chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vision blurred, Visual impairment
Clinical narrative: Information has been received from a consumer regarding herself a 78 year old female with an allergy to Aspirin and penicillin, concurrent conditions were not provided. The patient reported her medical history as "none" and she reported that she had never had shingles before. Concomitant medication included vitamins (NOS). On an unspecified date (noted by the patient as "a few years back") the patient was vaccinated with ZOSTAVAX, "2-dose administration of the vaccine," (route and lot# unknown) for prophylaxis.  The patient also received sterile diluent (MERCK), (route and lot# unknown). The patient reported that she was diagnosed in February 2017 (also noted as, "a few years later") with shingles in her left eye and that she had a relapses in August 2017 and November 2017. The patient also wrote in an email "I contacted a very severe attack of Shingles/Herpes Zoster which has affected my left eye vision. Not only did I get the shingles, but had two relapses with a threat of vision loss. Treatment to get my vision back since February 2017 is still on-going with an Ophthalmologist for more than a year now (15 months now)." "I was visiting the doctor once a week and now I visit once a month. I take an (unspecified) antiviral medication and Prednisolone eye drops. At first I had to take the eye drops every 3 hours but then they tested my eye and I could see a little light so they reduced it to 5 times a day." "I have blurry vision in my left eye. I don't know if I'm legally blind. I may have to take medicine for the rest of my life. It's been more than a year and I'm trying to restore my vision in that eye." The patient is requesting that Merck & Co., Inc. provide assistance to pay for SHINGRIX which was recommended for treatment plus the medications and medical expenses since the diagnosis. The patient also mentioned that she has kept receipts for all the medical/Rx expenses. "I was told that I might have to continue the eye drops and anti-viral for the rest of my life." "Blurry vision in my left eye. I don't know if I'm legally blind" was considered disabling. Upon internal review "I have blurry vision in my left eye. I don't know if I'm legally blind" and shingles in her left eye were considered medically significant events. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 16 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 08-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot reported as "N021572"; Expiry date: 01-MAY-2020) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several reports linked via same reporter link.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 15 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 01-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot reported as "N021572"; Expiry date: 01-MAY-2020) (product storage error) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 degrees F to 77 degrees F (67.3 degrees F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several reports linked via same reporter link.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 20 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 13-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot reported as "N021572" Expiry date: 01-MAY-2020) (product storage error) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 degrees F to 77 degrees F (67.3 degrees F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several reports linked via same reporter link.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 14 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 13-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot reported as "N021572"; Expiry date: 01-MAY-2020) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several reports linked via same reporter link.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: Moderate tenderness, redness, swelling and heat (warmth compared to non-injection site) at injection site. Started within 1 hour of injection and persisting for 24 hours so far. Couldn't sleep on that arm due to the tenderness.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: 2 days after receiving vaccination a rash broke out on patient's buttocks. Doctor confirmed the rash was shingles and gave patient an antiviral med.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: 2 days after receiving vaccination a rash broke out on patient's buttocks. Doctor confirmed the rash was shingles and gave patient an antiviral med.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Manifested shingles symptoms immediately after getting SHINGRIX vaccine.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: Manifested shingles symptoms immediately after getting SHINGRIX vaccine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Limb mass, Pyrexia, Tremor
Clinical narrative: Patient reported fever, chills, a walnut-sized lump in her injection arm, and tremors in her hand. The fever, chills, and lump went away within a couple of days, but she still occasionally has tremors in her hand.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Rash macular, Skin warm
Clinical narrative: Patient came in with a reaction on her right arm. It was red, blotchy, and warm to the touch. The reaction did not look like a cellulitis but an allergic reaction. The reaction was spread out and not in a  circular area. The patient said that it does not itch. The reaction started two days after the vaccine was giving. The patient also had a SHINGRIX vaccine in the left arm. We called today to notify Dr. Told the patient to take two benadryl 25mg at tonight. We are calling to follow up with the patient tomorrow to see if the reaction got better or spread. We will then call the doctor tomorrow depending how the patient feels.
Age: 5.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: There is some redness and swelling at the injection site.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt c/o pink, tender, warm to touch area approximately 2" below inj site. Denies fever, chills, itchiness, or resp distress this AM.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pain, erythema, hot about 2-3 inches inferior to injection site.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever, severe muscle pain in deltoid, back, and neck.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Erythema, Malaise, Nodule
Clinical narrative: Arm very sore, red with raised knot and hot to touch, general aches and pains primarily legs, back and hip. Generally not feeling well but not severe. Shot was given more than 48 hours ago, still have symptoms.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Skin warm
Clinical narrative: Arm very sore, red with raised knot and hot to touch, general aches and pains primarily legs, back and hip. Generally not feeling well but not severe. Shot was given more than 48 hours ago, still have symptoms.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Redness, raised welt, itchy, painful area, approximately 8cmX10cm around the injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Injection site warmth, tenderness, erythema. Deltoid muscle is hard. Extremely painful. Can't lift arm or sleep on that side. Redness the size of a silver dollar that grew in size over several days and then subsided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: Injection site warmth, tenderness, erythema. Deltoid muscle is hard. Extremely painful. Can't lift arm or sleep on that side. Redness the size of a silver dollar that grew in size over several days and then subsided.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling of both hands and wrists. Also soreness up the left arm.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Pt received immunization 4/23 @ 7pm and reported a rash starting on the am of 4/26. It was a red rash starting about 2 inches below where immunization was given.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, Swelling, and Pain at the injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lymphadenopathy, Swelling, Ultrasound scan abnormal
Clinical narrative: Patient had swelling in her collarbone area and she went to her doctor and the doctor ordered an ultrasound which indicated she had severely swollen lymph nodes.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain, Mass, Myalgia
Clinical narrative: Patient had swelling in her collarbone area and she went to her doctor and the doctor ordered an ultrasound which indicated she had severely swollen lymph nodes.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nasopharyngitis, Tenderness
Clinical narrative: Patient had swelling in her collarbone area and she went to her doctor and the doctor ordered an ultrasound which indicated she had severely swollen lymph nodes.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Dizziness, Headache, Injection site erythema, Injection site nodule
Clinical narrative: Headache, body aches, dizzy, weak. Site of injection is sore, has a knot and red with fever in it.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site warmth, Pain
Clinical narrative: Headache, body aches, dizzy, weak. Site of injection is sore, has a knot and red with fever in it.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site inflammation, Injection site swelling
Clinical narrative: After the flu shot was given the patient always had a bump at the injection site. On 4-4-18 inflammation of the site began. When she came to the pharmacy on 4-25-28 the site was inflammed and purple.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Shivers for 5 min.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscle atrophy, Muscular weakness, Musculoskeletal pain, Neck pain
Clinical narrative: Awoke with excruciating pain from neck, shoulder blade and down left arm. After many MRI's, diagnosed with Parsonage-Turner syndrome. Still have muscle weakness, and numbness in left hand and wrist. Have some muscle atrophy in left hand.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Nerve conduction studies, Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Awoke with excruciating pain from neck, shoulder blade and down left arm. After many MRI's, diagnosed with Parsonage-Turner syndrome. Still have muscle weakness, and numbness in left hand and wrist. Have some muscle atrophy in left hand.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Rash
Clinical narrative: Shingles infection (rash) manifested itself in the right side of her head, including her eye. Gabapentin. Valacyclovir. Tramadol. Gabapentin and Tramadol have lessened her pain some.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Loss of consciousness, Syncope, Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: Patient began to experience syncope within a few minutes after receiving the vaccine. This quickly progressed to unconsciousness and the patient was unresponsive for about a minute. The patient experienced a short tonic-clonic episode before regaining consciousness. After the patient was responsive she expressed difficulty breathing at which time a dose of epinephrine was administered. Medical services responded and monitored the patient for that time forward.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV1
Symptoms: Electroencephalogram, Seizure
Clinical narrative: Seizures started day after injections were given.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Dyspnoea, Fatigue, Myalgia, Painful respiration
Clinical narrative: Symptoms began with generalized myalgias and right pleural pain, presenting below left clavicle - occurring in the evening after the injection. The following day I experienced lassitude, high fever (to 103.5 F) and vomiting. On day 3 I developed a cough, difficulty taking a deep breath, and pain with deep breaths - occurring under my left clavicle.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pleuritic pain, Pyrexia, Vomiting
Clinical narrative: Symptoms began with generalized myalgias and right pleural pain, presenting below left clavicle - occurring in the evening after the injection. The following day I experienced lassitude, high fever (to 103.5 F) and vomiting. On day 3 I developed a cough, difficulty taking a deep breath, and pain with deep breaths - occurring under my left clavicle.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Dyskinesia, Emotional distress, Screaming, Staring, Strabismus
Clinical narrative: She had high pitched screaming, completely inconsolable for couple hours, crossing of eyes, staring, and periodic jerking movements. I called doctor but they completely dismissed my concerns and doctor did not return my call or want to see her in office. I brought her for checkup at 7 months and explained again adverse reaction and the Dr completely dismissed the reaction and failed to report it.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient received HAVRIX vaccine and a few minutes later he lost consciousness and collapsed for a few seconds.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Large welt formed on her arm that started out small and grew in size then got smaller a week later but still present.
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on front of body waist to lower chest. Pt reported event to us on 04/26/2018.
Age: 17.0
Sex: F
Vaccine: MENHIB
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Left upper arm has tender mass 5 inches by 3 + 3/4 inches. Subcutaneously and erythema w/warmth 1 + 1/2 by 1 + 1/2 inches. Neg axillary nodes.
Age: 21.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Foaming at mouth
Clinical narrative: After vaccine, pt. lay down on bed, straightened legs, according to Mom, had "bubbling" around her mouth. Mom called out, as soon as 1(nurse) came in the, pt. was talking, with eyes open.
Age: 60.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received BOOSTRIX (batch number EY273, expiry date 18th March 2019). On 12th February 2018, the patient received BOOSTRIX (intramuscular) .5 ml. In February 2018, 2 days after receiving BOOSTRIX, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved. The reporter considered the pain in arm to be related to BOOSTRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX vaccine in left deltoid. The patient was still unable to raise her arm or bend it backwards. The patient required an emergency room visit.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Facial pain, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of discomfort in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown. It was unknown if the reporter considered the discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that she had other patients of unknown number that reported discomfort after the SHIGNRIX injection. This case was linked with US2018065917, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Neck pain, Swelling face
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of discomfort in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown. It was unknown if the reporter considered the discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that she had other patients of unknown number that reported discomfort after the SHIGNRIX injection. This case was linked with US2018065917, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of discomfort in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown. It was unknown if the reporter considered the discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that she had other patients of unknown number that reported discomfort after the SHIGNRIX injection. This case was linked with US2018065917, reported by the same reporter.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hypersomnia, Pyrexia, Strabismus
Clinical narrative: High fever, excessive sleep, eyes started crossing.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Aphasia, Fall, Gait disturbance
Clinical narrative: Stopped talking and can still hardly talk and couldn't walk for a couple weeks without falling down.
Age: 31.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 102-103 F.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Dizziness, Injection site pain
Clinical narrative: Extreme lightheadedness and dizziness upon waking getting out of bed. I felt as if I were going to fall over/pass out as I was urinating and had to get on my knees. Also, extreme soreness at the shot location.
Age: 36.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This non-valid spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent condition, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (MRK INJ). On 29-MAR-2018, the patient was vaccinated with VARIVAX (dose, units and frequency not reported) (lot # N014368, expiration date: 09-MAY-2019), intramuscularly. No adverse events were reported. No product quality complaint was reported. This is a non-valid spontaneous report due to lack of patient identifiers. Follow up information has been received on 10-APR-2018 from an other reporter concerning the 36 year old male patient. The patient's concomitant therapy also included hepatitis B virus vaccine (unspecified). The patient had no pre-existing physician-diagnosed allergies, birth defects or medical history. On 39-MAR-2018, the patient was vaccinated with his second dose of VARIVAX (previous dose reported as 1)(right arm, lot# reported as NO14368 which was invalid) by intramuscular instead of subcutaneous. There was no treatment performed. There was no illness at time of vaccination.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Condition aggravated, Eczema
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 4 month old male patient. The patient's medical history included eczema. The patient's concurrent conditions and concomitant medications were not provided. On 09-FEB-2018, the patient was vaccinated with ROTATEQ oral liquid, orally, lot # N005626 with expiration date 26-NOV-2018, for routine vaccinations (anatomical location was not provided). Also, on the same day, the patient was vaccinated with PREVNAR, lot # S43842 with expiration date 31-OCT-2018, and PENTACEL, lot #C5418AA with expiration date 2-SEP-2018 (strength, dose, frequency, route and indication were not provided). On an unspecified date in February 2018, reported as within 48 hours after vaccination, the patient experienced a "horrible exacerbation of eczema". Treatment was given for the event but the patient did not seek medical attention. At the reporting time, the outcome of eczema was reported as resolving. Laboratory studies were not performed. The reporter did not assess the relatedness between ROTATEQ and the aforementioned event.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This retrospective cohort study report has been received from the authors of a published literature, title as stated above. This paper described a 9.5-year cohort study evaluating the incidence of herpes zoster after concomitant administration of ZOSTAVAX (ZVL) and PNEUMOVAX 23 (PPSV23).  A retrospective cohort study was conducted from 01-JAN-2007 to 30-JUN-2016. The exposed cohort (concomitant vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL and PPSV23 on the same day from 01-JAN-2007 to 31-DEC-2014. The comparator cohort (prior vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL during the same period as the exposed cohort but were previously vaccinated with a dose of PPSV23 from 365 days to 30 days prior to receiving ZVL. Both groups had been continuous members in the year prior to date of ZVL vaccination, allowing for a 31-day gap in membership. The patients from both groups were followed from the date of ZVL vaccination until the date of herpes zoster occurrence, termination of membership (allowing for a 31-day gap), death, or 30-JUN-2016, whichever was earliest. This report refers to 154 adult (60 year old to 64 year old) patients. On unknown dates the patients were concomitantly vaccinated with ZOSTAVAX (lot#, expiration date, dose, route and frequency unknown) and PNEUMOVAX 23 (lot#, expiration date, dose, route and frequency unknown) for prophylaxis. The prescribing information stated that these vaccines should not be given concurrently. On unknown dates, the patients experienced incident severe herpes zoster. The outcome of drug the events was unknown. The reporter considered the vaccination failure and herpes zoster to be related ZOSTAVAX. This is one of several reports from the same literature (linked report MARRS # 1804USA010349, 1804USA010350, 1804USA010351, 1804USA010352, 1804USA010377).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (MERCK), lot# and expiration date were not provided. The patient's medical history and concurrent conditions were not provided. On 02-APR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX injection, lot # N020016 with expiration date 17-JUL-2019, for prophylaxis (route and anatomical location were not provided). The administered doses of the vaccines experienced a temperature excursion in the range between -9 degrees C to 8 degrees C during 1 minute as recorded by a data logger. The vaccines also experienced a previous temperature excursions in the range between -9 degrees C to 8 degrees C for 5 minutes. There were no adverse effects reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a 1 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 23-APR-2018 the patient was vaccinated with a dose of PROQUAD lot# N034560 with expiration date: 03-JUN-2019 and VARIVAX lot# N028711 with expiration date: 13-OCT-2019 subcutaneously for prophylaxis. The reporter mentioned that this was not a product confusion. Concomitant therapies included sterile diluent (manufacturer unknown). No lot information was provided for the sterile diluent (manufacturer unknown) used to reconstitute the PROQUAD or VARIVAX. No adverse effects were reported.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This retrospective cohort study report has been received from the authors of a published literature. This paper described a 9.5-year cohort study evaluating the incidence of herpes zoster after concomitant administration of ZOSTAVAX (ZVL) and PNEUMOVAX 23 (PPSV23). A retrospective cohort study was conducted from 01-JAN-2007 to 30-JUN-2016. The exposed cohort (concomitant vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL and PPSV 23 on the same day from 01-JAN-2007 to 31-DEC-2014. The comparator cohort (prior vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL during the same period as the exposed cohort but were previously vaccinated with a dose of PPSV 23 from 365 days to 30 days prior to receiving ZVL. Both groups had been continuous members in the year prior to date of ZVL vaccination, allowing for a 31-day gap in membership. The patients from both groups were followed from the date of ZVL vaccination until the date of herpes zoster occurrence, termination of membership (allowing for a 31-day gap), death, or 30-JUN-2016, whichever was earliest. This report refers to 445 elderly (age 65 years and older) patients. On unknown dates the patients were concomitantly vaccinated with ZOSTAVAX (lot#, expiration date, dose, route and frequency unknown) and PNEUMOVAX 23 (lot#, expiration date, dose, route and frequency unknown) for prophylaxis. The prescribing information stated that these vaccines should not be given concurrently (product use issue). On unknown dates, the patients experienced incident severe herpes zoster. The outcome of the events was unknown. The reporter considered vaccination failure and herpes zoster to be related ZOSTAVAX. This is one of several reports received from the same literature (linked report MARRS #1804USA008699, 1804USA010350, 1804USA010351, 1804USA010352, 1804USA010377).
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This retrospective cohort study report has been received from the authors of a published literature. This paper described a 9.5-year cohort study evaluating the incidence of herpes zoster after concomitant administration of ZOSTAVAX (ZVL) and PNEUMOVAX 23 (PPSV 23).  A retrospective cohort study was conducted from 01-JAN-2007 to 30-JUN-2016. The exposed cohort (concomitant vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL and PPSV23 on the same day from 01-JAN-2007 to 31-DEC-2014. The comparator cohort (prior vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL during the same period as the exposed cohort but were previously vaccinated with a dose of PPSV 23 from 365 days to 30 days prior to receiving ZVL. Both groups had been continuous members in the year prior to date of ZVL vaccination, allowing for a 31-day gap in membership. The patients from both groups were followed from the date of ZVL vaccination until the date of herpes zoster occurrence, termination of membership (allowing for a 31-day gap), death, or 30-JUN-2016, whichever was earliest. This report refers to 137 adult patients (60 year old to 64 year old). On unknown dates the patients were previously vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, dose, route and frequency unknown) from 365 days to 30 days prior to receiving ZOSTAVAX (lot#, expiration date, dose, route and frequency unknown) for prophylaxis. On unknown dates, the patients experienced incident severe herpes zoster. The outcome of drug the events was unknown. The reporter considered vaccination failure and herpes zoster to be related ZOSTAVAX. This is one of several reports received from the same literature (linked report MARRS #1804USA008699, 1804USA010349, 1804USA010351, 1804USA010352, 1804USA010377).
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This retrospective cohort study report has been received from the authors of a published literature, title as stated above. This paper described a 9.5-year cohort study evaluating the incidence of herpes zoster after concomitant administration of ZOSTAVAX (ZVL) and PNEUMOVAX 23 (PPSV 23). A retrospective cohort study was conducted from 01-JAN-2007 to 30-JUN-2016. The exposed cohort (concomitant vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL and PPSV 23 on the same day from 01-JAN-2007 to 31-DEC-2014. The comparator cohort (prior vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL during the same period as the exposed cohort but were previously vaccinated with a dose of PPSV 23 from 365 days to 30 days prior to receiving ZVL. Both groups had been continuous members in the year prior to date of ZVL vaccination, allowing for a 31-day gap in membership. The patients from both groups were followed from the date of ZVL vaccination until the date of herpes zoster occurrence, termination of membership (allowing for a 31-day gap), death, or 30-JUN-2016, whichever was earliest. This report refers to 604 elderly patients (age 65 years and older). On unknown dates the patients were previously vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, dose, route and frequency unknown) from 365 days to 30 days prior to receiving ZOSTAVAX (lot#, expiration date, dose, route and frequency unknown) for prophylaxis. On unknown dates, the patients experienced incident severe herpes zoster. The outcome of the events was unknown. The reporter considered vaccination failure and herpes zoster to be related ZOSTAVAX. This is one of several reports received from the same literature (linked report MARRS #1804USA008699, 1804USA010349, 1804USA010350, 1804USA010352, 1804USA010377).
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This retrospective cohort study report has been received from the authors of a published literature. This paper described a 9.5-year cohort study evaluating the incidence of herpes zoster after concomitant administration of ZOSTAVAX (ZVL) and PNEUMOVAX 23 (PPSV23). A retrospective cohort study was conducted from 01-JAN-2007 to 30-JUN-2016. The exposed cohort (concomitant vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL and PPSV23 on the same day from 01-JAN-2007 to 31-DEC-2014. The comparator cohort (prior vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL during the same period as the exposed cohort but were previously vaccinated with a dose of PPSV23 from 365 days to 30 days prior to receiving ZVL. Both groups had been continuous members in the year prior to date of ZVL vaccination, allowing for a 31-day gap in membership. The patients from both groups were followed from the date of ZVL vaccination until the date of herpes zoster occurrence, termination of membership (allowing for a 31-day gap), death, or 30-JUN-2016, whichever was earliest. This report refers to 4509 adult (60 year old to 64 year old) patients. On unknown dates the patients were concomitantly vaccinated with ZOSTAVAX (lot#, expiration date, dose, route and frequency unknown) and PNEUMOVAX 23 (lot#, expiration date, dose, route and frequency unknown) for prophylaxis. The prescribing information stated that these vaccines should not be given concurrently. This is one of several reports from the same literature (linked report MARRS #1804USA008699, 1804USA010349, 1804USA010350, 1804USA010351, 1804USA010377).
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This retrospective cohort study report has been received from the authors of a published literature. This paper described a 9.5-year cohort study evaluating the incidence of herpes zoster after concomitant administration of ZOSTAVAX (ZVL) and PNEUMOVAX 23 (PPSV 23). A retrospective cohort study was conducted from 01-JAN-2007 to 30-JUN-2016. The exposed cohort (concomitant vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL and PPSV23 on the same day from 01-JAN-2007 to 31-DEC-2014. The comparator cohort (prior vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL during the same period as the exposed cohort but were previously vaccinated with a dose of PPSV 23 from 365 days to 30 days prior to receiving ZVL. Both groups had been continuous members in the year prior to date of ZVL vaccination, allowing for a 31-day gap in membership. The patients from both groups were followed from the date of ZVL vaccination until the date of herpes zoster occurrence, termination of membership (allowing for a 31-day gap), death, or 30-JUN-2016, whichever was earliest. This report refers to 11424 elderly (65 years and older) patients. On unknown dates the patients were concomitantly vaccinated with ZOSTAVAX (lot#, expiration date, dose, route and frequency unknown) and PNEUMOVAX 23 (lot#, expiration date, dose, route and frequency unknown) for prophylaxis. The prescribing information stated that these vaccines should not be given concurrently (product use issue). This is one of several reports received from the same literature (linked report MARRS #1804USA008699, 1804USA010349, 1804USA010350, 1804USA010351, 1804USA010352).
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Crying, Haematochezia, Intussusception
Clinical narrative: This spontaneous report was received from a physician via company representative, concerning a 4 month old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date in October 2017 (reported as "6 months ago"), the patient was vaccinated with a dose of ROTATEQ, orally, for prevention of rotavirus (lot number and expiration date were not reported). On the same day, the patient received a dose of PEDIARIX and one of PREVNAR 13, for an unknown indication (route of administration, anatomical location, lot numbers and expiration dates were not reported). On an unknown date in 2017 (reported as "8 days" after receiving the vaccines), the patient began to experience inconsolable crying and bloody stools. The physician reported that the patient was diagnosed with intussusception, which resolved without treatment by the next day. It was unknown by the reporter if lab diagnostics or studies were performed. The reporter did not assess the causal relationship between the suspect vaccines and the event. Upon internal review, intussusception was considered to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician's assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were not reported. On an unknown date, the patient inadvertently received an expired dose of VARIVAX lot # M019641, expiration date 24-APR-2018, subcutaneous for prophylaxis (strength and dosage schedule not reported). Concomitant therapies included sterile diluent, expiration date 18-NOV-2019 (lot number not provided). No adverse effects reported.
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix, Cervical dysplasia, Colposcopy
Clinical narrative: This spontaneous report was received from a physician via a field representative regarding a currently 32 year old female patient. The patient's medical history included melanoma. Her concurrent conditions and concomitant therapies were not reported. On unknown dates in 2009, the patient received a 3 dose series of GARDASIL (lot #, expiration date, dose, anatomical location and route of administration were not reported) for prevention of HPV. On an unspecified date, after receiving the 3 dose series of the vaccine, the patient was diagnosed with cervical intraepithelial neoplasia III (CIN 3 carcinoma) by an obstetric and gynecology physician. It was unknown if any treatment was given for the event. On an unspecified date in December 2017, a colposcopy was performed to the patient, and on an unspecified date in April 2018, a cone biopsy was done, both results were not provided. The outcome of the cervical intraepithelial neoplasia III was unknown as well as the causality assessment. Upon internal review, the cervical intraepithelial neoplasia III (cervix carcinoma in situ) was considered to be medically significant.
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 34 year old male patient. On an unknown date in APR-2018 (reported as about 2 weeks ago), the patient was vaccinated with an pediatric dose of VAQTA lot # N017094, expiry date 31-AUG-2018, intramuscularly for prophylaxis. No adverse effects were reported. No product quality complaint was present.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 29 year old female patient. Patient had no medical history and concurrent condition. Concomitant medication was reported as none. On 18-APR-2018 the patient was vaccinated with VARIVAX (lot # N022981, 23-AUG-2019) via intramuscular route instead of the intended subcutaneous route, in the left arm for prophylaxis. The vaccine was reconstituted with a sterile diluent (MERCK). On 19-APR-2018 or 20-APR-2018, the patient started to complain of redness, swelling and pain at the injection site. The Pharmacist reports that the injection site reaction did not look like a rash. The Pharmacist reports that the patient received the VARIVAX because she had a titer drawn (on an unspecified date) at a dental school and the titer showed negative for Varicella, and it was unknown if the patient ever received VARIVAX or a Varicella vaccination in the past. Patient sought medical attention by visiting the pharmacy. An unspecified treatment was given for the events. No lab tests were performed. The outcome of varicella virus test negative, vaccination site pain, vaccination site erythema and vaccination site swelling was unknown. Causality assessment was not provided. No product quality complaint was present.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 25-APR-2018, the patient received an expired dose of VAQTA lot # N005605, expiration date on 08-APR-2018, intramuscularly, for prophylaxis. For the patient, that dose would be considered her second dose but it was not stated when the first dose was administered. No adverse effects were reported.
Sex: M
Vaccine: RV5
Symptoms: Vomiting, Wrong technique in product usage process
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 2 month old male patient. There were not pertinent medical history, drug reaction allergies or concomitant therapies. The Licensed Practical Nurse reported that on 25-APR-2018, the patient vomited after received the first dose of ROTATEQ orally, lot # N009962, expiration date: 15-NOV-2018, for prophylaxis, (strength, dosage and frequency were not provided). Also, it was stated that ROTATEQ was administered with milk. There were not treatment given for the adverse event, nor laboratories diagnostics were performed. The outcome of vomiting was reported as recovered on an unspecified date in April 2018. The reporter did not provide causality assessment between ROTATEQ and vomiting.
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report was received from a registered nurse via company representative regarding male patients of unknown age. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with GARDASIL 9 (lot#, expiration date and dosing details were not reported), intramuscularly for prophylaxis. On an unknown date, one out of five male patients experienced syncope immediately after administration of GARDASIL 9. The patients visited physician to seek medical attention. The outcome of syncope was reported as fully recovered. Causality assessment was not provided by the reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 12-JAN-2018, the patient was vaccinated with improperly stored (at a temperature excursion of 0 degree centigrade to 1 degree centigrade for 5 hours) PEDVAXHIB lot # N003537 (expiry date: 17-NOV-2019) for prophylaxis (dosage not reported). A digital data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA011627: US-009507513-1804USA011628: US-009507513-1804USA011629.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 17-JAN-2018, the patient was vaccinated with improperly stored (at a temperature excursion of 0 degree centigrade to 1 degree centigrade for 5 hours) PEDVAXHIB lot # N003537 (expiry date: 17-NOV-2019) for prophylaxis (dosage not reported). A digital data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA011456: US-009507513-1804USA011628: US-009507513-1804USA011629.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 19-JAN-2018, the patient was vaccinated with improperly stored (at a temperature excursion of 0 degree centigrade to 1 degree centigrade for 5 hours) PEDVAXHIB lot # N003537 (expiry date: 17-NOV-2019) for prophylaxis (dosage not reported). A digital data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1804USA011456: US-009507513-1804USA011627: US-009507513-1804USA011629.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 29-JAN-2018, the patient was vaccinated with improperly stored (at a temperature excursion of 0 degree centigrade to 1 degree centigrade for 5 hours) ROTATEQ lot # N000172 (expiry date: 10-JUN-2018) orally (dosage not reported) for prophylaxis. A digital data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA011456: US-009507513-1804USA011627: US-009507513-1804USA011628.