chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored MMR II. Strength, dose, route and lot number were not provided. MMR II was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. Follow up information has been received from two registered nurse (R.N.) reported that a 1 year old patient (gender not reported) who on an unknown date in 2014 received the MMR II (lot # reported as J004210 expiration 12-APR-2015; lot# J007155 expiration 20-JUN-2015) (the R.N. was unable to break out per Lot number of vaccine) (dose and route not reported) that had a temperature excursion and were found to be unstable. The MMR II was unstable after 12-APR-2014. The registered nurse stated that the patient needed to be contacted for re-vaccination. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004215, 1405USA002823, from 1405USA012477 to 1405USA012482 and 1405USA004216). 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 Nurse refers to a patient of unknown demography. On 23-JAN-2014, the patient was vaccinated with first dose of GARDASIL 0.5 ml, intramuscular. On 20-MAY-2014, the patient was vaccinated with second dose of GARDASIL 0.5 ml intramuscular. No adverse effects reported. No further information was provided. This case linked to the case 1405USA011872 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored MMR II. Strength, dose, route and lot number were not provided. MMR II was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. Follow up information has been received from two registered nurse (R.N.) reported that a 1 year old patient (gender not reported) who on an unknown date in 2014 received the MMR II (lot # reported as J004210 expiration 12-APR-2015; lot# J007155 expiration 20-JUN-2015) (the R.N. was unable to break out per Lot number of vaccine) (dose and route not reported) that had a temperature excursion and were found to be unstable. The MMR II was unstable after 12-APR-2014. The registered nurse stated that the patient needed to be contacted for re-vaccination. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004215, 1405USA002823, 1405USA012476, 1405USA012478 to 1405USA012482 and 1405USA004216). Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored MMR II. Strength, dose, route and lot number were not provided. MMR II was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. Follow up information has been received from two registered nurse (R.N.) reported that a 1 year old patient (gender not reported) who on an unknown date in 2014 received the MMR II (lot # reported as J004210 expiration 12-APR-2015; lot# J007155 expiration 20-JUN-2015) (the R.N. was unable to break out per Lot number of vaccine) (dose and route not reported) that had a temperature excursion and were found to be unstable. The MMR II was unstable after 12-APR-2014. The registered nurse stated that the patient needed to be contacted for re-vaccination. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004215, 1405USA002823, 1405USA012476,  1405USA012477, from 1405USA012479 to 1405USA012482 and 1405USA004216). Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored MMR II. Strength, dose, route and lot number were not provided. MMR II was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. Follow up information has been received from two registered nurse (R.N.) reported that a 1 year old patient (gender not reported) who on an unknown date in 2014 received the MMR II (lot # reported as J004210 expiration 12-APR-2015; lot# J007155 expiration 20-JUN-2015) (the R.N. was unable to break out per Lot number of vaccine) (dose and route not reported) that had a temperature excursion and were found to be unstable. The MMR II was unstable after 12-APR-2014. The registered nurse stated that the patient needed to be contacted for re-vaccination. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004215, 1405USA002823, 1405USA012476 to 1405USA012480, 1405USA012482 and 1405USA004216). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 61 year old female patient. The patient pertinent medial history included breast cancer, GERD, vitamin D deficiency, osteoporosis and insomnia. On 13-MAY-2014, the patient was vaccinated with ZOSTAVAX, Lot # J014566, 0.65 ml, subcutaneous. Concomitant therapies included ZYRTEC, ESTRACE, OTC vitamins (manufacturer unknown) and TRAZODONE. On an unknown date in May 2014 the patient experienced a hard lump, with redness, pain, swelling, induration of 3cm and erythema of 9 cm at the injection site, after receiving ZOSTAVAX. The patient sought medical attention and was seen in the office. The patient was treated with ice compress at the injection site and TYLENOL. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect drug. This case is linked to the case 1405USA012484 (same literature link). Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored MMR II. Strength, dose, route and lot number were not provided. MMR II was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. Follow up information has been received from two registered nurse (R.N.) reported that a 1 year old patient (gender not reported) who on an unknown date in 2014 received the vaccine MMR II (lot # reported as J004210 expiration 12-APR-2015; lot# J007155 expiration 20-JUN-2015) (the R.N. was unable to break out per lot number of vaccine) (dose and route not reported) that had a temperature excursion and were found to be unstable. The MMR II was unstable after 12-APR-2014. The registered nurse stated that the patient needed to be contacted for re-vaccination. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004215, 1405USA002823, 1405USA012476 to 1405USA012481 and 1405USA004216). Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored M-M-R II. Strength, dose, route and lot number were not provided. M-M-R II was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014; Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on `4-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. Follow up information has been received from two registered nurse (R.N.) reported that a 1 year old patient (gender not reported) who on an unknown date in 2014 received the M-M-R II (lot # reported as J004210 expiration 12-APR-2015; lot# J007155 expiration 20-JUN-2015) (the R.N. was unable to break out per Lot number of vaccine) (dose and route not reported) that had a temperature excursion and were found to be unstable. The M-M-R II was unstable after 12-APR-2014. The registered nurse stated that the patient needed to be contacted for re-vaccination. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004215, 1405USA002823, 1405USA012476, 1405USA012477, 1405USA012478, 1405USA012480 to 1405USA012482 and 1405USA004216). Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health professional concerning a 5 year old, male subject, who had been receiving nasal FLUMIST QUADRIVALENT. FLUMIS QUADRIVALENT started on 17-Dec-2013. The patient was administered expired FLUMIST which started on 17-Dec-2013. The outcome od the event of expired FLUMIST administered is unknown. The report was considered to be non-serious.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Back pain, Rash erythematous
Clinical narrative: This spontaneous report as received from a 80 year old male patient refers to himself with diabetes, high blood pressure and high cholesterol and none of drug reactions/allergies. Concomitant medications included unspecified blood pressure medication, cholesterol medication, and diabetes medication. On 07-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route unspecified). In 12-MAY-2014 the patient developed shingles and went to the emergency room on an unspecified hospital to confirm it was shingles. Patient was treated with valcyclovir (manufacturer unknown). No lab diagnostics studies performed. The outcome of event was reported as not recovered/not resolved. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Back pain, Rash
Clinical narrative: This spontaneous report as received from a 80 year old male patient refers to himself with diabetes, high blood pressure and high cholesterol and none of drug reactions/allergies. Concomitant medications included unspecified blood pressure medication, cholesterol medication, and diabetes medication. On 07-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route unspecified). In 12-MAY-2014 the patient developed shingles and went to the emergency room on an unspecified hospital to confirm it was shingles. Patient was treated with valcyclovir (manufacturer unknown). No lab diagnostics studies performed. The outcome of event was reported as not recovered/not resolved. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 80 year old male patient refers to himself with diabetes, high blood pressure and high cholesterol and none of drug reactions/allergies. Concomitant medications included unspecified blood pressure medication, cholesterol medication, and diabetes medication. On 07-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route unspecified). In 12-MAY-2014 the patient developed shingles and went to the emergency room on an unspecified hospital to confirm it was shingles. Patient was treated with valcyclovir (manufacturer unknown). No lab diagnostics studies performed. The outcome of event was reported as not recovered/not resolved. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 28 year old female patient. On 19-MAY-2014 the patient was vaccinated with MMR II (dose and route were not provided). An unspecified number of previous doses was given at unspecified dates. Concomitant medication included prenatal vitamins (unspecified). The patient became pregnant with LMP of 14-MAR-2014 and EDD of 19-DEC-2014. On 20-MAY-2014 the pregnancy was confirmed by a urine pregnancy test. Initial exposure to MMR II was at 9 weeks. The pregnancy outcome was pending. It was reported that the patient sought medical attention by an office visit. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 28 year old female patient. On 19-MAY-2014 the patient was vaccinated with MMR II (dose and route were not provided). An unspecified number of previous doses was given at unspecified dates. Concomitant medication included prenatal vitamins (unspecified). The patient became pregnant with LMP of 14-MAR-2014 and EDD of 19-DEC-2014. On 20-MAY-2014 the pregnancy was confirmed by a urine pregnancy test. Initial exposure to MMR II was at 9 weeks. The pregnancy outcome was pending. It was reported that the patient sought medical attention by an office visit. Additional information has been requested.
Sex: U
Vaccine: MMR, MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refers to a patient of unknown age and gender. No information provided regarding concurrent conditions and medical history. On an unknown date the patient was vaccinated with M-M-R II (dose, route, lot# not reported). No concomitant medications were reported. It was reported that the vaccine M-M-R II was exposed to 20.5 degree Celsius for 2.5 hours and may have been administered to patients and no adverse effects reported. PQC was not involved. This is one of the 3 report reported by the same reporter (1405USA009701, 1405USA009702). Follow up information has been received. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: HIBV, HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refers to a patient of unknown age and gender. No information provided regarding concurrent conditions and medical history. On an unknown date the patient was vaccinated with PEDVAXHIB (dose, route, lot# not reported). No concomitant medications were reported. It was reported that the vaccine PEDVAXHIB was exposed to 20.5 degree Celsius for 2.5 hours and may have been administered to patients and no adverse effects reported. PQC was not involved. This is one of the 3 report reported by the same reporter (1405USA009701, 1405USA008829). Follow up information has been received. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient with drug reactions to sulfa (manufacturer unknown), Cephalosporin (manufacturer unknown) and TAVIST. The patient pertinent medical history was none. On 10-MAY-2014 the patient was vaccinated with ZOSTAVAX (lot # J014812, Expiry date: 20-FEB-2015) 0.65 milliliter (ml), subcutaneous (SQ) for prevention for shingles. Concomitant medications were none. Approximately on 11-MAY-2014 (reported as following day), the patient developed a red sore spot the size of an orange cutie (fruit) at the injection site area. The injection site area appears to be a larger than normal injection site reaction with no appearance of a rash. The outcome of a patient developed a red sore spot the size of an orange cutie (fruit) was reported as recovering/resolving. The patient sought medical attention by contacting the pharmacist. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient with drug reactions to sulfa (manufacturer unknown), Cephalosporin (manufacturer unknown) and TAVIST. The patient pertinent medical history was none. On 10-MAY-2014 the patient was vaccinated with ZOSTAVAX (lot # J014812, Expiry date: 20-FEB-2015) 0.65 milliliter (ml), subcutaneous (SQ) for prevention for shingles. Concomitant medications were none. Approximately on 11-MAY-2014 (reported as following day), the patient developed a red sore spot the size of an orange cutie (fruit) at the injection site area. The injection site area appears to be a larger than normal injection site reaction with no appearance of a rash. The outcome of a patient developed a red sore spot the size of an orange cutie (fruit) was reported as recovering/resolving. The patient sought medical attention by contacting the pharmacist. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Middle insomnia, Mobility decreased, Musculoskeletal pain, Weight bearing difficulty
Clinical narrative: From 03/04/14 I began to have shoulder pain and limited movement when raising my arm crossed in front of me.  The pain increased up until month 2.  By then I couldn't sleep on my left side, carry things on my left arm, and would wake up with pain.  After trying hot compress, cold compress, and mud patches the pain diminished some.  Now after 3 months I only have pain when I use my arm to carry or lift.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Computerised tomogram, Hypoaesthesia, Lumbar puncture, Pain, Paraesthesia
Clinical narrative: Numbness, tingling, and pain in left foot then it proceeded up the leg, then into the groin area and by 3:00pm it all the way up the left side where I began having a shocking sensation and it unable to be touched and stopped just below the shoulder area.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Numbness, tingling, and pain in left foot then it proceeded up the leg, then into the groin area and by 3:00pm it all the way up the left side where I began having a shocking sensation and it unable to be touched and stopped just below the shoulder area.
Age: 21.0
Sex: F
Vaccine: PNC
Symptoms: Bacterial infection, Bacterial test positive, Diarrhoea, Injection site reaction, Local swelling
Clinical narrative: High fever, vomiting, diarrhea, and muscle pain at shot site lasting four days. Large painful rash and swelling on upper arm lasting one week.
Age: 21.0
Sex: F
Vaccine: PNC
Symptoms: Myalgia, Pain in extremity, Pyrexia, Rash, Vomiting
Clinical narrative: High fever, vomiting, diarrhea, and muscle pain at shot site lasting four days. Large painful rash and swelling on upper arm lasting one week.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Headache, chills, temperature, tiredness, loss of appetite, extreme arm and shoulder pain with swelling and temperature at the sight of the vaccine. The first 5 side effects lasted 48 hours and the arm pain continued a weeks decreasing in intensity a bit each day.  No treatment sought just bed rest.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Musculoskeletal pain, Pain in extremity
Clinical narrative: Headache, chills, temperature, tiredness, loss of appetite, extreme arm and shoulder pain with swelling and temperature at the sight of the vaccine. The first 5 side effects lasted 48 hours and the arm pain continued a weeks decreasing in intensity a bit each day.  No treatment sought just bed rest.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Body aches, fever, chills, flu like symptom, severe headache, sinus dripping.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Upper-airway cough syndrome
Clinical narrative: Body aches, fever, chills, flu like symptom, severe headache, sinus dripping.
Age: 76.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Erythema, Pain, Skin warm
Clinical narrative: Spreading redness, warmth and pain. Diagnosed with cellulitis, responded to Keflex.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients. On unknown date an unspecified number of patients were administered with doses of GARDASIL (lot#, strength, dose, frequency, route unknown) that were improperly stored. No adverse effects were reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Patient got ZOSTAVAX on 5/22 and came back to the pharmacy on 5/25. She had a large, red spot on her arm that was warm to the touch. Told her to watch it.
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Mom stated he has headache, dizziness, fever and aches which start 12 days after vaccine given.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients of unknown ages and gender. On an unspecified date the multiple unspecified patients were administered VAQTA (Lot# unspecified) (dose, frequency, route and location unspecified) that was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects were reported. Follow up information has been received from the registered nurse via telephone call indicating that she did not have the information available at that time and she might be able to fax it early the following week. This is one of several reports received from the same source. Follow up has been received from the registered nurse. The nurse provided lot numbers, expiration dates and a list of patient identifier representing patients given affected vaccine from 16-APR-2014 though 23-APR-2014. On unspecified dates in April 2014, 11 (eleven) patients were given affected VAQTA (lot # J011629, expiration date: 20-SEP-2015). The 11 patients included: 3593352 (MARRS# 1404USA014966), 6547442 (MARRS# 1405USA013228), 5318597 (MARRS# 1405USA013233), 6195937 (MARRS# 1405USA013234), 7016548 (MARRS# 1405USA013235), 6772082 (MARRS# 1405USA013236), 6988402 (MARRS# 1405USA013232), 6987130 (MARRS# 1405USA013231), 7032168 (MARRS# 1405USA013237), 7240186 (MARRS# 1405USA013229), 7012827 (MARRS# 1405USA013230). Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients of unknown ages and gender. On an unspecified date the multiple unspecified patients were administered VAQTA (Lot# unspecified) (dose, frequency, route and location unspecified) that was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects were reported. Follow up information has been received from the registered nurse via telephone call indicating that she did not have the information available at that time and she might be able to fax it early the following week. This is one of several reports received from the same source. Follow up has been received from the registered nurse. The nurse provided lot numbers, expiration dates and a list of patient identifier representing patients given affected vaccine from 16-APR-2014 through 23-APR-2014. On unspecified dates in April 2014, 11 (eleven) patients were given affected VAQTA (lot # J011629, expiration date: 20-SEP-2015). The 11 patients included: (MARRS# 1404USA014966), (MARRS# 1405USA013228), (MARRS# 1405USA013233), (MARRS# 1405USA013234), (MARRS# 1405USA013235), (MARRS# 1405USA013236), (MARRS# 1405USA013232), (MARRS# 1405USA013231), (MARRS# 1405USA013237), (MARRS# 1405USA013229), (MARRS# 1405USA013230). Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients. On unknown dates an unspecified number of patients were administered with doses of RECOMBIVAX HB (lot#, strength, dose, frequency, route unknown) that were improperly stored. No adverse effects were reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The nurse reported that the patient was an expired dose of GARDASIL, lot # 658490/0802U, expiration date 05-APR-2010 (dose and route not reported) on 25-AUG-2010. No adverse effects were reported. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients of unknown ages and gender. On an unspecified date the multiple unspecified patients were administered VAQTA (Lot# unspecified) (dose, frequency, route and location unspecified) that was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects were reported. Follow up information has been received from the registered nurse via telephone call indicating that she did not have the information available at that time and she might be able to fax it early the following week. This is one of several reports received from the same source. Follow up has been received from the registered nurse. The nurse provided lot numbers, expiration dates and a list of patient identifier representing patients given affected vaccine from 16-APR-2014 through 23-APR-2014. On unspecified date in April 2014, 11 (eleven) patient were given affected VAQTA (lot # J011629, epiration date: 20-SEP-2015). The 11 patients included: MARRS# 1404USA014966, MARRS# 1405USA013228, MARRS# 1405USA013233, MARRS# 1405USA013234, MARRS# 1405USA013235, MARRS# 1405USA013236, MARRS# 1405USA013232, MARRS# 1405USA013231, MARRS# 1405USA013237, MARRS# 1405USA013229, MARRS# 1405USA013230. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients of unknown ages and gender. On an unspecified date the multiple unspecified patients were administered VAQTA (Lot# unspecified) (dose, frequency, route and location unspecified) that was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects were reported. Follow up information has been received from the registered nurse via telephone call indicating that she did nothave the information available at that time and she might be able to fax it early the following week. This is one of several received from the registered nurse. The nurse provided lot numbers, expiration dates and a list of patient identifiers representing patients given affected vaccine from 16-APR-2014 through 23-APR-2014, 11 (eleven) patients were given affected VAQTA (lot # J011629, expiration date: 20-SEP-2015). The 11 patients included: MARRS# 1404USA014966, MARRS# 1405USA013228, MARRS# 1405USA013233, MARRS# 1405USA013234, MARRS# 1405USA013235, MARRS# 1405USA013236, MARRS# 1405USA013232, MARRS# 1405USA013231, MARRS# 1405USA013237, MARRS# USA013229, MARRS# 1405USA013230. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health worker concerning an unknown number of patients, of an unknown gender and age. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of ROTATEQ (dose, strength, lot number, expiration date and route were not reported). The healthcare worker reported that an improperly stored ROTATEQ, "may" have been administered. The reporter stated that the ROTATEQ, were exposed to a temperature as low as 26F for a total of 238 hours over multiple excursions which started on 06-MAY-2014. No adverse effect reported. These case is one (1) of four (4) reports from the same reporter (MARRS 1405USA009827, 1405USA013153, 1405USA013154, 1405USA013155). Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old patient of unknown gender. Medical history and drug reactions/allergies were not reported. On 21-APR-2014, the patient was vaccinated with VARIVAX (Merck), 0.5 ml subcutaneous (lot not reported), in place of ZOSTAVAX. Concomitant medication was not reported. No adverse effect reported. This is one of two reports from the same source (1405USA013190). Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a male patient of unknown age who on 22-MAY-2014 the patient was vaccinated with ZOSTAVAX (Vial 19,400 Unit) lot # J008802 expiration date 19-OCT-2014, (dose and route was not provided). The Nurse stated that on 22-MAY-2014, the patient presented to office with ZOSTAVAX, given to him by a pharmacy one day before. On 22-MAY-2014, ZOSTAVAX was exposed to 75F for one hour during transport by patient to healthcare provider office. No adverse effects were reported. No additional information was provided. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: This spontaneous report as received from a male patient of unknown age refers to himself. Medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose number, frequency, route of administration, anatomical location, lot number was not reported). Concomitant medications were not reported. On an unknown date the patient developed an injection site rash after receiving ZOSTAVAX vaccine and by that time it was spreading down his arm. The outcome of events was not reported. The relatedness between events and ZOSTAVAX was not reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route, frequency, lot # and expiration date not reported) that was improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health worker concerning an unknown number of patients, of an unknown gender and age. Medical history and concurrent conditions were not reported. On an unknown date the patient's were vaccinated with a dose of VAQTA (dose, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that an improperly stored VAQTA, "may" have been administered. The reporter stated that the VAQTA, were exposed to a temperature as low as 26F for a total of 238 hours over multiple excursions which started on 06-MAY-2014. No adverse effect reported. These case is one (1) of four (4) reports from the same reporter (MARRS 1405USA009827, 1405USA013153, 1405USA013154, 1405USA013155). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health worker concerning an unknown number of patients, of an unknown gender and age. Medical history and concurrent conditions were not reported. On an unknown date the patient's were vaccinated with a dose of GARDASIL (dose, strength, lot number, expiration date and route were not reported). The healthcare worker reported that an improperly stored GARDASIL, "may" have been administered. The reporter stated that the GARDASIL, were exposed to a temperature as low as 26F for a total of 238 hours over multiple excursions which started on 06-MAY-2014. No adverse effect reported. These case is one (1) of four (4) reports from the same reporter (MARRS 1405USA009827, 1405USA013153, 1405USA013154, 1405USA013155). 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 health worker concerning an unknown number of patients, of an unknown gender and age. Medical history and concurrent conditions were not reported. On an unknown date the patient's were vaccinated with a dose of RECOMBIVAX HB (dose, strength, lot number, expiration date and route were not reported). The healthcare worker reported that an improperly stored RECOMBIVAX HB, "may" have been administered. Reporter stated that the RECOMBIVAX HB, were exposed to a temperature as low as 26F for a total of 238 hours over multiple excursions which started on 06-MAY-2014. No adverse effect reported. These case is one (1) of four (4) reports from the same reporter (MARRS 1405USA009827, 1405USA013153, 1405USA013154, 1405USA013155). Additonal information has been requested.
Age: 65.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old patient of unknown gender. Medical history and drug reactions/allergies were not reported. On 23-APR-2014, the patient was vaccinated with VARIVAX (Merck), 0.5 ml subcutaneous (lot not reported), in place of ZOSTAVAX. Concomitant medication was not reported. No adverse effect reported. This is one of two reports from the same source (1405USA007734). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients (age and gender unknown). On an unknown date, the patients were vaccinated with ROTATEQ, oral (dose, lot not reported). It was reported that ROTATEQ reached 54 degrees F for 192 hours which was not supported by our in house stability data and was administered to an unknown and unspecified number of patients. No adverse effects reported. A different batch of ROTATEQ reached 52 degrees F for 8 hours and also reached a temperature of 30 F for a total of 171 hours. This was supported by our in house stability data, but some of the ROTATEQ was administered to an unknown and unspecified number of patients. No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients. On unknown dates an unspecified number of patients were administered with doses of VAQTA (lot#, strength, dose, frequency, route unknown) that were improperly stored. No adverse effects were reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site swelling, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient with sulfa allergy and allergic to SYMBICORT and no other pertinent medical history. On 19-MAY-2014 the patient was vaccinated with ZOSTAVAX lot # J011341, expiring on 13-DEC-2014, 0.65 ml, subcutaneous prescribed by physician. Concomitant therapies included fluoxetine, atorvastatin, furosemide (manufacturer unspecified), magnesium citrate, tramadol, gabapentin, amlodipine, buspirone hydrochloride, trazodone hydrochloride and pantoprazole. The day after receiving ZOSTAVAX, on 20-MAY-2014, the patient developed itchiness over her entire body, a red discolored skin mark at the site of injection which was raised and hard underneath like an egg, constant headache, and swollen throat glands. No treatment was given for the adverse events. No lab diagnostic tests were performed. The itchiness had since subsided however the other symptoms were still present; the patient said the induration had gone done and it was not as bad as it was the day after. The pharmacist instructed the patient to seek medical advice with her physician. The causal relationship was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient with sulfa allergy and allergic to SYMBICORT and no other pertinent medical history. On 19-MAY-2014 the patient was vaccinated with ZOSTAVAX lot # J011341, expiring on 13-DEC-2014, 0.65 ml, subcutaneous prescribed by physician. Concomitant therapies included fluoxetine, atorvastatin, furosemide (manufacturer unspecified), magnesium citrate, tramadol, gabapentin, amlodipine, buspirone hydrochloride, trazodone hydrochloride and pantoprazole. The day after receiving ZOSTAVAX, on 20-MAY-2014, the patient developed itchiness over her entire body, a red discolored skin mark at the site of injection which was raised and hard underneath like an egg, constant headache, and swollen throat glands. No treatment was given for the adverse events. No lab diagnostic tests were performed. The itchiness had since subsided however the other symptoms were still present; the patient said the induration had gone done and it was not as bad as it was the day after. The pharmacist instructed the patient to seek medical advice with her physician. The causal relationship was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of unknown age. The medical assistant reported that the patient received all three doses of GARDASIL (lot#, dose, route not reported) but doses were given outside of recommended schedule in Pl. Patient received his first dose of GARDASIL on 28-NOV-2011, second dose on 07-NOV-2012 and third dose on 18-DEC-2013. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients of unknown ages and gender. On an unspecified date the multiple unspecified patients were administered VAQTA (Lot# unspecified) (dose, frequency, route and location unspecified) that was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects were reported. Follow up information has been received from the registered nurse via telephone call indicating that she did not have the information available at that time and she might be able to fax it early the following week. This is one of several reports received from the same source. Follow up has been received from the registered nurse. The nurse provided lot numbers, expiration dates and a list of patient identifier representing patients given affected vaccine from 16-APR-2014 through 23-APR-2014. On unspecified dates in April 2014, 11 (eleven) patients were given affected VAQTA (lot # J011629, expiration dates: 20-SEP-2015). The 11 patients included: MARRS# 1404USA014966, MARRS# 1405USA013228, MARRS# 1405USA013233, MARRS# 1405USA013234, MARRS# 1405USA013235, MARRS# 1405USA013236, MARRS# 1405USA013232, MARRS# 1405USA013231, MARRS# 1405USA013237, MARRS# 1405USA013229, MARRS# 1405USA013230. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an expired dose of ZOSTAVAX (19400 PFU) (dose, route and lot # were not reported). Concomitant therapy was not reported. The reporting pharmacist stated that the vaccine was used 14 days past expiry. No adverse effects reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 13 year old male patient. On 27-JAN-2014, the patient was vaccinated with first dose of GARDASIL lot # J012212 (dose and frequency were not reported) intramuscular. Concomitant therapies included FLUARIX and T-DAP. On 27-JAN-2014, 2 hours after receiving the vaccination the patient experienced rash from head to toe. The patient sought the medical attention and reported to the physician during the follow up appointment to receive the second dose of GARDASIL. It was reported that on an unknown date, the patient visited the unspecified emergency room and received steroids (manufacturer unknown). On 28-JAN-204, the patient recovered from rash from head to toe. It is unknown if the patient received dose two and/or three in the series of GARDASIL. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 50 year old patient's. On an unknown date in 2010 (also reported as four or five years ago) two or three patients who may have been under the age of 50 years old may have been vaccinated with ZOSTAVAX (dose, route and frequency were not reported). No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old patient. On 19-MAY-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, expiration date, dose, patient route of administration not reported) and PROQUAD (Merck) (lot#, expiration date, dose, patient route of administration not reported). No concomitant medications were reported. No adverse effects noted. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness, Headache, Hypoaesthesia, Insomnia, Migraine
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient (reported as student) of unknown age. The patient's medical history was not reported. On an unknown date the patient was vaccinated with 1st dose of GARDASIL. Concomitant therapies included ATIVAN 1 milligram (mg) administered an hour before the GARDASIL. No adverse effects occurred after the first dose. On an unknown date the patient was vaccinated with 2nd dose of GARDASIL. ATIVAN 1 mg was administered an hour before the GARDASIL vaccination. On an unknown date (reported as within an unspecified period) after receiving GARDASIL the patient experienced lightheaded, dizzy, had a migraine, had insomnia, felt feverish, and had numbness on the right side of the face. The patient also had a neck pain. The patient experienced Bell's palsy within 24 hours of second dose as per diagnosis of another health care professional (HCP). Other symptoms included headaches, dizziness, insomnia and muscle pain. The outcome of lightheaded, dizzy, had a migraine, had insomnia, felt feverish, neck pain, numbness on the right side of the face and Bell's palsy was unknown. The relatedness of the events with the therapy was not reported. Additional information has been requested.