chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Vaccination site discolouration, Vaccination site reaction
Clinical narrative: Itchy rash; COVID arm; pinkish-reddish discoloration of the underside of forearms; Rash from neck down; Stinging rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Itchy rash), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE DISCOLOURATION (pinkish-reddish discoloration of the underside of forearms), RASH (Rash from neck down) and RASH (Stinging rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008b212a and 014m20a) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic reaction (Ragweed and bees). Concurrent medical conditions included Blood pressure, Gout and Fibromyalgia.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-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 RASH PRURITIC (Itchy rash), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE DISCOLOURATION (pinkish-reddish discoloration of the underside of forearms), RASH (Rash from neck down) and RASH (Stinging rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash), VACCINATION SITE DISCOLOURATION (pinkish-reddish discoloration of the underside of forearms), RASH (Rash from neck down) and RASH (Stinging rash) had resolved and VACCINATION SITE REACTION (COVID arm) outcome was unknown.            Concomitant medications include Blood pressure medication, Gout medication and Fibromyalgia medication.  Patient was checked out by an EMT at the clinic and took two Benadryl. She had no breathing problems and ended up going home. She says the rash was itchy. She let her practitioner know, who said to keep taking Benadryl for the rash. She says she took Benadryl every 4-6 hours for a couple days, then every 12 hours for a couple more days.   This case was linked to US-MODERNATX, INC.-MOD-2021-071363 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow-up included outcome of the event rash, rash pruritic was updated to not recovered and treatment drug frequency was updated. On 12-May-2021: Outcome of events( Rash and vaccination site discolouration ) changed to Recovered.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071363:First dose case
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Lymphadenopathy
Clinical narrative: glands in the neck were completely swollen; had a clogged ear with fluid; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (glands in the neck were completely swollen) and EAR CONGESTION (had a clogged ear with fluid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced LYMPHADENOPATHY (glands in the neck were completely swollen) and EAR CONGESTION (had a clogged ear with fluid). At the time of the report, LYMPHADENOPATHY (glands in the neck were completely swollen) and EAR CONGESTION (had a clogged ear with fluid) outcome was unknown.            The action taken was assessed as not applicable since the patient had already taken the second dose. No concomitant drugs were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B21A) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.   On 01-Apr-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 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Products known to have been used by the patient, within two weeks prior to the event, included blood thinners.       This case was linked to MOD-2021-072067, MOD-2021-077195, MOD-2021-070997, MOD-2021-071416, MOD-2021-070988 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain in extremity, Pyrexia, Retching
Clinical narrative: She has been dry heaving; She has been dizzy also; Arm was sore; Been nauseated; She had a fever; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (She has been dry heaving), DIZZINESS (She has been dizzy also), PAIN IN EXTREMITY (Arm was sore), NAUSEA (Been nauseated) and PYREXIA (She had a fever) 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 07-Apr-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 07-Apr-2021, the patient experienced RETCHING (She has been dry heaving), DIZZINESS (She has been dizzy also), PAIN IN EXTREMITY (Arm was sore), NAUSEA (Been nauseated) and PYREXIA (She had a fever). At the time of the report, RETCHING (She has been dry heaving), DIZZINESS (She has been dizzy also), PAIN IN EXTREMITY (Arm was sore), NAUSEA (Been nauseated) and PYREXIA (She had a fever) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable. .
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The second dose administered 38 days from the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The second dose administered 38 days from the first dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 028A21A) for COVID-19 vaccination.     Previously administered products included for Injury: tetanus on 23-Mar-2021.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The second dose administered 38 days from the first dose). On 06-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The second dose administered 38 days from the first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications and treatment information were not provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant patient reported on 8Apr2021 that she received the vaccine on 15Mar2021.; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient reported on 8Apr2021 that she received the vaccine on 15Mar2021.) in a 31-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 027B21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth) on 27-Nov-2013 and Pregnancy (Live, full-term birth) on 29-Jul-2016. Concurrent medical conditions included Hypothyroidism (hypothyroidism/Hachimoto's diagnosed at age 7) since 1996. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, VITAMIN B6 for Nausea, VITAMIN D [VITAMIN D NOS], MAGNESIUM and PROBIOTICS NOS for an unknown indication.   On 15-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 13-Feb-2021 and the estimated date of delivery was 19-Nov-2021. On 15-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient reported on 8Apr2021 that she received the vaccine on 15Mar2021.). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 15-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient reported on 8Apr2021 that she received the vaccine on 15Mar2021.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Pregnancy test: positive (Positive) Positive.         No concomitant medication provided. No treatment medication provided. The patient's expected date of conception was 26-Feb-2021. The patient had previous 2 pregnancies. First full term birth was on 27-Nov-2013 in 40 weeks and second was on 29-Jul-2016 in 39 weeks.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up information received on 2-jun-2021 contains COVID-19 vaccine dose two  and linked case details.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swelling and itching at the injection site; swelling and itching at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (swelling and itching at the injection site) and VACCINATION SITE SWELLING (swelling and itching at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (swelling and itching at the injection site) and VACCINATION SITE SWELLING (swelling and itching at the injection site). At the time of the report, VACCINATION SITE PRURITUS (swelling and itching at the injection site) and VACCINATION SITE SWELLING (swelling and itching at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: injection site hotness; injection site swelling; injection site tenderness; injection site red circle; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (injection site hotness), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE PAIN (injection site tenderness) and INJECTION SITE ERYTHEMA (injection site red circle) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-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 INJECTION SITE WARMTH (injection site hotness), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE PAIN (injection site tenderness) and INJECTION SITE ERYTHEMA (injection site red circle). On 04-Apr-2021, INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE PAIN (injection site tenderness) had resolved. At the time of the report, INJECTION SITE WARMTH (injection site hotness) and INJECTION SITE ERYTHEMA (injection site red circle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PALPITATIONS (Heart racing), the first episode of HEART RATE INCREASED (Increase in pulse rate to 180), the second episode of PALPITATIONS (Heart racing) and the second episode of HEART RATE INCREASED (Increase in pulse rate to 180) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029120A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced the first episode of PALPITATIONS (Heart racing) and the first episode of HEART RATE INCREASED (Increase in pulse rate to 180). On 03-Feb-2021, the patient experienced the second episode of PALPITATIONS (Heart racing) and the second episode of HEART RATE INCREASED (Increase in pulse rate to 180). On 03-Feb-2021, last episode of PALPITATIONS (Heart racing) and the last episode of HEART RATE INCREASED (Increase in pulse rate to 180) had resolved. Not Provided. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. The patient did not take any medication during the first episode of palpitations and heart rate increase. The patient started meditating to bring the heartrate down to 135.   The patients normal heart rate ranges from 70 to 72. Patients primary doctor advised her not to get the second dose.  Patient visited a cardiologist and was asked to wear a heart monitor for two weeks.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dysphagia, Gingival pain, Glossodynia, Mucosal inflammation
Clinical narrative: Lips tingled; Panic attack; Could nt sleep; Hurt in chest; Mouth swollen; Couldn't swallow; Upper part of gums, throat, and tongue felt like razor blades with sores; upper part of gums, throat, and tongue felt like razor blades with sores; upper part of gums, throat, and tongue felt like razor blades with sores; upper part of gums, throat, and tongue felt like razor blades with sores; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (Lips tingled), PANIC ATTACK (Panic attack), SLEEP DISORDER (Could nt sleep), CHEST PAIN (Hurt in chest) and OEDEMA MOUTH (Mouth swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ORAL DISCOMFORT (Lips tingled), PANIC ATTACK (Panic attack), SLEEP DISORDER (Could nt sleep), CHEST PAIN (Hurt in chest), OEDEMA MOUTH (Mouth swollen), DYSPHAGIA (Couldn't swallow), GINGIVAL PAIN (Upper part of gums, throat, and tongue felt like razor blades with sores), OROPHARYNGEAL PAIN (upper part of gums, throat, and tongue felt like razor blades with sores), GLOSSODYNIA (upper part of gums, throat, and tongue felt like razor blades with sores), MUCOSAL INFLAMMATION (upper part of gums, throat, and tongue felt like razor blades with sores) and NAUSEA (nausea). On 19-Feb-2021, ORAL DISCOMFORT (Lips tingled), PANIC ATTACK (Panic attack), SLEEP DISORDER (Could nt sleep), CHEST PAIN (Hurt in chest), OEDEMA MOUTH (Mouth swollen), DYSPHAGIA (Couldn't swallow), GINGIVAL PAIN (Upper part of gums, throat, and tongue felt like razor blades with sores), OROPHARYNGEAL PAIN (upper part of gums, throat, and tongue felt like razor blades with sores), GLOSSODYNIA (upper part of gums, throat, and tongue felt like razor blades with sores) and MUCOSAL INFLAMMATION (upper part of gums, throat, and tongue felt like razor blades with sores) outcome was unknown. At the time of the report, NAUSEA (nausea) outcome was unknown.            This case was linked to -MODERNATX, INC.-MOD-2021-071324 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-071324:Linked case for second vaccine dose
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oedema mouth, Oral discomfort, Oropharyngeal pain, Panic attack
Clinical narrative: Lips tingled; Panic attack; Could nt sleep; Hurt in chest; Mouth swollen; Couldn't swallow; Upper part of gums, throat, and tongue felt like razor blades with sores; upper part of gums, throat, and tongue felt like razor blades with sores; upper part of gums, throat, and tongue felt like razor blades with sores; upper part of gums, throat, and tongue felt like razor blades with sores; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (Lips tingled), PANIC ATTACK (Panic attack), SLEEP DISORDER (Could nt sleep), CHEST PAIN (Hurt in chest) and OEDEMA MOUTH (Mouth swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ORAL DISCOMFORT (Lips tingled), PANIC ATTACK (Panic attack), SLEEP DISORDER (Could nt sleep), CHEST PAIN (Hurt in chest), OEDEMA MOUTH (Mouth swollen), DYSPHAGIA (Couldn't swallow), GINGIVAL PAIN (Upper part of gums, throat, and tongue felt like razor blades with sores), OROPHARYNGEAL PAIN (upper part of gums, throat, and tongue felt like razor blades with sores), GLOSSODYNIA (upper part of gums, throat, and tongue felt like razor blades with sores), MUCOSAL INFLAMMATION (upper part of gums, throat, and tongue felt like razor blades with sores) and NAUSEA (nausea). On 19-Feb-2021, ORAL DISCOMFORT (Lips tingled), PANIC ATTACK (Panic attack), SLEEP DISORDER (Could nt sleep), CHEST PAIN (Hurt in chest), OEDEMA MOUTH (Mouth swollen), DYSPHAGIA (Couldn't swallow), GINGIVAL PAIN (Upper part of gums, throat, and tongue felt like razor blades with sores), OROPHARYNGEAL PAIN (upper part of gums, throat, and tongue felt like razor blades with sores), GLOSSODYNIA (upper part of gums, throat, and tongue felt like razor blades with sores) and MUCOSAL INFLAMMATION (upper part of gums, throat, and tongue felt like razor blades with sores) outcome was unknown. At the time of the report, NAUSEA (nausea) outcome was unknown.            This case was linked to -MODERNATX, INC.-MOD-2021-071324 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-071324:Linked case for second vaccine dose
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Lips tingled; Panic attack; Could nt sleep; Hurt in chest; Mouth swollen; Couldn't swallow; Upper part of gums, throat, and tongue felt like razor blades with sores; upper part of gums, throat, and tongue felt like razor blades with sores; upper part of gums, throat, and tongue felt like razor blades with sores; upper part of gums, throat, and tongue felt like razor blades with sores; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (Lips tingled), PANIC ATTACK (Panic attack), SLEEP DISORDER (Could nt sleep), CHEST PAIN (Hurt in chest) and OEDEMA MOUTH (Mouth swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ORAL DISCOMFORT (Lips tingled), PANIC ATTACK (Panic attack), SLEEP DISORDER (Could nt sleep), CHEST PAIN (Hurt in chest), OEDEMA MOUTH (Mouth swollen), DYSPHAGIA (Couldn't swallow), GINGIVAL PAIN (Upper part of gums, throat, and tongue felt like razor blades with sores), OROPHARYNGEAL PAIN (upper part of gums, throat, and tongue felt like razor blades with sores), GLOSSODYNIA (upper part of gums, throat, and tongue felt like razor blades with sores), MUCOSAL INFLAMMATION (upper part of gums, throat, and tongue felt like razor blades with sores) and NAUSEA (nausea). On 19-Feb-2021, ORAL DISCOMFORT (Lips tingled), PANIC ATTACK (Panic attack), SLEEP DISORDER (Could nt sleep), CHEST PAIN (Hurt in chest), OEDEMA MOUTH (Mouth swollen), DYSPHAGIA (Couldn't swallow), GINGIVAL PAIN (Upper part of gums, throat, and tongue felt like razor blades with sores), OROPHARYNGEAL PAIN (upper part of gums, throat, and tongue felt like razor blades with sores), GLOSSODYNIA (upper part of gums, throat, and tongue felt like razor blades with sores) and MUCOSAL INFLAMMATION (upper part of gums, throat, and tongue felt like razor blades with sores) outcome was unknown. At the time of the report, NAUSEA (nausea) outcome was unknown.            This case was linked to -MODERNATX, INC.-MOD-2021-071324 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-071324:Linked case for second vaccine dose
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at the injection site) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INJECTION SITE PAIN (Pain at the injection site). At the time of the report, INJECTION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-071407 (E2B Linked Report); Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071407:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Lightheaded/dizziness; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded/dizziness), HEADACHE (Headache) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced DIZZINESS (Lightheaded/dizziness), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Lightheaded/dizziness), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and Treatment medications were not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm  the next day after receiving first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm  the next day after receiving first dose) 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 (No reported medical history).    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm  the next day after receiving first dose). At the time of the report, PAIN IN EXTREMITY (Sore arm  the next day after receiving first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported  Treatment information was not provided.   This case was linked to MOD21-071940 (E2B Linked Report).; Sender's Comments:  MOD21-071940:crosslinked, reporter case
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Pyrexia, Tremor
Clinical narrative: Breathing issues; Became ill the next day/still sick; Shakes; got a high fever; head pain; Chills; sore/it hurt; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Breathing issues), VACCINATION COMPLICATION (Became ill the next day/still sick), TREMOR (Shakes), PYREXIA (got a high fever) and HEADACHE (head pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and CETIRIZINE HYDROCHLORIDE (CHILDREN'S ZYRTEC) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore/it hurt). On 05-Mar-2021, the patient experienced VACCINATION COMPLICATION (Became ill the next day/still sick), TREMOR (Shakes), PYREXIA (got a high fever), HEADACHE (head pain) and CHILLS (Chills). On an unknown date, the patient experienced DYSPNOEA (Breathing issues). At the time of the report, DYSPNOEA (Breathing issues), TREMOR (Shakes), PYREXIA (got a high fever), HEADACHE (head pain), VACCINATION SITE PAIN (sore/it hurt) and CHILLS (Chills) outcome was unknown and VACCINATION COMPLICATION (Became ill the next day/still sick) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       She was admitted to the hospital but was discharged the same day. The doctor put her on Prednisone 50mg for 5 days and an antibiotic. She was sick for 27 days and was on breathing treatment for 23 of those days. She saw the doctor on 22 Mar 2021 and was still sick by the 25 Mar 2021, she started getting off breathing treatment. On 31 Mar 2021, she was off the breathing treatment and was doing well and that was the day she was scheduled for the second dose of the vaccine. Saw the doc on 22 Mar 2021 and was still sick.    This case was linked to US-MODERNATX, INC.-MOD-2021-071782 (E2B Linked Report). This case was linked to MOD-2021-071782 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071782:Dose 2 case
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain
Clinical narrative: Breathing issues; Became ill the next day/still sick; Shakes; got a high fever; head pain; Chills; sore/it hurt; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Breathing issues), VACCINATION COMPLICATION (Became ill the next day/still sick), TREMOR (Shakes), PYREXIA (got a high fever) and HEADACHE (head pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and CETIRIZINE HYDROCHLORIDE (CHILDREN'S ZYRTEC) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore/it hurt). On 05-Mar-2021, the patient experienced VACCINATION COMPLICATION (Became ill the next day/still sick), TREMOR (Shakes), PYREXIA (got a high fever), HEADACHE (head pain) and CHILLS (Chills). On an unknown date, the patient experienced DYSPNOEA (Breathing issues). At the time of the report, DYSPNOEA (Breathing issues), TREMOR (Shakes), PYREXIA (got a high fever), HEADACHE (head pain), VACCINATION SITE PAIN (sore/it hurt) and CHILLS (Chills) outcome was unknown and VACCINATION COMPLICATION (Became ill the next day/still sick) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       She was admitted to the hospital but was discharged the same day. The doctor put her on Prednisone 50mg for 5 days and an antibiotic. She was sick for 27 days and was on breathing treatment for 23 of those days. She saw the doctor on 22 Mar 2021 and was still sick by the 25 Mar 2021, she started getting off breathing treatment. On 31 Mar 2021, she was off the breathing treatment and was doing well and that was the day she was scheduled for the second dose of the vaccine. Saw the doc on 22 Mar 2021 and was still sick.    This case was linked to US-MODERNATX, INC.-MOD-2021-071782 (E2B Linked Report). This case was linked to MOD-2021-071782 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071782:Dose 2 case
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: extreme amount of stress; vertigo that comes and goes; headache; severe fatigue; severe dizziness; arm hurt; fogginess; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (fogginess), DIZZINESS (severe dizziness), PAIN IN EXTREMITY (arm hurt), VERTIGO (vertigo that comes and goes) and STRESS (extreme amount of stress) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Shoulder surgery) on 22-Mar-2021. Concomitant products included PARACETAMOL (TYLENOL) for Pain, ESTRADIOL (ESTROGEN) and TESTOSTERONE for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FEELING ABNORMAL (fogginess). On 07-Mar-2021, the patient experienced DIZZINESS (severe dizziness) and PAIN IN EXTREMITY (arm hurt). On 08-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (severe fatigue). On 08-Apr-2021, the patient experienced VERTIGO (vertigo that comes and goes). On an unknown date, the patient experienced STRESS (extreme amount of stress). On 10-Mar-2021, FEELING ABNORMAL (fogginess), DIZZINESS (severe dizziness), PAIN IN EXTREMITY (arm hurt), HEADACHE (headache) and FATIGUE (severe fatigue) had resolved. At the time of the report, VERTIGO (vertigo that comes and goes) and STRESS (extreme amount of stress) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Stress, Vertigo
Clinical narrative: extreme amount of stress; vertigo that comes and goes; headache; severe fatigue; severe dizziness; arm hurt; fogginess; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (fogginess), DIZZINESS (severe dizziness), PAIN IN EXTREMITY (arm hurt), VERTIGO (vertigo that comes and goes) and STRESS (extreme amount of stress) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Shoulder surgery) on 22-Mar-2021. Concomitant products included PARACETAMOL (TYLENOL) for Pain, ESTRADIOL (ESTROGEN) and TESTOSTERONE for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FEELING ABNORMAL (fogginess). On 07-Mar-2021, the patient experienced DIZZINESS (severe dizziness) and PAIN IN EXTREMITY (arm hurt). On 08-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (severe fatigue). On 08-Apr-2021, the patient experienced VERTIGO (vertigo that comes and goes). On an unknown date, the patient experienced STRESS (extreme amount of stress). On 10-Mar-2021, FEELING ABNORMAL (fogginess), DIZZINESS (severe dizziness), PAIN IN EXTREMITY (arm hurt), HEADACHE (headache) and FATIGUE (severe fatigue) had resolved. At the time of the report, VERTIGO (vertigo that comes and goes) and STRESS (extreme amount of stress) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), HYPERHIDROSIS (Bad sweating), ASTHENIA (Could not get up), VOMITING (Vomiting) and PYREXIA (Fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 06-Apr-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 07-Apr-2021, the patient experienced NIGHT SWEATS (Night sweats), HYPERHIDROSIS (Bad sweating), ASTHENIA (Could not get up), VOMITING (Vomiting), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Severe chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Apr-2021, NIGHT SWEATS (Night sweats), HYPERHIDROSIS (Bad sweating), VOMITING (Vomiting), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Severe chills) had resolved. At the time of the report, ASTHENIA (Could not get up) and HEADACHE (Headache) had resolved. Concomitant medicines include thyroid medicine, cumidine, advil, Zerculas (for allergy).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), HYPERHIDROSIS (Bad sweating), ASTHENIA (Could not get up), VOMITING (Vomiting) and PYREXIA (Fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 06-Apr-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 07-Apr-2021, the patient experienced NIGHT SWEATS (Night sweats), HYPERHIDROSIS (Bad sweating), ASTHENIA (Could not get up), VOMITING (Vomiting), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Severe chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Apr-2021, NIGHT SWEATS (Night sweats), HYPERHIDROSIS (Bad sweating), VOMITING (Vomiting), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Severe chills) had resolved. At the time of the report, ASTHENIA (Could not get up) and HEADACHE (Headache) had resolved. Concomitant medicines include thyroid medicine, cumidine, advil, Zerculas (for allergy).
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 17-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment details were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypokinesia, Lymphadenopathy, Vaccination site erythema
Clinical narrative: range of motion restricted left arm; swelling size of softball, hot; rash on left arm; lymph node swelling left arm; knot on left arm; fatigue; headache; redness left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (knot on left arm), HYPOKINESIA (range of motion restricted left arm), FATIGUE (fatigue), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness left arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE MASS (knot on left arm), FATIGUE (fatigue), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness left arm). On 07-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling size of softball, hot), VACCINATION SITE RASH (rash on left arm) and LYMPHADENOPATHY (lymph node swelling left arm). On 08-Apr-2021, the patient experienced HYPOKINESIA (range of motion restricted left arm). At the time of the report, VACCINATION SITE MASS (knot on left arm), HYPOKINESIA (range of motion restricted left arm), FATIGUE (fatigue), HEADACHE (headache), VACCINATION SITE ERYTHEMA (redness left arm), VACCINATION SITE SWELLING (swelling size of softball, hot), VACCINATION SITE RASH (rash on left arm) and LYMPHADENOPATHY (lymph node swelling left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concurrent medication reported. Treatment included antibiotic and steroid
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site rash, Vaccination site swelling
Clinical narrative: range of motion restricted left arm; swelling size of softball, hot; rash on left arm; lymph node swelling left arm; knot on left arm; fatigue; headache; redness left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (knot on left arm), HYPOKINESIA (range of motion restricted left arm), FATIGUE (fatigue), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness left arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE MASS (knot on left arm), FATIGUE (fatigue), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness left arm). On 07-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling size of softball, hot), VACCINATION SITE RASH (rash on left arm) and LYMPHADENOPATHY (lymph node swelling left arm). On 08-Apr-2021, the patient experienced HYPOKINESIA (range of motion restricted left arm). At the time of the report, VACCINATION SITE MASS (knot on left arm), HYPOKINESIA (range of motion restricted left arm), FATIGUE (fatigue), HEADACHE (headache), VACCINATION SITE ERYTHEMA (redness left arm), VACCINATION SITE SWELLING (swelling size of softball, hot), VACCINATION SITE RASH (rash on left arm) and LYMPHADENOPATHY (lymph node swelling left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concurrent medication reported. Treatment included antibiotic and steroid
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Temperature of 103.5Degress Farenheit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature of 103.5Degress Farenheit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PYREXIA (Temperature of 103.5Degress Farenheit). At the time of the report, PYREXIA (Temperature of 103.5Degress Farenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-May-2021, no new information was recorded
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient was tested positive for COVID-19 infection after the first dose; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Patient was tested positive for COVID-19 infection after the first dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient was tested positive for COVID-19 infection after the first dose). At the time of the report, COVID-19 (Patient was tested positive for COVID-19 infection after the first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19.     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 product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-MAY-2021 had no new information. On 16-Jul-2021: Follow-up received on 16-Jul-2021, in which No new information is given.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and stat date of the event, a causal relationship cannot be excluded.