chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Crying, Cyanosis, Pain, Pyrexia, Tremor
Clinical narrative: Returned home at 11:30AM, uncontrollable crying and obvious pain. Gave Tylenol at 1:30pm to aid with pain. Temperature at 3:00pm was over 103F, crying and obvious pain, blue feet lips and consistent shaking. Called Dr. and reported to Hospital. Temperature at 104 and would not reduce with administration of Tylenol. Motrin given and fever still at 104. Released from hospital with 24 follow-up instructed.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Small amt of bruising surrounded by area of erythema near injection site.  Area slightly warmer than surrounding skin.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Cough, Decreased appetite, Febrile convulsion, Irritability
Clinical narrative: Cough, congestion, runny nose, fever, not himself, loss of appetite, irritability, febrile seizure. Returned to pediatrician at onset of symptoms. Prescribed breathing treatments. Gave Motrin. Ambulance to the ER following seizure.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Cough, congestion, runny nose, fever, not himself, loss of appetite, irritability, febrile seizure. Returned to pediatrician at onset of symptoms. Prescribed breathing treatments. Gave Motrin. Ambulance to the ER following seizure.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Muscle spasms, Musculoskeletal pain, Neck pain, Peripheral swelling
Clinical narrative: Severe neck scapula and shoulder pain and muscle spasms and cramping. Swollen arm and fingers. Unable to lift arm more than 6 inches.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Discomfort, Dizziness, Loss of consciousness
Clinical narrative: Pt was given the yellow fever vaccine via sq injection into the left arm. After about 5min when pt stood to leave pt said she felt heavy and became dizzy. Pt was instructed to sit back down, and from the sitting position she passed out for a few seconds. I checked pt's breathing and asked for 911 to be called. Pt then regained consciousness and was informed of what happened, and that the EMS system was activated. RPh stayed with pt to monitor while ems could arrive. EMS checked pt and pt said she felt fine and didn't want to go to the hospital.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Oligomenorrhoea
Clinical narrative: Flu shot administered on 11/07/2016, began menstrual cycle on 11/28/2016 and still have a menstrual flow (13+ days as of today, 12/10/2016).
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Back pain, Fatigue, Fibromyalgia, Hypoaesthesia, Insomnia
Clinical narrative: Symtoms of chronic fatigue, fibromyalgia, insomnia, migraine headache, TMJ disorder, Tinnitus, severe pain in neck, shoulders, back, numbness in arms, menstrual disorder, restless leg syndrome, rosacea. Tried physical therapy, chiropractic treatment, Doctors have thrown so many medications at me that I don't know where to begin. Currently taking Lyrica, Baclofen, restorol, sumatriptan, toradol.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Menstrual disorder, Migraine, Musculoskeletal pain, Neck pain, Restless legs syndrome
Clinical narrative: Symtoms of chronic fatigue, fibromyalgia, insomnia, migraine headache, TMJ disorder, Tinnitus, severe pain in neck, shoulders, back, numbness in arms, menstrual disorder, restless leg syndrome, rosacea. Tried physical therapy, chiropractic treatment, Doctors have thrown so many medications at me that I don't know where to begin. Currently taking Lyrica, Baclofen, restorol, sumatriptan, toradol.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Rosacea, Temporomandibular joint syndrome, Tinnitus
Clinical narrative: Symtoms of chronic fatigue, fibromyalgia, insomnia, migraine headache, TMJ disorder, Tinnitus, severe pain in neck, shoulders, back, numbness in arms, menstrual disorder, restless leg syndrome, rosacea. Tried physical therapy, chiropractic treatment, Doctors have thrown so many medications at me that I don't know where to begin. Currently taking Lyrica, Baclofen, restorol, sumatriptan, toradol.
Age: 90.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Local swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Arm pain and swelling lasting 10 + days, Dizziness and Fatigue for 5 days. Swelling extended into neck and hand.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Dyspnoea, Injection site haematoma, Swelling face, Throat tightness, Urticaria
Clinical narrative: Throat tightness, difficulty breathing, face swelling, hives, hematoma at injection site. BENADRL and steroids administered.
Age: 44.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Paraesthesia, Rash
Clinical narrative: Rash with later tingling in hands. Went to Urgent (not emergency room) Care. Then I followed up with a visit to my primary because I was still having problems with the tingling in my hands. I am saying I am recovered based on my current status, but I don't full know the damage inflicted by the shots.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Activities of daily living impaired, Asthenia, Bursitis, Injected limb mobility decreased, Injection site pain
Clinical narrative: Acute left shoulder pain, resulting in ER visit. X/ray, pain medication, orthopedic specialist, MRI, Bursitis/Tear, anti-inflammatory, Cortisone injection. Left with limited range of motion and weakness in left shoulder with possibility of further injections, therapy, surgery.  Restriction on multiple activities.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Injection site reaction, Nuclear magnetic resonance imaging, Rotator cuff syndrome, X-ray
Clinical narrative: Acute left shoulder pain, resulting in ER visit. X/ray, pain medication, orthopedic specialist, MRI, Bursitis/Tear, anti-inflammatory, Cortisone injection. Left with limited range of motion and weakness in left shoulder with possibility of further injections, therapy, surgery.  Restriction on multiple activities.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Aggression, Asterixis, Decreased eye contact, Decreased interest, Emotional distress
Clinical narrative: Extreme tantruming, thrashing in crib, unconsolable, unresponsive to name, spinning in circles, flapping hand, repetitive behavior, loss of eye contact and interest in surroundings.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Stereotypy, Unresponsive to stimuli
Clinical narrative: Extreme tantruming, thrashing in crib, unconsolable, unresponsive to name, spinning in circles, flapping hand, repetitive behavior, loss of eye contact and interest in surroundings.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Henoch-Schonlein purpura
Clinical narrative: Henoch-Schonlein Purpura (HSP).
Age: 4.0
Sex: F
Vaccine: DTAP, FLUX, IPV, MMRV
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Erythematous 9x7cm patch with centralized vesicles on left thigh.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Bronchial secretion retention, Chills, Deafness, Dysphagia
Clinical narrative: Fever, chills, weakness, nausea, further progressed. Ended up with pneumonia, metabolic encephalitis of unknown cause. Hearing loss and vision changes. Vasculitis. Ended up on life support for the mucous plugs. Peg tube placement for inability to swallow.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Gastrostomy, Life support, Metabolic encephalopathy, Nausea, Pneumonia
Clinical narrative: Fever, chills, weakness, nausea, further progressed. Ended up with pneumonia, metabolic encephalitis of unknown cause. Hearing loss and vision changes. Vasculitis. Ended up on life support for the mucous plugs. Peg tube placement for inability to swallow.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Vasculitis, Visual impairment
Clinical narrative: Fever, chills, weakness, nausea, further progressed. Ended up with pneumonia, metabolic encephalitis of unknown cause. Hearing loss and vision changes. Vasculitis. Ended up on life support for the mucous plugs. Peg tube placement for inability to swallow.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Intensive care, Renal failure, Respiratory failure
Clinical narrative: Pt claims in intensive are for 1 and 1/2 weeks with renal and respiratory failure.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site pain
Clinical narrative: Pain in left arm from neck to elbow since immunization, patient is unable to maintain normal activities.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Injection site swelling, swollen underarm lymph nodes, bicep soreness, limited arm movement.
Age: 83.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Immediate post-injection reaction, Influenza like illness
Clinical narrative: Patient claims to have had immediate flu like symptoms after her vaccination.
Age: 83.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Immediate post-injection reaction, Influenza
Clinical narrative: Patient claims to have had immediate flu like symptoms after her vaccination.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Sleep disorder
Clinical narrative: Experiencing very painful left shoulder blade extending up to elbow. Can't sleep on her left side. Worse at night. Tried heat and cold compress. NORCO and TYLENOL with no much help.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Altered state of consciousness, Flushing, Syncope
Clinical narrative: Flushing. Syncope. Almost lost of consciousness.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Severe swelling and redness of rear right arm from top of arm to elbow. Reported to MD and MD recommended warm compress and IBU.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Site reaction, redding of upper arm, that started that night and continued for roughly 5 days. Warm to touch, painful, and covered a large part of the upper arm. Patient took BENADRYL but did not improve the reaction "by much".
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Mobility decreased, Nuclear magnetic resonance imaging abnormal, Pain, Periarthritis
Clinical narrative: Initially, there was brusing and terrible pain -- soreness. Within weeks I could not move my shoulder. I went to Dr. orthopaedics and was diagnosed with frozen shoulder. I was in PT for months -- and although I gained 81 percent mobility, the pain is still horrible. The doctor ordered MRIs -- had one on shoulder and one week later one on the neck. The shoulder revealed very minor fraying -- BUT there are five issues -- and I realized this evening these match exactly those of the rare cases that result in in a small tear to rotator cuff, tendon trouble and adhension capsultis due to flu vaccine administration. I have been asking the PT people for months if they believe the vaccine caused this. They said no. But this evening -- rather early this morning, the pain was so bad. I got up and began reading medical articles and found not only the exact situation but matching MRI findings. I will call Dr. Monday morning and tell him what I have found out and I will tell Dr. He did not mean to hurt me. I like him very much -- but I know this condition I have is related to the vaccine injection and that the vaccine itself in that area has caused this extreme inflammation. You may call me and get more details, and I do not mind showing you my medical records. The result is pain that keeps me from sleeping properly and requires I be in PT 2x weekly and do PT at home additionally.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Sleep disorder
Clinical narrative: Initially, there was brusing and terrible pain -- soreness. Within weeks I could not move my shoulder. I went to Dr. orthopaedics and was diagnosed with frozen shoulder. I was in PT for months -- and although I gained 81 percent mobility, the pain is still horrible. The doctor ordered MRIs -- had one on shoulder and one week later one on the neck. The shoulder revealed very minor fraying -- BUT there are five issues -- and I realized this evening these match exactly those of the rare cases that result in in a small tear to rotator cuff, tendon trouble and adhension capsultis due to flu vaccine administration. I have been asking the PT people for months if they believe the vaccine caused this. They said no. But this evening -- rather early this morning, the pain was so bad. I got up and began reading medical articles and found not only the exact situation but matching MRI findings. I will call Dr. Monday morning and tell him what I have found out and I will tell Dr. He did not mean to hurt me. I like him very much -- but I know this condition I have is related to the vaccine injection and that the vaccine itself in that area has caused this extreme inflammation. You may call me and get more details, and I do not mind showing you my medical records. The result is pain that keeps me from sleeping properly and requires I be in PT 2x weekly and do PT at home additionally.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Irritability, Nasopharyngitis, Pyrexia, Rash
Clinical narrative: Fever, rash, cold symptoms, irritable.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: Intense pain in left arm and shoulder radiating down to hand. I am unable to raise my left arm more than a few inches. I cannot sleep on my left side without excruciating pain. It is now 48 hours after my Pneumovax 23 injection in my upper left arm and I am still in excruciating pain. I called and reported this to Pharmacy on 12/11/2016 at 10:30 AM and the Pharmacist said she had never heard of this type of reaction and that there must be some sort of inflammation going on where the injection was given. She told me to ice the arm and take an anti-inflammatory medication like Advil. She said she would investigate and call me back. I still have heard nothing......I am calling my Primary Care Doctor tomorrow. I have never had this type of reaction from a shot before. I have had the flu shot with no difficulty and also 1 year ago the Previlar 13 Pneumonia Vaccine with no problem. On a scale of 1 to 10 this pain and lack of being able to move my whole arm without excruciating pain is horrible.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Tenderness
Clinical narrative: Patient describes pain at site.  Painful to touch on scale of 0-10 rates pain at a 5.  Patient took 4 Ibuprofen 200 mg with no relief.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Nausea, Ocular hyperaemia, Pyrexia
Clinical narrative: Patient is experiencing fever, nausea without vomitting, and malaise. Eyes are red.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Asthenia, Body temperature increased, Feeling abnormal, Oral pain, Oral pruritus
Clinical narrative: Vomiting and elevated temperature resolved over night. 12/09/16 very low energy and "spacing out". 12/10/16 sudden and unusual pain in mouth after eating a banana (favorite fruit), developed hives around mouth and one in throat, still continuing 12/11/16, woke up at 1:00 am screaming about pain and itchiness around his mouth. Developed hives on hands and arms.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Screaming, Urticaria, Vomiting
Clinical narrative: Vomiting and elevated temperature resolved over night. 12/09/16 very low energy and "spacing out". 12/10/16 sudden and unusual pain in mouth after eating a banana (favorite fruit), developed hives around mouth and one in throat, still continuing 12/11/16, woke up at 1:00 am screaming about pain and itchiness around his mouth. Developed hives on hands and arms.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Chest discomfort, Cough, Headache, Injection site pain, Productive cough
Clinical narrative: Dry, wheezing cough; by 8 AM 12/11/2016 cough is more intense, more frequent, and productive; sensation of restriction in chest; headache; respirations 27/minute; resting heart rate 78; temperature unknown but at or near normal (98.6) by estimate; blood pressure unknown but not noticeably elevated; no chills as of 12:32 PM 12/11/2016; mild muscular soreness at injection site (left deltoid); patient self-administered 400 mg guafenesin approximately 11:30 AM 12/11/2016, 600 mg Inuprofen, and menthol cough drop; and used existing CPAP for improved breathing. Will report changes/outcome subsequent to this report.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Wheezing
Clinical narrative: Dry, wheezing cough; by 8 AM 12/11/2016 cough is more intense, more frequent, and productive; sensation of restriction in chest; headache; respirations 27/minute; resting heart rate 78; temperature unknown but at or near normal (98.6) by estimate; blood pressure unknown but not noticeably elevated; no chills as of 12:32 PM 12/11/2016; mild muscular soreness at injection site (left deltoid); patient self-administered 400 mg guafenesin approximately 11:30 AM 12/11/2016, 600 mg Inuprofen, and menthol cough drop; and used existing CPAP for improved breathing. Will report changes/outcome subsequent to this report.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Musculoskeletal stiffness, Myalgia
Clinical narrative: Muscle aches throughout entire body with stiffness; unable to perform normal activities. This is the first time that I have been administered the FLUZONE HIGH DOSE and will refuse High-Dose in future. Never had reaction like this to "normal" strength flu vaccine.
Age: 63.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site rash, Palpitations
Clinical narrative: Patient reported heart palpitations on Friday 12-9-16 but was gone the next day. Patient then reported a rash at injection site Saturday 12-10-16, but rash has not changed, worsened or spread as of 12-11-16.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain, Pruritus, Swelling
Clinical narrative: Massive swelling, pain, redness, difficulty using arm, slight itching. Has not abated as of 12/11/16.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of arm near injection site. Treated with Cephalexin.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Contusion
Clinical narrative: Cellulitis of arm near injection site. Treated with Cephalexin.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Cough, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: PAIN IN LEFT SHOULDER AND ARM WHICH LAST FOR 2 DAYS. 5 DAYS LATER  I HAD ACHES IN MY MUSCLES AND JOINTS THAT LAST FOR 4 DAYS.AFTER THAT I WAS COUGHING UP MUCUS FOR 3 WEEKS. NOW FOR THE PAST 3 DAYS I HAD A RUNNY NOSE AND A DRY COUGHT.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Productive cough, Rhinorrhoea
Clinical narrative: PAIN IN LEFT SHOULDER AND ARM WHICH LAST FOR 2 DAYS. 5 DAYS LATER  I HAD ACHES IN MY MUSCLES AND JOINTS THAT LAST FOR 4 DAYS.AFTER THAT I WAS COUGHING UP MUCUS FOR 3 WEEKS. NOW FOR THE PAST 3 DAYS I HAD A RUNNY NOSE AND A DRY COUGHT.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Sudden onset of explosive diarrhea. Seventeen episodes of watery, explosive diarrhea and fever. Diarrhea lasted approximately three hours.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Chorea, Cyanosis, Feeling hot, Muscle spasms, Peripheral coldness
Clinical narrative: L hand became blue, felt cold initially then hot, patient then developed L arm spasms and/or chorea.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke.
Age: 51.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Nausea, Viral infection, Vomiting
Clinical narrative: Extreme nausea, vomiting. Went to ER to see if he had a virus infection. No definite answer from MD ER.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dysgeusia, Headache, Immediate post-injection reaction
Clinical narrative: Patient immediately had a strange taste in his mouth and a horrible headache. He was dizzy for a short time. Recovered after 20 minutes but still had headache.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Swelling, Tenderness
Clinical narrative: Vomiting, diarrhea, sound sensitivity, abdominal pain, dizziness, headache, fatigue.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Vomiting, diarrhea, sound sensitivity, abdominal pain, dizziness, headache, fatigue.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hyperacusis, Vomiting
Clinical narrative: Vomiting, diarrhea, sound sensitivity, abdominal pain, dizziness, headache, fatigue.
Age: 0.0
Sex: U
Vaccine: HEP, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 6 days old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with RECOMBIVAX HB (lot number: K010216, dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830: US-009507513-1609USA013814: US-009507513-1610USA004339.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring an unknown number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the unspecified patients were vaccinated with VARIVAX (lot number L025205 and expiration date 07-JUL-2017, lot number L042266 and expiration date 27-OCT-2017, lot number L048462 and expiration date 02-DEC-2017, lot number L048465 and expiration date 02-DEC-2017, lot number M009765 and expiration date 23-FEB-2018, dose and route of administration were not reported). The temperature of excursion was 24.1F and the time frame was 5 hours and 41 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. Follow-up information has been received from the registered nurse on 14-NOV-2016. The administration of improperly stored vaccine occurred on 17-JUN-2016. A new lot L044524 was reported (expiration date was not reported) for VARIVAX. It was stated that based on stability data, the vaccine was good to use. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1607USA009049: MERCK 1607USA010526:Mfr number.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. No concurrent conditions, medical history and concomitant therapies were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored PROQUAD (dose, frequency and route of administration were not reported) with lot number of M007963 and expiration date of 15-AUG-2017, for prophylaxis. No adverse effects were reported. No further information was provided. As of 30-NOV-2016, all telephone attempts to obtain follow up information have been unsuccessful. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA000978: MERCK 1610USA004065:Mfr number.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients (age and gender unknown). The patients' concurrent conditions, medical history and concomitant therapies were not reported. The patients received unspecified doses in PROQUAD (lot # M029595 with expiration date of 10-DEC-2017, and lot # M004892 with expiration date of 25-JUL-2017, dose and route unknown) immunization series that were improperly stored, for prophylaxis. The vaccines were exposed at minus 10 degrees Celsius for 24 hours. The excursion occurred on 08-JUN-2016 and the vaccinations occurred from that point through 07-OCT-2016. No adverse effects were reported. This is one of two reports received from the same reporter. All telephone attempts to obtain follow-up information on 29-NOV-2016 have been unsuccessful. On 01-DEC-2016, a return call was received from the certified medical assistant. She was unable to provide any additional information. The Merck  correspondence process was received with her, should information become available. Additional information has been requested. Narrative was updated.; Sender's Comments: US-009507513-1610USA004335: MERCK 1610USA004337:Mfr number.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via field representative referring to a female patient in her 60's. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX 19400 PFU, (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. On an unknown date (reported as "within a week" of receiving ZOSTAVAX the patient experienced "shingles" (unspecified location of the body). At the time of reporting, the outcome of "shingles" was unknown. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMRV, MNQ, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse referring to a 16 year old patient of unknown gender. The patient's medical history, drug reactions/allergies and concurrent conditions were not reported. On 14-NOV-2016, the patient was vaccinated with a dose of VARIVAX lot # L048463, expiration date: 02-DEC-2017 (strenght, dose, frequency and route of administration were not reported) for prophylaxis and then inadvertently received a dose of PROQUAD lot # M022399, expiration date: 01-NOV-2017 (strenght, dose, frequency and route of administration were not reported) for prophylaxis, instead of the intended dose of M-M-R II, because the medical assistant "grabbed the wrong vaccine". No adverse events were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Product use issue
Clinical narrative: This spontaneous report was received from a consumer via social media regarding her kids of unknown age and gender. The kid's were sexually abused by their farther who had genital warts surgically removed resulting in other infections of STD (Sexually transmitted infection) in one of them. On an unknown date, the patient was vaccinated with unspecified quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (Manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (Manufacturer unknown) (dosing details, route of administration and lot# unknown) for infections of STD (product use issue) for use other than indicated (treatment of existing HPV infection or prior HPV exposure). There was no product quality complaint (PQC) involved. Additional information is not expected as there was no contact details.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 29-JUN-2016, the patient was inadvertently vaccinated with a dose of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, dose not reported) subcutaneously for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005165: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005168: US-009507513-1612USA005169.
Sex: F
Vaccine: MMR
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On approximately November 2016, the patient received dose of M-M-R II (lot #, expiration date, exact dose and route of administration were not reported). It was reported that on approximately November 2016 (about 4 weeks ago), the patient had experienced a huge rash in the size of a two by three at the injection site within 48 hours of receiving the vaccine. The pharmacist stated that she viewed the patient's rash. No further information was provided. The outcome of the event was reported as not recovered. The relatedness between the event and M-M-R II was not provided. Additional information has been requested.
Sex: U
Vaccine: UNK
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored vaccine. It was stated that the vaccine was either RECOMBIVAX HB (lot # L048236 and expiration date 31-MAR-2018, strength: 10/1.0 microgram/ml; dose and route of administration were not reported) or M-M-R II (lot number L049455 and expiration date 03-DEC-2017; lot number M002418 and expiration date 12-JAN-2018; albumin status therapy type, dose and route of administration were not reported) or ROTATEQ (lot number reported as M026315 and expiration date 26-JAN-2018; lot number M002254 and expiration date 17-NOV-2017; lot number M016238 and expiration date 07-DEC-2017, orally; dose was not reported). No adverse reactions were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 26-NOV-2016, the patient was vaccinated with expired ZOSTAVAX expiration date 07-JUL-2016; lot #, dose and route unknown for prophylaxis. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 01-DEC-2016, the patients were vaccinated with improperly stored doses of ZOSTAVAX injection, subcutaneously, lot # M032360, expiration date: 18-AUG-2017 (exact dose and anatomical location were not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32.54 degrees Fahrenheit for 4.5 hours. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nuclear magnetic resonance imaging brain
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 13 year old female patient. Patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with GARDASIL dose 1, intramuscular (dosage regimen, lot # and expiry date unspecified) for prophylaxis. On an unknown date, the patient received dose 2 of GARDASIL. On an unknown date, two months after receiving the second dose of the vaccine series, the patient experienced headache. On an unknown date, the patient underwent an Magnetic Resonance Imaging (MRI) on the head (results unspecified). It was reported that the patient sought medical attention by contacting the physician. Patient did not receive treatment for the event. The outcome of headache was reported as not recovered. No product quality complaint (PQC) was involved.      Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Orthostatic hypertension
Clinical narrative: This spontaneous report was received from a Nurse Practitioner via a company representative and refers to an adolescent female patient who was 15 or 16 years old. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was intramuscularly vaccinated with GARDASIL (dose, lot # and expiration date were not reported). On an unknown date, the patient developed orthostatic hypertension. There was no treatment given for the event. The outcome of orthostatic hypertension and the relatedness between the event and quadrivalent GARDASIL were not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications were not reported. On 02-DEC-2016, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU lot # L032184, expiration date 25-NOV-2016 (dose and route were not provided) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This solicited report has been received from a 55 year old male patient enrolled in a study. The patient's concurrent condition, historical conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with dose of Pneumovax 23 (dose, route and anatomical location were not reported) for prophylaxis. On an unknown date, he had gotten sick after taking the shot. The outcome of event was unknown. Action taken with the therapy was unknown (not applicable). The causality between the event and Pneumovax 23 was not reported. Additional information is not expected as the reporter did not consent for further follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Erythema, Incoherent, Laboratory test, Mobility decreased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old female patient. The patient's medical history included shingles (8-10 months ago). She did not had any drug reactions/allergies. On 30-NOV-2016, the patient was vaccinated with ZOSTAVAX, (dose, lot # and expiry date unknown) subcutaneously for prophylaxis. Concomitant therapies included CHANTIX, phentermine, raloxifene, tramadol hydrochloride, amlodipine, clonidine, omeprazole, simvastatin (manufacturer unknown) and gemfibrozil. On 30-NOV-2016 evening, the patient became red. On 01-DEC-2016 (reported as about 24 hours later), the patient was still red, became incoherent and she was unable to answer the phone or get up from the chair. On the same day, the patient did not recognize anyone and she was brought to the hospital on an ambulance where she stayed for 12-18 hours. She received an unspecified treatment for the events. The patient had an unspecified lab work done and a computerized tomography scan, results of which were not provided. The outcome of the events was unknown. The causality assessment was not provided by the reporter. The reporter considered events to be life threatening. Upon internal review, the event of unable to answer the phone or get up from the chair was determined to be disability. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Disability, Immobile
Clinical narrative: This spontaneous report was received from a consumer via social media refers to some female patients of unknown age. There is no information of concomitant medication, medical history and concurrent condition. On an unknown date, the patient was vaccinated with GARDASIL for prophylaxis. On an unknown date, the patients ended up crippled (disability). The outcome of disability was unknown. Causality assessment was not provided. This case has been linked with the MARRS case no. 1612USA004594 as E2B Linked Report. Additional information has been requested. Sender's Comments:  US-009507513-1612USA004594.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Abasia, Spinal pain, Throat tightness
Clinical narrative: Information has been received from a pharmacist referring to a 67 year old male patient with no drug reactions/allergies. The patient's pertinent medical history was not reported. Concomitant therapies included thyroid medications, benzodiazepines and glaucoma medications (names of medications unspecified). On 19-NOV-2016, the patient received a dose of PNEUMOVAX23 lot # M038216 with expiration date of 09-MAY-2018 (strength, dose and dose number unknown) intramuscularly for immunization. Then, the patient left the pharmacy with no problem. However, about 15 minutes later, the patient came back to pharmacy complaining that he was having pain in his spine and he was not able to walk due to pain. The pharmacist asked the patient to stay in pharmacy so she could observe him. The patient was in the waiting area for about 20-30 minutes and he reported to pharmacist that he felt like his throat was little bit tight. The Pharmacist asked patient if he wanted to go to emergency room (ER) but the patient told pharmacist that he was not having any trouble breathing or shortness of breath but his throat felt little bit tight. The pharmacist continued to observe the patient and about 30 minutes after patient complained of tight throat, he reported to pharmacist that his throat was fine and his pain in spine was also subsiding. No treatment was given for the events. The patient eventually felt completely fine and was able to walk and went home. No product quality complaint (PQC) was involved. The relationship between the events and PNEUMOVAX23 was not provided. Upon internal review, the event of unable to walk was determined to be medically significant. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report was received from a 66 year old female patient referring to herself. Information about concomitant medication and medical history was not provided. On 03-JUN-2016 the patient was vaccinated with PNEUMOVAX23 (Lot # M005287, Expiration date unknown) as routine vaccine. The patient reported that she developed an allergic reaction (hives) after receiving the PNEUMOVAX23 within 24 hours, which lasted for about 10 days. The patient had sought medical attention via spoke with her physician. The patient was received treatment and recovered at the time of report in June 2016. No further AE information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history regarding the multiple unspecified patients was not provided. On multiple unspecified dates the multiple unspecified patients might be vaccinated with improperly stored doses of VARIVAX (lot # L044525, expiration date 07-NOV-2017, dose and route unknown) for prophylaxis. The vaccines were exposed to 18.3 F for 1 hour and 10 minutes. The temperatures were logged with a data logger and there were no previous excursions. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding a patient of unknown demographics. There was no information about concurrent condition, historical medication and concomitant medication. On an unknown date the patient was vaccinated with improperly stored VARIVAX lot # M031970/ expiration date- 30-JUN-2018, for prophylaxis. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 15 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 23-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M020103, dose, frequency, expiry date were not reported) for prophylaxis. The patient was vaccinated under Vaccines for Children Program (VCF). The vaccines underwent a temperature excursion of -0.3 C for 22 hours. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. Digital data logger was involved. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 15 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 27-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: L036301, dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/Insurance. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 01-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M009378, dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/Insurance. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 02-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: L043214, dose, frequency, expiry date were not reported) for prophylaxis. The patient was vaccinated under Vaccines for Children Program (VCF). The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments:  US-009507513-1609USA014830,
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 12 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 02-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M009378, dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/Insurance. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 12-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M009378, dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/Insurance. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 12 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 13-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M009378, dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/Insurance. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 16-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M020103, dose, frequency, expiry date were not reported) for prophylaxis. The patient was vaccinated under Vaccines for Children Program (VCF). The vaccines underwent a temperature excursion of -0.3 C for 22 hours. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. Digital data logger was involved. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.