chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sluggishness
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.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Hypertension, Oropharyngeal pain
Clinical narrative: No significant symptoms on the day of the vaccine, I had general body aches and fatigue for about 24 hours. I contracted COVID19, my symptoms started on September 21st but I tested positive on October 1st and that resolved pretty quickly. I only took a few ibuprofen for body aches and sore throat and I may have taken some DAYQUIL at some point for a bad cough. A few weeks later, October 25th, I went to go donate blood and my blood pressure was really high, 180s over 130s, and they told me to go calm down and come back. Came back and tested again later and it was still the same, so they recommended I see my PCP. My PCP monitored my blood pressure for 3 months and it remained high, which is something I've never had an issue with. She started me on low dose lisinopril which has helped a little but it's still marginally high, we are continuing to monitor it. The only other thing is that I still have fatigue since having COVID19.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, SARS-CoV-2 test positive
Clinical narrative: No significant symptoms on the day of the vaccine, I had general body aches and fatigue for about 24 hours. I contracted COVID19, my symptoms started on September 21st but I tested positive on October 1st and that resolved pretty quickly. I only took a few ibuprofen for body aches and sore throat and I may have taken some DAYQUIL at some point for a bad cough. A few weeks later, October 25th, I went to go donate blood and my blood pressure was really high, 180s over 130s, and they told me to go calm down and come back. Came back and tested again later and it was still the same, so they recommended I see my PCP. My PCP monitored my blood pressure for 3 months and it remained high, which is something I've never had an issue with. She started me on low dose lisinopril which has helped a little but it's still marginally high, we are continuing to monitor it. The only other thing is that I still have fatigue since having COVID19.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The pharmacist states they gave a Moderna bivalent on 10Mar2023. Over the weekend, they realized the BUD was 9Mar2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 7Feb2023 and Date of administration of vaccine was 10Mar2023) and NO ADVERSE EVENT (No adverse event) in a 59-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: SHINGRIX. Past adverse reactions to the above products included No adverse event with SHINGRIX.    On 10-Mar-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 50 microgram. On 10-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (The pharmacist states they gave a Moderna bivalent on 10Mar2023. Over the weekend, they realized the BUD was 9Mar2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 7Feb2023 and Date of administration of vaccine was 10Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The pharmacist states they gave a Moderna bivalent on 10Mar2023. Over the weekend, they realized the BUD was 9Mar2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 7Feb2023 and Date of administration of vaccine was 10Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Fall, Malaise, SARS-CoV-2 test positive
Clinical narrative: I did not have an adverse reaction to the vaccine. I started feeling symptoms on 01/29/2023. I tested positive for COVID-19 on 02/01/2023. I contacted my doctor and got the prescription PAXLOVID. I tolerated the medication well without any issues. As of today, I do not have any lingering COVID-19 symptoms. Also, I slipped and fell on 03/01/2023.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Feeling abnormal, Head discomfort, Malaise
Clinical narrative: I started feeling symptoms on the evening of 02/24. It caught my attention because I don't get sick very often. I started feeling symptoms like a congested head and felt off. I used a rapid test that evening and had a negative result. I went to bed and the next morning, my head felt even more congested. I was a little tired and a little achy. I took another test on 02/25/2023 and it was positive immediately. Because that was a Saturday, I called my doctor's office and had the on call doctor. I discussed my symptoms with him and I told him I had mild symptoms. He said my only risk factor is age. We talked about PAXLOVID and he said that I did meet the requirements and I would be eligible if I wanted to. He said I may not need to take it because of the mild symptoms, but I can if I want to. He did also notate that the atorvastatin was not compatible with the PAXLOVID. I last took atorvastatin on 02/24/2023 and on the 02/26/2023 was when I started taking the PAXLOVID. On the 26th, the head fullness was going away and I didn't have any body aches anymore. Just tired. On Monday, my nose wasn't running as much. I was never really too sick and I was still able to do things. I didn't feel super sick. The doctor said on Saturday that if I didn't feel better on that Sunday, he said to call back. I continued to feel pretty good really. I was never horribly ill and wasn't too frightened by it either. I was concerned about long COVID. I've been doing well and I'm still testing positive. I got in touch with my doctor and he noted it was possible to test positive for 3 months. They said I was long past the 5 and 10 day windows and they said I can go out with a mask and to avoid large crowds. I do feel great.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I started feeling symptoms on the evening of 02/24. It caught my attention because I don't get sick very often. I started feeling symptoms like a congested head and felt off. I used a rapid test that evening and had a negative result. I went to bed and the next morning, my head felt even more congested. I was a little tired and a little achy. I took another test on 02/25/2023 and it was positive immediately. Because that was a Saturday, I called my doctor's office and had the on call doctor. I discussed my symptoms with him and I told him I had mild symptoms. He said my only risk factor is age. We talked about PAXLOVID and he said that I did meet the requirements and I would be eligible if I wanted to. He said I may not need to take it because of the mild symptoms, but I can if I want to. He did also notate that the atorvastatin was not compatible with the PAXLOVID. I last took atorvastatin on 02/24/2023 and on the 02/26/2023 was when I started taking the PAXLOVID. On the 26th, the head fullness was going away and I didn't have any body aches anymore. Just tired. On Monday, my nose wasn't running as much. I was never really too sick and I was still able to do things. I didn't feel super sick. The doctor said on Saturday that if I didn't feel better on that Sunday, he said to call back. I continued to feel pretty good really. I was never horribly ill and wasn't too frightened by it either. I was concerned about long COVID. I've been doing well and I'm still testing positive. I got in touch with my doctor and he noted it was possible to test positive for 3 months. They said I was long past the 5 and 10 day windows and they said I can go out with a mask and to avoid large crowds. I do feel great.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Infection, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: I experienced a breakthrough case of COVID-19 with sore throat, cough and congestion.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I experienced a breakthrough case of COVID-19 with sore throat, cough and congestion.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Diarrhoea
Clinical narrative: While my wife and I were out of the country in from January 27, 2023, to February 14, 2023, I experienced traveler's diarrhea.  We had come prepared with medication to take just in case this happened, but I am still experiencing episodes periodically. I have not consulted with my doctor as of yet I am trying to wait to see if it will work itself out.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Pain, Pyrexia
Clinical narrative: I started having a dry cough. I had a low-grade fever the first day with body aches. Then I got a high fever on March 1, 2023, of 101.5 degrees. I was very fatigue at this point and decided to call the nurse line because the Tylenol and Advil weren't working anymore. I tested mostly negative on March 7, 2023. I experienced sinus congestion up until March 12th and am still experiencing fatigue.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: I started having a dry cough. I had a low-grade fever the first day with body aches. Then I got a high fever on March 1, 2023, of 101.5 degrees. I was very fatigue at this point and decided to call the nurse line because the Tylenol and Advil weren't working anymore. I tested mostly negative on March 7, 2023. I experienced sinus congestion up until March 12th and am still experiencing fatigue.
Age: 67.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Blood culture positive, COVID-19, Cardiac disorder, Computerised tomogram normal, Dialysis
Clinical narrative: During Dialysis I started feeling cold. I started getting colder and couldn't warm up. Then, I started vomiting. I called the on-call nurse, and she told me to go to the Emergency Room because she suspected blood poisoning. I went to the Emergency Room and the blood cultures came back negative, but I tested positive for COVID-19. On 2/18/23, I was seeing my Cardiologist and they did an Ultrasound and they told me I had something suspicious on my heart. The asked me to have more blood cultures done. They results came back positive, so I had to go to the Emergency Room and spent 10 days in the hospital.
Age: 67.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Echocardiogram, Echocardiogram normal, Feeling cold, Positron emission tomogram normal, SARS-CoV-2 test positive
Clinical narrative: During Dialysis I started feeling cold. I started getting colder and couldn't warm up. Then, I started vomiting. I called the on-call nurse, and she told me to go to the Emergency Room because she suspected blood poisoning. I went to the Emergency Room and the blood cultures came back negative, but I tested positive for COVID-19. On 2/18/23, I was seeing my Cardiologist and they did an Ultrasound and they told me I had something suspicious on my heart. The asked me to have more blood cultures done. They results came back positive, so I had to go to the Emergency Room and spent 10 days in the hospital.
Age: 67.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Vomiting
Clinical narrative: During Dialysis I started feeling cold. I started getting colder and couldn't warm up. Then, I started vomiting. I called the on-call nurse, and she told me to go to the Emergency Room because she suspected blood poisoning. I went to the Emergency Room and the blood cultures came back negative, but I tested positive for COVID-19. On 2/18/23, I was seeing my Cardiologist and they did an Ultrasound and they told me I had something suspicious on my heart. The asked me to have more blood cultures done. They results came back positive, so I had to go to the Emergency Room and spent 10 days in the hospital.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Fatigue, Infection, Myalgia
Clinical narrative: I experienced a breakthrough case of COVID-19 with myalgia, muscle aches, lower back pain, fatigue, and fever.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I experienced a breakthrough case of COVID-19 with myalgia, muscle aches, lower back pain, fatigue, and fever.
Age: 67.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Computerised tomogram thorax abnormal, Malaise, Pneumonia, Pneumonitis
Clinical narrative: On 02/20/2023 I was not feeling well. I reached out to my Physician via Telehealth and was prescribed Antibiotics for 1 week afterwards I was still feeling sick and was sent to get a CT scan which confirmed that it was Pneumonia I was put on a course of Prednisone and a Nebulizer. I am feeling a lot better now.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Headache, Malaise, Nasal discomfort
Clinical narrative: The initial symptom I felt was burning in my nose. It felt like I had fire in my nose. I took a COVID-19 test at home on February 20, 2023. The result was positive. I also had body aches, headache, runny nose, and general feeling of malaise. On February 21, 2023, I went to my doctor. He prescribed Ivermectin. On February 25, 2023, I was not feeling any better. I went back to the doctor. He prescribed Paxlovid. I started taking it that day. I started feeling a little better. I tested for COVID-19 again on March 2, 2023. I was still positive. I went back to the doctor. He said that it would take a while to feel better and did not give me any other medications. I still have a lingering cough. I finally tested negative for COVID-19 on March 10, 2023.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: The initial symptom I felt was burning in my nose. It felt like I had fire in my nose. I took a COVID-19 test at home on February 20, 2023. The result was positive. I also had body aches, headache, runny nose, and general feeling of malaise. On February 21, 2023, I went to my doctor. He prescribed Ivermectin. On February 25, 2023, I was not feeling any better. I went back to the doctor. He prescribed Paxlovid. I started taking it that day. I started feeling a little better. I tested for COVID-19 again on March 2, 2023. I was still positive. I went back to the doctor. He said that it would take a while to feel better and did not give me any other medications. I still have a lingering cough. I finally tested negative for COVID-19 on March 10, 2023.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Malaise, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: I was sneezing quite a bit, not feeling very well, tired. It felt like a cold. I was very fatigued but only lasted for a couple of days. I took a home COVID-19 test that came back positive. I made an appointment with my PA, I was retested there in the office with a PCR COVID-19 test it also came back positive. We decided against any medication, I just stayed hydrated and rested. I retested on the 23rd was negative.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sneezing
Clinical narrative: I was sneezing quite a bit, not feeling very well, tired. It felt like a cold. I was very fatigued but only lasted for a couple of days. I took a home COVID-19 test that came back positive. I made an appointment with my PA, I was retested there in the office with a PCR COVID-19 test it also came back positive. We decided against any medication, I just stayed hydrated and rested. I retested on the 23rd was negative.
Age: 55.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: I had a sore arm for about two days after receiving the vaccine. I tested positive for COVID-19 on 02/27/2023. I contacted my provider and got a prescription for Paxlovid. Within a few hours after taking the medication, I started feeling better. I did have the metallic taste in mouth, but I was able to complete the medication.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aphonia, Bronchitis, COVID-19, Exposure to SARS-CoV-2, Laboratory test
Clinical narrative: We went on a 11-day cruise and 2-3 people ended up getting the illness of COVID-19. I started having allergies like sneezing runny nose and on Monday and Tuesday I lost my voice, and I could feel it in my chest early Wednesday I tested positive for COVID-19, then I called my doctor and told them. I was then seen outside and was then diagnosed with bronchitis and COVID-19. We cruise a lot and we usually follow the guidelines as required. My husband is isolated on the other side of the house. I was prescribed methylprednisolone, PAXLOVID, cough medication, and benzonatate. The medication is working but I am still testing positive.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: We went on a 11-day cruise and 2-3 people ended up getting the illness of COVID-19. I started having allergies like sneezing runny nose and on Monday and Tuesday I lost my voice, and I could feel it in my chest early Wednesday I tested positive for COVID-19, then I called my doctor and told them. I was then seen outside and was then diagnosed with bronchitis and COVID-19. We cruise a lot and we usually follow the guidelines as required. My husband is isolated on the other side of the house. I was prescribed methylprednisolone, PAXLOVID, cough medication, and benzonatate. The medication is working but I am still testing positive.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: Red, inflamed, hot arm
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chest X-ray normal, Cough, Diarrhoea, Headache
Clinical narrative: On 09/13/2022 I received my covid-19 vaccine. On 12/07/2022 I started experiencing a low-grade fever, sore throat, coughing, and headache. After reaching out to doctor I tested positive for Covid-19. I was prescribed PAXLOVID. After taking the medication I started experiencing extreme diarrhea. I also developed a post viral bronchial cough that lasted  approx. 6 weeks.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: On 09/13/2022 I received my covid-19 vaccine. On 12/07/2022 I started experiencing a low-grade fever, sore throat, coughing, and headache. After reaching out to doctor I tested positive for Covid-19. I was prescribed PAXLOVID. After taking the medication I started experiencing extreme diarrhea. I also developed a post viral bronchial cough that lasted  approx. 6 weeks.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Laboratory test normal, Rosacea, Skin disorder, Skin warm
Clinical narrative: I had a lot of skin issues, my cheeks were very red, and hot to the touch. I went to the Dermatologist, and I was diagnosed with Rosacea. I was prescribed Oxymetazoline HCL/Ivermectin/Niacinamide. It is improving but I am still dealing with this currently.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood potassium decreased, Blood test, Chest X-ray normal, Computerised tomogram thorax normal, Cough
Clinical narrative: 1/17/2023 I had a cold with coughing and postnatal drip. I felt pretty decent. I did a home COVID test that was negative. I also had a COVID PCR test was negative. That evening I was achy, coughing and felt worse. By early morning, I began having trouble breathing. I called an ambulance; they gave me oxygen and took me to the hospital. My pulse ox was in the 80?s when I got to the hospital. I was given a breathing treatment and oxygen. I had a complete viral panel which was negative; Chest x-ray showed no pneumonia; CT of lungs, no blood clot; Echocardiogram, within normal limits. I had bloodwork and my WBC was within normal limits and my potassium was a little low. I was treated with albuterol, oxygen and a steroid shot. I was also prescribed antibiotics in case there was a bacterial infection, a Z PAK. I stayed overnight to be monitored. I was released to home on 1/19/23. My pulse ox stayed in the low 90-s for a week to two weeks and I had a cough that lasted at least six weeks. I have recovered.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Echocardiogram normal, Nasopharyngitis, Pain, SARS-CoV-2 test negative
Clinical narrative: 1/17/2023 I had a cold with coughing and postnatal drip. I felt pretty decent. I did a home COVID test that was negative. I also had a COVID PCR test was negative. That evening I was achy, coughing and felt worse. By early morning, I began having trouble breathing. I called an ambulance; they gave me oxygen and took me to the hospital. My pulse ox was in the 80?s when I got to the hospital. I was given a breathing treatment and oxygen. I had a complete viral panel which was negative; Chest x-ray showed no pneumonia; CT of lungs, no blood clot; Echocardiogram, within normal limits. I had bloodwork and my WBC was within normal limits and my potassium was a little low. I was treated with albuterol, oxygen and a steroid shot. I was also prescribed antibiotics in case there was a bacterial infection, a Z PAK. I stayed overnight to be monitored. I was released to home on 1/19/23. My pulse ox stayed in the low 90-s for a week to two weeks and I had a cough that lasted at least six weeks. I have recovered.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Upper-airway cough syndrome, Viral test negative, White blood cell count normal
Clinical narrative: 1/17/2023 I had a cold with coughing and postnatal drip. I felt pretty decent. I did a home COVID test that was negative. I also had a COVID PCR test was negative. That evening I was achy, coughing and felt worse. By early morning, I began having trouble breathing. I called an ambulance; they gave me oxygen and took me to the hospital. My pulse ox was in the 80?s when I got to the hospital. I was given a breathing treatment and oxygen. I had a complete viral panel which was negative; Chest x-ray showed no pneumonia; CT of lungs, no blood clot; Echocardiogram, within normal limits. I had bloodwork and my WBC was within normal limits and my potassium was a little low. I was treated with albuterol, oxygen and a steroid shot. I was also prescribed antibiotics in case there was a bacterial infection, a Z PAK. I stayed overnight to be monitored. I was released to home on 1/19/23. My pulse ox stayed in the low 90-s for a week to two weeks and I had a cough that lasted at least six weeks. I have recovered.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Brain fog, COVID-19, Cough, Fatigue, Feeling abnormal
Clinical narrative: I contracted COVID-19. I first started feeling a cough in addition I had a fever of 106. I am really exhausted; I almost did not get out of bed the whole day. I am now feeling sort of achy but not bad. Today I feel pretty bad. I called my doctor that evening when the cough began. The doctor told me I could chose to take PAXLOVID because of my age. I chose not to take it, because my symptoms are not dramatic. I am taking ADVIL occasionally I am having brain fog.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Mobility decreased, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I contracted COVID-19. I first started feeling a cough in addition I had a fever of 106. I am really exhausted; I almost did not get out of bed the whole day. I am now feeling sort of achy but not bad. Today I feel pretty bad. I called my doctor that evening when the cough began. The doctor told me I could chose to take PAXLOVID because of my age. I chose not to take it, because my symptoms are not dramatic. I am taking ADVIL occasionally I am having brain fog.
Age: 67.0
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.; 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.) and NO ADVERSE EVENT (No adverse event) in a 67-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.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer: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) 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 .) 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.).    No concomitant medications were reported. HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent . 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 3. No treatment medications were reported.  This case pertains to Patient 3.   This case was linked to US-MODERNATX, INC.-MOD-2023-715321, US-MODERNATX, INC.-MOD-2023-715347, US-MODERNATX, INC.-MOD-2023-715325 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715321:Patient 4 case US-MODERNATX, INC.-MOD-2023-715347:Patient 1 case US-MODERNATX, INC.-MOD-2023-715325:Patient 2  case
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: On 02/25/2023, I noticed a sore knot in my left arm at the injection site. It is barely there. It has mostly dispersed. I went to the doctor for something unrelated and she said it would absorb.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chest X-ray normal, Cough, Nausea, Pyrexia
Clinical narrative: I developed symptoms 12/13/2022 coughing. 12/14 horrible cough with fever. I took a home COVID-19 test, and it was negative. I was nauseous, I took a chest pusher &Tylenol. On Dec 15 I tested Positive for Covid, I contacted my Oncologist Team and recommended cough medicine, I did not do well with that, I did a telehealth on Dec20, main complaint was cough and congestion. I had Xray of the chest and it was no pneumonia. I used Nyquil - that helped the cough. On Jan 9th I went to a walking clinic, and I developed a secondary infection, and they recommended Amoxicillin for 7 days. A month later I was fine.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I developed symptoms 12/13/2022 coughing. 12/14 horrible cough with fever. I took a home COVID-19 test, and it was negative. I was nauseous, I took a chest pusher &Tylenol. On Dec 15 I tested Positive for Covid, I contacted my Oncologist Team and recommended cough medicine, I did not do well with that, I did a telehealth on Dec20, main complaint was cough and congestion. I had Xray of the chest and it was no pneumonia. I used Nyquil - that helped the cough. On Jan 9th I went to a walking clinic, and I developed a secondary infection, and they recommended Amoxicillin for 7 days. A month later I was fine.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Diarrhoea, Headache, Middle insomnia, Myalgia
Clinical narrative: I woke up around 03:00AM on 01/03/2023 with a bit of a sore throat so I took an at home COVID-19 test and it was positive. I took a second one and it was also positive. I was away from home, so I went to a local urgent care clinic where they confirmed my results. They prescribed PAXLOVID. I experienced a slight headache, slight muscle pain, and diarrhea. After beginning the PAXLOVID, my symptoms improved. On the morning of 01/06/2023, I took two additional COVID-19 tests, and they were negative, and my symptoms were gone, but I finished the full five days of the PAXLOVID.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I woke up around 03:00AM on 01/03/2023 with a bit of a sore throat so I took an at home COVID-19 test and it was positive. I took a second one and it was also positive. I was away from home, so I went to a local urgent care clinic where they confirmed my results. They prescribed PAXLOVID. I experienced a slight headache, slight muscle pain, and diarrhea. After beginning the PAXLOVID, my symptoms improved. On the morning of 01/06/2023, I took two additional COVID-19 tests, and they were negative, and my symptoms were gone, but I finished the full five days of the PAXLOVID.
Age: 57.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Infusion, Porphyria non-acute
Clinical narrative: I did not have an adverse reaction to the vaccine. I was diagnosed with porphyria Cutanea Tarda (PCT). I take medication as an infusion every two weeks. I had gallbladder surgery 08/2022.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Flushing, Heart rate increased, Malaise, Palpitations
Clinical narrative: Patient presents to PCP for routine physical. Patient reports palpitations after COVID booster in 11/22. Noted multiple resting HR in the 140s and one time in the 180s sustained for several minutes at rest. Felt unwell, flushed but no chest pain or SOB, nausea, or dizziness. PCP believes temporally related to COVID shot and recommended avoiding further boosters. Has seemingly resolved and hasn't felt ill since November. Some elevated HR readings on smart watch but patient isn't sure if related to working out or not.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Lethargy, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I had a cough, extreme sore throat, and lethargy. The sore throat was the worst. I took at COVID-19 on 01/08/2023 at home which came positive. Then, I went to urgent care and was prescribed Paxlovid. By the fourth day, I felt much improved. I tested positive for even two weeks after recovering.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Swelling face
Clinical narrative: 24 hours after injection patient experienced swelling of her face and weakness in her legs. These symptoms lasted for approximately 24 hours
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Bile duct stone, Blood test
Clinical narrative: I woke up with really extreme pain in my back stomach and my right shoulder so I went to the ER. I was told I had gallstones and was told to find a surgeon and ended up back in the hospital before then and was told I had a gallstone in my liver that caused Pancreatitis and waited for the inflammation to go down to remove my gallbladder which was removed 10MAR2023. I left the hospital 12MAR2023.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cholecystectomy, Cholelithiasis, Inflammation, Magnetic resonance cholangiopancreatography, Pancreatitis
Clinical narrative: I woke up with really extreme pain in my back stomach and my right shoulder so I went to the ER. I was told I had gallstones and was told to find a surgeon and ended up back in the hospital before then and was told I had a gallstone in my liver that caused Pancreatitis and waited for the inflammation to go down to remove my gallbladder which was removed 10MAR2023. I left the hospital 12MAR2023.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ultrasound scan
Clinical narrative: I woke up with really extreme pain in my back stomach and my right shoulder so I went to the ER. I was told I had gallstones and was told to find a surgeon and ended up back in the hospital before then and was told I had a gallstone in my liver that caused Pancreatitis and waited for the inflammation to go down to remove my gallbladder which was removed 10MAR2023. I left the hospital 12MAR2023.
Age: 70.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Biopsy lung abnormal, Computerised tomogram thorax abnormal, Lung lobectomy, Pulmonary mass
Clinical narrative: Five years ago, I was diagnosed with lung cancer. I had a lower lobectomy. In January the found nodules in my right lung. I had a biopsy done on 02/08/2022. On 02/27/2023 I had a right upper lobectomy done. I am feeling fairly well now since surgery.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I was positive for COVID- 19 on 18DEC2022, I had runny nose, stuffy sinus, very fatigued and a bit of a cough. I called my doctor, I was prescribed paxlovid. I started feeling better after few days to really feel better.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinus congestion
Clinical narrative: I was positive for COVID- 19 on 18DEC2022, I had runny nose, stuffy sinus, very fatigued and a bit of a cough. I called my doctor, I was prescribed paxlovid. I started feeling better after few days to really feel better.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: None in regard to the vaccination. I did catch COVID-19 three months later.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Malaise, Oropharyngeal pain
Clinical narrative: I tested positive for COVID-19 on 1/27/23. I had a sore throat, cough, congestion, and fatigue. I contacted my doctor and was prescribed 5 days' worth of PAXLOVID. I finally tested negative 2/4/23, then I started having symptoms again and tested positive on 2/10/23. I am still dealing with these symptoms at this time.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID-19 on 1/27/23. I had a sore throat, cough, congestion, and fatigue. I contacted my doctor and was prescribed 5 days' worth of PAXLOVID. I finally tested negative 2/4/23, then I started having symptoms again and tested positive on 2/10/23. I am still dealing with these symptoms at this time.
Age: 69.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Chills, Feeling cold, Rash, Rash vesicular
Clinical narrative: The night of the vaccine, I had the severe chills and unable to get warm. I was shivering everywhere. That passed ultimately and by the next day that was gone. In the next 2 days, the rash appeared. It was initially on my left forearm then got to my right forearm. It got worse over a few days and began to blister so I went to my doctor. He prescribed a course of tapering steroids. I was also given a topical cream, a lotion of sort that was also prescription. It may have been a steroid lotion. Those reduced the symptoms over a period of 4 to 5 days. The rash would come and go in small patches. Nothing severe compared to the initial rash, but that did last for some time.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given a 3rd dose of Moderna Monovalent when they were due for their 1st Moderna Bivalent Booster. No harm to the patient. Patient was advised to return in 60 days from date of 3rd Moderna Monovalent vaccination to receive their 1st Bivalent Booster dose.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, COVID-19, Chills
Clinical narrative: I developed symptoms of a cough, sore throat, fever, and chills on 12/28/22. That went into joint achiness, continued cough, and loss of taste and smell as well as fatigue and bad headache. That lasted until February 1st. I was still testing positive through January 17th, testing weekly to determine when I could resume treatments. But I was told that because of my cancer and treatments I would test positive longer. They advised I take low dose TYLENOL, over the counter cold and flu medications, and I took CORICIDIN. That did help and I also took ROBITUSSIN. The cough is what lasted the longest. My saturation oxygen was mid to high 80s during week two, but during week three It started to go back up. I practiced breathing exercises during that time.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: I developed symptoms of a cough, sore throat, fever, and chills on 12/28/22. That went into joint achiness, continued cough, and loss of taste and smell as well as fatigue and bad headache. That lasted until February 1st. I was still testing positive through January 17th, testing weekly to determine when I could resume treatments. But I was told that because of my cancer and treatments I would test positive longer. They advised I take low dose TYLENOL, over the counter cold and flu medications, and I took CORICIDIN. That did help and I also took ROBITUSSIN. The cough is what lasted the longest. My saturation oxygen was mid to high 80s during week two, but during week three It started to go back up. I practiced breathing exercises during that time.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I developed symptoms of a cough, sore throat, fever, and chills on 12/28/22. That went into joint achiness, continued cough, and loss of taste and smell as well as fatigue and bad headache. That lasted until February 1st. I was still testing positive through January 17th, testing weekly to determine when I could resume treatments. But I was told that because of my cancer and treatments I would test positive longer. They advised I take low dose TYLENOL, over the counter cold and flu medications, and I took CORICIDIN. That did help and I also took ROBITUSSIN. The cough is what lasted the longest. My saturation oxygen was mid to high 80s during week two, but during week three It started to go back up. I practiced breathing exercises during that time.
Age: 67.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: COVID-19, Chills, Cough, Pain, Pyrexia
Clinical narrative: I felt chills and body aches with coughing. I had a fever as well low grade never above one hundred degrees. I had a virtual conference with a physicians assistant and was offered Pacxlovid but did not take it. As of Friday of that same week I was still Positive for COVID-19 and the following week, day seven a test still showed a very faint line, during this time I was not working.
Age: 67.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I felt chills and body aches with coughing. I had a fever as well low grade never above one hundred degrees. I had a virtual conference with a physicians assistant and was offered Pacxlovid but did not take it. As of Friday of that same week I was still Positive for COVID-19 and the following week, day seven a test still showed a very faint line, during this time I was not working.
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was signed up for the bivalent Pfizer COVID19 vaccine.  Pharmacist did not review the database to see that they had never received any COVID vaccination.  Patient should have received the initial monovalent dose series to start.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Chills, Cough, Eye pain, Feeling abnormal
Clinical narrative: 3/1/2023 I was going to bed and I had a sore throat, it got really bad quickly. I also had a headache and did not sleep well at all that night. I felt bad the next morning. I had a headache, my eyeballs hurt, sore throat, a cough and chills. I assumed I felt bad because I slept so poorly. I was out of the country and did not see a doctor. I wasn't feeling so sick that I was afraid, so I just kept going. That evening, I took a shower and went to bed earlier. The next day, I felt a little better, but did not feel good. On 3/5/23 I had a positive at home COVID test. I called my doctor the next morning and had a telehealth appointment. I was prescribed PAXLOVID and began taking it that day. I am feeling better, but am still congested.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Foreign travel, Headache, Malaise, Oropharyngeal pain, Poor quality sleep
Clinical narrative: 3/1/2023 I was going to bed and I had a sore throat, it got really bad quickly. I also had a headache and did not sleep well at all that night. I felt bad the next morning. I had a headache, my eyeballs hurt, sore throat, a cough and chills. I assumed I felt bad because I slept so poorly. I was out of the country and did not see a doctor. I wasn't feeling so sick that I was afraid, so I just kept going. That evening, I took a shower and went to bed earlier. The next day, I felt a little better, but did not feel good. On 3/5/23 I had a positive at home COVID test. I called my doctor the next morning and had a telehealth appointment. I was prescribed PAXLOVID and began taking it that day. I am feeling better, but am still congested.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: 3/1/2023 I was going to bed and I had a sore throat, it got really bad quickly. I also had a headache and did not sleep well at all that night. I felt bad the next morning. I had a headache, my eyeballs hurt, sore throat, a cough and chills. I assumed I felt bad because I slept so poorly. I was out of the country and did not see a doctor. I wasn't feeling so sick that I was afraid, so I just kept going. That evening, I took a shower and went to bed earlier. The next day, I felt a little better, but did not feel good. On 3/5/23 I had a positive at home COVID test. I called my doctor the next morning and had a telehealth appointment. I was prescribed PAXLOVID and began taking it that day. I am feeling better, but am still congested.
Age: 47.0
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 published expiration date and 30 day BUD.) and NO ADVERSE EVENT (No adverse event) in a 47-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     Patient received unknown vaccine in the 4 weeks prior to COVID-19 vaccine.  Concomitant products included INFLUENZA VACCINE for an unknown indication.          For mRNA-1273 (Spikevax) (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 published expiration date and 30 day BUD.).    Patient had no reported symptoms. No treatment information was provided by the reporter.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cardiac failure, Cardiogenic shock, Computerised tomogram head normal, Endotracheal intubation
Clinical narrative: Patient is an 84yo female with extensive PMH as listed above who presented to the ED due to AMS with question of stroke v. Seizure activity. Patient was intubated on arrival for airway protection. Patient has no new stroke findings on CTH. Still question of seizure activity with unknown etiology. Neurology consult in ED suggested correlation with stroke HX. Question of infectious process as well with acute hypoxic respiratory failure after just having COVID v. Cardiogenic shock form CHF (congestive heart failure) with recently found severe reduced EF of 26%, PH, severe MR. Patient's declining status could be multifactorial.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: General physical health deterioration, Mental status changes, Mitral valve incompetence
Clinical narrative: Patient is an 84yo female with extensive PMH as listed above who presented to the ED due to AMS with question of stroke v. Seizure activity. Patient was intubated on arrival for airway protection. Patient has no new stroke findings on CTH. Still question of seizure activity with unknown etiology. Neurology consult in ED suggested correlation with stroke HX. Question of infectious process as well with acute hypoxic respiratory failure after just having COVID v. Cardiogenic shock form CHF (congestive heart failure) with recently found severe reduced EF of 26%, PH, severe MR. Patient's declining status could be multifactorial.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Blood test abnormal, Condition aggravated, Rash, Rash pruritic
Clinical narrative: For fifteen years I have had a small rash on my abdomen. In the early part of January 2021, I noticed that it had started to spread to other areas of my body and itch where it had never been symptomatic before. I called to make an appointment with my primary care physician. She referred me to a dermatologist, who at the time only advised me to moisturize the area. In November of 2022, I went to the local urgent care a couple of times as the itching was unbearable. They prescribed oral steroids, topical creams, lotions, a KENALOG cream was the only one that seemed to work. I went to a new dermatologist who did a biopsy and discovered it was Grover's disease. My primary care also did bloodwork to rule out an autoimmune disease, the bloodwork came back negative. I cannot remember the exact dates of the test they were ran in February of this year. I am still using KENALOG cream and phototherapy. I am still itchy and the issue had not resolved. I am not sure if they will be able to find a way to make this better.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Transient acantholytic dermatosis
Clinical narrative: For fifteen years I have had a small rash on my abdomen. In the early part of January 2021, I noticed that it had started to spread to other areas of my body and itch where it had never been symptomatic before. I called to make an appointment with my primary care physician. She referred me to a dermatologist, who at the time only advised me to moisturize the area. In November of 2022, I went to the local urgent care a couple of times as the itching was unbearable. They prescribed oral steroids, topical creams, lotions, a KENALOG cream was the only one that seemed to work. I went to a new dermatologist who did a biopsy and discovered it was Grover's disease. My primary care also did bloodwork to rule out an autoimmune disease, the bloodwork came back negative. I cannot remember the exact dates of the test they were ran in February of this year. I am still using KENALOG cream and phototherapy. I am still itchy and the issue had not resolved. I am not sure if they will be able to find a way to make this better.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: I first started showing symptom on the 4th of October, I was on a trip and when I returned, I tested on the 6 and it was negative. On the next day I tested again and, I was positive. I was having symptoms like a bad cold. I then went to a urgent care and was suggested to get an infusion since I was on a blood thinner. I was not showing any symptoms after 5 days of the infusion. On the 6th of January I had a third booster shot.