chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: VARCEL
Symptoms: Eye pain, Skin lesion, Varicella post vaccine, Visual acuity reduced
Clinical narrative: Received varicella vaccine on 10/29/15 at our office as part of routine post transplant allogeneic immunizations. On 11/4/16, patient called to report that he was seen by PCP and told he had chicken pox with lesions on his head. As per APN, he was phoned in Valtrex 1 gram TID at that time. The patient called 11/5/15 to report eye pain and decreased vision, instructed to contact eye doctor, started on steroid eye drop by an outside prescriber.  Under care of his PCP and also eye doctor.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Hepatitis A immunization given 2 months to soon.
Age: 34.0
Sex: M
Vaccine: HEP, HEPA, TYP
Symptoms: Muscular weakness
Clinical narrative: Bilateral leg weakness.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Suspected shingles outbreak - diagnosis not confirmed by physician.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Dizziness, Injection site mass
Clinical narrative: Patients states she felt a "pushing" feeling in the middle of her back along with dizziness. Two days later, she noticed a 3"x1" raised lump at injection site.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: He had a fever, arm extremely sore, red swollen (half dollar coin size), very warm to the touch.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia, Injection site reaction, Psychomotor hyperactivity, Urticaria
Clinical narrative: On day of shot patient said it made her hyper.  Today (12/17/15) she said that she had tingling around the injection site and now the area below the injection site has a welt that is ~3"x1" as well as another area below the injection site ~ 6"x3" that is numb to touch sensation.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: PATIENT PRESENTED STATING SHE HAD HIGHER PAIN AFTER VACCINATION.  PAIN LEVEL HAD DECREASED AFTER A FEW DAYS.  ON 6 DAY PAIN LEVEL IS AT A CONSISTENT LEVEL OF PAIN.  PATIENT TAKES TYLENOL FOR PAIN RELIEF.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Dysgeusia, Headache, Nausea
Clinical narrative: Donor stated approximately one hour post Hep B immunization, he began to experience a metallic taste which caused intermittent nausea. Donor stated that a headache type pain then began and persisted. No additional symptoms were noted. No redness or inflammation noted at injection site.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial pain, Swelling face, Tenderness
Clinical narrative: Wife called to say his side and face and above the eye was sore, swollen, tender and possibly breaking out.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Erythema, Injection site cellulitis, Peripheral swelling, Skin warm
Clinical narrative: Two days after injection (L) arm turned red, warm and swollen. Seen by provider dx with mild cellulitis of (L) upper arm and treated with oral antibiotic.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Acne, Rash erythematous, Skin test negative
Clinical narrative: Patient received PENTACEL, PCV13 and ROTATEQ 12/04/15. Mother called 12/07/15 stating that pt developed "pimples" on the (L) leg the night of 12/04/15. Rash became red 12/06 and 12/07 and had spread to the (R) leg, abdomen, arms and chin. Pt seen in office 12/07, referred to ED where pt was treated with BENADRYL. Pt saw allergy 12/16/15, negative skin testing - hives resolved 12/09/15.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Left arm hard to lift still. Started day after shot was received. Soreness still there.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: It was warm and swollen. It was hurtful, red, swollen at the site of injection. When pt came on 12/17 to pick up medication, it looks OK.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient had some swelling and redness at the injection site along with a rash around the site. Patient also complaining of tenderness at the site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning unspecified patients of unknown age. Concurrent conditions and pertinent medical history were not reported. On an unknown date the patients were vaccinated with improperly stored doses of (Merck) VARIVAX, lot number L023588, expiration date 26-JUN-2017 (dose and route not reported). Concomitant therapies were not mentioned. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning unspecified patients of unknown age. Concurrent conditions and pertinent medical history were not reported. On an unknown date the patients were vaccinated with improperly stored doses of PROQUAD (Merck), lot number L031602, expiration date 18-FEB-2017 (dose and route not reported). Concomitant therapies were not mentioned. No adverse effects were reported. No product quality complaint (PQC) was involved. 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 physician's assistant refers to a patient of unknown age and gender. On 09-SEP-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 27-AUG-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse referring to an unspecified number of patients of unknown age and gender, whom concurrent condition and medical history were not provided. On an unknown dates in 2015, reported as since 02-NOV-2015, an unspecified number of patients were vaccinated with GARDASIL lot # K010215, expiration date 05-MAY-2017, oral (Dose, concentration and dose number were not provided) exposed to temperatures outside of the recommended range, concomitant therapies were reported. No adverse experience was reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 10-SEP-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 11-SEP-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 14-SEP-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 15-SEP-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 17-SEP-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 18-SEP-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. Since the excursion on 21-OCT-2015, doses of PNEUMOVAX 23 (lot # K007826, expiration date 03-FEB-2016, dose and route unknown) which were exposed to temperatures outside of the recommended range, had been administered to the patients on unspecified dates in 2015. No adverse experience was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker (certificated medical assistant) concerning a patient of unknown age and gender. On 08-DEC-2015 the patient inadvertently was given a dose of (Merck) VARIVAX (lot # and expiration date unspecified), when ZOSTAVAX was the intended vaccine to be administered (wrong vaccine administered). The healthcare worker reported that ZOSTAVAX was not administered. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. Since the excursion on 21-OCT-2015, doses of GARDASIL (lot # K008931, expiration date 04-MAR-2017; lot # K011562, expiration date 08-APR-2017; dose and route unknown) which were exposed to temperatures outside of the recommended range, had been administered to the patients on unspecified dates in 2015. No adverse experience was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. Since the excursion on 21-OCT-2015, doses of MMR II (lot # K001230, expiration date 27-JAN-2016; Lot # L000459, expiration date 06-JAN-2017; dose and route unknown) which were exposed to temperatures outside of the recommended range, had been administered to the patients on unspecified dates in 2015. No adverse experience was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a register nurse referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. The nurse stated that another unspecified nurse might have inadvertently used the 0.4% sodium chloride diluent for ACTHIB instead of sterile water diluent to reconstitute a dose of MMR II (dosage, lot# and route not reported) on an unknown date. The nurse could not confirm whether this improper reconstitution of MMR II had actually occurred, or if it had, whether this improperly reconstituted dose of MMR II was administered to a patient. The nurse stated the other unspecified nurse might have confused sterile water diluent with the ACTHIB 0.4% sodium chloride because the vials looked similar, as they were both clear vials with white labels. No adverse effect reported. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from an 82 year old male pharmacist referring to himself. The patient had multiple unspecified pertinent medical history and unspecified drug reactions/allergies. On 04-DEC-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, dose and strength unknown) intramuscularly. Concomitant medication included multiple unspecified medications. On 05-DEC-2015, the patient began to experience redness, pain and slight swelling around the injection site which extended about one to two inches beyond the injection site. The patient reported that the injection site also felt warm to touch. On 08-DEC-2015, the patient went back to see the physician who administered the vaccine and the physician told him to rub BENADRYL cream on the injection site every 4-5 hours as needed for the itching and swelling. The outcome of the events was unknown. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unspecified dates on or after 23-NOV-2015, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (albumin status rHA, lot# L034933, expiration date 11-MAR-2017, strength, dose, dose# and route unknown). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: Information has been received from a female consumer of unknown age referring to herself. Information about patient's concurrent conditions and medical history was not reported. "Recently", in 2015 the patient was vaccinated with a dose of M-M-R II subcutaneous injection (lot#/expiration date not reported, 1 shot). Concomitant medications were not provided. On an unknown date in 2015 a blood test was performed and the result showed somewhat low titers for the rubella. No treatment was given for the event. Outcome of the event was unknown. The causality was not provided. Additional information is not expected because there was no reporter's contact information.
Age: 54.0
Sex: M
Vaccine: FLUC3
Symptoms: Asthenia, Decreased appetite, Guillain-Barre syndrome, Headache, Immunoglobulin therapy
Clinical narrative: Case number PHHY2015US028443, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555278) website on 05 Mar 2015 and a follow up report from VAERS received on 25 Aug 2015. This report refers to a 54-year-old male patient. The patient was allergic to sulfa drugs and previous medical history included back pain. He was vaccinated with FLUCELVAX (batch number: 017021A) on 21 Oct 2014. On 27 Oct 2014, the patient experienced paresthesia in upper and lower extremities, anorexia, low grade fever, headache and weakness. The patient was diagnosed with Guillain Barre Syndrome. The patient was treated with immunoglobulin therapy and was not responsive to the treatment. Further, the patient was transferred to a tertiary hospital. The final outcome of the events was unknown. The events were assessed as serious (hospitalized for 35 days). Causality was not reported. Follow up report from VAERS received on 25 Aug 2015: Changed coding of suspect vaccine (from seasonal influenza vaccine to FLUCELVAX) and updated seriousness from non-serious to serious (hospitalization). Added batch number.
Age: 54.0
Sex: M
Vaccine: FLUC3
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Case number PHHY2015US028443, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555278) website on 05 Mar 2015 and a follow up report from VAERS received on 25 Aug 2015. This report refers to a 54-year-old male patient. The patient was allergic to sulfa drugs and previous medical history included back pain. He was vaccinated with FLUCELVAX (batch number: 017021A) on 21 Oct 2014. On 27 Oct 2014, the patient experienced paresthesia in upper and lower extremities, anorexia, low grade fever, headache and weakness. The patient was diagnosed with Guillain Barre Syndrome. The patient was treated with immunoglobulin therapy and was not responsive to the treatment. Further, the patient was transferred to a tertiary hospital. The final outcome of the events was unknown. The events were assessed as serious (hospitalized for 35 days). Causality was not reported. Follow up report from VAERS received on 25 Aug 2015: Changed coding of suspect vaccine (from seasonal influenza vaccine to FLUCELVAX) and updated seriousness from non-serious to serious (hospitalization). Added batch number.
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2015US113972 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 558497) website on 10-SEP-2015. This report refers to a 12 years old female patient.  Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELAX 2014/2015 (batch number: 161281) intramuscularly into left arm on 16 DEC 2014. The case was assessed as non-serious. No adverse event was reported.
Age: 31.0
Sex: M
Vaccine: FLUC3
Symptoms: Rash
Clinical narrative: Case number PHHY2015US117240, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 559112) received on 10 Sep 2015. This report refers to a 31-year-old male patient. Historical conditions were none. No concomitant medication was reported. The patient received FLUCELVAX (batch number: 017031A) intramuscularly into the left arm on 03 Oct 2014, the patient experienced rash inside both palms. The patient was treated with steroids. Final outcome of the event was recovered. The event was reported as non-serious and causality was not reported.
Age: 43.0
Sex: M
Vaccine: FLUC3
Symptoms: Injection site rash, Rash
Clinical narrative: Case number PHHY2015US115749 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 559796) website on 10 Sep 2015. This report refers to a 43 years old male patient. Medical history and concomitant conditions were reported as none. Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 011021A) intramuscularly into right arm on 09 Dec 2014. On the same day after couple of hours after vaccination the patient had rash on the right arm where he had the shot. It had spread to the right arm and to his armpits on 28 Dec 2014. The patient did not receive any treatment yet. The patient stated that he would consult physician. Outcome of the event was unknown. The case was assessed as non-serious. Causality of the event was not reported.
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Angiogram abnormal, Chorioretinal scar, Choroiditis, Eye inflammation, Fundoscopy abnormal
Clinical narrative: Report received from literature. A previously healthy 33 year old male, (weight unspecified), received simultaneous vaccinations with inactivated Hepatitis A vaccine (unspecified), Typhoid Vaccine (unspecified) and non-company Yellow Fever Vaccine. The subject had previously received one dose of the hepatitis A vaccine 12 years prior (he did not complete the series) and had never before been exposed to typhoid or yellow fever immunizations. There was no family history of autoimmune disease. On an unspecified date, 3 weeks following vaccination, the subject was referred to the reporter's retina service for sudden onset of intermittent floaters and flashing lights in his right eye.  Fundus examination and angiography confirmed the presence of multiple peripheral chorioretinal lesions. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. The subject was diagnosed as having acute multifocal choroiditis and was observed. After 2 weeks, the subject continued to describe occasional floaters. Close observation continued. At 8 weeks, the subject's symptoms had resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. The reporter stated that these lesions demonstrated characteristic morphologic changes over a period of 8 weeks which were consistent with a diagnosis of self-resolving multifocal choroiditis. Vaccine-induced intraocular inflammation has been described infrequently. Vaccines potentiate both humoral and cellular immune responses by exposing lymphocytes to pathogen-specific antigens which triggers an inflammatory T cell-mediated reaction and initiates the steps of adaptive immunity and development of cellular memory. This report is serious (medically significant). This case version was created on 23-JAN-2015 for the purpose of quality improvement. Upon review the following corrections were made: Slit-lamp examination revealed 1+ anterior vitreous inflammation bilaterally and action taken with suspect drugs was unknown. Additional information was received on 13-JAN-2015. It has been determined that this case is a duplicate of Manufacturer Report Number 20140827515. This case (Manufacturer Report Number 20150108873) will be deleted. All relevant information regarding this case will be submitted under Manufacturer Report Number 20140827515. Sender's Comments: Indeterminate causal association due to lack of clear evidence for a causal link. Latency of 3 weeks following vaccination with Hep A, typhoid and yellow fever vaccines.
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Photopsia, Retinal depigmentation, Vitreous floaters
Clinical narrative: Report received from literature. A previously healthy 33 year old male, (weight unspecified), received simultaneous vaccinations with inactivated Hepatitis A vaccine (unspecified), Typhoid Vaccine (unspecified) and non-company Yellow Fever Vaccine. The subject had previously received one dose of the hepatitis A vaccine 12 years prior (he did not complete the series) and had never before been exposed to typhoid or yellow fever immunizations. There was no family history of autoimmune disease. On an unspecified date, 3 weeks following vaccination, the subject was referred to the reporter's retina service for sudden onset of intermittent floaters and flashing lights in his right eye.  Fundus examination and angiography confirmed the presence of multiple peripheral chorioretinal lesions. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. The subject was diagnosed as having acute multifocal choroiditis and was observed. After 2 weeks, the subject continued to describe occasional floaters. Close observation continued. At 8 weeks, the subject's symptoms had resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. The reporter stated that these lesions demonstrated characteristic morphologic changes over a period of 8 weeks which were consistent with a diagnosis of self-resolving multifocal choroiditis. Vaccine-induced intraocular inflammation has been described infrequently. Vaccines potentiate both humoral and cellular immune responses by exposing lymphocytes to pathogen-specific antigens which triggers an inflammatory T cell-mediated reaction and initiates the steps of adaptive immunity and development of cellular memory. This report is serious (medically significant). This case version was created on 23-JAN-2015 for the purpose of quality improvement. Upon review the following corrections were made: Slit-lamp examination revealed 1+ anterior vitreous inflammation bilaterally and action taken with suspect drugs was unknown. Additional information was received on 13-JAN-2015. It has been determined that this case is a duplicate of Manufacturer Report Number 20140827515. This case (Manufacturer Report Number 20150108873) will be deleted. All relevant information regarding this case will be submitted under Manufacturer Report Number 20140827515. Sender's Comments: Indeterminate causal association due to lack of clear evidence for a causal link. Latency of 3 weeks following vaccination with Hep A, typhoid and yellow fever vaccines.
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Angiogram abnormal, Chorioretinal disorder, Choroiditis, Eye inflammation, Fundoscopy abnormal
Clinical narrative: Report received from literature. A previously healthy 33 year old male, (weight unspecified), received simultaneous vaccinations with inactivated Hepatitis A vaccine (unspecified), Typhoid Vaccine (unspecified) and non-company Yellow Fever Vaccine. The subject had previously received one dose of the hepatitis A vaccine 12 years prior (he did not complete the series) and had never before been exposed to typhoid or yellow fever immunizations. There was no family history of autoimmune disease. On an unspecified date, 3 weeks following vaccination, the subject was referred to the reporter's retina service for sudden onset of intermittent floaters and flashing lights in his right eye.  Fundus examination and angiography confirmed the presence of multiple peripheral chorioretinal lesions. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. The subject was diagnosed as having acute multifocal choroiditis and was observed. After 2 weeks, the subject continued to describe occasional floaters. Close observation continued. At 8 weeks, the subject's symptoms had resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. The reporter stated that these lesions demonstrated characteristic morphologic changes over a period of 8 weeks which were consistent with a diagnosis of self-resolving multifocal choroiditis. Vaccine-induced intraocular inflammation has been described infrequently. Vaccines potentiate both humoral and cellular immune responses by exposing lymphocytes to pathogen-specific antigens which triggers an inflammatory T cell-mediated reaction and initiates the steps of adaptive immunity and development of cellular memory. This report is serious (medically significant). This case version was created on 23-JAN-2015 for the purpose of quality improvement. Upon review the following corrections were made: Slit-lamp examination revealed 1+ anterior vitreous inflammation bilaterally and action taken with suspect drugs was unknown. Additional information was received on 13-JAN-2015. It has been determined that this case is a duplicate of Manufacturer Report Number 20140827515. This case (Manufacturer Report Number 20150108873) will be deleted. All relevant information regarding this case will be submitted under Manufacturer Report Number 20140827515. Sender's Comments: Indeterminate causal association due to lack of clear evidence for a causal link. Latency of 3 weeks following vaccination with Hep A, typhoid and yellow fever vaccines.
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Intraocular pressure test normal, Photopsia, Retinal depigmentation, Slit-lamp tests abnormal, Visual acuity tests normal
Clinical narrative: Report received from literature. A previously healthy 33 year old male, (weight unspecified), received simultaneous vaccinations with inactivated Hepatitis A vaccine (unspecified), Typhoid Vaccine (unspecified) and non-company Yellow Fever Vaccine. The subject had previously received one dose of the hepatitis A vaccine 12 years prior (he did not complete the series) and had never before been exposed to typhoid or yellow fever immunizations. There was no family history of autoimmune disease. On an unspecified date, 3 weeks following vaccination, the subject was referred to the reporter's retina service for sudden onset of intermittent floaters and flashing lights in his right eye.  Fundus examination and angiography confirmed the presence of multiple peripheral chorioretinal lesions. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. The subject was diagnosed as having acute multifocal choroiditis and was observed. After 2 weeks, the subject continued to describe occasional floaters. Close observation continued. At 8 weeks, the subject's symptoms had resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. The reporter stated that these lesions demonstrated characteristic morphologic changes over a period of 8 weeks which were consistent with a diagnosis of self-resolving multifocal choroiditis. Vaccine-induced intraocular inflammation has been described infrequently. Vaccines potentiate both humoral and cellular immune responses by exposing lymphocytes to pathogen-specific antigens which triggers an inflammatory T cell-mediated reaction and initiates the steps of adaptive immunity and development of cellular memory. This report is serious (medically significant). This case version was created on 23-JAN-2015 for the purpose of quality improvement. Upon review the following corrections were made: Slit-lamp examination revealed 1+ anterior vitreous inflammation bilaterally and action taken with suspect drugs was unknown. Additional information was received on 13-JAN-2015. It has been determined that this case is a duplicate of Manufacturer Report Number 20140827515. This case (Manufacturer Report Number 20150108873) will be deleted. All relevant information regarding this case will be submitted under Manufacturer Report Number 20140827515. Sender's Comments: Indeterminate causal association due to lack of clear evidence for a causal link. Latency of 3 weeks following vaccination with Hep A, typhoid and yellow fever vaccines.
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Vitreous floaters
Clinical narrative: Report received from literature. A previously healthy 33 year old male, (weight unspecified), received simultaneous vaccinations with inactivated Hepatitis A vaccine (unspecified), Typhoid Vaccine (unspecified) and non-company Yellow Fever Vaccine. The subject had previously received one dose of the hepatitis A vaccine 12 years prior (he did not complete the series) and had never before been exposed to typhoid or yellow fever immunizations. There was no family history of autoimmune disease. On an unspecified date, 3 weeks following vaccination, the subject was referred to the reporter's retina service for sudden onset of intermittent floaters and flashing lights in his right eye.  Fundus examination and angiography confirmed the presence of multiple peripheral chorioretinal lesions. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. The subject was diagnosed as having acute multifocal choroiditis and was observed. After 2 weeks, the subject continued to describe occasional floaters. Close observation continued. At 8 weeks, the subject's symptoms had resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. The reporter stated that these lesions demonstrated characteristic morphologic changes over a period of 8 weeks which were consistent with a diagnosis of self-resolving multifocal choroiditis. Vaccine-induced intraocular inflammation has been described infrequently. Vaccines potentiate both humoral and cellular immune responses by exposing lymphocytes to pathogen-specific antigens which triggers an inflammatory T cell-mediated reaction and initiates the steps of adaptive immunity and development of cellular memory. This report is serious (medically significant). This case version was created on 23-JAN-2015 for the purpose of quality improvement. Upon review the following corrections were made: Slit-lamp examination revealed 1+ anterior vitreous inflammation bilaterally and action taken with suspect drugs was unknown. Additional information was received on 13-JAN-2015. It has been determined that this case is a duplicate of Manufacturer Report Number 20140827515. This case (Manufacturer Report Number 20150108873) will be deleted. All relevant information regarding this case will be submitted under Manufacturer Report Number 20140827515. Sender's Comments: Indeterminate causal association due to lack of clear evidence for a causal link. Latency of 3 weeks following vaccination with Hep A, typhoid and yellow fever vaccines.
Age: 88.0
Sex: F
Vaccine: FLU3, FLUC3
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2015US150218, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 584859) website 23 Oct 2015. This report refers to a 88 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number, expiry date: not reported) on an unknown 03 Nov 2014. On the same day after vaccination, patient experienced soreness in arm still when reaching high or sleeping on arm. The outcome of the event was reported as condition unchanged. Event was reported as non-serious and causality was not reported.
Age: 88.0
Sex: F
Vaccine: FLU3, FLUC3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2015US150218, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 584859) website 23 Oct 2015. This report refers to a 88 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number, expiry date: not reported) on an unknown 03 Nov 2014. On the same day after vaccination, patient experienced soreness in arm still when reaching high or sleeping on arm. The outcome of the event was reported as condition unchanged. Event was reported as non-serious and causality was not reported.
Age: 31.0
Sex: F
Vaccine: FLUC3, FLUC3, FLUC3
Symptoms: Malaise, Nasal congestion, Nasopharyngitis
Clinical narrative: Case number PHHY2015US147017, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 589517) website on 02 Nov 2015. This report refers to a 31-year-old female patient. She was vaccinated with FLUCELVAX (batch number: 014011A) in the left arm intramuscularly on 17 Sep 2014. It was reported that, since vaccination the patient was sick every month. She also mentioned stuffy nose and cold symptoms. The outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported.
Age: 31.0
Sex: F
Vaccine: FLUC3, FLUC3, FLUC3
Symptoms: Malaise, Nasal congestion, Nasopharyngitis
Clinical narrative: Case number PHHY2015US0150851 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 589517) website on 23 Oct 2015. This report refers to a 31 year old female patient. Past medical history and concomitant medications were not reported. The patient's vaccination history included the administration of FLUCELVAX and it was well tolerated. The patient was vaccinated with FLUCELVAX (batch number: 014011A) in the left arm intramuscularly on 17 Sep 2014. After vaccination, the patient became sick every month since she received FLUCELVAX. The patient also experienced stuffy nose and cold symptoms. Outcome of the events was reported as unknown. Events were reported as non serious and causality was not reported.
Age: 43.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Case number PHEH2015US021160 is an initial spontaneous report from a nurse on 20 Oct 2015. This report refers to a 43-year-old female patient. She was vaccinated with FLUCELVAX (batch number: 174084, expiry date: 01 May 2016) at a dose of 0.5 ml intramuscularly on 28 Sep 2015. On the same date, after vaccination she had pain at site of injection and pain in arm. Her pain increased when she tried to raise her arm and having difficulty getting dressed. She had no numbness or tingling unless she laid on the arm for long period of time, had no swelling in arm, no fever and site of injection was normal. She had a doctor appointment on 23 Oct 2015 to examine. The final outcome of the events reported as ongoing. The events reported as serious (medically significant). The causality of the events was not reported.
Age: 43.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Activities of daily living impaired, Injection site pain, Pain, Pain in extremity
Clinical narrative: Case number PHEH2015US021160 is an initial spontaneous report from a nurse on 20 Oct 2015. This report refers to a 43-year-old female patient. She was vaccinated with FLUCELVAX (batch number: 174084, expiry date: 01 May 2016) at a dose of 0.5 ml intramuscularly on 28 Sep 2015. On the same date, after vaccination she had pain at site of injection and pain in arm. Her pain increased when she tried to raise her arm and having difficulty getting dressed. She had no numbness or tingling unless she laid on the arm for long period of time, had no swelling in arm, no fever and site of injection was normal. She had a doctor appointment on 23 Oct 2015 to examine. The final outcome of the events reported as ongoing. The events reported as serious (medically significant). The causality of the events was not reported.
Age: 75.0
Sex: M
Vaccine: PPV, PNC13
Symptoms: Computerised tomogram head normal, Computerised tomogram normal, Faecal incontinence, Loss of consciousness, Pain in extremity
Clinical narrative: This is a spontaneous report obtained from a contactable consumer (patient). A 75-year-old male patient received, on 27Oct2015, PREVNAR 13 single dose. Relevant medical history included resistant prostate cancer and cancer. Concomitant medication included ZYTIGA 1000 mg, daily, for cancer. On 27Oct2015, about 3 hours after the vaccination, the patient experienced pain in arm ("his left arm started hurting seriously") and finally he fainted, lost his bowels and his urinary control and could barely move. Due to the events, the patient was hospitalized from 27Oct2015 to 28Oct2015. The patient received a treatment for probably a month and half. Prostatic specific antigen (PSA), performed on an unspecified date (two weeks before the onset of the events), went up a little bit. The patient did not recover from the event, pain in arm; while clinical outcome of the other events was unknown.
Age: 75.0
Sex: M
Vaccine: PPV, PNC13
Symptoms: Urinary incontinence
Clinical narrative: This is a spontaneous report obtained from a contactable consumer (patient). A 75-year-old male patient received, on 27Oct2015, PREVNAR 13 single dose. Relevant medical history included resistant prostate cancer and cancer. Concomitant medication included ZYTIGA 1000 mg, daily, for cancer. On 27Oct2015, about 3 hours after the vaccination, the patient experienced pain in arm ("his left arm started hurting seriously") and finally he fainted, lost his bowels and his urinary control and could barely move. Due to the events, the patient was hospitalized from 27Oct2015 to 28Oct2015. The patient received a treatment for probably a month and half. Prostatic specific antigen (PSA), performed on an unspecified date (two weeks before the onset of the events), went up a little bit. The patient did not recover from the event, pain in arm; while clinical outcome of the other events was unknown.
Age: 75.0
Sex: M
Vaccine: PPV, PNC13
Symptoms: Faecal incontinence, Mobility decreased, Pain in extremity, Prostatic specific antigen increased, Syncope
Clinical narrative: This is a spontaneous report obtained from a contactable consumer (patient). A 75-year-old male patient received, on 27Oct2015, PREVNAR 13 single dose. Relevant medical history included resistant prostate cancer and cancer. Concomitant medication included ZYTIGA 1000 mg, daily, for cancer. On 27Oct2015, about 3 hours after the vaccination, the patient experienced pain in arm ("his left arm started hurting seriously") and finally he fainted, lost his bowels and his urinary control and could barely move. Due to the events, the patient was hospitalized from 27Oct2015 to 28Oct2015. The patient received a treatment for probably a month and half. Prostatic specific antigen (PSA), performed on an unspecified date (two weeks before the onset of the events), went up a little bit. The patient did not recover from the event, pain in arm; while clinical outcome of the other events was unknown.
Age: 11.0
Sex: F
Vaccine: VARZOS, MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 11 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-MAY-2008, the patient was vaccinated with a dose of M-M-R II (lot #, dose and route were not provided). It was reported that "this dose counted as varicella". On an unknown date in 2009, the patient had a brain damage caused by a car accident (reported as "car wreck"). The patient had to use a wheelchair. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported. The event was considered to be serious due to disability. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Age: 11.0
Sex: F
Vaccine: VARZOS, MMR
Symptoms: Brain injury, Medication error, Road traffic accident, Wheelchair user
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 11 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-MAY-2008, the patient was vaccinated with a dose of M-M-R II (lot #, dose and route were not provided). It was reported that "this dose counted as varicella". On an unknown date in 2009, the patient had a brain damage caused by a car accident (reported as "car wreck"). The patient had to use a wheelchair. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported. The event was considered to be serious due to disability. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Grip strength decreased, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Extreme pain for seven weeks in left arm and should. Unable to move arm in certain ways, loss of physical control (like grasping objects), sharp pain, numbness in hand and arm.
Age: 1.27
Sex: M
Vaccine: DTAP, HEP
Symptoms: Abnormal behaviour, Crying, Feeling abnormal, Irritability, Lethargy
Clinical narrative: Got the DTaP and Heb B shots around 10:00 AM, son had a mild cold with no fever. Later in the afternoon to early evening my son was very irritable and felt slightly warm. I gave him Tylenol around 5 pm. We went to bed around 8 pm. I woke around 2 am because my son's body was so hot it woke me up. Our thermometer is very unreliable but he got more Tylenol and husband went to store for a new thermometer. About 1 hour after Tylenol his temperature was 101. In the morning my son was not his usual happy self. He usually greets anyone (especially cashiers) with a giant smile. Instead he just stared lethargically. He was very irritable and clingy all day. Fever present at all times, temp depended on how recently he got Tylenol or Motrin and how much he managed to spit out. It is now 6:30 am on 12/18/2014 and he's puked a tiny bit this morning, still has a raging fever and is absolutely miserable. He cries any time we aren't laying down in bed together, with my breast out and available to him if he needs to nurse and/or cuddle.