chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Blood test, Chills, Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: I was given adult doses of the Pneumococcal vaccine and ZOSTAVAX in my upper left arm. They were administered in my physicians office on 10/30/24. In less than 8 hours following the vaccinations I experienced chills, shakes and fever that went as high as 101.2. The area of the Shingles immunization swelled to the size of my hand, turned bright red and was hot to the touch. Approximately 24 hours later the site of the Pneumococcal vaccine swelled, turned red and was hot to the touch however the swelling and redness were limited to an oval shaped area that was only 2 inches at its widest point. The lymph glands under my left arm swelled and were tender to the touch. By 11/9/14 all of the visible signs of the vaccination had pretty much dissipated with the exception of a slightly bruised skin color in the area of the Shingles vaccine. My doctor checked in with me multiple times during the week following the vaccines with advice to take TYLENOL to reduce the fever which lasted 4 days. I later took ALEVE for the swelling and body aches. It was also recommended that I not get the Flu vaccine for a few weeks.
Age: 59.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site warmth, Lymph node pain, Lymphadenopathy, Neutrophil count increased, Pain
Clinical narrative: I was given adult doses of the Pneumococcal vaccine and ZOSTAVAX in my upper left arm. They were administered in my physicians office on 10/30/24. In less than 8 hours following the vaccinations I experienced chills, shakes and fever that went as high as 101.2. The area of the Shingles immunization swelled to the size of my hand, turned bright red and was hot to the touch. Approximately 24 hours later the site of the Pneumococcal vaccine swelled, turned red and was hot to the touch however the swelling and redness were limited to an oval shaped area that was only 2 inches at its widest point. The lymph glands under my left arm swelled and were tender to the touch. By 11/9/14 all of the visible signs of the vaccination had pretty much dissipated with the exception of a slightly bruised skin color in the area of the Shingles vaccine. My doctor checked in with me multiple times during the week following the vaccines with advice to take TYLENOL to reduce the fever which lasted 4 days. I later took ALEVE for the swelling and body aches. It was also recommended that I not get the Flu vaccine for a few weeks.
Age: 59.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia, Tremor, White blood cell count increased
Clinical narrative: I was given adult doses of the Pneumococcal vaccine and ZOSTAVAX in my upper left arm. They were administered in my physicians office on 10/30/24. In less than 8 hours following the vaccinations I experienced chills, shakes and fever that went as high as 101.2. The area of the Shingles immunization swelled to the size of my hand, turned bright red and was hot to the touch. Approximately 24 hours later the site of the Pneumococcal vaccine swelled, turned red and was hot to the touch however the swelling and redness were limited to an oval shaped area that was only 2 inches at its widest point. The lymph glands under my left arm swelled and were tender to the touch. By 11/9/14 all of the visible signs of the vaccination had pretty much dissipated with the exception of a slightly bruised skin color in the area of the Shingles vaccine. My doctor checked in with me multiple times during the week following the vaccines with advice to take TYLENOL to reduce the fever which lasted 4 days. I later took ALEVE for the swelling and body aches. It was also recommended that I not get the Flu vaccine for a few weeks.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: I received my ZOSTAVAX shot (the vaccine to prevent shingles) yesterday afternoon. The area became very itchy, and after I finished my work and remove my lab coat realized that posterior to the area of injection it was swollen, red, indurated, and warm. It had a circumference of 2 inches. It was extremely itchy overnight. Today the redness traveled posterior to my arm and is getting more diffused. Still indurated but less. Very itchy. Arm feels heavy and yesterday night felt like numbed. Today feel better. Still very itchy and warm.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Limb discomfort
Clinical narrative: I received my ZOSTAVAX shot (the vaccine to prevent shingles) yesterday afternoon. The area became very itchy, and after I finished my work and remove my lab coat realized that posterior to the area of injection it was swollen, red, indurated, and warm. It had a circumference of 2 inches. It was extremely itchy overnight. Today the redness traveled posterior to my arm and is getting more diffused. Still indurated but less. Very itchy. Arm feels heavy and yesterday night felt like numbed. Today feel better. Still very itchy and warm.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with an improperly stored dose of VAQTA (dose, route of administration and lot # 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: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB strength: 2.5mcg/0.5 ml (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 13-OCT-2014, an unspecified number of patients were vaccinated with improperly stored PEDVAXHIB lot # J014279, expiration date: 16-SEP-2016 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, route of administration and lot # 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 as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date of 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Oka/Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from a physician concerning a patient (age range reported as 2-5, units not reported) of unknown gender. On 15-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 20-OCT-2014, an unspecified number of patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # J014279, expiration date: 16-SEP-2016 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date of 2014 (reported as since 08-AUG-2014), the patient were vaccinated with (Oka/Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from a physician concerning a patient (age range reported as 2-5, units not reported) of unknown gender. On 17-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, route of administration and lot # 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: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with an improperly stored dose of M-M-R II (dose, route of administration and lot # 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 as received from a nurse on 12-NOV-2014 refers to an unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored doses of 0.5 ml (Oka/Merck) VARIVAX, (lot #, expiration date and route unspecified). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Between 16-OCT-2014 and 06-NOV-2014 the patients were vaccinated with an improperly stored dose RECOMBIVAX HB (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Between 16-OCT-2014 and 06-NOV-2014 the patients were vaccinated with an improperly stored dose of GARDASIL (dose, route of administration and lot # 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: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Post herpetic neuralgia, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacy student refers to an approximately 57 year old at the time of event female patient. On 29-MAY-2014 the patient was vaccinated with ZOSTAVAX, (lot# and expiration date not provided) (dose not reported). In approximately 2014 the patient experienced postherpetic neuralgia after receiving ZOSTAVAX. The reporter stated that the patient reported the postherpetic neuralgia had occurred once monthly for an unspecified duration of time since receiving vaccine. The reporter stated that the patient experienced itching on her back (without a rash) as well as joint pain in her knees and fingers. It was reported that the patient was prescribed an unspecified antiviral medication on an unspecified day approximately 2 weeks ago. The patient did seek medical attention by visiting the office. The outcome of postherpetic neuralgia after receiving ZOSTAVAX, joint pain in her knees and fingers and itching on her back (without a rash) was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 08-OCT-2014, an unspecified number of patients were vaccinated with improperly stored PEDVAXHIB lot # J016186, expiration date: 24-OCT-2016 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site warmth, Mobility decreased, Pruritus
Clinical narrative: 11/10/14 started itching-night. Fever (did not take). 11/11/14 joints hurt (toes, hands, feet, hips). 11/12/14 couldn't get out of bed. 11/13/14 OV to PCP given PHENERGAN 25mg IM. Rx BENADRYL 25mg every 6 hours prn, clindamycin 150mg TID. OV HD. Lt upper arm red 12cm x 9cm. Warm to touch.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 11/10/14 started itching-night. Fever (did not take). 11/11/14 joints hurt (toes, hands, feet, hips). 11/12/14 couldn't get out of bed. 11/13/14 OV to PCP given PHENERGAN 25mg IM. Rx BENADRYL 25mg every 6 hours prn, clindamycin 150mg TID. OV HD. Lt upper arm red 12cm x 9cm. Warm to touch.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date of 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from a physician concerning a patient (age range reported as 2-5, units not reported) of unknown gender. On 14-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016: dose number, dose and route were not reported). This is one of several reports from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 07-OCT-2014, an unspecified number of patients were vaccinated with improperly stored PEDVAXHIB lot # J014279, expiration date: 16-SEP-2016 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with an improperly stored dose of GARDASIL (dose, route of administration and lot # 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 certified medical assistant refers to an unspecified number of patients of unknown age and gender. Between 16-OCT-2014 and 06-NOV-2014 the patients were vaccinated with an improperly stored VAQTA (dose, route of administration and lot # 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: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Between 16-OCT-2014 and 06-NOV-2014 the patients were vaccinated with an improperly stored dose of M-M-R II (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 28-OCT-2014, an unspecified number of patients were vaccinated with improperly stored GARDASIL lot # H020901, expiration date: 05-JUL-2015 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Rash, Rash maculo-papular, Vaccination site erythema
Clinical narrative: Erythema at vaccine site. DTaP #4 on 11/14/14 at 10:30 AM. Rash maculopapular started on 11/14/14 at around 8:00 PM. Rash covers neck to feet including palms of hands/feet.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reaction or allergies were not reported. On 21-OCT-2014 the patient was inadvertently vaccinated with an expired dose of M-M-R II, lot # H018945, expiration date 18-OCT-2014, (dose, dose number, route and anatomical location were unspecified). No adverse effect reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. On 05-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, route not reported, product lot# J011212) that expired on 29-AUG-2014. No adverse effects was reported. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. In July 2014 the patients were vaccinated with GARDASIL (dose, route of administration and lot # 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: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. In July 2014 the patients were vaccinated with PEDVAXHIB (dose, route of administration and lot # were 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: MMRV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. In July 2014 the patients were vaccinated with PROQUAD (Merck) (dose, route of administration and lot # 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 as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. In July 2014 the patients were vaccinated with VARIVAX (Merck) (dose, route of administration and lot # 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: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. In July 2014 the patients were vaccinated with M-M-R II (dose, route of administration and lot # 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: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. In July 2014 the patients were vaccinated with COMVAX (dose, route of administration and lot # 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: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 20-SEP-2014 the patient was vaccinated with improperly stored dose of PNEUMOVAX 23, 0.5 ml, intramuscular (lot number not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient received a dose of ZOSTAVAX (lot#, dose, route not reported) that was reconstituted and then left out at "room temperature for 40-45 minutes" before being administered to the patient. No concomitant medications were provided. The pharmacist stated "this was past the 30 minutes given in the prescribing information so the patient was questioning the validity of the dose". No adverse effects were reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count normal, Headache, Herpes simplex, Nausea, Pyrexia
Clinical narrative: Distal to vaccine large area of warm, erythema, swelling, HSV I outbreak, low grade fever, headache and nausea. Given -> MEDROL and BENADRYL.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Distal to vaccine large area of warm, erythema, swelling, HSV I outbreak, low grade fever, headache and nausea. Given -> MEDROL and BENADRYL.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Flushing
Clinical narrative: Flushed, fatigue, and joint aches.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pallor, Paraesthesia
Clinical narrative: Extreme Paleness (entire body).  Tingling sensation in head.  Chills.
Age: 52.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Rash generalised
Clinical narrative: Peripheral Rash on arms, trunk, neck and face. No shortness of breath.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphasia, Cerebral haemorrhage, Computerised tomogram head abnormal, Confusional state, Gastrointestinal tube insertion
Clinical narrative: This spontaneous report as received from a nurse refers to her 65 year old male husband without drug reactions/allergies. The patient had history of shingles, right hip replacement in 1990's, radiation for malignant lesion of right 1997 and hemochromatosis. On 30-OCT-2014 (also reported as 30-NOV-2014), the patient was vaccinated with ZOSTAVAX (dose, route, lot# and expiration date not reported). Concomitant therapies included PROTONIX, UROXATRAL, ibuprofen, baby aspirin and omega-3 marine triglycerides (reported as fish oil). Nurse reported that patient experienced being confused and unable to speak on 07-NOV-2014, after receiving ZOSTAVAX on 30-OCT-2014. Patient was taken by ambulance to a hospital, computerised tomogram (CT) scan showed a left frontal bleed and patient medevaced to another hospital on 07-NOV-2014. Left frontal lobe bleed affected patient's right side and speech. Patient was on life support. Nurse reported that patient had no use of his right arm and cannot speak. Nurse reported patient was now off ventilator, feeding tube remained in place; however, patient was advancing to a soft diet. Nurse reported patient was transferred to step down unit on 13-NOV-2014, and anticipated start of rehabilitation. The outcome of the events was recovering. The events were considered by the reporter as requiring intervention to prevent serious criteria, significant disability or incapacity and life threatening. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Life support, Mobility decreased, Speech disorder
Clinical narrative: This spontaneous report as received from a nurse refers to her 65 year old male husband without drug reactions/allergies. The patient had history of shingles, right hip replacement in 1990's, radiation for malignant lesion of right 1997 and hemochromatosis. On 30-OCT-2014 (also reported as 30-NOV-2014), the patient was vaccinated with ZOSTAVAX (dose, route, lot# and expiration date not reported). Concomitant therapies included PROTONIX, UROXATRAL, ibuprofen, baby aspirin and omega-3 marine triglycerides (reported as fish oil). Nurse reported that patient experienced being confused and unable to speak on 07-NOV-2014, after receiving ZOSTAVAX on 30-OCT-2014. Patient was taken by ambulance to a hospital, computerised tomogram (CT) scan showed a left frontal bleed and patient medevaced to another hospital on 07-NOV-2014. Left frontal lobe bleed affected patient's right side and speech. Patient was on life support. Nurse reported that patient had no use of his right arm and cannot speak. Nurse reported patient was now off ventilator, feeding tube remained in place; however, patient was advancing to a soft diet. Nurse reported patient was transferred to step down unit on 13-NOV-2014, and anticipated start of rehabilitation. The outcome of the events was recovering. The events were considered by the reporter as requiring intervention to prevent serious criteria, significant disability or incapacity and life threatening. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 63 year old male patient. The patient has no pertinent medical history and he had no known allergies. On 13-NOV-2014 the patient was vaccinated with his first dose of PNEUMOVAX 23 lot # K005797, exp. date: 21-MAR-2015, 0.5 ml, intramuscularly in the left deltoid. Concomitant therapies included lidocaine (manufacturer unknown) and DEPO-MEDROL, which were injection in the right knee trigger point. Approximately on 13-NOV-2014, 12 hours post the vaccination, the patient could not move his left arm and he sought medical attention by coming into clinic on 14-NOV-2014. During the visit, his left arm was so bad, patient had to use his right hand to pick up his left arm. No treatment was given for event, and none of lab diagnostics studies were performed. The outcome of event was reported as not recovered/not resolved. The causality was not reported. Nurse practitioner stated she was monitoring the client and some comfort measures might be recommended; such as ice. The event was reported as significant disability or incapacity. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Patient had hives on both legs. I gave her Benadryl and she applied calamine lotion. This helped but they came back the following evening but worse. She took another Benadryl and applied more calamine and they have not returned.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Laboratory test, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Pain in L shoulder/arm and tingling in L hand (at this time continuing 6 weeks post injection).
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Convulsion, Disorientation, Erythema, Face injury, Fall
Clinical narrative: Approximately 10 minutes after the patient received the immunization, she fell face first to the floor - without warning - from a standing position. As she was turned over onto her back she appeared to have a seizure - she was unresponsive and had clonic tonic movements that lasted 10 - 15 seconds. She was placed on her side until the movements ceased and then turned to her back - with feet elevated - to assess for injury and/or airway obstruction. She was slightly disoriented and her mother was encouraged to ask her questions. The patient could not explain what happened but knew her name and where she was. The patient was gradually assisted into a sitting position and a cold water bottle was applied to her chin (slight redness noted, no lacerations). She was assisted to stand about 20 minutes after the fall and was able to do so without support. Her mother was encouraged to seek emergency attention if this happened again and to follow up with her primary care provider to apprise them of the situation. The patient, her mother and younger sibling exited the mobile unit without incident. The patient was able to ambulate without apparent disability and without assistance.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: Approximately 10 minutes after the patient received the immunization, she fell face first to the floor - without warning - from a standing position. As she was turned over onto her back she appeared to have a seizure - she was unresponsive and had clonic tonic movements that lasted 10 - 15 seconds. She was placed on her side until the movements ceased and then turned to her back - with feet elevated - to assess for injury and/or airway obstruction. She was slightly disoriented and her mother was encouraged to ask her questions. The patient could not explain what happened but knew her name and where she was. The patient was gradually assisted into a sitting position and a cold water bottle was applied to her chin (slight redness noted, no lacerations). She was assisted to stand about 20 minutes after the fall and was able to do so without support. Her mother was encouraged to seek emergency attention if this happened again and to follow up with her primary care provider to apprise them of the situation. The patient, her mother and younger sibling exited the mobile unit without incident. The patient was able to ambulate without apparent disability and without assistance.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Musculoskeletal pain, Pain
Clinical narrative: Intense shoulder pain felt immediately (more so than on prior flu shots). Pain did decrease some but has continued and it is now almost 3 weeks later. Pain is felt mostly when lifting shirts above my head.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient reported a sore arm that did not subside as of 11/18. Patient was advised by immunizing pharmacist to take Advil or Tylenol and call back if symptoms persisted. Patient stated she might visit a clinic if her arm was still sore. I tried following up 11/17 in afternoon but was unable to reach pt. Will try make contact again on 11/18.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised, Rash maculo-papular, Urticaria
Clinical narrative: Rash believed to be hives. Extensive and covering the entire body. Benadryl and Allegra ineffective.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX, DTAPIPVHIB, PNC13
Symptoms: Respiratory distress
Clinical narrative: This is a spontaneous report from a Licensed Practical Nurse (LPN). A 2-month-old male patient received on 04Nov2014 first dose of PREVNAR 13 (lot h86680; expiration date 31Oct2015; NDC number: 0005197102), intramuscular at 0.5 ml single, first dose of PENTACEL at 1 DF single and first dose of rotavirus vaccine at 1 DF single. The patient did not have any known medical conditions. Patient was not taking any other medications at that time or two weeks prior. The patient experienced respiratory distress on 04Nov2014, within 20 minutes of receiving the vaccines. The patient wound up in the Emergency Room and always on 04Nov2014 was admitted to the hospital overnight but stayed less than 24 hours. The patient was discharged on 05Nov2014 and was followed up in clinic and was doing well. No lasting effects noted. The patient completely recovered from the event on an unknown date.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX, DTAPIPVHIB, PNC13
Symptoms: Breath sounds abnormal, Pallor, Respiratory distress
Clinical narrative: This is a spontaneous report from a Licensed Practical Nurse (LPN). A 2-month-old male patient received on 04Nov2014 first dose of PREVNAR 13 (lot h86680; expiration date 31Oct2015; NDC number: 0005197102), intramuscular at 0.5 ml single, first dose of PENTACEL at 1 DF single and first dose of rotavirus vaccine at 1 DF single. The patient did not have any known medical conditions. Patient was not taking any other medications at that time or two weeks prior. The patient experienced respiratory distress on 04Nov2014, within 20 minutes of receiving the vaccines. The patient wound up in the Emergency Room and always on 04Nov2014 was admitted to the hospital overnight but stayed less than 24 hours. The patient was discharged on 05Nov2014 and was followed up in clinic and was doing well. No lasting effects noted. The patient completely recovered from the event on an unknown date.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 27-OCT-2014, an unspecified number of patients were vaccinated with improperly stored ROTATEQ lot # K001716, expiration date: 24-NOV-2015, oral (dose was not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pain, Tenderness
Clinical narrative: Weakness, sore, aching, unable to lay on arm.  Applied heat, may help some.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Gait disturbance, Injection site pain, Injection site swelling, Muscle spasms
Clinical narrative: Severe joint and muscle pain as well as muscle spasms in legs lasting through 11/07/2014.  Could barely walk or use my hands the pain was so bad.  Did not sleep on 11/05/2014 due to pain.  Injection site was swollen and painful and could not be touched or slept on for four days.  Went to Emergency Department either on 11/06/2014 or 11/07/2014.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Pain in extremity, Sleep disorder
Clinical narrative: Severe joint and muscle pain as well as muscle spasms in legs lasting through 11/07/2014.  Could barely walk or use my hands the pain was so bad.  Did not sleep on 11/05/2014 due to pain.  Injection site was swollen and painful and could not be touched or slept on for four days.  Went to Emergency Department either on 11/06/2014 or 11/07/2014.
Age: 69.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient developed severe pain to the touch and erythema at site of pneumococal injection and proximal to the injections.  Symptoms continued until Tuesday 11/11/2014.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Heart rate increased, Paraesthesia, Syncope
Clinical narrative: Severe dizziness, tingling hands, feet, scalp, rapid heart rate, fainted.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Asthenia, Dizziness, Heart rate increased, Neck pain, Pain in extremity
Clinical narrative: SHE AWOKE NEXT DAY WITH PALENESS DIZZINESS SORE AND SWOLLEN ARM NECK HURT FAST HEARTRATE THROAT CLOSING WEAK.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Pallor, Peripheral swelling, Throat tightness
Clinical narrative: SHE AWOKE NEXT DAY WITH PALENESS DIZZINESS SORE AND SWOLLEN ARM NECK HURT FAST HEARTRATE THROAT CLOSING WEAK.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Patient called to report possible Shingles vaccine reaction.  I spoke with patient on 18 Nov. Pt states she received Shingles vaccine on 13 November at pharmacy where nursing was providing Shingles vaccines to TRICARE Beneficiaries on 12, 13, and 14 Nov.  Pt states she noticed swelling "size of a goose egg, with rash in circle and itching around vaccine site on L arm on Saturday the 15th. She stated, she spoke with local pharmacist who recommended she take Benadryl, which she is currently taking. Pt denied swelling in her arm or fingers of left arm, no fever, no behavior changes, no face or throat swelling, no difficulty breathing, no dizziness or weakness.  She states the swelling has gone down.  I recommended to patient to draw a circle around swelling and if swelling exceeds circle or she has a fever or does not feel well to visit her PCM.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site of injection when seen on 11/11/14.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Malaise, Pain in extremity
Clinical narrative: Severe malaise, joint pain/arm pain.
Sex: U
Vaccine: RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patient of unknown age and gender. On 07-OCT-2014, an unspecified number of patients were vaccinated with improperly stored ROTATEQ lot # K001716, expiration date: 24-NOV-2015, oral (dose was not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patient of unknown age and gender. On 07-OCT-2014, an unspecified number of patients were vaccinated with improperly stored ROTATEQ lot # K001716, expiration date: 24-NOV-2015, oral (dose was not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak along right side of torso, including back and front.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Insomnia, Pain, Tenderness
Clinical narrative: Constant shooting pain in shoulder area, weakness, trouble sleeping, cannot lay on that side, heating pad, Motrin or Tylenol.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pain, Pain in extremity
Clinical narrative: Pain when raising arm, ROM, weakness at certain spots, heat, Tylenol, Mortin.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Feeling abnormal, Immediate post-injection reaction, Lethargy, Muscle tightness
Clinical narrative: Immediately after flu shot began feeling tingling to neck and mouth, then feeling of tightness to neck and mouth.  Stated felt "weird".
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: Immediately after flu shot began feeling tingling to neck and mouth, then feeling of tightness to neck and mouth.  Stated felt "weird".
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 21-OCT-2014, an unspecified number of patients were vaccinated with improperly stored ROTATEQ lot # K001716, expiration date: 24-NOV-2015, oral (dose was not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 20-OCT-2014, an unspecified number of patients were vaccinated with improperly stored ROTATEQ lot # K001716, expiration date: 24-NOV-2015, oral (dose was not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 20-OCT-2014, an unspecified number of patients were vaccinated with improperly stored ROTATEQ lot # K001716, expiration date: 24-NOV-2015, oral (dose was not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 08-OCT-2014, an unspecified number of patients were vaccinated with improperly stored ROTATEQ lot # K001716, expiration date: 24-NOV-2015, oral (dose was not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema
Clinical narrative: Patient reports receiving vaccine on 11/10/14 without complication and on 11/17/14 reports a pinkish/red 4" long reaction. States on 11/18/14 may be itchy.
Age: 1.26
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Abnormal behaviour, Cough, Rhinitis
Clinical narrative: H/O Behavioral disturbance to the influenza vaccine coryza, cough; P/E No s/s of allergic reaction intervened while pt in Peds clinic.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Diarrhoea, Headache, Nausea
Clinical narrative: Several hours after receiving flu vaccine, developed headache, then back ache, a feeling being close to vomiting. On 11/16, developed diarrhea.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Injection site warmth, Local swelling
Clinical narrative: Pain, arm swollen 2 inches larger than normal for 3 days raised red welt 6 inches by 4 inches around site, fever at site, intense itching at site w/moderate itching all over. Started acetaminophen alternated w/ibuprofen closing and cont. x 4 days on 10/9. Also iced and gave BENADRYL x for 2 weeks after due to systemic itching.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus generalised
Clinical narrative: Pain, arm swollen 2 inches larger than normal for 3 days raised red welt 6 inches by 4 inches around site, fever at site, intense itching at site w/moderate itching all over. Started acetaminophen alternated w/ibuprofen closing and cont. x 4 days on 10/9. Also iced and gave BENADRYL x for 2 weeks after due to systemic itching.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Insomnia, Joint range of motion decreased, Lacrimation increased, Pain
Clinical narrative: Pain, limited ROM, unable to sleep, weakness, brings tears to your eyes at times. Motrin, heat as of yesterday.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Autopsy, Death, Respiration abnormal, Resuscitation, Unresponsive to stimuli
Clinical narrative: Patient was found unresponsive at his home the next day by his mother. She called 911 and reported very light breathing. She and the paramedics tried to perform CPR but were unsuccessful and reported him dead at 2pm. Paramedics stated that it was similar to what they see in heart attack victims. No autopsy reports have been received as of 11-18-14.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Noticed that my arm continued to hurt after initial pain had cleared. It is now Nov 18 and I still have pain in my arm which is more muscular, and occurs more if I use the arm which was not present prior to the flu injection.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Exposure during pregnancy
Clinical narrative: Complaint of bilateral armpit pain.   Pain started the day after vaccine. Pain in R axilla actually was more sharp and the pain in the L axilla is more sore and achy.  She denies any pain elsewhere of symptoms of systemic illness.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Lip pruritus, Oropharyngeal pain, Pruritus generalised, Rash macular
Clinical narrative: Starting feeling "strange".  Itching all over, red splotchy areas over chest area.  Lips itchings, throat sore. Treated with Benadryl 50 mg IM.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Developed hives on elbow and knee joints. Some shortness of breath. Treated with inhaler and Benadryl.
Sex: U
Vaccine: RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 13-OCT-2014, an unspecified number of patients were vaccinated with improperly stored ROTATEQ lot # K001716, expiration date: 24-NOV-2015, oral (dose was not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 13-OCT-2014, an unspecified number of patients were vaccinated with improperly stored ROTATEQ lot # K001716, expiration date: 24-NOV-2015, oral (dose was not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal chest pain, Myalgia, Swelling
Clinical narrative: 3 days post vaccination developed pain/swelling to upper chest wall, shoulder and down left arm. Medical evaluation on 11/4/2014. Directed to take OTC BENADRYL and ibuprofen, apply ice. S/s resolving on 11/7/14, released from care 11/14/14-swelling resolved, only very mild deltoid pain, that is improving.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Asthenia, Headache
Clinical narrative: Give FLUMIST vaccine 10-23-14 at 9am, 920 am c/o weakness and headache. Vitals within normal limits no respiratory distress. Monitored for one hour.