chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Nasopharyngitis, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I experienced in July 2022, I had fever, fatigue, mild cold symptoms. I took Paxlovid on the second day of my symptoms. My symptoms went away in 24 hours.  When I stopped my Paxlovid medicine my symptoms returned. My antigen test became negative after 18 days of onset. Three days after my rebound I recovered.  Within one day of symptoms, I was positive, one day before I was negative.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Electrocardiogram, Laboratory test, Palpitations, Renal function test, Thyroid function test
Clinical narrative: I started experiencing heart palpitations at rest and when in motion on 03/05/23. I continued experiencing the sensation that my heart was racing, both during the day and at nighttime. I visited my PCP on 03/09/23 and again on 03/17/23 . These symptoms have since dissipated (04/04/23) I still felt it necessary to report this change in my medical health.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I just had a sore throat and a little fatigue. I tested positive for COVID-19 and called a doctor and they prescribed me Paxlovid. I think the Paxlovid kept my symptoms from getting worse.
Age: 1.25
Sex: F
Vaccine: PPV
Symptoms: No adverse event
Clinical narrative: Patient did not have any noted adverse reaction at the time the vaccine was given or after the visit.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Lung disorder, Nasopharyngitis
Clinical narrative: The second time I had COVID-19 was worse than the first time. It started as a cold with a runny nose but no fever. At night I had the chills, and it also affected my lungs. My doctor put me on PAXLOVID and then the following Thursday I was fine. I also had a runny nose and a cough.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: The second time I had COVID-19 was worse than the first time. It started as a cold with a runny nose but no fever. At night I had the chills, and it also affected my lungs. My doctor put me on PAXLOVID and then the following Thursday I was fine. I also had a runny nose and a cough.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient received a 5-11 years bivalent booster 0.3mL instead of a 12+  bivalent booster. Patient was notified with error and correct dose was administered.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Blood test normal, Clostridium difficile colitis, Clostridium test positive, Fatigue
Clinical narrative: It started with some fatigue and GI symptoms like nausea, upset stomach and it progressed. To the point where I was extremely fatigued and so I went to the doctor.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Stool analysis abnormal
Clinical narrative: It started with some fatigue and GI symptoms like nausea, upset stomach and it progressed. To the point where I was extremely fatigued and so I went to the doctor.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chest X-ray, Cough, Nasal congestion, Pulmonary function test
Clinical narrative: Started getting fever chills stuffy nose tested positive for Covid. Took PAXLOVID for 5 days felt better than had a rebound case that was worse. For weeks intermittent symptoms cough didn't go away. Went to urgent care prescribed antibiotic. Still had cough while leaving states. Pulmonary function test performed. Prescribed inhaler. Going on for 3 months.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Started getting fever chills stuffy nose tested positive for Covid. Took PAXLOVID for 5 days felt better than had a rebound case that was worse. For weeks intermittent symptoms cough didn't go away. Went to urgent care prescribed antibiotic. Still had cough while leaving states. Pulmonary function test performed. Prescribed inhaler. Going on for 3 months.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Drain placement, Infection, Localised infection
Clinical narrative: I went to the hospital for an MRI for another health concern and found they an infection on my back and front hip area and leg. They called me and told me to go to the ER when they gave me my results. When I got to the ER, they did a CT scan and blood work. They sent me to the hospital, and they did more tests and another CT scan, they put in a drain to remove the infection, and gave me antibiotics.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging abnormal
Clinical narrative: I went to the hospital for an MRI for another health concern and found they an infection on my back and front hip area and leg. They called me and told me to go to the ER when they gave me my results. When I got to the ER, they did a CT scan and blood work. They sent me to the hospital, and they did more tests and another CT scan, they put in a drain to remove the infection, and gave me antibiotics.
Age: 17.0
Sex: U
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: administration of an adult dose to a 17 yo; administration of an adult dose to a 17 yo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 17-year-old patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: administration of an adult dose to a 17 yo) and adult product administered to child (Verbatim: administration of an adult dose to a 17 yo). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 24-Mar-2023 The reporter asked how to proceed with this patient. The reporter did not provide patient identifiers nor information about the adult Engerix-B dose given (Lot number, expiry date, date of administration). The follow-up could not be possible as no contact details were available. The patient received an adult dose of Engerix-B, which led to overdose and adult product administered by child.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Periorbital swelling, Skin texture abnormal
Clinical narrative: My eye (above my eye) starting swallow and turn red, got bumpy, in both edges. I went to the urgent care and prescribed steroids medicine plus the cream, and I used that for 5 days, it mostly cleared up after a few days. .
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Vaccine administered without correct liquid; Vaccine administered without correct liquid; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Vaccine administered without correct liquid) and inappropriate dose of vaccine administered (Verbatim: Vaccine administered without correct liquid). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-MAR-2023 The clinic had a vial of Menveo liquid left over.  When they find the patient that had the incorrect dosing, would that dose need to be repeated and how much time did the patient need to wait between doses. Upon callback to health care professional (HCP), she stated she was informed yesterday and it discovered wednesday.  They were still researching. The lot or expiry date not available but gave consent for follow up to obtain this info at a later time. The reporter consented to follow up. The patient had Menveo vaccine administered without correct liquid, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient  was to received first dose of primary series monovalent Pfizer;however patient received bivalent instead. No adverse reaction reported.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Eye pain, Headache, Neck pain
Clinical narrative: I had vaccination on 10/25/2022. By mid-November 2022 I started to have extreme throbbing headaches into the temple and eye region and up the neck. I had a car accident in 01/2022. I have had various vaccinations in 2022 to include flu MMR Shingles and Hepatitis B. I am referred to neurology and prescribed medication that did not work for the headaches. I am being sent for a contrast MRI on 04/10/2023. I am also being prescribed an anti-seizure medication to start after the upcoming MRI.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Fatigue, Malaise, Oropharyngeal pain
Clinical narrative: I experienced COVID-19 on February 2023. I experienced a cough which became very bad, sore throat, body aches, runny nose, fatigued, productive coughing. I went to the ER where chest x-ray was performed and a physical exam. I was told by the ER doctor I had pharyngitis secondary to my COVID symptoms and they gave me a cough medicine. I took a COVID rapid test at home on 02/01/2023 and it was positive. I have recovered from my COVID symptoms.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pharyngitis, Productive cough, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I experienced COVID-19 on February 2023. I experienced a cough which became very bad, sore throat, body aches, runny nose, fatigued, productive coughing. I went to the ER where chest x-ray was performed and a physical exam. I was told by the ER doctor I had pharyngitis secondary to my COVID symptoms and they gave me a cough medicine. I took a COVID rapid test at home on 02/01/2023 and it was positive. I have recovered from my COVID symptoms.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills Extreme fatigue  Full body aches and pains Strong headache Swollen vaccination site Had to take two Tylenols which helped a little.  Still feeling the fatigue after one day.  But not as bad as before probably due to the Tylenol.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: Fever, chills Extreme fatigue  Full body aches and pains Strong headache Swollen vaccination site Had to take two Tylenols which helped a little.  Still feeling the fatigue after one day.  But not as bad as before probably due to the Tylenol.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination error, Wrong product administered
Clinical narrative: At time of 3rd dose patient is age 5 . Patient should have received 3rd dose of Pfizer monovalent ( 0.2ml 3mcg). Med error occurred with 3rd dose.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive, Sinusitis
Clinical narrative: My son in law came into town sick and tested positive for COVID-19. I began to have symptoms and tested negative 3 times. I came down with a sinus infection and was sick for about 5 weeks before getting better.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling in hands and feet; numbness/loss of sensation in fingers
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Nausea, Pyrexia
Clinical narrative: I started to have a mild sinus headache, a mild fever at 100.6 degrees, I was coughing, I had congestion, I was super tired, and a little bit of nausea. I was taking Tylenol and Mucinex.  I tested with a COVID-19 home test.  I called the nurse line and I had to go in and they prescribed me Paxlovid.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Sinus headache
Clinical narrative: I started to have a mild sinus headache, a mild fever at 100.6 degrees, I was coughing, I had congestion, I was super tired, and a little bit of nausea. I was taking Tylenol and Mucinex.  I tested with a COVID-19 home test.  I called the nurse line and I had to go in and they prescribed me Paxlovid.
Age: 76.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Chills, Fatigue, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I felt really tired the first day which was 12/14/2022. 12/15/2022 I did a home COVID-19 test and it was positive. On the 12/15/2022 Chills, fever of 103.5. I went online to my providers website and requested prescription for PAXLOVID. I felt better that same day.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was 5 years old at the time of administration for dose 3 on 10/28/2022, patient not turning 6 until  12/7/2022. Since patient is 5 years old at time of vaccine , patient should have received Pfizer bivalent booster ( 0.2ml 10mcg) only and should not have started the Moderna series or received the Moderna monovalent vaccine dosage of 0.2ml 3mcg.
Age: 33.0
Sex: F
Vaccine: COVID19-2, FLUN4
Symptoms: Back pain, Computerised tomogram kidney abnormal, Decreased appetite, Fatigue, Herpes zoster
Clinical narrative: I had an itchy, painful shingles rash on the left side of my back and left torso. I started having bad nerve pain in my back. I also so had fatigue and loss of appetite. I went to the doctor, and I was diagnosed with shingles, and they prescribed me an antiviral. On the 10th I went to the urgent care because I had kidney stones, and they did a CAT scan to confirm.
Age: 33.0
Sex: F
Vaccine: COVID19-2, FLUN4
Symptoms: Nephrolithiasis, Neuralgia, Rash, Rash pruritic
Clinical narrative: I had an itchy, painful shingles rash on the left side of my back and left torso. I started having bad nerve pain in my back. I also so had fatigue and loss of appetite. I went to the doctor, and I was diagnosed with shingles, and they prescribed me an antiviral. On the 10th I went to the urgent care because I had kidney stones, and they did a CAT scan to confirm.
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pfizer 12+ Bivalent booster vaccine was administered instead of Pfizer 12+ monovalent vaccine for 2nd dose in primary series. No symptoms are adverse reactions.
Age: 68.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Amaurosis fugax, Angiogram cerebral normal, Arteriogram carotid normal, Blindness transient, Blindness unilateral
Clinical narrative: Amaurosis fugax, loss of vision in right eye for 4 minutes.  Vision returned without treatment and the condition has not reoccurred.  Treated with Aspirin 325 mg QD (started 3/17/23) and Atorvastatin (Lipitor) 40 mg QD (started 3/17/23)
Age: 68.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Computerised tomogram head normal, Laboratory test
Clinical narrative: Amaurosis fugax, loss of vision in right eye for 4 minutes.  Vision returned without treatment and the condition has not reoccurred.  Treated with Aspirin 325 mg QD (started 3/17/23) and Atorvastatin (Lipitor) 40 mg QD (started 3/17/23)
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Peripheral swelling
Clinical narrative: Patient has swelling in her right arm and stated that it started right after getting vaccine but she didn't come into the pharmacy until 4/4/2023 stating that the swelling was getting worse. She got tests completed.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time shortened, Adnexa uteri pain, Blood test abnormal, COVID-19, Condition aggravated
Clinical narrative: I had had 3 COVID vaccines (3/6/21, 3/27/21, 9/29/21) all Pfizer, which had resulted in a change in my menstrual cycle. My period was starting later each month, having significant headaches, cramping, and intermittent bleeding (which most likely were cysts but I did not have any ultrasounds). I thought I was experiencing per-Menopause and my PCP did a hormone panel, which was normal. But my menstrual changes have continued for the next 2 years (to present day). I had not considered that this could have been related to my COVID vaccines until my 4 shot and the significant issues.   Per my PCP bloodwork, I had also developed increased blood clotting factors.   I contracted COVID for the first time Holiday weekend May 2022. I was rx'd Paxlovid by my PCP and took the full course but had significant COVID symptoms for 1.5 months after having COVID including heart palpitations, shortness of breath, fatigue, and confusion.   I started having significant menstrual type cramps and ovarian pain after my 4th COVID vaccine. They progressed with more pain throughout the month. Then, as I was flying back on Monday Aug 15, 2022, my ovarian cysts ruptured very painfully where I wasn't able to move for several minutes and had to be escorted off of a plane I was taken by ambulance to airport, waited 12 hours to be seen, then it was confirmed via ultrasound that I had ruptured ovarian cysts. I have continued to experience such cysts monthly for the past 7 months to this day, which are worsening over time. I then developed a blood clot in my left bicep at the same time. And still contracted COVID exactly 2 weeks after my vaccine (even though I was double masked in the airport, plane, and hospital). It was a horrible experience, I was discharged at 3 am onto the streets with no luggage and had to find a way back to the airport to get home .   I was COVID positive for the second time on Aug 21, 2022 (90 days later than my first COVID positive occurrence).  I was rx'd Paxlovid by my PCP and took the full course. I had fewer COVID symptoms for a shorter duration than the first time I had it.   Because of the blood clotting risk, I have not been able to take a hormonal rx to help with the ovarian cysts and am experiencing ongoing challenges. Over the past 30 days, my cysts have bled for 25 of those days and continue today.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Haemorrhagic ovarian cyst, Malaise, Mobility decreased, Ovarian cyst
Clinical narrative: I had had 3 COVID vaccines (3/6/21, 3/27/21, 9/29/21) all Pfizer, which had resulted in a change in my menstrual cycle. My period was starting later each month, having significant headaches, cramping, and intermittent bleeding (which most likely were cysts but I did not have any ultrasounds). I thought I was experiencing per-Menopause and my PCP did a hormone panel, which was normal. But my menstrual changes have continued for the next 2 years (to present day). I had not considered that this could have been related to my COVID vaccines until my 4 shot and the significant issues.   Per my PCP bloodwork, I had also developed increased blood clotting factors.   I contracted COVID for the first time Holiday weekend May 2022. I was rx'd Paxlovid by my PCP and took the full course but had significant COVID symptoms for 1.5 months after having COVID including heart palpitations, shortness of breath, fatigue, and confusion.   I started having significant menstrual type cramps and ovarian pain after my 4th COVID vaccine. They progressed with more pain throughout the month. Then, as I was flying back on Monday Aug 15, 2022, my ovarian cysts ruptured very painfully where I wasn't able to move for several minutes and had to be escorted off of a plane I was taken by ambulance to airport, waited 12 hours to be seen, then it was confirmed via ultrasound that I had ruptured ovarian cysts. I have continued to experience such cysts monthly for the past 7 months to this day, which are worsening over time. I then developed a blood clot in my left bicep at the same time. And still contracted COVID exactly 2 weeks after my vaccine (even though I was double masked in the airport, plane, and hospital). It was a horrible experience, I was discharged at 3 am onto the streets with no luggage and had to find a way back to the airport to get home .   I was COVID positive for the second time on Aug 21, 2022 (90 days later than my first COVID positive occurrence).  I was rx'd Paxlovid by my PCP and took the full course. I had fewer COVID symptoms for a shorter duration than the first time I had it.   Because of the blood clotting risk, I have not been able to take a hormonal rx to help with the ovarian cysts and am experiencing ongoing challenges. Over the past 30 days, my cysts have bled for 25 of those days and continue today.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ovarian cyst ruptured, SARS-CoV-2 test positive, Scan abnormal, Thrombosis, Ultrasound scan vagina abnormal
Clinical narrative: I had had 3 COVID vaccines (3/6/21, 3/27/21, 9/29/21) all Pfizer, which had resulted in a change in my menstrual cycle. My period was starting later each month, having significant headaches, cramping, and intermittent bleeding (which most likely were cysts but I did not have any ultrasounds). I thought I was experiencing per-Menopause and my PCP did a hormone panel, which was normal. But my menstrual changes have continued for the next 2 years (to present day). I had not considered that this could have been related to my COVID vaccines until my 4 shot and the significant issues.   Per my PCP bloodwork, I had also developed increased blood clotting factors.   I contracted COVID for the first time Holiday weekend May 2022. I was rx'd Paxlovid by my PCP and took the full course but had significant COVID symptoms for 1.5 months after having COVID including heart palpitations, shortness of breath, fatigue, and confusion.   I started having significant menstrual type cramps and ovarian pain after my 4th COVID vaccine. They progressed with more pain throughout the month. Then, as I was flying back on Monday Aug 15, 2022, my ovarian cysts ruptured very painfully where I wasn't able to move for several minutes and had to be escorted off of a plane I was taken by ambulance to airport, waited 12 hours to be seen, then it was confirmed via ultrasound that I had ruptured ovarian cysts. I have continued to experience such cysts monthly for the past 7 months to this day, which are worsening over time. I then developed a blood clot in my left bicep at the same time. And still contracted COVID exactly 2 weeks after my vaccine (even though I was double masked in the airport, plane, and hospital). It was a horrible experience, I was discharged at 3 am onto the streets with no luggage and had to find a way back to the airport to get home .   I was COVID positive for the second time on Aug 21, 2022 (90 days later than my first COVID positive occurrence).  I was rx'd Paxlovid by my PCP and took the full course. I had fewer COVID symptoms for a shorter duration than the first time I had it.   Because of the blood clotting risk, I have not been able to take a hormonal rx to help with the ovarian cysts and am experiencing ongoing challenges. Over the past 30 days, my cysts have bled for 25 of those days and continue today.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Induration, Pain, Peripheral swelling, Swelling
Clinical narrative: Arthus reaction, redness, swelling, induration, warmth, pain. Started at about an inch and grew to over 4x2.5 with whole arm and hand swelling.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Arthus reaction, redness, swelling, induration, warmth, pain. Started at about an inch and grew to over 4x2.5 with whole arm and hand swelling.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Insomnia, Loss of personal independence in daily activities, Mental disorder
Clinical narrative: The symptoms were dizziness, mental gaps & unable to sleep well, it was hard to rest.  I noted the day the symptoms started until I stopped feeling them.  The discomfort started the day after vaccination, October 28 and lasted around 43 days, when I noted I no longer had the discomforts and could return to my normal life.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Brain fog, COVID-19, Fatigue, Malaise, Myalgia
Clinical narrative: I contracted COVID-19 in mid-December 2022. Symptoms included fever, muscle ache, sore throat, general malaise, brain fog, and sinus congestion. The day I tested positive, I took Paxlovid, which helped resolve the disease in five days. Three days after that, however, I had a relapse, but this time, it was more like a very bad cold or a mild flu. This relapse lasted another five days, and after that I was fine, albeit fatigued. No long COVID ensued.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: I contracted COVID-19 in mid-December 2022. Symptoms included fever, muscle ache, sore throat, general malaise, brain fog, and sinus congestion. The day I tested positive, I took Paxlovid, which helped resolve the disease in five days. Three days after that, however, I had a relapse, but this time, it was more like a very bad cold or a mild flu. This relapse lasted another five days, and after that I was fine, albeit fatigued. No long COVID ensued.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: Patient was found deceased as reported via phone call by a member of the police department. No details were provided by the individual.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Cerebral haemorrhage, Computerised tomogram head abnormal, Walking aid user
Clinical narrative: lost sight in one eye, walker, brain hemmorhage
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 3/3/21 Lot# ER2613;  Pfizer 4/13/21 Lot# EW0150
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Product administered to patient of inappropriate age, Product use issue, Vaccination error
Clinical narrative: Patient's parent provided a date of birth Indicating they were eligible to receive the vaccine. Their actual date of birth was, so they were actually 4 yrs old at the time when the vaccine was not approved for this age group.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Through the previous 3 vaccines which I had breast cancer but the Doctor okayed with getting pfizer in that arm. The 4th dose I got intense itching and migrating all around my body with urticaria and have continued for the past year. I didn't know if it was vaccine related.
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; PNEUMOVAX 23 expired on 1/13/2023 and was administered on 3/3/2023; This spontaneous report was received from a pharmacist and referred to a patient of unknown age and gender. The patient's medical history concurrent conditions and concomitant therapies were not reported.  On 03-MAR-2023, the patient was vaccinated pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U021995, expiration date: 13-JAN-2023, administered for prophylaxis (strength, anatomical location and route of administration were not provided) (expired product administered).
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; PNEUMOVAX 23 expired on 1/13/2023 and was administered on 3/3/2023; This spontaneous report was received from a pharmacist and referred to a patient of unknown age and gender. The patient's medical history concurrent conditions and concomitant therapies were not reported.  On 03-MAR-2023, the patient was vaccinated pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U021995, expiration date: 13-JAN-2023, administered for prophylaxis (strength, anatomical location and route of administration were not provided) (expired product administered).
Age: 39.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19-2
Symptoms: Anal incontinence, Back pain, CSF oligoclonal band present, CSF white blood cell count increased, Electromyogram normal
Clinical narrative: muscle weakness, fatigue, numbness and tingling both legs, bowel and bladder incontinence, pain in both legs.   Covid19 bivalent booster on Jan 23/2023. 3 days later, she started to have leg weakness, numbness and tingling of legs, and bowel and bladder incontinence. Evaluation for cauda equina syndrome was negative for compression, however Gd was not given in the hospital and thus unable to assess if nerve roots were enhancing. Symptoms localize to cauda equina. She has slowly improved post-hospitalization in terms on weakness and bowel/bladder symptoms. She still has residual numbness.
Age: 39.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19-2
Symptoms: Fatigue, Hypoaesthesia, Lumbar puncture abnormal, Magnetic resonance imaging spinal normal, Muscular weakness
Clinical narrative: muscle weakness, fatigue, numbness and tingling both legs, bowel and bladder incontinence, pain in both legs.   Covid19 bivalent booster on Jan 23/2023. 3 days later, she started to have leg weakness, numbness and tingling of legs, and bowel and bladder incontinence. Evaluation for cauda equina syndrome was negative for compression, however Gd was not given in the hospital and thus unable to assess if nerve roots were enhancing. Symptoms localize to cauda equina. She has slowly improved post-hospitalization in terms on weakness and bowel/bladder symptoms. She still has residual numbness.
Age: 39.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19-2
Symptoms: Nerve conduction studies normal, Pain, Pain in extremity, Paraesthesia, Scan with contrast normal
Clinical narrative: muscle weakness, fatigue, numbness and tingling both legs, bowel and bladder incontinence, pain in both legs.   Covid19 bivalent booster on Jan 23/2023. 3 days later, she started to have leg weakness, numbness and tingling of legs, and bowel and bladder incontinence. Evaluation for cauda equina syndrome was negative for compression, however Gd was not given in the hospital and thus unable to assess if nerve roots were enhancing. Symptoms localize to cauda equina. She has slowly improved post-hospitalization in terms on weakness and bowel/bladder symptoms. She still has residual numbness.
Age: 39.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19-2
Symptoms: Urinary incontinence, Viral test negative
Clinical narrative: muscle weakness, fatigue, numbness and tingling both legs, bowel and bladder incontinence, pain in both legs.   Covid19 bivalent booster on Jan 23/2023. 3 days later, she started to have leg weakness, numbness and tingling of legs, and bowel and bladder incontinence. Evaluation for cauda equina syndrome was negative for compression, however Gd was not given in the hospital and thus unable to assess if nerve roots were enhancing. Symptoms localize to cauda equina. She has slowly improved post-hospitalization in terms on weakness and bowel/bladder symptoms. She still has residual numbness.
Age: 39.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19-2
Symptoms: Anal incontinence, CSF oligoclonal band present, CSF white blood cell count increased, Fatigue, Hypoaesthesia
Clinical narrative: muscle weakness, fatigue, numbness and tingling both legs, bowel and bladder incontinence, pain in both legs.   Covid19 bivalent booster on Jan 23/2023. 3 days later, she started to have leg weakness, numbness and tingling of legs, and bowel and bladder incontinence. Evaluation for cauda equina syndrome was negative for compression, however Gd was not given in the hospital and thus unable to assess if nerve roots were enhancing. Symptoms localize to cauda equina. She has slowly improved post-hospitalization in terms on weakness and bowel/bladder symptoms. She still has residual numbness.
Age: 39.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19-2
Symptoms: Lumbar puncture abnormal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Muscular weakness, Pain in extremity
Clinical narrative: muscle weakness, fatigue, numbness and tingling both legs, bowel and bladder incontinence, pain in both legs.   Covid19 bivalent booster on Jan 23/2023. 3 days later, she started to have leg weakness, numbness and tingling of legs, and bowel and bladder incontinence. Evaluation for cauda equina syndrome was negative for compression, however Gd was not given in the hospital and thus unable to assess if nerve roots were enhancing. Symptoms localize to cauda equina. She has slowly improved post-hospitalization in terms on weakness and bowel/bladder symptoms. She still has residual numbness.
Age: 39.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19-2
Symptoms: Paraesthesia, Urinary incontinence
Clinical narrative: muscle weakness, fatigue, numbness and tingling both legs, bowel and bladder incontinence, pain in both legs.   Covid19 bivalent booster on Jan 23/2023. 3 days later, she started to have leg weakness, numbness and tingling of legs, and bowel and bladder incontinence. Evaluation for cauda equina syndrome was negative for compression, however Gd was not given in the hospital and thus unable to assess if nerve roots were enhancing. Symptoms localize to cauda equina. She has slowly improved post-hospitalization in terms on weakness and bowel/bladder symptoms. She still has residual numbness.
Age: 13.0
Sex: M
Vaccine: FLUA4, FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 3rd dose of influenza vaccine on 4/4/23 and 2nd dose of influenza vaccine was on 11/2/22. No abnormal signs and symptoms. No adverse events. No adverse reactions. Pt tolerated influenza vaccine well.
Age: 3.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no additional AE's; PNEUMOVAX 23 was administered to 3 year 1 month old patient on 9/2/2021 rather than 4th dose of PREVNAR 13; This spontaneous report has been received from a medical assistant regarding to a and refers to a 3-year-old male patient.  The patient's medical history, concurrent conditions, concomitant therapies, and previous drugs reactions or allergies were not reported.  On 02-SEP-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, at a dose of 0.5 milliliters (mL) once (lot #T021329 confirmed to be valid, expiration date: reported and stablished as 03-OCT-2021) administered for prophylaxis (strength, and route of administration were not provided), instead of the fourth dose of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (wrong product adminsitered). Prior to that, the third dose of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) was administered on 14-MAR-2019. No additional adverse events (AEs).
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Administered dose of expired vial to patient; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose of expired vial to patient) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose of expired vial to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered dose of expired vial to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered dose of expired vial to patient).    No concomitant medications were provided. It was reported that 2 vials were transferred to another site this morning and vaccines were showing expired. Vaccines expired on 11-Feb-2023. Site administered 3 doses from these expired vials to patients this morning. It was unknown if they experienced symptoms. No treatment medication was provided. This case contains information for the 2nd of 3 child patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-718082, MODERNATX, INC.-MOD-2023-718085 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-718082:Patient 1 out of 3 patients MODERNATX, INC.-MOD-2023-718085:Patient 3 out of 3 patients
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First Moderna Dose : 21-Jan-2021 and Second Moderna dose: 8-Feb-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna Dose : 21-Jan-2021 and Second Moderna dose: 8-Feb-2021) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A, 029K20A, 93990S and 005M21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma and Drug allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna Dose : 21-Jan-2021 and Second Moderna dose: 8-Feb-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna Dose : 21-Jan-2021 and Second Moderna dose: 8-Feb-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication included Vitamin supplements from 01-Jan-2023. Patient received dose 5 of Moderna on 16-Oct-2022. Batch/Lot No: AS7169B Location of injection: Arm Left. patient received Pfizer Paxlovid from 20-Mar-2023 to 25-Mar-2023 for treatment of COVID-19. On 29-Mar-2023, patient had Paxlovid rebound which was reported as recovering. Treatment medication was not reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Myasthenia gravis
Clinical narrative: Myasthenia gravis; This spontaneous case was reported by a consumer and describes the occurrence of MYASTHENIA GRAVIS (Myasthenia gravis) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYASTHENIA GRAVIS (Myasthenia gravis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYASTHENIA GRAVIS (Myasthenia gravis) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that patient took the Moderna vaccine, had Myasthenia gravis and was in ICU. No treatment information was provided.  Company comment: This spontaneous case concerns an adult male patient with no medical history information reported, who experienced the unexpected serious (hospitalization and medically significant) AESI of myasthenia gravis. The event occurred on an unknown date. Temporal relationship with a dose of mRNA-1273 bivalent BA.4/BA.5 is unclear. Dose number and vaccination schedule were also not provided. As reported, the patient received Moderna vaccine, had Myasthenia gravis and was in ICU.  No further information about the event was provided. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-717748 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717748:Son case
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Headache, Myalgia, Vaccination site pain
Clinical narrative: Soreness at the site; Body ache; Headache; Administered first dose. with expiration date of March 11, 2023. was administered on March 28, 2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered first dose. with expiration date of March 11, 2023. was administered on March 28, 2023), VACCINATION SITE PAIN (Soreness at the site), MYALGIA (Body ache) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered first dose. with expiration date of March 11, 2023. was administered on March 28, 2023). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the site), MYALGIA (Body ache) and HEADACHE (Headache). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered first dose. with expiration date of March 11, 2023. was administered on March 28, 2023) outcome was unknown and VACCINATION SITE PAIN (Soreness at the site), MYALGIA (Body ache) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient reported that the events soreness at the site, body ache and headache lasted for 24hrs. It is unknown if the patient experienced any additional symptoms/events. Treatment information was not provided.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Maternal exposure during pregnancy, No adverse event
Clinical narrative: Dose administered after 30-day use by date; No adverse event; Drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 24-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event). On 24-Mar-2023, MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date).    Concomitant and treatment medications were not reported.  It was unknown if the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The registered nurse called to find out what should be done if a Moderna COVID vaccine monovalent dose was given after the best use date. The lot number was same for both dates of administration. The fridge expiration date was 03-Feb-2023, the website expiration was 01-Apr-2023, and the pharmacy was saying 30-Apr-2023. Vial size was 5.5 ml. Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions.  Company Comment: This spontaneous case concerns a 24-year-old female patient, with no medical history reported, who experienced non serious unexpected Maternal exposure during pregnancy and Expired product administered with No adverse event that occurred in association with second dose of mRNA-1273 vaccine.  Details regarding gestation period, Last menstrual period and estimated date of delivery were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.