chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administration error
Clinical narrative: Error: Booster Given Too Early
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administration error
Clinical narrative: Error: Booster Given Too Early
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Breast pain, Lymphadenopathy, Neck pain
Clinical narrative: Severe swelling and pain in right arm pit, swelling in left arm pit, neck and pain in Lymph glands. Pain under left side of breast bone and shoulder blade.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administration error
Clinical narrative: Error: Booster Given Too Early
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administration error
Clinical narrative: Error: Booster Given Too Early
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administration error
Clinical narrative: Error: Booster Given Too Early
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disturbance in attention, Dysstasia, Fatigue, Feeling abnormal
Clinical narrative: Reaction to 2nd Dose Pfizer covid19 vaccine  I had second dose of the experimental Pfizer vacine February 17, 2021.  1st dose was on January 27, 2021  I had reactions both times.  I already reported on this site, on my 1/27/2021 reaction  Received through a pharmacy clinic set up at my work.  Lot#.   EL9263  Received dose #2 about 10:30am on Wednesday 2/17/2021 during my work hours. (7-4pm)  Paid closer attention to how I felt during the day, I could feel, I was going to be foggy in my head again. I was getting tried quickly. My left arm was not sore this time.  Got home about 4pm (left a little early). Very tired, went to bed by 5:30pm. Slept, woke up to heat soup and eat.   7pm: Back to sleep. Very exhausted, my eyes were hurting (a sign I have a fever) I did not care enough to take my temp. Seemed to hard to try and find the thermometer.   7:30pm: Back to bed. Sleep. I'm very warm in my bed, sweating under arms and chest, I don't care, I can sleep thru that. Smells funny  (sweat has a distinct oder)  11pm: wake up. I want to go pee, but I'm too cold to leave my warm covers. as soon as I uncover to get up, I have violent chills. I don't have chills if I stay covered. This was the exact same symtom I had on May 11, 2021 when I had the covid19 and came home sick from work. Violent chills, barely able to stand and walk alone.  After midnight: I wait for someone to come upstairs to help me get up, with a blanket ready to throw over me and help me to toilet. I was too weak to call for him or to care, I just slept and waited for him to check on me.   someone helped me to to tiolet, chills are under control if I have a blanket on me. The house is not cold, someone has the wood stove cranking that night, it's 70 in my bedroom.  I sleep all night Wednesday.   6:30am: Thursday My eyes still hurt, I'm still hot. I don't care what my temp is. No more chills.  I'm smelly from sweating all night. I'm motivated to shower, I think maybe I can do stuff today, I try to plan some things for the day. I shower and eat some oatmeal. I'm exhausted from doing those two things.   My lower back/hips and neck are and shoulders are tight and sore, aches all over, especially neck. It's hard to think, brain fog, finding the right words. The injection site is not really sore though (last time it was).   I have to just go back to bed. I sleep all day Thursday. Get up late afternoon to eat a little bit (soup and crackers) I try to watch TV. I  can't focus on the show. I go back to bed by 5:30pm. I look at dumb funny videos on social media. Asleep by 6pm on Thursday evening. Sleep all night and wake up Friday 5am.  I'm able to function and do most of my usual activities on Friday, but not very motivated to exercise or go for with dogs like I normally would do. Still stiff muscles. I do play in snow Friday night with dogs.   By Saturday most of the stiffness is much better, I'm moving, walking dogs outside, moving furniture, doing my  usual activities. I care about things again.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feeling hot, Hyperhidrosis, Hypersomnia, Injection site pain
Clinical narrative: Reaction to 2nd Dose Pfizer covid19 vaccine  I had second dose of the experimental Pfizer vacine February 17, 2021.  1st dose was on January 27, 2021  I had reactions both times.  I already reported on this site, on my 1/27/2021 reaction  Received through a pharmacy clinic set up at my work.  Lot#.   EL9263  Received dose #2 about 10:30am on Wednesday 2/17/2021 during my work hours. (7-4pm)  Paid closer attention to how I felt during the day, I could feel, I was going to be foggy in my head again. I was getting tried quickly. My left arm was not sore this time.  Got home about 4pm (left a little early). Very tired, went to bed by 5:30pm. Slept, woke up to heat soup and eat.   7pm: Back to sleep. Very exhausted, my eyes were hurting (a sign I have a fever) I did not care enough to take my temp. Seemed to hard to try and find the thermometer.   7:30pm: Back to bed. Sleep. I'm very warm in my bed, sweating under arms and chest, I don't care, I can sleep thru that. Smells funny  (sweat has a distinct oder)  11pm: wake up. I want to go pee, but I'm too cold to leave my warm covers. as soon as I uncover to get up, I have violent chills. I don't have chills if I stay covered. This was the exact same symtom I had on May 11, 2021 when I had the covid19 and came home sick from work. Violent chills, barely able to stand and walk alone.  After midnight: I wait for someone to come upstairs to help me get up, with a blanket ready to throw over me and help me to toilet. I was too weak to call for him or to care, I just slept and waited for him to check on me.   someone helped me to to tiolet, chills are under control if I have a blanket on me. The house is not cold, someone has the wood stove cranking that night, it's 70 in my bedroom.  I sleep all night Wednesday.   6:30am: Thursday My eyes still hurt, I'm still hot. I don't care what my temp is. No more chills.  I'm smelly from sweating all night. I'm motivated to shower, I think maybe I can do stuff today, I try to plan some things for the day. I shower and eat some oatmeal. I'm exhausted from doing those two things.   My lower back/hips and neck are and shoulders are tight and sore, aches all over, especially neck. It's hard to think, brain fog, finding the right words. The injection site is not really sore though (last time it was).   I have to just go back to bed. I sleep all day Thursday. Get up late afternoon to eat a little bit (soup and crackers) I try to watch TV. I  can't focus on the show. I go back to bed by 5:30pm. I look at dumb funny videos on social media. Asleep by 6pm on Thursday evening. Sleep all night and wake up Friday 5am.  I'm able to function and do most of my usual activities on Friday, but not very motivated to exercise or go for with dogs like I normally would do. Still stiff muscles. I do play in snow Friday night with dogs.   By Saturday most of the stiffness is much better, I'm moving, walking dogs outside, moving furniture, doing my  usual activities. I care about things again.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Musculoskeletal stiffness, Myalgia, Pain, Skin tightness
Clinical narrative: Reaction to 2nd Dose Pfizer covid19 vaccine  I had second dose of the experimental Pfizer vacine February 17, 2021.  1st dose was on January 27, 2021  I had reactions both times.  I already reported on this site, on my 1/27/2021 reaction  Received through a pharmacy clinic set up at my work.  Lot#.   EL9263  Received dose #2 about 10:30am on Wednesday 2/17/2021 during my work hours. (7-4pm)  Paid closer attention to how I felt during the day, I could feel, I was going to be foggy in my head again. I was getting tried quickly. My left arm was not sore this time.  Got home about 4pm (left a little early). Very tired, went to bed by 5:30pm. Slept, woke up to heat soup and eat.   7pm: Back to sleep. Very exhausted, my eyes were hurting (a sign I have a fever) I did not care enough to take my temp. Seemed to hard to try and find the thermometer.   7:30pm: Back to bed. Sleep. I'm very warm in my bed, sweating under arms and chest, I don't care, I can sleep thru that. Smells funny  (sweat has a distinct oder)  11pm: wake up. I want to go pee, but I'm too cold to leave my warm covers. as soon as I uncover to get up, I have violent chills. I don't have chills if I stay covered. This was the exact same symtom I had on May 11, 2021 when I had the covid19 and came home sick from work. Violent chills, barely able to stand and walk alone.  After midnight: I wait for someone to come upstairs to help me get up, with a blanket ready to throw over me and help me to toilet. I was too weak to call for him or to care, I just slept and waited for him to check on me.   someone helped me to to tiolet, chills are under control if I have a blanket on me. The house is not cold, someone has the wood stove cranking that night, it's 70 in my bedroom.  I sleep all night Wednesday.   6:30am: Thursday My eyes still hurt, I'm still hot. I don't care what my temp is. No more chills.  I'm smelly from sweating all night. I'm motivated to shower, I think maybe I can do stuff today, I try to plan some things for the day. I shower and eat some oatmeal. I'm exhausted from doing those two things.   My lower back/hips and neck are and shoulders are tight and sore, aches all over, especially neck. It's hard to think, brain fog, finding the right words. The injection site is not really sore though (last time it was).   I have to just go back to bed. I sleep all day Thursday. Get up late afternoon to eat a little bit (soup and crackers) I try to watch TV. I  can't focus on the show. I go back to bed by 5:30pm. I look at dumb funny videos on social media. Asleep by 6pm on Thursday evening. Sleep all night and wake up Friday 5am.  I'm able to function and do most of my usual activities on Friday, but not very motivated to exercise or go for with dogs like I normally would do. Still stiff muscles. I do play in snow Friday night with dogs.   By Saturday most of the stiffness is much better, I'm moving, walking dogs outside, moving furniture, doing my  usual activities. I care about things again.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Reaction to 2nd Dose Pfizer covid19 vaccine  I had second dose of the experimental Pfizer vacine February 17, 2021.  1st dose was on January 27, 2021  I had reactions both times.  I already reported on this site, on my 1/27/2021 reaction  Received through a pharmacy clinic set up at my work.  Lot#.   EL9263  Received dose #2 about 10:30am on Wednesday 2/17/2021 during my work hours. (7-4pm)  Paid closer attention to how I felt during the day, I could feel, I was going to be foggy in my head again. I was getting tried quickly. My left arm was not sore this time.  Got home about 4pm (left a little early). Very tired, went to bed by 5:30pm. Slept, woke up to heat soup and eat.   7pm: Back to sleep. Very exhausted, my eyes were hurting (a sign I have a fever) I did not care enough to take my temp. Seemed to hard to try and find the thermometer.   7:30pm: Back to bed. Sleep. I'm very warm in my bed, sweating under arms and chest, I don't care, I can sleep thru that. Smells funny  (sweat has a distinct oder)  11pm: wake up. I want to go pee, but I'm too cold to leave my warm covers. as soon as I uncover to get up, I have violent chills. I don't have chills if I stay covered. This was the exact same symtom I had on May 11, 2021 when I had the covid19 and came home sick from work. Violent chills, barely able to stand and walk alone.  After midnight: I wait for someone to come upstairs to help me get up, with a blanket ready to throw over me and help me to toilet. I was too weak to call for him or to care, I just slept and waited for him to check on me.   someone helped me to to tiolet, chills are under control if I have a blanket on me. The house is not cold, someone has the wood stove cranking that night, it's 70 in my bedroom.  I sleep all night Wednesday.   6:30am: Thursday My eyes still hurt, I'm still hot. I don't care what my temp is. No more chills.  I'm smelly from sweating all night. I'm motivated to shower, I think maybe I can do stuff today, I try to plan some things for the day. I shower and eat some oatmeal. I'm exhausted from doing those two things.   My lower back/hips and neck are and shoulders are tight and sore, aches all over, especially neck. It's hard to think, brain fog, finding the right words. The injection site is not really sore though (last time it was).   I have to just go back to bed. I sleep all day Thursday. Get up late afternoon to eat a little bit (soup and crackers) I try to watch TV. I  can't focus on the show. I go back to bed by 5:30pm. I look at dumb funny videos on social media. Asleep by 6pm on Thursday evening. Sleep all night and wake up Friday 5am.  I'm able to function and do most of my usual activities on Friday, but not very motivated to exercise or go for with dogs like I normally would do. Still stiff muscles. I do play in snow Friday night with dogs.   By Saturday most of the stiffness is much better, I'm moving, walking dogs outside, moving furniture, doing my  usual activities. I care about things again.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administration error
Clinical narrative: Error: Booster Given Too Late
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Wrong patient
Clinical narrative: Error: Wrong Patient (documentation in EMR)
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swollenz itchy, pain where shot was administered
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: High fever, body aches worse than I?ve ever had with a flu or virus
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Mild
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: ?COVID Arm?. Delayed reaction, red and itchy  with heat.  I have fatigue. But being a woman over 70 that is probably not unusual.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Sore arm at injection site.  Soreness included sore to touch and muscle pain when lifting arm.  Duration 2 days.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Gait disturbance, Pain
Clinical narrative: Pt felt the chills shortly after receiving his first Pfizer dose. Pt had no other symptoms. I explained that chills are a common side effect after the vaccine. Pt felt well enough to sign out. We discussed options for worsening symptoms. Pt verbalized understanding importance of reporting worsening symptoms to PCP and me as well as going to the ED for life threatening symptoms. Pt came back at 4:30PM after signing out and asked to stay in observation. During this time, his symptoms worsened from chills to body aches and dizziness. Gait with assist was unsteady. I brought him down to the ED at 4:50.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Swollen tongue, Throat tightness, Tongue disorder
Clinical narrative: Patient was here for her 2nd dose vaccine and during her wait time her tongue started to feel funny and swell slightly. Staff was notified as they were talking with her that  her voice sounded a little funny and thick. She also started to cough on a regular interval. As staff continued talking with her she stated her throat started to feel funny and tight. Staff notified other healthcare personal and moved her to the private  treatment area. She continued to complain of thick tongue and continued to speak different then her baseline. We elected to give 50 mg Benadryl IM. She was also placed on the ECG showing sinus rhythm with O2 stats of 100 % and her blood pressure was 149/61, After the Benadryl, she stated she started to fell somewhat better. After about 10 minutes her tongue started to swell again and when she turned her head to speak to a staff member her airway shut off due to swelling. Staff quickly turned her head back to forward she was able to breath again.  She advised that she needed to be transported and was going to get 0.3 epi IM in her left arm. She did state prior to Epi being given she was now also having trouble focusing visually. Dr arrive to assess her and agreed that she needed transported. EMS arrived and care was turned over to Huntertown EMS to transport the patient to Medical Center.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Patient was here for her 2nd dose vaccine and during her wait time her tongue started to feel funny and swell slightly. Staff was notified as they were talking with her that  her voice sounded a little funny and thick. She also started to cough on a regular interval. As staff continued talking with her she stated her throat started to feel funny and tight. Staff notified other healthcare personal and moved her to the private  treatment area. She continued to complain of thick tongue and continued to speak different then her baseline. We elected to give 50 mg Benadryl IM. She was also placed on the ECG showing sinus rhythm with O2 stats of 100 % and her blood pressure was 149/61, After the Benadryl, she stated she started to fell somewhat better. After about 10 minutes her tongue started to swell again and when she turned her head to speak to a staff member her airway shut off due to swelling. Staff quickly turned her head back to forward she was able to breath again.  She advised that she needed to be transported and was going to get 0.3 epi IM in her left arm. She did state prior to Epi being given she was now also having trouble focusing visually. Dr arrive to assess her and agreed that she needed transported. EMS arrived and care was turned over to Huntertown EMS to transport the patient to Medical Center.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Systemic: Joint Pain-Mild, Additional Details: Patient was being observed, at the 15 minute mark the pharmacist asked how the patient was doing and to see if she had any issues or comments or concerns after the injection, she complained of pain and soreness in her leg but this was from previously diagnosed arthritis and it happens when she sits for long. She had no further questions and felt healthy to go.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Within three hours I experienced stiffness in my left knee which escalated to incapacitating pain and inability to support my weight, this lasted for three days with 2nd day being the worst pain and discomfort.  Also had a headache for most of the day on the second day.   Four days following vaccine I started to notice the injection site was getting itchy, then on day Five it was increasing and started getting red, swollen, hot and itch increased.  Day Six it is still itchy, red, hot and swollen.  Red site is about the size of an orange. As of Day Six, No fever, headache or other symptoms and knee has returned to normal discomfort.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Muscular weakness, Musculoskeletal stiffness, Pain
Clinical narrative: Within three hours I experienced stiffness in my left knee which escalated to incapacitating pain and inability to support my weight, this lasted for three days with 2nd day being the worst pain and discomfort.  Also had a headache for most of the day on the second day.   Four days following vaccine I started to notice the injection site was getting itchy, then on day Five it was increasing and started getting red, swollen, hot and itch increased.  Day Six it is still itchy, red, hot and swollen.  Red site is about the size of an orange. As of Day Six, No fever, headache or other symptoms and knee has returned to normal discomfort.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pyrexia
Clinical narrative: Fever (103.5), chills, feeling really cold
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Mobility decreased, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Sharp, radiating pain from injection site to the hand. Jolts of pain occured about every 10 to 15 minutes for 10 hours. Could not be relieved. Once the stabbing pain subsided could not lift/use arm for 2 days followed by 3 days of arm weakness and throbbing pain.  All pain resolved one week post injection.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Muscular weakness
Clinical narrative: Extreme fatigue and muscle weakness
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest discomfort, Chest pain, Discomfort, Swelling
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: Patient stated she was experiencing some \"pressure and swelling under her upper ribcage\" and that she has had this reaction in the past when she accidently inhaled some chemicals. Patient was given one dose of Epinephrine IM into her left thigh and felt relief in pressure after 3 minutes. Patient was advised that if she experiences other symptoms to go to the ER.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Injection site bruising, Injection site mass, Pyrexia
Clinical narrative: Fever, chills, dizziness, bruise @ the injection site, raised red lump below injection site
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Hypertension, Hyperventilation, Nausea
Clinical narrative: Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia, Tremor
Clinical narrative: Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Condition aggravated
Clinical narrative: Intense back pain that confined me to my bed. Doctors told me to take Nsaid and my prescription muscle relaxant Flexeril.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Injection site erythema, Injection site pruritus, Injection site reaction, Peripheral swelling
Clinical narrative: Large, hard bump on upper right arm at injection sight;  itchiness and redness
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: redness upper arm under injection site; size about 6 inches by 3 inches
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Haematochezia
Clinical narrative: Blood in the stool 10 days after the vaccine for 3 days
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Pyrexia
Clinical narrative: I had chills last night.  Have a fever of 100.2 this morning.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Covid arm
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature increased, Chills, Coordination abnormal, Headache
Clinical narrative: Sore, achy headache ,  Unable to sleep at all and during the whent shivers to sweating thru my clothes. My temperatue. in the night was 101.6. Coordianation and balance are affeced the following morning as is my spatial awareness of whereI am in a room relative to a counter or chair.  Sligj cognitive impact with spelling and typeing and forming thoughts which is taking a lot longer and my typin is slower by a third or more.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Intellectual disability, Pain, Sleep disorder
Clinical narrative: Sore, achy headache ,  Unable to sleep at all and during the whent shivers to sweating thru my clothes. My temperatue. in the night was 101.6. Coordianation and balance are affeced the following morning as is my spatial awareness of whereI am in a room relative to a counter or chair.  Sligj cognitive impact with spelling and typeing and forming thoughts which is taking a lot longer and my typin is slower by a third or more.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pruritus, Rash
Clinical narrative: Itchiness and Rash:  Multiple body areas:  between and under breasts, lower back area, under arms.  It was also on my left arm around the injection site but that has gone away.   Date of 1st dose:  1/8/2021 - ELO140 Date of 2nd dose:  1/29/2021 - EJ1686
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Live birth, Pregnancy, Premature labour
Clinical narrative: Approximately 36 hours after second dose- patient went into late preterm labor of 36w6d. Infant was born weighing 6lbs 3.8oz on 2/21/21. Due date was 3/14/21.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Decreased appetite, Eye pain, Feeling abnormal
Clinical narrative: I was miserable .   Was hard to walk from my bed to toilet. 20 feet. Couldn't eat. Felt like my eyes were exploding. Threw up. Muscles and joint pain 8/10. Weak.  Could not sleep night of injection
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Myalgia, Sleep disorder, Vomiting
Clinical narrative: I was miserable .   Was hard to walk from my bed to toilet. 20 feet. Couldn't eat. Felt like my eyes were exploding. Threw up. Muscles and joint pain 8/10. Weak.  Could not sleep night of injection
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Pain, Pyrexia
Clinical narrative: received dose on 2-19 Friday.  Saturday had body aches and 101.7 fever.  Felt better Sunday.  Rash at injection site started Monday March 22 and is still there today Friday March 26. It is red and itchy.  Its size is comparable to a dollar bill.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: red raised rash around injection site, swollen, itchy, hot to the touch, accompanied by headache
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular
Clinical narrative: red raised rash around injection site, swollen, itchy, hot to the touch, accompanied by headache
Sex: F
Vaccine: HEPA
Symptoms: Limb injury
Clinical narrative: cut the HCP's middle finger; the rim (plastic collar) broke off / BROKEN FINGER FLANGE; This spontaneous report was received from a female nurse of unknown age referring to herself. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reaction or allergy were not reported.  On 29-JAN-2021, the patient was administering a dose of hepatitis a vaccine, inactivated (VAQTA) (25U/0.5ML, lot # T020442, Expiration Date: 26-JAN-2022, 0.5 milliliter, route and indication was not reported) in a prefilled syringe this am to her patient. While the patient was just finishing administration, as the plunger was pushed fully into the syringe hub, the finger flange fell off, cutting her middle finger (unknown depth of injury, just stated cut) before it fell to the ground. The patient was able to maintain the hub of the syringe and plunger and withdraw it out of the patient without injury to her patient or affecting the administration. The full dose of hepatitis a vaccine, inactivated (VAQTA) was injected without a problem. The broken syringe would be obtained and the finger flange that broke off would not be returned as it was thrown in the sharp's container. The patient had a small cut to her middle finger that did not need any attention other than to be cleansed and bandaged. The outcome of finger injury was not recovered. The causality assessment was not provided.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020442; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA002696:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEs; patient received PROQUAD by intramuscular route, instead of subcutaneously; This spontaneous report was received from a nurse referring to a 4 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported.  On 15-FEB-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (0.5 ml, strength was not reported, lot #T027116 has been verified as valid, expiration date was 07-FEB-2022) intramuscularly instead of subcutaneously for prophylaxis (subcutaneous injection formulation administered by other route) with 5/8 inch needle. No additional adverse events were reported. The outcome of the events was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: multiple outbreaks of herpes zoster; postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and unknown gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On 02-NOV-2015 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after the vaccination), the patient suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, patient was seen and treated by medical providers and was still under their care. As the result of vaccine live(ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. He also suffered medical expenses, the loss of accumulations and other economic and non-economic damages. The outcome of herpes zoster and postherpetic neuralgia was considered as not recovered. The reporter considered the events to be disabled and related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: Abdominal pain upper
Clinical narrative: No other AE's reported; temperature excursion/Varivax administered to a patient during a temperature excursion .; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.      On 15-FEB-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength and route of administration were not reported, lot # T021821, expiration date was 25-JUN-2022) 0.5 milliliter for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of minus 7.4 degree Celsius for a time frame of 3 hours and 54 minutes, as recorded by the digital data logger. There were no previous temperature excursions. No further adverse event (AE) information was provided.  This is one of the several reports reported by the same reporter.; Sender's Comments:  US-009507513-2102USA008793:
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: no additional AE; the physician administered an expired dose of PNEUMOVAX 23 to the patient; This spontaneous report was received from a physician and refers to a 64-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-FEB-2021, the physician vaccinated the patient with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) expiration date reported as December 2020 (exact dose, route of administration, anatomical location and lot # were not provided) for prophylaxis. The reporter stated that according to his knowledge, the administered vaccine did not experience a prior temperature excursion. No adverse event (AE) was reported.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Scab
Clinical narrative: tiny scabby spot on part of the rash / entire rash has been scabby; rash on abdomen approx 3/4 inch wide, 3 inches long, about 3 inches above navel; This case was reported by a consumer and described the occurrence of rash in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number FY5H2, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 22nd December 2020, the patient received the 2nd dose of Shingrix. On 23rd December 2020, 1 days after receiving Shingrix, the patient experienced rash. On 27th December 2020, the patient experienced scab. On an unknown date, the outcome of the rash and scab were not recovered/not resolved.   It was unknown if the reporter considered the rash and scab to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received 1st dose of Shingrix on 8th October 2020 and had no adverse reaction. After 2nd dose patient had a rash on abdomen approximately 3/4 inch wide, 3 inches long, about 3 inches above navel. Rash was smooth as rest of skin, no itching or pain. The patient had a tiny scabby spot on part of the rash. Ever since 28th December 2020, the entire rash had been scabby. Still had no itching or pain. The patient was concerned that this might affect her ability to obtain the Covid vaccine. The reporter wanted to know if this kind of adverse reaction to the Shingrix vaccine was something she should be concerned about when she would be able to get the Covid vaccine.  The patient was in the high risk group, due to age and underlying medical conditions.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: Soreness / Pain; Swelling; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain and swelling. On an unknown date, the outcome of the pain and swelling were not recovered/not resolved.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional details were provided as follows:   The patient reported for herself/himself. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced side effects of soreness, swelling and pain.  The patient asked what could be done to calm this reaction.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Headache, Pyrexia
Clinical narrative: headache; fever; fatigue; This case was reported by a consumer and described the occurrence of headache in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received on an unknown date and patient experienced fatigue, fever and headache refer case US2021000494).   On 31st December 2020, the patient received the 2nd dose of Shingrix. On 1st January 2021, 1 days after receiving Shingrix, the patient experienced headache, fever and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, fever and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the headache, fever and fatigue to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient received dose 2nd of Shingrix and reported that she experienced fatigue, headache, and fever of 99.9 degree Fahrenheit. The patient also reported that the events from the 2nd dose were more severe after the 2nd dose than the 1st. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021000494:same patient, 1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness / at the injection site; Swelling / at the injection site; Pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19 (had COVID in September 2020).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 63 or 64 years. The patient received the first dose in either October or November of 2020. The patient had redness, swelling and pain at the injection site.  For tolerence with 2nd dose refer case US2021005929. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021005929:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Genital herpes
Clinical narrative: genital herpes infection / major flare up 2 days post vaccination; genital herpes infection / major flare up 2 days post vaccination; This case was reported by a physician and described the occurrence of genital herpes in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included genital herpes.   In October 2020, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced genital herpes and condition aggravated. On an unknown date, the outcome of the genital herpes and condition aggravated were unknown.   It was unknown if the reporter considered the genital herpes and condition aggravated to be related to Shingrix.  Additional details were provided as follows:   The patient was over 50 years of age. The patient was immunized at physician's recommendation with Shingrix in late October 2020.  The patient had previously been diagnosed with genital herpes infection, and had major flare up 2 days post vaccination. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Flushing, Injection site pain, Nausea, Pain
Clinical narrative: Both shots hurt; face was hot all the time; Major body aches; mixed with a sudden sense I might vomit right then and there; when the vaccine was pushed in, it was a different kind of pain; This case was reported by a consumer and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, feeling hot, general body pain, nausea and injection site pain. On an unknown date, the outcome of the injection site pain, feeling hot, general body pain, nausea and injection site pain were unknown.   It was unknown if the reporter considered the injection site pain, feeling hot, general body pain, nausea and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st shots of Shingrix and it hurt Around 36 hours after 1st dose, the patient was afflicted with major body aches and face was hot all the time. When the needle actually punctured to flesh, yowza then, when the vaccine was pushed in, it was a different kind of pain, mixed with a sudden sense that the patient might vomit right then and there. For tolerance in 2nd dose refer case US2021AMR015447.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR015452:same reporter
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Flushing, Injection site pain, Nausea, Pain
Clinical narrative: Both shots hurt / needle actually punctured my flesh, yowza. And, then, when the vaccine was pushed in, it was a different kind of pain; face was hot all the time; major body aches; sense I might vomit; upper arm hurt for days, again, more than after any other shot I've gotten; fever; This case was reported by a consumer and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date refer case US2021AMR015401).   On 12th January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, feeling hot, general body pain, nausea, pain in arm and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved and the outcome of the feeling hot, general body pain, nausea and fever were unknown.   The reporter considered the injection site pain, feeling hot, general body pain, nausea, pain in arm and fever to be possibly related to Shingrix.  Additional details were provided as follows: The patient received the 2nd shot of Shingrix and it hurt.  When the needle actually punctured his flesh and the vaccine was pushed in, it was a different kind of pain, mixed with a sudden sense of vomit right then and there. Afterward, his upper arm hurt for days, again, more than after any other shot the patient have gotten in his life.  Around 36 hours after 2nd dose, the patient was afflicted with major body aches and his face was hot all the time.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR015452:same reporter
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Both shots hurt / needle actually punctured my flesh, yowza. And, then, when the vaccine was pushed in, it was a different kind of pain; face was hot all the time; major body aches; sense I might vomit; upper arm hurt for days, again, more than after any other shot I've gotten; fever; This case was reported by a consumer and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date refer case US2021AMR015401).   On 12th January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, feeling hot, general body pain, nausea, pain in arm and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved and the outcome of the feeling hot, general body pain, nausea and fever were unknown.   The reporter considered the injection site pain, feeling hot, general body pain, nausea, pain in arm and fever to be possibly related to Shingrix.  Additional details were provided as follows: The patient received the 2nd shot of Shingrix and it hurt.  When the needle actually punctured his flesh and the vaccine was pushed in, it was a different kind of pain, mixed with a sudden sense of vomit right then and there. Afterward, his upper arm hurt for days, again, more than after any other shot the patient have gotten in his life.  Around 36 hours after 2nd dose, the patient was afflicted with major body aches and his face was hot all the time.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR015452:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: shivering; This case was reported by a consumer via interactive digital media and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2021, the patient received the 2nd dose of Shingrix. On 21st January 2021, 1 days after receiving Shingrix, the patient experienced shivering. On an unknown date, the outcome of the shivering was not recovered/not resolved.   It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received shingles shot on Wednesday and since Thursday been experiencing shivering episodes at least 2 a day.  The reporter asked was that normal.