chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bacterial test negative, Culture throat negative, Exposure to communicable disease, Immediate post-injection reaction, Oropharyngeal pain
Clinical narrative: Right after my vaccination, I developed a small rash on my arm. In February, I was exposed to Strep. I had a sore red throat. I went to a walk-in clinic to test for Strep. They cultured my throat after doing a rapid test for Strep. The test was never received by the lab. I returned to the walk-in clinic to repeat the culture. The results indicated the sample was insufficient. The walk-in clinic prescribed penicillin which I took for 10 days.  I followed up with my regular doctor who repeated the culture. The culture proved negative for any concerning bacteria including Strep. My doctor thought it was viral. Now, I'm fine.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pharyngeal erythema, Rash, Streptococcus test negative, Viral infection
Clinical narrative: Right after my vaccination, I developed a small rash on my arm. In February, I was exposed to Strep. I had a sore red throat. I went to a walk-in clinic to test for Strep. They cultured my throat after doing a rapid test for Strep. The test was never received by the lab. I returned to the walk-in clinic to repeat the culture. The results indicated the sample was insufficient. The walk-in clinic prescribed penicillin which I took for 10 days.  I followed up with my regular doctor who repeated the culture. The culture proved negative for any concerning bacteria including Strep. My doctor thought it was viral. Now, I'm fine.
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Asthenia, Blood test, COVID-19, Chest pain, Cough
Clinical narrative: On 10/04/2022, I had a scratchy throat, I took a COVID-19 test and it was negative. The next day, no fever, cough, no energy, no pain. On the 7th, I tested again, negative, no energy, cough, sneezing, congestion with no production. On the 8th, I had head cold, headache, stuffiness. On the 9th, cough, energy low. On the 10th, hoarse, beginning to feel better. On the 17th, I was still coughing but I felt 98 percent better.  By the 19th, cough was gone.  In November, I had food poisoning with diarrhea and took an antibiotic.  On November 27, I had a vertigo episode and spent two days in the hospital. I had fallen and cracked my head and went by ambulance. I required 4 stitches beneath my eyebrow.  In January, I started a slight cough on the 11th. I went on a cruise and I started coughing and had a temperature of 100.2 on January 26. On the 27th, I had a deep cough at night. On the 28th, I coughed all day, chest pains, minor body aches.  On the 29th, I had 101.2, coughing, red and sore eyes and diarrhea. On the 30th, I felt better, still diarrhea.  On the 31st, no fever but diarrhea. On February 8, still mucous but felt great.  On the February 24, my congestion cleaned.  On the 28th, phlegm and cough were gone. I went on another cruise and came home March 12.  On the 13th, I had sinus congestion, fatigue, throat clearing, runny nose, I took Tylenol for headache.  On Tuesday, still sneezing, runny nose, fatigue and diarrhea, dry mouth. I tested positive for COVID-19.  Today I took my temperature and I was at 98, stuffy nose, annoying headache, body aches. Head feels full. I have a slight non-productive cough and I am tired.
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Diarrhoea, Dry mouth, Dysphonia, Eye pain, Fall
Clinical narrative: On 10/04/2022, I had a scratchy throat, I took a COVID-19 test and it was negative. The next day, no fever, cough, no energy, no pain. On the 7th, I tested again, negative, no energy, cough, sneezing, congestion with no production. On the 8th, I had head cold, headache, stuffiness. On the 9th, cough, energy low. On the 10th, hoarse, beginning to feel better. On the 17th, I was still coughing but I felt 98 percent better.  By the 19th, cough was gone.  In November, I had food poisoning with diarrhea and took an antibiotic.  On November 27, I had a vertigo episode and spent two days in the hospital. I had fallen and cracked my head and went by ambulance. I required 4 stitches beneath my eyebrow.  In January, I started a slight cough on the 11th. I went on a cruise and I started coughing and had a temperature of 100.2 on January 26. On the 27th, I had a deep cough at night. On the 28th, I coughed all day, chest pains, minor body aches.  On the 29th, I had 101.2, coughing, red and sore eyes and diarrhea. On the 30th, I felt better, still diarrhea.  On the 31st, no fever but diarrhea. On February 8, still mucous but felt great.  On the February 24, my congestion cleaned.  On the 28th, phlegm and cough were gone. I went on another cruise and came home March 12.  On the 13th, I had sinus congestion, fatigue, throat clearing, runny nose, I took Tylenol for headache.  On Tuesday, still sneezing, runny nose, fatigue and diarrhea, dry mouth. I tested positive for COVID-19.  Today I took my temperature and I was at 98, stuffy nose, annoying headache, body aches. Head feels full. I have a slight non-productive cough and I am tired.
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Fatigue, Food poisoning, Head discomfort, Head injury, Headache
Clinical narrative: On 10/04/2022, I had a scratchy throat, I took a COVID-19 test and it was negative. The next day, no fever, cough, no energy, no pain. On the 7th, I tested again, negative, no energy, cough, sneezing, congestion with no production. On the 8th, I had head cold, headache, stuffiness. On the 9th, cough, energy low. On the 10th, hoarse, beginning to feel better. On the 17th, I was still coughing but I felt 98 percent better.  By the 19th, cough was gone.  In November, I had food poisoning with diarrhea and took an antibiotic.  On November 27, I had a vertigo episode and spent two days in the hospital. I had fallen and cracked my head and went by ambulance. I required 4 stitches beneath my eyebrow.  In January, I started a slight cough on the 11th. I went on a cruise and I started coughing and had a temperature of 100.2 on January 26. On the 27th, I had a deep cough at night. On the 28th, I coughed all day, chest pains, minor body aches.  On the 29th, I had 101.2, coughing, red and sore eyes and diarrhea. On the 30th, I felt better, still diarrhea.  On the 31st, no fever but diarrhea. On February 8, still mucous but felt great.  On the February 24, my congestion cleaned.  On the 28th, phlegm and cough were gone. I went on another cruise and came home March 12.  On the 13th, I had sinus congestion, fatigue, throat clearing, runny nose, I took Tylenol for headache.  On Tuesday, still sneezing, runny nose, fatigue and diarrhea, dry mouth. I tested positive for COVID-19.  Today I took my temperature and I was at 98, stuffy nose, annoying headache, body aches. Head feels full. I have a slight non-productive cough and I am tired.
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Nasal congestion, Nasopharyngitis, Ocular hyperaemia, Pain, Productive cough
Clinical narrative: On 10/04/2022, I had a scratchy throat, I took a COVID-19 test and it was negative. The next day, no fever, cough, no energy, no pain. On the 7th, I tested again, negative, no energy, cough, sneezing, congestion with no production. On the 8th, I had head cold, headache, stuffiness. On the 9th, cough, energy low. On the 10th, hoarse, beginning to feel better. On the 17th, I was still coughing but I felt 98 percent better.  By the 19th, cough was gone.  In November, I had food poisoning with diarrhea and took an antibiotic.  On November 27, I had a vertigo episode and spent two days in the hospital. I had fallen and cracked my head and went by ambulance. I required 4 stitches beneath my eyebrow.  In January, I started a slight cough on the 11th. I went on a cruise and I started coughing and had a temperature of 100.2 on January 26. On the 27th, I had a deep cough at night. On the 28th, I coughed all day, chest pains, minor body aches.  On the 29th, I had 101.2, coughing, red and sore eyes and diarrhea. On the 30th, I felt better, still diarrhea.  On the 31st, no fever but diarrhea. On February 8, still mucous but felt great.  On the February 24, my congestion cleaned.  On the 28th, phlegm and cough were gone. I went on another cruise and came home March 12.  On the 13th, I had sinus congestion, fatigue, throat clearing, runny nose, I took Tylenol for headache.  On Tuesday, still sneezing, runny nose, fatigue and diarrhea, dry mouth. I tested positive for COVID-19.  Today I took my temperature and I was at 98, stuffy nose, annoying headache, body aches. Head feels full. I have a slight non-productive cough and I am tired.
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive, Secretion discharge, Sinus congestion
Clinical narrative: On 10/04/2022, I had a scratchy throat, I took a COVID-19 test and it was negative. The next day, no fever, cough, no energy, no pain. On the 7th, I tested again, negative, no energy, cough, sneezing, congestion with no production. On the 8th, I had head cold, headache, stuffiness. On the 9th, cough, energy low. On the 10th, hoarse, beginning to feel better. On the 17th, I was still coughing but I felt 98 percent better.  By the 19th, cough was gone.  In November, I had food poisoning with diarrhea and took an antibiotic.  On November 27, I had a vertigo episode and spent two days in the hospital. I had fallen and cracked my head and went by ambulance. I required 4 stitches beneath my eyebrow.  In January, I started a slight cough on the 11th. I went on a cruise and I started coughing and had a temperature of 100.2 on January 26. On the 27th, I had a deep cough at night. On the 28th, I coughed all day, chest pains, minor body aches.  On the 29th, I had 101.2, coughing, red and sore eyes and diarrhea. On the 30th, I felt better, still diarrhea.  On the 31st, no fever but diarrhea. On February 8, still mucous but felt great.  On the February 24, my congestion cleaned.  On the 28th, phlegm and cough were gone. I went on another cruise and came home March 12.  On the 13th, I had sinus congestion, fatigue, throat clearing, runny nose, I took Tylenol for headache.  On Tuesday, still sneezing, runny nose, fatigue and diarrhea, dry mouth. I tested positive for COVID-19.  Today I took my temperature and I was at 98, stuffy nose, annoying headache, body aches. Head feels full. I have a slight non-productive cough and I am tired.
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Sneezing, Suture insertion, Throat clearing, Throat irritation
Clinical narrative: On 10/04/2022, I had a scratchy throat, I took a COVID-19 test and it was negative. The next day, no fever, cough, no energy, no pain. On the 7th, I tested again, negative, no energy, cough, sneezing, congestion with no production. On the 8th, I had head cold, headache, stuffiness. On the 9th, cough, energy low. On the 10th, hoarse, beginning to feel better. On the 17th, I was still coughing but I felt 98 percent better.  By the 19th, cough was gone.  In November, I had food poisoning with diarrhea and took an antibiotic.  On November 27, I had a vertigo episode and spent two days in the hospital. I had fallen and cracked my head and went by ambulance. I required 4 stitches beneath my eyebrow.  In January, I started a slight cough on the 11th. I went on a cruise and I started coughing and had a temperature of 100.2 on January 26. On the 27th, I had a deep cough at night. On the 28th, I coughed all day, chest pains, minor body aches.  On the 29th, I had 101.2, coughing, red and sore eyes and diarrhea. On the 30th, I felt better, still diarrhea.  On the 31st, no fever but diarrhea. On February 8, still mucous but felt great.  On the February 24, my congestion cleaned.  On the 28th, phlegm and cough were gone. I went on another cruise and came home March 12.  On the 13th, I had sinus congestion, fatigue, throat clearing, runny nose, I took Tylenol for headache.  On Tuesday, still sneezing, runny nose, fatigue and diarrhea, dry mouth. I tested positive for COVID-19.  Today I took my temperature and I was at 98, stuffy nose, annoying headache, body aches. Head feels full. I have a slight non-productive cough and I am tired.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, CSF protein increased, Guillain-Barre syndrome, Magnetic resonance imaging
Clinical narrative: Weakness , elevated CSF protein  -guillian barre
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Anticoagulant therapy, Blood test, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: I developed a blood clot or deep vein thrombosis in the ulnar vein in the left upper extremity. On set of symptoms NOV2022 with routine bloodwork drawn from upper left extremity of minimal swelling pain and discoloration that continued and increased or worsened. Symptoms confirmed with Doppler imaging DEC2022 treatment was initiated with ELIQUIS and treatment continues at this time.
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Ultrasound Doppler abnormal, Venous thrombosis limb
Clinical narrative: I developed a blood clot or deep vein thrombosis in the ulnar vein in the left upper extremity. On set of symptoms NOV2022 with routine bloodwork drawn from upper left extremity of minimal swelling pain and discoloration that continued and increased or worsened. Symptoms confirmed with Doppler imaging DEC2022 treatment was initiated with ELIQUIS and treatment continues at this time.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Electrocardiogram normal, Nausea, Urine analysis normal, Vertigo positional
Clinical narrative: After being vaccinated I was a little nauseous after breakfast. I vomited and was still nauseous. I laid down and when I did, I got very dizzy. I stood up and the dizziness went away. I related the process three times, and it kept happening, so I decided to go to urgent care. I was prescribed medication for nausea, but I didn't take it. They couldn't diagnose anything but thought it might have been positional vertigo.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: After being vaccinated I was a little nauseous after breakfast. I vomited and was still nauseous. I laid down and when I did, I got very dizzy. I stood up and the dizziness went away. I related the process three times, and it kept happening, so I decided to go to urgent care. I was prescribed medication for nausea, but I didn't take it. They couldn't diagnose anything but thought it might have been positional vertigo.
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Chest discomfort, Cough, Fatigue, Feeling abnormal
Clinical narrative: I thought I was having an allergy attack. I was having tightness in my chest and runny nose in addition one evening. The next day, I had a steep cough and felt totally wiped out; I spent most of the day sleeping. I still felt pretty fatigue for the next couple of days. I decided to take a COVID-19 test on 02/19/2023, and it turned positive immediately. I called my doctor the next morning and was given PAXLOVID for treatment. Since then, I'm feeling better and back to normal activities; I haven't really had any residual symptoms other than fatigue sometimes.
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Hypersomnia, Loss of personal independence in daily activities, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I thought I was having an allergy attack. I was having tightness in my chest and runny nose in addition one evening. The next day, I had a steep cough and felt totally wiped out; I spent most of the day sleeping. I still felt pretty fatigue for the next couple of days. I decided to take a COVID-19 test on 02/19/2023, and it turned positive immediately. I called my doctor the next morning and was given PAXLOVID for treatment. Since then, I'm feeling better and back to normal activities; I haven't really had any residual symptoms other than fatigue sometimes.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood pressure increased, COVID-19, Cardiac disorder, Cough, Fatigue
Clinical narrative: Significant sore throat pain, moderate cough, low fever, fatigue. That's all I experienced as part of the acute disease. No significant treatment, just ADVIL and TYLENOL. I tested positive for COVID-19 with an at home test on 02/04/2023. I began to have heart issues subsequent to that. It seems to be caused by the COVID-19 infection. These symptoms have not gone away. It raised my heart rate and caused heart palpitations. It also increased my blood pressure. Six weeks later and I'm still experiencing these symptoms. I did talk to my PCP and we are in the process of seeing a cardiologist.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Heart rate increased, Oropharyngeal pain, Palpitations, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Significant sore throat pain, moderate cough, low fever, fatigue. That's all I experienced as part of the acute disease. No significant treatment, just ADVIL and TYLENOL. I tested positive for COVID-19 with an at home test on 02/04/2023. I began to have heart issues subsequent to that. It seems to be caused by the COVID-19 infection. These symptoms have not gone away. It raised my heart rate and caused heart palpitations. It also increased my blood pressure. Six weeks later and I'm still experiencing these symptoms. I did talk to my PCP and we are in the process of seeing a cardiologist.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Cough, Dyspnoea, Erythema, Fatigue
Clinical narrative: The symptoms didn't really change much. I got a very sore throat, very short of breath, a high fever of about 102. My skin became super hypersensitive sore and red. I was dry hacking when I coughed. I tested myself on December 16, 2022, and I was positive for COVID-19. My cough extremely severe and my fever elevated to 102 so I went to urgent care the next day. I was prescribed PAXLOVID and TESSALON PEARLS. After a few days I began to feel improvement. I was really sick but started to feel better. I did feel better after the 5 days I still didn't feel good. I was exhausted all the time which lasted for about 2 weeks.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Malaise, Oropharyngeal pain, Pain of skin, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: The symptoms didn't really change much. I got a very sore throat, very short of breath, a high fever of about 102. My skin became super hypersensitive sore and red. I was dry hacking when I coughed. I tested myself on December 16, 2022, and I was positive for COVID-19. My cough extremely severe and my fever elevated to 102 so I went to urgent care the next day. I was prescribed PAXLOVID and TESSALON PEARLS. After a few days I began to feel improvement. I was really sick but started to feel better. I did feel better after the 5 days I still didn't feel good. I was exhausted all the time which lasted for about 2 weeks.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Sensitive skin
Clinical narrative: The symptoms didn't really change much. I got a very sore throat, very short of breath, a high fever of about 102. My skin became super hypersensitive sore and red. I was dry hacking when I coughed. I tested myself on December 16, 2022, and I was positive for COVID-19. My cough extremely severe and my fever elevated to 102 so I went to urgent care the next day. I was prescribed PAXLOVID and TESSALON PEARLS. After a few days I began to feel improvement. I was really sick but started to feel better. I did feel better after the 5 days I still didn't feel good. I was exhausted all the time which lasted for about 2 weeks.
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Escherichia infection, Escherichia test positive, Incontinence, Micturition urgency, Urinary tract discomfort
Clinical narrative: 11/14/2022 I had some urgency for urination and discomfort after I voided. It moved into borderline incontinence. I had an appointment on 11/16/2022 with the doctor. I had a urine check; my lungs and heart were checked. It was likely an infection which was later diagnosed with E. coli. I was prescribed cephalexin. I began taking the medication that day. It was a 5 day supply and my symptoms were resolved after 2 days.
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Urine analysis
Clinical narrative: 11/14/2022 I had some urgency for urination and discomfort after I voided. It moved into borderline incontinence. I had an appointment on 11/16/2022 with the doctor. I had a urine check; my lungs and heart were checked. It was likely an infection which was later diagnosed with E. coli. I was prescribed cephalexin. I began taking the medication that day. It was a 5 day supply and my symptoms were resolved after 2 days.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blindness, Coccydynia, Corrective lens user, Dysstasia
Clinical narrative: I started losing my eye site and I now have to wear corrective lenses. Severe lower back/tailbone pain that started about 5 months after the second shot. Not able to sit for long periods of time. Very painful to stand from a sitting position.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Mobility decreased, Pain, Spinal X-ray
Clinical narrative: I started losing my eye site and I now have to wear corrective lenses. Severe lower back/tailbone pain that started about 5 months after the second shot. Not able to sit for long periods of time. Very painful to stand from a sitting position.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Headache, SARS-CoV-2 test positive
Clinical narrative: I had a really bad headache, that is really different than my other headaches. It was like the one I had the last time I had COVID-19. I took a home COVID-19 test that came back positive. I had an e-visit and was prescribed PAXLOVID that I started taking immediately. In a couple of days, I started feeling better. It was worth the nasty taste in my mouth to feel better so quickly.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Headache, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I have been traveling and I was having congestion and a cough along with a headache. I took a COVID-19 Home Test, and it was positive; I ended up taking three of them which all showed that I was positive. I called an urgent care and because I had three tests, they did not test me again. They said I should use Flonase and cough suppressant as well to help with the symptoms and to continue with the Tylenol and Sudafed that I had been taking. The cough has progressed, but it has not settled into my lungs which is a good thing. I am almost better but fully recovered at this point.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: I was positive for COVID-19 on 09DEC2022 I had a fever, I had headache, congestion body aches and soreness it felt like I had the flu. I contacted my doctor he prescribed me Paxlovid. It took about 3 days for me to feel better, I was up doing normal thing by the second day.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I was positive for COVID-19 on 09DEC2022 I had a fever, I had headache, congestion body aches and soreness it felt like I had the flu. I contacted my doctor he prescribed me Paxlovid. It took about 3 days for me to feel better, I was up doing normal thing by the second day.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023; No adverse event; a dose of the Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date), PRODUCT STORAGE ERROR (The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date), PRODUCT STORAGE ERROR (The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023) 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 EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date) and PRODUCT STORAGE ERROR (The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023).    No concomitant medications were reported.     It was reported that Spikevax of 5.5 mL was initially stored in the refrigerator on 13-Mar-2023. The vial did not undergo any temperature excursions. The vaccine was administered to 2 patients after the expiration date. No adverse reactions had been reported by any patients for this invalid dose.   No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715267 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715267:other patient, same reporter
Age: 67.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Dizziness, Pulse abnormal, Unresponsive to stimuli
Clinical narrative: One to two minutes after shot patient complained of seeing stars (light-headed) and felt nauseous.  Several minutes later the patient became unresponsive with eyes still open for around 2 minutes at which time EMS was called.  She was sweating profusely and had a week pulse.  The paramedics responded and checked her out.  They okayed her to leave with her husband after she was feeling better (15-20 minutes later) and there was NO transportation to the hospital needed.
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient stated she got Moderna COVID-19 Vaccine Bivalent on 28OCT2022 and she accidentally got another bivalent recently.; No Adverse Event; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient stated she got Moderna COVID-19 Vaccine Bivalent on 28OCT2022 and she accidentally got another bivalent recently.) and NO ADVERSE EVENT (No Adverse Event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     It was unknown if patient had any relevant medical history or conditions, allergy, concomitant diseases and risk factor.    On 28-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. 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 EXTRA DOSE ADMINISTERED (Patient stated she got Moderna COVID-19 Vaccine Bivalent on 28OCT2022 and she accidentally got another bivalent recently.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient stated she got Moderna COVID-19 Vaccine Bivalent on 28OCT2022 and she accidentally got another bivalent recently.) 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 EXTRA DOSE ADMINISTERED (Patient stated she got Moderna COVID-19 Vaccine Bivalent on 28OCT2022 and she accidentally got another bivalent recently.).    No concomitant medication were reported.  Patient stated she got Moderna COVID-19 Vaccine Bivalent and accidentally got another bivalent recently. Patient did not experience any AEs with any of the vaccines. No treatment information was provided by the reporter.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     Information regarding relevant medical history/conditions, allergy, concomitant diseases and risk factor were unknown.     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 EXPIRED PRODUCT ADMINISTERED (accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD) 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 (accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported.  HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD. HCP mentioned 2 doses were given on 19-FEB-2023, 1 dose on 20-FEB-2023, and 1 dose on 10-MAR-2023. Caller did not specified which date corresponded to patient 2. HCP stated patient 2 did not reported any AEs.   No treatment medications was reported.  This case contains information about patient-2 out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-715321, US-MODERNATX, INC.-MOD-2023-715348, US-MODERNATX, INC.-MOD-2023-715347 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715321:Patient 4 case US-MODERNATX, INC.-MOD-2023-715348:Patient 3 case US-MODERNATX, INC.-MOD-2023-715347:Patient 1 case
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD.) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19.  Patient relevant medical history/conditions, allergy, concomitant diseases and risk factor was reported as unknown.     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 EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD.) 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 (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD.).    No concomitant medications were reported. HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD. HCP mentioned 2 doses were given on 19FEB2023, 1 dose on 20FEB2023, and 1 dose on 10MAR2023. Caller did not specified which date corresponded to patient 4  but HCP stated patient 4 did not reported any AEs. No treatment medications were reported.  This case contains information for the 4th of 4 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-715325, US-MODERNATX, INC.-MOD-2023-715347, US-MODERNATX, INC.-MOD-2023-715348 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715325:Patient 2 US-MODERNATX, INC.-MOD-2023-715347:Patient 1 US-MODERNATX, INC.-MOD-2023-715348:Patient 3
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse Event; Moderna covid-19 monovalent red cap with expiration date 11 mar 2023 was administered to 1 patient of Lot 074B22A; first Moderna dose on 03 Feb 2023 and Date of administration of 2nd vaccine 13 Mar 2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 monovalent red cap with expiration date 11 mar 2023 was administered to 1 patient of Lot 074B22A), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna dose on 03 Feb 2023 and Date of administration of 2nd vaccine 13 Mar 2023) and NO ADVERSE EVENT (No Adverse Event) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 074B22A and 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2023, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 monovalent red cap with expiration date 11 mar 2023 was administered to 1 patient of Lot 074B22A). 13-Mar-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna dose on 03 Feb 2023 and Date of administration of 2nd vaccine 13 Mar 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 monovalent red cap with expiration date 11 mar 2023 was administered to 1 patient of Lot 074B22A), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna dose on 03 Feb 2023 and Date of administration of 2nd vaccine 13 Mar 2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 monovalent red cap with expiration date 11 mar 2023 was administered to 1 patient of Lot 074B22A) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna dose on 03 Feb 2023 and Date of administration of 2nd vaccine 13 Mar 2023).    No concomitant product reported by the reporter.  Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vial size was reported as 5.5 ml. Vial was initially stored in the refrigerator on 10-Mar-2023. Vial did not undergone any temperature excursion issue.  No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2023: Live significant follow up received. Dosage Information updated. Product coding changed from Moderna COVID-19 Vaccine to Spikevax. Event added. Narrative Updated.
Age: 5.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave a single pediatric dose of Moderna Covid-19 Vaccine, Bivalent BUD) and NO ADVERSE EVENT (No Adverse Event) in a 5-year-old 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.         For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave a single pediatric dose of Moderna Covid-19 Vaccine, Bivalent BUD).    No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient administered a vaccine which is undergone temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7171B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN.  On 13-Mar-2023 at 10:00 AM, 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 27-Feb-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 13-Mar-2023 at 10:00 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered a vaccine which is undergone temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient administered a vaccine which is undergone temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        No concomitant medications were reported.    All in Freezer were still totally frozen.  The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; The patient received a monovalent vaccine dose for his booster dose when he should have received a bivalent vaccine dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient received a monovalent vaccine dose for his booster dose when he should have received a bivalent vaccine dose) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 13-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2023, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (The patient received a monovalent vaccine dose for his booster dose when he should have received a bivalent vaccine dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient received a monovalent vaccine dose for his booster dose when he should have received a bivalent vaccine dose) 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 WRONG PRODUCT ADMINISTERED (The patient received a monovalent vaccine dose for his booster dose when he should have received a bivalent vaccine dose).    No concomitant medications were reported.  No treatment information was provided.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) 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 (Dose administered after 30-day Use By Date or after manufacturer date of expiry).    Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported.
Age: 77.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Brain fog, COVID-19, Cough, Epistaxis, Hypersensitivity
Clinical narrative: I got COVID-19 12/25/2022. It started uncontrollable coughing. I had a lot of congestion and sneezing. I went to bed and the next morning I tested positive at home. I had my symptoms for two weeks. A month after I contacted the doctor, because I still have the congestion and uncontrollable sneezing and nose bleeds with itching. This continued two months after COVID-19, and they determined it was allergies. It made no change; I was prescribed antibiotics. I just have finished them, because I feel no better. I believe I have the symptoms of long COVID-19. I have also developed foggy brain and the sneezing has not stopped. I am producing a lot of milky transparent mucus from my nose.
Age: 77.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Pruritus, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive, Secretion discharge
Clinical narrative: I got COVID-19 12/25/2022. It started uncontrollable coughing. I had a lot of congestion and sneezing. I went to bed and the next morning I tested positive at home. I had my symptoms for two weeks. A month after I contacted the doctor, because I still have the congestion and uncontrollable sneezing and nose bleeds with itching. This continued two months after COVID-19, and they determined it was allergies. It made no change; I was prescribed antibiotics. I just have finished them, because I feel no better. I believe I have the symptoms of long COVID-19. I have also developed foggy brain and the sneezing has not stopped. I am producing a lot of milky transparent mucus from my nose.
Age: 77.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Sneezing
Clinical narrative: I got COVID-19 12/25/2022. It started uncontrollable coughing. I had a lot of congestion and sneezing. I went to bed and the next morning I tested positive at home. I had my symptoms for two weeks. A month after I contacted the doctor, because I still have the congestion and uncontrollable sneezing and nose bleeds with itching. This continued two months after COVID-19, and they determined it was allergies. It made no change; I was prescribed antibiotics. I just have finished them, because I feel no better. I believe I have the symptoms of long COVID-19. I have also developed foggy brain and the sneezing has not stopped. I am producing a lot of milky transparent mucus from my nose.
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory symptom, SARS-CoV-2 test negative, Sinusitis
Clinical narrative: I had a sinus infection that resulted in upper respiratory stuff or a good ole fashioned sinus infection, I tested four times for COVID-19 all results being negative.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arrhythmia, C-reactive protein increased, Cardiac monitoring normal, Cardiac stress test normal, Chest X-ray normal
Clinical narrative: I had fatigue, difficulty breathing, low oxygen level, and just not feeling good in general. My blood oxygen was low 90's and sometimes in the 80's. Then, months later I started having heart arrythmias. I contacted my doctor and was told to take Baby Aspirin. No other medications were prescribed. I am starting to feel netter now. I still have a little breathing issue but not as bad.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram normal, Dyspnoea, Echocardiogram normal, Fatigue, Feeling abnormal
Clinical narrative: I had fatigue, difficulty breathing, low oxygen level, and just not feeling good in general. My blood oxygen was low 90's and sometimes in the 80's. Then, months later I started having heart arrythmias. I contacted my doctor and was told to take Baby Aspirin. No other medications were prescribed. I am starting to feel netter now. I still have a little breathing issue but not as bad.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Laboratory test normal, Oxygen saturation decreased
Clinical narrative: I had fatigue, difficulty breathing, low oxygen level, and just not feeling good in general. My blood oxygen was low 90's and sometimes in the 80's. Then, months later I started having heart arrythmias. I contacted my doctor and was told to take Baby Aspirin. No other medications were prescribed. I am starting to feel netter now. I still have a little breathing issue but not as bad.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Diarrhoea, Headache, Nasopharyngitis, Nausea
Clinical narrative: On 12/28/2022 I had a head cold, headache, felt sluggish. Then on 12/30/2022 diarrhea, sick to the stomach I tested positive for COVID-19 that day. Called provided and prescribed LAGEVRIO.