chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .     On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) 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.   No concomitant medication details was reported. No treatment medication details was reported.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Muscle spasms, Myalgia
Clinical narrative: cannot lift left leg; cramps in leg; soreness on her entire left side; her left knee is killing her. She states she cannot bend her knee, cannot lift it up and it is hard to walk right.; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (cannot lift left leg), MUSCLE SPASMS (cramps in leg), MYALGIA (soreness on her entire left side) and ARTHRALGIA (her left knee is killing her. She states she cannot bend her knee, cannot lift it up and it is hard to walk right.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included FLUPHENAZINE, SERTRALINE, CLONAZEPAM, METFORMIN, INSULIN GLARGINE (LANTUS) and LOVASTATIN for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (soreness on her entire left side) and ARTHRALGIA (her left knee is killing her. She states she cannot bend her knee, cannot lift it up and it is hard to walk right.). On 11-Mar-2021, the patient experienced MOBILITY DECREASED (cannot lift left leg) and MUSCLE SPASMS (cramps in leg). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (cannot lift left leg), MUSCLE SPASMS (cramps in leg), MYALGIA (soreness on her entire left side) and ARTHRALGIA (her left knee is killing her. She states she cannot bend her knee, cannot lift it up and it is hard to walk right.) 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.   Treatment drugs were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2021: concomitant medications were added, treatment medication was added, patient details were added, event were added. On 22-Jul-2021: Non significant information received: Patient wanted to get follow-up form to mailing address
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: worm in touch; Injection site itchy; Injection site red round (like circle); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (worm in touch), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (Injection site red round (like circle)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (worm in touch), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (Injection site red round (like circle)). At the time of the report, VACCINATION SITE WARMTH (worm in touch), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (Injection site red round (like circle)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is taking blood pressure and diabetes medications concomitantly.   Treatment medications include cortisone and antibacterial creams.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itching at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the site of injection) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the site of injection). At the time of the report, VACCINATION SITE PRURITUS (itching at the site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. The patient took Benadryl as treatment medication.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: dizziness; weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and ASTHENIA (weakness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (I have allergies.).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIZZINESS (dizziness) and ASTHENIA (weakness). At the time of the report, DIZZINESS (dizziness) and ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Chills, Dyspnoea, Dysstasia, Fatigue
Clinical narrative: could not walk and sit up, unable to move around too much; very sleepy and drowsy; unable to move around too much, unable to stand long, have to sit back; could not get out of bed; right arm itchy; Really bad headache; little bit of fever; Fatigue; Chills; allergic reaction - could not breath, started sweating; Could not breath; Started sweating; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergic reaction - could not breath, started sweating), DYSPNOEA (Could not breath), HYPERHIDROSIS (Started sweating), GAIT DISTURBANCE (could not walk and sit up, unable to move around too much) and SOMNOLENCE (very sleepy and drowsy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022MA0N) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Medical history was not reported by reporter.  Concomitant products included INSULIN GLARGINE (BASAGLAR), INSULIN LISPRO (HUMALOG), CLONIDINE, METFORMIN, METOPROLOL, ATORVASTATIN CALCIUM (AVASTIN [ATORVASTATIN CALCIUM]), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), RITUXIMAB (RITUXAN) and HYDROCHLOROTHIAZIDE, LISINOPRIL (ZESTORETIC) for an unknown indication.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 27-Feb-2021, the patient experienced ALLERGY TO VACCINE (allergic reaction - could not breath, started sweating), DYSPNOEA (Could not breath) and HYPERHIDROSIS (Started sweating). On 28-Feb-2021, the patient experienced GAIT DISTURBANCE (could not walk and sit up, unable to move around too much), SOMNOLENCE (very sleepy and drowsy), DYSSTASIA (unable to move around too much, unable to stand long, have to sit back), HYPOKINESIA (could not get out of bed), VACCINATION SITE PRURITUS (right arm itchy), HEADACHE (Really bad headache), PYREXIA (little bit of fever), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Feb-2021, ALLERGY TO VACCINE (allergic reaction - could not breath, started sweating), DYSPNOEA (Could not breath) and HYPERHIDROSIS (Started sweating) had resolved. At the time of the report, GAIT DISTURBANCE (could not walk and sit up, unable to move around too much), SOMNOLENCE (very sleepy and drowsy), DYSSTASIA (unable to move around too much, unable to stand long, have to sit back), HEADACHE (Really bad headache), PYREXIA (little bit of fever), FATIGUE (Fatigue) and CHILLS (Chills) had not resolved and HYPOKINESIA (could not get out of bed) and VACCINATION SITE PRURITUS (right arm itchy) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Hyperhidrosis, Hypokinesia, Pyrexia
Clinical narrative: could not walk and sit up, unable to move around too much; very sleepy and drowsy; unable to move around too much, unable to stand long, have to sit back; could not get out of bed; right arm itchy; Really bad headache; little bit of fever; Fatigue; Chills; allergic reaction - could not breath, started sweating; Could not breath; Started sweating; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergic reaction - could not breath, started sweating), DYSPNOEA (Could not breath), HYPERHIDROSIS (Started sweating), GAIT DISTURBANCE (could not walk and sit up, unable to move around too much) and SOMNOLENCE (very sleepy and drowsy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022MA0N) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Medical history was not reported by reporter.  Concomitant products included INSULIN GLARGINE (BASAGLAR), INSULIN LISPRO (HUMALOG), CLONIDINE, METFORMIN, METOPROLOL, ATORVASTATIN CALCIUM (AVASTIN [ATORVASTATIN CALCIUM]), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), RITUXIMAB (RITUXAN) and HYDROCHLOROTHIAZIDE, LISINOPRIL (ZESTORETIC) for an unknown indication.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 27-Feb-2021, the patient experienced ALLERGY TO VACCINE (allergic reaction - could not breath, started sweating), DYSPNOEA (Could not breath) and HYPERHIDROSIS (Started sweating). On 28-Feb-2021, the patient experienced GAIT DISTURBANCE (could not walk and sit up, unable to move around too much), SOMNOLENCE (very sleepy and drowsy), DYSSTASIA (unable to move around too much, unable to stand long, have to sit back), HYPOKINESIA (could not get out of bed), VACCINATION SITE PRURITUS (right arm itchy), HEADACHE (Really bad headache), PYREXIA (little bit of fever), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Feb-2021, ALLERGY TO VACCINE (allergic reaction - could not breath, started sweating), DYSPNOEA (Could not breath) and HYPERHIDROSIS (Started sweating) had resolved. At the time of the report, GAIT DISTURBANCE (could not walk and sit up, unable to move around too much), SOMNOLENCE (very sleepy and drowsy), DYSSTASIA (unable to move around too much, unable to stand long, have to sit back), HEADACHE (Really bad headache), PYREXIA (little bit of fever), FATIGUE (Fatigue) and CHILLS (Chills) had not resolved and HYPOKINESIA (could not get out of bed) and VACCINATION SITE PRURITUS (right arm itchy) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pruritus
Clinical narrative: could not walk and sit up, unable to move around too much; very sleepy and drowsy; unable to move around too much, unable to stand long, have to sit back; could not get out of bed; right arm itchy; Really bad headache; little bit of fever; Fatigue; Chills; allergic reaction - could not breath, started sweating; Could not breath; Started sweating; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergic reaction - could not breath, started sweating), DYSPNOEA (Could not breath), HYPERHIDROSIS (Started sweating), GAIT DISTURBANCE (could not walk and sit up, unable to move around too much) and SOMNOLENCE (very sleepy and drowsy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022MA0N) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Medical history was not reported by reporter.  Concomitant products included INSULIN GLARGINE (BASAGLAR), INSULIN LISPRO (HUMALOG), CLONIDINE, METFORMIN, METOPROLOL, ATORVASTATIN CALCIUM (AVASTIN [ATORVASTATIN CALCIUM]), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), RITUXIMAB (RITUXAN) and HYDROCHLOROTHIAZIDE, LISINOPRIL (ZESTORETIC) for an unknown indication.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 27-Feb-2021, the patient experienced ALLERGY TO VACCINE (allergic reaction - could not breath, started sweating), DYSPNOEA (Could not breath) and HYPERHIDROSIS (Started sweating). On 28-Feb-2021, the patient experienced GAIT DISTURBANCE (could not walk and sit up, unable to move around too much), SOMNOLENCE (very sleepy and drowsy), DYSSTASIA (unable to move around too much, unable to stand long, have to sit back), HYPOKINESIA (could not get out of bed), VACCINATION SITE PRURITUS (right arm itchy), HEADACHE (Really bad headache), PYREXIA (little bit of fever), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Feb-2021, ALLERGY TO VACCINE (allergic reaction - could not breath, started sweating), DYSPNOEA (Could not breath) and HYPERHIDROSIS (Started sweating) had resolved. At the time of the report, GAIT DISTURBANCE (could not walk and sit up, unable to move around too much), SOMNOLENCE (very sleepy and drowsy), DYSSTASIA (unable to move around too much, unable to stand long, have to sit back), HEADACHE (Really bad headache), PYREXIA (little bit of fever), FATIGUE (Fatigue) and CHILLS (Chills) had not resolved and HYPOKINESIA (could not get out of bed) and VACCINATION SITE PRURITUS (right arm itchy) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain, Arthralgia, Dysuria, Fatigue, Headache
Clinical narrative: Possible UTI; Frequent urination; Sense of urgency with urination; Feeling rough; Burning pain with urination; Mild abdominal pain; Joint pain especially both shoulders; On and off headaches; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Possible UTI), POLLAKIURIA (Frequent urination), MICTURITION URGENCY (Sense of urgency with urination), VACCINATION COMPLICATION (Feeling rough) and DYSURIA (Burning pain with urination) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    Concurrent medical conditions included Ulcerative colitis, Asthma (Asthma/COPD), Seasonal allergy and Drug allergy (Sulfa). Concomitant products included MESALAMINE, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), SALBUTAMOL SULFATE (PROAIR HFA), COLECALCIFEROL (VITAMIN D 3) and CALCIUM for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On 11-Mar-2021, the patient experienced POLLAKIURIA (Frequent urination), MICTURITION URGENCY (Sense of urgency with urination), VACCINATION COMPLICATION (Feeling rough), DYSURIA (Burning pain with urination), ABDOMINAL PAIN (Mild abdominal pain), ARTHRALGIA (Joint pain especially both shoulders), HEADACHE (On and off headaches) and FATIGUE (Tiredness). On an unknown date, the patient experienced URINARY TRACT INFECTION (Possible UTI). At the time of the report, URINARY TRACT INFECTION (Possible UTI), POLLAKIURIA (Frequent urination), MICTURITION URGENCY (Sense of urgency with urination), VACCINATION COMPLICATION (Feeling rough), DYSURIA (Burning pain with urination), ABDOMINAL PAIN (Mild abdominal pain), ARTHRALGIA (Joint pain especially both shoulders), HEADACHE (On and off headaches) and FATIGUE (Tiredness) 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.   Patient reported improvement of her symptoms except urinary symptoms  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up information received on 18-May-2021 contains non significant information-Contact information updated.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Micturition urgency, Pollakiuria, Urinary tract infection, Vaccination complication
Clinical narrative: Possible UTI; Frequent urination; Sense of urgency with urination; Feeling rough; Burning pain with urination; Mild abdominal pain; Joint pain especially both shoulders; On and off headaches; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Possible UTI), POLLAKIURIA (Frequent urination), MICTURITION URGENCY (Sense of urgency with urination), VACCINATION COMPLICATION (Feeling rough) and DYSURIA (Burning pain with urination) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    Concurrent medical conditions included Ulcerative colitis, Asthma (Asthma/COPD), Seasonal allergy and Drug allergy (Sulfa). Concomitant products included MESALAMINE, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), SALBUTAMOL SULFATE (PROAIR HFA), COLECALCIFEROL (VITAMIN D 3) and CALCIUM for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On 11-Mar-2021, the patient experienced POLLAKIURIA (Frequent urination), MICTURITION URGENCY (Sense of urgency with urination), VACCINATION COMPLICATION (Feeling rough), DYSURIA (Burning pain with urination), ABDOMINAL PAIN (Mild abdominal pain), ARTHRALGIA (Joint pain especially both shoulders), HEADACHE (On and off headaches) and FATIGUE (Tiredness). On an unknown date, the patient experienced URINARY TRACT INFECTION (Possible UTI). At the time of the report, URINARY TRACT INFECTION (Possible UTI), POLLAKIURIA (Frequent urination), MICTURITION URGENCY (Sense of urgency with urination), VACCINATION COMPLICATION (Feeling rough), DYSURIA (Burning pain with urination), ABDOMINAL PAIN (Mild abdominal pain), ARTHRALGIA (Joint pain especially both shoulders), HEADACHE (On and off headaches) and FATIGUE (Tiredness) 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.   Patient reported improvement of her symptoms except urinary symptoms  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up information received on 18-May-2021 contains non significant information-Contact information updated.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Muscle spasms, Nausea
Clinical narrative: Diarrhea; Cramps; Chills; Nausea; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps), CHILLS (Chills), NAUSEA (Nausea) and ARTHRALGIA (Joint pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps), CHILLS (Chills), NAUSEA (Nausea) and ARTHRALGIA (Joint pain). At the time of the report, DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps), CHILLS (Chills), NAUSEA (Nausea) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Medication error
Clinical narrative: Patient received vaccine 2 days in a row/Vaccine administered not waiting 28 days; Received three doses of Moderna covid-19; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Received three doses of Moderna covid-19) and MEDICATION ERROR (Patient received vaccine 2 days in a row/Vaccine administered not waiting 28 days) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 026L20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Psychiatric disorder NOS.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received three doses of Moderna covid-19). On an unknown date, the patient experienced MEDICATION ERROR (Patient received vaccine 2 days in a row/Vaccine administered not waiting 28 days). On 10-Feb-2021, EXTRA DOSE ADMINISTERED (Received three doses of Moderna covid-19) had resolved. At the time of the report, MEDICATION ERROR (Patient received vaccine 2 days in a row/Vaccine administered not waiting 28 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up received on 12-APR-2021 and contains no new information.; Reporter's Comments: This report refers to a case of extra dose administered for mRNA-1273 with no associated AEs.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Palpitations, Pyrexia, Troponin
Clinical narrative: Increased Heart rate/palpitations; Difficulty in breathing; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Increased Heart rate/palpitations), DYSPNOEA (Difficulty in breathing) and PYREXIA (Fever) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Polycystic ovarian syndrome and Hashimoto's thyroiditis. Concomitant products included METOPROLOL for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PALPITATIONS (Increased Heart rate/palpitations), DYSPNOEA (Difficulty in breathing) and PYREXIA (Fever). At the time of the report, PALPITATIONS (Increased Heart rate/palpitations), DYSPNOEA (Difficulty in breathing) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Electrocardiogram: normal (normal) normal. In March 2021, Troponin: negative (Negative) negative.     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.   Patient was having iron pills (325 mg) and birth control as concomitant medication. No treatment medication were reported Patient has also undergone D-dimer test which was negative.   This case was linked to MOD-2021-219670 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Follow up received and email address updated On 18-May-2021: Follow up received and no significant information updated On 11-Jun-2021: Follow up received contains concomitant drugs, medical history, laboratory data, and second dose details.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Feelin achy; Slight temp of 99 degrees; Felt like had the flu for couple of days; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Mar-2021 and was forwarded to Moderna on 12-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Feelin achy), PYREXIA (Slight temp of 99 degrees), INFLUENZA LIKE ILLNESS (Felt like had the flu for couple of days) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included Sarcoidosis since 01-Jan-2014. Concurrent medical conditions included Drug allergy (Codeine). Concomitant products included LOSARTAN POTASSIUM (COZAAR) from 01-Jan-2010 to an unknown date for Blood pressure, ATORVASTATIN CALCIUM (LIPITOR) from 01-Jan-2010 to an unknown date for High cholesterol.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (Headache). On 10-Feb-2021, the patient experienced PAIN (Feelin achy), PYREXIA (Slight temp of 99 degrees) and INFLUENZA LIKE ILLNESS (Felt like had the flu for couple of days). On 10-Feb-2021, PAIN (Feelin achy), PYREXIA (Slight temp of 99 degrees) and INFLUENZA LIKE ILLNESS (Felt like had the flu for couple of days) outcome was unknown. On 16-Feb-2021, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Tylenol and ibuprofen.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Past medical history was updated. Concomitant medications were updated.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: sore arm; slight sore throat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and OROPHARYNGEAL PAIN (slight sore throat) 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 09-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 PAIN IN EXTREMITY (sore arm) and OROPHARYNGEAL PAIN (slight sore throat). At the time of the report, PAIN IN EXTREMITY (sore arm) and OROPHARYNGEAL PAIN (slight sore throat) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Patient has taken no medications for his side effects and letting it run its course.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Spot was warm to the touch,Spot where she had the vaccine had some heat; Redness at the spot where she got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Spot was warm to the touch,Spot where she had the vaccine had some heat) and VACCINATION SITE ERYTHEMA (Redness at the spot where she got the vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical history Information was reported.  Concomitant products included FLUCONAZOLE, TIZANIDINE, TRAMADOL, METOPROLOL, URSODIOL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), ATORVASTATIN, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S), FAMOTIDINE (PEPCID AC), ACETYLSALICYLIC ACID (BABY ASPIRIN), CLOPIDOGREL BISULFATE (PLAVIX), FOLIC ACID, CALCIUM and VITAMIN D NOS for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Spot was warm to the touch,Spot where she had the vaccine had some heat) and VACCINATION SITE ERYTHEMA (Redness at the spot where she got the vaccine). At the time of the report, VACCINATION SITE WARMTH (Spot was warm to the touch,Spot where she had the vaccine had some heat) and VACCINATION SITE ERYTHEMA (Redness at the spot where she got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Lymphadenopathy, Vaccination site erythema, Vaccination site pain
Clinical narrative: lymph nodes got really big on the same side as where she received the vaccine/ They almost felt like gel marbles.; Felt like she was arm wrestling and unable to reach to the top of her head/arm felt extremely heavy; soreness and redness around injection site; soreness and redness around injection site; fatigued; arm felt extremely heavy; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm felt extremely heavy), LYMPHADENOPATHY (lymph nodes got really big on the same side as where she received the vaccine/ They almost felt like gel marbles.), VACCINATION SITE SWELLING (Felt like she was arm wrestling and unable to reach to the top of her head/arm felt extremely heavy), VACCINATION SITE PAIN (soreness and redness around injection site) and VACCINATION SITE ERYTHEMA (soreness and redness around injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced LIMB DISCOMFORT (arm felt extremely heavy), VACCINATION SITE SWELLING (Felt like she was arm wrestling and unable to reach to the top of her head/arm felt extremely heavy), VACCINATION SITE PAIN (soreness and redness around injection site), VACCINATION SITE ERYTHEMA (soreness and redness around injection site) and FATIGUE (fatigued). On 09-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph nodes got really big on the same side as where she received the vaccine/ They almost felt like gel marbles.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, VACCINATION SITE SWELLING (Felt like she was arm wrestling and unable to reach to the top of her head/arm felt extremely heavy) had resolved. On 06-Mar-2021, LIMB DISCOMFORT (arm felt extremely heavy) had resolved. At the time of the report, LYMPHADENOPATHY (lymph nodes got really big on the same side as where she received the vaccine/ They almost felt like gel marbles.) had not resolved and VACCINATION SITE PAIN (soreness and redness around injection site), VACCINATION SITE ERYTHEMA (soreness and redness around injection site) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: lymph nodes got really big on the same side as where she received the vaccine/ They almost felt like gel marbles.; Felt like she was arm wrestling and unable to reach to the top of her head/arm felt extremely heavy; soreness and redness around injection site; soreness and redness around injection site; fatigued; arm felt extremely heavy; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm felt extremely heavy), LYMPHADENOPATHY (lymph nodes got really big on the same side as where she received the vaccine/ They almost felt like gel marbles.), VACCINATION SITE SWELLING (Felt like she was arm wrestling and unable to reach to the top of her head/arm felt extremely heavy), VACCINATION SITE PAIN (soreness and redness around injection site) and VACCINATION SITE ERYTHEMA (soreness and redness around injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced LIMB DISCOMFORT (arm felt extremely heavy), VACCINATION SITE SWELLING (Felt like she was arm wrestling and unable to reach to the top of her head/arm felt extremely heavy), VACCINATION SITE PAIN (soreness and redness around injection site), VACCINATION SITE ERYTHEMA (soreness and redness around injection site) and FATIGUE (fatigued). On 09-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph nodes got really big on the same side as where she received the vaccine/ They almost felt like gel marbles.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, VACCINATION SITE SWELLING (Felt like she was arm wrestling and unable to reach to the top of her head/arm felt extremely heavy) had resolved. On 06-Mar-2021, LIMB DISCOMFORT (arm felt extremely heavy) had resolved. At the time of the report, LYMPHADENOPATHY (lymph nodes got really big on the same side as where she received the vaccine/ They almost felt like gel marbles.) had not resolved and VACCINATION SITE PAIN (soreness and redness around injection site), VACCINATION SITE ERYTHEMA (soreness and redness around injection site) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Fever of 101; chills; joint pain; Headache; nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101), CHILLS (chills), ARTHRALGIA (joint pain), HEADACHE (Headache) and NAUSEA (nausea) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (Fever of 101), CHILLS (chills), ARTHRALGIA (joint pain), HEADACHE (Headache), NAUSEA (nausea) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Pain, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 101), CHILLS (chills), ARTHRALGIA (joint pain), HEADACHE (Headache), NAUSEA (nausea) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Pyrexia: 101 (High) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 101; chills; joint pain; Headache; nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101), CHILLS (chills), ARTHRALGIA (joint pain), HEADACHE (Headache) and NAUSEA (nausea) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (Fever of 101), CHILLS (chills), ARTHRALGIA (joint pain), HEADACHE (Headache), NAUSEA (nausea) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Pain, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 101), CHILLS (chills), ARTHRALGIA (joint pain), HEADACHE (Headache), NAUSEA (nausea) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Pyrexia: 101 (High) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Faeces discoloured, Oropharyngeal pain, Pain in extremity
Clinical narrative: Bright orange colored fluid in bowel; Sore throat; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (Bright orange colored fluid in bowel), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Sore arm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Bladder cancer (low grade) since an unknown date, Atrial fibrillation, Knee replacement and Spinal cord operation (Bolts in back). Concomitant products included WARFARIN, SPIRONOLACTONE, TAMSULOSIN, PRAVASTATIN, OXYBUTYNIN, ATENOLOL, BENAZEPRIL, FUROSEMIDE, DIGOXIN, CLOPIDOGREL, GABAPENTIN, ZINC and MAGNESIUM for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FAECES DISCOLOURED (Bright orange colored fluid in bowel), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FAECES DISCOLOURED (Bright orange colored fluid in bowel), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Body temperature increased, Incorrect route of product administration, Vaccination site mass, Vaccination site pain
Clinical narrative: Thinks got the vaccine subcutaneously; Drip of the vaccine came out of injection site; Hard lump at injection site; elevated temperature 98.4; Pain at injection site; Swollen at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Thinks got the vaccine subcutaneously), ACCIDENTAL UNDERDOSE (Drip of the vaccine came out of injection site), VACCINATION SITE MASS (Hard lump at injection site), BODY TEMPERATURE INCREASED (elevated temperature 98.4) and VACCINATION SITE PAIN (Pain at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported. ). Concomitant products included ESTRIOL, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 11-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) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Thinks got the vaccine subcutaneously), ACCIDENTAL UNDERDOSE (Drip of the vaccine came out of injection site), VACCINATION SITE MASS (Hard lump at injection site), BODY TEMPERATURE INCREASED (elevated temperature 98.4), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swollen at injection site). On 11-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Thinks got the vaccine subcutaneously) and ACCIDENTAL UNDERDOSE (Drip of the vaccine came out of injection site) had resolved. At the time of the report, VACCINATION SITE MASS (Hard lump at injection site), BODY TEMPERATURE INCREASED (elevated temperature 98.4), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swollen at injection site) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Thinks got the vaccine subcutaneously; Drip of the vaccine came out of injection site; Hard lump at injection site; elevated temperature 98.4; Pain at injection site; Swollen at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Thinks got the vaccine subcutaneously), ACCIDENTAL UNDERDOSE (Drip of the vaccine came out of injection site), VACCINATION SITE MASS (Hard lump at injection site), BODY TEMPERATURE INCREASED (elevated temperature 98.4) and VACCINATION SITE PAIN (Pain at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported. ). Concomitant products included ESTRIOL, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 11-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) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Thinks got the vaccine subcutaneously), ACCIDENTAL UNDERDOSE (Drip of the vaccine came out of injection site), VACCINATION SITE MASS (Hard lump at injection site), BODY TEMPERATURE INCREASED (elevated temperature 98.4), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swollen at injection site). On 11-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Thinks got the vaccine subcutaneously) and ACCIDENTAL UNDERDOSE (Drip of the vaccine came out of injection site) had resolved. At the time of the report, VACCINATION SITE MASS (Hard lump at injection site), BODY TEMPERATURE INCREASED (elevated temperature 98.4), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swollen at injection site) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.