chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Malaise, Pain, Pyrexia
Clinical narrative: After the 1st dose, which she got in her left arm, she had a roaring case of Covid arm that lasted for 6 days, cleared up, then came back for 6 days again; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (After the 1st dose, which she got in her left arm, she had a roaring case of Covid arm that lasted for 6 days, cleared up, then came back for 6 days again) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (After the 1st dose, which she got in her left arm, she had a roaring case of Covid arm that lasted for 6 days, cleared up, then came back for 6 days again). At the time of the report, VACCINATION SITE REACTION (After the 1st dose, which she got in her left arm, she had a roaring case of Covid arm that lasted for 6 days, cleared up, then came back for 6 days again) outcome was unknown.            No concomitant medication were provided. No treatment medication were provided.   This case was linked to MOD-2022-600694, MOD-2022-600693.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Asthenia, Atrial fibrillation, Cough, Death
Clinical narrative: Patient presented to ED on 09/14/2021 with shortness of breath.  His symptoms started two days prior to admission.  He also had cough, congestion, weakness and fatigue.  He was admitted for treatment.  He was admitted to the Care Unit on High flow nasal cannula at 15L, he later required BiPAP shortly after admission.  He was given azithromycin, Rocephin, Remdesivir, Dexamethasone.  He developed A fib with RVR on 09/12/2022 requiring a Cardizem drip, and weaned to metroprol 25 mg daily.  Patient was transferred to CCU.  Patient developed an acute change, with the recognition of a transient wide complex cardiac rhythm, later developed unsustained with was treated with amiodarone.  He expired on 09/14/2021.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Intensive care, Positive airway pressure therapy, Respiratory tract congestion
Clinical narrative: Patient presented to ED on 09/14/2021 with shortness of breath.  His symptoms started two days prior to admission.  He also had cough, congestion, weakness and fatigue.  He was admitted for treatment.  He was admitted to the Care Unit on High flow nasal cannula at 15L, he later required BiPAP shortly after admission.  He was given azithromycin, Rocephin, Remdesivir, Dexamethasone.  He developed A fib with RVR on 09/12/2022 requiring a Cardizem drip, and weaned to metroprol 25 mg daily.  Patient was transferred to CCU.  Patient developed an acute change, with the recognition of a transient wide complex cardiac rhythm, later developed unsustained with was treated with amiodarone.  He expired on 09/14/2021.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular tachycardia
Clinical narrative: Patient presented to ED on 09/14/2021 with shortness of breath.  His symptoms started two days prior to admission.  He also had cough, congestion, weakness and fatigue.  He was admitted for treatment.  He was admitted to the Care Unit on High flow nasal cannula at 15L, he later required BiPAP shortly after admission.  He was given azithromycin, Rocephin, Remdesivir, Dexamethasone.  He developed A fib with RVR on 09/12/2022 requiring a Cardizem drip, and weaned to metroprol 25 mg daily.  Patient was transferred to CCU.  Patient developed an acute change, with the recognition of a transient wide complex cardiac rhythm, later developed unsustained with was treated with amiodarone.  He expired on 09/14/2021.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Cough, Diarrhoea, Dyspnoea
Clinical narrative: 05/13/2022   I was having heavy leg pain that gradually moved up from the feet to my hips.  It felt heavy and was very painful.  I went to the Emergency Room, and they ruled out blood clots and GBS. I was diagnosed with severe myalgia in both legs from feet to hip from having COVID. My bloodwork was normal.  I had very delayed reflex in my legs.  The doctor said I had the latest variant of COVID and that they were seeing a lot of people with it.  I was told to take Motrin and Tylenol for the pain.  I have recovered from that. On 5/21/2022. I was having difficulty breathing and my chest felt heavy. My pulse ox was as low as 93.  I was diagnosed with Pneumonia in both lungs.  If I did not get better within 6 hours, my doctor told me to go to the hospital.   I was prescribed Prednisone, rescue inhaler, an antibiotic and an inspired spirometer I did not get worse, so I continued on these medications and did not need to go to the hospital. My doctor told me to sleep in the prone position. I started to get better. By Day3 on the drugs, I could tell I was going to be better. My oxygen levels were better. On 6/21/2022 I noticed my eyes were worse. My central vision was blurry. I went to the doctor on 6/21/2022.  I had a right eye scan, and it showed the right eye was affected with vascular changes from having COVID.  The left eye was minor. On 6/22/2022, I started passing blood clots in my urine. It was very painful. I contacted my Urologist and had a CT of pelvis and abdomen on 7/6/2022 which showed large hiatal hernia with partial intra thoracic stomach. I have low density foci on both kidneys and 2 centimeters right Adnexal cyst. I also have degenerative lumbar spine changes at multiple levels.  The urinary bladder was unremarkable. Tomorrow I am having a cystoscopy. I feel like I am recovered.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Malaise, Nasopharyngitis, Oxygen saturation abnormal
Clinical narrative: 05/13/2022   I was having heavy leg pain that gradually moved up from the feet to my hips.  It felt heavy and was very painful.  I went to the Emergency Room, and they ruled out blood clots and GBS. I was diagnosed with severe myalgia in both legs from feet to hip from having COVID. My bloodwork was normal.  I had very delayed reflex in my legs.  The doctor said I had the latest variant of COVID and that they were seeing a lot of people with it.  I was told to take Motrin and Tylenol for the pain.  I have recovered from that. On 5/21/2022. I was having difficulty breathing and my chest felt heavy. My pulse ox was as low as 93.  I was diagnosed with Pneumonia in both lungs.  If I did not get better within 6 hours, my doctor told me to go to the hospital.   I was prescribed Prednisone, rescue inhaler, an antibiotic and an inspired spirometer I did not get worse, so I continued on these medications and did not need to go to the hospital. My doctor told me to sleep in the prone position. I started to get better. By Day3 on the drugs, I could tell I was going to be better. My oxygen levels were better. On 6/21/2022 I noticed my eyes were worse. My central vision was blurry. I went to the doctor on 6/21/2022.  I had a right eye scan, and it showed the right eye was affected with vascular changes from having COVID.  The left eye was minor. On 6/22/2022, I started passing blood clots in my urine. It was very painful. I contacted my Urologist and had a CT of pelvis and abdomen on 7/6/2022 which showed large hiatal hernia with partial intra thoracic stomach. I have low density foci on both kidneys and 2 centimeters right Adnexal cyst. I also have degenerative lumbar spine changes at multiple levels.  The urinary bladder was unremarkable. Tomorrow I am having a cystoscopy. I feel like I am recovered.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive, Sinus headache
Clinical narrative: 05/13/2022   I was having heavy leg pain that gradually moved up from the feet to my hips.  It felt heavy and was very painful.  I went to the Emergency Room, and they ruled out blood clots and GBS. I was diagnosed with severe myalgia in both legs from feet to hip from having COVID. My bloodwork was normal.  I had very delayed reflex in my legs.  The doctor said I had the latest variant of COVID and that they were seeing a lot of people with it.  I was told to take Motrin and Tylenol for the pain.  I have recovered from that. On 5/21/2022. I was having difficulty breathing and my chest felt heavy. My pulse ox was as low as 93.  I was diagnosed with Pneumonia in both lungs.  If I did not get better within 6 hours, my doctor told me to go to the hospital.   I was prescribed Prednisone, rescue inhaler, an antibiotic and an inspired spirometer I did not get worse, so I continued on these medications and did not need to go to the hospital. My doctor told me to sleep in the prone position. I started to get better. By Day3 on the drugs, I could tell I was going to be better. My oxygen levels were better. On 6/21/2022 I noticed my eyes were worse. My central vision was blurry. I went to the doctor on 6/21/2022.  I had a right eye scan, and it showed the right eye was affected with vascular changes from having COVID.  The left eye was minor. On 6/22/2022, I started passing blood clots in my urine. It was very painful. I contacted my Urologist and had a CT of pelvis and abdomen on 7/6/2022 which showed large hiatal hernia with partial intra thoracic stomach. I have low density foci on both kidneys and 2 centimeters right Adnexal cyst. I also have degenerative lumbar spine changes at multiple levels.  The urinary bladder was unremarkable. Tomorrow I am having a cystoscopy. I feel like I am recovered.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: 05/13/2022   I was having heavy leg pain that gradually moved up from the feet to my hips.  It felt heavy and was very painful.  I went to the Emergency Room, and they ruled out blood clots and GBS. I was diagnosed with severe myalgia in both legs from feet to hip from having COVID. My bloodwork was normal.  I had very delayed reflex in my legs.  The doctor said I had the latest variant of COVID and that they were seeing a lot of people with it.  I was told to take Motrin and Tylenol for the pain.  I have recovered from that. On 5/21/2022. I was having difficulty breathing and my chest felt heavy. My pulse ox was as low as 93.  I was diagnosed with Pneumonia in both lungs.  If I did not get better within 6 hours, my doctor told me to go to the hospital.   I was prescribed Prednisone, rescue inhaler, an antibiotic and an inspired spirometer I did not get worse, so I continued on these medications and did not need to go to the hospital. My doctor told me to sleep in the prone position. I started to get better. By Day3 on the drugs, I could tell I was going to be better. My oxygen levels were better. On 6/21/2022 I noticed my eyes were worse. My central vision was blurry. I went to the doctor on 6/21/2022.  I had a right eye scan, and it showed the right eye was affected with vascular changes from having COVID.  The left eye was minor. On 6/22/2022, I started passing blood clots in my urine. It was very painful. I contacted my Urologist and had a CT of pelvis and abdomen on 7/6/2022 which showed large hiatal hernia with partial intra thoracic stomach. I have low density foci on both kidneys and 2 centimeters right Adnexal cyst. I also have degenerative lumbar spine changes at multiple levels.  The urinary bladder was unremarkable. Tomorrow I am having a cystoscopy. I feel like I am recovered.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adnexa uteri mass, Blood test normal, COVID-19, Chest discomfort, Computerised tomogram abdomen abnormal
Clinical narrative: 05/13/2022   I was having heavy leg pain that gradually moved up from the feet to my hips.  It felt heavy and was very painful.  I went to the Emergency Room, and they ruled out blood clots and GBS. I was diagnosed with severe myalgia in both legs from feet to hip from having COVID. My bloodwork was normal.  I had very delayed reflex in my legs.  The doctor said I had the latest variant of COVID and that they were seeing a lot of people with it.  I was told to take Motrin and Tylenol for the pain.  I have recovered from that. On 5/21/2022. I was having difficulty breathing and my chest felt heavy. My pulse ox was as low as 93.  I was diagnosed with Pneumonia in both lungs.  If I did not get better within 6 hours, my doctor told me to go to the hospital.   I was prescribed Prednisone, rescue inhaler, an antibiotic and an inspired spirometer I did not get worse, so I continued on these medications and did not need to go to the hospital. My doctor told me to sleep in the prone position. I started to get better. By Day3 on the drugs, I could tell I was going to be better. My oxygen levels were better. On 6/21/2022 I noticed my eyes were worse. My central vision was blurry. I went to the doctor on 6/21/2022.  I had a right eye scan, and it showed the right eye was affected with vascular changes from having COVID.  The left eye was minor. On 6/22/2022, I started passing blood clots in my urine. It was very painful. I contacted my Urologist and had a CT of pelvis and abdomen on 7/6/2022 which showed large hiatal hernia with partial intra thoracic stomach. I have low density foci on both kidneys and 2 centimeters right Adnexal cyst. I also have degenerative lumbar spine changes at multiple levels.  The urinary bladder was unremarkable. Tomorrow I am having a cystoscopy. I feel like I am recovered.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Culture urine positive, Dyspnoea, Dysuria, Eye disorder, Haemorrhage urinary tract
Clinical narrative: 05/13/2022   I was having heavy leg pain that gradually moved up from the feet to my hips.  It felt heavy and was very painful.  I went to the Emergency Room, and they ruled out blood clots and GBS. I was diagnosed with severe myalgia in both legs from feet to hip from having COVID. My bloodwork was normal.  I had very delayed reflex in my legs.  The doctor said I had the latest variant of COVID and that they were seeing a lot of people with it.  I was told to take Motrin and Tylenol for the pain.  I have recovered from that. On 5/21/2022. I was having difficulty breathing and my chest felt heavy. My pulse ox was as low as 93.  I was diagnosed with Pneumonia in both lungs.  If I did not get better within 6 hours, my doctor told me to go to the hospital.   I was prescribed Prednisone, rescue inhaler, an antibiotic and an inspired spirometer I did not get worse, so I continued on these medications and did not need to go to the hospital. My doctor told me to sleep in the prone position. I started to get better. By Day3 on the drugs, I could tell I was going to be better. My oxygen levels were better. On 6/21/2022 I noticed my eyes were worse. My central vision was blurry. I went to the doctor on 6/21/2022.  I had a right eye scan, and it showed the right eye was affected with vascular changes from having COVID.  The left eye was minor. On 6/22/2022, I started passing blood clots in my urine. It was very painful. I contacted my Urologist and had a CT of pelvis and abdomen on 7/6/2022 which showed large hiatal hernia with partial intra thoracic stomach. I have low density foci on both kidneys and 2 centimeters right Adnexal cyst. I also have degenerative lumbar spine changes at multiple levels.  The urinary bladder was unremarkable. Tomorrow I am having a cystoscopy. I feel like I am recovered.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hiatus hernia, Myalgia, Ophthalmological examination abnormal, Oxygen saturation decreased, Pain in extremity
Clinical narrative: 05/13/2022   I was having heavy leg pain that gradually moved up from the feet to my hips.  It felt heavy and was very painful.  I went to the Emergency Room, and they ruled out blood clots and GBS. I was diagnosed with severe myalgia in both legs from feet to hip from having COVID. My bloodwork was normal.  I had very delayed reflex in my legs.  The doctor said I had the latest variant of COVID and that they were seeing a lot of people with it.  I was told to take Motrin and Tylenol for the pain.  I have recovered from that. On 5/21/2022. I was having difficulty breathing and my chest felt heavy. My pulse ox was as low as 93.  I was diagnosed with Pneumonia in both lungs.  If I did not get better within 6 hours, my doctor told me to go to the hospital.   I was prescribed Prednisone, rescue inhaler, an antibiotic and an inspired spirometer I did not get worse, so I continued on these medications and did not need to go to the hospital. My doctor told me to sleep in the prone position. I started to get better. By Day3 on the drugs, I could tell I was going to be better. My oxygen levels were better. On 6/21/2022 I noticed my eyes were worse. My central vision was blurry. I went to the doctor on 6/21/2022.  I had a right eye scan, and it showed the right eye was affected with vascular changes from having COVID.  The left eye was minor. On 6/22/2022, I started passing blood clots in my urine. It was very painful. I contacted my Urologist and had a CT of pelvis and abdomen on 7/6/2022 which showed large hiatal hernia with partial intra thoracic stomach. I have low density foci on both kidneys and 2 centimeters right Adnexal cyst. I also have degenerative lumbar spine changes at multiple levels.  The urinary bladder was unremarkable. Tomorrow I am having a cystoscopy. I feel like I am recovered.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Reflexes abnormal, Scan with contrast abnormal, Spinal osteoarthritis, Urinary tract infection
Clinical narrative: 05/13/2022   I was having heavy leg pain that gradually moved up from the feet to my hips.  It felt heavy and was very painful.  I went to the Emergency Room, and they ruled out blood clots and GBS. I was diagnosed with severe myalgia in both legs from feet to hip from having COVID. My bloodwork was normal.  I had very delayed reflex in my legs.  The doctor said I had the latest variant of COVID and that they were seeing a lot of people with it.  I was told to take Motrin and Tylenol for the pain.  I have recovered from that. On 5/21/2022. I was having difficulty breathing and my chest felt heavy. My pulse ox was as low as 93.  I was diagnosed with Pneumonia in both lungs.  If I did not get better within 6 hours, my doctor told me to go to the hospital.   I was prescribed Prednisone, rescue inhaler, an antibiotic and an inspired spirometer I did not get worse, so I continued on these medications and did not need to go to the hospital. My doctor told me to sleep in the prone position. I started to get better. By Day3 on the drugs, I could tell I was going to be better. My oxygen levels were better. On 6/21/2022 I noticed my eyes were worse. My central vision was blurry. I went to the doctor on 6/21/2022.  I had a right eye scan, and it showed the right eye was affected with vascular changes from having COVID.  The left eye was minor. On 6/22/2022, I started passing blood clots in my urine. It was very painful. I contacted my Urologist and had a CT of pelvis and abdomen on 7/6/2022 which showed large hiatal hernia with partial intra thoracic stomach. I have low density foci on both kidneys and 2 centimeters right Adnexal cyst. I also have degenerative lumbar spine changes at multiple levels.  The urinary bladder was unremarkable. Tomorrow I am having a cystoscopy. I feel like I am recovered.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: 05/13/2022   I was having heavy leg pain that gradually moved up from the feet to my hips.  It felt heavy and was very painful.  I went to the Emergency Room, and they ruled out blood clots and GBS. I was diagnosed with severe myalgia in both legs from feet to hip from having COVID. My bloodwork was normal.  I had very delayed reflex in my legs.  The doctor said I had the latest variant of COVID and that they were seeing a lot of people with it.  I was told to take Motrin and Tylenol for the pain.  I have recovered from that. On 5/21/2022. I was having difficulty breathing and my chest felt heavy. My pulse ox was as low as 93.  I was diagnosed with Pneumonia in both lungs.  If I did not get better within 6 hours, my doctor told me to go to the hospital.   I was prescribed Prednisone, rescue inhaler, an antibiotic and an inspired spirometer I did not get worse, so I continued on these medications and did not need to go to the hospital. My doctor told me to sleep in the prone position. I started to get better. By Day3 on the drugs, I could tell I was going to be better. My oxygen levels were better. On 6/21/2022 I noticed my eyes were worse. My central vision was blurry. I went to the doctor on 6/21/2022.  I had a right eye scan, and it showed the right eye was affected with vascular changes from having COVID.  The left eye was minor. On 6/22/2022, I started passing blood clots in my urine. It was very painful. I contacted my Urologist and had a CT of pelvis and abdomen on 7/6/2022 which showed large hiatal hernia with partial intra thoracic stomach. I have low density foci on both kidneys and 2 centimeters right Adnexal cyst. I also have degenerative lumbar spine changes at multiple levels.  The urinary bladder was unremarkable. Tomorrow I am having a cystoscopy. I feel like I am recovered.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Cerebrovascular accident, Ejection fraction decreased, Myocardial infarction
Clinical narrative: Patient had a serious stroke which affected his ability to walk, his speedh and memory and vision. He was in the hospital for over a week. Then he was in a rehabilitation hospital followed by a care home. Then he lived with me, his farther, for about a month and he is now living with his mother. He could not walk without assistance or talk very well and remember much. His vision was unfocused. Now he can walk and remember many things, but his heart is weak, sleeps alot in the daytime and cannot work or drive. His cognition is not back to to way it was. His heart ejection infraction level was quite low. Now it is getting better. Wore a heart monitor for 3 months. Dr. knows about his heart.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Cerebrovascular accident, Cognitive disorder, Ejection fraction decreased, Electrocardiogram ambulatory
Clinical narrative: Patient had a serious stroke which affected his ability to walk, his speedh and memory and vision. He was in the hospital for over a week. Then he was in a rehabilitation hospital followed by a care home. Then he lived with me, his farther, for about a month and he is now living with his mother. He could not walk without assistance or talk very well and remember much. His vision was unfocused. Now he can walk and remember many things, but his heart is weak, sleeps alot in the daytime and cannot work or drive. His cognition is not back to to way it was. His heart ejection infraction level was quite low. Now it is getting better. Wore a heart monitor for 3 months. Dr. knows about his heart.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Hypersomnia, Impaired driving ability, Impaired work ability, Memory impairment
Clinical narrative: Patient had a serious stroke which affected his ability to walk, his speedh and memory and vision. He was in the hospital for over a week. Then he was in a rehabilitation hospital followed by a care home. Then he lived with me, his farther, for about a month and he is now living with his mother. He could not walk without assistance or talk very well and remember much. His vision was unfocused. Now he can walk and remember many things, but his heart is weak, sleeps alot in the daytime and cannot work or drive. His cognition is not back to to way it was. His heart ejection infraction level was quite low. Now it is getting better. Wore a heart monitor for 3 months. Dr. knows about his heart.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Somnolence, Speech disorder, Thalamic infarction, Visual impairment
Clinical narrative: Patient had a serious stroke which affected his ability to walk, his speedh and memory and vision. He was in the hospital for over a week. Then he was in a rehabilitation hospital followed by a care home. Then he lived with me, his farther, for about a month and he is now living with his mother. He could not walk without assistance or talk very well and remember much. His vision was unfocused. Now he can walk and remember many things, but his heart is weak, sleeps alot in the daytime and cannot work or drive. His cognition is not back to to way it was. His heart ejection infraction level was quite low. Now it is getting better. Wore a heart monitor for 3 months. Dr. knows about his heart.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I woke up in the morning with a very profuse post nasal drip and it felt like my upper sinuses were burning. I also had a sore throat. I tested on June 17, 2022 and it was positive. I called the doctor to inquire about Paxlovid. They prescribed it and I began to take it immediately. I felt like I had a head cold. The symptoms began to improve after the 3 or 4th. After finishing the medication, I still had not recovered. The symptoms returned again a day after I finished the medication, I retested and was still positive. The symptoms worsened where I progressed to  having intense violent sneezing. I could not stop my nose from running and I was getting cramps in my diaphragm and having leaks. It lasted for 6 or 7 days and then started to get better. I had also started coughing during this time period. I tested negative on July 02, 2022, My throat was still hurting and it felt like it was pain in my left ear. I went to the doctor and found that I had positive strep test.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Burning sensation, COVID-19, Cough, Ear pain
Clinical narrative: I woke up in the morning with a very profuse post nasal drip and it felt like my upper sinuses were burning. I also had a sore throat. I tested on June 17, 2022 and it was positive. I called the doctor to inquire about Paxlovid. They prescribed it and I began to take it immediately. I felt like I had a head cold. The symptoms began to improve after the 3 or 4th. After finishing the medication, I still had not recovered. The symptoms returned again a day after I finished the medication, I retested and was still positive. The symptoms worsened where I progressed to  having intense violent sneezing. I could not stop my nose from running and I was getting cramps in my diaphragm and having leaks. It lasted for 6 or 7 days and then started to get better. I had also started coughing during this time period. I tested negative on July 02, 2022, My throat was still hurting and it felt like it was pain in my left ear. I went to the doctor and found that I had positive strep test.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: I woke up in the morning with a very profuse post nasal drip and it felt like my upper sinuses were burning. I also had a sore throat. I tested on June 17, 2022 and it was positive. I called the doctor to inquire about Paxlovid. They prescribed it and I began to take it immediately. I felt like I had a head cold. The symptoms began to improve after the 3 or 4th. After finishing the medication, I still had not recovered. The symptoms returned again a day after I finished the medication, I retested and was still positive. The symptoms worsened where I progressed to  having intense violent sneezing. I could not stop my nose from running and I was getting cramps in my diaphragm and having leaks. It lasted for 6 or 7 days and then started to get better. I had also started coughing during this time period. I tested negative on July 02, 2022, My throat was still hurting and it felt like it was pain in my left ear. I went to the doctor and found that I had positive strep test.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Streptococcus test positive, Upper-airway cough syndrome
Clinical narrative: I woke up in the morning with a very profuse post nasal drip and it felt like my upper sinuses were burning. I also had a sore throat. I tested on June 17, 2022 and it was positive. I called the doctor to inquire about Paxlovid. They prescribed it and I began to take it immediately. I felt like I had a head cold. The symptoms began to improve after the 3 or 4th. After finishing the medication, I still had not recovered. The symptoms returned again a day after I finished the medication, I retested and was still positive. The symptoms worsened where I progressed to  having intense violent sneezing. I could not stop my nose from running and I was getting cramps in my diaphragm and having leaks. It lasted for 6 or 7 days and then started to get better. I had also started coughing during this time period. I tested negative on July 02, 2022, My throat was still hurting and it felt like it was pain in my left ear. I went to the doctor and found that I had positive strep test.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; a 34 year old male was administered PROQUAD on 5/4/2022; This spontaneous report was received from a registered nurse, referring to a 34 years old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.     On 04-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (0.5 milliliter, quantity 1, lot # u029147, expiration date 16-MAR-2023; strength and route were not provided) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events (AEs) or product quality complaint (PQC) reported.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; inadvertently administered an expired dose of PNEUMOVAX 23; This spontaneous report has been received from a health care professional (also reported as other) referring to a patient of unknown gender and age. The patients' concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 16-JUN-2022, the patient was inadvertently administered an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe (lot # T035379 with expiry date 31-MAY-2022) (strength, dose, and route of administration were not provided) for prophylaxis (expired product administered). There was no symptomatic adverse event reported and no additional adverse event details (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VARIVAX was delivered on 07JUN2022 after the receive by date of 06JUN2022 and was administered to a patient; This spontaneous report was received from a medical technologist lab manager and referred to a patient of unknown age and gender. the patient's concurrent conditions, medical history, and concomitant therapies were not reported. There was no information regarding the patient's allergies or drug reactions.  On 07-JUN-2022, varicella virus vaccine live (oka/merck) (VARIVAX) was delivered after the received by the date of 06-JUN-2022. On 15-JUN-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, dose number, route of administration and anatomical location were not reported; valid lot number: W002599 with an expiration date: 24-JAN-2024) for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event). There was no reported previous temperature excursion.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: contracted COVID-19 confirmed by test around 18JUN2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID-19 confirmed by test around 18JUN2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jun-2022, the patient experienced COVID-19 (contracted COVID-19 confirmed by test around 18JUN2022). In June 2022, COVID-19 (contracted COVID-19 confirmed by test around 18JUN2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Negative) Negative. On 18-Jun-2022, SARS-CoV-2 test: (Positive) positive.         No concomitant medications were reported. Patient had symptoms included fever, sore throat, a scratchy cough, body aches, hip pain, and back pain and diagnosed with Covid-19. It was reported that patient feeling better around the 24th or 25th of June 2022. No treatment medications were reported.  Company Comment: This is a spontaneous case concerning  a patient of unknown age and gender with no reported medical history, who experienced the unexpected non-serious AESI events of COVID-19. The events occurred on 18-Jun-2022 after the third dose of mRNA-1273 Vaccine was given on unrecalled day of in November 2021. Patient had symptoms included fever, sore throat, a scratchy cough, body aches, hip pain, and back pain and diagnosed with Covid-19. Patient tested positive for SARS-CoV-2 test. No treatment medications were reported. The event were reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Event terms, seriousness criteria and product information were captured as provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-600557 (Linked Report).; Sender's Comments: This is a spontaneous case concerning  a patient of unknown age and gender with no reported medical history, who experienced the unexpected non-serious AESI events of COVID-19. The events occurred on 18-Jun-2022 after the third dose of mRNA-1273 Vaccine was given on unrecalled day of in November 2021. Patient had symptoms included fever, sore throat, a scratchy cough, body aches, hip pain, and back pain and diagnosed with Covid-19. Patient tested positive for SARS-CoV-2 test. No treatment medications were reported. The event were reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Event terms, seriousness criteria and product information were captured as provided. US-MODERNATX, INC.-MOD-2022-600557:MOD22-017744
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Facial tingling; This spontaneous case was reported by a nurse and describes the occurrence of PARAESTHESIA (Facial tingling) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (Left) in January 2013. Concurrent medical conditions included Breast cancer (9th year after breast cancer) since December 2012. Concomitant products included VITAMIN D [VITAMIN D NOS], FAMOTIDINE, ANASTROZOLE, ALENDRONATE SODIUM (FOSAMAX) and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PARAESTHESIA (Facial tingling). At the time of the report, PARAESTHESIA (Facial tingling) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had none allergies. Patient was not diagnosed with or tested positive for COVID-19.  The patient had seen several doctors (ENT, dentist, neurologist) and they have not seen what the cause. The patient believes it was from  the Moderna vaccine. The patient ENT gave steroids  (taper for a week ) and it did not help.   This case was linked to MOD-2022-600654 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Had a sore injection arm after his 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Had a sore injection arm after his 1st dose) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Had a sore injection arm after his 1st dose). At the time of the report, VACCINATION SITE PAIN (Had a sore injection arm after his 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Rash papular, Urticaria
Clinical narrative: Red bumps covered body 1 week after 2nd shot; Covered in hives 1 week after 2nd shot; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH PAPULAR (Red bumps covered body 1 week after 2nd shot) and URTICARIA (Covered in hives 1 week after 2nd shot) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 939676) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced RASH PAPULAR (Red bumps covered body 1 week after 2nd shot) and URTICARIA (Covered in hives 1 week after 2nd shot). The patient was treated with CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL [CAMPHOR;DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]) at an unspecified dose and frequency. On 19-Aug-2021, RASH PAPULAR (Red bumps covered body 1 week after 2nd shot) and URTICARIA (Covered in hives 1 week after 2nd shot) had resolved.            No concomitant medication reported.  It had been stated that patient did not had a history of allergic reactions and also did not visit the doctor and the reaction went away by itself.  It was reported that they would like to perform allergy tests now, and they need to know the ingredients of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2022: Follow up received. Event added
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Type 2 narcolepsy" (unspecified if ongoing); "ultra-rapid metabolizer" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Drug Allergy". The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Negative; (05Jul2022) Unknown results. Therapeutic measures were taken as a result of suspected covid-19, drug ineffective. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: HCP believes that diluent for Proquad was used to reconstitute YF VAX. Is this okay? Is it the same diluent? with no reported adverse event; Initial information received on 05-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered with yellow fever vaccine [YF-VAX] which was reconstituted with diluent for proquad with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect yellow fever vaccine (formulation, strength, dose, route, lot number not reported) for immunization  On an unknown date, the patient was administered with yellow fever vaccine [YF-VAX] which was reconstituted with diluent for proquad with no reported adverse event (product preparation error).  Action taken was unknown.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Got very weak a day later and I'm still weak
Age: 2.0
Sex: M
Vaccine: HEPAB
Symptoms: Pruritus, Rash
Clinical narrative: Rash on face, and itchiness on arms, face, head 2 days after vaccine
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: patient was administered 3rd dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 1-year-old female patient who received HAV (Havrix) (batch number AP47C, expiry date 28th April 2023) for prophylaxis.   Previously administered products included Havrix (received 2 doses on an unknown date).   On an unknown date, the patient received the 3rd dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 01-JULY-2022 Reporter's Comment: The patient inadvertently administered with 3rd dose of Havrix.  The consent to follow up was given. The Vaccine Administration Facility was the same as Primary Reporter Additional supportive information: The patient received 3rd dose of Havrix, which led to extra dose administered.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anuria, COVID-19, Dialysis, Diarrhoea
Clinical narrative: Pt presented due to hypotension during dialysis session. He reported having diarrhea over the last week and is unsure if he has had fevers as he has not been checking his temperatures.  Unsure if he has any blood in the stool.  States that he does not produce any urine.  Complains of nausea and slight abdominal discomfort but no vomiting. He was found to be COVID positive upon arrival.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Nausea, SARS-CoV-2 test positive
Clinical narrative: Pt presented due to hypotension during dialysis session. He reported having diarrhea over the last week and is unsure if he has had fevers as he has not been checking his temperatures.  Unsure if he has any blood in the stool.  States that he does not produce any urine.  Complains of nausea and slight abdominal discomfort but no vomiting. He was found to be COVID positive upon arrival.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Mass, Pain in extremity
Clinical narrative: Systemic: thigh pain and burning on night off vaccine, then 2 lumps appeared on upper thigh left side on 7/5-Severe
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Nausea
Clinical narrative: Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Fever-Medium
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Fever-Medium
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chest discomfort, Chest pain, Confusional state
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: patient complains of weakness, dizziness. has not been able to go to work for the past 5 months. Patients actual dates of vaccines are 12/06/2021 and 12/27/2021.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Headache, Hyperhidrosis
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: patient complains of weakness, dizziness. has not been able to go to work for the past 5 months. Patients actual dates of vaccines are 12/06/2021 and 12/27/2021.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Lethargy, Nausea, Pain
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: patient complains of weakness, dizziness. has not been able to go to work for the past 5 months. Patients actual dates of vaccines are 12/06/2021 and 12/27/2021.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 4/7/21, 4/28/21, 12/14/21. Positive on 7/8/22