chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: To top it off my hair started falling out by the handfuls; tire quickly.; trouble breathing; fever; Severe headache like migraine; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing), ALOPECIA (To top it off my hair started falling out by the handfuls), HEADACHE (Severe headache like migraine), NAUSEA (nausea) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021. Concomitant products included LOSARTAN, OMEPRAZOLE, ROSUVASTATIN, GABAPENTIN, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), UBIDECARENONE (COQ) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced CHILLS (chills). On 28-Apr-2021, the patient experienced DYSPNOEA (trouble breathing), HEADACHE (Severe headache like migraine), NAUSEA (nausea) and PYREXIA (fever). On an unknown date, the patient experienced ALOPECIA (To top it off my hair started falling out by the handfuls) and FATIGUE (tire quickly.). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 29-Apr-2021, HEADACHE (Severe headache like migraine), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, DYSPNOEA (trouble breathing) and NAUSEA (nausea) had not resolved and ALOPECIA (To top it off my hair started falling out by the handfuls) and FATIGUE (tire quickly.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Antibody test: other (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Added two additional events fatigue and alopecia.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: Came down with bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Came down with bronchitis) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032MzoA) for COVID-19 vaccination.     The patient's past medical history included Bronchitis. Concurrent medical conditions included Thyroid disorder. Concomitant products included AMLODIPINE for Blood pressure, ATORVASTATIN for Cholesterol, LEVOTHYROXINE for Thyroid disorder, TRIAMTERENE and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced BRONCHITIS (Came down with bronchitis). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Bronchitis, at a dose of 4 mg. At the time of the report, BRONCHITIS (Came down with bronchitis) outcome was unknown. Not Provided      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.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed the 2nd appointment for the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the 2nd appointment for the vaccination) 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 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the 2nd appointment for the vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the 2nd appointment for the vaccination) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported.  Treatment medication not reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Rash on the back as eczema; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Rash on the back as eczema) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was reported  by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Rash on the back as eczema). At the time of the report, ECZEMA (Rash on the back as eczema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-103381 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dyspnoea, Heart rate increased, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Breathing became very difficult; Blood pressure was really high; Heart rate was off the charts; Face numb; Tongue numb; Throat numb; Lips numb; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Breathing became very difficult), BLOOD PRESSURE INCREASED (Blood pressure was really high), HEART RATE INCREASED (Heart rate was off the charts), HYPOAESTHESIA (Face numb) and HYPOAESTHESIA ORAL (Tongue numb) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DYSPNOEA (Breathing became very difficult), BLOOD PRESSURE INCREASED (Blood pressure was really high), HEART RATE INCREASED (Heart rate was off the charts), HYPOAESTHESIA (Face numb), HYPOAESTHESIA ORAL (Tongue numb), PHARYNGEAL HYPOAESTHESIA (Throat numb) and HYPOAESTHESIA ORAL (Lips numb). The patient was treated with EPINEPHRINE at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Breathing became very difficult), BLOOD PRESSURE INCREASED (Blood pressure was really high), HEART RATE INCREASED (Heart rate was off the charts), HYPOAESTHESIA (Face numb), HYPOAESTHESIA ORAL (Tongue numb), PHARYNGEAL HYPOAESTHESIA (Throat numb) and HYPOAESTHESIA ORAL (Lips numb) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal hypoaesthesia
Clinical narrative: Breathing became very difficult; Blood pressure was really high; Heart rate was off the charts; Face numb; Tongue numb; Throat numb; Lips numb; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Breathing became very difficult), BLOOD PRESSURE INCREASED (Blood pressure was really high), HEART RATE INCREASED (Heart rate was off the charts), HYPOAESTHESIA (Face numb) and HYPOAESTHESIA ORAL (Tongue numb) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DYSPNOEA (Breathing became very difficult), BLOOD PRESSURE INCREASED (Blood pressure was really high), HEART RATE INCREASED (Heart rate was off the charts), HYPOAESTHESIA (Face numb), HYPOAESTHESIA ORAL (Tongue numb), PHARYNGEAL HYPOAESTHESIA (Throat numb) and HYPOAESTHESIA ORAL (Lips numb). The patient was treated with EPINEPHRINE at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Breathing became very difficult), BLOOD PRESSURE INCREASED (Blood pressure was really high), HEART RATE INCREASED (Heart rate was off the charts), HYPOAESTHESIA (Face numb), HYPOAESTHESIA ORAL (Tongue numb), PHARYNGEAL HYPOAESTHESIA (Throat numb) and HYPOAESTHESIA ORAL (Lips numb) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), IRON and FOLIC ACID for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported.   This case was linked to MOD-2021-103190 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up information was received on 4 Jun 2021: updated the outcome of the event from unknown to Recovering/Resolving.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hair colour changes
Clinical narrative: the hair was completely white grey and now is starting to have black hair; This spontaneous case was reported by a consumer and describes the occurrence of HAIR COLOUR CHANGES (the hair was completely white grey and now is starting to have black hair) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAIR COLOUR CHANGES (the hair was completely white grey and now is starting to have black hair). At the time of the report, HAIR COLOUR CHANGES (the hair was completely white grey and now is starting to have black hair) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old male was administered moderna vaccine on the left arm; This spontaneous case was reported by a medical assistant and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old male was administered moderna vaccine on the left arm) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.No concomitant medication was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old male was administered moderna vaccine on the left arm). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old male was administered moderna vaccine on the left arm) outcome was unknown. Not Provided   Treatment medication was not provided. Action taken with mRNA-1273 in response to the events was not applicable    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: Dry cough; a little fever; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), COUGH (Dry cough) and PYREXIA (a little fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included prostate medication for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 18-Apr-2021, the patient experienced COUGH (Dry cough) and PYREXIA (a little fever). On 25-Apr-2021, OROPHARYNGEAL PAIN (Sore throat), COUGH (Dry cough) and PYREXIA (a little fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Hiccups, Somnolence
Clinical narrative: diarrhea several times a day; Sleepy lot; Hiccough; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea several times a day), SOMNOLENCE (Sleepy lot), HICCUPS (Hiccough) and FATIGUE (feeling tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced DIARRHOEA (diarrhea several times a day), SOMNOLENCE (Sleepy lot), HICCUPS (Hiccough) and FATIGUE (feeling tired). At the time of the report, DIARRHOEA (diarrhea several times a day), SOMNOLENCE (Sleepy lot), HICCUPS (Hiccough) and FATIGUE (feeling tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No treatment information provided.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to touch at site of injection; Injection site developed hard area; Swollen at site of injection; Red at site of injection/Increased redness at site of injection; Painful at site of injection; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch at site of injection), VACCINATION SITE INDURATION (Injection site developed hard area), VACCINATION SITE SWELLING (Swollen at site of injection), VACCINATION SITE ERYTHEMA (Red at site of injection/Increased redness at site of injection) and VACCINATION SITE PAIN (Painful at site of injection) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LANSOPRAZOLE for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch at site of injection), VACCINATION SITE INDURATION (Injection site developed hard area), VACCINATION SITE SWELLING (Swollen at site of injection), VACCINATION SITE ERYTHEMA (Red at site of injection/Increased redness at site of injection) and VACCINATION SITE PAIN (Painful at site of injection). At the time of the report, VACCINATION SITE WARMTH (Hot to touch at site of injection), VACCINATION SITE INDURATION (Injection site developed hard area), VACCINATION SITE SWELLING (Swollen at site of injection), VACCINATION SITE ERYTHEMA (Red at site of injection/Increased redness at site of injection) and VACCINATION SITE PAIN (Painful at site of injection) outcome was unknown.            Concomitant medication also included Antihistamine for an unknown indication. Treatment medication included Tylenol, Aleve and Ice pack.   This case was linked to MOD-2021-103133 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeding disorder, Feeling cold, Hyperhidrosis, Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweat), FEELING COLD (ice cold), FEEDING DISORDER (not able to eat) and PYREXIA (temperature of 101F) in an 82-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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweat), PYREXIA (temperature of 101F) and CHILLS (chills). On 03-May-2021, the patient experienced FEELING COLD (ice cold) and FEEDING DISORDER (not able to eat). On 03-May-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweat), FEELING COLD (ice cold), FEEDING DISORDER (not able to eat), PYREXIA (temperature of 101F) and CHILLS (chills) had resolved. Not Provided
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweat), FEELING COLD (ice cold), FEEDING DISORDER (not able to eat) and PYREXIA (temperature of 101F) in an 82-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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweat), PYREXIA (temperature of 101F) and CHILLS (chills). On 03-May-2021, the patient experienced FEELING COLD (ice cold) and FEEDING DISORDER (not able to eat). On 03-May-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweat), FEELING COLD (ice cold), FEEDING DISORDER (not able to eat), PYREXIA (temperature of 101F) and CHILLS (chills) had resolved. Not Provided
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received 1st dose at 17 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st dose at 17 years of age) 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 (Received 1st dose at 17 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st dose at 17 years of age) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment drugs were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pyrexia, Vaccination site pain
Clinical narrative: fever of 100.8; Her left arm was sore; she felt dizzy; Light headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (she felt dizzy), HEADACHE (Light headache), PYREXIA (fever of 100.8) and VACCINATION SITE PAIN (Her left arm was sore) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S), IRON and FOLIC ACID for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced DIZZINESS (she felt dizzy), HEADACHE (Light headache) and VACCINATION SITE PAIN (Her left arm was sore). On 04-May-2021, the patient experienced PYREXIA (fever of 100.8). At the time of the report, DIZZINESS (she felt dizzy), HEADACHE (Light headache), PYREXIA (fever of 100.8) and VACCINATION SITE PAIN (Her left arm was sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   She wants to know if she can take Tylenol.   This case was linked to (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mild headache.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (mild headache.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Osteoarthritis. Concomitant products included CENTRUM SILVER ADVANCE, CALTRATE + D PLUS and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION AREDS) for an unknown indication.    On 18-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 HEADACHE (mild headache.). At the time of the report, HEADACHE (mild headache.) outcome was unknown. Not Provided      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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pruritus
Clinical narrative: arm feels sore; arm does feel sore, heavy and it hurts; itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), PAIN IN EXTREMITY (arm feels sore) and MYALGIA (arm does feel sore, heavy and it hurts) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0071321A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), OMEPRAZOLE and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced PRURITUS (itchy). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm feels sore) and MYALGIA (arm does feel sore, heavy and it hurts). On 04-May-2021, PRURITUS (itchy) had resolved. At the time of the report, PAIN IN EXTREMITY (arm feels sore) and MYALGIA (arm does feel sore, heavy and it hurts) 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.   Concomitant medication includes Eldeberry Vitamin once a day and Vital Protein Hair Boost Vitamin 200mg once a day
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site anaesthesia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Waking up with a sore at the site of injection; swollen arm at site of injection; that feels numb where injection was given; experienced soreness in left arm, body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (experienced soreness in left arm, body aches), VACCINATION SITE PAIN (Waking up with a sore at the site of injection), VACCINATION SITE SWELLING (swollen arm at site of injection) and VACCINATION SITE ANAESTHESIA (that feels numb where injection was given) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, ATORVASTATIN, VITAMIN B COMPLEX (VIT B COMPLEX) and BIOTIN for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced MYALGIA (experienced soreness in left arm, body aches). On 04-May-2021, the patient experienced VACCINATION SITE PAIN (Waking up with a sore at the site of injection), VACCINATION SITE SWELLING (swollen arm at site of injection) and VACCINATION SITE ANAESTHESIA (that feels numb where injection was given). At the time of the report, MYALGIA (experienced soreness in left arm, body aches), VACCINATION SITE PAIN (Waking up with a sore at the site of injection), VACCINATION SITE SWELLING (swollen arm at site of injection) and VACCINATION SITE ANAESTHESIA (that feels numb where injection was given) outcome was unknown. Not Provided      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 product details not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Nasal congestion
Clinical narrative: a lot of congestion; dizziness; trouble breathing; fever of 101.5 F; really bad chills; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (a lot of congestion), DIZZINESS (dizziness), DYSPNOEA (trouble breathing), PYREXIA (fever of 101.5 F) and CHILLS (really bad chills) in a 56-year-old female 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 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced NASAL CONGESTION (a lot of congestion), DIZZINESS (dizziness), DYSPNOEA (trouble breathing), PYREXIA (fever of 101.5 F), CHILLS (really bad chills) and HEADACHE (bad headache). At the time of the report, NASAL CONGESTION (a lot of congestion), DIZZINESS (dizziness), DYSPNOEA (trouble breathing), PYREXIA (fever of 101.5 F), CHILLS (really bad chills) and HEADACHE (bad headache) outcome was unknown. Not Provided      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 details were provided No treatment details were provided
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: a lot of congestion; dizziness; trouble breathing; fever of 101.5 F; really bad chills; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (a lot of congestion), DIZZINESS (dizziness), DYSPNOEA (trouble breathing), PYREXIA (fever of 101.5 F) and CHILLS (really bad chills) in a 56-year-old female 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 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced NASAL CONGESTION (a lot of congestion), DIZZINESS (dizziness), DYSPNOEA (trouble breathing), PYREXIA (fever of 101.5 F), CHILLS (really bad chills) and HEADACHE (bad headache). At the time of the report, NASAL CONGESTION (a lot of congestion), DIZZINESS (dizziness), DYSPNOEA (trouble breathing), PYREXIA (fever of 101.5 F), CHILLS (really bad chills) and HEADACHE (bad headache) outcome was unknown. Not Provided      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 details were provided No treatment details were provided
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (she administered a dose of MODERNA COVID 19 Vaccine outside the normal storage range) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004c21a) for COVID-19 vaccination. The patient's past medical history included No adverse reaction. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PRODUCT STORAGE ERROR (she administered a dose of MODERNA COVID 19 Vaccine outside the normal storage range). At the time of the report, PRODUCT STORAGE ERROR (she administered a dose of MODERNA COVID 19 Vaccine outside the normal storage range) outcome was unknown. Not Provided. 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 and treatment medication were provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Fatigue, felt drained for 4-5 days; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue, felt drained for 4-5 days), HEADACHE (headache) and NAUSEA (nausea) 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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced FATIGUE (Fatigue, felt drained for 4-5 days), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, FATIGUE (Fatigue, felt drained for 4-5 days), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.   This case was linked to MOD-2021-103247 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Weird smell after the second dose/I had initially smelled smoke after the second dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Weird smell after the second dose/I had initially smelled smoke after the second dose of the vaccine) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAROSMIA (Weird smell after the second dose/I had initially smelled smoke after the second dose of the vaccine). At the time of the report, PAROSMIA (Weird smell after the second dose/I had initially smelled smoke after the second dose of the vaccine) had resolved. Not Provided          Concomitant product use was not provided by the reporter. Patient had initially smelled smoke after the second dose of the vaccine. That condition returned about a month later and has not reappeared since.  However, patient believe this was due to Phantosmia, and unrelated to the vaccine. Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up received - Patient demographics, suspect product dose details, vaccination facility type and narrative updated.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Chills, Dyspnoea
Clinical narrative: She was feeling really cold; shivering; Pain in the arm,complaining aches and pain; fever of 102degF; started sweating; feet were numb; heart was racing; breathing was heavy; even complained of chest pain; lower back was hurting; shoulder were hurting too in the middle of the night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (She was feeling really cold), CHILLS (shivering), PAIN IN EXTREMITY (Pain in the arm,complaining aches and pain), PYREXIA (fever of 102degF) and HYPERHIDROSIS (started sweating) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced FEELING COLD (She was feeling really cold), CHILLS (shivering), PAIN IN EXTREMITY (Pain in the arm,complaining aches and pain), PYREXIA (fever of 102degF), HYPERHIDROSIS (started sweating), HYPOAESTHESIA (feet were numb), HEART RATE INCREASED (heart was racing), DYSPNOEA (breathing was heavy), CHEST PAIN (even complained of chest pain), BACK PAIN (lower back was hurting) and ARTHRALGIA (shoulder were hurting too in the middle of the night). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FEELING COLD (She was feeling really cold), CHILLS (shivering), PAIN IN EXTREMITY (Pain in the arm,complaining aches and pain), PYREXIA (fever of 102degF), HYPERHIDROSIS (started sweating), HYPOAESTHESIA (feet were numb), HEART RATE INCREASED (heart was racing), DYSPNOEA (breathing was heavy), CHEST PAIN (even complained of chest pain), BACK PAIN (lower back was hurting) and ARTHRALGIA (shoulder were hurting too in the middle of the night) outcome was unknown. Not Provided      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.   Concomitant medications were not provided by reporter.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Heart rate increased, Hyperhidrosis, Hypoaesthesia, Pain in extremity
Clinical narrative: She was feeling really cold; shivering; Pain in the arm,complaining aches and pain; fever of 102degF; started sweating; feet were numb; heart was racing; breathing was heavy; even complained of chest pain; lower back was hurting; shoulder were hurting too in the middle of the night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (She was feeling really cold), CHILLS (shivering), PAIN IN EXTREMITY (Pain in the arm,complaining aches and pain), PYREXIA (fever of 102degF) and HYPERHIDROSIS (started sweating) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced FEELING COLD (She was feeling really cold), CHILLS (shivering), PAIN IN EXTREMITY (Pain in the arm,complaining aches and pain), PYREXIA (fever of 102degF), HYPERHIDROSIS (started sweating), HYPOAESTHESIA (feet were numb), HEART RATE INCREASED (heart was racing), DYSPNOEA (breathing was heavy), CHEST PAIN (even complained of chest pain), BACK PAIN (lower back was hurting) and ARTHRALGIA (shoulder were hurting too in the middle of the night). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FEELING COLD (She was feeling really cold), CHILLS (shivering), PAIN IN EXTREMITY (Pain in the arm,complaining aches and pain), PYREXIA (fever of 102degF), HYPERHIDROSIS (started sweating), HYPOAESTHESIA (feet were numb), HEART RATE INCREASED (heart was racing), DYSPNOEA (breathing was heavy), CHEST PAIN (even complained of chest pain), BACK PAIN (lower back was hurting) and ARTHRALGIA (shoulder were hurting too in the middle of the night) outcome was unknown. Not Provided      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.   Concomitant medications were not provided by reporter.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: She was feeling really cold; shivering; Pain in the arm,complaining aches and pain; fever of 102degF; started sweating; feet were numb; heart was racing; breathing was heavy; even complained of chest pain; lower back was hurting; shoulder were hurting too in the middle of the night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (She was feeling really cold), CHILLS (shivering), PAIN IN EXTREMITY (Pain in the arm,complaining aches and pain), PYREXIA (fever of 102degF) and HYPERHIDROSIS (started sweating) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced FEELING COLD (She was feeling really cold), CHILLS (shivering), PAIN IN EXTREMITY (Pain in the arm,complaining aches and pain), PYREXIA (fever of 102degF), HYPERHIDROSIS (started sweating), HYPOAESTHESIA (feet were numb), HEART RATE INCREASED (heart was racing), DYSPNOEA (breathing was heavy), CHEST PAIN (even complained of chest pain), BACK PAIN (lower back was hurting) and ARTHRALGIA (shoulder were hurting too in the middle of the night). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FEELING COLD (She was feeling really cold), CHILLS (shivering), PAIN IN EXTREMITY (Pain in the arm,complaining aches and pain), PYREXIA (fever of 102degF), HYPERHIDROSIS (started sweating), HYPOAESTHESIA (feet were numb), HEART RATE INCREASED (heart was racing), DYSPNOEA (breathing was heavy), CHEST PAIN (even complained of chest pain), BACK PAIN (lower back was hurting) and ARTHRALGIA (shoulder were hurting too in the middle of the night) outcome was unknown. Not Provided      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.   Concomitant medications were not provided by reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Heart rate increased, Pyrexia, Vaccination site erythema
Clinical narrative: Heart beating fast; Weakness; Headache in the front top left side of head; Redness and soreness at the injection site; Small fever; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart beating fast), ASTHENIA (Weakness), HEADACHE (Headache in the front top left side of head), VACCINATION SITE ERYTHEMA (Redness and soreness at the injection site) and PYREXIA (Small fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness and soreness at the injection site) and PYREXIA (Small fever). On 03-May-2021, the patient experienced HEART RATE INCREASED (Heart beating fast), ASTHENIA (Weakness) and HEADACHE (Headache in the front top left side of head). On 03-May-2021, VACCINATION SITE ERYTHEMA (Redness and soreness at the injection site) and PYREXIA (Small fever) had resolved. On 04-May-2021, HEART RATE INCREASED (Heart beating fast), ASTHENIA (Weakness) and HEADACHE (Headache in the front top left side of head) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.    Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: FollowUp received on 14-JUN-2021 contains Non Significant Information; 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Headache, Influenza, Myalgia
Clinical narrative: patient had flu; cough; patient doesnot feel well; patient had lot of body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (patient had flu), COUGH (cough), FEELING ABNORMAL (patient doesnot feel well), MYALGIA (patient had lot of body aches) and HEADACHE (headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Fibromyalgia, Arthritis and Depression.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced INFLUENZA (patient had flu), COUGH (cough), FEELING ABNORMAL (patient doesnot feel well), MYALGIA (patient had lot of body aches) and HEADACHE (headache). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at a dose of 1 dosage form. At the time of the report, INFLUENZA (patient had flu), COUGH (cough), FEELING ABNORMAL (patient doesnot feel well), MYALGIA (patient had lot of body aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include Diabetes Type 2 medication, Arthritis medication, Fibromyalgia medication and antidepressants.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: TCR received on 07 Jun 2021 and patient ethnicity was updated and adverse event onset date changed
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Chills; Fever; Very Tired; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Very Tired) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and METFORMIN for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Very Tired). At the time of the report, CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Very Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pruritus
Clinical narrative: redness; Itchiness; having reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PRURITUS (Itchiness) and HYPERSENSITIVITY (having reaction to the vaccine) in a 100-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced ERYTHEMA (redness), PRURITUS (Itchiness) and HYPERSENSITIVITY (having reaction to the vaccine). At the time of the report, ERYTHEMA (redness), PRURITUS (Itchiness) and HYPERSENSITIVITY (having reaction to the vaccine) outcome was unknown. Not Provided      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.   Concomitant medication was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: FU attempt 2- NNI, patient hung up during call
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error, Product preparation issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PREPARATION ISSUE (Improper preparation of thawed vial) and PRODUCT ADMINISTRATION ERROR (Improper preparation of thawed vial administered to patient) in a 27-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 PREPARATION ISSUE (Improper preparation of thawed vial) and PRODUCT ADMINISTRATION ERROR (Improper preparation of thawed vial administered to patient). At the time of the report, PRODUCT PREPARATION ISSUE (Improper preparation of thawed vial) and PRODUCT ADMINISTRATION ERROR (Improper preparation of thawed vial administered to patient) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication included. No treatment medication included.   This case was linked to MOD21-085461 (E2B Linked Report).; Sender's Comments:  MOD21-085461: