chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered, Wrong technique in product usage process
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 18 month old patient of unknown gender. No information regarding to the patient's medical history, concurrent conditions and concomitant medications was provided. On 10-MAR-2016, unspecified nurse in the practice inadvertently administered to a patient a dose of GARDASIL 9 injection, Lot L014415, expiration date 25-JUL-2017 (dose and route of administration were not reported) instead of the intended dose of VAQTA (not administered at the time of the call) due to product confusion. The reporter stated the nurse that administered the dose didn't check the vial before administering the vaccine. No adverse effect were reported. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 10-MAR-2016, the patient was vaccinated with VARIVAX (Merck) lot # K026386 expiry date 15-DEC-2016, 0.65 ml, subcutaneously instead of ZOSTAVAX (wrong vaccine administered). No adverse effects were reported. No concomitant medications were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
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 an unknown date the patient was vaccinated with improperly stored VAQTA (lot # L015460, expiration date 20-JUL-2017, dose and route were unknown). 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, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored VAQTA (lot # K018181, expiration date 04-JUN-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
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 an unknown date the patient was vaccinated with improperly stored ROTATEQ (lot # L023870, expiration date 20-APR-2017, dose was unknown) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
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 an unknown date the patient was vaccinated with improperly stored ROTATEQ (lot # L023870, expiration date 20-APR-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
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 an unknown date the patient was vaccinated with improperly stored ROTATEQ (lot # L029615, expiration date 15-MAY-2017, dose and route were unknown). 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, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 01-MAR-2016, the patient was vaccinated with improperly stored VAQTA (lot # L015460, expiration date 20-JUL-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Computerised tomogram, Emotional disorder, New daily persistent headache, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician via a company representative referring to a 20 (currently 21) years old female patient of unknown age. "2 to 3 years ago", in approximately March 2013 the patient was vaccinated with her first dose of GARDASIL (lot#, dose not reported) intramuscularly. Concomitant medications were not provided. The physician stated that "about a year ago", in approximately March 2015 the patient began complaining of headaches which gradually increased in frequency to a daily occurrence with occasional sharp pains which physician described as "atypical headaches". The physician stated the patient was seen by an unspecified pediatrician and referred to an unspecified neurologist. The physician stated there had been at least one 'normal' Magnetic Resonance Imaging (MRI) completed (date unspecified) but headaches were becoming increasingly debilitating for this patient and the patient was "now" demonstrating emotional issues (in approximately March 2016). It was also reported that the patient had received multiple diagnostic tests, Computerized Tomography (CR) scans and unspecified blood tests to try and determine the cause of the headaches. The physician stated the patient took TRILEPTAL and was prescribed an unspecified antidepressant "today", on 11-MAR-2016. The physician stated the patient, at unspecified time since headaches started, "she tried anti-seizure medications (not specified) that did not do much." The physician stated the patient was not a drug user and appeared healthy. The physician stated the patient was scheduled, at an unspecified time, for a lumbar puncture as "everything (other diagnostic tests) came up negative". Outcome of the events was reported as not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a physician via a company representative referring to a 20 (currently 21) years old female patient of unknown age. "2 to 3 years ago", in approximately March 2013 the patient was vaccinated with her first dose of GARDASIL (lot#, dose not reported) intramuscularly. Concomitant medications were not provided. The physician stated that "about a year ago", in approximately March 2015 the patient began complaining of headaches which gradually increased in frequency to a daily occurrence with occasional sharp pains which physician described as "atypical headaches". The physician stated the patient was seen by an unspecified pediatrician and referred to an unspecified neurologist. The physician stated there had been at least one 'normal' Magnetic Resonance Imaging (MRI) completed (date unspecified) but headaches were becoming increasingly debilitating for this patient and the patient was "now" demonstrating emotional issues (in approximately March 2016). It was also reported that the patient had received multiple diagnostic tests, Computerized Tomography (CR) scans and unspecified blood tests to try and determine the cause of the headaches. The physician stated the patient took TRILEPTAL and was prescribed an unspecified antidepressant "today", on 11-MAR-2016. The physician stated the patient, at unspecified time since headaches started, "she tried anti-seizure medications (not specified) that did not do much." The physician stated the patient was not a drug user and appeared healthy. The physician stated the patient was scheduled, at an unspecified time, for a lumbar puncture as "everything (other diagnostic tests) came up negative". Outcome of the events was reported as not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Blood test, Computerised tomogram, Emotional disorder, Headache
Clinical narrative: Information has been received from a physician via a company representative referring to a 20 (currently 21) years old female patient of unknown age. "2 to 3 years ago", in approximately March 2013 the patient was vaccinated with her first dose of GARDASIL (lot#, dose not reported) intramuscularly. Concomitant medications were not provided. The physician stated that "about a year ago", in approximately March 2015 the patient began complaining of headaches which gradually increased in frequency to a daily occurrence with occasional sharp pains which physician described as "atypical headaches". The physician stated the patient was seen by an unspecified pediatrician and referred to an unspecified neurologist. The physician stated there had been at least one 'normal' Magnetic Resonance Imaging (MRI) completed (date unspecified) but headaches were becoming increasingly debilitating for this patient and the patient was "now" demonstrating emotional issues (in approximately March 2016). It was also reported that the patient had received multiple diagnostic tests, Computerized Tomography (CR) scans and unspecified blood tests to try and determine the cause of the headaches. The physician stated the patient took TRILEPTAL and was prescribed an unspecified antidepressant "today", on 11-MAR-2016. The physician stated the patient, at unspecified time since headaches started, "she tried anti-seizure medications (not specified) that did not do much." The physician stated the patient was not a drug user and appeared healthy. The physician stated the patient was scheduled, at an unspecified time, for a lumbar puncture as "everything (other diagnostic tests) came up negative". Outcome of the events was reported as not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician via a company representative referring to a 20 (currently 21) years old female patient of unknown age. "2 to 3 years ago", in approximately March 2013 the patient was vaccinated with her first dose of GARDASIL (lot#, dose not reported) intramuscularly. Concomitant medications were not provided. The physician stated that "about a year ago", in approximately March 2015 the patient began complaining of headaches which gradually increased in frequency to a daily occurrence with occasional sharp pains which physician described as "atypical headaches". The physician stated the patient was seen by an unspecified pediatrician and referred to an unspecified neurologist. The physician stated there had been at least one 'normal' Magnetic Resonance Imaging (MRI) completed (date unspecified) but headaches were becoming increasingly debilitating for this patient and the patient was "now" demonstrating emotional issues (in approximately March 2016). It was also reported that the patient had received multiple diagnostic tests, Computerized Tomography (CR) scans and unspecified blood tests to try and determine the cause of the headaches. The physician stated the patient took TRILEPTAL and was prescribed an unspecified antidepressant "today", on 11-MAR-2016. The physician stated the patient, at unspecified time since headaches started, "she tried anti-seizure medications (not specified) that did not do much." The physician stated the patient was not a drug user and appeared healthy. The physician stated the patient was scheduled, at an unspecified time, for a lumbar puncture as "everything (other diagnostic tests) came up negative". Outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
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 01-MAR-2016 the patient was vaccinated with improperly stored ROTATEQ (lot # L023870, expiration date 20-APR-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient might have been vaccinated with a fourth dose of GARDASIL (dose, lot #, expiry date and route were unknown). No adverse effects were reported. The reporter stated that she needed to find out if this fourth dose had been given to the patient. Additional information has been requested.
Sex: U
Vaccine: RV5
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 01-MAR-2016 the patient was vaccinated with improperly stored ROTATEQ (lot # L029615, expiration date 15-MAY-2017, dose was unknown) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 11-MAR-2016 the patient was vaccinated with an expired dose of GARDASIL (lot # J013324, expiration date: 12-FEB-2016, dose and route were not reported). Concomitant drug was not reported. No adverse effects were reported. Additional information is not expected as there was no consent for follow up.
Sex: M
Vaccine: HEP
Symptoms: Arthritis, Hepatitis A antibody positive, Hepatitis B antibody positive
Clinical narrative: Information has been received from a physician via a field employee referring to a male patient of unknown age. The patient was not the physician's patient. The physician heard of the patient. The patient had positive hepatitis A and hepatitis B antibodies. On an unknown date the patient was vaccinated with a dose of hepatitis B vaccine (manufacturer unknown) (dose, strength and route unknown) while he had positive hepatitis A and hepatitis B antibodies. Subsequently on an unknown date the patient developed major arthritis problems. The outcome of the event was unknown. Causality was not provided. Additional information is not expected as the physician refused to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a patient of unknown age and gender. On 25-FEB-2016 the patient was vaccinated with an expired dose of VAQTA (dose not provided; lot # L001627 and expiration date: 11-NOV-2015) intramuscularly. No known adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical technician referring to multiple unspecified patients of unknown gender and age. The information of concurrent conditions, medical history and concomitant medications was not provided. On unknown dates the patients were vaccinated with VARIVAX (lot # L031065 and expired date 18-AUG-2017, dose, frequency and route were not provided) that were improperly stored. The vaccines were stored at temperature of -7.8 degree C with time frame of 30 hours. There was no previous temperature excursion. No adverse effects reported. This is one of two reports received from the same source (linked report # 1603USA001449). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical technician referring to multiple unspecified patients of unknown gender and age. The information of concurrent conditions, medical history and concomitant medications was not provided. On unknown dates the patients were vaccinated with GARDASIL (lot # K008931, expired date 04-MAR-2017, dose, frequency and route were not provided) that were improperly stored (incorrect product storage). The vaccines were stored at temperature of -0.5 degree C with time frame of 218 hours. There was no previous temperature excursion. No adverse effects reported. This is one of two reports received from the same source (linked report MARRS#1603USA006564). Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Vaccination site pain
Clinical narrative: Received phone call at clinic from patient. States left arm where vaccine was given is still sore.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injection site pain
Clinical narrative: Received phone call at clinic from patient. States left arm where vaccine was given is still sore.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via a field representative. The reporter totally reported 4 patients of unknown age and gender: 2 were teenagers, 1 baby and 1 child whose age could not be determined but was described as immunocompromised. It was reported that one of the 4 patients received 2 doses of VARIVAX (Merck). The immunocompromised patient had only one dose of VARIVAX (Merck). The dose for the other 2 patients was unspecified. It was reported that 3 out of the 4 patients each developed shingles, including the immunocompromised child; the fourth patient developed unspecified reaction to the vaccine (it was unspecified what specific symptoms or reaction the patient developed, however the patient did developed). The physician did not define how long past the VARIVAX (Merck) the adverse events happened. One of the adverse events happened in December 2015 and another in February 2016. The time of the other 2 adverse events was unspecified. This report referred to 2 out of the 3 patients who developed shingles (the immunocompromised child who developed shingle was captured in MAARS# 1603USA005974). This is one of several cases reported from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster, Medication error
Clinical narrative: Information has been received from a physician via a field representative. The reporter totally reported 4 patients of unknown age and gender: 2 were teenagers, 1 baby and 1 child whose age could not be determined but was described as immunocompromised. It was reported that one of the 4 patients received 2 doses of (Oka/Merck) VARIVAX. The immunocompromised patient had only one dose of (Oka/Merck) VARIVAX. The dose for the other 2 patients was unspecified. It was reported that 3 out of the 4 patients each developed shingles, including the immunocompromised child; the fourth patient developed unspecified reaction to the vaccine (it was unspecified what specified symptoms or reaction the patient developed, however the patient did developed). The physician did not define how long past the (Oka/Merck) VARIVAX the adverse events happened. One of the adverse events happened in December 2015 and another in February 2016. The time of the other 2 adverse events was unspecified. This report referred to immunocompromised child who developed shingles (the other 2 patients who developed shingle was captured in MAARS#1603USA004656). This is one of several cases reported from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Adverse event
Clinical narrative: Information has been received from a physician via a field representative. The reporter totally reported 4 patients of unknown age and gender: 2 were teenagers, 1 baby and 1 child whose age could not be determined but was described as immunocompromised. It was reported that one of the 4 patients received 2 dose of VARIVAX (Merck). The immunocompromised patient had only one dose of VARIVAX (Merck). The dose for the other 2 patients was unspecified. It was reported that 3 out of the 4 patients each developed shingles, including the immunocompromised child; the fourth patient developed unspecified reaction to the vaccine (it was unspecified what specific symptoms or reaction the patient developed, however the patient did developed). The physician did not define how long past the VARIVAX (Merck) the adverse events happened. One of the adverse events happened in December 2015 and another in February 2016. The time of the other 2 adverse events was unspecified. This report referred to the unspecified patient who developed unspecified reaction to the vaccine. This is one of several cases reported from the same reporter. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Vaccination site pain
Clinical narrative: Received phone call at clinic from patient. States left arm where vaccine was given is still sore.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Injection site pain
Clinical narrative: Received phone call at clinic from patient. States left arm where vaccine was given is still sore.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a "couple" of unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patients were vaccinated with VARIVAX (strength, dose, frequency and route were unknown). The patient's concomitant medication was not reported. On an unknown date the patient developed shingles an unspecified time after receiving an unspecified dose of VARIVAX. Action taken and outcome were unknown. The causality between the events and VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to 2 patients of unknown age and gender. There was no medical history of drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L003777 with expired date 04-FEB-2017, dose and route were unknown). No concomitant medication was reported. No adverse effect was reported. This is one of several reports from the same source. Additional information is not expected since the reporter refused further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 09-MAR-2016, the patients was vaccinated orally with a dose of oral ROTATEQ lot # L026740, expiry date 16-APR-2017 (dose was not specified). The administered dose of oral ROTATEQ underwent temperature excursion at 11 Celsius degrees for 15.5 hours. No previous temperature excursions were reported. No adverse events were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Left shoulder pain developed within 2 days of influenza vaccine administration in left arm IM.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Malaise, Nausea
Clinical narrative: First time having high dose Flu vaccine: first time increased reaction. Soreness at site x 3-4 days, malaise 3-4 days, nausea 3-4 days. If I am forced to get this high of dose through insurance due to age, I will take my chances with the flu!
Age: 20.0
Sex: M
Vaccine: FLUN4, HPV9, MENB, MNQ, TD
Symptoms: Blood bilirubin increased, Jaundice, Splenomegaly
Clinical narrative: Pt was seen at ER for jaundice 3/5/16. Pt's labs showed elevated bili. Enlarged spleen. Pt seen today 3/7/16 in office for reck. and orders given for repeat labs.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: Administered PEDIARIX and Hep B, so patient received two Hep B's. Called father on 3-15-16 and he stated that she was fine and was at day care.
Age: 1.08
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: (R) thigh (lateral) sub-cut VARIVAX site became red and indurated 10 days post vaccine no fever on pain and seen office 11 day post vaccine 2 x  cm induration.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and concerns an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with oral ROTATEQ (Lot# L02086, expiry: 09-FEB-2017; Lot# L035510, expiry: 13-MAY-2017) (route, dose and strength were not reported) that was improperly stored at 46.7 Fahrenheit for 14 hours and 40 minutes. No adverse effects were reported. There was no prior temperature excursions noted. This is one of the two cases from the same reporter. 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 healthcare worker refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 09-MAR-2016, the patient was vaccinated orally with a dose of ROTATEQ lot # L026740, expiry date 16-APR-2017 (dose was not specified). The administered dose of ROTATEQ underwent temperature excursion at 11 Celsius degrees for 15.5 hours. No previous temperature excursions were reported. No adverse events were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blister, Erythema, Herpes zoster, Injection site rash, Otitis media acute
Clinical narrative: 3/5/16 Sx blisters on arm. Spreading red and yellow fluid filled. 3/8/16 left arm rash started 3 days ago. Increased in vesicles in past 24 hrs. Left arm only. Color erythematous. Sx sudden in onset. Left arm multiple clusters of vesicles. Dx acute supportive otitis media with spontaneous rupture of ear drum, left ear. Zoster with complications rx amoxicillin 400 mg/5 mL 5 mL PO BID x 10 days. ZOVIRAX 200 mg/5mL 6 mL PO QUD x 10 days.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Tympanic membrane perforation
Clinical narrative: 3/5/16 Sx blisters on arm. Spreading red and yellow fluid filled. 3/8/16 left arm rash started 3 days ago. Increased in vesicles in past 24 hrs. Left arm only. Color erythematous. Sx sudden in onset. Left arm multiple clusters of vesicles. Dx acute supportive otitis media with spontaneous rupture of ear drum, left ear. Zoster with complications rx amoxicillin 400 mg/5 mL 5 mL PO BID x 10 days. ZOVIRAX 200 mg/5mL 6 mL PO QUD x 10 days.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: (L) deltoid with erythema/induration, tender, warm approximately 2 cm diam. No fluctuance. (+) fever 103.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: See ER note.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Erythematous rash on (L) upper arm, warm to touch.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Within 6 hours of receiving vaccine pt developed pain, swelling from (R) shoulder to elbow - skin warm, red. No fever. Used BENADRYL. Seen by PCP - tx for cellulitis, given pain meds as well. Follow up planned.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site streaking, Vaccination site swelling
Clinical narrative: Swelling in the area vaccine was given, and a line going down the leg.
Age: 48.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site rash, Rash
Clinical narrative: Patient got vaccine in the morning on a Friday, 2 days later (Sunday) developed rash on biceps of both arms - took antihistamine and rash mostly resolved. Also started new medication fluconazole on date of vaccine.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Fatigue, Odynophagia, Pain
Clinical narrative: Vaccine given 2/26/16 as part of physical exam. Per pt next morning 2/27 all over body red patchy blanching rash, neck tenderness, painful swallowing, body ache, joint ache, fatigue, fever, chills.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Pallor, Pyrexia, Rash, Rash erythematous, Rash generalised
Clinical narrative: Vaccine given 2/26/16 as part of physical exam. Per pt next morning 2/27 all over body red patchy blanching rash, neck tenderness, painful swallowing, body ache, joint ache, fatigue, fever, chills.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Tenderness
Clinical narrative: Vaccine given 2/26/16 as part of physical exam. Per pt next morning 2/27 all over body red patchy blanching rash, neck tenderness, painful swallowing, body ache, joint ache, fatigue, fever, chills.
Age: 44.0
Sex: M
Vaccine: HEPA
Symptoms: Computerised tomogram, Erythema, Pruritus, Scan with contrast
Clinical narrative: Redness and itching to face and neck. No other sx. Hep A 3-7-16. Called with sx today 3-9-16. Had CT with contrast yesterday.
Sex: U
Vaccine: HEP
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 an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB (Lot # L019298, expiration date 22-JUN-2017, dose and route were unknown). 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 as received from a healthcare worker refers to 4 unspecified patients of an unknown age. The patients' relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 lot # L025737 (expiry date: 28-JUL-2017) (start date and dosage not reported). No adverse effect reported. The nurse reported a temperature excursion for the GARDASIL 9. No further details provided. This case is linked to case # 1603USA005930 and 1603USA003817 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to 5 unspecified patients of an unknown age. The patients' relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, 5 unspecified patients were vaccinated with improperly stored dose of VARIVAX (Merck) lot # K005427 (expiry date: 15-APR-2016) (start date and dosage not reported). No adverse effect reported. The nurse reported a temperature excursion for the VARIVAX (Merck). No further details provided. This case is linked to case# 1603USA005931 and 1603USA003817 via same reporter link, Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Pt noticed redness and swelling in injection site when woke up. Proceeded to then get severe joint pain, neck pain, headache, fatigue and nausea. Severe on 3/13 and 3/14 - staring to improve today.
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Nausea, Neck pain
Clinical narrative: Pt noticed redness and swelling in injection site when woke up. Proceeded to then get severe joint pain, neck pain, headache, fatigue and nausea. Severe on 3/13 and 3/14 - staring to improve today.
Age: 34.0
Sex: M
Vaccine: HEPAB, IPV, TDAP, TYP
Symptoms: Dizziness, Fall, Unresponsive to stimuli
Clinical narrative: After vaccination administration (approximately 5 min), pt c/o lightheadedness, slumped in chair and fell over - breathing with pulse though unresponsive for approximately 3 min transported to hospital due to continued symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Haemorrhage, Injection site nodule, Injection site pruritus, Injection site rash, Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 60 year old female patient. The patient's concurrent and historical conditions included an unspecified reaction to morphine. On 04-NOV-2015 the patient was vaccinated with ZOSTAVAX (Lot # L029480, expiration date 16-MAR-2016) dose was unknown, subcutaneous on an unknown anatomical location for prevention of shingles. The patient's concomitant medication was not reported. On an unknown date (also reported as "right after" receiving the vaccine), the patient experienced itching and a knot at the injection site which lasted for weeks. It was reported that the patient stated that 6 age spots (senilo lentigo) on an unspecified area of her body were "itchy" on an unspecified date and 1 or 2 of these spots were located at the injection site, these spots looked like "tiny cluster of warts", a different one of these spots were under the patient's bra strap and bled. The patient sought additional medical attention at an unspecified physician's office where the patient had this particular spot under her bra strap removed on an unspecified date. At the time of the report, the outcome of injection site pruritus, injection site nodule, injection site discolouration, solar lentigo, skin papilloma and pruritus was reported as not recovered/not resolved. The outcome of skin haemorrhage was recovered/resolved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin papilloma, Solar lentigo
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 60 year old female patient. The patient's concurrent and historical conditions included an unspecified reaction to morphine. On 04-NOV-2015 the patient was vaccinated with ZOSTAVAX (Lot # L029480, expiration date 16-MAR-2016) dose was unknown, subcutaneous on an unknown anatomical location for prevention of shingles. The patient's concomitant medication was not reported. On an unknown date (also reported as "right after" receiving the vaccine), the patient experienced itching and a knot at the injection site which lasted for weeks. It was reported that the patient stated that 6 age spots (senilo lentigo) on an unspecified area of her body were "itchy" on an unspecified date and 1 or 2 of these spots were located at the injection site, these spots looked like "tiny cluster of warts", a different one of these spots were under the patient's bra strap and bled. The patient sought additional medical attention at an unspecified physician's office where the patient had this particular spot under her bra strap removed on an unspecified date. At the time of the report, the outcome of injection site pruritus, injection site nodule, injection site discolouration, solar lentigo, skin papilloma and pruritus was reported as not recovered/not resolved. The outcome of skin haemorrhage was recovered/resolved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Gait disturbance, Hyperhidrosis, Immediate post-injection reaction, Joint stiffness
Clinical narrative: Information has been received from a 71 year old female concerning herself with no pertinent medical history and no drug reactions who on unspecified date of August 2011, was vaccinated with ZOSTAVAX (Merck) (lot# and exp unspecified). She also received PNEUMOVAX 23 (MSD) (lot# and exp date unspecified) on the same day with ZOSTAVAX (Merck). Concomitant therapy included heart and cholesterol medicines and ATARAX. The patient experienced adverse effect after receiving ZOSTAVAX (Merck) in August 2011. She noticed problem with walking on her way home immediately after receiving ZOSTAVAX (Merck). She had been having severe muscle cramps in her leg when walking and bending over, and she had to stop and take a rest to continue with walking most of the time due to "excruciating pain". She also had fever on occasions and she sweated profusely on those occasions but "feels much better afterwards". The patient said that "I looked online for my symptoms and what I thought I had was a condition called polymyalgia rheumatica. Symptoms I had been experiencing sound just like polymyalgia rheumatica. I saw polymyalgia rheumatica was also mentioned in your package insert for ZOSTAVAX (Merck)." The patient sought medial attention by calling the office. No treatment was given to the patient and no lab diagnostics studies were performed. At the time of reporting, the patient had not recovered from all reported adverse effects. Follow up information has been received for a patient on 07-MAR-2016. Information has been received from a current 75 year old female reporting on herself. The patient's concurrent conditions included hypertension and high cholesterol (untreated) no pertinent medical history and no drug reactions reported. On 23-JUN-2008, the patient was vaccinated with ZOSTAVAX 0.65 ml subcutaneous (lot number and expiration date were not provided). On the same date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route, indication, lot number and expiration date were not provided) (previously reported as August 2011). No concomitant therapies were reported. On the same day and immediately after vaccination, the patient experienced severe joint stiffness and trouble walking. The patient stated, that since that time the severity of joint pain and stiffness has increased. On an unknown date, the patient sought for medical attention with a rheumatologist and changed primary physician. No laboratory diagnostics studies were performed and no product quality issue was involved. At the time of the report, the outcome of joint stiffness, arthralgia and gait disturbance was reported as not recovered. Relatedness between the adverse events and vaccination with ZOSTAVAX and PNEUMOVAX 23 was not provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Muscle spasms, Pain, Pyrexia
Clinical narrative: Information has been received from a 71 year old female concerning herself with no pertinent medical history and no drug reactions who on unspecified date of August 2011, was vaccinated with ZOSTAVAX (Merck) (lot# and exp unspecified). She also received PNEUMOVAX 23 (MSD) (lot# and exp date unspecified) on the same day with ZOSTAVAX (Merck). Concomitant therapy included heart and cholesterol medicines and ATARAX. The patient experienced adverse effect after receiving ZOSTAVAX (Merck) in August 2011. She noticed problem with walking on her way home immediately after receiving ZOSTAVAX (Merck). She had been having severe muscle cramps in her leg when walking and bending over, and she had to stop and take a rest to continue with walking most of the time due to "excruciating pain". She also had fever on occasions and she sweated profusely on those occasions but "feels much better afterwards". The patient said that "I looked online for my symptoms and what I thought I had was a condition called polymyalgia rheumatica. Symptoms I had been experiencing sound just like polymyalgia rheumatica. I saw polymyalgia rheumatica was also mentioned in your package insert for ZOSTAVAX (Merck)." The patient sought medial attention by calling the office. No treatment was given to the patient and no lab diagnostics studies were performed. At the time of reporting, the patient had not recovered from all reported adverse effects. Follow up information has been received for a patient on 07-MAR-2016. Information has been received from a current 75 year old female reporting on herself. The patient's concurrent conditions included hypertension and high cholesterol (untreated) no pertinent medical history and no drug reactions reported. On 23-JUN-2008, the patient was vaccinated with ZOSTAVAX 0.65 ml subcutaneous (lot number and expiration date were not provided). On the same date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route, indication, lot number and expiration date were not provided) (previously reported as August 2011). No concomitant therapies were reported. On the same day and immediately after vaccination, the patient experienced severe joint stiffness and trouble walking. The patient stated, that since that time the severity of joint pain and stiffness has increased. On an unknown date, the patient sought for medical attention with a rheumatologist and changed primary physician. No laboratory diagnostics studies were performed and no product quality issue was involved. At the time of the report, the outcome of joint stiffness, arthralgia and gait disturbance was reported as not recovered. Relatedness between the adverse events and vaccination with ZOSTAVAX and PNEUMOVAX 23 was not provided. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: HEPAB
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of alanine aminotransferase increased in a 54-year-old female patient who received TWINRIX adult. On an unknown date, the patient received the 2nd dose of TWINRIX adult. On an unknown date, an unknown time after receiving TWINRIX adult, the patient experienced alanine aminotransferase increased and aspartate aminotransferase increased. On an unknown date, the outcome of the alanine aminotransferase increased and aspartate aminotransferase increased were unknown. It was unknown if the reporter considered the alanine aminotransferase increased and aspartate aminotransferase increased to be related to TWINRIX adult. Additional details were received as follows: This case was received from other healthcare provider via click to chat. The reporter was asking, whether there were some abnormalities in liver enzymes in the clinical trials after receiving TWINRIX or acute hepatitis with the onset after vaccination. Further the reporter stated that, he had one patient who experienced an increase in alanine aminotransferase and aspartate aminotransferase after receiving the 2nd dose of TWINRIX adult. The reporter did not have batch number and expiry date of TWINRIX adult. The reporter's call was transferred to Medical Information System.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Eye swelling, Swelling face
Clinical narrative: Pt rec'd Dtap #4, Hib #4 and varicella #1 on 3/14 am. Throughout that day developed worsening swelling of eyes and then face. Called on call MD. Went to ED but was not evaluated. Mom gave BENADRYL and on 3/15 was fine.
Sex: M
Vaccine: HPV9
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: This spontaneous report was received from a male patient of unknown age, regarding himself. Patient's concurrent condition included arthritis, HIV infection and herpes. On an unknown date, while trying to administer the GARDASIL 9 with a prefilled syringe, no needle was attached and the patient spilled the medicine on his right shoulder, hand and fingers. The patient had not yet started the therapy with GARDASIL 9. Concomitant therapies included ATRIPLA, valacyclovir hydrochloride, ACIDOPHILUS, gabapentin, naproxen, DEXILANT, propranolol hydrochloride (manufacturer unknown) and zolpidem tartrate (Manufacturer unknown). No adverse effects were reported. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information on patient's concurrent condition and medical history was not reported. On an unspecified date of November 2015, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, lot number and route were unspecified). The patient was then administered another dose of ZOSTAVAX on unspecified date of March 2016. No adverse effect was reported. No further information was provided. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff repair, Rotator cuff syndrome
Clinical narrative: Severe pain in (R) shoulder joint following vaccine administration. Same area MRI (R) shoulder - showed torn rotator cuff tear, large partial articular full thickness tear reaching to bursa. Pt had to have rotator cuff surgery.
Age: 54.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site injury, Injection site pain, Injection site reaction
Clinical narrative: Severe pain in (R) shoulder joint following vaccine administration. Same area MRI (R) shoulder - showed torn rotator cuff tear, large partial articular full thickness tear reaching to bursa. Pt had to have rotator cuff surgery.
Age: 54.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Nuclear magnetic resonance imaging abnormal, Periarthritis, Rotator cuff syndrome, Shoulder operation
Clinical narrative: Severe pain in (R) shoulder joint following vaccine administration. Same area MRI (R) shoulder - showed torn rotator cuff tear, large partial articular full thickness tear reaching to bursa. Pt had to have rotator cuff surgery.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Fever since vaccines received, now has rash.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Influenza virus test negative, Pyrexia, Rash, Streptococcus test negative
Clinical narrative: Fever since vaccines received, now has rash.
Age: 58.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Severe swelling of left arm with pain.
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma, Loop electrosurgical excision procedure, Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a medical assistant (patient) via field representative, reporting on herself. The patient was currently 26 years of age. Information about patient's medical history, concurrent condition, drug reactions/allergies and concomitant medications were unspecified. On an unknown date, ten years ago, in approximately 2006, the patient was vaccinated with GARDASIL series. The patient experienced cervical cancer from an unknown date. She sought medical attention and went to her doctor. Thereafter, she underwent a loop electrosurgical excision procedure (LEEP) procedure on an unknown date and was currently being treated for the event (hence outcome of cervical cancer was considered not recovered). Patient was also pregnant with the last menstrual period (LMP) and estimated date of delivery (EDD) not reported. The pregnancy outcome was pending. Causality assessment was not provided. Upon internal review, the event cervical cancer was considered to be medically significant. Additional information has been requested.