chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: off and on breathing problem that felt worse last night; lymph nodes swelling on their left arm and a little on the right arm; hard, tender, reddish, inflamed spots on different parts of their body; joints were swelling, specially their elbow, and they feel their knees have stiffen up since last; red patch area of 2 inches long by 1.5 inches wide on their left arm; tenderness in their arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (tenderness in their arm), INFLAMMATION (hard, tender, reddish, inflamed spots on different parts of their body), JOINT SWELLING (joints were swelling, specially their elbow, and they feel their knees have stiffen up since last), ERYTHEMA (red patch area of 2 inches long by 1.5 inches wide on their left arm) and DYSPNOEA (off and on breathing problem that felt worse last night) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included PRAVASTATIN for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (tenderness in their arm). On 01-Mar-2021, the patient experienced INFLAMMATION (hard, tender, reddish, inflamed spots on different parts of their body), JOINT SWELLING (joints were swelling, specially their elbow, and they feel their knees have stiffen up since last), ERYTHEMA (red patch area of 2 inches long by 1.5 inches wide on their left arm) and LYMPHADENOPATHY (lymph nodes swelling on their left arm and a little on the right arm). On 03-Mar-2021, the patient experienced DYSPNOEA (off and on breathing problem that felt worse last night). At the time of the report, PAIN IN EXTREMITY (tenderness in their arm), INFLAMMATION (hard, tender, reddish, inflamed spots on different parts of their body), JOINT SWELLING (joints were swelling, specially their elbow, and they feel their knees have stiffen up since last), ERYTHEMA (red patch area of 2 inches long by 1.5 inches wide on their left arm), DYSPNOEA (off and on breathing problem that felt worse last night) and LYMPHADENOPATHY (lymph nodes swelling on their left arm and a little on the right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other Medications: thyroid medication, blood pressure medicine. Claritin is used for treatment.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: elevation in my blood pressure; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) and HYPERTENSION (elevation in my blood pressure) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (dizzy). On 18-Feb-2021, the patient experienced HYPERTENSION (elevation in my blood pressure). On 21-Feb-2021, DIZZINESS (dizzy) had resolved. At the time of the report, HYPERTENSION (elevation in my blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant included blood pressure medication Treatment included Allergy medication and Ibuprofen and Tylenol hoping that would help. I tried to rest as much as I could.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Rash pruritic, Swelling
Clinical narrative: the rash became red and solid, itchy, swollen and it spread to her shoulder and elbow; the rash became red and solid, itchy, swollen and it spread to her shoulder and elbow; a trace of redness; a little bit of a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a little bit of a rash), RASH PRURITIC (the rash became red and solid, itchy, swollen and it spread to her shoulder and elbow), SWELLING (the rash became red and solid, itchy, swollen and it spread to her shoulder and elbow) and ERYTHEMA (a trace of redness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031l20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced RASH (a little bit of a rash). On 20-Feb-2021, the patient experienced RASH PRURITIC (the rash became red and solid, itchy, swollen and it spread to her shoulder and elbow), SWELLING (the rash became red and solid, itchy, swollen and it spread to her shoulder and elbow) and ERYTHEMA (a trace of redness). On 15-Feb-2021, RASH (a little bit of a rash) had resolved. On 03-Mar-2021, RASH PRURITIC (the rash became red and solid, itchy, swollen and it spread to her shoulder and elbow), SWELLING (the rash became red and solid, itchy, swollen and it spread to her shoulder and elbow) and ERYTHEMA (a trace of redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant included High blood pressure med, Cholesterol med Treatment included Tylenol and benadryl cream
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Oropharyngeal discomfort, Throat tightness
Clinical narrative: throat began to close up; difficulty breathing; throat tightening up; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (throat began to close up), DYSPNOEA (difficulty breathing) and THROAT TIGHTNESS (throat tightening up) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shellfish allergy. Previously administered products included for Shellfish allergy: Epipen.    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 OROPHARYNGEAL DISCOMFORT (throat began to close up), DYSPNOEA (difficulty breathing) and THROAT TIGHTNESS (throat tightening up). The patient was treated with EPINEPHRINE (EPIPEN) for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, OROPHARYNGEAL DISCOMFORT (throat began to close up), DYSPNOEA (difficulty breathing) and THROAT TIGHTNESS (throat tightening up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Patient stated throat tightening up then it would go away in waves then tighten up again worse than before. Patient reported she had to use her EpiPen. Patient stated she went to the hospital and was given a steroid shot and Benadryl. Patient stated she does feel better but tired.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Nasal congestion, Pain in extremity
Clinical narrative: stomach upset; Dry heaves; Stuffy nose; Sore arm; chills; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Mar-2021 and was forwarded to Moderna on 07-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset), RETCHING (Dry heaves), NASAL CONGESTION (Stuffy nose), PAIN IN EXTREMITY (Sore arm) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 05-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach upset), RETCHING (Dry heaves), NASAL CONGESTION (Stuffy nose), PAIN IN EXTREMITY (Sore arm), CHILLS (chills) and HEADACHE (Headache). At the time of the report, ABDOMINAL DISCOMFORT (stomach upset), RETCHING (Dry heaves), NASAL CONGESTION (Stuffy nose), PAIN IN EXTREMITY (Sore arm), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: stomach upset; Dry heaves; Stuffy nose; Sore arm; chills; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Mar-2021 and was forwarded to Moderna on 07-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset), RETCHING (Dry heaves), NASAL CONGESTION (Stuffy nose), PAIN IN EXTREMITY (Sore arm) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 05-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach upset), RETCHING (Dry heaves), NASAL CONGESTION (Stuffy nose), PAIN IN EXTREMITY (Sore arm), CHILLS (chills) and HEADACHE (Headache). At the time of the report, ABDOMINAL DISCOMFORT (stomach upset), RETCHING (Dry heaves), NASAL CONGESTION (Stuffy nose), PAIN IN EXTREMITY (Sore arm), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: localized rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (localized rash) 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 RASH (localized rash). At the time of the report, RASH (localized rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information provided by Reporter.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Ear discomfort, Electric shock sensation, Headache, Oropharyngeal pain
Clinical narrative: a left throat soreness; his left eyelash follicles that had a burning and painful sensation; it was sensitive to the touch but no rash or itchiness; side effects; headache; the rear quadrant behind his left ear was where he was experiencing the shocks; a burning sensation in his left ear; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (a burning sensation in his left ear), OROPHARYNGEAL PAIN (a left throat soreness), ELECTRIC SHOCK SENSATION (the rear quadrant behind his left ear was where he was experiencing the shocks), BURNING SENSATION (his left eyelash follicles that had a burning and painful sensation) and PARAESTHESIA (it was sensitive to the touch but no rash or itchiness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced EAR DISCOMFORT (a burning sensation in his left ear), ELECTRIC SHOCK SENSATION (the rear quadrant behind his left ear was where he was experiencing the shocks), PARAESTHESIA (it was sensitive to the touch but no rash or itchiness), VACCINATION COMPLICATION (side effects) and HEADACHE (headache). On 04-Mar-2021 at 4:00 PM, the patient experienced BURNING SENSATION (his left eyelash follicles that had a burning and painful sensation). On 04-Mar-2021 at 7:00 PM, the patient experienced OROPHARYNGEAL PAIN (a left throat soreness). On 04-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, EAR DISCOMFORT (a burning sensation in his left ear), OROPHARYNGEAL PAIN (a left throat soreness), ELECTRIC SHOCK SENSATION (the rear quadrant behind his left ear was where he was experiencing the shocks), BURNING SENSATION (his left eyelash follicles that had a burning and painful sensation), PARAESTHESIA (it was sensitive to the touch but no rash or itchiness) and VACCINATION COMPLICATION (side effects) 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 treatment information include Tylenol and Motrin. He was prescribed Valtrex.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination complication
Clinical narrative: a left throat soreness; his left eyelash follicles that had a burning and painful sensation; it was sensitive to the touch but no rash or itchiness; side effects; headache; the rear quadrant behind his left ear was where he was experiencing the shocks; a burning sensation in his left ear; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (a burning sensation in his left ear), OROPHARYNGEAL PAIN (a left throat soreness), ELECTRIC SHOCK SENSATION (the rear quadrant behind his left ear was where he was experiencing the shocks), BURNING SENSATION (his left eyelash follicles that had a burning and painful sensation) and PARAESTHESIA (it was sensitive to the touch but no rash or itchiness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced EAR DISCOMFORT (a burning sensation in his left ear), ELECTRIC SHOCK SENSATION (the rear quadrant behind his left ear was where he was experiencing the shocks), PARAESTHESIA (it was sensitive to the touch but no rash or itchiness), VACCINATION COMPLICATION (side effects) and HEADACHE (headache). On 04-Mar-2021 at 4:00 PM, the patient experienced BURNING SENSATION (his left eyelash follicles that had a burning and painful sensation). On 04-Mar-2021 at 7:00 PM, the patient experienced OROPHARYNGEAL PAIN (a left throat soreness). On 04-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, EAR DISCOMFORT (a burning sensation in his left ear), OROPHARYNGEAL PAIN (a left throat soreness), ELECTRIC SHOCK SENSATION (the rear quadrant behind his left ear was where he was experiencing the shocks), BURNING SENSATION (his left eyelash follicles that had a burning and painful sensation), PARAESTHESIA (it was sensitive to the touch but no rash or itchiness) and VACCINATION COMPLICATION (side effects) 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 treatment information include Tylenol and Motrin. He was prescribed Valtrex.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Inflammation, Pain in extremity
Clinical narrative: achy arm; arthritis off the charts; inflammation; pain in hands/pain in fingers; pain in knee/pain in joints; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy arm), ARTHRITIS (arthritis off the charts), INFLAMMATION (inflammation), PAIN IN EXTREMITY (pain in hands/pain in fingers) and ARTHRALGIA (pain in knee/pain in joints) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (achy arm), ARTHRITIS (arthritis off the charts), INFLAMMATION (inflammation), PAIN IN EXTREMITY (pain in hands/pain in fingers) and ARTHRALGIA (pain in knee/pain in joints). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (achy arm), ARTHRITIS (arthritis off the charts), INFLAMMATION (inflammation), PAIN IN EXTREMITY (pain in hands/pain in fingers) and ARTHRALGIA (pain in knee/pain in joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was reported that, on 21-Feb-2021, patient experienced a normal achy arm but since then, her arthritis is off the charts and her inflammation got triggered. She felt it was out of control and experienced pain in her hands, fingers, knees, and all her joints. She took some Tylenol but it did not help.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Erythema, Fatigue, Flushing, Headache
Clinical narrative: lethargic; tired; little headache; face got red; felt flush; skin was itching; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (face got red), FLUSHING (felt flush), PRURITUS (skin was itching), OROPHARYNGEAL PAIN (sore throat) and LETHARGY (lethargic) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ERYTHEMA (face got red), FLUSHING (felt flush), PRURITUS (skin was itching), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (little headache). On an unknown date, the patient experienced LETHARGY (lethargic) and FATIGUE (tired). At the time of the report, ERYTHEMA (face got red), FLUSHING (felt flush), PRURITUS (skin was itching), OROPHARYNGEAL PAIN (sore throat), LETHARGY (lethargic), HEADACHE (little headache) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood pressure measurement: 161/100 (High) 161/100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 22-Jul-2021 included no new information.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Oropharyngeal pain, Pruritus
Clinical narrative: lethargic; tired; little headache; face got red; felt flush; skin was itching; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (face got red), FLUSHING (felt flush), PRURITUS (skin was itching), OROPHARYNGEAL PAIN (sore throat) and LETHARGY (lethargic) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ERYTHEMA (face got red), FLUSHING (felt flush), PRURITUS (skin was itching), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (little headache). On an unknown date, the patient experienced LETHARGY (lethargic) and FATIGUE (tired). At the time of the report, ERYTHEMA (face got red), FLUSHING (felt flush), PRURITUS (skin was itching), OROPHARYNGEAL PAIN (sore throat), LETHARGY (lethargic), HEADACHE (little headache) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood pressure measurement: 161/100 (High) 161/100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 22-Jul-2021 included no new information.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Injection site pain, Pain, Pyrexia
Clinical narrative: Hurting Injection Site; Fever 100 F; Aches all over; No Appetite; Sick to her Stomach; A spontaneous report (United States) was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hurting injection site/Injection site pain, fever 100 f/Pyrexia, aches all over/Pain, no appetite/Decreased appetite, sick to her stomach/Abdominal discomfort.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Mar 2021, approximately 2 days prior to the onset of the events the patient received their second planned dose of mRNA-1273 (lot/batch: 010A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 7 Mar 2021, the patient experienced the events hurting injection site. fever 100 f, aches all over, no appetite, sick to her stomach. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  At the time of this report, the outcome of events, hurting injection site, fever 100 f, aches all over, no appetite, sick to her stomach was considered as unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chills, Erythema, Feeling cold, Pain in extremity
Clinical narrative: sore arm; pain into her left breast; so cold that thought she was going to went in shock/teeth was cold; redness in her face; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), BREAST PAIN (pain into her left breast), FEELING COLD (so cold that thought she was going to went in shock/teeth was cold), ERYTHEMA (redness in her face) and CHILLS (chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Apple allergy- itching, throat close up and problem with the tongue), Fruit allergy (Peach allergy-itching, throat close up and problem with the tongue), Allergy to nuts (Itching, throat close up and problem with the tongue) and Food allergy.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 8:00 AM, 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 PAIN IN EXTREMITY (sore arm), BREAST PAIN (pain into her left breast), FEELING COLD (so cold that thought she was going to went in shock/teeth was cold), ERYTHEMA (redness in her face) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), BREAST PAIN (pain into her left breast) and CHILLS (chills) outcome was unknown, FEELING COLD (so cold that thought she was going to went in shock/teeth was cold) was resolving and ERYTHEMA (redness in her face) had resolved. Not Provided          For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  No concomitant medications were reported.  The action taken with mRNA-1273 in response to the event was not applicable.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Lethargy, Malaise
Clinical narrative: chills/Body shivers; low grade fever of about 99.3-99.5 F/constant mild fever of 99.5 to 99.8 degrees; Feeling cold; constant trembling; lethargic episode; was a little off last night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling cold), TREMOR (constant trembling), LETHARGY (lethargic episode), MALAISE (was a little off last night) and CHILLS (chills/Body shivers) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes since 2001. Concomitant products included METFORMIN, AMLODIPINE and LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FEELING COLD (Feeling cold), TREMOR (constant trembling), LETHARGY (lethargic episode) and MALAISE (was a little off last night). On 05-Mar-2021, the patient experienced CHILLS (chills/Body shivers) and PYREXIA (low grade fever of about 99.3-99.5 F/constant mild fever of 99.5 to 99.8 degrees). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (Feeling cold), TREMOR (constant trembling), LETHARGY (lethargic episode), MALAISE (was a little off last night), CHILLS (chills/Body shivers) and PYREXIA (low grade fever of about 99.3-99.5 F/constant mild fever of 99.5 to 99.8 degrees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 99.3-99.5 (High) 99.3-99.5 degree Fahrenheit.     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.   Patient had a period of discomfort for 24 hours.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Patient Demographics were added.Concomitant medication (metformin, Levothyroxine)were added.Events Body Shivers,Constant trembling,Feeling cold.were added. Outcome of the events Events lethargic episode,low grade fever of about 99.3-99.5 F/constant mild fever of 99.5 to 99.8 degrees,was a little off last night got resolved.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: chills/Body shivers; low grade fever of about 99.3-99.5 F/constant mild fever of 99.5 to 99.8 degrees; Feeling cold; constant trembling; lethargic episode; was a little off last night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling cold), TREMOR (constant trembling), LETHARGY (lethargic episode), MALAISE (was a little off last night) and CHILLS (chills/Body shivers) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes since 2001. Concomitant products included METFORMIN, AMLODIPINE and LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FEELING COLD (Feeling cold), TREMOR (constant trembling), LETHARGY (lethargic episode) and MALAISE (was a little off last night). On 05-Mar-2021, the patient experienced CHILLS (chills/Body shivers) and PYREXIA (low grade fever of about 99.3-99.5 F/constant mild fever of 99.5 to 99.8 degrees). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (Feeling cold), TREMOR (constant trembling), LETHARGY (lethargic episode), MALAISE (was a little off last night), CHILLS (chills/Body shivers) and PYREXIA (low grade fever of about 99.3-99.5 F/constant mild fever of 99.5 to 99.8 degrees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 99.3-99.5 (High) 99.3-99.5 degree Fahrenheit.     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.   Patient had a period of discomfort for 24 hours.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Patient Demographics were added.Concomitant medication (metformin, Levothyroxine)were added.Events Body Shivers,Constant trembling,Feeling cold.were added. Outcome of the events Events lethargic episode,low grade fever of about 99.3-99.5 F/constant mild fever of 99.5 to 99.8 degrees,was a little off last night got resolved.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Pregnancy test
Clinical narrative: No menses continues after 2nd Vaccination; No menses after 1st Vaccination; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (No menses after 1st Vaccination) and AMENORRHOEA (No menses continues after 2nd Vaccination) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 013L20A) for COVID-19 vaccination.     No Medical History Information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced AMENORRHOEA (No menses after 1st Vaccination). On 04-Mar-2021, the patient experienced AMENORRHOEA (No menses continues after 2nd Vaccination). At the time of the report, AMENORRHOEA (No menses after 1st Vaccination) and AMENORRHOEA (No menses continues after 2nd Vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Pregnancy test: negative.          No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (No menses after 1st Vaccination) and AMENORRHOEA (No menses continues after 2nd Vaccination) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 013L20A) for COVID-19 vaccination.     No Medical History Information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced AMENORRHOEA (No menses after 1st Vaccination). On 04-Mar-2021, the patient experienced AMENORRHOEA (No menses continues after 2nd Vaccination). At the time of the report, AMENORRHOEA (No menses after 1st Vaccination) and AMENORRHOEA (No menses continues after 2nd Vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Pregnancy test: negative.          No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Musculoskeletal discomfort, Rash erythematous, Rash pruritic
Clinical narrative: itchy rash; red rash; itchy red rash on both legs up past groin area; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash), RASH ERYTHEMATOUS (red rash) and MUSCULOSKELETAL DISCOMFORT (itchy red rash on both legs up past groin area) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.  On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced RASH PRURITIC (itchy rash), RASH ERYTHEMATOUS (red rash) and MUSCULOSKELETAL DISCOMFORT (itchy red rash on both legs up past groin area). The patient was treated with TRIAMCINOLONE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itchy rash), RASH ERYTHEMATOUS (red rash) and MUSCULOSKELETAL DISCOMFORT (itchy red rash on both legs up past groin area) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: normal (normal) Patient had bloodwork done.   Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-035720 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Injection site pruritus, Vaccination site pain, Vaccination site warmth
Clinical narrative: itching at the injection site; little bit of burning; little tired arm; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little tired arm), AXILLARY PAIN (sore arm), INJECTION SITE PRURITUS (itching at the injection site) and VACCINATION SITE WARMTH (little bit of burning) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.  On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (little tired arm) and AXILLARY PAIN (sore arm).   On 05-Mar-2021, the patient experienced INJECTION SITE PRURITUS (itching at the injection site) and VACCINATION SITE WARMTH (little bit of burning). At the time of the report, VACCINATION SITE PAIN (little tired arm), AXILLARY PAIN (sore arm), INJECTION SITE PRURITUS (itching at the injection site) and VACCINATION SITE WARMTH (little bit of burning) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was very sore), PRURITUS (severe itching all over my body focusing on the chest and arms, with no rash) and MYALGIA (cant lift arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was very sore) and MYALGIA (cant lift arm). On an unknown date, the patient experienced PRURITUS (severe itching all over my body focusing on the chest and arms, with no rash). At the time of the report, PAIN IN EXTREMITY (Arm was very sore) and MYALGIA (cant lift arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pyrexia
Clinical narrative: Feels worse than when she had Covid"; she woke up with a fever 102.9.; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels worse than when she had Covid"), CHILLS (chills) and PYREXIA (she woke up with a fever 102.9.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (chills). On 05-Mar-2021, the patient experienced FEELING ABNORMAL (Feels worse than when she had Covid") and PYREXIA (she woke up with a fever 102.9.). At the time of the report, FEELING ABNORMAL (Feels worse than when she had Covid"), CHILLS (chills) and PYREXIA (she woke up with a fever 102.9.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nasopharyngitis, Neck pain, Vaccination site pain
Clinical narrative: felt dizzy; he feels like he is going to catch a cold; neck pain; headache; injection site was sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy), NASOPHARYNGITIS (he feels like he is going to catch a cold), NECK PAIN (neck pain), HEADACHE (headache) and VACCINATION SITE PAIN (injection site was sore) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 075AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced DIZZINESS (felt dizzy), NASOPHARYNGITIS (he feels like he is going to catch a cold), NECK PAIN (neck pain), HEADACHE (headache) and VACCINATION SITE PAIN (injection site was sore). At the time of the report, DIZZINESS (felt dizzy), NASOPHARYNGITIS (he feels like he is going to catch a cold), NECK PAIN (neck pain), HEADACHE (headache) and VACCINATION SITE PAIN (injection site was sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications provided. No treatment information provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash in her whole body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash in her whole body) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033A21A) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (esophageal) since an unknown date. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced RASH (rash in her whole body). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (rash in her whole body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Email ID Updated This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash in her whole body) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033A21A) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (esophageal) since an unknown date. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced RASH (rash in her whole body). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (rash in her whole body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Email ID Updated
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination complication, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Moderna arm; Redness goes down all the way around to elbow; hard; itching; red; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Moderna arm), ERYTHEMA (Redness goes down all the way around to elbow), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION COMPLICATION (Moderna arm), ERYTHEMA (Redness goes down all the way around to elbow), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen). At the time of the report, VACCINATION COMPLICATION (Moderna arm), ERYTHEMA (Redness goes down all the way around to elbow), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Moderna arm; Redness goes down all the way around to elbow; hard; itching; red; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Moderna arm), ERYTHEMA (Redness goes down all the way around to elbow), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION COMPLICATION (Moderna arm), ERYTHEMA (Redness goes down all the way around to elbow), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen). At the time of the report, VACCINATION COMPLICATION (Moderna arm), ERYTHEMA (Redness goes down all the way around to elbow), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Neck pain, Odynophagia, Oropharyngeal pain
Clinical narrative: Neck pain; fatigue; Tiredness; Throar pain; hard to swallo; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NECK PAIN (Neck pain), FATIGUE (fatigue), FATIGUE (Tiredness) and OROPHARYNGEAL PAIN (Throar pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN, PRAVASTATIN, FUROSEMIDE, GLIPIZIDE, PIOGLITAZONE, METOPROLOL, POTASSIUM, ACETYLSALICYLIC ACID (ASPIRIN 81) and VITAMIN D3 for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEADACHE (headache), OROPHARYNGEAL PAIN (Throar pain) and ODYNOPHAGIA (hard to swallo). On 24-Feb-2021, the patient experienced NECK PAIN (Neck pain), FATIGUE (fatigue) and FATIGUE (Tiredness). At the time of the report, HEADACHE (headache), NECK PAIN (Neck pain), FATIGUE (fatigue), FATIGUE (Tiredness), OROPHARYNGEAL PAIN (Throar pain) and ODYNOPHAGIA (hard to swallo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included Tylenol.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Somnolence, Throat irritation
Clinical narrative: sleepy; itchy throat; sore arm; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), THROAT IRRITATION (itchy throat), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) 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 an unknown date, the patient experienced SOMNOLENCE (sleepy), THROAT IRRITATION (itchy throat), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and CHILLS (chills). At the time of the report, SOMNOLENCE (sleepy), THROAT IRRITATION (itchy throat), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.