chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue
Clinical narrative: Loss of Appetite; Chills; Fatigue / Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of Appetite), CHILLS (Chills) and FATIGUE (Fatigue / Exhaustion) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DECREASED APPETITE (Loss of Appetite), CHILLS (Chills) and FATIGUE (Fatigue / Exhaustion). On 28-Feb-2021, DECREASED APPETITE (Loss of Appetite), CHILLS (Chills) and FATIGUE (Fatigue / Exhaustion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: arm itchy; arm splotchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm itchy) and RASH (arm splotchy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced PRURITUS (arm itchy) and RASH (arm splotchy). At the time of the report, PRURITUS (arm itchy) and RASH (arm splotchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 immunisation.     The patient's past medical history included Pregnancy (Premature rupture of embyro, twins 32 weeks live pre-term birth) from February 2008 to 02-Nov-2008. Concurrent medical conditions included Asthma since July 1995 and Allergy to antibiotic (Cephalosporin, melons, squash, pumpkin, cucumber and kiwi). Concomitant products included CETIRIZINE HYDROCHLORIDE (CITIRIZINE [CETIRIZINE HYDROCHLORIDE]) for Asthma, MAGNESIUM and CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D) for Headache, DOXYLAMINE SUCCINATE (UNISOM 2).    On 01-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 24-Jan-2021 and the estimated date of delivery was 31-Oct-2021. On 01-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 01-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Pregnancy test: positive (Positive) POSITIVE.     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 treatment drug provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: fatigue; severe body ache; headache; left arm site of injection pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (severe body ache), HEADACHE (headache) and VACCINATION SITE PAIN (left arm site of injection pain) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02SO20A and 013M20A) for COVID-19 vaccination.     Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D3), ZINC, VITAMIN B COMPLEX and PROLIFE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-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 FATIGUE (fatigue), MYALGIA (severe body ache), HEADACHE (headache) and VACCINATION SITE PAIN (left arm site of injection pain). At the time of the report, FATIGUE (fatigue), MYALGIA (severe body ache), HEADACHE (headache) and VACCINATION SITE PAIN (left arm site of injection pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-048002 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Pain, Rash
Clinical narrative: Mild headache; aches and pains; Rashes around right arm and his eyes; Second dose administered on day 50; A spontaneous report was received from a healthcare professional who was also a 48-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced aches and pains, rashes around eyes and right arm, headache and received 2nd dose on day 50/ inappropriate schedule of vaccine administration.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 07 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 014M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced aches and pains which resolved on 28Feb2021. During this time he also noted rashes around his eyes and right arm. On 28 Feb 2021, he had mild headache. Treatment information included Benadryl, prednisolone pack, and Tylenol  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcomes of the events inappropriate schedule of vaccine administration, aches and pains, and headache were considered recovered. The outcome of the event, rashes, was considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Got sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Got sore arm) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Guillain-Barre syndrome (Guillain-Barre syndrome was diagnosed 4 years ago).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Got sore arm). At the time of the report, PAIN IN EXTREMITY (Got sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.   This case was linked to MOD-2021-058132 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: mild redness towards biceps; injection site redness; injection site swelling; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site redness), INJECTION SITE SWELLING (injection site swelling), PRURITUS (itchiness) and ERYTHEMA (mild redness towards biceps) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site redness), INJECTION SITE SWELLING (injection site swelling) and PRURITUS (itchiness). On 02-Mar-2021, the patient experienced ERYTHEMA (mild redness towards biceps). At the time of the report, INJECTION SITE ERYTHEMA (injection site redness), INJECTION SITE SWELLING (injection site swelling), PRURITUS (itchiness) and ERYTHEMA (mild redness towards biceps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vomiting
Clinical narrative: very very fatigued from losing all this fluid; Vomiting/ throwing up; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very very fatigued from losing all this fluid) and VOMITING (Vomiting/ throwing up) in an 82-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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VOMITING (Vomiting/ throwing up). On an unknown date, the patient experienced FATIGUE (very very fatigued from losing all this fluid). At the time of the report, FATIGUE (very very fatigued from losing all this fluid) and VOMITING (Vomiting/ throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Chills; Nausea; Headache; Extreme Fatigue; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache), FATIGUE (Extreme Fatigue) and PAIN IN EXTREMITY (Arm Pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache), FATIGUE (Extreme Fatigue) and PAIN IN EXTREMITY (Arm Pain). At the time of the report, CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache), FATIGUE (Extreme Fatigue) and PAIN IN EXTREMITY (Arm Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-027587 (Patient Link).
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Drug ineffective
Clinical narrative: Negative antibody (test); A spontaneous report was received from a nurse concerning a 56 years-old, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and had negative antibody test/Drug ineffective.   The patient's medical history as reported by the reporter was that the patient has had cancer with stem cells. Concomitant medications were not provided.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route at unspecified site for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient received their second dose of mRNA-1273 (Lot number: unknown) through an unknown route at unspecified site for prophylaxis of COVID-19 infection.  On 19 Feb 2021 the reporter reported that the patient had a negative antibody (test). Laboratory test included antibody test on an unspecified date in 2021. Treatment for the event was not reported.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of event, negative antibody test was unknown.; Reporter's Comments: This report refers to a case of a 56-year old patient who received mRNA-1273 (lot # not provided) and experienced drug ineffective with no associated AEs. The causality for the event drug ineffective is assessed to be Not Applicable
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Influenza like illness
Clinical narrative: uneasy stomach; severe diarrhea; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (uneasy stomach), DIARRHOEA (severe diarrhea) and INFLUENZA LIKE ILLNESS (flu-like symptoms) 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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (uneasy stomach), DIARRHOEA (severe diarrhea) and INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, ABDOMINAL DISCOMFORT (uneasy stomach), DIARRHOEA (severe diarrhea) and INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache
Clinical narrative: Didn't feel having coffee today, and patient usually has 1 to 1 and a half cups of coffee a day; Headache; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Didn't feel having coffee today, and patient usually has 1 to 1 and a half cups of coffee a day), HEADACHE (Headache) and FATIGUE (Fatigue) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Didn't feel having coffee today, and patient usually has 1 to 1 and a half cups of coffee a day), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, FEELING ABNORMAL (Didn't feel having coffee today, and patient usually has 1 to 1 and a half cups of coffee a day), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment information was provided
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vaccination site erythema, Vaccination site swelling, Vomiting
Clinical narrative: diarrhea; nausea; vomitting; redness; swollen bump; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swollen bump), NAUSEA (nausea) and VOMITING (vomitting) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swollen bump). On 01-Mar-2021, the patient experienced DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomitting). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swollen bump), NAUSEA (nausea) and VOMITING (vomitting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Nausea, Vomiting
Clinical narrative: Feeling hot; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling hot), NAUSEA (Nausea) and VOMITING (Vomiting) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced FEELING HOT (Feeling hot), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, FEELING HOT (Feeling hot), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: diarrhea; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and HEADACHE (headache) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (headache). On 01-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: sore arm; red; itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ERYTHEMA (red) and PRURITUS (itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ERYTHEMA (red) and PRURITUS (itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), ERYTHEMA (red) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vision blurred
Clinical narrative: Blurred vision; Big knot at site of injection; Itchy at site of injection; Red at site of injection; Welt at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision), VACCINATION SITE INDURATION (Big knot at site of injection), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE ERYTHEMA (Red at site of injection) and VACCINATION SITE SWELLING (Welt at site of injection) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included RANITIDINE HYDROCHLORIDE (ZANTAC) for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VISION BLURRED (Blurred vision), VACCINATION SITE INDURATION (Big knot at site of injection), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE ERYTHEMA (Red at site of injection) and VACCINATION SITE SWELLING (Welt at site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VISION BLURRED (Blurred vision), VACCINATION SITE INDURATION (Big knot at site of injection), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE ERYTHEMA (Red at site of injection) and VACCINATION SITE SWELLING (Welt at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included unspecified high blood pressure medications.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Vaccination site erythema
Clinical narrative: itching; rash over her chest/ rash on her back site close the waist; 2 by 3 inches red (injection site); sore arm/ arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/ arm hurts), PRURITUS (itching), RASH (rash over her chest/ rash on her back site close the waist) and VACCINATION SITE ERYTHEMA (2 by 3 inches red (injection site)) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included CALCIUM and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm/ arm hurts). On an unknown date, the patient experienced PRURITUS (itching), RASH (rash over her chest/ rash on her back site close the waist) and VACCINATION SITE ERYTHEMA (2 by 3 inches red (injection site)). At the time of the report, PAIN IN EXTREMITY (sore arm/ arm hurts), PRURITUS (itching) and VACCINATION SITE ERYTHEMA (2 by 3 inches red (injection site)) outcome was unknown and RASH (rash over her chest/ rash on her back site close the waist) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.    Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash, Swelling
Clinical narrative: has raised bumps on her chest; terrible rash; burning; itching; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning), PRURITUS (itching), SWELLING (has raised bumps on her chest) and RASH (terrible rash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced BURNING SENSATION (burning), PRURITUS (itching) and RASH (terrible rash). On 03-Mar-2021, the patient experienced SWELLING (has raised bumps on her chest). At the time of the report, BURNING SENSATION (burning), PRURITUS (itching) and RASH (terrible rash) was resolving and SWELLING (has raised bumps on her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not reported  Treatment information was not provided
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Scab, Vaccination site erythema
Clinical narrative: scab on arm; redness on arm; This spontaneous case was reported by a consumer and describes the occurrence of SCAB (scab on arm) and VACCINATION SITE ERYTHEMA (redness on arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced SCAB (scab on arm) and VACCINATION SITE ERYTHEMA (redness on arm). The patient was treated with GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [GRAMICIDIN;NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) at an unspecified dose and frequency. At the time of the report, SCAB (scab on arm) and VACCINATION SITE ERYTHEMA (redness on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: right arm developed a knot and had a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (right arm developed a knot and had a lot of pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE MASS (right arm developed a knot and had a lot of pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, VACCINATION SITE MASS (right arm developed a knot and had a lot of pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment : Azaprocin   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia, Pyrexia
Clinical narrative: chills; high grade fever (T-39.9C); muscle ache; weakness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (high grade fever (T-39.9C)), MYALGIA (muscle ache) and ASTHENIA (weakness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced CHILLS (chills), PYREXIA (high grade fever (T-39.9C)), MYALGIA (muscle ache) and ASTHENIA (weakness). On 01-Mar-2021, CHILLS (chills) and PYREXIA (high grade fever (T-39.9C)) had resolved. At the time of the report, MYALGIA (muscle ache) and ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not reported  Treatment information was not provided   This case was linked to MOD-2021-030562 (E2B Linked Report).; Sender's Comments:  MOD-2021-030562:crosslink
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Nausea, Pain in extremity, Rash pruritic
Clinical narrative: A rash, it itches. about the size of a baseball. The rest of the; nauseated; tired; kinda lost the appetite; didn't have any reaction, just hurt on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (didn't have any reaction, just hurt on the arm), DECREASED APPETITE (kinda lost the appetite), RASH PRURITIC (A rash, it itches. about the size of a baseball. The rest of the), NAUSEA (nauseated) and FATIGUE (tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (didn't have any reaction, just hurt on the arm). On 26-Feb-2021, the patient experienced DECREASED APPETITE (kinda lost the appetite), NAUSEA (nauseated) and FATIGUE (tired). On 01-Mar-2021, the patient experienced RASH PRURITIC (A rash, it itches. about the size of a baseball. The rest of the). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 26-Feb-2021 at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (didn't have any reaction, just hurt on the arm), DECREASED APPETITE (kinda lost the appetite), RASH PRURITIC (A rash, it itches. about the size of a baseball. The rest of the), NAUSEA (nauseated) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up received on 17-JUNE-2021 and does not contain any new information
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). 26-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and HEADACHE (Headache) had resolved.            No concomitant medications provided. No treatment information provided. Upon internal review on 21-May-2021, the age was corrected to unknown.   This case was linked to MOD-2021-028429 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Report received. Unknown. On 05-Jul-2021: Report received. Unknown provided pertinent to the case, requested to not to call again.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Faeces discoloured, Nausea, Pyrexia
Clinical narrative: Black stool; chills; nauseous; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nauseous), PYREXIA (fever) and FAECES DISCOLOURED (Black stool) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 27-Feb-2021, the patient experienced CHILLS (chills), NAUSEA (nauseous) and PYREXIA (fever). On 28-Feb-2021, the patient experienced FAECES DISCOLOURED (Black stool). On 01-Mar-2021, FAECES DISCOLOURED (Black stool) had resolved. At the time of the report, CHILLS (chills), NAUSEA (nauseous) and PYREXIA (fever) outcome was unknown.            Concomitant product use was not reported  Treatment information was not provided   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Muscle rigidity, Myalgia, Pyrexia
Clinical narrative: Intense body aches; Muscles were rigid; Fever and severe headaches; Fever and severe headaches; Covid-19 like symptoms; Laid up for 36 hours; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (Intense body aches), MUSCLE RIGIDITY (Muscles were rigid), PYREXIA (Fever and severe headaches), HEADACHE (Fever and severe headaches) and COVID-19 (Covid-19 like symptoms) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced MYALGIA (Intense body aches), MUSCLE RIGIDITY (Muscles were rigid), PYREXIA (Fever and severe headaches), HEADACHE (Fever and severe headaches), COVID-19 (Covid-19 like symptoms) and SOMNOLENCE (Laid up for 36 hours). On 24-Feb-2021, MYALGIA (Intense body aches), MUSCLE RIGIDITY (Muscles were rigid), PYREXIA (Fever and severe headaches), HEADACHE (Fever and severe headaches), COVID-19 (Covid-19 like symptoms) and SOMNOLENCE (Laid up for 36 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2021, SARS-CoV-2 test: positive (Positive) positive.     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.   Lab test : IgG antibody test - positive  Concomitant product use was not reported  Treatment information was not provided
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Somnolence
Clinical narrative: Intense body aches; Muscles were rigid; Fever and severe headaches; Fever and severe headaches; Covid-19 like symptoms; Laid up for 36 hours; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (Intense body aches), MUSCLE RIGIDITY (Muscles were rigid), PYREXIA (Fever and severe headaches), HEADACHE (Fever and severe headaches) and COVID-19 (Covid-19 like symptoms) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced MYALGIA (Intense body aches), MUSCLE RIGIDITY (Muscles were rigid), PYREXIA (Fever and severe headaches), HEADACHE (Fever and severe headaches), COVID-19 (Covid-19 like symptoms) and SOMNOLENCE (Laid up for 36 hours). On 24-Feb-2021, MYALGIA (Intense body aches), MUSCLE RIGIDITY (Muscles were rigid), PYREXIA (Fever and severe headaches), HEADACHE (Fever and severe headaches), COVID-19 (Covid-19 like symptoms) and SOMNOLENCE (Laid up for 36 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2021, SARS-CoV-2 test: positive (Positive) positive.     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.   Lab test : IgG antibody test - positive  Concomitant product use was not reported  Treatment information was not provided
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Mobility decreased, Pain, Pain in extremity, Sensory disturbance
Clinical narrative: couldn't move right arm/ couldn't use right arm/ unable to use her right arm for two days; ongoing severe pain/ excruciating pain/ like someone was "stabbing" her in her right arm; flu-like symptoms; severe pain right arm/ severe pain right forearm/ throbbing right arm/ throbbing right forearm; "horrible sensation"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain right arm/ severe pain right forearm/ throbbing right arm/ throbbing right forearm), SENSORY DISTURBANCE ("horrible sensation"), MOBILITY DECREASED (couldn't move right arm/ couldn't use right arm/ unable to use her right arm for two days), PAIN (ongoing severe pain/ excruciating pain/ like someone was "stabbing" her in her right arm) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Pain. Concurrent medical conditions included Hypertension (Hypertension) since 2003, Rheumatoid arthritis (Rheumatoid arthritis) since 2003 and Hypothyroidism since 2003. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROXYCHLOROQUINE, TRAMADOL, CARVEDILOL and LOSARTAN for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (severe pain right arm/ severe pain right forearm/ throbbing right arm/ throbbing right forearm), SENSORY DISTURBANCE ("horrible sensation"), PAIN (ongoing severe pain/ excruciating pain/ like someone was "stabbing" her in her right arm) and INFLUENZA LIKE ILLNESS (flu-like symptoms). On an unknown date, the patient experienced MOBILITY DECREASED (couldn't move right arm/ couldn't use right arm/ unable to use her right arm for two days). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 22-Feb-2021, PAIN IN EXTREMITY (severe pain right arm/ severe pain right forearm/ throbbing right arm/ throbbing right forearm), SENSORY DISTURBANCE ("horrible sensation"), MOBILITY DECREASED (couldn't move right arm/ couldn't use right arm/ unable to use her right arm for two days), PAIN (ongoing severe pain/ excruciating pain/ like someone was "stabbing" her in her right arm) and INFLUENZA LIKE ILLNESS (flu-like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Very Achy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Very Achy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had this in September 2020.).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced MYALGIA (Very Achy). On 27-Feb-2021, MYALGIA (Very Achy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on stomach; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash on stomach). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash on stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Pain in extremity
Clinical narrative: Sore arm; Confusion in head that lasted couple hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and CONFUSIONAL STATE (Confusion in head that lasted couple hours) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included REPAGLINIDE for Product used for unknown indication, QUINAPRIL, LEVOTHYROXINE, CLOPIDOGREL, ATORVASTATIN, OXYCODONE, GLIMEPIRIDE, METFORMIN, COLESEVELAM HYDROCHLORIDE (WELCHOL), MIRABEGRON (MYRBETRIQ), LORATADINE, FLUTICASONE, ALCLOMETASONE, ACETYLSALICYLIC ACID (ASPIRIN LOW), MULTIVITAMINS [VITAMINS NOS], UBIDECARENONE (COQ), BIOTIN, ZINC, VITAMIN D3 and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and CONFUSIONAL STATE (Confusion in head that lasted couple hours). At the time of the report, PAIN IN EXTREMITY (Sore arm) and CONFUSIONAL STATE (Confusion in head that lasted couple hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: stiff neck; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and MUSCULOSKELETAL STIFFNESS (stiff neck) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and High cholesterol. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), GLIMEPIRIDE, METOPROLOL, METFORMIN, OMEPRAZOLE and ROSUVASTATIN for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 20-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown and MUSCULOSKELETAL STIFFNESS (stiff neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       HCP told patient to use hot and cold compress and Tylenol.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: tenderness in right arm for two days; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness in right arm for two days) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, AMLODIPINE, ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM, UBIDECARENONE (COQ), FISH OIL, GLUCOSE, SODIUM CHLORIDE, SODIUM LACTATE (LACTATE 1 2 3), MAGNESIUM, SIMVASTATIN and LEVOTHYROXINE SODIUM (THYROXIN) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced TENDERNESS (tenderness in right arm for two days). On 12-Feb-2021, TENDERNESS (tenderness in right arm for two days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.   This case was linked to MOD-2021-097147 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Information about first dose event outcome and second dose events.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Feeling abnormal, Limb discomfort, Pain in extremity, Peripheral coldness
Clinical narrative: Adverse drug reaction; Weird sensation; Arm was very heavy like rubber bands were around it tight; Painful; Hands were icy cold; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Adverse drug reaction), FEELING ABNORMAL (Weird sensation), LIMB DISCOMFORT (Arm was very heavy like rubber bands were around it tight), PAIN IN EXTREMITY (Painful) and PERIPHERAL COLDNESS (Hands were icy cold) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 27-Feb-2021, the patient experienced ADVERSE DRUG REACTION (Adverse drug reaction), FEELING ABNORMAL (Weird sensation), LIMB DISCOMFORT (Arm was very heavy like rubber bands were around it tight), PAIN IN EXTREMITY (Painful) and PERIPHERAL COLDNESS (Hands were icy cold). At the time of the report, ADVERSE DRUG REACTION (Adverse drug reaction), FEELING ABNORMAL (Weird sensation), LIMB DISCOMFORT (Arm was very heavy like rubber bands were around it tight), PAIN IN EXTREMITY (Painful) and PERIPHERAL COLDNESS (Hands were icy cold) outcome was unknown.            Concomitant product use was not reported.  Treatment information was not provided.