chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient (relative of physician) of unknown age. Patients medical history, reactions and allergies were unspecified. On an unknown date the patient was vaccinated with ZOSTAVAX, Subcutaneous injection, (Lot Number unspecified) (dose and frequency as directed) subcutaneous for prevention of shingles. Concomitant medications were unspecified. On an unknown date the patient experienced fairly serious rash about 5 days after receiving ZOSTAVAX. The event was treated with unspecified anti viral therapy. the physician told that the patient was otherwise healthy when the vaccine was administered. There was no significant disability or incapacity to the patient due to the event. The event was not life threatening. The patient was not hospitalized. No product quality complaint was involved. The outcome of fairly serious rash was reported as recovered (on an unknown date). The reporters causality assessment for the event fairly serious rash with the therapy of ZOSTAVAX was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unkonwn age with no drug reactions or allergies. On approximately 30-JAN-2014 (reported as about a week ago), the patient was vaccinated with a dose of ZOSTAVAX (lot# J011339, expiry 13-DEC-2014), 0.65 ml once, subcutaneous. There were no concomitant medication and pertinent medical history. The pharmacist stated patient returned to pharmacy at an unspecified time recently with a prescription from an unspecified physician for a "MEDROL dose pack" for an unspecified ailment that developed at an unidentified recent time in 2014. The outcome of an unspecified ailment was unkonwn. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Blood test, Erythema, Mobility decreased, Pain in extremity
Clinical narrative: My arm hurt very very bad right away and continued to feel this way, then I had a red mark that kept getting bigger and bigger and then it got to the pint to where I couldnt even move my arm at all I couldnt lift it to get clothing off or even pick up anything with any weight to it at all.. it became very very hot to the touch and I went back to the doctors office they then sent me to the hospital to have blood work and all done .. and then I was given medication as well it eventually got better.. however I missed work and all due to this as well.. I didnt even go in for a shot however I was told that I should get the shot even though I had a cold and was getting over it. But this shot would prevent me from getting sick and all ..
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: My arm hurt very very bad right away and continued to feel this way, then I had a red mark that kept getting bigger and bigger and then it got to the pint to where I couldnt even move my arm at all I couldnt lift it to get clothing off or even pick up anything with any weight to it at all.. it became very very hot to the touch and I went back to the doctors office they then sent me to the hospital to have blood work and all done .. and then I was given medication as well it eventually got better.. however I missed work and all due to this as well.. I didnt even go in for a shot however I was told that I should get the shot even though I had a cold and was getting over it. But this shot would prevent me from getting sick and all ..
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood glucose decreased, Dyspnoea, Fatigue, Hypoglycaemia, Hypotension
Clinical narrative: Information has been received from a third party claims administrator concerning a 56 year old male patient with diabetes, hypertension and cholesterol. On 17-JAN-2014 the patient was vaccinated with ZOSTAVAX lot # J007208 expiration 20-SEP-2014, 0.5 ml in his right arm. It was reported that the patient sustained a reaction of fever, chills and nausea. The patient was hospitalized five days later due to "water in his lungs and a double pneumonia." At the time of this report the patient is currently hospitalized and outcome is unknown. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Infection, Pneumonia, Sepsis
Clinical narrative: Information has been received from a third party claims administrator concerning a 56 year old male patient with diabetes, hypertension and cholesterol. On 17-JAN-2014 the patient was vaccinated with ZOSTAVAX lot # J007208 expiration 20-SEP-2014, 0.5 ml in his right arm. It was reported that the patient sustained a reaction of fever, chills and nausea. The patient was hospitalized five days later due to "water in his lungs and a double pneumonia." At the time of this report the patient is currently hospitalized and outcome is unknown. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Nausea, Pleural effusion, Pneumonia, Pyrexia
Clinical narrative: Information has been received from a third party claims administrator concerning a 56 year old male patient with diabetes, hypertension and cholesterol. On 17-JAN-2014 the patient was vaccinated with ZOSTAVAX lot # J007208 expiration 20-SEP-2014, 0.5 ml in his right arm. It was reported that the patient sustained a reaction of fever, chills and nausea. The patient was hospitalized five days later due to "water in his lungs and a double pneumonia." At the time of this report the patient is currently hospitalized and outcome is unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Asthenia, Dizziness, Erythema, Fatigue, Hyperhidrosis
Clinical narrative: This spontaneous report as received from an approximately 62 year old (currently 63) female nurse practitioner who is also the patient with Crohn's disease, high blood pressure and osteoporosis. The patient did not have drug reactions/allergies. In 2013 (last year), the patient was vaccinated with influenza (manufacturer unknown) (lot number, dose and route were not reported). Other suspect therapies included pneumococcal, polyvalent (23-valent) (manufacturer unknown) (lot number, dose and route were not reported. In 2013, the patient developed swelling and soreness at an unspecified time after influenza (manufacturer unknown) and pneumococcal, polyvalent (23-valent) (manufacturer unknown). The outcome of the events was unknown. The patient also experienced her left arm became sore, "intense" itching, redness, tenderness, swelling on her left arm, she "did not feel very well", got up and became very diaphoretic and "felt" as if she was going to faint and had difficulty with being "upright" after AFLURIA administration (MARRS 1204USA000407). This is one of several cases from teh same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Local swelling, Pain in extremity, Pruritus, Swelling
Clinical narrative: This spontaneous report as received from an approximately 62 year old (currently 63) female nurse practitioner who is also the patient with Crohn's disease, high blood pressure and osteoporosis. The patient did not have drug reactions/allergies. In 2013 (last year), the patient was vaccinated with influenza (manufacturer unknown) (lot number, dose and route were not reported). Other suspect therapies included pneumococcal, polyvalent (23-valent) (manufacturer unknown) (lot number, dose and route were not reported. In 2013, the patient developed swelling and soreness at an unspecified time after influenza (manufacturer unknown) and pneumococcal, polyvalent (23-valent) (manufacturer unknown). The outcome of the events was unknown. The patient also experienced her left arm became sore, "intense" itching, redness, tenderness, swelling on her left arm, she "did not feel very well", got up and became very diaphoretic and "felt" as if she was going to faint and had difficulty with being "upright" after AFLURIA administration (MARRS 1204USA000407). This is one of several cases from teh same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Dizziness, Erythema, Hyperhidrosis, Local swelling, Malaise
Clinical narrative: This spontaneous report as received from an approximately 62 year old (currently 63) female nurse practitioner who is also the patient with Crohn's disease, high blood pressure and osteoporosis. The patient did not have drug reactions/allergies. In 2013 (last year), the patient was vaccinated with influenza (manufacturer unknown) (lot number, dose and route were not reported). Other suspect therapies included pneumococcal, polyvalent (23-valent) (manufacturer unknown) (lot number, dose and route were not reported. In 2013, the patient developed swelling and soreness at an unspecified time after influenza (manufacturer unknown) and pneumococcal, polyvalent (23-valent) (manufacturer unknown). The outcome of the events was unknown. The patient also experienced her left arm became sore, "intense" itching, redness, tenderness, swelling on her left arm, she "did not feel very well", got up and became very diaphoretic and "felt" as if she was going to faint and had difficulty with being "upright" after AFLURIA administration (MARRS 1204USA000407). This is one of several cases from teh same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Pain, Pain in extremity, Pruritus, Swelling, Tenderness
Clinical narrative: This spontaneous report as received from an approximately 62 year old (currently 63) female nurse practitioner who is also the patient with Crohn's disease, high blood pressure and osteoporosis. The patient did not have drug reactions/allergies. In 2013 (last year), the patient was vaccinated with influenza (manufacturer unknown) (lot number, dose and route were not reported). Other suspect therapies included pneumococcal, polyvalent (23-valent) (manufacturer unknown) (lot number, dose and route were not reported. In 2013, the patient developed swelling and soreness at an unspecified time after influenza (manufacturer unknown) and pneumococcal, polyvalent (23-valent) (manufacturer unknown). The outcome of the events was unknown. The patient also experienced her left arm became sore, "intense" itching, redness, tenderness, swelling on her left arm, she "did not feel very well", got up and became very diaphoretic and "felt" as if she was going to faint and had difficulty with being "upright" after AFLURIA administration (MARRS 1204USA000407). This is one of several cases from teh same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure decreased, Ear discomfort, Feeling abnormal, Pallor, Respiration abnormal
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to her 17 year old daughter who was in good health. The patient did not have any pertinent medical history or drug reactions/allergies. On 22-JAN-2014 the patient was vaccinated with her first dose of GARDASIL (lot # J010668, expiration date 29-APR-2016). There were no concomitant medications. Within minutes of receiving the dose, her daughter began to feel "dizzy", and then she reported that her ears felt like they were "filling up with water." Her daughter reported that her head "felt weird", and her breathing became labored. She reported that her daughter became diaphoretic and pale, and she assisted her daughter to lie down. Her daughter's blood pressure was measured, and it had decreased from earlier in the office visit. After an unspecified period of time, "maybe 30 minutes", during the same office visit, the patient recovered. Her vital signs returned to her baseline, and she currently had no residual effects. The patient did not see one specific doctor in the practice where she was a patient. The patient had frequent blood pressure measurements and the results were not specified. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Visual acuity reduced
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to her 17 year old daughter who was in good health. The patient did not have any pertinent medical history or drug reactions/allergies. On 22-JAN-2014 the patient was vaccinated with her first dose of GARDASIL (lot # J010668, expiration date 29-APR-2016). There were no concomitant medications. Within minutes of receiving the dose, her daughter began to feel "dizzy", and then she reported that her ears felt like they were "filling up with water." Her daughter reported that her head "felt weird", and her breathing became labored. She reported that her daughter became diaphoretic and pale, and she assisted her daughter to lie down. Her daughter's blood pressure was measured, and it had decreased from earlier in the office visit. After an unspecified period of time, "maybe 30 minutes", during the same office visit, the patient recovered. Her vital signs returned to her baseline, and she currently had no residual effects. The patient did not see one specific doctor in the practice where she was a patient. The patient had frequent blood pressure measurements and the results were not specified. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure decreased, Dizziness, Dyspnoea, Ear discomfort, Head discomfort
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to her 17 year old daughter who was in good health. The patient did not have any pertinent medical history or drug reactions/allergies. On 22-JAN-2014 the patient was vaccinated with her first dose of GARDASIL (lot # J010668, expiration date 29-APR-2016). There were no concomitant medications. Within minutes of receiving the dose, her daughter began to feel "dizzy", and then she reported that her ears felt like they were "filling up with water." Her daughter reported that her head "felt weird", and her breathing became labored. She reported that her daughter became diaphoretic and pale, and she assisted her daughter to lie down. Her daughter's blood pressure was measured, and it had decreased from earlier in the office visit. After an unspecified period of time, "maybe 30 minutes", during the same office visit, the patient recovered. Her vital signs returned to her baseline, and she currently had no residual effects. The patient did not see one specific doctor in the practice where she was a patient. The patient had frequent blood pressure measurements and the results were not specified. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to her 17 year old daughter who was in good health. The patient did not have any pertinent medical history or drug reactions/allergies. On 22-JAN-2014 the patient was vaccinated with her first dose of GARDASIL (lot # J010668, expiration date 29-APR-2016). There were no concomitant medications. Within minutes of receiving the dose, her daughter began to feel "dizzy", and then she reported that her ears felt like they were "filling up with water." Her daughter reported that her head "felt weird", and her breathing became labored. She reported that her daughter became diaphoretic and pale, and she assisted her daughter to lie down. Her daughter's blood pressure was measured, and it had decreased from earlier in the office visit. After an unspecified period of time, "maybe 30 minutes", during the same office visit, the patient recovered. Her vital signs returned to her baseline, and she currently had no residual effects. The patient did not see one specific doctor in the practice where she was a patient. The patient had frequent blood pressure measurements and the results were not specified. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Full blood count, Metabolic function test, Pain in jaw, Red blood cell sedimentation rate
Clinical narrative: Acute right jaw pain and discomfort on opening jaw.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Disability, Fatigue, Headache, Infectious mononucleosis
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 12 year old female patient (also reported as the pharmacist's daughter). The patient did not have any pertinent medical history. On an unknown date in October 2013, the patient was vaccinated with a first dose of GARDASIL (route, dose, lot number and expiry date were not reported). On an unknown date in 2013, a couple of weeks later, after administration of GARDASIL the patient developed mononucleosis (disability) with a chronic headache (disability) and fatigue (disability). The pharmacist did not administer GARDASIL again and therapy with GARDASIL was discontinued. The outcome of the events mononucleosis, chronic headache and fatigue were unknown. The events mononucleosis, chronic headache and fatigue led to disability. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Asthenia, Bed rest, Computerised tomogram head abnormal, Ear pain
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 12 year old female patient (also reported as the pharmacist's daughter). The patient did not have any pertinent medical history. On an unknown date in October 2013, the patient was vaccinated with a first dose of GARDASIL (route, dose, lot number and expiry date were not reported). On an unknown date in 2013, a couple of weeks later, after administration of GARDASIL the patient developed mononucleosis (disability) with a chronic headache (disability) and fatigue (disability). The pharmacist did not administer GARDASIL again and therapy with GARDASIL was discontinued. The outcome of the events mononucleosis, chronic headache and fatigue were unknown. The events mononucleosis, chronic headache and fatigue led to disability. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Headache, Hyperacusis, Infectious mononucleosis, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 12 year old female patient (also reported as the pharmacist's daughter). The patient did not have any pertinent medical history. On an unknown date in October 2013, the patient was vaccinated with a first dose of GARDASIL (route, dose, lot number and expiry date were not reported). On an unknown date in 2013, a couple of weeks later, after administration of GARDASIL the patient developed mononucleosis (disability) with a chronic headache (disability) and fatigue (disability). The pharmacist did not administer GARDASIL again and therapy with GARDASIL was discontinued. The outcome of the events mononucleosis, chronic headache and fatigue were unknown. The events mononucleosis, chronic headache and fatigue led to disability. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Mononucleosis heterophile test positive, Nausea, Nuclear magnetic resonance imaging normal, Peripheral coldness, Sinusitis
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 12 year old female patient (also reported as the pharmacist's daughter). The patient did not have any pertinent medical history. On an unknown date in October 2013, the patient was vaccinated with a first dose of GARDASIL (route, dose, lot number and expiry date were not reported). On an unknown date in 2013, a couple of weeks later, after administration of GARDASIL the patient developed mononucleosis (disability) with a chronic headache (disability) and fatigue (disability). The pharmacist did not administer GARDASIL again and therapy with GARDASIL was discontinued. The outcome of the events mononucleosis, chronic headache and fatigue were unknown. The events mononucleosis, chronic headache and fatigue led to disability. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apnoea, Oxygen saturation decreased, Vomiting
Clinical narrative: Reported apneic x5-7 sec. Vomited x2. Sats 80s in ER. Received epinephrine in ER.
Sex: M
Vaccine: VARZOS
Symptoms: Sensory disturbance
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). "6 weeks' after the patient received ZOSTAVAX he developed a "pulling" sensation in his arm. The reporter stated "when the patient raises his arm he got a pulling sensation". It was unknown if the patient had sought medical attention. The outcome of the event and action taken with suspect therapy was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age (the sister is a nursing student at the nurse practitioner's office). On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot # not reported). It was reported that the patient was being followed at a hospital for an autoimmune disorder after receiving GARDASIL. The outcome of the autoimmune disorder was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refers to a patient of unknown age and gender. On 07-DEC-2005 patient was vaccinated with VAQTA first dose (dose unit, lot number and expiry date route unknown). On 12-JUl-2006, patient was vaccinated with second dose of VAQTA, third dose on 15-NOV-2012, fourth dose on 20-MAY-2013. No adverse effect reported. The outcome of events was unknown. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 year old patient of unknown gender. On 06-FEB-2014 the patient was vaccinated with a dose of MMR II (lot number J003625; expiry date 22-MAR-2015). Strength, dose and route were not reported. The MMR II that was administered to the patient had been exposed to 15.9 C for 5 hours. No adverse effect was reported. No further information was reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Feeling jittery, Irritability, Nervousness
Clinical narrative: This spontaneous report was received from a 60 year old male patient. On approximately 23-DEC-2013, "6 weeks ago on a Monday in December 2013", the patient was vaccinated with ZOSTAVAX injection (dose/frequency was reported as "as directed"). Concomitant therapies included diclofenac sodium and various unspecified supplements. There was no pertinent medical history or drug allergy. On approximately 24-DEC-2013, the following day of vaccination, the patient developed "the jitters". The patient explained that the "jitters" lasted for about a week and included feelings of anxiety, irritability, and nervousness. No treatment was given. No lab test was done. The patient talked to pharmacist to seek medical attention. The outcome of events was unspecified. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23. Dosing information, route of administration and lot number were not provided. The pharmacist reported that the patient was inadvertently administered a dose of PNEUMOVAX23 2 days in a row. Dosing information, route of administration and lot number for second dose were also not provided. The dates of administration were not provided. No adverse effects reported. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a 56 year old female patient. The patient is allergic to latex. No pertinent history. On 03-FEB-2014 the patient was vaccinated with ZOSTAVAX (one single injection, dosing information and route were not provided). Concomitant therapies included CELEBREX and "many other unspecified medications". On 03-FEB-2014 the patient experienced "bumpy rash as big as a softball", fever and pain at the injection site. The patient reported that the pain is getting worse and has not yet gone away. The patient did not seek medical attention. No treatment was given. The outcome of "bumpy rash as big as a softball", fever and pain at the injection site was reported as not recovered/not resolved. The causal relationship was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and frequency was not reported). On an unknown date (also reported as couple of years ago), the patient experienced golf ball-sized swelling at the injection site. The outcome of the event golf ball-sized swelling at the injection site was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information is not expected.
Age: 23.0
Sex: M
Vaccine: HPV4
Symptoms: Anxiety
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 23 year old male patient. On an unknown date the patient was vaccinated with GARDASIL first dose (strength, dose, unit, route, lot number and expiry date unknown). On an unknown date after first dose of with GARDASIL patient felt anxious for couple of days. The outcome of felt anxious for a couple days was unknown. This case # 1402USA005386 has been linked to case # 1402USA005566 via same reporter link. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Feeling abnormal
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. On unknown date the patient was vaccinated with GARDASIL first dose (strength, dose unit, route, lot number and expiry date unknown). On an unknown date after first dose of with GARDASIL patient felt weird. The outcome of felt weird was unknown. This case # 1402USA005566 has been linked to case # 1402USA005386 via same reporter link. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 06-JUN-2013 the patient was vaccinated with GARDASIL, first dose. On 17-JUL-2013 the patient was vaccinated with GARDASIL, second dose. On 02-JAN-2014 the patient was vaccinated with GARDASIL, third dose. Pharmacist reported that the patient received an expired dose of GARDASIL on 02-JAN-2014 that was expired on 02-DEC-2013. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). It was reported that the physician administered a first and second dose of GARDASIL according to PI and a third dose of GARDASIL outside of PI timing recommendations on unspecified dates to an unspecified patient. After completing this GARDASIL series, the patient was administered a second series of GARDASIL vaccines on unspecified dates by an unspecified physician. Additional information has been requested.
Sex: M
Vaccine: FLUN4
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Pulmonary hypertension
Clinical narrative: A report from a health professional concerns a male (weight: 2.72 kilograms) who born via caesarean section. His medical history, concurrent diseases, and concomitant medications were not reported. During Oct-2013, his mother received FLUMIST Quadrivalent (intranasal) while pregnant. The patient developed pulmonary hypertension on 06-Nov-2013, an hour after birth. There was a prolongation in hospitalization due to the pulmonary hypertension. The patient recovered from pulmonary hypertension on an unspecified date and was discharged from the hospital on 18-Nov-2013. The reporter considered the event to be serious as an important medical event.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a consumer refers to a male patient of unknown age (the reporter's grandson). In approximately 2013 (also reported as a couple of months ago) the patient was vaccinated with VARIVAX (Merck) (dose, route, lot number, expiration date and indication were not provided). The reporter stated that recently the patient was diagnosed with a mild case of chickenpox (onset date not provided). No symptoms were provided. The patient's outcome was not provided. The relatedness between the event of chickenpox and the vaccination with VARIVAX (Merck) was not reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer (report received from patient's friend) refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX. On an unknown date, the patient experienced shingles. The patients friend reported that the patient had shingles about 5 times, some before having ZOSTAVAX and some after. The outcome of shingles was unknown. The causality was not reported. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (C.M.A.), refers to a 17 year old male patient. No pertinent medical history or drug reactions/allergies were provided. On 29-JAN-2014, the patient was vaccinated with a dose of PROQUAD (Merck) INJ (Lot number J010159; expiration date 23-FEB-2015), 0.5 ml, subcutaneously, in the right deltoid region. On the same day, during the same office visit, the patient was vaccinated with a dose of VARIVAX (Merck) INJ (Lot number J003541; expiration date 25-MAR-2015), subcutaneously, in the left deltoid region. No concomitant therapies were reported. The C.M.A. had initially reported that the two doses were administered in the deltoid muscle, and when informed that the route of administration for these two products was subcutaneous, she confirmed that the doses were administered subcutaneously. She stated that the patient stated that he "felt fine," and she did not observe any adverse effects. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events. A flu shot was given to a 4 month old. Parents were informed of incident.
Age: 0.9
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Per nurse "did not realize the year was 2013 Nov for vaccine" she stated got confused with dates. Pt is fine. Follow up call, provider spoke with pt and parent.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Dyspnoea, Erythema, Eyelid oedema, Injection site swelling
Clinical narrative: At bedtime, the day of receiving the influenza vaccine, spike a temp of > 101 and developed SOB. Next a.m. vaccinated arm was swollen: shoulder to elbow, facial and eyelid swelling and reports face was beet red. Self tx: BENADRYL.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: At bedtime, the day of receiving the influenza vaccine, spike a temp of > 101 and developed SOB. Next a.m. vaccinated arm was swollen: shoulder to elbow, facial and eyelid swelling and reports face was beet red. Self tx: BENADRYL.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Crying, Decreased activity, Feeling abnormal, Head banging
Clinical narrative: 1.5 days after vaccines give pt began being dazed, inactive - only responding for basic needs - to eat sleep. 1 week later she began hitting self in head, crying for no reason. Symptoms gradually resolved 3.5 weeks after vaccine given.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Blindness, Hyperhidrosis, Retching
Clinical narrative: 5 minutes aafter receiving vaccines, patient complained of loss of vision, became diaphoretic, weak and had dry heaves. Systolic BP was < 100. Recovery (complete) occurred within 15-20 min.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Skin warm, Swelling
Clinical narrative: Redness at site of injection, swelling, warm to the touch. Patient saw doctor on 2/7/14 and was prescribed 10 day course Cephalexin.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Heat, pain, swelling, knot at injection site.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Herpes zoster, Ocular hyperaemia
Clinical narrative: Extreme redness of right eye and beginning of pox blistering surrounding; went to doctor & diagnosed as shingles.
Age: 28.0
Sex: F
Vaccine: HIBV, MEN, PPV
Symptoms: Injection site pain, Injection site swelling, Laboratory test normal, Pain
Clinical narrative: Swelling and pain at injection site initially; presented to ED following AM (0130) with pain on movement and shoulder abduction; no fever or numbness; received pain medication (Norco 5/325 X 2 tablets) and ice pack; all on left deltoid where received Pneumovax injection.
Age: 1.21
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Hives on leg, belly and face.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Condition aggravated, Dizziness, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Patient recieved vaccine and went back to work (in the same building). Approx. 1 hour after recieving vaccine, she reported feeling hot/sweaty, itchy with rash, nausea (did not vomit), and dizzy. Other than being hot and sweaty while working, patient states she was not experiencing these symptoms prior to recieving the vaccine. She did not report symptoms until 01/03/2014 when she was preparing for her 3rd vaccine. However, the third vaccine was not given because of her reporting reaction to previous dose.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Patient recieved vaccine and went back to work (in the same building). Approx. 1 hour after recieving vaccine, she reported feeling hot/sweaty, itchy with rash, nausea (did not vomit), and dizzy. Other than being hot and sweaty while working, patient states she was not experiencing these symptoms prior to recieving the vaccine. She did not report symptoms until 01/03/2014 when she was preparing for her 3rd vaccine. However, the third vaccine was not given because of her reporting reaction to previous dose.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, pain, felt warm at injection site.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Barium enema, Enema administration, Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Patient was diagnosed with intussusception via abdominal ultrasound; she presented with billous vomiting for 2 days and was then admitted to Medical Center, where she was diagnosed by myself. While in the hospital she had a barium enema reduction of the intussusception that reduced the ailment without surgery. Patient was discharged the next day in stable condition. She was found to have the Rotavirus vaccine (as well as her other 2 month vaccines) given on 02/05/2014 by her PMD.
Age: 7.0
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was inadvertently given Dtap vaccine, not indicated for patient's age group. According to immunization guidelines the dose of Dtap the patient received is counted as a valid dose, but the patient should have been given Tdap vaccine.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic, Scar
Clinical narrative: States she began having very itchy bumps over her extremities, neck and some on trunk begining approximately 2 weeks after receiving the vaccine. She continued to get them for 2-3 more weeks. They are resolving now with only scarring remaining.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Body temperature increased, Muscular weakness, Pain in extremity
Clinical narrative: T. 103 degrees. Leg pain. Muscle weakness.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Musculoskeletal stiffness, Tinnitus
Clinical narrative: Sudden rise in BP, stiff neck and tinnitus.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever peaking at 102, terrible searing pain in arms.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Pruritus, Urticaria
Clinical narrative: Pruritis and hives started aound 3pm to clients abdominal region. 6pm hives covered entire body. Oral Benadryl taken at 6:15pm. Several hours later client had no symptoms.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient reported to pharmacy staff that she was feeling dizzy. Patient was observed and asked to lie flat with feet elevated for about 10 minutes. Blood pressure was 113/71 and pulse was 81 BPM. Patient felt better, sat up, and drank fluids. Pateint was observed for anohter 10 minutes. Blood pressure was checked again (118/79) and pulse (78 BPM). Pateint felt fine standing and left the pharmacy. She was advised to contact primary care provider or emergency room in the event of deteriorating condition.
Age: 1.51
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 10 cm localized redness on right thigh where Hep A was given on 2-10-2014, warm to touch. No fever. Symptom began on 2-11-2014 and noticed by mother, brought to clinic on 2-12-2014.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Skin reaction
Clinical narrative: Large local skin reaction with swelling >2 cm, redness, induration. Swelling still present. Monitoring located on right thigh - site of MMR.
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Asthma, Condition aggravated
Clinical narrative: A report has been received from a consumer, concerning a 44 year old, male patient. The patient suffered concomitantly of hypertension since 2011, and was taking unspecified medication as therapy since then. Additional concomitant medication was AIRCOMB for allergic asthma. The patient was user respiratory (inhalation) SYMBCORT Forte Turbuhaler 320 mcg / 90 mcg two times a day since 2007 for allergic asthma. His physician suggested him to use SYMBICORT 160 mcg/4.5 mcg in summer. Influenza (unknown) was applied to the patient in Oct-2013. After the vaccination, the patient's asthma level had increased and exacerbated, so he was hospitalized on 23-Dec-2013. During hospitalisation, he did not use SYMBICORT. The patient was discharged on 29-Dec2013, and has started to use SYMBICORT. However, the medication was finished earlier than normal duration, on 31-Dec-2013. The dosage indicator showed 'red'. Actually, the medication should be used longer. He started to use a new SYMBICORT on 31-Dec-2013. That one's dosage indicator showed 'red' on 12-Jan-2014, however it should have been used until the end of January. Therapy with SYMBICORT was reported to be continued. The patient recovered from the event of exacerbation of asthma on 29-Dec-2013. The reporter considered the event of exacerbation of asthma on 29-Dec-2013. The reporter considered the event of exacerbation of asthma to be serious due hospitalization. The patient thought the reason of exacerbation of asthma was the influenza vaccine. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event of exacerbation of asthma to be unrelated to the suspect product of SYMBICORT Forte Turbuhaler.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Unevaluable event
Clinical narrative: MIC form document lot # AHAVB532AA - adult dose Hep A. In chart document AHAVB532AA - shows < 19 yo unsure of dose given.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness/tingling sensation to arm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain, Rash
Clinical narrative: Developed pain and blistering rash on (L) lower extremity several days after ZOSTAVAX.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: Large bumpy rash at injection (1 x 3 inches) for 3 weeks - went away - but severe pain in the arm when patient moves the arm still exists.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Patient reported and showed a redness and swelling at injection site. Red area was about 1.5" in diameter. Patient also reported itchiness and discomfort. This appeared in the morning after the vaccination was given.
Age: 1.82
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Rash
Clinical narrative: Rash appeared the following morning 02/12/2014. Pt. Father states pt. had fish for dinner also.
Age: 0.19
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Crying, Emotional distress, Insomnia, Screaming
Clinical narrative: Baby screamed and cried in a panicked manner and was inconsolable even with breastfeeding for at least 9-10 hours.  She had difficulty sleeping that night and was not her normal self until the following morning.  I called the doctor and spoke with the advice nurse and was told that this was a normal reaction, however if I would have known more I would have taken my baby to the emergency room and I remain concerned about what happened.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain, Ultrasound scan normal, X-ray limb normal
Clinical narrative: On 8/30/2013 patient presented to employee health clinic complaining of pain in left arm deltoid area where she had received MMR shot and felt swollen to her.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Fibrin D dimer increased, Headache, Palpitations
Clinical narrative: Shortness of breath, racing heart beat, dizzy, headache, vomiting. At ER elevated D-Dimer.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Shortness of breath, racing heart beat, dizzy, headache, vomiting. At ER elevated D-Dimer.
Age: 22.0
Sex: F
Vaccine: FLU3, MMRV, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None. Pt needed MMR and varicella. Nurse found MMRV together and gave pt. MMRV (PROQUAD) is licensed for 12 year old and under. Next time will have separate injections. No symptoms occurred.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Night sweats
Clinical narrative: Itching, erythema and soft tissue swelling on (L) upper arm, warm to touch. Night sweats. V/S: BP = 153/74, PR = 74; RR = 17, T = 97.1, O2 sat = 98% RA.
Age: 0.36
Sex: M
Vaccine: DTAP, PNC13, RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: None stated.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Condition aggravated, Mobility decreased, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Hurting in top part of left arm. Sharp pain, couldn't lift above head. Took 2 rounds of steroids then went to orthopedic doctor and was told that it was my rotator cuff but the shot caused it to flare up. Going for a follow up with the ortho Dr. in March.
Age: 1.59
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Rash
Clinical narrative: Fine rash forehead, chest, abdomen and back noticed on awakening in a.m. Seen by Dr on 2/12/14. No treatment.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen negative, Incomplete course of vaccination
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 25 year old female patient with allergy to amoxicillin and no pertinent medical history. On 03-AUG-1999 and 03-NOV-1999, the patient was vaccinated with doses 1 and 2 of RECOMBIVAX HB intramuscular (dose was not reported) lot numbers reported as 0137J and 0904A respectively. The patient had never received the third dose. On 06-FEB-2013, the patient had B surface antigens drawn and the results were non-reactive. At the time of the report, outcome for the event was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Erythema, Feeling hot, Gait disturbance, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a 70 years old male patient refers to himself with high blood pressure. The patient had no drug reactions/allergies. On 01-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # unspecified) dose, route and location unspecified and an influenza virus vaccine (unspecified) (Lot # U8908AA, expiry date: 30-JUN-2014, Sanofi Pharmaceuticals) at the same time, and had developed "numbness" in both of his feet after receiving these two vaccines. The patient reported that the numbness in his feet happened "immediately" after receiving the two vaccines, "at the same time on the same exact day". The patient stated "certain days my feet feel like I am walking with broken bones and the numbness is always there." The patient then reported that the numbness would go into the "ankle" area and half way up into his knees. The reporter stated the he felt like was "walking on nails". The reporter also stated that he had experienced the numbness in his hands. The patient then stated that within the last 4 or 5 days (estimated in January 2014), the bottoms of his feet are "red hot". The patient also stated he was using many other"unspecified medications" (names/dosage/frequencies/manufacturers unspecified). The patient stated that he was not recovered and now he was using a "cane" to help him walk. The patient had sought medical attention via saw the doctor. Upon internal review, these events were considered as disability. Follow up information was received from a registered nurse which reported that was administered the ZOSTAVAX at the local pharmacy (unknown). On 31-OCT-2013 the patient was last seen in physician's office for significant numbness and tingling in his feet. He was referred to a Neurologist and was seen on 29-OCT-2013. Outcome of tingling in his feet was unknown. Causality was not reported. Concomitant therapies included DIOVAN, NEURONTIN, allopurinol, metoprolol, clonidine, DETROL, hydralazine (Dosage and frequency unspecified). Additional information has been requested.