chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative (field employee) refers to a male patient of unknown age with hypertension and hypercholesterolemia. In 2011 (exact day unspecified) the patient was vaccinated with ZOSTAVAX, one time, subcutaneously (dose and lot number not reported). Other suspect therapies included PNEUMOVAX23 (dose, lot number and route not reported), given about the same time (in 2011) as receiving ZOSTAVAX vaccine. On an unknown date the patient developed a severely debilitating case of shingles. The physician reported that it was the worst case of shingles that they had ever seen in 30 years. The patient had also been traveling and it was upon his return that he developed shingles. There was unspecified treatment given for the event. The patient sought medical attention (doctor visit). The outcome of the event was unknown. Relatedness between the therapies and the event was unknown. Reporting physician considered shingles to be disabling. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Coma, Convulsion, Endotracheal intubation, Intensive care, Laboratory test normal
Clinical narrative: This spontaneous report as received from a physician via Company Representative refers to a 12 year old male patient. In October 2013, the patient was vaccinated with the second dose of GARDASIL (dose, route, lot number not reported). No concomitant medication, pertinent medical history or drug allergies were reported. After receiving the second dose of the GARDASIL the patient experienced multiple seizures (date unspecified). In March 2014, the physician learned that the patient experienced atypical seizures with no loss of consciousness that would go longer than normal (onset date: 25-MAR-2014). The patient was admitted to the hospital on 25-Mar-2014 to 17-APR-2014 and had to be intubated (unknown date in 2014). It was reported that hospitalization was prolonged due to the event. During the time in hospital (unspecified days) the patient was in coma for 2 days and was also in the ICU (Intensive Care Unit) for 2 weeks. During the hospital stay, the patient had unspecified labs performed and the results were negative. The patient was prescribed an acyclovir and other unspecified antibiotics and medications to control seizures. The patient was currently seeing a neurologist. Therapy with GARDASIL was withdrawn, third dose would not be given. The patient's outcome was unknown. Causality assessment was not reported. Upon internal review the events of multiple seizures, atypical seizures with no loss of consciousness, intubation and coma were considered as medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a physician via Company Representative refers to a 12 year old male patient. In October 2013, the patient was vaccinated with the second dose of GARDASIL (dose, route, lot number not reported). No concomitant medication, pertinent medical history or drug allergies were reported. After receiving the second dose of the GARDASIL the patient experienced multiple seizures (date unspecified). In March 2014, the physician learned that the patient experienced atypical seizures with no loss of consciousness that would go longer than normal (onset date: 25-MAR-2014). The patient was admitted to the hospital on 25-Mar-2014 to 17-APR-2014 and had to be intubated (unknown date in 2014). It was reported that hospitalization was prolonged due to the event. During the time in hospital (unspecified days) the patient was in coma for 2 days and was also in the ICU (Intensive Care Unit) for 2 weeks. During the hospital stay, the patient had unspecified labs performed and the results were negative. The patient was prescribed an acyclovir and other unspecified antibiotics and medications to control seizures. The patient was currently seeing a neurologist. Therapy with GARDASIL was withdrawn, third dose would not be given. The patient's outcome was unknown. Causality assessment was not reported. Upon internal review the events of multiple seizures, atypical seizures with no loss of consciousness, intubation and coma were considered as medically significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: TDAP given on 4/24/14. Per clt's mother on 4/26/14, clt stated area of injection was itching. When observed by clt's mother a reddened/raised area the size of a nickle was noted. Clt's mother stated the she did not have a fever or diffuculity breathing.  Clt was taken to an outpt. clinic on Sunday 4/27/14. She was advised to apply cool compresses as needed and give her daughter Benadryl if needed.
Age: 30.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Nurse reported that the patient was not a patient of the office but called to the office for medical advice. On an unknown date, the patient was vaccinated with two doses of GARDASIL injection, (dose and route of administration not provided), over the age of twenty six. No concomitant medications were reported. No adverse effects reported. Nurse asked if there was any data regarding the efficacy of GARDASIL after only two doses, what was the long term efficacy and if they should administer the third dose to a patient who was 30 years old. No Product quality complaint was involved. The outcome of events was unknown. No further information was provided. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Dyskinesia, Grand mal convulsion, Staring
Clinical narrative: Grand Mal seizure - jerking, staring x 1 minute.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest pain, Dizziness, Headache, Nausea, Vertigo
Clinical narrative: Pt complained of HA, nausea and dizziness five minutes after getting varicella vaccine. After 30 minutes of laying down with her head elevated new symptoms chest burning and room spinning. BP 126/76, HR 100 R-16, T 98.6. No rash, lungs clear x 4, resp even and unlabored skin dry to touch. Sent to ER with mom.
Age: 36.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Abscess, Erythema, Induration, Local swelling, Pain in extremity
Clinical narrative: Tdap given 4-15-14 (R) deltoid. To clinic 4-24-14 with (R) arm pain, swelling, redness, warm to touch and hardening of area. PA-C assessed and believes is an abscess. Referred to Urgent Care.
Age: 36.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Skin warm
Clinical narrative: Tdap given 4-15-14 (R) deltoid. To clinic 4-24-14 with (R) arm pain, swelling, redness, warm to touch and hardening of area. PA-C assessed and believes is an abscess. Referred to Urgent Care.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Injection site erythema, Insomnia
Clinical narrative: Site of vaccine red and swollen 3-4 days (normal). Day after, tired, but 2 nites after, wide awake - weird feeling! Very achy in joints/muscles for next 10-12 days, and tired. (Husband had felt achy/tired for 2 days previous to my shot). I realize that there is a good likelihood that I picked up a bit of whatever bug my husband had (he got just before I had the vaccine) - combined with effects of shot, since some of the symptoms I had were similar to his, but manifested about 50X! Also could have been coincidental timing with minor backache I had just previous to shot but the aches I had (back, knees, etc) after shot were quite extreme for 10 days or so. Never had anything like that before!
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: Site of vaccine red and swollen 3-4 days (normal). Day after, tired, but 2 nites after, wide awake - weird feeling! Very achy in joints/muscles for next 10-12 days, and tired. (Husband had felt achy/tired for 2 days previous to my shot). I realize that there is a good likelihood that I picked up a bit of whatever bug my husband had (he got just before I had the vaccine) - combined with effects of shot, since some of the symptoms I had were similar to his, but manifested about 50X! Also could have been coincidental timing with minor backache I had just previous to shot but the aches I had (back, knees, etc) after shot were quite extreme for 10 days or so. Never had anything like that before!
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Fever 104.6, swelling, erythema, and induration of the left thigh treatment: BACTRIM.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, and pain at injection site.
Age: 1.37
Sex: F
Vaccine: MMR
Symptoms: Crying, Fatigue, Irritability
Clinical narrative: Frequent episodes of crying, general fussiness, and fatigue for 7 days.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 2 1/2 cm x 2 1/2 cm erythema reaction (L) posterior upper arm. Warm to touch.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Skin warm, Upper extremity mass
Clinical narrative: Left arm, swollen, hot red with large lump for 3 days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient has had a site reaction swelling, redness, heat on rash that started 2 days after injection. Doctor was notified.
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a male patient of unknown age. On 25-APR-2014 (also reported as today), the patient was vaccinated with expired dose ZOSTAVAX (lot number J001008, expiry date 24-APR-2014), 0.65 ml, subcutaneous. Patients concomitantn therapy was unspecified. The rerpoter was asking for potency information. Potency support as per solution. Patient did not seek medical attention. No adverse effect noted to patient. No product quality complaint was involved. The outcome of expired ZOSTAVAX was administered was unknown. No further information was available. Available information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Blood test, Herpes zoster, Pruritus
Clinical narrative: This spontaneous report was received from a 80 year old female patient referred to herself. The patient's current condition included penicillin allergy and blood pressure abnormal. No pertinent medical history. On 04-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # unspecified), single 0.65 ml shot, subcutaneous for the prevention of shingles. Concomitant medication included unspecified blood pressure medication. The reporter reported that "on 12-APR-2014 my back began to itch and now I can not lie on my back because it is to painful after I received the ZOSTAVAX vaccine 04-NOV-2013." The reporter also reported that "my physician confirmed on 16-APR-2014 that I have shingles." Patient was treated with VALTREX and DIPROLENE. "Blood work" was performed, results were not reported. The patient had sought medical attention by visiting physician. The patient's status was not recovered. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Back pain, Blood test, Erythema, Herpes zoster
Clinical narrative: This spontaneous report was received from a 80 year old female patient referred to herself. The patient's current condition included penicillin allergy and blood pressure abnormal. No pertinent medical history. On 04-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # unspecified), single 0.65 ml shot, subcutaneous for the prevention of shingles. Concomitant medication included unspecified blood pressure medication. The reporter reported that "on 12-APR-2014 my back began to itch and now I can not lie on my back because it is to painful after I received the ZOSTAVAX vaccine 04-NOV-2013." The reporter also reported that "my physician confirmed on 16-APR-2014 that I have shingles." Patient was treated with VALTREX and DIPROLENE. "Blood work" was performed, results were not reported. The patient had sought medical attention by visiting physician. The patient's status was not recovered. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pruritus, Skin lesion
Clinical narrative: This spontaneous report was received from a 80 year old female patient referred to herself. The patient's current condition included penicillin allergy and blood pressure abnormal. No pertinent medical history. On 04-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # unspecified), single 0.65 ml shot, subcutaneous for the prevention of shingles. Concomitant medication included unspecified blood pressure medication. The reporter reported that "on 12-APR-2014 my back began to itch and now I can not lie on my back because it is to painful after I received the ZOSTAVAX vaccine 04-NOV-2013." The reporter also reported that "my physician confirmed on 16-APR-2014 that I have shingles." Patient was treated with VALTREX and DIPROLENE. "Blood work" was performed, results were not reported. The patient had sought medical attention by visiting physician. The patient's status was not recovered. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 2 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 03-MAR-2014, the patient was vaccinated with ROTATEQ, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reported. Additional information has been requested.
Age: 0.16
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 1 month infant, of unknown gender. Medical history and concurrent conditions were not reported. On 27-FEB-2014, the patient was vaccinated with first dose of ROTATEQ, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reported. 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 Registered Nurse refers to multiple unspecified patients of unknown age and gender. On an unspecified date the multiple unspecified patients were administered ROCOMBIVAX HB (Lot# unspecified) dose, frequency, route and location unspecified was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.56
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 28-FEB-2014, the patient was vaccinated with dose 3 of ROTATEQ, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reported. Additional information has been requested.
Age: 0.21
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 2 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 26-FEB-2014, the patient was vaccinated with first dose of ROTATEQ, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reported. Additional information has been requested.
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 multiple unspecified patients of unkonwn age and gender. On an unspecified date the multiple unspecified patients were administered GARDASIL (Lot# unspecified) dose, frequency, route and location unspecified was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects reported. This is one of several reports received from the same reporter. 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 age and gender. On an unspecified date the multiple unspecified patients were administered VAQTA (Lot# unspecified) dose, frequency, route and location unspecified was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
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 age and gender. On an unspecified date the multiple unspecified patients were administered COMVAX (Lot # unspecified) dose, frequency, route and location unspecified was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 5 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 25-FEB-2014, the patient was vaccinated with dose 3 of ROTATEQ oral, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm- 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 months old patient of unknown gender. The nurse reported that on 03-FEB-2014, the patient was vaccinated with the second dose of ROTATEQ, lot #J007283; expiration date: 27-SEP-2014. Route and dose were not reported. On 17-MAR-2014, the patient received the third dose of ROTATEQ, (Lot # J008735), expiration date: 24-MAR-2015. No other co-suspect or concomitant medications were reported. The nurse reported that both doses received by patient were vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report as received from a medical librarian regarding unspecified patient (no specific patients mentioned) of unknown age. The reporter stated that she has read "anecdotal literature resources stating that ZOSTAVAX (lot # and expiry date not provided) cured cold sores, as well as reports that ZOSTAVAX caused cold sores. It was also reported that reporter wanted off-label information on "the usage of ZOSTAVAX as treatment of cold sores. There was no product quality complaint. The reporter was offered to discuss the PI but she disconnected without giving any demographic information. Action taken with the reported event was not applicable. Outcome and causality of the reported event was unknown (not provided). Additional information is not expected.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Chills, Dizziness, Fatigue, Feeling hot
Clinical narrative: This spontaneous report as received from a non pregnant 37 years old female pharmacist refers to herself. The pharmacist had no pertinent medical history, drug reactions or allergies. On 25-MAR-2014 the pharmacist was vaccinated with a dose of RECOMBIVAX HB (therapy type not reported) 0.5 ml, intramuscular (lot # J008506, expiry date 07-FEB-2016, reported as 04-FEB-2016). The pharmacist did not take any concomitant medications. On an unknown date, in 2014 (reported as "a few weeks ago") the pharmacist experienced some initial vomiting, fatigue, stomach cramps all week. The pharmacist stated on an approximately 05-APR-2014 (reported as "this weekend") she had chills, night sweats and problems focusing on near objects, presbyopia, She also stated that gastrointestinal symptoms subsided (date unspecified, in 2014) but the vision was still a concern. The pharmacist also stated that currently she was experiencing dizziness with the difficulty with vision and focus along with periodic waves of heat. The pharmacist was unsure if she should have second dose in series. There were no lab diagnostic studies performed. There was no treatment given for adverse events. The pharmacist did not seek medical attention. The outcome of night sweats, fatigue and chills was not reported. The relatedness between all events and RECOMBIVAX HB was not reported. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Night sweats, Presbyopia, Vision blurred, Vomiting
Clinical narrative: This spontaneous report as received from a non pregnant 37 years old female pharmacist refers to herself. The pharmacist had no pertinent medical history, drug reactions or allergies. On 25-MAR-2014 the pharmacist was vaccinated with a dose of RECOMBIVAX HB (therapy type not reported) 0.5 ml, intramuscular (lot # J008506, expiry date 07-FEB-2016, reported as 04-FEB-2016). The pharmacist did not take any concomitant medications. On an unknown date, in 2014 (reported as "a few weeks ago") the pharmacist experienced some initial vomiting, fatigue, stomach cramps all week. The pharmacist stated on an approximately 05-APR-2014 (reported as "this weekend") she had chills, night sweats and problems focusing on near objects, presbyopia, She also stated that gastrointestinal symptoms subsided (date unspecified, in 2014) but the vision was still a concern. The pharmacist also stated that currently she was experiencing dizziness with the difficulty with vision and focus along with periodic waves of heat. The pharmacist was unsure if she should have second dose in series. There were no lab diagnostic studies performed. There was no treatment given for adverse events. The pharmacist did not seek medical attention. The outcome of night sweats, fatigue and chills was not reported. The relatedness between all events and RECOMBIVAX HB was not reported. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 25-FEB-2014, the patient was vaccinated with dose 3 of ROTATEQ oral, lot # J007283; expiration date: 27-SEP-2014 (dose and strength were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stores as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 72 year old female patient. The patient's medical history included shingles. On 25-APR-2014, the patient was vaccinated with expired VARIVAX (Merck) lot # H006529 (dose, route and frequency were not reported) instead of ZOSTAVAX in error. No product confusion reported, just medication error, no PQC discovered. No adverse effect reported. No other information was reported. Additional information is not expected.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 2 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 21-FEB-2014, the patient was vaccinated with dose 1 of ROTATEQ, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with ROTATEQ (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. ROTATEQ was administered to a 7 month old patient. ROTATEQ lot number J008725. This is case 1 of 4 patients. This case was linked to cases: 1403USA007267, 1404USA014642, 1404USA014643. Additional information has been requested, all scheduled correspondence was scheduled.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 2 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 03-MAR-2014, the patient was vaccinated with first dose of ROTATEQ oral, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm- 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient. On 11-APR-2014, the patient was vaccinated with ZOSTAVAX (lot # H019092, expiration date: 09-FEB-2014). Dose, route of administration and anatomical location were not provided by the reporter. The pharmacist stated that, on 11-APR-2014 reported as today, a nurse administered an expired ZOSTAVAX to a patient. No adverse effects were reported. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Tachypnoea
Clinical narrative: Headache, tachypnea and feeling unable to breathe, shortness of breath. Acetaminophen.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Abdominal discomfort, Activities of daily living impaired, Adverse drug reaction, Computerised tomogram head normal, Diplopia
Clinical narrative: This spontaneous report as received from a consumer (mother of the patient) refers to a 15 year old female patient. Patient's medical history and concurrent conditions was not reported. On 08-AUG-2013 the patient was vaccinated with GARDASIL (reported as GARDASIL INJ 120 Y) Strength 120MCG, dose 1. Concomitant therapies included ALLEGRA. On an unknown date in November 2012 the patient experienced migraine headaches. On an unknown date the patient experienced chronic fatigue, is missing a lot of school due to her not feeling well (disability), is having difficulty in school and her grades are dropping, can't focus, is sensitive to light and noise, nauseous, feels dizzy, has her period every 2 weeks, low blood pressure, fainted, vision problems (double vision), and neck pain. The reporter stated that her daughter's migraine headaches started on an unspecified date in November 2013 and lasted for 4 days. The patient had a second migraine headache in February 2014. The reporter also stated that the patient was a swimmer and used to swim 4 hours per day and was in good health prior to receiving GARDASIL. The reporter stated that the patient had fainted and had an irregular EKG after fainting. The patient's second EKG was normal. It was reported that in November 2013 the CT of Brain done by the neurologist was normal. The patient was treated for the adverse events with cyproheptadine and Ondansetron. The outcome of the events was unknown. The reporter's causality assessment was not provided. The patient developed severe stomach problems, hyperthyroidism and early menopause after taking VIOXX (MARRS ID 1404USA014704). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Disturbance in attention, Dizziness, Electrocardiogram abnormal, Fatigue, Hyperacusis
Clinical narrative: This spontaneous report as received from a consumer (mother of the patient) refers to a 15 year old female patient. Patient's medical history and concurrent conditions was not reported. On 08-AUG-2013 the patient was vaccinated with GARDASIL (reported as GARDASIL INJ 120 Y) Strength 120MCG, dose 1. Concomitant therapies included ALLEGRA. On an unknown date in November 2012 the patient experienced migraine headaches. On an unknown date the patient experienced chronic fatigue, is missing a lot of school due to her not feeling well (disability), is having difficulty in school and her grades are dropping, can't focus, is sensitive to light and noise, nauseous, feels dizzy, has her period every 2 weeks, low blood pressure, fainted, vision problems (double vision), and neck pain. The reporter stated that her daughter's migraine headaches started on an unspecified date in November 2013 and lasted for 4 days. The patient had a second migraine headache in February 2014. The reporter also stated that the patient was a swimmer and used to swim 4 hours per day and was in good health prior to receiving GARDASIL. The reporter stated that the patient had fainted and had an irregular EKG after fainting. The patient's second EKG was normal. It was reported that in November 2013 the CT of Brain done by the neurologist was normal. The patient was treated for the adverse events with cyproheptadine and Ondansetron. The outcome of the events was unknown. The reporter's causality assessment was not provided. The patient developed severe stomach problems, hyperthyroidism and early menopause after taking VIOXX (MARRS ID 1404USA014704). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Hyperthyroidism, Hypotension, Malaise, Migraine, Nausea
Clinical narrative: This spontaneous report as received from a consumer (mother of the patient) refers to a 15 year old female patient. Patient's medical history and concurrent conditions was not reported. On 08-AUG-2013 the patient was vaccinated with GARDASIL (reported as GARDASIL INJ 120 Y) Strength 120MCG, dose 1. Concomitant therapies included ALLEGRA. On an unknown date in November 2012 the patient experienced migraine headaches. On an unknown date the patient experienced chronic fatigue, is missing a lot of school due to her not feeling well (disability), is having difficulty in school and her grades are dropping, can't focus, is sensitive to light and noise, nauseous, feels dizzy, has her period every 2 weeks, low blood pressure, fainted, vision problems (double vision), and neck pain. The reporter stated that her daughter's migraine headaches started on an unspecified date in November 2013 and lasted for 4 days. The patient had a second migraine headache in February 2014. The reporter also stated that the patient was a swimmer and used to swim 4 hours per day and was in good health prior to receiving GARDASIL. The reporter stated that the patient had fainted and had an irregular EKG after fainting. The patient's second EKG was normal. It was reported that in November 2013 the CT of Brain done by the neurologist was normal. The patient was treated for the adverse events with cyproheptadine and Ondansetron. The outcome of the events was unknown. The reporter's causality assessment was not provided. The patient developed severe stomach problems, hyperthyroidism and early menopause after taking VIOXX (MARRS ID 1404USA014704). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Neck pain, Photophobia, Polymenorrhoea, Premature menopause, Syncope
Clinical narrative: This spontaneous report as received from a consumer (mother of the patient) refers to a 15 year old female patient. Patient's medical history and concurrent conditions was not reported. On 08-AUG-2013 the patient was vaccinated with GARDASIL (reported as GARDASIL INJ 120 Y) Strength 120MCG, dose 1. Concomitant therapies included ALLEGRA. On an unknown date in November 2012 the patient experienced migraine headaches. On an unknown date the patient experienced chronic fatigue, is missing a lot of school due to her not feeling well (disability), is having difficulty in school and her grades are dropping, can't focus, is sensitive to light and noise, nauseous, feels dizzy, has her period every 2 weeks, low blood pressure, fainted, vision problems (double vision), and neck pain. The reporter stated that her daughter's migraine headaches started on an unspecified date in November 2013 and lasted for 4 days. The patient had a second migraine headache in February 2014. The reporter also stated that the patient was a swimmer and used to swim 4 hours per day and was in good health prior to receiving GARDASIL. The reporter stated that the patient had fainted and had an irregular EKG after fainting. The patient's second EKG was normal. It was reported that in November 2013 the CT of Brain done by the neurologist was normal. The patient was treated for the adverse events with cyproheptadine and Ondansetron. The outcome of the events was unknown. The reporter's causality assessment was not provided. The patient developed severe stomach problems, hyperthyroidism and early menopause after taking VIOXX (MARRS ID 1404USA014704). Additional information has been requested.