chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood cortisol, Blood test normal, Chest X-ray normal, Fatigue, Headache
Clinical narrative: Constant muscle pain in the neck, shoulder arm, collar bone, back elbow; Low blood pressure. fatigue, headache, balance. Injection site swelling, redness, pain. Symptoms still exist today went to visit rheumatologist performed blood tests, MRI. X-ray from primary physician. Treatment - Meloxicam 15 mg.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypotension, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Constant muscle pain in the neck, shoulder arm, collar bone, back elbow; Low blood pressure. fatigue, headache, balance. Injection site swelling, redness, pain. Symptoms still exist today went to visit rheumatologist performed blood tests, MRI. X-ray from primary physician. Treatment - Meloxicam 15 mg.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Nuclear magnetic resonance imaging normal, Urine analysis
Clinical narrative: Constant muscle pain in the neck, shoulder arm, collar bone, back elbow; Low blood pressure. fatigue, headache, balance. Injection site swelling, redness, pain. Symptoms still exist today went to visit rheumatologist performed blood tests, MRI. X-ray from primary physician. Treatment - Meloxicam 15 mg.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Back pain, Bone pain, Chest pain, Expired product administered
Clinical narrative: Constant muscle pain in the neck, shoulder arm, collar bone, back elbow; Low blood pressure. fatigue, headache, balance. Injection site swelling, redness, pain. Symptoms still exist today went to visit rheumatologist performed blood tests, MRI. X-ray from primary physician. Treatment - Meloxicam 15 mg.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: Constant muscle pain in the neck, shoulder arm, collar bone, back elbow; Low blood pressure. fatigue, headache, balance. Injection site swelling, redness, pain. Symptoms still exist today went to visit rheumatologist performed blood tests, MRI. X-ray from primary physician. Treatment - Meloxicam 15 mg.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Tendon pain
Clinical narrative: Constant muscle pain in the neck, shoulder arm, collar bone, back elbow; Low blood pressure. fatigue, headache, balance. Injection site swelling, redness, pain. Symptoms still exist today went to visit rheumatologist performed blood tests, MRI. X-ray from primary physician. Treatment - Meloxicam 15 mg.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of an unknown age and gender. No information of their medical history, concurrent conditions or concomitant drugs was provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot # and expiration date unknown). One month after the first dose, the patient was vaccinated with the second dose of GARDASIL (dose, route of administration, lot # and expiration date unknown) (coded as inappropriate schedule of drug administration). No adverse effects were noted. Additional information is not expected because the reporter did not provide their contact details.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Back pain, Bone pain, Chest pain, Lymphadenopathy, Myalgia
Clinical narrative: Swollen lymph glands under (L) arm. Started 72 hr after injection, muscle and skeletal pain- Back and chest area started 72 hr after injection. Pain increased 1 week later. Lasted 16 days. Seen by PCP. Treated with ADVIL, Rest and Heat Pad.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Pain
Clinical narrative: Swollen lymph glands under (L) arm. Started 72 hr after injection, muscle and skeletal pain- Back and chest area started 72 hr after injection. Pain increased 1 week later. Lasted 16 days. Seen by PCP. Treated with ADVIL, Rest and Heat Pad.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Rash
Clinical narrative: No complaints of SOB or facial edema. Rash to Right Upper arm and chest treated wit diphenhydramine 25 mg as directed mg PRN
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and concurrent conditions were reported. The nurse reported that on an unknown date and time after 02-FEB-2015, unspecified number of patients were vaccinated with GARDASIL 0.5 ml intramuscularly (lot # K007264, expiry date 02-MAR-2017; lot # K007828, expiry date 02-MAR-2017 and lot # K009482, expiry date 06-MAR-2017). On an unspecified date, the vaccine had been improperly stored. No adverse effects were reported. There was no product quality complaints (PQC) involved. The outcome of the event was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 26-MAR-2015, the patient was vaccinated with expired dose of (Oka/Merck) VARIVAX (lot # J002317, expiration date 22-FEB-2015, subcutaneously, dose was not provided) in error. There were no known adverse effects. All of the data was reconfirmed with the reporter. There was no further information provided. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Mobility decreased, Pain in extremity
Clinical narrative: Pt reports arm starting to hurt within 3-4 hours of administration. He reports losing all strength in his arm and having weakness and trouble lifting things. He came in today 4/20/15 to report this and says the pain is subsiding and he is using a sling to support the arm. He says he did not need to take any additional pain medication that he already has on hand for another condition. He says he will follow up with his MD.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Blood creatine phosphokinase increased, Body temperature increased, HIV test negative, Headache, Liver function test abnormal
Clinical narrative: Nausea, vomiting, headache, oral temp 100.2.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Renal function test normal, Varicella virus test positive, Vomiting
Clinical narrative: Nausea, vomiting, headache, oral temp 100.2.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist referring to two patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On unknown dates each of the patients were vaccinated with a dose of ZOSTAVAX (strength, dose, dose number, lot #, route and application site were not reported). Concomitant therapy was not reported. Since unknown date, about one year after receiving ZOSTAVAX injection the patients developed shingles. The outcome of shingles was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
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. On unknown dates, the patients were vaccinated with ROTATEQ, oral, that had been improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 15-NOV-2104 the patient was vaccinated with the first dose and on 17-APR-2015 with the second dose of VAQTA (strength: 25/0.5 (units not provided), 0.5 ml, intramuscular). No adverse effects were reported. Additional information is not expected as there was no consent to follow up contact.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Headache, Injection site warmth, Lymph node pain, Lymphadenopathy
Clinical narrative: 17Apr15-chills, body aches, h/a, hives on trunk, site is hot to touch, swollen/painful lymphnodes.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Pain, Urticaria
Clinical narrative: 17Apr15-chills, body aches, h/a, hives on trunk, site is hot to touch, swollen/painful lymphnodes.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria. Pruritus.
Age: 78.0
Sex: M
Vaccine: DTP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient developed prominent erythema, pruritus and soft tissue swelling in left upper arm and subsequently in left forearm after Tdap vaccine in that arm.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to unspecified number of patients. No information regarding current condition, medical history or drug allergies were reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (strength, dose unit, lot number and frequently unknown) (incorrect product storage). No concomitant therapy was reported. No adverse effect was reported. The outcome of event was unknown. No further adverse event information was provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician via a company representative referring to a 13 year old female patient. Information about patient's current conditions and medical history was not reported. On 15-APR-2015 the patient was vaccinated with her first dose of GARDASIL (single dose 0.5ml suspension/1 injection, intramuscularly for prevention of HPV). Concomitant medications were not provided. On 15-APR-2015 the patient experienced an acute "severe, temporal headache, right at the temporal node" immediately after receiving her first dose [of a suggested three dose series] of GARDASIL. It was reported that the event occurred in the physician's office. Ibuprofen was given for the event. It was reported that therapy with GARDASIL was continued. Outcome of the event was not reported. The causality was not provided. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 26 year old female patient. On an unknown date in April 2010 (reported as 5 years ago), the patient was vaccinated with the first dose of GARDASIL (dose, route and lot# unknown). ON 10-APR-2015 the patient was vaccinated with the second dose of GARDASIL 9 (dose, route and lot# unknown) inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. No information regarding current condition, medical history or drug allergies were reported. On 08-APR-2015 the patient was vaccinated with first dose of improperly stored GARDASIL injection (strength, dose unit and route unknown) (also reported as confirmed as not GARDASIL 9) lot # K006117 and expiry date 14-JAN-2017. No concomitant therapy was reported. The temperature excursion for GARDASIL was supported with in-house stability data and no adverse symptoms were reported. The outcome of event was unknown. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. ON 06-APR-2015 the patient was received a dose of improperly stored LIQUID PEDVAXHIB (lot# reported as K016965, expiration date: 20-JUL-2017, route and dose were unknown). The temperature excursion for LIQUID PEDVAXHIB was supported with in-house stability data. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with doses of improperly stored PNEUMOVAX23 (dose, route, lot# were not reported). No adverse effects reported. this is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist via a field representative refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown dater, the patient received at least 1 dose of M-M-R II, injection (strength, dose, route of administration, lot# and expiry date unspecified) as a child but pharmacist was not sure if M-M-R II series was completed. No concomitant medications were reported. The pharmacist reported that the patient came in for M-M-R II because titer was drawn for school entrance and titer for one of the measles, mumps, and rubella virus vaccine components (type unspecified) was low (dates not provided). The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Tooth fracture
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a male patient of unknown age. There was no information on pertinent medical history and drug reactions or allergies. On an unknown date, the patient was vaccinated with GARDASIL strength reported as 120 Y (unspecified units) (dose, route, product lot# not reported) and immediately afterwards, he passed out, face first on the floor and cracked a bunch of teeth out. There was no product quality complaint involved. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Face injury, Fall, Immediate post-injection reaction, Loss of consciousness, Tooth fracture
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a male patient of unknown age. There was no information on pertinent medical history and drug reactions or allergies. On an unknown date, the patient was vaccinated with GARDASIL strength reported as 120 Y (unspecified units) (dose, route, product lot# not reported) and immediately afterwards, he passed out, face first on the floor and cracked a bunch of teeth out. There was no product quality complaint involved. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Tooth loss
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a male patient of unknown age. There was no information on pertinent medical history and drug reactions or allergies. On an unknown date, the patient was vaccinated with GARDASIL strength reported as 120 Y (unspecified units) (dose, route, product lot# not reported) and immediately afterwards, he passed out, face first on the floor and cracked a bunch of teeth out. There was no product quality complaint involved. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Information has been received from a registered nurse referring to a 29 year old female patient with asthma. On 07-APR-2015 the patient was vaccinated with PNEUMOVAX 23 (lot number K021030, expiration date 22-JUN-2016, 0.5 ml, subcutaneous in left upper arm). Concomitant therapies included DTAP vaccinated in right deltoid. On 08-APR-2015, the patient had erythema, pain, itchiness and swelling that had spread beyond the injection site of the left arm and she sought medical attention via office visit. The patient also would have follow up appointment with the physician in October 2015. Body temperature test was developed, and her temperature was 97.6F and she did not have a fever. No other lab diagnostics studies were performed. Unspecified antibiotics were given for the events. At the time of report, the patient was not recovered from the events. The causality between PNEUMOVAX 23 and the events was unknown. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant via company representative regarding unspecified number of patients of unknown demographics. There was no information regarding concurrent condition and historical medication. It was reported that on an unknown date, an unknown number of patients had been administered with GARDASIL outside the recommended time frame (dose strength, route and lot number was unknown). No concomitant medication was reported. No product quality complaint was involved. No adverse effect was reported. The outcome of event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from Licensed Practical Nurse refers to a patient of unknown age and gender. No information regarding current condition, medical history or drug allergies were reported. On 16-SEP-2014, patient was vaccinated with first dose of GARDASIL injection (also reported as confirmed as not GARDASIL 9) (strength, dose unit and route unknown). No concomitant therapy was reported. On 02-DEC-2014 and 03-MAR-2015 the patient was vaccinated with second dose and third dose of GARDASIL (strength, dose unit and route unknown) respectively (inappropriate schedule of drug administration). No adverse symptoms were reported. The outcome of event was unknown. No further information provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Arthritis
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a female patient of unknown age. There was no information on pertinent medical history and drug reactions or allergies. The nurse reported that the patient was vaccinated with two doses of GARDASIL (dose, route, vaccination dates not reported). After receiving two doses of GARDASIL, she then developed arthritis. Medical attention was sought by visiting the physician. There was no product quality complaint involved. The patient did not recover from the event. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a patient of unknown demographics. There was no information regarding concurrent condition and historical medication. On an unknown date, over 1 year ago the patient was vaccinated with first 2 doses of GARDASIL (dose strength, route and lot number was unknown) and now the patient would like to receive the third dose (inappropriate schedule of drug administration). No concomitant medication was reported. No product quality complaint was involved. No adverse effect was reported. The outcome of event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician's business manager referring to 2 patients of unknown age and gender. The patients' drug reactions/allergies and pertinent medical history were not reported. On unspecified dates from 03-MAR-2015 to 15-APR-2015, the patients were vaccinated with (Oka/Merck) VARIVAX (dose, frequency, route and lot # were not reported) which were improperly stored. No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified patient of unknown age and gender. No medical history and concurrent conditions were reported. The reporter reported that on an unknown date, unknown number of patients were administered GARDASIL (unspecified dose and route) lot # J010668, expiry date 29-APR-2016 and lot # K007264 expiry date 02-MAR-2017. On an unspecified date the vaccine had been improperly stored. No adverse effects were reported. There was no product quality complaints (PQC) involved. The outcome of the event was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt received vaccine on 4/5/15. Returned to pharmacy 4/19/15 stating her had rash on hands and skin; which began 4/16/15. Unclear as to if this was caused by vacccine since it was given 2 weeks earlier. Instructed pt to take BENADRYL and follow up w/MD.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. It was reported that these patients were administered doses of improperly stored PNEUMOVAX23. Lot number and administered date was reported as following: Lot # K008410, expiration 26-FEB-2016; 1 dose administered on 11-FEB-2015, 1 dose administered on 13-FEB-2015, 1 dose administered on 19-FEB-2015, 1 dose administered on 17-MAR-2015. Lot# K005402 expiration 07-NOV-2015): 1 dose administered on 18-MAR-2015, 1 dose administered on 31-MAR-2015, 1 dose administered on 01-APR-2015, 1 dose administered on 02-APR-2015.  This is one of the several reports from the same reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain
Clinical narrative: Pain under the arm
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding to a patient of unknown demographics. There was no information regarding concurrent conditions and historical medication. On an unknown date, the patient was vaccinated with ROTATEQ (dose strength, frequency and lot number was unknown) which was improperly stored. No concomitant medication was reported. No product quality complaint was not involved. No adverse effect was reported. The outcome of event was unknown. 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: This spontaneous report as received from a medical assistant regarding to a patient of unknown demographics. There was no information regarding concurrent condition and historical medication. On an unknown date, the patient was vaccinated with GARDASIL (dose strength, frequency and lot number was unknown) which was improperly stored. No concomitant medication was reported. No product quality complaint was involved. No adverse effect was reported. The outcome of event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. It was reported that the patient were administered a dose of improperly stored ROTATEQ (lot# J013587. EXP date 03-JUN-2015) (dose, route not reported) on 11-MAR-2015. This is one of the several reports with the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. It was reported that these patients were administered doses of improperly stored GARDASIL (lot# K004205, Exp date 12-JAN-2017) (dose and route not reported). It was reported that 1 dose was administered on 10-FEB-2015, 1 dose on 12-FEB-2015, 1 dose on 26-FEB-2015, 1 dose on 06-MAR-2015, 2 dose on 17-MAR-2015 and 1 dose on 25-MAR-2015. This is one of the several reports with 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 healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. On an unknown date, the patients were vaccinated with doses of GARDASIL that were improperly stored (dose, product lot#, expiry date not reported). No adverse experiences were reported until 01-APR-2015. There was no product quality complaint involved. The outcome of the events was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with no current conditions and a history of unspecified reaction to penicillin and aspirin. On 13-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # K020801, expiration date January 2016 (dose and route were not reported) for vaccination. Concomitant therapies included morphine, torsemide, NEXIUM and DEPAKOTE. Subsequently, on an unknown date in April 2015, the patient experienced swelling and redness like the size of a baseball at the injection site. The patient was given BENADRYL as treatment. The patient sought medical attention, she spoke to the pharmacist. No laboratory studies were performed. The outcome of the events was reported as recovering. Relatedness between the therapy and the events was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. On an unknown date, the patients were vaccinated with doses of VAQTA that were improperly stored (dose, product lot#, expiry date not reported). No adverse experiences were reported until 01-APR-2015. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. It was reported that these patients were administered doses of improperly stored PEDVAXHIB (dose and route not reported). Lot number and administered date was reported as following: Lot# J014281 expiration 16-SEP-2016): 1 dose was administered on 09-FEB-2015 and 1 dose on 16-FEB-2015: Lot#k002746 expiration 09-DEC-2016): 1 dose was administered on 25-FEB-2015, 1 dose on 11-MAR-2015 and 1 dose on 25-MAR-2015. This is one of the several reports with the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to unspecified number of patients. No information regarding current condition, medical history or drug allergies were reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored VAQTA (strength, dose unit, lot number and frequency unknown) for routine vaccination. No concomitant therapy was reported. No adverse effect was reported. The outcome of event was unknown. No further adverse event information was provided. 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: This spontaneous report as received from registered nurse refers to unspecified number of patients. No information regarding current condition, medical history or drug allergies were reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (strength, dose unit, lot number and frequency unknown) for routine vaccination. No concomitant therapy was reported. No adverse effect was reported. The outcome of event was unknown. No further adverse event information was provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to unspecified number of patients. No information regarding current condition, medical history or drug allergies were reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored LIQUID PEDVAXHIB (strength, dose unit, lot number and frequency unknown) for routine vaccination. No concomitant therapy was reported. No adverse effect was reported. The outcome of event was unknown. No further adverse event information was provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema
Clinical narrative: Angioedema, loratadine 10 mg every day
Age: 23.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and skin rash, doxycycline 100 mg BID.
Age: 26.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Malaise, Rash, Vaccination complication
Clinical narrative: Patient did not feel well after injection, MD states that he either had a reaction to the vaccine or a localized cellulitis. Skin rash and chills. Ibuprofen 600 mg PRN.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Dysphagia, Hyperhidrosis, Mobility decreased, Muscular weakness, Oropharyngeal pain
Clinical narrative: Shaey, weak legs-couldn;t lift legs easily. Sweaty symptoms lasted for about 1hr and 15 minutes and continued to feel weak for awhile. Pt complaint of "difficulty swallowing" and throat pain. Pt stated she wll follow up with PCP.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Tremor
Clinical narrative: Shaey, weak legs-couldn;t lift legs easily. Sweaty symptoms lasted for about 1hr and 15 minutes and continued to feel weak for awhile. Pt complaint of "difficulty swallowing" and throat pain. Pt stated she wll follow up with PCP.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and concurrent conditions were reported. The nurse reported that on an unknown date and time after 02-FEB-2015, unspecified number of patients were inadvertently vaccinated with VAQTA (unspecified dose and route) lot # K007791, expiry date 22-AUG-2016 (also reported as 22-MAY-2016) and lot # K018182, expiry date 12-FEB-2017. On an unspecified date, the vaccine had been improperly stored. No adverse effects were reported. There was no product quality complaints (PQC) involved. The outcome of the event was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Rash papular
Clinical narrative: Mother described papular erythemic rash localized on upper torso and arms; resolving w/MOTRIN and EUCERIN bath.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified patient of unknown age and gender. No medial history and concurrent conditions were reported. The reporter reported that on an unknown date, unknown number of patients were administered ROTATEQ (unspecified dose and route) lot @ K004468, expiry date 08-DEC-2015 and lot # K0006457, expiry date 09-MAR-2016. On an unspecified date the vaccine had been improperly stored. No adverse effects were reported. There was no product quality complaints (PQC) involved. The outcome of the event was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Very large, raised, and painful at injection site and beyond. Patient made an appointment with primary doctor for him to look at it.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Arthralgia, Blood test, Cognitive disorder, Computerised tomogram
Clinical narrative: This spontaneous report as received from other health professional via company representative refers to a female patient of unknown age which was published in an article. No information regarding current condition, medical history or drug allergies were reported. On 02-SEP-2010 the patient was vaccinated with GARDASIL injection (strength, dose unit, lot number and expiry date was unknown). No concomitant therapy was reported. On an unknown date the patient experienced headaches, abdominal and joint pain, fatigue, sleepiness, cognitive issues, nausea and pain in her ears after receiving the first dose of GARDASIL. On an unknown date the patient received many different types of treatment (unspecified names, doses/frequencies and manufacturers), and also underwent blood tests, computed axial tomography (CAT) scans, nuclear magnetic resonance imaging (MRI) and other various unspecified labs and diagnostics testing. It was not specified if the patient received subsequent doses of GARDASIL. It was not specified if the patient received GARDASIL or GARDASIL 9. The outcomes of the events were unknown. The reporter did not provide the causality of events to GARDASIL. No further adverse event information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Ear pain, Fatigue, Headache, Laboratory test, Nausea
Clinical narrative: This spontaneous report as received from other health professional via company representative refers to a female patient of unknown age which was published in an article. No information regarding current condition, medical history or drug allergies were reported. On 02-SEP-2010 the patient was vaccinated with GARDASIL injection (strength, dose unit, lot number and expiry date was unknown). No concomitant therapy was reported. On an unknown date the patient experienced headaches, abdominal and joint pain, fatigue, sleepiness, cognitive issues, nausea and pain in her ears after receiving the first dose of GARDASIL. On an unknown date the patient received many different types of treatment (unspecified names, doses/frequencies and manufacturers), and also underwent blood tests, computed axial tomography (CAT) scans, nuclear magnetic resonance imaging (MRI) and other various unspecified labs and diagnostics testing. It was not specified if the patient received subsequent doses of GARDASIL. It was not specified if the patient received GARDASIL or GARDASIL 9. The outcomes of the events were unknown. The reporter did not provide the causality of events to GARDASIL. No further adverse event information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Somnolence
Clinical narrative: This spontaneous report as received from other health professional via company representative refers to a female patient of unknown age which was published in an article. No information regarding current condition, medical history or drug allergies were reported. On 02-SEP-2010 the patient was vaccinated with GARDASIL injection (strength, dose unit, lot number and expiry date was unknown). No concomitant therapy was reported. On an unknown date the patient experienced headaches, abdominal and joint pain, fatigue, sleepiness, cognitive issues, nausea and pain in her ears after receiving the first dose of GARDASIL. On an unknown date the patient received many different types of treatment (unspecified names, doses/frequencies and manufacturers), and also underwent blood tests, computed axial tomography (CAT) scans, nuclear magnetic resonance imaging (MRI) and other various unspecified labs and diagnostics testing. It was not specified if the patient received subsequent doses of GARDASIL. It was not specified if the patient received GARDASIL or GARDASIL 9. The outcomes of the events were unknown. The reporter did not provide the causality of events to GARDASIL. No further adverse event information was provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV2, MNQ, TDAP
Symptoms: Injection site swelling, Local swelling
Clinical narrative: Swollen around area.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an adult patient of unknown age. No medical history and current conditions were reported. On 10-APR-2015 the patient was vaccinated with pediatric formulation of RECOMBIVAX HB VIAL SD IM 2.5 y, (0.5 ml, intramuscular). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was reported. Additional information has been requested.
Age: 1.59
Sex: F
Vaccine: DTAP
Symptoms: Allergy test, Rash, Urticaria
Clinical narrative: 3/19 - started AMOXICILLIN for OM. 3/26 - WC visit, received DTAP, started CLARITIN. 3/28 - developed rash on thighs and over 48-72 hrs, became larger like hives, spread to abd., chest, arms and face. Saw allergist 4/2. See attached letter from allergist.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Lethargy, Pain in extremity
Clinical narrative: Early A.M. (1:30) I awakened with pain in right arm. Applied heating pad for next 4 to 5 days with little relief. Visited Dr's off. on Mon. 3-30-15. Saw PC who ordered addl and higher dose of hydrocodone which take by script (1 x day) for continuing back pain. This dosage caused hallucination-type dreams, and so I discontinued it. I experienced loss of appetite, severe lethargy and continuing arm pain. No rise in temp, if I'd been employed, I'd have lost approx. 10 to 12 workdays. I wondered if I would ever feel "normal".
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Tdap given 4-3-15. LD. Pt noticed red swollen area at site of inj. Warm to touch. 3" area of swelling and redness. Taking ibuprofen.
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Pt states she developed HA, sweating, joint pain, fever, diarrhea on 3/23. (Vaccine given 3/11/15). Rash not hives) covered body beginning on chest on 3/25. Felt very fatigued as well.
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Pt states she developed HA, sweating, joint pain, fever, diarrhea on 3/23. (Vaccine given 3/11/15). Rash not hives) covered body beginning on chest on 3/25. Felt very fatigued as well.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea, Irritability
Clinical narrative: Diarrhea, irritability.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 13-APR-2015, the patient was vaccinated with dose of RECOMIVAX HB (reported batch#J010201, lot# 0589AE, exp date: 27-MAR-2015) (strength and route not reported) which was expired. No adverse effcts were reported. The outcome of the patient's events was not reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pt received Tdap and PNEUMOVAX on 4-7-2015 at 3:20 PM. Pt returned to clinic on 4-8-15 (-) 10:00 AM with left arm swelling and pain. Pt sent to ER for evaluation and treatment.
Age: 58.0
Sex: M
Vaccine: MEN
Symptoms: Chest pain, Dysgeusia, Eye pruritus, Headache, Hypersensitivity
Clinical narrative: Approx. 0129 Vaccine administered at pharmacy. Approx 0130 Felt itchy in my stomach, face and eyes, began feeling nausea in my stomach with a funny taste in mouth. Approx 02015 Face slightly puffy and itchy. Called pharmacy, spoke to a pharmacist who said I was having an allergic reaction and to take some BENADRYL. That if I begin to have difficulty breathing or my face swells any larger to get to the ER. Approx 0330 Felt itchy in my hands and back. 0350 purchased BENADRYL and took 25 mg. As time went on I felt sick like I had a stomach virus or the flu. Later that nite and early the next morning I began feeling a burning in my chest and throat with shooting headache pains. 4/9/15 informed my doctors office who advised me to come in the following morning at 9:00 am if I still feel sick. I took a total of two BENADRYLs 6 hours apart. 04/10/15 Approx 0130 am still feeling sick like flu: Burning in my chest and throat. 4/10/15 Doctor appoint at 9:00 am.
Age: 58.0
Sex: M
Vaccine: MEN
Symptoms: Influenza like illness, Malaise, Nausea, Pruritus, Swelling face
Clinical narrative: Approx. 0129 Vaccine administered at pharmacy. Approx 0130 Felt itchy in my stomach, face and eyes, began feeling nausea in my stomach with a funny taste in mouth. Approx 02015 Face slightly puffy and itchy. Called pharmacy, spoke to a pharmacist who said I was having an allergic reaction and to take some BENADRYL. That if I begin to have difficulty breathing or my face swells any larger to get to the ER. Approx 0330 Felt itchy in my hands and back. 0350 purchased BENADRYL and took 25 mg. As time went on I felt sick like I had a stomach virus or the flu. Later that nite and early the next morning I began feeling a burning in my chest and throat with shooting headache pains. 4/9/15 informed my doctors office who advised me to come in the following morning at 9:00 am if I still feel sick. I took a total of two BENADRYLs 6 hours apart. 04/10/15 Approx 0130 am still feeling sick like flu: Burning in my chest and throat. 4/10/15 Doctor appoint at 9:00 am.
Age: 58.0
Sex: M
Vaccine: MEN
Symptoms: Throat irritation
Clinical narrative: Approx. 0129 Vaccine administered at pharmacy. Approx 0130 Felt itchy in my stomach, face and eyes, began feeling nausea in my stomach with a funny taste in mouth. Approx 02015 Face slightly puffy and itchy. Called pharmacy, spoke to a pharmacist who said I was having an allergic reaction and to take some BENADRYL. That if I begin to have difficulty breathing or my face swells any larger to get to the ER. Approx 0330 Felt itchy in my hands and back. 0350 purchased BENADRYL and took 25 mg. As time went on I felt sick like I had a stomach virus or the flu. Later that nite and early the next morning I began feeling a burning in my chest and throat with shooting headache pains. 4/9/15 informed my doctors office who advised me to come in the following morning at 9:00 am if I still feel sick. I took a total of two BENADRYLs 6 hours apart. 04/10/15 Approx 0130 am still feeling sick like flu: Burning in my chest and throat. 4/10/15 Doctor appoint at 9:00 am.
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Inflammation, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Pt received MMR vaccine on Tuesday 4/14/15 that evening (L) arm was sore. Pt was seen 4/16-15 at the center Dr seen pt. (L) arm was red in color, warm, inflamed, and itched. No treatment was given. (SM) Ice package given to pt.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and concurrent conditions were reported. The nurse reported that on an unknown date and time after 02-FEB-2015, unspecified number of patients were inadvertently vaccinated with ROTATEQ (unspecified dose and route) lot # K00900, expiry date 04-MAY-2016 and lot # K010224, expiry date 13-MAY-2016. On an unspecified date, the vaccine had been improperly stored. No adverse effects were reported. There was no product quality complaints (PQC) involved. The outcome of the event was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Headache, Impaired driving ability, Neck pain, Pain in extremity
Clinical narrative: I received injection on Feb. 11, 2015 on Feb.13 I had severe pain in my left arm, Rt. Arm and back and neck and head. After 1 week I also had a bad headache. Called doctors office and was told it possibly was a muscle problem. Was given rx for baclofen. These pains continued for six weeks. I could not drive my auto during this time.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. The patient was not a pregnant. No medical history and current conditions were reported. On 01-APR-2015 the patient was vaccinated with ZOSTAVAX (As per the prescribing information, injection) for prevention of shingles. No concomitant medications were reported. On an unknown date the patient experienced lump at the injection site. Sought medical attention, contacted the pharmacist. No product quality complaint was involved. The outcome of lump at the injection site was unknown. The reporter causality was not provided. No further information was reported. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Urticaria pruritus and swelling. Diphenhydramine.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a nurse via call enter representative and described the occurrence of pain in arm in a adult female patient who received FLUARIX QUADIRVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT (injection). On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were recovering/resolving. The reporter considered the pain in arm and mobility decreased to be possibly related to FLUARIX QUADRIVALENT. Additional information received: A nurse reported adverse events for 3 patients. Each patient was a female adult patient between 30 and 40 years of age. The patients all received flu vaccine from the same lot number. Each patient experienced extreme arm pain and limited arm mobility. The patients are recovering. The dose given was 0.5 mL for each patient. The field rep had no other information about the event. Additional information received on 07 April 2015: This case was reported for a 51-year-old female patient. On 3rd October 2014, the patient experienced extreme arm pain and limited mobility in the arm.