chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: FLUA4
Symptoms: Plasmapheresis, Red blood cell sedimentation rate normal, Vitamin B12 normal, Walking aid user
Clinical narrative: The patient received influenza high dose quadrivalent vaccine on 9/3/2020.  He woke up 09/18/2020 at 4:00 AM with the inability to stand.  He was completely normal on the evening before he went to bed (21-22:00).  He fell a few times because he could not lock his legs.  He denied numbness in the feet.  He came to the ED 9/20/2020 and wanted to be discharged home with pain medications and close monitoring, of which he was able to walk with a walker. The patient was admitted to Hospital on 9/21/2020 with sudden onset leg weakness and numbness in the hands. The numbness was involving the inner surface of the hands and slightly in the forearm.  He did not think he is weak in the arms.  He denied any recent trauma.  He had a fall a few days ago, bruising his knees- after the onset of leg weakness. The patient also complained of a transient episode of severe leg and low back pain that started 9/20/2020 and resolved with narcotics. He also complained of a two day history of severe neck pain, radiating to the back of the head, and between the scapular region. The pain was sudden in onset and it spontaneously resolved.  The pain occurred three days before he developed weakness in the legs. Neurology consulted and diagnosed the patient with Guillain-Barré syndrome (GBS). The patient was given 25g of 10% immune globulin IV on 9/21/2020 at 20:33. The patient experienced hypertension that may have been exacerbated by IVIG volume, so treatment was changed to plasma exchange (PLEX) once every other day for a total of 5 treatments over 10 days. Today on 9/25/2020, the patient continues to have weakness in his legs.  He is having trouble swallowing and coughing.  He is receiving the second PLEX session. He still remains hospitalized on 9/25/2020.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient felt ok right after getting the shot, but due to her past history of fainting, she was asked to stay at the pharmacy afterward. After 5 minutes or so, pt passed out, loss of consciousness for 30 seconds or so
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Dizziness, Feeling abnormal, Headache, Nausea, Neck pain
Clinical narrative: Racing heart beginning 1/2 hr later, lasting 2 hrs?  Headache, mostly in neck and jaw, still present  Dizziness, extreme beginning about an hr later, finishing but still present at times Nausea beginning 1/2 hr later, diminishing still present Fuzzy thinking, still present
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pain in jaw, Palpitations
Clinical narrative: Racing heart beginning 1/2 hr later, lasting 2 hrs?  Headache, mostly in neck and jaw, still present  Dizziness, extreme beginning about an hr later, finishing but still present at times Nausea beginning 1/2 hr later, diminishing still present Fuzzy thinking, still present
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: High fever for two days (102-103 deg F). Never had any reaction to previous flu vaccinations, or any other vaccines). Back to normal after two days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Malaise, Pain
Clinical narrative: Chills initially then a feeling of strong malaise. Feeling faint. I had to leave work because felt like I was beaten up  and have no energy. I am very sore and tired. This is my second dose. First dose of vaccine was on 3/5/20 and I felt exhausted for nearly a month.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Disorientation, Disturbance in attention, Erythema, Fatigue
Clinical narrative: I had shingles in the early 1990's .  I consulted with a nurse, who is a friend, about the shingles vaccination, and she recommended I still take it. I told her about my previous episode with shingles. (This morning I checked with web site, which states it unlikely I would again contract shingles. Perhaps I should have consulted with that before getting the vaccination.)  Within a couple hours of the vaccine I felt stiffness in my left arm where the vaccination was administered. Around 7:00PM, I began to feel flush, and hot. I felt my forehead and did not detect a fever. I did not feel like I had symptoms of the flu. My head turned reddish. This continued throughout the evening.   I was functioning: I am the primary caregiver for my 100 year old Mom, and tended to her as I usually would. I cooked dinner,  set the table, after dinner I helped her to bed, and then I did the dishes. The hotness and some stiffness continued. I also felt a slight disorientation, and weakness. I usually shower before going to bed, but I thought this was not a good idea. I was losing strength and concentration.   I went to bed around 11:15PM. During the night I had some slight sweating, but again, this did not feel like the flu. During the night the hotness remained, and some stiffness. As early morning approached the hotness had mostly dissipated. I did sleep in because I was tired, and it was a day off for me. I did my usual morning exercises and stretching, thinking those may speed recovery. I think it helped.  I made breakfast for my Mom and myself, and as of now 12:25PM, I am felling much better, but there is some residual weakness, but not the hotness nor flushing.  I am of mind to not get the second, follow-up vaccine.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Flushing, Hyperhidrosis, Musculoskeletal stiffness
Clinical narrative: I had shingles in the early 1990's .  I consulted with a nurse, who is a friend, about the shingles vaccination, and she recommended I still take it. I told her about my previous episode with shingles. (This morning I checked with web site, which states it unlikely I would again contract shingles. Perhaps I should have consulted with that before getting the vaccination.)  Within a couple hours of the vaccine I felt stiffness in my left arm where the vaccination was administered. Around 7:00PM, I began to feel flush, and hot. I felt my forehead and did not detect a fever. I did not feel like I had symptoms of the flu. My head turned reddish. This continued throughout the evening.   I was functioning: I am the primary caregiver for my 100 year old Mom, and tended to her as I usually would. I cooked dinner,  set the table, after dinner I helped her to bed, and then I did the dishes. The hotness and some stiffness continued. I also felt a slight disorientation, and weakness. I usually shower before going to bed, but I thought this was not a good idea. I was losing strength and concentration.   I went to bed around 11:15PM. During the night I had some slight sweating, but again, this did not feel like the flu. During the night the hotness remained, and some stiffness. As early morning approached the hotness had mostly dissipated. I did sleep in because I was tired, and it was a day off for me. I did my usual morning exercises and stretching, thinking those may speed recovery. I think it helped.  I made breakfast for my Mom and myself, and as of now 12:25PM, I am felling much better, but there is some residual weakness, but not the hotness nor flushing.  I am of mind to not get the second, follow-up vaccine.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Discomfort, Hypophagia
Clinical narrative: Seen for her one year physical 4 days; mom notes that she developed a rash about 24 hours after vaccination; noted initially on the chin and the neck, few on the forehead at the hairline; she started to feel warm but no documented fever as per mom; that evening and the next day the rash started to move towards her chest, trunk and her legs; she is acting normally and she doesn't appear to be itching/in pain; she was uncomfortable the night of her vaccinations but this resolved; there is no lesion at the injection sites; she had mildly decreased po intake the day of the vaccines but this also resolved; no other rash in the family; no runny nose or cough; normal urine output and no vomiting or diarrhea; no creams or lotions; using aveeno; she has no new foods introduced; no wheezing;
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: pt got shot in left arm on 9/16/20 and on 9/19/20 she noticed a warm red circle area about 3 inches in diameter. the outer edge was located about 2-3 inches away from the original vaccine site.
Age: 70.0
Sex: M
Vaccine: FLUA4
Symptoms: Mobility decreased, Pain in extremity, Skin discolouration
Clinical narrative: Patient stated that after receiving his vaccination (approximately 2 days afterwards) his arm was sore, hard to move a and little yellowish.
Age: 77.0
Sex: F
Vaccine: FLUA4, PNC13
Symptoms: Arthralgia, Mass, Pain, Skin warm
Clinical narrative: Patient stated that she had" a red 4 inch lump that was hot feverish that is painful" she also said her shoulder was in pain. I told her to contact her physician if the pain doesn't go away
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: After injection in right upper arm, has pain, and can not raise arm.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: Gave patient a vaccine that expired on 9/14/2020.
Age: 74.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Erythema, Pain, Pruritus, Urticaria
Clinical narrative: patient had a large red raised area that look like a big hive that was on the front of the shoulder that went over to the chest area. it was not on the area of where the vaccine would have been injected. patient says that it is itchy and that it is sore if it is touched. patient had the vaccine on 9/19 and he said he believes that the area appeared on 9/21. it was reported to us on 9/25. he states that it has not gotten worse or better, that it has stayed the same. advised that patient could take some Benadryl and Tylenol. also advised since it had been awhile since getting the shot and that it wasn't any better, that he should contact his doctor to let them know.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: PATIENT RECEIVED FLUZONE HD ON 9/24/20, RETURNED TO PHARMACY THE NEXT DAY 9/25/20. PATIENT COMPLAINED OF REDNESS (SIZE OS A HAND) ITCHINESS AND HEAT AROUND THE SITE.  PATIENT WAS ADVISED TO TAKE OTC ANTI HISTAMINE, USE HYDROCORTISONE CREAM AND COLD COMPRESS AND MONITOR.  PT WAS ADVISED TO CONTACT DR IF SYMPTOMS DON'T IMPROVE OR WORSENS.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: On 9/15/20 at 8 PM injection site became red,  warm to touch, painful  and itchy. On 9/16/20 6 AM had headache,dizzy, nauseated. On 9/17 6 AM had a raised,  red itchy rash from my neck down to my thighs front and back,  still red and warm at injection site. Dizziness and nausea gone. Rash lasted for 2 days.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site warmth, Nausea, Rash papular, Rash pruritic
Clinical narrative: On 9/15/20 at 8 PM injection site became red,  warm to touch, painful  and itchy. On 9/16/20 6 AM had headache,dizzy, nauseated. On 9/17 6 AM had a raised,  red itchy rash from my neck down to my thighs front and back,  still red and warm at injection site. Dizziness and nausea gone. Rash lasted for 2 days.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Aspiration, Dyspnoea, Headache, Nausea, Pain
Clinical narrative: Vomited in my sleep. Was unable to inhale for perhaps 45 seconds after inhaling vomit after 2nd dose. I was also unable to leave home for about 36 hours with severe headache, nausea, body aches and fever after both doses.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomited in my sleep. Was unable to inhale for perhaps 45 seconds after inhaling vomit after 2nd dose. I was also unable to leave home for about 36 hours with severe headache, nausea, body aches and fever after both doses.
Age: 30.0
Sex: M
Vaccine: FLUR4
Symptoms: Anxiety, Laboratory test, Urticaria
Clinical narrative: Adverse event - Hives all over body evening of vaccination Treatment - Patient presented to ER evening of 9/24/2020, was observed and given Benadryl and Pepcid Outcome - Patient released from ER morning of 9/25/2020, was prescribed Claritin daily, Benadryl daily, and Pepcid 2xdaily.  At time of interview patient continues with hives and states has mild anxiety due to worry of further reaction.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pt was given fluzone HD quad for pt's over 65yrs old. She is only 61 yrs old.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Ageusia, Asthenia, Chills, Cough, Diarrhoea
Clinical narrative: Chills (shaking), Nausea, diarrhea, numbness tingling in fingers, weakness, some loss of taste, pressure in both ears, dry cough
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Ear discomfort, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: Chills (shaking), Nausea, diarrhea, numbness tingling in fingers, weakness, some loss of taste, pressure in both ears, dry cough
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Severe nausea and stomach pain beginning a few hours (3:00PM) after the injection, with ongoing moderate symptoms as of 9/25/2020.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Expired product administered
Clinical narrative: Patient vaccinated today with expired Proquad dated 9/16/20. Merck notified- states based on the vaccine expiration date and todays date the stability of the vaccine is good. However, it is up to the provider to decide whether or not to re-vaccinate this patient. Case number. Dr.  informed of the above information and has chosen not to vaccinate the patient again.
Age: 9.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia
Clinical narrative: patient received vaccine with no incident.  Upon finishing the vaccine, her sister, who was holding her opposite hand began to collapse which slightly pulled on the opposite arm (left arm, the arm receiving the vaccine).  the patient later complained of soreness/pain in her shoulder.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Numbness and weakness of arm
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Vertigo
Clinical narrative: headache and vertigo
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash papular
Clinical narrative: 9/17/2020 Developed systemic rash, red papule covering trunk, legs, arms. It appeared approximately 12 hours after receiving vaccine.  Patient took 50mg of Benadryl oral the evening and used 1% cortisone cream topically.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Cough, Fatigue, Headache, Pain
Clinical narrative: Chills, cough, headache on the evening of the vaccine turning to fever and chills, headache, cough, and body aches early this morning.  Today, same symptoms with fatique
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Chills, cough, headache on the evening of the vaccine turning to fever and chills, headache, cough, and body aches early this morning.  Today, same symptoms with fatique
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site pain, Local reaction, Paraesthesia, Pruritus
Clinical narrative: Patient developed local reaction to injection with itching, localized erythema. Increased pain at injection site. Tingling of left upper extremity with certain arm movements, but this may be secondary to chronic injury. Appeared one day after injection. Itching mildly improved with diphenhydramine.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chills, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Pt states that about 3 days after his vaccine he developed a sore arm, chills, severe tremors, ringing in ears, fever and drowsiness and low energy.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Tinnitus, Tremor
Clinical narrative: Pt states that about 3 days after his vaccine he developed a sore arm, chills, severe tremors, ringing in ears, fever and drowsiness and low energy.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Nausea
Clinical narrative: pt  complained of headache and nausea several hours after receiving vaccine
Age: 93.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pt received Fluzone HD Quad on 09/04/20. He reported to the pharmacy on 9/25/20 stating that he is still experiencing pain at the site of injection
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Patient developed swelling and redness at site of injection the night of vaccine and developed hives on trunk and arms two days after receiving vaccine.
Age: 30.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills, Deafness, Hyperhidrosis, Injection site pain, Pyrexia
Clinical narrative: Pain at injection site, lost hearing and fainted for short period of time, fever and severe chills and sweating for about 1 hour
Age: 30.0
Sex: F
Vaccine: FLUA3
Symptoms: Syncope
Clinical narrative: Pain at injection site, lost hearing and fainted for short period of time, fever and severe chills and sweating for about 1 hour
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Patient had redness swelling around the injection site. Red ring around bicep.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Back injury, Fatigue, Feeling abnormal, Feeling hot, Head injury
Clinical narrative: Patient was given a flu shot at the pharmacy and was feeling fine right afterwards.  The patient and his family shopped a little while and came back to the pharmacy to checkout.  It was about 5-10 minutes since he received the flu shot when he suddenly collapsed to the floor and fainted.  His mom was able to catch him so he only bumped the back of his head slightly on the floor.  EMS was immediately notified.  I was also immediately notified and went around the pharmacy counter to see how I could assist.  By the time I went to the patient's side, he opened his eyes and was conscious.  He was unconscious for about 5 seconds.  The patient complained of being hot and very tired and his face was very pale.  Mom mentioned that he had slight tremors while he was unconscious also.  Patient had some cold water while he was sitting on the floor.  EMS arrived about 5 minutes later and took over.  They took the patient's vital signs.  While this occurred, the patient vomited a couple times.  Once the patient looked stable, EMS recommended transport to the hospital for monitoring and tests.  His parents agreed to this and they left the pharmacy.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Laboratory test, Loss of consciousness, Pallor, Syncope, Tremor
Clinical narrative: Patient was given a flu shot at the pharmacy and was feeling fine right afterwards.  The patient and his family shopped a little while and came back to the pharmacy to checkout.  It was about 5-10 minutes since he received the flu shot when he suddenly collapsed to the floor and fainted.  His mom was able to catch him so he only bumped the back of his head slightly on the floor.  EMS was immediately notified.  I was also immediately notified and went around the pharmacy counter to see how I could assist.  By the time I went to the patient's side, he opened his eyes and was conscious.  He was unconscious for about 5 seconds.  The patient complained of being hot and very tired and his face was very pale.  Mom mentioned that he had slight tremors while he was unconscious also.  Patient had some cold water while he was sitting on the floor.  EMS arrived about 5 minutes later and took over.  They took the patient's vital signs.  While this occurred, the patient vomited a couple times.  Once the patient looked stable, EMS recommended transport to the hospital for monitoring and tests.  His parents agreed to this and they left the pharmacy.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Patient was given a flu shot at the pharmacy and was feeling fine right afterwards.  The patient and his family shopped a little while and came back to the pharmacy to checkout.  It was about 5-10 minutes since he received the flu shot when he suddenly collapsed to the floor and fainted.  His mom was able to catch him so he only bumped the back of his head slightly on the floor.  EMS was immediately notified.  I was also immediately notified and went around the pharmacy counter to see how I could assist.  By the time I went to the patient's side, he opened his eyes and was conscious.  He was unconscious for about 5 seconds.  The patient complained of being hot and very tired and his face was very pale.  Mom mentioned that he had slight tremors while he was unconscious also.  Patient had some cold water while he was sitting on the floor.  EMS arrived about 5 minutes later and took over.  They took the patient's vital signs.  While this occurred, the patient vomited a couple times.  Once the patient looked stable, EMS recommended transport to the hospital for monitoring and tests.  His parents agreed to this and they left the pharmacy.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Dysuria, Pyrexia
Clinical narrative: Fever, chills, urinary pain.  "felt like when [he] had sepsis before".    this was his second dose and reports to reaction from first dose. Reports dizziness persists and his blood pressure was 80/60 at one point.  Back to 117/76 today.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV
Symptoms: Unevaluable event
Clinical narrative: Treatment included monitoring for 30 minutes
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cardiac stress test normal, Chest discomfort, Computerised tomogram thorax, Dyspnoea, Echocardiogram normal
Clinical narrative: 1) Swelling, pain, tenderness, redness of entire left arm from shoulder to wrist, fever 100.5. Physician observed and ordered Augmentin x 7 days. Symptoms slowly improved over about two weeks. 2) Tachycardia, irregular heart beat, chest pressure, shortness of breath, fatigue beginning two days after vaccine and although I feel better now, symptoms are still present at the time of this report (lasting over a month)
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Electrocardiogram, Electrocardiogram ambulatory normal, Electrocardiogram normal, Erythema, Extensive swelling of vaccinated limb
Clinical narrative: 1) Swelling, pain, tenderness, redness of entire left arm from shoulder to wrist, fever 100.5. Physician observed and ordered Augmentin x 7 days. Symptoms slowly improved over about two weeks. 2) Tachycardia, irregular heart beat, chest pressure, shortness of breath, fatigue beginning two days after vaccine and although I feel better now, symptoms are still present at the time of this report (lasting over a month)
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fatigue, Heart rate irregular, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 1) Swelling, pain, tenderness, redness of entire left arm from shoulder to wrist, fever 100.5. Physician observed and ordered Augmentin x 7 days. Symptoms slowly improved over about two weeks. 2) Tachycardia, irregular heart beat, chest pressure, shortness of breath, fatigue beginning two days after vaccine and although I feel better now, symptoms are still present at the time of this report (lasting over a month)
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Laboratory test normal, Pain in extremity, Pulmonary function test, Pyrexia, SARS-CoV-2 test
Clinical narrative: 1) Swelling, pain, tenderness, redness of entire left arm from shoulder to wrist, fever 100.5. Physician observed and ordered Augmentin x 7 days. Symptoms slowly improved over about two weeks. 2) Tachycardia, irregular heart beat, chest pressure, shortness of breath, fatigue beginning two days after vaccine and although I feel better now, symptoms are still present at the time of this report (lasting over a month)
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Tachycardia, Tenderness
Clinical narrative: 1) Swelling, pain, tenderness, redness of entire left arm from shoulder to wrist, fever 100.5. Physician observed and ordered Augmentin x 7 days. Symptoms slowly improved over about two weeks. 2) Tachycardia, irregular heart beat, chest pressure, shortness of breath, fatigue beginning two days after vaccine and although I feel better now, symptoms are still present at the time of this report (lasting over a month)
Age: 17.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Paraesthesia, Skin warm, Tinnitus
Clinical narrative: Patient experienced tingling in her arm immediately after the vaccine.  Minutes later, the tingling moved into her entire body and she passed out in the store.  She was out for approximately 30 seconds.  Her right arm was very warm compared to the rest of her body.  She also reported ringing in both of her ears immediately after the vaccine was administered.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Electrocardiogram normal, Fatigue, Headache, Hypotension
Clinical narrative: pt called morning after shingrix admin w/ c/o nausea, near syncope, lightheadedness, widespread body aches, headache, and fatigue. Pt evaluated in ED with BP of 97/64 (low for pt) she was given NS bolus, oral ondansetron, and diphenhydramine. She was discharged as stable and is to follow up with PCP with failure to improve or return to ED with worsening.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Presyncope
Clinical narrative: pt called morning after shingrix admin w/ c/o nausea, near syncope, lightheadedness, widespread body aches, headache, and fatigue. Pt evaluated in ED with BP of 97/64 (low for pt) she was given NS bolus, oral ondansetron, and diphenhydramine. She was discharged as stable and is to follow up with PCP with failure to improve or return to ED with worsening.
Age: 76.0
Sex: F
Vaccine: FLUR4
Symptoms: Asthenia, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: Also received Shingrix First Series Left Deltoid IM Lot# 7SK92. Didn't feel good about an hour after immunization.  Felt bad all day and the next morning (09-25-20)   had diarrhea starting around 6:30AM.  Contines to feel week and tired. Told to stay home and symptoms should resolve by Monday (09-28-2020).
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, warm area around injection site, about 3 inches in diameter that did not resolve when an ice pack was used.  No systemic fever or chills, redness elsewhere.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Myalgia
Clinical narrative: sore arm, mild; tiredness, muscle pain, headache, shivering, fever, stomach pain, nausea, lasting from Wed. night to Fri morning.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: sore arm, mild; tiredness, muscle pain, headache, shivering, fever, stomach pain, nausea, lasting from Wed. night to Fri morning.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Malaise, Nausea
Clinical narrative: fatigue, feeling unwell, nausea
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Rash vesicular
Clinical narrative: Patient came into pharmacy 9/25 and states that she has a blistery rash on her armpit and chest that started when she received her flu vaccine on 9/15.
Age: 71.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Pain in extremity, Swelling
Clinical narrative: swelling, soreness, pain in left arm
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain started in right arm and spread to whole body over 24 hours
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain in jaw, Pyrexia, Toothache
Clinical narrative: Patient experienced fever 99.5 degrees F, molar/jaw pain, and neck pain that began the night of receiving flu vaccine. Patient used OTC ibuprofen for symptomatic relief. Per patient, first time receiving high dose flu shot.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Redness, warmth, swelling, pain of R arm. Appeared consistent with cellulitis.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Erythema, Pyrexia, Skin warm
Clinical narrative: Patient called with concerns after getting flu shot.  Experienced redness from shoulder to elbow, warm to touch, fever and chills for one day.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: patient said his arm is red from shoulder to elbow
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site haemorrhage
Clinical narrative: after vaccination the patient began to bleed. a bandaid was applied. Within seconds the area where the injection was given had bubbled up and the blood had soaked through the bandaid. The patient reported that it did not hurt but was given an ice pack to apply to the area.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Hypersensitivity, Influenza like illness, Injection site erythema
Clinical narrative: pt states on 9/23 had flu-like symptoms and noticed redness at injection site-redness spread-seeked medical help and md diagnosed as allergic reaction-rph 98% sure pt recevied pneumovax 23 in left arm where allergic reaction site is
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia, Visual impairment
Clinical narrative: Patient reports experiencing a change in vision approximately 15-20 minutes after receiving the Shingrix vaccination.  Patient reports fluttering/wavy lines in the perphery of her right eye.  Also reported numbness or tingling in her left hand and on the right side of her head.  Symptoms resolved within one hour.  Patient made an emergency room visit to address symptoms.  She made a visit to an optometrist.  Patient reports that the ER ruled out stroke and that the optometrist reported the retina/ocular nerve appeared normal.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: Body temperature increased, Dizziness, Fatigue
Clinical narrative: Dizziness, Fatigue started around 4PM on 9/22/2020.  Patient claims he slept for about an hour from fatigue but when woke up from phone ringing, he did not realized he had slept and he may have passed out because he does not remember going to sleep.  Around 7PM, his temperature was 101F oral.  He claims his temperature has been getting better as of today, Friday 9/25/2020 around 12PM and did not record it but his fatigue is better also.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Dehydration, Diarrhoea, Extra dose administered, Wrong product administered
Clinical narrative: Patient received a dose of FluAd on 9/5/20, Patient already received flu vaccine of Fluzone HD on 8/25/20. Patient stated that she had extreme diarrhea and dehydration for several days after the second vaccination. Patient came in for a Shingles vaccine instead the patient received another HD flu vaccine.
Age: 37.0
Sex: F
Vaccine: FLUR4
Symptoms: Blood pressure increased, Dyspnoea, Heart rate increased, Hyperventilation, Hypoaesthesia
Clinical narrative: On 09/23/2020 patient came in to receive a flu shot. FluBlok was administered to left deltoid of patient. Rx# 6706598. Approximately 10 minutes after receiving the flu shot, patient came to pharmacy window complaining of tingling sensation in her left arm and thumb. I then advised her to come into the immunization room for further screening and questions. Patient has received flu shot in the past and denied any prior reactions to flu shots or vaccines in the past, and denied having any underlying health conditions or taking any medications. As patient was sitting in the vaccination room, she complained of the numbing sensation now going up her entire left arm and losing feeling in all 5 left fingers, blurry vision, inability to feel her face, and could no longer speak in full sentences due to shortness of breath. This is when I called 911. The paramedics arrived within minutes and immediately checked patient?s vitals and began questioning. Her blood pressure and heart rate were significantly elevated and paramedics performed breathing exercises with patient as she continued to hyperventilate. After 15 minutes, patient?s hyperventilation and vitals did not subside, and the paramedics decided it was best to take the patient to the hospital as they could not diagnose her at the scene. We later confirmed with the paramedics and they were concluding that it might have been a panic attack.
Age: 37.0
Sex: F
Vaccine: FLUR4
Symptoms: Paraesthesia, Sensory loss, Speech disorder, Vision blurred
Clinical narrative: On 09/23/2020 patient came in to receive a flu shot. FluBlok was administered to left deltoid of patient. Rx# 6706598. Approximately 10 minutes after receiving the flu shot, patient came to pharmacy window complaining of tingling sensation in her left arm and thumb. I then advised her to come into the immunization room for further screening and questions. Patient has received flu shot in the past and denied any prior reactions to flu shots or vaccines in the past, and denied having any underlying health conditions or taking any medications. As patient was sitting in the vaccination room, she complained of the numbing sensation now going up her entire left arm and losing feeling in all 5 left fingers, blurry vision, inability to feel her face, and could no longer speak in full sentences due to shortness of breath. This is when I called 911. The paramedics arrived within minutes and immediately checked patient?s vitals and began questioning. Her blood pressure and heart rate were significantly elevated and paramedics performed breathing exercises with patient as she continued to hyperventilate. After 15 minutes, patient?s hyperventilation and vitals did not subside, and the paramedics decided it was best to take the patient to the hospital as they could not diagnose her at the scene. We later confirmed with the paramedics and they were concluding that it might have been a panic attack.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Felt Feverish, headache, muscle aches, stomach pain, fatigued. Next day developed a fine rash on lower chest and back. Took Motrin for the headache and muscle pain. Took Zertec 24 hr for the rash. Called nurse advice line.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Felt Feverish, headache, muscle aches, stomach pain, fatigued. Next day developed a fine rash on lower chest and back. Took Motrin for the headache and muscle pain. Took Zertec 24 hr for the rash. Called nurse advice line.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Patient reported bruising around the site of injection that started 2 days after injection. Bruising still on 9/25/20.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient's site of injection is still painful and sore after two weeks since shot given
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Cytogenetic analysis normal, Disturbance in social behaviour, Language disorder, Metabolic function test normal, Nervous system disorder
Clinical narrative: Mother came today asking for school letter to not get mmr. She said that child had  following vaccination fever followed by a neurological reaction. There is documentation of temp 100F, om and uri on 10/31/2016 However more notable is the exam on 2/2/17 were a regression in speech was documented also decreased socializing.  A work up was initiated and child was referred. Speech therapy was started  diagnosed with receptive expressive language disorder, as well as occupational therapy. By age 4 his language has improved and therapy stopped This may or may not be a vaccine reaction but was unusual (documented temporary regression following vaccination).
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Speech disorder developmental, Upper respiratory tract infection
Clinical narrative: Mother came today asking for school letter to not get mmr. She said that child had  following vaccination fever followed by a neurological reaction. There is documentation of temp 100F, om and uri on 10/31/2016 However more notable is the exam on 2/2/17 were a regression in speech was documented also decreased socializing.  A work up was initiated and child was referred. Speech therapy was started  diagnosed with receptive expressive language disorder, as well as occupational therapy. By age 4 his language has improved and therapy stopped This may or may not be a vaccine reaction but was unusual (documented temporary regression following vaccination).
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had redness and swelling around the injection site, described as 5" in diameter.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Bedridden, Erythema, Injection site swelling, Loss of personal independence in daily activities, Peripheral swelling
Clinical narrative: PATIENT'S FAMILY IS REPORTING THE PATIENT IS CURRENTLY BEDBOUND AND MISSING WORK DUE TO EXTREME SWELLING AT THE INJECTION SITE. THE ARM IS REPORTEDLY RED, TENDER, AND SWOLLEN. PATIENT WAS SEEN BY A LOCAL CLINIC ON 9/25/2020. PATIENT'S REPRESENTATIVES WERE ADVISED TO MONITOR SWELLING BY DEMARCATING THE AREA WITH A MARKER, AND TO SEEK ADDITIONAL TREATMENT IF CONDITION PERSISTS OR GROWS.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Tenderness
Clinical narrative: PATIENT'S FAMILY IS REPORTING THE PATIENT IS CURRENTLY BEDBOUND AND MISSING WORK DUE TO EXTREME SWELLING AT THE INJECTION SITE. THE ARM IS REPORTEDLY RED, TENDER, AND SWOLLEN. PATIENT WAS SEEN BY A LOCAL CLINIC ON 9/25/2020. PATIENT'S REPRESENTATIVES WERE ADVISED TO MONITOR SWELLING BY DEMARCATING THE AREA WITH A MARKER, AND TO SEEK ADDITIONAL TREATMENT IF CONDITION PERSISTS OR GROWS.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: PT STATED SHE HAD SEVERE PAIN AT THE INJECTION AREA AND RIGHT SHOULDER. THERE WERE NO REDNESS, SWELLING, NOR WARMING AT THE PAIN AREAS. SHE TRIED MOTRIN 1 TAB THREE TIME A DAY.  THE PAIN AT THE INJECTION AREA WENT AWAY AFTER 10 DAYS. HOWEVER, THE PAIN ON HER RIGHT SHOULDER STILL BOTHERED HER. SHE SAW DR TODAY;9/25/20. SHE GOT DICLOFENAC GEL TO APPLY ON HER SHOULDER. SHE FELT A BIT BETTER AFTER 2 APPLICATIONS.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Patient states that she is having persistent arm pain for a week starting right after administration of the vaccine
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Fall, Loss of consciousness
Clinical narrative: Patient was shopping after shot with family and as described by family passed out and fell to floor. Family came running back to pharmacy with child in arms awake and not seizing. 911 was called. Pt remained alert. Pt was examined and returned to shopping with parents.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: rash on both legs below the knees on both arms starting on day 3 post vaccine
Age: 4.0
Sex: M
Vaccine: FLU4, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: (L) Thigh Has a Round 8 cms Induration &  Redness + Tenderness to the Site of Place where influenza vaccine was given
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Presented to pharmacy with swelling and redness (moderate)  of the left upper arm, extending down to the elbow. Reports hives appeared 09/24, but none present 09/25. Symptoms improving per pt. report. Advised pt. to monitor for progression, and ice and/or benadryl for pain, itching, swell.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Nerve injury, Pain in extremity
Clinical narrative: Patient called stating that his arm hurt terribly from his flu shot and that he feels like a nerve was hit
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Patient complains of pains in her lower back, shoulders, neck, and hands.  She describes the pain as being both  muscular and joint pains.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Throat irritation
Clinical narrative: PATIENT SAID SHE HAD "HIVES AND FEVER WITH A FLU SHOT IN ABOUT 2013" BEFORE VACCINE. SHE SAID SHE HAD BENADRYL AND WOULD TAKE SOME AFTER THE SHOT TODAY. ABOUT 10 MIN AFTER VACCINATIION SHE COMPLAINED OF ITCY THROAT AND TOOK 25MG BENADRYL (IMMUNIZER WATCHED HER TAKE) AND DECLINED MORE BENADRYL AND EPINEPHRINE OFFERED BY IMMUNIZER. AT 1225PM SHE SAID SHE FELT BETTER AND LEFT. PATIENT DECLINED EPINEPHRINE AGAIN AND A RIDE OFFERED BY OTHER PERSON OR EMS. SAID SHE WAS GOING TO HER DAUGHTERS BECASUE SHE LIVED CLOSE AND HADNT EATEN ANY THING YET. SHE SAID SHE WAS GOING TO EAT, TAKE ANOTHER BENADRYL, AND RELAX. SAID SHE JUST "HAD ANXIETY". IMMUNIZER CALLED PATIENT AT 1235 TO ASK HOW SHE WAS DOING AND SHE SAID "BETTER, I'M ALMOST HOME." FOUND OUT AT 130P FROM PATIENT HUMAN RESOURCES REPRESENTATIVE THAT SHE WENT TO ED.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Patient stated that she got the pneumonia shot on 09-15 and she couldn't move her arm and it was very painful where it limited her ability to change clothes. She stated she had fever too. She stated that she had that feeling for about 5 days. Patient called today on 09-25 to tell me. Patient eventually her arm got better.
Age: 26.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Syncope
Clinical narrative: Pt fainted, 911 came to monitor Pt, after 15-20mins, parents came to pick up Pt.
Age: 65.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Per patient report: Received Fluarix Quad 9/8/20 but wanted the high dose for seniors. Told to come back when available (?!). She came in and received Fluad Quad HD and Pneumovax 23 on 9/23/20. States she started having redness, soreness, swelling, stiffness and heat on on shoulder/arm where she had injections. That night symptoms increased and spread up her shoulder towards neck, down her arm to elbow, and to her side towards breast. She has been taking ibuprofen and icing the area but with no improvement. She called to report these adverse effects today 9/25/20. Pharmacist on duty advised her to see' a physician for further evaluation. Will follow-up with patient. In 3 days.
Age: 65.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Musculoskeletal stiffness
Clinical narrative: Per patient report: Received Fluarix Quad 9/8/20 but wanted the high dose for seniors. Told to come back when available (?!). She came in and received Fluad Quad HD and Pneumovax 23 on 9/23/20. States she started having redness, soreness, swelling, stiffness and heat on on shoulder/arm where she had injections. That night symptoms increased and spread up her shoulder towards neck, down her arm to elbow, and to her side towards breast. She has been taking ibuprofen and icing the area but with no improvement. She called to report these adverse effects today 9/25/20. Pharmacist on duty advised her to see' a physician for further evaluation. Will follow-up with patient. In 3 days.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient called on 9/24/20 and stated the injection site reaction was still present. The site was red, itchy, & is size of dollar coin.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out for couple minutes after  getting the vaccination but regained  consciousness within couple minutes.  She was talking and felt fine. She said  it happened once before at doctors office  her spouse came & picked her up.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint range of motion decreased, Myalgia, Pain in extremity
Clinical narrative: Pt received vaccine 9/11/2020. Called on 9/25/20 stated night of vaccine arm muscle very sore, then seemed to get better. By late next day very sore with decreased range of motion. This is still ongoing after 2 weeks she is going to call her doctor.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pts daughter, called the Rx on 09/25/20 to report patient experienced sore arm and swelling that did not resolve and was currently seeking treatment at the doctor. The possibility of either a defective batch/lot, allergic reaction to an ingredient, side effect, or technique was addressed by daughter. Pt arrived at the pharmacy about an hour later around 12:45pm. Pt did not show his arm but stated that he went to the clinic to see his Dr. He also stated this also occurred back in 2006 from a Pneumonia vaccine.
Age: 68.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: very swollen, painful arm for approximately 6 days
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Magnetic resonance imaging abnormal, Mobility decreased, Pain in extremity, Rotator cuff syndrome, Urticaria
Clinical narrative: Extreme pain in arm within hours slowly subsiding over few days. Could not raise arm or extend. PT (Physical therapy) prescribed by primary care physician. Had therapy for 5 months still not being able to completely raise arm. MRI done Apr 7, 2020 determining a rotator cuff tear. Saw orthopedist May 19. Was told that although not common she sees tears from flu shots 5-6 times/yr and strongly urged me to report it for training purposes. Also had a reaction of hives that required an ER visit on 10/6. This is a totally different issue than the rotator.
Sex: U
Vaccine: FLUX
Symptoms: Incorrect dose administered, Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 patients who were under 65 yrs of age was vaccinated with FLUZONE HIGH-DOSE QUADRIVALENT by mistake/ No AE; 4 patients who were under 65 yrs of age was vaccinated with FLUZONE HIGH-DOSE QUADRIVALENT by mistake/ No AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA242184, 2020SA242186 and 2020SA242185 (same reporter).  This case involves 4 patients who were under 65 years of age with unknown demographics, vaccinated with a dose (unclear whether 0.5 mL or 0.7 mL was administered) of QUADRIVALENT INFLUENZA VACCINE [INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE] by mistake (Lot number: UJ450AB and expiry date: 30-Jun-2021) via unknown route in an unknown administration site as prophylactic vaccination on an unknown date (product administered to patient of inappropriate age and overdose).   Medical history, medical treatment, vaccination and family history were not provided for patients.  Concomitant medication were not reported.  It was a case of an actual medication error due to inappropriate age at vaccine administration and overdose. (Latency: on the same day of vaccination)  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.