chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness, Vomiting
Clinical narrative: Very larger area of induration with warmth, pain, and tenderness on palpitation, body aches, nausea and vomiting, headaches.
Age: 47.0
Sex: M
Vaccine: TDAP, UNK
Symptoms: Asthenia, Back pain, CSF glucose increased, CSF protein increased, CSF red blood cell count positive
Clinical narrative: I'm a neurologic ICU physician and I'm taking care of patient in my ICU.  He's got a severe case of Guillain-Barre, so I'm filling this out for him. Patient got a piece of metal in his leg while working on a motorcycle on 2/12. He went to an urgent care clinic the following day and got a TDaP (I can't find if it was ADACEL or BOOSTRIX, sorry!). A few weeks later, he started developing back and lower extremity pain and went to an ED twice on 3/2. He got an urgent referral to a neurosurgery outpatient clinic on 3/4 due to back pain, and the neurosurgeon quickly realized he had GBS. He was referred to medical center and was hospitalized on 3/4. IVIg was started and the patient finished the standard dosing on 3/9. Unfortunately, he continued to progress and required intubation. He was trialed for extubation on 3/16 and 3/27, but ultimately failed and received a tracheostomy 3/28. We've started plasma exchange on 3/23 and he's set to get his 5th session today. His GBS was consistent with his lumbar puncture and an EMG/NCS study. He remains in the ICU and has just now regained barely antigravity strength in his left arm.
Age: 47.0
Sex: M
Vaccine: TDAP, UNK
Symptoms: CSF white blood cell count negative, Electromyogram abnormal, Endotracheal intubation, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: I'm a neurologic ICU physician and I'm taking care of patient in my ICU.  He's got a severe case of Guillain-Barre, so I'm filling this out for him. Patient got a piece of metal in his leg while working on a motorcycle on 2/12. He went to an urgent care clinic the following day and got a TDaP (I can't find if it was ADACEL or BOOSTRIX, sorry!). A few weeks later, he started developing back and lower extremity pain and went to an ED twice on 3/2. He got an urgent referral to a neurosurgery outpatient clinic on 3/4 due to back pain, and the neurosurgeon quickly realized he had GBS. He was referred to medical center and was hospitalized on 3/4. IVIg was started and the patient finished the standard dosing on 3/9. Unfortunately, he continued to progress and required intubation. He was trialed for extubation on 3/16 and 3/27, but ultimately failed and received a tracheostomy 3/28. We've started plasma exchange on 3/23 and he's set to get his 5th session today. His GBS was consistent with his lumbar puncture and an EMG/NCS study. He remains in the ICU and has just now regained barely antigravity strength in his left arm.
Age: 47.0
Sex: M
Vaccine: TDAP, UNK
Symptoms: Intensive care, Laboratory test, Nerve conduction studies abnormal, Pain in extremity, Plasmapheresis
Clinical narrative: I'm a neurologic ICU physician and I'm taking care of patient in my ICU.  He's got a severe case of Guillain-Barre, so I'm filling this out for him. Patient got a piece of metal in his leg while working on a motorcycle on 2/12. He went to an urgent care clinic the following day and got a TDaP (I can't find if it was ADACEL or BOOSTRIX, sorry!). A few weeks later, he started developing back and lower extremity pain and went to an ED twice on 3/2. He got an urgent referral to a neurosurgery outpatient clinic on 3/4 due to back pain, and the neurosurgeon quickly realized he had GBS. He was referred to medical center and was hospitalized on 3/4. IVIg was started and the patient finished the standard dosing on 3/9. Unfortunately, he continued to progress and required intubation. He was trialed for extubation on 3/16 and 3/27, but ultimately failed and received a tracheostomy 3/28. We've started plasma exchange on 3/23 and he's set to get his 5th session today. His GBS was consistent with his lumbar puncture and an EMG/NCS study. He remains in the ICU and has just now regained barely antigravity strength in his left arm.
Age: 47.0
Sex: M
Vaccine: TDAP, UNK
Symptoms: Tracheostomy
Clinical narrative: I'm a neurologic ICU physician and I'm taking care of patient in my ICU.  He's got a severe case of Guillain-Barre, so I'm filling this out for him. Patient got a piece of metal in his leg while working on a motorcycle on 2/12. He went to an urgent care clinic the following day and got a TDaP (I can't find if it was ADACEL or BOOSTRIX, sorry!). A few weeks later, he started developing back and lower extremity pain and went to an ED twice on 3/2. He got an urgent referral to a neurosurgery outpatient clinic on 3/4 due to back pain, and the neurosurgeon quickly realized he had GBS. He was referred to medical center and was hospitalized on 3/4. IVIg was started and the patient finished the standard dosing on 3/9. Unfortunately, he continued to progress and required intubation. He was trialed for extubation on 3/16 and 3/27, but ultimately failed and received a tracheostomy 3/28. We've started plasma exchange on 3/23 and he's set to get his 5th session today. His GBS was consistent with his lumbar puncture and an EMG/NCS study. He remains in the ICU and has just now regained barely antigravity strength in his left arm.
Age: 47.0
Sex: M
Vaccine: TDAP, UNK
Symptoms: Unevaluable event
Clinical narrative: I'm a neurologic ICU physician and I'm taking care of patient in my ICU.  He's got a severe case of Guillain-Barre, so I'm filling this out for him. Patient got a piece of metal in his leg while working on a motorcycle on 2/12. He went to an urgent care clinic the following day and got a TDaP (I can't find if it was ADACEL or BOOSTRIX, sorry!). A few weeks later, he started developing back and lower extremity pain and went to an ED twice on 3/2. He got an urgent referral to a neurosurgery outpatient clinic on 3/4 due to back pain, and the neurosurgeon quickly realized he had GBS. He was referred to medical center and was hospitalized on 3/4. IVIg was started and the patient finished the standard dosing on 3/9. Unfortunately, he continued to progress and required intubation. He was trialed for extubation on 3/16 and 3/27, but ultimately failed and received a tracheostomy 3/28. We've started plasma exchange on 3/23 and he's set to get his 5th session today. His GBS was consistent with his lumbar puncture and an EMG/NCS study. He remains in the ICU and has just now regained barely antigravity strength in his left arm.
Age: 58.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: The usual side effects include swelling and pain at the injection site. I experience muscular pain that was not relieved with the traditional analgesics, i.e. Tylenol ES or Aleve. I am now experiencing a tremendous amount of tingling in my left arm and had along with intermittent periods of pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyskinesia, Eyelid ptosis, Facial asymmetry, Facial paralysis, Muscle disorder
Clinical narrative: Patient received SHINGRIX vaccination on 1/23/19 through Agency. She presented to our office on 3/29/19 with the following concerns: Patient states that on the right side of face mostly near upper lip to check. Patient states that the feeling in right side of face has been going on for about a week. Patient states that the muscles just dont seem to be working well. Patient is not having any issues near eye. Patient has feeling but it feels like it is puffy. Patient states that there is a tickle on right side of nose. Like there is something there. She describes it as like when you have novocaine is wearing off. Yesterday she was unable to drink due to not being able to hold lips closed. Patient didn't notice any dropping of the face yesterday. Patient states that she didn't have any problem with words or any other symptoms. Patient states that about two weeks ago she did have a sore on the right side of tongue but then gone. Symptoms started about a month ago, where she felt like her right side of her lip muscles were not moving properly. When she got up in the morning her lips were tight and didn't look right. Two weeks ago got a horrible cold sore on the right side of tongue that made it hard to speak. 2 months ago had the first shingles vaccine. Now having some more facial assymetry and right eye lid drooping/ weakness. PHYSICIAN SUSPECTS BELLS PALSY LIKELY ADVERSE EVENT FROM SHINGRIX VACCINATION. Plan from visit as follows: Bell's Palsy: Will treat with prednisone 40 mg x 3 days, 20 x 3 days, 10 for 2 days and 5 mg x 4 days. Will also give VALTREX 500 mg twice a day for 5 days. Will have use lacrilube at night to keep eye moist and may want to get an eye patch so eye doesn't dry out. Make take months to get full strength back. Do think there is good possibility that this was triggered by the shingles vaccine, given timing where shortly after vaccine got severe cold sore and started to notice facial symptoms. No evidence of stroke or intracranial event.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Paraesthesia, Swelling face, Tongue ulceration, Vaccination complication
Clinical narrative: Patient received SHINGRIX vaccination on 1/23/19 through Agency. She presented to our office on 3/29/19 with the following concerns: Patient states that on the right side of face mostly near upper lip to check. Patient states that the feeling in right side of face has been going on for about a week. Patient states that the muscles just dont seem to be working well. Patient is not having any issues near eye. Patient has feeling but it feels like it is puffy. Patient states that there is a tickle on right side of nose. Like there is something there. She describes it as like when you have novocaine is wearing off. Yesterday she was unable to drink due to not being able to hold lips closed. Patient didn't notice any dropping of the face yesterday. Patient states that she didn't have any problem with words or any other symptoms. Patient states that about two weeks ago she did have a sore on the right side of tongue but then gone. Symptoms started about a month ago, where she felt like her right side of her lip muscles were not moving properly. When she got up in the morning her lips were tight and didn't look right. Two weeks ago got a horrible cold sore on the right side of tongue that made it hard to speak. 2 months ago had the first shingles vaccine. Now having some more facial assymetry and right eye lid drooping/ weakness. PHYSICIAN SUSPECTS BELLS PALSY LIKELY ADVERSE EVENT FROM SHINGRIX VACCINATION. Plan from visit as follows: Bell's Palsy: Will treat with prednisone 40 mg x 3 days, 20 x 3 days, 10 for 2 days and 5 mg x 4 days. Will also give VALTREX 500 mg twice a day for 5 days. Will have use lacrilube at night to keep eye moist and may want to get an eye patch so eye doesn't dry out. Make take months to get full strength back. Do think there is good possibility that this was triggered by the shingles vaccine, given timing where shortly after vaccine got severe cold sore and started to notice facial symptoms. No evidence of stroke or intracranial event.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Fever, aches, pains all over and chills. Pain, redness and swelling below injection site. All gone by 03/18/19.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Immediate post-injection reaction, Injection site rash
Clinical narrative: Immediate rash surrounding injection area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cyanosis, Feeling abnormal, Pallor, Somnolence, Syncope
Clinical narrative: Child was given shots at 2:05 p.m. per protocol, child was up talking and playing, then stated he didn't feel good, child fainted,  noticed child was very pale, emergency cart obtained, O2sat/74, B/P 98/60, P)92, R)16, lips turning blue, no s/s of SOB, Rash, or seizures, Oxygen applied at 2/LM via face mask, 2:30 p.m. B/P)100/70, P)100, o2sat/85%, R)14, child talking and laughing, fainted again.  Epinephrine 0.15 prepared, ambulance called, oxygen increased to 4/LM, EMA arrives, child talking at this time, faints again and EMT increase oxygen to 6/LM via blow by method, child still groggy and in/out of conversations, child taken to Center via ambulance with Mother/Father/Brother following.  Epinephrine 0.15 wasted, d/t EMA in building, and not needed. PC to mother at 4:30, reported just left ER, child doing fine, color back to normal, lips pink, and playing with dad/brother. Mom encouraged to follow up with child PMD/Dr. On Monday Morning 04/01/2019; has not made appointment as of today 04/01/2019, encouraged to do so.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown. It was unknown if the reporter considered the fever and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had most of the common side effects. The patient wanted to know how long the patient would feel sore, feverish. The patient not even called the doctor.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain, Chills, Hyperhidrosis, Nasopharyngitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced abdominal pain, bloating, sweating, shivers, fever and cold. On an unknown date, the outcome of the abdominal pain, bloating, sweating, shivers, fever and cold were unknown. It was unknown if the reporter considered the abdominal pain, bloating, sweating, shivers, fever and cold to be related to SHINGRIX. Additional details were provided as follows: The patient experienced abdominal pain, bloating, sweating that did not start till Saturday and got worse on Wednesday with shivers and slight fever, and the patient asked if these symptoms were the result of the shot or if they were the effects too long after the vaccination.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced abdominal pain, bloating, sweating, shivers, fever and cold. On an unknown date, the outcome of the abdominal pain, bloating, sweating, shivers, fever and cold were unknown. It was unknown if the reporter considered the abdominal pain, bloating, sweating, shivers, fever and cold to be related to SHINGRIX. Additional details were provided as follows: The patient experienced abdominal pain, bloating, sweating that did not start till Saturday and got worse on Wednesday with shivers and slight fever, and the patient asked if these symptoms were the result of the shot or if they were the effects too long after the vaccination.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction, Deafness, Deafness unilateral, Influenza, Meniere's disease
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of meniere's disease in a 50-year-old male patient who received SHINGRIX for prophylaxis. On 21st March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced meniere's disease (serious criteria GSK medically significant), deafness (serious criteria GSK medically significant), tinnitus, influenza and adverse reaction. On an unknown date, the outcome of the meniere's disease, deafness, tinnitus, influenza and adverse reaction were unknown. It was unknown if the reporter considered the meniere's disease, deafness, tinnitus, influenza and adverse reaction to be related to SHINGRIX. Additional details were provided as follows: On 15th July 2018, the patient received 2nd dose of SHINGRIX. The patient experienced severe reactions like the flu and was told that it was expected and was told that it had nothing to do with SHINGRIX. The patient experienced sudden deafness in one ear in between the two doses of SHINGRIX. At the time of reporting, the patient visited a second specialist and confirmed abnormal Magnetic resonance imaging (MRI) and experienced Meniere's disease which never had prior along with hearing loss in his ear and constant tinnitus. The neurological otolaryngology specialist had confirmed that these symptoms were due to zoster virus and wanted to report the severe reaction for SHINGRIX. The patient had not experienced any symptoms of the zoster virus and only got the vaccine due to his age and risk of exposure. Lab Comments: on an unknown date magnetic resonance imaging (MRI) was performed.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging abnormal, Sudden hearing loss, Tinnitus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of meniere's disease in a 50-year-old male patient who received SHINGRIX for prophylaxis. On 21st March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced meniere's disease (serious criteria GSK medically significant), deafness (serious criteria GSK medically significant), tinnitus, influenza and adverse reaction. On an unknown date, the outcome of the meniere's disease, deafness, tinnitus, influenza and adverse reaction were unknown. It was unknown if the reporter considered the meniere's disease, deafness, tinnitus, influenza and adverse reaction to be related to SHINGRIX. Additional details were provided as follows: On 15th July 2018, the patient received 2nd dose of SHINGRIX. The patient experienced severe reactions like the flu and was told that it was expected and was told that it had nothing to do with SHINGRIX. The patient experienced sudden deafness in one ear in between the two doses of SHINGRIX. At the time of reporting, the patient visited a second specialist and confirmed abnormal Magnetic resonance imaging (MRI) and experienced Meniere's disease which never had prior along with hearing loss in his ear and constant tinnitus. The neurological otolaryngology specialist had confirmed that these symptoms were due to zoster virus and wanted to report the severe reaction for SHINGRIX. The patient had not experienced any symptoms of the zoster virus and only got the vaccine due to his age and risk of exposure. Lab Comments: on an unknown date magnetic resonance imaging (MRI) was performed.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 53-year-old male patient who received SHINGRIX for prophylaxis. On 12th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 12th January 2019, immediately after receiving SHINGRIX, the patient experienced tingling of extremity. On an unknown date, the outcome of the tingling of extremity was not recovered/not resolved. It was unknown if the reporter considered the tingling of extremity to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The caller reported that just after injection, he experienced tingling in his left hand which was the same arm where he received the injection. The reporter did not give consent to follow up. The caller had not notified his physician and therefore denies GlaxoSmithKline to follow up with his doctor.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 19th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, 7 days after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. In February 2019, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had current ongoing illness of arthritis. The patient received the dose of SHINGRIX and experienced pain at the injection site about a week after the injection. It basically hurts to raise her hand, the patient can raised it but it was painful. The patient's known, how bad that arthritis pain was and this was worse than that. The patient experienced no pain in her arm, when the arm was resting, but had the pain when patient moved her arm. The patient also felt pain, when she press at the injection site. The injection site was not red nor swollen nor lumpy. The patient said that she visited her physician about this pain and physician asked her to call us directly. The patient did not want to provide any details and wanted to stay anonymous. The patient did not gave the consent for follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient got the 1st dose of SHINGRIX it was very painful and his arm was sore afterwards. The patient got the 2nd dose on the day of reporting and he did not feel anything at all. The patient was concerned that the pharmacist missed the muscle, though the pharmacist says it was administered correctly. The pharmacist pinched his arm, so he thinks the needle did not get deep enough to reach the muscle. The patient thought it felt more like when he got allergy shots than when he got the 1st dose of SHINGRIX. The reporter did not give consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Herpes zoster, Pain, Pain in extremity, Rash erythematous
Clinical narrative: Two days after the injection (3/28/2019), I began to develop a small painful reddish rash near my left ankle (inside). That night, pain radiated up my leg from the spot and it was painful for anything to be against my ankle. By 3/31/2019, there were raised bumps on the rash spot and it was even more painful (burning, sometimes throbbing, pain). It was enough to wake me up every night in the interim. I went to a local hospital ER and was diagnosed with Shingles. Also, I should note, this vaccination made my left arm ache for about 5 days - longer than any other vaccination I have had, as most make my arm sore for a few hours at most.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Rash papular
Clinical narrative: Two days after the injection (3/28/2019), I began to develop a small painful reddish rash near my left ankle (inside). That night, pain radiated up my leg from the spot and it was painful for anything to be against my ankle. By 3/31/2019, there were raised bumps on the rash spot and it was even more painful (burning, sometimes throbbing, pain). It was enough to wake me up every night in the interim. I went to a local hospital ER and was diagnosed with Shingles. Also, I should note, this vaccination made my left arm ache for about 5 days - longer than any other vaccination I have had, as most make my arm sore for a few hours at most.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Pain in extremity, Pruritus, Skin warm
Clinical narrative: I started to notice swelling the night of the 26th. The next morning it was red, itchy, swollen, and hot to the touch. I contacted a colleague (FNP) who advised ice, Benadryl, and drawing a circle around the red site to see if it increased. The following day it had more than doubled and my entire upper are was red, swollen and itchy. The evening of the 28th I went to my primary providers walk in hours to have it checked as my arm also began to throb.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling
Clinical narrative: I started to notice swelling the night of the 26th. The next morning it was red, itchy, swollen, and hot to the touch. I contacted a colleague (FNP) who advised ice, Benadryl, and drawing a circle around the red site to see if it increased. The following day it had more than doubled and my entire upper are was red, swollen and itchy. The evening of the 28th I went to my primary providers walk in hours to have it checked as my arm also began to throb.
Age: 54.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Pt  had high fever of 102.7 Saturday 03/29/2018. Then pt experienced left sided pain, level 10/10.  Pain to the left arm, left shoulder, neck and under left  scapula. Hurt to touch those areas. Pt able to move fingers and arm from elbow down. Hurts too much to move. Pt presented to the ER on Saturday 03.29.19 and was transported to med center and is currently admitted and obtaining physical therapy.
Age: 54.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Pt  had high fever of 102.7 Saturday 03/29/2018. Then pt experienced left sided pain, level 10/10.  Pain to the left arm, left shoulder, neck and under left  scapula. Hurt to touch those areas. Pt able to move fingers and arm from elbow down. Hurts too much to move. Pt presented to the ER on Saturday 03.29.19 and was transported to med center and is currently admitted and obtaining physical therapy.
Age: 54.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Blood creatine phosphokinase normal, Cellulitis, Computerised tomogram abnormal, Injection site pain, Myositis
Clinical narrative: Pt  had high fever of 102.7 Saturday 03/29/2018. Then pt experienced left sided pain, level 10/10.  Pain to the left arm, left shoulder, neck and under left  scapula. Hurt to touch those areas. Pt able to move fingers and arm from elbow down. Hurts too much to move. Pt presented to the ER on Saturday 03.29.19 and was transported to med center and is currently admitted and obtaining physical therapy.
Age: 54.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pyrexia, Tachycardia, White blood cell count decreased
Clinical narrative: Pt  had high fever of 102.7 Saturday 03/29/2018. Then pt experienced left sided pain, level 10/10.  Pain to the left arm, left shoulder, neck and under left  scapula. Hurt to touch those areas. Pt able to move fingers and arm from elbow down. Hurts too much to move. Pt presented to the ER on Saturday 03.29.19 and was transported to med center and is currently admitted and obtaining physical therapy.
Age: 95.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: Flu like symptoms with body soreness and very tired.
Age: 95.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Feeling abnormal, Influenza like illness, Pain
Clinical narrative: Flu like symptoms with body soreness and very tired.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral, Laboratory test
Clinical narrative: Hearing loss in right ear- complete.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling and and warmth to the touch.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Arthralgia, Chills, Muscle spasms, Myalgia
Clinical narrative: 12 hours after vaccine patient experienced severe chills, bilateral muscle spasms in legs, muscular/ joint pain, resolved on its own, patient did not take any medications, attempted to warm herself with clothing. tTme course at least 4 hours.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, HEPA
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Vaccines administered on 3/20/19, on 3/22/19 MOC reported redness and swelling to left thigh. Keflex was prescribed by PCP.  Later on 3/22/19 patient presented to ED of Hospital, concerned that even after starting medication the redness hadn't gone down yet. Dx of cellulitis to left thigh. Staff noted, patient afebrile, no pain to leg, normal gait and patient is happy and playful running around the room.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Lymphadenopathy
Clinical narrative: Redness at site, L axilla swelling of lymph nodes.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Dizziness, Fatigue, Hyperhidrosis, Hypersomnia
Clinical narrative: The morning following the injection, patient was incredibly fatigued, dizzy and nauseated. She also had chills/sweats. States she slept for over 12 hours just after waking for the day. Dizziness and fatigue lasted just under 48 hours post injection.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Nausea
Clinical narrative: The morning following the injection, patient was incredibly fatigued, dizzy and nauseated. She also had chills/sweats. States she slept for over 12 hours just after waking for the day. Dizziness and fatigue lasted just under 48 hours post injection.
Age: 67.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Patient was given Dtap INFANRIX vaccine instead of a Td TENIVAC. Reached out to health department for advice. Was advised to not repeat Tetanus injection. Will inform patient.
Age: 19.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Headache, Pyrexia, Rash, Rash macular
Clinical narrative: Patient developed a dull headache and low grade fever (99.4) 10 days after recieving the MMR and Influenza vaccine. She then developed a macular, non-blanching, errythemenous rash over face and neck and then distally more scattered. Headache and low grade fever stopped after 2 days and rash continued. She was seen in the clinic 4/1/19 with the rash. In the past she only had recieved the Measles and Mumps vaccines seperately in 2005. This was also her first influenza vaccine.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Erythema, Irritability, Rash
Clinical narrative: Rash covering torso area. Slight spots around face area, but not very prominent. Back was very visible and red for one day. Faded over a four day period. No fever. No appetite. Cranky.
Age: 24.0
Sex: U
Vaccine: HPV9, TDAP
Symptoms: Flushing, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: 24yo F who came in today for vaccines and a few moments after receiving vaccine, while walking down the hall, felt sweaty, flushed, nauseous, and per father, lost consciousness. No fall/head trauma. Father helped her to the grown the hall, felt sweaty, flushed, nauseous, and per father, lost consciousness. No fall/head trauma. Father helped her to the ground. Awoke a few seconds later with normal mental status. Per pt, this has happened to her several times in the past after receiving vaccines or having blood draws. Had been feeling completely fine prior to vaccine today. No wheezing or SOB. No CP or lightheadedness.
Age: 4.0
Sex: F
Vaccine: HEPA, HIBV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT WAS IN THE OFFICE AT THE TIME OF INCIDENT  PATIENT HAD NO ADVERSE REACTIONS TO VACCINE.
Age: 15.0
Sex: M
Vaccine: FLU4, HEP, MMR, MNQ, TDAP, VARCEL
Symptoms: Chills, Dizziness, Hyperhidrosis, Loss of consciousness, Peripheral coldness
Clinical narrative: VasoVagal response after last injection, within 2 minutes. Feeling faint, increased respiration, sweating, cold palms, chills later. Patient was given ice packs on back of neck, forehead, and chest. Placed in Trendelenburg, BP monitored, respiration monitored. Some loss of conscientiousness but revived quickly. 911 was called. BP was stable. Patient given a snack and drink after he was sufficiently recovered and remained at the clinic until he was able to move on his own. Parents declined transportation to ED.
Age: 15.0
Sex: M
Vaccine: FLU4, HEP, MMR, MNQ, TDAP, VARCEL
Symptoms: Presyncope, Respiratory rate increased
Clinical narrative: VasoVagal response after last injection, within 2 minutes. Feeling faint, increased respiration, sweating, cold palms, chills later. Patient was given ice packs on back of neck, forehead, and chest. Placed in Trendelenburg, BP monitored, respiration monitored. Some loss of conscientiousness but revived quickly. 911 was called. BP was stable. Patient given a snack and drink after he was sufficiently recovered and remained at the clinic until he was able to move on his own. Parents declined transportation to ED.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Muscular weakness, Nausea
Clinical narrative: Chilling/fever, weak legs, great fatigue, naseau, feel faint at times, very sore arm.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chilling/fever, weak legs, great fatigue, naseau, feel faint at times, very sore arm.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Pain in extremity, Rash
Clinical narrative: Day of administration patient reported a headache and arm ache which was relieved with ibuprofen and next day a rash developed for 2 days all symptoms resolved in 4 days.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Musculoskeletal pain, Musculoskeletal stiffness, Urticaria
Clinical narrative: Day of administration patient reported a headache and arm ache which was relieved with ibuprofen and next day a rash developed for 2 days all symptoms resolved in 4 days.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Headache, general achiness, chills, sore arm, tiredness.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood culture, Blood test, Differential white blood cell count, Full blood count, Injection site erythema
Clinical narrative: Client called the office 3 days after vaccine regarding pain, redness and swelling at the site of injection with fever of 101.8 noted day prior to phone call. The next day client stated she went to the ER for Treatment due to symptoms not improving and arm becoming more swollen. She states that she receive IV antibodies (Vancomycin and Dablavomycin) in the ER. Client was discharged from ER and not admitted to hospital.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling, Pyrexia
Clinical narrative: Client called the office 3 days after vaccine regarding pain, redness and swelling at the site of injection with fever of 101.8 noted day prior to phone call. The next day client stated she went to the ER for Treatment due to symptoms not improving and arm becoming more swollen. She states that she receive IV antibodies (Vancomycin and Dablavomycin) in the ER. Client was discharged from ER and not admitted to hospital.
Age: 1.75
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness around injection site and minor swelling the night of the 03/29/2019 and painful when the thigh was touched. The next day around noon, the red area had spread and the thigh was still swollen. On 03/31/2019 the redness spread further, almost around to the back of the thigh and down to the knee and whole upper thigh was swollen to knee. Not firm and did not seem to be painful.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 4 month old patient, of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 18-MAR-2019, the patient was inadvertently vaccinated with the second expired dose of ROTATEQ orally, lot # N030364, expiration date on 06-MAR-2019 (strength was not provided) for prophylaxis, however no adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown. On 28-MAR-2019, the patient was vaccinated with an expired dose of VAQTA intramuscularly, for prophylaxis, lot # R010369 and expiration date 25-MAR-2019 (strength, dose, and frequency were unknown). No adverse effects were reported. It was mentioned that VAQTA had been properly stored.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 69-year-old male patient who received SHINGRIX (batch number 5CYXDMC P1C?, GSK note the reported batch number did not match with any GSK lot number expiry date unknown,) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (For tolerance of 1st dose, refer case US2019GSK055185 ). On 20th March 2019, the patient received the 2nd dose of SHINGRIX. On 20th March 2019, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too long. On 21st March 2019, the patient experienced injection site pain, fever, fatigue and chills. Rechallenge with SHINGRIX was positive. On 22nd March 2019, the outcome of the injection site pain was recovering/resolving and the outcome of the fever, fatigue and chills were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too long was unknown. The reporter considered the injection site pain, fever, fatigue and chills to be probably related to SHINGRIX. Additional details were provided as follows: Within 24 hours patient was seen by a doctor due to fever 101.4 Degree F, chills, extreme fatigue and injection site pain beyond what would be expected for a vaccination. The patient was instructed to not return to work. The condition was greatly improved after 24 hours of rest.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 69-year-old male patient who received SHINGRIX (batch number 5CYXDMC P1C ?, GSK note the reported batch number did not match with any GSK lot number expiry date unknown,) for prophylaxis.  In March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced injection site pain. This case linked with US2019GSK052547, reported by same reporter for the same patient.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated she received the 1st dose of SHINGRIX vaccine in April of 2018. She experienced pain at the injection site that lasted for about 3 hours with dose one. She experienced pain at the injection site with dose number two and that lasted for about one hour and it was less severe than the dose one. The reporter gave consent to follow up. No further details were provided. For tolerance after 2nd dose of SHINGRIX, refer case US2019052631.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (on 15th January 2019, received 1st dose (for tolerance refer case US2019052669)). On 21st March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: After the 2nd dose of SHINGRIX, the patient's arm got really, really sore. The reporter stated that, the patient's arm was not looking like bad sunburn as it looked after the 1st dose, but it had only been 1 day so it might still appear. The patient gave consent to follow up. Note: clarification has been raised regarding event confirmation after each dose. For now, events are considered as per case narrative.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (In April 2018, 1st dose received and experienced Injection site pain. Please refer the case US2019GSK056615.). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. And, about two months later she received her 2nd dose of SHINGRIX in left arm. She experienced pain at the injection site and that lasted for about one hour and it was less severe than the dose one. The reporter gave consent to follow up. No further details were provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dysgeusia, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 16th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th March 2019, less than a day after receiving SHINGRIX, the patient experienced smell alteration, nasal sinus discharge and taste metallic. On 17th March 2019, the patient experienced fever, pain, chills, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the fever, pain, chills and pain in arm were recovered/resolved and the outcome of the smell alteration, nasal sinus discharge and taste metallic were not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the fever, pain, chills, pain in arm, smell alteration, nasal sinus discharge, taste metallic and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on the left arm. Later that evening, the patient developed a metallic taste in mouth, medicinal smell in nose and sinus drainage in throat. The next day of vaccination, the patient could barely raise her left arm because it was sore. The day after vaccination, the patient also experienced a low grade fever, aching and chills. The reporter did not consent to follow-up. This case has been linked with case US2019052653, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Paranasal sinus hypersecretion, Parosmia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 16th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th March 2019, less than a day after receiving SHINGRIX, the patient experienced smell alteration, nasal sinus discharge and taste metallic. On 17th March 2019, the patient experienced fever, pain, chills, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the fever, pain, chills and pain in arm were recovered/resolved and the outcome of the smell alteration, nasal sinus discharge and taste metallic were not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the fever, pain, chills, pain in arm, smell alteration, nasal sinus discharge, taste metallic and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on the left arm. Later that evening, the patient developed a metallic taste in mouth, medicinal smell in nose and sinus drainage in throat. The next day of vaccination, the patient could barely raise her left arm because it was sore. The day after vaccination, the patient also experienced a low grade fever, aching and chills. The reporter did not consent to follow-up. This case has been linked with case US2019052653, reported by the same reporter.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Lymphadenopathy, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 12th March 2019, the patient received the 2nd dose of SHINGRIX. On 12th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain and drug dose administration interval too long. On 15th March 2019, the patient experienced enlargement of lymph nodes and pain localized. On an unknown date, the outcome of the injection site pain, enlargement of lymph nodes, pain localized and drug dose administration interval too long were unknown. It was unknown if the reporter considered the injection site pain, enlargement of lymph nodes and pain localized to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported this case for his wife. The patient received 2nd dose of SHINGRIX at greater than 6 month interval, which led to lengthening of the vaccination schedule. Three days after receiving SHINGRIX, the patient experienced Swollen lymph nodes and pain under right mandible.