chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: A little Sore Arm; Tingling in face; Left side of face numbness; A little Chills; A little Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little Sore Arm), PARAESTHESIA (Tingling in face), HYPOAESTHESIA (Left side of face numbness), CHILLS (A little Chills) and FATIGUE (A little Fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (A little Sore Arm), PARAESTHESIA (Tingling in face), HYPOAESTHESIA (Left side of face numbness), CHILLS (A little Chills) and FATIGUE (A little Fatigue). On 23-Feb-2021, PAIN IN EXTREMITY (A little Sore Arm), PARAESTHESIA (Tingling in face), CHILLS (A little Chills) and FATIGUE (A little Fatigue) had resolved. At the time of the report, HYPOAESTHESIA (Left side of face numbness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Erythema, Paraesthesia
Clinical narrative: Turned bright red; Had a little tingling in their nerves; 4 nose bleeds; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Turned bright red), PARAESTHESIA (Had a little tingling in their nerves) and EPISTAXIS (4 nose bleeds) 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) dosage form. On an unknown date, the patient experienced ERYTHEMA (Turned bright red), PARAESTHESIA (Had a little tingling in their nerves) and EPISTAXIS (4 nose bleeds). At the time of the report, ERYTHEMA (Turned bright red) and PARAESTHESIA (Had a little tingling in their nerves) outcome was unknown and EPISTAXIS (4 nose bleeds) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not Provided by the reporter. Treatment Medications were not provided by the reporter.   This case was linked to MOD-2021-099813 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: New AE Added
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Patient experienced muscle pain at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Patient experienced muscle pain at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Patient experienced muscle pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Patient experienced muscle pain at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: Symptoms included Sciatica on legs; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (Symptoms included Sciatica on legs) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCIATICA (Symptoms included Sciatica on legs). At the time of the report, SCIATICA (Symptoms included Sciatica on legs) outcome was unknown. Not Provided          Concomitant medication was not reported.  Treatment included acupuncture.  Action taken with mRNA-1273 in response to the event was Not Applicable
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Eyelid ptosis, Fatigue, Pain
Clinical narrative: Very red face; Droopy eyes; Achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Very red face), EYELID PTOSIS (Droopy eyes), PAIN (Achy) and FATIGUE (Tired) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced ERYTHEMA (Very red face), EYELID PTOSIS (Droopy eyes), PAIN (Achy) and FATIGUE (Tired). At the time of the report, ERYTHEMA (Very red face), EYELID PTOSIS (Droopy eyes), PAIN (Achy) and FATIGUE (Tired) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dehydration, Illness
Clinical narrative: Weak; Sick/Illness; Dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), ILLNESS (Sick/Illness) and DEHYDRATION (Dehydrated) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Stent insertion NOS (Has 2 stents.). Concurrent medical conditions included Fish allergy and Diabetes. Concomitant products included ATORVASTATIN, METOPROLOL and VITAMIN D NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ASTHENIA (Weak), ILLNESS (Sick/Illness) and DEHYDRATION (Dehydrated). At the time of the report, ASTHENIA (Weak), ILLNESS (Sick/Illness) and DEHYDRATION (Dehydrated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also mentioned diabetes medication NOS. Treatment information provided was fluids.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; Couldn't move, had to stay in the bed; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS and FATIGUE in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Previously administered products included for an unreported indication: INFLUENZA VACCINE, PNEUMOCOCCAL VACCINE, and TUBERCULOSIS VACCINES.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS and FATIGUE. At the time of the report, CHILLS and FATIGUE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On an unknown date, the patient received shingle shot. No relevant concomitant medications were reported. No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension, Hypoacusis, Pain in extremity, Pyrexia
Clinical narrative: "Eco" in the right ear; high blood pressure 15/9; Pain in the arm; fever 101 F; Lightheaded feeling in the right side; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS ("Eco" in the right ear), HYPERTENSION (high blood pressure 15/9), PAIN IN EXTREMITY (Pain in the arm), PYREXIA (fever 101 F) and DIZZINESS (Lightheaded feeling in the right side) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced HYPOACUSIS ("Eco" in the right ear), HYPERTENSION (high blood pressure 15/9), PAIN IN EXTREMITY (Pain in the arm), PYREXIA (fever 101 F) and DIZZINESS (Lightheaded feeling in the right side). At the time of the report, HYPOACUSIS ("Eco" in the right ear), HYPERTENSION (high blood pressure 15/9), PAIN IN EXTREMITY (Pain in the arm), PYREXIA (fever 101 F) and DIZZINESS (Lightheaded feeling in the right side) outcome was unknown.            No concomitant medication were reported. No treatment medication were reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dysarthria
Clinical narrative: Slurred speech; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (Slurred speech) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FENOFIBRATE, AMLODIPINE, ALLOPURINOL, ASPIRIN [ACETYLSALICYLIC ACID] and VITAMIN D3 for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced DYSARTHRIA (Slurred speech). At the time of the report, DYSARTHRIA (Slurred speech) had resolved. Not Provided          A procedure done before few days before getting Moderna vaccine. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: the follow-up was received  on 03-may-2021 and contains following updated significant information : outcome updated.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Red swelling like a bump; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red swelling like a bump) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red swelling like a bump). At the time of the report, ERYTHEMA (Red swelling like a bump) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: The event outcome was updated as recovering.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling, Vaccination site pain
Clinical narrative: minimal discomfort; redness in a 2 x 3 inch area on her left arm/red and a little raised; redness in a 2 x 3 inch area on her left arm/red and a little raised; itchy; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (redness in a 2 x 3 inch area on her left arm/red and a little raised), SWELLING (redness in a 2 x 3 inch area on her left arm/red and a little raised), PRURITUS (itchy) and VACCINATION SITE PAIN (minimal discomfort) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ERYTHEMA (redness in a 2 x 3 inch area on her left arm/red and a little raised), SWELLING (redness in a 2 x 3 inch area on her left arm/red and a little raised) and PRURITUS (itchy). On an unknown date, the patient experienced VACCINATION SITE PAIN (minimal discomfort). At the time of the report, ERYTHEMA (redness in a 2 x 3 inch area on her left arm/red and a little raised), SWELLING (redness in a 2 x 3 inch area on her left arm/red and a little raised), PRURITUS (itchy) and VACCINATION SITE PAIN (minimal discomfort) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by patient  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow-up information received on 28-JUL-2021 contains significant information outcome updated.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mass, Rash pruritic
Clinical narrative: Red Lump below injection site; Red Lump below injection site; Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red Lump below injection site), MASS (Red Lump below injection site) and RASH PRURITIC (Itchy rash) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN and FAMOTIDINE for an unknown indication.    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 ERYTHEMA (Red Lump below injection site), MASS (Red Lump below injection site) and RASH PRURITIC (Itchy rash). At the time of the report, ERYTHEMA (Red Lump below injection site), MASS (Red Lump below injection site) and RASH PRURITIC (Itchy rash) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included application of ice.
Sex: F
Vaccine: COVID19
Symptoms: Allergic sinusitis, Eye pruritus, Headache
Clinical narrative: Sinus Allergies; Itchy eye; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGIC SINUSITIS (Sinus Allergies), EYE PRURITUS (Itchy eye) and HEADACHE (Headache) 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 04-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 ALLERGIC SINUSITIS (Sinus Allergies), EYE PRURITUS (Itchy eye) and HEADACHE (Headache). At the time of the report, ALLERGIC SINUSITIS (Sinus Allergies), EYE PRURITUS (Itchy eye) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product use was reported. No treatment details were provided.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Hardness at the site of injection; Itchy at the site of injection; Redness at the site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INDURATION (Hardness at the site of injection), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Redness at the site of injection) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) 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-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Hardness at the site of injection), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Redness at the site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (Hardness at the site of injection), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Redness at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Induration, Pruritus
Clinical narrative: large lump on her arm that is very hot, itching and hard; large lump on her arm that is very hot, itching and hard; large lump on her arm that is very hot, itching and hard; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (large lump on her arm that is very hot, itching and hard), FEELING HOT (large lump on her arm that is very hot, itching and hard) and PRURITUS (large lump on her arm that is very hot, itching and hard) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, LORAZEPAM, FISH OIL, VITAMIN B COMPLEX, FOLIC ACID (FOLATE) and CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) for an unknown indication.   On 28-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) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced INDURATION (large lump on her arm that is very hot, itching and hard), FEELING HOT (large lump on her arm that is very hot, itching and hard) and PRURITUS (large lump on her arm that is very hot, itching and hard). The patient was treated with BENZETHONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (CALAGEL) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INDURATION (large lump on her arm that is very hot, itching and hard), FEELING HOT (large lump on her arm that is very hot, itching and hard) and PRURITUS (large lump on her arm that is very hot, itching and hard) had not resolved.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities
Clinical narrative: Wasn't able to go to work; Body is tired/Felt fatigue for three days; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Wasn't able to go to work) and FATIGUE (Body is tired/Felt fatigue for three days) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    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 LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Wasn't able to go to work) and FATIGUE (Body is tired/Felt fatigue for three days). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Wasn't able to go to work) and FATIGUE (Body is tired/Felt fatigue for three days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: The email address was deleted as it was wrong. No other significant information reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Myalgia, Peripheral swelling
Clinical narrative: Red left arm; Swelling left arm; Hard left arm; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA, PERIPHERAL SWELLING, LIMB DISCOMFORT, and MYALGIA in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 09-Mar-2021, the patient experienced ERYTHEMA, PERIPHERAL SWELLING, LIMB DISCOMFORT, and MYALGIA. At the time of the report, ERYTHEMA, PERIPHERAL SWELLING, LIMB DISCOMFORT and MYALGIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site erythema
Clinical narrative: itch; Redness around injection site on Left Arm; I had a rash in both of my arms, from my wrists to my shoulders; Redness to right arm at injection site; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itch), RASH (I had a rash in both of my arms, from my wrists to my shoulders) and VACCINATION SITE ERYTHEMA (Redness to right arm at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to insect sting (Allergic to Mosquito). Concomitant products included LEVOTHYROXINE, ROSUVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE ERYTHEMA (Redness to right arm at injection site). On 01-Mar-2021, the patient experienced RASH (I had a rash in both of my arms, from my wrists to my shoulders). On 03-Mar-2021, the patient experienced PRURITUS (itch). The patient was treated with TRIAMCINOLONE ACETONIDE (topical) on 27-May-2021 for Rash, at a dose of .1 % once a day and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itch) outcome was unknown and RASH (I had a rash in both of my arms, from my wrists to my shoulders) and VACCINATION SITE ERYTHEMA (Redness to right arm at injection site) had not resolved.            Treatment included methyl prednisone 4mg , cholesterol medication used with unknown brand name.   This case was linked to MOD-2021-028111, MOD-2021-028111 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Followup Received on 21-APR-2021 contains significant information. Patient Medical history added. Updated outcome of event  Pruritus from Unknown to Resolved.Updated outcome of event Rash, Injection site erythema from Unknown to Not Recovered. On 30-Apr-2021: Follow-up received on 30-APR-2021 contains significant information. Added Reporter mail id and event outcome rash from unknown to not recovered updated. On 05-Aug-2021: Follow up information received contains significant information. Treatment medication was updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Confusional state, Dry throat, Feeling abnormal, Heart rate increased
Clinical narrative: arm pain; Was little confused; Had pain; felt fuggy or maybe like drunk; Felt like chest pressure in her left site; Rapid heartbeat; throat really dry; throat swollen; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Felt like chest pressure in her left site), HEART RATE INCREASED (Rapid heartbeat), DRY THROAT (throat really dry), PHARYNGEAL SWELLING (throat swollen) and PAIN IN EXTREMITY (arm pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included NAPROXEN for Arthritis.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CHEST DISCOMFORT (Felt like chest pressure in her left site), HEART RATE INCREASED (Rapid heartbeat), DRY THROAT (throat really dry), PHARYNGEAL SWELLING (throat swollen) and FEELING ABNORMAL (felt fuggy or maybe like drunk). On 06-Mar-2021, the patient experienced CONFUSIONAL STATE (Was little confused) and PAIN (Had pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, CHEST DISCOMFORT (Felt like chest pressure in her left site), HEART RATE INCREASED (Rapid heartbeat), DRY THROAT (throat really dry), PHARYNGEAL SWELLING (throat swollen), PAIN IN EXTREMITY (arm pain), FEELING ABNORMAL (felt fuggy or maybe like drunk), CONFUSIONAL STATE (Was little confused) and PAIN (Had pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of the events included loratadine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pharyngeal swelling
Clinical narrative: arm pain; Was little confused; Had pain; felt fuggy or maybe like drunk; Felt like chest pressure in her left site; Rapid heartbeat; throat really dry; throat swollen; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Felt like chest pressure in her left site), HEART RATE INCREASED (Rapid heartbeat), DRY THROAT (throat really dry), PHARYNGEAL SWELLING (throat swollen) and PAIN IN EXTREMITY (arm pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included NAPROXEN for Arthritis.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CHEST DISCOMFORT (Felt like chest pressure in her left site), HEART RATE INCREASED (Rapid heartbeat), DRY THROAT (throat really dry), PHARYNGEAL SWELLING (throat swollen) and FEELING ABNORMAL (felt fuggy or maybe like drunk). On 06-Mar-2021, the patient experienced CONFUSIONAL STATE (Was little confused) and PAIN (Had pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, CHEST DISCOMFORT (Felt like chest pressure in her left site), HEART RATE INCREASED (Rapid heartbeat), DRY THROAT (throat really dry), PHARYNGEAL SWELLING (throat swollen), PAIN IN EXTREMITY (arm pain), FEELING ABNORMAL (felt fuggy or maybe like drunk), CONFUSIONAL STATE (Was little confused) and PAIN (Had pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of the events included loratadine.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 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 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment for the event included none. Patient scheduled for 2nd dose of Moderna COVID -19 on 1st Apr2021.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Dizziness, Illness, Pain in extremity
Clinical narrative: laid up; light headedness; coughing; joint in her feet hurt; joints in her knees hurt; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (laid up), DIZZINESS (light headedness), COUGH (coughing), ARTHRALGIA (joints in her knees hurt) and PAIN IN EXTREMITY (joint in her feet hurt) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 Vaccination.     The patient's past medical history included No adverse event (medical information not provided).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced ILLNESS (laid up), DIZZINESS (light headedness), COUGH (coughing), ARTHRALGIA (joints in her knees hurt) and PAIN IN EXTREMITY (joint in her feet hurt). At the time of the report, ILLNESS (laid up), DIZZINESS (light headedness), COUGH (coughing), ARTHRALGIA (joints in her knees hurt) and PAIN IN EXTREMITY (joint in her feet hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication not provided  Treatment information not provided
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Somnolence
Clinical narrative: Sleepiness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepiness) and PYREXIA (Fever) in a 21-year-old male 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 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 02-Mar-2021, the patient experienced SOMNOLENCE (Sleepiness) and PYREXIA (Fever). At the time of the report, SOMNOLENCE (Sleepiness) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 105 (Inconclusive) 105 and 98.9 (Inconclusive) 98.9..         Concomitant product use was not provided by the reporter. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Erythema, Headache, Lymph node pain
Clinical narrative: Large Redness on the Right Arm from Shoulder to Elbow; Itching Right Arm from Shoulder to Elbow; Sore Lymph node under arm; Fever 99.5 F; Shortness Of Breath; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness Of Breath), ERYTHEMA (Large Redness on the Right Arm from Shoulder to Elbow), PRURITUS (Itching Right Arm from Shoulder to Elbow), LYMPH NODE PAIN (Sore Lymph node under arm) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 18-Dec-2020.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DYSPNOEA (Shortness Of Breath) and HEADACHE (Headache). On 27-Feb-2021, the patient experienced ERYTHEMA (Large Redness on the Right Arm from Shoulder to Elbow), PRURITUS (Itching Right Arm from Shoulder to Elbow), LYMPH NODE PAIN (Sore Lymph node under arm) and PYREXIA (Fever 99.5 F). On 08-Mar-2021, ERYTHEMA (Large Redness on the Right Arm from Shoulder to Elbow), PRURITUS (Itching Right Arm from Shoulder to Elbow), LYMPH NODE PAIN (Sore Lymph node under arm), HEADACHE (Headache) and PYREXIA (Fever 99.5 F) had resolved. At the time of the report, DYSPNOEA (Shortness Of Breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive. On 27-Feb-2021, Body temperature: 99.5 (High) 99.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.  Patient stated that her breathing was better but she was still having issues. Patient also stated that on 27-Feb-2021 she had a significant reaction.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, SARS-CoV-2 test
Clinical narrative: Large Redness on the Right Arm from Shoulder to Elbow; Itching Right Arm from Shoulder to Elbow; Sore Lymph node under arm; Fever 99.5 F; Shortness Of Breath; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness Of Breath), ERYTHEMA (Large Redness on the Right Arm from Shoulder to Elbow), PRURITUS (Itching Right Arm from Shoulder to Elbow), LYMPH NODE PAIN (Sore Lymph node under arm) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 18-Dec-2020.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DYSPNOEA (Shortness Of Breath) and HEADACHE (Headache). On 27-Feb-2021, the patient experienced ERYTHEMA (Large Redness on the Right Arm from Shoulder to Elbow), PRURITUS (Itching Right Arm from Shoulder to Elbow), LYMPH NODE PAIN (Sore Lymph node under arm) and PYREXIA (Fever 99.5 F). On 08-Mar-2021, ERYTHEMA (Large Redness on the Right Arm from Shoulder to Elbow), PRURITUS (Itching Right Arm from Shoulder to Elbow), LYMPH NODE PAIN (Sore Lymph node under arm), HEADACHE (Headache) and PYREXIA (Fever 99.5 F) had resolved. At the time of the report, DYSPNOEA (Shortness Of Breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive. On 27-Feb-2021, Body temperature: 99.5 (High) 99.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.  Patient stated that her breathing was better but she was still having issues. Patient also stated that on 27-Feb-2021 she had a significant reaction.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain
Clinical narrative: Pain; Chills; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received 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 08-Mar-2021, the patient experienced PAIN (Pain), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, PAIN (Pain), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Gingival pain, Glossodynia, Lip pain
Clinical narrative: Pain in the gums, tongue and lips; Pain in the gums, tongue and lips; Pain in the gums, tongue and lips; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (Pain in the gums, tongue and lips), GLOSSODYNIA (Pain in the gums, tongue and lips) and LIP PAIN (Pain in the gums, tongue and lips) 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 04-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 an unknown date, the patient experienced GINGIVAL PAIN (Pain in the gums, tongue and lips), GLOSSODYNIA (Pain in the gums, tongue and lips) and LIP PAIN (Pain in the gums, tongue and lips). At the time of the report, GINGIVAL PAIN (Pain in the gums, tongue and lips), GLOSSODYNIA (Pain in the gums, tongue and lips) and LIP PAIN (Pain in the gums, tongue and lips) had resolved.            No concomitant medications were reported.  Treatment information was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Event outcome updated to recovered and resolved.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Joint swelling, Musculoskeletal stiffness, Peripheral swelling, Vaccination site pain
Clinical narrative: Her fingers were so tight and inflamed; both of her hands and wrists started to get swollen.; both of her hands and wrists started to get swollen.; Her fingers were so tight and inflamed; very sore at the injection site for 2-3 days.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (both of her hands and wrists started to get swollen.), JOINT SWELLING (both of her hands and wrists started to get swollen.), MUSCULOSKELETAL STIFFNESS (Her fingers were so tight and inflamed), INFLAMMATION (Her fingers were so tight and inflamed) and VACCINATION SITE PAIN (very sore at the injection site for 2-3 days.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (very sore at the injection site for 2-3 days.). On 24-Feb-2021, the patient experienced PERIPHERAL SWELLING (both of her hands and wrists started to get swollen.), JOINT SWELLING (both of her hands and wrists started to get swollen.) and MUSCULOSKELETAL STIFFNESS (Her fingers were so tight and inflamed). On an unknown date, the patient experienced INFLAMMATION (Her fingers were so tight and inflamed). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 13-Feb-2021, VACCINATION SITE PAIN (very sore at the injection site for 2-3 days.) had resolved. At the time of the report, PERIPHERAL SWELLING (both of her hands and wrists started to get swollen.), JOINT SWELLING (both of her hands and wrists started to get swollen.), MUSCULOSKELETAL STIFFNESS (Her fingers were so tight and inflamed) and INFLAMMATION (Her fingers were so tight and inflamed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Illness, Nausea, Somnolence
Clinical narrative: Breathing difficult; Sickness; Chills; Nauseous; Vaccination site pain; Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing difficult ), SOMNOLENCE (Sleepy), ILLNESS (Sickness), VACCINATION SITE PAIN (Vaccination site pain) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced SOMNOLENCE (Sleepy) and VACCINATION SITE PAIN (Vaccination site pain). On 05-Mar-2021, the patient experienced DYSPNOEA (Breathing difficult ), ILLNESS (Sickness), CHILLS (Chills) and NAUSEA (Nauseous). At the time of the report, DYSPNOEA (Breathing difficult ), SOMNOLENCE (Sleepy), ILLNESS (Sickness), VACCINATION SITE PAIN (Vaccination site pain), CHILLS (Chills) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided. Patient developed soreness at injection site , right after the vaccine shot at the injection site. and after 5 hours after the shot felt very sleepy and slept for 38 hours. Patient also developed very bad chills, nauseous, felt very sick , and little bit breathing difficulties 20 hours after the vaccine shot.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Breathing difficult; Sickness; Chills; Nauseous; Vaccination site pain; Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing difficult ), SOMNOLENCE (Sleepy), ILLNESS (Sickness), VACCINATION SITE PAIN (Vaccination site pain) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced SOMNOLENCE (Sleepy) and VACCINATION SITE PAIN (Vaccination site pain). On 05-Mar-2021, the patient experienced DYSPNOEA (Breathing difficult ), ILLNESS (Sickness), CHILLS (Chills) and NAUSEA (Nauseous). At the time of the report, DYSPNOEA (Breathing difficult ), SOMNOLENCE (Sleepy), ILLNESS (Sickness), VACCINATION SITE PAIN (Vaccination site pain), CHILLS (Chills) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided. Patient developed soreness at injection site , right after the vaccine shot at the injection site. and after 5 hours after the shot felt very sleepy and slept for 38 hours. Patient also developed very bad chills, nauseous, felt very sick , and little bit breathing difficulties 20 hours after the vaccine shot.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: aches/Pain; Chills; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches/Pain), CHILLS (Chills) and FATIGUE (fatigued) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.    On 02-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 PAIN (aches/Pain) and FATIGUE (fatigued). 02-Mar-2021, the patient experienced CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (aches/Pain), CHILLS (Chills) and FATIGUE (fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive. In February 2021, SARS-CoV-2 antibody test: 12.5 (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she stayed in bed for several days.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: dizziness; Headache; nausea; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (dizziness), HEADACHE (Headache) and NAUSEA (nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (dizziness), HEADACHE (Headache) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) at a dose of 1 dosage form and DIMENHYDRINATE (DRAMAMINE) at a dose of 1 dosage form. At the time of the report, DIZZINESS (dizziness), HEADACHE (Headache) and NAUSEA (nausea) outcome was unknown.        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.   Action taken for Moderna COVID-19 Vaccine was not applicable..