chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide increased
Clinical narrative: Service member received smallpox and anthrax # 1 on 19 Jul 06 without any apparent difficulties. On 30 Jul 06 @ 2 AM he began having constant, non-radiating chest pains described as both dull and sharp at various intervals. The pains ranged in severity from 4-5/10 to 8-9/10 VAS, were worse when lying down, with increased physical activity and with rapid or deep respirations. Additionally he describes episodes of SOB with exertion, an awareness of rapid heart beat sensation within his chest and a cough productive for small amounts of clear mucus. While running during a physical training exercise he collapsed with a witness episode of loss of consciousness (only for a few seconds).There was no bowel or bladder control or any seizure activity. He took no medication for pain relief. He was admitted to  Medical Center where he had an abnormal EKG sinus rhythm with diffuse ST elevation with upright T-waves and P-R segment depression in multiple leads consistent with acute pericarditis. Labs-elevated cardiac enzymes  troponin I 7.42, CPK 532,  CPK-MB 22.2, CKP-MB percentage 4.1%; D. dimmer slightly elevated 572; slightly elevated AST & total protein 8.4 ; CBC- low MCV 76.8, low MCH; BMP  Normal.  He was placed on telemetry with serial cardiac enzymes and EKGs. An echo was performed and he was medicated with Prednisone, Ibuprofen and Protonix. Smoker
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Condition aggravated, Dyspnoea exertional, Echocardiogram, Electrocardiogram PR segment depression
Clinical narrative: Service member received smallpox and anthrax # 1 on 19 Jul 06 without any apparent difficulties. On 30 Jul 06 @ 2 AM he began having constant, non-radiating chest pains described as both dull and sharp at various intervals. The pains ranged in severity from 4-5/10 to 8-9/10 VAS, were worse when lying down, with increased physical activity and with rapid or deep respirations. Additionally he describes episodes of SOB with exertion, an awareness of rapid heart beat sensation within his chest and a cough productive for small amounts of clear mucus. While running during a physical training exercise he collapsed with a witness episode of loss of consciousness (only for a few seconds).There was no bowel or bladder control or any seizure activity. He took no medication for pain relief. He was admitted to  Medical Center where he had an abnormal EKG sinus rhythm with diffuse ST elevation with upright T-waves and P-R segment depression in multiple leads consistent with acute pericarditis. Labs-elevated cardiac enzymes  troponin I 7.42, CPK 532,  CPK-MB 22.2, CKP-MB percentage 4.1%; D. dimmer slightly elevated 572; slightly elevated AST & total protein 8.4 ; CBC- low MCV 76.8, low MCH; BMP  Normal.  He was placed on telemetry with serial cardiac enzymes and EKGs. An echo was performed and he was medicated with Prednisone, Ibuprofen and Protonix. Smoker
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Electrocardiogram ST segment elevation, Electrocardiogram T wave peaked, Electrocardiogram abnormal, Fibrin D dimer increased, Haematocrit normal
Clinical narrative: Service member received smallpox and anthrax # 1 on 19 Jul 06 without any apparent difficulties. On 30 Jul 06 @ 2 AM he began having constant, non-radiating chest pains described as both dull and sharp at various intervals. The pains ranged in severity from 4-5/10 to 8-9/10 VAS, were worse when lying down, with increased physical activity and with rapid or deep respirations. Additionally he describes episodes of SOB with exertion, an awareness of rapid heart beat sensation within his chest and a cough productive for small amounts of clear mucus. While running during a physical training exercise he collapsed with a witness episode of loss of consciousness (only for a few seconds).There was no bowel or bladder control or any seizure activity. He took no medication for pain relief. He was admitted to  Medical Center where he had an abnormal EKG sinus rhythm with diffuse ST elevation with upright T-waves and P-R segment depression in multiple leads consistent with acute pericarditis. Labs-elevated cardiac enzymes  troponin I 7.42, CPK 532,  CPK-MB 22.2, CKP-MB percentage 4.1%; D. dimmer slightly elevated 572; slightly elevated AST & total protein 8.4 ; CBC- low MCV 76.8, low MCH; BMP  Normal.  He was placed on telemetry with serial cardiac enzymes and EKGs. An echo was performed and he was medicated with Prednisone, Ibuprofen and Protonix. Smoker
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Haemoglobin normal, Heart rate increased, Loss of consciousness, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased
Clinical narrative: Service member received smallpox and anthrax # 1 on 19 Jul 06 without any apparent difficulties. On 30 Jul 06 @ 2 AM he began having constant, non-radiating chest pains described as both dull and sharp at various intervals. The pains ranged in severity from 4-5/10 to 8-9/10 VAS, were worse when lying down, with increased physical activity and with rapid or deep respirations. Additionally he describes episodes of SOB with exertion, an awareness of rapid heart beat sensation within his chest and a cough productive for small amounts of clear mucus. While running during a physical training exercise he collapsed with a witness episode of loss of consciousness (only for a few seconds).There was no bowel or bladder control or any seizure activity. He took no medication for pain relief. He was admitted to  Medical Center where he had an abnormal EKG sinus rhythm with diffuse ST elevation with upright T-waves and P-R segment depression in multiple leads consistent with acute pericarditis. Labs-elevated cardiac enzymes  troponin I 7.42, CPK 532,  CPK-MB 22.2, CKP-MB percentage 4.1%; D. dimmer slightly elevated 572; slightly elevated AST & total protein 8.4 ; CBC- low MCV 76.8, low MCH; BMP  Normal.  He was placed on telemetry with serial cardiac enzymes and EKGs. An echo was performed and he was medicated with Prednisone, Ibuprofen and Protonix. Smoker
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Mean cell volume decreased, Metabolic function test normal, Neutrophil count increased, Neutrophil percentage increased, Pain
Clinical narrative: Service member received smallpox and anthrax # 1 on 19 Jul 06 without any apparent difficulties. On 30 Jul 06 @ 2 AM he began having constant, non-radiating chest pains described as both dull and sharp at various intervals. The pains ranged in severity from 4-5/10 to 8-9/10 VAS, were worse when lying down, with increased physical activity and with rapid or deep respirations. Additionally he describes episodes of SOB with exertion, an awareness of rapid heart beat sensation within his chest and a cough productive for small amounts of clear mucus. While running during a physical training exercise he collapsed with a witness episode of loss of consciousness (only for a few seconds).There was no bowel or bladder control or any seizure activity. He took no medication for pain relief. He was admitted to  Medical Center where he had an abnormal EKG sinus rhythm with diffuse ST elevation with upright T-waves and P-R segment depression in multiple leads consistent with acute pericarditis. Labs-elevated cardiac enzymes  troponin I 7.42, CPK 532,  CPK-MB 22.2, CKP-MB percentage 4.1%; D. dimmer slightly elevated 572; slightly elevated AST & total protein 8.4 ; CBC- low MCV 76.8, low MCH; BMP  Normal.  He was placed on telemetry with serial cardiac enzymes and EKGs. An echo was performed and he was medicated with Prednisone, Ibuprofen and Protonix. Smoker
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Painful respiration, Pericarditis, Platelet count normal, Productive cough, Protein total increased
Clinical narrative: Service member received smallpox and anthrax # 1 on 19 Jul 06 without any apparent difficulties. On 30 Jul 06 @ 2 AM he began having constant, non-radiating chest pains described as both dull and sharp at various intervals. The pains ranged in severity from 4-5/10 to 8-9/10 VAS, were worse when lying down, with increased physical activity and with rapid or deep respirations. Additionally he describes episodes of SOB with exertion, an awareness of rapid heart beat sensation within his chest and a cough productive for small amounts of clear mucus. While running during a physical training exercise he collapsed with a witness episode of loss of consciousness (only for a few seconds).There was no bowel or bladder control or any seizure activity. He took no medication for pain relief. He was admitted to  Medical Center where he had an abnormal EKG sinus rhythm with diffuse ST elevation with upright T-waves and P-R segment depression in multiple leads consistent with acute pericarditis. Labs-elevated cardiac enzymes  troponin I 7.42, CPK 532,  CPK-MB 22.2, CKP-MB percentage 4.1%; D. dimmer slightly elevated 572; slightly elevated AST & total protein 8.4 ; CBC- low MCV 76.8, low MCH; BMP  Normal.  He was placed on telemetry with serial cardiac enzymes and EKGs. An echo was performed and he was medicated with Prednisone, Ibuprofen and Protonix. Smoker
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Red blood cell sedimentation rate normal, Red cell distribution width normal, Syncope, Troponin I increased, White blood cell count increased
Clinical narrative: Service member received smallpox and anthrax # 1 on 19 Jul 06 without any apparent difficulties. On 30 Jul 06 @ 2 AM he began having constant, non-radiating chest pains described as both dull and sharp at various intervals. The pains ranged in severity from 4-5/10 to 8-9/10 VAS, were worse when lying down, with increased physical activity and with rapid or deep respirations. Additionally he describes episodes of SOB with exertion, an awareness of rapid heart beat sensation within his chest and a cough productive for small amounts of clear mucus. While running during a physical training exercise he collapsed with a witness episode of loss of consciousness (only for a few seconds).There was no bowel or bladder control or any seizure activity. He took no medication for pain relief. He was admitted to  Medical Center where he had an abnormal EKG sinus rhythm with diffuse ST elevation with upright T-waves and P-R segment depression in multiple leads consistent with acute pericarditis. Labs-elevated cardiac enzymes  troponin I 7.42, CPK 532,  CPK-MB 22.2, CKP-MB percentage 4.1%; D. dimmer slightly elevated 572; slightly elevated AST & total protein 8.4 ; CBC- low MCV 76.8, low MCH; BMP  Normal.  He was placed on telemetry with serial cardiac enzymes and EKGs. An echo was performed and he was medicated with Prednisone, Ibuprofen and Protonix. Smoker
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: red warm localized reaction at injection site
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Lip erythema, Lip swelling, Myalgia, Nausea
Clinical narrative: Fever of 101, muscle aches, nausea began 03/07/2020, lasting approx. 12 hours.  Woke on 03/08/2020 with red, swollen lips.  Took 50 mg Benadryl, swelling began going down within a few hours.  When swelling was gone, small vesicles began to appear across upper and lower lips, lasting approx. 2 weeks.  Swelling of lips and vesicles continue to appear every few days-few weeks.  Each subsequent episode is slightly less than previous episode and symptoms disappear more quickly, usually within 2-4 days at present.  In April 2020, vesicles began to form above upper lip, which continues to become red from time to time, and again each episode is more minor than previous. At present, vesicles seem to only appear in corners of mouth.  Saw health care provider in April and given antiviral, which cleared symptoms within 1-2 days, although they have continued to appear as noted above.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 101, muscle aches, nausea began 03/07/2020, lasting approx. 12 hours.  Woke on 03/08/2020 with red, swollen lips.  Took 50 mg Benadryl, swelling began going down within a few hours.  When swelling was gone, small vesicles began to appear across upper and lower lips, lasting approx. 2 weeks.  Swelling of lips and vesicles continue to appear every few days-few weeks.  Each subsequent episode is slightly less than previous episode and symptoms disappear more quickly, usually within 2-4 days at present.  In April 2020, vesicles began to form above upper lip, which continues to become red from time to time, and again each episode is more minor than previous. At present, vesicles seem to only appear in corners of mouth.  Saw health care provider in April and given antiviral, which cleared symptoms within 1-2 days, although they have continued to appear as noted above.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Pain immediately following vaccine injections, then next day 10/29 had itching, swelling, redness, and warmth to the area that has been progressively enlarging, on 10/30 area is round 3 inx3.5 in, red, swollen, and warm to touch. Patient recommended to use cold compresses, take Tylenol over the counter, and prescribed Augmentin for 10 day course due to possible cellulitis.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Physiotherapy, Sensory loss
Clinical narrative: Patient experienced shoulder pain beginning the day after the injection. Began to have some loss of sensation and treated care with ortho and physical therapy.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Chills, Fatigue, Nausea
Clinical narrative: Pt states she got home that evening and felt a bit tired.  THe next morning at work about 10am, she started feeling a bit nauseous.  She went home and about noon started throwing up.  SHe took her temp that afternoon about 1pm and it was 102.  She also states feeling week, having chills and body aches.   ALso states that she tried taking ibuprofen and could not keep anything down.  She went to bed and states she started feeling better that evening and felt much better the next day.  As of today, Friday, october 30, pt feels back to normal.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Vomiting
Clinical narrative: Pt states she got home that evening and felt a bit tired.  THe next morning at work about 10am, she started feeling a bit nauseous.  She went home and about noon started throwing up.  SHe took her temp that afternoon about 1pm and it was 102.  She also states feeling week, having chills and body aches.   ALso states that she tried taking ibuprofen and could not keep anything down.  She went to bed and states she started feeling better that evening and felt much better the next day.  As of today, Friday, october 30, pt feels back to normal.
Age: 89.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: PATIENT WAS GIVEN A FLUZONE HD AND HAD ALREADY HAD A FLU SHOT AT HER DRS OFFICE THIS SEASON
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Paraesthesia
Clinical narrative: pt woke up and stated that her arm felt like it was asleep , but then she realized that she couldn't move it. Went to her PCP and PCP referred her to ER.  At ER, dr gave rx for muscle relaxant and diclofenac.  She was told to wait four days and if no better go back to dr or return sooner to dr if worse.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: sore arm that started day after injection but continued for a month. patient says has not gotten worse but remains the same or healing slowly
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Discomfort, Injection site pain, Insomnia
Clinical narrative: First course of this vaccine only had injection site pain.  Second shot started with injection site pain which moved to whole body pain, chills and sleeplessness.  One day after, body pains continue and some intestinal issues have been noted, chills have subsided.  OTC ibuprofen (600mg) took the edge off the discomfort so I could work but I've been feeling quite uncomfortable all day.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: First course of this vaccine only had injection site pain.  Second shot started with injection site pain which moved to whole body pain, chills and sleeplessness.  One day after, body pains continue and some intestinal issues have been noted, chills have subsided.  OTC ibuprofen (600mg) took the edge off the discomfort so I could work but I've been feeling quite uncomfortable all day.
Age: 38.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: redness inflamation on site of injection
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: vasovagal syncope right after administration, recovered in a couple of minutes
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient had three vaccines that day, Boostrix,Pneumovax, and Afluria. PAtient called on 10/20/00 to say that her arm hurt very badly. I was not the one who administered the shots, but instructed her to ice the area and use ibuprofen. patient called 4 hours later and said depsite these measures, she was in extreme pain. Subsequent calls to her from the  supervisor went unanswered.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Pyrexia
Clinical narrative: Patient reported having low fever for 2 days after vaccination and feeling dizzy the next day. She spoke with her doctor and was advised to call the pharmacy to report the adverse effects
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: vasovagal syncope occurred right after administration, pt recovered within a couple of minutes
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Patient is experiencing shoulder pain and loss of range of motion when she raises her arm.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: We had a pt today , saying that he got Fluzone HD last week and his arm started turning red and was  swollen from around one week. Almost the whole arm turned red and swollen which is not subsided with Advil
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Fatigue, Mobility decreased, Nodule, Pain in extremity
Clinical narrative: Patient said she felt fine at time of vaccination and requested that the pharmacist give them both in the same arm despite recommendation of pharmacist to do otherwise. Patient stated it became painful the evening after shot was given. She called me the morning of 10/30 complaining of not being able to move arm at all, pain, fever, fatigue, bright red area, can feel heat through shirt and having a baseball size knot under the skin. She had been applying compresses and taking ibuprofen and Benadryl the night before to sleep. I advised her to seek medical advice/attention since the pain was worsening. She said she would do so but at the time of the report, she has not followed up with any additional information.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Patient said she felt fine at time of vaccination and requested that the pharmacist give them both in the same arm despite recommendation of pharmacist to do otherwise. Patient stated it became painful the evening after shot was given. She called me the morning of 10/30 complaining of not being able to move arm at all, pain, fever, fatigue, bright red area, can feel heat through shirt and having a baseball size knot under the skin. She had been applying compresses and taking ibuprofen and Benadryl the night before to sleep. I advised her to seek medical advice/attention since the pain was worsening. She said she would do so but at the time of the report, she has not followed up with any additional information.
Age: 36.0
Sex: F
Vaccine: FLUR4
Symptoms: Rotator cuff syndrome
Clinical narrative: Patient received their flu shot on 10/19/2020. The patient came to the pharmacy today 10/30/2020 to pick up Celebrex and Voltaren gel to treat a rotator cuff injury as a result of the vaccination.
Age: 41.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Patient works store, came to the pharmacy a few hours into her shift and said her arm was swollen, red, and she felt very achy all over. From what she described it did not sound like anaphylaxis, just very severe processing of a flu and pneumonia shot. I checked her temperature (98.4), and she said she wasn't having any rash, trouble breathing, swollen tongue, glands, etc. I recommended that she alternate tylenol and ibuprofen, as well as take benadryl. I recommended that she go home, get some rest, and call me if anything got worse. I spoke to her around 3pm and 6pm for follow up calls, and she did say she felt a little worse, but the reaction didn't really seem to be spreading. I told her to keep an eye on her breathing, skin, and temperature, continue with the medication, ice her arm, and to go to an urgent care or ER if anything progressed. I also left a note for the RPH in the AM to call her at 9am for a follow up call.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Patient reports feeling intense pain at the time of the injection and by the next morning the pain was still present and he was unable to raise his left arm in his normal range of motion without severe pain. He reports no prior injection site reactions to previous year's flu shots.
Age: 76.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity, Rash, Tenderness
Clinical narrative: Patient stated that about 3-4 days after vaccination he experienced a rash over a large portion of his left arm encompassing the forearm.  Patient is also experiencing pain and tenderness radiating from the injection site in the left deltoid to the wrist.  For many days he stated that it was very painful to the touch.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Patient informed  she had develop a rash two days after her flu shot.  Her pictures shows a rash from elbow down to wrist from outside of arm, and from inside of arm a rash from wrist to armpit. No redness or swollen at site of injection.  No fever or pain.  She said day after injection she got a few mosquitos bite at injection arm.  The next day rash develop and it was very itchy at rash areas. She called her doctor who advice her to go emergency room. She said doctor prescribed prenidone.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Large red swelling around the shot area. Red and itchy and hot to the touch. No breathing issues.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: pain in shoulder for a month with no improvement. loss of range of mobility.  Patient reported to MD for follow up and came to pharmacy to fill medication and VAERS was created.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Bruxism, Chills, Headache, Heart rate increased
Clinical narrative: Acute onset of fever (101 1 hr after 2 tabs Tylenol),  high BP; 168/80 (prior BP=120/70), HR: 92 (typically 74) acute chills w/ profound, uncontrolled shaking , muscle rigidity, clenched jaw, nausea and vomiting, severe headache.  Symptoms lasted 12-16 hrs.   Note: no redness or swelling at injection site.   R arm sore/ tender to touch.   Headache and muscle aches persisted through day 10/30.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle rigidity, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Acute onset of fever (101 1 hr after 2 tabs Tylenol),  high BP; 168/80 (prior BP=120/70), HR: 92 (typically 74) acute chills w/ profound, uncontrolled shaking , muscle rigidity, clenched jaw, nausea and vomiting, severe headache.  Symptoms lasted 12-16 hrs.   Note: no redness or swelling at injection site.   R arm sore/ tender to touch.   Headache and muscle aches persisted through day 10/30.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness, Tremor, Vomiting
Clinical narrative: Acute onset of fever (101 1 hr after 2 tabs Tylenol),  high BP; 168/80 (prior BP=120/70), HR: 92 (typically 74) acute chills w/ profound, uncontrolled shaking , muscle rigidity, clenched jaw, nausea and vomiting, severe headache.  Symptoms lasted 12-16 hrs.   Note: no redness or swelling at injection site.   R arm sore/ tender to touch.   Headache and muscle aches persisted through day 10/30.
Age: 39.0
Sex: F
Vaccine: FLUA3
Symptoms: Burning sensation, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: I receive my flu shot every year. I always have a severe headache after the flu shot and have one this time as well. However, that is listed as a normal side effect, so I just expect that will happen every time. This time I am experiencing numbness and tingling in my feet and lower legs. There is a tingling/burning sensation that has moved into my upper thigh. It is Friday night so I will contact my primary care physician on Monday. If the symptoms becomes worse I will seek medical attention.
Age: 17.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Skin reaction
Clinical narrative: Reaction to vaccines (flu, Menactra) left arm Note - pt has had Menactra before without issues. Localized skin reaction LA.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction
Clinical narrative: Recieved flu injection 10/28, reaction 10/30 - Made an appointment for Dr. appt. Reaction measures 4" x 3.25" on the left deltoid Meds given - Diphenhydramine HCL 25MG Hydrocortisone 1# cream Ibuprofen 600mg
Age: 61.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Diarrhoea, Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: Patient states had violently vomiting, diarrhea about 3 hours after vaccine, high fever, on 10/28/20 got rash. Vomiting and fever stopped after 3 days. She is still has nausea.  She thinks reacted from Shingrix.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Pain in extremity, Pulmonary congestion, Pyrexia, Sinus congestion
Clinical narrative: Extreme soreness of right arm & spreading red spot on arm as well. Fever, sinus & some lung congestion in the morning
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: R upper arm redness & warmth 10x8 cm on 10/30/2020 No F/C/N/V
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin discolouration, Swelling
Clinical narrative: Patient experienced intense itching, redness & white raised patch waist up all over her body the next day of vaccination. She took Benadryl for several days & tried Zyrtec at last. Zyrtec gave her longer relief.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Was seen on 10-28-20 For a WC, had a TDap vaccine. Came in on 10-30-20 Due to possible allergic reaction to vaccine. Mom stated red, swollen on (Lt) arm. And also itchy. Given Amox
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Diarrhoea
Clinical narrative: Patient had approximately 4 inch round welt around site where injection was administered. Site red, raised and painful.. Presented to clinic for c/o nausea, body aches, joint pain, dizziness, weakness, numbness, tingling, chills, low back pain, headache, vomiting and diarrhea x 3 days post injection. No fever.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Gastroenteritis viral, Headache, Hypoaesthesia, Influenza virus test
Clinical narrative: Patient had approximately 4 inch round welt around site where injection was administered. Site red, raised and painful.. Presented to clinic for c/o nausea, body aches, joint pain, dizziness, weakness, numbness, tingling, chills, low back pain, headache, vomiting and diarrhea x 3 days post injection. No fever.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Nausea
Clinical narrative: Patient had approximately 4 inch round welt around site where injection was administered. Site red, raised and painful.. Presented to clinic for c/o nausea, body aches, joint pain, dizziness, weakness, numbness, tingling, chills, low back pain, headache, vomiting and diarrhea x 3 days post injection. No fever.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, SARS-CoV-2 test negative, Streptococcus test, Urticaria
Clinical narrative: Patient had approximately 4 inch round welt around site where injection was administered. Site red, raised and painful.. Presented to clinic for c/o nausea, body aches, joint pain, dizziness, weakness, numbness, tingling, chills, low back pain, headache, vomiting and diarrhea x 3 days post injection. No fever.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Viral test, Vomiting
Clinical narrative: Patient had approximately 4 inch round welt around site where injection was administered. Site red, raised and painful.. Presented to clinic for c/o nausea, body aches, joint pain, dizziness, weakness, numbness, tingling, chills, low back pain, headache, vomiting and diarrhea x 3 days post injection. No fever.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Flu vaccine from last year that was inadvertently injected to a patient with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from other healthcare professional via Company (Reference number- 00309466) and transmitted to Sanofi on 09-Oct-2020.  This case is linked to cases 2020SA283092 and 2020SA283083 (same reporter).  This case involved a 46 years old male patient who received a dose 0.5 ml of expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot number- UJ247AA, expiration date- 30-Jun-2020) via intramuscular route in left deltoid for prophylactic vaccination on 07-Oct-2020 (Expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medication was reported as none.  It was a case of actual medication error as expired vaccine was administered (Latency: Same day).  At the time of reporting, no adverse event was experienced by the patient.  It was reported that 3 boxes of Fluzone QD NP (no preservative) which was from last year. Each box had 10 syringes.One box was open. There were 3 Flu vaccines from last year that were inadvertently injected to 3 different patients. One of the patient was a doctor.  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.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Neck pain, Pain
Clinical narrative: Patient is reporting excruciating left arm pain that has continued to this date 10/31/2020 from the Shingrix immunization. the administering pharmacist remembers giving the vaccine properly into left arm deltoid using 1 inch 25G needle. Patient only reported mild pain in the injection at this time. Patient called the pharmacy Friday 10/23/2020 to report extreme left arm pain to pharmacist. He reported that he could not sleep on his arm and could not lift it for several days. He treated it with ibuprofen, acetaminophen and hydrocodone. He did not seek medical care at this point. He reported on 10/26/2020 in person to pharmacist that his arm was improving but not completely. He also submitted a survey stating that the injection was above deltoid on 10/26/2020. After speaking on the phone on 10/31/2020, he is going to seek medical treatment on Monday or Tuesday upcoming and will report back to pharmacy.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Sleep disorder
Clinical narrative: Patient is reporting excruciating left arm pain that has continued to this date 10/31/2020 from the Shingrix immunization. the administering pharmacist remembers giving the vaccine properly into left arm deltoid using 1 inch 25G needle. Patient only reported mild pain in the injection at this time. Patient called the pharmacy Friday 10/23/2020 to report extreme left arm pain to pharmacist. He reported that he could not sleep on his arm and could not lift it for several days. He treated it with ibuprofen, acetaminophen and hydrocodone. He did not seek medical care at this point. He reported on 10/26/2020 in person to pharmacist that his arm was improving but not completely. He also submitted a survey stating that the injection was above deltoid on 10/26/2020. After speaking on the phone on 10/31/2020, he is going to seek medical treatment on Monday or Tuesday upcoming and will report back to pharmacy.
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: Patient is reporting excruciating left arm pain that has continued to this date 10/31/2020 from the Shingrix immunization. the administering pharmacist remembers giving the vaccine properly into left arm deltoid using 1 inch 25G needle. Patient only reported mild pain in the injection at this time. Patient called the pharmacy Friday 10/23/2020 to report extreme left arm pain to pharmacist. He reported that he could not sleep on his arm and could not lift it for several days. He treated it with ibuprofen, acetaminophen and hydrocodone. He did not seek medical care at this point. He reported on 10/26/2020 in person to pharmacist that his arm was improving but not completely. He also submitted a survey stating that the injection was above deltoid on 10/26/2020. After speaking on the phone on 10/31/2020, he is going to seek medical treatment on Monday or Tuesday upcoming and will report back to pharmacy.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Bradyphrenia, Dysstasia, Feeling abnormal, Fine motor skill dysfunction, Gait disturbance
Clinical narrative: Heaviness/weakness in both arms/legs. Feels like I've lost 15-20 percent of manual dexterity. Takes more effort to type. Arms feel like there is extra 15 pounds in them + upper body pulled down by it.  When I relax them after flexing it wants to flop down the last few degrees of extension. Collapsing feeling in chest, like much more effort needed to stand upright. Head feels harder to hold up.  Feels like I've lost 15-20 percent of lower limb control and stability. Left leg adducts/externally rotates when walking where before it didn't. Foot hits ground differently, knees hyper extend. Mental processing slow, brain fog feeling. Pressure feeling pushing out through eyes, causing mental fatigue dullness of thought.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Head discomfort, Limb discomfort, Muscular weakness, Ocular discomfort
Clinical narrative: Heaviness/weakness in both arms/legs. Feels like I've lost 15-20 percent of manual dexterity. Takes more effort to type. Arms feel like there is extra 15 pounds in them + upper body pulled down by it.  When I relax them after flexing it wants to flop down the last few degrees of extension. Collapsing feeling in chest, like much more effort needed to stand upright. Head feels harder to hold up.  Feels like I've lost 15-20 percent of lower limb control and stability. Left leg adducts/externally rotates when walking where before it didn't. Foot hits ground differently, knees hyper extend. Mental processing slow, brain fog feeling. Pressure feeling pushing out through eyes, causing mental fatigue dullness of thought.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Presyncope
Clinical narrative: Patient received the flu vaccine and was nearly fainting afterwards.  Mom was with the patient.  We called 911.  Patient was sitting down.  Patient did not lose consciousness entirely.  Mom kept talking to patient and patient was nearly fainting.  The paramedics came and assessed patient.  Paramedics said patient probably had a vasovagal attack.  After around 15-20 minutes, patient was better.  Paramedics said patient did not need to go to the hospital.  Paramedics left with patient and mom to escort them back to mom's vehicle.  I phoned mom to follow up after a couple of hours.  Mom said patient got home and was all well.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Vertigo, Vestibular neuronitis, Vomiting
Clinical narrative: Acute vestibular neuritis -  four days of vertigo, dizziness, nausea, vomiting and lingering effects I know it was a quad virus vaccine but I do not remember the exact manufacturer. This would need to be confirmed with the clinic.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Immediate pain that left me gasping.  My arm hurt more than it ever had with any vaccination.  I complained and the medical assistant said it was normal.  Over the next week, my arm was swollen, red, and was running a fever over 100 degrees although I wasn't sick and a thermometer on my forehead showed normal temp.  The second week it was still very sore.  I talked to the regular nurse on 8/31 and reported I was still in a lot of pain, but she said a lot of people say that.  As the pain and swelling slowly subsided, I realized I was having shoulder pain.  I have never had shoulder pain before.  I didn't originally associate it with the shot, but when I finally saw an Orthopedic doctor on October 16, he questioned me about anything at all that could have injured the shoulder, and that's when I realized it had started around the time of the vaccination.  My arm from the shoulder to the elbow has pain now, that feels like neuropathy.  Sharp, shooting pain.  I had my second Shingles shot on 10/17 at pharmacy in my left arm.  I felt just normal injection soreness, no fever or swelling, and have not had any pain since.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Immediate pain that left me gasping.  My arm hurt more than it ever had with any vaccination.  I complained and the medical assistant said it was normal.  Over the next week, my arm was swollen, red, and was running a fever over 100 degrees although I wasn't sick and a thermometer on my forehead showed normal temp.  The second week it was still very sore.  I talked to the regular nurse on 8/31 and reported I was still in a lot of pain, but she said a lot of people say that.  As the pain and swelling slowly subsided, I realized I was having shoulder pain.  I have never had shoulder pain before.  I didn't originally associate it with the shot, but when I finally saw an Orthopedic doctor on October 16, he questioned me about anything at all that could have injured the shoulder, and that's when I realized it had started around the time of the vaccination.  My arm from the shoulder to the elbow has pain now, that feels like neuropathy.  Sharp, shooting pain.  I had my second Shingles shot on 10/17 at pharmacy in my left arm.  I felt just normal injection soreness, no fever or swelling, and have not had any pain since.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Myalgia, Pyrexia
Clinical narrative: fever muscle pain lack of energy
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Death, Feeling abnormal, Neoplasm malignant, Pain
Clinical narrative: High fever , sore arm , aching body , foggy mind, not thinking  as normally , she began to have a cough that lasted for months  at the point where her rib was fractured from coughing severely and it was then when she saw a doctor and they found out she had stage 4 cancer my wife passed away in December 27 2019
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia, Rib fracture, Thinking abnormal
Clinical narrative: High fever , sore arm , aching body , foggy mind, not thinking  as normally , she began to have a cough that lasted for months  at the point where her rib was fractured from coughing severely and it was then when she saw a doctor and they found out she had stage 4 cancer my wife passed away in December 27 2019
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Rash
Clinical narrative: Itchy  Swollen rash at  Injection site. Random sites of  itchy pox on left arm, neck, back, & upper legs noticed 2 days after vaccination
Age: 28.0
Sex: F
Vaccine: FLUA4
Symptoms: Fatigue, Paranasal sinus discomfort, Rhinorrhoea
Clinical narrative: Runny nose, sinus pressure, fatigue from day of vaccine, continuing three days later
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Areflexia, CSF protein increased, Hypoaesthesia, Lumbar puncture, Taste disorder
Clinical narrative: Onset of altered taste 24 hours after flu vaccination, w/o fever, cough, or other URI symptoms.  Onset of numbness in feet 48 hours after vaccination, with progression to numbness from knees down, and in fingers, resulting in hospital admission for possible Guillain Barre Syndrome on 10/28, 5 days after vaccination.  Exam on admission c/w GBS w/ length dependent loss of large fiber sensation in legs up to knees, and in fingertips, with normal strength, and w/ absent reflexes throughout.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Dry mouth, Headache, Lymphadenopathy, Night sweats, Pyrexia
Clinical narrative: has had a fever since 10 hours after and still has a fever and headache, also had a splitting HA 103 fever swallon limp nodes night sweats very dry mouth
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: SARS-CoV-2 test
Clinical narrative: has had a fever since 10 hours after and still has a fever and headache, also had a splitting HA 103 fever swallon limp nodes night sweats very dry mouth
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Approximately 9 inch rash on left arm (at and below injection site), red in appearance that turns a shade of purple near the elbow. Patient reports no pain or itching, but area is raised and warm to the touch. Patient did not notice rash until shower, and states the rash appeared suddenly. Patient also reports body aches but no other systemic symptoms.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea vomiting fever
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Condition aggravated, Erythema, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: 1 day after vaccine, experienced fatigue and a fever of 101.3 at 6PM. Temperature at 9:30 PM was 99.5. Left arm was painful to touch and swollen. Facial and neck tics began to increase. 2 days after vaccine administration,  temperature was 98.6. Arm was red, swollen and painful to touch.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: 1 day after vaccine, experienced fatigue and a fever of 101.3 at 6PM. Temperature at 9:30 PM was 99.5. Left arm was painful to touch and swollen. Facial and neck tics began to increase. 2 days after vaccine administration,  temperature was 98.6. Arm was red, swollen and painful to touch.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Soeness in the arm, fatigue,  muscle pain, headache,  sweating at night.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain upper, Disorientation, Dyskinesia, Erythema, Lethargy
Clinical narrative: Per mom,  about 20-25 min after receiving vaccine pt and his mom were driving home.  Pt was acting normal, laughing and talking, then he complained that his stomach felt knotted and he blacked out.  Mom said that patients face was beet red, looked disoriented, he was making gurgling noises, his left arm was extended out to the side w/left had curled in, neck curled in and chin pressed against his chest.  His face then went pale and he flopped over against the  passenger door, was lethargic, and moaning slightly.  The incident happened while mom was driving and lasted about 20-30 sec.   Mom took patient to Hospital were an EKG and MRI were done.  Per mom neurologist dismissed a link to vaccines and said a VAERS report did not need to be done.  Mom felt incident was dismissed at syncope.  Pt has a follow up appt w/Dr at Pediatrics on Wed 11/4/20.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness, Moaning, Pallor, Syncope
Clinical narrative: Per mom,  about 20-25 min after receiving vaccine pt and his mom were driving home.  Pt was acting normal, laughing and talking, then he complained that his stomach felt knotted and he blacked out.  Mom said that patients face was beet red, looked disoriented, he was making gurgling noises, his left arm was extended out to the side w/left had curled in, neck curled in and chin pressed against his chest.  His face then went pale and he flopped over against the  passenger door, was lethargic, and moaning slightly.  The incident happened while mom was driving and lasted about 20-30 sec.   Mom took patient to Hospital were an EKG and MRI were done.  Per mom neurologist dismissed a link to vaccines and said a VAERS report did not need to be done.  Mom felt incident was dismissed at syncope.  Pt has a follow up appt w/Dr at Pediatrics on Wed 11/4/20.
Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Rash
Clinical narrative: patients hands became rashy looking.  patient did not experience shortness of breath or itching.  i advised her to take benadryl.  i called her about 3 hours later to check on her and she had not experienced any further reactions.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Sensation of foreign body
Clinical narrative: I thought I was getting a sore throat, but then I realized it didn't hurt, it was like I had a lump in my throat. I was alone so I hurried home and took Tylenol. The swelling subsided.
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Haemorrhage
Clinical narrative: I GAVE THE INJECTION AND BLOOD SQUIRTED OUT. STOPPED THE BLEEDING BY PRESSURE. WAITED UNTIL HER DAD GOT THE SHOT. PATIENT FEELING NORMAL AT THE TIME SHE LEFT THE STORE. FOLLOWED UP AND ALL GOOD.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever up to 102.5, chills, aches, beginning 12 hrs after injection, lasting 1 day
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Dyspnoea, Eye discharge, Eye swelling, Headache
Clinical narrative: About 2 hours after shot - went for a run and noticed she had difficulty breathing which continue through the night. About 3 hours later pt had swelling in eyes and lips with discharge in eyes. Pt had headache runny nose, chills through night. Next day lips and eyes slightly swollen and the headache continues. Pt just took some Benadryl and Ibuprofen. No longer having difficulty breathing. This was patients first flu vaccine.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Lip swelling, Rhinorrhoea
Clinical narrative: About 2 hours after shot - went for a run and noticed she had difficulty breathing which continue through the night. About 3 hours later pt had swelling in eyes and lips with discharge in eyes. Pt had headache runny nose, chills through night. Next day lips and eyes slightly swollen and the headache continues. Pt just took some Benadryl and Ibuprofen. No longer having difficulty breathing. This was patients first flu vaccine.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills, uncontrollable shivering, headache, body ache, mild fever set I'm the night of the vaccine. Bed rest, water, and tylenol to treat.