chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Rash generalised
Clinical narrative: Case number PHEH2014US001797 is an initial spontaneous report received from a pharmacist on 22 Jan 2014: This report refers to an adult male patient. He was vaccinated with FLUCELVAX (batch number: 004031A) intramuscularly on 09 Jan 2014 and then developed a rash that spread over his entire body two to three days later. He came to the pharmacy to report his symptoms on 14 Jan 2014. Reporter did not know what caused the rash. No further information about outcome and seriousness was reported.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chapped lips, Lip blister, Lip exfoliation, Lip swelling, Oral pruritus
Clinical narrative: Swelling of lips.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lip swelling
Clinical narrative: Swelling of lips.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Blood culture negative, Bradycardia, C-reactive protein normal, CSF culture negative, CSF glucose normal
Clinical narrative: Patient went to the ER at Hospital for fever. He was lethargy, pallor, pale, poor responsive and flaccid. FYI: Event reported by the Hospital.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: CSF protein normal, CSF white blood cell count negative, Coma scale, Culture urine negative, Hyporesponsive to stimuli
Clinical narrative: Patient went to the ER at Hospital for fever. He was lethargy, pallor, pale, poor responsive and flaccid. FYI: Event reported by the Hospital.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Hypotension, Hypotonia, Pallor, Pyrexia, Red blood cell count normal
Clinical narrative: Patient went to the ER at Hospital for fever. He was lethargy, pallor, pale, poor responsive and flaccid. FYI: Event reported by the Hospital.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Respiration abnormal, Urine analysis normal, Viral test
Clinical narrative: Patient went to the ER at Hospital for fever. He was lethargy, pallor, pale, poor responsive and flaccid. FYI: Event reported by the Hospital.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Hyporesponsive to stimuli, Hypotonia, Lethargy, Pallor, Pyrexia
Clinical narrative: Patient went to the ER at Hospital for fever. He was lethargy, pallor, pale, poor responsive and flaccid. FYI: Event reported by the Hospital.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Slow response to stimuli
Clinical narrative: Patient went to the ER at Hospital for fever. He was lethargy, pallor, pale, poor responsive and flaccid. FYI: Event reported by the Hospital.
Sex: U
Vaccine: PPV
Symptoms: Medication error, No adverse event, Underdose, Wrong drug administered
Clinical narrative: This spontaneous report was received from a health care worker refers to a patient of unknown demographics. On 28-JAN-2014 the patient was vaccinated with PNEUMOVAX23, injection, 0.1 ml (millilitres), intradermal (dosing regimen unspecified). On 28-JAN-2014 the patient experienced accidentally administered with PNEUMOVAX23, the patient received 0.1 ml intradermally (underdose). She reports that a patient was due to receive a tuberculin skin test, but was accidentally administered PNEUMOVAX23 due to product confusion. She stated that the patient received 0.1 ml intradermally. She stated that no adverse reactions reported at this time. The outcome of the medication errors and underdose were unknown. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Neuropathy peripheral
Clinical narrative: Peripheral neuropathy intensified within 24 hours after vaccination.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Extremely itchy scalp, not normal for patient.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Urticaria
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a female patient of unknown age. On 22-JAN-2011, the patient was vaccinated with ZOSTAVAX (dose and frequency was not reported). On 06-DEC-2013, 1050 days after onset of therapy, the patient developed welt on her right trunk and 3 days later many more welts with blistering on the original ones. The patient experienced shingles and the shingles were 2 to 3 inches wide. The physician prescribed VALTREX to the patient on 11-DEC-2013. The outcome of the event shingles was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Suicidal ideation
Clinical narrative: This spontaneous report as received from health professional via company representative refers to a male patient of unknown age. Patients concurrent conditions and medical history were not reported. On an unknown date in July 2013, the patient was vaccinated with GARDASIL first dose, (dose unspecified). Concomitant therapy was unspecified. On an unknown date in September 2013, the patient experienced suicidality (hospitalization). The patient was hospitalized following suicidality. It was reported that the patient received second dose of GARDASIL on an unknown date in December 2013. No Product quality issue involved. The outcome of suicidality was unknown. The reporters causality assessment with the event suicidality and the therapy with GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 02-MAY-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0079AE, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 1.79
Sex: M
Vaccine: DTAP, FLUX, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: 103°F fever, 2+ days duration, treated with Tylenol.
Age: 50.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Cardiac stress test, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Pt. was given ADACEL and FLUVIRIN on 10/14/13. On 10/26/13 she developed numbness and tingling. Was admitted to hospital with Guillain Barre syndrome. Tx with steroids, IV globulins.
Age: 50.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Paraesthesia
Clinical narrative: Pt. was given ADACEL and FLUVIRIN on 10/14/13. On 10/26/13 she developed numbness and tingling. Was admitted to hospital with Guillain Barre syndrome. Tx with steroids, IV globulins.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 22-MAY-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # 670799/0975AA, expiry date 17-JUN-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 15-MAY-2013, the patient was administered with a dose of VARIVAX (merck) (Lot # H012351, expiry date 21-JUN-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Fall, Head injury, Seizure like phenomena, Syncope
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 20 year old male patient with eating disorder, anorexia nervosa and none drug reactions or allergies. On 21-MAY-2012 the patient was vaccinated with the first dose of GARDASIL injection, intramuscularly in the deltoid (strength, lot number and expiration date not provided). No adverse event reported with the first dose of GARDASIL. On 27-JAN-2014 the patient was vaccinated with the second dose of GARDASIL 0.5 ml injection, intramuscularly in the deltoid (lot number # J009243, expiration date: 23-APR-2016). Concomitant therapies included PROZAC (dosage not provided). The nurse reported that on 27-JAN-2014 a patient developed syncope 20 minutes after the second dose of GARDASIL was given, he fell and hit his head and then had seizure like activity. The nurse reported that the patient was made to lie down with feet elevated and was recovered within 45 minutes of the syncope attack. The patient sought medical attention during office visit and had a blood pressure monitored. The outcome of events was reported as recovered/resolved on 27-JAN-2014. The relatedness between vaccination with GARDASIL and events was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 22-NOV-2013, the patient was administered with a dose of VARIVAX (merck) (Lot # 0079AE, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 18-NOV-2013, the patient was administered with a dose of VARIVAX (merck) (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV, TDAP, HEPAB, PPV, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old male patient. Patients historical condition reported as Hepatitis C. Patient had no known drug allergies. On 24-JAN-2014, the patient was vaccinated with PNEUMOVAX23 (lot # J010332, expiry date: 14-JAN-2015) in the outer aspect of the left arm. Concomitant therapies included tdap (manufacturer unknown). The redness and swelling at site of injection had extended from the axilla to elbow and slightly beyond. On 26-JAN-2014, the patient was hospitalized for an over night stay. On 26-JAN-2014, patient was diagnosed with cellulitis (hospitalization). The patient was treated with Clindamycin and SEPTRA DS for an unspecified time. On 27-JAN-2014, the patient was discharged from hospital. He was currently prescribed an unspecified blood pressure medication. The outcome of event cellulitis was unknown. The reporter causality for the event cellulitis with the therapy of PNEUMOVAX23 was reported as to be related. This case is linked to several reports via same reporter link. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV, TDAP, HEPAB, PPV, TDAP
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old male patient. Patients historical condition reported as Hepatitis C. Patient had no known drug allergies. On 24-JAN-2014, the patient was vaccinated with PNEUMOVAX23 (lot # J010332, expiry date: 14-JAN-2015) in the outer aspect of the left arm. Concomitant therapies included tdap (manufacturer unknown). The redness and swelling at site of injection had extended from the axilla to elbow and slightly beyond. On 26-JAN-2014, the patient was hospitalized for an over night stay. On 26-JAN-2014, patient was diagnosed with cellulitis (hospitalization). The patient was treated with Clindamycin and SEPTRA DS for an unspecified time. On 27-JAN-2014, the patient was discharged from hospital. He was currently prescribed an unspecified blood pressure medication. The outcome of event cellulitis was unknown. The reporter causality for the event cellulitis with the therapy of PNEUMOVAX23 was reported as to be related. This case is linked to several reports via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-OCT-2013, the patient was administered with a dose of VARIVAX (merck) (Lot # 0079AE, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 10-OCT-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-OCT-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0079AE, expiry date unknown) (Route, dosing reigmen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unkonwn age and gender. On 25-NOV-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0079AE, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 05-NOV-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 18-JUN-2013, the patient was administered with a dose of VARIVAX (merck) (Lot # H012351, expiry date 21-JUN-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a 17 year old patient of unknown demography. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose and frequency was not reported). It was reported that the 17 year old patient has been receiving PNEUMOVAX23 every three years since an unspecified date. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 15-JUL-2013, the patient was administered with a dose of VARIVAX (merck) (Lot # H012351, expiry date 21-JUN-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-AUG-2013, the patient was administered with a dose of VARIVAX (merck) (Lot # H012351, expiry date 21-JUN-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age (also reported as about 45 years old). On an unknown date, the patient was vaccinated with ZOSTAVAX (dose and frequency was not reported). On an unknown date, the patient experienced cold sores after administering with ZOSTAVAX. It was reported that the patient was not sought any medical attention. It was also reported that the patient had not received any treatment. The pharmacist also reported that developing of the cold sores happens frequently. The outcome of the event cold sores was unknown. This case is linked to case 1401USA014439 and 1401USA014549 (same reporter link). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age (also reported as about 45 years old). On an unknown date, the patient was vaccinated with ZOSTAVAX (dose and frequency was not reported). On an unknown date, the patient experienced cold sores after administering with ZOSTAVAX. It was reported that the patient was not sought any medical attention. It was also reported that the patient had not received any treatment. The pharmacist also reported that developing cold sores happens frequently to the patient. The outcome of the event cold sores was unknown. This case is linked to the cases 1401USA014549 and 1401USA014550 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 11-NOV-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 11-NOV-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 25-SEP-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 07-AUG-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0079AE, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-SEP-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age (also reported as about 45 years old). On an unknown date, the patient was vaccinated with ZOSTAVAX (dose and frequency was not reported). On an unknown date, the patient experienced cold sores after administering with ZOSTAVAX. It was reported that the patient was not sought any medical attention. It was also reported that the patient had not received any treatment. The pharmacist also reported that developing of cold sores happens frequently. The outcome of the event cold sores was unknown. The case is linked to case 1401USA014439 and 1401USA014550 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 07-AUG-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # H012351, expiry date 21-JUN-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Convulsion, Feeling abnormal
Clinical narrative: This spontaneous report as received from a nurse refers to a 11 year old patient of unknown gender who on approximately on December 2013 (within the last month or two), was vaccinated with the first dose of GARDASIL dose 1 (Dose, route and lot number was not provided). The reporter informed that the patient experienced that they "felt funny" and then had a seizure, after receiving the "eleven year old shots" which included the first dose of GARDASIL, "within the last month or two." The patient was sent to the Hospital, as per the office protocol. The patient did not required intervention to prevent serious criteria. At the time of the report the patient was well. The outcome of had a seizure, after receiving their first dose of GARDASIL and felt funny was unknown. Upon internal review, the event of seizure was considered as medically significant. The relationship between adverse events and GARDASIL was unknown. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 04-DEC-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0079AE, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 29-NOV-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 42 year old male patient. The patient's medical history included hepatitis C. Patient had no known drug allergies. On 23-JAN-2014, the patient was vaccinated with PNEUMOVAX23 (lot # J010332, expiry date: 14-Jan-2015) in the left arm. Concomitant medication was not reported. On 24-JAN-2014, the patient experienced left arm pain (hospitalization), swelling and warm to touch at the site of injection (hospitalization), redness (hospitalization). Patient was kept overnight in the Hospital Unit for observation. On 25-JAN-2014 (following day), the patient was discharged from hospital with no left arm pain less redness. Patient was prescribed a shot of BENADRYL and a MEDROL dose pack and 10 days as well as an unspecified sulfa antibiotic. The outcome of event swelling and warm to touch at the site of injection was unknown. The reporter causality for the events with the therapy of PNEUMOVAX23 was reported as to be related. The case was linked to several reports via same reporter. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 42 year old male patient. The patient's medical history included hepatitis C. Patient had no known drug allergies. On 23-JAN-2014, the patient was vaccinated with PNEUMOVAX23 (lot # J010332, expiry date: 14-Jan-2015) in the left arm. Concomitant medication was not reported. On 24-JAN-2014, the patient experienced left arm pain (hospitalization), swelling and warm to touch at the site of injection (hospitalization), redness (hospitalization). Patient was kept overnight in the Hospital Unit for observation. On 25-JAN-2014 (following day), the patient was discharged from hospital with no left arm pain less redness. Patient was prescribed a shot of BENADRYL and a MEDROL dose pack and 10 days as well as an unspecified sulfa antibiotic. The outcome of event swelling and warm to touch at the site of injection was unknown. The reporter causality for the events with the therapy of PNEUMOVAX23 was reported as to be related. The case was linked to several reports via same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 04-DEC-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: This medically confirmed report (initial receipt 20-Jan-2014) concerns a female patient who had a medical history of mild anaemia, egg allergy (but still able to eat eggs) and had received a pneumonia vaccine when younger, and the HPV vaccine. On the 02-Jul-2012, the patient received the influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route in the right deltoid. On an unspecified date, the patient developed a serious reaction to the influenza vaccine. Outcome was not reported.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site induration
Clinical narrative: Day 1 induration about 6 cm, day 2 redness and induration with chills 8 x 7 cm at injection site.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Dizziness, Dyspnoea, Heart rate increased, Pneumonia
Clinical narrative: Dizziness, rapid heart rate and dyspnea. CXR perfromed; pneumonia dx.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Insomnia, Paraesthesia, Quality of life decreased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. On 02-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot# not reported) 0.65 ml, subcutaneous, in the left arm (frequency not reported). On an unknown date the patient experienced numbness and tingling down her left arm, same arm as vaccination, from her elbow to her thumb. It was also reported that the patient was losing sleep and it was affecting her quality of life. The patient had gone to local urgent care center on unspecified date and was treated with prednisone. The outcome of the events was reported as not recovered. Relatedness between the events and the ZOSTAVAX was not assessed by the reporter. The event losing sleep which was affecting quality of life was considered to be disability. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster
Clinical narrative: This spontaneous report as received from a retired physician refers to herself, a 70 year old female patient with drug reaction/allergy to LEVAQUIN. In 2006 the patient was vaccinated with ZOSTAVAX. Dose number, lot number, expiry date, route of administration and anatomical location were not reported. On 19-JAN-2014 the patient developed an area of redness in the L1 distribution. The patient self-diagnosed this as shingles. This diagnosis was confirmed by her neurologist during a routine follow up visit on 20-JAN-2014. The patient was prescribed FAMVIR and Prednisone. The patient was recovering from the shingles at the time of reporting. No causality assessment was reported, the action taken was reported as not applicable. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female nurse of unknown age. Patients concurrent condition and medical history were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot number and expiry date unspecified) (dose, route unspecified). No concomitant therapy was reported. On an unknown date, the patient experienced could not lift her arm for a week (disability). The outcome of event was unknown. The reporter considered the event to be related to PNEUMOVAX23. This case is linked to several reports via same reporter link. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Rash
Clinical narrative: Redness, rash.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion, Feeling abnormal, Urinary incontinence
Clinical narrative: This spontaneous report as received from a nurse refers to a 11 year old patient who in approximately December 2013 (within the last month or two), was vaccinated with the first dose of GARDASIL dose 1 (dose, route and lot number was not provided). The reporter informed that the patient experienced that they "felt funny" and then had a seizure, after receiving the "eleven year old shots" which included the first dose of GARDASIL, "within the last month or two." The patient urinated upon himself, during the seizure. The patient was sent to the hospital, as per the office protocol. The patient did not require intervention to prevent serious criteria. At the time of the report the patient was well. No further information was provided. The outcome of had a seizure, after receiving their first dose of GARDASIL, urinated upon himself, during the seizure and "felt funny" was unknown. Upon internal review, the event of seizure was considered as medically significant. The relationship between adverse events and GARDASIL was unknown. This is one of two reports from the same source. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3, TYP
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash on midriff.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Extreme pain in upper arm. Feeling like my body was shutting down.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: 2 Small red rashes to right lateral thigh.  Rashes enlarged over next 24 hours.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Allergy to vaccine, Arthralgia, Arthritis, Blood test, Electromyogram
Clinical narrative: Started with severe pain in hips joints - had Xrays, just regular arthritis, not enough for this amount of pain.  That slowly cleared up, then severe pain in shoulders, wrists and hands and fingers.  Fingers on right hand swollen, skin peeling.  Pins and needles, and electric shock sensations.  Lost 10 pounds, couldn't sleep, paced the floor at night.  Horrible.  Have seen a neurologist and rheumatologist and have been on two rounds of prednisone.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Insomnia, Local swelling, Musculoskeletal pain, Nuclear magnetic resonance imaging spinal, Pain in extremity
Clinical narrative: Started with severe pain in hips joints - had Xrays, just regular arthritis, not enough for this amount of pain.  That slowly cleared up, then severe pain in shoulders, wrists and hands and fingers.  Fingers on right hand swollen, skin peeling.  Pins and needles, and electric shock sensations.  Lost 10 pounds, couldn't sleep, paced the floor at night.  Horrible.  Have seen a neurologist and rheumatologist and have been on two rounds of prednisone.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Skin exfoliation, Weight decreased, X-ray of pelvis and hip abnormal
Clinical narrative: Started with severe pain in hips joints - had Xrays, just regular arthritis, not enough for this amount of pain.  That slowly cleared up, then severe pain in shoulders, wrists and hands and fingers.  Fingers on right hand swollen, skin peeling.  Pins and needles, and electric shock sensations.  Lost 10 pounds, couldn't sleep, paced the floor at night.  Horrible.  Have seen a neurologist and rheumatologist and have been on two rounds of prednisone.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Joint range of motion decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Acute - chronic arm/shoulder pain. Symptoms have lasted over 3 months. NSAIDs taken PO are helpful. Gradual improvement. Continue to have decreased range of motion, weakness, and intermittent pain.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HPV4, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 8 week old patient of an unknown gender. On 29-JAN-2014 the patient was vaccinated with a dose of GARDASIL, intramuscularly (dose, frequency were not reported) in the right thigh in error. No product confusion discovered, just medication error. No adverse event reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Arm redness (R) deltoid 2 days after, after removal of bandage, some in shape of bandage. No fever.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a third party administrator on behalf of a pharmacy concerning a female patient, who on 14DEC2013 was vaccinated with PNEUMOVAX vaccine with lot # J009827 and an expiration date of 01AUG2014. The patient experienced an adverse reaction (not further specified). Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site urticaria, Rash erythematous, Rash pruritic
Clinical narrative: 1/25/14 - patient called to report noticed itchy red (hives) spots at injection site on night of 1/23/14. Stated spots had started to improve already but wanted to report reaction. Not able to finish conversation at that time. I called her again on 1/26/14, said rash was continuing to improve but not able to talk at the time. I called 1/27/14 to complete form.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Asthma, Cough, Dyspnoea, Respiratory distress
Clinical narrative: This spontaneous report as received from a 65 year old diabetic female consumer with high blood pressure, irritable bowel syndrome, drug reaction/allergy to morphine and DARVOCET-N refers to herself. On 10-NOV-2013 the patient received unspecified flu vaccine (manufacturer unknown) (lot #, dose and route unknown) and pneumococcal vaccine(manufacturer unknown) (lot #, dose and route unknown). On 17-NOV-2013, reported as the following Sunday, she experienced a severe cough with respiratory distress which caused her difficulty breathing and eventually she was hospitalized (hospital unspecified) over Christmas time (unspecified date) for 3 days. Consumer stated that she used a nebulizer with an unspecified medication to help treat her condition while in the hospital. Consumer stated that after she was discharged from the hospital, she was seen by another physician at the same facility. Consumer noted that the physician stated that her lungs indicated that she had a severe asthma attack. Outcome of adverse event was not reported. The relatedness between adverse event and pneumococcal vaccine (manufacturer unknown) and unspecified flu vaccine (manufacturer unknown) was unknown. Additional information has been requested. This report is linked to same patient report MARRS 1401USA013330.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Asthma, Cough, Dyspnoea, Feeling abnormal, Respiratory distress
Clinical narrative: This spontaneous report as received from a 65 year old diabetic female consumer with high blood pressure, irritable bowel syndrome, drug reaction/allergy to morphine and DARVOCET-N refers to herself. On 10-NOV-2013 the patient received unspecified flu vaccine (manufacturer unknown) (lot #, dose and route unknown) and pneumococcal vaccine(manufacturer unknown) (lot #, dose and route unknown). On 17-NOV-2013, reported as the following Sunday, she experienced a severe cough with respiratory distress which caused her difficulty breathing and eventually she was hospitalized (hospital unspecified) over Christmas time (unspecified date) for 3 days. Consumer stated that she used a nebulizer with an unspecified medication to help treat her condition while in the hospital. Consumer stated that after she was discharged from the hospital, she was seen by another physician at the same facility. Consumer noted that the physician stated that her lungs indicated that she had a severe asthma attack. Outcome of adverse event was not reported. The relatedness between adverse event and pneumococcal vaccine (manufacturer unknown) and unspecified flu vaccine (manufacturer unknown) was unknown. Additional information has been requested. This report is linked to same patient report MARRS 1401USA013330.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Arthralgia, Asthenia, Asthma, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: This spontaneous report as received from a 65 year old diabetic female consumer with high blood pressure, irritable bowel syndrome, drug reaction/allergy to morphine and DARVOCET-N refers to herself. On 10-NOV-2013 the patient received unspecified flu vaccine (manufacturer unknown) (lot #, dose and route unknown) and pneumococcal vaccine(manufacturer unknown) (lot #, dose and route unknown). On 17-NOV-2013, reported as the following Sunday, she experienced a severe cough with respiratory distress which caused her difficulty breathing and eventually she was hospitalized (hospital unspecified) over Christmas time (unspecified date) for 3 days. Consumer stated that she used a nebulizer with an unspecified medication to help treat her condition while in the hospital. Consumer stated that after she was discharged from the hospital, she was seen by another physician at the same facility. Consumer noted that the physician stated that her lungs indicated that she had a severe asthma attack. Outcome of adverse event was not reported. The relatedness between adverse event and pneumococcal vaccine (manufacturer unknown) and unspecified flu vaccine (manufacturer unknown) was unknown. Additional information has been requested. This report is linked to same patient report MARRS 1401USA013330.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Cough, Dermatitis contact, Dyspnoea, General physical condition abnormal, Malaise
Clinical narrative: This spontaneous report as received from a 65 year old diabetic female consumer with high blood pressure, irritable bowel syndrome, drug reaction/allergy to morphine and DARVOCET-N refers to herself. On 10-NOV-2013 the patient received unspecified flu vaccine (manufacturer unknown) (lot #, dose and route unknown) and pneumococcal vaccine(manufacturer unknown) (lot #, dose and route unknown). On 17-NOV-2013, reported as the following Sunday, she experienced a severe cough with respiratory distress which caused her difficulty breathing and eventually she was hospitalized (hospital unspecified) over Christmas time (unspecified date) for 3 days. Consumer stated that she used a nebulizer with an unspecified medication to help treat her condition while in the hospital. Consumer stated that after she was discharged from the hospital, she was seen by another physician at the same facility. Consumer noted that the physician stated that her lungs indicated that she had a severe asthma attack. Outcome of adverse event was not reported. The relatedness between adverse event and pneumococcal vaccine (manufacturer unknown) and unspecified flu vaccine (manufacturer unknown) was unknown. Additional information has been requested. This report is linked to same patient report MARRS 1401USA013330.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Respiratory distress, Respiratory tract congestion, Type 1 diabetes mellitus
Clinical narrative: This spontaneous report as received from a 65 year old diabetic female consumer with high blood pressure, irritable bowel syndrome, drug reaction/allergy to morphine and DARVOCET-N refers to herself. On 10-NOV-2013 the patient received unspecified flu vaccine (manufacturer unknown) (lot #, dose and route unknown) and pneumococcal vaccine(manufacturer unknown) (lot #, dose and route unknown). On 17-NOV-2013, reported as the following Sunday, she experienced a severe cough with respiratory distress which caused her difficulty breathing and eventually she was hospitalized (hospital unspecified) over Christmas time (unspecified date) for 3 days. Consumer stated that she used a nebulizer with an unspecified medication to help treat her condition while in the hospital. Consumer stated that after she was discharged from the hospital, she was seen by another physician at the same facility. Consumer noted that the physician stated that her lungs indicated that she had a severe asthma attack. Outcome of adverse event was not reported. The relatedness between adverse event and pneumococcal vaccine (manufacturer unknown) and unspecified flu vaccine (manufacturer unknown) was unknown. Additional information has been requested. This report is linked to same patient report MARRS 1401USA013330.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Impetigo, Injection site erythema, Injection site pain, Injection site reaction, Pruritus
Clinical narrative: Redness and pain at injection site, persistent itching developed impetigo at injection site. Pt being treated with Mupirocin.
Age: 1.25
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash, Scab, Vaccination site rash
Clinical narrative: Pt had approximately 20 lesions. At first developed bumps at vaccination site then developed rash on trunk, back and face. Some spots are starting to scab over. No fever, no s/s of cellulitis or pneumonia.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dyspnoea, Influenza, Pyrexia, Tremor
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 17 year old female patient with thalassemia and no drug reactions or allergies. Concomitant medications were not specified by the reporter. On 24-SEP-2013 the patient was vaccinated with GARDASIL (lot number, expiration date, dose and strength were not reported) intramuscularly. On 25-SEP-2013 the patient developed flu, trouble breathing, fever, shakes and shivers. The patient went to the emergency room. On 26-SEP-2013 the patient recovered from the events. The patient sought medical attention - went to the emergency room at hospital, the patient was not hospitalized. The relatedness between the events and GARDASIL was not reported. Additional information is expected.