chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Pain, Pain in extremity, Poor quality sleep, Product administered at inappropriate site, Sleep disorder
Clinical narrative: While having my flu vaccination at approximately 9:30 AM on Ocotber 16, 2020, I thought she seemed to be a bit high with the placement of the needle, but since I do not look, I could not see.  It felt a bit "thick" going in, but I was not sure what that meant.   Within  a few hours of having the injection, my muscle felt a bit sore - which is the usual reaction -  but by midafternoon 3:30 pm, there was this very intense pain on the front of my shoulder,  that did not feel muscular.   It intensified into the evening until I went to bed around 9 pm and took 600MG of Advil to calm the pain.  I awoke around 2:30 with such pain in front of my arm, I was awake for about an hour and then took 400 mg of Advil to return to some unrestful sleep as I could not get comfortable.  This has continued every night since - icing the front of my shoulder and taking 600 mg of Advil before sleep and then being awakened between 2-3:30 am due to the pain in my arm.    It is difficult to get comfortable even with the ice and Advil.  During the day on Saturday 10/17, Sunday 10/18 the pain was evident all day but most excruciating when I attempted to move my right arm back - to put my hand in my right pant or jacket pocket or to pull up my pants on the right side.  Additionally, I could not buckle with my right hand but had to reach over with my left.     There were times over those two days and every day since that moving my right arm just the slightest ?wrong way? causes such excruciating pain, it takes my breath away.   On Monday 10/19 I called to make a doctor?s appointment, but they could not see me for two days. I already had a previously schedule PT appointment for Wednesday 10/21, that I did not need for the previous issues but decided to keep it and have MPT examine my shoulder and arm and make a diagnosis.  She examined me and wrote her observations which can be obtained at Physical Therapy.  She recommended to ice it whenever it hurts and limit any range of motions that aggravated it but to do hanging circles to keep the shoulder moving and reduce the risk of frozen shoulder.  We made a follow-up appointment for 10/26. 10/25/20 The pain continues every day and night and has severely restricted my active lifestyle.  It has also interrupted any sense of restful sleep as I am aware of the pain every time I turn over and awakened every morning between 2-3:30AM.  This lack of restful sleep severely affects my ability to be clearheaded and productive in my job.  10/26/20 I visited Physical Therapist again today at 7:45 am.   She did some laser therapy and some message and taped it with KT tape.  She believes that either a tendon or bursae were struck with the needle and that is what is causing the pain.  She also explained that this could be a 4-6-week recovery. My shoulder felt calm when I left PT and for about 7 hours.  If is now fatigued and had some ?toothache? pain radiating out.
Age: 60.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Arthralgia, Mobility decreased, Shoulder injury related to vaccine administration
Clinical narrative: While having my flu vaccination at approximately 9:30 AM on Ocotber 16, 2020, I thought she seemed to be a bit high with the placement of the needle, but since I do not look, I could not see.  It felt a bit "thick" going in, but I was not sure what that meant.   Within  a few hours of having the injection, my muscle felt a bit sore - which is the usual reaction -  but by midafternoon 3:30 pm, there was this very intense pain on the front of my shoulder,  that did not feel muscular.   It intensified into the evening until I went to bed around 9 pm and took 600MG of Advil to calm the pain.  I awoke around 2:30 with such pain in front of my arm, I was awake for about an hour and then took 400 mg of Advil to return to some unrestful sleep as I could not get comfortable.  This has continued every night since - icing the front of my shoulder and taking 600 mg of Advil before sleep and then being awakened between 2-3:30 am due to the pain in my arm.    It is difficult to get comfortable even with the ice and Advil.  During the day on Saturday 10/17, Sunday 10/18 the pain was evident all day but most excruciating when I attempted to move my right arm back - to put my hand in my right pant or jacket pocket or to pull up my pants on the right side.  Additionally, I could not buckle with my right hand but had to reach over with my left.     There were times over those two days and every day since that moving my right arm just the slightest ?wrong way? causes such excruciating pain, it takes my breath away.   On Monday 10/19 I called to make a doctor?s appointment, but they could not see me for two days. I already had a previously schedule PT appointment for Wednesday 10/21, that I did not need for the previous issues but decided to keep it and have MPT examine my shoulder and arm and make a diagnosis.  She examined me and wrote her observations which can be obtained at Physical Therapy.  She recommended to ice it whenever it hurts and limit any range of motions that aggravated it but to do hanging circles to keep the shoulder moving and reduce the risk of frozen shoulder.  We made a follow-up appointment for 10/26. 10/25/20 The pain continues every day and night and has severely restricted my active lifestyle.  It has also interrupted any sense of restful sleep as I am aware of the pain every time I turn over and awakened every morning between 2-3:30AM.  This lack of restful sleep severely affects my ability to be clearheaded and productive in my job.  10/26/20 I visited Physical Therapist again today at 7:45 am.   She did some laser therapy and some message and taped it with KT tape.  She believes that either a tendon or bursae were struck with the needle and that is what is causing the pain.  She also explained that this could be a 4-6-week recovery. My shoulder felt calm when I left PT and for about 7 hours.  If is now fatigued and had some ?toothache? pain radiating out.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Hypotonia, Immediate post-injection reaction, Loss of consciousness, Malaise, Nausea
Clinical narrative: Patient experience syncopy right after the flu vaccine was administered.  Patient reported not feeling well when the bandage was being put on the injection site and became limp on the chair she was sitting.  She seemed to have lost consciousness for less than a minute and woke up and vomited a little bit of fluid due to nausea.  She rested for about 30 minutes in the sitting position with head down on the table and was able to walk out of the pharmacy to go home with her mom.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Vomiting
Clinical narrative: Patient experience syncopy right after the flu vaccine was administered.  Patient reported not feeling well when the bandage was being put on the injection site and became limp on the chair she was sitting.  She seemed to have lost consciousness for less than a minute and woke up and vomited a little bit of fluid due to nausea.  She rested for about 30 minutes in the sitting position with head down on the table and was able to walk out of the pharmacy to go home with her mom.
Age: 65.0
Sex: M
Vaccine: FLUA4
Symptoms: Dizziness, Urticaria, Vomiting
Clinical narrative: Within 48 hours a   severe case of hives developed eventually covering about 50-60% of my body.  Self administered OTC antihistamine for about 36 hours.  When the hives continued to get worse, sought medical attention the morning of 9/12/2020.  The MD visually confirmed hives and prescribed different antihistamine and pepcid. The hives subside over the next 48-72 hours.  Sought medical attention for dizziness and vomiting that began on 9/15/2020.  By the time of the televisit, I was feeling better.  No action was taken.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Neck pain, Pain
Clinical narrative: I lost all use of my left arm  within the period  of 4-5 hours accompanied by extreme pain in the shoulder and upper arm. I could not lift my arm from the shoulder and to attempt that movement  caused excruciating pain. The pain, which also began to be in the neck and elbow, kept me awake all night. I took ibuprofen and Tylenol with no relief.  On 10/26/2020 I was able to use my arm below the elbow,  which caused pain to the upper arm.  The following day I was able to lift the entire arm straight out with pain in the shoulder--but not acute. Today,  10/27 I am still having pain in the shoulder--not as acute as initially but still with some pain and am still unable to lift my arm straight up.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Sleep disorder
Clinical narrative: I lost all use of my left arm  within the period  of 4-5 hours accompanied by extreme pain in the shoulder and upper arm. I could not lift my arm from the shoulder and to attempt that movement  caused excruciating pain. The pain, which also began to be in the neck and elbow, kept me awake all night. I took ibuprofen and Tylenol with no relief.  On 10/26/2020 I was able to use my arm below the elbow,  which caused pain to the upper arm.  The following day I was able to lift the entire arm straight out with pain in the shoulder--but not acute. Today,  10/27 I am still having pain in the shoulder--not as acute as initially but still with some pain and am still unable to lift my arm straight up.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Mobility decreased, Pain in extremity, Product administered at inappropriate site, Sleep disorder
Clinical narrative: I lost all use of my left arm  within the period  of 4-5 hours accompanied by extreme pain in the shoulder and upper arm. I could not lift my arm from the shoulder and to attempt that movement  caused excruciating pain. The pain, which also began to be in the neck and elbow, kept me awake all night. I took ibuprofen and Tylenol with no relief.  On 10/26/2020 I was able to use my arm below the elbow,  which caused pain to the upper arm.  The following day I was able to lift the entire arm straight out with pain in the shoulder--but not acute. Today,  10/27 I am still having pain in the shoulder--not as acute as initially but still with some pain and am still unable to lift my arm straight up.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Communication disorder, Lethargy, Pallor, Vomiting
Clinical narrative: Pale, lethargic, vomited, weakness, not responding well verbally when spoken to.
Age: 50.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Pain in extremity, Rash erythematous, Skin warm, Swelling
Clinical narrative: Patient had severe arm pain, swelling, red raised rash that was warm to the touch
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site warmth, Pruritus, Rash
Clinical narrative: Rash, itching, and hit to touch at injection site
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Shot was painful when received.  Pharmisist noted this was because it went into the muscle.  Four hours later, I had so much pain in my arm from shoulder to elbow I could not move it.  Later that night I began to experience all the other symptoms (fatigue, chills, fever, fatigue, headache, upset stomach)  By the next day I was so ill I could not get out of bed for 24 hours, along with extreme pain every time I moved my arm.   I experienced all these symptoms, less the arm pain, after my first dose but at a significantly lower level. Today is 3 days since my 2nd dose and I an just starting to feel better, with only mild pain in my arm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Mobility decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: Shot was painful when received.  Pharmisist noted this was because it went into the muscle.  Four hours later, I had so much pain in my arm from shoulder to elbow I could not move it.  Later that night I began to experience all the other symptoms (fatigue, chills, fever, fatigue, headache, upset stomach)  By the next day I was so ill I could not get out of bed for 24 hours, along with extreme pain every time I moved my arm.   I experienced all these symptoms, less the arm pain, after my first dose but at a significantly lower level. Today is 3 days since my 2nd dose and I an just starting to feel better, with only mild pain in my arm.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Swelling
Clinical narrative: The two locations on the back of my neck where I had been stung by a wasp two months before swelled up again as if I had been stung again by a wasp.  The swelling lasted for 4 to 7 days.  The pain was similar to the lingering pain of a wasp sting.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Herpes virus infection, Herpes zoster
Clinical narrative: Patient said 3 days after she received the vaccine she broke out with herpies.  She does have history, but it only occurs once or twice a year.  She treated with acyclovir and it resolved.  Then on 10/25 she had an outbreak of shingles.  She was previously vaccinated for shingles
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient complained of redness, itching, and warmth at injection site starting day after injection. Symptoms abating as day progressed. Continued lessening today, 10-26-2020..
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: When she received the shot she said it burned. The next day the area was really sore and by the day after that pt had difficulty lifting her arm. About 4 days after the shot her arm hurt so bad she could not put her arm into gear. Pt went to the dr on 10/22 and the dr told her it was a side effect and prescribed her tramadol for the pain.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea
Clinical narrative: once the patient left the pharmacy after receiving the flu shot (about 35 mins after the injection), patient was shopping and felt very light headed, dizzy and had a little bit of shortness of breath. She said she felt fine when she went home. She said she didn't feel the need to seek treatment. I told her I didn't feel comfortable giving her the flu shot again until she got her doctor's okay. This happened over a year ago and she has no current complaints.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Influenza like illness
Clinical narrative: Fever/shivering (99F or so), fatigue and muscle pain started 12 hours after injection and lasted for one day or so; swelling and rash on the injection site, 2 inches area (started on Day 3 and lasted for one day only); other flu-like symptoms (could not sleep well, shivering, headache, poor appetite) lasted for 3 days or so.  Ibuprofen was taken for 2 days and it was helpful.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Myalgia, Sleep disorder
Clinical narrative: Fever/shivering (99F or so), fatigue and muscle pain started 12 hours after injection and lasted for one day or so; swelling and rash on the injection site, 2 inches area (started on Day 3 and lasted for one day only); other flu-like symptoms (could not sleep well, shivering, headache, poor appetite) lasted for 3 days or so.  Ibuprofen was taken for 2 days and it was helpful.
Age: 27.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: on 10/26/20  at 10:53am, patient came by pharmacy complaining of discomfort and redness and swelling at both injection sites on left and right upper arms.   Boostrix site was still about .75" radius from injection site and the flu shot site had slight redness.   Patient said she never had this much discomfort nor side effects in the past.
Age: 91.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Vomiting
Clinical narrative: Patient received vaccine around 3pm and felt normal. Around 11pm he woke up and had chills and vomited, which dissipated around 2am. Came into pharmacy next afternoon feeling well and normal.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Contusion, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Dark red, hot to touch, swelling from shoulder to forearm, blisters on skin, bruising inside arm due to swelling.  Urgent care pediatrician said it was the worse local reaction to the flu shot she's ever seen.
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness, Presyncope, Syncope
Clinical narrative: After receiving the shot patient had a vasovagal reaction a faint. Patient came back in less than a minute.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: terrible chills, T 100, every joint in her body hurt, terrible headache, skin hurt all over like when you have the "flu", nauseous, stiff neck. fatigue over the course of a few days
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain of skin
Clinical narrative: terrible chills, T 100, every joint in her body hurt, terrible headache, skin hurt all over like when you have the "flu", nauseous, stiff neck. fatigue over the course of a few days
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Nausea, Vomiting
Clinical narrative: Fire Engineer came to clinic for vaccine for PPD, and Flu vaccine. After vaccine administration outside of clinic EE became lightheaded, and was eased to ground by follow employee. Per employee said EE said he felt woozy, and LOC unknown how long. EE was awake and pale when clinic nurse RN went to EE at front of clinic. EE noted to be pale, diaphoretic, and asking to throw up. Ice pack placed on patient for cooling procedures.  Emesis of morning breakfast,  of trail mix and two large cups of coffee.  Nurse called for additional help from staff and EE intial vital sign 106/66 p50, SaO2 99. EE placed in wheel chair and placed into clinic area. Fire Staff notified Chief Supervisor on duty of situation.  1115 am vitals 94/ 62 p 52 SaO2 96 after two minutes room air 99. Per EE normal pulse is 55 blood sugar 100 by figer stick. EE denied any medical history of DM. HTN or any conditions. Did state has been on shift for 40 days.  Peer notified Chief Supervisor and notified EE of alternates of care.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Throat irritation
Clinical narrative: Pt received flu shot the day prior, on 10/23.  It seemed more likely the SHINGRIX would have given her the reaction as she was tolerating the flu shot for a day, plus she has had flu shots, FLUCELVAX specifically, before.  The pt said she came home from work sunday evening and noticed her body and back and part of throat were covered in small bumps, she was bright red like a sunburn, but had no itching, no swelling, no tenderness, no pain. It was only on her trunk, not on her arms or legs or face.  To our knowledge she has had no treatment. Left message with pt's Dr, no response yet.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Fatigue, Headache, Migraine, Mobility decreased
Clinical narrative: Pt's husband states pt had extreme fatigue, unable to get out of bed, HA/Migraine, Weak/slow breathing from 10/21 to 10/25.  Pt took Ibuprofen 600mg and felt better and now without issues.  Pt's husband was counseled to continue monitoring the pt and to inform of other issues as they appear.  Pt did not visit the md since she's better.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Respiratory rate decreased
Clinical narrative: Pt's husband states pt had extreme fatigue, unable to get out of bed, HA/Migraine, Weak/slow breathing from 10/21 to 10/25.  Pt took Ibuprofen 600mg and felt better and now without issues.  Pt's husband was counseled to continue monitoring the pt and to inform of other issues as they appear.  Pt did not visit the md since she's better.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Skin tightness
Clinical narrative: Patient stated that it started out with a  tightness in her arm. Then later that day it turned into numbness of both her ring and pinky finger on her left hand. The numbness is still present 7 days later on 10/26/20 when the patient called in to report the adverse event.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Irritability, Pyrexia, Urticaria
Clinical narrative: Hives, extreme fussiness, low grade fever.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient requested Shingrix vaccine. Pharmacist thought patient requested for Flu vaccine. Flu vaccine was given instead
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection, Pain
Clinical narrative: Herpes Break OUT per patient  on chin, mouth, painfull
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia, Nausea, Nodule
Clinical narrative: muscle pain from neck down  arms. all joints, headaches with no relief with tylenol or aleve, lower  extremities, nausea nausea  LE swelling joint pain rash:  2nd, 3rd, 4th fingers (spots)  Both palms - pink spots (L) arm above elbow - violaceous  papule/nodule.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Papule, Peripheral swelling, Rash
Clinical narrative: muscle pain from neck down  arms. all joints, headaches with no relief with tylenol or aleve, lower  extremities, nausea nausea  LE swelling joint pain rash:  2nd, 3rd, 4th fingers (spots)  Both palms - pink spots (L) arm above elbow - violaceous  papule/nodule.
Age: 65.0
Sex: U
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 3 inch red mark below injection site, feel slightly warm and tender, per patient report by phone to pharmacy on 10/16/2020, 2 days later. Advised patient to see urgent care right away.
Age: 41.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Myalgia, Pain in extremity, Skin warm, Swelling, X-ray
Clinical narrative: After injection patient felt severe arm pain. Thought it was normal but in Continued for a week after. Pain was described as a very deep pain in the muscle that was warm to touch & slight swelling. Patient did say she felt shot was given high up on the arm and took a while to go in. Pt continued to have pain a week after where she then went to her primary doctor who wanted to do an X-Ray. Results are Pending at the time of this Report.
Age: 41.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Injection site pain, Pain, X-ray
Clinical narrative: After injection patient felt severe arm pain. Thought it was normal but in Continued for a week after. Pain was described as a very deep pain in the muscle that was warm to touch & slight swelling. Patient did say she felt shot was given high up on the arm and took a while to go in. Pt continued to have pain a week after where she then went to her primary doctor who wanted to do an X-Ray. Results are Pending at the time of this Report.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Headache, Injection site pain, Mobility decreased, Myalgia
Clinical narrative: Later in day of administration, pt experienced bad headache, muscle aches. Nausea. Arm hard to lift, achy 2 days later still has pain at injectionsite hurts to lift arm. Still has "massive" headache & nausea
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Later in day of administration, pt experienced bad headache, muscle aches. Nausea. Arm hard to lift, achy 2 days later still has pain at injectionsite hurts to lift arm. Still has "massive" headache & nausea
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: Pt started with redness/swelling of leg after flu vaccine. worsened -per parent pt  with significant swelling of leg. Symptoms  improved with Benadryl + Motrin. Mom  reports redness after flu vaccine last year but  not to this extent recommend Allergic evaluation.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Body temperature increased, Urticaria
Clinical narrative: 5 hours after received vaccines pt started with urticaria under her chin. Continued in different areas. No sign of illness. Temp 99.9. No difficulty breathing or vomiting. Resolved with benadryl.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: flu vaccine given by co-worker CRNA in a mall or fluvax clinic on 9/23/00@0845. Injection was placed high in L arm @ Subacromial space per employee. She felt immediate severe pain @ site which lasted @ that intensity for two days before lessening but still present almost 5 wks later - worse in last week no redness swelling or bruising. Pain with certain movements of L arm and especially 5/10 @ night - a constant ache. No prior L arm problems. Pt is right handed - referred to shoulder specialist
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: pt fainted 5 min after administration of the flu shot , with possible seizure . she was seating down. we called 911..she was taken to ER.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Dizziness
Clinical narrative: intermittent dizziness; This spontaneous report was received from a health professional. via and refers to a 17-year-old White (not Hispanic or Latino) female patient. The patient's concurrent conditions included allergy to apple juice, restless sleep, sweating, tiredness and anxiety. She had no known drug allergies. Her medical history was not reported. The patient's concomitant therapies included escitalopram oxalate (LEXAPRO) and unspecified oral contraceptive pills.  On 11-SEP-2019 at 19:50, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (first dose, lot # R017624, expiry date was not reported but upon internal validation was established as 17-MAR-2021, intramuscularly, in the left upper arm; exact dose was not reported), with meningococcal acyw conj vaccine (dip toxoid) (first dose, lot # U6521AA, intramuscularly, in the right upper arm) and with hepatitis a virus vaccine (unspecified) (second dose, lot # BE544, intramuscularly, in the left upper arm), all for prophylaxis.  On 12-SEP-2019, the patient experienced intermittent dizziness that has lasted 7 days thus far. She was being treated with increased hydration and a trial of antihistamine. She was avoiding driving for that time. She needed doctor visit. Her orthostatic blood pressure was testes, however the results were not reported.  The patient did not recover from the event. The causality assessment was not reported.  Follow up received from the registered nurse on behalf of the physician on 22-OCT-2020. The registered nurse stated that they had received some forms in the mail, but it did not contain the patient's information. The registered nurse then stated the following: "I don't know who the patient is, so therefore I can't fill out this form."
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: Pain at injection site at time of injection.  Serious pain in entire arm a few hours later and continuing for a week - fingers on left hand had strange sensations.  Pain in arm gradually subsided.  But by April, noticed pain in left shoulder and limited range of motion in left arm.  Saw primary care on 05/20/2020 and then orthopedist on 06/23/2020.  Had physical therapy 3x week from early July until September.  Some improvement but still difficulty with discomfort attempting to sleep, upon awakening,  and in certain positions and activities during the day.  Difficulty putting certain items of clothing on.  The discomfort is always there - depending on the position of the arm - and range of motion is much more limited than normal.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities, Pain in extremity, Paraesthesia
Clinical narrative: Pain at injection site at time of injection.  Serious pain in entire arm a few hours later and continuing for a week - fingers on left hand had strange sensations.  Pain in arm gradually subsided.  But by April, noticed pain in left shoulder and limited range of motion in left arm.  Saw primary care on 05/20/2020 and then orthopedist on 06/23/2020.  Had physical therapy 3x week from early July until September.  Some improvement but still difficulty with discomfort attempting to sleep, upon awakening,  and in certain positions and activities during the day.  Difficulty putting certain items of clothing on.  The discomfort is always there - depending on the position of the arm - and range of motion is much more limited than normal.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Sleep disorder, Ultrasound scan
Clinical narrative: Pain at injection site at time of injection.  Serious pain in entire arm a few hours later and continuing for a week - fingers on left hand had strange sensations.  Pain in arm gradually subsided.  But by April, noticed pain in left shoulder and limited range of motion in left arm.  Saw primary care on 05/20/2020 and then orthopedist on 06/23/2020.  Had physical therapy 3x week from early July until September.  Some improvement but still difficulty with discomfort attempting to sleep, upon awakening,  and in certain positions and activities during the day.  Difficulty putting certain items of clothing on.  The discomfort is always there - depending on the position of the arm - and range of motion is much more limited than normal.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS, FLU3, VARZOS
Symptoms: Chills, Cough, Dry eye, Eye discharge, Eye pain
Clinical narrative: fever last night; throat congestion; coughing; dry red painful eyes; red painful eyes/Eyes are also very red; swollen eyelids; dry red painful eyes with swollen eyelids and a lot of mucus build-up; Eyes are also very red/discomfort; whole arm shoulder and neck are quite sore; arm soreness; feel achy all over; chills; neck are quite sore; This case was reported by a consumer and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (AFLURIA) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular) and AFLURIA. In October 2020, 1 day after receiving Shingrix, the patient experienced fever, upper respiratory tract congestion, cough, eye dryness, painful red eyes, swelling of eyelid, mucus in eyes, eye discomfort, shoulder soreness, pain in arm, general body pain, chills and neck pain. The patient was treated with allergy medication {nos} (Allergy Drops (Allergy Medication Nos)), artificial tears nos (Artificial Tears) and ophthalmologicals (nos) (Eye Ointment (Ingredients Or Trade Name Unknown)). On an unknown date, the outcome of the fever, upper respiratory tract congestion, cough, eye dryness, painful red eyes, swelling of eyelid, mucus in eyes, eye discomfort, shoulder soreness, pain in arm, general body pain, chills and neck pain were unknown.   It was unknown if the reporter considered the fever, upper respiratory tract congestion, cough, eye dryness, painful red eyes, swelling of eyelid, mucus in eyes, eye discomfort, shoulder soreness, pain in arm, general body pain, chills and neck pain to be related to Shingrix.  Additional details were provided as follows: The patient stated that she had fever. The patient received first shingrix vaccine in evening on 19th October 2020 and also got the flu shot at the same time. About 3 hours afterwards the patient started having throat congestion and coughing.  The patient drank some tea and it resolved. However, the patient also began to experience symptoms with my eyes. The symptoms with my eyes were dry red painful eyes with swollen eyelids and a lot of mucus build-up. It was reported that the eyes were also very red. The patient tried allergy drops and that did not work. The patient was using artificial tears and that seems to relieve the discomfort for about 10 minutes. The patient also put in a lubrication ointment before bed last night  and that also helped some. The patient asked if this could be a side effect of shingrix? The patient stated that some people get the actual shingles infection in their eyes.  The patient was thinking it could just be that a rare side effect. The patient experienced whole arm shoulder and neck were quite sore, the patient felt achy all over and experiencing chills and fever.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS, FLU3, VARZOS
Symptoms: Ocular hyperaemia, Pyrexia, Respiratory tract congestion, Swelling of eyelid
Clinical narrative: fever last night; throat congestion; coughing; dry red painful eyes; red painful eyes/Eyes are also very red; swollen eyelids; dry red painful eyes with swollen eyelids and a lot of mucus build-up; Eyes are also very red/discomfort; whole arm shoulder and neck are quite sore; arm soreness; feel achy all over; chills; neck are quite sore; This case was reported by a consumer and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (AFLURIA) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular) and AFLURIA. In October 2020, 1 day after receiving Shingrix, the patient experienced fever, upper respiratory tract congestion, cough, eye dryness, painful red eyes, swelling of eyelid, mucus in eyes, eye discomfort, shoulder soreness, pain in arm, general body pain, chills and neck pain. The patient was treated with allergy medication {nos} (Allergy Drops (Allergy Medication Nos)), artificial tears nos (Artificial Tears) and ophthalmologicals (nos) (Eye Ointment (Ingredients Or Trade Name Unknown)). On an unknown date, the outcome of the fever, upper respiratory tract congestion, cough, eye dryness, painful red eyes, swelling of eyelid, mucus in eyes, eye discomfort, shoulder soreness, pain in arm, general body pain, chills and neck pain were unknown.   It was unknown if the reporter considered the fever, upper respiratory tract congestion, cough, eye dryness, painful red eyes, swelling of eyelid, mucus in eyes, eye discomfort, shoulder soreness, pain in arm, general body pain, chills and neck pain to be related to Shingrix.  Additional details were provided as follows: The patient stated that she had fever. The patient received first shingrix vaccine in evening on 19th October 2020 and also got the flu shot at the same time. About 3 hours afterwards the patient started having throat congestion and coughing.  The patient drank some tea and it resolved. However, the patient also began to experience symptoms with my eyes. The symptoms with my eyes were dry red painful eyes with swollen eyelids and a lot of mucus build-up. It was reported that the eyes were also very red. The patient tried allergy drops and that did not work. The patient was using artificial tears and that seems to relieve the discomfort for about 10 minutes. The patient also put in a lubrication ointment before bed last night  and that also helped some. The patient asked if this could be a side effect of shingrix? The patient stated that some people get the actual shingles infection in their eyes.  The patient was thinking it could just be that a rare side effect. The patient experienced whole arm shoulder and neck were quite sore, the patient felt achy all over and experiencing chills and fever.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS, FLU3, VARZOS
Symptoms: Arthralgia, Chills, Cough, Dry eye, Eye discharge
Clinical narrative: fever last night; throat congestion; coughing; dry red painful eyes; red painful eyes/Eyes are also very red; swollen eyelids; dry red painful eyes with swollen eyelids and a lot of mucus build-up; Eyes are also very red/discomfort; whole arm shoulder and neck are quite sore; arm soreness; feel achy all over; chills; neck are quite sore; This case was reported by a consumer and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (AFLURIA) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular) and AFLURIA. In October 2020, 1 day after receiving Shingrix, the patient experienced fever, upper respiratory tract congestion, cough, eye dryness, painful red eyes, swelling of eyelid, mucus in eyes, eye discomfort, shoulder soreness, pain in arm, general body pain, chills and neck pain. The patient was treated with allergy medication {nos} (Allergy Drops (Allergy Medication Nos)), artificial tears nos (Artificial Tears) and ophthalmologicals (nos) (Eye Ointment (Ingredients Or Trade Name Unknown)). On an unknown date, the outcome of the fever, upper respiratory tract congestion, cough, eye dryness, painful red eyes, swelling of eyelid, mucus in eyes, eye discomfort, shoulder soreness, pain in arm, general body pain, chills and neck pain were unknown.   It was unknown if the reporter considered the fever, upper respiratory tract congestion, cough, eye dryness, painful red eyes, swelling of eyelid, mucus in eyes, eye discomfort, shoulder soreness, pain in arm, general body pain, chills and neck pain to be related to Shingrix.  Additional details were provided as follows: The patient stated that she had fever. The patient received first shingrix vaccine in evening on 19th October 2020 and also got the flu shot at the same time. About 3 hours afterwards the patient started having throat congestion and coughing.  The patient drank some tea and it resolved. However, the patient also began to experience symptoms with my eyes. The symptoms with my eyes were dry red painful eyes with swollen eyelids and a lot of mucus build-up. It was reported that the eyes were also very red. The patient tried allergy drops and that did not work. The patient was using artificial tears and that seems to relieve the discomfort for about 10 minutes. The patient also put in a lubrication ointment before bed last night  and that also helped some. The patient asked if this could be a side effect of shingrix? The patient stated that some people get the actual shingles infection in their eyes.  The patient was thinking it could just be that a rare side effect. The patient experienced whole arm shoulder and neck were quite sore, the patient felt achy all over and experiencing chills and fever.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS, FLU3, VARZOS
Symptoms: Eye pain, Neck pain, Ocular discomfort, Pain, Pain in extremity
Clinical narrative: fever last night; throat congestion; coughing; dry red painful eyes; red painful eyes/Eyes are also very red; swollen eyelids; dry red painful eyes with swollen eyelids and a lot of mucus build-up; Eyes are also very red/discomfort; whole arm shoulder and neck are quite sore; arm soreness; feel achy all over; chills; neck are quite sore; This case was reported by a consumer and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (AFLURIA) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular) and AFLURIA. In October 2020, 1 day after receiving Shingrix, the patient experienced fever, upper respiratory tract congestion, cough, eye dryness, painful red eyes, swelling of eyelid, mucus in eyes, eye discomfort, shoulder soreness, pain in arm, general body pain, chills and neck pain. The patient was treated with allergy medication {nos} (Allergy Drops (Allergy Medication Nos)), artificial tears nos (Artificial Tears) and ophthalmologicals (nos) (Eye Ointment (Ingredients Or Trade Name Unknown)). On an unknown date, the outcome of the fever, upper respiratory tract congestion, cough, eye dryness, painful red eyes, swelling of eyelid, mucus in eyes, eye discomfort, shoulder soreness, pain in arm, general body pain, chills and neck pain were unknown.   It was unknown if the reporter considered the fever, upper respiratory tract congestion, cough, eye dryness, painful red eyes, swelling of eyelid, mucus in eyes, eye discomfort, shoulder soreness, pain in arm, general body pain, chills and neck pain to be related to Shingrix.  Additional details were provided as follows: The patient stated that she had fever. The patient received first shingrix vaccine in evening on 19th October 2020 and also got the flu shot at the same time. About 3 hours afterwards the patient started having throat congestion and coughing.  The patient drank some tea and it resolved. However, the patient also began to experience symptoms with my eyes. The symptoms with my eyes were dry red painful eyes with swollen eyelids and a lot of mucus build-up. It was reported that the eyes were also very red. The patient tried allergy drops and that did not work. The patient was using artificial tears and that seems to relieve the discomfort for about 10 minutes. The patient also put in a lubrication ointment before bed last night  and that also helped some. The patient asked if this could be a side effect of shingrix? The patient stated that some people get the actual shingles infection in their eyes.  The patient was thinking it could just be that a rare side effect. The patient experienced whole arm shoulder and neck were quite sore, the patient felt achy all over and experiencing chills and fever.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS, FLU3, VARZOS
Symptoms: Pyrexia, Swelling of eyelid, Upper respiratory tract congestion
Clinical narrative: fever last night; throat congestion; coughing; dry red painful eyes; red painful eyes/Eyes are also very red; swollen eyelids; dry red painful eyes with swollen eyelids and a lot of mucus build-up; Eyes are also very red/discomfort; whole arm shoulder and neck are quite sore; arm soreness; feel achy all over; chills; neck are quite sore; This case was reported by a consumer and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (AFLURIA) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular) and AFLURIA. In October 2020, 1 day after receiving Shingrix, the patient experienced fever, upper respiratory tract congestion, cough, eye dryness, painful red eyes, swelling of eyelid, mucus in eyes, eye discomfort, shoulder soreness, pain in arm, general body pain, chills and neck pain. The patient was treated with allergy medication {nos} (Allergy Drops (Allergy Medication Nos)), artificial tears nos (Artificial Tears) and ophthalmologicals (nos) (Eye Ointment (Ingredients Or Trade Name Unknown)). On an unknown date, the outcome of the fever, upper respiratory tract congestion, cough, eye dryness, painful red eyes, swelling of eyelid, mucus in eyes, eye discomfort, shoulder soreness, pain in arm, general body pain, chills and neck pain were unknown.   It was unknown if the reporter considered the fever, upper respiratory tract congestion, cough, eye dryness, painful red eyes, swelling of eyelid, mucus in eyes, eye discomfort, shoulder soreness, pain in arm, general body pain, chills and neck pain to be related to Shingrix.  Additional details were provided as follows: The patient stated that she had fever. The patient received first shingrix vaccine in evening on 19th October 2020 and also got the flu shot at the same time. About 3 hours afterwards the patient started having throat congestion and coughing.  The patient drank some tea and it resolved. However, the patient also began to experience symptoms with my eyes. The symptoms with my eyes were dry red painful eyes with swollen eyelids and a lot of mucus build-up. It was reported that the eyes were also very red. The patient tried allergy drops and that did not work. The patient was using artificial tears and that seems to relieve the discomfort for about 10 minutes. The patient also put in a lubrication ointment before bed last night  and that also helped some. The patient asked if this could be a side effect of shingrix? The patient stated that some people get the actual shingles infection in their eyes.  The patient was thinking it could just be that a rare side effect. The patient experienced whole arm shoulder and neck were quite sore, the patient felt achy all over and experiencing chills and fever.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Injection site pain, Joint range of motion decreased
Clinical narrative: Right deltoid pain progressing to limited range of motion and weakness
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Lymphangitis, Pain, Skin warm
Clinical narrative: lymphangitis 48 hours after immunization (pain, warmth, red streak down left arm extending from axilla, lymphadenopathy of left axilla)  provided medrol dosepak and doxycycline
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus
Clinical narrative: Very itchy all over my body. No new foods or drinks or anything to cause it. It started at my neck and worked its way all over my body. My scalp even got itchy.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored VARIVAX administered to patient; No adverse event; This non-valid spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, and previous drug allergies or reactions were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis  (dose and vaccination scheme frequency, were unknown by the reporter; route of administration and anatomical location were not reported; lot number T006345 with expiration date 20-FEB-2022 and T010298 with expiration date of 24-MAR-2022). It was unknown which of the two lot numbers was the one administered to the patient. The administered dose of the vaccine experienced a temperature excursion on 03-OCT-2020, at -6 degrees Celsius for 3 hours, as recorded by a data logger (product storage error); there were not previous temperature excursions.  This case was considered to be non-valid due to the lack of patient's identifiers.  As of 16-OCT-2020, an inbound telephone call was received from the clinic manager and Licensed Practical nurse who informed that the varicella virus vaccine live (oka/merck) (VARIVAX) administered to the patient was safe and no adverse event occurred, nor no side effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: GARDASIL 9 was given to a patient on October 9, 2020 after undergoing a temperature excursion; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 09-OCT-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: S022598, expiration date: 25-FEB-2022, 0.5 milliliter; route was unknown) for prophylaxis. The vaccine was undergoing a temperature excursion of below 36 degrees Fahrenheit (16.5 degrees Fahrenheit) for 1 hour and above 47 degrees Fahrenheit (73 degrees Fahrenheit) for 4 hours (product storage error). There were no previous temperature excursions. There was no digital data logger involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S022598; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability.