chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dysgeusia, Fatigue, Lethargy
Clinical narrative: I had a mild metallic taste in my mouth /  I had a mild soapy taste; generally felt sick; vertigo; quarter size welt/welt became angry looking; Left Shoulder joint lymph nodes became swollen; left shoulder joint hurt; Covid Arm; Left Arm hurt; tired; lethargic; body aches; sore back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), BACK PAIN (sore back), DYSGEUSIA (I had a mild metallic taste in my mouth /  I had a mild soapy taste), LETHARGY (lethargic) and MALAISE (generally felt sick) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (body aches), BACK PAIN (sore back), LETHARGY (lethargic) and FATIGUE (tired). On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left Arm hurt) and VACCINATION SITE PAIN (Covid Arm). On 11-Mar-2021, the patient experienced URTICARIA (quarter size welt/welt became angry looking), LYMPHADENOPATHY (Left Shoulder joint lymph nodes became swollen) and ARTHRALGIA (left shoulder joint hurt). On 21-Mar-2021, the patient experienced MALAISE (generally felt sick) and VERTIGO (vertigo). On an unknown date, the patient experienced DYSGEUSIA (I had a mild metallic taste in my mouth /  I had a mild soapy taste). On 17-Mar-2021, URTICARIA (quarter size welt/welt became angry looking), VACCINATION SITE PAIN (Left Arm hurt) and VACCINATION SITE PAIN (Covid Arm) had resolved. At the time of the report, PAIN (body aches), BACK PAIN (sore back), DYSGEUSIA (I had a mild metallic taste in my mouth /  I had a mild soapy taste), LETHARGY (lethargic), MALAISE (generally felt sick), VERTIGO (vertigo), LYMPHADENOPATHY (Left Shoulder joint lymph nodes became swollen), FATIGUE (tired) and ARTHRALGIA (left shoulder joint hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-089204 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Follow-up contains Image evidence of adverse event and additional adverse event.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089204:second dose
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Pain, Urticaria, Vaccination site pain
Clinical narrative: I had a mild metallic taste in my mouth /  I had a mild soapy taste; generally felt sick; vertigo; quarter size welt/welt became angry looking; Left Shoulder joint lymph nodes became swollen; left shoulder joint hurt; Covid Arm; Left Arm hurt; tired; lethargic; body aches; sore back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), BACK PAIN (sore back), DYSGEUSIA (I had a mild metallic taste in my mouth /  I had a mild soapy taste), LETHARGY (lethargic) and MALAISE (generally felt sick) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (body aches), BACK PAIN (sore back), LETHARGY (lethargic) and FATIGUE (tired). On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left Arm hurt) and VACCINATION SITE PAIN (Covid Arm). On 11-Mar-2021, the patient experienced URTICARIA (quarter size welt/welt became angry looking), LYMPHADENOPATHY (Left Shoulder joint lymph nodes became swollen) and ARTHRALGIA (left shoulder joint hurt). On 21-Mar-2021, the patient experienced MALAISE (generally felt sick) and VERTIGO (vertigo). On an unknown date, the patient experienced DYSGEUSIA (I had a mild metallic taste in my mouth /  I had a mild soapy taste). On 17-Mar-2021, URTICARIA (quarter size welt/welt became angry looking), VACCINATION SITE PAIN (Left Arm hurt) and VACCINATION SITE PAIN (Covid Arm) had resolved. At the time of the report, PAIN (body aches), BACK PAIN (sore back), DYSGEUSIA (I had a mild metallic taste in my mouth /  I had a mild soapy taste), LETHARGY (lethargic), MALAISE (generally felt sick), VERTIGO (vertigo), LYMPHADENOPATHY (Left Shoulder joint lymph nodes became swollen), FATIGUE (tired) and ARTHRALGIA (left shoulder joint hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-089204 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Follow-up contains Image evidence of adverse event and additional adverse event.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089204:second dose
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: I had a mild metallic taste in my mouth /  I had a mild soapy taste; generally felt sick; vertigo; quarter size welt/welt became angry looking; Left Shoulder joint lymph nodes became swollen; left shoulder joint hurt; Covid Arm; Left Arm hurt; tired; lethargic; body aches; sore back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), BACK PAIN (sore back), DYSGEUSIA (I had a mild metallic taste in my mouth /  I had a mild soapy taste), LETHARGY (lethargic) and MALAISE (generally felt sick) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (body aches), BACK PAIN (sore back), LETHARGY (lethargic) and FATIGUE (tired). On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left Arm hurt) and VACCINATION SITE PAIN (Covid Arm). On 11-Mar-2021, the patient experienced URTICARIA (quarter size welt/welt became angry looking), LYMPHADENOPATHY (Left Shoulder joint lymph nodes became swollen) and ARTHRALGIA (left shoulder joint hurt). On 21-Mar-2021, the patient experienced MALAISE (generally felt sick) and VERTIGO (vertigo). On an unknown date, the patient experienced DYSGEUSIA (I had a mild metallic taste in my mouth /  I had a mild soapy taste). On 17-Mar-2021, URTICARIA (quarter size welt/welt became angry looking), VACCINATION SITE PAIN (Left Arm hurt) and VACCINATION SITE PAIN (Covid Arm) had resolved. At the time of the report, PAIN (body aches), BACK PAIN (sore back), DYSGEUSIA (I had a mild metallic taste in my mouth /  I had a mild soapy taste), LETHARGY (lethargic), MALAISE (generally felt sick), VERTIGO (vertigo), LYMPHADENOPATHY (Left Shoulder joint lymph nodes became swollen), FATIGUE (tired) and ARTHRALGIA (left shoulder joint hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-089204 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Follow-up contains Image evidence of adverse event and additional adverse event.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089204:second dose
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: severe body aches; headache; fatigue; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (severe body aches), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and NAUSEA (nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 immunisation.     No medical history was provided by the reporter.  Concomitant products included APREMILAST (OTEZLA) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced MYALGIA (severe body aches), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and NAUSEA (nausea). The patient was treated with IBUPROFEN ongoing since an unknown date for Myalgia, Headache and Fatigue, at an unspecified dose and frequency and PARACETAMOL (TYLENOL 8 HOUR) for Myalgia, Headache, Fatigue and Chills, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: hot injection site; tight injection site; bright red 3 inches area on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE INDURATION (tight injection site) and VACCINATION SITE ERYTHEMA (bright red 3 inches area on injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE INDURATION (tight injection site) and VACCINATION SITE ERYTHEMA (bright red 3 inches area on injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Injection site reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE INDURATION (tight injection site) and VACCINATION SITE ERYTHEMA (bright red 3 inches area on injection site) outcome was unknown.            No relevant concomitant medications were reported. Patient treated reaction also by ice pack.   This case was linked to MOD-2021-089152 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: unbearable pain in his arm; he doesn't feel good; tenderness; swelling and his arm; when he breaths it feels like something is stabbing him; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (unbearable pain in his arm), FEELING ABNORMAL (he doesn't feel good), TENDERNESS (tenderness), PERIPHERAL SWELLING (swelling and his arm) and DYSPNOEA (when he breaths it feels like something is stabbing him) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-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 PAIN IN EXTREMITY (unbearable pain in his arm), FEELING ABNORMAL (he doesn't feel good), TENDERNESS (tenderness), PERIPHERAL SWELLING (swelling and his arm) and DYSPNOEA (when he breaths it feels like something is stabbing him). At the time of the report, PAIN IN EXTREMITY (unbearable pain in his arm), FEELING ABNORMAL (he doesn't feel good), TENDERNESS (tenderness), PERIPHERAL SWELLING (swelling and his arm) and DYSPNOEA (when he breaths it feels like something is stabbing him) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported  No treatment medication was reported
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: Adverse reaction to vaccine; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction to vaccine) and PAIN IN EXTREMITY (Sore arm) 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 21-Apr-1900, 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 an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction to vaccine) and PAIN IN EXTREMITY (Sore arm). At the time of the report, VACCINATION COMPLICATION (Adverse reaction to vaccine) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up received on 03-Aug-2021: Patient initials, gender, New event (sore arm) was updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site mass
Clinical narrative: Itchy; Mass under the skin; Lump the size of a golfball on arm; Redness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), VACCINATION SITE MASS (Mass under the skin), VACCINATION SITE MASS (Lump the size of a golfball on arm) and VACCINATION SITE ERYTHEMA (Redness around injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PRURITUS (Itchy), VACCINATION SITE MASS (Mass under the skin), VACCINATION SITE MASS (Lump the size of a golfball on arm) and VACCINATION SITE ERYTHEMA (Redness around injection site). At the time of the report, PRURITUS (Itchy), VACCINATION SITE MASS (Mass under the skin), VACCINATION SITE MASS (Lump the size of a golfball on arm) and VACCINATION SITE ERYTHEMA (Redness around injection site) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: nausea; headache; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), HEADACHE (headache) and VOMITING (vomiting) 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 NAUSEA (nausea), HEADACHE (headache) and VOMITING (vomiting). At the time of the report, NAUSEA (nausea), HEADACHE (headache) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.  Patient stated it's been 2 weeks since she was experiencing the events.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: upset stomach; Fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (Fever) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (Fever) and HEADACHE (headache). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (Fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, SARS-CoV-2 test negative: (Negative) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Bodyache; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Bodyache), FATIGUE (Tiredness) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (Bodyache), FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, PAIN (Bodyache), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants was reported. No treatments was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: TCR received on 28-05-2021 contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypersomnia, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: hives underneath her neck; swollen underneath her neck; 3 days after rash she had hives underneath her neck and swollen; Soon after the shot, her arm started going numb, it went to fingers initially to third, fourth and fifth respectively; Sore arm; Fast heart beat; excruciating pain everywhere in her body; Sleeping by 6:30 every evening; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Soon after the shot, her arm started going numb, it went to fingers initially to third, fourth and fifth respectively), PAIN IN EXTREMITY (Sore arm), HEART RATE INCREASED (Fast heart beat), URTICARIA (hives underneath her neck) and SWELLING (swollen underneath her neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced HYPOAESTHESIA (Soon after the shot, her arm started going numb, it went to fingers initially to third, fourth and fifth respectively), PAIN IN EXTREMITY (Sore arm) and HEART RATE INCREASED (Fast heart beat). On 04-Apr-2021, the patient experienced URTICARIA (hives underneath her neck), SWELLING (swollen underneath her neck) and RASH (3 days after rash she had hives underneath her neck and swollen). In April 2021, the patient experienced PAIN (excruciating pain everywhere in her body) and HYPERSOMNIA (Sleeping by 6:30 every evening). The patient was treated with Bed rest for Hypoaesthesia; Bed rest for Pain in extremity and Bed rest for Heart rate increased. On 01-Apr-2021, HYPOAESTHESIA (Soon after the shot, her arm started going numb, it went to fingers initially to third, fourth and fifth respectively) had resolved. In April 2021, PAIN (excruciating pain everywhere in her body) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Sore arm), HEART RATE INCREASED (Fast heart beat), URTICARIA (hives underneath her neck), SWELLING (swollen underneath her neck), HYPERSOMNIA (Sleeping by 6:30 every evening) and RASH (3 days after rash she had hives underneath her neck and swollen) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided.  Aside from bed rest, there was no other treatment reported.  The reporter consented for Safety follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: hives underneath her neck; swollen underneath her neck; 3 days after rash she had hives underneath her neck and swollen; Soon after the shot, her arm started going numb, it went to fingers initially to third, fourth and fifth respectively; Sore arm; Fast heart beat; excruciating pain everywhere in her body; Sleeping by 6:30 every evening; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Soon after the shot, her arm started going numb, it went to fingers initially to third, fourth and fifth respectively), PAIN IN EXTREMITY (Sore arm), HEART RATE INCREASED (Fast heart beat), URTICARIA (hives underneath her neck) and SWELLING (swollen underneath her neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced HYPOAESTHESIA (Soon after the shot, her arm started going numb, it went to fingers initially to third, fourth and fifth respectively), PAIN IN EXTREMITY (Sore arm) and HEART RATE INCREASED (Fast heart beat). On 04-Apr-2021, the patient experienced URTICARIA (hives underneath her neck), SWELLING (swollen underneath her neck) and RASH (3 days after rash she had hives underneath her neck and swollen). In April 2021, the patient experienced PAIN (excruciating pain everywhere in her body) and HYPERSOMNIA (Sleeping by 6:30 every evening). The patient was treated with Bed rest for Hypoaesthesia; Bed rest for Pain in extremity and Bed rest for Heart rate increased. On 01-Apr-2021, HYPOAESTHESIA (Soon after the shot, her arm started going numb, it went to fingers initially to third, fourth and fifth respectively) had resolved. In April 2021, PAIN (excruciating pain everywhere in her body) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Sore arm), HEART RATE INCREASED (Fast heart beat), URTICARIA (hives underneath her neck), SWELLING (swollen underneath her neck), HYPERSOMNIA (Sleeping by 6:30 every evening) and RASH (3 days after rash she had hives underneath her neck and swollen) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided.  Aside from bed rest, there was no other treatment reported.  The reporter consented for Safety follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vaccine leaked out of patients arm; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (Vaccine leaked out of patients arm) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Vaccine leaked out of patients arm). On 23-Apr-2021, INCORRECT DOSE ADMINISTERED (Vaccine leaked out of patients arm) had 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.   No Concomitant medication were reported.  No treatment medication were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and MYALGIA (sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039a21a and 036b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced HEADACHE (headache) and MYALGIA (sore arm). On 28-Mar-2021, MYALGIA (sore arm) had resolved. On 29-Mar-2021, HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment with ADVIL was provided.   This case was linked to MOD-2021-089200 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Vision blurred
Clinical narrative: Shingles on right breast; Trouble focusing eyes; Headache; This spontaneous case was reported by a nurse and describes the occurrence of HERPES ZOSTER (Shingles on right breast), VISION BLURRED (Trouble focusing eyes) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No Adverse Event.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-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 HERPES ZOSTER (Shingles on right breast), VISION BLURRED (Trouble focusing eyes) and HEADACHE (Headache). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) at a dose of 1 g three times a day. At the time of the report, HERPES ZOSTER (Shingles on right breast), VISION BLURRED (Trouble focusing eyes) and HEADACHE (Headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   This case was linked to MOD-2021-089205 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: Constant pressure at the back of his knee/putting pressure on right knee/hearing creaking and cracking from left knee; pain in his knee; Leg discomfort; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Constant pressure at the back of his knee/putting pressure on right knee/hearing creaking and cracking from left knee), LIMB DISCOMFORT (Leg discomfort) and ARTHRALGIA (pain in his knee) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced LIMB DISCOMFORT (Leg discomfort). On 18-Apr-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Constant pressure at the back of his knee/putting pressure on right knee/hearing creaking and cracking from left knee) and ARTHRALGIA (pain in his knee). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Constant pressure at the back of his knee/putting pressure on right knee/hearing creaking and cracking from left knee), LIMB DISCOMFORT (Leg discomfort) and ARTHRALGIA (pain in his knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose schedualed >36 after the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose schedualed >36 after the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose schedualed >36 after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose schedualed >36 after the first dose) had 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up was received on 27 May 2021 included no new information.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Tachycardia
Clinical narrative: pain radiating down to the index finger; Tachycardia; pain at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (pain radiating down to the index finger), TACHYCARDIA (Tachycardia) and INJECTION SITE PAIN (pain at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN (pain radiating down to the index finger), TACHYCARDIA (Tachycardia) and INJECTION SITE PAIN (pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (pain radiating down to the index finger), TACHYCARDIA (Tachycardia) and INJECTION SITE PAIN (pain at the injection site) outcome was unknown.        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 takes an injection once in every 8 weeks for Psoriasis. Patient  body temperature also increased.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Nausea
Clinical narrative: Blood from nose on each side; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Blood from nose on each side) and NAUSEA (Nauseous) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced EPISTAXIS (Blood from nose on each side) and NAUSEA (Nauseous). At the time of the report, EPISTAXIS (Blood from nose on each side) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: difficulty breathing; shortness of breath; can't hold breath for longer than 6 seconds; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), DYSPNOEA (shortness of breath) and DYSPNOEA (can't hold breath for longer than 6 seconds) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-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 DYSPNOEA (difficulty breathing), DYSPNOEA (shortness of breath) and DYSPNOEA (can't hold breath for longer than 6 seconds). At the time of the report, DYSPNOEA (difficulty breathing), DYSPNOEA (shortness of breath) and DYSPNOEA (can't hold breath for longer than 6 seconds) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness) in a female 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness). At the time of the report, FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  There was no treatment reported.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Nausea; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METOPROLOL for an unknown indication.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            This case was linked to MOD-2021-089324 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Head discomfort, Injection site pain, Insomnia
Clinical narrative: have a tired face; can not sleep, because her head is very active, can not sleep at night; Very dizzy, she can not move her head because of the dizziness; some discomfort on the ¨crown of the head as if it squeezed me¨; pain in the arm of the injection ( Left arm) for 3 days; severe headache , like migraine; could not see the light ¨ for the 1st 2 days after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (severe headache , like migraine), PHOTOPHOBIA (could not see the light ¨ for the 1st 2 days after the vaccination), INSOMNIA (can not sleep, because her head is very active, can not sleep at night), DIZZINESS (Very dizzy, she can not move her head because of the dizziness) and HEAD DISCOMFORT (some discomfort on the ¨crown of the head as if it squeezed me¨) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for Thyroid disorder, BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE (CONTRAVE) and METFORMIN for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced MIGRAINE (severe headache , like migraine), PHOTOPHOBIA (could not see the light ¨ for the 1st 2 days after the vaccination) and INJECTION SITE PAIN (pain in the arm of the injection ( Left arm) for 3 days). On 19-Apr-2021, the patient experienced INSOMNIA (can not sleep, because her head is very active, can not sleep at night), DIZZINESS (Very dizzy, she can not move her head because of the dizziness) and HEAD DISCOMFORT (some discomfort on the ¨crown of the head as if it squeezed me¨). On 23-Apr-2021, the patient experienced FATIGUE (have a tired face). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 650 mg a day ¨ since 4 or 5 days ago. On 16-Apr-2021, MIGRAINE (severe headache , like migraine) and PHOTOPHOBIA (could not see the light ¨ for the 1st 2 days after the vaccination) had resolved. On 17-Apr-2021, INJECTION SITE PAIN (pain in the arm of the injection ( Left arm) for 3 days) had resolved. At the time of the report, INSOMNIA (can not sleep, because her head is very active, can not sleep at night), DIZZINESS (Very dizzy, she can not move her head because of the dizziness), HEAD DISCOMFORT (some discomfort on the ¨crown of the head as if it squeezed me¨) and FATIGUE (have a tired face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The blood pressure levels are normal : 124-80 mmHg. Patient stated that she is not able to drive the car due to the dizziness she is experiencing, and also has some discomfort on the ¨crown of the head as if it squeezed her¨.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Photophobia
Clinical narrative: have a tired face; can not sleep, because her head is very active, can not sleep at night; Very dizzy, she can not move her head because of the dizziness; some discomfort on the ¨crown of the head as if it squeezed me¨; pain in the arm of the injection ( Left arm) for 3 days; severe headache , like migraine; could not see the light ¨ for the 1st 2 days after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (severe headache , like migraine), PHOTOPHOBIA (could not see the light ¨ for the 1st 2 days after the vaccination), INSOMNIA (can not sleep, because her head is very active, can not sleep at night), DIZZINESS (Very dizzy, she can not move her head because of the dizziness) and HEAD DISCOMFORT (some discomfort on the ¨crown of the head as if it squeezed me¨) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for Thyroid disorder, BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE (CONTRAVE) and METFORMIN for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced MIGRAINE (severe headache , like migraine), PHOTOPHOBIA (could not see the light ¨ for the 1st 2 days after the vaccination) and INJECTION SITE PAIN (pain in the arm of the injection ( Left arm) for 3 days). On 19-Apr-2021, the patient experienced INSOMNIA (can not sleep, because her head is very active, can not sleep at night), DIZZINESS (Very dizzy, she can not move her head because of the dizziness) and HEAD DISCOMFORT (some discomfort on the ¨crown of the head as if it squeezed me¨). On 23-Apr-2021, the patient experienced FATIGUE (have a tired face). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 650 mg a day ¨ since 4 or 5 days ago. On 16-Apr-2021, MIGRAINE (severe headache , like migraine) and PHOTOPHOBIA (could not see the light ¨ for the 1st 2 days after the vaccination) had resolved. On 17-Apr-2021, INJECTION SITE PAIN (pain in the arm of the injection ( Left arm) for 3 days) had resolved. At the time of the report, INSOMNIA (can not sleep, because her head is very active, can not sleep at night), DIZZINESS (Very dizzy, she can not move her head because of the dizziness), HEAD DISCOMFORT (some discomfort on the ¨crown of the head as if it squeezed me¨) and FATIGUE (have a tired face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The blood pressure levels are normal : 124-80 mmHg. Patient stated that she is not able to drive the car due to the dizziness she is experiencing, and also has some discomfort on the ¨crown of the head as if it squeezed her¨.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (pain in arm, unbearable, excruciating pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 017B21A and 02A21A) for COVID-19 immunization. No medical history reported. On Apr 22, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 24, 2021, patient experienced pain in extremity (pain in arm, unbearable, excruciating pain). At the time of the report, pain in extremity (pain in arm, unbearable, excruciating pain) outcome: unknown/not provided. Treatment: Tylenol and heating pad.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression, Stress, Tinnitus, Weight decreased
Clinical narrative: Anxiety; lost 20 punds; Severe distress; Depression; Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus), ANXIETY (Anxiety), WEIGHT DECREASED (lost 20 punds), STRESS (Severe distress) and DEPRESSION (Depression) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LORAZEPAM (ATIVAN) for an unknown indication.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced TINNITUS (Tinnitus). On an unknown date, the patient experienced ANXIETY (Anxiety), WEIGHT DECREASED (lost 20 punds), STRESS (Severe distress) and DEPRESSION (Depression). At the time of the report, TINNITUS (Tinnitus), ANXIETY (Anxiety), WEIGHT DECREASED (lost 20 punds), STRESS (Severe distress) and DEPRESSION (Depression) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: fallow up received and concomitant medication added. new events were added.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Pain
Clinical narrative: sore arm; Achy; Fever  99.4-101.4; chills; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (Achy), PYREXIA (Fever  99.4-101.4), CHILLS (chills) and ARTHRALGIA (joint pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (Achy), PYREXIA (Fever  99.4-101.4), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (Achy), PYREXIA (Fever  99.4-101.4), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 99.4-101.4 (abnormal) 99.4-101.4.         No concomitant medications provided.    This case was linked to MOD-2021-089180 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; Achy; Fever  99.4-101.4; chills; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (Achy), PYREXIA (Fever  99.4-101.4), CHILLS (chills) and ARTHRALGIA (joint pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (Achy), PYREXIA (Fever  99.4-101.4), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (Achy), PYREXIA (Fever  99.4-101.4), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 99.4-101.4 (abnormal) 99.4-101.4.         No concomitant medications provided.    This case was linked to MOD-2021-089180 (Patient Link).