chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Flushing, Pruritus, Rash, Rash generalised
Clinical narrative: Patient states she took a hot shower the day after vaccine administration and developed a rash - associated symptoms including itching, facial flushing and rash all over body except hands and feet.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Diarrhoea, Pain, Peripheral swelling
Clinical narrative: Had vaccine 11/11/15. Soreness 11/12. 11/15, felt achy all over. 11/16, arm swelling, diarrhea. 11/17, weak and still achy. Pt starting to feel better.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Local reaction, Rash erythematous, Rash pruritic
Clinical narrative: Pt describes red, swollen, itchy, mild rash at site of injection and states is warm to the touch. Patient requested we report. Appears to be localized reaction.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dizziness, Fatigue, Laboratory test normal, Vision blurred
Clinical narrative: Blurry vision, dizziness, fatigue, back pain.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Bone pain, Contusion, Injected limb mobility decreased, Injection site pain
Clinical narrative: On 10/23/15, patient received influenza vaccine in the left deltoid area. The vaccine was given in the left deltoid. Patient reports (via translator) that a few hours after the vaccination she developed the following symptoms: persistent pain in her left arm radiating up and down from elbow to neck. Denies numbness or tingling in arm or hand. Denies similar pain in the past. Pain is "bone-like" in nature and not relieved with OTC pain meds. Also reports left middle finer is flexed towards palm of hand every morning. Patient returned to Wellness Program on 11/20/15 to report the above symptoms. She states that pain is limiting her ability to perform her daily personal and work activities. She reports a history of back pain due to an accident and also history of arthritis "throughout her body". Patient received the Vaccine Information Statement on day of vaccination and signed a consent form as per Wellness Program's standard policy. On 11/20/15, patient was examined by RN. There was no visible redness, swelling, lumps or striations at left arm injection site. Left forearm did have 2 nickel-size bruises (patient reports she gets these bruises spontaneously on arms and legs). Active ROM of left arm limited to 45 degrees. Patient was referred to Hospital for evaluation of left arm pain with the plan for Wellness Program to call her next week for follow-up. Follow-up call to patient 11/24/15 was made. She reports she went to ER on 11/20/15. She states she received an injection for pain but it did not relieve the pain in left arm. The ER staff referred her to specialist for further evaluation.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Muscle contracture
Clinical narrative: On 10/23/15, patient received influenza vaccine in the left deltoid area. The vaccine was given in the left deltoid. Patient reports (via translator) that a few hours after the vaccination she developed the following symptoms: persistent pain in her left arm radiating up and down from elbow to neck. Denies numbness or tingling in arm or hand. Denies similar pain in the past. Pain is "bone-like" in nature and not relieved with OTC pain meds. Also reports left middle finer is flexed towards palm of hand every morning. Patient returned to Wellness Program on 11/20/15 to report the above symptoms. She states that pain is limiting her ability to perform her daily personal and work activities. She reports a history of back pain due to an accident and also history of arthritis "throughout her body". Patient received the Vaccine Information Statement on day of vaccination and signed a consent form as per Wellness Program's standard policy. On 11/20/15, patient was examined by RN. There was no visible redness, swelling, lumps or striations at left arm injection site. Left forearm did have 2 nickel-size bruises (patient reports she gets these bruises spontaneously on arms and legs). Active ROM of left arm limited to 45 degrees. Patient was referred to Hospital for evaluation of left arm pain with the plan for Wellness Program to call her next week for follow-up. Follow-up call to patient 11/24/15 was made. She reports she went to ER on 11/20/15. She states she received an injection for pain but it did not relieve the pain in left arm. The ER staff referred her to specialist for further evaluation.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pyrexia, Vaccination site pain
Clinical narrative: Fever and headache.  Pain at vaccination site. Allergy on the body -> Allegra 18D , beclomethasone dipropionate.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine given - adult hepatitis A given. No adverse reaction/event.
Age: 32.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe (L) shoulder pain which has currently lasted for 2 weeks. Pain limiting course of motion and activities. No weakness or numbness. Icing and using NSAIDs.
Age: 39.0
Sex: F
Vaccine: FLU4, HEP, PPV, TDAP
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Fever - up to 103 degrees. Next day - for about 6 hours chills. Rt arm "Very sore" - x 1 day resolving next day.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Hard red area appx 2" in diameter at site of injection. Dr. concerned about cellulitis in area concerned prescribed cephalexin 500mg.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Pt reports arm swollen/tender to the touch 2 days after vaccine was given. Told to follow up MD.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pt reports arm swollen/tender to the touch 2 days after vaccine was given. Told to follow up MD.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Large red, warm, inflamed area on arm where vaccination was given for over a week. Patient describes the area getting larger/warmer over the course of the week.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 17-AUG-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L013068 with exp. 14-APR-2017, (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, refers to an unknown number of patients, of unknown and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 single vial dose, Lot#: L012215, expiration date: 21-JAN-2017; lot# K009874, expiration date: 19-MAR-2016; Lot#: L012215, expiration date: 13-JAN-2017; Lot#: L199261, expiration date: 28-FEB-2017; Lot#: L99271, expiration date: 30-MAR-2017; Lot# M03211, expiration date: 01-MAR-2017; (strength, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects reported. No product quality complain was involved. Lot numbers L199261, L199271, M03211 are an invalid lot number for PNEUMOVAX 23. 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: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral, Lot # K004468 with expiry date of 08-DEc-2015 or lot # K013410 with expiry date of 27-FEB-2016, or lot # K015831 with expiry date of 18-APR-2016. No adverse effects were reported. The nurse confirmed that no vaccines were administered after the labeled expiration dates. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates these patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L007560 with expiration 15-JUN-2017; dose, frequency and route were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. Around on 09-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, lot # K016294, expiration date: 28-APR-2016, (dose, anatomical location and route were not reported). Co-suspect therapies or concomitant medications were not provided. On an unknown date in November 2015, the patient experienced cellulitis at the injection site after receiving of PNEUMOVAX 23. The pharmacist reported that patient could not work for 3 days due to cellulitis. The outcome of injection site cellulitis was unknown. The relatedness between the event and suspect therapy was not provided. No product quality complaint was involved. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction, Local swelling, Myalgia, Rash
Clinical narrative: A day or 2 later, soreness, redness, pain, swelling from shoulder to elbow in upper muscle area, warmth and rash. Started home treatment ice packs, cortisone ointment. It bothered mostly at night so slept with ice pack. Had no fever or fatigue. Did not bother for exercise. On 10/28 went back to doctor who specified she was having a local reaction. to continue with home treatment and to take antihistamine (over the counter) which only took 1 or 2 because reaction was going away. Today doing well. By 11/2 reaction was gone.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: A day or 2 later, soreness, redness, pain, swelling from shoulder to elbow in upper muscle area, warmth and rash. Started home treatment ice packs, cortisone ointment. It bothered mostly at night so slept with ice pack. Had no fever or fatigue. Did not bother for exercise. On 10/28 went back to doctor who specified she was having a local reaction. to continue with home treatment and to take antihistamine (over the counter) which only took 1 or 2 because reaction was going away. Today doing well. By 11/2 reaction was gone.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N.) referring to unspecified number of patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with doses of M-M-R II (dose and route of administration were not reported) (Lot# K007107, expiration date: 16-MAY-2016; Lot# J015505, expiration date: 05-DEC-2015; Lot# J008729, expiration date: 31-JUL-2015: Lot# K021152, expiration date: 02-NOV-2016), which were exposed to temperatures outside of the recommended range. No adverse experiences have been reported. There was no product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Anogenital warts
Clinical narrative: This spontaneous report was received from a registered nurse via company representative regarding a female patient of unknown age. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of HPV (manufacturer unknown), (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medications reported. On an unknown date, the patient had genital warts. It was reported that it could not be determinate if the patient developed the warts before or after the HPV vaccine (manufacturer unknown). At the time of the report, the outcome of the genital warts was reported as not recovered. The relatedness between the event and therapy with HPV (manufacturer unknown) was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N) referring to unspecified number of patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with doses of VARIVAX (Merck) (Lot# K002046, expiration date: 10-FEB-2016), which were exposed to temperatures outside of the recommended range. No adverse experiences have been reported. There was no product quality compliant (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. In approximately 2011 (about 4 years ago), the patient was vaccinated with the first dose of GARDASIL (lot#, expiration date, strength, dose and route were unknown) and did not get any other dose. The patient was in the office but did not get another dose yet. No adverse effect reported. 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 registered nurse, refers to an unknown number of patients, of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL, (lot#, expiration date, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects reported. No product quality complain was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route, lot # and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (dose, route, lot # and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported, Since 08-SEPT-2015, an unspecified number of improperly stored doses of GARDASIL 9 (lot # L016428) were inadvertently administered to the unspecified number of patients. No adverse effects have been reported. The reporter refers that was not product quality complaints involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unspecified date, the patient was vaccinated with improperly stored dose of ZOSTAVAX (strength, dose, route of administration, lot # and expiration date were not provided). No adverse effect was reported. Additional information has ben requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N.)) referring to unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with doses of GARDASIL 9 (dose and route of administration were not reported) (Lot# K026246, expiration date: 02-JAN-2017; Lot# K026246, expiration date: 28-JAN-2017; Lot# L000610, expiration date: 31-JAN-2017; Lot# L007560, expiration date: 15-JUN-2017), which were exposed to temperatures outside of the recommended range. No adverse experiences have been reported. There was no product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (unknown route and strength) Lot # K015827 with expiry date of 11-MAR-2016. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored PROQUAD (Merck) (dose, strength and frequency not reported, lot # L014401, expiry date: 23-OCT-2016). No adverse effects were reported. This case is one of several cases received from the same source. Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist concerning a 68 patient of unknown gender. The patient's concurrent conditions and pertinent medical history were not reported. On 22-DEC-2014, the patient was vaccinated with the first dose of ZOSTAVAX, (lot #, exp. date, strength, route of administration and dose were not provided). On 15-NOV-2015, the patient inadvertently received a second dose of ZOSTAVAX lot # L012477, exp. date on 10-JUL-2016, (strength, route of administration and dose were not provided. No adverse effect 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 registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL (unknown route and strength) Lot # K009482 with expiry date of 06-MAR-2017 or lot # K010574 with expiry date of 08-APR-2017. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # L007720, expiration date 08-JUL-2016. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. Additional information is not expected because reporter does not want to get contacted.
Age: 2.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a patient's mother refers to a 2 year old male patient. No concurrent condition or medical history was reported. On 29-OCT-2014, the patient was vaccinated with MMR II (dose and route of administration not provided) and RECOMBIVAX HB (dose and route of administration not provided). No concomitant therapy was reported. Since an unknown date after vaccination the patient began to experience intermittent fevers. The patient sought medical attention. The patient currently experiences intermittent fevers. The causality assessment was not reported. No product quality issue was involved. Additional information is not expected since no healthcare professional contact details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (unknown route, dose and strength) for vaccination. The patient had received other two unspecified vaccinations on the same day of vaccination with ZOSTAVAX. On an unknown date, after being vaccinated, developed a rash on her arm, arm not specified. The patient was referred to dermatologist. The outcome of the event was resolved on an unknown date. The reporting physician and the dermatologist stated that the rash was not from the ZOSTAVAX vaccination. Additional information is not expected as the reporter did not provide consent for further contact.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified number of patients of unknown age and gender. On 18-NOV-2015 these patients were vaccinated with unspecified number of improperly stored doses of PNEUMOVAX 23 (lot # reported as L029093, expiration date 19-APR-2017) (dose and route were not reported). 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 a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL (dose and route were not reported, lot # K023432 with expiration date: 18-JUN-2016; lot # K009482 with expiration date: 06-MAR-2017) which were exposed to temperatures outside of the recommended range. No adverse experience was 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: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. In November 2015 (during the time frame of 05-NOV-2015 through 15-NOV-2015), the patients were vaccinated with improperly stored doses of VAQTA (lot # reported as K005558 (an invalid lot number for VAQTA)) and expiry date 09-FEB-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patient were vaccinated with improperly stored doses of ROTATEQ (dose, lot # and expiration date were not reported, orally). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a 35 year old female pharmacy student regarding herself. No medical history and concurrent conditions were reported. On an unknown date approximately in September 2015 (also reported as 2 months ago) the patient was vaccinated with GARDASIL dose 4 (Extra dose administered) (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (unknown route and strength) lot # K009953 with expiry date of 03-APR-2016 or lot # K004989 with expiry date of 14-NOV-2015. No adverse effects were reported. The nurse confirmed that no vaccines were administered after the labeled expiration dates. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a field representative refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Approximately on 05-OCT-2015 (6 weeks ago), the patient was vaccinated with ZOSTAVAX (unknown dose, route and strength). Concomitant medications were not reported. Approximately in 2015, after receiving ZOSTAVAX, the patient had an injection site reaction that was swollen and tender. The outcome of the events was unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash vesicular, Viral test positive
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding to his approximately 23 month old son. Patient's concurrent condition, medical history and concomitant medications were not reported. On 01-MAY-2007, the patient was vaccinated with first dose of (Oka/Merck) VARIVAX (lot #, expiry date not specified). On 04-APR-2008, the patient experienced a vesicular like rash on his right leg. The pharmacist had took his son to an unspecified pediatrician, who cultured the vesicles and reported that the patient had herpes zoster. The patient had been treated with anti-virals for the rash and on an unspecified date it was reported to have been recovered/resolved. On 27-APR-2010, the patient was administered with a second dose of (Oka/Merck) VARIVAX. There was no product quality complaint filed. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot number # L022261, expiration date 01-APR-2016, route and dose not provided) on multiple unspecified dates ranging from 01-SEP-2015 tot 19-NOV-2015. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Rash, Skin reaction
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative and refers to a male patient of unknown age. The patient's current conditions, medical history and concomitant medications were not reported. On 10-NOV-2015, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route and lot number were not reported). On 18-NOV-2015, the patient experienced "a skin reaction with burning and itching down the back of the arm and under the armpit on the left side". On an unknown date in November 2015, the patient experienced rash. Product quality complaint (PQC) was not involved. The outcome of the events was unknown. The reporter did not provide the causal relationship between the events and suspect therapy. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 08-OCT-2015 the patient was vaccinated with improperly stored ZOSTAVAX (lot # L003216, expiration date 30-APR-2016, strength, dose and route were unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcre worker refers to a female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were unknown. On 27-MAY-2013, the patient received her first dose of GARDASIL. On 08-OCT-2013, she received her second dose of GARDASIL and on 02-JAN-2014, she received her third dose of GARDASIL (lot# were unspecified for all the three doses). on 25-AUG-2015, she inadvertently received another dose of unspecified GARDASIL (lot # L01051, expiry date 23-JUL-2017) (fourth total dose of HPV vaccine) (extra dose administered). No adverse effects were reported. The reporter was unable to confirm whether fourth dose was GARDASIL or GARDASIL 9. Additional informatin has been requested.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Had redness, swelling, pain lasted about 5 days and treated w/an ice pack.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Aphonia, Cough
Clinical narrative: 3 days after receiving vaccine, lost voice completely. Also had a non productive cough. Three weeks later voice is 98% back.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red circle (2" in diameter) around area vaccine was given, warm to touch, hard to touch.
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Irritability, Joint range of motion decreased, Nasal congestion, Oropharyngeal pain
Clinical narrative: Influenza shot virus vaccine. Back pain, upper arm pain for a month, sore throat fever, stuffy nose. Irritability upper arm tenderness and decreased range of movement.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Influenza shot virus vaccine. Back pain, upper arm pain for a month, sore throat fever, stuffy nose. Irritability upper arm tenderness and decreased range of movement.
Age: 1.76
Sex: M
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Immediately after the vaccine was given in the right thigh, the patient developed a hive around the injection site measuring 11 x 7 cm at its largest. He was given BENADRYL and TYLENOL in the clinic. When he left 1 hour later, the hive was decreasing in size.
Age: 84.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Diarrhoea, Eye pain, Pain, Pyrexia
Clinical narrative: Fever, vomiting, diarrhea, aches, sore eyes. weakness.
Age: 84.0
Sex: M
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: Fever, vomiting, diarrhea, aches, sore eyes. weakness.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Antibody test negative, Arthralgia, Asthenia, Blood immunoglobulin G normal
Clinical narrative: The patient developed a sudden onset of bilateral hamstring pain within seven days following the shingles vaccine administration 4/28/15. Left shoulder pain followed over the next two weeks with limited mobility in the left arm. During this time, the patient continued to develop weakness in the lower extremities with difficulty in gait function. The patient was unable to dress or shower without assistance due to pain and weakness. Myalgia and joint pain continued throughout the month of May and June. The patient saw an orthopedic physician on 5/11/15 for gait weakness and left shoulder joint pain. The patient received a steroid joint injection into the left shoulder. A return follow-up visit on 5/27/15 indicated lab work studies and physical therapy implementation. The physician diagnosis was noted to be "adhesive capsulitis left shoulder; myofascial pain, and hamstring tightness both lower extremities". On 6/4/15, the patient was seen at the Clinic and more lab studies were ordered. Other return visits for medical assessment followed 6/11/15, 6/17/15, and 7/14/15. On 7/14/15 a different orthopedic physician injected steroid injections into both shoulders for frozen shoulders and joint pain. The patient was prescribed Meloxicam on a daily basis. On 7/29/15, the patient was seen by a rheumatologist.  A confirmed diagnosis for rheumatoid arthritis was discussed with the patient. The patient was healthy prior to this event and was highly recognized as a referee in high school football for over thirty years. The rheumatologist said the patient would be unable to referee football this season. The rheumatologist said there was possible association of this condition/disease with the shingles vaccine in discussion with the patient. The patient was prescribed RA medication (Sulfasalazine) to be taken on a daily basis. Also, Methylpred pak was prescribed as needed for flare-up with joint pain and swelling. Prior to the 7/29/15 appointment, the patient had swelling and finger joint pain to the left and right hands. Each hand would swell approximately 2.5 times the size of the opposite hand. The events were separate and continued for at least ten days in each hand. These events happened during the months of June and July. Please note the patient reported no fever (> 100.4 degree F) anytime following vaccine administration.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Ehrlichia test, Joint injection, Joint stiffness, Lymphocyte count normal
Clinical narrative: The patient developed a sudden onset of bilateral hamstring pain within seven days following the shingles vaccine administration 4/28/15. Left shoulder pain followed over the next two weeks with limited mobility in the left arm. During this time, the patient continued to develop weakness in the lower extremities with difficulty in gait function. The patient was unable to dress or shower without assistance due to pain and weakness. Myalgia and joint pain continued throughout the month of May and June. The patient saw an orthopedic physician on 5/11/15 for gait weakness and left shoulder joint pain. The patient received a steroid joint injection into the left shoulder. A return follow-up visit on 5/27/15 indicated lab work studies and physical therapy implementation. The physician diagnosis was noted to be "adhesive capsulitis left shoulder; myofascial pain, and hamstring tightness both lower extremities". On 6/4/15, the patient was seen at the Clinic and more lab studies were ordered. Other return visits for medical assessment followed 6/11/15, 6/17/15, and 7/14/15. On 7/14/15 a different orthopedic physician injected steroid injections into both shoulders for frozen shoulders and joint pain. The patient was prescribed Meloxicam on a daily basis. On 7/29/15, the patient was seen by a rheumatologist.  A confirmed diagnosis for rheumatoid arthritis was discussed with the patient. The patient was healthy prior to this event and was highly recognized as a referee in high school football for over thirty years. The rheumatologist said the patient would be unable to referee football this season. The rheumatologist said there was possible association of this condition/disease with the shingles vaccine in discussion with the patient. The patient was prescribed RA medication (Sulfasalazine) to be taken on a daily basis. Also, Methylpred pak was prescribed as needed for flare-up with joint pain and swelling. Prior to the 7/29/15 appointment, the patient had swelling and finger joint pain to the left and right hands. Each hand would swell approximately 2.5 times the size of the opposite hand. The events were separate and continued for at least ten days in each hand. These events happened during the months of June and July. Please note the patient reported no fever (> 100.4 degree F) anytime following vaccine administration.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphocyte percentage decreased, Mobility decreased, Musculoskeletal pain, Myalgia, Myofascial pain syndrome
Clinical narrative: The patient developed a sudden onset of bilateral hamstring pain within seven days following the shingles vaccine administration 4/28/15. Left shoulder pain followed over the next two weeks with limited mobility in the left arm. During this time, the patient continued to develop weakness in the lower extremities with difficulty in gait function. The patient was unable to dress or shower without assistance due to pain and weakness. Myalgia and joint pain continued throughout the month of May and June. The patient saw an orthopedic physician on 5/11/15 for gait weakness and left shoulder joint pain. The patient received a steroid joint injection into the left shoulder. A return follow-up visit on 5/27/15 indicated lab work studies and physical therapy implementation. The physician diagnosis was noted to be "adhesive capsulitis left shoulder; myofascial pain, and hamstring tightness both lower extremities". On 6/4/15, the patient was seen at the Clinic and more lab studies were ordered. Other return visits for medical assessment followed 6/11/15, 6/17/15, and 7/14/15. On 7/14/15 a different orthopedic physician injected steroid injections into both shoulders for frozen shoulders and joint pain. The patient was prescribed Meloxicam on a daily basis. On 7/29/15, the patient was seen by a rheumatologist.  A confirmed diagnosis for rheumatoid arthritis was discussed with the patient. The patient was healthy prior to this event and was highly recognized as a referee in high school football for over thirty years. The rheumatologist said the patient would be unable to referee football this season. The rheumatologist said there was possible association of this condition/disease with the shingles vaccine in discussion with the patient. The patient was prescribed RA medication (Sulfasalazine) to be taken on a daily basis. Also, Methylpred pak was prescribed as needed for flare-up with joint pain and swelling. Prior to the 7/29/15 appointment, the patient had swelling and finger joint pain to the left and right hands. Each hand would swell approximately 2.5 times the size of the opposite hand. The events were separate and continued for at least ten days in each hand. These events happened during the months of June and July. Please note the patient reported no fever (> 100.4 degree F) anytime following vaccine administration.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Neutrophil count increased, Neutrophil percentage increased, Pain, Periarthritis, Peripheral swelling
Clinical narrative: The patient developed a sudden onset of bilateral hamstring pain within seven days following the shingles vaccine administration 4/28/15. Left shoulder pain followed over the next two weeks with limited mobility in the left arm. During this time, the patient continued to develop weakness in the lower extremities with difficulty in gait function. The patient was unable to dress or shower without assistance due to pain and weakness. Myalgia and joint pain continued throughout the month of May and June. The patient saw an orthopedic physician on 5/11/15 for gait weakness and left shoulder joint pain. The patient received a steroid joint injection into the left shoulder. A return follow-up visit on 5/27/15 indicated lab work studies and physical therapy implementation. The physician diagnosis was noted to be "adhesive capsulitis left shoulder; myofascial pain, and hamstring tightness both lower extremities". On 6/4/15, the patient was seen at the Clinic and more lab studies were ordered. Other return visits for medical assessment followed 6/11/15, 6/17/15, and 7/14/15. On 7/14/15 a different orthopedic physician injected steroid injections into both shoulders for frozen shoulders and joint pain. The patient was prescribed Meloxicam on a daily basis. On 7/29/15, the patient was seen by a rheumatologist.  A confirmed diagnosis for rheumatoid arthritis was discussed with the patient. The patient was healthy prior to this event and was highly recognized as a referee in high school football for over thirty years. The rheumatologist said the patient would be unable to referee football this season. The rheumatologist said there was possible association of this condition/disease with the shingles vaccine in discussion with the patient. The patient was prescribed RA medication (Sulfasalazine) to be taken on a daily basis. Also, Methylpred pak was prescribed as needed for flare-up with joint pain and swelling. Prior to the 7/29/15 appointment, the patient had swelling and finger joint pain to the left and right hands. Each hand would swell approximately 2.5 times the size of the opposite hand. The events were separate and continued for at least ten days in each hand. These events happened during the months of June and July. Please note the patient reported no fever (> 100.4 degree F) anytime following vaccine administration.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Platelet count increased, Red blood cell count normal, Red blood cell sedimentation rate increased, Rheumatoid arthritis, Rheumatoid factor positive
Clinical narrative: The patient developed a sudden onset of bilateral hamstring pain within seven days following the shingles vaccine administration 4/28/15. Left shoulder pain followed over the next two weeks with limited mobility in the left arm. During this time, the patient continued to develop weakness in the lower extremities with difficulty in gait function. The patient was unable to dress or shower without assistance due to pain and weakness. Myalgia and joint pain continued throughout the month of May and June. The patient saw an orthopedic physician on 5/11/15 for gait weakness and left shoulder joint pain. The patient received a steroid joint injection into the left shoulder. A return follow-up visit on 5/27/15 indicated lab work studies and physical therapy implementation. The physician diagnosis was noted to be "adhesive capsulitis left shoulder; myofascial pain, and hamstring tightness both lower extremities". On 6/4/15, the patient was seen at the Clinic and more lab studies were ordered. Other return visits for medical assessment followed 6/11/15, 6/17/15, and 7/14/15. On 7/14/15 a different orthopedic physician injected steroid injections into both shoulders for frozen shoulders and joint pain. The patient was prescribed Meloxicam on a daily basis. On 7/29/15, the patient was seen by a rheumatologist.  A confirmed diagnosis for rheumatoid arthritis was discussed with the patient. The patient was healthy prior to this event and was highly recognized as a referee in high school football for over thirty years. The rheumatologist said the patient would be unable to referee football this season. The rheumatologist said there was possible association of this condition/disease with the shingles vaccine in discussion with the patient. The patient was prescribed RA medication (Sulfasalazine) to be taken on a daily basis. Also, Methylpred pak was prescribed as needed for flare-up with joint pain and swelling. Prior to the 7/29/15 appointment, the patient had swelling and finger joint pain to the left and right hands. Each hand would swell approximately 2.5 times the size of the opposite hand. The events were separate and continued for at least ten days in each hand. These events happened during the months of June and July. Please note the patient reported no fever (> 100.4 degree F) anytime following vaccine administration.