chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Adenoma benign, Arthralgia, Arthropathy, Bursitis, Immediate post-injection reaction
Clinical narrative: Immediate deep muscle/joint pain beginning 4 hours since injection in the right shoulder, arm and neck - limited range of motion, limited right arm function, night pain, sleep disturbances; physical therapy and cortisone injections. 11/19/14 Doctor appointment for flu vaccination. (Doctor records, by treating physician show vaccine administered by medical assistant - however, she only observed and coached - vaccine as actually administered by new student nurse-trainee, her first time to administer a shot/vaccine - administered high into right shoulder - I was sitting on exam table and she was standing - a 25-gauge 1" needle was used.) I experienced immediate deep muscle and joint ache, with more severe pain following about 4 hours later. 12/3/14 Doctor appointment to report improper vaccine administration and get cortisone shot for pain. (Cortisone shot was administered and may not have given it properly since the greater pain relief only lasted 3-4 days.) 1/7/15 Physical therapy appointment. Diagnosed as adhesive capsulitis or frozen shoulder (After several months of physical therapy, now on limited basis since health insurance co-pay is $35 per visit, and I am on limited income of social security only - I continue prescribed exercises at home - I also purchased a tens unit to help with pain.) 3/24/15 Doctor appointment to secure: 2nd cortisone shot (can only get every 3 months) - X-ray of my right shoulder (AP view of right shoulder) - Pain medication for shoulder pain and sleep (only able to sleep 2-3 hours a night due to pain). 4/14/15 MRI Results: Adenoma, Tendonitis. 5/18/15 Doctor appointment with orthopedist to follow up with MRI results: Additional X-rays ordered: Outlet and Axial views. Diagnosis: Right shoulder bursitis and adhesive capsulitis. Treatment plan: Continued physical therapy - NSAID: MOBIC (anti-inflammatory) - Next appointment: 3rd and last cortisone - Discussed pathology of shoulder and subacromial bursitis/discussed possibility of surgery if treatment plan does not yield results. 5/19/15 6 months from Vaccine Administration. 7/22/15 Follow-up appointment with Dr. 2nd cortisone shot has now worn off and severe pain/shoulder dysfunction/loss of sleep has returned - new course of action planned: Distention Arthrogram schedule for August 13th at hospital - Surgery follow-up appointment scheduled for September 9th. 8/13/15 Distention arthrogram performed on right shoulder at hospital. Next doctor appt in 3 weeks - meanwhile, physical therapy 2 x week.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Musculoskeletal pain, Myalgia, Neck pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Immediate deep muscle/joint pain beginning 4 hours since injection in the right shoulder, arm and neck - limited range of motion, limited right arm function, night pain, sleep disturbances; physical therapy and cortisone injections. 11/19/14 Doctor appointment for flu vaccination. (Doctor records, by treating physician show vaccine administered by medical assistant - however, she only observed and coached - vaccine as actually administered by new student nurse-trainee, her first time to administer a shot/vaccine - administered high into right shoulder - I was sitting on exam table and she was standing - a 25-gauge 1" needle was used.) I experienced immediate deep muscle and joint ache, with more severe pain following about 4 hours later. 12/3/14 Doctor appointment to report improper vaccine administration and get cortisone shot for pain. (Cortisone shot was administered and may not have given it properly since the greater pain relief only lasted 3-4 days.) 1/7/15 Physical therapy appointment. Diagnosed as adhesive capsulitis or frozen shoulder (After several months of physical therapy, now on limited basis since health insurance co-pay is $35 per visit, and I am on limited income of social security only - I continue prescribed exercises at home - I also purchased a tens unit to help with pain.) 3/24/15 Doctor appointment to secure: 2nd cortisone shot (can only get every 3 months) - X-ray of my right shoulder (AP view of right shoulder) - Pain medication for shoulder pain and sleep (only able to sleep 2-3 hours a night due to pain). 4/14/15 MRI Results: Adenoma, Tendonitis. 5/18/15 Doctor appointment with orthopedist to follow up with MRI results: Additional X-rays ordered: Outlet and Axial views. Diagnosis: Right shoulder bursitis and adhesive capsulitis. Treatment plan: Continued physical therapy - NSAID: MOBIC (anti-inflammatory) - Next appointment: 3rd and last cortisone - Discussed pathology of shoulder and subacromial bursitis/discussed possibility of surgery if treatment plan does not yield results. 5/19/15 6 months from Vaccine Administration. 7/22/15 Follow-up appointment with Dr. 2nd cortisone shot has now worn off and severe pain/shoulder dysfunction/loss of sleep has returned - new course of action planned: Distention Arthrogram schedule for August 13th at hospital - Surgery follow-up appointment scheduled for September 9th. 8/13/15 Distention arthrogram performed on right shoulder at hospital. Next doctor appt in 3 weeks - meanwhile, physical therapy 2 x week.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Periarthritis, Tendonitis, X-ray
Clinical narrative: Immediate deep muscle/joint pain beginning 4 hours since injection in the right shoulder, arm and neck - limited range of motion, limited right arm function, night pain, sleep disturbances; physical therapy and cortisone injections. 11/19/14 Doctor appointment for flu vaccination. (Doctor records, by treating physician show vaccine administered by medical assistant - however, she only observed and coached - vaccine as actually administered by new student nurse-trainee, her first time to administer a shot/vaccine - administered high into right shoulder - I was sitting on exam table and she was standing - a 25-gauge 1" needle was used.) I experienced immediate deep muscle and joint ache, with more severe pain following about 4 hours later. 12/3/14 Doctor appointment to report improper vaccine administration and get cortisone shot for pain. (Cortisone shot was administered and may not have given it properly since the greater pain relief only lasted 3-4 days.) 1/7/15 Physical therapy appointment. Diagnosed as adhesive capsulitis or frozen shoulder (After several months of physical therapy, now on limited basis since health insurance co-pay is $35 per visit, and I am on limited income of social security only - I continue prescribed exercises at home - I also purchased a tens unit to help with pain.) 3/24/15 Doctor appointment to secure: 2nd cortisone shot (can only get every 3 months) - X-ray of my right shoulder (AP view of right shoulder) - Pain medication for shoulder pain and sleep (only able to sleep 2-3 hours a night due to pain). 4/14/15 MRI Results: Adenoma, Tendonitis. 5/18/15 Doctor appointment with orthopedist to follow up with MRI results: Additional X-rays ordered: Outlet and Axial views. Diagnosis: Right shoulder bursitis and adhesive capsulitis. Treatment plan: Continued physical therapy - NSAID: MOBIC (anti-inflammatory) - Next appointment: 3rd and last cortisone - Discussed pathology of shoulder and subacromial bursitis/discussed possibility of surgery if treatment plan does not yield results. 5/19/15 6 months from Vaccine Administration. 7/22/15 Follow-up appointment with Dr. 2nd cortisone shot has now worn off and severe pain/shoulder dysfunction/loss of sleep has returned - new course of action planned: Distention Arthrogram schedule for August 13th at hospital - Surgery follow-up appointment scheduled for September 9th. 8/13/15 Distention arthrogram performed on right shoulder at hospital. Next doctor appt in 3 weeks - meanwhile, physical therapy 2 x week.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 09-JUL-2015, the patient was vaccinated with an improperly stored dose of MMR II lot # K016154 with exp 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.15
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Skin lesion, Urticaria
Clinical narrative: 13 mo. old M who developed urticarial lesions after immunizations given. 8/18/15 mom notices non pruritic lesions on face and arms approx 10:30 last evening. Mom gave BENADRYL lotion no shortness of breath or swelling.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 15-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On 19-AUG-2015, the patient indicated for ZOSTAVAX was accidentally vaccinated with (Oka/Merck) VARIVAX (dose, route and lot# were not reported) instead. No adverse effect reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 15-JUL-2015, the patient was vaccinated with an improperly stored dose of MMR II lot # K016154 with exp. 24-SEP-2016, (route and dose were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 16-JUL-2015, the patient was vaccinated with an improperly stored dose of MMR II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect 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 medical assistant refers to multiple unspecified patients of unknown age and unknown gender. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored oral, ROTATEQ, (dose, frequency and route were not reported). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Cellulitis, Diarrhoea, Erythema, Limb discomfort
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a 34 year old female patient. The patient's pertinent medical history and drug reactions allergies were not specified by the reporter. On 23-JUL-2015 the patient was vaccinated with MMR II (Lot # K026366, exp. date was not reported) (dose, frequency and route were not provided), VAQTA (Lot # and exp. date were not reported) (dose, frequency and route were not provided), DTaP (unspecified) (dose, frequency and route were not provided), tetanus toxoid and typhoid vaccine (unspecified) (dose, frequency and route were not provided). Concomitant therapies were not reported. The patient's mother stated on 24-JUL-2015 her daughter developed a red patch on her arm which was warm to touch. Her arm felt like dead weight (limb discomfort), she had diarrhea, pain and stomach cramps (abdominal pain upper). The patient went back to the doctor who prescribed her an unspecified antibiotic. Because she did not improve, she sought medical attention and went to an emergency room. Lab diagnostics studies performed were not specified by the reporter. Later, she was diagnosed with cellulitis and was informed that she would need another unspecified medication, but she was not admitted to the hospital. She was recovering but was still not well. No product quality complaint was involved. The outcome of limb discomfort, diarrhoea, abdominal pain upper, pain, cellulitis and skin warm was reported as recovering. The patient's mother did not assess the causal relationship between MMR II, DTaP (unspecified), tetanus toxoid and typhoid vaccine (unspecified) and the events. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Skin warm
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a 34 year old female patient. The patient's pertinent medical history and drug reactions allergies were not specified by the reporter. On 23-JUL-2015 the patient was vaccinated with MMR II (Lot # K026366, exp. date was not reported) (dose, frequency and route were not provided), VAQTA (Lot # and exp. date were not reported) (dose, frequency and route were not provided), DTaP (unspecified) (dose, frequency and route were not provided), tetanus toxoid and typhoid vaccine (unspecified) (dose, frequency and route were not provided). Concomitant therapies were not reported. The patient's mother stated on 24-JUL-2015 her daughter developed a red patch on her arm which was warm to touch. Her arm felt like dead weight (limb discomfort), she had diarrhea, pain and stomach cramps (abdominal pain upper). The patient went back to the doctor who prescribed her an unspecified antibiotic. Because she did not improve, she sought medical attention and went to an emergency room. Lab diagnostics studies performed were not specified by the reporter. Later, she was diagnosed with cellulitis and was informed that she would need another unspecified medication, but she was not admitted to the hospital. She was recovering but was still not well. No product quality complaint was involved. The outcome of limb discomfort, diarrhoea, abdominal pain upper, pain, cellulitis and skin warm was reported as recovering. The patient's mother did not assess the causal relationship between MMR II, DTaP (unspecified), tetanus toxoid and typhoid vaccine (unspecified) and the events. This is one of two 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 registered nurse refers to a patient of unkonwn age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 20-APR-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reproter. 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 a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. The nurse reported that on 02-APR-2015, the patient was vaccinated with improperly stored GARDASIL (lot # J015378, expiry date 09-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash erythematous, Skin warm, Swelling
Clinical narrative: This patient came back Saturday 08.16.2015 saying her arm still feels warm and she did have a big red rash too. She said she had fever the first few days. Her rash was not blistering or anything, its slightly raised.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site joint movement impairment
Clinical narrative: Right arm numbness and decreased ROM of right shoulder.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Induration, Pruritus, Skin warm
Clinical narrative: Warm skin, red wheal about 2 1/2 inches in diameter, itchy, hard. Injection was given IM instead of SQ.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Warm skin, red wheal about 2 1/2 inches in diameter, itchy, hard. Injection was given IM instead of SQ.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistance, refers to an unspecified numbers of patient of unknown age and gender. On unspecified dates, the unspecified number of patients were vaccinated with an improperly stored dose of VAQTA, lot # L018499, expiration date on 25-FEB-2017, lot # K005323, expiration date 10-FEB-2017 (dose #, dose and route of administration were not provided). There was not concomitant medication reported. No adverse effects were reported. There was not a product quality complain involved. It was unknown if the patients sought medical attention. 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 was received from a medical assistance, refers to an unspecified numbers of patients of unknown age and gender. On unspecified dates, the unspecified number of patients were vaccinated with an improperly stored dose of ROTATEQ orally, lot # L000431, expiration date on 11-AUG-2016, lot # K017576, expiration date on 12-JUN-2016 and lot # K013868, expiration date on 27-MAY-2016 (dose # and dose were not provided). There was not concomitant medication reported. No adverse effects were reported. There was not a product quality complaint involved. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse regarding a patient of unknown age and gender. Patient's medical history or concurrent conditions were not reported. On an unknown date, the patient received improperly stored dose of GARDASIL lot #K010574, expiration date 08-APR-2017 (dose, strength and route were unknown). There was no concomitant therapies reported and also received an improperly stored dose of VAQTA lot # L008665, expiration date 10-FEB-2017 (dose, strength and route were unknown). At the time of the report, no adverse effects were reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, who refers to an unspecified numbers of patient of unknown age and gender. On unspecified dates, the unspecified number of patients were vaccinated with an improperly stored dose of RECOMBIVAX HB 5mcg/0.5 ml, lot # K008988, expiration date on 01-APR-2016, lot # K026666, expiration date on 22-OCT-2016 (dose #, dose and route of administration were not provided). There was not concomitant medication reported. No adverse effects were reported. There was not a product quality complaint involved. It was unknown if the patient sought medical attention. 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 registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 04-MAY-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2015 (dose and route of administration unspecified). No adverse symptoms were reported. 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 registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history, or concomitant medications were not reported. The nurse reported that on 15-MAY-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional niofmration 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 a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 20-MAY-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On 06-AUG-2015, the patients were vaccinated with an improperly stored (Oka/Merck) VARIVAX, (dose and route of administration were not provided), (lot # L005298, expiration date 17-FEB-2017; lot # L001325, expiration date: 13-JAN-2017, lot # L015046, expiration date 29-APR-2017; lot # L013827, expiration date: 21-APR-2017) route not reported. At the time of this report, no adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Follow up information has been received on 13-AUG-2015, from the nurse referring to the unspecified number of patients. 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 a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 20-APR-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacy intern regarding a female patient of unknown age. Patient's concurrent conditions were unspecified. Patient was allergic to Penicillin. She underwent a periodontal procedure on an unspecified date. On 28-JUL-2015 the patient was vaccinated with 19400 plaque-forming united (PFA) ZOSTAVAX (lot # L007222, expiry date: 03-JUN-2016) subcutaneously in the right arm (reported as right posterior triceps area). Concomitant therapies included PERCOCET, hydrochlorothiazide (manufacturer unknown), prednisone (manufacturer unknown), VICODIN, atorvastatin, meloxicam (manufacturer unknown) and Z-PAK. Reporting pharmacy intern stated that the patient experienced redness at her injection site (injection site erythema) since an unspecified date in 2015. The injection site redness was 1 by 2 inches in size. Reporting pharmacy intern stated that the patient did not experienced a rash. Pharmacy intern also stated that the patient did not consulted her healthcare provider, who was unaware about this redness at  her injection site. Till 11-AUG-2015, the patient still experienced redness in her injection site. No treatment was provided for the adverse event. Reporting pharmacy intern stated that the patient started to take azithromycin (Z-PAK) on 25-JUL-2015 (reported as three days before she received ZOSTAVAX for a periodontal procedure which was performed on an unspecified date. Outcome of the event, injection site erythema was reported as not recovered. Pharmacy intern did not assessed the causality of the event with respect to vaccination with ZOSTAVAX. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patient of unknown age and gender. On an unknown dates the patients were vaccinated with ZOSTAVAX (doses and lot numbers not reported). On an unknown dates the patients experienced swelling reaction described as "as big as a baseball" at the injection site. The outcome of injection site swelling and relatedness between event and vaccination were not 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 a patient of unknown age and gender. The patient's  concurrent conditions, medical history or concomitant medications were not reported. The nurse reported that on 26-FEB-2015 and on 29-APR-2015, the patient was vaccinated with improperly stored GARDASIL lot # J015378, expiry date 09-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. There was no pertinent medical history or drug allergies/drug reactions reported. On an unknown date, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX injection (dose, route, lot number and expiration date not provided). There was no concomitant medication described. The physician reported that on an unknown date, the patient experienced shingles after receiving (Oka/Merck) VARIVAX. At the time of the report, the outcome of herpes zoster was unknown. The causality assessment was not reported. No product quality complaint was involved. 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 a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. The nurse reported that on 16-JAN-2015, the patient was vaccinated with improperly stored GARDASIL lot # J015378, expiry date 09-APR-2016 (dose and route of administration unspecified). No adverse symptoms 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 registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. The nurse reported that on 04-JUN-2015, the patient was vaccinated with improperly stored GARDASIL lot # J015378, expiry date 09-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 01-JUL-2015 and 03-JUL-2015, the patient was vaccinated with improperly stored dose of MMR II lot # K016154 with exp. 24-AUG-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 01-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of 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: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L005292, expiration date: 17-AUG-2016 and lot# L008353, expiration date: 11-AUG-2016). dose nad route were not reported. No adverse effects reported. This is one of two reports received from same reporter. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Pain
Clinical narrative: This is a prospective case. This 29-year-old female subject was enrolled in an open label study: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX or FLUARIX QUADRIVALENT or FLULAVAL or FLULAVAL QUADRIVALENT during pregnancy or within 28 days preceding conception. The subject received FLUARIX on 12th August 2015. Concomitant products included minerals nos + vitamins nos (Prenatal Vitamins). The subject's estimated date of delivery was 16th December 2015. The subject received FLU Seasonal QIV, the subject developed general body pain (Non-serious). Additional event(s) included vaccine exposure during pregnancy. The outcome of general body pain was not recovered/not resolved. the outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. The investigator considered the general body pain to be almost certainly related to FLUARIX. The investigator considered that there was no reasonable possibility that the vaccine exposure during pregnancy may have been caused by FLUARIX. The reporter is a pharmacist, but also the patient. Additional details provided are as follows: This case was not previously reported to anyone. The reported batch number for FLUARIX vaccine was C75ES (expiry date: 5th June 2016). The patient's last menstrual period date was not provided. The patient received FLUARIX during the second trimester of pregnancy (unknown weeks). The patient reported body aches about 24 hours after receiving the FLUARIX vaccine.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 13-JUL-2015, the patient was vaccinated with a dose of improperly stored MMR II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 09-JUL-2015, the patient was vaccinated with an improperly stored dose of MMR II lot # K016154 with exp. 24-SEP-2016 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. The patient was vaccinated with a first dose of MMR II on 14-FEB-2008, a second dose on 16-APR-2008 and inadvertently administered a third dose on 19-AUG-2015 (lot#, route, dose and expiry date were unspecified). No adverse effect was reported. Additional information is not expected because there was no consent to contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 09-JUL-2015, the patient was vaccinated with an improperly stored dose of MMR II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an 11 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 24-JUN-2015 the patient was vaccinated with expired doses of MMR II, lot # J006953, (dose and route were not reported). This dose of MMR II had an expiration date of 07-JUN-2015. No adverse events were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 years old female patient with no pertinent medical history and no drug reactions or allergies. On 04-AUG-2015, the patient was vaccinated intramuscularly with an unknown dose of GARDASIL 9 (lot# reported as L006547 (invalid lot number), expiry date: 04-MAR-2017). No concomitant medications were administered. On 16-AUG-2015, the patient experienced pain at the injection site. No lab diagnostics studies were performed. The outcome of injection site pain was reported as not recovered. The medical attention was sought via a call to the physician performed by the patient's mother. The relatedness between the events and dose of GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and unknown gender. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, frequency and route were not reported). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 09-JUL-2015, the patient was vaccinated with a second dose of improperly stored M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: DTAPIPV
Symptoms: Accidental exposure to product, Eye irritation, Eye pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of burning in eyes in a adult female patient who received KINRIX (batch number 3N7Y7, expiry date 27th May 2017). On an unknown date, the patient received KINRIX. On an unknown date, immediately after receiving KINRIX, the patient experienced burning in eyes, stinging and inadvertent exposure to vaccine. On an unknown date, the outcome of the burning in eyes, ocular stinging and inadvertent exposure to vaccine were unknown. It was unknown if the reporter considered the burning in eyes and ocular stinging to be related to KINRIX. Additional details were provided as follows: The reporter stated that while, the patient (physician) was administering KINRIX to a vaccine, it splashed into her eyes and the vaccinee's mother's eyes. The patient reported burning and stinging in her eyes. The patient rinsed her eyes out immediately and she did not have any visual difficulties. No other information was reported. This case has been linked to case US2015GSK119587 (vaccinee's mother's case), reported by the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 09-JUL-2015 and 03-AUG-2015, the patient was vaccinated with improperly stored doses of M-M-R II lot # K016154 exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 13-JUL-2015, the patient was vaccinated with a dose of improperly stored MMR II lot # K016154 and expiration date on 24-SEP-2016, (route and dose were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L001326, expiration date: 13-JAN-2017 and lot# L006384, expiration date: 25-FEB-2017), dose and route were not reported. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 03-JUL-2015, the patient was vaccinated with improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with GARDASIL dose 1 (dosing regimen unspecified). On an unknown date the patient was vaccinated with second dose of GARDASIL one week too early (dosing regimen unspecified) (inappropriate schedule of vaccine administered). No adverse symptoms reported. No further information provided. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hearing impaired, Hypersensitivity, Hypoaesthesia, Insomnia
Clinical narrative: Woke at 5:00 am with pain, tingling, numbness on left side of neck, left arm, dizzy & lightheaded, nauseated. Went to Emergency Room where it was diagnosed as a shoulder sprain & side effect of flu vaccine. However, there was no injury or accident to account for sprain. No medication or treatment prescribed. Later that same day symptoms expanded to include pain radiating onto left side & down left leg with increasing pain & needle-like tingling. Unable to sleep, called primary care physician at 8:00 am 08/21/2015 to make appointment to be seen. By the time of appointment at 10:45, pain had increased to episodes every 15-20 minutes and hearing in left ear was affected. After careful examination by Dr., her tentative diagnosis was an allergic reaction to the flu vaccine. She prescribed a 6 day regimen of steroids & advised monitoring the condition & reporting to ER again if exacerbated.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Ligament sprain, Nausea, Neck pain, Paraesthesia
Clinical narrative: Woke at 5:00 am with pain, tingling, numbness on left side of neck, left arm, dizzy & lightheaded, nauseated. Went to Emergency Room where it was diagnosed as a shoulder sprain & side effect of flu vaccine. However, there was no injury or accident to account for sprain. No medication or treatment prescribed. Later that same day symptoms expanded to include pain radiating onto left side & down left leg with increasing pain & needle-like tingling. Unable to sleep, called primary care physician at 8:00 am 08/21/2015 to make appointment to be seen. By the time of appointment at 10:45, pain had increased to episodes every 15-20 minutes and hearing in left ear was affected. After careful examination by Dr., her tentative diagnosis was an allergic reaction to the flu vaccine. She prescribed a 6 day regimen of steroids & advised monitoring the condition & reporting to ER again if exacerbated.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Diarrhoea, Exposure during pregnancy, Nausea, Vomiting
Clinical narrative: Severe diarrhea and nausea, episodes of vomiting, low grade temperature.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Immediate post-injection reaction
Clinical narrative: Symptoms got worse throughout the day, extreme pain at injection site, body aches, swollen glands in neck, shortness of breath, dizziness, weakness, fatigue.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Lymphadenopathy, Pain
Clinical narrative: Symptoms got worse throughout the day, extreme pain at injection site, body aches, swollen glands in neck, shortness of breath, dizziness, weakness, fatigue.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen, red area on arm at injection site (4x5 cm).
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Platelet count increased, Pruritus, Pyrexia, Rhinorrhoea, Tympanic membrane hyperaemia
Clinical narrative: Pt w fever to 103 and pruritic, urticarial rash to arms, flank & cheeks. Pt with rhinorrhea the next day. At eval resolution of rash, erythematous TM, but without effusion. No abx prescribed, but had CBC resulted from 8/18/15 with a WBC: 18, Rx for Omnicef given, but will not initiate unless child with persistent fevers, otalgia or protracted emesis.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria, White blood cell count increased
Clinical narrative: Pt w fever to 103 and pruritic, urticarial rash to arms, flank & cheeks. Pt with rhinorrhea the next day. At eval resolution of rash, erythematous TM, but without effusion. No abx prescribed, but had CBC resulted from 8/18/15 with a WBC: 18, Rx for Omnicef given, but will not initiate unless child with persistent fevers, otalgia or protracted emesis.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Hives around the neck and abdominal region. No other symptoms reported.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Vaccination site abscess, Vaccination site warmth
Clinical narrative: Vaccine site was red, hot and had abscess under the skin. Pt has received Gardasil-9 previously and never had this response. This was her 2nd Gardasil-9.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Reaction at site where vaccine was given, swelling, redness.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Gardasil vaccine administered during well child physical on 8-18-15. Mother called clinic the following day at 12:47 reporting that child had fever, headache and vomiting starting in the middle of the night and woke up with the same. Mother did not have thermometer but gave Ibuprofen. Vomiting has ceased and fever has gone down. Tolerating fluids. Mother told to watch for increased fever, vomiting and go to medical care if worsens 8-21-15. Phone call to mother reports child  is well.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Nausea, Oropharyngeal pain, Pyrexia, Retching
Clinical narrative: Pt woke up at 3AM today with nausea and headache. Fever this morning. Vom and dry heaves several times. (+) sore throat after vom.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Pt woke up at 3AM today with nausea and headache. Fever this morning. Vom and dry heaves several times. (+) sore throat after vom.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received ZOSTAVAX vaccine 8/19/15. Area was raised, warm, red that day. Progressively got more severe. Patient saw physician 8/21/15 was given antibiotic. Area was now approximately 6 in long by 2 in wide.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Chest discomfort, Headache, Paraesthesia, Urticaria
Clinical narrative: Headache, left arm tingling, welts on back, tight feeling when breathing.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy test, Condition aggravated, Erythema, Food allergy, Inflammation
Clinical narrative: Swelling, inflmmation, redness, (allergic to eggs)
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Swelling, inflmmation, redness, (allergic to eggs)
Sex: U
Vaccine: HEPA, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse regarding a patient of unknown age and gender. Patient's medical history or concurrent conditions were not reported. On an unknown date, the patient received improperly stored GARDASIL lot # K010574, expiration date 08-APR-2017 (dose, strength and route were unknown). It was also received an inappropriate stored dose of VAQTA lot # L008665, expiration date 10-FEB-2017 (dose, strength and route were unknown). There was no concomitant therapies reported. At the time of the report, no adverse effects were reported. Additional information has been requested. This is one of several reports received from the same reporter.