chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Blood creatinine increased, Brain natriuretic peptide normal, COVID-19, Chest X-ray abnormal
Clinical narrative: Hospital Course:  The patient is a 74 year old gentleman with an extensive medical history including but not limited to metastatic right upper lung cancer to the adrenal gland and sacrum started on immunotherapy (Nivo/ipi) on 3/9/2023 (follows with Dr.  oncology) who was admitted for acute hypoxemic respiratory failure (88 on room air).   Noted to be COVID 19 positive.   Admitted -- >started on decadron, RDV.   Also with worsening renal function since 3/20 (creat 1.10 on 3/6/2023)-started immunotherapy 3/9/2023.   First for the hypoxemic respiratory failure with + COVID, the patient was treated with decadron from 3/21 to 3/25/2023.  He also received 2 doses of RDV (stopped -see below paragraph about renal failure) CXR revealed a right basilar opacity.   The patient had a normal BNP Of 56 on admit so less concern for fluid overload.   D-dimer on admit >4, but with worsening kidney function, CTA Chest not pursued.  The d-dimer is non specific and likely elevated in setting of cancer.  Patient also with no leg pain.  The patient's SOB Subjectively improved and objectively, the patient was on 3/25 (day of discharge) 96% on room air.  However, with exertion, his O2 sat did drop to 88.  As such, I ordered home O2 for the patient and it was delivered 3/25.   An alternative explanation to for the hypoxemic respiratory failure, is possible concomitant bacterial PNA.  A serum procalcitonin was elevated at 0.96 on 3/23 (result came back 3.25) and with basilar opacity present, I did add augmentin 875/125 x 5 days to cover for possible bacterial PNA.   As for the renal failure, the patient's creatinine rose to 3.41 on 3/23.  I spoke with Dr nephrology who recommended sodium bicarb pills and bicarb gtt as patient had associated metabolic acidosis.   I did a renal ultrasound which was negative for hydronephrosis.  I stopped RDV on 3/23 as RDV can cause creatinine elevation.   Fena 3/23 only 0.8% suggesting prerenal disease.  With bicarb hydration 3/23-3/25, serum creatinine normalized to normal at 1.30 on 3/25. Losartan was held during admission course.  I will have patient recheck his serum creatinine on 4/1 (which is when his isolation date for COVID ends).  Immunotherapy nephritis is a possibility but no way to know unless kidney biopsy done.   I will have Dr oncology follow up to see if she will continue with immunotherapy.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fibrin D dimer, Lung opacity, Metabolic acidosis, Oxygen saturation decreased
Clinical narrative: Hospital Course:  The patient is a 74 year old gentleman with an extensive medical history including but not limited to metastatic right upper lung cancer to the adrenal gland and sacrum started on immunotherapy (Nivo/ipi) on 3/9/2023 (follows with Dr.  oncology) who was admitted for acute hypoxemic respiratory failure (88 on room air).   Noted to be COVID 19 positive.   Admitted -- >started on decadron, RDV.   Also with worsening renal function since 3/20 (creat 1.10 on 3/6/2023)-started immunotherapy 3/9/2023.   First for the hypoxemic respiratory failure with + COVID, the patient was treated with decadron from 3/21 to 3/25/2023.  He also received 2 doses of RDV (stopped -see below paragraph about renal failure) CXR revealed a right basilar opacity.   The patient had a normal BNP Of 56 on admit so less concern for fluid overload.   D-dimer on admit >4, but with worsening kidney function, CTA Chest not pursued.  The d-dimer is non specific and likely elevated in setting of cancer.  Patient also with no leg pain.  The patient's SOB Subjectively improved and objectively, the patient was on 3/25 (day of discharge) 96% on room air.  However, with exertion, his O2 sat did drop to 88.  As such, I ordered home O2 for the patient and it was delivered 3/25.   An alternative explanation to for the hypoxemic respiratory failure, is possible concomitant bacterial PNA.  A serum procalcitonin was elevated at 0.96 on 3/23 (result came back 3.25) and with basilar opacity present, I did add augmentin 875/125 x 5 days to cover for possible bacterial PNA.   As for the renal failure, the patient's creatinine rose to 3.41 on 3/23.  I spoke with Dr nephrology who recommended sodium bicarb pills and bicarb gtt as patient had associated metabolic acidosis.   I did a renal ultrasound which was negative for hydronephrosis.  I stopped RDV on 3/23 as RDV can cause creatinine elevation.   Fena 3/23 only 0.8% suggesting prerenal disease.  With bicarb hydration 3/23-3/25, serum creatinine normalized to normal at 1.30 on 3/25. Losartan was held during admission course.  I will have patient recheck his serum creatinine on 4/1 (which is when his isolation date for COVID ends).  Immunotherapy nephritis is a possibility but no way to know unless kidney biopsy done.   I will have Dr oncology follow up to see if she will continue with immunotherapy.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Procalcitonin increased, Renal impairment, SARS-CoV-2 test positive, Ultrasound kidney normal
Clinical narrative: Hospital Course:  The patient is a 74 year old gentleman with an extensive medical history including but not limited to metastatic right upper lung cancer to the adrenal gland and sacrum started on immunotherapy (Nivo/ipi) on 3/9/2023 (follows with Dr.  oncology) who was admitted for acute hypoxemic respiratory failure (88 on room air).   Noted to be COVID 19 positive.   Admitted -- >started on decadron, RDV.   Also with worsening renal function since 3/20 (creat 1.10 on 3/6/2023)-started immunotherapy 3/9/2023.   First for the hypoxemic respiratory failure with + COVID, the patient was treated with decadron from 3/21 to 3/25/2023.  He also received 2 doses of RDV (stopped -see below paragraph about renal failure) CXR revealed a right basilar opacity.   The patient had a normal BNP Of 56 on admit so less concern for fluid overload.   D-dimer on admit >4, but with worsening kidney function, CTA Chest not pursued.  The d-dimer is non specific and likely elevated in setting of cancer.  Patient also with no leg pain.  The patient's SOB Subjectively improved and objectively, the patient was on 3/25 (day of discharge) 96% on room air.  However, with exertion, his O2 sat did drop to 88.  As such, I ordered home O2 for the patient and it was delivered 3/25.   An alternative explanation to for the hypoxemic respiratory failure, is possible concomitant bacterial PNA.  A serum procalcitonin was elevated at 0.96 on 3/23 (result came back 3.25) and with basilar opacity present, I did add augmentin 875/125 x 5 days to cover for possible bacterial PNA.   As for the renal failure, the patient's creatinine rose to 3.41 on 3/23.  I spoke with Dr nephrology who recommended sodium bicarb pills and bicarb gtt as patient had associated metabolic acidosis.   I did a renal ultrasound which was negative for hydronephrosis.  I stopped RDV on 3/23 as RDV can cause creatinine elevation.   Fena 3/23 only 0.8% suggesting prerenal disease.  With bicarb hydration 3/23-3/25, serum creatinine normalized to normal at 1.30 on 3/25. Losartan was held during admission course.  I will have patient recheck his serum creatinine on 4/1 (which is when his isolation date for COVID ends).  Immunotherapy nephritis is a possibility but no way to know unless kidney biopsy done.   I will have Dr oncology follow up to see if she will continue with immunotherapy.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Pneumonia, Post-thoracotomy pain syndrome, Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM, UNSPECIFIED. 12/18/2021 CHRONIC POSTTHORACOTOMY PAIN  HYPOTENSION 12/18/2021 CHRONIC POSTTHORACOTOMY PAIN  PULMONARY EMBOLISM, UNSPECIFIED. 12/18/2021 PNEUMONIA  HYPOTENSION 12/18/2021 PNEUMONIA
Age: 13.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 13 yo pt received MMRV in clinic.  Appeared in system as a valid dose. Pt had no adverse reaction while in clinic.  Per protocol, pt should have received MMR and Varicella separately. MMRV only indicated for patients up to 12 yrs of age. Pt did not have to return to clinic since the dose was considered valid.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypertension, Hypoxia
Clinical narrative: ACUTE RESPIRATORY FAILURE 11/26/2021 HTN (HYPERTENSION)  HYPOXIA 10/26/2021 HTN (HYPERTENSION)
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthma, Hypoxia, Leukocytosis, Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED 7/26/2022 LEUKOCYTOSIS  ACUTE RESPIRATORY FAILURE 7/26/2022 LEUKOCYTOSIS  HYPOXIA 7/26/2022 LEUKOCYTOSIS  PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED 7/26/2022 ASTHMA, UNSPECIFIED  ACUTE RESPIRATORY FAILURE 7/26/2022 ASTHMA, UNSPECIFIED  HYPOXIA 7/26/2022 ASTHMA, UNSPECIFIED
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary infarction
Clinical narrative: PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED 7/26/2022 LEUKOCYTOSIS  ACUTE RESPIRATORY FAILURE 7/26/2022 LEUKOCYTOSIS  HYPOXIA 7/26/2022 LEUKOCYTOSIS  PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED 7/26/2022 ASTHMA, UNSPECIFIED  ACUTE RESPIRATORY FAILURE 7/26/2022 ASTHMA, UNSPECIFIED  HYPOXIA 7/26/2022 ASTHMA, UNSPECIFIED
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Exposure to SARS-CoV-2, Nausea, Uterine spasm
Clinical narrative: 23yo G1P0 at 38+4 presents to L&d with n/v/d since 0400 3/23. Reports +COVID exposure. Denies SOB. +intermittent chest pain, sharp, goes away on its own. No SOB. Intermittent uterine cramping, no contractions, no LOF, no vaginal bleeding, no DFM. No headaches, vision changes, RUQ pain.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 23yo G1P0 at 38+4 presents to L&d with n/v/d since 0400 3/23. Reports +COVID exposure. Denies SOB. +intermittent chest pain, sharp, goes away on its own. No SOB. Intermittent uterine cramping, no contractions, no LOF, no vaginal bleeding, no DFM. No headaches, vision changes, RUQ pain.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Dysphagia
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/29/2022 HX OF LARYNGEAL CANCER J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/29/2022 DYSPHAGIA
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: I went to bed on Monday 01/16/2023 with slight chills and a slight sore throat. I woke up the next day on Tuesday 01/17/2023 with a fever of 101, a sore throat and a headache. I took a COVID-19 test and tested positive. On that day, I had a telehealth visit with my doctor who prescribed PAXLOVID. I filled and took that the same day as well. I took the PAXLOVID for 5 days. The symptoms went away, then a few days later, I had a relapse and had symptoms for another 5 days. After that, the symptoms finally went away. One thing to note: the side effect of the bad taste in my mouth while taking PAXLOVID was the worst part of taking the medication.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Symptom recurrence
Clinical narrative: I went to bed on Monday 01/16/2023 with slight chills and a slight sore throat. I woke up the next day on Tuesday 01/17/2023 with a fever of 101, a sore throat and a headache. I took a COVID-19 test and tested positive. On that day, I had a telehealth visit with my doctor who prescribed PAXLOVID. I filled and took that the same day as well. I took the PAXLOVID for 5 days. The symptoms went away, then a few days later, I had a relapse and had symptoms for another 5 days. After that, the symptoms finally went away. One thing to note: the side effect of the bad taste in my mouth while taking PAXLOVID was the worst part of taking the medication.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: large circular rash in the area of injection and then another circular rash just below it. Red, itchy, swollen and hot to touch.  Saw it first on Wed April 5th , then it progressively got larger the next day. On the 3rd day (today) it's not so bad. I have rubbed the area with an ice cube to cool it down.  That's all.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine given 04/06/2023.  Moderna notified and will instruct on if there is a need to revaccinate.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Left should pain from vaccine until 4-7-2023
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Coagulopathy, Otitis externa, Septic shock
Clinical narrative: COAGULOPATHY, UNSPECIFIED TYPE 11/13/2021 BILAT ACUTE OTITIS EXTERNA  ACUTE RESPIRATORY FAILURE 11/14/2021 BILAT ACUTE OTITIS EXTERNA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/13/2021 BILAT ACUTE OTITIS EXTERNA  COAGULOPATHY, UNSPECIFIED TYPE 11/13/2021 SEPTIC SHOCK  ACUTE RESPIRATORY FAILURE 11/14/2021 SEPTIC SHOCK  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/13/2021 SEPTIC SHOCK
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Condition aggravated, Gait disturbance, General physical health deterioration, Inflammation
Clinical narrative: About a week after receiving my vaccine, I went to the doctor for hip pain. He noticed in my x-rays that I had severe osteoarthritis. After that, everything went downhill even further more. I started limping more and went to see to my ortho doctors. My restless leg syndrome flared up; I went from walking normally and freely to now having to use a walker for assistance for the last 3 or 4 months to get around due to severe pains I'll have shooting up my leg. I have an appointment with my ortho and neurologist soon for updates soon.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Osteoarthritis, Pain, Pain in extremity, Restless legs syndrome, Walking aid user
Clinical narrative: About a week after receiving my vaccine, I went to the doctor for hip pain. He noticed in my x-rays that I had severe osteoarthritis. After that, everything went downhill even further more. I started limping more and went to see to my ortho doctors. My restless leg syndrome flared up; I went from walking normally and freely to now having to use a walker for assistance for the last 3 or 4 months to get around due to severe pains I'll have shooting up my leg. I have an appointment with my ortho and neurologist soon for updates soon.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: X-ray abnormal
Clinical narrative: About a week after receiving my vaccine, I went to the doctor for hip pain. He noticed in my x-rays that I had severe osteoarthritis. After that, everything went downhill even further more. I started limping more and went to see to my ortho doctors. My restless leg syndrome flared up; I went from walking normally and freely to now having to use a walker for assistance for the last 3 or 4 months to get around due to severe pains I'll have shooting up my leg. I have an appointment with my ortho and neurologist soon for updates soon.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Anticoagulant therapy, Thrombosis, Ultrasound scan abnormal
Clinical narrative: 03/07/2023 I developed a blood clot in my right leg. I contacted my Physician and was given an Ultrasound of my leg. I was prescribed on ELIQUIS indefinitely to prevent further clotting.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Headache, Nasopharyngitis, Respiratory tract congestion
Clinical narrative: Had a cold with a bad cough, headache and congestion. Took a Home COVID-19 test and was positive. Contacted doctor and was prescribed Paxlovid. Felt better a couple of days later.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Had a cold with a bad cough, headache and congestion. Took a Home COVID-19 test and was positive. Contacted doctor and was prescribed Paxlovid. Felt better a couple of days later.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Nasal congestion, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: I woke up with a sore throat that felt like allergies. I tested positive for COVID-19 on March 24, 2023. I was pretty exhausted and sleepy. I had five full days of a sore throat. I took PAXLOVID and felt better. On day six I was negative but two days later I tested positive. I have a rebound infection. I now have bad cold symptoms. I have severe nasal congestion and I am coughing phlegm. I have not had a fever at all.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Productive cough, SARS-CoV-2 test positive, Somnolence
Clinical narrative: I woke up with a sore throat that felt like allergies. I tested positive for COVID-19 on March 24, 2023. I was pretty exhausted and sleepy. I had five full days of a sore throat. I took PAXLOVID and felt better. On day six I was negative but two days later I tested positive. I have a rebound infection. I now have bad cold symptoms. I have severe nasal congestion and I am coughing phlegm. I have not had a fever at all.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast abnormal, Breast calcifications, Breast cancer stage I, Breast conserving surgery, Breast mass
Clinical narrative: In March 2022, I went to get my yearly mammogram. I had developed calcifications on my right breast, so my doctor prescribed a diagnostic mammogram, which I got in April 2022. I wasn't able to get a biopsy done until mid-May 2022. At around the end of May 2022, I received a diagnosis of stage I-A breast cancer. The cancer was 7 mm, and there was a suspicious mass medial to the cancerous growth. I underwent an MRI-guided biopsy of the suspicious mass in July 2022, and it turned out to be benign. In August 2022, I underwent a lumpectomy to remove the cancer, the benign growth, and some healthy tissue surrounding them. I also had three sentinel lymph nodes removed from the right armpit. During the last week of September 2022, I began taking anastrozole daily.  I also began getting Goserelin acetate implants monthly.  I receive zoledronic acid infusions every six months; I received two in September 2022 and March 2023. In October 2022, I underwent 21 days of radiation treatment. I underwent two months of physical therapy for lymphedema of the right arm from November 2022 to January 2023. In February 2023, after I received a Goserelin acetate implant, I developed an infection in the right breast. On 2/17/2023, I saw my medical oncologist, who diagnosed me with an infection. She prescribed me tramadol for the pain and amoxicillin with clavulanic acid to treat the infection. She advised me to go to the ER if I didn't feel better and to instruct the ER personnel to give me intravenous antibiotics. The incision on my breast opened up and the infection oozed out on 2/19/2023. I ended up going to the emergency room on 2/19/2023; at the ER, I informed them of the situation and requested intravenous antibiotics. I was given intravenous antibiotics, and the ER doctor prescribed me clindamycin and instructed me to stop taking amoxicillin with clavulanic acid. I took the clindamycin for ten days; the infection cleared up, but after I finished taking the medicine, the wound was still open and draining. On around 2/21/2023 or 2/22/2023, I saw my breast surgeon. She has been monitoring my breast ever since, and the last time I saw her was 3/22/2023. At the time of this writing, there is still a small opening where the incision was, and it's still draining. My surgeon doesn't think I have an infection, anymore, but there is a reddish area above my right breast towards the sternum, and my surgeon is monitoring that closely. I have an appointment with the surgeon in the very near future, and she will let me know what she would like to do about the situation then.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Incisional drainage, Infusion, Lymphadenectomy, Lymphoedema
Clinical narrative: In March 2022, I went to get my yearly mammogram. I had developed calcifications on my right breast, so my doctor prescribed a diagnostic mammogram, which I got in April 2022. I wasn't able to get a biopsy done until mid-May 2022. At around the end of May 2022, I received a diagnosis of stage I-A breast cancer. The cancer was 7 mm, and there was a suspicious mass medial to the cancerous growth. I underwent an MRI-guided biopsy of the suspicious mass in July 2022, and it turned out to be benign. In August 2022, I underwent a lumpectomy to remove the cancer, the benign growth, and some healthy tissue surrounding them. I also had three sentinel lymph nodes removed from the right armpit. During the last week of September 2022, I began taking anastrozole daily.  I also began getting Goserelin acetate implants monthly.  I receive zoledronic acid infusions every six months; I received two in September 2022 and March 2023. In October 2022, I underwent 21 days of radiation treatment. I underwent two months of physical therapy for lymphedema of the right arm from November 2022 to January 2023. In February 2023, after I received a Goserelin acetate implant, I developed an infection in the right breast. On 2/17/2023, I saw my medical oncologist, who diagnosed me with an infection. She prescribed me tramadol for the pain and amoxicillin with clavulanic acid to treat the infection. She advised me to go to the ER if I didn't feel better and to instruct the ER personnel to give me intravenous antibiotics. The incision on my breast opened up and the infection oozed out on 2/19/2023. I ended up going to the emergency room on 2/19/2023; at the ER, I informed them of the situation and requested intravenous antibiotics. I was given intravenous antibiotics, and the ER doctor prescribed me clindamycin and instructed me to stop taking amoxicillin with clavulanic acid. I took the clindamycin for ten days; the infection cleared up, but after I finished taking the medicine, the wound was still open and draining. On around 2/21/2023 or 2/22/2023, I saw my breast surgeon. She has been monitoring my breast ever since, and the last time I saw her was 3/22/2023. At the time of this writing, there is still a small opening where the incision was, and it's still draining. My surgeon doesn't think I have an infection, anymore, but there is a reddish area above my right breast towards the sternum, and my surgeon is monitoring that closely. I have an appointment with the surgeon in the very near future, and she will let me know what she would like to do about the situation then.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram abnormal, Mastitis, Postoperative wound infection, Radiotherapy, Wound
Clinical narrative: In March 2022, I went to get my yearly mammogram. I had developed calcifications on my right breast, so my doctor prescribed a diagnostic mammogram, which I got in April 2022. I wasn't able to get a biopsy done until mid-May 2022. At around the end of May 2022, I received a diagnosis of stage I-A breast cancer. The cancer was 7 mm, and there was a suspicious mass medial to the cancerous growth. I underwent an MRI-guided biopsy of the suspicious mass in July 2022, and it turned out to be benign. In August 2022, I underwent a lumpectomy to remove the cancer, the benign growth, and some healthy tissue surrounding them. I also had three sentinel lymph nodes removed from the right armpit. During the last week of September 2022, I began taking anastrozole daily.  I also began getting Goserelin acetate implants monthly.  I receive zoledronic acid infusions every six months; I received two in September 2022 and March 2023. In October 2022, I underwent 21 days of radiation treatment. I underwent two months of physical therapy for lymphedema of the right arm from November 2022 to January 2023. In February 2023, after I received a Goserelin acetate implant, I developed an infection in the right breast. On 2/17/2023, I saw my medical oncologist, who diagnosed me with an infection. She prescribed me tramadol for the pain and amoxicillin with clavulanic acid to treat the infection. She advised me to go to the ER if I didn't feel better and to instruct the ER personnel to give me intravenous antibiotics. The incision on my breast opened up and the infection oozed out on 2/19/2023. I ended up going to the emergency room on 2/19/2023; at the ER, I informed them of the situation and requested intravenous antibiotics. I was given intravenous antibiotics, and the ER doctor prescribed me clindamycin and instructed me to stop taking amoxicillin with clavulanic acid. I took the clindamycin for ten days; the infection cleared up, but after I finished taking the medicine, the wound was still open and draining. On around 2/21/2023 or 2/22/2023, I saw my breast surgeon. She has been monitoring my breast ever since, and the last time I saw her was 3/22/2023. At the time of this writing, there is still a small opening where the incision was, and it's still draining. My surgeon doesn't think I have an infection, anymore, but there is a reddish area above my right breast towards the sternum, and my surgeon is monitoring that closely. I have an appointment with the surgeon in the very near future, and she will let me know what she would like to do about the situation then.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Wound dehiscence
Clinical narrative: In March 2022, I went to get my yearly mammogram. I had developed calcifications on my right breast, so my doctor prescribed a diagnostic mammogram, which I got in April 2022. I wasn't able to get a biopsy done until mid-May 2022. At around the end of May 2022, I received a diagnosis of stage I-A breast cancer. The cancer was 7 mm, and there was a suspicious mass medial to the cancerous growth. I underwent an MRI-guided biopsy of the suspicious mass in July 2022, and it turned out to be benign. In August 2022, I underwent a lumpectomy to remove the cancer, the benign growth, and some healthy tissue surrounding them. I also had three sentinel lymph nodes removed from the right armpit. During the last week of September 2022, I began taking anastrozole daily.  I also began getting Goserelin acetate implants monthly.  I receive zoledronic acid infusions every six months; I received two in September 2022 and March 2023. In October 2022, I underwent 21 days of radiation treatment. I underwent two months of physical therapy for lymphedema of the right arm from November 2022 to January 2023. In February 2023, after I received a Goserelin acetate implant, I developed an infection in the right breast. On 2/17/2023, I saw my medical oncologist, who diagnosed me with an infection. She prescribed me tramadol for the pain and amoxicillin with clavulanic acid to treat the infection. She advised me to go to the ER if I didn't feel better and to instruct the ER personnel to give me intravenous antibiotics. The incision on my breast opened up and the infection oozed out on 2/19/2023. I ended up going to the emergency room on 2/19/2023; at the ER, I informed them of the situation and requested intravenous antibiotics. I was given intravenous antibiotics, and the ER doctor prescribed me clindamycin and instructed me to stop taking amoxicillin with clavulanic acid. I took the clindamycin for ten days; the infection cleared up, but after I finished taking the medicine, the wound was still open and draining. On around 2/21/2023 or 2/22/2023, I saw my breast surgeon. She has been monitoring my breast ever since, and the last time I saw her was 3/22/2023. At the time of this writing, there is still a small opening where the incision was, and it's still draining. My surgeon doesn't think I have an infection, anymore, but there is a reddish area above my right breast towards the sternum, and my surgeon is monitoring that closely. I have an appointment with the surgeon in the very near future, and she will let me know what she would like to do about the situation then.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chills, Cough, Diarrhoea
Clinical narrative: It started out with diarrhea for 3 or 4 days, chills, sore throat, upper respiratory symptoms, slight cough, fatigue, running nose, and weak. I went to an urgent care clinic, and they tested me for strep and COVID-19. I tested positive for COVID-19 and negative for strep. They prescribed me an oral steroid and it helped with my sore throat. I saw my doctor 03/20/2023 for a regular visit but I was still feeling tired and unwell. She told me to rest.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Oropharyngeal pain, Respiratory symptom, Rhinorrhoea
Clinical narrative: It started out with diarrhea for 3 or 4 days, chills, sore throat, upper respiratory symptoms, slight cough, fatigue, running nose, and weak. I went to an urgent care clinic, and they tested me for strep and COVID-19. I tested positive for COVID-19 and negative for strep. They prescribed me an oral steroid and it helped with my sore throat. I saw my doctor 03/20/2023 for a regular visit but I was still feeling tired and unwell. She told me to rest.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Streptococcus test negative
Clinical narrative: It started out with diarrhea for 3 or 4 days, chills, sore throat, upper respiratory symptoms, slight cough, fatigue, running nose, and weak. I went to an urgent care clinic, and they tested me for strep and COVID-19. I tested positive for COVID-19 and negative for strep. They prescribed me an oral steroid and it helped with my sore throat. I saw my doctor 03/20/2023 for a regular visit but I was still feeling tired and unwell. She told me to rest.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis, Exposure to communicable disease, Fatigue, Furuncle, Influenza like illness
Clinical narrative: 30 hours after my 2nd dose, I ended up with Flu like symptoms. I was having body ache and fatigue for hours. I was extremely tired. A week afterwards I am starting to fall asleep in the middle of the day sitting up. I am constantly tired; I will fall asleep watching television. I went to my doctor, to check it I had Lyme Disease but it's not that. I believe this is related to Narcolepsy, just as in the past Flu vaccines. I am mostly fatigue and falling asleep. I have never had these problems. I am a scientist; I see that this just happens to coincide with the vaccine. I consulted my PCP and my infectious disease doctor. She gave a long dose of medications for three months. The combination was to treat boils on my scalp and Lyme disease. I was exposed but it was not active. She could not explain the tiredness of falling asleep. I tried another antibiotic, but it didn't make a difference. Nothing has happened since then. The back surgeon back in February I mentioned to him about the steroid injections I had in my spine I was given the prednisone I had got colitis and boils in my head. I found out I had a Staph Infection. We found out the bacterial defense is not as good as viral defense and when on the medication I was low at fighting the boils. I have since been given a antibiotic lotion, that's helping. My sleeping spells are the same today. I sat up and fell asleep and been in bed over eight. I sleep and wake up every two hours or so to switch positions. But I should not be sleeping sitting up, especially when my intentions are not to take a nap.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Narcolepsy, Pain, Sleep disorder, Somnolence, Spinal disorder
Clinical narrative: 30 hours after my 2nd dose, I ended up with Flu like symptoms. I was having body ache and fatigue for hours. I was extremely tired. A week afterwards I am starting to fall asleep in the middle of the day sitting up. I am constantly tired; I will fall asleep watching television. I went to my doctor, to check it I had Lyme Disease but it's not that. I believe this is related to Narcolepsy, just as in the past Flu vaccines. I am mostly fatigue and falling asleep. I have never had these problems. I am a scientist; I see that this just happens to coincide with the vaccine. I consulted my PCP and my infectious disease doctor. She gave a long dose of medications for three months. The combination was to treat boils on my scalp and Lyme disease. I was exposed but it was not active. She could not explain the tiredness of falling asleep. I tried another antibiotic, but it didn't make a difference. Nothing has happened since then. The back surgeon back in February I mentioned to him about the steroid injections I had in my spine I was given the prednisone I had got colitis and boils in my head. I found out I had a Staph Infection. We found out the bacterial defense is not as good as viral defense and when on the medication I was low at fighting the boils. I have since been given a antibiotic lotion, that's helping. My sleeping spells are the same today. I sat up and fell asleep and been in bed over eight. I sleep and wake up every two hours or so to switch positions. But I should not be sleeping sitting up, especially when my intentions are not to take a nap.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Staphylococcal infection
Clinical narrative: 30 hours after my 2nd dose, I ended up with Flu like symptoms. I was having body ache and fatigue for hours. I was extremely tired. A week afterwards I am starting to fall asleep in the middle of the day sitting up. I am constantly tired; I will fall asleep watching television. I went to my doctor, to check it I had Lyme Disease but it's not that. I believe this is related to Narcolepsy, just as in the past Flu vaccines. I am mostly fatigue and falling asleep. I have never had these problems. I am a scientist; I see that this just happens to coincide with the vaccine. I consulted my PCP and my infectious disease doctor. She gave a long dose of medications for three months. The combination was to treat boils on my scalp and Lyme disease. I was exposed but it was not active. She could not explain the tiredness of falling asleep. I tried another antibiotic, but it didn't make a difference. Nothing has happened since then. The back surgeon back in February I mentioned to him about the steroid injections I had in my spine I was given the prednisone I had got colitis and boils in my head. I found out I had a Staph Infection. We found out the bacterial defense is not as good as viral defense and when on the medication I was low at fighting the boils. I have since been given a antibiotic lotion, that's helping. My sleeping spells are the same today. I sat up and fell asleep and been in bed over eight. I sleep and wake up every two hours or so to switch positions. But I should not be sleeping sitting up, especially when my intentions are not to take a nap.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Bed sharing, Blood pressure increased, Blood test normal, Dyspnoea, Electrocardiogram normal
Clinical narrative: I had a tickle in my throat. I didn't feel right, and I tested myself and, I was positive. I had a runny nose for a few days. I was tired but I didn't feel really bad at all. I developed high blood pressure. I had shortness of breath. The doctor wanted me to take a low dose of blood pressure medicine, but it didn't make a difference.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Fatigue, Feeling abnormal, Hypertension, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had a tickle in my throat. I didn't feel right, and I tested myself and, I was positive. I had a runny nose for a few days. I was tired but I didn't feel really bad at all. I developed high blood pressure. I had shortness of breath. The doctor wanted me to take a low dose of blood pressure medicine, but it didn't make a difference.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Throat irritation
Clinical narrative: I had a tickle in my throat. I didn't feel right, and I tested myself and, I was positive. I had a runny nose for a few days. I was tired but I didn't feel really bad at all. I developed high blood pressure. I had shortness of breath. The doctor wanted me to take a low dose of blood pressure medicine, but it didn't make a difference.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient left office without issue.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Mental impairment
Clinical narrative: Degraded thinking; shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Lot number: ew0173) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: er8734), for COVID-19 immunization, reaction(s): "Shortness of breath", "Degraded thinking". The following information was reported: MENTAL IMPAIRMENT (medically significant), outcome "unknown", described as "Degraded thinking"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath".  Clinical Course: The patient had the first 2 Pfizer shots: er8734 and ew0173. The patient might has side effect shortness of breath and degraded thinking.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202300063628 Same patient/vaccine/event, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Mental impairment
Clinical narrative: Degraded thinking; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: er8734) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENTAL IMPAIRMENT (medically significant), outcome "unknown", described as "Degraded thinking"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath". Clinical course: may have side effect shortness of breath degraded thinking.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-202300146260 Same patient/drug/ different dose/event;
Sex: U
Vaccine: MMR, UNK
Symptoms: Accidental underdose, No adverse event, Unintentional medical device removal
Clinical narrative: The patient received less than recommended dose of MMR II vaccine because the patient moved during the administration/The patient received only about 40% of the total dose; No AE; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin [rHA]) (M-M-R II) subcutaneous injection (lot# W011885 has been verified to be a valid lot number and expiration date was 04-SEP-2023; strength, dose, and route were not provided) for prophylaxis with sterile diluent, solution for injection/infusion (lot #U033553 has been verified to be a valid lot number and expiration date was 07-MAY-2024; strength, dose, and route were not provided).  It was reported that the patient received less than recommended dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) vaccine because the patient moved during the administration. The patient received only about 40% of the total dose (Accidental underdose). No adverse event was reported. The outcome of the event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the shot and got them now/ Suspected vaccination failure; Still getting shingles, got them now, Shingles twice; Very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had twice).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shot and got them now/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Still getting shingles, got them now, Shingles twice) and pain (Verbatim: Very painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 02-APR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she had shingles shots 2 years ago but got shingles at the time of reporting. They were very painful.  The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shot did not work for me/Suspected vaccination failure; Shot did not work for me; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shot did not work for me/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shot did not work for me). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that shingles shot did not work for him/her. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Mobility decreased, Musculoskeletal disorder, Nervous system disorder, Paralysis
Clinical narrative: her legs dont work at all; Guillain-Barré syndrome (GBS); serious nervous system disorder; is paralyzed; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Additional patient notes included The patient was completely healthy women in her 50s.   On an unknown date, the patient received Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barré syndrome (GBS)) (serious criteria GSK medically significant), nervous system disorder (Verbatim: serious nervous system disorder) (serious criteria other: serious per reporter) and paralysis (Verbatim: is paralyzed) (serious criteria GSK medically significant). On an unknown date, the patient experienced mobility decreased (Verbatim: her legs dont work at all). The outcome of the guillain barre syndrome, nervous system disorder and paralysis were not recovered/not resolved and the outcome of the mobility decreased was not reported.   It was unknown if the reporter considered the guillain barre syndrome, nervous system disorder, paralysis and mobility decreased to be related to Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome, nervous system disorder, paralysis and mobility decreased to be related to Shingles vaccine.   Additional Information: GSK receipt date: 16-Mar-2023 The case was received from the patient's friend via interactive digital media. The patient got her shingles shot and now (at the time of reporting) had guillain-barre syndrome, a serious nervous system disorder and was paralyzed. The patient's legs did not work at all. The follow-up could not be possible as no contact details were available. The case was linked case US2023AMR050646, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR050646:same reporter - reporter´s case
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Bad shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Bad shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient's friend via interactive digital media. The reporter stated that the shingle shot gave the patient bad shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shots and still had shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Zostavax.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shots and still had shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received two vaccines the old vaccines and the new one shingles vaccine and still experienced shingles twice and they are bad. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.