chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Erythema, Fatigue, Pain, Poor quality product administered
Clinical narrative: Sleepy tiredness; Pain; Redness; Stress; fatigue; I worry this is sabotage; "Mediciny" taste in my mouth; Soreness in arm where the injection was given; Received a dose of the vaccine from a vial that was left out at room temperature over the weekend/got the spoiled 2nd Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER ("Mediciny" taste in my mouth), ANXIETY (I worry this is sabotage), SOMNOLENCE (Sleepy tiredness), PAIN (Pain) and ERYTHEMA (Redness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D3 and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced TASTE DISORDER ("Mediciny" taste in my mouth), POOR QUALITY PRODUCT ADMINISTERED (Received a dose of the vaccine from a vial that was left out at room temperature over the weekend/got the spoiled 2nd Vaccine) and VACCINATION SITE PAIN (Soreness in arm where the injection was given). On 15-Apr-2021, the patient experienced ANXIETY (I worry this is sabotage). On an unknown date, the patient experienced SOMNOLENCE (Sleepy tiredness), PAIN (Pain), ERYTHEMA (Redness), STRESS (Stress) and FATIGUE (fatigue). On 12-Apr-2021, POOR QUALITY PRODUCT ADMINISTERED (Received a dose of the vaccine from a vial that was left out at room temperature over the weekend/got the spoiled 2nd Vaccine) had resolved. At the time of the report, TASTE DISORDER ("Mediciny" taste in my mouth), ANXIETY (I worry this is sabotage), SOMNOLENCE (Sleepy tiredness), PAIN (Pain), ERYTHEMA (Redness), STRESS (Stress), FATIGUE (fatigue) and VACCINATION SITE PAIN (Soreness in arm where the injection was given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also include herbal medicines. No treatment information was provided. she went for the Antibody testing and results are back she has a number of 20.2   This case was linked to MOD-2021-093943 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received on 3-MAY-2021 :  First dose start date and batch number, new event were updated On 08-Jun-2021: follow up received on 8-jun-2021 contain no new information
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Stress, Taste disorder, Vaccination site pain
Clinical narrative: Sleepy tiredness; Pain; Redness; Stress; fatigue; I worry this is sabotage; "Mediciny" taste in my mouth; Soreness in arm where the injection was given; Received a dose of the vaccine from a vial that was left out at room temperature over the weekend/got the spoiled 2nd Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER ("Mediciny" taste in my mouth), ANXIETY (I worry this is sabotage), SOMNOLENCE (Sleepy tiredness), PAIN (Pain) and ERYTHEMA (Redness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D3 and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced TASTE DISORDER ("Mediciny" taste in my mouth), POOR QUALITY PRODUCT ADMINISTERED (Received a dose of the vaccine from a vial that was left out at room temperature over the weekend/got the spoiled 2nd Vaccine) and VACCINATION SITE PAIN (Soreness in arm where the injection was given). On 15-Apr-2021, the patient experienced ANXIETY (I worry this is sabotage). On an unknown date, the patient experienced SOMNOLENCE (Sleepy tiredness), PAIN (Pain), ERYTHEMA (Redness), STRESS (Stress) and FATIGUE (fatigue). On 12-Apr-2021, POOR QUALITY PRODUCT ADMINISTERED (Received a dose of the vaccine from a vial that was left out at room temperature over the weekend/got the spoiled 2nd Vaccine) had resolved. At the time of the report, TASTE DISORDER ("Mediciny" taste in my mouth), ANXIETY (I worry this is sabotage), SOMNOLENCE (Sleepy tiredness), PAIN (Pain), ERYTHEMA (Redness), STRESS (Stress), FATIGUE (fatigue) and VACCINATION SITE PAIN (Soreness in arm where the injection was given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also include herbal medicines. No treatment information was provided. she went for the Antibody testing and results are back she has a number of 20.2   This case was linked to MOD-2021-093943 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received on 3-MAY-2021 :  First dose start date and batch number, new event were updated On 08-Jun-2021: follow up received on 8-jun-2021 contain no new information
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Herpes zoster, Rash, SARS-CoV-2 test
Clinical narrative: COVID-19; Shingles; Rash; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), COVID-19 (COVID-19) and RASH (Rash) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025L202A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Had gotten higher) and Hyperlipidemia. Concomitant products included PRAVASTATIN for Hyperlipidaemia, LOSARTAN POTASSIUM (LOSARTIN), MELOXICAM, VITAMINS NOS, FISH OIL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and CARVEDILOL for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced RASH (Rash). On 13-Jan-2021, the patient experienced HERPES ZOSTER (Shingles). On 19-Jul-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, HERPES ZOSTER (Shingles) and RASH (Rash) had resolved and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive, Type of test - saliva..         No treatment information were reported.  Action taken with the drug in response to events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29 Jul 2021 includes new concomitant medication, one event of COVID-19 and lab data updated
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Vaccination site pain
Clinical narrative: Anxiety; Soreness sensation; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety) and VACCINATION SITE PAIN (Soreness sensation) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Penicillin allergy (Penicillin). Concomitant products included LISINOPRIL for Blood pressure high, IBUPROFEN and VITAMINS NOS for an unknown indication.    On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness sensation). On an unknown date, the patient experienced ANXIETY (Anxiety). On 25-Jan-2021, VACCINATION SITE PAIN (Soreness sensation) had resolved. At the time of the report, ANXIETY (Anxiety) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-013541 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Non-significant FUP information obtained about contact information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Felt very Sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt very Sick) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced MALAISE (Felt very Sick). On 04-Feb-2021, MALAISE (Felt very Sick) had resolved.            concomitant medicines was not reported by reporter   treatment information was not provided  The action taken with mRNA-1273 with the events was considered as not applicable  For mRNA-1273 (Moderna COVID-19 Vaccine) (intramascular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-014267 (Patient Link).   Reporter did not allow further contact
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Raised Red Rash on bilateral Lower Legs and left Forearm; This spontaneous case was reported by a nurse and describes the occurrence of RASH (Raised Red Rash on bilateral Lower Legs and left Forearm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Raised Red Rash on bilateral Lower Legs and left Forearm). On 08-Feb-2021, RASH (Raised Red Rash on bilateral Lower Legs and left Forearm) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm hurts where shot was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurts where shot was given) 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 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION SITE PAIN (Arm hurts where shot was given). At the time of the report, VACCINATION SITE PAIN (Arm hurts where shot was given) had not resolved.            No concomitant medications provided.  Treatment information was not provided    The action taken with mRNA-1273 with the events was considered as not applicable  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever; Chills; Nausea; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Myalgia) 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.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Myalgia). At the time of the report, PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Myalgia) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. No treatment information was provided. No relevant concomitant medications were reported.   This case was linked to MOD-2021-021174 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Headache, Neurological symptom, Spinal pain, Vaccination complication
Clinical narrative: pain in my spine; My typing is really off; Neurological issues; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (pain in my spine), VACCINATION COMPLICATION (My typing is really off), NEUROLOGICAL SYMPTOM (Neurological issues) and HEADACHE (Headache) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SPINAL PAIN (pain in my spine), VACCINATION COMPLICATION (My typing is really off), NEUROLOGICAL SYMPTOM (Neurological issues) and HEADACHE (Headache). At the time of the report, SPINAL PAIN (pain in my spine), VACCINATION COMPLICATION (My typing is really off), NEUROLOGICAL SYMPTOM (Neurological issues) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: fallow up  received on 19-apr-21 contains no new information
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Surgery, Tic, Vaccination site pain
Clinical narrative: finger surgery; facial tics; pain at the injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (finger surgery), TIC (facial tics), VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced SURGERY (finger surgery), TIC (facial tics), VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (fatigue). On 03-Mar-2021, SURGERY (finger surgery), TIC (facial tics), VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The Action taken with mRNA-1273 (Moderna covid-19 vaccine) was not applicable.  No concomitant medications were reported  Treatment includes Anesthesia for surgery on index finger   This case was linked to MOD-2021-064175 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received on 13 MAY 2021 and does not contain any new information
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under the recommended age to receive vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the recommended age to receive vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 19-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021 at 1:00 PM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the recommended age to receive vaccine). On 19-Mar-2021 at 1:00 PM, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the recommended age to receive vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided. Treatment medication not provided.    This case was linked to MOD-2021-072269 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Rash, Wound
Clinical narrative: Raw skin (open wound) on the bottom of my right leg from shin dow and was also leaking; difficulty breathing; both arms and across my shoulders developed extreme and severe rash, also at the top of my right thigh and calf; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of WOUND (Raw skin (open wound) on the bottom of my right leg from shin dow and was also leaking), DYSPNOEA (difficulty breathing), RASH (both arms and across my shoulders developed extreme and severe rash, also at the top of my right thigh and calf) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced WOUND (Raw skin (open wound) on the bottom of my right leg from shin dow and was also leaking), DYSPNOEA (difficulty breathing), RASH (both arms and across my shoulders developed extreme and severe rash, also at the top of my right thigh and calf) and CHILLS (chills). At the time of the report, WOUND (Raw skin (open wound) on the bottom of my right leg from shin dow and was also leaking) and RASH (both arms and across my shoulders developed extreme and severe rash, also at the top of my right thigh and calf) was resolving and DYSPNOEA (difficulty breathing) and CHILLS (chills) had resolved.            Concomitant Product use was not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up received on 10 May 2021 .Event outcomes were updated.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Debilitating shoulder pain in my left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Debilitating shoulder pain in my left shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse reaction.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced ARTHRALGIA (Debilitating shoulder pain in my left shoulder). At the time of the report, ARTHRALGIA (Debilitating shoulder pain in my left shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nervousness, Restlessness
Clinical narrative: Felt nervous; Felt "restless",; Could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Felt nervous), RESTLESSNESS (Felt "restless",) and INSOMNIA (Could not sleep) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced NERVOUSNESS (Felt nervous), RESTLESSNESS (Felt "restless",) and INSOMNIA (Could not sleep). At the time of the report, NERVOUSNESS (Felt nervous), RESTLESSNESS (Felt "restless",) and INSOMNIA (Could not sleep) outcome was unknown.            No treatment information was provided.    This case was linked to MOD-2021-076761 (Patient Link).
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia, Tremor
Clinical narrative: diarrhea; shaking; chills; high temperature; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), TREMOR (shaking), CHILLS (chills) and PYREXIA (high temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DIARRHOEA (diarrhea), TREMOR (shaking), CHILLS (chills) and PYREXIA (high temperature). At the time of the report, DIARRHOEA (diarrhea), TREMOR (shaking), CHILLS (chills) and PYREXIA (high temperature) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Illness, Rash
Clinical narrative: a lot of red dots, like a rash; a lot of red dots, like a rash; bruises on both arms, but mostly on my left; sick; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (a lot of red dots, like a rash), RASH (a lot of red dots, like a rash), CONTUSION (bruises on both arms, but mostly on my left) and ILLNESS (sick) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A and 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 02 Apr 2021, the  patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On an unknown date, the patient experienced ERYTHEMA (a lot of red dots, like a rash), RASH (a lot of red dots, like a rash), CONTUSION (bruises on both arms, but mostly on my left) and ILLNESS (sick). At the time of the report, ERYTHEMA (a lot of red dots, like a rash), RASH (a lot of red dots, like a rash), CONTUSION (bruises on both arms, but mostly on my left) and ILLNESS (sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: we have 17 years old to whom we administered a Moderna Vaccine today; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (we have 17 years old to whom we administered a Moderna Vaccine today) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (we have 17 years old to whom we administered a Moderna Vaccine today). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (we have 17 years old to whom we administered a Moderna Vaccine today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Body temperature: 99 (High) 99 degrees Fahrenheit..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Upon an internal review on 21 May 2021, the age was corrected to an unknown age.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site swelling
Clinical narrative: swelling at the injection site; soreness/pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site) and PAIN (soreness/pain) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site) and PAIN (soreness/pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 25-Mar-2021, VACCINATION SITE SWELLING (swelling at the injection site) had resolved. At the time of the report, PAIN (soreness/pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Secretion discharge
Clinical narrative: ¨have a cold¨ with cold symptoms; little cough¨; ¨mucus¨; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (¨have a cold¨ with cold symptoms), COUGH (little cough¨) and SECRETION DISCHARGE (¨mucus¨) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced NASOPHARYNGITIS (¨have a cold¨ with cold symptoms), COUGH (little cough¨) and SECRETION DISCHARGE (¨mucus¨). At the time of the report, NASOPHARYNGITIS (¨have a cold¨ with cold symptoms), COUGH (little cough¨) and SECRETION DISCHARGE (¨mucus¨) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: unspecified adverse events; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (unspecified adverse events) 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 09-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 ADVERSE EVENT (unspecified adverse events). At the time of the report, ADVERSE EVENT (unspecified adverse events) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Weight decreased
Clinical narrative: Lost 1.5 lbs; diarrhea off and on for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea off and on for 2 weeks) and WEIGHT DECREASED (Lost 1.5 lbs) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced DIARRHOEA (diarrhea off and on for 2 weeks). On 16-Apr-2021, the patient experienced WEIGHT DECREASED (Lost 1.5 lbs). At the time of the report, DIARRHOEA (diarrhea off and on for 2 weeks) and WEIGHT DECREASED (Lost 1.5 lbs) outcome was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: Other symptoms; Caller said she had Covid; No appetite; Poundind and stabbing headache; Very fatigued; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Other symptoms), COVID-19 (Caller said she had Covid), DECREASED APPETITE (No appetite), HEADACHE (Poundind and stabbing headache) and FATIGUE (Very fatigued) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-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 VACCINATION COMPLICATION (Other symptoms), COVID-19 (Caller said she had Covid), DECREASED APPETITE (No appetite), HEADACHE (Poundind and stabbing headache), FATIGUE (Very fatigued) and NAUSEA (Nausea). At the time of the report, VACCINATION COMPLICATION (Other symptoms), COVID-19 (Caller said she had Covid), DECREASED APPETITE (No appetite), HEADACHE (Poundind and stabbing headache), FATIGUE (Very fatigued) and NAUSEA (Nausea) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: New event was added.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Other symptoms; Caller said she had Covid; No appetite; Poundind and stabbing headache; Very fatigued; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Other symptoms), COVID-19 (Caller said she had Covid), DECREASED APPETITE (No appetite), HEADACHE (Poundind and stabbing headache) and FATIGUE (Very fatigued) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-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 VACCINATION COMPLICATION (Other symptoms), COVID-19 (Caller said she had Covid), DECREASED APPETITE (No appetite), HEADACHE (Poundind and stabbing headache), FATIGUE (Very fatigued) and NAUSEA (Nausea). At the time of the report, VACCINATION COMPLICATION (Other symptoms), COVID-19 (Caller said she had Covid), DECREASED APPETITE (No appetite), HEADACHE (Poundind and stabbing headache), FATIGUE (Very fatigued) and NAUSEA (Nausea) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: New event was added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Swelling
Clinical narrative: hand was so swollen it looked that it was going to burst; chills; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (hand was so swollen it looked that it was going to burst), CHILLS (chills), HEADACHE (headache) and MYALGIA (body aches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (hand was so swollen it looked that it was going to burst), CHILLS (chills), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, SWELLING (hand was so swollen it looked that it was going to burst), CHILLS (chills), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old daughter received the Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old daughter received the Moderna Vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    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 (17 years old daughter received the Moderna Vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old daughter received the Moderna Vaccine) 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.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Vaccination site rash
Clinical narrative: rash; headache; weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), VACCINATION SITE RASH (rash) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 180B2A) for COVID-19 vaccination.     No medical history was provided.     On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced ASTHENIA (weakness). On 03-Apr-2021, the patient experienced HEADACHE (headache). On 14-Apr-2021, the patient experienced VACCINATION SITE RASH (rash). At the time of the report, ASTHENIA (weakness) had resolved and VACCINATION SITE RASH (rash) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Nausea, Peripheral swelling
Clinical narrative: Arm was swollen; Arm was red; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen), ERYTHEMA (Arm was red), NAUSEA (Nausea) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen), ERYTHEMA (Arm was red), NAUSEA (Nausea) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Apr-2021, NAUSEA (Nausea) and CHILLS (Chills) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm was swollen) and ERYTHEMA (Arm was red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Muscle spasms, Tension, Vaginal haemorrhage
Clinical narrative: is scared; felt funny at work and had to come home from work; vaginal bleeding, described as the blood was completely red in color; horrible heavy cramps, described as felt like someone was grabbing her ovaries and twisting them; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal bleeding, described as the blood was completely red in color), MUSCLE SPASMS (horrible heavy cramps, described as felt like someone was grabbing her ovaries and twisting them), TENSION (is scared) and FEELING ABNORMAL (felt funny at work and had to come home from work) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCLE SPASMS (horrible heavy cramps, described as felt like someone was grabbing her ovaries and twisting them). On 15-Apr-2021, the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding, described as the blood was completely red in color) and FEELING ABNORMAL (felt funny at work and had to come home from work). On 16-Apr-2021, the patient experienced TENSION (is scared). At the time of the report, VAGINAL HAEMORRHAGE (vaginal bleeding, described as the blood was completely red in color), MUSCLE SPASMS (horrible heavy cramps, described as felt like someone was grabbing her ovaries and twisting them), TENSION (is scared) and FEELING ABNORMAL (felt funny at work and had to come home from work) had not resolved. Unknown          No concomitant medications were reported. Patient was asked to monitor her bleeding and often she has to change her sanitary napkin.  The action taken with mRNA-1273 in response to the event was not applicable.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: Had twitching in muscle in leg; a A involuntary muscle spasm in both legs.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Had twitching in muscle in leg) and MUSCLE SPASMS (a A involuntary muscle spasm in both legs.) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included ALLERGY MEDICATION 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 MUSCLE TWITCHING (Had twitching in muscle in leg) and MUSCLE SPASMS (a A involuntary muscle spasm in both legs.). At the time of the report, MUSCLE TWITCHING (Had twitching in muscle in leg) and MUSCLE SPASMS (a A involuntary muscle spasm in both legs.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received first Moderna vaccine on 3-31-2021 first. Patient stated shortly after he had twitching in muscle in leg. Patient stated it got progressively more noticed. Patient stated its like a involuntary muscle spasm in both legs. Patient stated it is now progressively near both ankle and feet. Patient stated he can notice the most in his calf. Patient expressed he has always been in good health. Patient wants to know has anyone reported his side effects. Consent to Safety
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Symptoms like a strong flu. as CC reported , no further details provided; Pain in the arm of the injection, as CC reported , no further details provided; Chills, as CC reported , no further details provided; ¨Pain in the axilla after the vaccination¨; Fever, as CC reported , no further details provided.; Body aches, as CC reported , no further details provided; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Symptoms like a strong flu. as CC reported , no further details provided), VACCINATION SITE PAIN (Pain in the arm of the injection, as CC reported , no further details provided), CHILLS (Chills, as CC reported , no further details provided), AXILLARY PAIN (¨Pain in the axilla after the vaccination¨) and PYREXIA (Fever, as CC reported , no further details provided.) in a female patient of an unknown age 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 was provided.     On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Symptoms like a strong flu. as CC reported , no further details provided), VACCINATION SITE PAIN (Pain in the arm of the injection, as CC reported , no further details provided), CHILLS (Chills, as CC reported , no further details provided), AXILLARY PAIN (¨Pain in the axilla after the vaccination¨), PYREXIA (Fever, as CC reported , no further details provided.) and MYALGIA (Body aches, as CC reported , no further details provided). At the time of the report, INFLUENZA LIKE ILLNESS (Symptoms like a strong flu. as CC reported , no further details provided), VACCINATION SITE PAIN (Pain in the arm of the injection, as CC reported , no further details provided), CHILLS (Chills, as CC reported , no further details provided), AXILLARY PAIN (¨Pain in the axilla after the vaccination¨), PYREXIA (Fever, as CC reported , no further details provided.) and MYALGIA (Body aches, as CC reported , no further details provided) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Symptoms like a strong flu. as CC reported , no further details provided; Pain in the arm of the injection, as CC reported , no further details provided; Chills, as CC reported , no further details provided; ¨Pain in the axilla after the vaccination¨; Fever, as CC reported , no further details provided.; Body aches, as CC reported , no further details provided; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Symptoms like a strong flu. as CC reported , no further details provided), VACCINATION SITE PAIN (Pain in the arm of the injection, as CC reported , no further details provided), CHILLS (Chills, as CC reported , no further details provided), AXILLARY PAIN (¨Pain in the axilla after the vaccination¨) and PYREXIA (Fever, as CC reported , no further details provided.) in a female patient of an unknown age 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 was provided.     On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Symptoms like a strong flu. as CC reported , no further details provided), VACCINATION SITE PAIN (Pain in the arm of the injection, as CC reported , no further details provided), CHILLS (Chills, as CC reported , no further details provided), AXILLARY PAIN (¨Pain in the axilla after the vaccination¨), PYREXIA (Fever, as CC reported , no further details provided.) and MYALGIA (Body aches, as CC reported , no further details provided). At the time of the report, INFLUENZA LIKE ILLNESS (Symptoms like a strong flu. as CC reported , no further details provided), VACCINATION SITE PAIN (Pain in the arm of the injection, as CC reported , no further details provided), CHILLS (Chills, as CC reported , no further details provided), AXILLARY PAIN (¨Pain in the axilla after the vaccination¨), PYREXIA (Fever, as CC reported , no further details provided.) and MYALGIA (Body aches, as CC reported , no further details provided) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Malaise, Swelling face
Clinical narrative: flushed face; Face swollen; felt funny; face warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flushed face), SWELLING FACE (Face swollen), MALAISE (felt funny) and FEELING HOT (face warm to the touch) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A--A) for COVID-19 vaccination.     No medical history information were reported.  Concomitant products included LATANOPROST for Eye drop instillation, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced FLUSHING (flushed face), SWELLING FACE (Face swollen), MALAISE (felt funny) and FEELING HOT (face warm to the touch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Mar-2021, FLUSHING (flushed face), SWELLING FACE (Face swollen), MALAISE (felt funny) and FEELING HOT (face warm to the touch) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information were Tylenol provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: - contact information was updated .