chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypertension, Hypertensive crisis, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Approximately 10 minutes after vaccination, patient came up to pharmacy counter and reported feeling light headed, dizzy, having blurred vision, headache and chills. Patient had significant high blood pressure after taking her blood pressure with an automatic cuff. She also appeared disoriented and anxious. Emergency services were called but patient refused transport to the emergency room.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Palpitations, Pyrexia, Retching
Clinical narrative: Approximately 10 minutes after vaccination, patient came up to pharmacy counter and reported feeling light headed, dizzy, having blurred vision, headache and chills. Patient had significant high blood pressure after taking her blood pressure with an automatic cuff. She also appeared disoriented and anxious. Emergency services were called but patient refused transport to the emergency room.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: Approximately 10 minutes after vaccination, patient came up to pharmacy counter and reported feeling light headed, dizzy, having blurred vision, headache and chills. Patient had significant high blood pressure after taking her blood pressure with an automatic cuff. She also appeared disoriented and anxious. Emergency services were called but patient refused transport to the emergency room.
Age: 77.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Chills, Oral herpes, Tremor
Clinical narrative: Patient received vaccination on a Thursday and side effects started on the following Sunday. He would get chills and shaking spells that would last for about 2 hours and occured about twice daily for 10 days. He also got many cold sores covering 2/3 of his lower and upper lips. He received the flu shot and the RSV vaccine on the same day. He has received the flu shot every year for decades and has never had a reaction; he believes the reaction was caused by the RSV vaccine.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Facial pain, Histamine level, Lip pain, Lip swelling, Swelling face
Clinical narrative: This was an unusual presentation, it is not entirely clear is this was due to the vaccine (especially given the reaction history to naproxen in the past).  Patient presented with swelling below the left side of his lip to his chin, it then progressed to include the half of his lower lip.  He had no systemic symptoms (no respiratory, cardiovascular, or other skin symptoms).  No tongue swelling.  The area was painful, no vesicles/ulcerations, and non-pruritic.  He did not have a rash.  There was no local reaction at the site of the vaccine injections.   He was given IV methylpredisolone 40mg x1 with improvement (not complete resolution).   He was hypertensive on presentation which improved while observed and with reduction in swelling.  His lisinopril was stopped (although lower suspicion, but could not completely exclude); he last took lisinopril the morning of 10/26.  He was sent home on Zyrtec and a short course of prednisone 20mg.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Tryptase
Clinical narrative: This was an unusual presentation, it is not entirely clear is this was due to the vaccine (especially given the reaction history to naproxen in the past).  Patient presented with swelling below the left side of his lip to his chin, it then progressed to include the half of his lower lip.  He had no systemic symptoms (no respiratory, cardiovascular, or other skin symptoms).  No tongue swelling.  The area was painful, no vesicles/ulcerations, and non-pruritic.  He did not have a rash.  There was no local reaction at the site of the vaccine injections.   He was given IV methylpredisolone 40mg x1 with improvement (not complete resolution).   He was hypertensive on presentation which improved while observed and with reduction in swelling.  His lisinopril was stopped (although lower suspicion, but could not completely exclude); he last took lisinopril the morning of 10/26.  He was sent home on Zyrtec and a short course of prednisone 20mg.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Coronary artery occlusion, Inflammation, Myocardial infarction, Oesophageal discomfort
Clinical narrative: Heart attack, 100% blockage LAD. had lots of inflammation and body pain which is normal after a Covid booster for me. Symptom of heart attack was slight tightness in my chest, and a cramp feeling in my esophagus.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Heart attack, 100% blockage LAD. had lots of inflammation and body pain which is normal after a Covid booster for me. Symptom of heart attack was slight tightness in my chest, and a cramp feeling in my esophagus.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Musculoskeletal stiffness, Neck pain
Clinical narrative: UNILATERAL STIFF NECK STARTED ON DAY 5 AND PROGERESSED OVER 24 HOURS TO SEVERE BILATERAL NECK PAIN AND COULD NOT FLEX OR TURN HEAD. PAIN SEVERE REQUIRING NARCOTIC MEDS FOR 2 DAYS (PAIN 8 OUT OF 10) BEFORE STARTING A 3 DAY COURSE OF PREDNISONE AT 30 MG PER DAY. GOT RELIEF WITHIN 12 HOURS OF STARTING STEROIDS. HAD SOME CONTINUED NECK PAIN FOR 4-5 DAYS BEFORE BACK TO NORMAL AT THE MOST SEWVERE POINT I WAS CONSERNED ABOUT MENINGITIS BUT I HAD NO FEVER.   THIS IS MY 5TH COVID VACCINE INJECTION OVER THE LAST 2 YEARS AND THIS NEVER HAPPENED BEFORE
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Chills, Migraine, Nausea, Pain
Clinical narrative: Chills, chest pain, nausea, severe migraine, body pain, especially in legs and feet.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Chills, chest pain, nausea, severe migraine, body pain, especially in legs and feet.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, PNC13, RV5
Symptoms: No adverse event
Clinical narrative: No adverse reaction presented at the time of administration.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Tinnitus
Clinical narrative: Received the dose in Jan 2023 in the same arm as prior 4 Covid shots and within the week ,?5-6 days, I started noticing ringing in my Right ear. It is most noticeable in the PM hours. I never had any ringing in my ears prior to Jan 2023.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Pericardial effusion
Clinical narrative: Excess fluid around the heart: pericardial effusion
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Adult Havrix instead of pediatric Havrix
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Decreased appetite, Dizziness
Clinical narrative: I felt a little dizzy after 30 mins of vaccine administration and started feeling chest tightness and loss of appetite all day
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Migraine, Urticaria
Clinical narrative: Migraine and hives all over body for 1 week. Hives on elbows, knees, ankles, feet, hands.
Age: 73.0
Sex: F
Vaccine: COVID19, FLUA4, RSV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was administered a flu vaccine in error due to misunderstanding of requested vaccines.  This was the patient's 2nd flu vaccine of the season.  Patient received Covid vaccine and RSV as desired.  No adverse outcomes are known at this time.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Dry skin, Flushing, Urticaria
Clinical narrative: 20 mins after vaccine had dry flush of face lasting 5 mins, then patchy hives on face/neck for 24 hrs. Treated with Zyrtec after 12 hrs
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Heart rate irregular, Malaise
Clinical narrative: Heartbeat uneven and with occasional prominent heartbeat. Dizzyness, overall feeling of being sick.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Nausea
Clinical narrative: Diarrhea & nausea in the AM. done by noon
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Injection site pain, Maternal exposure before pregnancy, Myalgia, Product administered to patient of inappropriate age
Clinical narrative: Patient presented to clinic for an RSV vaccine. Arexvy was given. Patient should have received Abrysvo, which is approved for pregnant women. Abrysvo was not available in clinic. Post vaccine symptoms include headache, muscle aches, soreness at injection site. 36 weeks gestation in pregnancy, due date is November 25, 2023
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Product use issue, Wrong product administered
Clinical narrative: Patient presented to clinic for an RSV vaccine. Arexvy was given. Patient should have received Abrysvo, which is approved for pregnant women. Abrysvo was not available in clinic. Post vaccine symptoms include headache, muscle aches, soreness at injection site. 36 weeks gestation in pregnancy, due date is November 25, 2023
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Brain fog, Condition aggravated, Dyspnoea
Clinical narrative: Patient received Spikevax '23-'24 and a few days later was still lethargic and had brain fog. The patient also stated that his arthritis had worsened and his joint pain was much worse than ever before. He also stated that he had labored breathing, which could be heard over the phone when speaking to the patient. It was suggested that the patient contact his primary care physician to discuss symptoms and treatment options. He has an appointment with PCP sometime next week (10/30/23 to 11/3/23).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Patient received Spikevax '23-'24 and a few days later was still lethargic and had brain fog. The patient also stated that his arthritis had worsened and his joint pain was much worse than ever before. He also stated that he had labored breathing, which could be heard over the phone when speaking to the patient. It was suggested that the patient contact his primary care physician to discuss symptoms and treatment options. He has an appointment with PCP sometime next week (10/30/23 to 11/3/23).
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site pain, Local reaction, Product administered to patient of inappropriate age
Clinical narrative: Patient presented to clinic for an RSV vaccination as prescribed by her OB/GYN provider. She was given Arexvy. Being pregnant, she should have received Abrysvo. This vaccine was not available in the clinic. Experienced localized reaction - redness and sore at injection site. She is 34 weeks gestation. Due date is December 4, 2023
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Product use issue, Wrong product administered
Clinical narrative: Patient presented to clinic for an RSV vaccination as prescribed by her OB/GYN provider. She was given Arexvy. Being pregnant, she should have received Abrysvo. This vaccine was not available in the clinic. Experienced localized reaction - redness and sore at injection site. She is 34 weeks gestation. Due date is December 4, 2023
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoaesthesia, Myalgia, Vision blurred
Clinical narrative: After receiving the vaccine the patient started experiencing  numbness on the left side of the body, dizziness, headache, blurry vision, muscle pain.  The patient has been treated by Dr and given a prescription for Prednisone.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Computerised tomogram abdomen abnormal, Diarrhoea, Diverticulitis
Clinical narrative: This was my second Covid -19 Vaccine but my first dose of the Pfizer vaccine. My first dose was the J & J vaccine, I also had a very severe and extended adverse reaction to the J and J vaccine ( previously reported in VAERS).  I had the vaccine around 4 pm. I felt a bit lightheaded and dizzy immediately after the injection but felt ok after 45 mintues of waiting at the facility.   Around 1 AM I develped a very rapid hearbeat, sweating , feverish feeling with intermittent chills, headache, followed by nausea and diarrhea several hours later. By 9 am the next morning the nausea was so bad that I contacted my PCP's office who told me it was a common  side effec from the vaccine. By noon the nausea was so bad that  I could not eat or drink  and had developed abdominal pain . By 2 pm I was vomiting and had severe abdominal pain. After speaking to my PCP's office staff,  I proceeded to go to the ER at Hospital as they ecommended.  I had severe abdominal pain on both sides of my stomach and severe nausea and  could not swallow water without vomiting. The pain was a 8 or 9 out of 10 at its worse.  I was evalulated and following an abdominal CAT scan I was diagnosed with Acute Diverticulitis.  I was admitted to the hospital and was there for a total of 5 days for treatment. This included IV fluids , IV pain meds ,  nothing by mouth for several days and monitoring of my blood count.  I had to follow a special post Diverticulitis diet for two weeks following my discharge and had a follow up colonscopy. These symptoms occured within 24 hours of receiving the Pfizer Covid 19 vaccine. I had no abdominal symptoms the day I received the covid vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Feeding disorder, Full blood count, Headache
Clinical narrative: This was my second Covid -19 Vaccine but my first dose of the Pfizer vaccine. My first dose was the J & J vaccine, I also had a very severe and extended adverse reaction to the J and J vaccine ( previously reported in VAERS).  I had the vaccine around 4 pm. I felt a bit lightheaded and dizzy immediately after the injection but felt ok after 45 mintues of waiting at the facility.   Around 1 AM I develped a very rapid hearbeat, sweating , feverish feeling with intermittent chills, headache, followed by nausea and diarrhea several hours later. By 9 am the next morning the nausea was so bad that I contacted my PCP's office who told me it was a common  side effec from the vaccine. By noon the nausea was so bad that  I could not eat or drink  and had developed abdominal pain . By 2 pm I was vomiting and had severe abdominal pain. After speaking to my PCP's office staff,  I proceeded to go to the ER at Hospital as they ecommended.  I had severe abdominal pain on both sides of my stomach and severe nausea and  could not swallow water without vomiting. The pain was a 8 or 9 out of 10 at its worse.  I was evalulated and following an abdominal CAT scan I was diagnosed with Acute Diverticulitis.  I was admitted to the hospital and was there for a total of 5 days for treatment. This included IV fluids , IV pain meds ,  nothing by mouth for several days and monitoring of my blood count.  I had to follow a special post Diverticulitis diet for two weeks following my discharge and had a follow up colonscopy. These symptoms occured within 24 hours of receiving the Pfizer Covid 19 vaccine. I had no abdominal symptoms the day I received the covid vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Immediate post-injection reaction, Nausea, Pyrexia
Clinical narrative: This was my second Covid -19 Vaccine but my first dose of the Pfizer vaccine. My first dose was the J & J vaccine, I also had a very severe and extended adverse reaction to the J and J vaccine ( previously reported in VAERS).  I had the vaccine around 4 pm. I felt a bit lightheaded and dizzy immediately after the injection but felt ok after 45 mintues of waiting at the facility.   Around 1 AM I develped a very rapid hearbeat, sweating , feverish feeling with intermittent chills, headache, followed by nausea and diarrhea several hours later. By 9 am the next morning the nausea was so bad that I contacted my PCP's office who told me it was a common  side effec from the vaccine. By noon the nausea was so bad that  I could not eat or drink  and had developed abdominal pain . By 2 pm I was vomiting and had severe abdominal pain. After speaking to my PCP's office staff,  I proceeded to go to the ER at Hospital as they ecommended.  I had severe abdominal pain on both sides of my stomach and severe nausea and  could not swallow water without vomiting. The pain was a 8 or 9 out of 10 at its worse.  I was evalulated and following an abdominal CAT scan I was diagnosed with Acute Diverticulitis.  I was admitted to the hospital and was there for a total of 5 days for treatment. This included IV fluids , IV pain meds ,  nothing by mouth for several days and monitoring of my blood count.  I had to follow a special post Diverticulitis diet for two weeks following my discharge and had a follow up colonscopy. These symptoms occured within 24 hours of receiving the Pfizer Covid 19 vaccine. I had no abdominal symptoms the day I received the covid vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This was my second Covid -19 Vaccine but my first dose of the Pfizer vaccine. My first dose was the J & J vaccine, I also had a very severe and extended adverse reaction to the J and J vaccine ( previously reported in VAERS).  I had the vaccine around 4 pm. I felt a bit lightheaded and dizzy immediately after the injection but felt ok after 45 mintues of waiting at the facility.   Around 1 AM I develped a very rapid hearbeat, sweating , feverish feeling with intermittent chills, headache, followed by nausea and diarrhea several hours later. By 9 am the next morning the nausea was so bad that I contacted my PCP's office who told me it was a common  side effec from the vaccine. By noon the nausea was so bad that  I could not eat or drink  and had developed abdominal pain . By 2 pm I was vomiting and had severe abdominal pain. After speaking to my PCP's office staff,  I proceeded to go to the ER at Hospital as they ecommended.  I had severe abdominal pain on both sides of my stomach and severe nausea and  could not swallow water without vomiting. The pain was a 8 or 9 out of 10 at its worse.  I was evalulated and following an abdominal CAT scan I was diagnosed with Acute Diverticulitis.  I was admitted to the hospital and was there for a total of 5 days for treatment. This included IV fluids , IV pain meds ,  nothing by mouth for several days and monitoring of my blood count.  I had to follow a special post Diverticulitis diet for two weeks following my discharge and had a follow up colonscopy. These symptoms occured within 24 hours of receiving the Pfizer Covid 19 vaccine. I had no abdominal symptoms the day I received the covid vaccine.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Product preparation error
Clinical narrative: 26 Oct. '23 @ 10:33 ~ RSV (Arexvy) ~ Administered Diluent only ~ Left Deltoid IM..  10:35 ~ Moderna (Spikevax) ~ Right Deltoid IM..   10:40 ~ Notified Pharmacist ~ ..  10:41 ~ Notified patient.   10:47 ~ RSV (Arexvy) ~ Administered Reconsituted vaccine ~ Left Deltoid.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acne, Arthralgia, Asthenia, Chills, Fatigue
Clinical narrative: Lower grade fever 99.5 for several days, chills, fatiged, joint and muscle pains, headaches, wheezing for a few days (all these started 4 days after vaccination and lasted for 4-5 days) . The skin rash started a litle later than 5, 6 days but it is still lingering.  Oral thrush/mouth ulcers with a white like sods now yellow tongue.  Very bad taste of mouth and some skin pimples that thought where mosquito bites... These last symptoms snuck up on me and I dont seem to be able to shake them off.  At present I dont feel very well and I my level of energy is very, very low.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Malaise, Mouth ulceration, Myalgia, Oral candidiasis
Clinical narrative: Lower grade fever 99.5 for several days, chills, fatiged, joint and muscle pains, headaches, wheezing for a few days (all these started 4 days after vaccination and lasted for 4-5 days) . The skin rash started a litle later than 5, 6 days but it is still lingering.  Oral thrush/mouth ulcers with a white like sods now yellow tongue.  Very bad taste of mouth and some skin pimples that thought where mosquito bites... These last symptoms snuck up on me and I dont seem to be able to shake them off.  At present I dont feel very well and I my level of energy is very, very low.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Taste disorder, Tongue coated, Tongue discolouration, Wheezing
Clinical narrative: Lower grade fever 99.5 for several days, chills, fatiged, joint and muscle pains, headaches, wheezing for a few days (all these started 4 days after vaccination and lasted for 4-5 days) . The skin rash started a litle later than 5, 6 days but it is still lingering.  Oral thrush/mouth ulcers with a white like sods now yellow tongue.  Very bad taste of mouth and some skin pimples that thought where mosquito bites... These last symptoms snuck up on me and I dont seem to be able to shake them off.  At present I dont feel very well and I my level of energy is very, very low.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Very dizzy 24 hours after I received injection. Very tired and achy in muscles and joints. Also had a headache. I went to bed at night and woke up after two hours. I was completely drenched in sweat, and still dizzy. I went back to sleep and felt a little better in the morning. I did not call my doctor because I thought it probably was a small side affect. Forty eight hours after the injection I felt better.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Middle insomnia, Myalgia, Night sweats
Clinical narrative: Very dizzy 24 hours after I received injection. Very tired and achy in muscles and joints. Also had a headache. I went to bed at night and woke up after two hours. I was completely drenched in sweat, and still dizzy. I went back to sleep and felt a little better in the morning. I did not call my doctor because I thought it probably was a small side affect. Forty eight hours after the injection I felt better.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Underdose, Wrong patient received product
Clinical narrative: The 5-11 year dose that was drawn up for the sibling was administered in error to patient, who should have received the 12+ dose.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Axillary pain, Erythema, Fatigue, Induration, Pain
Clinical narrative: 6 cm hot, red, indurated, painful area, increasing in size each day; low grade fever; fatigue; axillary pain
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia, Skin warm
Clinical narrative: 6 cm hot, red, indurated, painful area, increasing in size each day; low grade fever; fatigue; axillary pain
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: all day nausea and vomiting
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: too much vaccine given
Age: 2.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Patient was given entire vial of Covid-19 vaccine 2023-2024 6m-4yr formula, approximately 0.5ml. Failing to dilute the vial with sodium chloride and separate the vial into three doses. Pts mother was contacted 5 hours after injection and reports no Sx. Encouraged to seek medical attention if patient develops severe symptoms as described in the fact sheet.
Age: 70.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Aphasia, Hyperhidrosis, Mobility decreased
Clinical narrative: Patient said that she woke on the floor in her bedroom (wasn't sure how) and was unable to move or call out for help. When her husband found her he had to lift her up onto the bed and he noticed that she was soaking wet from sweating. She believes that it was from getting both vaccines at the same time.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Asthenia, Back pain, Balance disorder, Body temperature increased
Clinical narrative: tightness in chest, a little harder to breathe, lower back, hips in pain, temp. of 102.85 after tylenol was taken, head hurting, freezing with trembling, sweating, sick at stomach,weak, unsteady,  this all the same day and evening into night, couldn't really go to sleep till way up the next morning, felt bad day after didn't want to do anything. Felt better by late evening of 10/25/2023.  But don't look forward of ever receiving any more flu shots!
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Chest discomfort, Dyspnoea, Feeling abnormal, Feeling cold, Headache
Clinical narrative: tightness in chest, a little harder to breathe, lower back, hips in pain, temp. of 102.85 after tylenol was taken, head hurting, freezing with trembling, sweating, sick at stomach,weak, unsteady,  this all the same day and evening into night, couldn't really go to sleep till way up the next morning, felt bad day after didn't want to do anything. Felt better by late evening of 10/25/2023.  But don't look forward of ever receiving any more flu shots!
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Hyperhidrosis, Nausea, Sleep disorder, Tremor
Clinical narrative: tightness in chest, a little harder to breathe, lower back, hips in pain, temp. of 102.85 after tylenol was taken, head hurting, freezing with trembling, sweating, sick at stomach,weak, unsteady,  this all the same day and evening into night, couldn't really go to sleep till way up the next morning, felt bad day after didn't want to do anything. Felt better by late evening of 10/25/2023.  But don't look forward of ever receiving any more flu shots!
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. The patient received her second Moderna Covid-19 vaccine on 26-Mar-2021.   This case was linked to US-MODERNATX, INC.-MOD-2023-746599 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746599:Same Reporter different Product (SPIKEVAX 203-2024)
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pain in extremity, Paraesthesia oral, Tenderness
Clinical narrative: the patients lips swelled to the double the size; Both of my face cheeks got tender 24 hours after my injection; sore arm; My upper lip was a tingling sensation; This spontaneous case was reported by an other health care professional and describes the occurrence of LIP SWELLING (the patients lips swelled to the double the size), TENDERNESS (Both of my face cheeks got tender 24 hours after my injection), PAIN IN EXTREMITY (sore arm) and PARAESTHESIA (My upper lip was a tingling sensation) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Dermal filler in both of lips (3 times) and cheeks (one time) in the past.     On 16-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 17-Oct-2023, the patient experienced LIP SWELLING (the patients lips swelled to the double the size). 17-Oct-2023, the patient experienced TENDERNESS (Both of my face cheeks got tender 24 hours after my injection), PAIN IN EXTREMITY (sore arm) and PARAESTHESIA (My upper lip was a tingling sensation). At the time of the report, LIP SWELLING (the patients lips swelled to the double the size), TENDERNESS (Both of my face cheeks got tender 24 hours after my injection) and PAIN IN EXTREMITY (sore arm) was resolving and PARAESTHESIA (My upper lip was a tingling sensation) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  On 03-Jan-2021, the patient received first dose of Moderna COVID-19 Vaccine; lot: 026L20A. On 30-Jan-2021, received second dose of Moderna COVID-19 Vaccine; lot: 012L20A. On 29-Oct-2021, received third dose of Moderna COVID-19 Vaccine; lot: 939905, expiration date: 23-Jan-2022. On 13-Oct-2022, received fourth dose of Spikevax Bivalent .222; lot: AS7164B.  On 17-Oct-2023, 24 hours after the fifth dose of Spikevax vaccine, patient had a sore arm. The patient's lips swelled to the double the size. Patient's upper lip had tingling sensation. Both of patient's face cheeks got tender 24 hours after injection. Since then, nearly 48 hours later the pain was better however lips were still swollen. The swelling in lips was starting to go down. Cheeks were still tender if patient push on them. The patient reported that she had Dermal Filler in both of her lips and cheeks in the past, and that the dermal filler was why she got this.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746430 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746430:Monovalent dose
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered after BUD
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine adminstered after BUD
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine adminstered after BUD
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Limb mass, Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Patient states that they have had aches and pains since the vaccine which was nearly a month ago. At the time of vaccine pt had got an egg shaped swelling and redness at the site of injection. Had fever, aches, and chills, the same day which eventually resolved but pt states they are having persistant body pain and aches since. They are also have allergy congestion like symptoms ever since. pt and pt's dr claim it has to be from the vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin exfoliation
Clinical narrative: Patient states that they have had aches and pains since the vaccine which was nearly a month ago. At the time of vaccine pt had got an egg shaped swelling and redness at the site of injection. Had fever, aches, and chills, the same day which eventually resolved but pt states they are having persistant body pain and aches since. They are also have allergy congestion like symptoms ever since. pt and pt's dr claim it has to be from the vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Immunisation reaction, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient states that they have had aches and pains since the vaccine which was nearly a month ago. At the time of vaccine pt had got an egg shaped swelling and redness at the site of injection. Had fever, aches, and chills, the same day which eventually resolved but pt states they are having persistant body pain and aches since. They are also have allergy congestion like symptoms ever since. pt and pt's dr claim it has to be from the vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Patient states that they have had aches and pains since the vaccine which was nearly a month ago. At the time of vaccine pt had got an egg shaped swelling and redness at the site of injection. Had fever, aches, and chills, the same day which eventually resolved but pt states they are having persistant body pain and aches since. They are also have allergy congestion like symptoms ever since. pt and pt's dr claim it has to be from the vaccine.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, SARS-CoV-2 test, Tinnitus
Clinical narrative: Bilateral tinnitus, worsens with each subsequent COVID-19 vaccination dose All Pfizer COVID-19 vaccinations received as follows: Dose 1 - 3/4/2021 lot number EN6198 Dose 2 - 3/25/2021 lot number: EP6955 Dose 3 - 10/13/2021 lot number: FF 2590 Dose 4 - 3/31/2022 lot number: FM0698 Dose 5 - 10/6/2022 lot number: GH9693 Dose 6 - 9/30/2023 lot number: HF9275 Bitaleral worsens after receiving subsequent does of COVID-19 vaccinations
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Tinnitus
Clinical narrative: Bilateral tinnitus, worsens with each subsequent COVID-19 vaccination dose All Pfizer COVID-19 vaccinations received as follows: Dose 1 - 3/4/2021 lot number EN6198 Dose 2 - 3/25/2021 lot number: EP6955 Dose 3 - 10/13/2021 lot number: FF 2590 Dose 4 - 3/31/2022 lot number: FM0698 Dose 5 - 10/6/2022 lot number: GH9693 Dose 6 - 9/30/2023 lot number: HF9275 Bitaleral worsens after receiving subsequent does of COVID-19 vaccinations
Age: 15.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Blood pressure decreased, Electrocardiogram, Nausea, Presyncope, Syncope
Clinical narrative: The Health Department hosted a public health influenza clinic at the High School. The patient reported no previous adverse reactions to the flu vaccine, no health conditions, and no allergies. Reported feeling well. Immediately upon administration of vaccine, patient slumped forward, becoming unresponsive. Within 4-5 seconds, awoke to verbal and tactile stimulation. Was alert and oriented to himself and his surroundings, but reported feeling "tired." 911 one was called. Patient became pale and diaphoretic. BP checked to be 79/44. Transported by EMS to the hospital for evaluation. Upon conversation with patient's mother the following day, she reported that medical team in hospital diagnosed the event as a vasovagal episode. Patient was recovered and feeling well per mother.
Age: 15.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Vision blurred
Clinical narrative: The Health Department hosted a public health influenza clinic at the High School. The patient reported no previous adverse reactions to the flu vaccine, no health conditions, and no allergies. Reported feeling well. Immediately upon administration of vaccine, patient slumped forward, becoming unresponsive. Within 4-5 seconds, awoke to verbal and tactile stimulation. Was alert and oriented to himself and his surroundings, but reported feeling "tired." 911 one was called. Patient became pale and diaphoretic. BP checked to be 79/44. Transported by EMS to the hospital for evaluation. Upon conversation with patient's mother the following day, she reported that medical team in hospital diagnosed the event as a vasovagal episode. Patient was recovered and feeling well per mother.
Age: 15.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Fatigue, Hyperhidrosis, Immediate post-injection reaction, Pallor, Posture abnormal
Clinical narrative: The Health Department hosted a public health influenza clinic at the High School. The patient reported no previous adverse reactions to the flu vaccine, no health conditions, and no allergies. Reported feeling well. Immediately upon administration of vaccine, patient slumped forward, becoming unresponsive. Within 4-5 seconds, awoke to verbal and tactile stimulation. Was alert and oriented to himself and his surroundings, but reported feeling "tired." 911 one was called. Patient became pale and diaphoretic. BP checked to be 79/44. Transported by EMS to the hospital for evaluation. Upon conversation with patient's mother the following day, she reported that medical team in hospital diagnosed the event as a vasovagal episode. Patient was recovered and feeling well per mother.
Age: 15.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Presyncope, Unresponsive to stimuli
Clinical narrative: The Health Department hosted a public health influenza clinic at the High School. The patient reported no previous adverse reactions to the flu vaccine, no health conditions, and no allergies. Reported feeling well. Immediately upon administration of vaccine, patient slumped forward, becoming unresponsive. Within 4-5 seconds, awoke to verbal and tactile stimulation. Was alert and oriented to himself and his surroundings, but reported feeling "tired." 911 one was called. Patient became pale and diaphoretic. BP checked to be 79/44. Transported by EMS to the hospital for evaluation. Upon conversation with patient's mother the following day, she reported that medical team in hospital diagnosed the event as a vasovagal episode. Patient was recovered and feeling well per mother.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: could not get off from bed; She was nauseated; exhausted/tired; fever; shivering bad; could not eat; She went to the pharmacy on 20Oct2023 to get her pneumonia vaccine but the pharmacy inadvertently gave her another dose of the Spikevax.; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (could not get off from bed), NAUSEA (She was nauseated), FATIGUE (exhausted/tired), PYREXIA (fever) and CHILLS (shivering bad) in a 64-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8(or a 3)031278) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:asthma.    On 25-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Oct-2023, received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2023, the patient experienced ILLNESS (could not get off from bed), NAUSEA (She was nauseated), FATIGUE (exhausted/tired), PYREXIA (fever), CHILLS (shivering bad), FEEDING DISORDER (could not eat) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She went to the pharmacy on 20Oct2023 to get her pneumonia vaccine but the pharmacy inadvertently gave her another dose of the Spikevax.). In October 2023, FATIGUE (exhausted/tired) had resolved. At the time of the report, ILLNESS (could not get off from bed), NAUSEA (She was nauseated), PYREXIA (fever), CHILLS (shivering bad) and FEEDING DISORDER (could not eat) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She went to the pharmacy on 20Oct2023 to get her pneumonia vaccine but the pharmacy inadvertently gave her another dose of the Spikevax.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient was administered with the flu vaccine in between the 2 doses of the Spikevax. She does not have the exact date.   This case was linked to MOD-2023-747023, MOD-2023-733621 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Fatigue, Feeding disorder, Illness, Mobility decreased
Clinical narrative: could not get off from bed; She was nauseated; exhausted/tired; fever; shivering bad; could not eat; She went to the pharmacy on 20Oct2023 to get her pneumonia vaccine but the pharmacy inadvertently gave her another dose of the Spikevax.; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (could not get off from bed), NAUSEA (She was nauseated), FATIGUE (exhausted/tired), PYREXIA (fever) and CHILLS (shivering bad) in a 64-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8(or a 3)031278) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:asthma.    On 25-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Oct-2023, received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2023, the patient experienced ILLNESS (could not get off from bed), NAUSEA (She was nauseated), FATIGUE (exhausted/tired), PYREXIA (fever), CHILLS (shivering bad), FEEDING DISORDER (could not eat) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She went to the pharmacy on 20Oct2023 to get her pneumonia vaccine but the pharmacy inadvertently gave her another dose of the Spikevax.). In October 2023, FATIGUE (exhausted/tired) had resolved. At the time of the report, ILLNESS (could not get off from bed), NAUSEA (She was nauseated), PYREXIA (fever), CHILLS (shivering bad) and FEEDING DISORDER (could not eat) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She went to the pharmacy on 20Oct2023 to get her pneumonia vaccine but the pharmacy inadvertently gave her another dose of the Spikevax.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient was administered with the flu vaccine in between the 2 doses of the Spikevax. She does not have the exact date.   This case was linked to MOD-2023-747023, MOD-2023-733621 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nausea, Pyrexia, Wrong product administered
Clinical narrative: could not get off from bed; She was nauseated; exhausted/tired; fever; shivering bad; could not eat; She went to the pharmacy on 20Oct2023 to get her pneumonia vaccine but the pharmacy inadvertently gave her another dose of the Spikevax.; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (could not get off from bed), NAUSEA (She was nauseated), FATIGUE (exhausted/tired), PYREXIA (fever) and CHILLS (shivering bad) in a 64-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8(or a 3)031278) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:asthma.    On 25-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Oct-2023, received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2023, the patient experienced ILLNESS (could not get off from bed), NAUSEA (She was nauseated), FATIGUE (exhausted/tired), PYREXIA (fever), CHILLS (shivering bad), FEEDING DISORDER (could not eat) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She went to the pharmacy on 20Oct2023 to get her pneumonia vaccine but the pharmacy inadvertently gave her another dose of the Spikevax.). In October 2023, FATIGUE (exhausted/tired) had resolved. At the time of the report, ILLNESS (could not get off from bed), NAUSEA (She was nauseated), PYREXIA (fever), CHILLS (shivering bad) and FEEDING DISORDER (could not eat) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She went to the pharmacy on 20Oct2023 to get her pneumonia vaccine but the pharmacy inadvertently gave her another dose of the Spikevax.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient was administered with the flu vaccine in between the 2 doses of the Spikevax. She does not have the exact date.   This case was linked to MOD-2023-747023, MOD-2023-733621 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site warmth, Therapeutic product ineffective
Clinical narrative: INJECTION SITE WARM TO TOUCH AND ITCHY. NOT RELIEVED WITH TOPICAL HYDROCORTISONE CREAM OR BENADRYL CREAM. SYMPTOMS BEGAN SAME DAY AS INJECTION AND CONTINUED THROUGH 24 HOURS SO FAR.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Chills, Muscle discomfort, Pyrexia
Clinical narrative: Low fever, mild chills, mild muscular discomfort commencing approximately 11 hours after injection & lasting approximately 8 hours.  Took 500mg Tylenol approximately 6 hours into symptoms to finally fall asleep.
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: Swelling and pain at the injection site over a day later, limited range of motion in the upper arm (can't raise it), chills, fatigue, headache, and sneezing
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site swelling, Joint range of motion decreased, Sneezing
Clinical narrative: Swelling and pain at the injection site over a day later, limited range of motion in the upper arm (can't raise it), chills, fatigue, headache, and sneezing
Sex: M
Vaccine: PPV
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: PNEU: Allergic Reaction to Pneumo; This spontaneous report was received from a physician and refers to a male patient of unknown age.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, vaccination scheme, anatomical site location, lot number, expiration date, and route of administration were not provided).  On an unknown date, the patient experienced an allergic reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)(reported as "pneumo") (allergy to vaccine). At the time of reporting, the outcome of the event was not provided.   Per internal guidelines the event allergy to vaccine was considered to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  This is one of two cases regarding the same patient.; Sender's Comments:  US-009507513-2309USA005368:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP calling to report VARIVAX was administered after it experienced a supported temperature excursion. HCP reports she only knows of one of the patient's names, but there were others who received it as well, additional AE filed under #02486705. No a; This spontaneous report was received from Medical Assistant and referred to a patient of unknown gender and unknown age. Concomitant medications included sterile diluent. The patient's concurrent conditions, historical drugs and historical conditions were not reported.  On 26-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milligram, lot #X006982, expiration date: 07-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided). It was reported temperature excursion occurred (Temperature: -12 C, Time frame: 55 minutes) (product storage error). There was no previous temperature excursion. No additional adverse event (AE).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Nurse reported PROQUAD was administered after TE; see TE case 02487539. See full details below. No additional AE/no PQCs.Names of vaccines involved PROQUAD X013909 11/10/2024 Temperature 8.1°F Time frame 3 hours 0 min; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 29-SEP-2023, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) rHA injection, (lot # X013909 has been verified to be valid, expiration date: 10-NOV-2024), administered for prophylaxis (strength, and route of administration were not provided) after temperature excursion (product storage error). The administered dose underwent a temperature excursion of 8.1 degrees Fahrenheit for 3 hours. No previous temperature excursion was reported. No adverse events reported.