chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: Kidney Pain; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (Kidney Pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced RENAL PAIN (Kidney Pain). At the time of the report, RENAL PAIN (Kidney Pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in the right calf. Pain in the right inner thigh area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the right calf. Pain in the right inner thigh area) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Prostatitis, unspecified (Prostrate problems). Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for Prostatitis, unspecified.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in the right calf. Pain in the right inner thigh area). At the time of the report, PAIN IN EXTREMITY (Pain in the right calf. Pain in the right inner thigh area) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Patient reported that, he was taking tamsulosin for prostrate problems, but had stopped before vaccination. Patient experienced difficulty in urination, post vaccination therefore patient started tamsulosin again. Patient also reported that the events started before , he started taking Tamsulosin.
Age: 66.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Condition aggravated, Conjunctivitis, Dizziness, Dysphagia
Clinical narrative: difficulty swallowing; throat felt uncomfortable; pink eye; Weak; He was having a lot of asthma symptoms/asthma was worse; dizzy; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVITIS (pink eye), OROPHARYNGEAL DISCOMFORT (throat felt uncomfortable), ASTHENIA (Weak), DYSPHAGIA (difficulty swallowing) and CONDITION AGGRAVATED (He was having a lot of asthma symptoms/asthma was worse) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ALBUTEROL [SALBUTAMOL] for Asthma.    Concurrent medical conditions included Asthma.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started ALBUTEROL [SALBUTAMOL] (unknown route) at an unspecified dose. On 14-Feb-2021, the patient experienced ASTHENIA (Weak), CONDITION AGGRAVATED (He was having a lot of asthma symptoms/asthma was worse), DIZZINESS (dizzy) and PYREXIA (slight fever). On 19-Feb-2021, the patient experienced CONJUNCTIVITIS (pink eye). On 21-Feb-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (throat felt uncomfortable) and DYSPHAGIA (difficulty swallowing). On 22-Feb-2021, ASTHENIA (Weak), DIZZINESS (dizzy) and PYREXIA (slight fever) had resolved. On 23-Feb-2021, OROPHARYNGEAL DISCOMFORT (throat felt uncomfortable) and DYSPHAGIA (difficulty swallowing) had resolved. At the time of the report, CONJUNCTIVITIS (pink eye) and CONDITION AGGRAVATED (He was having a lot of asthma symptoms/asthma was worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Oropharyngeal discomfort, Pyrexia
Clinical narrative: difficulty swallowing; throat felt uncomfortable; pink eye; Weak; He was having a lot of asthma symptoms/asthma was worse; dizzy; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVITIS (pink eye), OROPHARYNGEAL DISCOMFORT (throat felt uncomfortable), ASTHENIA (Weak), DYSPHAGIA (difficulty swallowing) and CONDITION AGGRAVATED (He was having a lot of asthma symptoms/asthma was worse) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ALBUTEROL [SALBUTAMOL] for Asthma.    Concurrent medical conditions included Asthma.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started ALBUTEROL [SALBUTAMOL] (unknown route) at an unspecified dose. On 14-Feb-2021, the patient experienced ASTHENIA (Weak), CONDITION AGGRAVATED (He was having a lot of asthma symptoms/asthma was worse), DIZZINESS (dizzy) and PYREXIA (slight fever). On 19-Feb-2021, the patient experienced CONJUNCTIVITIS (pink eye). On 21-Feb-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (throat felt uncomfortable) and DYSPHAGIA (difficulty swallowing). On 22-Feb-2021, ASTHENIA (Weak), DIZZINESS (dizzy) and PYREXIA (slight fever) had resolved. On 23-Feb-2021, OROPHARYNGEAL DISCOMFORT (throat felt uncomfortable) and DYSPHAGIA (difficulty swallowing) had resolved. At the time of the report, CONJUNCTIVITIS (pink eye) and CONDITION AGGRAVATED (He was having a lot of asthma symptoms/asthma was worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site discomfort
Clinical narrative: Minor discomfort on injection Site; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Minor discomfort on injection Site) and MYALGIA (muscle aches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (BENADRYL ALLERGY & COLD) and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE DISCOMFORT (Minor discomfort on injection Site) and MYALGIA (muscle aches). On 01-Feb-2021, VACCINATION SITE DISCOMFORT (Minor discomfort on injection Site) and MYALGIA (muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pruritus, Rash
Clinical narrative: redness; itching; rash; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PRURITUS (itching), RASH (rash) and FATIGUE (fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), PRURITUS (itching), RASH (rash) and FATIGUE (fatigue). At the time of the report, ERYTHEMA (redness), PRURITUS (itching), RASH (rash) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Hardness; Pain at injection site; Swelling 6x4 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swelling 6x4 inches wide) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hardness), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swelling 6x4 inches wide). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (Hardness), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swelling 6x4 inches wide) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Shingles and Diabetes. Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had not resolved. 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.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Lymphadenopathy, Myalgia, Neck pain
Clinical narrative: night sweat; tension in neck; dizziness in the morning; pain on the site of injection; muscle pain; lymph node swollen left more inflamed than right; headache; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweat), NECK PAIN (tension in neck), DIZZINESS (dizziness in the morning), VACCINATION SITE PAIN (pain on the site of injection) and MYALGIA (muscle pain) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced NIGHT SWEATS (night sweat), NECK PAIN (tension in neck), DIZZINESS (dizziness in the morning), VACCINATION SITE PAIN (pain on the site of injection), MYALGIA (muscle pain), LYMPHADENOPATHY (lymph node swollen left more inflamed than right) and HEADACHE (headache). On 04-Feb-2021, HEADACHE (headache) had resolved. At the time of the report, NIGHT SWEATS (night sweat), NECK PAIN (tension in neck), DIZZINESS (dizziness in the morning), VACCINATION SITE PAIN (pain on the site of injection), MYALGIA (muscle pain) and LYMPHADENOPATHY (lymph node swollen left more inflamed than right) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.   Reporter did not allow further contact
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Vaccination site pain
Clinical narrative: night sweat; tension in neck; dizziness in the morning; pain on the site of injection; muscle pain; lymph node swollen left more inflamed than right; headache; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweat), NECK PAIN (tension in neck), DIZZINESS (dizziness in the morning), VACCINATION SITE PAIN (pain on the site of injection) and MYALGIA (muscle pain) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced NIGHT SWEATS (night sweat), NECK PAIN (tension in neck), DIZZINESS (dizziness in the morning), VACCINATION SITE PAIN (pain on the site of injection), MYALGIA (muscle pain), LYMPHADENOPATHY (lymph node swollen left more inflamed than right) and HEADACHE (headache). On 04-Feb-2021, HEADACHE (headache) had resolved. At the time of the report, NIGHT SWEATS (night sweat), NECK PAIN (tension in neck), DIZZINESS (dizziness in the morning), VACCINATION SITE PAIN (pain on the site of injection), MYALGIA (muscle pain) and LYMPHADENOPATHY (lymph node swollen left more inflamed than right) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.   Reporter did not allow further contact
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: experiencing headache; a bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (experiencing headache) and INJECTION SITE PAIN (a bit of a sore arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (experiencing headache) and INJECTION SITE PAIN (a bit of a sore arm). At the time of the report, HEADACHE (experiencing headache) and INJECTION SITE PAIN (a bit of a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: Reactions due to polyethylene glycol; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Reactions due to polyethylene glycol) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Reactions due to polyethylene glycol). At the time of the report, ADVERSE DRUG REACTION (Reactions due to polyethylene glycol) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: 2 doses in same day/3 doses overall; A spontaneous report was received from a physician concerning a 91-years-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and had 2 doses in same day/3 doses overall.  No medical history was provided. The concomitant medications were not reported.  The patient received their first of two planned doses of mRNA-1273 on an unknown date. On 25 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: not provided), intramuscularly for the prophylaxis of COVID-19 infection.  On 25 Feb 2021, at 11:30 am, the patient received second dose of vaccine and on the same day, at 3:15 pm, at patient's assisted living home was inadvertently administered another dose of the vaccine making it two in the same day and three overall.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The event of 2 doses in same day/3 doses overall was considered resolved on 25 Feb 2021.; Reporter's Comments: This report refers to a case of extra dose administered for mRNA-1273 with no associated AEs.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 101 fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (101 fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (101 fever). At the time of the report, PYREXIA (101 fever) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: 101 (Inconclusive) 101 fever.         No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site erythema, Vaccination site pain
Clinical narrative: lymph node pain; patient's arm was extremely painful; arm was very very red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (patient's arm was extremely painful), VACCINATION SITE ERYTHEMA (arm was very very red) and LYMPHADENOPATHY (lymph node pain) 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-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (patient's arm was extremely painful) and VACCINATION SITE ERYTHEMA (arm was very very red). On 06-Feb-2021, the patient experienced LYMPHADENOPATHY (lymph node pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 04-Feb-2021, VACCINATION SITE PAIN (patient's arm was extremely painful) and VACCINATION SITE ERYTHEMA (arm was very very red) had resolved. At the time of the report, LYMPHADENOPATHY (lymph node pain) had not resolved. Not Provided          No relevant concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (patient's arm was extremely painful), VACCINATION SITE ERYTHEMA (arm was very very red) and LYMPHADENOPATHY (lymph node pain) 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-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (patient's arm was extremely painful) and VACCINATION SITE ERYTHEMA (arm was very very red). On 06-Feb-2021, the patient experienced LYMPHADENOPATHY (lymph node pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 04-Feb-2021, VACCINATION SITE PAIN (patient's arm was extremely painful) and VACCINATION SITE ERYTHEMA (arm was very very red) had resolved. At the time of the report, LYMPHADENOPATHY (lymph node pain) had not resolved. Not Provided          No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: face started tingling/most in her cheeks as opposed to her forehead; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (face started tingling/most in her cheeks as opposed to her forehead) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PARAESTHESIA (face started tingling/most in her cheeks as opposed to her forehead). On 12-Feb-2021, PARAESTHESIA (face started tingling/most in her cheeks as opposed to her forehead) had resolved. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain
Clinical narrative: feel like a complete vegetable and fuzzy headed; bad body aches, hurts to move around; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel like a complete vegetable and fuzzy headed) and PAIN (bad body aches, hurts to move around) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hernia. Concomitant products included LOSARTAN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), LEVOTHYROXINE SODIUM (SYNTHROID) and PARACETAMOL (TYLENOL) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced FEELING ABNORMAL (feel like a complete vegetable and fuzzy headed) and PAIN (bad body aches, hurts to move around). At the time of the report, FEELING ABNORMAL (feel like a complete vegetable and fuzzy headed) and PAIN (bad body aches, hurts to move around) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: feeling really bad, Feel icky; fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling really bad, Feel icky), PYREXIA (fever) and MYALGIA (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced FEELING ABNORMAL (feeling really bad, Feel icky), PYREXIA (fever) and MYALGIA (sore arm). At the time of the report, FEELING ABNORMAL (feeling really bad, Feel icky), PYREXIA (fever) and MYALGIA (sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: lump at injection site; hot at injection site; Redness at injection site (3-4in diameter); Joint pain everywhere; soreness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump at injection site), VACCINATION SITE WARMTH (hot at injection site), PAIN IN EXTREMITY (soreness in left arm), VACCINATION SITE ERYTHEMA (Redness at injection site (3-4in diameter)) and ARTHRALGIA (Joint pain everywhere) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D NOS and METHOTREXATE for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness in left arm) and ARTHRALGIA (Joint pain everywhere). On 02-Feb-2021, the patient experienced VACCINATION SITE MASS (lump at injection site), VACCINATION SITE WARMTH (hot at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site (3-4in diameter)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 05-Feb-2021, VACCINATION SITE MASS (lump at injection site), VACCINATION SITE WARMTH (hot at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site (3-4in diameter)) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in left arm) and ARTHRALGIA (Joint pain everywhere) had not resolved.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Diarrhoea, Myalgia, Pain
Clinical narrative: Felt achy and had pain on her; Constant pain; Felt achy; Diarrhea; Vertigo; A very bad cough; Arm was pretty sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (A very bad cough), VERTIGO (Vertigo), PAIN IN EXTREMITY (Arm was pretty sore), CHEST PAIN (Felt achy and had pain on her) and DIARRHOEA (Diarrhea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia (Symptoms include tiredness, achiness, headaches, cognitive problems) and Asthma. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) 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 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was pretty sore). On 28-Jan-2021, the patient experienced COUGH (A very bad cough). On 04-Feb-2021, the patient experienced VERTIGO (Vertigo). On 06-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced CHEST PAIN (Felt achy and had pain on her), PAIN (Constant pain) and MYALGIA (Felt achy). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form; CODEINE for Cough, at a dose of UNK dosage form and LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) for Diarrhea, at a dose of UNK dosage form. On 29-Jan-2021, PAIN IN EXTREMITY (Arm was pretty sore) had resolved. At the time of the report, COUGH (A very bad cough), VERTIGO (Vertigo), CHEST PAIN (Felt achy and had pain on her), DIARRHOEA (Diarrhea), PAIN (Constant pain) and MYALGIA (Felt achy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included inhaler for her breathing. On 09 Mar 2021, the patient went to ENT doctor. The patient got tested with negative results. It was reported that it took eight weeks to get back to normal.   This case was linked to MOD-2021-040255 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: The patient historical condition updated. The event constant pain was added. The patient visit to doctor and testing details were added. On 21-Apr-2021: The event outcome updated as resolved.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vertigo
Clinical narrative: Felt achy and had pain on her; Constant pain; Felt achy; Diarrhea; Vertigo; A very bad cough; Arm was pretty sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (A very bad cough), VERTIGO (Vertigo), PAIN IN EXTREMITY (Arm was pretty sore), CHEST PAIN (Felt achy and had pain on her) and DIARRHOEA (Diarrhea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia (Symptoms include tiredness, achiness, headaches, cognitive problems) and Asthma. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) 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 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was pretty sore). On 28-Jan-2021, the patient experienced COUGH (A very bad cough). On 04-Feb-2021, the patient experienced VERTIGO (Vertigo). On 06-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced CHEST PAIN (Felt achy and had pain on her), PAIN (Constant pain) and MYALGIA (Felt achy). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form; CODEINE for Cough, at a dose of UNK dosage form and LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) for Diarrhea, at a dose of UNK dosage form. On 29-Jan-2021, PAIN IN EXTREMITY (Arm was pretty sore) had resolved. At the time of the report, COUGH (A very bad cough), VERTIGO (Vertigo), CHEST PAIN (Felt achy and had pain on her), DIARRHOEA (Diarrhea), PAIN (Constant pain) and MYALGIA (Felt achy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included inhaler for her breathing. On 09 Mar 2021, the patient went to ENT doctor. The patient got tested with negative results. It was reported that it took eight weeks to get back to normal.   This case was linked to MOD-2021-040255 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: The patient historical condition updated. The event constant pain was added. The patient visit to doctor and testing details were added. On 21-Apr-2021: The event outcome updated as resolved.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash pruritic, Swelling, Vaccination site erythema, Vaccination site pain
Clinical narrative: swelling; itching; Arm is sore; Rash; 3 in. red circle. Inside the redness there is another circle of a different color.; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), RASH PRURITIC (itching), VACCINATION SITE PAIN (Arm is sore), INJECTION SITE RASH (Rash) and VACCINATION SITE ERYTHEMA (3 in. red circle. Inside the redness there is another circle of a different color.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), METHOTREXATE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), MONTELUKAST SODIUM (SINGULAIR), POTASSIUM and PARACETAMOL (TYLENOL) for an unknown indication.    On 17-Feb-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 SWELLING (swelling), RASH PRURITIC (itching), VACCINATION SITE PAIN (Arm is sore), INJECTION SITE RASH (Rash) and VACCINATION SITE ERYTHEMA (3 in. red circle. Inside the redness there is another circle of a different color.). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING (swelling), RASH PRURITIC (itching), VACCINATION SITE PAIN (Arm is sore), INJECTION SITE RASH (Rash) and VACCINATION SITE ERYTHEMA (3 in. red circle. Inside the redness there is another circle of a different color.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Two nights ago patient  took some Benadryl when patient  went to bed. Today, patient  put some Benadryl cream, and patient  am feeling better.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Discomfort in swallowing; pain in the left breast; left arm pain/discomfort; headache; chills; swollen lymph nodes in my left neck. area  and left breast; This spontaneous case was reported by a nurse and describes the occurrence of DYSPHAGIA (Discomfort in swallowing), BREAST PAIN (pain in the left breast), PAIN IN EXTREMITY (left arm pain/discomfort), HEADACHE (headache) and CHILLS (chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Latex allergy, Allergy to antibiotic (Bacitrin), Drug allergy (Tegaderm patch), Allergy to antibiotic (Biaxin), Drug allergy (Codeine), Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Penicillin allergy, Allergy to antibiotic, Allergy to antibiotic, Allergy to antibiotic, Allergy to antibiotic, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy and Hypothyroidism since 29-Mar-2015. Concomitant products included LEVOTHYROXINE from 29-Mar-2015 to an unknown date, CLOPIDOGREL, KETOROLAC TROMETHAMINE (TORADOL), SERTRALINE HYDROCHLORIDE (RESTRALINE), LORAZEPAM (LORAZEPAN), LEVOFLOXACIN (LEVAQUIN), CIPROFLOXACIN HYDROCHLORIDE (CIPRO 1A PHARMA), HYDROXYZINE, HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]), MIDAZOLAM HYDROCHLORIDE (VERSED), ONDANSETRON, LEVOFLOXACIN, KETOROLAC, FAMOTIDINE, CLINDAMYCIN, DEXAMETHASONE, MUPIROCIN, CEFIXIME (FLEXERIL [CEFIXIME]), METHYLPREDNISOLONE ACEPONATE and AZITHROMYCIN for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DYSPHAGIA (Discomfort in swallowing), BREAST PAIN (pain in the left breast), PAIN IN EXTREMITY (left arm pain/discomfort), HEADACHE (headache), CHILLS (chills) and LYMPHADENOPATHY (swollen lymph nodes in my left neck. area  and left breast). On 24-Jan-2021, DYSPHAGIA (Discomfort in swallowing), BREAST PAIN (pain in the left breast), PAIN IN EXTREMITY (left arm pain/discomfort), CHILLS (chills) and LYMPHADENOPATHY (swollen lymph nodes in my left neck. area  and left breast) had resolved and HEADACHE (headache) 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.   This case was linked to MOD-2021-024374 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: On 27-MAY-2021, Non significant follow up was received. On 01-Jun-2021: On 01-JUN-2021, Non significant follow up was received On 22-Jun-2021: Follow-up information received on 22-JUN-2021 contains significant information-Concomitant medications added, Events And outcome of event added. Medical history added
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Headache; Body aches; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches) in a 39-year-old male patient 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 31-Jan-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches) had not resolved. 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.   Patient didn't clarify about the Concomitant drug.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Ocular hyperaemia, Pruritus, Rash
Clinical narrative: rash; itching; Lip Numbness; Red Puffy eyes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), PRURITUS (itching), HYPOAESTHESIA ORAL (Lip Numbness) and OCULAR HYPERAEMIA (Red Puffy eyes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not available) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced RASH (rash), PRURITUS (itching), HYPOAESTHESIA ORAL (Lip Numbness) and OCULAR HYPERAEMIA (Red Puffy eyes). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (rash), PRURITUS (itching), HYPOAESTHESIA ORAL (Lip Numbness) and OCULAR HYPERAEMIA (Red Puffy eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: red spot on injection site; size of a dime and a bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red spot on injection site) and VACCINATION SITE MASS (size of a dime and a bump) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-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 VACCINATION SITE ERYTHEMA (red spot on injection site) and VACCINATION SITE MASS (size of a dime and a bump). At the time of the report, VACCINATION SITE ERYTHEMA (red spot on injection site) and VACCINATION SITE MASS (size of a dime and a bump) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Adverse reaction, Diarrhoea, Hyperhidrosis, Vaccination site pain
Clinical narrative: stomach pains; Bad reaction; vomiting; profusely sweating/head dripping with sweat; diarrhea; She reported left arm soreness; left arm swelling after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (She reported left arm soreness), VACCINATION SITE SWELLING (left arm swelling after vaccination), ABDOMINAL PAIN UPPER (stomach pains), ADVERSE REACTION (Bad reaction) and VOMITING (vomiting) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic lymphocytic leukemia (Cancer diagnosis). Concurrent medical conditions included Penicillin allergy, Hypertension and High cholesterol. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA) and ACEBUTOLOL for BP raised, IBRUTINIB for Cancer, LOVASTATIN for High cholesterol.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (She reported left arm soreness) and VACCINATION SITE SWELLING (left arm swelling after vaccination). On 06-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pains), ADVERSE REACTION (Bad reaction), VOMITING (vomiting), HYPERHIDROSIS (profusely sweating/head dripping with sweat) and DIARRHOEA (diarrhea). On 07-Feb-2021, VACCINATION SITE PAIN (She reported left arm soreness), VACCINATION SITE SWELLING (left arm swelling after vaccination), ABDOMINAL PAIN UPPER (stomach pains), ADVERSE REACTION (Bad reaction), VOMITING (vomiting), HYPERHIDROSIS (profusely sweating/head dripping with sweat) and DIARRHOEA (diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: stomach pains; Bad reaction; vomiting; profusely sweating/head dripping with sweat; diarrhea; She reported left arm soreness; left arm swelling after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (She reported left arm soreness), VACCINATION SITE SWELLING (left arm swelling after vaccination), ABDOMINAL PAIN UPPER (stomach pains), ADVERSE REACTION (Bad reaction) and VOMITING (vomiting) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic lymphocytic leukemia (Cancer diagnosis). Concurrent medical conditions included Penicillin allergy, Hypertension and High cholesterol. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA) and ACEBUTOLOL for BP raised, IBRUTINIB for Cancer, LOVASTATIN for High cholesterol.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (She reported left arm soreness) and VACCINATION SITE SWELLING (left arm swelling after vaccination). On 06-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pains), ADVERSE REACTION (Bad reaction), VOMITING (vomiting), HYPERHIDROSIS (profusely sweating/head dripping with sweat) and DIARRHOEA (diarrhea). On 07-Feb-2021, VACCINATION SITE PAIN (She reported left arm soreness), VACCINATION SITE SWELLING (left arm swelling after vaccination), ABDOMINAL PAIN UPPER (stomach pains), ADVERSE REACTION (Bad reaction), VOMITING (vomiting), HYPERHIDROSIS (profusely sweating/head dripping with sweat) and DIARRHOEA (diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: Sore Arm after second dose; Swelling; Little bump at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm after second dose), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE MASS (Little bump at the site of injection) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore Arm after second dose), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE MASS (Little bump at the site of injection). At the time of the report, VACCINATION SITE PAIN (Sore Arm after second dose), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE MASS (Little bump at the site of injection) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD21-023217 (Patient Link).
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Nausea
Clinical narrative: Lost appetite; Nauseated when see or think of food; A spontaneous report was received from a consumer, concerning himself, a 23-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and had lost appetite and also nauseated when see or think of food.  The patient's medical history was not provided. Concomitant medications reported included vitamin D NOS.  On 14 Feb 2021, one day prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 15 Feb 2021, after vaccination, the patient lost his appetite which had not improved and felt nauseated when he see or think of food. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event lost appetite was not resolved at the time of this report. The outcome of event nauseated when see or think of food was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on body
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Dyskinesia, Hypotonia, Musculoskeletal stiffness, Seizure, Staring
Clinical narrative: Child experienced seizure activity. This event lasted around two to three minutes and then stopped. Her body was never limp during the episode. Her whole body including left and right side was stiff and jerky. Blank stare noted during episode and could not respond anything at that time.