot, hard and swollen. The patient spoke with her pharmacist who gave her hydrocortisone to treat the AE. No laboratory studies were performed. Patient spoke to pharmacist to seek medical attention. The outcome of itching at the injection site and it became red, achy, hot, hard and swollen was reported as not resolved as reported she was still experiencing the AE. Causality between itching at the injection site and it became red, achy, hot, hard and swollen and ZOSTAVAX was unknown. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous reporter was received from a consumer regarding herself a 59 year old female patient. The patient's pertinent medical history included shingles years ago from which she recovered. Patient had no drug allergies or reactions. On 12-JAN-2016, the patient was vaccinated with ZOSTAVAX, 19400 PFU(DF), 0.65 ML, subcutaneous. Patient was on none concomitant medication. On 15-JAN-2016, the patient in the morning woke up with an itching at the injection site. Later in the day it became red, achy, hot, hard and swollen. The patient spoke with her pharmacist who gave her hydrocortisone to treat the AE. No laboratory studies were performed. Patient spoke to pharmacist to seek medical attention. The outcome of itching at the injection site and it became red, achy, hot, hard and swollen was reported as not resolved as reported she was still experiencing the AE. Causality between itching at the injection site and it became red, achy, hot, hard and swollen and ZOSTAVAX was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: This spontaneous social media report was received from an unspecified reporter and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (exact dose, route, lot # and expiration date were not reported). On an unknown date, the patient experienced a "mysterious" sickness the doctors could not find the answer to. It turned out the sickness was related to having the GARDASIL received. The patient was able to heal herself by changing her diet and using traditional Chinese medicine versus western medicine. This is one of several reports received from the same source. Additional information is not expected as no contact details were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. In approximately January 2016, reported as on multiple unspecified dates following a temperature excursion reported on 15-JAN-2016, the patients were vaccinated with improperly stored dose of (Oka/Merck) VARIVAX injection (lot# L003774, expiry date 04-FEB-2017; lot# L020000, expiry date 02-JUN-2017 and lot# L030160, expiry date 11-AUG-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. The reporter stated that the doses of (Oka/Merck) VARIVAX were exposed to the temperature of 6.1 degrees Fahrenheit for a period of 70 hours on an unknown date (with previous temperature excursions: 5.9 degrees Fahrenheit for 15 hours, 6.8 degrees Fahrenheit for 48 hours, 5.5 degrees Fahrenheit for 72 hours, 6.8 degrees Fahrenheit for 15 hours, 6.6 degrees Fahrenheit for 120 hours, 5.9 degrees Fahrenheit for 72 hours, 5.2 degree Fahrenheit for 16 hours and 6.1 degrees Fahrenheit for 70 hours-on unspecified dates). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative refers to an adult patient of unknown age and gender. The patient's current condition and medical history was not provided. On 20-JAN-2016 the patient was vaccinated with an expired dose of VAQTA injection of strength 50/1.0 U/ml  (therapy route reported as injection, lot# not reported). Concomitant medication was not mentioned. The patient did not seek medical attention. The healthcare worker did not supply the patient's specific demographic data. No further information was available. Product quality complaint was not filed. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacists via a company representative refers to a female (above 60 years old). The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date in 2015 (also reported last year) the patient was vaccinated with ZOSTAVAX (dosing details were not reported). No concomitant medications were reported. On an unknown date in 2015 the patient experienced adverse reaction. The patient developed the shingles type rash and blister. Patient did not receive any treatment for the events. Patient sought medical attention by speaking to the pharmacists. The outcome of the events were reported as recovered/resolved. The reporter did not provide the causality between the event and the suspect therapy. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 17-SEP-2015, patient was vaccinated with her first dose of GARDASIL, the second dose of GARDASIL injection 1 DF (one injection/ three dose series) (lot # not reported) was administered on 19-NOV-2015 followed by the third dose on 19-JAN-2016. The reporter stated that patient was off scheduled for her GARDASIL series (inappropriate schedule of drug administration). No adverse experience reported. No concomitant medications were reported. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L030867, expiration date 09-JUN-2018, dose and route unknown), which were under the temperature of 24 degree Celsius with time frame 838 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site swelling
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date in November 2013 the patient was vaccinated with ZOSTAVAX injection 1 DF (one shot/once). On an unknown date the patient experienced injection site swelling after vaccination with ZOSTAVAX. The patient also developed shingles. The outcome of the event injection site swelling was reported as never healed fully (not recovered/not resolved). The outcome of event shingles was unknown. The reporter did not provide the causality between the event and the suspect therapy. There was no product quality complaint. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Abnormal weight gain, Blood cortisol increased, Fatigue, Hair growth abnormal, Injection site discomfort
Clinical narrative: Rapid weight gain, fatigue, hair growth on face and midsection, stretch marks on abdomen, elevated cortisol levels, MRI revealed pituitary adenoma.  Two transphenodial surgeries and radiation followed.  Diagnosed Cushings Disease.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Laboratory test, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging abnormal, Pituitary tumour benign, Pituitary-dependent Cushing's syndrome
Clinical narrative: Rapid weight gain, fatigue, hair growth on face and midsection, stretch marks on abdomen, elevated cortisol levels, MRI revealed pituitary adenoma.  Two transphenodial surgeries and radiation followed.  Diagnosed Cushings Disease.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Radiotherapy, Skin striae, Surgery, Weight increased
Clinical narrative: Rapid weight gain, fatigue, hair growth on face and midsection, stretch marks on abdomen, elevated cortisol levels, MRI revealed pituitary adenoma.  Two transphenodial surgeries and radiation followed.  Diagnosed Cushings Disease.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Pain, Peripheral swelling
Clinical narrative: Arm was red, swollen, hurt to move. Low grade temp. Advised anti-inflammatories, antihistamines, cold compress and office visit the next day to follow-up.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's current condition and pertinent medical history were not mentioned. On unspecified dates the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 of batch# L035687, expiry date: 16-FEB-2017 (route and indication not reported). The vaccine was stored at 70 degrees Fahrenheit for a time frame of 24 hours. There was no previous temperature excursion. No adverse effects reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Injection site atrophy, Injection site nodule
Clinical narrative: 1/25/16 left leg has 4mm indentation w/had 4mm nodule. Parents have rubbed area and given warm baths. This is smaller than what parents said site was previously. Has not been in pain.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Activities of daily living impaired, Blood creatine phosphokinase, Differential white blood cell count, Full blood count, Lethargy
Clinical narrative: Pain in arm (of immunization), (B) leg pain, lethargic. Mom had to lift patient to assist out of bed.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Metabolic function test, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: Pain in arm (of immunization), (B) leg pain, lethargic. Mom had to lift patient to assist out of bed.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Witnessed pt. pass out. (1/19) mom called 1/25 with c/o dizziness since receiving vaccine.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Rash papular, Rash pruritic
Clinical narrative: (+) red papules on the legs then spread to other body parts. Papules initially red -> vesicles -> open -> crusted papules (different stages) noted 10 days after varicella vaccine given. No symptoms of varicella illness. Patient in for itchy red papules initially on the legs and now from head to toe since 5 days ago. Rashes came out not at the same time. It started on the right leg. It starts as red papules then become blistery then open up then dry up. Most of it are on his extremities. No contacts with anybody with Varicella or similar rashes. Mother denies cough, colds, or fever. Patient's appetite is good and active. 12 month old vaccines were given on 1-4-16.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding multiple, unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with oral, ROTATEQ, lot # L020859, expiration date- 19-JAN-2017, lot # L006181, expiration date -13-DEC-2016, lot # L020861, expiration date- 25-JAN-2017 and lot number- L035508, expiration date- 12-MAY-2017. No adverse event was reported. No concomitant medication was reported. The outcome of event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.