chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Skin burning sensation
Clinical narrative: Bumps; Burning; Rash covered her entire body; Possible allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Bumps), SKIN BURNING SENSATION (Burning), RASH (Rash covered her entire body) and HYPERSENSITIVITY (Possible allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced RASH (Bumps), SKIN BURNING SENSATION (Burning), RASH (Rash covered her entire body) and HYPERSENSITIVITY (Possible allergic reaction). At the time of the report, RASH (Bumps), SKIN BURNING SENSATION (Burning), RASH (Rash covered her entire body) and HYPERSENSITIVITY (Possible allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment provided was Antihistamines and Zyrtec.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Rash, Vaccination site erythema
Clinical narrative: rash on chest, back, arms, face; difficulty sleeping; spots were red; spots were very itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on chest, back, arms, face), INSOMNIA (difficulty sleeping), VACCINATION SITE ERYTHEMA (spots were red) and PRURITUS (spots were very itchy) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A. and 013M20A.) for COVID-19 vaccination.     Concurrent medical conditions included CML.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced RASH (rash on chest, back, arms, face), INSOMNIA (difficulty sleeping), VACCINATION SITE ERYTHEMA (spots were red) and PRURITUS (spots were very itchy). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, RASH (rash on chest, back, arms, face), INSOMNIA (difficulty sleeping), VACCINATION SITE ERYTHEMA (spots were red) and PRURITUS (spots were very itchy) outcome was unknown. Not Provided          No concomitant medication was taken. Prednisone was taken as a treatment medication.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Headache; Fever of 101.4F; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever of 101.4F) and PAIN IN EXTREMITY (Sore arm) in a 62-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.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever of 101.4F) and PAIN IN EXTREMITY (Sore arm). At the time of the report, HEADACHE (Headache), PYREXIA (Fever of 101.4F) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment medication - Advil consent for follow-up given   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache
Clinical narrative: Very strong headache; Felt warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Very strong headache) and FEELING HOT (Felt warm to the touch) in a 61-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 reaction.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced HEADACHE (Very strong headache) and FEELING HOT (Felt warm to the touch). At the time of the report, HEADACHE (Very strong headache) and FEELING HOT (Felt warm to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment information was provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: pain in arm; fatigued; painful headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), FATIGUE (fatigued) and HEADACHE (painful headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in arm), FATIGUE (fatigued) and HEADACHE (painful headache). On 26-Mar-2021, PAIN IN EXTREMITY (pain in arm) had resolved. At the time of the report, FATIGUE (fatigued) and HEADACHE (painful headache) outcome was unknown.            No relevant concomitant medications provided. No relevant treatment information provided
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Product administered to patient of inappropriate age
Clinical narrative: received first dose at seventeen years of age; concerned and freaked out; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose at seventeen years of age) and FEELING ABNORMAL (concerned and freaked out) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event (No medical history reported).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose at seventeen years of age) and FEELING ABNORMAL (concerned and freaked out). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose at seventeen years of age) and FEELING ABNORMAL (concerned and freaked out) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not reported by reporter. Treatment information is not provided
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Throat irritation
Clinical narrative: shortness of breathe; Itchiness of throat; weakness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breathe), THROAT IRRITATION (Itchiness of throat) and ASTHENIA (weakness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DYSPNOEA (shortness of breathe), THROAT IRRITATION (Itchiness of throat) and ASTHENIA (weakness). At the time of the report, DYSPNOEA (shortness of breathe), THROAT IRRITATION (Itchiness of throat) and ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: administered 1ml to five patients; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (administered 1ml to five patients) in a 40-year-old male 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 30-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (administered 1ml to five patients). At the time of the report, ACCIDENTAL OVERDOSE (administered 1ml to five patients) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Corrective treatment was not reported. Reporter did not allow further contact.; Sender's Comments: This report refers to a case of accidental overdose for mRNA-1273 with no associated AEs.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Feeling abnormal, Vaccination site pain
Clinical narrative: Whole system went haywire; Abdominal pain; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Whole system went haywire), ABDOMINAL PAIN (Abdominal pain) and VACCINATION SITE PAIN (Pain at injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.) Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (SLEEP TABS) and MEDROXYPROGESTERONE ACETATE (MENOPAUSE [MEDROXYPROGESTERONE ACETATE]) for an unknown indication.    On 09-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 VACCINATION SITE PAIN (Pain at injection site). On 15-Mar-2021, the patient experienced FEELING ABNORMAL (Whole system went haywire) and ABDOMINAL PAIN (Abdominal pain). At the time of the report, FEELING ABNORMAL (Whole system went haywire), ABDOMINAL PAIN (Abdominal pain) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 15-Mar-2021, Patient had fitz maker test.  Treatment included none.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: hives all over the body/Redness of hives; itchy sensations on hives/large red, itchy circle around the injection site; Redness of hives/itchy sensations on hives/large red, itchy circle around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives all over the body/Redness of hives), VACCINATION SITE PRURITUS (itchy sensations on hives/large red, itchy circle around the injection site) and VACCINATION SITE ERYTHEMA (Redness of hives/itchy sensations on hives/large red, itchy circle around the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included Hay fever. Concurrent medical conditions included Allergy to antibiotic (tetracycline _skin rashes) and Sulfonamide allergy (sulfa drugs _skin rashes). Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for Reflux esophagitis, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced URTICARIA (hives all over the body/Redness of hives), VACCINATION SITE PRURITUS (itchy sensations on hives/large red, itchy circle around the injection site) and VACCINATION SITE ERYTHEMA (Redness of hives/itchy sensations on hives/large red, itchy circle around the injection site). On 10-Apr-2021, URTICARIA (hives all over the body/Redness of hives) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchy sensations on hives/large red, itchy circle around the injection site) and VACCINATION SITE ERYTHEMA (Redness of hives/itchy sensations on hives/large red, itchy circle around the injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient continued to had redness, itching and splotches off and on her arms. Treatment medicines included anti histamine.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Patient demographics, medical history, allergic reaction, concomitant medication, treatment medication added. event hives stop date and event outcome updated, reporter causality updated.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Sound on his head; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Sound on his head) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN for an unknown indication.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced TINNITUS (Sound on his head). At the time of the report, TINNITUS (Sound on his head) outcome was unknown. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site mass, Vaccination site reaction
Clinical narrative: a lump at the site; swollen arm size of 2 quarters; a big circle bigger than a half a dollar at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (a big circle bigger than a half a dollar at the injection site), VACCINATION SITE MASS (a lump at the site) and PERIPHERAL SWELLING (swollen arm size of 2 quarters) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071L20A) for COVID-19 vaccination.     Concomitant products included LIRAGLUTIDE (VICTOZA), RIVASTIGMINE, AMLODIPINE, AMIODARONE, RABEPRAZOLE SODIUM (ACIPHEX), ESCITALOPRAM, APIXABAN (ELIQUIS), BUSPIRONE, ACETYLSALICYLIC ACID (ASPIRIN 81), METFORMIN HYDROCHLORIDE (METFORMIN ER), MEMANTINE, PITAVASTATIN CALCIUM (LIVALO) and LEVOTHYROXINE.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE REACTION (a big circle bigger than a half a dollar at the injection site). On an unknown date, the patient experienced VACCINATION SITE MASS (a lump at the site) and PERIPHERAL SWELLING (swollen arm size of 2 quarters). At the time of the report, VACCINATION SITE REACTION (a big circle bigger than a half a dollar at the injection site), VACCINATION SITE MASS (a lump at the site) and PERIPHERAL SWELLING (swollen arm size of 2 quarters) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Feeding disorder, Pain in extremity
Clinical narrative: unable to drink; teeth are hurting; fingers hurting; back hurting; every joint in body hurts; chills; fever; arm hurt all day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt all day), FEEDING DISORDER (unable to drink), TOOTHACHE (teeth are hurting), PAIN IN EXTREMITY (fingers hurting) and BACK PAIN (back hurting) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history was not provided). Concomitant products included MELOXICAM (MOBIC), DULOXETINE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for an unknown indication, CALCIUM.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt all day). On 30-Mar-2021, the patient experienced FEEDING DISORDER (unable to drink), TOOTHACHE (teeth are hurting), PAIN IN EXTREMITY (fingers hurting), BACK PAIN (back hurting), ARTHRALGIA (every joint in body hurts), CHILLS (chills) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (arm hurt all day), FEEDING DISORDER (unable to drink), TOOTHACHE (teeth are hurting), PAIN IN EXTREMITY (fingers hurting), BACK PAIN (back hurting), ARTHRALGIA (every joint in body hurts), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Toothache
Clinical narrative: unable to drink; teeth are hurting; fingers hurting; back hurting; every joint in body hurts; chills; fever; arm hurt all day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt all day), FEEDING DISORDER (unable to drink), TOOTHACHE (teeth are hurting), PAIN IN EXTREMITY (fingers hurting) and BACK PAIN (back hurting) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history was not provided). Concomitant products included MELOXICAM (MOBIC), DULOXETINE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for an unknown indication, CALCIUM.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt all day). On 30-Mar-2021, the patient experienced FEEDING DISORDER (unable to drink), TOOTHACHE (teeth are hurting), PAIN IN EXTREMITY (fingers hurting), BACK PAIN (back hurting), ARTHRALGIA (every joint in body hurts), CHILLS (chills) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (arm hurt all day), FEEDING DISORDER (unable to drink), TOOTHACHE (teeth are hurting), PAIN IN EXTREMITY (fingers hurting), BACK PAIN (back hurting), ARTHRALGIA (every joint in body hurts), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Erythema, Rash macular
Clinical narrative: big red blotch; big red blotch; looks like bug bite; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (big red blotch), ERYTHEMA (big red blotch) and ARTHROPOD BITE (looks like bug bite) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced RASH MACULAR (big red blotch), ERYTHEMA (big red blotch) and ARTHROPOD BITE (looks like bug bite). At the time of the report, RASH MACULAR (big red blotch), ERYTHEMA (big red blotch) and ARTHROPOD BITE (looks like bug bite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: facial swelling; swelling of the lips; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling) and LIP SWELLING (swelling of the lips) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A OR 006B71A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 27-Mar-2021, the patient experienced SWELLING FACE (facial swelling) and LIP SWELLING (swelling of the lips). At the time of the report, SWELLING FACE (facial swelling) and LIP SWELLING (swelling of the lips) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. Patient received Benadryl medication. At ER patient received saline drip and did some blood work and said they are suspecting possible cellulitis and prescribed antibiotics which patient refused and got discharged.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Very bad headache 5 or 6 days after the vaccine) 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 HEADACHE (Very bad headache 5 or 6 days after the vaccine). At the time of the report, HEADACHE (Very bad headache 5 or 6 days after the vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24-MAY-2021: Event outcome updated and denied for further follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Feeling hot, Headache, Limb discomfort
Clinical narrative: terrible headache; on and off nausea; her arm kept getting fever; more of a weird headache like a fog that she can't get rid of; The redness keeps getting bigger and is around the shoulder now; arm started to feel like someone punched her; her arm felt like it was on fire; had a red feverish big lump on it; Little bit of soreness the next day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Little bit of soreness the next day), LIMB DISCOMFORT (arm started to feel like someone punched her), FEELING HOT (her arm felt like it was on fire), VACCINATION SITE MASS (had a red feverish big lump on it) and HEADACHE (terrible headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD (COPD with emphysema) and Emphysema (uses nocturnal oxygen). Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), GABAPENTIN, ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM, OMEPRAZOLE and ALPRAZOLAM (XANAX) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced MYALGIA (Little bit of soreness the next day). On 26-Mar-2021, the patient experienced LIMB DISCOMFORT (arm started to feel like someone punched her), FEELING HOT (her arm felt like it was on fire) and VACCINATION SITE MASS (had a red feverish big lump on it). On 27-Mar-2021, the patient experienced HEADACHE (terrible headache), NAUSEA (on and off nausea), VACCINATION SITE WARMTH (her arm kept getting fever), FEELING ABNORMAL (more of a weird headache like a fog that she can't get rid of) and ERYTHEMA (The redness keeps getting bigger and is around the shoulder now). On 20-Mar-2021, MYALGIA (Little bit of soreness the next day) had resolved. At the time of the report, LIMB DISCOMFORT (arm started to feel like someone punched her), FEELING HOT (her arm felt like it was on fire), VACCINATION SITE MASS (had a red feverish big lump on it), HEADACHE (terrible headache), NAUSEA (on and off nausea), VACCINATION SITE WARMTH (her arm kept getting fever), FEELING ABNORMAL (more of a weird headache like a fog that she can't get rid of) and ERYTHEMA (The redness keeps getting bigger and is around the shoulder now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included tried ice, cool compress, tylenol, neosporin, benadryl cream with little relief.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination site mass, Vaccination site warmth
Clinical narrative: terrible headache; on and off nausea; her arm kept getting fever; more of a weird headache like a fog that she can't get rid of; The redness keeps getting bigger and is around the shoulder now; arm started to feel like someone punched her; her arm felt like it was on fire; had a red feverish big lump on it; Little bit of soreness the next day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Little bit of soreness the next day), LIMB DISCOMFORT (arm started to feel like someone punched her), FEELING HOT (her arm felt like it was on fire), VACCINATION SITE MASS (had a red feverish big lump on it) and HEADACHE (terrible headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD (COPD with emphysema) and Emphysema (uses nocturnal oxygen). Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), GABAPENTIN, ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM, OMEPRAZOLE and ALPRAZOLAM (XANAX) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced MYALGIA (Little bit of soreness the next day). On 26-Mar-2021, the patient experienced LIMB DISCOMFORT (arm started to feel like someone punched her), FEELING HOT (her arm felt like it was on fire) and VACCINATION SITE MASS (had a red feverish big lump on it). On 27-Mar-2021, the patient experienced HEADACHE (terrible headache), NAUSEA (on and off nausea), VACCINATION SITE WARMTH (her arm kept getting fever), FEELING ABNORMAL (more of a weird headache like a fog that she can't get rid of) and ERYTHEMA (The redness keeps getting bigger and is around the shoulder now). On 20-Mar-2021, MYALGIA (Little bit of soreness the next day) had resolved. At the time of the report, LIMB DISCOMFORT (arm started to feel like someone punched her), FEELING HOT (her arm felt like it was on fire), VACCINATION SITE MASS (had a red feverish big lump on it), HEADACHE (terrible headache), NAUSEA (on and off nausea), VACCINATION SITE WARMTH (her arm kept getting fever), FEELING ABNORMAL (more of a weird headache like a fog that she can't get rid of) and ERYTHEMA (The redness keeps getting bigger and is around the shoulder now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included tried ice, cool compress, tylenol, neosporin, benadryl cream with little relief.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Intraocular pressure increased, Ocular discomfort
Clinical narrative: Eye pressure in both eyes risen unexpectedly, today eye pressure was 13 and 16; Discomfort in eye; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Discomfort in eye) and INTRAOCULAR PRESSURE INCREASED (Eye pressure in both eyes risen unexpectedly, today eye pressure was 13 and 16) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced OCULAR DISCOMFORT (Discomfort in eye). On 30-Mar-2021, the patient experienced INTRAOCULAR PRESSURE INCREASED (Eye pressure in both eyes risen unexpectedly, today eye pressure was 13 and 16). At the time of the report, INTRAOCULAR PRESSURE INCREASED (Eye pressure in both eyes risen unexpectedly, today eye pressure was 13 and 16) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site pain
Clinical narrative: She got a brown spot on injection site 9 days after receiving 1st dose; It is very sore and achy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (She got a brown spot on injection site 9 days after receiving 1st dose) and INJECTION SITE PAIN (It is very sore and achy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced INJECTION SITE DISCOLOURATION (She got a brown spot on injection site 9 days after receiving 1st dose) and INJECTION SITE PAIN (It is very sore and achy). At the time of the report, INJECTION SITE DISCOLOURATION (She got a brown spot on injection site 9 days after receiving 1st dose) and INJECTION SITE PAIN (It is very sore and achy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include unspecified medication for Diabetes (Type not reported) and unspecified medication for high blood pressure.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired product administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired product administered) in a  patient of an unknown age and gender 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 EXPIRED PRODUCT ADMINISTERED (Expired product administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired product administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported. Reporter did not allow further contact.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: Unknown)  with no associated AEs.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Skin mass
Clinical narrative: headache; Head Bumps; Head itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN MASS (Head Bumps), PRURITUS (Head itching) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG), METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), CLOPIDOGREL, METOPROLOL, LOSARTAN and GABAPENTIN for an unknown indication.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced SKIN MASS (Head Bumps) and PRURITUS (Head itching). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with FLUOCINONIDE at a dose of 0.05 %; TEA TREE OIL for Itching, at a dose of 1 dosage form and CLINDAMYCIN at a dose of 0.1 %. At the time of the report, SKIN MASS (Head Bumps), PRURITUS (Head itching) and HEADACHE (headache) outcome was unknown.            other concomitant medication were supplements
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site erythema
Clinical narrative: Tinnitus; Red circle on arm and shoulder; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus) and VACCINATION SITE ERYTHEMA (Red circle on arm and shoulder) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus) and VACCINATION SITE ERYTHEMA (Red circle on arm and shoulder). At the time of the report, TINNITUS (Tinnitus) and VACCINATION SITE ERYTHEMA (Red circle on arm and shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Pain in arm; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Head ache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Migraine (headache). Concomitant products included SULFASALAZINE, INFLIXIMAB (INFLECTRA [INFLIXIMAB]) and METHOTREXATE SODIUM for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Head ache). On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Head ache) outcome was unknown.            No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-043299 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-043299:Case for first dose
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Administered 1ml to five patients; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Administered 1ml to five patients) in a 54-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 30-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (Administered 1ml to five patients). On 30-Mar-2021, ACCIDENTAL OVERDOSE (Administered 1ml to five patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This report refers to a case of accidental overdose for mRNA-1273 with no associated AEs.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Vaccinated after tested positive for COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Vaccinated after tested positive for COVID 19) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Vaccinated after tested positive for COVID 19). At the time of the report, SARS-COV-2 TEST POSITIVE (Vaccinated after tested positive for COVID 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication including  diabetic medication and blood pressure medication werereported  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 12-May-2021 doesn't contain any new information
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction). At the time of the report, HYPERSENSITIVITY (allergic reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided by the reporter.  Treatment information was not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Pyrexia
Clinical narrative: Asleep all day, slept for 2 days after; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Asleep all day, slept for 2 days after) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 026A21A) 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) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced HYPERSOMNIA (Asleep all day, slept for 2 days after) and PYREXIA (Fever). At the time of the report, HYPERSOMNIA (Asleep all day, slept for 2 days after) and PYREXIA (Fever) had resolved.            The concomitant medication was not provided.  The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received on 10-JUN-2021. Added information include patient race and  outcome of the events was updated from unknown to recovered/resolved.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Red rash on arm; Itching; This spontaneous case was reported by a nurse and describes the occurrence of RASH ERYTHEMATOUS (Red rash on arm) and PRURITUS (Itching) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic patient with drugs).    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on arm) and PRURITUS (Itching). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash on arm) and PRURITUS (Itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Administered 1ml to five patients; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Administered 1ml to five patients) in a 48-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 30-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (Administered 1ml to five patients). On 30-Mar-2021, ACCIDENTAL OVERDOSE (Administered 1ml to five patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-062261, MOD-2021-062169, MOD-2021-062219, MOD-2021-062188 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: While giving the vaccination the needle retracted; Patient did not receive full dose. Pharmacist said that half of the dose was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of SYRINGE ISSUE (While giving the vaccination the needle retracted) and UNDERDOSE (Patient did not receive full dose. Pharmacist said that half of the dose was administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 30-Mar-1900, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 UNK. On 30-Mar-2021, the patient experienced SYRINGE ISSUE (While giving the vaccination the needle retracted) and UNDERDOSE (Patient did not receive full dose. Pharmacist said that half of the dose was administered). On 30-Mar-2021, SYRINGE ISSUE (While giving the vaccination the needle retracted) and UNDERDOSE (Patient did not receive full dose. Pharmacist said that half of the dose was administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Injection site induration, Injection site pain, Pain
Clinical narrative: 3 inches circle at the injection site; hard; swollen; red; sore; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (3 inches circle at the injection site), INDURATION (hard), SWELLING (swollen), ERYTHEMA (red) and PAIN (sore) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced INJECTION SITE PAIN (soreness at the injection site). On 29-Mar-2021, the patient experienced INJECTION SITE INDURATION (3 inches circle at the injection site), INDURATION (hard), SWELLING (swollen), ERYTHEMA (red) and PAIN (sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 23-Mar-2021, INJECTION SITE PAIN (soreness at the injection site) had resolved. At the time of the report, INJECTION SITE INDURATION (3 inches circle at the injection site), INDURATION (hard), SWELLING (swollen), ERYTHEMA (red) and PAIN (sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: 3 inches circle at the injection site; hard; swollen; red; sore; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (3 inches circle at the injection site), INDURATION (hard), SWELLING (swollen), ERYTHEMA (red) and PAIN (sore) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced INJECTION SITE PAIN (soreness at the injection site). On 29-Mar-2021, the patient experienced INJECTION SITE INDURATION (3 inches circle at the injection site), INDURATION (hard), SWELLING (swollen), ERYTHEMA (red) and PAIN (sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 23-Mar-2021, INJECTION SITE PAIN (soreness at the injection site) had resolved. At the time of the report, INJECTION SITE INDURATION (3 inches circle at the injection site), INDURATION (hard), SWELLING (swollen), ERYTHEMA (red) and PAIN (sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.