chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Fibrin D dimer increased, HIV test negative, Lymphadenopathy, Migraine, Mononucleosis heterophile test negative
Clinical narrative: This spontaneous report was received from the patient's mother concerning her 23 years old daughter. The patient's concurrent conditions and medical history were not provided. On 15-JUN-2015, the patient was vaccinated with the first dose of M-M-R II (dose, route and anatomical location were not specified) (lot # L002242, expiration date unknown). On 24-JUL-2015, the patient was vaccinated with a second dose of M-M-R II (dose, route and anatomical location were not specified). There was no concomitant medication reported. On an unknown date in 2015, reported as a few days later the first dose of M-M-R II, the patient experienced "light headed" and was having difficulty breathing. Later, on an unspecified date in approximately 2015, the patient experienced inability to catch breath, her heart rates was spiking and she felt muscle spasm in her legs (both). The patient went to an unspecified Emergency Room (date not described) and her blood pressure was 165/100 (units unspecified). A computed tomography san of lungs was performed to check for blood clots but the results were negative, a biopsy on thyroid was also performed and the result was described as benign. Additionally, the reporter added that the patient was an avid runner prior to vaccine, since the vaccine she has not been able to run and has diminished physical activity. The patient has to lay flat in a recliner. The patient also experienced sensitivity to loud music or bright lights. Patient experienced nausea and was heat intolerant. The patient breaks out in a hive looking rash when she takes a shower or uses any heat. Also she experienced severe pain in her face, behind her eyes, in her teeth and gums. Reporter stated that her daughter was unable to lay flat and has not been able to work out due to extreme fatigue. The patient was not hospitalized. At the time of this report, the outcome of exercise tolerance decreased, decreased activity, fatigue, heart rate abnormal, muscle spasm, blood pressure increased, hyperacusis, photophobia, temperature intolerance, facial pain, eye pain, gingival pain, toothache, movement disorder, urticarial thermal, dyspnea, dizziness and nausea was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Muscle spasms, Nausea, Nodule, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: This spontaneous report was received from the patient's mother concerning her 23 years old daughter. The patient's concurrent conditions and medical history were not provided. On 15-JUN-2015, the patient was vaccinated with the first dose of M-M-R II (dose, route and anatomical location were not specified) (lot # L002242, expiration date unknown). On 24-JUL-2015, the patient was vaccinated with a second dose of M-M-R II (dose, route and anatomical location were not specified). There was no concomitant medication reported. On an unknown date in 2015, reported as a few days later the first dose of M-M-R II, the patient experienced "light headed" and was having difficulty breathing. Later, on an unspecified date in approximately 2015, the patient experienced inability to catch breath, her heart rates was spiking and she felt muscle spasm in her legs (both). The patient went to an unspecified Emergency Room (date not described) and her blood pressure was 165/100 (units unspecified). A computed tomography san of lungs was performed to check for blood clots but the results were negative, a biopsy on thyroid was also performed and the result was described as benign. Additionally, the reporter added that the patient was an avid runner prior to vaccine, since the vaccine she has not been able to run and has diminished physical activity. The patient has to lay flat in a recliner. The patient also experienced sensitivity to loud music or bright lights. Patient experienced nausea and was heat intolerant. The patient breaks out in a hive looking rash when she takes a shower or uses any heat. Also she experienced severe pain in her face, behind her eyes, in her teeth and gums. Reporter stated that her daughter was unable to lay flat and has not been able to work out due to extreme fatigue. The patient was not hospitalized. At the time of this report, the outcome of exercise tolerance decreased, decreased activity, fatigue, heart rate abnormal, muscle spasm, blood pressure increased, hyperacusis, photophobia, temperature intolerance, facial pain, eye pain, gingival pain, toothache, movement disorder, urticarial thermal, dyspnea, dizziness and nausea was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Ophthalmological examination normal, Palpitations, Photophobia, Red blood cell count normal, Sleep disorder
Clinical narrative: This spontaneous report was received from the patient's mother concerning her 23 years old daughter. The patient's concurrent conditions and medical history were not provided. On 15-JUN-2015, the patient was vaccinated with the first dose of M-M-R II (dose, route and anatomical location were not specified) (lot # L002242, expiration date unknown). On 24-JUL-2015, the patient was vaccinated with a second dose of M-M-R II (dose, route and anatomical location were not specified). There was no concomitant medication reported. On an unknown date in 2015, reported as a few days later the first dose of M-M-R II, the patient experienced "light headed" and was having difficulty breathing. Later, on an unspecified date in approximately 2015, the patient experienced inability to catch breath, her heart rates was spiking and she felt muscle spasm in her legs (both). The patient went to an unspecified Emergency Room (date not described) and her blood pressure was 165/100 (units unspecified). A computed tomography san of lungs was performed to check for blood clots but the results were negative, a biopsy on thyroid was also performed and the result was described as benign. Additionally, the reporter added that the patient was an avid runner prior to vaccine, since the vaccine she has not been able to run and has diminished physical activity. The patient has to lay flat in a recliner. The patient also experienced sensitivity to loud music or bright lights. Patient experienced nausea and was heat intolerant. The patient breaks out in a hive looking rash when she takes a shower or uses any heat. Also she experienced severe pain in her face, behind her eyes, in her teeth and gums. Reporter stated that her daughter was unable to lay flat and has not been able to work out due to extreme fatigue. The patient was not hospitalized. At the time of this report, the outcome of exercise tolerance decreased, decreased activity, fatigue, heart rate abnormal, muscle spasm, blood pressure increased, hyperacusis, photophobia, temperature intolerance, facial pain, eye pain, gingival pain, toothache, movement disorder, urticarial thermal, dyspnea, dizziness and nausea was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Swelling, Thyroiditis, Ultrasound thyroid abnormal, Urine analysis normal, Vomiting
Clinical narrative: This spontaneous report was received from the patient's mother concerning her 23 years old daughter. The patient's concurrent conditions and medical history were not provided. On 15-JUN-2015, the patient was vaccinated with the first dose of M-M-R II (dose, route and anatomical location were not specified) (lot # L002242, expiration date unknown). On 24-JUL-2015, the patient was vaccinated with a second dose of M-M-R II (dose, route and anatomical location were not specified). There was no concomitant medication reported. On an unknown date in 2015, reported as a few days later the first dose of M-M-R II, the patient experienced "light headed" and was having difficulty breathing. Later, on an unspecified date in approximately 2015, the patient experienced inability to catch breath, her heart rates was spiking and she felt muscle spasm in her legs (both). The patient went to an unspecified Emergency Room (date not described) and her blood pressure was 165/100 (units unspecified). A computed tomography san of lungs was performed to check for blood clots but the results were negative, a biopsy on thyroid was also performed and the result was described as benign. Additionally, the reporter added that the patient was an avid runner prior to vaccine, since the vaccine she has not been able to run and has diminished physical activity. The patient has to lay flat in a recliner. The patient also experienced sensitivity to loud music or bright lights. Patient experienced nausea and was heat intolerant. The patient breaks out in a hive looking rash when she takes a shower or uses any heat. Also she experienced severe pain in her face, behind her eyes, in her teeth and gums. Reporter stated that her daughter was unable to lay flat and has not been able to work out due to extreme fatigue. The patient was not hospitalized. At the time of this report, the outcome of exercise tolerance decreased, decreased activity, fatigue, heart rate abnormal, muscle spasm, blood pressure increased, hyperacusis, photophobia, temperature intolerance, facial pain, eye pain, gingival pain, toothache, movement disorder, urticarial thermal, dyspnea, dizziness and nausea was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: White blood cell count normal
Clinical narrative: This spontaneous report was received from the patient's mother concerning her 23 years old daughter. The patient's concurrent conditions and medical history were not provided. On 15-JUN-2015, the patient was vaccinated with the first dose of M-M-R II (dose, route and anatomical location were not specified) (lot # L002242, expiration date unknown). On 24-JUL-2015, the patient was vaccinated with a second dose of M-M-R II (dose, route and anatomical location were not specified). There was no concomitant medication reported. On an unknown date in 2015, reported as a few days later the first dose of M-M-R II, the patient experienced "light headed" and was having difficulty breathing. Later, on an unspecified date in approximately 2015, the patient experienced inability to catch breath, her heart rates was spiking and she felt muscle spasm in her legs (both). The patient went to an unspecified Emergency Room (date not described) and her blood pressure was 165/100 (units unspecified). A computed tomography san of lungs was performed to check for blood clots but the results were negative, a biopsy on thyroid was also performed and the result was described as benign. Additionally, the reporter added that the patient was an avid runner prior to vaccine, since the vaccine she has not been able to run and has diminished physical activity. The patient has to lay flat in a recliner. The patient also experienced sensitivity to loud music or bright lights. Patient experienced nausea and was heat intolerant. The patient breaks out in a hive looking rash when she takes a shower or uses any heat. Also she experienced severe pain in her face, behind her eyes, in her teeth and gums. Reporter stated that her daughter was unable to lay flat and has not been able to work out due to extreme fatigue. The patient was not hospitalized. At the time of this report, the outcome of exercise tolerance decreased, decreased activity, fatigue, heart rate abnormal, muscle spasm, blood pressure increased, hyperacusis, photophobia, temperature intolerance, facial pain, eye pain, gingival pain, toothache, movement disorder, urticarial thermal, dyspnea, dizziness and nausea was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. The patient had no known pertinent medical history and no known drug reactions or allergies. On 11-JAN-2016, the patient was vaccinated with dose of ZOSTAVAX injection, 0.5 ml/once, subcutaneously, lot # L032397, expiration date: 26-NOV-2016. Concomitant therapies included sertraline hydrochloride, pravastatin and amlodipine besylate (+) benazepril hydrochloride. On 12-JAN-2016, the patient experienced persistent headache. The treatment was not given for adverse event. The patient did not seek medical attention. There were no lab diagnostics studies performed. The outcome of persistent headache was reported as not recovered. The relatedness between the persistent headache and ZOSTAVAX was not reported. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, RVX
Symptoms: Body temperature decreased, Body temperature increased, Diet refusal, Lethargy, Sleep disorder
Clinical narrative: Severe lethargy, refused feeds for 8+ hours, yelling out in sleep every 30 seconds to 1 minutes, alternating low body temp to high body temp (96 degrees to 102 degrees).
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: WAS GIVEN PNEUMOVAX THEN CALLED NURSE TRIAGE AT 4:47 PM THEN PRESENTED TO ER WITH INJECTION SITE BRUISED, TENDER TO TOUCH, BURNING SENSATION GOING DOWN R ARM THROUGH THE BONE AT 5:37.
Age: 0.38
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, hard, hot, and painful to touch all at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Redness and irritation near injection site on left thigh. Vaccines given on left thigh were DTaP -IPV and Var. on 1/11/16 at 4:43.
Age: 26.0
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 26 year old patient. The patient's concurrent conditions and medical history were not reported. On 13-JAN-2016, the patient received an expired dose of GARDASIL injection, lot # J005661, expiration date: 26-SEP-2014 (dose, dose number, route of administration and anatomical location were not reported). There were no concomitant medications provided. There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-OCT-2015, the patient was vaccinated with the involved in the temperature excursion dose of VAQTA (lot # K012457, expiration date 04-JUN-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
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 medical history, concurrent conditions and concomitant medications were not reported. On 13-OCT-2015, the patient was vaccinated with the involved in the temperature excursion dose of VAQTA (lot # K012457, expiration date 04-JUN-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
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 medical history, concurrent conditions and concomitant medications were not reported. On 15-OCT-2015, the patient was vaccinated with the involved in the temperature excursion dose of VAQTA (lot # K012457, expiration date 04-JUN-2017; dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-OCT-2015, the patient was vaccinated with the involved in the temperature excursion dose of VAQTA (lot # K012457, expiration date 04-JUN-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to unspecified patients of unknown ages and genders. Medical history and concurrent conditions were not provided. On an unknown date, the unspecified patients were vaccinated with two doses of improperly stored of VARIVAX (Merck) (lot # L029466 expiration date on 06-Aug-2017) (lot # reported as L030160 expiration date 11-AUG-2017) (Lot # L027287 expiration date 21-JUL-2017) (Lot # L019124 expiration date 27-MAY-2017) (strength, dose and frequency were not provided). Concomitant therapies were not provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-OCT-2015, the patient was vaccinated with the involved in the temperature excursion dose of VAQTA (lot # K012457, expiration date 04-JUN-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site rash
Clinical narrative: Mild rash noted around bilateral thighs where vaccines were given 2 days prior (1/11/2016). No redness noted. BENADRYL 1.25 ml PO administered (1/13/16).
Age: 50.0
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 50 year old patient of unknown gender. On an unspecified date in August 2008 the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot 13834, no expiration date available, national drug code (NDC) 0006-4739-00, dose and route unknown). On an unspecified date in September 2009 the patient received the second dose of PNEUMOVAX 23 (lot 0468X, expiration 26-JUN-2010, NDC 0006-4943-00, dose and route unknown) in less than indicated time interval (inappropriate schedule of drug administration). No adverse effects was reported. The pharmacist stated the patient indicated for PNEUMOVAX 23 by past medical conditions including but not limited to chronic obstructive pulmonary disease (COPD). Lot number 13834 and 0468X are invalid lot numbers for PNEUMOVAX 23. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenopia, Pruritus, Vision blurred
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 73 year old female patient with no drug reactions or allergies. The patient's pertinent medical history included asthma, high blood pressure and hypothyroid. The patient had a case of shingles in her right eye in September 2015 and was treated with an unspecified antiviral. On an unknown date in the last week of November 2015, the patient was vaccinated by a local pharmacist with a dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy included unspecified low dose medications for blood pressure and thyroid. On an unknown date in 2015 (reported as two weeks later), the patient felt like she was getting the shingles again in her right eye, she described it as a line on her forehead above her right eye, itchiness, heaviness and blurriness of the right eye. She had been treating her right eye with a medication reported as "CLEAR EYES" and it made her eye feel better. The patient sought medical attention and she noted that she had spoke to her pharmacist who told her there was nothing that could have been done to treat those symptoms. The outcome of the event was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning unspecified number of patients of unknown age and gender. Patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (strength, unit frequency and route not reported, lot # K016966 and Exp. date 10-MAY-2017). Temperature that the vaccine exposed to was 34.81 F to 34.84 F with time frame 32 hours (non-consecutive). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because of no consent to contact physician.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 21-DEC-2015 the patient was vaccinated with a dose of improperly stored (unspecified temperature excursions) ZOSTAVAX (Lot# reported as L027327, expiration date 21-OCT-2016, dose and route unknown). No adverse symptoms was reported. Lot number L02737 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bronchitis, Feeling abnormal, Inflammation, Malaise, Respiratory disorder
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of bronchitis in a 67-year-old female patient who received Seasonal Influenza vaccine. Co-suspect products included Pneumococcal vaccine and ADVAIR inhalation powder for asthma and pneumonia. In 2015, the patient received Seasonal Influenza vaccine and Pneumococcal vaccine. On an unknown date, the patient started ADVAIR 500/50 ug 500 ug at an unknown frequency. In 2015, an unknown time after receiving Seasonal Influenza vaccine, Pneumococcal vaccine and ADVAIR, the patient experienced bronchitis, inflammation localized, feeling abnormal, respiratory disorder and sickness. The patient was treated with azithromycin. The action taken with ADVAIR was unknown. On an unknown date, the outcome of the bronchitis, inflammation localized, feeling abnormal, respiratory disorder and sickness were unknown. It was unknown if the reporter considered the bronchitis, inflammation localized, feeling abnormal, respiratory disorder and sickness to be related to Seasonal Influenza vaccine, Pneumococcal vaccine and ADVAIR. Additional details were provided as follows: This case was received from the healthcare provider via the vaccine patient assistance program. The patient was so sick with bronchitis and she came down with that like 2 weeks ago from reporting date. Around 14th December 2015, the patient saw her doctor was given a Z-pack-Azithromycin. It was 5 day pack that worked like she had taken that for a month. The patient also had inflammation in her chest and she felt yucky. In 2015, the patient had been pretty sick with upper respiratory stuff. No other dates or specific details were provided by the patient and she could not recall how long she was taking the ADVAIR 500/50 mcg. The patient also did not have diskus she was taking, she just had a box available and no batch number and expiry date were found.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Lip swelling, Myalgia, Oropharyngeal pain, Peripheral swelling, Pharyngeal oedema
Clinical narrative: STARTED WITH FEVER, SORE THROAT AND MUSCLE ACHES. THEN DEVELOPED SWELLING OF LIPS AND ARM. GIVEN BENADRYL BUT SWELLING INCREASED AND INCLUDED THE THROAT. TAKEN TO ER WHERE ONE DOSE OF ORAL STEROIDS GIVEN. ALREADY IMPROVING FROM PREVIOUS DOSE OF BENADRLYL. INSTRUCTED TO CONTINUE BENADRYL FOR 2 MORE DAYS. IF BENADRYL DOESN'T HELP WILL CONTINUE STEROIDS.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: STARTED WITH FEVER, SORE THROAT AND MUSCLE ACHES. THEN DEVELOPED SWELLING OF LIPS AND ARM. GIVEN BENADRYL BUT SWELLING INCREASED AND INCLUDED THE THROAT. TAKEN TO ER WHERE ONE DOSE OF ORAL STEROIDS GIVEN. ALREADY IMPROVING FROM PREVIOUS DOSE OF BENADRLYL. INSTRUCTED TO CONTINUE BENADRYL FOR 2 MORE DAYS. IF BENADRYL DOESN'T HELP WILL CONTINUE STEROIDS.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Area is slightly warm to touch. 2 inch red circle around injection site.  A slight hardness where shot was given.  A small amount of discomfort.
Age: 35.0
Sex: M
Vaccine: FLUC3
Symptoms: Dysuria, Skin irritation, Urinary retention, Urinary tract disorder
Clinical narrative: I felt my skin was irritating while coming back from work at evening on 10/27. Next day started some urination problem and on 10/28, I was not able to pass urine at all.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Bursitis, Joint range of motion decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Pain and limited range of motion in arm and shoulder.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Rotator cuff syndrome, Ultrasound scan abnormal
Clinical narrative: Pain and limited range of motion in arm and shoulder.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-JAN-2106, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 lot # K005957, expiry date 08-MAR-2015, (dose and frequency not reported). The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further details provided. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Urticaria
Clinical narrative: Hives. Methylprednisolone 40 mg once, diphenhydramine 50 mg once.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Soreness lt. arm almost down to top of elbow, limited range of motion.
Age: 78.0
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm swelling and redness. Steroid regimen.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Laboratory test normal
Clinical narrative: This is a spontaneous report from a contactable consumer by way of Claim Letter and Medical Records. A patient of an unknown age, gender and ethnicity was injected with PREVNAR 13 vaccine 0.5 ml one dose (single) on 15Dec2015 in the right arm through intramuscular route. The lot number was reported as 406899, expiration date was Mar2017 and NDC number was 00005-1971-01. The frequency was unknown. The relevant medical history, concomitant medication and past drug history were unknown. On 15Dec2015, the patient developed cellulitis in the right arm. On 21Dec2015 it was reported that, at the site of right arm after intramuscular injection the patient developed redness and swelling. On 21Dec2015, the patient underwent unknown lab tests for which results were normal. The action taken with PREVNAR 13 in response to the event was unknown. On 21Dec2015, the patient was prescribed and treated with unknown antibiotics. As of 04Jan2016, the clinical outcome of the event cellulitis in the right arm was unknown.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Inflammation, Pruritus, Pyrexia, Skin warm
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). This 77-year-old female patient received PREVNAR 13, intramuscular, on 22Sep2015, at 0.5 ml, single. She took it as she was immunologically compromised. Medical history included splenectomy. No other products were taken together with pneumococcal vaccine. The patient experienced inflammation, fever, terrible itching sensation, redness and swelling, all on 22Sep2015. The patient mentioned that she received an injection of PREVNAR 13 in her doctor's office. She had a reaction that was showing up and affected her arm, it was inflamed from her shoulder to half way down to her upper arm mostly in area of 6 and half inches and it was feverish. She had terrible itching sensation, fever and redness. The patient mentioned that she first noticed the reactions like her arm inflamed and fever. The patient received CLARITIN 0.25 mg to ease her itching. She did not undergo any lab work. All events required office visit. Hospital admission was required for fever, itching, redness and swelling. Inflammation did not require hospitalization. All the events resolved on an unknown date. Follow-up (05Jan2016): New information from the same contactable consumer includes: medical history, vaccination date, updated events onset date, seriousness criteria and outcome. Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). This 77-year-old female patient received PREVNAR 13, intramuscular, on 22Sep2015, at 0.5 ml, single. She took it as she was immunologically compromised. Medical history included splenectomy. No other products were taken together with pneumococcal vaccine. The patient experienced inflammation, fever, terrible itching sensation, redness and swelling, all on 22Sep2015. The patient mentioned that she received an injection of PREVNAR 13 in her doctor's office. She had a reaction that was showing up and affected her arm, it was inflamed from her shoulder to half way down to her upper arm mostly in area of 6 and half inches and it was feverish. She had terrible itching sensation, fever and redness. The patient mentioned that she first noticed the reactions like her arm inflamed and fever. The patient received CLARITIN 0.25 mg to ease her itching. She did not undergo any lab work. All events required office visit. Hospital admission was required for fever, itching, redness and swelling. Inflammation did not require hospitalization. All the events resolved on an unknown date. Follow-up (05Jan2016): New information from the same contactable consumer includes: medical history, vaccination date, updated events onset date, seriousness criteria and outcome. Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: M
Vaccine: YF, YF
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, tenderness, warmth at injection site, spreading from posterior deltoid site of injection distally toward elbow.
Age: 44.0
Sex: M
Vaccine: YF, YF
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Type III immune complex mediated reaction
Clinical narrative: Redness, swelling, tenderness, warmth at injection site, spreading from posterior deltoid site of injection distally toward elbow.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route lot # and expiration date were not reported). On an unknown date, the patient developed a rash and pain at the site of ZOSTAVAX injection. The outcome of the rash and pain at the injection site was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected as the reporter did not wish to be contacted.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Mom phoned to clinic stating pt woke up with a fever (100.1), nausea, and a horrible HA. Second HPV received yesterday (1/13/16). First injection 11/8/15, mom states pt c/o HA day after injection.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, drug reaction or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (exact dose, dose number, lot # and expiration date were not reported, route was reported as "injection"). On an unknown date, the patient had a positive Papanicolaou (PAP smear) test result. The patient did not seek medical attention. It was reported that the therapy with GARDASIL was continued. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and GARDASIL was not reported. Additional information is not expected as the physician did not wish to be contacted. +
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient received an improperly stored dose of (Oka/Merck) VARIVAX injection, lot # L030158, expiration date: 11-AUG-2017 (dose and route of administration was not reported). There were no concomitant medications provided. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 13-JAN-2016, the patient was vaccinated with an expired dose of PROQUAD (Merck) (lot # K009891, expiry date 11-JAN-2016; dose and route were not reported). The nurse reported that PROQUAD did not have any previous temperature excursions. No adverse symptoms were reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTP
Symptoms: Injection site discolouration, Injection site rash, Lethargy, Peripheral swelling, Pyrexia
Clinical narrative: Arm Swelled enormous (we have pictures) rash at site of injection, mottled purple, fever, lethargy, sleeping all day, rash.
Age: 11.0
Sex: F
Vaccine: DTP
Symptoms: Rash, Somnolence
Clinical narrative: Arm Swelled enormous (we have pictures) rash at site of injection, mottled purple, fever, lethargy, sleeping all day, rash.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Half dollar sized raised redness, textured and warm.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Headache, Lymphadenopathy, Pain
Clinical narrative: High Fever of 104.1-103.8 for three consecutive days. Body aches, chills, joint pain, severe headaches and swelling of glands.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: High Fever of 104.1-103.8 for three consecutive days. Body aches, chills, joint pain, severe headaches and swelling of glands.
Age: 1.58
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HEPA, MMRV
Symptoms: Epistaxis, Increased tendency to bruise, Platelet count, Thrombocytopenia
Clinical narrative: EASY BRUISING, NOSEBLEEDS AND THROMBOCYTOPENIA.
Age: 42.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Limb discomfort, Pruritus, Rash macular
Clinical narrative: Arm where injection was, right arm, hurt and felt heavy. Red blotchy skin on right arm, stomach, and back. Next day red blotchy skin also on breast and itchy.
Age: 1.01
Sex: M
Vaccine: PNC13
Symptoms: Injection site induration, Injection site mass, Injection site reaction, Rash macular
Clinical narrative: Hard oval shaped lump at the injection site as well as a red splotch.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient received an improperly stored dose of VARIVAX (Merck) injection, lot # L030158, expiration date: 11-AUG-2017 (dose and route of administration was not reported). There were no concomitant medications provided. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.21
Sex: U
Vaccine: HEPA, MMR, VARCEL, FLU3, HEPA, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 10 week old (also reported as 2 month old) patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 13-JAN-2016, the patient was inadvertently vaccinated with doses of M-M-R II (exact dose and route were not reported, lot # L012479, expiration date: 10-APR-2017), VAQTA (exact dose and route were not reported, lot # L02936, expiration date: 15-MAR-2017) and VARIVAX (Merck) (exact dose and route were not reported, lot # L024250, expiration date: 30-JUN-2017), that are supposed to be given at 12 months of age. No adverse effects were noted. 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 healthcare worker and refers to a patient of unknown age and gender.  The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient received an improperly stored dose of VARIVAX (Merck) injection, lot # L030158, expiration date: 11-AUG-2017 (dose and route of administration was not reported). There were no concomitant medications provided. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site infection
Clinical narrative: Injections site reaction that led to an infection.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Decreased appetite, Diarrhoea, Somnolence, Vomiting
Clinical narrative: Vomiting, no fever, 48 hours diarrhea, drowsy, not eating much.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Nausea, Palpitations, Pyrexia
Clinical narrative: Patient was not feeling well around 9 pm and used ProAir inhaler. Patient began having chills, fever, and nausea around 9:30 pm. Patient woke up at 3 am and was still experiencing these symptoms so took 2 Tylenol which helped decrease the symptoms some. At 4 am the patient had heart palpitations (however, this is not unusual for her.. ) and at 10 am she was still having chills. At 10:15 am the patient took another Tylenol and at 7 pm she was feeling a little better and more energetic.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Case number PHEH2016US001006, is an initial spontaneous report received from a healthcare professional on 11 Jan 2016. This report refers to a 34 years old male patient. Past medical history and concomitant medications were not reported. Patient prior vaccination history included as, he vaccinated with FLUVIRIN in last year without adverse event (well tolerated). He was vaccinated with FLUVIRIN (batch number: 1516601, expiry date: not reported) intramuscularly on an unknown date. On 08 Jan 2016, he experienced lost consciousness, mild seizure and went to the hospital after receiving FLUVIRIN. The patient records show as a child, he had an egg allergy, but current records do not show that. The outcome of events was reported as complete recovery on 08 Jan 2016. The seriousness of events was reported as serious (hospitalization). The causality of the events was not reported.
Sex: F
Vaccine: PPV
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 14-OCT-2015 the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot number and expiration date were not provided). The pharmacist reported that the patient received less than a full dose of PNEUMOVAX 23 when the needle leaked and the vaccine ran down the patient's arm. No adverse symptoms or product quality complaints were reported. No further information provided. Follow up information was received on 02-JAN-2016, from the pharmacist who reported that the female patient was vaccinated with public funds. Additional information is not expected as all correspondence was received. Patient, product, event and narrative were updated.
Sex: U
Vaccine: HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients received an improperly stored dose of GARDASIL injection, lot # K020215, expiration date: 05-MAY-2017 (dose, dose number and route of administration were not reported) or improperly stored dose of ROTATEQ orally, lot # L013202, expiration date: 27-JAN-2017 (dose was not reported). There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L018499, expiration date 25-FEB-2017; dose and route of administration were not provided). No adverse events were reported. Follow up information has been received from the registered nurse on 06-NOV-2015. The nurse reported that on unknown dates, the doses of improperly stored VAQTA (lot # K012457, expiration date 04-JUN-2017) (dose and route were not reported) were also administered to unspecified number of patients. Follow up information has been received on 30-DEC-2015. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information was received on 07-JAN-2016 from the registered nurse. On 26-OCT-2015, the patient of unknown age and gender was vaccinated with a dose of VAQTA (lot # L018499, expiration date 25-FEB-2017; dose and route were not reported) that was involved in the temperature excursion. The nurse confirmed that no adverse events were reported. This is one of several reports received from the same source. Additional information has been requested. Patient tab, product tab, event tab and analysis were updated.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L018499, expiration date 25-FEB-2017; dose and route of administration were not provided). No adverse events were reported. Follow up information has been received from the registered nurse on 06-NOV-2015. The nurse reported that on unknown dates, the doses of improperly stored VAQTA (lot # K012457, expiration date 04-JUN-2017) (dose and route were not reported) were also administered to unspecified number of patients. Follow up information has been received on 30-DEC-2015. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information was received on 07-JAN-2016 from the registered nurse. On 27-OCT-2015, the patient of unknown age and gender was vaccinated with a dose of VAQTA (lot # L018499, expiration date 25-FEB-2017; dose and route were not reported) that was involved in the temperature excursion. The nurse confirmed that no adverse events were reported. This is one of several reports received from the same source. Additional information has been requested. Patient tab, product tab, event tab and analysis were updated.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L018499, expiration date 25-FEB-2017; dose and route of administration were not provided). No adverse events were reported. Follow up information has been received from the registered nurse on 06-NOV-2015. The nurse reported that on unknown dates, the doses of improperly stored VAQTA (lot # K012457, expiration date 04-JUN-2017) (dose and route were not reported) were also administered to unspecified number of patients. Follow up information has been received on 30-DEC-2015. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information was received on 07-JAN-2016 from the registered nurse. On 29-OCT-2015, the patient of unknown age and gender was vaccinated with a dose of VAQTA (lot # L018499, expiration date 25-FEB-2017; dose and route were not reported) that was involved in the temperature excursion. The nurse confirmed that no adverse events were reported. This is one of several reports received from the same source. Additional information has been requested. Patient tab, product tab, event tab and analysis were updated.