chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Feeling hot, Full blood count normal, Headache, Heart rate increased, Hypertension
Clinical narrative: Got the 2nd Shingrix shot at about 10:30AM today (10/07/19).  Immediately swollen.  Slightly tender.  Have seen this before. Before going to bed, had headache.  Checked reactions to Shingrix vaccine, and swollen, tenderness, redness, headache, muscle pain.  Thought headache could be due to shot.  Went to bed at about 10:30 and woke up at 12:30, feeling very hot and pulse was fast though I should have been relaxed.  Hoping it would go away, but decided to get up and check temp, BP. Temp was 100.5F and my resting pulse was 156 and BP was 141/82.   Went to ER at about 2am, 10/08/19.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling, Myalgia, Tachycardia
Clinical narrative: Got the 2nd Shingrix shot at about 10:30AM today (10/07/19).  Immediately swollen.  Slightly tender.  Have seen this before. Before going to bed, had headache.  Checked reactions to Shingrix vaccine, and swollen, tenderness, redness, headache, muscle pain.  Thought headache could be due to shot.  Went to bed at about 10:30 and woke up at 12:30, feeling very hot and pulse was fast though I should have been relaxed.  Hoping it would go away, but decided to get up and check temp, BP. Temp was 100.5F and my resting pulse was 156 and BP was 141/82.   Went to ER at about 2am, 10/08/19.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Vaccination complication
Clinical narrative: Got the 2nd Shingrix shot at about 10:30AM today (10/07/19).  Immediately swollen.  Slightly tender.  Have seen this before. Before going to bed, had headache.  Checked reactions to Shingrix vaccine, and swollen, tenderness, redness, headache, muscle pain.  Thought headache could be due to shot.  Went to bed at about 10:30 and woke up at 12:30, feeling very hot and pulse was fast though I should have been relaxed.  Hoping it would go away, but decided to get up and check temp, BP. Temp was 100.5F and my resting pulse was 156 and BP was 141/82.   Went to ER at about 2am, 10/08/19.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Started vomiting within an hour....with no warning followed by uncontrollable diahrea over a few hours.  Contacted doc office at 4:45 PM; I was told that nurse may not call me back until next day.  Got a nurse to call back about 6 PM who thought my symptoms were 24 stomach virus or flu; no mention was made of allergic reaction to the shot....or possibly nurse wearing possible latex gloves.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Headache Fever - 105.2 Lightheaded/dizzy Rapid heartrate Short of breath All joints in the body extremely painful Rash and lump the size of the baseball at the injection site Small rash on neck and chest Symptoms lasted until Saturday 1/18/2020 noon except injection site reaction and rash on neck and chest
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site rash, Pyrexia, Rash
Clinical narrative: Headache Fever - 105.2 Lightheaded/dizzy Rapid heartrate Short of breath All joints in the body extremely painful Rash and lump the size of the baseball at the injection site Small rash on neck and chest Symptoms lasted until Saturday 1/18/2020 noon except injection site reaction and rash on neck and chest
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Discomfort, Hypotonia, Injection site erythema, Injection site swelling
Clinical narrative: Significant swelling/redness as far as 15cm from site of injection; limp; discomfort.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Blood culture negative, Chest X-ray normal, Fatigue, Headache, Influenza virus test negative
Clinical narrative: fever of 105 starting on 12/7/19, hives several days later; headache, fatigue
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Mononucleosis heterophile test negative, Pyrexia, Streptococcus test negative, Urticaria, Viral test positive
Clinical narrative: fever of 105 starting on 12/7/19, hives several days later; headache, fatigue
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: White blood cells urine positive
Clinical narrative: fever of 105 starting on 12/7/19, hives several days later; headache, fatigue
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: A week after I was given the second dose of Shingrix, I developed a full blown and sever case of shingles.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, Foetal disorder, Ultrasound antenatal screen abnormal
Clinical narrative: Pregnant at the time the flu shot was administered (9 weeks) and baby stopped developing at 9 weeks, 1 day (showed on ultrasound at 12 week appointment). Would be due 05/31/2020.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Loss of personal independence in daily activities, Product administered at inappropriate site
Clinical narrative: Pain in left shoulder since date of injection. Injection was administered too high on the shoulder. I have experienced almost constant pain while trying to do most normal activities, such as driving, dressing & undressing , house work, exercising, sleeping, etc.  Nothing helps to relieve the pain, except for not moving at all, which is impossible.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: patient noted redness of entire upper arm at area of injection then started spreading to the other arm after sometime. Then it spread to the chest area and small area of the  leg.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Feeling cold, Headache, Injection site erythema, Injection site pain
Clinical narrative: Swollen muscles upper left arm, skin red on upper left arm, very painful to touch or to extend arm at elbow. Light headed with headache. Had an episode of being very cold and unable to get warm, lasted 1-2 hours. No temperature. Symptoms slowly abated over 3 days.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Muscle swelling, Pain
Clinical narrative: Swollen muscles upper left arm, skin red on upper left arm, very painful to touch or to extend arm at elbow. Light headed with headache. Had an episode of being very cold and unable to get warm, lasted 1-2 hours. No temperature. Symptoms slowly abated over 3 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Injection site pain, Pain in extremity
Clinical narrative: Pain at site, shivering, chills, burning, fever 101, headache, weakness. Fever gone by morning; other side effects gone by evening, other than arm still sore. I did not seek medical treatment.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain at site, shivering, chills, burning, fever 101, headache, weakness. Fever gone by morning; other side effects gone by evening, other than arm still sore. I did not seek medical treatment.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Headache, Pain, Peripheral swelling
Clinical narrative: My arm became swollen, tender and red with hours of vaccine.  Stayed red for 5 days. I had a low grade fever for 2 days. I had a horrible headache for 4 days, backache and body aches for 2 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tenderness
Clinical narrative: My arm became swollen, tender and red with hours of vaccine.  Stayed red for 5 days. I had a low grade fever for 2 days. I had a horrible headache for 4 days, backache and body aches for 2 days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Ear congestion, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: I woke up during the night, after the shot was administered with chills, fever of 101 F, achy muscles, stuffy head and ears. There was swelling and soreness at the site of injection the first day, and I was very tired for 2 days, improving on the 2nd day, and feeling normal on the 3rd day. With my 1st Shingrix vaccination, of 11/6/2019, I only had the soreness and swelling at the site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nasal congestion, Pyrexia
Clinical narrative: I woke up during the night, after the shot was administered with chills, fever of 101 F, achy muscles, stuffy head and ears. There was swelling and soreness at the site of injection the first day, and I was very tired for 2 days, improving on the 2nd day, and feeling normal on the 3rd day. With my 1st Shingrix vaccination, of 11/6/2019, I only had the soreness and swelling at the site.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Cellulitis of the left arm. Given cefdinir suspension 250mg/5ml once a day for 10 days
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Muscle atrophy
Clinical narrative: Pain experienced during vaccination.  In days, weeks and months that followed, inflammation, chronic pain and restricted mobility. Sought medical attention after four weeks.  It is believed that the vaccination was injected into my sub delta bursa sac instead of my upper deltoid muscle.  During November, December and continuing through January (and possibly beyond) ultra sound and cupping to reduce inflammation.  Physical therapy to regain mobility. Addition physical therapy to rebuild strength in arm, neck and shoulder muscles that had atrophied. Unable to perform normal daily activities.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Product administered at inappropriate site, Therapeutic procedure, Ultrasound scan
Clinical narrative: Pain experienced during vaccination.  In days, weeks and months that followed, inflammation, chronic pain and restricted mobility. Sought medical attention after four weeks.  It is believed that the vaccination was injected into my sub delta bursa sac instead of my upper deltoid muscle.  During November, December and continuing through January (and possibly beyond) ultra sound and cupping to reduce inflammation.  Physical therapy to regain mobility. Addition physical therapy to rebuild strength in arm, neck and shoulder muscles that had atrophied. Unable to perform normal daily activities.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Herpes zoster
Clinical narrative: Vaccine administered on 8/19/2019. Shingles diagnosis 9/6/2019
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Influenza like illness, Injection site pain
Clinical narrative: Flu-like symptoms: Fever, chills, aches, fatigue, stomach issues including nausea    Day 1 - severe      Day 2 - symptoms present but lessened    Day 3 - most symptoms resolved except stomach discomfort.  Still nagging.       Just to note this is the same reaction I had after initial vaccination in November, 2019 at the same pharmacy.  At the time I held open the possibility I'd acquired a virus coincidentally at the same time.  The reaction was the same to both vaccinations with the same duration.   There was soreness at the injection site as anticipated both times.  That was not a problem.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Flu-like symptoms: Fever, chills, aches, fatigue, stomach issues including nausea    Day 1 - severe      Day 2 - symptoms present but lessened    Day 3 - most symptoms resolved except stomach discomfort.  Still nagging.       Just to note this is the same reaction I had after initial vaccination in November, 2019 at the same pharmacy.  At the time I held open the possibility I'd acquired a virus coincidentally at the same time.  The reaction was the same to both vaccinations with the same duration.   There was soreness at the injection site as anticipated both times.  That was not a problem.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: A few hours after injection  patient reported she noticed some itching and a small lump around injection site.  Later that evening there was also some redness around the area.  The next day patient the lump had disappeared and the redness/heat had moved down and around the back of the arm .  The patient contacted her physician and he determined a local reaction to injection but gave patient a prescription for cephalexin (in case of cellulitis with instructions to only take if redness worsened).  Physician also instructed patient to take acetaminophen and use ice as needed.  Patient followed up with pharmacy two days later to report that heat had disappeared the redness was improved but had moved to front of arm in between injection site and elbow.  Patient stated she had not taken the antibiotics and would continue with acetaminophen as needed.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms
Clinical narrative: Patient stated he was getting muscle spasms in the neck and back after the flu shot.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Excessive swelling from top of shoulder to right above elbow. Affected shoulder/upper arm area is about twice as big as non-vaccinated arm/shoulder. Affected arm has a large, hard, and hot red mark extending the width of upper arm. The mark extends to downward and stops right above his elbow measuring approximately 6 inches long. Fever began approximately 2:00 on 1/19/2020 of 101.4.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Injection site pain, Pain
Clinical narrative: patient called following morning, stating the night following her shot she started getting freezing chills, body aches, and had a 102 temperature.  it started a few hours after the shot when she felt warmer than usual at work. also some pain at the injection site
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Injection site erythema, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: I experienced uncomfortable stomach pain within the first hour of receiving the shot (intramuscular, right hip).  Within 3 hours I was experiencing sharp knifing pain in my lower intestines and this lasted approximately 12 hours after receiving the shot.  Within 24 hours the injection site was swollen and red over an area of 2"x5".  The swelling and redness lasted 6 days.  Approximately 8 days after the injection, I noticed pain and swelling in the inguinal (groin) lymph nodes near the injection site.  It is now 12 days after the injection and the lymph nodes are still painful and swollen (the width and breadth of the swelling approximates the size of an adult thumb), to the point that I cannot sleep on my right side at night.  I called my doctor but her clinic is an hour's drive away and I will not schedule an appointment unless the condition continues to persist.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: I experienced uncomfortable stomach pain within the first hour of receiving the shot (intramuscular, right hip).  Within 3 hours I was experiencing sharp knifing pain in my lower intestines and this lasted approximately 12 hours after receiving the shot.  Within 24 hours the injection site was swollen and red over an area of 2"x5".  The swelling and redness lasted 6 days.  Approximately 8 days after the injection, I noticed pain and swelling in the inguinal (groin) lymph nodes near the injection site.  It is now 12 days after the injection and the lymph nodes are still painful and swollen (the width and breadth of the swelling approximates the size of an adult thumb), to the point that I cannot sleep on my right side at night.  I called my doctor but her clinic is an hour's drive away and I will not schedule an appointment unless the condition continues to persist.
Age: 17.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Chemotherapy, Hodgkin's disease, Pneumonia, Vaccination complication
Clinical narrative: measles vaccine associated pneumonia in pt. with Hodgkins lymphoma treated with chemotherapy.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Respiratory tract congestion
Clinical narrative: Reaction lasted more than 3 days, progressed to chest congestion on fifth day
Age: 8.0
Sex: M
Vaccine: UNK
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Pain, Peripheral swelling
Clinical narrative: Swelling of upper arm, redness in a demarcated band 5 inches wide around entire circumference of arm below injection site and 1 inch above,  severe pain and tenderness including underside of arm near armpit, pain when raising arm, bruising
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: Swollen lips, itching  on upper arms/back, hives on back of thighs. Began day after immunization. Happens irregularly but pretty much every day. Spoke with pharmacist who recommended taking OTC Benadryl, which seems to alleviate  symptoms  for 12 -24 hours. Still occurring today (01/19/2020).
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt states he has been unable lift arm more than 90' due to pain that still remains in shoulder of arm where shot was given. It remains 3-4 weeks after vaccine w/slight improvement. Had seen doctor. Doctor also gave him flu shot, in other arm, and the same thing is happening in that arm, too. Pt told to watch and wait.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Influenza like illness, Nasopharyngitis, Pain
Clinical narrative: Patient Received 2 Shingrix vaccines. Had same Reaction with both vaccines. Which included Flu-like symptoms- chills, cold, weakness, body aches
Age: 20.0
Sex: M
Vaccine: HEPAB, HPV9, MENB
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: dizziness; fall; loss of consciousness; This report was identified from a line listing obtained on request by the Company from the Food and Drug Administration under the Act and refers to a 20-year-old male patient. The patient's current illnesses, medical history and concomitant medications were not reported.  On 21-APR-2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the right arm, lot# N014464, expiration date: 19-DEC-2019, first dose of hepatitis a virus vaccine inactivated, hepatitis b virus vaccine rhbsag (yeast) (TWINRIX) and the second dose of meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) (indication, dose, route of administration, anatomical location, lot/batch # and expiration date from both vaccines were not provided). The patient received vaccines and then, approximately five minutes later, he reported feeling lightheaded (dizziness). He sat down on a bench and then lost consciousness and slid off bench onto the floor (fall). He regained consciousness almost immediately. He remained in the pharmacy for another 15 minutes eating an orange and a protein bar. He also took sips of water. He reported feeling okay and felt comfortable leaving the pharmacy. The patient was called 5 hours later in the evening and he reported feeling fine since leaving.  The outcome of the events was reported as recovered on 21-APR-2018. The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), hepatitis a virus vaccine inactivated, hepatitis b virus vaccine rhbsag (yeast) (TWINRIX) and meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) was not provided.  Upon internal review, the event of loss of consciousness was considered to be medically significant.  Follow up information was from the agency on 29-OCT-2019.   It was confirmed that the primary reporter was a health care professional. The patient was a male. The time of vaccination was on 21-APR-2018 at 11:15 and the first adverse event of dizziness started at 11:20.  Follow up information was received on 17-JAN-2020. On 17-JAN-2020, a phone call was placed to the a reporting health care professional but he was not available. The phone call was answered by pharmacy technician. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Canalith repositioning procedure, Computerised tomogram, Deafness unilateral, Electroencephalogram
Clinical narrative: and barely able to stand or walk /unable to walk without assistance; Unable to stand; dizziness; no hearing/ hearing loss in my left ear; went from totally independent to being a burden; She and I were both in bed for holiday; This case was reported by a nurse and described the occurrence of hearing loss unilateral in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received Merck's version of the shingles vaccine only to find out it did not measure up).   On 26th November 2019, the patient received Shingrix. On 28th November 2019, 2 days after receiving Shingrix, the patient experienced bedridden. On 26th December 2019, the patient experienced hearing loss unilateral (serious criteria hospitalization and GSK medically significant). On 27th December 2019, the patient experienced unable to walk (serious criteria hospitalization), difficulty in standing (serious criteria hospitalization), dizziness (serious criteria hospitalization) and loss of personal independence in daily activities. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the hearing loss unilateral, unable to walk and loss of personal independence in daily activities were not recovered/not resolved and the outcome of the difficulty in standing, dizziness and bedridden were unknown.   The reporter considered the hearing loss unilateral to be related to Shingrix. It was unknown if the reporter considered the unable to walk, difficulty in standing, dizziness, bedridden and loss of personal independence in daily activities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Two days before holiday 2019 the patient was vaccinated with no idea of how bad it would become. The patient was in bed for holiday.  On 26th December 2019, a month later the patient woke up with complete hearing loss in his left ear. On 27th December 2019 evening, 31 days after vaccination the patient was with no hearing and barely able to stand or walk due to dizziness.  The patient was hospitalized from 27th December 2019 till 29th December 2019. The patient was unable to walk without assistance, drive, and have went from totally independent to being a burden. The patient underwent all kinds of tests from CT,MRI, EEG to blood tests for legionaires to lymes. The patient stated he looked as best he could while head spinning on computer and literally hundreds of incidents involving shingrix and hearing loss. The patient inquired was he was not given any information that Shingrix could be involved in hearing loss. The patient had steroid injections into middle ear as a last resort. This case is linked to case US2020AMR007057 reported by the same reporter for different patient.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Magnetic resonance imaging
Clinical narrative: and barely able to stand or walk /unable to walk without assistance; Unable to stand; dizziness; no hearing/ hearing loss in my left ear; went from totally independent to being a burden; She and I were both in bed for holiday; This case was reported by a nurse and described the occurrence of hearing loss unilateral in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received Merck's version of the shingles vaccine only to find out it did not measure up).   On 26th November 2019, the patient received Shingrix. On 28th November 2019, 2 days after receiving Shingrix, the patient experienced bedridden. On 26th December 2019, the patient experienced hearing loss unilateral (serious criteria hospitalization and GSK medically significant). On 27th December 2019, the patient experienced unable to walk (serious criteria hospitalization), difficulty in standing (serious criteria hospitalization), dizziness (serious criteria hospitalization) and loss of personal independence in daily activities. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the hearing loss unilateral, unable to walk and loss of personal independence in daily activities were not recovered/not resolved and the outcome of the difficulty in standing, dizziness and bedridden were unknown.   The reporter considered the hearing loss unilateral to be related to Shingrix. It was unknown if the reporter considered the unable to walk, difficulty in standing, dizziness, bedridden and loss of personal independence in daily activities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Two days before holiday 2019 the patient was vaccinated with no idea of how bad it would become. The patient was in bed for holiday.  On 26th December 2019, a month later the patient woke up with complete hearing loss in his left ear. On 27th December 2019 evening, 31 days after vaccination the patient was with no hearing and barely able to stand or walk due to dizziness.  The patient was hospitalized from 27th December 2019 till 29th December 2019. The patient was unable to walk without assistance, drive, and have went from totally independent to being a burden. The patient underwent all kinds of tests from CT,MRI, EEG to blood tests for legionaires to lymes. The patient stated he looked as best he could while head spinning on computer and literally hundreds of incidents involving shingrix and hearing loss. The patient inquired was he was not given any information that Shingrix could be involved in hearing loss. The patient had steroid injections into middle ear as a last resort. This case is linked to case US2020AMR007057 reported by the same reporter for different patient.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Blood test, Borrelia test, Computerised tomogram, Deafness unilateral
Clinical narrative: and barely able to stand or walk /unable to walk without assistance; Unable to stand; dizziness; no hearing/ hearing loss in my left ear; went from totally independent to being a burden; She and I were both in bed for holiday; This case was reported by a nurse and described the occurrence of hearing loss unilateral in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received Merck's version of the shingles vaccine only to find out it did not measure up).   On 26th November 2019, the patient received Shingrix. On 28th November 2019, 2 days after receiving Shingrix, the patient experienced bedridden. On 26th December 2019, the patient experienced hearing loss unilateral (serious criteria hospitalization and GSK medically significant). On 27th December 2019, the patient experienced unable to walk (serious criteria hospitalization), difficulty in standing (serious criteria hospitalization), dizziness (serious criteria hospitalization) and loss of personal independence in daily activities. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the hearing loss unilateral, unable to walk and loss of personal independence in daily activities were not recovered/not resolved and the outcome of the difficulty in standing, dizziness and bedridden were unknown.   The reporter considered the hearing loss unilateral to be related to Shingrix. It was unknown if the reporter considered the unable to walk, difficulty in standing, dizziness, bedridden and loss of personal independence in daily activities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Two days before holiday 2019 the patient was vaccinated with no idea of how bad it would become. The patient was in bed for holiday.  On 26th December 2019, a month later the patient woke up with complete hearing loss in his left ear. On 27th December 2019 evening, 31 days after vaccination the patient was with no hearing and barely able to stand or walk due to dizziness.  The patient was hospitalized from 27th December 2019 till 29th December 2019. The patient was unable to walk without assistance, drive, and have went from totally independent to being a burden. The patient underwent all kinds of tests from CT,MRI, EEG to blood tests for legionaires to lymes. The patient stated he looked as best he could while head spinning on computer and literally hundreds of incidents involving shingrix and hearing loss. The patient inquired was he was not given any information that Shingrix could be involved in hearing loss. The patient had steroid injections into middle ear as a last resort. This case is linked to case US2020AMR007057 reported by the same reporter for different patient.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Dysstasia, Electroencephalogram, Gait inability, Impaired driving ability
Clinical narrative: and barely able to stand or walk /unable to walk without assistance; Unable to stand; dizziness; no hearing/ hearing loss in my left ear; went from totally independent to being a burden; She and I were both in bed for holiday; This case was reported by a nurse and described the occurrence of hearing loss unilateral in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received Merck's version of the shingles vaccine only to find out it did not measure up).   On 26th November 2019, the patient received Shingrix. On 28th November 2019, 2 days after receiving Shingrix, the patient experienced bedridden. On 26th December 2019, the patient experienced hearing loss unilateral (serious criteria hospitalization and GSK medically significant). On 27th December 2019, the patient experienced unable to walk (serious criteria hospitalization), difficulty in standing (serious criteria hospitalization), dizziness (serious criteria hospitalization) and loss of personal independence in daily activities. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the hearing loss unilateral, unable to walk and loss of personal independence in daily activities were not recovered/not resolved and the outcome of the difficulty in standing, dizziness and bedridden were unknown.   The reporter considered the hearing loss unilateral to be related to Shingrix. It was unknown if the reporter considered the unable to walk, difficulty in standing, dizziness, bedridden and loss of personal independence in daily activities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Two days before holiday 2019 the patient was vaccinated with no idea of how bad it would become. The patient was in bed for holiday.  On 26th December 2019, a month later the patient woke up with complete hearing loss in his left ear. On 27th December 2019 evening, 31 days after vaccination the patient was with no hearing and barely able to stand or walk due to dizziness.  The patient was hospitalized from 27th December 2019 till 29th December 2019. The patient was unable to walk without assistance, drive, and have went from totally independent to being a burden. The patient underwent all kinds of tests from CT,MRI, EEG to blood tests for legionaires to lymes. The patient stated he looked as best he could while head spinning on computer and literally hundreds of incidents involving shingrix and hearing loss. The patient inquired was he was not given any information that Shingrix could be involved in hearing loss. The patient had steroid injections into middle ear as a last resort. This case is linked to case US2020AMR007057 reported by the same reporter for different patient.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Legionella test, Loss of personal independence in daily activities, Magnetic resonance imaging, Vertigo
Clinical narrative: and barely able to stand or walk /unable to walk without assistance; Unable to stand; dizziness; no hearing/ hearing loss in my left ear; went from totally independent to being a burden; She and I were both in bed for holiday; This case was reported by a nurse and described the occurrence of hearing loss unilateral in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received Merck's version of the shingles vaccine only to find out it did not measure up).   On 26th November 2019, the patient received Shingrix. On 28th November 2019, 2 days after receiving Shingrix, the patient experienced bedridden. On 26th December 2019, the patient experienced hearing loss unilateral (serious criteria hospitalization and GSK medically significant). On 27th December 2019, the patient experienced unable to walk (serious criteria hospitalization), difficulty in standing (serious criteria hospitalization), dizziness (serious criteria hospitalization) and loss of personal independence in daily activities. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the hearing loss unilateral, unable to walk and loss of personal independence in daily activities were not recovered/not resolved and the outcome of the difficulty in standing, dizziness and bedridden were unknown.   The reporter considered the hearing loss unilateral to be related to Shingrix. It was unknown if the reporter considered the unable to walk, difficulty in standing, dizziness, bedridden and loss of personal independence in daily activities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Two days before holiday 2019 the patient was vaccinated with no idea of how bad it would become. The patient was in bed for holiday.  On 26th December 2019, a month later the patient woke up with complete hearing loss in his left ear. On 27th December 2019 evening, 31 days after vaccination the patient was with no hearing and barely able to stand or walk due to dizziness.  The patient was hospitalized from 27th December 2019 till 29th December 2019. The patient was unable to walk without assistance, drive, and have went from totally independent to being a burden. The patient underwent all kinds of tests from CT,MRI, EEG to blood tests for legionaires to lymes. The patient stated he looked as best he could while head spinning on computer and literally hundreds of incidents involving shingrix and hearing loss. The patient inquired was he was not given any information that Shingrix could be involved in hearing loss. The patient had steroid injections into middle ear as a last resort. This case is linked to case US2020AMR007057 reported by the same reporter for different patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever 99.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported; Patient received second dose in PEDVAXHIN immunization series that was improperly stored. Temperature 15C. Time frame: 2 hours 56 minutes. Previous temperature excursion? Y. 10 C 1 hour 1 minute and 12.5 C 1 hour 22 minutes.; This spontaneous report as received from a other health professional refers to a patient of unknown age. On 15-JAN-2020, the patient was vaccinated with  improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot# S000355 has been verified to be a valid lot number, expiration date 10-OCT-2021) (second dose) for prophylaxis. On 15-JAN-2020, the vaccine was improperly stored temperature 15 Celsius degree (C), time frame 2 hours 56 minutes, previously there were temperature excursion: 10 C for 1 hour 1 minute and 12.5C for 1 hour 22 minutes. No symptoms reported.  Digital data logger was involved.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: doses of improperly stored MMR II were administered to 9 patients on  unspecified dates; No additional adverse symptoms reported; This spontaneous report has been received from an officer manager, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and, previous drugs reactions or allergies were not provided by the reporter.  On an unknown date, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (therapy type: Digital Data Logger), lot number S006051, and expiration date 27-FEB-2021 for prophylaxis. Details about strength, dose, dose number, route of administration, and anatomical location were not provided. It was unknown if the sterile diluent (DILUENT MRK) (lot number and expiration date were unknown by the reporter) used for reconstitution of the vaccine, was stored at proper temperature.  The highest temperature was above 47 degree Fahrenheit (°F) (53 F), for a timeframe of 17 hours, with no previous temperature excursion. The call was due to the digital data logger.  No additional adverse symptoms were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA005522: US-009507513-2001USA005523: US-009507513-2001USA005524: US-009507513-2001USA005525: US-009507513-2001USA005520: US-009507513-2001USA005519: US-009507513-2001USA005518: US-009507513-2001USA005521:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: doses of improperly stored MMR II were administered to 9 patients on  unspecified dates; No additional adverse symptoms reported; This spontaneous report has been received from an officer manager, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications or previous drugs reactions or allergies were not provided by the reporter.  On an unknown date, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (therapy type: Digital Data Logger), lot number S006051, and expiration date 27-FEB-2021 for prophylaxis. Details about strength, dose, dose number, route of administration, and anatomical location were not provided. Other suspected therapy included the sterile diluent (DILUENT MRK) (lot number and expiration date were unknown by the reporter) used for reconstitution of the vaccine, since it was unknown if it was stored at proper temperature.  The highest temperature was above 47 degree Fahrenheit (°F) (53 F), for a timeframe of 17 hours, with no previous temperature excursion. The call was due to the digital data logger.  No additional adverse symptoms were reported.  This case is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2001USA005521: US-009507513-2001USA005522: US-009507513-2001USA005523: US-009507513-2001USA005524: US-009507513-2001USA005525: US-009507513-2001USA005519: US-009507513-2001USA005516: US-009507513-2001USA005520:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient did not experience any symptoms. No additional AE information was provided.; inadvertently administered one dose of expired VAQTA; This spontaneous report was received from a nurse via a company representative referring to a 12 months old patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.   On 13-JAN-2020, the patient was inadvertently administered one dose of expired hepatitis a vaccine, inactivated (VAQTA)(strength: 25/0.5, lot # R035227, expiration date 01-JAN-2020) (route was not reported) for prophylaxis. The patient did not experience any symptoms. No additional AE information was provided.
Age: 0.5
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; 6 month old patient was inadvertently administered Pneumovax23; This spontaneous report was received from a nurse referring to a 6-month-old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy details were not reported.  On 14-JAN-2020, the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength was not reported) lot # S029265, expiry date: 31-MAR-2021) as prophylaxis (product administered to patient of inappropriate age). No adverse event was reported. No product quality complaint was reported.
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: Got a little sick; Information has been received regarding a case in litigation for zoster vaccine live (ZOSTAVAX) (number US-009507513-1908USA001036) from a lawyer who provided Plaintiff Fact Sheet concerning a female patient of an unknown age. The pt had never smoked. The patient's concurrent conditions included therapy with chiropractor, fibromyalgia, diabetes, herpes zoster keratoconjunctivitis, unspecified tear film insufficiency, depression, anxiety, insomnia, nerve pain, pain, high cholesterol, osteoporosis, dry eye syndrome secondary, shingles and allergies. The patient's historical conditions included chicken pox (1958), back surgery (2005 and 2016) and neck surgery (2016). The patient's concomitant therapies included pregabalin (LYRICA), promethazine, azelastine hydrochloride, acetaminophen (TYLENOL), eszopiclone, pregabalin, celecoxib and valacyclovir hydrochloride.  On an unknown date in 2018, the patient was vaccinated with a dose of pneumonia vaccine (manufacturer unknown) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) administered by a physician.  On an unknown date, the patient got a little sick. The outcome of the events was unknown. The causality assessment was not provided.  This is one of two reports concerning the same patient.; Sender's Comments:  US-009507513-1908USA001036:
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a patient who is 14 years old was administered a dose of PROQUAD; No adverse effects reported; This spontaneous report was received from a nurse and refers to a 14 year old patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On an unknown date in December 2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (product administered to patient of inappropriate age) lot # S008571 and expiration date 16-SEP-2020, for prophylaxis (dose, strength, route of administration and frequency were unknown).         No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Iritis, Neuralgia, Neuritis, Pain
Clinical narrative: vitreous hemorrhage; iritis in her eyes; neuritis; neuralgia; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported.   On or around 10-JAN-2017 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).         On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered sudden and severe vision loss and was diagnosed with vitreous hemorrhage and iritis in her eyes. The patient also suffered from burning pain and itching sensation on left side of her chest and radiated around to the side of her back resulting in a diagnosis of neuritis and neuralgia most likely viral related. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using Merck's product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of  zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Merck's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all the events was reported as not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).The reporter considered the events to be serious due to disability.  Upon internal review, the event vitreous hemorrhage was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Vitreous haemorrhage
Clinical narrative: vitreous hemorrhage; iritis in her eyes; neuritis; neuralgia; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported.   On or around 10-JAN-2017 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).         On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered sudden and severe vision loss and was diagnosed with vitreous hemorrhage and iritis in her eyes. The patient also suffered from burning pain and itching sensation on left side of her chest and radiated around to the side of her back resulting in a diagnosis of neuritis and neuralgia most likely viral related. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using Merck's product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of  zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Merck's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all the events was reported as not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).The reporter considered the events to be serious due to disability.  Upon internal review, the event vitreous hemorrhage was determined to be medically significant.