chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUC4
Symptoms: Computerised tomogram head, Demyelinating polyneuropathy, Electromyogram, Fatigue, Gait disturbance
Clinical narrative: 11/15/2017  generalized fatigue and muscle aches. 12/9/2017 increased fatigue and starting pin and needles feeling in both feet. 12/15/17 pain in feet increasing, hard to ambulate, fatigue. 1/12/18 ER VISIT minimal ambulation, legs and arms weak, numbness noted, spreading from feet to arms. 1/19/18 Neurology visit with diagnosis of Guillian Barre ordered to recieve IVIG infusion. 2/19/18 EMG and nerve cobduction studies performed performed with demyelinating polyneuropathy- Guillian Barre.
Sex: U
Vaccine: FLUC4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Laboratory test, Muscular weakness
Clinical narrative: 11/15/2017  generalized fatigue and muscle aches. 12/9/2017 increased fatigue and starting pin and needles feeling in both feet. 12/15/17 pain in feet increasing, hard to ambulate, fatigue. 1/12/18 ER VISIT minimal ambulation, legs and arms weak, numbness noted, spreading from feet to arms. 1/19/18 Neurology visit with diagnosis of Guillian Barre ordered to recieve IVIG infusion. 2/19/18 EMG and nerve cobduction studies performed performed with demyelinating polyneuropathy- Guillian Barre.
Sex: U
Vaccine: FLUC4
Symptoms: Myalgia, Nerve conduction studies, Pain in extremity, Paraesthesia, Pulmonary function test
Clinical narrative: 11/15/2017  generalized fatigue and muscle aches. 12/9/2017 increased fatigue and starting pin and needles feeling in both feet. 12/15/17 pain in feet increasing, hard to ambulate, fatigue. 1/12/18 ER VISIT minimal ambulation, legs and arms weak, numbness noted, spreading from feet to arms. 1/19/18 Neurology visit with diagnosis of Guillian Barre ordered to recieve IVIG infusion. 2/19/18 EMG and nerve cobduction studies performed performed with demyelinating polyneuropathy- Guillian Barre.
Age: 1.67
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Onset of hives 24 hrs after administration of vaccine.
Age: 0.42
Sex: F
Vaccine: DTAP
Symptoms: Diet refusal, Injection site pain, Screaming
Clinical narrative: Non-stop screaming. Refusing to eat and screaming when trying to feed. Sore at spot of injection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Moderate pain in left arm in the hour following the injection, and muscle pain in arms and legs later that evening. Chills overnight. Mild pain at injection site, headache, tiredness, and nausea the next day. Nausea and headache resolved by midday, tiredness and pain at injection site persisted into the afternoon.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: Moderate pain in left arm in the hour following the injection, and muscle pain in arms and legs later that evening. Chills overnight. Mild pain at injection site, headache, tiredness, and nausea the next day. Nausea and headache resolved by midday, tiredness and pain at injection site persisted into the afternoon.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Diffused red rash (similar to rash experienced with sulfa drug) from top of chest to neck. No itching at first sign of rash, but itching developed later that day and has persisted for a few days.
Age: 1.58
Sex: M
Vaccine: MMRV
Symptoms: Cough, Dry skin, Ear pain, Febrile convulsion, Pyrexia
Clinical narrative: Fever 101°F. Febrile convulsions. Ear pain. Cough. Dry skin. Hives.
Age: 1.58
Sex: M
Vaccine: MMRV
Symptoms: Urticaria
Clinical narrative: Fever 101°F. Febrile convulsions. Ear pain. Cough. Dry skin. Hives.
Age: 80.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Peripheral swelling, X-ray
Clinical narrative: Patient reports a lot of pain in right shoulder. Unable to lift right arm due to stiffness. Swelling and stiffness in right hand.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever began at 100.3 at 9am, patient complained of a severe headache and the injection sites were red and raised to the size of a dime, Temperature was taken an hour afterwards and it rose to 102.5. Symptoms began to subside after I put him into a detox bath of lavender oil, bentonite clay and magnesium flakes. Within an hour of the bath (around noon) his temprature dropped to 99.5.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood electrolytes, Blood magnesium decreased, Blood potassium decreased, Blood test, Chest X-ray
Clinical narrative: Weakness on right side of body, numbness in hands; nausea & light headiness. Weakness & numbness outside upper left & right legs & knees/numbness in fingers. On Sept. 28, 2017 got a Flu Shot another shot (not sure if it was a ZOSTAVAX shot) from Clinic. As of Feb. 24, 2018 Still have some numbness in fingers and some weakness left & right knees.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head, Dehydration, Dizziness, Electromyogram normal, Hemiparesis
Clinical narrative: Weakness on right side of body, numbness in hands; nausea & light headiness. Weakness & numbness outside upper left & right legs & knees/numbness in fingers. On Sept. 28, 2017 got a Flu Shot another shot (not sure if it was a ZOSTAVAX shot) from Clinic. As of Feb. 24, 2018 Still have some numbness in fingers and some weakness left & right knees.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Muscular weakness, Nausea
Clinical narrative: Weakness on right side of body, numbness in hands; nausea & light headiness. Weakness & numbness outside upper left & right legs & knees/numbness in fingers. On Sept. 28, 2017 got a Flu Shot another shot (not sure if it was a ZOSTAVAX shot) from Clinic. As of Feb. 24, 2018 Still have some numbness in fingers and some weakness left & right knees.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt. described injection site/arm as in excruciating pain. Injection site presented red and swollen. 48 hours after all symptoms resolved.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Insomnia, Myalgia
Clinical narrative: HUSBAND REPORTS PT'S SX FOLLOWING DAY AS MUSCLE ACHES, HEADACHE, SORE ARM, HARD TIME SLEEPING NIGHT BEFORE - DID SAY SX IMPROVING - REC F/U W/DR IF SX DON'T IMPROVE - SX LISTED ADES FOR SHINGRIX, FLU SHOT DAY PRIOR - PT WAS COUNSELED ON THESE ADES PRIOR TO RECEIVING VACCINES - HAVE NOT HEARD FROM PT SINCE INITIAL REPORT.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash papular
Clinical narrative: After about 7 hours, I developed severe pruritis in my left arm just above the elbow. This was accompanied by 4 papular lesions at this site reminiscent of my recent herpetic attack.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Blister, Cheilitis, Chest X-ray abnormal, Constipation
Clinical narrative: Dizziness, Weakness, Sores in mouth and lips, large red spots and sores all over back, head, neck, chest, small red blisters on bottom of feet. Problems breathing, pain in lungs, coughing. Treatment was cortisone cream, antibiotic ointments, antifungal creams, steroids, antibiotic oral, PROVENTIL albuterol sulfate inhalation aerosol. I have photos of my back. I still have sores in my mouth and lips and have had severe constipation; am eating lots of fruits and veggies.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Dizziness, Dyspnoea, Erythema, Pneumonia
Clinical narrative: Dizziness, Weakness, Sores in mouth and lips, large red spots and sores all over back, head, neck, chest, small red blisters on bottom of feet. Problems breathing, pain in lungs, coughing. Treatment was cortisone cream, antibiotic ointments, antifungal creams, steroids, antibiotic oral, PROVENTIL albuterol sulfate inhalation aerosol. I have photos of my back. I still have sores in my mouth and lips and have had severe constipation; am eating lots of fruits and veggies.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pulmonary pain, Skin ulcer, Stomatitis
Clinical narrative: Dizziness, Weakness, Sores in mouth and lips, large red spots and sores all over back, head, neck, chest, small red blisters on bottom of feet. Problems breathing, pain in lungs, coughing. Treatment was cortisone cream, antibiotic ointments, antifungal creams, steroids, antibiotic oral, PROVENTIL albuterol sulfate inhalation aerosol. I have photos of my back. I still have sores in my mouth and lips and have had severe constipation; am eating lots of fruits and veggies.
Age: 38.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain in extremity
Clinical narrative: Pt complained of tingling, pain and loss of movement in arm that was vaccinated. Followed up with patient but have not gotten update on outcome. Pt had an appointment with her dr and was pending insurance approval for a scan.
Age: 38.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Pt complained of tingling, pain and loss of movement in arm that was vaccinated. Followed up with patient but have not gotten update on outcome. Pt had an appointment with her dr and was pending insurance approval for a scan.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, RV1
Symptoms: Intussusception, Pyrexia, Ultrasound abdomen abnormal, Vomiting projectile, X-ray abnormal
Clinical narrative: Projectile vomiting, fever, intussusception.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure in the afternoon, fever -recovered within 1 minute.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Electroencephalogram abnormal, Febrile convulsion
Clinical narrative: Complex febrile seizures- 2 within 24 hour period; up to 8 minutes; MOTRIN/TYLENOL; CIPRODEX gtts; OMNICEF.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity, Periarthritis, X-ray
Clinical narrative: Frozen Left Shoulder, loss of range of motion and pain in left arm, NOVOCAIN shot, NSAIDs, Steroid shots, planned physical therapy.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Pt developed a red, hot patch about the size of 2"x3" on the right arm. Stated a little pain but no fever. Pt stated it occurred the night that the shot was given.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: I expected the normal tenderness after the flu shot but I was surprised when, a week after the shot, my colleague who received the shot after me had no tenderness and my left arm was still sore. I had reduced range of motion and it hurt to raise my arm. Now, 3 weeks after the injection, I have sudden severe pain when I move my left arm (including but not limited to when I lift it over my head, bend it behind my head, extend it back behind me, or turn my arm to check my watch).  The pain can be in either the bicep, tricep, or deltoid. I also have reduced strength when I try to grasp and lift something like a cup of water. When I type or hold my arm out I also feel a numbness and tingling in my left hand, especially between my middle finger and pointer finger. It is also painful when I sleep on it or when I try to use the arm to lift myself out of bed. It also hurts when I try to pull up my jeans/pants. While I received the injection at the local Clinic, I went to my GP's office Thursday, February 22, for treatment and saw her nurse practitioner. The nurse practitioner suggested I use heat or alternate heat and cold on the arm, use BENADRYL and ADVIL to treat the pain and to keep them posted.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: I expected the normal tenderness after the flu shot but I was surprised when, a week after the shot, my colleague who received the shot after me had no tenderness and my left arm was still sore. I had reduced range of motion and it hurt to raise my arm. Now, 3 weeks after the injection, I have sudden severe pain when I move my left arm (including but not limited to when I lift it over my head, bend it behind my head, extend it back behind me, or turn my arm to check my watch).  The pain can be in either the bicep, tricep, or deltoid. I also have reduced strength when I try to grasp and lift something like a cup of water. When I type or hold my arm out I also feel a numbness and tingling in my left hand, especially between my middle finger and pointer finger. It is also painful when I sleep on it or when I try to use the arm to lift myself out of bed. It also hurts when I try to pull up my jeans/pants. While I received the injection at the local Clinic, I went to my GP's office Thursday, February 22, for treatment and saw her nurse practitioner. The nurse practitioner suggested I use heat or alternate heat and cold on the arm, use BENADRYL and ADVIL to treat the pain and to keep them posted.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm was very swollen and red the next day, went from just below shoulder to just above elbow, was also warm to the touch. It also hurt to touch.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Injection site bruising, Injection site mass, Injection site nodule
Clinical narrative: Patient followed up with OB-GYN on 1/18/2018 after delivery. Patient had been administered an MMR vaccination on 1/6/2018. Had bruising and a "nodule" located at injection site that was not resolving. Documented is a 15 cm x 7 cm yellowish bruised area with a quarter sized palpable lump within noted bruising area. Patient reported minimal resolution within the 12 days since discharge.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: Two weeks after administration, patient awoke to a burning sensation bilaterally above each hip. The sensation has come and gone since it first appeared and each occurrence lasts for 2 hours or more. Patient has still had symptoms as late as date of report (02/25/2018). Patient has obtained symptom relief using ice-packs on area and rest.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Hypersensitivity, Lethargy, Pyrexia, Tremor, Unresponsive to stimuli
Clinical narrative: High fever, vomiting, lethargic, unresponsive, tremors.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: High fever, vomiting, lethargic, unresponsive, tremors.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Crying, Gastroenteritis viral, Irritability, Vomiting projectile
Clinical narrative: Projectile vomiting, crankiness, and crying.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Hyperhidrosis
Clinical narrative: Moderate soreness, hardness and acute swelling at, above and below  injection site; hives on upper arm; mild nausea for 4 days; loss of appetite for one week; muscle aches all over for 2.5 days; severe headache for a week; mild fever for 3 days; weakness for a week; chills with severe night sweats for two days; weakness for a week.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Myalgia, Nausea
Clinical narrative: Moderate soreness, hardness and acute swelling at, above and below  injection site; hives on upper arm; mild nausea for 4 days; loss of appetite for one week; muscle aches all over for 2.5 days; severe headache for a week; mild fever for 3 days; weakness for a week; chills with severe night sweats for two days; weakness for a week.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Urticaria
Clinical narrative: Moderate soreness, hardness and acute swelling at, above and below  injection site; hives on upper arm; mild nausea for 4 days; loss of appetite for one week; muscle aches all over for 2.5 days; severe headache for a week; mild fever for 3 days; weakness for a week; chills with severe night sweats for two days; weakness for a week.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Husband stated that the pt had noticed swelling around the inside of her left elbow, swelling of her lower left arm, and possibly swelling of her hand. Stated that there was no reaction around the site of injection, but the symptoms were in the same arm. When asked if the patient had hives, rash, itching, swelling of the face or throat or anywhere above the neck or difficulty breathing, he said "no". He was speaking with the patient in the background while I was on the phone with him.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient said he had high fever (he did not measure it) for several days, general body aches, and a sore arm. He took Tylenol for the fever.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling and burning sensation that has traveled from feet to hands administered prednisone, symptoms have improved.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site atrophy
Clinical narrative: Patient had an indentation developed in the upper right arm a few weeks after receiving the FLUCELVAX vaccine. She reported she was not having any pain or loss of function but just a "dent" in the right upper arm. She reported that she had no other signs or symptoms. She also stated she did not have the indentation evaluated by her doctor and she had not reported it.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Localised oedema, Myalgia
Clinical narrative: Myalgia and localized edema; erythema.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Headache, Tachypnoea
Clinical narrative: Dizziness, headache and tachypnea.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Rash
Clinical narrative: Myalgia and skin rash.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain
Clinical narrative: Pain, decreased range of motion. Got physical therapy, steroid injections, anti-inflammatories, MRI.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Pain, decreased range of motion. Got physical therapy, steroid injections, anti-inflammatories, MRI.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a Nurse Practitioner refers to a 59 year old female patient. The patient's relevant medical history included hypertension and anxiety. None drug reactions/ allergies. On 16-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 injection, lot # N029303 (expiry date: 21-APR-2019) in the right arm (dose not reported) for vaccination. Concomitant therapies included nifedipine (PROCARDIA XL) 60 mg and alprazolam (XANAX) 0.5 mg. On 16-FEB-2018 (began in the afternoon), the patient excruciating pain and had only gotten worse. The patient also stated "that the pain radiated down her right arm and was worse when she makes a fist. On 19-FEB-2018, physician prescribed tramadol (unspecified brand and manufacturer) for the pain. When Physician was asked if the adverse event was a significant disability or incapacity to the patient, she stated "yes", because the pain is a 10 out of 10 on the pain scale. No laboratory diagnostics/studies performed. The outcome of pain was not recovered. No product quality compliant (PQC) was involved. The reporter did not provide any causality assessment. The event pain was considered as serious due to disability.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye pain, Neuralgia
Clinical narrative: A vesicular rash at the site of injection on my left arm and left eye pain began on 02/22/2018. Eye pain was intermittent and in the OS retrobulbar region as well as the left nasal periorbital region. It was a very sharp, pricking sensation. I am an optometrist so I had my associate examine me. She prescribed Valacyclovir 1 gram tid on 02/23/2018 which resolved the eye pain after 24 hours of using the med; however the pain worsened in the interim on 02/24/2018 with maximum pain occurring during the night around 3:00 a.m. It was so painful that the discomfort awakened me. In addition I experienced fatigue, muscle ache, joint edema and pain in my left hand, stomach pain, and nausea for 48 hours immediately following the vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Eye pain, Fatigue, Immediate post-injection reaction
Clinical narrative: A vesicular rash at the site of injection on my left arm and left eye pain began on 02/22/2018. Eye pain was intermittent and in the OS retrobulbar region as well as the left nasal periorbital region. It was a very sharp, pricking sensation. I am an optometrist so I had my associate examine me. She prescribed Valacyclovir 1 gram tid on 02/23/2018 which resolved the eye pain after 24 hours of using the med; however the pain worsened in the interim on 02/24/2018 with maximum pain occurring during the night around 3:00 a.m. It was so painful that the discomfort awakened me. In addition I experienced fatigue, muscle ache, joint edema and pain in my left hand, stomach pain, and nausea for 48 hours immediately following the vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Intraocular pressure increased, Joint effusion, Myalgia, Nausea
Clinical narrative: A vesicular rash at the site of injection on my left arm and left eye pain began on 02/22/2018. Eye pain was intermittent and in the OS retrobulbar region as well as the left nasal periorbital region. It was a very sharp, pricking sensation. I am an optometrist so I had my associate examine me. She prescribed Valacyclovir 1 gram tid on 02/23/2018 which resolved the eye pain after 24 hours of using the med; however the pain worsened in the interim on 02/24/2018 with maximum pain occurring during the night around 3:00 a.m. It was so painful that the discomfort awakened me. In addition I experienced fatigue, muscle ache, joint edema and pain in my left hand, stomach pain, and nausea for 48 hours immediately following the vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ophthalmological examination normal, Rash vesicular, Sleep disorder
Clinical narrative: A vesicular rash at the site of injection on my left arm and left eye pain began on 02/22/2018. Eye pain was intermittent and in the OS retrobulbar region as well as the left nasal periorbital region. It was a very sharp, pricking sensation. I am an optometrist so I had my associate examine me. She prescribed Valacyclovir 1 gram tid on 02/23/2018 which resolved the eye pain after 24 hours of using the med; however the pain worsened in the interim on 02/24/2018 with maximum pain occurring during the night around 3:00 a.m. It was so painful that the discomfort awakened me. In addition I experienced fatigue, muscle ache, joint edema and pain in my left hand, stomach pain, and nausea for 48 hours immediately following the vaccination.
Age: 2.0
Sex: M
Vaccine: IPV, PNC13
Symptoms: Erythema, Eyelid disorder, Pyrexia, Respiratory tract congestion, Sneezing
Clinical narrative: Fever 102.2 F since 2:45 p.m until now the time of report 9:45 p.m. Sneezing, congestion, heavy eyelids, red cheeks.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling, Mobility decreased, Muscular weakness
Clinical narrative: Soreness and swelling in injection site, then 3-4 days later, muscle pain developed in left arm between elbow and shoulder. Muscle weakness still present. Pain and difficulty when raising my left arm. The act of pulling a top off and over my head almost impossible due to pain. It started as minor and annoying, and today, 2/26/18, is to the point that I can't lift left arm straight up.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified patient of unknown age and gender. The patient's medical history, concomitant medication and drug reactions or allergies were not provided. On30-JAN-2018, an unspecified patient received an expired dose of VARIVAX lot number# M000761, expiration date: 06-JAN-2018 for prophylaxis (dose and route of administration were not provided). No adverse events were reported. Follow-up information was received from the nurse on 15-FEB-2018. This report refers to a 15-month-old female patient. This was first in the series of VARIVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report was received from a physician assistant via company representative refers to a 65 year old female patient. The patient's concurrent conditions were not reported. The patient's historical condition included shingles. The patient's historical drugs, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent. On 10-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose, units, frequency and route not reported) (lot # and expiration date not reported). On an unknown date in 2017, patient developed recurrence of shingles. Reporter explained that, the patient developed shingles, would recover, and then would developed shingles again. Reporter stated that this has happened many times and that if the patient was removed from treatment, the patient develops shingles again. Patient sought medical attention for recurrence of shingles and received treatment. The outcome of the event recurrence of shingles was not reported. The reporter did not provide causal assessment for the event recurrence of shingles. No further adverse event information was provided. No product quality compliant was involved.
Sex: F
Vaccine: PPV
Symptoms: Chills, Cough, Fatigue, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from an 80 year old female patient referring herself. The patient had no pertinent medical history and concomitant medication. The patient's drug reactions/allergies were not reported. On 29-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, lot/batch# and expiration date were not reported) (parenteral) for prevention of pneumococcal disease. On an unknown date in January 2018 (reported as "soon after the vaccination with PNEUMOVAX 23) the patient experienced chills, fever, body aches, tiredness, and cough. The patient contacted her physician and was prescribed with MOTRIN and another unspecified medication, which to date 09-FEB-2018, she hadn't retrieved from the pharmacy. Patient decided to treat herself with unspecified home remedies. No lab diagnostics were performed. The patient sought medical attention and contacted office by phone. At the time of the report, the patient was recovering and only still had the coughing. There was no product quality complaint (PQC) involved. There was no hospitalization involved. The causality assessment was not provided by the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information on patient's pertinent medical history and drug reactions/allergies were not reported. On 08-FEB-2018, the patient was vaccinated with an expired dose of VARIVAX (strength and dose were not reported) (lot # M003440, expiration date: 20-JAN-2018) subcutaneously for prophylaxis. The administered dose of VARIVAX was reconstituted with sterile diluent (lot# and expiry date were not reported). No adverse effects were reported. There was no product quality complaint (PQC) reported.
Age: 23.0
Sex: M
Vaccine: HPV9
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: This spontaneous report was received from a pharmacist (who was also the father of the patient) and refers to a 24 year old male patient. The patient did not have any pertinent medical history, drug reactions or allergies and concomitant therapies. On an unknown date in June 2017 (reported as on an unknown date two months before 21-AUG-2017), the patient was vaccinated with first dose of GARDASIL 9 intramuscular for prevention of Human papilloma virus (HPV) (exact dose, site of the administration, lot# and expiration date were not reported). On 21-AUG-2017, the patient received a second dose of GARDASIL 9 intramuscular for prevention of HPV, lot # M035486, expiration date on 05-JUN-2019 (exact dose and site of the administration were not reported). On an unknown date in February 2018 (reported as about a week ago (prior to 12-FEB-2018)), the patient experienced flu. On an unknown date in February 2018, the patient visited physician where a flu culture was obtained to confirmed that he did have an actual case of the flu. The patient was prescribed TAMIFLU and amoxicillin as a treatment. The patient was scheduled to receive his third dose of GARDASIL 9 on 12-FEB-2018. The outcome of flu was reported as recovered on an unknown date in February 2018. The relatedness between the event of flu and GARDASIL 9 was not reported.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and a female patient of unknown age regarding the patient herself. Her concurrent conditions, concomitant medications, medical history and past drugs, drug allergies/reactions were not reported. On 08-FEB-2018, the patient was vaccinated with expired dose of GARDASIL 9 (dose not reported) (intramuscularly, lot # M007764, expiry date: 30-JAN-2018) for prophylaxis (Expired product administered). No adverse effects were reported. The patient was told on 05-FEB-2018 (reported as "1 week ago") that she would need to be re-vaccinated. On 12-FEB-2018, the patient was informed by the pharmacist that it was ok and she "would not have to be re-vaccinated." The patient wanted a second opinion and enquired whether or not she would need to be re-vaccinated. The patient was referred back to her primary care physician (PCP).
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and a female patient of unknown age regarding the patient herself. Her concurrent conditions, concomitant medications, medical history and past drugs, drug allergies/reactions were not reported. On 08-FEB-2018, the patient was vaccinated with expired dose of GARDASIL 9 (dose not reported) (intramuscularly, lot # M007764, expiry date: 30-JAN-2018) for prophylaxis (Expired product administered). No adverse effects were reported. The patient was told on 05-FEB-2018 (reported as "1 week ago") that she would need to be re-vaccinated. On 12-FEB-2018, the patient was informed by the pharmacist that it was ok and she "would not have to be re-vaccinated." The patient wanted a second opinion and enquired whether or not she would need to be re-vaccinated. The patient was referred back to her primary care physician (PCP).
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medication was provided. On 13-FEB-2018, the patient was vaccinated with a dose of M-M-R II lot # N008365 with expiration date on 13-MAR-2019 intramuscularly (instead of subcutaneously) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a consumer (compliance specialist) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-FEB-2018, the patient was vaccinated with a properly stored expired dose of PROQUAD (lot # M035690, Expiry date : 06-FEB-2018) for prophylaxis (expired product administered). Other suspect therapies included sterile diluent (STERILE DILUENT).  No adverse effects were reported. There was no product quality complaint involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992: US-009507513-1802USA012204: US-009507513-1802USA012205: US-009507513-1802USA012206: US-009507513-1802USA012207: US-009507513-1802USA012208: US-009507513-1802USA012209: US-009507513-1802USA012210: US-009507513-1802USA012211: US-009507513-1802USA012212: US-009507513-1802USA012213: US-009507513-1802USA012214: US-009507513-1802USA012215: US-009507513-1802USA012216: US-009507513-1802USA012217: US-009507513-1802USA012218: US-009507513-1802USA012219: US-009507513-1802USA012220: US-009507513-1802USA012221: US-009507513-1802USA012222: US-009507513-1802USA012223: US-009507513-1802USA012224: US-009507513-1802USA012225: US-009507513-1802USA012226: US-009507513-1802USA012227: US-009507513-1802USA012228: US-009507513-1802USA012229: US-009507513-1802USA012230: US-009507513-1802USA012231: US-009507513-1802USA012232: US-009507513-1802USA012233: US-009507513-1802USA012234: US-009507513-1802USA012235: US-009507513-1802USA012236: US-009507513-1802USA012237: US-009507513-1802USA012238: US-009507513-1802USA012239: US-009507513-1802USA012240: US-009507513-1802USA012241: US-009507513-1802USA012242: US-009507513-1802USA012243: US-009507513-1802USA012244: US-009507513-1802USA012245: US-009507513-1802USA012246: US-009507513-1802USA012247: US-009507513-1802USA012248: US-009507513-1802USA012249: US-009507513-1802USA012250: US-009507513-1802USA012251: US-009507513-1802USA012252: US-009507513-1802USA012253: US-009507513-1802USA012254: US-009507513-1802USA012255: US-009507513-1802USA012256: US-009507513-1802USA012257: US-009507513-1802USA012258: US-009507513-1802USA012259: US-009507513-1802USA012260: US-009507513-1802USA012261: US-009507513-1802USA012262: US-009507513-1802USA012263: US-009507513-1802USA012264: US-009507513-1802USA012265: US-009507513-1802USA012266: US-009507513-1802USA012267: US-009507513-1802USA012268: US-009507513-1802USA012269: US-009507513-1802USA012270: US-009507513-1802USA012271.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified patients of unknown demographics. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapies included sterile diluents. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (Lot # N012619 and expiration date 21-APR-2019), (Lot # N025932 and expiration date 19-SEP-2019) and PROQUAD (Lot # N020618 and expiration date 22-JAN-2019), (Lot# N025923 and expiration date 18-MAR-2019) for prophylaxis. Temperature excursion details were provided. Temperature/Time frame was -14 C to -10 C (-14.3 C) for 1 hour 6 minutes. There were no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. Lot number [N012619 and N025932] has been verified to be a valid lot number for [varicella virus vaccine live (oka/merck)]. Lot number [N020618 and N025923] has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live].
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Patient's concurrent conditions, concomitant medications, medical history and past drugs, drug allergies/reactions were not reported. On 17-JUN-2017, the patient was vaccinated with first dose of GARDASIL 9 lot # M035486 (expiry date: 05-JUN-2019) (dose and route not reported) for prophylaxis. On 13-JUL-2017, the patient received second dose of GARDASIL 9 lot # M035486 (expiry date: 05-JUN-2019) (dose and route not reported) for prophylaxis (inappropriate schedule of drug administration). No adverse events were reported. A product quality complaint (PQC) was not present.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 16-FEB-2018, the patient was inadvertently vaccinated with VARIVAX lot # N025932, expiration date on 19-SEP-2019, subcutaneously, for prophylaxis (strength and dose were not reported) instead of ZOSTAVAX for prophylaxis (strength, dose, route, lot # and expiration date were not reported). No adverse effects were reported in the patient.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 20-FEB-2018, the patient was vaccinated with an expired dose of M-M-R II lot # M031943, expiration date 27-DEC-2017 (dose, route of administration were not reported) for prophylaxis. The vaccine was reconstituted with an expired sterile diluent (MERCK) Lot # L012345, expiration date 23-JAN-2018. There was no adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. Information regarding patient's concomitant medications, pertinent medical history, drug reactions, allergies, concurrent conditions, past therapies were not reported. On 19-FEB-2018, the patient was vaccinated with expired dose of GARDASIL 9 injection, expiry date: 01-FEB-2018 for prophylaxis whose dose, route and frequency were not reported (lot number was reported as unknown). It was reported that GARDASIL 9 did not have any temperature excursions prior to administration. No adverse effects were reported. It was reported that there was no product quality complaint (PQC) involved.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 20-NOV-2017, the patient was vaccinated with the first dose RECOMBIVAX HB for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 20-FEB-2018, the patient would like to receive the second dose of RECOMBIVAX HB.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia, Rash
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was vaccinated by at a physician's office by a nurse with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles, or severe herpes zoster. On or about 25-JAN-2016, the patient was treated by a physician for the onset of a painful rash, which was diagnosed as herpes zoster, or shingles. The patient was prescribed acyclovir and gabapentin for management of her painful symptoms. On or about 04-FEB-2016, subsequent treatment for a follow up on her shingles diagnosis and was prescribed prednisone and continued on gabapentin for management of her painful symptoms. On or about 22-MAR-2016, she had ongoing treatment for her painful blistery strain of shingles. On about 27-JUL-2016, she sought subsequent treatment to follow up on her post-herpetic neuralgia and was prescribed gabapentin for management of her painful symptoms. On or about 27-SEP-2016, she had ongoing treatment for her post-herpetic neuralgia and was prescribed capsaicin topical cream with continued gabapentin. As a direct and proximate result of ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-JAN-2013, the patient was vaccinated at a physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-APR-2016, the patient was treated by at a physician's office for the onset of a rash, which was diagnosed as herpes zoster, or shingles. As a further proximate result of the ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a baby of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with (wistar ra 27-3) M-M-R II (lot # and expiry date not reported) (dosing details were not reported) that was reconstituted with sterile diluent, intramuscularly for prophylaxis. The reporter stated that the vaccine started subcutaneously but the bay was kicking and some of the dose may have been intramuscular (incorrect route of drug administration). No adverse effects reported. No product quality complaint involved.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 17 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PROQUAD subcutaneously, lot # N020617, expiration date 22-JAN-2019, for prophylaxis (Strength, dose and frequency were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-FEB-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N025929 and expiration date on 18-MAR-2019, for prophylaxis (dose, route of administration and anatomical location were not reported). The sterile diluent (MERCK) lot # M017324 and expiration date on 25-SEP-2018, used to reconstitute the vaccine was properly stored. The administered dose of the vaccine experienced a temperature excursion of -14°C to-10°C for 22 minutes as recorded by a data logger, with a previous temperature excursion report in the range between -14°C to -10°C for 22 minutes. There was no adverse effect reported. No product quality complaint was involved. Lot number N025929 has been verified to be a valid lot number for PROQUAD. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA012119.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from an office manager referring to a 12 months old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions was not reported. Concomitant therapies included sterile diluent. 22-FEB-2018, the patient was vaccinated with VARIVAX lot # N024567, expiration date of 07-SEP-2019, for prophylaxis (strength, dose, route and anatomical location were not provided). No adverse events reported. The vaccine was exposed to a temperature range of 39.5°F, during a time frame of 15 hours, which was called by a data logger. No previous temperature excursions were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1802USA012116: US-009507513-1802USA012115.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JUN-2012, the patient received ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of ZOSTAVAX, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient did not have a shingles outbreak until 17-MAR-2017. The outcome of the events is unknown. As a direct result of ZOSTAVAX, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of the condition. Further, as a tragic consequence, the patient suffered severe, serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Shingles outbreak, in addition to chronic pain, rash and lesions to various parts of body were considered to be disabling. Additional information has been requested.