chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: FLUX, PPV, TD
Symptoms: Bacterial test, Chills, Full blood count, Hypotension, Immune system disorder
Clinical narrative: On November 10th patient received influenza, PNEUMOVAX, and Td vaccines. On November 11th, he presented to the emergency room with muscle pain, chills, fever, nausea, and cramping. He was admitted to inpatient on November 11th, requiring IV fluids and IV clindamycin therapy. MD could not rule out probable immunologic reaction to the PNEUMOVAX with fever and hypotension in his differential diagnosis. Patient was discharged to home on 11/13/16 with prescription for cephalexin 500 mg PO four times a day x 3 days.
Age: 46.0
Sex: M
Vaccine: FLUX, PPV, TD
Symptoms: Influenza virus test, Metabolic function test, Muscle spasms, Myalgia, Nausea
Clinical narrative: On November 10th patient received influenza, PNEUMOVAX, and Td vaccines. On November 11th, he presented to the emergency room with muscle pain, chills, fever, nausea, and cramping. He was admitted to inpatient on November 11th, requiring IV fluids and IV clindamycin therapy. MD could not rule out probable immunologic reaction to the PNEUMOVAX with fever and hypotension in his differential diagnosis. Patient was discharged to home on 11/13/16 with prescription for cephalexin 500 mg PO four times a day x 3 days.
Age: 46.0
Sex: M
Vaccine: FLUX, PPV, TD
Symptoms: Pyrexia, Respiratory syncytial virus test, Urine analysis, Vaccination complication
Clinical narrative: On November 10th patient received influenza, PNEUMOVAX, and Td vaccines. On November 11th, he presented to the emergency room with muscle pain, chills, fever, nausea, and cramping. He was admitted to inpatient on November 11th, requiring IV fluids and IV clindamycin therapy. MD could not rule out probable immunologic reaction to the PNEUMOVAX with fever and hypotension in his differential diagnosis. Patient was discharged to home on 11/13/16 with prescription for cephalexin 500 mg PO four times a day x 3 days.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Information has been received from a Registered Nurse, via a company representative, concerning two unspecified patients of unknown ages and gender. The patients' pertinent medical history and concurrent conditions were not informed. On an unknown date, the patients were vaccinated with ZOSTAVAX (lot #, expiration date, dosage and therapy route were not provided). Concomitant therapies were not informed. It was reported that on unspecified dates, the patients were diagnosed with cellulitis after receiving a ZOSTAVAX injection. The nurse stated that the patient contacted her for medical attention. The outcome of cellulitis was unknown at the time of the report. The causal relationship between cellulitis and ZOSTAVAX was not informed. Upon internal review cellulitis was determined to be a medically significant event. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: FLU4
Symptoms: Computerised tomogram head, Eyelid ptosis, Facial paralysis, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Began experiencing mild numbness in left side of lip 10/23/16. By mid-morning 10/24/16, whole left side of face was numb with droop eyelid and lip.
Age: 1.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt had no adverse events at time. Pt was given KINRIX instead of Hep A.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site urticaria, Macule
Clinical narrative: Numerous bright red discrete 1-3 mm macules scattered on head, face, neck, arms, legs, and trunk, with hyperconcentration of macules surrounding 3 cm area of subcutaneous swelling and erythema with wheal on right anterior thigh. There is no corollary swelling on left thigh.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Death, Malaise, Vomiting
Clinical narrative: 10:13 had pre-op work for upcoming knee surgery. Took flu shot after had to stop along road twice on way home to throw up stayed sick 14th 15th of Oct. Got her in bed about 11:30pm on the 15th. Went in to get her out of bed at 10:00 AM on the 16th, she had passed away several hours prior to. Patient had taken flu shot for years. She felt good morning of 13th.
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist referring to a currently 63 year old male patient. The patient's medical history and concurrent conditions were not reported. None drug reactions or allergies were reported. On 24-OCT-2016, the patient was vaccinated with ZOSTAVAX lot # L035505, expiration date: 16-DEC-2016, dose: 0.65 ml, once, via subcutaneous in the right upper arm. At the same visit, the patient was vaccinated with FLUARIX (lot number, expiration date, concentration, dose, frequency, route of administration and indication were not reported) that was administered the same date at an unspecified site. Concomitant medications were not reported. On 28-OCT-2016, the patient experienced a "widespread rash, which started in his armpits, to his back and groin area, it was also reported that the rash was red and itches", no treatment was given for the adverse event, furthermore, none laboratories or studies were performed, additionally the patient sought medical attention by calling the pharmacist. At the time of the report, the outcome of rash generalised, rash erythematous and rash pruritic was unknown, the causality between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Chemotherapy, Leiomyosarcoma, Pyrexia
Clinical narrative: Fever of 102-104 approximately 12hrs after. Ibuprofen/TYLENOL for relief.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Neuralgia
Clinical narrative: Pt repeated going to MD for nerve pain related to injection.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Pain
Clinical narrative: Rcvd flu vaccine 10/13/16. Continued w/discomfort on 10/22/16. No redness, no swelling, full ROM (R) arm. Seen 10/25/16 by PA, for continued pain. Taking NSAID. Seen 11/1/16 with some improvement-continue NSAID and ROM.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injection site pain, Joint range of motion decreased
Clinical narrative: Received flu shot 10/26/16. Presented next day with C/O (L) shoulder pain and decreased ROM. Prescribed Naproxen, heating pad and arm exercises. F/U apt 11/1 - DX: bursitis - continue anti-inflammatories and exercises.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient describes receiving vaccine on 11/7/16 and on the next day she had redness and swelling in the area of injection.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging, Rotator cuff syndrome, Tendonitis, Tenosynovitis
Clinical narrative: Bicepital tendonitis diagnosis code M75.21. Biceps Tenosynovitis diagnosis code 726.12. Impingent syndrome M75.41. Received cortisone, physical therapy.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site infection, Injection site pain, Injection site vesicles
Clinical narrative: Pt had flu shot in left deltoid/arm hurt after shot, came back had reaction in area below where shot was given. Skin had sac of fluid looks like infection. Pt went to Dr. Dr prescribe Cephalexin and Mupirocin.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Fatigue, Ocular hyperaemia, Oropharyngeal pain, Pain
Clinical narrative: Red eyes, fatigue, aches, sore throat, dyspnea. Tx: Dexamethasone/BENADRYL.
Sex: U
Vaccine: FLU3
Symptoms: Dyspnoea, Ocular hyperaemia, Swelling face
Clinical narrative: Per patient: Difficulty breathing face swelling eye red.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Sharp pain radiating down arm; pain down in shoulder and back (L).
Age: 47.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Drug administered at inappropriate site, Injection site inflammation
Clinical narrative: Pt returned the following day with a prescription for steroids to help the should inflammation where immunizations where given. She stated that the shots were given too high up on the arm and that the doctor was afraid of an infection in the bursa sac.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Pt. here 11/10/16 for flu clinic 0.5 QUAF flu dose. S/s developed later that eve and pt was seen for same in office on 11/11/16. S/s = (Lt) upper arm with 71/2 x 6 cm erythema, induration, warmth and tenderness. Afebrile tx with ibuprofen and warm compresses prn.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness. Swelling on left arm.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Arthralgia, Back pain, Blood test normal, Hypoaesthesia, Pain
Clinical narrative: 10/16/16 approximately 900-930 AM onset of numbness both legs and feet with pins and needles. Back pain. Hip pain. Moderate swelling in feet. No discoloration. 10/17/16 ER at 900 AM d.t. severe pain. They questioned Guillain-Barre Syndrome. A spinal tap was going to be performed; however, her symptoms improved and it was not done. They gave her pain Rx x 2 days. 10/20/16 doctor visit with Dr (primary provider). He drew blood which was within normal limits. He also questioned GBS. Over the next 1 1/2 weeks the symptoms gradually resolved. She is reported to be back to normal by her mother which provided this summary of events.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: 10/16/16 approximately 900-930 AM onset of numbness both legs and feet with pins and needles. Back pain. Hip pain. Moderate swelling in feet. No discoloration. 10/17/16 ER at 900 AM d.t. severe pain. They questioned Guillain-Barre Syndrome. A spinal tap was going to be performed; however, her symptoms improved and it was not done. They gave her pain Rx x 2 days. 10/20/16 doctor visit with Dr (primary provider). He drew blood which was within normal limits. He also questioned GBS. Over the next 1 1/2 weeks the symptoms gradually resolved. She is reported to be back to normal by her mother which provided this summary of events.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-OCT-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot number K016322, with expiration date of 24-DEC-2015) (dose, administration route an anatomical location were not reported). Additionally, no adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 11 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L024993 with expiration date 17-SEP-2017, (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Sex: U
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On an unknown date, the pharmacist administered PNEUMVOAX 23 (expiration date, dose and route not reported) to the patient. The patient experienced severe soreness (onset date unknown). This particular shot was from lot # M036161. The outcome of the event was unknown. The causality between PNEUMOVAX 23 and the event was not provided. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Skin abrasion, Syncope, Tooth fracture
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a patient (age and gender not specified). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unknown date the patient was administered an unspecified dose in the GARDASIL series. It could not be confirmed if the product that was administered was GARDASIL or GARDASIL 9. The patient went out to the car to go home at an unspecified time after the GARDASIL injection and experienced syncope. The patient scraped his or her face and chipped a tooth while experiencing syncope. The patient was taken to the emergency room for unspecified treatment. The outcome of syncope, scraped face and chipped tooth was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 21-OCT-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot # L020482 and expiration date 02-SEP-2016 (Dose and route were not reported). No adverse effects were reported. There was not a product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 16 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L024993 with expiration date 17-SEP-2017, (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patient of unknown age. Medical history, concurrent conditions and concomitant medication were not reported. The nurse reported that on 30-JUN-2009 the patient received a dose of VARIVAX (reported lot# 0228Y, exp date 13-FEB-2011) instead of ZOSTAVAX. No adverse events were reported. The outcome of the event was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 15 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L024993 with expiration date 17-SEP-2017, (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On unknown dates, the patients were administered improperly stored doses of ZOSTAVAX lot # M032139, expiration date 02-OCT-2017, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. The doses of ZOSTAVAX were exposed to 21.3 degrees C for 1 hour. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 11 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant  medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L024993 with expiration date 17-SEP-2017, (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Chills and fever first night, red and blotchy day 2. Day 3 injection site red and warm. Day 5 area clear no redness at site.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rash macular
Clinical narrative: Chills and fever first night, red and blotchy day 2. Day 3 injection site red and warm. Day 5 area clear no redness at site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: This spontaneous report was received from a physician and refers to his wife 62 year old female patient. The patient's concurrent conditions included postherpetic neuralgia (for many years). The patient's medical history included shingles (3 or 4 times). The patient suffered from postherpetic neuralgia for many years and she has experienced shingles 3 or 4 times. As a result of her postherpetic neuralgia symptoms, the patient received many unspecified injections for treatment of back pain along her spine for years and years. On 29-JUL-2016, the patient was vaccinated with ZOSTAVAX 19400 PFU subcutaneously as routine vaccination (lot number and expiration date were not reported). Concomitant therapies included influenza virus vaccine (unspecified), ADVIL, desloratadine, atorvastatin, pantoprazole, Vitamin D3, PROVERA and PREMARIN. The physician and his wife reported that his wife experienced positive result after receiving ZOSTAVAX. After she received ZOSTAVAX at her physician's practice, the patient became aware that she was no longer experiencing the pain from her postherpetic neuralgia. She was not able to identify exactly when her pain began to alleviate, but she became conscious of her increased mobility and comfort on 29-OCT-2016. She stated that it is like a headache, you don't notice it until it is gone. The patient also reported that after she received ZOSTAVAX, she also received on 19-SEP-2016, an unspecified influenza vaccine (also reported as the one that doesn't have mercury in it). The physician and his wife were agreeable to follow up to discuss this unexpected improvement in postherpetic neuralgia symptoms after ZOSTAVAX. No additional information was provided. No treatment was given for the event and no lab tests were drawn. The outcome of the event was unknown. No product quality complaint was involved in this case. The causality between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site pruritus, Nausea, Vomiting
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 60 year old non pregnant female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 29-OCT-2016, the patient was vaccinated in her right arm with ZOSTAVAX subcutaneously, lot # L034726, expiration date on 09-DEC-2016 (strength and dose number were not provided). On 30-OCT-2016, the patient experienced nausea, vomiting along with diarrhea and some itching at the injection site, no rash noted. It was reported that no specific treatment had been given for the events. There was no intervention to prevent serious criteria, the case did not involve cancer or overdose. No product quality complaint was involved. The outcome of vomiting, injection site pruritus and nausea was reported as recovering, but the outcome of diarrhoea was reported as not recovered. The reporter did not assess the relatedness between the events and ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. Medical history, concurrent conditions and concomitant medication were not provided. The nurse reported that on 12-OCT-2016 the patient was administered a dose of improperly stored PNEUMOVAX 23 (lot # L035687, Exp date 16-FEB-2017), intramuscular. No adverse events were reported. The outcome of the event was unknown. Excursion details included: temperature 47.5F; time frame: 25 minutes. Previous temperature excursion: 33.5F for 20 minutes. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Musculoskeletal disorder, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 78 year old female patient. The patient had no drug reactions or allergies. The patient's pertinent medical history and concomitant medications were not reported. On 08-NOV-2016 the patient was vaccinated with PNEUMOVAX 23, one injection (1 DF), (lot # M000592, expiry date 21-OCT-2017). The patient called the pharmacist at an unspecified time (approximately November 2016) after being administered the PNEUMOVAX 23, her arm was extremely sore and she couldn't use her arm. Approximately in November 2016, the patient also experienced, swelling, pain and numbness in the left arm. The pharmacist referred to the physician or the hospital. But the patient did not want to do that. The pharmacist followed up with a phone call to the patient on 10-NOV-2016. The patient stated she was getting a little better, the swelling was going down but she was still in pain. No laboratory tests were done. It could not be confirmed if the patient called the physician but she was using "icing and MOTRIN as treatment". The patient had not completed recovered but was still improving (outcome of pain in extremity was considered not recovered while outcome of the other events was reported as recovering). No product quality complaint was filed. Causality assessment was not provided. 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 licensed vocational nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown dates, the patient were vaccinated with improperly stored doses of ROTATEQ (exact dose was not reported, orally, lot # L035510, expiration date 13-MAY-2017; lot # L023866, expiration date 24-MAR-2017). These doses were exposed to 56.80 degrees Fahrenheit (F) for 12 hours and 30 F for 24 hours. A data logger was used to log the temperatures. There were no prior excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of Gardasil 9 (exact dose, route of administration and anatomical location were not reported, lot # M023169, expiration date 13-JUN-2016). These doses were exposed to 56.80 degrees Fahrenheit (F) for 12 hours and 30 F for 24 hours. A data logger was used to log the temperatures. There were no prior excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored VAQTA (lot # L022259, expiration date 06-APR-2017, lot # L023936, expiration date 15-MAR-2017). The vaccines had been exposed under temperature 1.05 degree Centigrade for 49 hours, but did not undergo previous excursion. Data logger was used. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Information has been received from a nurse concerning a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. The reporter stated that a patient was vaccinated with expired RECOMBIVAX HB (dose and frequency unknown) (lot# K018796, expired date 24-OCT-2016) on either 29-OCT-2016 or 30-OCT-2016. The reporter was not sure which date the patient was vaccinated, and the RECOMBIVAX HB did not have any previous temperature excursions. Additional information is not expected because the reporter does not want to be contacted further.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, lot # L039638, expiry date 23-AUG-2017 (dose was not specified). The administered doses of ROTATEQ underwent temperature excursion under 13.3 Fahrenheit degrees for 7.5 hours in the freezer and 62.6 Fahrenheit for 10 hours in the refrigerator. No prior excursions were reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning 8 patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. From 04-NOV-2015 to 25-NOV-2015 the patients were each vaccinated with an improperly stored dose of GARDASIL (0.5 ml, intramuscular). Lot number (L021620) is an invalid lot number for GARDASIL. No adverse reactions reported. No product quality compliance (PQC) was reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Laboratory test, Vertigo
Clinical narrative: Information has been received from a 72 year old male patient referring to himself. The patient's concurrent condition included seasonal allergies and drug allergy: calcium channel blockers. It also reported that the patient had no pertinent medical history. Concomitant medication included unspecified blood pressure medication and unspecified thyroid medication. On 15-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously. On 15-AUG-2016, a few hours post vaccination of ZOSTAVAX, the patient developed vertigo. The patient did not seek medical attention and no treatment was given for the event. In August 2016, the patient did lab test: prostate and general blood work (result unknown). The symptoms lasted several hours and eventually dissipated in August 2016 (recovered). The causal relationship between the event and ZOSTAVAX was unknown. Additional information has been requested.
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Fall, Neck injury, Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a female patient of unknown age. Concomitant therapies included influenza virus vaccine (unspecified). Information about concurrent condition and medical history was not provided. In October 2016 ("within the last month"), the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, frequency, route, lot # and expiration date were not reported). Subsequently, on the same date, the patient experienced syncope while sitting on the exam table and fell forward. The patient experienced a neck injury and was taken to the emergency room. No treatment was given for the events. At the time of this report, the outcome of the events was unknown. The causality between the events and GARDASIL 9 was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster
Clinical narrative: Information was received from a pharmacist via Pfizer (other company number 2016 487382) referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date within three years, the patient was vaccinated with ZOSTAVAX (dose, lot# and route unknown) for the first time. The patient got shingles on an unspecified date, so the pharmacist gave her the ZOSTAVAX (dose, lot # and route unspecified) second time without realizing in August 2016. The pharmacist confirmed that the patient received ZOSTAVAX twice within three years time span and that was supposed to be a one time vaccination. On 03-OCT-2016, just a couple of weeks ago, the patient got shingles but with not medical diagnosis. The outcome of shingles was unknown. The relationship between the event shingles and ZOSTAVAX was not provided. Additional information is not expected as there was no medical information request.
Sex: M
Vaccine: PPV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a consumer referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were unknown. On 19-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot# and expiration date unknown), via the intravenous route. No adverse effects were reported. The reporter stated that the staff had continued to monitor the patient. Additional information is not expected as the reporter did not wish to be contacted.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a pharmacist via a field employee referring to a 92 year old female patient. The patient's medical history included multiple cases of shingles. The patient's concurrent condition, concomitant therapy and drug reactions were unknown. In approximately 2013 (reported as possibly 2 to 3 years ago), the patient was vaccinated with ZOSTAVAX (Lot#, expiration date, strength, dose, frequency and route unknown). Currently, the patient was experiencing a full blown case of shingles (onset date unspecified). The pharmacist was seeking information about ZOSTAVAX and shingles and would be receptive to analysis. It was unknown if patient had started any antiviral therapy. The outcome of the event was not recovered. The causality between the event and ZOSTAVAX was not provided. 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: Information has been received from a registered nurse referring to an unspecified number of patients of unknown ages 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 GARDASIL (lot # K010215, expiration date 05-MAY-2017; dose unknown) intramuscularly. No adverse effect was reported. The vaccines were stored under the temperature 1.9 Celsius degree for 6 minutes. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients received an improperly stored dose of GARDASIL 9 (lot # M009378, expiration date 23-APR-2016; dose unknown) intramuscularly. No adverse effect was reported. The vaccines were stored under the temperature 1.9 Celsius degree for 6 minutes. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports received rom the same reporter. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: This spontaneous report refers to an approximately 56 years old male patient reporting on himself. The patient reported allergy to certain type of adhesives like on band-aids, tape and patches; his concurrent conditions included hand-foot-mouth disease, since his early 30s. The patient's medical history included hand-foot-and-mouth-disease. In approximately July 2016, (reported as "about four months ago"), the patient was vaccinated with a dose of ZOSTAVAX (injection, lot#, expiry date, route and site of injection were not reported). Concomitant therapies included lisinopril (+) hydrochlorothiazide (manufacturer unknown) and XIAFLEX. Since receiving ZOSTAVAX the patient had not had an outbreak of his hand-foot-and-mouth disease. He stated that he had had the condition since his early 30s and used to get water blisters on feet and fingers. The patient was surprised with his unexpected result, but did not discuss this reaction with his physician. The patient did not receive any treatment and no lab diagnostic studies were performed. The outcome of the event was unknown at the time of the report. The relatedness between the event and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX lot # L046900, expiration date; 23-FEB-2018, (concentration, dose, frequency and route of administration were not reported), which was improperly stored at 8.6 Fahrenheit degrees for 1 hour and 15 minutes. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported. No adverse effect was reported. This is one of several cases from the same reporter. Additional information is not expected because the reporter did not give permission to be contacted.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX 19400 PFU, lot # M001746 with expiry: 17-APR-2017, (dose, route and anatomical location not reported), which had a temperature excursion of 31 degree Fahrenheit for 1 hour 30 minutes. No adverse effects reported. No further information provided. Additional information is not expected as the reporter did not give consent for follow up.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring an unknown number of patients of unknown age and gender. The patients' pertinent medical histories, concurrent conditions and concomitant medications were not reported. On an unknown date, the unspecified patients were vaccinated with a dose of PNEUMOVAX 23 (Dose, route, lot # and expiration date were not reported). It was stated that the patients experienced one or all of the following events: injection site pain, injection site erythema and/or injection site swelling, after vaccination. At the time of reporting the outcome of injection site pain, injection site erythema and injection site swelling was unknown. The reporter did not assess the causal relationship between the adverse events and the vaccination with PNEUMOVAX 23. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 13 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L024993 with expiration date 17-SEP-2017, (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 16 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with and improperly stored dose of GARDASIL 9, lot # L024993 with expiration date 17-SEP-2017, (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Sex: U
Vaccine: VARZOS
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 an unknown age and gender. No information on patients' pertinent medical history, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of ZOSTAVAX (lot # M017294 and expiration date 28-JUN-2017) (dose and route of administration were not reported). There were no adverse effects reported. The doses of ZOSTAVAX were stored in -1.9 degree Celsius for 7 hours and 30 minutes, on an unknown date. The previous temperature excursions were reported as -14 degree Celsius for 2 hours and -13.7 degree Celsius for 7 hours and 30 minutes, both on unknown dates. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # M017290, expiry date 07-APR-2018 (dose, route of administration and anatomical location were not specified). The administered doses of VARIVAX underwent temperature excursion under 13.3 Fahrenheit degrees for 7.5 hours in the freezer and 62.6 Fahrenheit degrees for 10 hours in the refrigerator. No prior excursions were reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II injection, lot # L036851, expiry date 23-SEP-2017 and lot # M008589, expiry date 16-FEB-2018 (albumin status, dose, route of administration and anatomical location were not specified). On 11-OCT-2016, 12-OCT-2016 and 21-OCT-2016, the patients were vaccinated with improperly stored doses of M-M-R II injection, lot # L032044, expiry date 24-AUG-2017 (albumin status, dose, route of administration and anatomical location were not specified). The administered doses of M-M-R II underwent temperature excursion under 13.3 Fahrenheit degrees for 7.5 hours in the freezer and 62.6 Fahrenheit degrees for 10 hours in the refrigerator. No prior excursions were reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Incorrect route of drug administration, Injection site nodule
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-OCT-2016 the patient was vaccinated with a dose of ZOSTAVAX 19400 DF reported as: 19400 PFU intramuscularly in error, on the right deltoid (expiration date, dose and lot number were not provided). At the same date, on 16-OCT-2016, reported as immediately, the patient developed a big knot at the injection site. No treatment was given for the adverse event. At the time of the report, the outcome of injection site nodule was unknown. There was no product quality complaint involved. The causal relationship between ZOSTAVAX and injection site nodule was unknown by the reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 04-NOV-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming units (PFU) injection, lot # reported as M026878, expiry date 27-JUL-2017 (dose, route of administration and anatomical location were not specified), in error. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-SEP-2014, the patient was vaccinated with a dose of GARDASIL (route of administration, lot number, expiration date, dose and frequency were not reported). On 28-SEP-2016, the patient was vaccinated with a dose of GARDASIL 9 (route of administration, lot number, expiration date, dose and frequency were not reported). The physician made the decision that this would be the dose 2 of the HPV series. Subsequently, on 18-OCT-2016, the patient inadvertently received a dose of GARDASIL 9 (route of administration, lot number, expiration date, dose and frequency were not reported). No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. Approximately in January 2016 (reported as "10 months ago"), patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry date, dose, strength, vaccination site, route not provided). The reporter stated that, the patient has received another dose of ZOSTAVAX on 13-OCT-2016 (reported as "3 weeks ago") (lot #, expiry date, dose, strength, vaccination site, route not provided). Product quality complaint (PQC) was not involved. No adverse symptoms were reported. No further information was provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis L arm at vaccine site.
Sex: U
Vaccine: PPV
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. No information regarding patient's concomitant medication, pertinent medical history, drug reactions, or allergies was provided. On 26-OCT-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (dose and route of administration, were not provided; lot #: L040181, expiration date: 18-AUG-2017). No adverse events were reported. Additional information has been requested.