chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Loss of consciousness, Nausea, Vomiting
Clinical narrative: Patient received dose #1 of TwinRix Hep A/B and passed out for approximately 5 seconds. Developed nausea with emesis, was dizzy. Was supine for observation for one hour, but still unable to ambulate without nausea and emesis. Was sent to ER via EMT/ambulance for evaluation.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: After receiving the immunization, she began to get a sore arm later that night.  The next day, she had redness and swelling around the injection site.  The redness and pain kept spreading and has since reached her elbow and gone around her arm.  She saw and urgent care over the weekend, but was only told to take benadryl and use ice.  It has since gotten worse.  She said she would call the urgent care back.  That is all we have currently heard about the issue.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Musculoskeletal stiffness, Neck pain, Skin warm, Swelling
Clinical narrative: Patient experienced swelling, warmness, and redness in the left arm that has progressed and worsened the last several days since the vaccine was given 3 days ago. The warmness has gone down but the swelling and redness has increased below the injection site. The reaction stops at the elbow. She has also noticed neck stiffness/pain correlating with the arm reaction. We have recommended she reach out and seek medical attention if worsens. She is already in touch with her doctor.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeding disorder, Hypersomnia, Injection site erythema, Injection site pain
Clinical narrative: Sore arm (expected) than the next morning I reported on Saturday 09-12-2020 for work by 7am as a nurse and noticed I felt tired; than by 10:30 am I became extremely fatigued which increased as my shift continued; I was unable to eat anything, and all I cared about was finishing my shift safely   which I was able to do; I focused on driving myself home which takes 20 minutes, I handed my uneaten lunch to my youngest son (20 years of age) and informed my family that I was retiring for the night; I slept from 4pm until 4am (awakening twice to urinate and able to return to sleep very quickly). I am widowed so I do not have the luxury to stay home without good cause. I felt much better on Sunday 09-13-2020 without any fatigue ; only noticeable sign was the continued soreness/redness at the injection site, by Monday Sept 14, 2020 injection site is still tender.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm (expected) than the next morning I reported on Saturday 09-12-2020 for work by 7am as a nurse and noticed I felt tired; than by 10:30 am I became extremely fatigued which increased as my shift continued; I was unable to eat anything, and all I cared about was finishing my shift safely   which I was able to do; I focused on driving myself home which takes 20 minutes, I handed my uneaten lunch to my youngest son (20 years of age) and informed my family that I was retiring for the night; I slept from 4pm until 4am (awakening twice to urinate and able to return to sleep very quickly). I am widowed so I do not have the luxury to stay home without good cause. I felt much better on Sunday 09-13-2020 without any fatigue ; only noticeable sign was the continued soreness/redness at the injection site, by Monday Sept 14, 2020 injection site is still tender.
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat
Clinical narrative: Experience a cold sweat with considerable water dripping from my face and upper body. Not sure if this was from flu shot but one of my neighbors experienced the same system after getting her flu shot.  She was was also about 70
Age: 58.0
Sex: M
Vaccine: FLUR4, PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Red arm, some swelling, warm to touch, and pain
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: patient received her vaccine and the next day her arm turned red  and warm under the site.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm swollen and red below deltoid.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Prefect red circle on deltoid, heat, redness and occasional itching reported.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Headache, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Pt developed fever, sore throat, runny nose and headache for 2 days following the pneumonia shot. He then developed congestion and cough .
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Rhinorrhoea
Clinical narrative: Pt developed fever, sore throat, runny nose and headache for 2 days following the pneumonia shot. He then developed congestion and cough .
Age: 15.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Patient came in two weeks after administration stating that the night she got a vaccine she got a rash on her arm and stomach- the rash on her hand looks like brown freckles on her wrist.
Age: 73.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain of skin, Peripheral swelling, Skin warm
Clinical narrative: Patient's right arm is swollen about 6 inches about the elbow.  Skin is warm and tender to the touch and has slight pain.  Area of injection is not swollen or painful.  Symptoms started 2 days after vaccination (started today 9/14/20, immunization occurred 9/12/200.  Pt will put cool compress on swollen area and contact doctor for follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: patient developed a rash the day after the vaccination and it has continued to spread, almost to the elbow
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Vertigo
Clinical narrative: diarrhea, vomiting, shivering, head-spinning & dizziness, weakness
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: diarrhea, vomiting, shivering, head-spinning & dizziness, weakness
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Pyrexia
Clinical narrative: diarrhea, vomiting, shivering, head-spinning & dizziness, weakness
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting, Weight decreased
Clinical narrative: diarrhea, vomiting, shivering, head-spinning & dizziness, weakness
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Discharge, Erythema, Feeling hot, Pain, Pruritus
Clinical narrative: Rash on the neck. Associated symptoms include redness, mild warmth, itchiness, stinging, discharge, body ache, and tenderness.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Tenderness
Clinical narrative: Rash on the neck. Associated symptoms include redness, mild warmth, itchiness, stinging, discharge, body ache, and tenderness.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: The patient has reported to the pharmacy with the adverse event almost a month after the injection. I asked how long this has been going on and she had stated a week. I mentioned that muscle soreness is common after injections. She then told me it had been going on for some time. I asked her more than one week and she said a couple. I asked if she had it with us and looked up the date. She did not report the soreness radiating or all over. She stated it was getting worse. I asked if she could point to where it hurt on her arm or shoulder. She pointed to her arm about 3-4 inches below the top of the shoulder. I asked if her shoulder hurt at all and she stated no. She did mention that her arm didn't hurt at rest, but when she picked it up. I instructed her to follow up with her doctor. I also instructed her to ice it and to take an OTC pain reliever.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Injection site swelling
Clinical narrative: bruising, raised at injection site
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: on vaccine site there is an area of 15 diameter circumference, raised erythematous borders with central clearing
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Patient called to report a hard, round lump under her skin at the injection site.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Shoulder and arm pain that is getting worse since after the injection of Vaccines
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Shivering
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: left upper arm got extremely red/hot/sore and swollen from site of injection almost down to 2 inches above where elbow angles.  this started 4 days after injections given.  Patient went to physician on 9-14 -20 for reassurence.   physician prescribed antibiotic for patient just in case.  Patient did not experience swollen lips/tongue or any other anaphylaxis type symptoms.    Patients arm has started to improve as of today.  rph
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Hives multiple sites on extremities. Arms and legs, some swelling, itching.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Mass, Pain, Swelling
Clinical narrative: local site reaction  and moved to elbow and then lower hand. Red and hard bump and it hurts a lot.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site swelling, Skin warm, Urticaria
Clinical narrative: Patient described having swelling in right arm that went from her shoulder area to her elbow and included the inner part of her upper arm as well. She also felt warmth on the arm and said it was pink in color. Patient also reported hives on arm. Patient states started on 9/12 and is now improving after taking antihistamine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Hypersomnia, Pain, Pain in extremity
Clinical narrative: Fever of 102. Headache Took 2 aspirin.  Drank some water. Slept about 12 hours. Headache. Took 2 more aspirin. And had some more water.  Slept on and off for another 18 hours. The fever broke about 4 this morning when everything was damp from sweat.  My temperature is at 99.9 now.   I ache all over and my arm is sore. Feeling much better, though.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 102. Headache Took 2 aspirin.  Drank some water. Slept about 12 hours. Headache. Took 2 more aspirin. And had some more water.  Slept on and off for another 18 hours. The fever broke about 4 this morning when everything was damp from sweat.  My temperature is at 99.9 now.   I ache all over and my arm is sore. Feeling much better, though.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: pateint recieved dose went to register to get rung up with his parent and fainted in aisle regained consciousness. no breathing difficulty but said he was very dizzy. at this point we called 911.  TPatient was transported to hospital tried to reach out to patient no response.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia
Clinical narrative: Patient developed shingles on rt side of face after receiving Shingrix vaccine at her pharmacy on 8/25/20.  Symptoms started on 9/3 with a blister between eyebrows and progressed down to tip of nose and into scalp on right side.  She continues to have severe neuralgia.  Treated with Valtrex and opiates.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Discomfort, Ear pain, Eyelid pain
Clinical narrative: Patient developed shingles on rt side of face after receiving Shingrix vaccine at her pharmacy on 8/25/20.  Symptoms started on 9/3 with a blister between eyebrows and progressed down to tip of nose and into scalp on right side.  She continues to have severe neuralgia.  Treated with Valtrex and opiates.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Headache, Hypoaesthesia, Injection site pain, Magnetic resonance imaging brain normal
Clinical narrative: Patient developed shingles on rt side of face after receiving Shingrix vaccine at her pharmacy on 8/25/20.  Symptoms started on 9/3 with a blister between eyebrows and progressed down to tip of nose and into scalp on right side.  She continues to have severe neuralgia.  Treated with Valtrex and opiates.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in jaw, Pruritus
Clinical narrative: Patient developed shingles on rt side of face after receiving Shingrix vaccine at her pharmacy on 8/25/20.  Symptoms started on 9/3 with a blister between eyebrows and progressed down to tip of nose and into scalp on right side.  She continues to have severe neuralgia.  Treated with Valtrex and opiates.
Age: 30.0
Sex: M
Vaccine: JEV1
Symptoms: Dizziness, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Nausea/vomiting, fever, headache. Extremely sore arm. Dizzy. Blurred vision.   Motrin 800mg every 6 hours
Age: 30.0
Sex: M
Vaccine: JEV1
Symptoms: Vision blurred, Vomiting
Clinical narrative: Nausea/vomiting, fever, headache. Extremely sore arm. Dizzy. Blurred vision.   Motrin 800mg every 6 hours
Age: 81.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: pt reported that the next day after receiving her IMZ she had a red rashy area at site of injection, it was swollen , and sore.  She was upset that we did  both injections in the same arm, but she indicated that she is not able to get injections in her right arm due to previous chemo in that arm.  We assured her  that it is ok per protocol to administer 2 in one arm, as long as they are 1 inch apart, and that the reaction she was having was very typical of side effects of the Pneumovax 23 in particular.  Pt took some ibuprofen and put a heating pad on it, and was going to have the doctor look at it, as she was going to the office for something else anyway.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Vertigo
Clinical narrative: 24 hours after vaccine, patient had vertigo and fatigue
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient called today to state that she had a swollen left arm at the site of injection 48 hours post injection which occurred on 9-12-20. She also stated that just under the injection site, she had about a 4x4 area that was red and had a burning sensation. She was not upset, but wanted us to know, and also inquire if this was normal. She may be contacting her doctor.  Told the patient I will be reporting this reaction and will also be reporting the reaction to VAERS.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Eye discharge, Eye swelling, Ocular hyperaemia, Pain in jaw
Clinical narrative: Patient states that the night of the day she received the flu shot her eyes turned bright red, started oozing white pus, became swollen, her jaw on the right side started hurting.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site joint pain, Injection site pain, Injection site swelling
Clinical narrative: headache,  joint pain and redness, swelling, pain and warmth at injection site
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: headache,  joint pain and redness, swelling, pain and warmth at injection site
Age: 81.0
Sex: F
Vaccine: FLUA3
Symptoms: Vaccination site bruising, Vaccination site warmth
Clinical narrative: PURPLE BRUISE LIKE AREA 4 INCHES IN SIZE AROUND WHERE VACCINE GIVEN IN LEFT ARM AND HOT TO TOUCH
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Pain in jaw
Clinical narrative: Patient had severe diarrhea and the left side of her jaw began hurting the night she received the vaccination
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature abnormal, Injection site bruising, Injection site cellulitis, Injection site discolouration, Injection site erythema
Clinical narrative: Injection into low end of deltoid.  Temperature on Wednesday night. Temperature returned to normal on Thursday. On Thursday: Black and blue mark at injection site. Redness around the bruised area. Hot feeling around the site. Inflamed area progressed on Friday and Saturday. On Saturday: Inflamation reached elbow. Patient visited physician who diagnosed cellulitis. Prescribed Cephalexin and bought Benadryl and a probiotic. As of Monday, 9/14: Inflammation still present but improved. Not a full recovery yet.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site inflammation, Injection site warmth
Clinical narrative: Injection into low end of deltoid.  Temperature on Wednesday night. Temperature returned to normal on Thursday. On Thursday: Black and blue mark at injection site. Redness around the bruised area. Hot feeling around the site. Inflamed area progressed on Friday and Saturday. On Saturday: Inflamation reached elbow. Patient visited physician who diagnosed cellulitis. Prescribed Cephalexin and bought Benadryl and a probiotic. As of Monday, 9/14: Inflammation still present but improved. Not a full recovery yet.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Feeling cold, Injection site rash, Pyrexia
Clinical narrative: Up at 2 AM , was very cold, throwing up, major chills, had a miserable next day with fever of 101.5. Had rash at injection site on 2nd day, was better on 3rd day
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Up at 2 AM , was very cold, throwing up, major chills, had a miserable next day with fever of 101.5. Had rash at injection site on 2nd day, was better on 3rd day
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood uric acid normal, Borrelia test negative, C-reactive protein normal, Neuropathy peripheral, White blood cell count normal
Clinical narrative: Left arm down to hand - peripheral neuropathy
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: Pt's husband called pharmacy to report pt had a "softball sized lump" that was "red and warm" and "getting bigger."
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: red, warm, tender at site of injection and it spread further down the arm towards elbow
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: Pt's father called pharmacy to report pt had a "softball sized lump" that was "red and warm" and "getting bigger."
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: Pt's father called pharmacy to report pt had a "softball sized lump" that was "red and warm" and "getting bigger."
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: patient reported right upper arm swelling, redness, pain and heat. she stated she did not take benadryl until the evening of 9/13 and it had improved by the morning of the 14th.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Arm became sore per usual vaccine reaction but got worse as the days went on.  The redness is now taken my entire upper 1/2 of my arm and the pain goes down the arm to the hand.  There has been swelling foe the last 2 days even with using ice packs and Ibuprofen.
Age: 85.0
Sex: M
Vaccine: FLUA3
Symptoms: Gait disturbance, Gait inability, Heart rate increased, Injection site pain, Pain in extremity
Clinical narrative: Patient received Fluad vaccine on 9/11/20 and complained of pain down his legs and arms while receiving vaccine. However, we were not notified until 3 days later on Monday 9/14/20. He had trouble walking to his car, When he got home, over the weekend he had trouble walking. Was not able to walk so paramedics were called. Vitals taken and all within normal range except slight evalated heart rate. Was told by paramedics to contact primary care provider. So patient has upcoming PCP appointment coming up on Tuesday for further assessment. Currently patient is being cared for by a family member.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: patient complained of numbness in right arm and limited mobility for the past 3 days since vaccination. He had radiating burning pain up his neck and down his arm.  patient has been taking aspirin for his pain. it has been getting better but has not completely gone away yet. patient pointed to just below his shoulder when asked where he received his vaccination.  Possibly vaccination given too high on his arm? patient got flu vaccine in left arm on 9/9/20 and said no symptoms from that.  Has not seen doctor about it. I did advise patient if pain persists to call MD.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Muscular weakness
Clinical narrative: I didn't see maker, lot # of the Shingrix shot that I received.  This was the 2nd dose in 2 months.  About 12 hr after the shot, I had chills, headache, body aches and weak muscles.   Later while laying down, I had stomach pain - center of stomach area and fever.    The next morning, I was fine as well as my arm.  But later in the afternoon, I was extremely tired and took a 3-hr nap.   That evening I had same stomach pain - short while, while laying down.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: I didn't see maker, lot # of the Shingrix shot that I received.  This was the 2nd dose in 2 months.  About 12 hr after the shot, I had chills, headache, body aches and weak muscles.   Later while laying down, I had stomach pain - center of stomach area and fever.    The next morning, I was fine as well as my arm.  But later in the afternoon, I was extremely tired and took a 3-hr nap.   That evening I had same stomach pain - short while, while laying down.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Immediate AEs: Severe swelling, redness, itchy, and pain at injection site.  Nausea, extreme fatigue and headache, body and muscle aches. Approx 4-5 weeks post injection: severe itching along back which progressed to stomach after several hundred hard red, itchy and painful bumps appeared - predominantly along right back (upper more, less lower) but across spine and to left side (25% of total).  Progressed to stomach (about 20% of total).  Tingling, pain, neuropathy feeling (similiar to shingles but appearance more in line with chicken pox.). Remained and got worse over course of 10-14 days.  At 6 weeks now reduction in size/pain.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pruritus, Injection site swelling, Myalgia, Nausea, Neurological symptom
Clinical narrative: Immediate AEs: Severe swelling, redness, itchy, and pain at injection site.  Nausea, extreme fatigue and headache, body and muscle aches. Approx 4-5 weeks post injection: severe itching along back which progressed to stomach after several hundred hard red, itchy and painful bumps appeared - predominantly along right back (upper more, less lower) but across spine and to left side (25% of total).  Progressed to stomach (about 20% of total).  Tingling, pain, neuropathy feeling (similiar to shingles but appearance more in line with chicken pox.). Remained and got worse over course of 10-14 days.  At 6 weeks now reduction in size/pain.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Paraesthesia, Pruritus, Rash, Rash erythematous
Clinical narrative: Immediate AEs: Severe swelling, redness, itchy, and pain at injection site.  Nausea, extreme fatigue and headache, body and muscle aches. Approx 4-5 weeks post injection: severe itching along back which progressed to stomach after several hundred hard red, itchy and painful bumps appeared - predominantly along right back (upper more, less lower) but across spine and to left side (25% of total).  Progressed to stomach (about 20% of total).  Tingling, pain, neuropathy feeling (similiar to shingles but appearance more in line with chicken pox.). Remained and got worse over course of 10-14 days.  At 6 weeks now reduction in size/pain.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Immediate AEs: Severe swelling, redness, itchy, and pain at injection site.  Nausea, extreme fatigue and headache, body and muscle aches. Approx 4-5 weeks post injection: severe itching along back which progressed to stomach after several hundred hard red, itchy and painful bumps appeared - predominantly along right back (upper more, less lower) but across spine and to left side (25% of total).  Progressed to stomach (about 20% of total).  Tingling, pain, neuropathy feeling (similiar to shingles but appearance more in line with chicken pox.). Remained and got worse over course of 10-14 days.  At 6 weeks now reduction in size/pain.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Head injury, Syncope
Clinical narrative: PT appeared to have fainted minutes after receiving vaccine injection. PT hit head during fall secondary to faint. Immediately after, PT's legs were raised as pressure was applied to head wound. PT became mentally aware moments after raising of legs. PT was taken to hospital by mother for treatment of head wound. No further outcomes to state at time of report.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Soreness at injection site and mild fever 99.3
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Miosis, Paraesthesia oral, Throat tightness
Clinical narrative: A couple hours after the shot, my throat started to close up , lips felt tingly and became puffy, pupils constricted.  My breathing was fine and I checked oxygen level which was app. 95..  After a few hours, symptoms did not subside so I took two Benadryl at app. 5:30pm, then slept for app. 14 hours. Next day lips were still a little puffy but I felt fine.  My husband and son got vaccine immediately after me and had no uncommon symptoms.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Fall, Feeling of relaxation, Heart rate increased, Loss of consciousness
Clinical narrative: Immediately after administering the vaccine, she relaxed her body and leaned forward into mom's arms. She then fell back onto the exam table and lost consciousness for approximately 10 seconds. I attempted to lay her flat and raise her legs, but before I could do so, she came to and I sat her up on the exam table. She opened her eyes and looked pale; while her heart rate was rapid, she had normal pulse oxygenation and her heart rate returned to normal within another minute. Her color returned by now. I got her water. She stayed for total approximately 5 minutes after event. She was walked out of clinic w/ mine and mom's assistance. She had no further events per parents. She was very anxious leading up to the administration of the vaccine.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Pallor
Clinical narrative: Immediately after administering the vaccine, she relaxed her body and leaned forward into mom's arms. She then fell back onto the exam table and lost consciousness for approximately 10 seconds. I attempted to lay her flat and raise her legs, but before I could do so, she came to and I sat her up on the exam table. She opened her eyes and looked pale; while her heart rate was rapid, she had normal pulse oxygenation and her heart rate returned to normal within another minute. Her color returned by now. I got her water. She stayed for total approximately 5 minutes after event. She was walked out of clinic w/ mine and mom's assistance. She had no further events per parents. She was very anxious leading up to the administration of the vaccine.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness at and around injection site swelling w/pain.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Pain, Rash
Clinical narrative: At 4PM. on 08/05/2020 rashes appeared on my chest and back. Due to their itchiness I applied vaseline based hand lotion and itchiness stopped. At about 7 P.M. I became extremely tired and went to bed. At about 9 PM I awoke shivering. I placed wool blanket over myself and put on knee-high socks. At about 11 P.M. I awoke. I was perspiring and had pain on the left side of my body. I had been sleeping on my left. I turned to sleep on my right side. The shooting pains on my left side continued for some time. The pain was from the left side of my head, neck, shoulder, lower ribs, hip, knee, mid-calf and ankle. When I awoke at about 7 A.M. I was fine. Note: 20 years ago I ripped the rotator cuff and I often have pain in the left shoulder. FYI: My 1st dose of Zoster Vaccine Shingrix was from the same pharmacy on 02/10/20. I had no side effects.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: At 4PM. on 08/05/2020 rashes appeared on my chest and back. Due to their itchiness I applied vaseline based hand lotion and itchiness stopped. At about 7 P.M. I became extremely tired and went to bed. At about 9 PM I awoke shivering. I placed wool blanket over myself and put on knee-high socks. At about 11 P.M. I awoke. I was perspiring and had pain on the left side of my body. I had been sleeping on my left. I turned to sleep on my right side. The shooting pains on my left side continued for some time. The pain was from the left side of my head, neck, shoulder, lower ribs, hip, knee, mid-calf and ankle. When I awoke at about 7 A.M. I was fine. Note: 20 years ago I ripped the rotator cuff and I often have pain in the left shoulder. FYI: My 1st dose of Zoster Vaccine Shingrix was from the same pharmacy on 02/10/20. I had no side effects.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Malaise, Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Received shot in morning. Woke up at night 3:00 with a fever 100 degrees and aching all over. Foot and neck completely stiff. Foot felt like it was broken. In a lot of pain and thought they gave me wrong shot. Could barely move neck. After about hour made it to bathroom and layed in hot water in bath tub. Eventually neck muscles relaxed and kept stretching foot with hands and it took awhile for foot to be normal. I was feeling very ill for two days. I never got a reaction from the first shingles shot. This one was Completely different and never had a reaction from a shot like this before.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Received shot in morning. Woke up at night 3:00 with a fever 100 degrees and aching all over. Foot and neck completely stiff. Foot felt like it was broken. In a lot of pain and thought they gave me wrong shot. Could barely move neck. After about hour made it to bathroom and layed in hot water in bath tub. Eventually neck muscles relaxed and kept stretching foot with hands and it took awhile for foot to be normal. I was feeling very ill for two days. I never got a reaction from the first shingles shot. This one was Completely different and never had a reaction from a shot like this before.
Age: 70.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Rash
Clinical narrative: Patient had Prevnar & Shingrix shot on 9/2/20. Develop rashes on arms & stomach areas. Advise taking Benadryl OTC & resolved.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No reactions noted however Menactra was ordered and Tumenba was given. Error was recognized by Medical Assistant and parent was notified with return to clinic for Menactra one month later. I became aware of this when I saw the patient this summer for well child and noted he had been given Trumenba at age 11. Reporting only because it is not routine schedule but no known adverse event for child.
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patients wife described rash on extremities of arms and lower abdomen. However, No rash or redness around injection site.
Sex: U
Vaccine: FLU4, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: pt broke out in hives 2 days after vaccines
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Large Amount Swelling & Redness on Left Arm at Immunization site-9/12/20, About 800pm,  Earlier in the day, complaints of Left shoulder itching. Advised cool compress, Antihistamine, Tylenol
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Mobility decreased, Pain in extremity
Clinical narrative: Patient experienced severe arm pain. She was unable to lift her arm and missed a day of work. She stated that her hand hurt on the arm in which vaccine was administered. Lasted 2 days, relieved by NSAID and ice packs. We called her doctor to report the event, as well. Spoke to staff. Patient was feeling better on 9/14/20. Vaccine administered 9/12/20.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: Feberile seizure
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Fatigue
Clinical narrative: Patient complained of severe cold chills. Upon morning raising patient experienced dizzyness and fatigue. Went back to bed and after nap felt better to resume normal activities.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Rash maculo-papular
Clinical narrative: maculopapular rash over her whole body. appeared 12 days after vaccine was given.
Age: 1.0
Sex: F
Vaccine: FLU4, HIBV, PNC13, VARCEL
Symptoms: Bronchiolitis, Chest X-ray abnormal, Electroencephalogram normal, Hypotonia, Postictal state
Clinical narrative: Received PCV, Hib, VZV, and flu vaccines 8/31. That evening had paroxysmal event of flaccidity and unresponsiveness without full LOC, apparently post-ictal. Had a similar episode in ER, witnessed by staff. Taken by EMS to ER, transferred to another Hospital for observation. No further episodes. Had normal EEG, labs; CXR consistent with bronchiolitis but suspect expiratory view given age and lack of URI sx. Has been well since. No family hx epilepsy.
Age: 1.0
Sex: F
Vaccine: FLU4, HIBV, PNC13, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Received PCV, Hib, VZV, and flu vaccines 8/31. That evening had paroxysmal event of flaccidity and unresponsiveness without full LOC, apparently post-ictal. Had a similar episode in ER, witnessed by staff. Taken by EMS to ER, transferred to another Hospital for observation. No further episodes. Had normal EEG, labs; CXR consistent with bronchiolitis but suspect expiratory view given age and lack of URI sx. Has been well since. No family hx epilepsy.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dysphonia, Eye discharge, Eye pruritus, Headache
Clinical narrative: Two hours after receiving vaccine she developed throat swelling, ear and sinus drainage, headache, tightness of chest, voice became hoarse and her eyes became itchy and drained mucus. She went to the local ER and was observed and given Benadryl. Rosacea intensified as well
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Otorrhoea, Paranasal sinus hypersecretion, Pharyngeal swelling, Rosacea
Clinical narrative: Two hours after receiving vaccine she developed throat swelling, ear and sinus drainage, headache, tightness of chest, voice became hoarse and her eyes became itchy and drained mucus. She went to the local ER and was observed and given Benadryl. Rosacea intensified as well
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: About 25 hours after receiving the flu vaccine, patient developed hives at the injection site. Mom gave Zyrtec. Hives started to clear the following day and resolved within 48 hours.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Acute sinusitis, Fatigue, Irritability, Nasal congestion, Pyrexia
Clinical narrative: mom reports symptoms began 8/31/20 with Fever of 101.8 accompanied by runny nose, congestion and mild fussiness and tired. Brought pt in the next day at which time pt was placed on Amoxicillin for acute sinusitis. Pt ran fevers x 5 days and developed a rash that progressively worsened. MOm reports rash started out on torso then spread from head to toe and rash appears to have a welted appearance (similar, in places to hives. Pt brought back on 9/9 to see provider again at which time viral vs drug allergy rash was considered and Steroid creams prescribed and advised to follow up in 2 days if not resolving and provider would consult with pediatric derm. Pt continued with progressive fussiness and worsening rash
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Rhinorrhoea, Urticaria
Clinical narrative: mom reports symptoms began 8/31/20 with Fever of 101.8 accompanied by runny nose, congestion and mild fussiness and tired. Brought pt in the next day at which time pt was placed on Amoxicillin for acute sinusitis. Pt ran fevers x 5 days and developed a rash that progressively worsened. MOm reports rash started out on torso then spread from head to toe and rash appears to have a welted appearance (similar, in places to hives. Pt brought back on 9/9 to see provider again at which time viral vs drug allergy rash was considered and Steroid creams prescribed and advised to follow up in 2 days if not resolving and provider would consult with pediatric derm. Pt continued with progressive fussiness and worsening rash
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Mom reports that patient developed a red, raised area below injection site about 31 hours after receiving the flu vaccine. The area was very itchy. Mom gave Zyrtec and the area returned to normal about 30 minutes later. Patient has not experienced a reaction to other vaccines and has no known allergies.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Adacel was administered to a patient after it underwent a temperature excursion of 30 degrees F, No AE; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to cases 2020SA241277, 2020SA241278, 2020SA241248, 2020SA241280, 2020SA241281, 2020SA241282, 2020SA241283, 2020SA241284, 2020SA241285, 2020SA241286 and 2020SA241287 (same reporter).  This case involves a 28 years old male patient who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine (lot number C5667AA and expiration date 26-Sep-2021), that underwent a temperature excursion of 30 degrees Fahrenheit on 19-Aug-2020 (PT: product storage error) via an unknown route at an unknown administration site for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  It was an actual medication error case due to product storage error temperature too low.  No adverse event reported at the time of reporting.  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: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: a 72 years old patient received a dose of Adacel vaccine, No AE; Adacel was administered to a patient after it underwent a temperature excursion of 30 degrees F, No AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to cases 2020SA241277, 2020SA241278, 2020SA241279, 2020SA241280, 2020SA241281, 2020SA241248, 2020SA241283, 2020SA241284, 2020SA241285, 2020SA241286 and 2020SA241287 (same reporter).   In this case involved a DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number C5667AA and expiration date 26-Sep-2021) which underwent a temperature excursion of 30 degrees Fahrenheit and was vaccinated with a dose of this vaccine to a 72 years old female patient on 20-Aug-2020 via an unknown route at an unknown administration site for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  It was an actual medication error case due to product storage error temperature too low and inappropriate age at vaccine administration.  No adverse event reported at the time of reporting.  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: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Adacel was administered to a patient after it underwent a temperature excursion of 30 degrees F, No AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to cases 2020SA241277, 2020SA241278, 2020SA241279, 2020SA241248, 2020SA241281, 2020SA241282, 2020SA241283, 2020SA241284, 2020SA241285, 2020SA241286 and 2020SA241287 (same reporter).  In this case involved a DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine (lot number C5667AA and expiration date 26-Sep-2021) which underwent a temperature excursion of 30 degrees Fahrenheit and was vaccinated with a dose of this vaccine to a 56 years old male patient on 19-Aug-2020 via an unknown route at an unknown administration site for prophylactic vaccination.  The patients medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  It was an actual medication error case due to product storage error temperature too low.  No adverse event reported at the time of reporting.  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: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Adacel was administered to a patient after it underwent a temperature excursion of 30 degrees F, No AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to cases 2020SA241248, 2020SA241278, 2020SA241279, 2020SA241280, 2020SA241281, 2020SA241282, 2020SA241283, 2020SA241284, 2020SA241285, 2020SA241286 and 2020SA241287 (same reporter).  This case involved a DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine (lot number C5667AA and expiration date 26-Sep-2021) which underwent a temperature excursion of 30 degrees Fahrenheit and was vaccinated with a dose of this vaccine to a 58 years old male patient on 13-Aug-2020 via an unknown route at an unknown administration site for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  It was an actual medication error case due to product storage error temperature too low.  No adverse event reported at the time of reporting.  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: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Adacel was administered to a patient after it underwent a temperature excursion of 30 degrees F, No AE; a 72 years old patient recived a dose of adacel vaccine, No AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to cases 2020SA241277, 2020SA241278, 2020SA241279, 2020SA241280, 2020SA241281, 2020SA241282, 2020SA241283, 2020SA241284, 2020SA241285, 2020SA241286 and 2020SA241287 (same reporter).   This case involved a DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number C5667AA and expiration date 26-Sep-2021) which underwent a temperature excursion of 30 degrees Fahrenheit and was vaccinated with a dose of this vaccine to a 72 years old female patient on 06-Aug-2020 via an unknown route at an unknown administration site, as prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  It was an actual medication error case due to product storage error temperature too low and inappropriate age at vaccine administration.  No adverse event reported at the time of reporting.  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.