chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Muscle spasms, Muscular weakness, Pain
Clinical narrative: On 2/12/21,"almost two weeks after the vaccine was received, I started having sever muscle spasms. They were shooting through the right side of my neck and shoulder. Any sudden movement or wrong movement triggered the spasms.  Even taking too deep of a breath triggered the spasms.  Using my left arm to lift something triggered the spasms. My pain level that day was at a 10+. On Saturday the spasms had subsided, but I  still had very limited ROM in my neck. It felt like my neck muscles had been over worked and my neck felt weak. Pain continued and I went my doctor on Monday 2/15/21. After me explaining to him the course of events and letting him know I did not do anything at all that could have caused an injury,  he felt this was a reaction to the Covid vaccine I had gotten on 2/1/21. He advised me to take my muscle relaxer that he had already prescribed to me and to use a heating pad.  He gave me some exercises to do with my neck and prescribed me Hydrocodone 5-325 mg to take as needed every 8 hours for pain. He told me if it got worse or did not get better to follow-up with him.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Received Pfizer vaccine at 1:00 p.m. on Friday 2/12. Mild headache at 10:00 p.m. Friday evening, 9 hours after vaccine.  Awake at 2:00 a.m. with nasty headache and 102.5 fever.  Fever and headache continued throughout the next day with fever diminishing to 101.7 and later 99.9  Fever subsided after 20-24 hours. Headache and mild nausea continued but diminished gradually through Sunday and into Monday a.m.  At 72 hours symptoms are basically gone, but left very tired.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea, Pain
Clinical narrative: Body aches, severe abdominal cramping, nausea
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Urticaria
Clinical narrative: Large warm welt on injection site. It is spreading. No antihistamine seems to help.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Pinpoint bruising in random places over the body - spreading to approximately the size of a nickel and fading over 8-10 days. Has persisted since date of first vaccination. Received second dose of vaccine on 2/13/2021. Not bothersome, just not an issue before I started the vaccine series.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site induration, Injection site inflammation, Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: A reddish rash appeared  approximately 2? x  3.5? that is a little itchy and slight inflammation and hardness in the area of the injection site upper right arm.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, body aches. Resolved within 48 hours of vaccine administration
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mobility decreased, Pain in extremity, Pruritus
Clinical narrative: Initially was fine but a few hours later arm hurt. Was unable to move arm the next day and felt tired but on day two, felt so much better. Noticed that now her arm w as itchy and had a small round circle. Notice that the red circle was getting bigger and felt hot.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Chills, Headache, Injection site rash, Pain
Clinical narrative: All day feb 14 2021: fever up to 102 degrees, massive massive headache, some congestion, body ache, chills Started late night 2/14/21 rash on injection site at two places , one round circle  w 1 in diameter, second site was patch about 5in long and 2.5 in wide , rash continues through the present time.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: All day feb 14 2021: fever up to 102 degrees, massive massive headache, some congestion, body ache, chills Started late night 2/14/21 rash on injection site at two places , one round circle  w 1 in diameter, second site was patch about 5in long and 2.5 in wide , rash continues through the present time.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Insomnia, Lymphadenopathy
Clinical narrative: Didn't get sick at all, but on second day felt soreness under armpit and had golf ball sized swollen lymph node.  Painful, made it hard to sleep, lasted about a week.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Swelling
Clinical narrative: patient presented on 2/15/21 via video to report ongoing swelling that has persisted since time of vaccination and is now increasing in size. unclear if direct result of vaccine vs cellulitis from injection. antibiotics prescribed to cover for possible cellulitis
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Deep vein thrombosis, Dyspnoea, Fibrin D dimer, Headache
Clinical narrative: Had daily headaches after first dose of vaccine. For 3 weeks. Decided to skip the second dose because of that. Then had leg pain after nearly a month of the vaccine. Thought it was muscle pain but landed up in ER with shortness of breath and was diagnosed with DVT and large PE.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pulmonary embolism, Ultrasound scan, Ultrasound scan abnormal
Clinical narrative: Had daily headaches after first dose of vaccine. For 3 weeks. Decided to skip the second dose because of that. Then had leg pain after nearly a month of the vaccine. Thought it was muscle pain but landed up in ER with shortness of breath and was diagnosed with DVT and large PE.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Petechiae
Clinical narrative: Large red swelling at the deltoid first it was small and continued to grow and became itchy still present although improved not as erythematous, petechiae in the abdomen 3 weeks after first dose
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in jaw
Clinical narrative: Sore neck from under jaw down on both sides of neck.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin induration, Skin warm
Clinical narrative: Rash on left arm started about 2inx2in but not perfectly circular.  Was itchy, red,  hot to touch, & firm. By the 3rd day, rash was more spread out 3inx2in, less red & warm but with a red rim around the rash. Same level of itchiness.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Pyrexia
Clinical narrative: Had normal fever and injection site pain on 2/12. 2/13-14 the fever was gone, but arm pain persisted. (After first dose, pain only lasted one day). 2/14 a large red lump appeared around the injection site, and itching began. Today, 2/15, pain is mostly gone, but red spot and itchiness persist. I'm not reporting because these are terrible side effects or were totally unexpected. But I don't find other reports of similar reactions, and I want to make sure this is okay.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Severe, itchy, red rash all over body for several days since the vaccine first dose.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Severe, itchy, red rash all over body for several days since the vaccine first dose.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Needle issue, Syringe issue, Underdose
Clinical narrative: vaccine administered, possibly defective needle/syringe caused some of the vaccine to discharge from the base of the needle where it is attached to the syringe.  as a result, RPh unable to determine if patient received more than half of the dose and per CDC guidance, another dose will be readministered to the patient tomorrow (2/16/2021) in the other arm (RA)
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: Lump in arm at injection site and itching
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash on arm occurred 9 days after vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills and fever of 99.9
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 1 week after receiving Moderna vaccine, noticed red, defined bump about 1/2" diameter  about 1" above the site of injection.  Several hours later, bump became sore and itchy.  Several hours after that, itching and warm to touch in 3 areas around the deltoid area.  By 5 hours after initial sensation of bump,  a 3 inch diam of erythema, and itchiness.  Also during that period of time had some sneezing and  runny nose. By the 13th day, the area is not swollen, but there is a ring of erythema about 6" long. on the deltoid/bicep area.  No itchiness, but is a bit tender at site of initial injection.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: 1 week after receiving Moderna vaccine, noticed red, defined bump about 1/2" diameter  about 1" above the site of injection.  Several hours later, bump became sore and itchy.  Several hours after that, itching and warm to touch in 3 areas around the deltoid area.  By 5 hours after initial sensation of bump,  a 3 inch diam of erythema, and itchiness.  Also during that period of time had some sneezing and  runny nose. By the 13th day, the area is not swollen, but there is a ring of erythema about 6" long. on the deltoid/bicep area.  No itchiness, but is a bit tender at site of initial injection.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness of the entire left side of the face. From the ear to the mouth. 2nd vaccine shot received in left arm today.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Eye pain
Clinical narrative: Chills; headache, dizziness, fatigue; sleepiness, weakness, neckache, eye  ache, rapid heartbeat, loss of appetite, nausea, hallucinations, cold sore.  Symptoms resolved 48 hours after injection.  Ibuprofen was taken to relieve headache and neck ache.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hallucination, Headache, Heart rate increased, Nausea
Clinical narrative: Chills; headache, dizziness, fatigue; sleepiness, weakness, neckache, eye  ache, rapid heartbeat, loss of appetite, nausea, hallucinations, cold sore.  Symptoms resolved 48 hours after injection.  Ibuprofen was taken to relieve headache and neck ache.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Oral herpes, Somnolence
Clinical narrative: Chills; headache, dizziness, fatigue; sleepiness, weakness, neckache, eye  ache, rapid heartbeat, loss of appetite, nausea, hallucinations, cold sore.  Symptoms resolved 48 hours after injection.  Ibuprofen was taken to relieve headache and neck ache.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, COVID-19, Chills, Headache, Malaise
Clinical narrative: Contracted/Tested positive for covid19 after receiving 1st dose of vaccine..*1st dose was 1/22/21 **Tested positive 2/4/21**2nd dose 2/12/21; After second dose, I had rash, discoloration along left leg and painful swelling in left axillary area for 3 days, bad headache, felt ill(chills).
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oedema peripheral, Rash, SARS-CoV-2 test positive, Skin discolouration
Clinical narrative: Contracted/Tested positive for covid19 after receiving 1st dose of vaccine..*1st dose was 1/22/21 **Tested positive 2/4/21**2nd dose 2/12/21; After second dose, I had rash, discoloration along left leg and painful swelling in left axillary area for 3 days, bad headache, felt ill(chills).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Had really sore left arm right after injection of moderna vaccine. Severe soreness lasted the first day and the whole night. But felt better the next day, and by third day, arm felt fine.  However, seven days after moderna vaccine injection, developed swelling, hardness, redness, hot to the touch, itchiness, at injection site. Hurt to raise left arm up high, left arm feels really stiff when trying to raise it.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Had really sore left arm right after injection of moderna vaccine. Severe soreness lasted the first day and the whole night. But felt better the next day, and by third day, arm felt fine.  However, seven days after moderna vaccine injection, developed swelling, hardness, redness, hot to the touch, itchiness, at injection site. Hurt to raise left arm up high, left arm feels really stiff when trying to raise it.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: (R) arm Opposite of vaccination  just above the elbow is Red and hot to the touch somewhat itchy.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram, Injection site pain, Pain, X-ray
Clinical narrative: Day 1-1-1/2  Slight soreness at vaccine site; Days 2-3  Soreness throughout chest (as with the flu); Days 4-5  Soreness in left side of chest; Day 6 - present  Soreness concentrated in one area of left chest/side; more intense and "takes my breath away," at times, with certain movement and total inflation or deflation of lungs.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Costochondritis, Dyspnoea, SARS-CoV-2 antibody test
Clinical narrative: Day 1-1-1/2  Slight soreness at vaccine site; Days 2-3  Soreness throughout chest (as with the flu); Days 4-5  Soreness in left side of chest; Day 6 - present  Soreness concentrated in one area of left chest/side; more intense and "takes my breath away," at times, with certain movement and total inflation or deflation of lungs.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: pt synopsized at home
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Chills  Headaches  Body aches  Fatigue Slight fever   Using Tylenol and  ibuprofen for treatment   Vaccine received on  2/14 effects still happening on night of 2/15 (Second dose)
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain, Rash, Urticaria
Clinical narrative: 15 hours after the 2nd dose I experienced moderately severe body aches and fatigue. 26 hours after 2nd dose I developed a severe rash on left arm, then bilateral knees, then 30 hours later hives on bilateral thighs. 37 hours hives again on bilateral calves. 55 hours later hives again on bilateral legs and throughout mid and low back.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Moderna COVID-19 Vaccine  MUSCLE PAIN-FULL BODY, EXTREME FATIGUE,  HEADACHE, NAUSEA, FEVER (101.0 reduced with 400mg ibuprofenx1).  Symptoms began with muscle pain/fatigue @0600 Feb 10th.  Headache/fever @ 1300 Feb 10th resolved with Ibuprofen, Nausea (mild) Feb 11 for < 4h.  Fatigue lasted from 0600-Feb 10th through roughly mid-day Feb 12th.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Fatigue, Migraine
Clinical narrative: Chills and fatigue next morning, migraine headache for about 4 days
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 1st vaccination  and two days later hives on right forearm and back   2nd vaccination and two days later hives on site of vaccination, stomach, shoulder, leg and arms
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Post-acute COVID-19 syndrome
Clinical narrative: Large red ?Covid arm? reaction.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Rash macular
Clinical narrative: Noticed a rash consisting of several red dots covering the top right side of my right hand, several days after receiving the vaccine. Slight burning sensation from the rash.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess drainage, Abscess limb, Dry eye, Genital discomfort, Headache
Clinical narrative: About 10:00 pm on Saturday evening of noon injection, injection site was painful--at the same time got intensive, but very brief headache, very dry eyes and, within minutes, (no idea if it's related) I noticed weird sensation in my nether regions, which felt like my underwear was knotted and pressing on it.  Went to check and found big kind of oblong lump (abscess) on outer labia extending to inside thigh--quite painful.    It came out of nowhere--hadn't noticed it at all before that moment.  Goggled it and thought it was probably Bartholin's Abscess and treated it as such.  (Later realized it couldn't be because it wasn't inner, but outer labia.)  Took sitz bath, and continued taking sitz baths next day and applying heat.  Abscess extremely painful, fever 100.3--quite high for me., rash on chest and abdomen.  It started draining while sleeping Sunday night and continued draining slowly on Monday with fever down to 99 and now down to 98.1.  Rash has disappeared.  Arm no longer sore.  Abscess still painful but less so
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Pyrexia, Rash, Vulval abscess
Clinical narrative: About 10:00 pm on Saturday evening of noon injection, injection site was painful--at the same time got intensive, but very brief headache, very dry eyes and, within minutes, (no idea if it's related) I noticed weird sensation in my nether regions, which felt like my underwear was knotted and pressing on it.  Went to check and found big kind of oblong lump (abscess) on outer labia extending to inside thigh--quite painful.    It came out of nowhere--hadn't noticed it at all before that moment.  Goggled it and thought it was probably Bartholin's Abscess and treated it as such.  (Later realized it couldn't be because it wasn't inner, but outer labia.)  Took sitz bath, and continued taking sitz baths next day and applying heat.  Abscess extremely painful, fever 100.3--quite high for me., rash on chest and abdomen.  It started draining while sleeping Sunday night and continued draining slowly on Monday with fever down to 99 and now down to 98.1.  Rash has disappeared.  Arm no longer sore.  Abscess still painful but less so
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Head ache, achy all over, nausea,  body sore left arm pain
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Gait inability, Heart rate increased, Hyperventilation
Clinical narrative: Elevated heart rate Hyperventilating, inability to catch breath, literally thought I was dying Beyond chills, my legs and lower back were shaking so bad I could not stand or walk Next day I felt as if I had been extensively beaten with a pool cue If I had a way to go to the emergency room I would have
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Elevated heart rate Hyperventilating, inability to catch breath, literally thought I was dying Beyond chills, my legs and lower back were shaking so bad I could not stand or walk Next day I felt as if I had been extensively beaten with a pool cue If I had a way to go to the emergency room I would have
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Loss of feeling in arm and hand
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Started with tenderness and mild redness, and itching at the injection site on day 9 after the inject. Proceeding to get bigger each day. Using ice and Antihistamine cream for the itching.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness soreness itchy at the injection site
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein normal, Drug screen negative, Dry skin, Intensive care, Myocarditis
Clinical narrative: 26 yo Male developed a laboratory confirmed myocarditis  on/about 7 February 2021 after receiving the 2nd dose of Moderna COVID19 Vaccine on 3 Feb 2021. His HS-Tropin peaked at 2179. He was admitted to the ICU for care. Discharged at 72 hour admission. Seen today (16 Feb 2021) for follow-up. Reports no sequela other than the development of dry skin that is pruritic. Multiple pending  lab studies ordered/collected to identify other etiologies (Lyme, RPR, Coxsackie, parvo ...).  Denies any vaping products.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Red blood cell sedimentation rate increased, Troponin increased
Clinical narrative: 26 yo Male developed a laboratory confirmed myocarditis  on/about 7 February 2021 after receiving the 2nd dose of Moderna COVID19 Vaccine on 3 Feb 2021. His HS-Tropin peaked at 2179. He was admitted to the ICU for care. Discharged at 72 hour admission. Seen today (16 Feb 2021) for follow-up. Reports no sequela other than the development of dry skin that is pruritic. Multiple pending  lab studies ordered/collected to identify other etiologies (Lyme, RPR, Coxsackie, parvo ...).  Denies any vaping products.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: I am experiencing diarrhea for the last 12 hours and have been having stomach issues since 2 days after receiving the vaccine but don't know if its related.
Age: 0.33
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness within 2 hours after getting Pfizer Injection. It's been 4 days and I'm still have the dizziness, it's almost like having Vertigo.  I haven't been able to get to my physician because we have had lots of ice and snow. The city is basically locked down due to inclement weather until further notice.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Post-acute COVID-19 syndrome
Clinical narrative: large red circle-  Covid arm
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Neck pain, Paraesthesia
Clinical narrative: After client received vaccine client states she has tingling in her fingers, pain in both sides of lower neck, dry mouth.  Vitals obtained by EMS O2 sat 99%, BP 168/87, Pulse 100. Client states she is feeling better.  Client discharged home.   Client advised to call if symptoms return.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever of 101.4, headache, body aches
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Caller is reporting that an improperly stored vaccine was administered on 25JAN202 l.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-JAN-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally , lot # 1688504, expiration date: 19-NOV-2021 (exact dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 13.4 degrees Celsius for 2 hours and 9 minutes. Data logger was involved. There were no previous temperature excursions reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details; Patient was administered an expired vaccine; This spontaneous report was received from a medical assistant concerning to a patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported.      On 08-FEB-2021, the patient was vaccinated with a dose of hepatitis A vaccine, inactivated (VAQTA) (at the dose of 0.5 ml, route was not reported; lot # S030587, expiration date 06-JAN-2021) for prophylaxis (expired product administered).  No additional adverse event (AE) details were reported (no adverse event).
Sex: U
Vaccine: TDAP
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm; Some fatigue; Headache; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced pain in arm, fatigue and headache. On an unknown date, the outcome of the pain in arm, fatigue and headache were unknown.   It was unknown if the reporter considered the pain in arm, fatigue and headache to be related to Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, they had some issues with lots of vaccines and had sore arm, some fatigue and headache with Tdap vaccine as well. This case has been linked with US2021AMR001161 (Shingrix case) reported by same reporter, same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR001161:Tdap vaccine, same reporter
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Developed a rash; Rash diagnosed as shingles; This case was reported by a nurse  and described the occurrence of rash in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced rash and shingles. On an unknown date, the outcome of the rash and shingles were unknown.   It was unknown if the reporter considered the rash and shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix in August 2020 and two to three days later he developed a rash that was diagnosed as shingles.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Chills, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: felt like had the flu; nausea; abdominal cramps; weak; low grade fever; shaking; shivering; could not go to work the day after receiving the vaccine; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th September 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, nausea, abdominal cramp, weakness, fever, tremor, shivering and malaise. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, nausea, abdominal cramp, weakness, fever, tremor, shivering and malaise were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, nausea, abdominal cramp, weakness, fever, tremor, shivering and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and at the same night experienced shivering, chills, tremor, fever, abdominal cramps, felt weak, nausea and had flu like symptoms. The reporter stated that, events lasted for about 12 hours and were resolved. The patient was treated with tyenelol for the eventsand was not able to go to work on the day after receiving vaccine. The reporter consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pyrexia, Tremor
Clinical narrative: felt like had the flu; nausea; abdominal cramps; weak; low grade fever; shaking; shivering; could not go to work the day after receiving the vaccine; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th September 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, nausea, abdominal cramp, weakness, fever, tremor, shivering and malaise. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, nausea, abdominal cramp, weakness, fever, tremor, shivering and malaise were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, nausea, abdominal cramp, weakness, fever, tremor, shivering and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and at the same night experienced shivering, chills, tremor, fever, abdominal cramps, felt weak, nausea and had flu like symptoms. The reporter stated that, events lasted for about 12 hours and were resolved. The patient was treated with tyenelol for the eventsand was not able to go to work on the day after receiving vaccine. The reporter consent to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Interchange of vaccine products, Wrong product administered
Clinical narrative: First dose of Engerix-B a month ago / Dose of Twinrix on Dec 2nd, 2020 instead of a second dose of Engerix-b; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 59-year-old female patient who received HAB (Twinrix) (batch number 9355D, expiry date 14th March 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HBV (Engerix B).   On 22nd December 2020, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 22nd December 2020, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported, however it could be 58 or 59 years. The patient received the first dose of Engerix-B a month ago from the reporting date and then received a dose of Twinrix vaccine instead of a second dose of Engerix B vaccine, which led to wrong vaccine administered for Hepatitis A antigen. The reporter consented to follow-up, however health care professional declined to provide address.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: Arm hurt; Didn't feel well; Made her sick; 1st dose of Shingrix a year ago; This case was reported by a pharmacist and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, between 1 and 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, feeling unwell, sickness and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm, feeling unwell, sickness and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain in arm, feeling unwell and sickness to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and arm hurt, just did not feel well and it made sick.  The patient the 1st dose of Shingrix a year ago and mentioned that had a rough time with the 1st dose and was probably part of the reason why had not returned for the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up. No vaccine details available at the time of the call. This case linked with US2020AMR257399, US2020AMR257416, US2020AMR257400 and US2020256891, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR257399:same reporter_individual pt US-GLAXOSMITHKLINE-US2020AMR257416:same reporter_some patients (sick, 2nd dose) US-GLAXOSMITHKLINE-US2020AMR257400:same reporter_some patients (sick, 1st dose) US-GLAXOSMITHKLINE-US2020256891:same reporter_some patients (late)
Age: 41.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Injection site pain, Injection site swelling, Off label use
Clinical narrative: pain / at the injection site; swelling at the injection site; felt tired, fatigue; fever; stomachache; receiving / first dose / on 05Jan2021/ is under 50 years of age; medical order to receive it even though is under 50 years of age; This case was reported by a physician and described the occurrence of injection site pain in a 41-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included crohn's disease.   On 5th January 2021, the patient received the 1st dose of Shingrix. On 5th January 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, fatigue, fever, stomach pain, inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the injection site pain, injection site swelling, fatigue, fever and stomach pain were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration and off label use were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, fatigue, fever and stomach pain to be related to Shingrix.  Additional details were provided as follows: The reporter reported for himself. The patient received dose of shingrix in the left deltoid. After vaccination, the patient experienced pain and swelling at the injection site, felt tired, fatigue, had a fever, stomachache and had not recovered till the time of reporting. The patient had medical order to receive Shingrix even though he was under 50 years of age, which led to and inappropriate age at vaccine administration and off label use. The reporter consented to follow up.
Age: 41.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: pain / at the injection site; swelling at the injection site; felt tired, fatigue; fever; stomachache; receiving / first dose / on 05Jan2021/ is under 50 years of age; medical order to receive it even though is under 50 years of age; This case was reported by a physician and described the occurrence of injection site pain in a 41-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included crohn's disease.   On 5th January 2021, the patient received the 1st dose of Shingrix. On 5th January 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, fatigue, fever, stomach pain, inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the injection site pain, injection site swelling, fatigue, fever and stomach pain were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration and off label use were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, fatigue, fever and stomach pain to be related to Shingrix.  Additional details were provided as follows: The reporter reported for himself. The patient received dose of shingrix in the left deltoid. After vaccination, the patient experienced pain and swelling at the injection site, felt tired, fatigue, had a fever, stomachache and had not recovered till the time of reporting. The patient had medical order to receive Shingrix even though he was under 50 years of age, which led to and inappropriate age at vaccine administration and off label use. The reporter consented to follow up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea
Clinical narrative: chills; nausea; This case was reported by a pharmacist and described the occurrence of nausea in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th January 2021, the patient received the 2nd dose of Shingrix. On 4th January 2021, 5 hrs after receiving Shingrix, the patient experienced nausea. On 5th January 2021, the patient experienced chills. On an unknown date, the outcome of the nausea and chills were unknown.   It was unknown if the reporter considered the nausea and chills to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with 2nd dose of Shingrix. 5 hours after vaccination patient had nausea. On next day after vaccination patient experienced Chills. The reporter consented to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Coma, Guillain-Barre syndrome
Clinical narrative: guillain barre syndrome; Coma; This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a adult male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant) and coma (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome and coma were unknown.   The reporter considered the guillain barre syndrome and coma to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received flu shot several years ago and experienced Guillain-barre syndrome, which led to hospitalization and coma. The reporter was uncertain of which vaccine the patient received and stated that, it may be quadrivalent or trivalent. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Throat was blistery; Right arm was sore; Throat was red; Throat was sore; Throat was raw; Had a low grade fever; Had a low grade fever for 3 days and stayed in bed; Fatigue; Headache; Shivering; Myalgia; This case was reported by a consumer via call center representative and described the occurrence of throat blister in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included peanut allergy.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than an hour after receiving Shingrix, the patient experienced throat blister (serious criteria GSK medically significant), pain in arm, red throat, sore throat, raw throat, low grade fever, activities of daily living impaired, fatigue, headache, shivering and myalgia. On an unknown date, the outcome of the throat blister, pain in arm, red throat, sore throat, raw throat, low grade fever, activities of daily living impaired, fatigue, headache, shivering and myalgia were recovered/resolved.   It was unknown if the reporter considered the throat blister, pain in arm, red throat, sore throat, raw throat, low grade fever, activities of daily living impaired, fatigue, headache, shivering and myalgia to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her right arm and her right arm was sore.  Within half hour, her throat was red, sore, blistery and raw and she had a low grade fever for 3 days and stayed in bed.  The patient's symptoms were so bad that she almost went to the hospital.  After three days, patient's symptoms resolved and she was back at work.  When reviewing the common side effects for Shingrix in the package insert, the patient stated that she had all of the following including, fatigue, headache, shivering and myalgia.  The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal blistering, Oropharyngeal pain, Pain in extremity, Pharyngeal erythema, Pyrexia
Clinical narrative: Throat was blistery; Right arm was sore; Throat was red; Throat was sore; Throat was raw; Had a low grade fever; Had a low grade fever for 3 days and stayed in bed; Fatigue; Headache; Shivering; Myalgia; This case was reported by a consumer via call center representative and described the occurrence of throat blister in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included peanut allergy.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than an hour after receiving Shingrix, the patient experienced throat blister (serious criteria GSK medically significant), pain in arm, red throat, sore throat, raw throat, low grade fever, activities of daily living impaired, fatigue, headache, shivering and myalgia. On an unknown date, the outcome of the throat blister, pain in arm, red throat, sore throat, raw throat, low grade fever, activities of daily living impaired, fatigue, headache, shivering and myalgia were recovered/resolved.   It was unknown if the reporter considered the throat blister, pain in arm, red throat, sore throat, raw throat, low grade fever, activities of daily living impaired, fatigue, headache, shivering and myalgia to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her right arm and her right arm was sore.  Within half hour, her throat was red, sore, blistery and raw and she had a low grade fever for 3 days and stayed in bed.  The patient's symptoms were so bad that she almost went to the hospital.  After three days, patient's symptoms resolved and she was back at work.  When reviewing the common side effects for Shingrix in the package insert, the patient stated that she had all of the following including, fatigue, headache, shivering and myalgia.  The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat irritation
Clinical narrative: Throat was blistery; Right arm was sore; Throat was red; Throat was sore; Throat was raw; Had a low grade fever; Had a low grade fever for 3 days and stayed in bed; Fatigue; Headache; Shivering; Myalgia; This case was reported by a consumer via call center representative and described the occurrence of throat blister in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included peanut allergy.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than an hour after receiving Shingrix, the patient experienced throat blister (serious criteria GSK medically significant), pain in arm, red throat, sore throat, raw throat, low grade fever, activities of daily living impaired, fatigue, headache, shivering and myalgia. On an unknown date, the outcome of the throat blister, pain in arm, red throat, sore throat, raw throat, low grade fever, activities of daily living impaired, fatigue, headache, shivering and myalgia were recovered/resolved.   It was unknown if the reporter considered the throat blister, pain in arm, red throat, sore throat, raw throat, low grade fever, activities of daily living impaired, fatigue, headache, shivering and myalgia to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her right arm and her right arm was sore.  Within half hour, her throat was red, sore, blistery and raw and she had a low grade fever for 3 days and stayed in bed.  The patient's symptoms were so bad that she almost went to the hospital.  After three days, patient's symptoms resolved and she was back at work.  When reviewing the common side effects for Shingrix in the package insert, the patient stated that she had all of the following including, fatigue, headache, shivering and myalgia.  The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: A spontaneous report (United States) was received from a healthcare professional concerning a patient, who was administered COVID-19 vaccine (mRNA-1273), and who experienced receiving half of a dose/ under dose and syringe fell apart/ device connection issue. The patient's medical history was not provided. No concomitant medications were reported. On 01 Feb 2021, prior to the onset of events, the patient received their first dose of  intramuscularly for prophylaxis of COVID-19 infection. While the vaccine was administered, the syringe fell apart, and patient only received half of a dose. No treatment information was provided. Action taken in response to the events was not reported. The outcome of the events, receiving half of a dose and the syringe fell apart, was resolved on 01 Feb 2021; Reporter's Comments: This case concerns a patient of unknown age and gender who received their first dose  intramuscularly for prophylaxis of COVID-19 infection and while the vaccine was administered, the syringe fell apart, and patient only received half of a dose. There were no reported adverse events after the vaccine was administered in this case of syringe connection issue and under dose.
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Vaccination site discharge
Clinical narrative: A spontaneous report was received from a consumer concerning a 78-year-old female, who was administered 2nd dose of Covid-19 vaccine and experienced vaccine leaked out of arm during administration. The medical history was not provided. No relevant concomitant medications were reported. On 06 Jan 2021, patient received first of the planned doses of (Batch number not provided) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection. On 04 Feb 2021, patient received second of the planned doses of (Batch number not provided) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection. On 04 Feb 2021, the vaccine leaked out during the administration. Action taken in response to the events was not applicable. The outcome of the event, vaccine leaked out of arm during administration, was resolved on 04 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered and Vaccination site discharge for.  There were no reported adverse events associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: A spontaneous report was received from a physician, concerning a patient of unknown age and gender, who received two COVID-19 vaccine accidentally on the same day. The patient's medical history was not provided.  No concomitant medications were reported. On an unknown date, prior to the onset of the events, the patient was accidentally administered two doses (Lot number: unknown) on the same day for prophylaxis of COVID-19 infection. Physician reported that, after administering both doses of the vaccines, the patient was followed closely for safety outcome and "did fine".  No treatment information was provided. Action taken with second dose in response to the event was not reported. The event administered two vaccinations on the same day was considered as resolved.; Reporter's Comments: This report refers to a case of extra dose administered.  There were no reported adverse events associated with this case.