chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Muscular weakness
Clinical narrative: Case number PHHY2014US000805, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 508952) website on 06 Jan 2014, with the follow-up received from PTC department on 16 Jan 2014. This report refers to 49-year-old male patient. His medical history included alcoholism and his current conditions included bilateral avascular necrosis and right hip fracture for which he underwent a surgery right hip arthroplasty. On the second and third day after surgery, he was having difficulty in getting out of bed, but was still able to ambulate. His concomitant medications included chlordiazepoxide at a dose of 25 mg orally thrice daily, docusate at a dose of 100 mg twice daily, enoxaparin at a dose of 40 mg once daily, folic acid at 1 mg orally daily, metaprolol at a dose of 25 mg twice daily orally, multivitamin daily, pantoprazole at a dose of 40 mg orally daily, MIRALAX twice daily. Four days after undergoing surgery, he was vacciated with FLUVIRIN (batch number: 13413P) intramuscularly in the right arm and PNEUMOVAX (other manufacturer, batch number: J007786) intramuscularly in the left arm on 05 Oct 2013. On 09 Oct 2013, he felt diffusely weak on his legs which progressed to a point where he had complete loss of strength in his legs. His speech became dysarthic, hoarse and was unable to swallow well. Lab test like modified barium swallow study was done which showed severe pharyngeal dysphagia. The event outcome was completely recovered. The seriousness was not reported. The causality was reported as not-suspected to the vaccination with FLUVIRIN but other issues related to admission diagnosis and condition. Follow-up received from PTC department on 16 Jan 2014: It was reported that, reported batch number (13413P) belongs to FLUVIRIN and AGRIFLU. Hence product recoded from AGRIFLU to FLUVIRIN.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest discomfort, Chills, Cough, Decreased appetite
Clinical narrative: Case number PHHY2014US001021, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509184) website on 06 Jan 2014 and a follow up received from the quality assurance department on 15 Jan 2014. This report refers to 70-year-old female patient. Her medical history included spinal stenosis. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly, in the right arm on 19 Oct 2013. On 20 Oct 2013, she experienced back pain, chills, cough, general body discomforts, headache,  and pain in the right shoulder, loss of appetite, tightness and heaviness of upper chest, depression, stuffy nose and congested throat. She visited the emergency room. The event outcome was condition unchanged as of 23 Oct 2013. The seriousness and causality were not reported. The quality assurance department has confirmed that the initially reported batch number: 2013-2014 was invalid and therefore, a QA investigation could not be performed. Follow up received from the quality assurance department on 15 Jan 2014: The quality assurance department has confirmed that the initially reported batch number: 2013-2014 was invalid and therefore, a QA investigation could not be performed.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Depression, Discomfort, Headache, Injection site pain, Nasal congestion
Clinical narrative: Case number PHHY2014US001021, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509184) website on 06 Jan 2014 and a follow up received from the quality assurance department on 15 Jan 2014. This report refers to 70-year-old female patient. Her medical history included spinal stenosis. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly, in the right arm on 19 Oct 2013. On 20 Oct 2013, she experienced back pain, chills, cough, general body discomforts, headache,  and pain in the right shoulder, loss of appetite, tightness and heaviness of upper chest, depression, stuffy nose and congested throat. She visited the emergency room. The event outcome was condition unchanged as of 23 Oct 2013. The seriousness and causality were not reported. The quality assurance department has confirmed that the initially reported batch number: 2013-2014 was invalid and therefore, a QA investigation could not be performed. Follow up received from the quality assurance department on 15 Jan 2014: The quality assurance department has confirmed that the initially reported batch number: 2013-2014 was invalid and therefore, a QA investigation could not be performed.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Case number PHHY2014US001021, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509184) website on 06 Jan 2014 and a follow up received from the quality assurance department on 15 Jan 2014. This report refers to 70-year-old female patient. Her medical history included spinal stenosis. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly, in the right arm on 19 Oct 2013. On 20 Oct 2013, she experienced back pain, chills, cough, general body discomforts, headache,  and pain in the right shoulder, loss of appetite, tightness and heaviness of upper chest, depression, stuffy nose and congested throat. She visited the emergency room. The event outcome was condition unchanged as of 23 Oct 2013. The seriousness and causality were not reported. The quality assurance department has confirmed that the initially reported batch number: 2013-2014 was invalid and therefore, a QA investigation could not be performed. Follow up received from the quality assurance department on 15 Jan 2014: The quality assurance department has confirmed that the initially reported batch number: 2013-2014 was invalid and therefore, a QA investigation could not be performed.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5, DTAPIPV, HIBV, PNC13, RV5
Symptoms: Chest X-ray abnormal, Crepitations, Diarrhoea, Dyspnoea, Gastroenteritis viral
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of interstitial lung disease in a 2-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included haemophilus influenzae type b (non-gsk) ;Sanofi;unknown;unknown given on 27 November 2013; pneumococcal (non-gsk) ;Wyeth Labs;unknown;unknown given on 27 November 2013; rotavirus (non-gsk) ;Merck;unknown given on 27 November 2013. Concurrent medications included Vitamin D. On 27 November 2013 the subject received 1st dose of KINRIX (unknown details, right thigh) as the first dose in the Dtap series and experienced inappropriate age of vaccine administration and vaccine administered at inappropriate site. Per the nurse, "KINRIX was inadvertently administered to a 2 month old" subject. The subject was younger than the indicated age for KINRIX. KINRIX is indicated to be used as the fifth dose in the DTaP and the fourth dose in the IPV series. The preferred site of administration for KINRIX is the deltoid of the upper arm. On 20 December 2013, 23 days after vaccination with KINRIX, the subject experienced interstitial lung disease, respiratory syncytial virus, and bronchiolitis. The diagnosis was given on 20 December 2013. Per the nurse, it was unknown if the immunization series was discontinued but the series was delayed. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5, DTAPIPV, HIBV, PNC13, RV5
Symptoms: Laboratory test, Lung infiltration, Oxygen saturation decreased, Rales, Respiratory syncytial virus bronchiolitis
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of interstitial lung disease in a 2-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included haemophilus influenzae type b (non-gsk) ;Sanofi;unknown;unknown given on 27 November 2013; pneumococcal (non-gsk) ;Wyeth Labs;unknown;unknown given on 27 November 2013; rotavirus (non-gsk) ;Merck;unknown given on 27 November 2013. Concurrent medications included Vitamin D. On 27 November 2013 the subject received 1st dose of KINRIX (unknown details, right thigh) as the first dose in the Dtap series and experienced inappropriate age of vaccine administration and vaccine administered at inappropriate site. Per the nurse, "KINRIX was inadvertently administered to a 2 month old" subject. The subject was younger than the indicated age for KINRIX. KINRIX is indicated to be used as the fifth dose in the DTaP and the fourth dose in the IPV series. The preferred site of administration for KINRIX is the deltoid of the upper arm. On 20 December 2013, 23 days after vaccination with KINRIX, the subject experienced interstitial lung disease, respiratory syncytial virus, and bronchiolitis. The diagnosis was given on 20 December 2013. Per the nurse, it was unknown if the immunization series was discontinued but the series was delayed. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5, DTAPIPV, HIBV, PNC13, RV5
Symptoms: Tachypnoea, Use of accessory respiratory muscles, Vomiting, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of interstitial lung disease in a 2-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included haemophilus influenzae type b (non-gsk) ;Sanofi;unknown;unknown given on 27 November 2013; pneumococcal (non-gsk) ;Wyeth Labs;unknown;unknown given on 27 November 2013; rotavirus (non-gsk) ;Merck;unknown given on 27 November 2013. Concurrent medications included Vitamin D. On 27 November 2013 the subject received 1st dose of KINRIX (unknown details, right thigh) as the first dose in the Dtap series and experienced inappropriate age of vaccine administration and vaccine administered at inappropriate site. Per the nurse, "KINRIX was inadvertently administered to a 2 month old" subject. The subject was younger than the indicated age for KINRIX. KINRIX is indicated to be used as the fifth dose in the DTaP and the fourth dose in the IPV series. The preferred site of administration for KINRIX is the deltoid of the upper arm. On 20 December 2013, 23 days after vaccination with KINRIX, the subject experienced interstitial lung disease, respiratory syncytial virus, and bronchiolitis. The diagnosis was given on 20 December 2013. Per the nurse, it was unknown if the immunization series was discontinued but the series was delayed. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5, DTAPIPV, HIBV, PNC13, RV5
Symptoms: Bronchiolitis, Drug administered at inappropriate site, Drug administered to patient of inappropriate age, Interstitial lung disease, Respiratory syncytial virus infection
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of interstitial lung disease in a 2-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included haemophilus influenzae type b (non-gsk) ;Sanofi;unknown;unknown given on 27 November 2013; pneumococcal (non-gsk) ;Wyeth Labs;unknown;unknown given on 27 November 2013; rotavirus (non-gsk) ;Merck;unknown given on 27 November 2013. Concurrent medications included Vitamin D. On 27 November 2013 the subject received 1st dose of KINRIX (unknown details, right thigh) as the first dose in the Dtap series and experienced inappropriate age of vaccine administration and vaccine administered at inappropriate site. Per the nurse, "KINRIX was inadvertently administered to a 2 month old" subject. The subject was younger than the indicated age for KINRIX. KINRIX is indicated to be used as the fifth dose in the DTaP and the fourth dose in the IPV series. The preferred site of administration for KINRIX is the deltoid of the upper arm. On 20 December 2013, 23 days after vaccination with KINRIX, the subject experienced interstitial lung disease, respiratory syncytial virus, and bronchiolitis. The diagnosis was given on 20 December 2013. Per the nurse, it was unknown if the immunization series was discontinued but the series was delayed. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Heart rate increased, Loss of consciousness, Nausea
Clinical narrative: Patient became faint and passed out in parking lot, patient was also dizzy, nauseous and had an elevated heart rate for the 72 hours after receiving the Gardasil vaccine. Patient was sent to the emergency room for observation.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Biopsy stomach, Blood test, Computerised tomogram, Convulsion, Electroencephalogram
Clinical narrative: Found face down in pack n play, gray and unresponsive. Called 911, taken by ambulance to hospital, airlifted to another hospital.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Endotracheal intubation, Gastrointestinal tube insertion, Lumbar puncture, Nuclear magnetic resonance imaging, Oesophagoscopy
Clinical narrative: Found face down in pack n play, gray and unresponsive. Called 911, taken by ambulance to hospital, airlifted to another hospital.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Skin discolouration, Unresponsive to stimuli
Clinical narrative: Found face down in pack n play, gray and unresponsive. Called 911, taken by ambulance to hospital, airlifted to another hospital.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema
Clinical narrative: Patient called PCP complaining of headache and a reaction at injection site. Went to MD, small red circle at injection site - pt recovering.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. On 27-DEC-2013 the patient was vaccinated with ZOSTAVAX vial (dose, frequency and lot# unknown) at her physician's office (name and location unspecified). On 14-JAN-2014, 19 days after onset of therapy the patient was diagnosed by her physician with "Shingles". The patient had sought medical attention via office visit. The outcome of shingles was unknown. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a his father of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# was not reported). The pharmacist mentioned his father developed nerve pain approximately one week after receiving ZOSTAVAX. The outcome of his father developed nerve pain was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Medical assistant refers to an unknown number of patients of unknown age and gender. The reporter mentioned that an unknown number of patients have received VARIVAX (Merck) (lot number and expiry date not reported) (dosing regimen and frequency unknown) from January 2013 to 16-DEC-2013 that may have had an unknown number of excursions with temperatures from 3 degrees C to 7 degrees C and each excursion being 64 hours. No adverse effects reported. No product quality issue was reported. Follow-up information has been received from a medical assistant (who called to report specific administration dates), concerning a patient of unknown age and gender. On 08-NOV-2013 the patient had received a dose of VARIVAX (Merck) (lot number #J004162, exp.date: 08-APR-2014) (dosing regimen and frequency were not provided). This dose of VARIVAX (Merck) had an unknown number of excursions with temperatures from minus 3 Celsius degree to minus 7 Celsius degree and each excursions being 64 hours. No adverse experiences was reported. This is one of 9 reports from the same source (# 1312USA011519; #1312USA011525; #1312USA011520; #1312USA011521; #1312USA011522; #1312USA011523; #1312USA011524; #1312USA008561). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Medical assistant refers to an unknown number of patients of unknown age and gender. The reporter mentioned that an unknown number of patients have received VARIVAX (merck) (lot number and expiry date not reported) (dosing regimen and frequency unknown) from January 2013 to 16-DEC-2013 that may have had an unknown number of excursions with temperatures from 3 degrees C to 7 degrees C and each excursion being 64 hours. No adverse effects reported. No product quality issue was reported. Follow-up information has been received from a medical assistant (who called to report specific administration dates), concerning a patient of unknown age and gender. On 07-OCT-2013 the patient had received a dose of VARIVAX (merck) (lot number #H011233, exp. date: 06-JUN-2014) (dosing regimen and frequency were not provided). This dose of VARIVAX (merck) had an unknown number of excursions with temperatures from minus 3 Celsius degree to minus 7 Celsius degree and each excursions being 64 hours. No adverse experiences was reported. This is one of 9 reports from the same source (# 1312USA011519; #1312USA008561; #1312USA011520; #1312USA011521; #1312USA011522; #1312USA011523; #1312USA011524; #1312USA011526). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 28-JUN-2013, lot # H010915 expiration date: 13-FEB-2013. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Medical assistant refers to an unknown number of patients of unknown age and gender. The reporter mentioned that an unknown number of patients have received VARIVAX (Merck) (lot number and expiry date not reported) (dosing regimen and frequnecy unknown) from January 2013 to 16-DEC-2013 that may have had an unknown number of excursions with temperatures from 3 degrees C to 7 degrees C and each excursion being 64 hours. No adverse effects reported. No product quality issue was reported. Follow-up information has been received from a medical assistant (who called to report specific adminstrarion dates), concerning a patient of unknown age and gender. On 30-SEP-2013 the patient had received a dose of VARIVAX (Merck) (lot number #H018797, exp. date:24-OCT-2014) (dosing regimen and frequency were not provided). This dose of VARIVAX (Merck) had an unknown number of excursions with temperatures from minus 3 Celsius degree to minus 7 Celsius degree and each excursions being 64 hours. No adverse experiences was reported. This is one of 9 reports from the same source (# 1312USA011519; #1312USA011525; #1312USA011520; #1312USA011521; #1312USA011522; #1312USA011523; #1312USA008561; #1312USA011526). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 02-JUL-2013, lot # H010915 expiration date: 13-FEB-2013. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Feeling hot, Hypoaesthesia, Injection site joint pain, Injection site mass
Clinical narrative: This spontaneous report as received from a 63 year old female patient regarding herself. The patient's medical history included dizzy and upset stomach while on some unspecified pain killers (details unspecified). On 06-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). Concomitant therapies included NITRO-BID. On 06-DEC-2013 in the evening of the vaccine, her arm felt heavy and warm. She also experienced arm pain since the day of the injection. It originated at the injection site but now went through her elbow and down into her fingers. Sometimes her fingers went numb. The pain was getting worse each day. She also stated that ever since getting the vaccine she feels light- headed every now and then. On 07-DEC-2013 the patient experienced small lump at the injection site. The patient saw the physician however he could not give her any treatment. The outcome of her arm felt heavy and warm, feeling light headed every now and then, fingers go numb, pain in elbow and down into fingers, arm pain and small lump at the injection site was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain in extremity, Sensation of heaviness
Clinical narrative: This spontaneous report as received from a 63 year old female patient regarding herself. The patient's medical history included dizzy and upset stomach while on some unspecified pain killers (details unspecified). On 06-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). Concomitant therapies included NITRO-BID. On 06-DEC-2013 in the evening of the vaccine, her arm felt heavy and warm. She also experienced arm pain since the day of the injection. It originated at the injection site but now went through her elbow and down into her fingers. Sometimes her fingers went numb. The pain was getting worse each day. She also stated that ever since getting the vaccine she feels light- headed every now and then. On 07-DEC-2013 the patient experienced small lump at the injection site. The patient saw the physician however he could not give her any treatment. The outcome of her arm felt heavy and warm, feeling light headed every now and then, fingers go numb, pain in elbow and down into fingers, arm pain and small lump at the injection site was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Dizziness, Hypoaesthesia, Injected limb mobility decreased, Injection site erythema
Clinical narrative: This spontaneous report as received from a 63 year old female patient regarding herself. The patient's medical history included dizzy and upset stomach while on some unspecified pain killers (details unspecified). On 06-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). Concomitant therapies included NITRO-BID. On 06-DEC-2013 in the evening of the vaccine, her arm felt heavy and warm. She also experienced arm pain since the day of the injection. It originated at the injection site but now went through her elbow and down into her fingers. Sometimes her fingers went numb. The pain was getting worse each day. She also stated that ever since getting the vaccine she feels light- headed every now and then. On 07-DEC-2013 the patient experienced small lump at the injection site. The patient saw the physician however he could not give her any treatment. The outcome of her arm felt heavy and warm, feeling light headed every now and then, fingers go numb, pain in elbow and down into fingers, arm pain and small lump at the injection site was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site joint pain, Injection site mass, Injection site pain, Injection site swelling, Muscular weakness
Clinical narrative: This spontaneous report as received from a 63 year old female patient regarding herself. The patient's medical history included dizzy and upset stomach while on some unspecified pain killers (details unspecified). On 06-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). Concomitant therapies included NITRO-BID. On 06-DEC-2013 in the evening of the vaccine, her arm felt heavy and warm. She also experienced arm pain since the day of the injection. It originated at the injection site but now went through her elbow and down into her fingers. Sometimes her fingers went numb. The pain was getting worse each day. She also stated that ever since getting the vaccine she feels light- headed every now and then. On 07-DEC-2013 the patient experienced small lump at the injection site. The patient saw the physician however he could not give her any treatment. The outcome of her arm felt heavy and warm, feeling light headed every now and then, fingers go numb, pain in elbow and down into fingers, arm pain and small lump at the injection site was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Sensation of heaviness, Skin warm
Clinical narrative: This spontaneous report as received from a 63 year old female patient regarding herself. The patient's medical history included dizzy and upset stomach while on some unspecified pain killers (details unspecified). On 06-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). Concomitant therapies included NITRO-BID. On 06-DEC-2013 in the evening of the vaccine, her arm felt heavy and warm. She also experienced arm pain since the day of the injection. It originated at the injection site but now went through her elbow and down into her fingers. Sometimes her fingers went numb. The pain was getting worse each day. She also stated that ever since getting the vaccine she feels light- headed every now and then. On 07-DEC-2013 the patient experienced small lump at the injection site. The patient saw the physician however he could not give her any treatment. The outcome of her arm felt heavy and warm, feeling light headed every now and then, fingers go numb, pain in elbow and down into fingers, arm pain and small lump at the injection site was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from the registered nurse on 31-DEC-2013. It was reported that PNEUMOVAX23 was administered to an unspecified number of patients. This report refers to one of the event: unspecified number of patients (unspecified age and gender) were administered doses of PNEUMOVAX23 in March 2013 (lot number and Expiration Date were not reported). This is one of the report from the same source, linked reports. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Flushing of face, stiffness of neck and arm, pain in arm (left side). Patient took BENADRYL for symptoms of reaction.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 11-JUL-2013, lot # H010915 expiration date: 13-FEB-2015. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date in July 2013 the patient was vaccinated with first GARDASIL, (lot number and expiry date was unknown) 0.5 ml, (dosing regimen and frequency unknown) intramuscularly. No concomitant medications were reported. On 11-JAN-2014 the patient was administered with second dose of GARDASIL. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 03-JUL-2013, lot # H010915 expiration date: 13-FEB-2015. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 20-DEC-2013 the patient received first dose of M-M-R II (lot # 671686/1874AA exp. date:30-NOV-2013, dose, strength, site and route of administration not reported) which has expired for vaccination. No adverse event reported. This is one of two reports from the same reporter. Linked case MARRS # 1401USA004043. Additional information is not expected.
Sex: M
Vaccine: MMRV, MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from an office administrator who is also a medical assistant refers to patient of unknown age and gender. On 09-JAN-2014, the patient was vaccinated with a first dose of PROQUAD (Merck) (lot # H015641, expire date 06-JAN-2014) injection, subcutaneous for vaccination (dose and strength not reported). No adverse effects reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: M
Vaccine: MMRV, MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from an office administrator who is also a medical assistant refers to patient of unknown age and gender. On 09-JAN-2014, the patient was vaccinated with a first dose of PROQUAD (Merck) (lot # H015641, expire date 06-JAN-2014) injection, subcutaneous for vaccination (dose and strength not reported). No adverse effects reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Monday January 13, patient broke out with just 4 spots of chicken pox. As of today January 17 they are still there but are starting to blister up. No treatment at this time.
Age: 1.1
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Possible allergic reaction to flu shot patient started breaking out with rash and hives one day after receiving flu shot.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Exposure during pregnancy, Incomplete course of vaccination
Clinical narrative: This spontaneous retrospective pregnancy report as received from a healthcare worker refers to a 26 year old female patient with none pertinent medical history and no drug reactions or allergies. On 06-NOV-2012 the patient was vaccinated with the first dose of GARDASIL injection (route, strength, lot number and expiration date not provided). In January 2013 (reported as 2 months later) the patient was vaccinated with the second dose of GARDASIL injection (route, strength, lot number and expiration date not provided) while the patient was assumed to be pregnant. Also was reported that the patient became pregnant with Last Menstrual Period (LMP) of 01-FEB-2013 and Estimated Delivery Day (EDD) of 08-NOV-2013. No concomitant medication was reported. The patient sought medical attention and contacted physician. The sonogram for pregnancy was performed. The patient never had the third injection of GARDASIL because a baby was delivered via caesarian section shortly after (in 2013, date and detailed information not specified). The pregnancy outcome was unknown). The relatedness between vaccination with GARDASIL and caesarean section was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL on 21-MAR-2013 (lot # H011350, Expiration Date: 21-FEB-2015). This is one of the report from the same source. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt complained of swollen, red, warm arm w/ harder area near site of injection.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional refers to a patient of unknown demography. On 25-SEP-2013, the patient was vaccinated with first dose of GARDASIL (route and frequency was not reported). The reporter stated that the second dose in GARDASIL was not administered until 27-DEC-2013. No adverse effects were reported. The outcome of second dose in GARDASIL series was not administered until 27-DEC-2013 was unknown. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: FLUX, HEP
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Arthralgia, Musculoskeletal pain, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Patient with polyarticular joint pain, to include neck, Left Shoulder and right hand that patient states developed within days of receiving Hep B #2 vaccine and IIV on 8 Dec 2006. Patient was eventually diagnosed with rheumatoid arthritis and has been under the care of a rheumatologist since.
Age: 41.0
Sex: M
Vaccine: FLUX, HEP
Symptoms: Rheumatoid factor positive
Clinical narrative: Patient with polyarticular joint pain, to include neck, Left Shoulder and right hand that patient states developed within days of receiving Hep B #2 vaccine and IIV on 8 Dec 2006. Patient was eventually diagnosed with rheumatoid arthritis and has been under the care of a rheumatologist since.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 18 year old male patient. The patient did not have pertinent medical history or drug reactions/allergies. On an unknown date, the patient who had received the three dose RECOMBIVAX HB series "as a baby" (lot number, dose and route were not reported). The patient was not taken concomitant medication. On an unknown date recently, the patient had titers performed for admission to college, and his titers "were less than 5" and considered to be too low for evidence of immunity. The outcome of the event was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 12-AUG-2013 (lot # H011350, Expiration Date: 21-FEB-2015). No adverse event was reported. This is one of the reports from the same source Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 19-AUG-2013 (lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 19-AUG-2013 (lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL (dose and route not reported) on 20-AUG-2013 (lot and expiration date not reported). No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL on 23-AUG-2013 (lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Oedema peripheral, Pyrexia, Rash
Clinical narrative: Rash, diarrhea and peripheral edema, fever. Clindamycin 600 mg MG once.
Age: 40.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 40 year old male patient. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose not specified) subcutaneously for an unknown indication. On an unknown date, the patient experienced headache and numbness of face after administration with ZOSTAVAX. The patient went to see pharmacist to seek medical attention. The outcome of numbness of face and headache was reported as recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 06-DEC-2012 (lot # H011350, expiration date 21-FEB-2015) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 23-AUG-2013 (lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the Registered Nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered a dose of GARDASIL (dose and route not reported) on 06-DEC-2012 (lot number 670048/0963AA, expiration date 09-NOV-2013) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Pruritus, Urticaria
Clinical narrative: Pt received the vaccine within two minutes the patients arm started to have swelling and itching. It then started to develop a hive and she felt systemic itchy mild. Treated ice and observation. She left at 20 min no new sxs, declined BENADRYL.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Chest pain, Urticaria
Clinical narrative: Reported today --> full body hives on 11/8/13 after 1st dose of HPV given. Full body hives and chest pain on 01/10/14 after 2nd dose given.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Burning feet syndrome, Pain in extremity, Rash generalised, Rash maculo-papular
Clinical narrative: Vaccines administered on 1/6/14, patient presented to office on 1/9/14 with generalized macula papular rash, pain/burning on bottom of feet. No treatment. Coming back for additional follow up on 1/16/14.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the Registered Nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered a dose of GARDASIL on 11-DEC-2012 (lot number 670048/0963AA, expiration date 09-NOV-2013) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the Registered Nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered a dose of GARDASIL (dose and route not reported) on 19-DEC-2012 (dose, route and lot number not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the Registered Nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered a dose of GARDASIL on 18-DEC-2012 (lot number 672834/0131AE, expiration date 26-OCT-2014) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the Registered Nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered a dose of GARDASIL on 24-DEC-2012 (lot number 672834/0131AE, expiration date 26-OCT-2014) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a Registered Nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered a dose of GARDASIL on 24-DEC-2012 (lot number 672834/0131AE, expiration date 26-OCT-2014) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness, swelling, pain, itching at vaccine site - approximately 2 x 3 inch size lump and bright red spot.  Continuing on 1/17/2014 as well.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Fatigue, Myalgia
Clinical narrative: Fatigue, muscle pain in legs, weakness.
Age: 54.0
Sex: M
Vaccine: FLU4, HEPAB, PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: Unable to move left arm, can move fingers.
Age: 1.22
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Crying, Erythema, Pallor, Skin warm
Clinical narrative: 2x2cm erythematous raised patch that is blanchable and warm to the touch; hard to tell if it is tender as patient is crying throughout the exam.
Age: 0.21
Sex: M
Vaccine: DTAP
Symptoms: Crying, Injection site pain
Clinical narrative: Severe, persistent, inconsolable crying for 4 hours. Called clinic which stated it was only due to pain in injection site and to put a cool cloth on it. Later read side effects of vaccine and realized the reaction was not normal.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rash severe itching.