chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand other Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 10:15 as dose 5 (booster), single (Lot number: GH 9702) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Feb2021 at 16:45 as dose 1, single (Lot number: EN 6203), in left arm, on 20Mar2021 at 16:45 as dose 2, single (Lot number: ER 2613), in left arm and on 01Nov2021 at 16:15 as dose 3 (booster), single (Lot number: FH 8030), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23May2022 at 15:15 as dose 4 (booster), single (Lot number: 059M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing), notes: received 2 heart stents in 2019; "known allergies: Shellfish" (unspecified if ongoing); "known allergies: bee stings" (unspecified if ongoing); "received 2 heart stents", start date: 2019 (unspecified if ongoing); "known allergies: ACE inhibitors" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23May2022 at 15:15, outcome "unknown", described as "vaccine brand other Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jan2023) positive; (29Jan2023) Negative; (02Feb2023) positive; (03Feb2023) positive; (04Feb2023) positive; (05Feb2023) positive; (06Feb2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was on a small ship in.Ship guests were from all over, so no idea where exposure came from. Felt Covid symptoms (fever 104F, very sore throat, chest congestion, coughing, runny nose) evening of 21Jan2023 (8th day of cruise). Tested positive 22Jan2023. Started Paxlovid on 22Jan2023, Paxlovid was obtained in on 09Jan2023 before departing to meet the ship. Symptoms worsened to include shortness of breath and difficulty breathing by 24Jan2023. Treated by ship's doctor on 24Jan2023 with over-the-counter decongestants & cough medicine and was put on a course of Ciprofloxacin for possible pneumonia. Tested negative for Covid 29Jan2023. Felt better but very weak. Began to feel poorly again (but not as sick) on 01Feb2023. Tested positive on 02Feb2023. Tested positive until 06Feb2023.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Paxlovid from 12Feb2023 to 16Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Pcn" (unspecified if ongoing), notes: Known allergies: Pcn; "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine received and No other medication in 2weeks  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of  "DRUG INEFFECTIVE " and "COVID 19 ".
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Disease recurrence
Clinical narrative: reoccurance of my pre-existing Chron's Disease; reoccurrence of my pre-existing Chron's Disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pre-existing crohn's disease " (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "feeling run down", "comparable to getting the flu", "malaise", "fever"; Bnt162b2 (Dose: 2), for COVID-19 immunization, reaction(s): "feeling run down", "comparable to getting the flu", "malaise", "fever".  The following information was reported: CROHN'S DISEASE (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "reoccurrence of my pre-existing Chron's Disease". Therapeutic measures were taken as a result of crohn's disease, disease recurrence.  Clinical information: With the first booster, there was a reoccurrence of patient's pre-existing crohn's disease characterized by Chronic pain in the ileocecal intestinal area. It was painful enough to require the patient's taking prednisolone (starting at 20mg) for about 6 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No adverse reactions were noted or reported since the dose was administered on  2/13/2023.
Age: 9.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: SYNCOPE EVENT IMMEDIATELY AFTER ADMINISTRATION OF VACCINE. STATES "HE WAS NERVOUS
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given 3rd dose of primary series of Covid Moderna (6months- 5 years) instead of dose of Moderna Covid Bivalent. No adverse symptoms noted after administration.
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest X-ray normal, Dyspnoea, Dyspnoea exertional, Electrocardiogram normal, Heart rate irregular
Clinical narrative: 2 days after receiving the flu shot and the covid bivalent booster, I was walking to my normal martial arts practice and noticed I was unusually winded just from the walk (10 minutes). This would persist for about a month anytime I would do any physical exercise. I also felt like my heart beat would sometimes be irregular. I suspected myocarditis based on some of the news I'd read and also saw that it was mild and people would completely recover. So I simply refrained from exercising for a month and attempt to make an appointment with my primary heathcare physician to get it checked out, but after trying for two months I couldn't make an appointment.
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted following receiving the vaccine. 911 was called. After some time, patient eventually regained consciousness
Age: 49.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Back pain, Injection site pain, Neck pain, Pain
Clinical narrative: Pt stated that when the tdap  vaccine was given she felt a sharp pain in her arm and then in the last 8 days since receiving the vaccine, pt states her pain is traveling up towards her neck/back.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pt was 6 years old at time of vaccine and given Moderna for ages 6m-5Y.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: Patient had no adverse event. Patient's doctor wanted recombivax 40mcg, which is not available. So she injected one prefilled Heplisav B 20mcg/0.5cc into another Heplisav B and the injected 1cc of Heplisav into the patients arm.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Anticoagulant therapy, Asthenia, Back pain, Blood test abnormal
Clinical narrative: Patient ran 6-10 miles daily and also hiked our neighboring mountains. In May, his stamina and ability started gradually failing. He was also in a community choir and couldn't understand why he couldn't get a good breath or hold notes out. By mid-May, he was concerned enough that he scheduled a dr appt for June. Since his mother had recently had a heart attack, he was concerned maybe it was his heart. On June 7, 2021, he met with the doctor, who did a lot of blood work as well. They thought maybe he had some virus or was run down. He had a persistent cough, too. Patient was a volunteer cross country coach as well and he usually could keep up with the kids, but wasn't able to.  By the end of the summer and into the xc season, he could barely walk across the parking lot without stopping. He had to forgo his weekend hikes because he could no longer hike more than a few minutes. The cough continued. It took several weeks, but he was able to get another dr appt on October 14, where the doctor did an electrocardiogram, which was normal. He referred him to a cardiologist. On October 28th, patient tried to do a treadmill stress test, but passed out. They scheduled him for an angiogram the next week. During that week, he could not stand more than a few minutes at a time. He could not carry the trash can the 20 feet to the garage. We tried to walk around the yard or down the street and he had to stop and catch his breath frequently.  By Oct. 30, he had pain in his back and abdomen. Starting Oct. 31, he could only stay awake a couple of hours and then he'd need to nap several hours.  We called the dr on Nov. 1 and in the afternoon they said he could come back in for blood work again. At that point we all thought he had a fast-growing cancer. That evening our daughter suggested we use the pulse oximeter. His heart rate wouldn't get below 100 and his oxygen wouldn't get into the 90s. I called the doctor on call for advice and he suggested we go to the ER. He was weak, had chest, back, and abdominal pain, a persistent cough, no stamina. We described the symptoms and they recognized it as PE. They did a CT scan and said his lungs were full of clots and there were parts of one lung that had died (infarcted). They gave him a shot of blood thinner, got him on oxygen, and admitted him to the hospital for observation. He was able to be released the next day, but needed to be on oxygen for a month and rest quite a bit. He will need to be on blood thinners the rest of his life.  He received the bivalent booster this fall without any complications. We believe he has made a full recovery. He finally contracted COVID in July of 2022 for the first time and was ill, but it wasn't severe. (I keep a daily journal and was able to go back and see symptoms and dates - sorry for all the details if not needed.)
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac stress test abnormal, Chest pain, Computerised tomogram thorax abnormal, Cough
Clinical narrative: Patient ran 6-10 miles daily and also hiked our neighboring mountains. In May, his stamina and ability started gradually failing. He was also in a community choir and couldn't understand why he couldn't get a good breath or hold notes out. By mid-May, he was concerned enough that he scheduled a dr appt for June. Since his mother had recently had a heart attack, he was concerned maybe it was his heart. On June 7, 2021, he met with the doctor, who did a lot of blood work as well. They thought maybe he had some virus or was run down. He had a persistent cough, too. Patient was a volunteer cross country coach as well and he usually could keep up with the kids, but wasn't able to.  By the end of the summer and into the xc season, he could barely walk across the parking lot without stopping. He had to forgo his weekend hikes because he could no longer hike more than a few minutes. The cough continued. It took several weeks, but he was able to get another dr appt on October 14, where the doctor did an electrocardiogram, which was normal. He referred him to a cardiologist. On October 28th, patient tried to do a treadmill stress test, but passed out. They scheduled him for an angiogram the next week. During that week, he could not stand more than a few minutes at a time. He could not carry the trash can the 20 feet to the garage. We tried to walk around the yard or down the street and he had to stop and catch his breath frequently.  By Oct. 30, he had pain in his back and abdomen. Starting Oct. 31, he could only stay awake a couple of hours and then he'd need to nap several hours.  We called the dr on Nov. 1 and in the afternoon they said he could come back in for blood work again. At that point we all thought he had a fast-growing cancer. That evening our daughter suggested we use the pulse oximeter. His heart rate wouldn't get below 100 and his oxygen wouldn't get into the 90s. I called the doctor on call for advice and he suggested we go to the ER. He was weak, had chest, back, and abdominal pain, a persistent cough, no stamina. We described the symptoms and they recognized it as PE. They did a CT scan and said his lungs were full of clots and there were parts of one lung that had died (infarcted). They gave him a shot of blood thinner, got him on oxygen, and admitted him to the hospital for observation. He was able to be released the next day, but needed to be on oxygen for a month and rest quite a bit. He will need to be on blood thinners the rest of his life.  He received the bivalent booster this fall without any complications. We believe he has made a full recovery. He finally contracted COVID in July of 2022 for the first time and was ill, but it wasn't severe. (I keep a daily journal and was able to go back and see symptoms and dates - sorry for all the details if not needed.)
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Dysstasia, Electrocardiogram normal, Exercise electrocardiogram, Exercise tolerance decreased
Clinical narrative: Patient ran 6-10 miles daily and also hiked our neighboring mountains. In May, his stamina and ability started gradually failing. He was also in a community choir and couldn't understand why he couldn't get a good breath or hold notes out. By mid-May, he was concerned enough that he scheduled a dr appt for June. Since his mother had recently had a heart attack, he was concerned maybe it was his heart. On June 7, 2021, he met with the doctor, who did a lot of blood work as well. They thought maybe he had some virus or was run down. He had a persistent cough, too. Patient was a volunteer cross country coach as well and he usually could keep up with the kids, but wasn't able to.  By the end of the summer and into the xc season, he could barely walk across the parking lot without stopping. He had to forgo his weekend hikes because he could no longer hike more than a few minutes. The cough continued. It took several weeks, but he was able to get another dr appt on October 14, where the doctor did an electrocardiogram, which was normal. He referred him to a cardiologist. On October 28th, patient tried to do a treadmill stress test, but passed out. They scheduled him for an angiogram the next week. During that week, he could not stand more than a few minutes at a time. He could not carry the trash can the 20 feet to the garage. We tried to walk around the yard or down the street and he had to stop and catch his breath frequently.  By Oct. 30, he had pain in his back and abdomen. Starting Oct. 31, he could only stay awake a couple of hours and then he'd need to nap several hours.  We called the dr on Nov. 1 and in the afternoon they said he could come back in for blood work again. At that point we all thought he had a fast-growing cancer. That evening our daughter suggested we use the pulse oximeter. His heart rate wouldn't get below 100 and his oxygen wouldn't get into the 90s. I called the doctor on call for advice and he suggested we go to the ER. He was weak, had chest, back, and abdominal pain, a persistent cough, no stamina. We described the symptoms and they recognized it as PE. They did a CT scan and said his lungs were full of clots and there were parts of one lung that had died (infarcted). They gave him a shot of blood thinner, got him on oxygen, and admitted him to the hospital for observation. He was able to be released the next day, but needed to be on oxygen for a month and rest quite a bit. He will need to be on blood thinners the rest of his life.  He received the bivalent booster this fall without any complications. We believe he has made a full recovery. He finally contracted COVID in July of 2022 for the first time and was ill, but it wasn't severe. (I keep a daily journal and was able to go back and see symptoms and dates - sorry for all the details if not needed.)
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Gait disturbance, Hypersomnia, Loss of consciousness, Loss of personal independence in daily activities
Clinical narrative: Patient ran 6-10 miles daily and also hiked our neighboring mountains. In May, his stamina and ability started gradually failing. He was also in a community choir and couldn't understand why he couldn't get a good breath or hold notes out. By mid-May, he was concerned enough that he scheduled a dr appt for June. Since his mother had recently had a heart attack, he was concerned maybe it was his heart. On June 7, 2021, he met with the doctor, who did a lot of blood work as well. They thought maybe he had some virus or was run down. He had a persistent cough, too. Patient was a volunteer cross country coach as well and he usually could keep up with the kids, but wasn't able to.  By the end of the summer and into the xc season, he could barely walk across the parking lot without stopping. He had to forgo his weekend hikes because he could no longer hike more than a few minutes. The cough continued. It took several weeks, but he was able to get another dr appt on October 14, where the doctor did an electrocardiogram, which was normal. He referred him to a cardiologist. On October 28th, patient tried to do a treadmill stress test, but passed out. They scheduled him for an angiogram the next week. During that week, he could not stand more than a few minutes at a time. He could not carry the trash can the 20 feet to the garage. We tried to walk around the yard or down the street and he had to stop and catch his breath frequently.  By Oct. 30, he had pain in his back and abdomen. Starting Oct. 31, he could only stay awake a couple of hours and then he'd need to nap several hours.  We called the dr on Nov. 1 and in the afternoon they said he could come back in for blood work again. At that point we all thought he had a fast-growing cancer. That evening our daughter suggested we use the pulse oximeter. His heart rate wouldn't get below 100 and his oxygen wouldn't get into the 90s. I called the doctor on call for advice and he suggested we go to the ER. He was weak, had chest, back, and abdominal pain, a persistent cough, no stamina. We described the symptoms and they recognized it as PE. They did a CT scan and said his lungs were full of clots and there were parts of one lung that had died (infarcted). They gave him a shot of blood thinner, got him on oxygen, and admitted him to the hospital for observation. He was able to be released the next day, but needed to be on oxygen for a month and rest quite a bit. He will need to be on blood thinners the rest of his life.  He received the bivalent booster this fall without any complications. We believe he has made a full recovery. He finally contracted COVID in July of 2022 for the first time and was ill, but it wasn't severe. (I keep a daily journal and was able to go back and see symptoms and dates - sorry for all the details if not needed.)
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pulmonary infarction, Pulmonary thrombosis, Thrombosis
Clinical narrative: Patient ran 6-10 miles daily and also hiked our neighboring mountains. In May, his stamina and ability started gradually failing. He was also in a community choir and couldn't understand why he couldn't get a good breath or hold notes out. By mid-May, he was concerned enough that he scheduled a dr appt for June. Since his mother had recently had a heart attack, he was concerned maybe it was his heart. On June 7, 2021, he met with the doctor, who did a lot of blood work as well. They thought maybe he had some virus or was run down. He had a persistent cough, too. Patient was a volunteer cross country coach as well and he usually could keep up with the kids, but wasn't able to.  By the end of the summer and into the xc season, he could barely walk across the parking lot without stopping. He had to forgo his weekend hikes because he could no longer hike more than a few minutes. The cough continued. It took several weeks, but he was able to get another dr appt on October 14, where the doctor did an electrocardiogram, which was normal. He referred him to a cardiologist. On October 28th, patient tried to do a treadmill stress test, but passed out. They scheduled him for an angiogram the next week. During that week, he could not stand more than a few minutes at a time. He could not carry the trash can the 20 feet to the garage. We tried to walk around the yard or down the street and he had to stop and catch his breath frequently.  By Oct. 30, he had pain in his back and abdomen. Starting Oct. 31, he could only stay awake a couple of hours and then he'd need to nap several hours.  We called the dr on Nov. 1 and in the afternoon they said he could come back in for blood work again. At that point we all thought he had a fast-growing cancer. That evening our daughter suggested we use the pulse oximeter. His heart rate wouldn't get below 100 and his oxygen wouldn't get into the 90s. I called the doctor on call for advice and he suggested we go to the ER. He was weak, had chest, back, and abdominal pain, a persistent cough, no stamina. We described the symptoms and they recognized it as PE. They did a CT scan and said his lungs were full of clots and there were parts of one lung that had died (infarcted). They gave him a shot of blood thinner, got him on oxygen, and admitted him to the hospital for observation. He was able to be released the next day, but needed to be on oxygen for a month and rest quite a bit. He will need to be on blood thinners the rest of his life.  He received the bivalent booster this fall without any complications. We believe he has made a full recovery. He finally contracted COVID in July of 2022 for the first time and was ill, but it wasn't severe. (I keep a daily journal and was able to go back and see symptoms and dates - sorry for all the details if not needed.)
Age: 75.0
Sex: F
Vaccine: FLUR4
Symptoms: Malaise, Rash
Clinical narrative: patient states she has not been well and has had a rash for over 2 years
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, Blood cholesterol increased, Blood creatine phosphokinase normal, Blood glucose normal
Clinical narrative: I started having joint/muscle pain since about one day after the vaccine.  I have had worsening joint/muscle pain since that time.  I took a break from my anastrazole in January 2022 and again in August/September 2022 with no difference in symptoms.  I went to a rheumatologist and was diagnosed with rheumatoid arthritis without rheumatoid factor, myalgias, and arthralgias in January 2023.  I also cannot concentrate enough to read a book any more.  I also have severe tinnitus that sometimes wakes me in the middle of the night and shortness of breath when I am not doing anything.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin A decreased, Blood immunoglobulin G decreased, Blood potassium decreased, Blood thyroid stimulating hormone normal, Bone scan normal
Clinical narrative: I started having joint/muscle pain since about one day after the vaccine.  I have had worsening joint/muscle pain since that time.  I took a break from my anastrazole in January 2022 and again in August/September 2022 with no difference in symptoms.  I went to a rheumatologist and was diagnosed with rheumatoid arthritis without rheumatoid factor, myalgias, and arthralgias in January 2023.  I also cannot concentrate enough to read a book any more.  I also have severe tinnitus that sometimes wakes me in the middle of the night and shortness of breath when I am not doing anything.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dyspnoea, Eosinophil count decreased, Full blood count, Lipids
Clinical narrative: I started having joint/muscle pain since about one day after the vaccine.  I have had worsening joint/muscle pain since that time.  I took a break from my anastrazole in January 2022 and again in August/September 2022 with no difference in symptoms.  I went to a rheumatologist and was diagnosed with rheumatoid arthritis without rheumatoid factor, myalgias, and arthralgias in January 2023.  I also cannot concentrate enough to read a book any more.  I also have severe tinnitus that sometimes wakes me in the middle of the night and shortness of breath when I am not doing anything.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count increased, Mean platelet volume increased, Metabolic function test, Myalgia, Red blood cell sedimentation rate
Clinical narrative: I started having joint/muscle pain since about one day after the vaccine.  I have had worsening joint/muscle pain since that time.  I took a break from my anastrazole in January 2022 and again in August/September 2022 with no difference in symptoms.  I went to a rheumatologist and was diagnosed with rheumatoid arthritis without rheumatoid factor, myalgias, and arthralgias in January 2023.  I also cannot concentrate enough to read a book any more.  I also have severe tinnitus that sometimes wakes me in the middle of the night and shortness of breath when I am not doing anything.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Rheumatoid factor, Tinnitus
Clinical narrative: I started having joint/muscle pain since about one day after the vaccine.  I have had worsening joint/muscle pain since that time.  I took a break from my anastrazole in January 2022 and again in August/September 2022 with no difference in symptoms.  I went to a rheumatologist and was diagnosed with rheumatoid arthritis without rheumatoid factor, myalgias, and arthralgias in January 2023.  I also cannot concentrate enough to read a book any more.  I also have severe tinnitus that sometimes wakes me in the middle of the night and shortness of breath when I am not doing anything.
Age: 51.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was inadvertently administered 2 doses of expired Twinrix on 1/18/2023 and 2/17/2023. Patient was contacted and reported no serious side effects.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Impaired gastric emptying, Malaise
Clinical narrative: Relapse of gastroparesis. My gastroparesis had been much better. As expected, I got sick after the vaccine. After this, my gastroparesis symptoms got worse and have stayed that way since.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: GENERALIZED ITCHING, RASH ON FACE PATIENT'S PRIMARY PHYSICIAN BELIEVED TO BE SHINGLES
Age: 76.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Discomfort, Injected limb mobility decreased, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Both vaccines given in left arm. Patient states that she is unable to move her left arm up all the way to dress herself and is only able to lift her arm to mid body level without discomfort and muscle soreness. She states that she has been feeling the muscle soreness and inability to raise left arm fully shortly after vaccine and for about two weeks now. She has visited the doctor's office and has been given a medrol dose pack to see if this helps her improve her mobility.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pain
Clinical narrative: Patient reported redness, local swelling around site of injection (pt noted it felt like a lump underneath the skin) and pain
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Cough, Fatigue, Headache
Clinical narrative: All symptoms listed started 14 hours after injection unless stATED OTHERWISE: 1)pain-mild 18 hrs, moderate L arm site 6 hrs; 2)fever-99.5F for 2 hrs starting 30 hrs after injection, 98.4 F for 10hrs; 3)fatigue-1-3 days after inj; 4)headache-mild frontal sinus 1-3 days;5)chills-mild 14 hrs, moderate 6 hrs;6) upset stomach mild days 1-4; 7)Perhaps had lisinopril side effect  dry cough only lasted 5 seconds each event but q 1/2 hr for 2 days, no effect on Bp, none thereafter.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Sinus headache
Clinical narrative: All symptoms listed started 14 hours after injection unless stATED OTHERWISE: 1)pain-mild 18 hrs, moderate L arm site 6 hrs; 2)fever-99.5F for 2 hrs starting 30 hrs after injection, 98.4 F for 10hrs; 3)fatigue-1-3 days after inj; 4)headache-mild frontal sinus 1-3 days;5)chills-mild 14 hrs, moderate 6 hrs;6) upset stomach mild days 1-4; 7)Perhaps had lisinopril side effect  dry cough only lasted 5 seconds each event but q 1/2 hr for 2 days, no effect on Bp, none thereafter.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Bilirubin excretion disorder, Cholecystectomy, Hepatic enzyme increased
Clinical narrative: EPIGASTRIC PAIN, NAUSEA, COLICS ON A MONTLY BASIS FOR THE NEXT 12 MONTHS AFTER VACCINE DOCTORS INITIALLY MISDIAGNOSE PATIENT AND SEND PATIENT HOME AFTER INITIAL ER VISIT 2 MONTHS AFTER VACCINATION. FOR THE NEXT 12 MONTHS AND AS STATED BEFORE THE SYMPTOMS AND PAIN INCREASED ON A MONTHLY BASIS  CONSECUENTLY , PATIENT WAS ADMITTED IN THE ER AGAIN, LATER HOSPITALIZED AND HAVE GALLDBLADDER REMOVAL ON AN EMERGENCY BASIS.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Jaundice cholestatic, Nausea
Clinical narrative: EPIGASTRIC PAIN, NAUSEA, COLICS ON A MONTLY BASIS FOR THE NEXT 12 MONTHS AFTER VACCINE DOCTORS INITIALLY MISDIAGNOSE PATIENT AND SEND PATIENT HOME AFTER INITIAL ER VISIT 2 MONTHS AFTER VACCINATION. FOR THE NEXT 12 MONTHS AND AS STATED BEFORE THE SYMPTOMS AND PAIN INCREASED ON A MONTHLY BASIS  CONSECUENTLY , PATIENT WAS ADMITTED IN THE ER AGAIN, LATER HOSPITALIZED AND HAVE GALLDBLADDER REMOVAL ON AN EMERGENCY BASIS.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Incorrect route of product administration, Pain
Clinical narrative: The shot was administered incorrectly-In my shoulder joint - I Have experienced numbness in my hand and fingers off and on for a over a week. I still DO NOT have mobility with my left arm. Loss of sleep and Tylenol doesn't help. The Pharmacist recommended I report this Information. I am taking HYPERICUM PEFORATUM for pain, And this is not helping. This is my second shot.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest X-ray normal, Dyspnoea
Clinical narrative: 04 4/11/21, I began experiencing shortness of breath I feel the need to take a deep breath. I'll try doing so and I can't get a full, deep breath. I'll wait and try again. I'm eventually able to get a deep breath, but moments later, I'll feel the need again & the same process continues. I've seen 2 doctors & they both think it's anxiety. (I was tested for covid & it came back negative). I honestly feel the vaccine did something to me. I was prescribed anti-anxiety medication (hydroxyzine pamoate 25mg), but it doesn't seem to be helping.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Husband called to report the patient had been diagnosed with SIRVA.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Right arm - random burning under side of arm in nerves/blood vessels
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product expiration date issue
Clinical narrative: No adverse event; My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Feb-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .).    No concomitant medication details was reported. No treatment medication details was reported.   This case contains information for the 4th patient out of 4 pediatric patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712814, US-MODERNATX, INC.-MOD-2023-712821, US-MODERNATX, INC.-MOD-2023-712819 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712814:Patient 1 case US-MODERNATX, INC.-MOD-2023-712821:Patient 3 case US-MODERNATX, INC.-MOD-2023-712819:Patient 2 case
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Laboratory test, Rash
Clinical narrative: rash, couldnt breathe
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood glucose normal, Diplegia, Dizziness, Nausea
Clinical narrative: Patient had a syncopal episode at 5 min post-vac. Pulse 100, reported a feeling of paralysis in both arms and legs. Patient complained of stomach pain and nausea. BP at 12:15 220/90, glucose 136. Moved to EMS station for observation. Patient felt lightheaded. EMS decided to transport to ED. Pulse 94, at time of transport.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient had a syncopal episode at 5 min post-vac. Pulse 100, reported a feeling of paralysis in both arms and legs. Patient complained of stomach pain and nausea. BP at 12:15 220/90, glucose 136. Moved to EMS station for observation. Patient felt lightheaded. EMS decided to transport to ED. Pulse 94, at time of transport.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines pfizer 4/1/21 Lot# ER8732;  Pfizer 4/2/21 Lot# EW0172
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Breakthrough Case
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough Case
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 27.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Expired Sterile Diluent was administered on 12/21/2022; Expired Sterile Diluent was administered on 12/21/2022; This spontaneous report has been received from a pharmacist, concerning a 27-year-old male patient.  The patient's medical history, concurrent conditions, concomitant therapies, and historical drugs were not reported.  On 21-DEC-2022, the patient received an expired sterile diluent (MERCK STERILE DILUENT) (lot number T014588 was verified to be valid for sterile diluent [MERCK STERILE DILUENT], expiration date reported and confirmed as 25-NOV-2022) (Expired product administered), and also received varicella virus vaccine live (oka/merck) (VARIVAX) (not expired and stored properly) (doses and routes of administration were not provided) (Product preparation error).  No additional adverse events (AEs) were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA008375:
Age: 27.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AEs; Expired Sterile Diluent was administered on 12/21/2022; Expired Sterile Diluent was administered on 12/21/2022; This spontaneous report has been received from a pharmacist, concerning a 27-year-old male patient.  The patient's medical history, concurrent conditions, concomitant therapies, and historical drugs were not reported.  On 21-DEC-2022, the patient received an expired sterile diluent (MERCK STERILE DILUENT) (lot number T014588 was verified to be valid for sterile diluent [MERCK STERILE DILUENT], expiration date reported and confirmed as 25-NOV-2022) (Expired product administered), and also received varicella virus vaccine live (oka/merck) (VARIVAX) (not expired and stored properly) (doses and routes of administration were not provided) (Product preparation error).  No additional adverse events (AEs) were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA008375:
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Computerised tomogram thorax normal, Cough, Dyspnoea, Resuscitation
Clinical narrative: Discharge summary "Patient with Chronic respiratory failure with hypoxia (Home oxygen @ 6 L/m) due to Severe pan lobular emphysema and COPD. Patient had a recent COVID-19 virus infection and after discharge from the hospital developed increased shortness of breath. On presentation had evidence of Acute on chronic respiratory failure with hypoxia as well as signs of Sepsis. These appear due to a Right lower lobe pneumonia suspected to be a superimposed bacterial pneumonia. She has been started on CEFTRIAXONE and continues her dose of prophylaxis AZITHROMYCIN.  She initially needed BiPAP but has been weaned down to supplemental oxygen per nasal cannula @ 6-7 L. "
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Discharge summary "Patient with Chronic respiratory failure with hypoxia (Home oxygen @ 6 L/m) due to Severe pan lobular emphysema and COPD. Patient had a recent COVID-19 virus infection and after discharge from the hospital developed increased shortness of breath. On presentation had evidence of Acute on chronic respiratory failure with hypoxia as well as signs of Sepsis. These appear due to a Right lower lobe pneumonia suspected to be a superimposed bacterial pneumonia. She has been started on CEFTRIAXONE and continues her dose of prophylaxis AZITHROMYCIN.  She initially needed BiPAP but has been weaned down to supplemental oxygen per nasal cannula @ 6-7 L. "
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Dyspnoea, Hypoxia, Pneumonia
Clinical narrative: Discharge summary "Patient with Chronic respiratory failure with hypoxia (Home oxygen @ 6 L/m) due to Severe pan lobular emphysema and COPD. Patient had a recent COVID-19 virus infection and after discharge from the hospital developed increased shortness of breath. On presentation had evidence of Acute on chronic respiratory failure with hypoxia as well as signs of Sepsis. These appear due to a Right lower lobe pneumonia suspected to be a superimposed bacterial pneumonia. She has been started on CEFTRIAXONE and continues her dose of prophylaxis AZITHROMYCIN.  She initially needed BiPAP but has been weaned down to supplemental oxygen per nasal cannula @ 6-7 L. "
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pneumonia bacterial, Positive airway pressure therapy, SARS-CoV-2 test positive, Sepsis, Superinfection
Clinical narrative: Discharge summary "Patient with Chronic respiratory failure with hypoxia (Home oxygen @ 6 L/m) due to Severe pan lobular emphysema and COPD. Patient had a recent COVID-19 virus infection and after discharge from the hospital developed increased shortness of breath. On presentation had evidence of Acute on chronic respiratory failure with hypoxia as well as signs of Sepsis. These appear due to a Right lower lobe pneumonia suspected to be a superimposed bacterial pneumonia. She has been started on CEFTRIAXONE and continues her dose of prophylaxis AZITHROMYCIN.  She initially needed BiPAP but has been weaned down to supplemental oxygen per nasal cannula @ 6-7 L. "
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Doses administered past the expiration and beyond-use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the expiration and beyond-use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the expiration and beyond-use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the expiration and beyond-use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses administered past the expiration and beyond-use date).    No concomitant information was reported. This case is reported for patient 2 of 3. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712873, US-MODERNATX, INC.-MOD-2023-712882 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712873:Same reporter US-MODERNATX, INC.-MOD-2023-712882:Same reporter
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP reports patient was accidently administered an expired dose of STERILE DILUENT on Jan 9, 2023. STERILE DILUENT expired on Dec 3, 2022. The expired STERILE DILUENT was used to reconstitute MMR II. However, the MMR II was within date, and not expir; This spontaneous report as received from a Medical Assistant concerning to a male patient of unknown age.      The health care professional (HCP) reported patient was accidently administered an expired dose of STERILE DILUENT on 09-JAN-2023. STERILE DILUENT expired on 03-DEC-2022, lot# T014300 (expired product administered). The expired STERILE DILUENT was used to reconstitute MMR II (lot# W002787, expiration date: 25-JAN-2024). However, the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) was within date, and not expired. Products had no prior temperature excursions.  Products had no prior temperature excursions. No further information provided.  No additional AE reported. No PQC reported.
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: An extra dose of VAQTA was given to an 8 year old female patient. She states that the physician did not have records at the time of administration and after going back to look at records when they became available the serie was completed; This spontaneous report has been received from a registered nurse regarding an 8-year-old female patient. Patient's pertinent medical history, drug reactions and allergies and concomitant medication were unknown by reporter.  On an unknown date, the patient was vaccinated with an extra dose of Hepatitis A Vaccine, Inactivated (VAQTA), intramuscular injection, at a dose of 0.5 mililliters, administered as prophylaxis, (strength, route of administration, and anatomical location were not provided; lot number W036268 had been verified as a valid number and the expiration date was established as 20-MAY-2024) (extra dose administered).