chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMR, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effects; received one dose of MMR II intramuscularly instead of subcutaneously; This spontaneous report was received from a nurse practitioner, who refers to herself, a female patient of an unknown age. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported.  On 13-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intramuscularly (instead of subcutaneously), (exact dose, injection site, lot# and expiration date were not provided) for prophylaxis. The administered vaccine was diluted in sterile diluent, intramuscularly (instead of subcutaneously), (exact dose, injection site, lot# and expiration date were not provided) for prophylaxis.  There was no adverse event reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; Nurse reports that one dose of PROQUAD (lot number R030800, expiration date 4/22/2020) was administered to the patient when the patient was 15-months-old. Nurse states the patient received an original dose of PROQUAD when he was 12-months old; This spontaneous report was received from a nurse practitioner and a registered nurse and refers to a 15-months-old patient of unknown gender. There was no information concerning the patient's pertinent medical history, concomitant medications, concurrent conditions or allergies provided. Approximatively in December 2018 (also reported as when the patient was 12-months old), the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)(dose, lot#, expiration date, therapy type and route of administration were not provided) for prophylaxis. On 18-MAR-2019, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) therapy type: rHA (lot # R030800, expiration date: 22-APR-2020, subcutaneously) for prophylaxis. There were no adverse effects reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; one dose of expired PNEUMOVAX 23 was given to the patient; This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided.   On 14-MAY-2019, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), intramuscularly, lot # N024717,  with expiration date 06-APR-2019, for prophylaxis (strength, dose, frequency and anatomical location were not provided). No adverse effects were reported.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: the patient does not have any titers for the measles virus; This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's pertinent medical history, allergies and concomitant drugs were unknown by the reporter. The patient's concurrent conditions were not provided.  On an unknown date, the patient was vaccinated as a child with unspecified Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) for prophylaxis (also reported as childhood vaccination) (dose, strength, frequency, route of administration, lot number and expiration date were not reported).   On an unknown date, the patient does not have any titers for the measles virus (Measles antibody negative). No medical attention was sought. The patient's wife was in her first trimester and was not sure that what her titer was for measles but did had an unspecified measles vaccine given on an unspecified date when she was a child.  The outcome of the event measles antibody negative and the causal relationship between the event and the vaccine Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) was not reported.
Age: 27.0
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects were reported; The patient was administered the first dose of the GARDASIL quadrivalent in April of 2013. The second dose of the GARDASIL quadrivalent on an unknown date in June of 2013. The aptient was then administered a dose of GARDASIL 9 on 05/14/2019; This spontaneous report was received from a nurse, referring to a 33 year old patient. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided.  In April 2013, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot number 1495AA with expiration date 22-AUG-2014. The second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was administered in June 2013, lot number 1495AA, expiration date 22-AUG-2014, both by intramuscular route, for prophylaxis (strengths were not reported) .   On 14-MAY-2019, the patient was administered one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength and administration route were not reported) lot number N023828 and expiration date on 25-JUN-2020.  No adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event
Clinical narrative: unspecified number of not previously vaccinated patients received first dose of PROQUAD at 12 months old; unspecified number of not previously vaccinated patients received first dose of PROQUAD at 12 months old; This spontaneous report was received from a physician, via a field employee, referring to an unspecified number of 12 month old patients. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On unknown dates, not previously vaccinated patients received the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) by subcutaneous route, for prophylaxis which was diluted with sterile diluent (MERCK STERILE DILUENT) (therapy naive). No adverse effects were reported.  At the reporting time, the outcome of therapy naive was unknown. The causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; the patient received improperly stored dose of Varivax; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 09-MAY-2019, the patient was vaccinated with with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # R027989, expiration date 01-OCT-2020; strength, frequency, route of administration was not reported for prophylaxis. The patient's concomitant therapies included sterile diluent. The temperature of excursion with varicella virus vaccine live (oka/merck) (VARIVAX) was from 6 to 14 Fahrenheit degrees (-14 to -10 Celsius degrees ) for 3 hours. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported.  This is one of three cases from the same reporter.; Sender's Comments:  US-009507513-1905USA011345: US-009507513-1905USA011344:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pneumonia, Vaccination failure
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. The pt was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on 17-MAR-2014 and 15-APR-2016 at a health center for its intended purpose: the prevention of shingles. ZOSTAVAX did not prevent shingles, but rather caused the pt to contract a persistent strain of herpes zoster and pneumonia. Shortly after vaccination, the pt suffered and was diagnosed with shingles on his left chest to back. The pt also suffered and was diagnosed with pneumonia. The pt sustained severe and permanent personal injuries. As a direct and proximate result of ZOSTAVAX, the pt suffered painful injuries and damages, and required extensive medical care and treatment(details not provided). As a result of the ZOSTAVAX, the pt suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical and impairment and injury. Vaccination failure, pneumonia and herpes zoster were considered to be disabling. Upon internal review, pneumonia was determined to be medically significant. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pain
Clinical narrative: she was diagnosed by an unspecified physician at a local Urgent Care with the shingles; This spontaneous report was received from a 84-year-old female patient reporting on herself. The patient's pertinent medical history included allergy to penicillin and erythromycin. The patient did not have any concomitant medications. On an unspecified date in 2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for vaccination (dose, route of administration, injection site, lot # and expiration date were not reported). The patient reported, than on 25-APR-2019, the right side of her back was real bright red, and it went down her underarm across chest and down chest. She reported "terrible" stinging blisters. On 29-APR-2019, the patient was diagnosed by an unspecified physician at a local Urgent Care with the shingles. The patient received an unspecified treatment. At the time of the report, the symptoms are resolving.  The relatedness between the event and the suspect product was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash vesicular
Clinical narrative: zoster rash which encompassed her left breast and wrapped around her back and was accompanied by severe pain, diagnosed with herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage, and route of administration not provided) for routine health maintenance and for the prevention of shingles. After receiving the vaccination, the pt suffered a zoster rash which encompassed her left breast and wrapped around her back and was accompanied by severe pain. As a result of these symptoms, the pt presented to a medical provider and was diagnosed with herpes zoster. Thereafter, the pt had continued to suffer from outbreaks of zoster rashes on her breast, torso and back, accompanied by sudden sharp pains. As a result, the pt has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. The outcome of    Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: red spots below the injection site area; spots were warm to touch, somewhat sore; spots were warm to touch, somewhat sore; calf pain and joint pain after receiving the vaccine; calf pain and joint pain after receiving the vaccine; fever; This spontaneous report was received from a pharmacist refers to a 68 year old female patient. Patient had no pertinent medical history and no drug allergies. Patient's current conditions included food or possibly a mold allergy. Past drugs included pneumococcal 13v conj vaccine (CRM197),,,, (PREVNAR 13) and zoster rgE vaccine (mammalian),,,,(SHINGRIX).  Concomitant medications included blood pressure medication and allergy shots. On 14-MAY-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R033342, 1 dosage form, expiry date 03-AUG-2020 (strength and batch were unknown) via intramuscular route for disease prevention (prophylaxis). Later that night, the patient got fever of 101.6 F. The patient took acetaminophen (TYLENOL) for the fever. It was reported that, on the evening of 16-MAY-2019, 3 days after onset of therapy the patient developed some "red spots" below the injection site area (vaccination site erythema), the pharmacist reported that one is 1" x 1" and below is it another red spot, 1.5" x 2" and also reported that spots were warm to the touch, some what sore, and not itchy (vaccination site warmth), vaccination site pain and also experienced calf pain and joint pain after receiving the vaccine (arthralgia and pain in extremity). Patient sought medical attention by visiting the pharmacist. The outcome of the events vaccination site erythema, vaccination site warmth, vaccination site pain, arthralgia and pain in extremity were unknown. Causality of the suspect therapy pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) with respect to event was not reported. PQC was not reported.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: red spots below the injection site area; spots were warm to touch, somewhat sore; spots were warm to touch, somewhat sore; calf pain and joint pain after receiving the vaccine; calf pain and joint pain after receiving the vaccine; fever; This spontaneous report was received from a pharmacist refers to a 68 year old female patient. Patient had no pertinent medical history and no drug allergies. Patient's current conditions included food or possibly a mold allergy. Past drugs included pneumococcal 13v conj vaccine (CRM197),,,, (PREVNAR 13) and zoster rgE vaccine (mammalian),,,,(SHINGRIX).  Concomitant medications included blood pressure medication and allergy shots. On 14-MAY-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R033342, 1 dosage form, expiry date 03-AUG-2020 (strength and batch were unknown) via intramuscular route for disease prevention (prophylaxis). Later that night, the patient got fever of 101.6 F. The patient took acetaminophen (TYLENOL) for the fever. It was reported that, on the evening of 16-MAY-2019, 3 days after onset of therapy the patient developed some "red spots" below the injection site area (vaccination site erythema), the pharmacist reported that one is 1" x 1" and below is it another red spot, 1.5" x 2" and also reported that spots were warm to the touch, some what sore, and not itchy (vaccination site warmth), vaccination site pain and also experienced calf pain and joint pain after receiving the vaccine (arthralgia and pain in extremity). Patient sought medical attention by visiting the pharmacist. The outcome of the events vaccination site erythema, vaccination site warmth, vaccination site pain, arthralgia and pain in extremity were unknown. Causality of the suspect therapy pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) with respect to event was not reported. PQC was not reported.
Sex: U
Vaccine: MMRV, UNK, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: administered PROQUAD and VARIVAX at the same visit; No adverse effetcs reported; This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapy and drug allergies were not reported. On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number: R002938, expiration date: 29-JUL-2019)for prophylaxis which was reconstituted with sterile diluent (lot number: N030179, expiration date: 03-JUL-2020). On the same day at the same visit, the patient was vaccinated with varicella virus vaccine live (Oka/Merck)(VARIVAX) (lot number: N034557, expiration date: 05-DEC-2019) for prophylaxis which was reconstituted with sterile diluent (lot number: N006324, expiration date: 24-JUL-2019)(Inappropriate schedule of product administration). No adverse events were reported. No product quality complaint involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; multiple patients were administered improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information concerning the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies provided. On 23-APR-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R023513, expiration date: 16-AUG-2020, subcutaneously)(exact dose was not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The administered dose of vaccine experienced a temperature excursion between -9 degrees Celsius (°C) to 8°C (-3.2C) for 5 hours 30 minutes. Digital data logger was involved in capturing the temperature excursion. There were no previous temperature excursions reported. No adverse effect was reported. This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-1905USA006376:
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; Information has been received from a lawyer regarding a case in litigation concerning a currently 88-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  In 2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, unit, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated for the event. The outcome of the event was not reported.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a  currently 73-year-old patient (pt) of unknown gender. No information was provided regarding concomitant medications, concurrent conditions or medical history.   On unknown date, zoster vaccine live (ZOSTAVAX) was prescribed by a healthcare provider and on or about 20-DEC-2011, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for routine long-term prevention of shingles and zoster-related conditions (dose, route, vaccination site, lot number and expiration date were not provided).   On unspecified date, the pt was treated by a healthcare provider for the following injuries resulting from the use of zoster vaccine live (ZOSTAVAX): herpes zoster. The outcome of the event was not provided.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Post herpetic neuralgia; Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a  currently 69 year old female patient (pt). No information was provided regarding concomitant medications, concurrent conditions or medical history.   On unknown date, zoster vaccine live (ZOSTAVAX) was prescribed by health care provider and on or about 16-AUG-2011, the pt was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX) for routine long-term prevention of shingles and zoster-related conditions.(strength, dosage schedule, route, lot number and expiration date were not provided).  On an unspecified date, the pt developed herpes zoster and post herpetic neuralgia. The pt was treated by physician. As result of these injuries, the pt experienced economic problems. The outcome of the events was not provided.  The reporter considered herpes zoster and postherpetic neuralgia  result from  zoster vaccine live (ZOSTAVAX) use.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a  currently 60 year old female patient (pt). No information was provided regarding concomitant medications, concurrent conditions or medical history.   On unknown date, zoster vaccine live (ZOSTAVAX) was prescribed by health care provider and in or about 2010, the pt was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX) for routine long-term prevention of shingles and zoster-related conditions (strength, dosage schedule, route, lot number and expiration date were not provided).  On an unspecified date, the pt developed herpes zoster. On unspecified date, the pt was treated health care center for herpes zoster t.  The outcome of the event was not provided. The reporter considered herpes zoster result from  zoster vaccine live (ZOSTAVAX) use.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71 year old female pt. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 01-DEC-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, route, dosage schedule, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the pt experienced shingles and she was treated by a healthcare provider. The outcome of shingles was not specified and the reporter considered this event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77 year old female pt. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 03-FEB-2012, the pt was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX) (strength, route, dosage schedule, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the pt experienced herpes zoster and she was treated by a healthcare provider. The outcome of herpes zoster was not specified and the reporter considered this event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old male pt. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 06-JUL-2016, the pt was vaccinated by a physician with zoster vaccine live (ZOSTAVAX) (strength, route, dosage schedule, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the pt experienced shingles and he was treated by a different physician. The outcome of shingles was not specified and the reporter considered this event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68 year old female pt. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 25-JUN-2017, the pt was vaccinated by a healthcare provider with zoster vaccine live (ZOSTAVAX) (strength, route, dosage schedule, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the pt experienced shingles and she was treated by a physician. The outcome of shingles was not specified, and the reporter considered this event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80 year old female pt. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 05-NOV-2007, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, route, dosage schedule, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the pt experienced herpes zoster and she was treated by a healthcare provider. The outcome of herpes zoster was not specified, and the reporter considered this event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; the patient was inadvertently administered an expired dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a patint of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 23-APR-2019, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) recombinant Human albumin (rHA), subcutaneous for prophylaxis (lot # N025718 with expiration date on 17-MAR-2019, dose, strength and frequency were not reported). No adverse effects were reported. No temperature excursion was involved. The outcome of expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) administered to the patient was unknown at the moment of this report.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects; the patient was inadvertently administered one dose of MMR II by intramuscular route.; This spontaneous report was received from a pharmacy technician, referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions, allergies, concurrent conditions, and concomitant medications were not provided.      On 26-MAR-2019, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), 1 dose, intramuscular (incorrect route of product administration) (strength, lot# and expiration date were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date were not provided). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Painful rash on her back and torso diagnosed as Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for prevention shingles. On an unspecified date, the patient suffered a painful rash on her back and torso.  As a result the patient presented to a medical provider and was diagnosed with herpes zoster. The patient continued to suffer the effect of these events.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Post herpetic neuralgia; Broke out in a painful rash on his stomach and back diagnosed with herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for prevention shingles. On an unspecified date, the patient broke out in rash on his stomach and back.  As a result the patient presented to a medical provider and was diagnosed with herpes zoster and postherpetic neuralgia. The patient continued to suffer the effect of these events.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Seizure like phenomena
Clinical narrative: This spontaneous report was received from a physician regarding his 15 year old son via company representative. The patient's concurrent conditions, concomitant medications, medical history, past drugs, allergies and reactions were unknown. On an unknown date, the patient was vaccinated with GARDASIL 9 (dosage schedule was not reported) (strength, lot#, batch and expiry date were unknown) via intramuscular route for prophylaxis. It was reported that few months ago, the patient passed out (loss of consciousness) shortly afterwards and showed seizure like activity (seizure like phenomena). It was reported that, patient had sought medical attention and was in physician's office when event occurred. The outcome of loss of consciousness and seizure like phenomena was reported as recovered. Causality of the suspect therapy GARDASIL 9 with respect to events was not reported by the reporter. No PQC(product quality complaint) was involved. Upon internal review, the events loss of consciousness and seizure like phenomena were considered as medically significant.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Full blood count, Human chorionic gonadotropin, Pregnancy test urine positive
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy report was received from a medical assistant, refers to a 21-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were unknown. The medical assistant reported the patient "had her titers drawn and was not immune to varicella" on an unspecified date. The medical assistant reported the patient had her last menstrual period on 31-MAR-2019 to 6-APR-2019. On 05-APR-2019 the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (dose, frequency and route of administration unknown) lot # R026715, expiry date: 18-SEP-2020 for prophylaxis. The medical assistant reported the patient missed her next menstrual period and did a home pregnancy test, a few days ago and it was positive (exposure during pregnancy). The medical assistant reported the patient had a urine pregnancy test done in the office on 21-MAY-2019 which was positive. The medical assistant reported the patient had blood work drawn on 21-MAY-2019 for a " complete blood count (CBC), human chorionic gonadotropin (HCG) total, HCG with gestational table", but results are not yet available. The patient became pregnant with last menstrual period (LMP) of 31-MAR-2019 and estimated date of delivery (EDD) of 05-JAN-2020. The pregnancy outcome was outcome pending.
Sex: U
Vaccine: MMR, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: incorrect product storage; no adverse effect; administered 1 dose of MMRII intramuscularly; This spontaneous report was received from an office manager refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On 21-MAY-2019, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # N020927, expiration date 01-AUG-2019) intramuscular route (incorrect route of product administration). It was unknown whether if the Sterile diluent was properly stored (incorrect product storage). On an unknown date the patient experienced no adverse event. PQC (product quality complaint) was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reaction; received one shot of GARDASIL 9 on 7 / 2017 and then a second one year later on 11/2018"; This spontaneous report was received from a pharmacist regarding a 20-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date in July 2017 the patient was vaccinated with one shot of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot#M037770 and expiry date: 01-JUN-2019) via intramuscular route for prophylaxis. On an unspecified date in November 2018, patient was vaccinated with second one a year later (inappropriate schedule of product administration). The patient was looking to complete the three dose series. Pharmacist inquired if she should continue with the third dose or restart the series due to the lapse in time. It was not specified if the patient will be given the third dose to complete the series or if the patient should be revaccinated. At the time of report, no adverse reaction was reported (no adverse event). The outcome of inappropriate schedule of product administration and no adverse event was unknown.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Nausea
Clinical narrative: the patient experienced dizziness and nausea; the patient experienced dizziness and nausea; This spontaneous report was received from a physician concerning to a male patient of unknown age. The patient's historical conditions, concurrent condition, and concomitant medications were not provided.  On 21-NOV-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route of administration, anatomical location were not reported; lot # R017249 and expiration date 04-MAY-2021) as prophylaxis.         The physician reported the patient experienced dizziness and nausea after being administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). They gave the patient water and a dextrose electrolytes (unspecified) (Pedialyte Popsicle).  The outcome of dizziness and nausea was not reported.      The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  was reported.    Lot number was reported in the source document but the expiration date was not. But, when entering the lot number in MARRS the system automatically auto-populated the expiration date.  This Case is one of three Multiple Patient Reports.; Sender's Comments:  US-009507513-1905USA011304:
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injected limb mobility decreased, Pain
Clinical narrative: The patient experienced severe pain reported as a "10 out of 10 on the pain scale"; The patient experienced numbness in face, lips, and fingers of her left hand; The patient experienced numbness in face, lips, and fingers of her left hand; The patient experienced numbness in face, lips, and fingers of her left hand; And "felt like her left arm (the same arm she got the injection in) was stuck and unable to move; This spontaneous report was received from a medical assistant and refers to a 57 year old female patient. The patient's pertinent medical history included diabetes as concurrent condition. The historical drug of the patient included pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (PREVNAR 7). No information was provided regarding the patient's drugs or allergies reactions.   On 20-MAY-2019, the patient was vaccinated with the first dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), 1 dose, by intramuscular route in the left arm, lot # R030140 and expiration date was 07-AUG-2020, for disease prevention (strength was not reported).   On the same date, the patient experienced severe pain reported as a "10 out of 10 on the pain scale" (pain). Three hours after the injection, the patient experienced numbness in face, lips, and fingers of her left hand; and "felt like her left arm was stuck and unable to move" (Movement disorder). The medical assistant reported that the patient took  naproxen sodium (ALEVE) treatment for the pain. The patient sought medical attention.   The outcome for the events was reported as unknown.   The causality assessment between Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) and the events was reported as unknown.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA011248:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects have been reported; a patient received one dose of MMR II that expired on 11-MAY-2019; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 22-MAY-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # N014635, expiration date 11-MAY-2019, 1 dosage form, intramuscular (strength and anatomical location were not provided) for prophylaxis. The vaccine and the sterile diluent had not any temperature excursions and no adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; the patient received improperly stored dose of Varivax; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 15-MAY-2019, the patient was vaccinated with with  improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # R027989, expiration date 01-OCT-2020; strength, frequency, route of administration was not reported for prophylaxis. The patient's concomitant therapies included properly stored sterile diluent. The temperature of excursion with varicella virus vaccine live (oka/merck) (VARIVAX) was from 6 to 14 Fahrenheit degrees (-14 to -10 Celsius degrees ) for 3 hours. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported.  This is one of three cases from the same reporter.; Sender's Comments:  US-009507513-1905USA011345: US-009507513-1905USA008600:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; the patient received improperly stored dose of Varivax; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 13-MAY-2019, the patient was vaccinated with with  improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # R027989, expiration date 01-OCT-2020; strength, frequency, route of administration was not reported for prophylaxis. The patient's concomitant therapies included properly stored sterile diluent. The temperature of excursion with varicella virus vaccine live (oka/merck) (VARIVAX) was from 6 to 14 Fahrenheit degrees (-14 to -10 Celsius degrees ) for 3 hours. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported.  This is one of three cases from the same reporter.; Sender's Comments:  US-009507513-1905USA011344: US-009507513-1905USA008600:
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a male patient who was reported to be 11 or 12 years old. There was no information concerning the patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (exact dose, route of administration, lot# and expiration date were not provided). On an unknown date, reported as after being administered a dose of GARDASIL 9, the patient experienced fainting. The outcome of the event was unknown. The causality assessment was not provided. Upon internal review the event of fainting was considered to be medically significant. This is one of several reports received form the same reporter. Sender's Comments: US-009507513-1905USA011304: US-009507513-1905USA011106: US-009507513-1905USA011790.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Hypersensitivity
Clinical narrative: the patient experienced unspecified allergic reaction after receiving his first dose of GARDASIL 9; This spontaneous report was received from a consumer (the patient's mother) via a company representative and refers to a 12-year-old male patient. His concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date the patient was vaccinated with the first dose of human papilloma virus rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, anatomical location, lot number and expiry date were not provided) for prophylaxis.  On an unknown date, after vaccination with human papilloma virus rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced an unspecified allergic reaction. The patient's mother stated, that he also ate some cashews before experiencing the unspecified allergic reaction and that she was not sure if the patient might be allergic to cashews. As a treatment the patient took "a couple of doses" of diphenhydramine (BENADRYL) but it did not help him. The patient would visit allergist on 24-MAY-2019.   The outcome of unspecified allergic reaction and the relatedness between the event and human papilloma virus rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not provided.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient who was reported to be 11 or 12 years old. There was no information concerning the patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (exact dose, route of administration, lot# and expiration date were not provided). On an unknown date, reported as after being administered a dose of GARDASIL 9, the patient experienced fainting. The outcome of the event was unknown. The causality assessment was not provided. Upon internal review the event of fainting was considered to be medically significant. This is one of several reports received form the same reporter. Sender's Comments: US-009507513-1905USA011304: US-009507513-1905USA011106: US-009507513-1905USA011668.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; inadvertently administered a dose of MMR II, that was expired; This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On 13-MAY-2019, the patient was inadvertently vaccinated with a dose of expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (also reported as M-M-R III) injection, lot # N013868, expiration date 04-MAY-2019, for prophylaxis (exact dose, route of administration and injection site were not reported). Concomitant therapies included sterile diluent. No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; improperly stored dose of vaccine was administered to the patient; This spontaneous report as received from a nurse 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 30-APR-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot # R026720, expiration date: 17-MAR-2020 for prophylaxis (dose and route of administration were not reported) reconstituted in sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported). It was unspecified of sterile diluent underwent any temperature excursions. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 16.6 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.  Lot No. R026720 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported as 17-MAY-2020, but upon internal validation established as 17-MAR-2020.; Sender's Comments:  US-009507513-1905USA004595: US-009507513-1905USA011855: US-009507513-1905USA011856: US-009507513-1905USA011857: US-009507513-1905USA011858: US-009507513-1905USA011859: US-009507513-1905USA011860: US-009507513-1905USA011861:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; improperly stored dose of vaccine was administered to the patient; This spontaneous report as received from a nurse 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 11-APR-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot # R026720, expiration date: 17-MAY-2020 for prophylaxis (dose and route of administration were not reported) reconstituted in sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported). It was unspecified of sterile diluent underwent any temperature excursions. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 16.6 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.  Lot No. R026720 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported as 17-MAY-2020, but upon internal validation established as 17-MAR-2020.; Sender's Comments:  US-009507513-1905USA004595: US-009507513-1905USA011854: US-009507513-1905USA011856: US-009507513-1905USA011857: US-009507513-1905USA011858: US-009507513-1905USA011859: US-009507513-1905USA011860: US-009507513-1905USA011861: