chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little achiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little achiness at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (little achiness at injection site). On 02-Mar-2021, VACCINATION SITE PAIN (little achiness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided. No concomitant medications were provided.   This case was linked to MOD21-066333 (E2B Linked Report). This case was linked to US-MODERNATX, INC.-MOD-2021-064999 (Patient Link).; Sender's Comments:  MOD21-066333:crosslinked case
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia, Rash erythematous, Vaccination site induration
Clinical narrative: the red circle got larger with rash around it; Soreness in the arm; a hard red circle with a ball underneath it in the arm; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (a hard red circle with a ball underneath it in the arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included GABAPENTIN (NEURONTIN) and LISINOPRIL for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE INDURATION (a hard red circle with a ball underneath it in the arm). At the time of the report, VACCINATION SITE INDURATION (a hard red circle with a ball underneath it in the arm) outcome was unknown.            No treatment information were reported. Action taken with the drug in response to events was not applicable.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: chills; fever; fatigue; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (body aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since 2000, Skin cancer, Latex allergy and Sulfonamide allergy. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), MONTELUKAST SODIUM (SINGULAIR) and SALBUTAMOL SULFATE (VENTOLIN HFA) for Asthma, ESOMEPRAZOLE MAGNESIUM (NEXIUM CONTROL) for GERD, ATORVASTATIN for Hypercholesterolemia, LOSARTAN for Hypertension.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced CHILLS (chills). 31-Jan-2021, the patient experienced PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (body aches). The patient was treated with AZITHROMYCIN (ZITHROMAX) (oral) from 05-Jan-2021 to 08-Jan-2021 for SARS-CoV-2 infection, at a dose of 500 milligram. At the time of the report, CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Body temperature: 100 (High) Body temperature-high. On 05-Jan-2021, SARS-CoV-2 test: positive (Positive) sars-cov2 rapid antigen-positive(nasopharyngeal sample).         Action taken with mRNA-1273 in response to the event was not applicable.       Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: chills; fever; fatigue; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (body aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since 2000, Skin cancer, Latex allergy and Sulfonamide allergy. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), MONTELUKAST SODIUM (SINGULAIR) and SALBUTAMOL SULFATE (VENTOLIN HFA) for Asthma, ESOMEPRAZOLE MAGNESIUM (NEXIUM CONTROL) for GERD, ATORVASTATIN for Hypercholesterolemia, LOSARTAN for Hypertension.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced CHILLS (chills). 31-Jan-2021, the patient experienced PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (body aches). The patient was treated with AZITHROMYCIN (ZITHROMAX) (oral) from 05-Jan-2021 to 08-Jan-2021 for SARS-CoV-2 infection, at a dose of 500 milligram. At the time of the report, CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Body temperature: 100 (High) Body temperature-high. On 05-Jan-2021, SARS-CoV-2 test: positive (Positive) sars-cov2 rapid antigen-positive(nasopharyngeal sample).         Action taken with mRNA-1273 in response to the event was not applicable.       Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: RASH; Could Not Breath; This spontaneous case was reported by a consumer and describes the occurrence of RASH (RASH) and DYSPNOEA (Could Not Breath) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021A12A) for COVID-19 vaccination.     The patient's past medical history included Angioedema and Asthma.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RASH (RASH) and DYSPNOEA (Could Not Breath). On 11-Mar-2021, RASH (RASH) and DYSPNOEA (Could Not Breath) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included, Asthma Inhaler. List of concomitant medication include, Asthma Inhaler.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Albumin globulin ratio, Aspartate aminotransferase, Blood albumin, Blood alkaline phosphatase
Clinical narrative: Verify fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Verify fatigue) in a 54-year-old female patient 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) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Verify fatigue). At the time of the report, FATIGUE (Verify fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Alanine aminotransferase (6-29): 93 (High) 93. On 25-Mar-2021, Albumin globulin ratio (1.0-2.5): 1.6 (normal) 1.6. On 25-Mar-2021, Aspartate aminotransferase (10-35): 54 (High) 54. On 25-Mar-2021, Blood albumin (3.6-5.1): 4.6 (normal) 4.6. On 25-Mar-2021, Blood alkaline phosphatase (37-163): 189 (High) 189. On 25-Mar-2021, Blood bilirubin (0.2-1.2): 0.3 (normal) 0.3. On 25-Mar-2021, Blood calcium (8.6-10.4): 9.5 (normal) 9.5. On 25-Mar-2021, Blood chloride (98-110): 102 (Low) 102. On 25-Mar-2021, Blood creatine phosphokinase (29-143): 39 (normal) 39. On 25-Mar-2021, Blood creatinine (0.50-1.05): 0.82 (normal) 0.82. On 25-Mar-2021, Blood glucose (65-99): 82 (normal) 82. On 25-Mar-2021, Blood potassium (3.5-5.3): 5.0 (normal) 5.0. On 25-Mar-2021, Blood sodium (135-146): 139 (normal) 139. On 25-Mar-2021, Blood urea increased (7-25): 19 (normal) 19. On 25-Mar-2021, Blood urea nitrogen/creatinine ratio (6-22): inconclusive (Inconclusive) inconclusive. On 25-Mar-2021, Carbon dioxide (20-32): 27 (Low) 27. On 25-Mar-2021, Gamma-glutamyltransferase (3-7.0): 267 (High) 267. On 25-Mar-2021, Globulin (1.9-3.7): 2.8 (normal) 2.8. On 25-Mar-2021, Glomerular filtration rate (60-Unknown): 81 (normal) >OR+60 ML/Min 1.73m2. On 25-Mar-2021, Hepatitis A antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B core antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B surface antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B surface antigen: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis C antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Protein total (6.1-8.1 g/dL): 7.4 g/dL (Low) 7.4. On 25-Mar-2021, SARS-CoV-2 antibody test (<1.00-Unknown Index of reactivity): 6.40 Index of reactivity (High) 6.40. On 25-Mar-2021, White blood cell count: tnp thousand per microlitre (Inconclusive) TNP.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided No treatment medication details were provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood bilirubin, Blood calcium, Blood chloride, Blood creatine phosphokinase, Blood creatinine
Clinical narrative: Verify fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Verify fatigue) in a 54-year-old female patient 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) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Verify fatigue). At the time of the report, FATIGUE (Verify fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Alanine aminotransferase (6-29): 93 (High) 93. On 25-Mar-2021, Albumin globulin ratio (1.0-2.5): 1.6 (normal) 1.6. On 25-Mar-2021, Aspartate aminotransferase (10-35): 54 (High) 54. On 25-Mar-2021, Blood albumin (3.6-5.1): 4.6 (normal) 4.6. On 25-Mar-2021, Blood alkaline phosphatase (37-163): 189 (High) 189. On 25-Mar-2021, Blood bilirubin (0.2-1.2): 0.3 (normal) 0.3. On 25-Mar-2021, Blood calcium (8.6-10.4): 9.5 (normal) 9.5. On 25-Mar-2021, Blood chloride (98-110): 102 (Low) 102. On 25-Mar-2021, Blood creatine phosphokinase (29-143): 39 (normal) 39. On 25-Mar-2021, Blood creatinine (0.50-1.05): 0.82 (normal) 0.82. On 25-Mar-2021, Blood glucose (65-99): 82 (normal) 82. On 25-Mar-2021, Blood potassium (3.5-5.3): 5.0 (normal) 5.0. On 25-Mar-2021, Blood sodium (135-146): 139 (normal) 139. On 25-Mar-2021, Blood urea increased (7-25): 19 (normal) 19. On 25-Mar-2021, Blood urea nitrogen/creatinine ratio (6-22): inconclusive (Inconclusive) inconclusive. On 25-Mar-2021, Carbon dioxide (20-32): 27 (Low) 27. On 25-Mar-2021, Gamma-glutamyltransferase (3-7.0): 267 (High) 267. On 25-Mar-2021, Globulin (1.9-3.7): 2.8 (normal) 2.8. On 25-Mar-2021, Glomerular filtration rate (60-Unknown): 81 (normal) >OR+60 ML/Min 1.73m2. On 25-Mar-2021, Hepatitis A antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B core antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B surface antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B surface antigen: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis C antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Protein total (6.1-8.1 g/dL): 7.4 g/dL (Low) 7.4. On 25-Mar-2021, SARS-CoV-2 antibody test (<1.00-Unknown Index of reactivity): 6.40 Index of reactivity (High) 6.40. On 25-Mar-2021, White blood cell count: tnp thousand per microlitre (Inconclusive) TNP.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided No treatment medication details were provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood potassium, Blood sodium, Blood urea increased, Blood urea nitrogen/creatinine ratio
Clinical narrative: Verify fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Verify fatigue) in a 54-year-old female patient 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) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Verify fatigue). At the time of the report, FATIGUE (Verify fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Alanine aminotransferase (6-29): 93 (High) 93. On 25-Mar-2021, Albumin globulin ratio (1.0-2.5): 1.6 (normal) 1.6. On 25-Mar-2021, Aspartate aminotransferase (10-35): 54 (High) 54. On 25-Mar-2021, Blood albumin (3.6-5.1): 4.6 (normal) 4.6. On 25-Mar-2021, Blood alkaline phosphatase (37-163): 189 (High) 189. On 25-Mar-2021, Blood bilirubin (0.2-1.2): 0.3 (normal) 0.3. On 25-Mar-2021, Blood calcium (8.6-10.4): 9.5 (normal) 9.5. On 25-Mar-2021, Blood chloride (98-110): 102 (Low) 102. On 25-Mar-2021, Blood creatine phosphokinase (29-143): 39 (normal) 39. On 25-Mar-2021, Blood creatinine (0.50-1.05): 0.82 (normal) 0.82. On 25-Mar-2021, Blood glucose (65-99): 82 (normal) 82. On 25-Mar-2021, Blood potassium (3.5-5.3): 5.0 (normal) 5.0. On 25-Mar-2021, Blood sodium (135-146): 139 (normal) 139. On 25-Mar-2021, Blood urea increased (7-25): 19 (normal) 19. On 25-Mar-2021, Blood urea nitrogen/creatinine ratio (6-22): inconclusive (Inconclusive) inconclusive. On 25-Mar-2021, Carbon dioxide (20-32): 27 (Low) 27. On 25-Mar-2021, Gamma-glutamyltransferase (3-7.0): 267 (High) 267. On 25-Mar-2021, Globulin (1.9-3.7): 2.8 (normal) 2.8. On 25-Mar-2021, Glomerular filtration rate (60-Unknown): 81 (normal) >OR+60 ML/Min 1.73m2. On 25-Mar-2021, Hepatitis A antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B core antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B surface antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B surface antigen: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis C antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Protein total (6.1-8.1 g/dL): 7.4 g/dL (Low) 7.4. On 25-Mar-2021, SARS-CoV-2 antibody test (<1.00-Unknown Index of reactivity): 6.40 Index of reactivity (High) 6.40. On 25-Mar-2021, White blood cell count: tnp thousand per microlitre (Inconclusive) TNP.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided No treatment medication details were provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Carbon dioxide, Fatigue, Gamma-glutamyltransferase, Globulin, Glomerular filtration rate
Clinical narrative: Verify fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Verify fatigue) in a 54-year-old female patient 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) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Verify fatigue). At the time of the report, FATIGUE (Verify fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Alanine aminotransferase (6-29): 93 (High) 93. On 25-Mar-2021, Albumin globulin ratio (1.0-2.5): 1.6 (normal) 1.6. On 25-Mar-2021, Aspartate aminotransferase (10-35): 54 (High) 54. On 25-Mar-2021, Blood albumin (3.6-5.1): 4.6 (normal) 4.6. On 25-Mar-2021, Blood alkaline phosphatase (37-163): 189 (High) 189. On 25-Mar-2021, Blood bilirubin (0.2-1.2): 0.3 (normal) 0.3. On 25-Mar-2021, Blood calcium (8.6-10.4): 9.5 (normal) 9.5. On 25-Mar-2021, Blood chloride (98-110): 102 (Low) 102. On 25-Mar-2021, Blood creatine phosphokinase (29-143): 39 (normal) 39. On 25-Mar-2021, Blood creatinine (0.50-1.05): 0.82 (normal) 0.82. On 25-Mar-2021, Blood glucose (65-99): 82 (normal) 82. On 25-Mar-2021, Blood potassium (3.5-5.3): 5.0 (normal) 5.0. On 25-Mar-2021, Blood sodium (135-146): 139 (normal) 139. On 25-Mar-2021, Blood urea increased (7-25): 19 (normal) 19. On 25-Mar-2021, Blood urea nitrogen/creatinine ratio (6-22): inconclusive (Inconclusive) inconclusive. On 25-Mar-2021, Carbon dioxide (20-32): 27 (Low) 27. On 25-Mar-2021, Gamma-glutamyltransferase (3-7.0): 267 (High) 267. On 25-Mar-2021, Globulin (1.9-3.7): 2.8 (normal) 2.8. On 25-Mar-2021, Glomerular filtration rate (60-Unknown): 81 (normal) >OR+60 ML/Min 1.73m2. On 25-Mar-2021, Hepatitis A antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B core antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B surface antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B surface antigen: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis C antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Protein total (6.1-8.1 g/dL): 7.4 g/dL (Low) 7.4. On 25-Mar-2021, SARS-CoV-2 antibody test (<1.00-Unknown Index of reactivity): 6.40 Index of reactivity (High) 6.40. On 25-Mar-2021, White blood cell count: tnp thousand per microlitre (Inconclusive) TNP.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided No treatment medication details were provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis A antibody, Hepatitis B core antibody, Hepatitis B surface antibody, Hepatitis B surface antigen, Hepatitis C antibody
Clinical narrative: Verify fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Verify fatigue) in a 54-year-old female patient 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) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Verify fatigue). At the time of the report, FATIGUE (Verify fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Alanine aminotransferase (6-29): 93 (High) 93. On 25-Mar-2021, Albumin globulin ratio (1.0-2.5): 1.6 (normal) 1.6. On 25-Mar-2021, Aspartate aminotransferase (10-35): 54 (High) 54. On 25-Mar-2021, Blood albumin (3.6-5.1): 4.6 (normal) 4.6. On 25-Mar-2021, Blood alkaline phosphatase (37-163): 189 (High) 189. On 25-Mar-2021, Blood bilirubin (0.2-1.2): 0.3 (normal) 0.3. On 25-Mar-2021, Blood calcium (8.6-10.4): 9.5 (normal) 9.5. On 25-Mar-2021, Blood chloride (98-110): 102 (Low) 102. On 25-Mar-2021, Blood creatine phosphokinase (29-143): 39 (normal) 39. On 25-Mar-2021, Blood creatinine (0.50-1.05): 0.82 (normal) 0.82. On 25-Mar-2021, Blood glucose (65-99): 82 (normal) 82. On 25-Mar-2021, Blood potassium (3.5-5.3): 5.0 (normal) 5.0. On 25-Mar-2021, Blood sodium (135-146): 139 (normal) 139. On 25-Mar-2021, Blood urea increased (7-25): 19 (normal) 19. On 25-Mar-2021, Blood urea nitrogen/creatinine ratio (6-22): inconclusive (Inconclusive) inconclusive. On 25-Mar-2021, Carbon dioxide (20-32): 27 (Low) 27. On 25-Mar-2021, Gamma-glutamyltransferase (3-7.0): 267 (High) 267. On 25-Mar-2021, Globulin (1.9-3.7): 2.8 (normal) 2.8. On 25-Mar-2021, Glomerular filtration rate (60-Unknown): 81 (normal) >OR+60 ML/Min 1.73m2. On 25-Mar-2021, Hepatitis A antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B core antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B surface antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B surface antigen: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis C antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Protein total (6.1-8.1 g/dL): 7.4 g/dL (Low) 7.4. On 25-Mar-2021, SARS-CoV-2 antibody test (<1.00-Unknown Index of reactivity): 6.40 Index of reactivity (High) 6.40. On 25-Mar-2021, White blood cell count: tnp thousand per microlitre (Inconclusive) TNP.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided No treatment medication details were provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Protein total, SARS-CoV-2 antibody test, White blood cell count
Clinical narrative: Verify fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Verify fatigue) in a 54-year-old female patient 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) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Verify fatigue). At the time of the report, FATIGUE (Verify fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Alanine aminotransferase (6-29): 93 (High) 93. On 25-Mar-2021, Albumin globulin ratio (1.0-2.5): 1.6 (normal) 1.6. On 25-Mar-2021, Aspartate aminotransferase (10-35): 54 (High) 54. On 25-Mar-2021, Blood albumin (3.6-5.1): 4.6 (normal) 4.6. On 25-Mar-2021, Blood alkaline phosphatase (37-163): 189 (High) 189. On 25-Mar-2021, Blood bilirubin (0.2-1.2): 0.3 (normal) 0.3. On 25-Mar-2021, Blood calcium (8.6-10.4): 9.5 (normal) 9.5. On 25-Mar-2021, Blood chloride (98-110): 102 (Low) 102. On 25-Mar-2021, Blood creatine phosphokinase (29-143): 39 (normal) 39. On 25-Mar-2021, Blood creatinine (0.50-1.05): 0.82 (normal) 0.82. On 25-Mar-2021, Blood glucose (65-99): 82 (normal) 82. On 25-Mar-2021, Blood potassium (3.5-5.3): 5.0 (normal) 5.0. On 25-Mar-2021, Blood sodium (135-146): 139 (normal) 139. On 25-Mar-2021, Blood urea increased (7-25): 19 (normal) 19. On 25-Mar-2021, Blood urea nitrogen/creatinine ratio (6-22): inconclusive (Inconclusive) inconclusive. On 25-Mar-2021, Carbon dioxide (20-32): 27 (Low) 27. On 25-Mar-2021, Gamma-glutamyltransferase (3-7.0): 267 (High) 267. On 25-Mar-2021, Globulin (1.9-3.7): 2.8 (normal) 2.8. On 25-Mar-2021, Glomerular filtration rate (60-Unknown): 81 (normal) >OR+60 ML/Min 1.73m2. On 25-Mar-2021, Hepatitis A antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B core antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B surface antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B surface antigen: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis C antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Protein total (6.1-8.1 g/dL): 7.4 g/dL (Low) 7.4. On 25-Mar-2021, SARS-CoV-2 antibody test (<1.00-Unknown Index of reactivity): 6.40 Index of reactivity (High) 6.40. On 25-Mar-2021, White blood cell count: tnp thousand per microlitre (Inconclusive) TNP.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided No treatment medication details were provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (allergic reaction) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HYPERSENSITIVITY (allergic reaction). At the time of the report, HYPERSENSITIVITY (allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pollakiuria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Little achy) and POLLAKIURIA (Frequent urination) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN (Little achy) and POLLAKIURIA (Frequent urination). At the time of the report, PAIN (Little achy) and POLLAKIURIA (Frequent urination) outcome was unknown. Treatment information not provided. List of concomitant medication were not given.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Lesion excision, Pain, Rash, Swelling
Clinical narrative: lesions; swelling; pain; difficulty walking; lesions and rash spread to her ankles and lower legs; rash on feet; This spontaneous case was reported by a physician and describes the occurrence of LESION EXCISION (lesions), SWELLING (swelling), PAIN (pain), GAIT DISTURBANCE (difficulty walking) and RASH (lesions and rash spread to her ankles and lower legs) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cryoglobulinemia.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced LESION EXCISION (lesions), SWELLING (swelling), PAIN (pain), GAIT DISTURBANCE (difficulty walking), RASH (lesions and rash spread to her ankles and lower legs) and RASH (rash on feet). On 25-Mar-2021, SWELLING (swelling), PAIN (pain), GAIT DISTURBANCE (difficulty walking) and RASH (lesions and rash spread to her ankles and lower legs) had resolved. At the time of the report, LESION EXCISION (lesions) and RASH (rash on feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication has provided. No treatment medication has provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received his second dose of Moderna today, he is 17; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received his second dose of Moderna today, he is 17) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received his second dose of Moderna today, he is 17). On 30-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received his second dose of Moderna today, he is 17) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.   This case was linked to MOD-2021-065078 (Patient Link).; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received Moderna Vaccine) in a 17-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received Moderna Vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received Moderna Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.    This case was linked to MOD-2021-065070 (Patient Link).; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: Unknown) with no associated AEs.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Hyperhidrosis, Oropharyngeal pain
Clinical narrative: Cough; Sore throat; Skin burning; Sweating; Fever; Fatigue; Chills; This case was received via an unknown source (no reference has been entered for a license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a nurse and describes the occurrence of COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), SKIN BURNING SENSATION (Skin burning ), HYPERHIDROSIS (Sweating) and PYREXIA (Fever) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gluten sensitivity and Milk allergy. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for BPH, LEVOTHYROXINE for Thyroid function abnormal, THYROID (ARMOUR THYROID) for Thyroid function decreased, LAMOTRIGINE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), SKIN BURNING SENSATION (Skin burning ), HYPERHIDROSIS (Sweating), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), SKIN BURNING SENSATION (Skin burning ), HYPERHIDROSIS (Sweating), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-017620 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Skin burning sensation
Clinical narrative: Cough; Sore throat; Skin burning; Sweating; Fever; Fatigue; Chills; This case was received via an unknown source (no reference has been entered for a license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a nurse and describes the occurrence of COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), SKIN BURNING SENSATION (Skin burning ), HYPERHIDROSIS (Sweating) and PYREXIA (Fever) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gluten sensitivity and Milk allergy. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for BPH, LEVOTHYROXINE for Thyroid function abnormal, THYROID (ARMOUR THYROID) for Thyroid function decreased, LAMOTRIGINE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), SKIN BURNING SENSATION (Skin burning ), HYPERHIDROSIS (Sweating), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), SKIN BURNING SENSATION (Skin burning ), HYPERHIDROSIS (Sweating), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-017620 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: mild fever; body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (mild fever), MYALGIA (body ache) and HEADACHE (headache) in a female patient of an unknown age 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 PYREXIA (mild fever), MYALGIA (body ache) and HEADACHE (headache). At the time of the report, PYREXIA (mild fever), MYALGIA (body ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.    Reporter did not allow further contact
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Hyperhidrosis, Pain in extremity
Clinical narrative: Skin felt like it was on fire; Low grade fever; Chills; Arm hurt really bad; Sweating; Cough; Scratchy throat; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm hurt really bad), SKIN BURNING SENSATION (Skin felt like it was on fire), HYPERHIDROSIS (Sweating), COUGH (Cough) and THROAT IRRITATION (Scratchy throat) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 20-Dec-2020 to 30-Dec-2020. Concurrent medical conditions included Gluten sensitivity and Milk allergy. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for BPH, LANSOPRAZOLE (LANSPRO) for Mood disorder, LAMOTRIGINE for Mood disorder NOS, LEVOTHYROXINE and THYROID (ARMOUR THYROID) for Thyroid disorder NOS.    On 21-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt really bad), HYPERHIDROSIS (Sweating) and FATIGUE (Fatigue). 21-Jan-2021, the patient experienced COUGH (Cough). 21-Jan-2021, the patient experienced THROAT IRRITATION (Scratchy throat). On 21-Jan-2021 at 3:00 PM, the patient experienced CHILLS (Chills). On 21-Jan-2021 at 6:00 PM, the patient experienced SKIN BURNING SENSATION (Skin felt like it was on fire) and PYREXIA (Low grade fever). On 24-Jan-2021, PAIN IN EXTREMITY (Arm hurt really bad), SKIN BURNING SENSATION (Skin felt like it was on fire), HYPERHIDROSIS (Sweating), COUGH (Cough), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved. At the time of the report, THROAT IRRITATION (Scratchy throat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Skin burning sensation, Throat irritation
Clinical narrative: Skin felt like it was on fire; Low grade fever; Chills; Arm hurt really bad; Sweating; Cough; Scratchy throat; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm hurt really bad), SKIN BURNING SENSATION (Skin felt like it was on fire), HYPERHIDROSIS (Sweating), COUGH (Cough) and THROAT IRRITATION (Scratchy throat) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 20-Dec-2020 to 30-Dec-2020. Concurrent medical conditions included Gluten sensitivity and Milk allergy. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for BPH, LANSOPRAZOLE (LANSPRO) for Mood disorder, LAMOTRIGINE for Mood disorder NOS, LEVOTHYROXINE and THYROID (ARMOUR THYROID) for Thyroid disorder NOS.    On 21-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt really bad), HYPERHIDROSIS (Sweating) and FATIGUE (Fatigue). 21-Jan-2021, the patient experienced COUGH (Cough). 21-Jan-2021, the patient experienced THROAT IRRITATION (Scratchy throat). On 21-Jan-2021 at 3:00 PM, the patient experienced CHILLS (Chills). On 21-Jan-2021 at 6:00 PM, the patient experienced SKIN BURNING SENSATION (Skin felt like it was on fire) and PYREXIA (Low grade fever). On 24-Jan-2021, PAIN IN EXTREMITY (Arm hurt really bad), SKIN BURNING SENSATION (Skin felt like it was on fire), HYPERHIDROSIS (Sweating), COUGH (Cough), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved. At the time of the report, THROAT IRRITATION (Scratchy throat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Hyperhidrosis, Pain in extremity
Clinical narrative: Skin felt like it was on fire; Hyperhidrosis; Throat irritation; Pain in extremity; Cough; Chills; Pyrexia; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of SKIN BURNING SENSATION (Skin felt like it was on fire), HYPERHIDROSIS (Hyperhidrosis), THROAT IRRITATION (Throat irritation), PAIN IN EXTREMITY (Pain in extremity) and COUGH (Cough) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 20-Dec-2020 to 30-Dec-2020. Concurrent medical conditions included Gluten sensitivity and Milk allergy (milk sensitivity). Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for BPH, LEVOTHYROXINE and THYROID (ARMOUR THYROID) for Disorder thyroid, LAMOTRIGINE and ALPRAZOLAM (LAMPRO) for Mood alteration NOS.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced SKIN BURNING SENSATION (Skin felt like it was on fire), HYPERHIDROSIS (Hyperhidrosis), THROAT IRRITATION (Throat irritation), PAIN IN EXTREMITY (Pain in extremity), COUGH (Cough), CHILLS (Chills), PYREXIA (Pyrexia) and FATIGUE (Fatigue). On 20-Feb-2021, SKIN BURNING SENSATION (Skin felt like it was on fire), HYPERHIDROSIS (Hyperhidrosis), THROAT IRRITATION (Throat irritation), PAIN IN EXTREMITY (Pain in extremity), COUGH (Cough), CHILLS (Chills), PYREXIA (Pyrexia) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Skin burning sensation, Throat irritation
Clinical narrative: Skin felt like it was on fire; Hyperhidrosis; Throat irritation; Pain in extremity; Cough; Chills; Pyrexia; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of SKIN BURNING SENSATION (Skin felt like it was on fire), HYPERHIDROSIS (Hyperhidrosis), THROAT IRRITATION (Throat irritation), PAIN IN EXTREMITY (Pain in extremity) and COUGH (Cough) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 20-Dec-2020 to 30-Dec-2020. Concurrent medical conditions included Gluten sensitivity and Milk allergy (milk sensitivity). Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for BPH, LEVOTHYROXINE and THYROID (ARMOUR THYROID) for Disorder thyroid, LAMOTRIGINE and ALPRAZOLAM (LAMPRO) for Mood alteration NOS.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced SKIN BURNING SENSATION (Skin felt like it was on fire), HYPERHIDROSIS (Hyperhidrosis), THROAT IRRITATION (Throat irritation), PAIN IN EXTREMITY (Pain in extremity), COUGH (Cough), CHILLS (Chills), PYREXIA (Pyrexia) and FATIGUE (Fatigue). On 20-Feb-2021, SKIN BURNING SENSATION (Skin felt like it was on fire), HYPERHIDROSIS (Hyperhidrosis), THROAT IRRITATION (Throat irritation), PAIN IN EXTREMITY (Pain in extremity), COUGH (Cough), CHILLS (Chills), PYREXIA (Pyrexia) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: fever; Vaccination site swelling; Vaccination site Pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site Pain) 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 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site Pain). On an unknown date, the patient experienced PYREXIA (fever) and VACCINATION SITE SWELLING (Vaccination site swelling). On 27-Mar-2021, VACCINATION SITE PAIN (Vaccination site Pain) had resolved. At the time of the report, PYREXIA (fever) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-065263 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dysgeusia, Fatigue, Parosmia
Clinical narrative: Fatigue; Smell smoking burning metal; Bizarre metallic taste in my mouth; Clammy; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Smell smoking burning metal), DYSGEUSIA (Bizarre metallic taste in my mouth), COLD SWEAT (Clammy) and FATIGUE (Fatigue) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAROSMIA (Smell smoking burning metal), DYSGEUSIA (Bizarre metallic taste in my mouth) and COLD SWEAT (Clammy). On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, PAROSMIA (Smell smoking burning metal), COLD SWEAT (Clammy) and FATIGUE (Fatigue) outcome was unknown and DYSGEUSIA (Bizarre metallic taste in my mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.