chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Fatigue, Feeling hot, Headache, Injected limb mobility decreased
Clinical narrative: I started out with soreness in my left arm late in the afternoon on Sunday (12/1).  By bedtime, I had trouble lifting my arm up.  I also had headaches and was very tired.  By Monday, I woke up (after 8 hours of sleep) totally exhausted and my arm was still painful but I didn't actually pay attention to the area where I received the shot.   By mid-day Monday, I was having chills and felt like I had a fever.  I was at work and didn't have a thermometer but took an Advil.  I went home by 3:00, totally achy, with off and on chills and my arm was hurting even more than the day before.  I slept for about 2.5 hours.  I took my temperature when I got up, which was 99.5.  I got up and had dinner and went to bed around 10:30 taking a Tylenol PM before going to bed.  I stayed home today (Tuesday) as I had off and on chills and achyness all over.  When I hopped into the shower at 11:00, I noticed that my left arm where I received the injections was seriously swollen, hot and a large rash developed with a red rash line that went down my arm.  I went to a Clinic to see what was going on and was prescribed Clindamycin (300MG)  Separately, my wife had sent photos of my arm to a friend who is a doctor of infectious diseases   as well as my physician, Dr.  Both pointed me to an article which pointed out that all of the symptoms I was experiencing was an infrequent reaction to the PS23 vaccine and I should NOT take the antibiotic (Clindamycin).  I only took 1 pill and have stopped treatment.
Age: 62.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site rash, Injection site streaking, Injection site swelling, Injection site warmth, Pain
Clinical narrative: I started out with soreness in my left arm late in the afternoon on Sunday (12/1).  By bedtime, I had trouble lifting my arm up.  I also had headaches and was very tired.  By Monday, I woke up (after 8 hours of sleep) totally exhausted and my arm was still painful but I didn't actually pay attention to the area where I received the shot.   By mid-day Monday, I was having chills and felt like I had a fever.  I was at work and didn't have a thermometer but took an Advil.  I went home by 3:00, totally achy, with off and on chills and my arm was hurting even more than the day before.  I slept for about 2.5 hours.  I took my temperature when I got up, which was 99.5.  I got up and had dinner and went to bed around 10:30 taking a Tylenol PM before going to bed.  I stayed home today (Tuesday) as I had off and on chills and achyness all over.  When I hopped into the shower at 11:00, I noticed that my left arm where I received the injections was seriously swollen, hot and a large rash developed with a red rash line that went down my arm.  I went to a Clinic to see what was going on and was prescribed Clindamycin (300MG)  Separately, my wife had sent photos of my arm to a friend who is a doctor of infectious diseases   as well as my physician, Dr.  Both pointed me to an article which pointed out that all of the symptoms I was experiencing was an infrequent reaction to the PS23 vaccine and I should NOT take the antibiotic (Clindamycin).  I only took 1 pill and have stopped treatment.
Age: 62.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain in extremity
Clinical narrative: I started out with soreness in my left arm late in the afternoon on Sunday (12/1).  By bedtime, I had trouble lifting my arm up.  I also had headaches and was very tired.  By Monday, I woke up (after 8 hours of sleep) totally exhausted and my arm was still painful but I didn't actually pay attention to the area where I received the shot.   By mid-day Monday, I was having chills and felt like I had a fever.  I was at work and didn't have a thermometer but took an Advil.  I went home by 3:00, totally achy, with off and on chills and my arm was hurting even more than the day before.  I slept for about 2.5 hours.  I took my temperature when I got up, which was 99.5.  I got up and had dinner and went to bed around 10:30 taking a Tylenol PM before going to bed.  I stayed home today (Tuesday) as I had off and on chills and achyness all over.  When I hopped into the shower at 11:00, I noticed that my left arm where I received the injections was seriously swollen, hot and a large rash developed with a red rash line that went down my arm.  I went to a Clinic to see what was going on and was prescribed Clindamycin (300MG)  Separately, my wife had sent photos of my arm to a friend who is a doctor of infectious diseases   as well as my physician, Dr.  Both pointed me to an article which pointed out that all of the symptoms I was experiencing was an infrequent reaction to the PS23 vaccine and I should NOT take the antibiotic (Clindamycin).  I only took 1 pill and have stopped treatment.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient states developed pain and soreness on day of injection 10/23/19. Arm continued to be sore and was still sore when he had well visit with this MD around 11/13/19---md advised that it should resolve itself. As of 12/3/19 patient still experiencing pain and soreness in his arm and he notified the pharmacy for the first time on 12/3/19. Patient advised by Pharmacist  to follow back up with MD for further evaluation and that I would submit a VAERS form
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Condition aggravated, Headache, Immediate post-injection reaction
Clinical narrative: Arm was sore right away.  By the evening, about 7 hours later, neck and head started hurting. Patient drank glass of water and went to bed later.   The next day, patient was very sore; everything was sore including tips of fingers, tips of toes, every muscle and every joint. Patient has never been sore to that degree even when had the flu.   Patient tried to stay hydrated and patient does not take pain medication but had to take aspirin.  Patient reports that even rolling in bed was painful.  Patient did not contact doctor or pharmacist.   Per patient, it took about 3 days to feel like had some energy and move around.  The site of injection was 3 inches wide now it looks like a bruise that is fading.  Pain on wrists going back to normal.   Recovery at 90% or more.  Psoriasis is forming in places that did not have them beforelike on forehead. Patient received Flu shot 5-6 weeks prior and 1st dose of shingles in August.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Myalgia, Neck pain, Pain, Pain in extremity
Clinical narrative: Arm was sore right away.  By the evening, about 7 hours later, neck and head started hurting. Patient drank glass of water and went to bed later.   The next day, patient was very sore; everything was sore including tips of fingers, tips of toes, every muscle and every joint. Patient has never been sore to that degree even when had the flu.   Patient tried to stay hydrated and patient does not take pain medication but had to take aspirin.  Patient reports that even rolling in bed was painful.  Patient did not contact doctor or pharmacist.   Per patient, it took about 3 days to feel like had some energy and move around.  The site of injection was 3 inches wide now it looks like a bruise that is fading.  Pain on wrists going back to normal.   Recovery at 90% or more.  Psoriasis is forming in places that did not have them beforelike on forehead. Patient received Flu shot 5-6 weeks prior and 1st dose of shingles in August.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Psoriasis
Clinical narrative: Arm was sore right away.  By the evening, about 7 hours later, neck and head started hurting. Patient drank glass of water and went to bed later.   The next day, patient was very sore; everything was sore including tips of fingers, tips of toes, every muscle and every joint. Patient has never been sore to that degree even when had the flu.   Patient tried to stay hydrated and patient does not take pain medication but had to take aspirin.  Patient reports that even rolling in bed was painful.  Patient did not contact doctor or pharmacist.   Per patient, it took about 3 days to feel like had some energy and move around.  The site of injection was 3 inches wide now it looks like a bruise that is fading.  Pain on wrists going back to normal.   Recovery at 90% or more.  Psoriasis is forming in places that did not have them beforelike on forehead. Patient received Flu shot 5-6 weeks prior and 1st dose of shingles in August.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Headache
Clinical narrative: Headache
Age: 66.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Bursal fluid accumulation, Injection site pain, Insomnia, Magnetic resonance imaging abnormal, Muscular weakness
Clinical narrative: I got my seasonal flu shot at an outdoor fall festival. on September 28th. The flu shots were sponsored by the local Hospital. I found out later the shots were being given by student nurses. I was asked to sit while she stood. I noticed the shot was given much higher on my right shoulder than usual. There was no pain at that time. My shoulder did not start hurting until early evening the next day, Sept. 29th. I awoke several times that night with pain. The next morning it really hurt to move. I thought it might just be a regular but extreme reaction to the shot. I waited until the end of the week and contacted my doctor. I also contacted the hospital to inform them of my reaction to the shot.  At the doctor appointment Oct. 9th my doctor said there was not much he could do and to take ibuprofen. It did nothing for the pain. I contacted my doctor Oct 29 with terrible pain and sleepless nights. There was also increasing weakness. The doctor ordered an MRI which was done Nov. 7th. It showed a supraspinatus tendon rotator cuff tear and fluid visible in the subacromial /subdeltoid bursa. My doctor sent me to physical therapy which started Nov. 19th. I have had 6 sessions with no relief. I recontacted my doctor and he has referred me to an orthopedic doctor. An appointment has not as yet been scheduled. I have pain with any movement, extreme weakness and a constant ache even when not moving.
Age: 66.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pain, Product administered at inappropriate site, Rotator cuff syndrome
Clinical narrative: I got my seasonal flu shot at an outdoor fall festival. on September 28th. The flu shots were sponsored by the local Hospital. I found out later the shots were being given by student nurses. I was asked to sit while she stood. I noticed the shot was given much higher on my right shoulder than usual. There was no pain at that time. My shoulder did not start hurting until early evening the next day, Sept. 29th. I awoke several times that night with pain. The next morning it really hurt to move. I thought it might just be a regular but extreme reaction to the shot. I waited until the end of the week and contacted my doctor. I also contacted the hospital to inform them of my reaction to the shot.  At the doctor appointment Oct. 9th my doctor said there was not much he could do and to take ibuprofen. It did nothing for the pain. I contacted my doctor Oct 29 with terrible pain and sleepless nights. There was also increasing weakness. The doctor ordered an MRI which was done Nov. 7th. It showed a supraspinatus tendon rotator cuff tear and fluid visible in the subacromial /subdeltoid bursa. My doctor sent me to physical therapy which started Nov. 19th. I have had 6 sessions with no relief. I recontacted my doctor and he has referred me to an orthopedic doctor. An appointment has not as yet been scheduled. I have pain with any movement, extreme weakness and a constant ache even when not moving.
Age: 66.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Magnetic resonance imaging, Product administered at inappropriate site
Clinical narrative: I got my seasonal flu shot at an outdoor fall festival. on September 28th. The flu shots were sponsored by the local Hospital. I found out later the shots were being given by student nurses. I was asked to sit while she stood. I noticed the shot was given much higher on my right shoulder than usual. There was no pain at that time. My shoulder did not start hurting until early evening the next day, Sept. 29th. I awoke several times that night with pain. The next morning it really hurt to move. I thought it might just be a regular but extreme reaction to the shot. I waited until the end of the week and contacted my doctor. I also contacted the hospital to inform them of my reaction to the shot.  At the doctor appointment Oct. 9th my doctor said there was not much he could do and to take ibuprofen. It did nothing for the pain. I contacted my doctor Oct 29 with terrible pain and sleepless nights. There was also increasing weakness. The doctor ordered an MRI which was done Nov. 7th. It showed a supraspinatus tendon rotator cuff tear and fluid visible in the subacromial /subdeltoid bursa. My doctor sent me to physical therapy which started Nov. 19th. I have had 6 sessions with no relief. I recontacted my doctor and he has referred me to an orthopedic doctor. An appointment has not as yet been scheduled. I have pain with any movement, extreme weakness and a constant ache even when not moving.
Age: 50.0
Sex: F
Vaccine: RAB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: My left shoulder was in severe pain within 2 hours of injection. I couldn?t raise my left arm and was in tears.  I treated with heat but got no relief. I took 2 Aleve once a day. After ten days, with no decrease in pain, I made appointment with Orthopedic doctor.
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Death, Gait inability, Hepatic failure, Peripheral swelling, Sepsis
Clinical narrative: Liver failure. Septic. Legs Swollen, couldn't walk. Was given Shingles and possibly flu vaccine.
Age: 2.58
Sex: F
Vaccine: UNK
Symptoms: Injection site reaction, Scab
Clinical narrative: My child has a crusty marking where the injection site was  She had the hep a and varceila (chickenpox) vaccine same day. I noticed it today then researched reactions to bth vaccines and what she has resembled reaction to the varceilpa vaccine
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema of eyelid, Rash, Urticaria
Clinical narrative: Mom states child developed rash day after flu vaccine. Pt developed hives on the back & body along w/redness around the eyes. However dates mom states symptoms began and when pt presented to clinic are 10 days apart.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: AS PER FATHER SITE OF INJECTION WAS RED AND SWOLLEN, ITCHY AND CHILD FELT A LITTLE PAIN. NO HIVES, NO FEVER, NO DIFFICULTY BREATHING. FATHER WALKED IN WITH DAUGHTER THE NEXT AM DAY. AS FOR DR. WHO SAW PT. ADVISED TO SEND IN REPORT. NO F/U WAS NEEDED.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Flu vaccine high in Deltoid area Nov 6, 2019. Persistent pain with arm elevation. Treatment: Moist heat, range of motion exercises, NSAIDS.
Age: 68.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: 09/16/2019 10:42 (1 hour 20 minutes post vaccination) Pt presented from MH apt w/ welts to bilateral arms and abdomen and lower back. Provider assessed. Issues 25 mg Benadryl orally at 1030. Administered 40 mg Depomedrol w/ 4 mg Decadron IM to right dorsogluteal at 1040. Pt tolerated well. States the itching has subsided. Pt will go home and take more Benadryl along w/ ranitidine per DO. Pt advised should throat start getting tight, tongue start to swell or should he feel short of breath to go straight to ER. Pt v/u and agreed to plain.
Age: 1.33
Sex: M
Vaccine: FLU4
Symptoms: Allergy to vaccine, Rash erythematous
Clinical narrative: Red rash started on face then spread to body on 11/19/2019. Went to Clinic 11/19/2019- prescription given for Prednisone & Zyrtec - to take OTC Benadryl. Also Benadryl given by Clinic. Seen in office 11/20/19 was diagnose with suspected allergy to Influenza. Vaccine & entry under allergy changed to reflect allergy to Influenza Vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: ON 08/29/19 PT RECEIVED HER FIRST SHINGLES SHOT, SHE STATES THAT THE INJECTION SITE IS RED AND SWOLLEN AND INCH BELOW THE INJECTION SITE ARE 2 HIVE THAT ARE BEGINNING TO MERGE TOGETHER & rED AND SWOLLEN AT INJECTION SITE, 1 INCH BELOW DEVELOPED 2 HIVES DIPHENHYDRAMINE 25 MG AT BEDTIME
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Dysstasia, Mobility decreased, Nasal congestion, Sneezing
Clinical narrative: 2 Hours aFter receiving vaccine while at school Patient started to Feel weak along with nasal congestion and sneezing. The Following morning patient was so weak she could not get out of bed. Unable to stand up and move her arms. For part oF That morning. Pt was able to get up towarD The end of The morning but still Had to sit down a lot due to Feeling weak.
Sex: F
Vaccine: FLUA3
Symptoms: Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: She developed extreme on her arm, in the same evening, she developed numbness and extreme pain suffered for 2 days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Condition aggravated, Fatigue, Myasthenia gravis
Clinical narrative: Patient came in to let RPh know that one week after receiving Shingrix Dose #1 she experienced severe weakness to the point of being exhausted from taking sHower. Episode lasted 5-6 weeks. Pt thinks vaccine likely exacerbated her myasthenia gRavis. could hardly get out of beD.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 11-25-19 received Flu Vaccine. Small amount of redness at site on Left Deltoid after 2 hours 11-26-19 Large amount of redness, swelling & warmth (L) deltoid at injection site 11-27-19 Seen at Clinic
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature decreased, Chills, Headache, Nausea, Pain in extremity
Clinical narrative: An acute generalized exanthematous pustulosar rash severe pain down to the hand lasting over a week Low body temp, diffuse rash on arm, back, chest, neck and scalp, shaking chills, bad headaches severe nausea.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pustular, Tremor
Clinical narrative: An acute generalized exanthematous pustulosar rash severe pain down to the hand lasting over a week Low body temp, diffuse rash on arm, back, chest, neck and scalp, shaking chills, bad headaches severe nausea.
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: C-reactive protein normal, Full blood count normal, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: worsening of upper body muscle constriction; Condition aggravated; This case was reported by a consumer via call center representative and described the occurrence of muscle contracture in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included muscle contracture (upper body muscle constriction from 23rd October 2019, went to ER and discharged home).   On 29th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th October 2019, less than a day after receiving Shingrix, the patient experienced muscle contracture and condition aggravated. The patient was treated with ketorolac trometamol (Toradol) and muscle relaxants (Muscle Relaxant). On an unknown date, the outcome of the muscle contracture and condition aggravated were not recovered/not resolved.   It was unknown if the reporter considered the muscle contracture and condition aggravated to be related to Shingrix.  Additional information was received as follows: The patient received Shingrix in the right arm. The patient experienced worsening of upper body muscle constriction, went back to the emergency room on 17th November 2019 and was discharged home. The patient reported that at in the emergency room he had additional testing and was prescribed a muscle relaxer and Toradol.  The outcome of muscle constriction was reported as not recovered in Argus while in source document it was reported as receovering/resolving'. The reporter consented to follow up.  The patient requested GlaxoSmithKline Legal requesting payment for medical bills and loss of wages. This case is one of 4 cases, reported by same reporter.      Lab Comments: On an unknown date, the patient had additional testing; results pending.
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Metabolic function test normal, Musculoskeletal stiffness, Pain, Red blood cell sedimentation rate normal, Swelling
Clinical narrative: worsening of upper body muscle constriction; Condition aggravated; This case was reported by a consumer via call center representative and described the occurrence of muscle contracture in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included muscle contracture (upper body muscle constriction from 23rd October 2019, went to ER and discharged home).   On 29th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th October 2019, less than a day after receiving Shingrix, the patient experienced muscle contracture and condition aggravated. The patient was treated with ketorolac trometamol (Toradol) and muscle relaxants (Muscle Relaxant). On an unknown date, the outcome of the muscle contracture and condition aggravated were not recovered/not resolved.   It was unknown if the reporter considered the muscle contracture and condition aggravated to be related to Shingrix.  Additional information was received as follows: The patient received Shingrix in the right arm. The patient experienced worsening of upper body muscle constriction, went back to the emergency room on 17th November 2019 and was discharged home. The patient reported that at in the emergency room he had additional testing and was prescribed a muscle relaxer and Toradol.  The outcome of muscle constriction was reported as not recovered in Argus while in source document it was reported as receovering/resolving'. The reporter consented to follow up.  The patient requested GlaxoSmithKline Legal requesting payment for medical bills and loss of wages. This case is one of 4 cases, reported by same reporter.      Lab Comments: On an unknown date, the patient had additional testing; results pending.
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Laboratory test, Muscle contracture
Clinical narrative: worsening of upper body muscle constriction; Condition aggravated; This case was reported by a consumer via call center representative and described the occurrence of muscle contracture in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included muscle contracture (upper body muscle constriction from 23rd October 2019, went to ER and discharged home).   On 29th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th October 2019, less than a day after receiving Shingrix, the patient experienced muscle contracture and condition aggravated. The patient was treated with ketorolac trometamol (Toradol) and muscle relaxants (Muscle Relaxant). On an unknown date, the outcome of the muscle contracture and condition aggravated were not recovered/not resolved.   It was unknown if the reporter considered the muscle contracture and condition aggravated to be related to Shingrix.  Additional information was received as follows: The patient received Shingrix in the right arm. The patient experienced worsening of upper body muscle constriction, went back to the emergency room on 17th November 2019 and was discharged home. The patient reported that at in the emergency room he had additional testing and was prescribed a muscle relaxer and Toradol.  The outcome of muscle constriction was reported as not recovered in Argus while in source document it was reported as receovering/resolving'. The reporter consented to follow up.  The patient requested GlaxoSmithKline Legal requesting payment for medical bills and loss of wages. This case is one of 4 cases, reported by same reporter.      Lab Comments: On an unknown date, the patient had additional testing; results pending.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Impaired driving ability, Insomnia, Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: sore arm with decreased mobility; decreased mobility/unable to raise her arm up; wakes her up at night; cannot carry anything/could not even undress herself; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, less than 3 weeks after receiving Shingrix, the patient experienced pain in arm, mobility decreased, nocturnal awakening and activities of daily living impaired. On an unknown date, the outcome of the pain in arm, mobility decreased, nocturnal awakening and activities of daily living impaired were recovering/resolving.   It was unknown if the reporter considered the pain in arm, mobility decreased, nocturnal awakening and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The patient experienced sore arm that wakes her up at night, she cannot carry anything, and at times could not even undress herself due to the pain. The patient was improving with the time, still persists and she was unable to raise her arm up. The patient's husband was a physician and she requested that he be copied on any correspondence with her physician. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paralysis
Clinical narrative: sore arm with decreased mobility; decreased mobility/unable to raise her arm up; wakes her up at night; cannot carry anything/could not even undress herself; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, less than 3 weeks after receiving Shingrix, the patient experienced pain in arm, mobility decreased, nocturnal awakening and activities of daily living impaired. On an unknown date, the outcome of the pain in arm, mobility decreased, nocturnal awakening and activities of daily living impaired were recovering/resolving.   It was unknown if the reporter considered the pain in arm, mobility decreased, nocturnal awakening and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The patient experienced sore arm that wakes her up at night, she cannot carry anything, and at times could not even undress herself due to the pain. The patient was improving with the time, still persists and she was unable to raise her arm up. The patient's husband was a physician and she requested that he be copied on any correspondence with her physician. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Middle insomnia, Mobility decreased, Pain in extremity
Clinical narrative: sore arm with decreased mobility; decreased mobility/unable to raise her arm up; wakes her up at night; cannot carry anything/could not even undress herself; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, less than 3 weeks after receiving Shingrix, the patient experienced pain in arm, mobility decreased, nocturnal awakening and activities of daily living impaired. On an unknown date, the outcome of the pain in arm, mobility decreased, nocturnal awakening and activities of daily living impaired were recovering/resolving.   It was unknown if the reporter considered the pain in arm, mobility decreased, nocturnal awakening and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The patient experienced sore arm that wakes her up at night, she cannot carry anything, and at times could not even undress herself due to the pain. The patient was improving with the time, still persists and she was unable to raise her arm up. The patient's husband was a physician and she requested that he be copied on any correspondence with her physician. The reporter consented to follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Acoustic stimulation tests abnormal, Balance disorder, Deafness unilateral, Magnetic resonance imaging brain normal, Magnetic resonance imaging normal
Clinical narrative: Patient received first shot if shingrix on 11/16 and experienced flu like symptoms for the first 2 days, then on 3rd day patient reported 100% hear loss in the right ear
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Vertigo, Viral infection, Vomiting
Clinical narrative: Patient received first shot if shingrix on 11/16 and experienced flu like symptoms for the first 2 days, then on 3rd day patient reported 100% hear loss in the right ear
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Deafness unilateral, Influenza like illness
Clinical narrative: Patient received first shot if shingrix on 11/16 and experienced flu like symptoms for the first 2 days, then on 3rd day patient reported 100% hear loss in the right ear
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: the Patient called with redness, a bard lump at the injection site and swelling about 3 inches in diameter below the injection site; the Patient called with redness, a bard lump at the injection site and swelling about 3 inches in diameter below the injection site / The next day the Patient came in to see; the Patient called with redness, a bard lump at the injection site and swelling about 3 inches in diameter below the injection site; This spontaneous report was received from a pharmacist concerning a 67-year-old female patient. The patient's concomitant medication included an unspecified antidepressant. Her concurrent condition included depression. Also, the patient's drug reaction and allergy included penicillin.       On 23-NOV-2019, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscular in the right deltoid, lot number R033343 and expiration date 03-AUG-2020, for prophylaxis (dosage schedule was not reported). On the same day, the patient experienced redness (injection site erythema), a bard lump at the injection site (injection site induration) and swelling about 3 inches in diameter below the injection site (injection site swelling). The Pharmacist recommended to applied ice and to take acetaminophen (TYLENOL). On 24-NOV-2019, the patient came in to see the pharmacist because the swelling bad progressed to about 6 inches in diameter, she had used acetaminophen (TYLENOL) for the pain but she didn't applied  iced on the area to reduce swelling. Also, she had also slept on her right arm which may have also contributed to the swelling. The Pharmacist advised the Patient to see her Physician, and went to an unspecified Urgent Care Center and was prescribed ice, and acetaminophen (TYLENOL), and to come back if not improved. No laboratories tests or studies were performed.   The outcome of injection site erythema, injection site induration and injection site swelling was reported as recovering since it is unknown if the patient was fully recovered.   The causality assessment between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Pain
Clinical narrative: the Patient called with redness, a bard lump at the injection site and swelling about 3 inches in diameter below the injection site; the Patient called with redness, a bard lump at the injection site and swelling about 3 inches in diameter below the injection site / The next day the Patient came in to see; the Patient called with redness, a bard lump at the injection site and swelling about 3 inches in diameter below the injection site; This spontaneous report was received from a pharmacist concerning a 67-year-old female patient. The patient's concomitant medication included an unspecified antidepressant. Her concurrent condition included depression. Also, the patient's drug reaction and allergy included penicillin.       On 23-NOV-2019, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscular in the right deltoid, lot number R033343 and expiration date 03-AUG-2020, for prophylaxis (dosage schedule was not reported). On the same day, the patient experienced redness (injection site erythema), a bard lump at the injection site (injection site induration) and swelling about 3 inches in diameter below the injection site (injection site swelling). The Pharmacist recommended to applied ice and to take acetaminophen (TYLENOL). On 24-NOV-2019, the patient came in to see the pharmacist because the swelling bad progressed to about 6 inches in diameter, she had used acetaminophen (TYLENOL) for the pain but she didn't applied  iced on the area to reduce swelling. Also, she had also slept on her right arm which may have also contributed to the swelling. The Pharmacist advised the Patient to see her Physician, and went to an unspecified Urgent Care Center and was prescribed ice, and acetaminophen (TYLENOL), and to come back if not improved. No laboratories tests or studies were performed.   The outcome of injection site erythema, injection site induration and injection site swelling was reported as recovering since it is unknown if the patient was fully recovered.   The causality assessment between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT EXPERIENCED PAIN, ITCHING, REDNESS AND SWELLING AT THE INJECTION SITE. NO TREATMENT OBTAINED YET.
Age: 83.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Pain in extremity
Clinical narrative: Onset of severe left leg pain 3 days after the vaccination that has persisted for more than 5 weeks now.
Age: 83.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Pain in extremity, Walking aid user
Clinical narrative: Onset of severe left leg pain 3 days after the vaccination that has persisted for more than 5 weeks now.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given a dose of High dose flu in place of the regular influenza Quad dose.  Medical assistant did not follow standard work and discovered the error after the patient had left the office.  no know side effects.  Patient was contacted about the error.  Documented in our records.  Medical assistant was retrained per standard work for our office.
Age: 81.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Pain in extremity
Clinical narrative: Onset 3 days after the vaccine of severe right leg pain that has persisted over 5 weeks
Age: 81.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Magnetic resonance imaging, Pain in extremity, Walking aid user
Clinical narrative: Onset 3 days after the vaccine of severe right leg pain that has persisted over 5 weeks
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Administered a dose of improperly stored MMR II,  PROQUAD, or VARIVAX; No adverse effects reported; Information has been received from a vaccine coordinator referring to an unspecified number of patients of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided.  On unknown dates, the patients were administered a dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # was R024897, expiration date was 30-AUG-2020; strength, dose and route was not provided), measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # was S003171, expiration date was 30-JUL-2020; strength, dose and route was not provided) or varicella virus vaccine live (oka/merck) (VARIVAX) (lot # was R030611, expiration date was 23-OCT-2020; strength, dose and route was not provided) for prophylaxis; reconstituted with properly stored sterile diluent.   The vaccine had temperature excursion of 8.49 C degree for 15 minutes, 50 C degree for 26 minutes. No previous temperature. The call was due to the digital data logger. No adverse event was reported.  This is a non-valid case due to lack of patient identifiers.  As of 03-DEC-2019, all telephone attempts trying to obtain additional information has been unsuccessful.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: no adverse effect; the 12 month old patient was inadvertently administered a dose of VARIVAX and PROQUAD on the same day; the 12 month old patient was inadvertently administered a dose of VARIVAX and PROQUAD on the same day; This spontaneous report was received from a licensed practical nurse regarding a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported.   On 06-NOV-2019, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection, therapy type: rHa (lot number S003862, expiration date: 08-AUG-2020) (dose, frequency and route of administration were not reported) and with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number S002393, expiration date: 23-JAN-2021) (dose, frequency and route of administration were not reported) both for prophylaxis.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Respiration abnormal, Swelling
Clinical narrative: Breathing; Swelling; This spontaneous report has been received from a lawyer referring to an elderly female patient who was currently 75 years old. The patient's medical history included chicken pox. Historical vaccines included zoster vaccine live (ZOSTAVAX). The patient was a non-smoker. The patient's concomitant medication was not reported.  On 12-JAN-2016 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, strength, batch/lot# and expiration date were unknown) for prophylaxis.         On an unknown date the patient experienced respiration abnormal and swelling. The outcome of respiration abnormal and swelling was unknown. The reporter considered respiration abnormal and swelling to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).  The case is linked to case# US-009507513-1809USA004647 due to the same patient.; Sender's Comments:  US-009507513-1809USA004647:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; one female patient received improperly stored PROQUAD; This spontaneous report was received from a nurse referring a 4 years old female patient. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.    On 14-NOV-2019, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S012470 and expiration date 20-OCT-2020; strength, dose, frequency and route were not reported) for prophylaxis (product storage error). No adverse effects were reported. The vaccine underwent highest temperature above 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.2 Fahrenheit) for a duration of 1 hour and 10 minutes. There was no previous temperature excursion and the call was because of data logger.
Sex: F
Vaccine: MMR
Symptoms: Injection site induration, Injection site mass, Injection site pain
Clinical narrative: lump formed on the back of my arm near the shot and it's hurting; a hard lump formed at the injection site, approximately 3 weeks after getting the vaccine/did not examine the patient's reported induration in person/lump formed on the back of my arm near the shot; This spontaneous report was received from a pharmacist referring to a 53 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 14-OCT-2019 the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (Albumin status of rHA (recombinant human albumin)) (M-M-R II) (lot # S015428, expiration date 20-MAY-2021; strength was not reported) subcutaneously and sterile diluent(STERILE DILUENT) (lot # S024969, expiration date 17-MAR-2021; strength, dose, frequency and route were not reported) for prophylaxis. On approximately 04-NOV-2019 (reported as approximately 3 weeks after getting the vaccine), a hard lump and induration formed at the injection site, lump formed on the back of the patient's arm near the shot and it was hurting. No treatment provided. No other adverse symptoms was reported. The outcome of the events was reported as not recovered. The patient sought medical attention. The patient was referred to a surgeon for examination and possible removal. The causality assessment was not reported by pharmacist and another healthcare provider told the patient induration did not appear to be from the vaccine.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Did not experience any symptoms; inadvertantly administered one dose of MMR II on 27NOV2019, that has expired on 03NOV2019; This spontaneous report was received from a nurse prescriber refers to a patient of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 27-NOV-2019, the patient was inadvertently vaccinated with one dose of expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (therapy type: recombinant Human albumin (rHA)) of lot # N031005 with an expiry date of 03-NOV-2019 for prophylaxis (strength and route of administration was not reported) (expired product administered). The patient did not experience any symptoms (no adverse event). The outcome of expired product administered was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: subsequently experienced ''bad pain" and swelling in her shoulder muscles two days later on 14-NOV-2019; subsequently experienced ''bad pain" and swelling in her shoulder muscles two days later on 14-NOV-2019; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's concomitant therapy included an unspecified "progestin only pill". And the patient doesn't referred allergies or pertinent medical history.  On 12-NOV-2019, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection in the left shoulder, for prophylaxis (dosage schedule, route, lot number, and expiration date were not reported).         On 14-NOV-2019, the patient experienced ''bad pain" (injection site pain) and swelling in her shoulder muscles (injection site swelling). The swelling had persisted for two and half weeks. The patient visited the physician for medical attention, and she didn't received treatment for the events. Also, no laboratory diagnostics or studies were performed.   The outcome of injection site pain and injection site swelling was reported as not recovered.   The causality between the aforementioned events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Full blood count normal, Metabolic function test normal, Mobility decreased, Muscular weakness
Clinical narrative: the patient started to experience weakness in her arm; severe shoulder pain; muscle pain in the arm and it is difficult to move; muscle pain in the arm; patient began to have difficulty breathing; This spontaneous report was received from a physician assistant referring to a 66-year-old female patient. The patient was allergic to some unspecified medications. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 04-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), intramuscular, in an unspecified arm (dosage schedule, lot number and expiration date were not reported), for prophylaxis.   On the same day 3 hours after the vaccination, the patient experienced weakness in her arm (muscular weakness), severe shoulder pain (musculoskeletal pain), muscle pain in the arm (myalgia) and difficulty to move the arm (injected limb mobility decreased). The patient sought medical attention by calling her physician assistant and she went to an unspecified emergency room. After calling the office, the patient began to have difficulty breathing (dyspnoea), which was handled with unspecified treatments and then she was discharged on the same day. While in the emergency room, comprehensive metabolic panel (CMP) and complete blood count (CBC) showed normal results. Additionally on 09-NOV-2019, the patient was given prednisone and referred to physical therapy. The outcome of muscular weakness, myalgia, injected limb mobility decreased, dyspnoea and musculoskeletal pain was reported as not recovered.  The causality assessment between the adverse event and the suspect therapy was not provided.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Myalgia
Clinical narrative: the patient started to experience weakness in her arm; severe shoulder pain; muscle pain in the arm and it is difficult to move; muscle pain in the arm; patient began to have difficulty breathing; This spontaneous report was received from a physician assistant referring to a 66-year-old female patient. The patient was allergic to some unspecified medications. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 04-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), intramuscular, in an unspecified arm (dosage schedule, lot number and expiration date were not reported), for prophylaxis.   On the same day 3 hours after the vaccination, the patient experienced weakness in her arm (muscular weakness), severe shoulder pain (musculoskeletal pain), muscle pain in the arm (myalgia) and difficulty to move the arm (injected limb mobility decreased). The patient sought medical attention by calling her physician assistant and she went to an unspecified emergency room. After calling the office, the patient began to have difficulty breathing (dyspnoea), which was handled with unspecified treatments and then she was discharged on the same day. While in the emergency room, comprehensive metabolic panel (CMP) and complete blood count (CBC) showed normal results. Additionally on 09-NOV-2019, the patient was given prednisone and referred to physical therapy. The outcome of muscular weakness, myalgia, injected limb mobility decreased, dyspnoea and musculoskeletal pain was reported as not recovered.  The causality assessment between the adverse event and the suspect therapy was not provided.