chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2017US021198, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 671957) on 23 Jan 2017. This report refers to a 40 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on 06 Dec 2016. On 07 Dec 2016 after vaccination, the patient was sick, had body aches, fever and arm pain that has not gone away. It was reported that, the patient need to see a physician concerning the issue. The patient went to emergency room (hospital) on an unknown date. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Sex: M
Vaccine: FLU4, FLUX, PNC13
Symptoms: Rash
Clinical narrative: Case number PHHY2017US025648, is an initial spontaneous report received from a pharmacist via pharmaceutical company via Vaccine Adverse Event Reporting System (VAERS reference number: 672031) website on 23 Jan 20173. This report refers to a 75-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer unknown, batch number: not reported), FLUZONE (batch number: H1637AA) into left arm intramuscular and PREVENAR 13 (batch number: L034335) into right arm intramuscularly on 30 Aug 2016. On an unknown date, after receiving pneumococcal 12 valent conjugate vaccine (diphtheria crm197 protein) and influenza vaccine, the patient experienced rash. The clinical outcome of the event, rash, was unknown. Seriousness was reported as non-serious. Causality was not reported.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Mobility decreased, Musculoskeletal disorder, Musculoskeletal pain, Pain
Clinical narrative: Case number PHHY2017US023101 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 672240) website on 23 Jan 2017. This report refers to a 39 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) into arm on 17 Nov 2016. On the same day after vaccination, it was reported that the whole arm of the patient was sore immediately after injection and eventually the patient was unable to use her arm. The patient experienced shoulder pain when moving her arm, unable to lift her arm, and sharp pain when sleeping and not even moved her arm. Following the events patient visited the emergency room. It was reported that the patient went to the nurse's office at her place of work on an unknown date (reported as about a week after getting the shot) at the school's clinic and the nurse had told that it was not normal and suggested the patient to visit physician if it did not go away. It was reported that the patient finally could not take the pain anymore and went to a clinic on 30 Nov 2016. The physician prescribed ibuprofen and a muscle relaxer for 8 days. It was reported that the patient felt some relief but was still unable to move her arm without pain and the patient visited to her physician second time on 14 Dec 2016, who referred the patient to an orthopedic physician visit which was scheduled on 15 Dec 2016 (reported as tomorrow). The outcome of the events immediate post injection reaction, mobility decreased, musculoskeletal pain, pain and pain in extremity was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2017US023101 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 672240) website on 23 Jan 2017. This report refers to a 39 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) into arm on 17 Nov 2016. On the same day after vaccination, it was reported that the whole arm of the patient was sore immediately after injection and eventually the patient was unable to use her arm. The patient experienced shoulder pain when moving her arm, unable to lift her arm, and sharp pain when sleeping and not even moved her arm. Following the events patient visited the emergency room. It was reported that the patient went to the nurse's office at her place of work on an unknown date (reported as about a week after getting the shot) at the school's clinic and the nurse had told that it was not normal and suggested the patient to visit physician if it did not go away. It was reported that the patient finally could not take the pain anymore and went to a clinic on 30 Nov 2016. The physician prescribed ibuprofen and a muscle relaxer for 8 days. It was reported that the patient felt some relief but was still unable to move her arm without pain and the patient visited to her physician second time on 14 Dec 2016, who referred the patient to an orthopedic physician visit which was scheduled on 15 Dec 2016 (reported as tomorrow). The outcome of the events immediate post injection reaction, mobility decreased, musculoskeletal pain, pain and pain in extremity was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Age: 59.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Arthralgia, Myalgia, Pain in extremity, Rhinorrhoea
Clinical narrative: Case number PHHY2017US020714 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 672360) website on 23 Jan 2017. This report refers to a 59 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with first dose of seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) into right arm on 17 Oct 2016. The patient was also vaccinated with first dose of PREVNAR 13 (manufacturer unknown, batch number: not reported) into left arm on 17 Oct 2016. After vaccination on 24 Oct 2016, patient experienced soreness in arms and joints, running nose and constant muscle pains. It was reported that patient would revisit for arm pain on 11 Nov 2016. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received on 14-MAR-2017 from a pharmacist regarding a 69 year old male patient.  Medical history, concurrent conditions and concomitant medications were not reported. On 02-MAR-2017 the patient received ZOSTAVAX (lot # M036296, expiration date 11-NOV-2017) and sterile diluent (lot # M022946, expiration date 17-DEC-2018). The pharmacist reported that "about 4-5 days later after administration, the patient broke out with shingled on an unspecified area of his body". The patient went to his family physician on an unspecified date and the physician prescribed valacyclovir (VALTREX). The patient has not yet begun to take the valacyclovir (VALTREX). The pharmacist reported that the patient's shingles rash is resolving without the valacyclovir (VALTREX), but it has not fully recovered yet. Varicella-zoster virus (VZV) packet was offered and the pharmacist declined. No additional information was provided. The pharmacist did not rate the causal relationship. Lot # M036296 has been verified as a valid lot # for ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received on 14-MAR-2017 from a pharmacist regarding a 69 year old male patient.  Medical history, concurrent conditions and concomitant medications were not reported. On 02-MAR-2017 the patient received ZOSTAVAX (lot # M036296, expiration date 11-NOV-2017) and sterile diluent (lot # M022946, expiration date 17-DEC-2018). The pharmacist reported that "about 4-5 days later after administration, the patient broke out with shingled on an unspecified area of his body". The patient went to his family physician on an unspecified date and the physician prescribed valacyclovir (VALTREX). The patient has not yet begun to take the valacyclovir (VALTREX). The pharmacist reported that the patient's shingles rash is resolving without the valacyclovir (VALTREX), but it has not fully recovered yet. Varicella-zoster virus (VZV) packet was offered and the pharmacist declined. No additional information was provided. The pharmacist did not rate the causal relationship. Lot # M036296 has been verified as a valid lot # for ZOSTAVAX. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Immobile, Pain, Skin warm, Urticaria
Clinical narrative: Information was received from a pharmacist, referring to a 68 year old female patient. The patient's past drug history included PREVNAR 13 received 1 year ago. The patient's concurrent conditions and concomitant therapies were not provided. On 18-MAR-2017 at about 11:00, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # M037669 with expiration date 09-MAY-2018, 0.5 ml, route and frequency were unknown) as follow-up immunization. On the same day at between 1500 and 1600, the patient began having aches and pains throughout her body. On 19-MAR-2017 and 20-MAR-2017, the patient felt bad as well. On an unknown date in March 2017, the patient's left arm was hot, red and swollen. Since an unspecified date in 2017, the spot on the patient's left arm started at the elbow, and went up her arm about 5 inches and formed a band about 50 to 60 percent around her left arm. The patient was taking an unknown antihistamine to stop the allergic reaction of "spot", and the symptoms were not worsening but were ongoing. The patient did not speak to her doctor about the symptoms. There was no relevant laboratory data. As of 20-MAR-2017, it was unknown if the patient continued PNEUMOVAX23. The outcome of events aches and pains throughout her body, feeling bad, and her left arm was hot, red, and swollen was unknown. The outcome of allergic reaction (symptoms related to "spot") was reported as not recovered. The causality between events and PNEUMOVAX23 was unknown. Product quality complaint was involved in this case. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Feeling abnormal, Hypersensitivity, Pain, Peripheral swelling
Clinical narrative: Information was received from a pharmacist, referring to a 68 year old female patient. The patient's past drug history included PREVNAR 13 received 1 year ago. The patient's concurrent conditions and concomitant therapies were not provided. On 18-MAR-2017 at about 11:00, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # M037669 with expiration date 09-MAY-2018, 0.5 ml, route and frequency were unknown) as follow-up immunization. On the same day at between 1500 and 1600, the patient began having aches and pains throughout her body. On 19-MAR-2017 and 20-MAR-2017, the patient felt bad as well. On an unknown date in March 2017, the patient's left arm was hot, red and swollen. Since an unspecified date in 2017, the spot on the patient's left arm started at the elbow, and went up her arm about 5 inches and formed a band about 50 to 60 percent around her left arm. The patient was taking an unknown antihistamine to stop the allergic reaction of "spot", and the symptoms were not worsening but were ongoing. The patient did not speak to her doctor about the symptoms. There was no relevant laboratory data. As of 20-MAR-2017, it was unknown if the patient continued PNEUMOVAX23. The outcome of events aches and pains throughout her body, feeling bad, and her left arm was hot, red, and swollen was unknown. The outcome of allergic reaction (symptoms related to "spot") was reported as not recovered. The causality between events and PNEUMOVAX23 was unknown. Product quality complaint was involved in this case. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Product quality issue, Skin warm
Clinical narrative: Information was received from a pharmacist, referring to a 68 year old female patient. The patient's past drug history included PREVNAR 13 received 1 year ago. The patient's concurrent conditions and concomitant therapies were not provided. On 18-MAR-2017 at about 11:00, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # M037669 with expiration date 09-MAY-2018, 0.5 ml, route and frequency were unknown) as follow-up immunization. On the same day at between 1500 and 1600, the patient began having aches and pains throughout her body. On 19-MAR-2017 and 20-MAR-2017, the patient felt bad as well. On an unknown date in March 2017, the patient's left arm was hot, red and swollen. Since an unspecified date in 2017, the spot on the patient's left arm started at the elbow, and went up her arm about 5 inches and formed a band about 50 to 60 percent around her left arm. The patient was taking an unknown antihistamine to stop the allergic reaction of "spot", and the symptoms were not worsening but were ongoing. The patient did not speak to her doctor about the symptoms. There was no relevant laboratory data. As of 20-MAR-2017, it was unknown if the patient continued PNEUMOVAX23. The outcome of events aches and pains throughout her body, feeling bad, and her left arm was hot, red, and swollen was unknown. The outcome of allergic reaction (symptoms related to "spot") was reported as not recovered. The causality between events and PNEUMOVAX23 was unknown. Product quality complaint was involved in this case. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Two red, raised itchy areas formed on right deltoid area approximately 1 inch apart. They became larger and more itchy within 4 hours. These symptoms continued through 03/27/2017. On 03/29/2017 threes areas erupted on right thigh at 10:30 am, two large on right buttock by 1:30pm & one small one on lateral left upper thigh by 5:20 pm.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Ill-defined disorder
Clinical narrative: He exploded.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild vaccine site swelling/tenderness.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: This spontaneous report was received from a currently 85 year old female patient concerning herself. The patient had past sensitivity to new medications taken (names of medications were not reported), and she had an allergic reaction with neomycin and all related drugs in the "mycin" family. On an unspecified date in 2014 (reported as "2-3 years ago"), the patient was vaccinated with ZOSTAVAX subcutaneous route (dose, anatomical site injection, lot number and expiration date were not reported) for prevent shingles (prophylaxis). The patient's concomitant drugs included unspecified sleep medications. On an unknown date after receiving the ZOSTAVAX vaccine, the patient developed a case of shingles outbreak which occurred on her abdomen and wrist area. According to her physician it was the "worst case he was ever seen". The patient had been prescribed with unspecified pain medications to treat the shingles outbreak. She reported that the rash had begun to "dry up", but it was still itching. It was reported that the patient sought medical attention talking with her physician. No laboratory diagnostics were performed. At the time of reporting, the outcome of herpes zoster was reported as not recovered. The causal relationship between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 66 year old male patient. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided. On 22-OCT-2015, at the age of 65 year old, the patient was vaccinated with a first dose of PNEUMOVAX 23 (dose, route of administration, lot number, expiration date were not provided). The patient did not recall receiving that dose and did not have documentation. As a result, on 24-FEB-2017, at the age of 66 year old (two months before his 67th birthday), the patient was vaccinated with a second dose of PNEUMOVAX 23 (dose and route of administration were not provided, lot # M013156, expiration date 15-OCT-2017). No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 60 year old female patient. Medical history and concurrent conditions were not provided. On 18-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M032141, the expiration date: 02-OCT-2017 (dose and route were not reported) for vaccination. There was no concomitant medication provided. The consumer came to the pharmacy on 20-MAR-2017 due to swelling at the injection site. Pharmacist confirmed "2.5 inch with and 3 inch length" swelling and redness at injection site, back of arm, (specific arm unspecified) on 19-MAR-2017. The patient did not receive any treatment for the events and there was no laboratory diagnostics performed. At the time of reporting, the outcome of injection site swelling and injection site erythema was reported as not recovered. The relatedness between the therapy with ZOSTAVAX and the events injection site swelling and injection site erythema was not reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Underdose
Clinical narrative: This spontaneous report as received from a registerd nurse concerning to a 26 year old female patient, who is also a nurse. The patient's medical history, concurrent conditions, and concomitant therapies, drug reactions and/ or allergieswere not provided. On an unknown date, the patient was vaccinated with unspecified series of hepatitis B vaccine (recombinant) (manufacturer unknown) (the lot #, expiration date, route, frequency, and strength were not reported). On an unspecified date, the patient had a failed serconversion response as show by negative lab titers (hepatitis B surface antibody negative). It was reported that on an unspecified date, the patient had received an inadvertent needle stick injury of an unspecified product (captured in MARRS# 1703USA012511). Reportedly, following the needle stick injury, the patient was given the RECOMVIBAX lot# M044032, expiration date 03-JUL-2019 (route, frequency, and strength were not reported), but the dosage used was actually a pediatric dose of 5 microgram  rather than the adult dose of 10 microgram. The outcome of the event of hepatitis B surface antibody negative was unknown.   The causal relationship between the event and the vaccine was not provided. Additional information is not expected because there was no consent to contact physician.; Sender's Comments: US-009507513-1703USA012511:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified numbers of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with VARIVAX lot # M032493 with an expiration date 06-JUL-2018 for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of VARIVAX experienced the temperature excursion from -14 degrees Celsius to -10 degrees Celsius for 20 hours and 53 minutes. A digital data logger was involved. There was previous temperature excursion with the temperature range from -14 degrees Celsius to -10 degrees Celsius for 13 hours and 56 minutes (date was not provided). Additional information has been requested.
Sex: U
Vaccine: MMRV, MNQ
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of PROQUAD (strength, dose number, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. Other suspect therapies included MENACTRA. On an unknown date, the patient experienced  a "bad reaction" (adverse event) after administration of PROQUAD and MENACTRA. The outcome of adverse event was unknown. Additional information is not expected, since no consent to contact the reporter was provided.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in the temperature of 47F to 77F for 1 hour) doses of PNEUMOVAX23 (lot # M037533, expiration date 17-MAY-2018; dose and route of administration were not reported) for prophylaxis. No adverse effect and no previous excursion were reported. The call was made because of a data logger. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013412: US-009507513-1703USA013413:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to an unspecified patient of unknown age and gender. There was no information about the patients' concurrent condition, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # M047658 with an expiration date 28-OCT-2017 for prophylaxis (dose, route of administration were not reported). There was no adverse effect reported. Administered doses of VAQTA experienced the temperature excursion of 1 degrees Celsius for 93 hours. A digital data logger was involved. There was no previous temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013107: US-009507513-1703USA012989: US-009507513-1703USA013106.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Information has been received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's medical history was not reported. Concurrent conditions and concomitant medications included treatment with interferon (manufacturer unknown) weekly for multiple sclerosis (diagnosed on an unknown date). On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis. No adverse symptoms reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 28-MAR-2017, the patient was vaccinated with an unspecified expired dose of ROTATEQ orally for prophylaxis (lot # L013197 with an expiration date of 26-JAN-2017). Other suspect and concomitant medications were not provided. No known adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions. drug reactions/allergies and concomitant medications were not reported. On unspecified dates since 10-FEB-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M037019, expiration date:04-NOV-2018, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of - 1.7 Celsius degrees for 4 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013313: US-009507513-1703USA013314: US-009507513-1703USA013315:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions. drug reactions/allergies and concomitant medications were not reported. On unspecified dates since 10-FEB-2017, the patients were vaccinated with improperly stored doses of VAQTA lot # M031806, expiration date:30-MAR-2018, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of - 1.7 Celsius degrees for 4 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013314: US-009507513-1703USA013315: US-009507513-1703USA013202.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in the temperature of 47F to 77F for 1 hour) doses of M-M-R II (lot #, expiration date, dose and route of administration were not reported) for prophylaxis. No adverse effect and no previous excursion were reported. The call was made because of a data logger. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA013413: US-009507513-1703USA012995:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in the temperature of 47F to 77F for 1 hour) doses of ROTATEQ (orally; lot #, expiration date and dose were not reported) for prophylaxis. No adverse effect and no previous excursion were reported. The call was made because of a data logger. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012995: US-009507513-1703USA013412.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Per patient report: dizziness, left arm weakness, headache, body aches, fatigue, chills, sweating.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Pain
Clinical narrative: Per patient report: dizziness, left arm weakness, headache, body aches, fatigue, chills, sweating.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13
Symptoms: Extra dose administered
Clinical narrative: I gave client PEDIARIX and Hep B also on same day so child had extra Hep B given.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided. On an unknown date, the patient was vaccinated with VAQTA injection (dose, route of administration, lot number and expiration date were not provided). On the previous day, the VAQTA has been drawn up into a syringe by a physician. Then the physician transported the syringe with VAQTA to his home to administer the product to his child. He did not administer it. He transported the syringe with VAQTA back to the office and placed it in a refrigerator overnight. The VAQTA did not have any temperature excursions prior to being administered to the patient (before or after being drawn up the syringe). No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M028552, expiration date 07-JUN-2018; lot # M031969, expiration date 30-JUN-2018 and lot # reported as M041079, expiration date 06-OCT-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 9 hours. There were no previous excursions reported. Digital data logger was not involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA011809: US-009507513-1703USA011810.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # L046508, expiration date 17-MAY-2017 and lot # M006104, expiration date 01-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 9 hours. There were no previous excursions reported. Digital data logger was not involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA011799: US-009507513-1703USA011810:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M032638, expiration date 04-OCT-2017; lot # M026876, expiration date 26-JUL-2017; lot # M036297, expiration date 14-NOV-2017 and lot # reported as M010144, expiration date 26-DEC-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 9 hours. There were no previous excursions reported. Digital data logger was not involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA011809: US-009507513-1703USA011799.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M031574 with an expiration date 11-NOV-2018 for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of RECOMBIVAX HB experienced the temperature excursion of 1 degree Celsius for 93 hours. A digital data logger was involved. There was no previous temperature excursion. This is one of several repots received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013107: US-009507513-1703USA013108: US-009507513-1703USA012989.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to an unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M018958 with an expiration date 03-MAR-2018 and lot# M035455 with an expiration date 22-APR-2018, orally for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of ROTATEQ experienced the temperature excursion of 1 degree Celsius for 93 hours. There was no previous temperature excursions. A digital data logger was involved. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012989: US-009507513-1703USA013108: US-009507513-1703USA013106:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions. drug reactions/allergies and concomitant medications were not reported. On unspecified dates since 10-FEB-2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # reported as M032816, expiration date:09-MAY-2018 and lot # M036161, expiration date: 06-MAY-2018, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of - 1.7 Celsius degrees for 4 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013313: US-009507513-1703USA013315: US-009507513-1703USA013202.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions. drug reactions/allergies and concomitant medications were not reported. On unspecified dates since 10-FEB-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M028323, expiration date:26-SEP-2018, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of - 1.7 Celsius degrees for 4 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013313: US-009507513-1703USA013314: US-009507513-1703USA013202:
Sex: F
Vaccine: PNC13
Symptoms: Pain, Rash erythematous
Clinical narrative: This is a spontaneous report obtained from a non-contactable pharmacist. A female patient of an unspecified age, race and ethnicity, received, PREVNAR 13 single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced red spots and it hurt too. Clinical outcome was unknown at time of this report. No follow up attempts possible. No further information expected.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Drug administered at inappropriate site, Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Unusual administration pain-pt sitting-administrator standing-gave extremely high in arm. Extreme pain top of shoulder x 1 week. Can't sleep on left side-upper arm aching-needle-like pain in upper arm radiating to forearm and to thumb. Pad of thumb numbness.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder, X-ray limb abnormal
Clinical narrative: Unusual administration pain-pt sitting-administrator standing-gave extremely high in arm. Extreme pain top of shoulder x 1 week. Can't sleep on left side-upper arm aching-needle-like pain in upper arm radiating to forearm and to thumb. Pad of thumb numbness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient states that she felt something on the area surrounding the vaccine, when she looked at it she found that it was red, swollen and warm. She came to the pharmacy today 3/30 and the area is still light red and a little warm. Patient was instructed to apply hydrocortisone on the area and she will visit her physician later today.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Insomnia, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Reported to pharmacy the day after vaccination was administered. Very painful and patient barely could sleep the evening of receiving the influenza vaccination. Swollen, and very painful to move her arm. Patient's husband reported that it was not muscle pain rather than pain in the joint. The pain in shoulder joint is still reported 1 and 1/2 months after the vaccination occurred with inability to use her shoulder. Follow up treatment(s) and care are unknown at this time but it believed to be at least several doctor's office follow up visits.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Erythema, Pain in extremity
Clinical narrative: Pt states that her arm is very red and sore.  Area of redness is approximately 5inches long and she is experiencing a little tightness in her chest.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a physician assistant via company representative and refers to a currently 25 years old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 02-JUL-2008, the patient was vaccinated with first dose of GARDASIL (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date after vaccine administration, the patient's arm hurt and she refused to to receive any other doses. The patient did not seek for medical attention. It was also reported that therapy with GARDASIL was continued. The outcome of pain in extremity and relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a 24 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unspecified date, when the patient was an infant, she was vaccinated with the complete series of RECOMBIVAX HB 2.5/0.5 (units not provided) (dose, route of administration, lot number and expiration date were not reported) as routine vaccine. Recently, on an unspecified date, the patient was tested for hepatitis B antibodies by her employer, and the titers were negative. The reporter stated that the patient was seeking revaccination, but she had not yet been revaccinated (also reported as no treatment was received). Additionally, the reporter said that the RECOMBIVAX HB could not be ruled out as the vaccine that the patient received as an infant. At the time of reporting the patient had not recovered from the event Hepatitis B antibody negative. The causal relationship between the event and the vaccine was not reported. Additional information is not expected because there was no consent to contact physician.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age or gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 14-DEC-2016, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On 10-MAR-2017, the patient received the second dose of GARDASIL 9 (lot # L040164 and expiration date of 20-FEB-2018) (strength, dose and route of administration were not reported) with the same indication as the first dose. No adverse effects were reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66-year-old male patient with no pertinent medical history, drug reactions or allergies. On 15-MAR-2017, the patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX lot # M036613, expiration date: 19-NOV-2017. Concomitant therapies included LIPTOR, hydrochlorothiazide and atenolol. On 17-MAR-2017, the patient experienced itching, swelling, redness and warmth at the injection site. The patient was not treated for the events. He sought medical attention by calling the pharmacy on 17-MAR-2017. The outcome of the adverse events was reported as not recovered. The causality between the adverse events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to an uncpecified number of patients below age of 50 years old. Patients' concurrent conditions, medical history, known allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) for unknown indication. No adverse effects were reported. Additional information is not expected as there was no consent for further contact.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist, referring to a 62 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-MAR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 PFU, administered subcutaneously, lot number reported as "M041669" with an expiration date on 09-JAN-2018 (dose and anatomical location were not reported) for prevention of shingles. On an unknown date in March 2017, the patient came back to the pharmacy with an "itchy, red, circular, silver dollar sized bump" around the injection site, which she also described as a "small rash".  The reporting pharmacist stated that the patient was advised to take BENADRYL as treatment, also recommended by her physician and no lab diagnostics studies were performed. The pharmacist reported that she had seen other vaccination site reaction with ZOSTAVAX, but it was much worse than this one (MARRS# 1703USA013799); also it was reported that two of her unspecified sisters experienced other reactions to unspecified influenza vaccines on unspecified dates. It was reported that the improperly stored vaccine has a temperature excursion of 15 Fahrenheit (F) to 46 F, during 14 hours. The reporter stated that no previous temperature excursion occurred or digital data logger involved. The outcome of the events was reported as not recovered and the causality between the vaccination with ZOSTAVAX and the events was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA013799.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-MAR-2017 the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M035691,expiration date 07-NOV-2017, subcutaneously, for prophylaxis (dose was not reported). The ZOSTAVAX was reconstituted with properly stored diluent (lot number and expiration date were unknown). No side effects were reported. Administered dose of vaccine was improperly stored for 3 hours and 30 minutes in a temperature range of 7 degrees Fahrenheit (also reported as between 6 degrees Fahrenheit and 14 degrees Fahrenheit). Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. In September 2016, the patient was vaccinated with the first dose of VAQTA 50 U/ml injection (route, lot and expiry date not reported). The patient was then inadvertently administered their second dose of VAQTA (lot M031806, expiry date 30-MAR-2018, route and dose not provided) in February 2017, five and a half months after the initial dose. No adverse effect was reported. There was no product quality complaint (PQC). Additional information has been requested.