chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Crying, Erythema, Fatigue
Clinical narrative: I had the vaccine Sunday night and experienced fatigue that night, and then developed arm soreness that lasted for a little over 24 hours. I also developed minor body aches and felt crummy Monday and Tuesday. I was then fine for the rest of that week. Monday, January 4th at 7:30 PM, I felt something tingly, burning, and hot on my left arm. When I looked at it, I had a large round red rash that had a knot and was hot to the touch and itchy. At 3:30 AM on Tuesday morning, I woke up in pain and crying. I went to Urgent Care to have it assessed. The doctor diagnosed it as cellulitis in relation to an infection at the injection site and gave me an antibiotic and drew around it with a surgical marker. He told me to go to my PCP if it grew outside of the line or to the ER if I developed severe symptoms. On Wednesday, it had grown and was not getting any better and had started forming blisters. I called my PCP and he told me to take 2 Loratadine every 24 hours and to come in if it was not better by Friday. It appeared to be getting better and I was fine on Thursday. Friday morning, I woke up in pain again. The rash had spread across the majority of my upper arm. It was red and painful and itching with heat. I went in to see my PCP and he diagnosed it as an allergic reaction to the vaccine. He gave me a steroid, which seems to be suppressing the rash and symptoms. I still have a rash and itchiness, but my physician said it could last for another week or two until it goes away.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersensitivity, Injection site cellulitis, Nodule, Pain
Clinical narrative: I had the vaccine Sunday night and experienced fatigue that night, and then developed arm soreness that lasted for a little over 24 hours. I also developed minor body aches and felt crummy Monday and Tuesday. I was then fine for the rest of that week. Monday, January 4th at 7:30 PM, I felt something tingly, burning, and hot on my left arm. When I looked at it, I had a large round red rash that had a knot and was hot to the touch and itchy. At 3:30 AM on Tuesday morning, I woke up in pain and crying. I went to Urgent Care to have it assessed. The doctor diagnosed it as cellulitis in relation to an infection at the injection site and gave me an antibiotic and drew around it with a surgical marker. He told me to go to my PCP if it grew outside of the line or to the ER if I developed severe symptoms. On Wednesday, it had grown and was not getting any better and had started forming blisters. I called my PCP and he told me to take 2 Loratadine every 24 hours and to come in if it was not better by Friday. It appeared to be getting better and I was fine on Thursday. Friday morning, I woke up in pain again. The rash had spread across the majority of my upper arm. It was red and painful and itching with heat. I went in to see my PCP and he diagnosed it as an allergic reaction to the vaccine. He gave me a steroid, which seems to be suppressing the rash and symptoms. I still have a rash and itchiness, but my physician said it could last for another week or two until it goes away.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Pruritus, Rash, Rash erythematous
Clinical narrative: I had the vaccine Sunday night and experienced fatigue that night, and then developed arm soreness that lasted for a little over 24 hours. I also developed minor body aches and felt crummy Monday and Tuesday. I was then fine for the rest of that week. Monday, January 4th at 7:30 PM, I felt something tingly, burning, and hot on my left arm. When I looked at it, I had a large round red rash that had a knot and was hot to the touch and itchy. At 3:30 AM on Tuesday morning, I woke up in pain and crying. I went to Urgent Care to have it assessed. The doctor diagnosed it as cellulitis in relation to an infection at the injection site and gave me an antibiotic and drew around it with a surgical marker. He told me to go to my PCP if it grew outside of the line or to the ER if I developed severe symptoms. On Wednesday, it had grown and was not getting any better and had started forming blisters. I called my PCP and he told me to take 2 Loratadine every 24 hours and to come in if it was not better by Friday. It appeared to be getting better and I was fine on Thursday. Friday morning, I woke up in pain again. The rash had spread across the majority of my upper arm. It was red and painful and itching with heat. I went in to see my PCP and he diagnosed it as an allergic reaction to the vaccine. He gave me a steroid, which seems to be suppressing the rash and symptoms. I still have a rash and itchiness, but my physician said it could last for another week or two until it goes away.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: I had the vaccine Sunday night and experienced fatigue that night, and then developed arm soreness that lasted for a little over 24 hours. I also developed minor body aches and felt crummy Monday and Tuesday. I was then fine for the rest of that week. Monday, January 4th at 7:30 PM, I felt something tingly, burning, and hot on my left arm. When I looked at it, I had a large round red rash that had a knot and was hot to the touch and itchy. At 3:30 AM on Tuesday morning, I woke up in pain and crying. I went to Urgent Care to have it assessed. The doctor diagnosed it as cellulitis in relation to an infection at the injection site and gave me an antibiotic and drew around it with a surgical marker. He told me to go to my PCP if it grew outside of the line or to the ER if I developed severe symptoms. On Wednesday, it had grown and was not getting any better and had started forming blisters. I called my PCP and he told me to take 2 Loratadine every 24 hours and to come in if it was not better by Friday. It appeared to be getting better and I was fine on Thursday. Friday morning, I woke up in pain again. The rash had spread across the majority of my upper arm. It was red and painful and itching with heat. I went in to see my PCP and he diagnosed it as an allergic reaction to the vaccine. He gave me a steroid, which seems to be suppressing the rash and symptoms. I still have a rash and itchiness, but my physician said it could last for another week or two until it goes away.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Immediate post-injection reaction, Rash, Rash erythematous
Clinical narrative: Immediate mild reaction to include shaking, flushing of skin, and dizziness. Vitals monitored for 30 minutes by staff. Symptoms resolved and sent home. 11Jan2021 red, itching rash appeared over entire body. Not responsive to zyrtec or atarax. Saw PCM 12Jan2021 and was prescribed dexamethosone 4mg twice a day for five days. Currently on day two of treatment with no improvement.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Immediate mild reaction to include shaking, flushing of skin, and dizziness. Vitals monitored for 30 minutes by staff. Symptoms resolved and sent home. 11Jan2021 red, itching rash appeared over entire body. Not responsive to zyrtec or atarax. Saw PCM 12Jan2021 and was prescribed dexamethosone 4mg twice a day for five days. Currently on day two of treatment with no improvement.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: fever, dizziness and headache
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Flushing, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: I got the first dose of the Moderna COVID-19 vaccine on Monday, January 4. I had a mildly sore arm for the first couple of days following the vaccine, but that was about it for side effects. I noticed my face was a little flushed when I was driving home afterward, but I chalked it up to being excited and nervous and wearing a face mask.  Seven days later, it started to feel itchy around my vaccination site (upper left arm). There has been some mild swelling around the site, in addition to being itchy. The area is also warmer than the rest of my arm or body. For one night, it was uncomfortable sleeping on my left side.  Starting on the 8th day after the vaccine, there is a small amount of redness just above the vaccine site, about an inch and a half wide, a little larger than a quarter.  Here are my doctor's notes, who I saw on January 12: Patient is a 40 y.o. female who presents for evaluation of rash/ possible injection reaction  involving the left upper arm. Rash started yesterday.. she noted slight swelling, warmth, and itching with pink erythema in a spot just above the area of her arm where she had her COVID injection 1 week ago. She received the Moderna vaccine.   Associated symptoms: no associated symptoms. Patient denies: fever, headache, arthralgia, abdominal pain, nausea, myalgia, decrease in energy level. She did not have significant pain at the time of the injection, and had a mild sore arm the following few days but no other symptoms after the shot. The warmth and swelling began just yesterday, almost a week later. She has reported this to the VARS website. She is employed by public health and is going to work at a covid vaccination site tonight, checking in people who are getting vaccines.  She has a h/o sensitive skin, but no h/o hives or urticaria, no previous injection reactions. She get racing heart from epinephrine but no other known allergies.  She denies dizziness, dyspnea, SOB, cough, or sensation of swelling in throat.  She has been using ibuprofen, cold compresses for sxs with some relief.  Assessment:  Probable injection site reaction, delayed reaction No strong evidence of cellulitis but we discussed signs and symptoms to be watchful for such as increased swelling and redness or tenderness of the overlying skin, fevers, chills, body aches.  Plan:  Medications: Benadryl 25 mg administered in clinic and discussed use of antihistamines to reduce injection site reaction. She can continue use of ibuprofen and cool compresses as well. Avoid over cooling of skin as this may also cause local reaction.  If pain, redness, or other sxs of concern progress she should follow up.  Verbal patient instruction given. Follow up: as needed.   If no further increase in sxs she should be able to receive her second vaccine but would premedicate with Benadryl to prevent local reaction again.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site reaction, Injection site swelling, Injection site warmth, Nervousness
Clinical narrative: I got the first dose of the Moderna COVID-19 vaccine on Monday, January 4. I had a mildly sore arm for the first couple of days following the vaccine, but that was about it for side effects. I noticed my face was a little flushed when I was driving home afterward, but I chalked it up to being excited and nervous and wearing a face mask.  Seven days later, it started to feel itchy around my vaccination site (upper left arm). There has been some mild swelling around the site, in addition to being itchy. The area is also warmer than the rest of my arm or body. For one night, it was uncomfortable sleeping on my left side.  Starting on the 8th day after the vaccine, there is a small amount of redness just above the vaccine site, about an inch and a half wide, a little larger than a quarter.  Here are my doctor's notes, who I saw on January 12: Patient is a 40 y.o. female who presents for evaluation of rash/ possible injection reaction  involving the left upper arm. Rash started yesterday.. she noted slight swelling, warmth, and itching with pink erythema in a spot just above the area of her arm where she had her COVID injection 1 week ago. She received the Moderna vaccine.   Associated symptoms: no associated symptoms. Patient denies: fever, headache, arthralgia, abdominal pain, nausea, myalgia, decrease in energy level. She did not have significant pain at the time of the injection, and had a mild sore arm the following few days but no other symptoms after the shot. The warmth and swelling began just yesterday, almost a week later. She has reported this to the VARS website. She is employed by public health and is going to work at a covid vaccination site tonight, checking in people who are getting vaccines.  She has a h/o sensitive skin, but no h/o hives or urticaria, no previous injection reactions. She get racing heart from epinephrine but no other known allergies.  She denies dizziness, dyspnea, SOB, cough, or sensation of swelling in throat.  She has been using ibuprofen, cold compresses for sxs with some relief.  Assessment:  Probable injection site reaction, delayed reaction No strong evidence of cellulitis but we discussed signs and symptoms to be watchful for such as increased swelling and redness or tenderness of the overlying skin, fevers, chills, body aches.  Plan:  Medications: Benadryl 25 mg administered in clinic and discussed use of antihistamines to reduce injection site reaction. She can continue use of ibuprofen and cool compresses as well. Avoid over cooling of skin as this may also cause local reaction.  If pain, redness, or other sxs of concern progress she should follow up.  Verbal patient instruction given. Follow up: as needed.   If no further increase in sxs she should be able to receive her second vaccine but would premedicate with Benadryl to prevent local reaction again.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: I got the first dose of the Moderna COVID-19 vaccine on Monday, January 4. I had a mildly sore arm for the first couple of days following the vaccine, but that was about it for side effects. I noticed my face was a little flushed when I was driving home afterward, but I chalked it up to being excited and nervous and wearing a face mask.  Seven days later, it started to feel itchy around my vaccination site (upper left arm). There has been some mild swelling around the site, in addition to being itchy. The area is also warmer than the rest of my arm or body. For one night, it was uncomfortable sleeping on my left side.  Starting on the 8th day after the vaccine, there is a small amount of redness just above the vaccine site, about an inch and a half wide, a little larger than a quarter.  Here are my doctor's notes, who I saw on January 12: Patient is a 40 y.o. female who presents for evaluation of rash/ possible injection reaction  involving the left upper arm. Rash started yesterday.. she noted slight swelling, warmth, and itching with pink erythema in a spot just above the area of her arm where she had her COVID injection 1 week ago. She received the Moderna vaccine.   Associated symptoms: no associated symptoms. Patient denies: fever, headache, arthralgia, abdominal pain, nausea, myalgia, decrease in energy level. She did not have significant pain at the time of the injection, and had a mild sore arm the following few days but no other symptoms after the shot. The warmth and swelling began just yesterday, almost a week later. She has reported this to the VARS website. She is employed by public health and is going to work at a covid vaccination site tonight, checking in people who are getting vaccines.  She has a h/o sensitive skin, but no h/o hives or urticaria, no previous injection reactions. She get racing heart from epinephrine but no other known allergies.  She denies dizziness, dyspnea, SOB, cough, or sensation of swelling in throat.  She has been using ibuprofen, cold compresses for sxs with some relief.  Assessment:  Probable injection site reaction, delayed reaction No strong evidence of cellulitis but we discussed signs and symptoms to be watchful for such as increased swelling and redness or tenderness of the overlying skin, fevers, chills, body aches.  Plan:  Medications: Benadryl 25 mg administered in clinic and discussed use of antihistamines to reduce injection site reaction. She can continue use of ibuprofen and cool compresses as well. Avoid over cooling of skin as this may also cause local reaction.  If pain, redness, or other sxs of concern progress she should follow up.  Verbal patient instruction given. Follow up: as needed.   If no further increase in sxs she should be able to receive her second vaccine but would premedicate with Benadryl to prevent local reaction again.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Otitis media, Pain
Clinical narrative: covid r/u body aches, otitis media
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Had red round site come up on my vaccination site, 3 weeks after receiving the vaccine. The area around the site itches.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Injection site pain, Malaise, Night sweats
Clinical narrative: pt received vaccine on 1/7/2021. He had soreness at the injection site following the injection. He has been having fatigue, malaise, decreased appetite and low grade fevers that occur at night since the injection. He feels fine most of the day but after leaving work mid to late afternoon, feels very fatigued and no interest in evening meal. Low grade fevers in low 100's in the evening and night sweats. has been self medicating with Tylenol for symptoms. No URI symptoms. Hx of COVID 19 virus in July 2020
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: pt received vaccine on 1/7/2021. He had soreness at the injection site following the injection. He has been having fatigue, malaise, decreased appetite and low grade fevers that occur at night since the injection. He feels fine most of the day but after leaving work mid to late afternoon, feels very fatigued and no interest in evening meal. Low grade fevers in low 100's in the evening and night sweats. has been self medicating with Tylenol for symptoms. No URI symptoms. Hx of COVID 19 virus in July 2020
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Ataxia, Dizziness
Clinical narrative: After her 15 min observation she appeared ataxic. Patient stated she felt dizzy, had some water and rested while under observation until dizziness subsided and she walked without losing her balance
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Raised, hard, warm, itchy, tender to the touch circular rash. Approximately 5-6 cm in diameter.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Raised, hard, warm, itchy, tender to the touch circular rash. Approximately 5-6 cm in diameter.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Headache, Pyrexia, Swelling, Urticaria
Clinical narrative: Moderate anaphylaxis reaction per urgent care provider. Developed severe hives and swelling, fever, severe headache 2 days after vaccination. Was treated with Benadryl, Solumedrol IM, and Prednisone taper at local urgent care center.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Fatigue, Headache, Injection site pain
Clinical narrative: No symptoms the day of vaccination but on 1/9 I woke with a headache and pain at the injection site. I had significant tiredness throughout the day. I also started to develop a painful area of redness distal to the injection site. On 1/10 I continued to have a headache and tiredness. The redness had increased on my left arm to ~6x3 inch area. By the afternoon I had a bumpy red itchy rash on several areas of both arms and my back and stomach. At that point I took Benadryl. The morning of 1/11 the rash had mostly resolved but I still experienced itchiness of the arms, stomach and back. I also had left armpit pain.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash pruritic
Clinical narrative: No symptoms the day of vaccination but on 1/9 I woke with a headache and pain at the injection site. I had significant tiredness throughout the day. I also started to develop a painful area of redness distal to the injection site. On 1/10 I continued to have a headache and tiredness. The redness had increased on my left arm to ~6x3 inch area. By the afternoon I had a bumpy red itchy rash on several areas of both arms and my back and stomach. At that point I took Benadryl. The morning of 1/11 the rash had mostly resolved but I still experienced itchiness of the arms, stomach and back. I also had left armpit pain.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling cold, Heart rate increased, Pain, Pyrexia
Clinical narrative: Beginning on 1/5 at 8 am Fever 101, body aches chills. (expected reaction), however over the course of the next 3 days,  short of breath with minimal exertion, increased heart rate to 150 with minimal movement.  Resolved symptoms on 1/10.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Beginning on 1/5 at 8 am Fever 101, body aches chills. (expected reaction), however over the course of the next 3 days,  short of breath with minimal exertion, increased heart rate to 150 with minimal movement.  Resolved symptoms on 1/10.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: WITHIN 24 HOURS OF SHOT: FATIGUE, MUSCLE ACHES, INJECTION SITE SORE, HEADACHE (LIKE SINUS PRESSURE) 24 HOURS AFTER SHOT:  SWOLLEN LYMPH NODE, CHILLS, FEVER (100.4) 36 HOURS AFTER SHOT:  LIKE NOTHING EVER HAPPENED
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Paranasal sinus discomfort, Pyrexia
Clinical narrative: WITHIN 24 HOURS OF SHOT: FATIGUE, MUSCLE ACHES, INJECTION SITE SORE, HEADACHE (LIKE SINUS PRESSURE) 24 HOURS AFTER SHOT:  SWOLLEN LYMPH NODE, CHILLS, FEVER (100.4) 36 HOURS AFTER SHOT:  LIKE NOTHING EVER HAPPENED
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Dizziness, Myalgia
Clinical narrative: 12 hours after vaccine ran 103 temp ,chills, severe joint pain, sever muscle, dizziness, fever lasted about 29 hours. ran low grade temp and still joint pain for about 6 hours. had some nausea for most of the 36 hours
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: 12 hours after vaccine ran 103 temp ,chills, severe joint pain, sever muscle, dizziness, fever lasted about 29 hours. ran low grade temp and still joint pain for about 6 hours. had some nausea for most of the 36 hours
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Light nausea
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: chills, low grade fever, diarrhea
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness to left deltoid. Redness extends past deltoid area, and is approximately around 4 inches wide, and like 6inches long. Oval shaped. Redness is a little raised. Itching noted the evening prior. Redness totally subsided on 1/13/20
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: Today started with arm soreness and redness extending upper arm
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pain
Clinical narrative: Temp 101.4  body aches  chills
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoaesthesia oral, Lip swelling, Pharyngeal paraesthesia
Clinical narrative: Headache within 15 minutes of vaccine , vomiting started about 2:00 am , at 10:30 am dizziness started, lips and face swelled, numbness of lips and roof of mouth, BP 180/100, HR 124, taken by ambulance to ER, throat tingling, given IV Solumedrol, IV Benadryl, IV Pepcid, IV Zofran, 4 hours later swelling reduced and sensation, diagnosed with angiosperms and discharged with Epi Pen, oral steroids for 10 days, 2 antihistamines BID and advised not to take second dose of vaccine
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vomiting
Clinical narrative: Headache within 15 minutes of vaccine , vomiting started about 2:00 am , at 10:30 am dizziness started, lips and face swelled, numbness of lips and roof of mouth, BP 180/100, HR 124, taken by ambulance to ER, throat tingling, given IV Solumedrol, IV Benadryl, IV Pepcid, IV Zofran, 4 hours later swelling reduced and sensation, diagnosed with angiosperms and discharged with Epi Pen, oral steroids for 10 days, 2 antihistamines BID and advised not to take second dose of vaccine
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: have had a red raised area at injection site, itches
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Both arms and back is sore. Fever of 100.4 and flu like symptoms
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue
Clinical narrative: Chest pain and fatigue
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: aprox 12 hours after injection, started with fever. chills.  fatigue, body aches, fever went up to 100.4 at 3am, 2  200 mg ibuprofen were taken. was in bed until 12 pm next day, fever gone, but still fatigue headache for aprox. 24 more hours. Symptoms then went away by Sat. am.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Chills, Malaise, Muscle spasms
Clinical narrative: Severe epigastric abdominal pain (cramping/boring, radiating to back) with associated nausea and vomiting - 4 hours Fever, chills, myalgia, malaise - 12 hours (treated with acetaminophen)
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Vomiting
Clinical narrative: Severe epigastric abdominal pain (cramping/boring, radiating to back) with associated nausea and vomiting - 4 hours Fever, chills, myalgia, malaise - 12 hours (treated with acetaminophen)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Moderna COVID-19 Vaccine   Exactly one week after the injection of the Moderna COVID-19 Vaccine EUA, the injection site began to itch.  I lightly scratched over the area, which itched similarly to a mosquito bite.  The morning after, the injection site on my arm had become very rosy and the bump had become more swollen.  I have had no other symptoms.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Hypoaesthesia, Injection site swelling, Pain
Clinical narrative: swelling at the injection site, pain, headache, feeling like numb, change in the taste, fever the 1st day x2, body ache, lower back pain.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Taste disorder
Clinical narrative: swelling at the injection site, pain, headache, feeling like numb, change in the taste, fever the 1st day x2, body ache, lower back pain.
Sex: U
Vaccine: VARZOS
Symptoms: Macular fibrosis, Macular oedema, Neuralgia, Retinal oedema
Clinical narrative: retinal edema; macular edema; macular pucker; neuralgia; Information has been received from a lawyer regarding a case in litigation concerning the currently approximately 72 years old patient (pt) of unknown gender. On or about 14-JUN-2012, the pt was administered the zoster vaccine live (ZOSTAVAX) (route, dose, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by a provider for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: neuralgia, retinal edema, macular edema and macular pucker. The outcome of the events was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, retinal edema, macular edema and macular pucker were determined to be medically significant.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Within roughly 15 mins of the 30 minute observation when she noted itching on her upper extremities.  There was a visible rash of the upper extremities b/l that extend from fingers to shoulders and across chest.  Assessed by observation room nurse who gave 50mg PO Benadryl per standing order protocol.  Vitals were taken HR 79, O2 97%.  Patient denied any SOB, CP, face/tongue swelling, no ulcerations of the mouth.  She was then taken to the ER for further observation.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, headache, body chills, body aches.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Violent chills starting at 9p, appx 13 hrs after injection, followed by fevers, shakes, myalgia, arthralgias, malaise. Pounding headache for appx 12 hrs until the following morning, Appx 12 hrs after symptoms began was left with myalgias, arthralgias and fatigue that lasted another 24 hrs. Fevers as high as 101.6 during the first 12 hrs when symptoms began.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: Violent chills starting at 9p, appx 13 hrs after injection, followed by fevers, shakes, myalgia, arthralgias, malaise. Pounding headache for appx 12 hrs until the following morning, Appx 12 hrs after symptoms began was left with myalgias, arthralgias and fatigue that lasted another 24 hrs. Fevers as high as 101.6 during the first 12 hrs when symptoms began.
Age: 79.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Muscular weakness
Clinical narrative: had severe muscle weakness /  had to go to the ER; This case was reported by a pharmacist via call center representative and described the occurrence of muscle weakness in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number 57EX2, expiry date 21st March 2022) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE HD) for prophylaxis.   On 26th September 2020, the patient received the 1st dose of Shingrix and FLUZONE HD. On an unknown date, less than a week after receiving Shingrix, the patient experienced muscle weakness. On an unknown date, the outcome of the muscle weakness was unknown.   It was unknown if the reporter considered the muscle weakness to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient had had severe muscle weakness and had to go to the emergency room one week after receiving the 1st dose of Shingrix and Fluzone high dose on the same day. It was unknown if the reporter considered the muscle weakness to be related to Fluzone HD. The reporter consented to follow up. This case was linked with case US2021000447, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021000447:same reporter
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pyrexia, Sneezing
Clinical narrative: Fevers, fatigue, sneezing, coughing
Age: 8.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK had been administered to a 8 years old patient/ No AE; Initial information received on 04-Jan-2021 regarding an unsolicited valid non-serious case received from a nurse via Medical Information (Reference number- 00414025).  This case is linked to case 2021SA002575 (same reporter).  This case involves an eight-years-old male patient who was administered a 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] Prefilled Syringe, Strength: Standard (batch number: UJ509AA, expiry date: 10-MAY-2021) via intramuscular route in the left deltoid on 22-Dec-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration (latency: same day).   Nurse with question regarding administration of FLUBLOK to patients under 18 years of age. Caller reports FLUBLOK had been administered to 11 pediatric patients and would like to know if they are covered for Influenza vaccination for the season.  Adverse Event symptoms: None reported.  First time product used and still using product: No.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001-83-EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: arm soreness day after vaccine, developed full body aches/chills about 25 hours later that lasted approximately 2 hours then passed.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: After 10 days injection area became red and hot
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Mechanical urticaria, Papule, Rash, Rash papular
Clinical narrative: 14 days after the vaccine, I developed a pruritic papular rash bilat on lower lateral flanks, with urticaria from pressure and scratching. Afebrile. (+) dermatographia. Over the last week there has been some improvement but 2 new papules developed on L inner thigh and R upper arm. No treatment. as it didn't bother me enough. Saw my dermatologist yesterday for routine f/u and he confirmed that Dermatologists are seeing an urticarial rash 1-3 weeks after the vaccine.. The question is: should I get the second shot in a week?
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Scratch, Urticaria
Clinical narrative: 14 days after the vaccine, I developed a pruritic papular rash bilat on lower lateral flanks, with urticaria from pressure and scratching. Afebrile. (+) dermatographia. Over the last week there has been some improvement but 2 new papules developed on L inner thigh and R upper arm. No treatment. as it didn't bother me enough. Saw my dermatologist yesterday for routine f/u and he confirmed that Dermatologists are seeing an urticarial rash 1-3 weeks after the vaccine.. The question is: should I get the second shot in a week?
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Swelling
Clinical narrative: Swollen, Red Circle with white inner
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen, Red Circle with white inner
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pain
Clinical narrative: Body Ache  Fatigue  Joint & Muscle Pain  Chills
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: spiked fever of 101.5 severe uncontrollable chills full body aches nausea
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Oedema peripheral, Pain in extremity, Rash erythematous, Rash pruritic
Clinical narrative: Vaccinated on 1/5, had normal side effects including soreness and swollen lymph nodes in axillary region of R arm. Soreness continued through 1/11 and worsened 1/11 at night. Woke up on 1/12 with red, itchy, raised rash which has since spread. Saw PCP 1/12 who determined it was cellulitis at the injection site, started on Keflex 4x daily for 10 days
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Vaccinated on 1/5, had normal side effects including soreness and swollen lymph nodes in axillary region of R arm. Soreness continued through 1/11 and worsened 1/11 at night. Woke up on 1/12 with red, itchy, raised rash which has since spread. Saw PCP 1/12 who determined it was cellulitis at the injection site, started on Keflex 4x daily for 10 days
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Paraesthesia oral, Swollen tongue
Clinical narrative: Patient vaccinated at 1715.  Almost immediately after vaccination patient experienced dizziness and tongue tingling.  Diphenhydramine 50 mg IM was administered at 1726.   Patient progressed to swollen tongue and inability to swallow.  Epinephrine 0.3 mg IM administered at 1800.   Patient transported to ED.    In ED patient received fluids, famotidine 20 mg at 1840, and dexamethasone 12 mg IV at 1858.    Patient symptoms resolved and she was discharged.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac telemetry, Dizziness, Dysgeusia, Dysphagia, Electrocardiogram
Clinical narrative: Patient vaccinated at 1715.  Almost immediately after vaccination patient experienced dizziness and tongue tingling.  Diphenhydramine 50 mg IM was administered at 1726.   Patient progressed to swollen tongue and inability to swallow.  Epinephrine 0.3 mg IM administered at 1800.   Patient transported to ED.    In ED patient received fluids, famotidine 20 mg at 1840, and dexamethasone 12 mg IV at 1858.    Patient symptoms resolved and she was discharged.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Heart rate increased, Hyperhidrosis, Hypertension, Lip swelling
Clinical narrative: Patient vaccinated at 1715.  Almost immediately after vaccination patient experienced dizziness and tongue tingling.  Diphenhydramine 50 mg IM was administered at 1726.   Patient progressed to swollen tongue and inability to swallow.  Epinephrine 0.3 mg IM administered at 1800.   Patient transported to ED.    In ED patient received fluids, famotidine 20 mg at 1840, and dexamethasone 12 mg IV at 1858.    Patient symptoms resolved and she was discharged.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pallor, Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia, Pulse waveform
Clinical narrative: Patient vaccinated at 1715.  Almost immediately after vaccination patient experienced dizziness and tongue tingling.  Diphenhydramine 50 mg IM was administered at 1726.   Patient progressed to swollen tongue and inability to swallow.  Epinephrine 0.3 mg IM administered at 1800.   Patient transported to ED.    In ED patient received fluids, famotidine 20 mg at 1840, and dexamethasone 12 mg IV at 1858.    Patient symptoms resolved and she was discharged.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: Patient vaccinated at 1715.  Almost immediately after vaccination patient experienced dizziness and tongue tingling.  Diphenhydramine 50 mg IM was administered at 1726.   Patient progressed to swollen tongue and inability to swallow.  Epinephrine 0.3 mg IM administered at 1800.   Patient transported to ED.    In ED patient received fluids, famotidine 20 mg at 1840, and dexamethasone 12 mg IV at 1858.    Patient symptoms resolved and she was discharged.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Paraesthesia oral, Swollen tongue
Clinical narrative: Vaccine animate administered at 5:15pm. 5 min after vaccination, pins and needles feeling started in tongue, pulse elevated, sweating, pale, dizzy, bp high, hot. Was monitored by medical services on site. Symptoms did not improve with rest and continued to worsen. Administered Benadryl injection, improvement for about 5 min b4 symptoms returned. Lips started swelling and tingling, throat tingly, metallic taste in month, was unable to swallow, tongue swelling: administered epi pen, ems was called and transported to the er via ambulance at 6:00pm. Some improvement post so I administration before symptoms of dizziness, sweating, swelling, tingling, and pins and needles returned at about 50%, bp and pulse continued to spike intermittently. ECG and waveforms were completed. Was administered Decadron injection 4mg/ml, Pepcid injection, sodium chloride 0.9%, symptoms subsided after about 2 hrs, monitored for 2 more hours and released at 10:15pm.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac telemetry, Dizziness, Dysgeusia, Dysphagia, Electrocardiogram
Clinical narrative: Vaccine animate administered at 5:15pm. 5 min after vaccination, pins and needles feeling started in tongue, pulse elevated, sweating, pale, dizzy, bp high, hot. Was monitored by medical services on site. Symptoms did not improve with rest and continued to worsen. Administered Benadryl injection, improvement for about 5 min b4 symptoms returned. Lips started swelling and tingling, throat tingly, metallic taste in month, was unable to swallow, tongue swelling: administered epi pen, ems was called and transported to the er via ambulance at 6:00pm. Some improvement post so I administration before symptoms of dizziness, sweating, swelling, tingling, and pins and needles returned at about 50%, bp and pulse continued to spike intermittently. ECG and waveforms were completed. Was administered Decadron injection 4mg/ml, Pepcid injection, sodium chloride 0.9%, symptoms subsided after about 2 hrs, monitored for 2 more hours and released at 10:15pm.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Heart rate increased, Hyperhidrosis, Hypertension, Lip swelling
Clinical narrative: Vaccine animate administered at 5:15pm. 5 min after vaccination, pins and needles feeling started in tongue, pulse elevated, sweating, pale, dizzy, bp high, hot. Was monitored by medical services on site. Symptoms did not improve with rest and continued to worsen. Administered Benadryl injection, improvement for about 5 min b4 symptoms returned. Lips started swelling and tingling, throat tingly, metallic taste in month, was unable to swallow, tongue swelling: administered epi pen, ems was called and transported to the er via ambulance at 6:00pm. Some improvement post so I administration before symptoms of dizziness, sweating, swelling, tingling, and pins and needles returned at about 50%, bp and pulse continued to spike intermittently. ECG and waveforms were completed. Was administered Decadron injection 4mg/ml, Pepcid injection, sodium chloride 0.9%, symptoms subsided after about 2 hrs, monitored for 2 more hours and released at 10:15pm.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pallor, Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia, Pulse waveform
Clinical narrative: Vaccine animate administered at 5:15pm. 5 min after vaccination, pins and needles feeling started in tongue, pulse elevated, sweating, pale, dizzy, bp high, hot. Was monitored by medical services on site. Symptoms did not improve with rest and continued to worsen. Administered Benadryl injection, improvement for about 5 min b4 symptoms returned. Lips started swelling and tingling, throat tingly, metallic taste in month, was unable to swallow, tongue swelling: administered epi pen, ems was called and transported to the er via ambulance at 6:00pm. Some improvement post so I administration before symptoms of dizziness, sweating, swelling, tingling, and pins and needles returned at about 50%, bp and pulse continued to spike intermittently. ECG and waveforms were completed. Was administered Decadron injection 4mg/ml, Pepcid injection, sodium chloride 0.9%, symptoms subsided after about 2 hrs, monitored for 2 more hours and released at 10:15pm.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: Vaccine animate administered at 5:15pm. 5 min after vaccination, pins and needles feeling started in tongue, pulse elevated, sweating, pale, dizzy, bp high, hot. Was monitored by medical services on site. Symptoms did not improve with rest and continued to worsen. Administered Benadryl injection, improvement for about 5 min b4 symptoms returned. Lips started swelling and tingling, throat tingly, metallic taste in month, was unable to swallow, tongue swelling: administered epi pen, ems was called and transported to the er via ambulance at 6:00pm. Some improvement post so I administration before symptoms of dizziness, sweating, swelling, tingling, and pins and needles returned at about 50%, bp and pulse continued to spike intermittently. ECG and waveforms were completed. Was administered Decadron injection 4mg/ml, Pepcid injection, sodium chloride 0.9%, symptoms subsided after about 2 hrs, monitored for 2 more hours and released at 10:15pm.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Soreness, swelling, redness, hardness and itching at the injection site remains significant eight days after the injection.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Malaise
Clinical narrative: Fever 102, myalgias, arthalgia, malaise, headach, chills, sweats  Lasted about 6 hours
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever 102, myalgias, arthalgia, malaise, headach, chills, sweats  Lasted about 6 hours
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Fatigue, Feeling abnormal, Headache
Clinical narrative: on tues jan 5th, my arm got extremely red and sore (like I got run over). it continually got worse, finally started improving on this past Monday. My arm was throbbing, yet feels "asleep", tingly/numb all the way to my hand. I had a horrible HA for 6 days. no fever, but episodes of extreme dizziness and drenched in sweat. extremely tired, could sleep for 14 hours and take a 3 hour nap. feeling "spacey" all day. I am still having symptoms now, but getting better.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypersomnia, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: on tues jan 5th, my arm got extremely red and sore (like I got run over). it continually got worse, finally started improving on this past Monday. My arm was throbbing, yet feels "asleep", tingly/numb all the way to my hand. I had a horrible HA for 6 days. no fever, but episodes of extreme dizziness and drenched in sweat. extremely tired, could sleep for 14 hours and take a 3 hour nap. feeling "spacey" all day. I am still having symptoms now, but getting better.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: on tues jan 5th, my arm got extremely red and sore (like I got run over). it continually got worse, finally started improving on this past Monday. My arm was throbbing, yet feels "asleep", tingly/numb all the way to my hand. I had a horrible HA for 6 days. no fever, but episodes of extreme dizziness and drenched in sweat. extremely tired, could sleep for 14 hours and take a 3 hour nap. feeling "spacey" all day. I am still having symptoms now, but getting better.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: *Fever, initially (my baseline is 97.5) of 99.2 on evening of day of injection 1/11/21 ,  evening of 1/12/21 was 100.9 , fever morning of 1/13/21  is 100.7. Fever being managed with Tylenol. * Mild transient dizziness. * Moderate pain and swelling at injection site. *SEVERE fatigue. *Severe muscle and joint pain over entire body.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: *Fever, initially (my baseline is 97.5) of 99.2 on evening of day of injection 1/11/21 ,  evening of 1/12/21 was 100.9 , fever morning of 1/13/21  is 100.7. Fever being managed with Tylenol. * Mild transient dizziness. * Moderate pain and swelling at injection site. *SEVERE fatigue. *Severe muscle and joint pain over entire body.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Muscular weakness
Clinical narrative: Extreme chills.   I was not cold but shook with every breath for about two hours.  Got up in middle of night and my legs would not support me, had to hold onto furniture in order to pull myself across room.  Morning, I get up and tend to lean forward when walking causing me to try and control my balance while walking at an excelerated speed.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria
Clinical narrative: 9 days after vaccine administration developed hives at the vaccine injection site (circumferential around the injection site). No other hives. No other source of hives and no contact exposures to that location (had been in same shirt all night with no changes). Priorities of hives at injection site as well.