chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED TO PATIENT, VACCINE EXPIRED 5/2/22
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE WAS ADMINISTERED TO PATIENT - EXPIRED ON 5/2/22
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Redness, itching and soreness persistent for 5 days following the injection
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED TO PATIENT, VACCINE EXPIRED 5/2/22
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Electrocardiogram, Facial paralysis
Clinical narrative: Bell's Palsy (left side face paralysis)
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Neurological symptom
Clinical narrative: Bell's Palsy (left side face paralysis)
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Photopsia
Clinical narrative: The patient stated that they sat down to wait for 20 minutes after receiving the vaccine. They did not experience any symptoms. When they exited the building and entered the sunlight, they stated their "eyes began flashing." It was described as bright flashing spots. This continued for about 30 minutes before it stopped. They did not experience this before and they have not had symptoms after it stopped. No other symptoms were experienced. It was recommended the patient follow up with an eye doctor to ensure there are no issues. Whether the patient went to see a provider is not known.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 12 year old client in for his booster recieved 0.2 ml of the pfizer pediatric 5-11 dose instead of the 12 and up dosage.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Dose administered without vial diluted
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Vaccine administered without vial diluted
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Vaccine administered without been diluted
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Vaccine administered without been diluted
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Oropharyngeal pain, Pain
Clinical narrative: Headache  Chills Body aches Sore throat
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Dyspnoea exertional, Interchange of vaccine products
Clinical narrative: This was 2nd covid booster. Doctor recommend Moderna for 2nd covid booster. The first three vaccinations were Pfizer. There was no reaction for 15 minutes, but when leaving clinic and walking to the car I had extreme shortness breath with chest pressure, and minimal pain in upper left chest area. This extreme reaction continued for several hours, but took about three days to diminish. Currently, I have shortess of breath when climbing stairs and walking short distances. Most of the time I am unable to take a deep breath, and feel as if I cannot breath when in a confined area. At times the tingling pain is still in the upper left chest area, but goes away in a couple of hours
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: This was 2nd covid booster. Doctor recommend Moderna for 2nd covid booster. The first three vaccinations were Pfizer. There was no reaction for 15 minutes, but when leaving clinic and walking to the car I had extreme shortness breath with chest pressure, and minimal pain in upper left chest area. This extreme reaction continued for several hours, but took about three days to diminish. Currently, I have shortess of breath when climbing stairs and walking short distances. Most of the time I am unable to take a deep breath, and feel as if I cannot breath when in a confined area. At times the tingling pain is still in the upper left chest area, but goes away in a couple of hours
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site injury, Pain
Clinical narrative: Patient moved arm while RN administering vaccine. Patient complained of pain. Small abrasion observed at injection site. Patient given an ice pack.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Low-Grade Fever
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: superficial complete layer of skin peeled off both palms of hands and soles of feet over a week time period. Similar to blistered skin would peel off.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Dizziness, Fatigue, Headache
Clinical narrative: 22 or so hours after my vaccination I had a 100 degree fever (I'm usually 97.7) , headaches, painful joint and muscle aches, nausea, extreme fatigue, dizziness. I experienced these same responses for my first 2 Pfizer vaccines and 1st Moderna booster. After this 2nd Pfizer booster I also had a constant urge to urinate for several hours, with no increase in my normal water consumption. My pelvic floor was aching and the urination was burning for the first couple hours. 24 hours after the onset of symptoms I am only experiencing fatigue. These were adverse reactions, but not too extreme and I wasn't overly worried. A friend encouraged me to report for research.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Micturition urgency, Myalgia, Nausea, Pelvic pain, Pyrexia
Clinical narrative: 22 or so hours after my vaccination I had a 100 degree fever (I'm usually 97.7) , headaches, painful joint and muscle aches, nausea, extreme fatigue, dizziness. I experienced these same responses for my first 2 Pfizer vaccines and 1st Moderna booster. After this 2nd Pfizer booster I also had a constant urge to urinate for several hours, with no increase in my normal water consumption. My pelvic floor was aching and the urination was burning for the first couple hours. 24 hours after the onset of symptoms I am only experiencing fatigue. These were adverse reactions, but not too extreme and I wasn't overly worried. A friend encouraged me to report for research.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Ear pain, Educational problem, Endoscopy abnormal
Clinical narrative: I have had 10 sinus infections since getting vaccinated in less than a year.  it started within two weeks of getting the vaccine. The firt I was sick for almost three then within two weeks of that infection I was sick again for over two weeks. Each one takes a minimum of 2 weeks to go away without antibiotics. I spent a large part of the following three months sick for many weeks until I started frequently taking antibiotics. I experience severe discomfort in my face, pain in my ears, very bad headaches, dizziness, 102-103 fevers each time I am sick. I experienced severe discomfort in my left ear and very painful headaches for several months following the vaccine even when I was not sick. I experienced disruption to my sleep as I had trouble falling asleep with severe pressure in my ear and head.Before the vaccine, I had not been sick for a year and it was a cold for a few days.  In the Fall of 2021, I took antibiotics four times in three months.  I have been to four ENTs and an allergist but they can not find the problem with what is causing this issue.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort, Fear, Head discomfort, Headache, Impaired work ability
Clinical narrative: I have had 10 sinus infections since getting vaccinated in less than a year.  it started within two weeks of getting the vaccine. The firt I was sick for almost three then within two weeks of that infection I was sick again for over two weeks. Each one takes a minimum of 2 weeks to go away without antibiotics. I spent a large part of the following three months sick for many weeks until I started frequently taking antibiotics. I experience severe discomfort in my face, pain in my ears, very bad headaches, dizziness, 102-103 fevers each time I am sick. I experienced severe discomfort in my left ear and very painful headaches for several months following the vaccine even when I was not sick. I experienced disruption to my sleep as I had trouble falling asleep with severe pressure in my ear and head.Before the vaccine, I had not been sick for a year and it was a cold for a few days.  In the Fall of 2021, I took antibiotics four times in three months.  I have been to four ENTs and an allergist but they can not find the problem with what is causing this issue.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Initial insomnia, Malaise, Pyrexia, Sinusitis, Sleep disorder
Clinical narrative: I have had 10 sinus infections since getting vaccinated in less than a year.  it started within two weeks of getting the vaccine. The firt I was sick for almost three then within two weeks of that infection I was sick again for over two weeks. Each one takes a minimum of 2 weeks to go away without antibiotics. I spent a large part of the following three months sick for many weeks until I started frequently taking antibiotics. I experience severe discomfort in my face, pain in my ears, very bad headaches, dizziness, 102-103 fevers each time I am sick. I experienced severe discomfort in my left ear and very painful headaches for several months following the vaccine even when I was not sick. I experienced disruption to my sleep as I had trouble falling asleep with severe pressure in my ear and head.Before the vaccine, I had not been sick for a year and it was a cold for a few days.  In the Fall of 2021, I took antibiotics four times in three months.  I have been to four ENTs and an allergist but they can not find the problem with what is causing this issue.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Angle closure glaucoma, Cataract operation, Headache, Intraocular pressure test, Iritis
Clinical narrative: On 4/5/2021, developed severe headache and visual change in left eye, presented to ER and was diagnosed with a severe case of acute narrow angle glaucoma ( no past history of glaucoma) and a uveitis/iritis
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Mydriasis, Optic nerve injury, Uveitis, Visual impairment
Clinical narrative: On 4/5/2021, developed severe headache and visual change in left eye, presented to ER and was diagnosed with a severe case of acute narrow angle glaucoma ( no past history of glaucoma) and a uveitis/iritis
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Joint stiffness, Muscle tightness, Myalgia
Clinical narrative: Onset of severe muscle and joint pain. Started tightness in neck. Then knees. Then hips and muscles. I took 400 acetaminophen at 10. Then 650mg at 130. 1 650mg at 5 then 1 250mg at 10pm. The next day i was fine
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Nausea
Clinical narrative: Patient came in on 5-28-22 to state that she have been nauseated and could not keep her balance and could only  attribute to the vaccine. She had the vaccine before but did not experience this reaction. Told patient to follow up with doctor if the symptoms continue or get worse.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Essential tremor, Head titubation
Clinical narrative: Developed a head tremor
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Full blood count, Urticaria
Clinical narrative: Two weeks to the day after my first booster I started to break out in hives over most of my body. I had not used or tired anything new in my diet, hygiene, clothing, laundry soap, etc. The hives would move from section to section and would be relieved with 50mg of Benadryl every 4-6 hours. I had two visits to the ER where they also prescribed Prednisone, Pepcid and an Epi-Pen. I had no other issues with the hives...no fever, no congestion, no nausea, no dizziness. I am currently still on Prednisone and Pepcid and am to use the Benadryl as needed. The hives would also appear symmetrically most times. When one foot started, so did the other. This also happened with my hands, knees, forearms, elbows, thighs, etc. Cont.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site pruritus, Pain, Rash, Skin warm
Clinical narrative: It's been 10 days and my arm is still experiencing a rash (red), bruising (purple), hot, throbbing, and itching around the injection site in a circle about 7 cm in diameter.  It's very painful and itchy.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Laboratory test
Clinical narrative: Got shingles
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Got shingles
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arterial occlusive disease, Blood cholesterol decreased, Myocardial infarction, Surgery
Clinical narrative: Heart attack. Emergency Surgery.  Only one artery totally clogged. No other signs of heart disease. All other arteries clear. Regular exercise, Low cholesterol,  blood pressure 125/72 , no family history, not overweight. 6'1" 221Lb  No apparent reason
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Feeling cold, Pulmonary pain
Clinical narrative: Shortness of breath Shivers Extreme cold Pin pain in lungs (very sharp - sword feeling) Exhausted  Thirsty
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Shortness of breath Shivers Extreme cold Pin pain in lungs (very sharp - sword feeling) Exhausted  Thirsty
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Hyperaesthesia, Injection site erythema, Injection site pruritus
Clinical narrative: Round red patch below injection site.   Slight chills first 8 hours.    Sensitive to touch and  Warm .  3 days later,  site began to itch.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Round red patch below injection site.   Slight chills first 8 hours.    Sensitive to touch and  Warm .  3 days later,  site began to itch.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Dementia Alzheimer's type, Vomiting
Clinical narrative: Three days after receiving the Janssen booster dose, she vomited twice at 4:25 AM while in be supine in bed with the head elevated a few inches.  Amount was one large and one medium emesis, brown and watery. Temp. was 98.1. At 5:00 AM she vomited again, a small amount of the same description. Then at 6:00 AM she vomited again, a small amount of mainly saliva.  After cleaning her up, she was back asleep by 7:30 AM and no further problems.  Temp. 98.0. This is a major concern because my mother is not able to manage any emesis or call /signal for assistance, due to her Alzheimer's. She could have choked/aspirated.  I just happened to be watching her on camera from the next room, and noticed that something looked amiss.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Condition aggravated, Disturbance in attention, Feeling abnormal, Heart rate increased
Clinical narrative: Got more migraines went from 10-15 days to 28+ days and 2-5 a day. My heart is beating faster, brain fog, loss of work. Loss of consentration
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Migraine
Clinical narrative: Got more migraines went from 10-15 days to 28+ days and 2-5 a day. My heart is beating faster, brain fog, loss of work. Loss of consentration
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives/skin rash on both legs and left arm last over a week.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Incorrect dose administered, Injection site pain, Pain, Pyrexia
Clinical narrative: Non toxic well appearing 6 yo female here for concerns over receiving concentrated COVID vaccine yesterday (adult dose rather than children's dose) and now with fever, chills, bodyaches, and pain at injection site. Note these side effects are common in patient for a few day after receiving COVID vaccine.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Injection site pain, Pain, Pyrexia
Clinical narrative: Non toxic well appearing 6 yo female here for concerns over receiving concentrated COVID (adult dose) vaccine yesterday and now with fever, chills, bodyaches, and pain at injection site. Note these side effects are common in patient for a few day after receiving COVID vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Dizziness, Fatigue, Headache
Clinical narrative: All joints hurt severely, fever 101, cough, headache, very tired and dizzy.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: All joints hurt severely, fever 101, cough, headache, very tired and dizzy.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Development of tender, mobile axillary lymphadenopathy  ~ 2cm in length on L (vaccine in L arm)
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Burning on and around the injection site, 5/27/2022 around 4:00pm, then itching and burning around 9:00pm same day. I put ice on it for 30 minutes.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: - No adverse event reported - Patient given larger dose than recommended (vaccination error)
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was 26.56 years.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 6-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 9-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 1:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 1:17 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 49.05.  Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 9-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 1:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 1:24 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 46.77  Concomitant products were not provided.  On 27-Apr-2021, Excursion time was 9AM temperature was 35 total doses given for the day was 42, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 27-Apr-2021. Vaccine BUD date was 19-May-2021.  On 27-Apr-2021 no hourly temperature recordings available.  The vial was only punctured right before administration and dose was drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.     On 20-Mar-2021 at 12:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 12:06 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 27.72.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 10A, temperature was 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.     On 27-Mar-2021 at 1:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 1:12 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  On 27-Mar-2021, Excursion time was 9A, temperature was 35, total doses given for the day was 195, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Chest discomfort, Chest pain, Injection site erythema, Myocardial infarction
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Heart Attack-Severe, Additional Details: From what I was told, the patient returned to the pharmacy 1 hour after the shot with chest pain. epinephrine was administered and 911 was called. the patient was admitted to a Medical Center where she later died.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Death, Dyspnoea, Injection site erythema, Myocardial infarction
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Heart Attack-Severe, Additional Details: From what I was told, the patient returned to the pharmacy 1 hour after the shot with chest pain. epinephrine was administered and 911 was called. the patient was admitted to a Medical Center where she later died.
Age: 49.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Decreased appetite, Headache, Injection site inflammation, Injection site nodule
Clinical narrative: swelling (knot), pain, stiffness, and inflammation at the injection site, fever, chills, body aches, headache, loss of appetite for 3 days and ongoing at present
Age: 49.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: swelling (knot), pain, stiffness, and inflammation at the injection site, fever, chills, body aches, headache, loss of appetite for 3 days and ongoing at present
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dehydration
Clinical narrative: Today I brought my child to the pharmacy to get her COVID booster. The pharmacist checked her temperature before giving the vaccine. She said it was 100.0 so she could not give the vaccine. She said my child must be dehydrated and needed to drink some water and return. I told the pharmacist that 100 is not a fever and asked if that was pharmacy policy. She said no that was just her policy. I told her that I would like her to give the vaccine. She did give it but I am very concerned that she is turning away people for the vaccine based on her own made up policies and made up medical advice. This needs to be stopped immediately.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood test normal, Chest pain, Electrocardiogram abnormal
Clinical narrative: Chest pain in center, right and left side of the chest. Pain radiating to right shoulder and back. I went to urgent care on 05/12/2022 where I got multiple lab tests & EKG done. EKG showed a sinus arrhythmia. I was sent home on 05/12/2022 with no treatment plan. The chest pain continues to this day.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Pain, Sinus arrhythmia, Urine analysis normal
Clinical narrative: Chest pain in center, right and left side of the chest. Pain radiating to right shoulder and back. I went to urgent care on 05/12/2022 where I got multiple lab tests & EKG done. EKG showed a sinus arrhythmia. I was sent home on 05/12/2022 with no treatment plan. The chest pain continues to this day.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Diarrhoea, Fatigue, Nausea
Clinical narrative: Developed covid on 5/6/2022.  Symptoms:  extreme fatigue, chills, body aches, diarrhea, nausea. Treatment:  Paxlovid started 5/7/2022; Cipro started 5/17/2022.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: Developed covid on 5/6/2022.  Symptoms:  extreme fatigue, chills, body aches, diarrhea, nausea. Treatment:  Paxlovid started 5/7/2022; Cipro started 5/17/2022.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Fatigue, Full blood count normal, Laboratory test normal
Clinical narrative: Early January began having palpitations. Cardiologist went up on metoprolol from 25 twice daily to 37.5 twice daily and down on lisinopril 15 to 10 daily. This had no effect. Had EKG which showed PAC's.  Tried ibuprofen 600 twice daily which stopped the palpitations for a month but every time weaning was tried the palpitations would start up again. Now on Mag Sulfate daily which has helped minimally and continues to have palpitations.  Next will be appointment with electrophysiologist and/or adding verapamil.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Palpitations, Supraventricular extrasystoles, Troponin normal
Clinical narrative: Early January began having palpitations. Cardiologist went up on metoprolol from 25 twice daily to 37.5 twice daily and down on lisinopril 15 to 10 daily. This had no effect. Had EKG which showed PAC's.  Tried ibuprofen 600 twice daily which stopped the palpitations for a month but every time weaning was tried the palpitations would start up again. Now on Mag Sulfate daily which has helped minimally and continues to have palpitations.  Next will be appointment with electrophysiologist and/or adding verapamil.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Skin warm, Swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Additional Details: patient called pharmacy regarding adverse reaction to vaccine; started with swelling and warmth under arm, now spreading to larger area of right arm. i advised patient contacting physician for further guidance
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Injection site erythema, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Numbness at injection site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient complaint of pain at injection site for 3 days, now some numbness and muscle burning feeling in shoulder
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Numbness at injection site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient complaint of pain at injection site for 3 days, now some numbness and muscle burning feeling in shoulder
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Rash macular
Clinical narrative: Swollen at sight  hard to touchand splotches and painful
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Heavy menstrual bleeding, irregular bleeding , painful menses
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Local reaction, Swelling
Clinical narrative: Local reaction, redness of ~6 cm in diameter with firm center. Slightly raised. Itching present. The symptoms improved after 5 days.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, COVID-19, Chills, Cough, SARS-CoV-2 test positive
Clinical narrative: Covid-19 (sneezing, coughing, chills, 101'F
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Covid-19 (sneezing, coughing, chills, 101'F
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Adverse drug reaction, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: At least 2 days; side effects-chills, slight fever, fatigue, headache
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria
Clinical narrative: Frequent urinating
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Within 2 or 3 days I developed tinnitus. It was a white noise kind of buzzing. It seems to be there all the time at a nuisance level and has not gone away or receded as of this date 5-29-22. It did not seem to get any worse when I received the second Moderna Covid shot, or the booster shot.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Insomnia, Muscle twitching, Nervous system disorder, Neuralgia
Clinical narrative: Sept 26/21 - 2 days after first shot I had a shooting pain up my nerve on my left leg. the pain persisted for a couple of weeks so called my doctor got an appoint with my GP Oct. 18/21 was the soonest I was able to get in.  My doctor made me feel comfortable in saying she didn't think it was a blood clot and it it persisted to see her again.  The pain did persist, and I was scared to went to emergency on Oct. 20/21.  They did blood work and told me if pain persisted after a week to come back to Emergency.  The shooting pain up my leg persisted even after my second shot so went back to Emergency on Nov. 6, 21 I ended up getting the same doctor I had on Oct. 20/21 at Emergency she thought it would be best to have an ultra sound so was able to one on Nov 7/21.  I was flying and wanted to be cleared of a potential blood clot in my leg.  I was worried and scared.  Nov 25/21 - Went to see Dr re nerve issues/vaccine related - pain still peristed  Was in another country Nov. 29-Dec 7 2021  Somewhere between Sept. 26 to Dec 5 the Nerve Pain turned into involuntary muscle twitches throughout my body that doesn't stop 24/7. I have video footage as early as Dec 5/21 of the muscle twitches. The twitching is all through my body in random places but mainly the leg's.  It doesn't stop, it hard to sleep, stay sleeping, I also have nerve fatigue along with this. This hasn't stopped for 8 months now and continues.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Ultrasound Doppler
Clinical narrative: Sept 26/21 - 2 days after first shot I had a shooting pain up my nerve on my left leg. the pain persisted for a couple of weeks so called my doctor got an appoint with my GP Oct. 18/21 was the soonest I was able to get in.  My doctor made me feel comfortable in saying she didn't think it was a blood clot and it it persisted to see her again.  The pain did persist, and I was scared to went to emergency on Oct. 20/21.  They did blood work and told me if pain persisted after a week to come back to Emergency.  The shooting pain up my leg persisted even after my second shot so went back to Emergency on Nov. 6, 21 I ended up getting the same doctor I had on Oct. 20/21 at Emergency she thought it would be best to have an ultra sound so was able to one on Nov 7/21.  I was flying and wanted to be cleared of a potential blood clot in my leg.  I was worried and scared.  Nov 25/21 - Went to see Dr re nerve issues/vaccine related - pain still peristed  Was in another country Nov. 29-Dec 7 2021  Somewhere between Sept. 26 to Dec 5 the Nerve Pain turned into involuntary muscle twitches throughout my body that doesn't stop 24/7. I have video footage as early as Dec 5/21 of the muscle twitches. The twitching is all through my body in random places but mainly the leg's.  It doesn't stop, it hard to sleep, stay sleeping, I also have nerve fatigue along with this. This hasn't stopped for 8 months now and continues.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Impaired work ability, Influenza like illness
Clinical narrative: Flu-like symptoms: headache, body ache, chills, runny nose, fatigue. Symptoms started at 11pm on day of injection, were very bad for next 3 days, then subsided. Almost back to normal after 7 days. "Very bad" means I had difficulty working at a computer. I work remotely, I wouldn't have been able to commute during the first three days  of symptoms.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Flu-like symptoms: headache, body ache, chills, runny nose, fatigue. Symptoms started at 11pm on day of injection, were very bad for next 3 days, then subsided. Almost back to normal after 7 days. "Very bad" means I had difficulty working at a computer. I work remotely, I wouldn't have been able to commute during the first three days  of symptoms.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Gingival discomfort, Glossitis, Lip swelling, Oedema
Clinical narrative: Sudden onset lower lip swelling diagnosed as angioedema. No response to diphenhydramine and 10mg of dexamethasone suggesting this was not an IgE mediated allergic reaction. Edema resolved spontaneously several hours after medication trial while en route to ER. Concern for airway compromise high due to irritation and tingling sensation of gums and tongue at onset of symptoms. No prior hx of angioedema.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral cyst, Cerebral ventricle dilatation, Magnetic resonance imaging head abnormal
Clinical narrative: Patient has a history of a pseudotumor from 1998 (patient was 9 years old) that required a resection.  Since being "immunized" patient has now had a recurrence of the brain cyst that will require a craniotomy in order to perform a resection of the cyst.  Patient's vitals have been stable but he has not had surgery yet.  Surgery is planned for Tuesday 5/31/22
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody, Blood immunoglobulin G, Blood iron, Disturbance in attention, Inflammation
Clinical narrative: Within weeks my special needs son started having memory issues and concentration issues. He went from a vibrant, social, young man to a sullen, moody individual who couldn't get out of bed.  He then started  having pica issues that increased as time went on. It wasn't until psychiatric hospitalizations with no improvement led me to insist that his iron levels be taken because of the pica. It was found that his iron number were off.  He also became very rigid and displayed full body inflammation.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Iron binding capacity total, Memory impairment, Mobility decreased, Mood altered, Morose
Clinical narrative: Within weeks my special needs son started having memory issues and concentration issues. He went from a vibrant, social, young man to a sullen, moody individual who couldn't get out of bed.  He then started  having pica issues that increased as time went on. It wasn't until psychiatric hospitalizations with no improvement led me to insist that his iron levels be taken because of the pica. It was found that his iron number were off.  He also became very rigid and displayed full body inflammation.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle rigidity, Pica, Transferrin saturation decreased
Clinical narrative: Within weeks my special needs son started having memory issues and concentration issues. He went from a vibrant, social, young man to a sullen, moody individual who couldn't get out of bed.  He then started  having pica issues that increased as time went on. It wasn't until psychiatric hospitalizations with no improvement led me to insist that his iron levels be taken because of the pica. It was found that his iron number were off.  He also became very rigid and displayed full body inflammation.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: patient hospitalized
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Vaccination of Moderna Booster #2 on April 14, 2022.  Onset of Urticaria 12 days later on April 26, 2022.  Urticaria started to resolve after approx. two weeks but did not completely resolve until three weeks after onset.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fall, Pain in extremity, Syncope, Walking aid user
Clinical narrative: Approximately 35 minutes after vaccination patient fainted and fell into a cardboard makeup display in the store.  Patient reports that she normally  has to use her walker due to back and leg pain. Requested that 911 be called, patient was taken to ER. No further information given.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The patient came in on Friday 05/27/2022 and stated that he has been having pain on the left arm since he received the booster vaccine
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Chills, Ear pain, Fatigue
Clinical narrative: Unbelievable STABBING PAINS IN MY EARS. BOTH MY EXTREMITIES ICE COLD NOT, like chills. SO COLD ALL MY FINGERS TURNED WHITE. EVEN running them under warm water did not HELP. Full body joint PAINS. HEADACHE, & EXTREME FATIGUE. My right hand middle finger was so arthritic, it got stuck straight up. I could not bend it. Hard to walk on my feet due to ankle pain. Again overall arthritic pain  It is Sunday. Still in bed, trying to just wait it out.  I switched to Pfizer from Moderna. The intensity of Moderna was even worse.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Mobility decreased, Peripheral coldness, Skin discolouration
Clinical narrative: Unbelievable STABBING PAINS IN MY EARS. BOTH MY EXTREMITIES ICE COLD NOT, like chills. SO COLD ALL MY FINGERS TURNED WHITE. EVEN running them under warm water did not HELP. Full body joint PAINS. HEADACHE, & EXTREME FATIGUE. My right hand middle finger was so arthritic, it got stuck straight up. I could not bend it. Hard to walk on my feet due to ankle pain. Again overall arthritic pain  It is Sunday. Still in bed, trying to just wait it out.  I switched to Pfizer from Moderna. The intensity of Moderna was even worse.