chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report was received from a 61 year old female patient. The patient's concurrent conditions included high blood pressure and allergy to latex and penicillin. The patient's medical history and concomitant medications were not provided. On 18-MAR-2016, the patient was vaccinated with ZOSTAVAX 1 shot (lot number, expiry date, route, dose and frequency were not reported) for shingles prevention. On 18-MAR-2016, after vaccination, the patient experienced injection site swelling about the size of a quarter, that increased to the size of a silver dollar. On 19-MAR-2016 (reported as on the next day), it was reported that the injection site was itchy and had a rash. The patient sought medical attention on 20-MAR-2016, when the swelling reached her shoulder area. The area was hot. The patient received a treatment with BENADRYL and camphor, methol, SARNA CREAM for the reported adverse events. No product quality complaint (PQC) was involved. At the time of this report, the outcome of injection site swelling, peripheral swelling, feeling hot, rash pruritic and Injection site pain was reported as not recovered. The reporter did not provide causality assessment between the reported events and the ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Peripheral swelling, Polymerase chain reaction positive
Clinical narrative: This spontaneous report was received from a 61 year old female patient. The patient's concurrent conditions included high blood pressure and allergy to latex and penicillin. The patient's medical history and concomitant medications were not provided. On 18-MAR-2016, the patient was vaccinated with ZOSTAVAX 1 shot (lot number, expiry date, route, dose and frequency were not reported) for shingles prevention. On 18-MAR-2016, after vaccination, the patient experienced injection site swelling about the size of a quarter, that increased to the size of a silver dollar. On 19-MAR-2016 (reported as on the next day), it was reported that the injection site was itchy and had a rash. The patient sought medical attention on 20-MAR-2016, when the swelling reached her shoulder area. The area was hot. The patient received a treatment with BENADRYL and camphor, methol, SARNA CREAM for the reported adverse events. No product quality complaint (PQC) was involved. At the time of this report, the outcome of injection site swelling, peripheral swelling, feeling hot, rash pruritic and Injection site pain was reported as not recovered. The reporter did not provide causality assessment between the reported events and the ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash maculo-papular, Rash pruritic, Scab, Skin lesion, Vaccination site pustule
Clinical narrative: This spontaneous report was received from a 61 year old female patient. The patient's concurrent conditions included high blood pressure and allergy to latex and penicillin. The patient's medical history and concomitant medications were not provided. On 18-MAR-2016, the patient was vaccinated with ZOSTAVAX 1 shot (lot number, expiry date, route, dose and frequency were not reported) for shingles prevention. On 18-MAR-2016, after vaccination, the patient experienced injection site swelling about the size of a quarter, that increased to the size of a silver dollar. On 19-MAR-2016 (reported as on the next day), it was reported that the injection site was itchy and had a rash. The patient sought medical attention on 20-MAR-2016, when the swelling reached her shoulder area. The area was hot. The patient received a treatment with BENADRYL and camphor, methol, SARNA CREAM for the reported adverse events. No product quality complaint (PQC) was involved. At the time of this report, the outcome of injection site swelling, peripheral swelling, feeling hot, rash pruritic and Injection site pain was reported as not recovered. The reporter did not provide causality assessment between the reported events and the ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination site scab, Varicella virus test positive
Clinical narrative: This spontaneous report was received from a 61 year old female patient. The patient's concurrent conditions included high blood pressure and allergy to latex and penicillin. The patient's medical history and concomitant medications were not provided. On 18-MAR-2016, the patient was vaccinated with ZOSTAVAX 1 shot (lot number, expiry date, route, dose and frequency were not reported) for shingles prevention. On 18-MAR-2016, after vaccination, the patient experienced injection site swelling about the size of a quarter, that increased to the size of a silver dollar. On 19-MAR-2016 (reported as on the next day), it was reported that the injection site was itchy and had a rash. The patient sought medical attention on 20-MAR-2016, when the swelling reached her shoulder area. The area was hot. The patient received a treatment with BENADRYL and camphor, methol, SARNA CREAM for the reported adverse events. No product quality complaint (PQC) was involved. At the time of this report, the outcome of injection site swelling, peripheral swelling, feeling hot, rash pruritic and Injection site pain was reported as not recovered. The reporter did not provide causality assessment between the reported events and the ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a consumer and refers to an unspecified number of children of an unknown ages and genders. The patient' medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with M-M-R II dose, frequency, anatomical location, lot # expiration date were not reported. Concomitant medications were not provided. On an unspecified date, the children had a reaction (vaccination complication) M-M-R II and it was stated by the reported that they were on alternated vaccine schedules. The outcome of vaccination complication was unknown. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 9 week old patient of unknown gender. Pertinent medical history, concurrent conditions and concomitant medications were not reported. On 22-MAR-2016 the patient was vaccinated with PEDVAXHIB, 0.5 ml (lot # L038502 expiry date: 16-AUG-2018), intramuscular in the left leg. On 25-MAR-2016, the patient was inadvertently vaccinated with 0.5 ml of PEDVAXHIB again in the same left leg. The second administration was also from the same lot/ expiration date as first however a different vial. The patient did not experience any adverse event. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to 7 patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored PEDVAXHIB (lot # L036685, expiration 12-AUG-2018, 0.5 ml) intramuscularly. The vaccine was stored in temperature of 57.2 F for 2.25 hours. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent condition, concomitant medication or drug allergy described. On an unspecified date in December 2015, the patient was administered a dose of improperly stored PNEUMOVAX 23 prefilled syringe (PFS) or single-dose vial (SDV) lot # L035686, expiration date unspecified (strength, dose and route were not reported). The vaccine was stored under an unspecified temperature for 3 weeks. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during breast feeding
Clinical narrative: This spontaneous report was received from a female consumer reporting on herself. The patient's relevant medical history, past drug history, and concomitant medications were unknown. On 24-MAR-2016, while breast feeding, the patient received one dose of GARDASIL 9 (lot number, and expiration date were unknown) in her right arm (dose number, frequency and indication were not provided). It was unknown if this was her first injection. Concomitant medication was not reported. On the same day, the consumer noticed a very mild rash and oral mucosal eruption on her 6-month old daughter's mouth and neck. (Captured in MARRS#1603USA03007). This is one of two reports from the same source. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Bursitis
Clinical narrative: Immediate burning and pain after the injection.  Over the next few days my shoulder became more sore and I had a very limited range of motion.  I have been to a chiropractor, orthopedic doctor, physical therapist, and my family physician for the pain and limited range of motion.  I received a cortisone injection to help relieve the pain and inflamation which was not successful.  I am still a lot experiencing pain and limited range of motion in my shoulder, almost 4 months after the injection.
Age: 33.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Burning sensation, Immediate post-injection reaction, Inflammation, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Immediate burning and pain after the injection.  Over the next few days my shoulder became more sore and I had a very limited range of motion.  I have been to a chiropractor, orthopedic doctor, physical therapist, and my family physician for the pain and limited range of motion.  I received a cortisone injection to help relieve the pain and inflamation which was not successful.  I am still a lot experiencing pain and limited range of motion in my shoulder, almost 4 months after the injection.
Age: 33.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain, Ultrasound scan, X-ray
Clinical narrative: Immediate burning and pain after the injection.  Over the next few days my shoulder became more sore and I had a very limited range of motion.  I have been to a chiropractor, orthopedic doctor, physical therapist, and my family physician for the pain and limited range of motion.  I received a cortisone injection to help relieve the pain and inflamation which was not successful.  I am still a lot experiencing pain and limited range of motion in my shoulder, almost 4 months after the injection.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Myalgia, Pain
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 65 year old male patient. The patient's concurrent conditions included diabetes and an unspecified heart disease. The patient did not have any known drug allergies. On 09-FEB-2016, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # L029306, expiry date-26-MAR-2017) intramuscularly in the left deltoid. On 12-FEB-2016, the patient experienced "body aches and pain all over" and also stated that he was "incapacitated by the pain". On 25-FEB-2016, the patient was prescribed a "MEDROL Dose Pack" and he stated that this "did not help at all". No laboratory tests were conducted. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The causality assessment was not provided. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Asthenia, Pain
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 65 year old male patient. The patient's concurrent conditions included diabetes and an unspecified heart disease. The patient did not have any known drug allergies. On 09-FEB-2016, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # L029306, expiry date-26-MAR-2017) intramuscularly in the left deltoid. On 12-FEB-2016, the patient experienced "body aches and pain all over" and also stated that he was "incapacitated by the pain". On 25-FEB-2016, the patient was prescribed a "MEDROL Dose Pack" and he stated that this "did not help at all". No laboratory tests were conducted. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The causality assessment was not provided. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 65 year old male patient. The patient's concurrent conditions included diabetes and an unspecified heart disease. The patient did not have any known drug allergies. On 09-FEB-2016, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # L029306, expiry date-26-MAR-2017) intramuscularly in the left deltoid. On 12-FEB-2016, the patient experienced "body aches and pain all over" and also stated that he was "incapacitated by the pain". On 25-FEB-2016, the patient was prescribed a "MEDROL Dose Pack" and he stated that this "did not help at all". No laboratory tests were conducted. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The causality assessment was not provided. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: YF, YF
Symptoms: Arthralgia, Chest discomfort, Electrocardiogram ambulatory, Joint swelling, Palpitations
Clinical narrative: Initial unsolicited report received from a nurse on 18 March 2016. This case involves 34-year-old female patient who was vaccinated with one dose of YELLOW FEVER VACCINE - US (Yellow fever) (batch number- U1266AA; expiry date 28 July 2017) subcutaneously in left arm on 08 March 2016 at 9:39 am. The patient's pre-existing conditions included nasopharyngeal allergy- throat itching, doxycycline allergy-blurry vision and asthma. The patient had no illness at the time of vaccination. The patient's concomitant medications included ZOLOFT, levocetirizine, DULERA and PROAIR HFA prn. On 09 March 2016, one day following the vaccination, the patient had experienced symmetrical bilateral wrist tenderness, swollen hands progressing over the next 5 days to majority of her joints. On 16 March 2016, eight days following the vaccination, the patient had experienced increased heart rate and chest discomfort. The patient required emergency room/ doctor visit. Laboratory data was not reported. The patient had received ibuprofen for events bilateral wrist tenderness, swollen hands corrective treatment and corrective treatment for events experienced increased heart rate and chest discomfort was not reported. The patient recovered from symmetrical bilateral wrist tenderness, swollen hands progressing over majority of her joints however stop date was not reported. The patient was not recovered from event increased heart rate and outcome of event chest discomfort was not reported. List of documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: YF, YF
Symptoms: Peripheral swelling, Supraventricular tachycardia
Clinical narrative: Initial unsolicited report received from a nurse on 18 March 2016. This case involves 34-year-old female patient who was vaccinated with one dose of YELLOW FEVER VACCINE - US (Yellow fever) (batch number- U1266AA; expiry date 28 July 2017) subcutaneously in left arm on 08 March 2016 at 9:39 am. The patient's pre-existing conditions included nasopharyngeal allergy- throat itching, doxycycline allergy-blurry vision and asthma. The patient had no illness at the time of vaccination. The patient's concomitant medications included ZOLOFT, levocetirizine, DULERA and PROAIR HFA prn. On 09 March 2016, one day following the vaccination, the patient had experienced symmetrical bilateral wrist tenderness, swollen hands progressing over the next 5 days to majority of her joints. On 16 March 2016, eight days following the vaccination, the patient had experienced increased heart rate and chest discomfort. The patient required emergency room/ doctor visit. Laboratory data was not reported. The patient had received ibuprofen for events bilateral wrist tenderness, swollen hands corrective treatment and corrective treatment for events experienced increased heart rate and chest discomfort was not reported. The patient recovered from symmetrical bilateral wrist tenderness, swollen hands progressing over majority of her joints however stop date was not reported. The patient was not recovered from event increased heart rate and outcome of event chest discomfort was not reported. List of documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: YF, YF
Symptoms: Chest discomfort, Heart rate increased, Peripheral swelling, Tenderness
Clinical narrative: Initial unsolicited report received from a nurse on 18 March 2016. This case involves 34-year-old female patient who was vaccinated with one dose of YELLOW FEVER VACCINE - US (Yellow fever) (batch number- U1266AA; expiry date 28 July 2017) subcutaneously in left arm on 08 March 2016 at 9:39 am. The patient's pre-existing conditions included nasopharyngeal allergy- throat itching, doxycycline allergy-blurry vision and asthma. The patient had no illness at the time of vaccination. The patient's concomitant medications included ZOLOFT, levocetirizine, DULERA and PROAIR HFA prn. On 09 March 2016, one day following the vaccination, the patient had experienced symmetrical bilateral wrist tenderness, swollen hands progressing over the next 5 days to majority of her joints. On 16 March 2016, eight days following the vaccination, the patient had experienced increased heart rate and chest discomfort. The patient required emergency room/ doctor visit. Laboratory data was not reported. The patient had received ibuprofen for events bilateral wrist tenderness, swollen hands corrective treatment and corrective treatment for events experienced increased heart rate and chest discomfort was not reported. The patient recovered from symmetrical bilateral wrist tenderness, swollen hands progressing over majority of her joints however stop date was not reported. The patient was not recovered from event increased heart rate and outcome of event chest discomfort was not reported. List of documents held by sender: none.
Age: 55.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Local swelling, Pain in extremity, Raynaud's phenomenon
Clinical narrative: Left Toe Pain and Swelling.
Age: 0.42
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Pain, Screaming
Clinical narrative: Bright red on entire leg.  Screaming in pain for three hours plus.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased
Clinical narrative: Reaction/Event: limited arm movement with the flu shot; Case Narrative: Initial unsolicited report received from a pharmacist via other company (Pfizer, reference number 2016108259) on 26 February 2016. This case involves a (age and gender not reporter) patient who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient had limited arm movement. Laboratory investigation and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Reaction/Event: cellulitis on her arm where she received the injection; Case Narrative: Initial unsolicited report received from a pharmacist on 7 March 2016. This case involves a 15-year-old (age reported as 16 years) female patient who was vaccinated with an intramuscular dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone QIV) (batch number UI493AB, expiration date 30 June 2016) in right deltoid and a subcutaneous dose of Pneumovax (batch number I022262) in right deltoid on 13 November 2015. Patient medical history included juvenile arthritis, Raynaulds Phenomenon. Patient did not have illness at the time of vaccination. Concomitant medications were not reported. On 16 November 2015, three days following the vaccination, the patient was diagnosed with cellulitis on her arm where she received the injection. Lab data and corrective treatments were not reported. On an unspecified date, the patient recovered from the event. List of documents held by sender: none.
Age: 46.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Started with a mosquito bite sized hard lump on the left arm at admin site and then turned into larger (42 mm wide) indurated/red area, warm to touch and radiates into shoulder.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a healthcare worker via company representative refers to a patient of unknown age. On 15-MAR-2015, the patient was vaccinated with ZOSTAVAX, dose 1. On 15-MAR-2016, the patient was vaccinated with dose 2 of ZOSTAVAX. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: MMR
Symptoms: Measles post vaccine, Morbillivirus test positive, Polymerase chain reaction positive, Rash, Vaccination failure
Clinical narrative: Information has been received from the authors in a literature article concerning a 48 year old father with MMR vaccine (manufacturer unknown) route, lot# and dose were unknown). In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigations with no further cases identified. Methods: Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, > 101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure had measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposures were defined, per Department of Public Health guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these areas within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evidence of immunity for those working in high-risk occupations (healthcare/daycare settings) was defined as written documentation of 2 measles, mumps, and rubella (MMR) vaccines doses or positive measles serum IgG. Serology was performed for measles-specific IgM/IgG at health care agency or at the facilities where patients presented. All positive samples from community laboratories were confirmed by health care agency, which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at health care agency using RT-PCR assay with the following 3 gene targets: nucleoprotein (N3), hemagglutinin (H), and fusion (Fl). The DPH Viral and Rickettsial Disease laboratory performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 secondary cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirators. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmissions. Overall, 13 of 15 secondary cases had face-to-face contact with measles patients, 8 with prior evidence of immunity. The patient developed measles despite evidence of prior immunity and documented the vaccine administration (vaccination failure). The outcome of the event was unknown. The reporter considered the event to be related MMR vaccine (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot #, dose and route were not provided). On an unknown date, two months after the first dose, the patient was administered the second dose in RECOMBIVAX HB series (lot #, dose and route were not provided). No adverse effect was reported. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 6 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 28-MAR-2016 the patient was inadvertently vaccinated with expired dose of PROQUAD (Merck) (dosing details were not reported) (lot # K014798 expiry date of 12-MAR-2016). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: MMR
Symptoms: Measles, Vaccination failure
Clinical narrative: Information has been received from the authors in a literature article titled as stated below concerning an 38 year old father with MMR (manufacturer unknown) (route, lot# and dose were unknown) therapy. In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigation with no further cases identified. Methods: Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, >101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure had measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposure were defined, per agency guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these area within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evidence of immunity for those working in high-risk occupations (healthcare/daycare setting) was defined as written documentation of 2 MMR vaccine doses or positive measles serum IgG. Serology was performed for measles-specifc IgM/IgG and agency or at the facilities where patients presented. All positive samples from community laboratories were confirmed by agency, which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at agency using RT-PCR assay with following 3 gene targets: nucleoprotein (N3), hemagglutinin (HI), and fusion (FI). The agency performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 second cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirations. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmissions. Overall, 13 of 15 secondary cases had face-to-face contact with measles patients, 8 with prior evidence of immunity. The patient developed measles despite evidence of prior immunity and documented the vaccine administration (vaccination failure). The outcome of the event was unknown. The reporter considered the event to be related MMR (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 37.0
Sex: U
Vaccine: MMR
Symptoms: Measles, Vaccination failure
Clinical narrative: Information has been received from the authors in a literature titled as stated below concerning an unknown gender 37 year old healthcare worker with MMR (manufacturer unknown) (route, lot# and dose were unknown) therapy for prophylaxis. In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigations with no further cases identified. Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, >101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure and measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposures were defined, per agency guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these areas within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evidence of immunity for those working in high-risk occupations (healthcare/daycare settings) was defined as written documentation of 2 MMR vaccine doses or positive measles serum IgG. Serology was performed for measles-specific IgM/IgG at agency or at the facilities where patients presented. All positive samples from community laboratories were confirmed by Health Agency, which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at agency using RT-PCR assay with the following 3 gene targets: nucleoprotein (N3), hemagglutinin (HI), and fusion (FI). The agency performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 secondary cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirations. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmission. Overall, 13 of 15 secondary case had face-to-face contact with measles patients, 8 with prior evidence of immunity. The patient developed measles despite evidence of prior immunity and documented the vaccine administration (vaccination failure). The outcome of the event was unknown. The reporter considered the event to be related MMR (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 41.0
Sex: U
Vaccine: MMR
Symptoms: Measles post vaccine, Morbillivirus test positive, Polymerase chain reaction positive, Rash, Vaccination failure
Clinical narrative: Information has been received from the authors in a literature article concerning an unknown gender 41 year old healthcare worker with MMR (manufacturer unknown) (route, lot# and dose were unknown). In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigations with no further cases identified. Methods: Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, > 101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure had measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposures were defined, per Department of Public Health (DPH) guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these areas within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evident of immunity for those working in high-risk occupations (healthcare/daycare settings) was defined as written documentation of 2 MMR vaccine doses or positive measles serum IgG. Serology was performed for measles-specific IgM/IgG at CH or at the facilities where patients presented. All positive samples from community laboratories were confirmed by County Health Care Agency (CHCA), which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at CHCA using RT-PCR assay with the following 3 gene targets: nucleoprotein (N3), hemagglutinin (HI), and fusion (FI). The DPH viral and Rickettsial Disease Laboratory performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 secondary cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirators. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmissions. Overall, 13 of 15 secondary cases had face-to-face contact with measles patients, 8 with prior evidence of immunity. The patient developed measles despite evidence of prior immunity and documented the vaccine administration. The outcome of the event was unknown. The reporter considered the event to be related MMR vaccine (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 36.0
Sex: U
Vaccine: MMR
Symptoms: Measles post vaccine, Morbillivirus test positive, Polymerase chain reaction positive, Rash, Vaccination failure
Clinical narrative: Information has been received from the authors in a literature article concerning an unknown gender 36 year old healthcare worker with MMR vaccine (manufacturer unknown) route, lot# and dose were unknown). In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigations with no further cases identified. Methods: Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, > 101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure had measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposures were defined, per Department of Public Health (DPH) guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these areas within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evidence of immunity for those working in high-risk occupations (healthcare/daycare settings) was defined as written documentation of 2 measles, mumps, and rubella (MMR) vaccines doses or positive measles serum IgG. Serology was performed for measles-specific IgM/IgG at HCA or at the facilities where patients presented. All positive samples from community laboratories were confirmed by health care agency (HCA), which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at HCA using RT-PCR assay with the following 3 gene targets: nucleoprotein (N3), hemagglutinin (Hl), and fusion (Fl). The DPH Viral and Rickettsial Disease laboratory performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 secondary cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirators. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmissions. Overall, 13 of 15 secondary cases had face-to-face contact with measles patients, 8 with prior evidence of immunity. The patient developed measles despite evidence of prior immunity and documented the vaccine administration (vaccination failure). The outcome of the event was unknown. The reporter considered the event to be related MMR vaccine (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant medications were not reported. On 22-MAR-2016 the patient was vaccinated with a dose of PROQUAD (Merck) lot # L044055 expiry date: 02-MAY-2017 in the right thigh. On 23-MAR-2016, the patient sought medical attention by calling the facility and stated that the patient had developed that morning (23-MAR-2016) a raised red bump at the injection site that was tender and warm to touch. There was no product quality complaint. The outcome of events was unknown. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history and drug reactions/allergies was not reported. On 29-MAR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L011080, expiration date 01-OCT-2016. Concomitant medication was not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unknown number of patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant medications were not provided. On unknown dates, these patients were inadvertently vaccinated with improperly stored PROQUAD (Merck) (lot # L034932, expiry date: 03-MAR-2017). The vaccine underwent a temperature excursion to -6 degrees Celsius for a time frame of 8 hours 58 minutes. No adverse effects were reported. This is one of the two reports received from the same reporter. 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 nurse referring to a 21 patient of unknown age and gender. Medical history and current conditions were not reported. On an unknown date, the patient were subcutaneously vaccinated with improperly stored doses of VARIVAX (Merck) (dose, frequency, indication were not reported, lot # L033138; expiration date : 31-AUG-2017 and lot: L015048; expiration: 29-APR-2017). It was unspecified which patients received which lot. No known adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Secondary transmission, Varicella
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to an infant (exact age was not reported) patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In approximately February 2016 (reported as about a month ago), the unspecified patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, lot # and expiration date were not reported). On an unknown date in 2016, after coming in contact with this unspecified patient, an "infant" patient was diagnosed with chickenpox 6 days later. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: HEPA, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to a 6 month old baby of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 25-MAR-2016 the patient was inadvertently administered VAQTA strength 25/0.5 (unit unknown) injection (dose, frequency and route were not provided) (drug administration error and drug administered to patient of inappropriate age). No adverse effects were reported. Additional information has been requested.
Age: 32.0
Sex: U
Vaccine: MMR
Symptoms: Measles post vaccine, Morbillivirus test positive, Polymerase chain reaction positive, Rash, Vaccination failure
Clinical narrative: Information has been received from the authors in a literature article concerning an unknown gender 32 year old healthcare worker with MMR vaccine (manufacturer unknown) (route, lot# and dose were unknown). In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigations with no further cases identified. Methods: Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, > 101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure had measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposures were defined, per Department of Public Health (DPH) guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these areas within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evidence of immunity for those working in high-risk occupations (healthcare/daycare settings) was defined as written documentation of 2 measles, mumps, and rubella (MMR) vaccines doses or positive measles serum IgG. Serology was performed for measles-specific IgM/IgG at HCA or at the facilities where patients presented. All positive samples from community laboratories were confirmed by health care agency (HCA), which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at HCA using RT-PCR assay with the following 3 gene targets: nucleoprotein (N3), hemagglutinin (Hl), and fusion (Fl). The DPH Viral and Rickettsial Disease laboratory performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 secondary cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirators. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmissions. Overall, 13 of 15 secondary cases had face-to-face contact with measles patients, 8 with prior evidence of immunity. The patient developed measles despite evidence of prior immunity and documented the vaccine administration (vaccination failure). The outcome of the event was unknown. The reporter considered the event to be related MMR vaccine (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 24-MAR-2016, the patient was vaccinated with an expired dose of ROTATEQ (lot # K004620, expiration date 16-FEB-2016, exact dose was not reported, orally). The nurse stated that the vaccine did not have any previous temperature excursions. No adverse symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a physician assistant referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 22-MAR-2016 the patient was inadvertently vaccinated with an expired dose of GARDASIL (lot # J009788, expiration date 17-MAR-2016, dose and route unknown). Concomitant medication was not reported. No adverse effect was reported. Additional information has been requested.