chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Guillain-Barre syndrome, Muscular weakness, Nerve conduction studies abnormal, Plasmapheresis
Clinical narrative: Case number PHHY2013US148728 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 512116) website on 16 Dec 2013 and a follow-up information was received from Quality Assurance department (reference number: 271503) on 20 Dec 2013 and another follow up was received from QA department on 16 Jan 2014. This report refers to a 77-year-old male patient. His medical history included diabetes, pacemaker and neuropathy. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1308201, expiry date: 31 Mar 2014) intramuscularly in to the left arm on 01 Oct 2013. On 08 Oct 2013, he experienced leg weakness that resulted in a fall. Weakness and paralysis moved to arms. His speech, swallowing and breathing were all affected adversely. Laboratory test included connective nerve study and muscle and nerve biopsy and he was diagnosed with Guillain-Barre Syndrome on an undetermined date. Plasmapheresis treatments (five, every other day) were given that yielded positive response. Patient was in rehabilitation at a 24/7 care facility at the time of reporting. Outcome of the events was reported as condition unchanged as on 08 Nov 2013. The reporter assessed the events as life threatening. No further information about causality was provided. Batch review report (reference number: 271503) received from quality assurance department on 20 Jan 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 1308201) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 271503) on 20 Dec 2013: Updated QA reference number only. Follow up received from Quality Assurance department on 16 Jan 2014: Updated Batch review report.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Speech disorder
Clinical narrative: Case number PHHY2013US148728 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 512116) website on 16 Dec 2013 and a follow-up information was received from Quality Assurance department (reference number: 271503) on 20 Dec 2013 and another follow up was received from QA department on 16 Jan 2014. This report refers to a 77-year-old male patient. His medical history included diabetes, pacemaker and neuropathy. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1308201, expiry date: 31 Mar 2014) intramuscularly in to the left arm on 01 Oct 2013. On 08 Oct 2013, he experienced leg weakness that resulted in a fall. Weakness and paralysis moved to arms. His speech, swallowing and breathing were all affected adversely. Laboratory test included connective nerve study and muscle and nerve biopsy and he was diagnosed with Guillain-Barre Syndrome on an undetermined date. Plasmapheresis treatments (five, every other day) were given that yielded positive response. Patient was in rehabilitation at a 24/7 care facility at the time of reporting. Outcome of the events was reported as condition unchanged as on 08 Nov 2013. The reporter assessed the events as life threatening. No further information about causality was provided. Batch review report (reference number: 271503) received from quality assurance department on 20 Jan 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 1308201) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 271503) on 20 Dec 2013: Updated QA reference number only. Follow up received from Quality Assurance department on 16 Jan 2014: Updated Batch review report.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Serum sickness
Clinical narrative: Case number PHHY2014US001132 is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 512779) website on 06 Jan 2014 with a follow up information received from quality assurance department (reference number: 274099) on 17 Jan 2014. This case refers to 18 year old female patient. The patient was vaccinated with MENVEO (batch number: M12098, expiry date: Sep 2014) and GARDASIL (other manufacturer, batch number: J007354) both on 07 Oct 2013. On 09 Oct 2013, the patient developed serum reaction. The outcome of event was reported as condition unchanged as of 13 Nov 2013. The seriousness and causality of event were not reported. Based on the batch review performed, it was concluded that this MENVEO batch number M12098 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up information received from QA department (reference number: 274099) on 17 Jan 2014: Updated batch review report.
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Shoulder pain beginning upon injection. Unresolved as of 6 weeks later. Injection administered too high (in shoulder). MD visit and x-rays indicated tendonitis.
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Incorrect route of drug administration, Musculoskeletal pain, Tendonitis, X-ray limb abnormal
Clinical narrative: Shoulder pain beginning upon injection. Unresolved as of 6 weeks later. Injection administered too high (in shoulder). MD visit and x-rays indicated tendonitis.
Age: 40.0
Sex: F
Vaccine: FLUR3, FLUX
Symptoms: Asthenia, Inflammation, Neuralgic amyotrophy, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Immediately same day experienced acute shoulder pain where vaccination was administered. Pain continued to worsen, feeling almost paralyzed at night and in the morning. Unable to perform full range of motion. Severe pain following flu vaccine. Diagnosed with Parsonage Turner Syndrome.
Age: 40.0
Sex: F
Vaccine: FLUR3, FLUX
Symptoms: Paraesthesia, X-ray normal
Clinical narrative: Immediately same day experienced acute shoulder pain where vaccination was administered. Pain continued to worsen, feeling almost paralyzed at night and in the morning. Unable to perform full range of motion. Severe pain following flu vaccine. Diagnosed with Parsonage Turner Syndrome.
Age: 40.0
Sex: F
Vaccine: FLUR3, FLUX
Symptoms: Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Vaccination site pain, X-ray limb
Clinical narrative: Immediately same day experienced acute shoulder pain where vaccination was administered. Pain continued to worsen, feeling almost paralyzed at night and in the morning. Unable to perform full range of motion. Severe pain following flu vaccine. Diagnosed with Parsonage Turner Syndrome.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, Pruritus, Rash, Swelling, Urticaria
Clinical narrative: Rash, hives, swelling, arm pain, pruritis.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to an unknown number of patients of unknown demographics. The patient's concurrent conditions and medical history were not reported. On an unknown date in 2013, an unspecified number of patients received improperly stored Vaccine For Children (VFC) doses of RECOMBIVAX HB (dose and route, lot and expiration date were not reported) exposed to 20F and 30F on multiple occasions, from 22-SEP-2013 until 20-DEC-2013 (for 122 days). No adverse effects were reported (the reporter stated that the vaccines administered were RECOMBIVAX HB and VAQTA but on a second call was reported that no doses of VAQTA were involved in this excursion). Follow up information has been received from the certified medical assistant which reported that one of the patients was vaccinated with a dose of RECOMBIVAX HB (lot number reported as J0030722) on 01-NOV-2013. This is one of several reports from the same source. J0030722 is not valid lot number for RECOMBIVAX HB. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from nurse practitioner via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route and administration unknown). No concomitant medication was reported. Approximately in January 2014 (reported as sometime last week) the patient experienced seizures (medically significant). The patient was referred to Emergency room for treatment. Patient sought medical attention. The outcome of seizures was unknown. Causality was unknown. No product quality complaint was reported. Upon internal review the event seizure was considered as medically significant. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Computerised tomogram, Gait disturbance, Laboratory test, Nerve injury
Clinical narrative: This medically confirmed report (initial receipt 09-Jan-2014) concerns a 55-year-old male patient. On 04-Oct-2013, the patient received an unspecified influenza virus vaccine (manufacturer and batch number not reported) in his right arm. On unspecified dates, within a couple of weeks after vaccination, the patient developed ongoing right-sided hip pain, right leg pain which affected his walking and right foot not wanting to work. He stated that the pain was constant, but sometimes worsened. On 08-Jan-2014, the patient was able to go for a jog and the pain increased thereafter. The patient also reported that sometime after the vaccine was administered, he developed rash on his buttocks which had resolved. The patient went to the emergency room where lab work was done but no MRI (magnetic resonance imaging) /CAT scan (computed tomography) /X-ray were performed. The patient was not admitted to the hospital. He had a follow-up appointment on 10-Jan-2014. The patient saw the physician for the first time and the patient stated to physician that he thought he had nerve damage. Outcome was reported as not yet recovered. Follow up (10-Jan-2014) Medical confirmation, additional events and details.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity, Rash, X-ray
Clinical narrative: This medically confirmed report (initial receipt 09-Jan-2014) concerns a 55-year-old male patient. On 04-Oct-2013, the patient received an unspecified influenza virus vaccine (manufacturer and batch number not reported) in his right arm. On unspecified dates, within a couple of weeks after vaccination, the patient developed ongoing right-sided hip pain, right leg pain which affected his walking and right foot not wanting to work. He stated that the pain was constant, but sometimes worsened. On 08-Jan-2014, the patient was able to go for a jog and the pain increased thereafter. The patient also reported that sometime after the vaccine was administered, he developed rash on his buttocks which had resolved. The patient went to the emergency room where lab work was done but no MRI (magnetic resonance imaging) /CAT scan (computed tomography) /X-ray were performed. The patient was not admitted to the hospital. He had a follow-up appointment on 10-Jan-2014. The patient saw the physician for the first time and the patient stated to physician that he thought he had nerve damage. Outcome was reported as not yet recovered. Follow up (10-Jan-2014) Medical confirmation, additional events and details.
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 16-MAY-2013 (lot number: H011350; exp date: 21-FEB-2015) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: F
Vaccine: HEPA
Symptoms: Booster dose missed, No adverse event
Clinical narrative: This spontaneous report as received from a consumer of unknown age concerning herself. On 04-NOV-2005 the patient was vaccinated with VAQTA injection (strength, dose, dose number, lot number and expiry date unknown) and never received a booster dose. No adverse event was reported. The outcome of never received a booster dose was unknown. 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-SEP-2011, the patient was administered with a dose of VARIVAX (Lot # 0345AA 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 121 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to an unknown number of patients of unknown demographics. The patient's concurrent conditions and medical history were not reported. On an unknown date in 2013, an unspecified number of patients received improperly stored Vaccine For Children (VFC) doses of RECOMBIVAX HB (dose and route, lot and expiration date were not reported) exposed to 20F and 30F on multiple occasions, from 22-SEP-2013 until 20-DEC-2013 (for 122 days. No adverse effects were reported (the reporter stated that the vaccines administered were RECOMBIVAX HB and VAQTA but on a second call was reported that no doses of VAQTA were involved in this excursion. Follow up information has been received from the certified medical assistant which reported that one of the patients was vaccinated with a dose of RECOMBIVAX HB (lot number reported as J0030722) on 29-AUG-2013. This is the one several reports from the same source. J0030722 is not valid lot number for RECOMBIVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to an unknown number of patients of unknown demographics. The patients' concurrent conditions and medical history were not reported. On an unknown date in 2013, an unspecified number of patients received improperly stored Vaccine For Children (VFC) doses of RECOMBIVAX HB (dose and route, lot and expiration date were not reported) exposed to 20F and 30F on multiple occasions, from 22-SEP-2013 until 20-DEC-2013 (for 122 days). No adverse effects were reported (the reporter stated that the vaccines administered were RECOMBIVAX HB and VAQTA but on a second call was reported that no doses of VAQTA were involved in this excursion). Follow up information has been received from the certified medical assistant which reported that one of the patients was vaccinated with a dose of RECOMBIVAX HB (lot number reported as J0030722) on 22-AUG-2013. This is the one of several reports from the same source. J0030722 is not valid lot number for RECOMBIVAX HB. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age. On 23-OCT-2013 the patient was vaccinated with GARDASIL dose 2. She had received her first dose of the GARDASIL vaccine sometime in 2012 and got her second dose of that vaccine on 23-OCT-2013. Next Tuesday, she will get her third dose of the vaccine. No side effects have been 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 14-SEP-2011, the patient was administered with a dose of VARIVAX (oka/merck) (Lot # 0345AA 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 121 reports received from the same source. 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 23-SEP-2011, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0345AA 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 121 reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18 year old patient of unknown gender. On 27-JUN-2013 the patient was vaccinated with the first dose of GARDASIL injection (strength, route, lot number and expiration date not provided). On 29-OCT-2013 the patient was vaccinated with the second dose of GARDASIL injection (strength, route, lot number and expiration date not provided). On 27-DEC-2013 the patient was vaccinated with the third dose of GARDASIL injection (strength, route, lot number and expiration date not provided). No adverse event was 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 29-MAY-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 1909AA 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 121 reports received from the same source. 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 09-MAY-2013 (lot number: 672232/1495AA; exp date: 22-AUG-2014) (dose, frequency, route and site of administration were 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: 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-MAY-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0345AA 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 121 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Booster dose missed, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 nurses of unknown age. On 28-DEC-2013 reported as two days ago, the patients were due a dose of RECOMBIVAX HB, injection, (strength, route, lot number and expiration date not provided). 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 had been administered dose of GARDAIL on 30-APR-2013 (lot number: H011350; exp date: 21-FEB-2015) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Local swelling, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 65 year old female patient with no pertinent medical history and no comorbidities. On an unknown date the patient was vaccinated with the first dose of PNEUMOVAX 23 0.5 ml intramuscularly (lot number and expiration date not provided). No concomitant medication was reported. On an unknown date the patient experienced erythema, fever, swelling, pain (unspecified) and severe arm swelling within 24 hours of receiving PNEUMOVAX 23. The patient was seen in unspecified emergency departments but was not admitted to the hospital. The patient was diagnosed with cellulitis. The patient was prescribed antibiotics in the ER, maybe received oral cephalexin or vancomycin IV. The outcome of events was reported as recovered. The relatedness between vaccination with PNEUMOVAX 23 and events was not reported. This is one of three reports from the same source (related to MARRS # 1401USA003077, related to MARRS # 1401USA003078). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 65 year old female patient with no pertinent medical history and no comorbidities. On an unknown date the patient was vaccinated with the first dose of PNEUMOVAX 23 0.5 ml intramuscularly (lot number and expiration date not provided). No concomitant medication was reported. On an unknown date the patient experienced erythema, fever, swelling, pain (unspecified) and severe arm swelling within 24 hours of receiving PNEUMOVAX 23. The patient was seen in unspecified emergency departments but was not admitted to the hospital. The patient was diagnosed with cellulitis. The patient was prescribed antibiotics in the ER, maybe received oral cephalexin or vancomycin IV. The outcome of events was reported as recovered. The relatedness between vaccination with PNEUMOVAX 23 and events was not reported. This is one of three reports from the same source (related to MARRS # 1401USA003077, related to MARRS # 1401USA003078). Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a female patient of unknown demographics concerning herself. On an unknown date the patient was vaccinated with RECOMBIVAX HB (dosing regimen unspecified0. No concomitant medications were reported. On an unknown date the patient reported a medication error that she received RECOMBIVAX HB (dosage unknown) after it had been in a back pack for several hours and was not kept in its correct storage conditions. No adverse events were reported. The patient did not wish to provide any information. There was no mention of a physician in this case. The outcome of the medication error was unknown. Additional information is not expected.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse of unknown age refers to herself. The patient reported that when she was younger (age unspecified) she had to restart the Hepatitis A (manufacturer unspecified, hepatitis a vaccine, inactivated (VAQTA) could not be ruled out) vaccine series twice because of an extended interval between doses (exact dates were not reported). She did not seek medical attention and reported that they kept forgetting to go to the doctors to get them. No adverse effects was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient had unspecified Psychiatric medical history. In November-2013 the patient was vaccinated with ZOSTAVAX dose 2 for shingles prevention. On an unknown date the patient developed a rash on an unknown apart of a body on an unspecified date after receiving second dose of ZOSTAVAX. The patient was taken to an unspecified Emergency room and discharged from the unspecified emergency room on an unspecified date. Patient was not admitted to a hospital. It was stated that the reporter did not know if any treatment was given to the patient at the time of the emergency room visit. No product quality complaint (PQC) was filed. The outcome of developed a rash on an unknown part of a body on an unspecified date after receiving second dose of ZOSTAVAX is recovered/resolved. The causality for the rash was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Gastroenteritis, Pain in extremity, Rash macular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient had unspecified Psychiatric medical history. In November-2013 the patient was vaccinated with ZOSTAVAX dose 2 for shingles prevention. On an unknown date the patient developed a rash on an unknown apart of a body on an unspecified date after receiving second dose of ZOSTAVAX. The patient was taken to an unspecified Emergency room and discharged from the unspecified emergency room on an unspecified date. Patient was not admitted to a hospital. It was stated that the reporter did not know if any treatment was given to the patient at the time of the emergency room visit. No product quality complaint (PQC) was filed. The outcome of developed a rash on an unknown part of a body on an unspecified date after receiving second dose of ZOSTAVAX is recovered/resolved. The causality for the rash was not reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Pain, Pruritus, Rash
Clinical narrative: This si spontaneous report as received from a 63 year old female patient refers to herself. The patient's current condition included stress. On 13-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX injection (route, strength, lot number and expiration date not provided). Concomitant therapies included sulfamethoxazole (+) trimethoprim 800/160. The patient experienced shingles symptoms including rash and pain on torso, after receiving ZOSTAVAX. On 28-DEC-2013 the patient began to experience significant pain in her side. She visited the Emergency Room. On 30-DEC-2013, in the emergency room, she was tested and diagnosed with a possible urinary tract infection, after also being tested for kidney and gallstones. The patient noted that she had no symptoms of urinary tract infection (UTI) but did not think her pain was the result of shingles, until she also experienced a patch of rash on her stomach, which was very sensitive. The rash then also appeared on her back, accompanied by intermittent itch and pain. Urine specimen and sonogram were performed (result unknown). An ibuprofen (OTC product) was given for treatment of events. The patient planned follow-up with her physician to see if anti-virals could be prescribed. The outcome of events was reported as not recovered/not resolved. The relatedness between vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound scan, Urine analysis
Clinical narrative: This si spontaneous report as received from a 63 year old female patient refers to herself. The patient's current condition included stress. On 13-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX injection (route, strength, lot number and expiration date not provided). Concomitant therapies included sulfamethoxazole (+) trimethoprim 800/160. The patient experienced shingles symptoms including rash and pain on torso, after receiving ZOSTAVAX. On 28-DEC-2013 the patient began to experience significant pain in her side. She visited the Emergency Room. On 30-DEC-2013, in the emergency room, she was tested and diagnosed with a possible urinary tract infection, after also being tested for kidney and gallstones. The patient noted that she had no symptoms of urinary tract infection (UTI) but did not think her pain was the result of shingles, until she also experienced a patch of rash on her stomach, which was very sensitive. The rash then also appeared on her back, accompanied by intermittent itch and pain. Urine specimen and sonogram were performed (result unknown). An ibuprofen (OTC product) was given for treatment of events. The patient planned follow-up with her physician to see if anti-virals could be prescribed. The outcome of events was reported as not recovered/not resolved. The relatedness between vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to several patients of unknown demographics. On an unknown date the patients were vaccinated with GARDASIL (dosing regimen unspecified). No concomitant medications were reported. On an unknown date, nurse reported that over the years, several patients of the office have had either several months or even years between the doses of GARDASIL. No adverse effects reported. Outcome of the medication error was unknown. 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 08-MAY-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 1909AA expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. 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 06-MAY-2013 (lot number 672232/1495AA; exp date: 22-AUG-2014) (dose, frequency, route and site of administration were 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: 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-MAY-2012, the patient was administered with a dose of VARIVAX (merck) (Lot # 1909AA 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 121 reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient no known allergies. On 18-JAN-2014, the patient was vaccinated with ZOSTAVAX. Dose, route and frequency were unspecified. Approximately in January 2014, the patient developed a rash at the injection site. Patient described the rash to the pharmacist as a shingles like rash. VZVIP packet faxed. The outcome of shingles like rash was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer (patients mother) refers to her daughter (11 years old). the patient was vaccinated with GARDASIL injection first shot on 23-APR-2013, second sot on 25-JUL-2013 and third shot on 08-OCT-2013. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose increased, Condition aggravated
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a female patient of unknown age. Patient is diabetic with previously good blood glucose control on an insulin pump. On an unknown date, the patient was vaccinated with GARDASIL injection. Dose, route and frequency were unspecified. Concomitant therapies included insulin pump. On an unknown date, after administration of GARDASIL the patient presented with sky high blood glucose level. The patient sought medical attention and visited the office. The outcome of sky high blood glucose level and causality assessment was not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Local swelling, Pain, Swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 65 year old female patient with none pertinent medical history and no comorbidities. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml intramuscularly (lot number and expiration date not provided). No concomitant medication was reported. On an unknown date the patient experienced erythema, fever, swelling, pain and severe arm swelling within 24 hours of receiving PNEUMOVAX 23. The patient sought medical attention - was seen in the emergency department but was not admitted to the hospital. The patient was diagnosed with cellulitis. The patient was prescribed vancomycin (manufacturer unknown) intravenously (dosage unspecified). The outcome of the events was reported as recovered. The relatedness between vaccination and PNEUMOVAX 23 and events was not reported. This is one of three reports from the same source (#1401USA0030078, #1401USA001748). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Local swelling, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 65 year old female patient with none pertinent medical history and no comorbidities. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscularly (lot number and expiration date not provided). No concomitant medication was reported. On an unknown date the patient experienced erythema, fever, swelling, pain (unspecified) and severe arm swelling within 24 hours of receiving PNEUMOVAX 23. The patient sought medical attention - was seen in the emergency department but was not admitted to the hospital. The patient was diagnosed with cellulitis. She was prescribed antibiotic: cephalexin (manufacturer unknown), tablet, orally (dosage unspecified). The outcome of events was reported as recovered. The relatedness between vaccination with PNEUMOVAX 23 and events was not reported. This is one of three reports from the same source (#1401USA003077, #1401USA001748). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 65 year old female patient with none pertinent medical history and no comorbidities. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscularly (lot number and expiration date not provided). No concomitant medication was reported. On an unknown date the patient experienced erythema, fever, swelling, pain (unspecified) and severe arm swelling within 24 hours of receiving PNEUMOVAX 23. The patient sought medical attention - was seen in the emergency department but was not admitted to the hospital. The patient was diagnosed with cellulitis. She was prescribed antibiotic: cephalexin (manufacturer unknown), tablet, orally (dosage unspecified). The outcome of events was reported as recovered. The relatedness between vaccination with PNEUMOVAX 23 and events was not reported. This is one of three reports from the same source (#1401USA003077, #1401USA001748). Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Mobility decreased, Musculoskeletal pain, Skin warm
Clinical narrative: Redness, 70 mm x 85 mm, warmth, hard to touch - difficulty lifting the (R) arm right shoulder soreness.
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 temperature 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 07-MAY-2013 (lot number: H011350; exp date: 21-FEB-2015) (dose, frequency, route and site of administration were 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 temperature 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 30-APR-2013 (lot number: 672232/1495AA; exp date: 22-AUG-2014) (dose, frequency, route and site of administration were 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: 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 06-OCT-2011, the patient was administered with a dose of VARIVAX (Lot # 0345AA 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 121 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date approximately in February 2013 the patient was vaccinated with PNEUMOVAX23 dose 1 at the dose of 0.5 milliliter (ml), intramuscular. The patient was inadvertently administered a second dose of PNEUMOVAX23 in December 2013. No adverse effects reported. No further information provided. Additional information is not expected.
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 08-JUN-2012, the patient was administered with a dose of VARIVAX (Lot # 1909AA 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 121 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-OCT-2011, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0345AA 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 121 reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Headache, Incomplete course of vaccination
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a female patient of unknown age. In January 2013 the patient was vaccinated with GARDASIL dose 1. Route of administration was not provided. Lot number 9725106. After the first dose of GARDASIL was administered, the patient developed shortness of breath and headache, which lasted 2 days post vaccination. Patient sought medical attention by contacting physician. This patient will not received the second or third dose of GARDASIL vaccine. Therapy was discontinued. The outcome of shortness of breath and headache was reported as recovered/resolved. Causality assessment was not provided. 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 13-SEP-2011, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0345AA 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 121 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to an unknown number of patients of unknown demographics. The patients' concurrent conditions and medical history were not reported. On an unknown date in 2013, an unspecified number of patients received improperly stored Vaccine For Children (VFC) doses of RECOMBIVAX HB (dose and route, lot and expiration date were not reported) exposed to 20F and 30F on multiple occasions, from 22-SEP-2013 until 20-DEC-2013 (for 122 days. No adverse effects were reported (the reporter stated that the vaccines administered were RECOMBIVAX HB and VAQTA but on a second call was reported that no doses of VAQTA were involved in this excursion). Follow up information has been received from the certified medical assistant which reported that one of the patients was vaccinated with a dose of RECOMBIVAX HB (lot number reported as J0030722) on 23-OCT-2013. This is one of several reports from the same source. J0030722 is not valid lot number for RECOMBIVAX HB. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Hyperhidrosis, Incorrect dose administered, Influenza like illness, Pain
Clinical narrative: This spontaneous report as received from a mother concerning her 19 year old daughter (patient). The patients concurrent condition included TYLENOL III allergy and had no pertinent medical history. The patients concomitant medication included oral birth control tablets (manufacturer not specified). On an unknown date the patient was vaccinated with GARDASIL. On 30-DEC-2013 the patient was mistakenly administered the 4th dose of GARDASIL instead of hepatitis A injection during her physician visit by the physicians nurse. The patient received her first dose of GARDASIL sometime during her Senior year of high school and had completed the dosing schedule (dates not specified). On 31-DEC-2013 the patient returned to the physician's office the next morning and received the HEPATITIS A vaccine. The consumer called the physician and hence was considered as sought medical attention. On 13-JAN-2014 the patient experienced flu like symptoms (high fever, hot and cold sweats, body aches) after receiving the 4th dose. The patient was administered with TAMIFLU as treatment. The outcome of flu like symptoms was recovering. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: This spontaneous report as received from a mother concerning her 19 year old daughter (patient). The patients concurrent condition included TYLENOL III allergy and had no pertinent medical history. The patients concomitant medication included oral birth control tablets (manufacturer not specified). On an unknown date the patient was vaccinated with GARDASIL. On 30-DEC-2013 the patient was mistakenly administered the 4th dose of GARDASIL instead of hepatitis A injection during her physician visit by the physicians nurse. The patient received her first dose of GARDASIL sometime during her Senior year of high school and had completed the dosing schedule (dates not specified). On 31-DEC-2013 the patient returned to the physician's office the next morning and received the HEPATITIS A vaccine. The consumer called the physician and hence was considered as sought medical attention. On 13-JAN-2014 the patient experienced flu like symptoms (high fever, hot and cold sweats, body aches) after receiving the 4th dose. The patient was administered with TAMIFLU as treatment. The outcome of flu like symptoms was recovering. 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 14-JUN-2012, the patient was administered with a dose of VARIVAX (merck) (Lot # 1909AA 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 121 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: This spontaneous report as received from clinical medical assistant refers to a patient of unknown age and gender. On 16-JAN-2014 the patient was vaccinated with VARIVAX (SDV, MDV OR ADDITIVE) (EA), lot # J003539 and 25-MAR-2015 (strength, dose and dose number was unknown) subcutaneously. On 16-JAN-2014, reconstituted VARIVAX was exposed to 42 F for 25 hours before being given to patient. No known adverse effects. The outcome of the exposed to 42F for 25 and no adverse event was unknown. No further information provided. Additional information has been requested.