chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received on 20-APR-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine on or about 21-JUL-2014 at a pharmacy, as recommended for adult routine health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-AUG-2015, the patient was treated by a physician's assistant at an urgent care center for a painful rash that was diagnosed as a severe case of shingles.  Although the shingles virus is an incurable condition, the patient was prescribed acyclovir (manufacturer unknown) for the management of her symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMR, DTAP, MMR
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, regarding a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions, or drug allergies were not reported. On 18-APR-2017, the patient was inadvertently vaccinated with the first dose of an expired M-M-R II injection (dose and route were not reported) (lot number: L012480; expiration date: 10-APR-2017) for prophylaxis, which was reconstituted with sterile diluent (manufacturer unknown) (lot number and expiration date were unknown by the reporter). According to the reporter, the M-M-R II that was administered to the patient had a prior temperature excursion in the range of 9 degrees Celsius (C) to 25 C for a cumulative time of 1 hour in 2016. No adverse effects were reported. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMR, DTAP, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, regarding a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions, or drug allergies were not reported. On 18-APR-2017, the patient was inadvertently vaccinated with the first dose of an expired M-M-R II injection (dose and route were not reported) (lot number: L012480; expiration date: 10-APR-2017) for prophylaxis, which was reconstituted with sterile diluent (manufacturer unknown) (lot number and expiration date were unknown by the reporter). According to the reporter, the M-M-R II that was administered to the patient had a prior temperature excursion in the range of 9 degrees Celsius (C) to 25 C for a cumulative time of 1 hour in 2016. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 22-DEC-2015, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated at an eye clinic for a painful rash that was diagnosed by the physician as a severe case of shingles keratitis, a condition where the shingles virus spreads to the eyes. Herpes viral keratitis can damage the eye and cause permanent blindness. Although shingles is an incurable condition, the patient was prescribed LYRICA, acyclovir, and trifluridine 1% eye drops to help manage her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, shingles keratitis was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: Information was received on 20-APR-2017 from an attorney in the from of an initial legal complaint regarding a female patient (age not reported).  Medical history, concurrent condition and concomitant therapy were not reported. On 09-DEC-2014 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance for the prevent of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-JUN-2016 the patient was treated for a painful rash which was diagnosed as shingles. On or about 17-JUN-2016 the patient was treated for a new outbreak of shingles vesicles. On or about 06-JUL-2016 the patient was treated for ongoing and worsening symptoms which were diagnosed as severe shingles. Although shingles is an incurable viral condition, the patient was prescribed Lidocaine for management of her pain and symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the patient suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received on 20-APR-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine on or about 04-OCT-2013 at a hospital and clinic, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-JAN-2016, the patient was treated by a physician for a painful rash that was diagnosed as shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Local reaction, Local swelling, Musculoskeletal pain, Neck pain, Tenderness
Clinical narrative: Large swollen local reaction (4/24 - measured 5.5 inches x 8 inches) with swelling and tenderness of upper extremity as well as pain and swelling in neck an L shoulder.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Exposure during pregnancy
Clinical narrative: No adverse event reported at this time. Residential home staff called clinic on 04/19/2017 and walked into the clinic that same day to report the mentioned patient received two vaccines on 01/06/2017 and to later find out the patient was pregnant. The staff report they recently took her to the doctor for an unrelated reason and found out she was pregnant. Staff report her last menses to have been in December 2016. Staff was not aware on the day of the visit to the immunization clinic and the patient withheld information from staff and immunization nurses. No further details were given.
Sex: U
Vaccine: VARCEL
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. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 03-FEB-2017, 06-FEB-2017, 07-FEB-2017, 14-FEB-2017, 15-FEB-2017, 16-FEB-2017, 22-FEB-2017, 24-FEB-2017, 06-MAR-2017, 07-MAR-2017, 08-MAR-2017, 13-MAR-2017, 17-MAR-2017, 21-MAR-2017, 23-MAR-2017, 24-MAR-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # M038224, expiration date 07-SEP-2018 (dose and route of administration were not reported) reconstituted with sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered doses of vaccines experienced many temperature excursions from -8.1 to -4.9 degrees Celsius for 24 minutes to 1 hour 52 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA011833.
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a female patient of unknown age.  The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, lot number, expiration date, route of administration were not reported) for prophylaxis.       On an unknown date, a month after receiving the vaccine, the patient developed a knot on her arm at the injection site (injection site nodule). The outcome of the event was reported as not recovered/not resolved. The product quality complaint was not involved. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX injection, lot # L040421 with expiry date on 15-OCT-2017 (dose and route of administration were not reported), for prophylaxis. The vaccine was administered with improperly stored diluent injection (dose, lot # and expiry date were not reported). Administered doses of vaccine and diluent experienced the temperature excursion in the range of 6 to 14 degrees Fahrenheit (reported also as 11.7 degree Fahrenheit) for 23 hours. Data logger was involved. There was no previous excursion reported. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received on 06-APR-2017 from a nurse regarding 73 year old female patient. Medical history, concurrent conditions and concomitant medications were not reported. On 29-AUG-2016 the patient was inadvertently administered a dose of GARDASIL 9 (lot # not reported). No adverse effects were reported. No further information was provided. Action taken with GARDASIL 9 is not applicable and the outcome was unknown. The nurse did not rate the causal relationship. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 45 year old female patient. The patient's concurrent conditions, medical history or concomitant medication were not reported. On 04-NOV-2016, the patient was vaccinated with the first dose of VAQTA (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On 21-FEB-2017, the patient was inadvertently given the second dose of VAQTA 50/1.0 u/ml, lot # M031806 and an expiration date on 30-MAR-2018, (dose and route of administration were not reported)for prophylaxis. There was no adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX intramuscularly instead of subcutaneously for prevention of shingles (lot # and expiration date were not reported). On an unknown date, the patient experienced swelling and redness. The patient saw the reporting physician due to the events. The outcome of the events and the relatedness between the events and ZOSTAVAX were not reported. Additional information is not expected as there is no consent to contact the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and was referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, multiple patients were vaccinated with improperly stored doses of VARIVAX injection, lot number M033904, expiration date 20-JUL-2018, subcutaneously (dose was not reported). The doses of the vaccines were reconstituted with properly stored sterile diluent (STERILE DILUENT). The doses of the vaccine were stored at a temperature of 42 degrees Fahrenheit for 17 hours, and previously at a temperature ranging from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 16 hours (dates of temperature excursions were not provided). The call was not because of a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA003689:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received on 19-APR-2017 from a lawyer and a female patient of unknown age regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 14-DEC-2012 as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-AUG-2015, the patient was treated by a physician for a painful rash that was diagnosed as shingles. While shingles is an incurable condition, the patient has been prescribed Acyclovir to manage her symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy on or about 22-DEC-2014, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-JUL-2015, the patient was treated at a clinic for an ongoing painful rash and persistent nerve pain which was then diagnosed as shingles, an incurable viral condition for which the patient was prescribed VALTREX for management of his symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information had been received on 20-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age not reported) was inoculated with ZOSTAVAX (dosage and lot#/expiration not reported) on or about 31-AUG-2013 at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused patient to contract a persistent strain of herpes zoster (onset not reported). On or about 06-DEC-2016, patient was treated at the same facility for an ongoing painful rash which was diagnosed as shingles with post herpetic neuralgia. Post herpetic neuralgia is a chronic condition involving nerve damage caused as the residual effect of severe shingles. Although shingles is an incurable viral condition, patient was prescribed gabapentin and hydrocodone for management of her symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received on 20-APR-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine on or about 24-FEB-2012 at a medical facility, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-MAR-2013, the patient was treated at a physician's office for a painful rash that was diagnosed as shingles. Although shingles is a viral condition that is incurable, the patient was prescribed valacyclovir (VALTREX) (manufacturer unknown) to manage his outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 30-SEP-2010, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about  01-JUN-2011, the patient was treated for a painful, blistering rash which was then diagnosed with shingles. It was reported although shingles is an incurable viral condition, the physician prescribed acyclovir for management of his symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: MMRV
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. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M037651, expiration date 28-AUG-2018 (dose and route of administration were not reported) reconstituted with sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered doses of vaccines experienced many temperature excursions from -8.1 to -4.9 degrees Celsius for 24 minutes to 1 hour 52 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013057:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was accidentally vaccinated with an expired dose of M-M-R II (dose, strength, frequency, route of administration and anatomical location were not provided) (lot # L010488 with expiration date 26-MAR-2017), for prophylaxis. No adverse effects were reported. This is one of 2 reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA010886.
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. An elderly female patient (over 65 years old) received PREVNAR 13 on an unspecified date at single dose for immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced hip muscular skeletal pain on an unspecified date after vaccination, with unknown outcome.  The patient believed it was caused by the suspect vaccine. Office health professionals believed it to be attributed to other underlying conditions. No follow-up attempts possible. No further information expected.; Sender's Comments: Reported event of hip muscular skeletal pain is more likely associated with the elder patient's underlying medical condition that is unrelated to the use of PREVNAR 13.
Age: 18.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Antinuclear antibody, Bacterial test, Borrelia test, C-reactive protein, Dermatitis contact
Clinical narrative: 1 referral for 18yo, NKDA, no food, latex environmental allergies, no health issues, on no medication 3/24 patient receive TWINRIX3 and first flu vaccine (SKB quad preservative free-FLUARIX). 3/25 went hiking on a wood path near ocean. She was in shorts, had 2 small dogs running in an out of bush/woods (a yorkie and a shiatzu) that may have come in contact with something - gave both baths that day. that evening noted swelling and itching of legs waxing and waning. She did not recall or see any specific insect bites. She self-treated with calamine lotion and noticed showers made rash redder and itch more. She had difficulty sleeping that night. 3/26 was feeling better, rash resolving and did not spread or worsen 3/27 presented to clinic with red hive to right temple region and the red rash was still present on both calves and anterior right shin/thigh and her lower gums were sore and swollen with white sores in mouth, and she had diffuse body pain, aches, muscle pain and fatigue (as if she were 82 yo and couldn't get out of bed). She used TYLENOL for discomfort. Denies any fever, no rash to palms/soles or anywhere else on body. No eye symptoms. EXAM: no rash Dx Irritant contact dermatitis to plants - Provider treated with ALLEGRA, hydrocortisone cream for rash. 3/31 Went to urgent care c/o tongue white and mouth sore (records not available), had normal CBC, and was given Amoxicillin and MEDROL dose pack. She again denies any fever (above 99), headaches, n/v/d or difficulty swallowing or any other symptom. 4/3 and 4/4 Seen by clinic - Feels worse today. Gums and mouth are in pain, "hard to get out of bed" due to body pains. States pain mostly to arms, legs and neck...no pain with flexion of neck, had difficulty eating but not swallowing. States roof of mouth feels swollen and fat, but again denies any SOB, not drooling, no throat tightness. Speech clear but sounds as if mouth has food in it. No current rashes on legs or face. Clinic treated with viscous lidocaine, BENADRYL, ZANTAC and had following labs drawn: ANA, CBC w/diff, CRP, ESR, Lyme, Ricketts.
Age: 18.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Differential white blood cell count, Discomfort, Fatigue, Full blood count normal, Gingival pain
Clinical narrative: 1 referral for 18yo, NKDA, no food, latex environmental allergies, no health issues, on no medication 3/24 patient receive TWINRIX3 and first flu vaccine (SKB quad preservative free-FLUARIX). 3/25 went hiking on a wood path near ocean. She was in shorts, had 2 small dogs running in an out of bush/woods (a yorkie and a shiatzu) that may have come in contact with something - gave both baths that day. that evening noted swelling and itching of legs waxing and waning. She did not recall or see any specific insect bites. She self-treated with calamine lotion and noticed showers made rash redder and itch more. She had difficulty sleeping that night. 3/26 was feeling better, rash resolving and did not spread or worsen 3/27 presented to clinic with red hive to right temple region and the red rash was still present on both calves and anterior right shin/thigh and her lower gums were sore and swollen with white sores in mouth, and she had diffuse body pain, aches, muscle pain and fatigue (as if she were 82 yo and couldn't get out of bed). She used TYLENOL for discomfort. Denies any fever, no rash to palms/soles or anywhere else on body. No eye symptoms. EXAM: no rash Dx Irritant contact dermatitis to plants - Provider treated with ALLEGRA, hydrocortisone cream for rash. 3/31 Went to urgent care c/o tongue white and mouth sore (records not available), had normal CBC, and was given Amoxicillin and MEDROL dose pack. She again denies any fever (above 99), headaches, n/v/d or difficulty swallowing or any other symptom. 4/3 and 4/4 Seen by clinic - Feels worse today. Gums and mouth are in pain, "hard to get out of bed" due to body pains. States pain mostly to arms, legs and neck...no pain with flexion of neck, had difficulty eating but not swallowing. States roof of mouth feels swollen and fat, but again denies any SOB, not drooling, no throat tightness. Speech clear but sounds as if mouth has food in it. No current rashes on legs or face. Clinic treated with viscous lidocaine, BENADRYL, ZANTAC and had following labs drawn: ANA, CBC w/diff, CRP, ESR, Lyme, Ricketts.
Age: 18.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Gingival swelling, Human chorionic gonadotropin negative, Insomnia, Mobility decreased, Myalgia
Clinical narrative: 1 referral for 18yo, NKDA, no food, latex environmental allergies, no health issues, on no medication 3/24 patient receive TWINRIX3 and first flu vaccine (SKB quad preservative free-FLUARIX). 3/25 went hiking on a wood path near ocean. She was in shorts, had 2 small dogs running in an out of bush/woods (a yorkie and a shiatzu) that may have come in contact with something - gave both baths that day. that evening noted swelling and itching of legs waxing and waning. She did not recall or see any specific insect bites. She self-treated with calamine lotion and noticed showers made rash redder and itch more. She had difficulty sleeping that night. 3/26 was feeling better, rash resolving and did not spread or worsen 3/27 presented to clinic with red hive to right temple region and the red rash was still present on both calves and anterior right shin/thigh and her lower gums were sore and swollen with white sores in mouth, and she had diffuse body pain, aches, muscle pain and fatigue (as if she were 82 yo and couldn't get out of bed). She used TYLENOL for discomfort. Denies any fever, no rash to palms/soles or anywhere else on body. No eye symptoms. EXAM: no rash Dx Irritant contact dermatitis to plants - Provider treated with ALLEGRA, hydrocortisone cream for rash. 3/31 Went to urgent care c/o tongue white and mouth sore (records not available), had normal CBC, and was given Amoxicillin and MEDROL dose pack. She again denies any fever (above 99), headaches, n/v/d or difficulty swallowing or any other symptom. 4/3 and 4/4 Seen by clinic - Feels worse today. Gums and mouth are in pain, "hard to get out of bed" due to body pains. States pain mostly to arms, legs and neck...no pain with flexion of neck, had difficulty eating but not swallowing. States roof of mouth feels swollen and fat, but again denies any SOB, not drooling, no throat tightness. Speech clear but sounds as if mouth has food in it. No current rashes on legs or face. Clinic treated with viscous lidocaine, BENADRYL, ZANTAC and had following labs drawn: ANA, CBC w/diff, CRP, ESR, Lyme, Ricketts.
Age: 18.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Neck pain, Oral pain, Pain, Pain in extremity, Palatal swelling
Clinical narrative: 1 referral for 18yo, NKDA, no food, latex environmental allergies, no health issues, on no medication 3/24 patient receive TWINRIX3 and first flu vaccine (SKB quad preservative free-FLUARIX). 3/25 went hiking on a wood path near ocean. She was in shorts, had 2 small dogs running in an out of bush/woods (a yorkie and a shiatzu) that may have come in contact with something - gave both baths that day. that evening noted swelling and itching of legs waxing and waning. She did not recall or see any specific insect bites. She self-treated with calamine lotion and noticed showers made rash redder and itch more. She had difficulty sleeping that night. 3/26 was feeling better, rash resolving and did not spread or worsen 3/27 presented to clinic with red hive to right temple region and the red rash was still present on both calves and anterior right shin/thigh and her lower gums were sore and swollen with white sores in mouth, and she had diffuse body pain, aches, muscle pain and fatigue (as if she were 82 yo and couldn't get out of bed). She used TYLENOL for discomfort. Denies any fever, no rash to palms/soles or anywhere else on body. No eye symptoms. EXAM: no rash Dx Irritant contact dermatitis to plants - Provider treated with ALLEGRA, hydrocortisone cream for rash. 3/31 Went to urgent care c/o tongue white and mouth sore (records not available), had normal CBC, and was given Amoxicillin and MEDROL dose pack. She again denies any fever (above 99), headaches, n/v/d or difficulty swallowing or any other symptom. 4/3 and 4/4 Seen by clinic - Feels worse today. Gums and mouth are in pain, "hard to get out of bed" due to body pains. States pain mostly to arms, legs and neck...no pain with flexion of neck, had difficulty eating but not swallowing. States roof of mouth feels swollen and fat, but again denies any SOB, not drooling, no throat tightness. Speech clear but sounds as if mouth has food in it. No current rashes on legs or face. Clinic treated with viscous lidocaine, BENADRYL, ZANTAC and had following labs drawn: ANA, CBC w/diff, CRP, ESR, Lyme, Ricketts.
Age: 18.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Peripheral swelling, Pruritus, Rash erythematous, Red blood cell sedimentation rate, Stomatitis
Clinical narrative: 1 referral for 18yo, NKDA, no food, latex environmental allergies, no health issues, on no medication 3/24 patient receive TWINRIX3 and first flu vaccine (SKB quad preservative free-FLUARIX). 3/25 went hiking on a wood path near ocean. She was in shorts, had 2 small dogs running in an out of bush/woods (a yorkie and a shiatzu) that may have come in contact with something - gave both baths that day. that evening noted swelling and itching of legs waxing and waning. She did not recall or see any specific insect bites. She self-treated with calamine lotion and noticed showers made rash redder and itch more. She had difficulty sleeping that night. 3/26 was feeling better, rash resolving and did not spread or worsen 3/27 presented to clinic with red hive to right temple region and the red rash was still present on both calves and anterior right shin/thigh and her lower gums were sore and swollen with white sores in mouth, and she had diffuse body pain, aches, muscle pain and fatigue (as if she were 82 yo and couldn't get out of bed). She used TYLENOL for discomfort. Denies any fever, no rash to palms/soles or anywhere else on body. No eye symptoms. EXAM: no rash Dx Irritant contact dermatitis to plants - Provider treated with ALLEGRA, hydrocortisone cream for rash. 3/31 Went to urgent care c/o tongue white and mouth sore (records not available), had normal CBC, and was given Amoxicillin and MEDROL dose pack. She again denies any fever (above 99), headaches, n/v/d or difficulty swallowing or any other symptom. 4/3 and 4/4 Seen by clinic - Feels worse today. Gums and mouth are in pain, "hard to get out of bed" due to body pains. States pain mostly to arms, legs and neck...no pain with flexion of neck, had difficulty eating but not swallowing. States roof of mouth feels swollen and fat, but again denies any SOB, not drooling, no throat tightness. Speech clear but sounds as if mouth has food in it. No current rashes on legs or face. Clinic treated with viscous lidocaine, BENADRYL, ZANTAC and had following labs drawn: ANA, CBC w/diff, CRP, ESR, Lyme, Ricketts.
Age: 18.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Tongue discolouration, Urine analysis, Urticaria
Clinical narrative: 1 referral for 18yo, NKDA, no food, latex environmental allergies, no health issues, on no medication 3/24 patient receive TWINRIX3 and first flu vaccine (SKB quad preservative free-FLUARIX). 3/25 went hiking on a wood path near ocean. She was in shorts, had 2 small dogs running in an out of bush/woods (a yorkie and a shiatzu) that may have come in contact with something - gave both baths that day. that evening noted swelling and itching of legs waxing and waning. She did not recall or see any specific insect bites. She self-treated with calamine lotion and noticed showers made rash redder and itch more. She had difficulty sleeping that night. 3/26 was feeling better, rash resolving and did not spread or worsen 3/27 presented to clinic with red hive to right temple region and the red rash was still present on both calves and anterior right shin/thigh and her lower gums were sore and swollen with white sores in mouth, and she had diffuse body pain, aches, muscle pain and fatigue (as if she were 82 yo and couldn't get out of bed). She used TYLENOL for discomfort. Denies any fever, no rash to palms/soles or anywhere else on body. No eye symptoms. EXAM: no rash Dx Irritant contact dermatitis to plants - Provider treated with ALLEGRA, hydrocortisone cream for rash. 3/31 Went to urgent care c/o tongue white and mouth sore (records not available), had normal CBC, and was given Amoxicillin and MEDROL dose pack. She again denies any fever (above 99), headaches, n/v/d or difficulty swallowing or any other symptom. 4/3 and 4/4 Seen by clinic - Feels worse today. Gums and mouth are in pain, "hard to get out of bed" due to body pains. States pain mostly to arms, legs and neck...no pain with flexion of neck, had difficulty eating but not swallowing. States roof of mouth feels swollen and fat, but again denies any SOB, not drooling, no throat tightness. Speech clear but sounds as if mouth has food in it. No current rashes on legs or face. Clinic treated with viscous lidocaine, BENADRYL, ZANTAC and had following labs drawn: ANA, CBC w/diff, CRP, ESR, Lyme, Ricketts.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Swelling, Tenderness
Clinical narrative: REDNESS, SWELLING ABOUT 1 1/2 X 3 INCHES, ITCHING, HARDNESS IN THE CENTER, TENDERNESS.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Fatigue, Infantile spasms
Clinical narrative: Extreme fatigue, eventually infantile spasms identified on Saturday, January 18, 2014.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal disorder, Pain, Pyrexia
Clinical narrative: Felt achy all over, fever over 100, felt like "he could not use his arm at all".
Age: 55.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site pain
Clinical narrative: Client reports continued pain to left arm at injection site.
Age: 17.0
Sex: F
Vaccine: HEP, HPV9, IPV, TD
Symptoms: Aphasia, Neurological examination normal, Salivary hypersecretion, Slow speech, Speech disorder
Clinical narrative: Since vaccination date, patient reported having intermittent difficulty with forming words and increased salivation. No other complaints reported. On exam patient had slow, mumbled speech. Rest of neuro exam was normal.  Patient was sent to Emergency Department for evaluation. On follow up 02/22/2017 patient reported that symptoms had resolved with no treatment.
Age: 60.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Administration site swelling, Influenza like illness, Injection site erythema
Clinical narrative: Patient came in today on 04/24/2017 around noon. Patient had an administration site reaction: right arm with mild swelling and redness, and mild flu-like symptoms that per the patient did not occur until the evening of the shot, and worsened the next day. Called patient's physician's office, spoke to RN, who asked the patient to come in for an immediate visit and asked that the patient take a BENADRYL prior to visit. Patient left the pharmacy to go to the doctor's office.
Age: 0.17
Sex: M
Vaccine: 6VAX-F
Symptoms: Anaphylactic shock
Clinical narrative: After being brought home from the doctor, where he received a round of shots, he went into anaphalactic shock and had to be rushed to the hospital.
Age: 30.0
Sex: F
Vaccine: TTOX
Symptoms: Herpes zoster
Clinical narrative: Full-blown shingles.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site warmth, Swelling
Clinical narrative: Patient had swelling and redness from elbow to shoulder. Patient also stated site is warm to touch.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy, rash, elevated rash, prickly red dots.
Age: 31.0
Sex: F
Vaccine: HPVX
Symptoms: Alopecia, Blood test, Drug administered to patient of inappropriate age, Lethargy
Clinical narrative: This spontaneous report was received from a 31 year old female patient, referring to herself. The patient had none pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 15-MAR-2017, the patient was vaccinated with GARDASIL or with GARDASIL 9 0.5 ml once (lot # and expiration date were not reported) therapy route reported as injection for prevention of human papillomavirus (HPV). Approximately on 22-MAR-2017 (reported as within a week), the patient started feeling lethargic and started losing hair like crazy (alopecia). The patient sought medical attention, she did not receive any treatment but she had an unspecified blood work (results were not reported). At the time of this report, she had about 40 % of her hair left and she had not recovered from both events. The patient was looking for reimbursement for the vaccine as well as compensation for medical expenses.  The causality between the events alopecia and lethargy with GARDASIL and with GARDASIL 9 was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeding disorder, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old female patient. The patient was on an unspecified biologic and kept getting urinary tract infections, but she had been off that biologic for 6 months and had not had an infection since. The patient did not have any known drug reactions or allergies. Concomitant therapies included a biologic for increased liver enzymes. On 07-APR-2017, the patient was vaccinated with ZOSTAVAX lot # M033910 (expiration date 19-OCT-2017) subcutaneously for shingles prevention (the strength, dose, and frequency were not provided) reconstituted with sterile diluent (lot # M022946 expiration date 17-DEC-2018). On 08-APR-2017, the patient noticed some redness around the injection site that was moving down toward the elbow. The area was very hot and tender, and the patient was also feeling nauseous and could not eat. On 09-APR-2017, the patient called the pharmacist and reported the symptoms and told her they were not getting away better. She also had chills, and still felt very nauseous. On the same day, the patient went to see the pharmacist, and the pharmacist reported that the redness around the injection site was about a 4-5 inch oval of redness and looked very hot and tender. Inside the 4-5 inch oval of redness was another different circular rash about 2 inches in circumference. The inner circle looked like a textured red rash, almost like a blistered burn and was very swollen. It was also informed that the patient could go to the hospital, but she declined it. On 11-APR-2017, the patient still had chills and was sweating profusely. She also reported that the inner circle rash was changing, it edges were were moving and becoming misshapen, it was not longer a circle. There was not treatment for the events  and no laboratory diagnostic studies were performed. At the reporting time, the patient had not recovered from the events. The relationship between the events and the suspect therapies was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Nausea, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old female patient. The patient was on an unspecified biologic and kept getting urinary tract infections, but she had been off that biologic for 6 months and had not had an infection since. The patient did not have any known drug reactions or allergies. Concomitant therapies included a biologic for increased liver enzymes. On 07-APR-2017, the patient was vaccinated with ZOSTAVAX lot # M033910 (expiration date 19-OCT-2017) subcutaneously for shingles prevention (the strength, dose, and frequency were not provided) reconstituted with sterile diluent (lot # M022946 expiration date 17-DEC-2018). On 08-APR-2017, the patient noticed some redness around the injection site that was moving down toward the elbow. The area was very hot and tender, and the patient was also feeling nauseous and could not eat. On 09-APR-2017, the patient called the pharmacist and reported the symptoms and told her they were not getting away better. She also had chills, and still felt very nauseous. On the same day, the patient went to see the pharmacist, and the pharmacist reported that the redness around the injection site was about a 4-5 inch oval of redness and looked very hot and tender. Inside the 4-5 inch oval of redness was another different circular rash about 2 inches in circumference. The inner circle looked like a textured red rash, almost like a blistered burn and was very swollen. It was also informed that the patient could go to the hospital, but she declined it. On 11-APR-2017, the patient still had chills and was sweating profusely. She also reported that the inner circle rash was changing, it edges were were moving and becoming misshapen, it was not longer a circle. There was not treatment for the events  and no laboratory diagnostic studies were performed. At the reporting time, the patient had not recovered from the events. The relationship between the events and the suspect therapies was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 19-APR-2017, during an office visit, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (dose, frequency and route were not reported) lot # L029113 with expiration date of 27-MAR-2017, for prophylaxis. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Blood pressure fluctuation, Depressed level of consciousness, Injection site reaction, Nausea, Palpitations
Clinical narrative: This spontaneous report was received from a currently a 57 year old male patient referring to himself. The patient's concurrent conditions included high blood pressure. His medical history was not reported. In approximately 2008, reported as about 9 years ago, the patient started therapy with REMERON 30 mg tablets, 30 mg once a day, orally (lot number and expiration date were not provided) for help him with sleep, which was other than indicated in the prescribing information (product use issue). Other suspect therapies included losartan (manufacturer unknown) 100 mg tablets, orally; ZOCOR 20 mg tablets, orally (dose, frequency, lot, numbers, expiration dates and indication of both therapies were not reported) and on an unknown date, while he was on those therapies, he received a dose of pneumococcal vaccine (manufacturer unknown) (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient had a reaction to the pneumococcal vaccine (manufacturer unknown); he developed sepsis at the site of the injection. The patient was treated by his physician with an unspecified treatment and recovered on an unknown date. The patient stated that after 9 years, he attempted to slowly take himself off REMERON. So, he started cutting the tablets in half and then stopped taking the medication completely (unknown dates). Thereafter, on an unspecified date, the patient experienced blood pressure being all over the place, wanting to pass out, his heart was racing and nausea. On approximately 05-APR-2017, reported as about two weeks ago, he was admitted to the hospital due to the events. The patient received unspecified treatment for the events and was discharged on an unspecified date in April 2017. No laboratory diagnostic studies were performed. At the time of the report, therapy with REMERON was continued and the patient was recovering from the events. However; he stated that he needed to be "off" REMERON as per his physician. The action taken with losartan (manufacturer unknown) and ZOCOR was unknown. The action taken with REMERON, losartan (manufacturer unknown) and ZOCOR regarding sepsis at the injection was unknown. The reporter considered the injection site infection to be related to pneumococcal vaccine (manufacturer unknown). The causal relationship between the other events and the suspect therapies was not reported. Upon internal review, the sepsis was considered to be a medically significant event. Additional information is not expected because there was no consent to contact the physician.