chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Ear infection, Respiratory tract congestion
Clinical narrative: This spontaneous report as received from a consumer (also reported as healthcare student) of 23 year old female patient refers to herself. Patient medical history and current condition was not reported. Approximately in JULY-2014 (reported as six months before December 17th, 2014), the patient was vaccinated with GARDASIL dose 2 vaccination. Other co-suspects and concomitant medication was not reported. Approximately in DECEMBER-2014 (reported as about the second week in DECEMBER-2014) the patient experienced right ear infection. Also reported that it was a normal ear infection. The patient was prescribed an antibiotic (unspecified) and Fluticasone nasal spray. It was reported that the patient has finished the antibiotic therapy but not the nasal spray. Also states that she was still congested. It was reported that she did not take the Fluticasone nasal spray the previous day or the present day (reported as yesterday or today), because she wants to get the third dose of GARDASIL. The outcome of the event was reported as not recovered/not resolved. The reporter states the event was not caused by the GARDASIL. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number patients of unknown age and gender. The pharmacist reported that on unknown dates other unspecified pharmacist administered ZOSTAVAX (strength, dose, lot # and route were unknown) to an unspecified amount of unspecified patients "behind the arm," clarified as in the back of the arm, lower than the deltoid region. Pharmacist reported he had never done this himself, but reported he and other unspecified pharmacist had all been specifically trained to administer ZOSTAVAX in this manner. It was unable to be asked whether any patients experienced adverse effects as a result. No additional information provided. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients. The patients' medical histories, past drug histories, and concomitant medications were unknown. The patients were vaccinated with PEDVAXHIB that had unsupported temperature excursions, (lot # K002935, expiration dates: 11-DEC-2016 and lot # K00331, expiration dates: 23-OCT-2016), 0.5 ml, unknown frequency, intramuscular between September 2014 and December 2014. The nurse believed that the vaccines were not really exposed to unsupported temperature excursions, but that the data was documented incorrectly. She believed that the medical assistant, who documented the vaccine temperatures between September 2014 and 23-DEC-2014, documented the set "high"and "low," which cause an alarm to sound. She should have recorded that "min" and "max." On 22-DEC-2014, an auditor visited the clinic and asked the nurse to check for stability data. It was unknown if there was any relevant laboratory data. As of 23-DEC-2014, it was unknown if the patients continue to take PEDVAXHIB or GARDASIL. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse concerning an unspecified number of patients (demographics not provided). On unknown dates, 15 doses of improperly stored PROQUAD (Merck) (dosage and route of administration not provided) were administered to an unspecified number of patients. No adverse symptoms were reported. The temperature excursion for PROQUAD (Merck) was found to be supported with in-house stability data. Follow up information has been received from the nurse on 19-DEC-2014. The nurse was available at the time of the report and was able to provide lot numbers, expiration dates, number of doses affected by the temperature excursion and remaining doses. The nurse provided that the approximate ages of the patients who received the vaccinations were 1 year old and 4 years old.  Additional walk in patients received the vaccinations were older from other countries. There have been no adverse reported since administration of the vaccinations and there was no need for revaccination. The nurse also reported that 20 doses of PROQUAD (Merck) (lot # reported as 5014800, expiration date: 12-MAR-2016) were affected and 3 doses with same lot number were remaining. Follow up information was received on 02-JAN-2014. Lot 5014800 is NOT a valid lot number for PROQUAD (Merck). Product information and narrative were updated. This is one of several reports from the same reporter. Additional information has been requested. Product information and narrative were updated.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received on 03-DEC-2014 from a registered nurse concerning an approximately 37 year old male patient. On 03-DEC-2014 the patient was vaccinated with expired adult formulation RECOMBIVAX HB (Lot # J00358 expiration date 07-NOV-2014), 1 ml, intramuscular in the left arm. No adverse effects were noted by the patient. The registered nurse reported "potency supported." No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were unspecified by reporter. On 26-DEC-2014 the patient was vaccinated with a dose of GARDASIL (lot # J011272, expiry date: 21-APR-2016, dose, route of administration and anatomical location was unknown) which was improperly stored. No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 2 year old patient of unknown gender. Information about concurrent conditions and medical history was not provided. On 30-JUL-2014 patient was vaccinated with VAQTA dose 1. On 29-DEC-2014 the patient was vaccinated with VAQTA dose 2. Co-suspect and concomitant therapies were not reported. No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (dose, frequency, route, anatomical location and lot number were not reported). Other suspect and concomitant therapies were not reported. On an unknown date, the patient developed a rash at her injection site and 8 days later, the site was still red. No further information was provided. The outcome of rash and the site was still red was reported as recovering/resolving. Additional information is not expected. The pharmacist declined to provide any information.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to several patients (reported as males and females) of unknown age. On 02-DEC-2014 these patients were vaccinated with RECOMBIVAX HB (dose, route not reported, lot# reported as K012933). The reporter reported this product had been exposed to temperatures outside of the required temperature range and the efficacy of this product outside the temperature range had not been established. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX (Merck), Lot # K006132, expiration date: 29-APR-16, via an unknown route of administration. Past medical history and concomitant medications were not reported. On an unknown date the patient was administered an improperly stored dose of VARIVAX. There were no reported adverse events and no need for revaccination. The outcome of the patient was administered an improperly stored dose of VARIVAX and no adverse events were reported is unknown. The reporter considered the patient was administered an improperly stored dose of VARIVAX and no adverse events were reported to be not related to VARIVAX (Merck). This is one of several reports received from the same reporter. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a female patient of over 70 years of age. The patient was reported to be relatively healthy without any relevant medical history. Approximately on an unknown date in 2013, reported as about two years ago, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). There were no concomitant medications reported. On an unknown date in October 2014, reported as about 3 months ago, the patient experienced a mild case of shingles. The patient was treated with acyclovir for the event. The patient sought medical attention by calling the physician's office for her symptoms. There was no product quality complaint reported. The outcome of mild case of shingles was unknown. The causality of the event was not provided. Additional information is not expected, because there was no consent to follow up with the physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX (Merck), Lot # K003406, expiration date: 06-MAR-16, via an unknown route of administration. Past medical history and concomitant medications were not reported. On an unknown date the patient was administered an improperly stored dose of VARIVAX. There were no reported adverse events and no need for revaccination. The outcome of the patient was administered an improperly stored dose of VARIVAX and no adverse events were reported is unknown. The reporter considered the patient was administered an improperly stored dose of VARIVAX and no adverse events were reported to be not related to VARIVAX (Merck). This is one of several reports received from the same reporter. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a late 60 years old female patient via company representative. The patient's pertinent medical history and drug allergies were unspecified. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency and route were unspecified). Concomitant medications were unspecified. On an unknown date the patient experienced shingles after receiving ZOSTAVAX. Sought medical attention and treatment received were unspecified. The outcome of shingles was reported as recovered on an unspecified date. The causality of shingles was not reported. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age. Patient medical history and current condition was not reported. On an unknown date the patient was vaccinated with GARDASIL second dose, 14 months after patient received first dose of GARDASIL. No adverse effects were reported. Product quality complaint was not reported. The outcome of the event was unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient had drug reactions/allergies to AMBIEN and morphine. On 29-DEC-2014 the patient was vaccinated with ZOSTAVAX (dose was unknown) lot # K012924, expired date 29-NOV-2015, subcutaneously. After receiving ZOSTAVAX in approximately December 2014 (date unspecified), the patient experienced pain, redness, swelling, burning, warmth and itching at the injection site. The reporter also mentioned the patient had been having numbness in her arm after ZOSTAVAX was administered. The patient contacted the pharmacist to seek medical attention. There was no lab diagnostics studies performed. The therapies with VISTARIL were given for the treatment of the events. The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient had drug reactions/allergies to AMBIEN and morphine. On 29-DEC-2014 the patient was vaccinated with ZOSTAVAX (dose was unknown) lot # K012924, expired date 29-NOV-2015, subcutaneously. After receiving ZOSTAVAX in approximately December 2014 (date unspecified), the patient experienced pain, redness, swelling, burning, warmth and itching at the injection site. The reporter also mentioned the patient had been having numbness in her arm after ZOSTAVAX was administered. The patient contacted the pharmacist to seek medical attention. There was no lab diagnostics studies performed. The therapies with VISTARIL were given for the treatment of the events. The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were inadvertently vaccinated with doses of RECOMBIVAX HB (lot # reported as K007798 exp April 2016) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were inadvertently vaccinated with doses of GARDASIL (lot # reported as 003520 exp April 2015) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. 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 an unknown date, the patients were inadvertently vaccinated with doses of oral, ROTATEQ (lot # reported as K007911 exp March 2016) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of swelling in a child male patient who received ENGERIX B (batch number 7CL99, expiry date 2nd April 2016). In September 2014, the patient received the 2nd dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown. It was unknown if the reporter considered the swelling to be related to ENGERIX B. Additional information received: The nurse reported that the mother stated that the child developed swelling after receiving the ENGERIX-B vaccines.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a male patient of unknown age. On approximately 20-DEC-2014, "about one and a half week ago", the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported that beginning on an unspecified date in December 2014, the patient developed shingles-like rash. The patient was prescribed unspecified antiviral therapy as treatment. The outcome of shingles-like rash was unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Bone scan, Injection site pain, Mobility decreased, Nuclear magnetic resonance imaging, Periarthritis
Clinical narrative: Onset of soreness at injection site w/i 24 hrs. Soreness continued, then worsened over period of 10 wks. Firm movement restrictions began approximately 10/16 and got progressively worse through late November. Frozen shoulder diagnosed 11-21-14. Manipulation under anesthesia performed 12/10/14; P.T. continues through 1-6-15.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: X-ray limb
Clinical narrative: Onset of soreness at injection site w/i 24 hrs. Soreness continued, then worsened over period of 10 wks. Firm movement restrictions began approximately 10/16 and got progressively worse through late November. Frozen shoulder diagnosed 11-21-14. Manipulation under anesthesia performed 12/10/14; P.T. continues through 1-6-15.
Sex: U
Vaccine: RV5
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 ages. On an unknown dates the patients were vaccinated with a improperly stored dose of ROTATEQ, oral (dose, strength, lot# and expiration date was not provided). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 23-DEC-2014, the patient was vaccinated with ZOSTAVAX lot # J011333, expiration date 13-DEC-2014, subcutaneous (dose and strength were not reported). Secondary and concomitant therapies were not reported. Pharmacist reported that the patient received an expire dose of ZOSTAVAX. No known adverse effects. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Postictal state, Syncope
Clinical narrative: Immunization given and within 10 seconds syncope occurred for approximately 30-60 sec. Post-ictal confusion x 5-10 minutes.
Age: 36.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Inflammation, Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: 12/24/ saw that the back of right arm tender and hot to touch where MMR and Varicella given pain range 5-6/10 redness and lump noted. 12/25/14 temp 99.9 nausea. Exam by myself, local inflammatory response as above. No sign of infection or systemic involvement. Pt advised ice alt heat, NSAID an continue antihistamines that she takes.
Age: 36.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Nausea
Clinical narrative: 12/24/ saw that the back of right arm tender and hot to touch where MMR and Varicella given pain range 5-6/10 redness and lump noted. 12/25/14 temp 99.9 nausea. Exam by myself, local inflammatory response as above. No sign of infection or systemic involvement. Pt advised ice alt heat, NSAID an continue antihistamines that she takes.
Age: 36.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Body temperature increased, Erythema, Injection site pain, Injection site warmth, Mass
Clinical narrative: 12/24/ saw that the back of right arm tender and hot to touch where MMR and Varicella given pain range 5-6/10 redness and lump noted. 12/25/14 temp 99.9 nausea. Exam by myself, local inflammatory response as above. No sign of infection or systemic involvement. Pt advised ice alt heat, NSAID an continue antihistamines that she takes.
Age: 36.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Nausea, Pain
Clinical narrative: 12/24/ saw that the back of right arm tender and hot to touch where MMR and Varicella given pain range 5-6/10 redness and lump noted. 12/25/14 temp 99.9 nausea. Exam by myself, local inflammatory response as above. No sign of infection or systemic involvement. Pt advised ice alt heat, NSAID an continue antihistamines that she takes.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2013US140301 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 504430) website on 03 Dec 2013. This report refers to a 60-years-old female patient. Her medical history included hypertension and asthma. Her concomitant medications included trazodone, Seroquel and paroxetine. She was vaccinated with FLUVIRIN (batch number: 1308501) and PNEUMOVAX (batch number: J002646); both vaccines administered intramuscularly in the left arm on 19 Sep 2013. On 20 Sep 2013, her arm was swollen, red and painful from elbow to shoulder. She went to emergency room, was kept over the night and given antibiotic. Diagnostic laboratory tests (unspecified) were done and the results were normal. The outcome of the event was reported as condition unchanged. The seriousness and causality was not reported.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Computerised tomogram, Dizziness, Electroencephalogram, Facial pain
Clinical narrative: Case number PHHY2014US006740, is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 513660) website on 20 Jan 2014, with a follow up received from vaccine adverse event reporting system on 24 Jul 2014. This report refers to a 51-year-old female patient. Her medical history included obstructive sleep apnea. Concomitant drugs included bupropion and ZYRTEC. Her vaccination history included neck and face swelling with the seasonal influenza vaccine (see case: PHHY2014US007516) and also with Tdap (other manufacturer). She was vaccinated with FLUVIRIN (batch number: 1206801) intramuscularly into the left arm on 23 Jan 2013. On 25 Jan 2013, she experienced pain and numbness in the left side of face, lip and tongue. Over two months, the pain and numbness progressed to left hand, fingers and toes and she had numbness in right hand, fingers and toes. She lost strength in hands by mid of Mar 2013, and got to see a neurologist. By this time, she could not lift her leg against slight pressure. She started ordering outpatient tests. Within a week or so, she was having trouble walking with weakness in both legs. On 02 Apr 2013, she started getting dizzy and felt that she would pass out and was taken to the ER. She was admitted that night and after a few days of tests (MRI of brain and C-spine, CT scan, spinal, nerve conduction test and EEG: results not provided), and she received 3 days of intravenous steroids. She was in the hospital for seven days. The final outcome of the events reported as not recovered as of 18 Nov 2013. Causality were not reported. Follow up information received from vaccine adverse event reporting system on 24 Jul 2014: Updated suspect product as FLUVIRIN and batch number.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Glossodynia, Hypoaesthesia, Hypoaesthesia oral, Lip pain
Clinical narrative: Case number PHHY2014US006740, is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 513660) website on 20 Jan 2014, with a follow up received from vaccine adverse event reporting system on 24 Jul 2014. This report refers to a 51-year-old female patient. Her medical history included obstructive sleep apnea. Concomitant drugs included bupropion and ZYRTEC. Her vaccination history included neck and face swelling with the seasonal influenza vaccine (see case: PHHY2014US007516) and also with Tdap (other manufacturer). She was vaccinated with FLUVIRIN (batch number: 1206801) intramuscularly into the left arm on 23 Jan 2013. On 25 Jan 2013, she experienced pain and numbness in the left side of face, lip and tongue. Over two months, the pain and numbness progressed to left hand, fingers and toes and she had numbness in right hand, fingers and toes. She lost strength in hands by mid of Mar 2013, and got to see a neurologist. By this time, she could not lift her leg against slight pressure. She started ordering outpatient tests. Within a week or so, she was having trouble walking with weakness in both legs. On 02 Apr 2013, she started getting dizzy and felt that she would pass out and was taken to the ER. She was admitted that night and after a few days of tests (MRI of brain and C-spine, CT scan, spinal, nerve conduction test and EEG: results not provided), and she received 3 days of intravenous steroids. She was in the hospital for seven days. The final outcome of the events reported as not recovered as of 18 Nov 2013. Causality were not reported. Follow up information received from vaccine adverse event reporting system on 24 Jul 2014: Updated suspect product as FLUVIRIN and batch number.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Mobility decreased, Muscular weakness, Nerve conduction studies, Nuclear magnetic resonance imaging brain
Clinical narrative: Case number PHHY2014US006740, is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 513660) website on 20 Jan 2014, with a follow up received from vaccine adverse event reporting system on 24 Jul 2014. This report refers to a 51-year-old female patient. Her medical history included obstructive sleep apnea. Concomitant drugs included bupropion and ZYRTEC. Her vaccination history included neck and face swelling with the seasonal influenza vaccine (see case: PHHY2014US007516) and also with Tdap (other manufacturer). She was vaccinated with FLUVIRIN (batch number: 1206801) intramuscularly into the left arm on 23 Jan 2013. On 25 Jan 2013, she experienced pain and numbness in the left side of face, lip and tongue. Over two months, the pain and numbness progressed to left hand, fingers and toes and she had numbness in right hand, fingers and toes. She lost strength in hands by mid of Mar 2013, and got to see a neurologist. By this time, she could not lift her leg against slight pressure. She started ordering outpatient tests. Within a week or so, she was having trouble walking with weakness in both legs. On 02 Apr 2013, she started getting dizzy and felt that she would pass out and was taken to the ER. She was admitted that night and after a few days of tests (MRI of brain and C-spine, CT scan, spinal, nerve conduction test and EEG: results not provided), and she received 3 days of intravenous steroids. She was in the hospital for seven days. The final outcome of the events reported as not recovered as of 18 Nov 2013. Causality were not reported. Follow up information received from vaccine adverse event reporting system on 24 Jul 2014: Updated suspect product as FLUVIRIN and batch number.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging spinal, Pain in extremity
Clinical narrative: Case number PHHY2014US006740, is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 513660) website on 20 Jan 2014, with a follow up received from vaccine adverse event reporting system on 24 Jul 2014. This report refers to a 51-year-old female patient. Her medical history included obstructive sleep apnea. Concomitant drugs included bupropion and ZYRTEC. Her vaccination history included neck and face swelling with the seasonal influenza vaccine (see case: PHHY2014US007516) and also with Tdap (other manufacturer). She was vaccinated with FLUVIRIN (batch number: 1206801) intramuscularly into the left arm on 23 Jan 2013. On 25 Jan 2013, she experienced pain and numbness in the left side of face, lip and tongue. Over two months, the pain and numbness progressed to left hand, fingers and toes and she had numbness in right hand, fingers and toes. She lost strength in hands by mid of Mar 2013, and got to see a neurologist. By this time, she could not lift her leg against slight pressure. She started ordering outpatient tests. Within a week or so, she was having trouble walking with weakness in both legs. On 02 Apr 2013, she started getting dizzy and felt that she would pass out and was taken to the ER. She was admitted that night and after a few days of tests (MRI of brain and C-spine, CT scan, spinal, nerve conduction test and EEG: results not provided), and she received 3 days of intravenous steroids. She was in the hospital for seven days. The final outcome of the events reported as not recovered as of 18 Nov 2013. Causality were not reported. Follow up information received from vaccine adverse event reporting system on 24 Jul 2014: Updated suspect product as FLUVIRIN and batch number.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Headache, Hypertension, Lumbar puncture, Malaise
Clinical narrative: Case number PHHY2014US012659 is in initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 514046) web site on 03 FEB 2014. This report refers to a 60-year-old poly medicated female patient. Her concurrent conditions included hypertension and hypothyroidism. She was vaccinated with FLUVIRIN 2013/2014 (batch number: unknown) intramuscularly into left arm on 02 OCT 2013. On 07 OCT 2013, five days after vaccination, she experienced nausea, dry heaves and extreme malaise. This was progressed to severe headache, vomiting and hypertension. She had to be admitted to hospital to rule out aneurysm due to severity of headaches. She had to have a magnetic resonance imaging (MRI)/magnetic resonance angiography (MRA), computed tomograph (CAT) scan of brain, lumbar puncture to rule out meningitis, brain bleed, etc. Outcome of the events were reported as recovered. Seriousness and causality of the events were not reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Nuclear magnetic resonance imaging brain, Retching, Vomiting
Clinical narrative: Case number PHHY2014US012659 is in initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 514046) web site on 03 FEB 2014. This report refers to a 60-year-old poly medicated female patient. Her concurrent conditions included hypertension and hypothyroidism. She was vaccinated with FLUVIRIN 2013/2014 (batch number: unknown) intramuscularly into left arm on 02 OCT 2013. On 07 OCT 2013, five days after vaccination, she experienced nausea, dry heaves and extreme malaise. This was progressed to severe headache, vomiting and hypertension. She had to be admitted to hospital to rule out aneurysm due to severity of headaches. She had to have a magnetic resonance imaging (MRI)/magnetic resonance angiography (MRA), computed tomograph (CAT) scan of brain, lumbar puncture to rule out meningitis, brain bleed, etc. Outcome of the events were reported as recovered. Seriousness and causality of the events were not reported.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysgeusia, Immediate post-injection reaction
Clinical narrative: Case numberPHEH2014US001207 is an initial spontaneous report received from a pharmacist on 10 Jan 2014 with a follow up information received from a pharmacist on 17 Jan 2014 and 12 Feb 2014. This report refers to a 44-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13474P, expiry date: May 2014) intramuscularly on 10 Jan 2014 (at 6:33 pm). It was reported that on the same date (at 6:34 pm), immediately after vaccination, the patient experienced metallic taste in mouth (unusual/weird taste/funny taste in her mouth). She drank some water and the taste was still there and it was reported that at around 7:00 pm, the taste went away. The event outcome was reported as complete recovery on 10 Jan 2014. The seriousness and causality of the event were not reported. Follow up information received from a pharmacist on 17 Jan 2014: Patient demographics (age and gender), batch number and expiry date of FLUVIRIN, stop date and outcome updated. Follow up report received from the pharmacist 12 Feb 2014: The duration of the event was updated. Follow up information received from a pharmacist on 12 Feb 2014: Event verbatim updated.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysgeusia
Clinical narrative: Case numberPHEH2014US001207 is an initial spontaneous report received from a pharmacist on 10 Jan 2014 with a follow up information received from a pharmacist on 17 Jan 2014 and 12 Feb 2014. This report refers to a 44-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13474P, expiry date: May 2014) intramuscularly on 10 Jan 2014 (at 6:33 pm). It was reported that on the same date (at 6:34 pm), immediately after vaccination, the patient experienced metallic taste in mouth (unusual/weird taste/funny taste in her mouth). She drank some water and the taste was still there and it was reported that at around 7:00 pm, the taste went away. The event outcome was reported as complete recovery on 10 Jan 2014. The seriousness and causality of the event were not reported. Follow up information received from a pharmacist on 17 Jan 2014: Patient demographics (age and gender), batch number and expiry date of FLUVIRIN, stop date and outcome updated. Follow up report received from the pharmacist 12 Feb 2014: The duration of the event was updated. Follow up information received from a pharmacist on 12 Feb 2014: Event verbatim updated.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Rash, Urticaria
Clinical narrative: Case number PHEH2014US017047 is an initial spontaneous report received from a pharmacist on 21 Aug 2014 and a follow up report from a physician received on 03 Oct 2014. This report refers to a 22 years old male patient. His current condition included urinary tract infection. He was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly on 21 Aug 2014. It was reported that 2 hours after vaccination he developed blisters on both arms and a rash on the right side of his trunk. On 25 Aug 2014, he experienced urticarial reaction. The outcome of the event urticarial reaction reported as recovered on 26 Aug 2014. The outcome of the remaining events was unknown. The seriousness and causality of the events were not reported. Follow up report from a physician received on 03 Oct 2014: Added medical history (URI) and event (urticarial reaction).
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head normal, VIIth nerve paralysis
Clinical narrative: Dr saw patient on 10/6/14 and ordered flu shot. Patient was given shot in left arm by nurse same day. Patient developed Bell's Palsy on right side of face on 10/23/14 and was seen in Emergency Room. Patient called office 10/27/14 spoke with receptionist and stated above. Dr saw patient on 10/31/14 referred her to speech therapist and PT. Dr will see patient on regular basis. Dr suggest appoint w/ optometrist.
Sex: M
Vaccine: HPV4
Symptoms: Anogenital warts, Lethargy, Pain
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) refers to a male patient of unknown age. On an unknown date the patient received dose 1 of GARDASIL (lot # H010428, expiration date: not provided). On an unknown date, patient received dose 2 (lot # H013977, expiration date: not provided) and dose 3 (lot # H020002, expiration date: not provided) of GARDASIL. On an unknown date (reported as about 7 months ago), patient experienced a severe case of genital warts after receiving GARDASIL. The patient experienced this after completing the last dose of GARDASIL. It was reported that the patient does not had any other symptoms than warts on his penis. On an unknown date, patient sought medical attention and went to see dermatologist. On an unknown date, patient was treated with cantharone and imiquimod. The treatment process was reported as painful and lethargy for the patient. It was explained that the urologist wanted the patient to be hospitalized and scheduled for surgery but the family wanted him to see a dermatologist instead. It was reported that the patient will have a biopsy done next week and laser treatment will be performed next week. The consumer was concerned as to how the patient got genital warts if he was been vaccinated  and did not had a lot of sexual contact. Therapy with GARDASIL was continued. Outcome of the event was not reported. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain
Clinical narrative: The soreness in the arm in which the shot was administered is unbearable.  I couldn't sleep on it, can't lift it without feeling sharp pain and I am afraid to move it.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Oral herpes, Rash vesicular, Scab
Clinical narrative: Increased temperature on 12/13 and 12/14, up to 101.2, on 12/15 developed 2 cold sores, but no other lesions.  On 12/16, called office, advised to seek medical attention as she divulged that she has been taking long-term Acyclovir for herpetic eye disease control.  Did not seek medical care as she states that the fever resolved and the cold sores didn't completely develop.  Reports that on 12/22 she developed 2 chickenpox-type lesions on right torso/chest, then between 12/22 and 12/16, she developed a total of approximately 10 lesions disseminated across trunk, ear, neck and foot.  Lesions faded or scabbed by 1/5/15.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: Pt woke up 1/1/15 with burning and itching sensation after getting vaccine on 12/31/14. Says it continued to worsen with Sat, 1/3/15, being the worst day. She started using hydrocortisone cream on 1/3/15. At this time, the rash was past her elbow. She states the full area was about 3 in by 6-7 in.  The rash started to subside on 1/4/15 and continues to improve.
Age: 1.34
Sex: F
Vaccine: FLU4, HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse event, pt was given hep B instead of DTaP.
Sex: U
Vaccine: FLUX
Symptoms: Retinal pigment epitheliopathy, Uveitis
Clinical narrative: Initial report received from literature on 28 December 2014. This case is linked to case number 2015SA000156, 2015SA000157 and 2015SA000158 (same literature report). The following is the verbatim for the article abstract: A number of medications have been associated with uveitis. This review highlights both well-established and recently reported systemic, topical, intraocular, and vaccine-associated causes of drug-induced uveitis, and assigns a quantitative score to each medication based upon criteria originally described. An unknown patient (age and gender was not reported), whose medical history and concomitant medications were not reported, had received a dose of INFLUENZA VACCINE (manufacturer- unknown, batch number, route, dose number and site of administration was not reported) on an unspecified date. On an unspecified date patient had experienced secondary uveitis/bilateral panuveitis/recurrent panuveitis and acute posterior multifocal placoid pigment epitheliopathy. It was reported that the influenza vaccination has been implicated in the development of secondary uveitis in several case reports, including bilateral panuveitis, recurrent panuveitis and acute posterior multifocal placoid pigment epitheliopathy (APMPPE). Anterior uveitis can be controlled with topical corticosteroids and a cycloplegic/mydriatic agent, whereas posterior involvement may require systemic corticosteroids. Laboratory investigation and corrective treatment was not reported. At the time of reporting, patient outcome was unknown. Upon medical review, the case was considered as serious due to important medical event: secondary uveitis/bilateral panuveitis/recurrent panuveitis and acute posterior multifocal placoid pigment epitheliopathy. List of documents held by sender: none.
Age: 0.38
Sex: M
Vaccine: DTPHEP
Symptoms: Electroencephalogram, Seizure
Clinical narrative: Began having Gelastic (hysterical laughter) seizures within the 3 weeks after his 4 month DTAP and HEPB.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Feeling cold, Hepatic enzyme
Clinical narrative: BEGAN WITH FEVER, CHILLS, JOINT PAIN, RUQ PAIN ON 12/5/14. BEGAN FEELING NEURITIS TYPE PAIN BEGAN IN LOWER MID BACK, EACH DAY IT PROGRESSED AROUND MY RIGHT SIDE TO ABDOMEN, AND ON 12/9/14 FIRST HERPETIC LESION NOTED ON MY ABDOMEN. CONTINUED TO HAVE RUQ AND LOWER RIGHT RIB PAIN WITH THIS AS IF SOMEONE HAD KICKED ME IN MY RIBS. SEEN BY DR. PCP WITH DX: SHINGLES AND TREATED X 7 DAYS WITH ACYCLOVIR. REMAINED OFF WORK X 7 DAYS PER DR. ORDER AS I HAVE PATIENT CONTACT IN MY JOB. REPORTED THIS TO OUR EMPLOYEE HEALTH AS THIS IS WHERE I RECEIVED MY HEPATITIS B VACCINE ON 12/3/14. AFTER 7 DAY COURSE OF ACYCLOVIR, CONTINUED OFF AND ON WITH RUQ PAIN.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Herpes virus infection, Herpes zoster, Neuritis, Pyrexia
Clinical narrative: BEGAN WITH FEVER, CHILLS, JOINT PAIN, RUQ PAIN ON 12/5/14. BEGAN FEELING NEURITIS TYPE PAIN BEGAN IN LOWER MID BACK, EACH DAY IT PROGRESSED AROUND MY RIGHT SIDE TO ABDOMEN, AND ON 12/9/14 FIRST HERPETIC LESION NOTED ON MY ABDOMEN. CONTINUED TO HAVE RUQ AND LOWER RIGHT RIB PAIN WITH THIS AS IF SOMEONE HAD KICKED ME IN MY RIBS. SEEN BY DR. PCP WITH DX: SHINGLES AND TREATED X 7 DAYS WITH ACYCLOVIR. REMAINED OFF WORK X 7 DAYS PER DR. ORDER AS I HAVE PATIENT CONTACT IN MY JOB. REPORTED THIS TO OUR EMPLOYEE HEALTH AS THIS IS WHERE I RECEIVED MY HEPATITIS B VACCINE ON 12/3/14. AFTER 7 DAY COURSE OF ACYCLOVIR, CONTINUED OFF AND ON WITH RUQ PAIN.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Itchy hives (small, red, raised areas) spread evenly over his body.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Myelitis transverse
Clinical narrative: Diagnosed transverse myelitis.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Child inadvertently given wrong influenza vaccine.  Should have gotten 3 years and up was given 6 months to 36 months.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Borrelia test, Burning sensation, Nerve conduction studies, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Flu vaccination on 10/23/2014 and approximately 7 days later began experiencing tingling/burning thru body. Currently still dealing more with tingling/burning mainly in upper body.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Dysstasia, Lethargy, Nasopharyngitis, Pain in extremity, Pallor
Clinical narrative: Woke up at 8 am with soreness of his leg where the vaccine was given but was able to eat breakfast. He began becoming lethargic and sleepy at 10 am. By 11 am, he was pale, cold and couldn't stand on his own. At around 12 pm, he vomited his breakfast and continued vomiting. From 12pm - 6pm, he was unable to hold down any food or liquids and was lethargic and drowsy. He was given sips of apple juice during this time but continued vomiting it. He was then given lollipops to suck on. Around 6pm, he stopped vomiting and was less lethargic and drowsy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Somnolence, Vomiting
Clinical narrative: Woke up at 8 am with soreness of his leg where the vaccine was given but was able to eat breakfast. He began becoming lethargic and sleepy at 10 am. By 11 am, he was pale, cold and couldn't stand on his own. At around 12 pm, he vomited his breakfast and continued vomiting. From 12pm - 6pm, he was unable to hold down any food or liquids and was lethargic and drowsy. He was given sips of apple juice during this time but continued vomiting it. He was then given lollipops to suck on. Around 6pm, he stopped vomiting and was less lethargic and drowsy.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Approx 3"x4" inflamed, swollen, tender area at injection site.....enlarged and worsened over next 5 days....Treated with Tylenol 2 tabs every 8 hrs and ice to site.
Age: 5.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Incorrect route of drug administration
Clinical narrative: Paperwork indicates child was given varicella and Proquad.  Two doses of varicella in the muscle instead of subcutaneously.
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis
Clinical narrative: This medically confirmed health authority report (initial receipt 25-Aug-2014) concerns a female patient. On an unspecified date in 2012, the patient received an influenza vaccine (manufacturer and batch number not reported) in the left arm. On an unspecified date, the patient developed left shoulder adhesive capsulitis. Outcome was unknown. Linked to 2014044809.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Pain, Pain in extremity
Clinical narrative: L arm became extremely sore at 04:30 PM. At 10:00 PM extremely dizzy and felt like I was going to faint. From 10:00 PM to 12:30 AM of 1/7/2015 had chills and body aches.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Left shoulder and left upper arm pain. Left thumb paresthesias.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Bone pain, Chills, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Raging sore throat, fever, chills, muscle aches, headache, bone pain, like I was hit by a truck, treatment was rest, fluids, throat spray, naproxen sodium.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Raging sore throat, fever, chills, muscle aches, headache, bone pain, like I was hit by a truck, treatment was rest, fluids, throat spray, naproxen sodium.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Cough, Depressed level of consciousness, Dizziness, Fatigue
Clinical narrative: Left side body pain, with no prior injury. Shot was given in left arm. 12 pm: Sinus pain. 11/22: 5 am: Sore throat, bodyache, extreme fatigue. 11/23: 5 am: Sore throat, sinus pain, bodyache, non-productive cough, chest pain. 11/24: 7 am: Extreme dizziness/numbness to the point I felt like I was going to fall over or pass out if I did not sit down. No SOB.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Oropharyngeal pain, Pain, Sinus headache
Clinical narrative: Left side body pain, with no prior injury. Shot was given in left arm. 12 pm: Sinus pain. 11/22: 5 am: Sore throat, bodyache, extreme fatigue. 11/23: 5 am: Sore throat, sinus pain, bodyache, non-productive cough, chest pain. 11/24: 7 am: Extreme dizziness/numbness to the point I felt like I was going to fall over or pass out if I did not sit down. No SOB.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Entire left thigh swollen and warm. Motrin and warm compresses given.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Limb discomfort
Clinical narrative: Headache and limbs feeling out of sorts.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives.