chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood culture, C-reactive protein, Chest X-ray, Electrocardiogram, Laboratory test
Clinical narrative: in case of bacterial pneumonia; fever for 14 days; This spontaneous case was reported by a physician and describes the occurrence of PNEUMONIA BACTERIAL (in case of bacterial pneumonia) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A, 010A21A and 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA BACTERIAL (in case of bacterial pneumonia) (seriousness criterion medically significant) and PYREXIA (fever for 14 days). The patient was treated with AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) for Bacterial pneumonia, unspecified, at a dose of UNK dosage form and PREDNISONE for Bacterial pneumonia, unspecified, at a dose of UNK dosage form. At the time of the report, PNEUMONIA BACTERIAL (in case of bacterial pneumonia) outcome was unknown and PYREXIA (fever for 14 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood culture: negative (Negative) Negative. On an unknown date, C-reactive protein: negative (Negative) Negative. On an unknown date, Chest X-ray: negative (Negative) Negative. On an unknown date, Electrocardiogram: negative (Negative) Negative. On an unknown date, Laboratory test: negative (Negative) Negative. On an unknown date, Red blood cell sedimentation rate: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient had Augmentin for 7 days started taking on day 11 of fever and Prednisone for 5 days states today is last day of prednisone. "in case of bacterial pneumonia".  Patient had the Moderna booster dose and has had a fever for 14 days; Sender's Comments: This case concerns a 81-year-old, male patient with no relevant medical history, who experienced the unexpected event of Pneumonia bacterial and the expected event of Pyrexia. The events occurred on an unknown date after the third dose of mRNA-1273 Vaccine. The patient was treated with Augmentin and Prednisone and the lab tests done ( blood culture, chest x-ray, labs, EKG, ESR, CRP) all came back negative. The events had an outcome of unknown. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia bacterial, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: in case of bacterial pneumonia; fever for 14 days; This spontaneous case was reported by a physician and describes the occurrence of PNEUMONIA BACTERIAL (in case of bacterial pneumonia) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A, 010A21A and 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA BACTERIAL (in case of bacterial pneumonia) (seriousness criterion medically significant) and PYREXIA (fever for 14 days). The patient was treated with AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) for Bacterial pneumonia, unspecified, at a dose of UNK dosage form and PREDNISONE for Bacterial pneumonia, unspecified, at a dose of UNK dosage form. At the time of the report, PNEUMONIA BACTERIAL (in case of bacterial pneumonia) outcome was unknown and PYREXIA (fever for 14 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood culture: negative (Negative) Negative. On an unknown date, C-reactive protein: negative (Negative) Negative. On an unknown date, Chest X-ray: negative (Negative) Negative. On an unknown date, Electrocardiogram: negative (Negative) Negative. On an unknown date, Laboratory test: negative (Negative) Negative. On an unknown date, Red blood cell sedimentation rate: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient had Augmentin for 7 days started taking on day 11 of fever and Prednisone for 5 days states today is last day of prednisone. "in case of bacterial pneumonia".  Patient had the Moderna booster dose and has had a fever for 14 days; Sender's Comments: This case concerns a 81-year-old, male patient with no relevant medical history, who experienced the unexpected event of Pneumonia bacterial and the expected event of Pyrexia. The events occurred on an unknown date after the third dose of mRNA-1273 Vaccine. The patient was treated with Augmentin and Prednisone and the lab tests done ( blood culture, chest x-ray, labs, EKG, ESR, CRP) all came back negative. The events had an outcome of unknown. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Dysgeusia, Fatigue, Haematoma, Pain in extremity
Clinical narrative: metallic taste in her mouth; arm pain; feeling fatigue; hematoma/bruising; shooting pins on my fingers; hematoma; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in her mouth), CONTUSION (hematoma/bruising), PARAESTHESIA (shooting pins on my fingers), HAEMATOMA (hematoma) and PAIN IN EXTREMITY (arm pain) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced DYSGEUSIA (metallic taste in her mouth), PAIN IN EXTREMITY (arm pain) and FATIGUE (feeling fatigue). In November 2021, the patient experienced CONTUSION (hematoma/bruising), PARAESTHESIA (shooting pins on my fingers) and HAEMATOMA (hematoma). At the time of the report, DYSGEUSIA (metallic taste in her mouth), CONTUSION (hematoma/bruising), PARAESTHESIA (shooting pins on my fingers), HAEMATOMA (hematoma), PAIN IN EXTREMITY (arm pain) and FATIGUE (feeling fatigue) outcome was unknown.            No concomitant medication reported. No treatment information was provided.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: metallic taste in her mouth; arm pain; feeling fatigue; hematoma/bruising; shooting pins on my fingers; hematoma; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in her mouth), CONTUSION (hematoma/bruising), PARAESTHESIA (shooting pins on my fingers), HAEMATOMA (hematoma) and PAIN IN EXTREMITY (arm pain) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced DYSGEUSIA (metallic taste in her mouth), PAIN IN EXTREMITY (arm pain) and FATIGUE (feeling fatigue). In November 2021, the patient experienced CONTUSION (hematoma/bruising), PARAESTHESIA (shooting pins on my fingers) and HAEMATOMA (hematoma). At the time of the report, DYSGEUSIA (metallic taste in her mouth), CONTUSION (hematoma/bruising), PARAESTHESIA (shooting pins on my fingers), HAEMATOMA (hematoma), PAIN IN EXTREMITY (arm pain) and FATIGUE (feeling fatigue) outcome was unknown.            No concomitant medication reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: #033C21A - 55 recipients identified-vaccine was stored in the refrigerator beyond-use-date of 30 days and provider continued to administer; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (#033C21A - 55 recipients identified-vaccine was stored in the refrigerator beyond-use-date of 30 days and provider continued to administer) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (#033C21A - 55 recipients identified-vaccine was stored in the refrigerator beyond-use-date of 30 days and provider continued to administer). At the time of the report, EXPIRED PRODUCT ADMINISTERED (#033C21A - 55 recipients identified-vaccine was stored in the refrigerator beyond-use-date of 30 days and provider continued to administer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment information was provided by the reporter
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash again in the same area as the second shot. At first it looked like welts and like mosquito bites. It was large but later flattened down.; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash again in the same area as the second shot. At first it looked like welts and like mosquito bites. It was large but later flattened down.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 028L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (itchy rash again in the same area as the second shot. At first it looked like welts and like mosquito bites. It was large but later flattened down.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Itchy rash, at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itchy rash again in the same area as the second shot. At first it looked like welts and like mosquito bites. It was large but later flattened down.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.   This case was linked to MOD-2021-395629 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: "felt like it went to the bone"/like a "bee sting"/needle felt big and long; Usually "feels perky" but feels "like crap".; No energy; Feeling faint; Left arm was sore; Fatigue; Muscle pain; Chills; Nausea; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE DISCOMFORT ("felt like it went to the bone"/like a "bee sting"/needle felt big and long), FEELING ABNORMAL (Usually "feels perky" but feels "like crap".), ASTHENIA (No energy), DIZZINESS (Feeling faint) and VACCINATION SITE PAIN (Left arm was sore) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0341F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disorder (he takes prescription medications for his heart and diabetes) and Diabetes.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Nov-2021, the patient experienced VACCINATION SITE DISCOMFORT ("felt like it went to the bone"/like a "bee sting"/needle felt big and long), FEELING ABNORMAL (Usually "feels perky" but feels "like crap".), ASTHENIA (No energy), DIZZINESS (Feeling faint), VACCINATION SITE PAIN (Left arm was sore), FATIGUE (Fatigue), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, VACCINATION SITE DISCOMFORT ("felt like it went to the bone"/like a "bee sting"/needle felt big and long), FEELING ABNORMAL (Usually "feels perky" but feels "like crap".), ASTHENIA (No energy), DIZZINESS (Feeling faint), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown and VACCINATION SITE PAIN (Left arm was sore) and FATIGUE (Fatigue) had not resolved.            He stated he is acting like "an old man". He stated he had not treated the events with any medications. The caller stated he was taking prescription medications for his heart and diabetes (names of medications not reported).   This case was linked to MOD-2021-396348, MOD-2021-396362, MOD-2021-396362 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination site discomfort, Vaccination site pain
Clinical narrative: "felt like it went to the bone"/like a "bee sting"/needle felt big and long; Usually "feels perky" but feels "like crap".; No energy; Feeling faint; Left arm was sore; Fatigue; Muscle pain; Chills; Nausea; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE DISCOMFORT ("felt like it went to the bone"/like a "bee sting"/needle felt big and long), FEELING ABNORMAL (Usually "feels perky" but feels "like crap".), ASTHENIA (No energy), DIZZINESS (Feeling faint) and VACCINATION SITE PAIN (Left arm was sore) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0341F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disorder (he takes prescription medications for his heart and diabetes) and Diabetes.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Nov-2021, the patient experienced VACCINATION SITE DISCOMFORT ("felt like it went to the bone"/like a "bee sting"/needle felt big and long), FEELING ABNORMAL (Usually "feels perky" but feels "like crap".), ASTHENIA (No energy), DIZZINESS (Feeling faint), VACCINATION SITE PAIN (Left arm was sore), FATIGUE (Fatigue), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, VACCINATION SITE DISCOMFORT ("felt like it went to the bone"/like a "bee sting"/needle felt big and long), FEELING ABNORMAL (Usually "feels perky" but feels "like crap".), ASTHENIA (No energy), DIZZINESS (Feeling faint), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown and VACCINATION SITE PAIN (Left arm was sore) and FATIGUE (Fatigue) had not resolved.            He stated he is acting like "an old man". He stated he had not treated the events with any medications. The caller stated he was taking prescription medications for his heart and diabetes (names of medications not reported).   This case was linked to MOD-2021-396348, MOD-2021-396362, MOD-2021-396362 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dysgeusia, Gastrointestinal disorder, Vaccination site lymphadenopathy
Clinical narrative: some GI side effects; metallic taste; diarrhea; upset stomach; some lymph node swelling in her left armpit; This spontaneous case was reported by a pharmacist and describes the occurrence of GASTROINTESTINAL DISORDER (some GI side effects), DYSGEUSIA (metallic taste), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and VACCINATION SITE LYMPHADENOPATHY (some lymph node swelling in her left armpit) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 GASTROINTESTINAL DISORDER (some GI side effects), DYSGEUSIA (metallic taste), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and VACCINATION SITE LYMPHADENOPATHY (some lymph node swelling in her left armpit). At the time of the report, GASTROINTESTINAL DISORDER (some GI side effects), DYSGEUSIA (metallic taste), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and VACCINATION SITE LYMPHADENOPATHY (some lymph node swelling in her left armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-396518 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Left pinky itching/Right forearm  itching/Right elbowband itching; Left pinky  red/Right forearm red/Right elbowband red; Left pinky rash/Right forearm rash/Right elbowband rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Left pinky itching/Right forearm  itching/Right elbowband itching), ERYTHEMA (Left pinky  red/Right forearm red/Right elbowband red) and RASH (Left pinky rash/Right forearm rash/Right elbowband rash) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 030L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced PRURITUS (Left pinky itching/Right forearm  itching/Right elbowband itching), ERYTHEMA (Left pinky  red/Right forearm red/Right elbowband red) and RASH (Left pinky rash/Right forearm rash/Right elbowband rash). The patient was treated with HYDROGEN PEROXIDE (PEROXIDE) for Adverse event, at a dose of 1 dosage form and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at a dose of 1 dosage form. At the time of the report, PRURITUS (Left pinky itching/Right forearm  itching/Right elbowband itching), ERYTHEMA (Left pinky  red/Right forearm red/Right elbowband red) and RASH (Left pinky rash/Right forearm rash/Right elbowband rash) had not resolved.            No Concomitants medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: Now I have (what I think ) is a cold (no fever); got my booster last Thursday and had a fever for a day and a half; This spontaneous case was reported by a pharmacist and describes the occurrence of NASOPHARYNGITIS (Now I have (what I think ) is a cold (no fever)) and PYREXIA (got my booster last Thursday and had a fever for a day and a half) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Now I have (what I think ) is a cold (no fever)) and PYREXIA (got my booster last Thursday and had a fever for a day and a half). At the time of the report, NASOPHARYNGITIS (Now I have (what I think ) is a cold (no fever)) and PYREXIA (got my booster last Thursday and had a fever for a day and a half) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination complication
Clinical narrative: Severe reaction; Sore arm; Headache that was severe; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe reaction), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache that was severe) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D NOS, MULTIVITAMIN [VITAMINS NOS] and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Severe reaction), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache that was severe). At the time of the report, VACCINATION COMPLICATION (Severe reaction), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache that was severe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported. Patient had a sore arm and a headache that was severe the day after.   This case was linked to MOD-2021-396560, MOD-2021-396561, MOD-2021-396066 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 9 patients received expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   No treatment information was provided by the reporter.  The vial was initially stored in the refrigerator on 11Nov2021 and was first punctured at10 AM on 18Nov2021. No temperature excursions occurred.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: HCP to return call with actual number of recipients vaccinated post expiry.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP to return call with actual number of recipients vaccinated post expiry.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP to return call with actual number of recipients vaccinated post expiry.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP to return call with actual number of recipients vaccinated post expiry.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.  The vial with Lot 038C21A, 4 vials had been used or administered, 1 open or punctured, other one was half used. Five vials remained unpunctured.  Sticker from State was 035C21A with expiration date as 30Dec2021 (extended expiration).   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Non-Significant Follow up- email information updated.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: arm has some redness; arm is a little sore/arm kind of hurts/it's still pretty sore; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm has some redness) and PAIN IN EXTREMITY (arm is a little sore/arm kind of hurts/it's still pretty sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065FZ114, 007B21A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ERYTHEMA (arm has some redness) and PAIN IN EXTREMITY (arm is a little sore/arm kind of hurts/it's still pretty sore). At the time of the report, ERYTHEMA (arm has some redness) outcome was unknown and PAIN IN EXTREMITY (arm is a little sore/arm kind of hurts/it's still pretty sore) had not resolved.            No concomitant drug details were reported. No treatment details were reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nervousness
Clinical narrative: very nervous/nerve-wracking; Patient received moderna booster dose after receiving two doses of pfizer; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (very nervous/nerve-wracking) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received moderna booster dose after receiving two doses of pfizer) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Lot Number ER8727 and Lot Number EW0162) from 26-Mar-2021 to 12-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received moderna booster dose after receiving two doses of pfizer). On an unknown date, the patient experienced NERVOUSNESS (very nervous/nerve-wracking). On 24-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received moderna booster dose after receiving two doses of pfizer) had resolved. At the time of the report, NERVOUSNESS (very nervous/nerve-wracking) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient thinking that he should not have to a gotten a full dose.  No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received the vaccine 12 hours after puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine 12 hours after puncture) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021 at 9:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 23-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine 12 hours after puncture). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine 12 hours after puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  After 12 hours the vial was punctured and was given to 3 patients. The patients received the booster dose of 0.25 ml. The vial was initially stored in the refrigerator on 10-Nov-2021 and  was first punctured on 22-Nov-2021 at 09:02 hours.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 007B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Ligament tear and Gout (bone on bone). Concomitant products included MELOXICAM for Knee ligament injury.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 24-Nov-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had not resolved and PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is having a torn ligament on his knees and waiting for MRI for his knee. Patient received a steroid shot for the knee in the past but that only worked for about 24 hours.  No treatment details were provided.   This case was linked to MOD-2021-395997 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: After 12 hours after the vial was punctured, it was given to 3 patients./Patient's received vaccine after expiry.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After 12 hours after the vial was punctured, it was given to 3 patients./Patient's received vaccine after expiry.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021 at 9:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 23-Nov-2021 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (After 12 hours after the vial was punctured, it was given to 3 patients./Patient's received vaccine after expiry.). On 23-Nov-2021 at 9:00 AM, EXPIRED PRODUCT ADMINISTERED (After 12 hours after the vial was punctured, it was given to 3 patients./Patient's received vaccine after expiry.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported, she did not believe that the patient reported having side effect.   Dose administered: >12/24 hours post puncture Number of doses/vials: 3 doses 1 vials  Date the vial was initially stored in the refrigerator: 10-Nov-2021 at 13:32 hour Date(s) and time(S) vial was first punctured: 22-Nov-2021 at 09:02 am  How was the vial stored post puncture (RT/fridge): Fridge Did the vial undergo any temperature excursions: No  No treatment information was provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Rhinorrhoea
Clinical narrative: Runny nose; stuffed up nose; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), NASAL CONGESTION (stuffed up nose) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Nov-2021, the patient experienced RHINORRHOEA (Runny nose), NASAL CONGESTION (stuffed up nose) and HEADACHE (Headache). At the time of the report, RHINORRHOEA (Runny nose), NASAL CONGESTION (stuffed up nose) and HEADACHE (Headache) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Liver function test, Liver function test increased
Clinical narrative: Elevated liver functions; This spontaneous case was reported by a physician and describes the occurrence of LIVER FUNCTION TEST INCREASED (Elevated liver functions) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 012L20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIVER FUNCTION TEST INCREASED (Elevated liver functions). At the time of the report, LIVER FUNCTION TEST INCREASED (Elevated liver functions) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Liver function test: normal (normal) normal. On 22-Nov-2021, Liver function test: elevated (High) Elevated liver functions.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Pain
Clinical narrative: everything hurts; Feels like shit today; his muscles hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (everything hurts), FEELING ABNORMAL (Feels like shit today) and MYALGIA (his muscles hurt) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced PAIN (everything hurts), FEELING ABNORMAL (Feels like shit today) and MYALGIA (his muscles hurt). At the time of the report, PAIN (everything hurts), FEELING ABNORMAL (Feels like shit today) and MYALGIA (his muscles hurt) outcome was unknown.            No concomitant medications were reported   No treatment information was provided
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Pain, Pain in extremity
Clinical narrative: Body aches; Sore arm; Chills; Vomiting every 16 minutes for 6 hours; Very bad Headache; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), VOMITING (Vomiting every 16 minutes for 6 hours) and HEADACHE (Very bad Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine on 10-Mar-2021 and Pfizer COVID-19 vaccine on 05-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine; and Vomiting with Pfizer COVID-19 vaccine.    On 22-Nov-2021 at 4:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021 at 4:30 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 23-Nov-2021 at 2:30 AM, the patient experienced PAIN (Body aches), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), VOMITING (Vomiting every 16 minutes for 6 hours) and HEADACHE (Very bad Headache). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency. On 22-Nov-2021 at 4:30 PM, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 24-Nov-2021, PAIN (Body aches), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), VOMITING (Vomiting every 16 minutes for 6 hours) and HEADACHE (Very bad Headache) had resolved.            No concomitant medications were provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Body aches; Sore arm; Chills; Vomiting every 16 minutes for 6 hours; Very bad Headache; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), VOMITING (Vomiting every 16 minutes for 6 hours) and HEADACHE (Very bad Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine on 10-Mar-2021 and Pfizer COVID-19 vaccine on 05-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine; and Vomiting with Pfizer COVID-19 vaccine.    On 22-Nov-2021 at 4:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021 at 4:30 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 23-Nov-2021 at 2:30 AM, the patient experienced PAIN (Body aches), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), VOMITING (Vomiting every 16 minutes for 6 hours) and HEADACHE (Very bad Headache). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency. On 22-Nov-2021 at 4:30 PM, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 24-Nov-2021, PAIN (Body aches), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), VOMITING (Vomiting every 16 minutes for 6 hours) and HEADACHE (Very bad Headache) had resolved.            No concomitant medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of NAUSEA (nausea) and VOMITING (vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Erythema, Laboratory test, Myalgia, Pain in extremity
Clinical narrative: Sore arm; Red circle; Body ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red circle), MYALGIA (Body ache) and PYREXIA (Fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 0251202A) for COVID-19 vaccination.     The patient's past medical history included Hives. Previously administered products included for Product used for unknown indication: Influenza (Route: Intramuscular and Body site/side: Left bicep). Past adverse reactions to the above products included No adverse event with Influenza. Concurrent medical conditions included Blood pressure high (High blood pressure (controlled for 12 years)) since 2009, Klippel-Feil syndrome, Chronic back pain, Drug allergy (Reaction: hives), Drug allergy (Reaction: hives) since 2004, Asthma, Depression since 2003, Anxiety since 2003 and Pain. Concomitant products included BUSPIRONE for Anxiety, PAROXETINE for Depression, LISINOPRIL for Hypertension, AMITRIPTYLINE and MELOXICAM for Pain, GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red circle), MYALGIA (Body ache) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red circle), MYALGIA (Body ache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Normal. On an unknown date, Laboratory test: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After First dose patient had no side effects. No treatment information was reported. It was unknown if patient had a medical history of hay fever.   This case was linked to MOD-2021-396172 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Follow up received includes reporter information added, patient demographics added, medical history added, Laboratory data added, new concomitant medication lisinopril added and previous concomitant medications dosage regimen information updated and added,
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore arm; Red circle; Body ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red circle), MYALGIA (Body ache) and PYREXIA (Fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 0251202A) for COVID-19 vaccination.     The patient's past medical history included Hives. Previously administered products included for Product used for unknown indication: Influenza (Route: Intramuscular and Body site/side: Left bicep). Past adverse reactions to the above products included No adverse event with Influenza. Concurrent medical conditions included Blood pressure high (High blood pressure (controlled for 12 years)) since 2009, Klippel-Feil syndrome, Chronic back pain, Drug allergy (Reaction: hives), Drug allergy (Reaction: hives) since 2004, Asthma, Depression since 2003, Anxiety since 2003 and Pain. Concomitant products included BUSPIRONE for Anxiety, PAROXETINE for Depression, LISINOPRIL for Hypertension, AMITRIPTYLINE and MELOXICAM for Pain, GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red circle), MYALGIA (Body ache) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red circle), MYALGIA (Body ache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Normal. On an unknown date, Laboratory test: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After First dose patient had no side effects. No treatment information was reported. It was unknown if patient had a medical history of hay fever.   This case was linked to MOD-2021-396172 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Follow up received includes reporter information added, patient demographics added, medical history added, Laboratory data added, new concomitant medication lisinopril added and previous concomitant medications dosage regimen information updated and added,