chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Scheduled to receive the second vaccine dose on 20Mar2021, but never went to receive it and did not receive it as of yet.) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Scheduled to receive the second vaccine dose on 20Mar2021, but never went to receive it and did not receive it as of yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Scheduled to receive the second vaccine dose on 20Mar2021, but never went to receive it and did not receive it as of yet.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment information was not provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: first dose after vaccine was open in refrigerator over 12 hour expiration time; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (first dose after vaccine was open in refrigerator over 12 hour expiration time) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (first dose after vaccine was open in refrigerator over 12 hour expiration time). On 14-May-2021, EXPIRED PRODUCT ADMINISTERED (first dose after vaccine was open in refrigerator over 12 hour expiration time) 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 medications were reported by the reporter. Treatment medications for this event was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-138655 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-138655:Crosslinked: Same Reporter
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased immune responsiveness, Pain in extremity
Clinical narrative: no immune response to the vaccine; Soreness of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED IMMUNE RESPONSIVENESS (no immune response to the vaccine) and PAIN IN EXTREMITY (Soreness of the left arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Mantle cell lymphoma (for about 20 years on and off.). Concomitant products included BENAZEPRIL, AMLODIPINE and COLESEVELAM for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Soreness of the left arm). On 17-May-2021, the patient experienced DECREASED IMMUNE RESPONSIVENESS (no immune response to the vaccine). At the time of the report, DECREASED IMMUNE RESPONSIVENESS (no immune response to the vaccine) and PAIN IN EXTREMITY (Soreness of the left arm) outcome was unknown.            Concomitant products included blood pressure medication.  No treatment medications provided by the reporter.  Action taken with mRNA-1273 in response to events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Pain in extremity, Pruritus, Vaccination site pruritus
Clinical narrative: scratching so much that his bone got sore; itch got wider, side to side but still around the injection site; arm is a little sore; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (scratching so much that his bone got sore), PRURITUS (itch got wider, side to side but still around the injection site), PAIN IN EXTREMITY (arm is a little sore) and VACCINATION SITE PRURITUS (itching at the injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003021A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site). On an unknown date, the patient experienced BONE PAIN (scratching so much that his bone got sore), PRURITUS (itch got wider, side to side but still around the injection site) and PAIN IN EXTREMITY (arm is a little sore). At the time of the report, BONE PAIN (scratching so much that his bone got sore), PRURITUS (itch got wider, side to side but still around the injection site), PAIN IN EXTREMITY (arm is a little sore) and VACCINATION SITE PRURITUS (itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that His pharmacist used latex to cover up the shot site so he thought the itching could be from that. The patient reported that the itching started second week after the shot.  He stated that the pharmacist at CVS told him to use itching relief cream which he said was just like Benadryl but CVS brand.  The patient reported that the cream helps a little but the itch comes back.  The pharmacist also recommended him to put ice on it which he said he had not done it yet.  He was asking if this was normal and if it lasts this long.  The patient was also concerned about getting the second shot.   This case was linked to MOD-2021-138543, MODERNATX, INC.-MOD-2021-138543 (E2B Linked Report).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: headache; myalgia; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (myalgia) and PYREXIA (fever) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced HEADACHE (headache), MYALGIA (myalgia) and PYREXIA (fever). The patient was treated with IBUPROFEN (ADVEL) at an unspecified dose and frequency. On 27-Apr-2021, HEADACHE (headache), MYALGIA (myalgia) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, Body temperature: 99.6 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was given.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Erythema, Pain, Pruritus, Skin discolouration
Clinical narrative: upper arm is still slightly pink in color with some small bumps; upper arm is still slightly pink in color with some small bumps; Patient had a bad reaction after the 2nd dose; Patient had a pain after the 2nd dose; Swelling; Redness; Itch; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Patient had a bad reaction after the 2nd dose), PAIN (Patient had a pain after the 2nd dose), SKIN DISCOLOURATION (upper arm is still slightly pink in color with some small bumps), SKIN MASS (upper arm is still slightly pink in color with some small bumps) and SWELLING (Swelling) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included ATENOLOL for Blood pressure management, PRAVASTATIN for Cholesterol, TRAVOPROST (TRAVATANZ) for Glaucoma, LEVOTHYROXINE for Thyroid disorder.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 03-Mar-2021, the patient experienced SWELLING (Swelling). 03-Mar-2021, the patient experienced ERYTHEMA (Redness) and PRURITUS (Itch). On 26-Mar-2021, the patient experienced ADVERSE DRUG REACTION (Patient had a bad reaction after the 2nd dose). 26-Mar-2021, the patient experienced PAIN (Patient had a pain after the 2nd dose). On an unknown date, the patient experienced SKIN DISCOLOURATION (upper arm is still slightly pink in color with some small bumps) and SKIN MASS (upper arm is still slightly pink in color with some small bumps). On 09-Apr-2021, SWELLING (Swelling), ERYTHEMA (Redness) and PRURITUS (Itch) had resolved with sequelae. At the time of the report, ADVERSE DRUG REACTION (Patient had a bad reaction after the 2nd dose) and PAIN (Patient had a pain after the 2nd dose) had resolved and SKIN DISCOLOURATION (upper arm is still slightly pink in color with some small bumps) and SKIN MASS (upper arm is still slightly pink in color with some small bumps) had not resolved.            No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Patient DOB added, Updated suspect drug start date and Added batch/lot number , Added Concomitant medications and Added New events - Considered significant On 19-Jul-2021: significant follow up contains no new information.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass, Swelling
Clinical narrative: upper arm is still slightly pink in color with some small bumps; upper arm is still slightly pink in color with some small bumps; Patient had a bad reaction after the 2nd dose; Patient had a pain after the 2nd dose; Swelling; Redness; Itch; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Patient had a bad reaction after the 2nd dose), PAIN (Patient had a pain after the 2nd dose), SKIN DISCOLOURATION (upper arm is still slightly pink in color with some small bumps), SKIN MASS (upper arm is still slightly pink in color with some small bumps) and SWELLING (Swelling) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included ATENOLOL for Blood pressure management, PRAVASTATIN for Cholesterol, TRAVOPROST (TRAVATANZ) for Glaucoma, LEVOTHYROXINE for Thyroid disorder.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 03-Mar-2021, the patient experienced SWELLING (Swelling). 03-Mar-2021, the patient experienced ERYTHEMA (Redness) and PRURITUS (Itch). On 26-Mar-2021, the patient experienced ADVERSE DRUG REACTION (Patient had a bad reaction after the 2nd dose). 26-Mar-2021, the patient experienced PAIN (Patient had a pain after the 2nd dose). On an unknown date, the patient experienced SKIN DISCOLOURATION (upper arm is still slightly pink in color with some small bumps) and SKIN MASS (upper arm is still slightly pink in color with some small bumps). On 09-Apr-2021, SWELLING (Swelling), ERYTHEMA (Redness) and PRURITUS (Itch) had resolved with sequelae. At the time of the report, ADVERSE DRUG REACTION (Patient had a bad reaction after the 2nd dose) and PAIN (Patient had a pain after the 2nd dose) had resolved and SKIN DISCOLOURATION (upper arm is still slightly pink in color with some small bumps) and SKIN MASS (upper arm is still slightly pink in color with some small bumps) had not resolved.            No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Patient DOB added, Updated suspect drug start date and Added batch/lot number , Added Concomitant medications and Added New events - Considered significant On 19-Jul-2021: significant follow up contains no new information.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site mass, Vaccination site warmth
Clinical narrative: Large swollen mass below injection site on the Right Dominant arm /Stayed swollen for approximately 2 weeks; The mass is hot to the touch; Swelling/firmness below injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Large swollen mass below injection site on the Right Dominant arm /Stayed swollen for approximately 2 weeks), VACCINATION SITE WARMTH (The mass is hot to the touch) and SWELLING (Swelling/firmness below injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 047B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (cephalosporins) and Allergy (Wasp). Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (BLISOVI FE 1.5/30) from 01-Jan-2012 to an unknown date for Birth control pill.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced VACCINATION SITE MASS (Large swollen mass below injection site on the Right Dominant arm /Stayed swollen for approximately 2 weeks), VACCINATION SITE WARMTH (The mass is hot to the touch) and SWELLING (Swelling/firmness below injection site). The patient was treated with IBUPROFEN, PARACETAMOL (ADVIL DUAL ACTION) at a dose of 1 dosage form and HYDROCORTISONE at a dose of 1 dosage form. On 30-May-2021, SWELLING (Swelling/firmness below injection site) had resolved. At the time of the report, VACCINATION SITE MASS (Large swollen mass below injection site on the Right Dominant arm /Stayed swollen for approximately 2 weeks) and VACCINATION SITE WARMTH (The mass is hot to the touch) outcome was unknown.            Patient also took pain killer cream along with other treatment products to help relieve side effects.     Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Patient demographic details were updated, relevant medical history was added, concomitant medication was added, event outcome for swelling updated to recovered/resolved.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received their first dose after vaccine was open in refrigerator over 12 hour expiration time; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received their first dose after vaccine was open in refrigerator over 12 hour expiration time) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received their first dose after vaccine was open in refrigerator over 12 hour expiration time). On 14-May-2021, EXPIRED PRODUCT ADMINISTERED (Received their first dose after vaccine was open in refrigerator over 12 hour expiration time) 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.   Concomitant medication list was not provided. Treatment information was not provided. The reporter states that on 13 May 2021, a vial, lot 005C21A, was punctured at 11:25 AM to administer a dose to a patient. The vaccine sat in the refrigerator overnight and on 14/May/2021 between 9:45 to 10 30 AM, a female patient received their first dose.   This case was linked to MODERNATX, INC.-MOD-2021-138655 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-138655:Crosslinked: Same Reporter
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Headache
Clinical narrative: headache pain; menstrual cycle cramps; This spontaneous case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (menstrual cycle cramps) and HEADACHE (headache pain) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A. and 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included IBUPROFEN for Menstrual cramps.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced DYSMENORRHOEA (menstrual cycle cramps). On 17-May-2021, the patient experienced HEADACHE (headache pain). At the time of the report, DYSMENORRHOEA (menstrual cycle cramps) and HEADACHE (headache pain) outcome was unknown.            Treatment medication included ibuprofen 800 mg.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Myalgia, Pyrexia
Clinical narrative: Diarrhea; Tiredness; Fever of 100.2 F; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Tiredness), PYREXIA (Fever of 100.2 F) and MYALGIA (Body aches) 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 08-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), FATIGUE (Tiredness), PYREXIA (Fever of 100.2 F) and MYALGIA (Body aches). At the time of the report, DIARRHOEA (Diarrhea), FATIGUE (Tiredness), PYREXIA (Fever of 100.2 F) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-039255 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received on 04-MAY-2021, contains no new information; Sender's Comments:  MOD-2021-039255:same reporter (daughter case)
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Eczema, Pain in extremity
Clinical narrative: Eczema flare up on legs, knees, hands and elbows; blisters on both palms; open and close his hands and is in pain; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema flare up on legs, knees, hands and elbows), BLISTER (blisters on both palms) and PAIN IN EXTREMITY (open and close his hands and is in pain) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026CV1A and 047B21A) for COVID-19 vaccination.     The patient's past medical history included Eczema (hereditary). Concurrent medical conditions included Drug allergy (penicillin). Concomitant products included GABAPENTIN for Sleep disorder and Anxiety.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced BLISTER (blisters on both palms) and PAIN IN EXTREMITY (open and close his hands and is in pain). On an unknown date, the patient experienced ECZEMA (Eczema flare up on legs, knees, hands and elbows). The patient was treated with CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE) ongoing since an unknown date for Pain, at a dose of 1 dosage form and CLOBETASOL PROPIONATE (CLOBETASOL [CLOBETASOL PROPIONATE]) at an unspecified dose and frequency. At the time of the report, ECZEMA (Eczema flare up on legs, knees, hands and elbows), BLISTER (blisters on both palms) and PAIN IN EXTREMITY (open and close his hands and is in pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information were Tylenol with Oxycodone, Clobetasol Topical with Gloves was provided. patient was diagnosed with dyshidrotic eczema.   This case was linked to MOD-2021-138262 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Reporter Email id is added
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: Itchy arm; red blotch going to collar bone; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotch going to collar bone) and PRURITUS (Itchy arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     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 17-May-2021, the patient experienced RASH MACULAR (red blotch going to collar bone). On an unknown date, the patient experienced PRURITUS (Itchy arm). At the time of the report, RASH MACULAR (red blotch going to collar bone) and PRURITUS (Itchy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported. No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: felt like she had a touch of the flu; Felt achy; had a headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had a touch of the flu), PAIN (Felt achy) and HEADACHE (had a headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, LISINOPRIL for Blood pressure, SIMVASTATIN for Cholesterol, PAROXETINE HYDROCHLORIDE (PAXIL CR) for Depression, LINUM USITATISSIMUM OIL (FLAXSEED OIL [LINUM USITATISSIMUM OIL]) for Heart disorder, PROGESTERONE and ESTRADIOL (MINIVELLE) for Hot flashes, OMEPRAZOLE for Indigestion and Acid reflux (oesophageal), MULTIVITAMIN [VITAMINS NOS] and VITAMIN C [ASCORBIC ACID] for Supplementation therapy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, SOLIFENACIN SUCCINATE (VESICARE) for Urine abnormal, CELECOXIB (CELEBREX) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had a touch of the flu), PAIN (Felt achy) and HEADACHE (had a headache). At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had a touch of the flu), PAIN (Felt achy) and HEADACHE (had a headache) outcome was unknown.            The patient was treated with some cough medicine. Patient was also having stool softeners for constipation as concomitant medication.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Illness, Malaise, Myalgia, Peripheral swelling
Clinical narrative: Felt Sick; Got very ill; Fever of 104 degrees Fahrenheit for 3 days; arm was big and round; arm was so swollen it would not fit in her sleeve; Patient has not received second dose of Moderna COVID-19 vaccine, with first dose being given 21JAN2021 /  Patient claiming they will decide to not get the second dose of the Moderna COVID-19 vaccine.; body ached so bad; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt Sick), ILLNESS (Got very ill), PYREXIA (Fever of 104 degrees Fahrenheit for 3 days), PERIPHERAL SWELLING (arm was big and round) and PERIPHERAL SWELLING (arm was so swollen it would not fit in her sleeve) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 08-Oct-2020. Concomitant products included DILTIAZEM HYDROCHLORIDE (CARTIA XT), POTASSIUM, LEVOTHYROXINE, ISOSORBIDE MONONITRATE (IMDUR), ARGININE, VITAMIN C [ASCORBIC ACID] (VITAMIN C), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), VITAMIN E NOS (VITAMIN E) and BIOTIN for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced MALAISE (Felt Sick), ILLNESS (Got very ill), PYREXIA (Fever of 104 degrees Fahrenheit for 3 days), PERIPHERAL SWELLING (arm was big and round), PERIPHERAL SWELLING (arm was so swollen it would not fit in her sleeve), PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose of Moderna COVID-19 vaccine, with first dose being given 21JAN2021 /  Patient claiming they will decide to not get the second dose of the Moderna COVID-19 vaccine.) and MYALGIA (body ached so bad). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Jan-2021, MALAISE (Felt Sick), ILLNESS (Got very ill), PYREXIA (Fever of 104 degrees Fahrenheit for 3 days), PERIPHERAL SWELLING (arm was big and round), PERIPHERAL SWELLING (arm was so swollen it would not fit in her sleeve), PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose of Moderna COVID-19 vaccine, with first dose being given 21JAN2021 /  Patient claiming they will decide to not get the second dose of the Moderna COVID-19 vaccine.) and MYALGIA (body ached so bad) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 104 (High) ..     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.    Concomitant medication include cranberry pill once a day.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia
Clinical narrative: Felt Sick; Got very ill; Fever of 104 degrees Fahrenheit for 3 days; arm was big and round; arm was so swollen it would not fit in her sleeve; Patient has not received second dose of Moderna COVID-19 vaccine, with first dose being given 21JAN2021 /  Patient claiming they will decide to not get the second dose of the Moderna COVID-19 vaccine.; body ached so bad; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt Sick), ILLNESS (Got very ill), PYREXIA (Fever of 104 degrees Fahrenheit for 3 days), PERIPHERAL SWELLING (arm was big and round) and PERIPHERAL SWELLING (arm was so swollen it would not fit in her sleeve) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 08-Oct-2020. Concomitant products included DILTIAZEM HYDROCHLORIDE (CARTIA XT), POTASSIUM, LEVOTHYROXINE, ISOSORBIDE MONONITRATE (IMDUR), ARGININE, VITAMIN C [ASCORBIC ACID] (VITAMIN C), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), VITAMIN E NOS (VITAMIN E) and BIOTIN for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced MALAISE (Felt Sick), ILLNESS (Got very ill), PYREXIA (Fever of 104 degrees Fahrenheit for 3 days), PERIPHERAL SWELLING (arm was big and round), PERIPHERAL SWELLING (arm was so swollen it would not fit in her sleeve), PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose of Moderna COVID-19 vaccine, with first dose being given 21JAN2021 /  Patient claiming they will decide to not get the second dose of the Moderna COVID-19 vaccine.) and MYALGIA (body ached so bad). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Jan-2021, MALAISE (Felt Sick), ILLNESS (Got very ill), PYREXIA (Fever of 104 degrees Fahrenheit for 3 days), PERIPHERAL SWELLING (arm was big and round), PERIPHERAL SWELLING (arm was so swollen it would not fit in her sleeve), PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose of Moderna COVID-19 vaccine, with first dose being given 21JAN2021 /  Patient claiming they will decide to not get the second dose of the Moderna COVID-19 vaccine.) and MYALGIA (body ached so bad) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 104 (High) ..     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.    Concomitant medication include cranberry pill once a day.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: A 16 year old pregnant patient received the first dose of the Moderna Covid-19 Vaccine; A 16 year old patient received the first dose of the Moderna Covid-19 Vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (A 16 year old pregnant patient received the first dose of the Moderna Covid-19 Vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received the first dose of the Moderna Covid-19 Vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy.    On 17-May-2021 at 10:08 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 26-Nov-2020 and the estimated date of delivery was 02-Sep-2021. On 17-May-2021 at 10:08 AM, the patient experienced EXPOSURE DURING PREGNANCY (A 16 year old pregnant patient received the first dose of the Moderna Covid-19 Vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received the first dose of the Moderna Covid-19 Vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 17-May-2021 at 10:08 AM, EXPOSURE DURING PREGNANCY (A 16 year old pregnant patient received the first dose of the Moderna Covid-19 Vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received the first dose of the Moderna Covid-19 Vaccine) 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 medications were reported. No treatment medication was reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Right arm itchy), VACCINATION SITE PAIN (Pain in right arm at the injection site), VACCINATION SITE SWELLING (Right arm swollen) and MYALGIA (Pain in back of right hand/Pain in back of lower part of arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 039821A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL, LOSARTAN POTASSIUM (LOSARTAN POTASIUM FFP) and AMLODIPINE BESILATE for Blood pressure management. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain in right arm at the injection site). On 15-May-2021, the patient experienced VACCINATION SITE PRURITUS (Right arm itchy), VACCINATION SITE SWELLING (Right arm swollen) and MYALGIA (Pain in back of right hand/Pain in back of lower part of arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (Right arm itchy), VACCINATION SITE PAIN (Pain in right arm at the injection site), VACCINATION SITE SWELLING (Right arm swollen) and MYALGIA (Pain in back of right hand/Pain in back of lower part of arm) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Energy increased, Fatigue, Feeling abnormal, Headache
Clinical narrative: I just don't feel right, I don't feel good; I am in a lot of pain; pain from my neck down; Every muscle in my body and joint hurts; Felt sluggish; My legs are starting to hurt; Burst of energy; I am tired, Starting to get fatigue; My knees and my legs are starting to hurt, and joint hurts; Got a headache, headache will not go away, headache is getting worst; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Felt sluggish), PAIN IN EXTREMITY (My legs are starting to hurt), FEELING ABNORMAL (I just don't feel right, I don't feel good), PAIN (I am in a lot of pain) and NECK PAIN (pain from my neck down) in a 59-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.     Concurrent medical conditions included Asthma. Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), MONTELUKAST and FEXOFENADINE for an unknown indication.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced SLUGGISHNESS (Felt sluggish), PAIN IN EXTREMITY (My legs are starting to hurt), ENERGY INCREASED (Burst of energy), FATIGUE (I am tired, Starting to get fatigue), ARTHRALGIA (My knees and my legs are starting to hurt, and joint hurts) and HEADACHE (Got a headache, headache will not go away, headache is getting worst). On 17-May-2021, the patient experienced FEELING ABNORMAL (I just don't feel right, I don't feel good), PAIN (I am in a lot of pain), NECK PAIN (pain from my neck down) and MYALGIA (Every muscle in my body and joint hurts). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 UNK. At the time of the report, SLUGGISHNESS (Felt sluggish), PAIN IN EXTREMITY (My legs are starting to hurt), FEELING ABNORMAL (I just don't feel right, I don't feel good), PAIN (I am in a lot of pain), NECK PAIN (pain from my neck down), ENERGY INCREASED (Burst of energy), FATIGUE (I am tired, Starting to get fatigue), ARTHRALGIA (My knees and my legs are starting to hurt, and joint hurts), HEADACHE (Got a headache, headache will not go away, headache is getting worst) and MYALGIA (Every muscle in my body and joint hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications Montelukast and Fexofenadine were taken daily and dulera was taken twice a day by the patient.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pain, Pain in extremity, Sluggishness
Clinical narrative: I just don't feel right, I don't feel good; I am in a lot of pain; pain from my neck down; Every muscle in my body and joint hurts; Felt sluggish; My legs are starting to hurt; Burst of energy; I am tired, Starting to get fatigue; My knees and my legs are starting to hurt, and joint hurts; Got a headache, headache will not go away, headache is getting worst; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Felt sluggish), PAIN IN EXTREMITY (My legs are starting to hurt), FEELING ABNORMAL (I just don't feel right, I don't feel good), PAIN (I am in a lot of pain) and NECK PAIN (pain from my neck down) in a 59-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.     Concurrent medical conditions included Asthma. Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), MONTELUKAST and FEXOFENADINE for an unknown indication.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced SLUGGISHNESS (Felt sluggish), PAIN IN EXTREMITY (My legs are starting to hurt), ENERGY INCREASED (Burst of energy), FATIGUE (I am tired, Starting to get fatigue), ARTHRALGIA (My knees and my legs are starting to hurt, and joint hurts) and HEADACHE (Got a headache, headache will not go away, headache is getting worst). On 17-May-2021, the patient experienced FEELING ABNORMAL (I just don't feel right, I don't feel good), PAIN (I am in a lot of pain), NECK PAIN (pain from my neck down) and MYALGIA (Every muscle in my body and joint hurts). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 UNK. At the time of the report, SLUGGISHNESS (Felt sluggish), PAIN IN EXTREMITY (My legs are starting to hurt), FEELING ABNORMAL (I just don't feel right, I don't feel good), PAIN (I am in a lot of pain), NECK PAIN (pain from my neck down), ENERGY INCREASED (Burst of energy), FATIGUE (I am tired, Starting to get fatigue), ARTHRALGIA (My knees and my legs are starting to hurt, and joint hurts), HEADACHE (Got a headache, headache will not go away, headache is getting worst) and MYALGIA (Every muscle in my body and joint hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications Montelukast and Fexofenadine were taken daily and dulera was taken twice a day by the patient.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache pain) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache pain). The patient was treated with IBUPROFEN for Headache and Pain, at a dose of 800 mg. At the time of the report, HEADACHE (Headache pain) outcome was unknown.            Patient reported that she had taken Ibuprofen a couple of days before on 15-May-2021 for Menstrual cycle cramps. No other concomitant medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-138608 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Product dose omission issue
Clinical narrative: Scared and not comfortable to go back for the second shot; Did not feel good after first vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Did not feel good after first vaccine) and PRODUCT DOSE OMISSION ISSUE (Scared and not comfortable to go back for the second shot) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced MALAISE (Did not feel good after first vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Scared and not comfortable to go back for the second shot). On 31-Dec-2020, MALAISE (Did not feel good after first vaccine) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Scared and not comfortable to go back for the second shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment information was provided no concomitant medication were reported   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow Up information was received on 17-May-2021 and contains No new information.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: first dose after vaccine was open in refrigerator over 12 hour expiration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (first dose after vaccine was open in refrigerator over 12 hour expiration time) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (first dose after vaccine was open in refrigerator over 12 hour expiration time). On 14-May-2021, EXPIRED PRODUCT ADMINISTERED (first dose after vaccine was open in refrigerator over 12 hour expiration time) 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 medications were mentioned. No treatment drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-138570, US-MODERNATX, INC.-MOD-2021-138601, MOD21-091233 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-138570:Crosslinked: Same Reporter US-MODERNATX, INC.-MOD-2021-138601:Crosslinked: Same Reporter MOD21-091233:Crosslinked: Same Reporter
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Rash at injection site; Itchy at injection site; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PRURITUS (Itchy at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). On 08-May-2021, the patient experienced VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PRURITUS (Itchy at injection site). At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PRURITUS (Itchy at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Neck pain, Night sweats
Clinical narrative: Profuse night sweat; Neck muscle ache; Sore arm; muscle ache; Fever 102; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Profuse night sweat), NECK PAIN (Neck muscle ache), PAIN IN EXTREMITY (Sore arm), MYALGIA (muscle ache) and PYREXIA (Fever 102) in a 59-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 27-Apr-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 NIGHT SWEATS (Profuse night sweat), NECK PAIN (Neck muscle ache), PAIN IN EXTREMITY (Sore arm), MYALGIA (muscle ache), PYREXIA (Fever 102) and HEADACHE (Headache). At the time of the report, NIGHT SWEATS (Profuse night sweat), NECK PAIN (Neck muscle ache), PAIN IN EXTREMITY (Sore arm), MYALGIA (muscle ache), PYREXIA (Fever 102) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided Treatment for the events were not provided