chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Hypersomnia, Malaise, Pain in extremity
Clinical narrative: arm was sore for two days; feels ill; kind of felt bad again/just didn't feel good; dizzy would come and go/still has dizzy spells; slept all day from 12:30-8; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore for two days), MALAISE (feels ill), FEELING ABNORMAL (kind of felt bad again/just didn't feel good), DIZZINESS (dizzy would come and go/still has dizzy spells) and HYPERSOMNIA (slept all day from 12:30-8) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-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 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore for two days), MALAISE (feels ill), FEELING ABNORMAL (kind of felt bad again/just didn't feel good), DIZZINESS (dizzy would come and go/still has dizzy spells) and HYPERSOMNIA (slept all day from 12:30-8). At the time of the report, PAIN IN EXTREMITY (arm was sore for two days), MALAISE (feels ill), FEELING ABNORMAL (kind of felt bad again/just didn't feel good), DIZZINESS (dizzy would come and go/still has dizzy spells) and HYPERSOMNIA (slept all day from 12:30-8) outcome was unknown. Not Provided          Concomitants - blood pressure and cholesterol medication Treatment -  Water, Gatorade Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Fingers hurt; hands swollen; wrist - ankles swelling; her joints in her body all at one time started hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Fingers hurt), PERIPHERAL SWELLING (hands swollen), JOINT SWELLING (wrist - ankles swelling) and ARTHRALGIA (her joints in her body all at one time started hurting) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (Fingers hurt), PERIPHERAL SWELLING (hands swollen), JOINT SWELLING (wrist - ankles swelling) and ARTHRALGIA (her joints in her body all at one time started hurting). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Fingers hurt), PERIPHERAL SWELLING (hands swollen), JOINT SWELLING (wrist - ankles swelling) and ARTHRALGIA (her joints in her body all at one time started hurting) 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.   Treatment medication include Tylenol . Patient already had both shots but a week after first shot this happened. It has intensified since then, took her to the emergency room, they only did some lab work and told her to take Tylenol but it is not helping. Had first shot on March 16th 2021 in her left arm and a week after first shot, maybe this would be on the week of the 28th or 29th of March, she says that all her joints in her body all at one time started hurting. Getting worse, for example she can't even cover herself because when she touches the blanket her fingers hurt. Her hands, wrists and ankles are all swollen. Talked to friends and we know that some had joint pains and it is normal from the vaccine but they it went away.  She had lab work done, and they came back normal except for the liver, the liver count was high. She had second shot of Moderna vaccine on April 18th 2021 in her right arm. Didn't have lot number to be able to provide, nor expiration date. Said she had a cold, never was sick, never had to be in hospital. No concomitant medicine, only has vitamins.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: night sweats; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced NIGHT SWEATS (night sweats). At the time of the report, NIGHT SWEATS (night sweats) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant details were provided No treatment details were provided Action taken with mRNA-1273 in response to the drug was no change The patient took the second dose of vaccine on 17-Apr-2021((Lot number:030M20A) on left arm.Complete blood work done and all the vitals are fine   This case was linked to MOD-2021-095228 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Muscle tightness, Myalgia
Clinical narrative: lower back pain; muscle tight; muscle pain; shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), MUSCLE TIGHTNESS (muscle tight), MYALGIA (muscle pain) and ARTHRALGIA (shoulder pain) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) 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 07-Apr-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 BACK PAIN (lower back pain), MUSCLE TIGHTNESS (muscle tight), MYALGIA (muscle pain) and ARTHRALGIA (shoulder pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (lower back pain), MUSCLE TIGHTNESS (muscle tight), MYALGIA (muscle pain) and ARTHRALGIA (shoulder pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided.  Patient took every day 2-3 Advil and Tylenol to ease   This case was linked to MOD-2021-095167 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: Chest heaviness; like someone was stepping on her chest/feel like someone is on her chest; hard to breath; headache; had chills; Feel lousy; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feel lousy), PAIN IN EXTREMITY (Sore arm), CHEST DISCOMFORT (Chest heaviness), CHEST DISCOMFORT (like someone was stepping on her chest/feel like someone is on her chest) and DYSPNOEA (hard to breath) in a 53-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 Overweight and Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced MALAISE (Feel lousy), PAIN IN EXTREMITY (Sore arm), HEADACHE (headache) and CHILLS (had chills). On 30-Apr-2021, the patient experienced CHEST DISCOMFORT (Chest heaviness), CHEST DISCOMFORT (like someone was stepping on her chest/feel like someone is on her chest) and DYSPNOEA (hard to breath). At the time of the report, MALAISE (Feel lousy), PAIN IN EXTREMITY (Sore arm), CHEST DISCOMFORT (Chest heaviness), CHEST DISCOMFORT (like someone was stepping on her chest/feel like someone is on her chest), DYSPNOEA (hard to breath), HEADACHE (headache) and CHILLS (had chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: normal (normal) Normal. On an unknown date, Electrocardiogram: normal (normal) Normal. On an unknown date, Full blood count: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Headache, Malaise, Pain in extremity
Clinical narrative: Chest heaviness; like someone was stepping on her chest/feel like someone is on her chest; hard to breath; headache; had chills; Feel lousy; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feel lousy), PAIN IN EXTREMITY (Sore arm), CHEST DISCOMFORT (Chest heaviness), CHEST DISCOMFORT (like someone was stepping on her chest/feel like someone is on her chest) and DYSPNOEA (hard to breath) in a 53-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 Overweight and Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced MALAISE (Feel lousy), PAIN IN EXTREMITY (Sore arm), HEADACHE (headache) and CHILLS (had chills). On 30-Apr-2021, the patient experienced CHEST DISCOMFORT (Chest heaviness), CHEST DISCOMFORT (like someone was stepping on her chest/feel like someone is on her chest) and DYSPNOEA (hard to breath). At the time of the report, MALAISE (Feel lousy), PAIN IN EXTREMITY (Sore arm), CHEST DISCOMFORT (Chest heaviness), CHEST DISCOMFORT (like someone was stepping on her chest/feel like someone is on her chest), DYSPNOEA (hard to breath), HEADACHE (headache) and CHILLS (had chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: normal (normal) Normal. On an unknown date, Electrocardiogram: normal (normal) Normal. On an unknown date, Full blood count: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information was not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Psoriasis, Pustule, Skin reaction
Clinical narrative: pus and severe reaction; pus and severe reaction on both hands; psoriasis breakout; Itchy; Plaque pileup; Red breakout; Painful when injected; This spontaneous case was reported by a consumer and describes the occurrence of PUSTULE (pus and severe reaction), SKIN REACTION (pus and severe reaction on both hands), PSORIASIS (psoriasis breakout), PRURITUS (Itchy) and PSORIASIS (Plaque pileup) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by reporter.  Concomitant products included GLIPIZIDE for Diabetes, CERTOLIZUMAB PEGOL (CIMZIA), COLECALCIFEROL (VITAMIN D3), FISH OIL (FISH OIL OMEGA 3) and LINUM USITATISSIMUM SEED (FLAXSEED) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PUSTULE (pus and severe reaction), SKIN REACTION (pus and severe reaction on both hands), PSORIASIS (psoriasis breakout), PRURITUS (Itchy), PSORIASIS (Plaque pileup), ERYTHEMA (Red breakout) and VACCINATION SITE PAIN (Painful when injected). At the time of the report, PUSTULE (pus and severe reaction), SKIN REACTION (pus and severe reaction on both hands), PSORIASIS (psoriasis breakout), PRURITUS (Itchy), PSORIASIS (Plaque pileup), ERYTHEMA (Red breakout) and VACCINATION SITE PAIN (Painful when injected) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. Patient took cocoa butter for psoriasis No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-101468 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pus and severe reaction; pus and severe reaction on both hands; psoriasis breakout; Itchy; Plaque pileup; Red breakout; Painful when injected; This spontaneous case was reported by a consumer and describes the occurrence of PUSTULE (pus and severe reaction), SKIN REACTION (pus and severe reaction on both hands), PSORIASIS (psoriasis breakout), PRURITUS (Itchy) and PSORIASIS (Plaque pileup) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by reporter.  Concomitant products included GLIPIZIDE for Diabetes, CERTOLIZUMAB PEGOL (CIMZIA), COLECALCIFEROL (VITAMIN D3), FISH OIL (FISH OIL OMEGA 3) and LINUM USITATISSIMUM SEED (FLAXSEED) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PUSTULE (pus and severe reaction), SKIN REACTION (pus and severe reaction on both hands), PSORIASIS (psoriasis breakout), PRURITUS (Itchy), PSORIASIS (Plaque pileup), ERYTHEMA (Red breakout) and VACCINATION SITE PAIN (Painful when injected). At the time of the report, PUSTULE (pus and severe reaction), SKIN REACTION (pus and severe reaction on both hands), PSORIASIS (psoriasis breakout), PRURITUS (Itchy), PSORIASIS (Plaque pileup), ERYTHEMA (Red breakout) and VACCINATION SITE PAIN (Painful when injected) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. Patient took cocoa butter for psoriasis No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-101468 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling hot, Musculoskeletal stiffness
Clinical narrative: chemical taste on tongue; stiff neck; felt a bit hot; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (chemical taste on tongue), MUSCULOSKELETAL STIFFNESS (stiff neck) and FEELING HOT (felt a bit hot) 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 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck) and FEELING HOT (felt a bit hot). On 30-Apr-2021, the patient experienced DYSGEUSIA (chemical taste on tongue). At the time of the report, DYSGEUSIA (chemical taste on tongue), MUSCULOSKELETAL STIFFNESS (stiff neck) and FEELING HOT (felt a bit hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depressed mood, Nausea, Nervousness, Sleep disorder
Clinical narrative: started to have sleeping problems, has almost not slept in the past two nights; nervous; anguish; in the morning has to get out of bed and has to go outside to catch their breath, if patient stays inside starts shaking every once in a while; desperate; has been experiencing nausea and desire to vomit, but has not vomited; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (started to have sleeping problems, has almost not slept in the past two nights), NERVOUSNESS (nervous), ANXIETY (anguish), TREMOR (in the morning has to get out of bed and has to go outside to catch their breath, if patient stays inside starts shaking every once in a while) and DEPRESSED MOOD (desperate) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced SLEEP DISORDER (started to have sleeping problems, has almost not slept in the past two nights), NERVOUSNESS (nervous), ANXIETY (anguish), TREMOR (in the morning has to get out of bed and has to go outside to catch their breath, if patient stays inside starts shaking every once in a while), DEPRESSED MOOD (desperate) and NAUSEA (has been experiencing nausea and desire to vomit, but has not vomited). At the time of the report, SLEEP DISORDER (started to have sleeping problems, has almost not slept in the past two nights), NERVOUSNESS (nervous), TREMOR (in the morning has to get out of bed and has to go outside to catch their breath, if patient stays inside starts shaking every once in a while), DEPRESSED MOOD (desperate) and NAUSEA (has been experiencing nausea and desire to vomit, but has not vomited) had resolved and ANXIETY (anguish) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.    This case was linked to MOD-2021-238968 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: event details updated
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: started to have sleeping problems, has almost not slept in the past two nights; nervous; anguish; in the morning has to get out of bed and has to go outside to catch their breath, if patient stays inside starts shaking every once in a while; desperate; has been experiencing nausea and desire to vomit, but has not vomited; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (started to have sleeping problems, has almost not slept in the past two nights), NERVOUSNESS (nervous), ANXIETY (anguish), TREMOR (in the morning has to get out of bed and has to go outside to catch their breath, if patient stays inside starts shaking every once in a while) and DEPRESSED MOOD (desperate) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced SLEEP DISORDER (started to have sleeping problems, has almost not slept in the past two nights), NERVOUSNESS (nervous), ANXIETY (anguish), TREMOR (in the morning has to get out of bed and has to go outside to catch their breath, if patient stays inside starts shaking every once in a while), DEPRESSED MOOD (desperate) and NAUSEA (has been experiencing nausea and desire to vomit, but has not vomited). At the time of the report, SLEEP DISORDER (started to have sleeping problems, has almost not slept in the past two nights), NERVOUSNESS (nervous), TREMOR (in the morning has to get out of bed and has to go outside to catch their breath, if patient stays inside starts shaking every once in a while), DEPRESSED MOOD (desperate) and NAUSEA (has been experiencing nausea and desire to vomit, but has not vomited) had resolved and ANXIETY (anguish) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.    This case was linked to MOD-2021-238968 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: event details updated
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Feeling abnormal, Impaired driving ability, Insomnia
Clinical narrative: trouble sleeping; almost falling over; Light headedness; fogginess; mother drive her home; injection site itchiness; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (trouble sleeping), FALL (almost falling over), DIZZINESS (Light headedness), FEELING ABNORMAL (fogginess) and IMPAIRED DRIVING ABILITY (mother drive her home) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017521A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced INSOMNIA (trouble sleeping), VACCINATION SITE PRURITUS (injection site itchiness) and VACCINATION SITE ERYTHEMA (injection site redness). 26-Apr-2021, the patient experienced FALL (almost falling over), DIZZINESS (Light headedness), FEELING ABNORMAL (fogginess) and IMPAIRED DRIVING ABILITY (mother drive her home). At the time of the report, INSOMNIA (trouble sleeping), FALL (almost falling over), DIZZINESS (Light headedness), FEELING ABNORMAL (fogginess), IMPAIRED DRIVING ABILITY (mother drive her home), VACCINATION SITE PRURITUS (injection site itchiness) and VACCINATION SITE ERYTHEMA (injection site redness) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: trouble sleeping; almost falling over; Light headedness; fogginess; mother drive her home; injection site itchiness; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (trouble sleeping), FALL (almost falling over), DIZZINESS (Light headedness), FEELING ABNORMAL (fogginess) and IMPAIRED DRIVING ABILITY (mother drive her home) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017521A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced INSOMNIA (trouble sleeping), VACCINATION SITE PRURITUS (injection site itchiness) and VACCINATION SITE ERYTHEMA (injection site redness). 26-Apr-2021, the patient experienced FALL (almost falling over), DIZZINESS (Light headedness), FEELING ABNORMAL (fogginess) and IMPAIRED DRIVING ABILITY (mother drive her home). At the time of the report, INSOMNIA (trouble sleeping), FALL (almost falling over), DIZZINESS (Light headedness), FEELING ABNORMAL (fogginess), IMPAIRED DRIVING ABILITY (mother drive her home), VACCINATION SITE PRURITUS (injection site itchiness) and VACCINATION SITE ERYTHEMA (injection site redness) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Influenza like illness, Pyrexia
Clinical narrative: flu like symptoms; difficulty breathing; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (difficulty breathing) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history provided by the patient.  Concomitant products included VITAMIN B [VITAMIN B NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (difficulty breathing) and PYREXIA (fever). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (difficulty breathing) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received the first dose of the Moderna Covid 19 vaccine (Lot: not provided, expiration:unknown) on 10APR2021. Two days after administration of the shot, patient started to experience flu like symptoms, fever and difficulty breathing. She received her first dose at PCAT college. Patient is currently taking Vitamin B and Vitamin C. Patient does not have a primary care physician. Patient provided consent for Safety team to contact her on her phone number Treatment information as not reported.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site lymphadenopathy, Vomiting
Clinical narrative: Nausea; Vomiting; Swelling under armpit of injected arm; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting) and VACCINATION SITE LYMPHADENOPATHY (Swelling under armpit of injected arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Allergic to Sulfa Medications).   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting) and VACCINATION SITE LYMPHADENOPATHY (Swelling under armpit of injected arm). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting) and VACCINATION SITE LYMPHADENOPATHY (Swelling under armpit of injected arm) outcome was unknown.            No concomitant medications were reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache) in a 35-year-old female patient who received mRNA-1273 (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). At the time of the report, CHILLS (Chills) and HEADACHE (Headache) had not resolved.            The patient reported that the chills were mild and headache has gotten worse.  No concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Eye pruritus, Eye swelling, Ocular hyperaemia
Clinical narrative: right upper arm sore; runny nose; She stated her face from under her eyes, around and under her nose, and her lips feel like they are sunburned; under eyes really red; under eyes swollen/puffy; under eyes really itchy; her lips, around and under nose swollen/puffy; lips and around and under nose really itchy; her lips , around and under her nose is really red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right upper arm sore), RHINORRHOEA (runny nose), BURNING SENSATION (She stated her face from under her eyes, around and under her nose, and her lips feel like they are sunburned), OCULAR HYPERAEMIA (under eyes really red) and EYE SWELLING (under eyes swollen/puffy) in a 53-year-old female patient who received mRNA-1273 (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rosacea. Concurrent medical conditions included Drug allergy (Patient is allergic to sulfa and codeine.) and Drug allergy (codeine.). Concomitant products included VITAMINS NOS (DAILY MULTIVITAMIN) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (right upper arm sore), RHINORRHOEA (runny nose), BURNING SENSATION (She stated her face from under her eyes, around and under her nose, and her lips feel like they are sunburned), OCULAR HYPERAEMIA (under eyes really red), EYE SWELLING (under eyes swollen/puffy), EYE PRURITUS (under eyes really itchy), SWELLING (her lips, around and under nose swollen/puffy), PRURITUS (lips and around and under nose really itchy) and ERYTHEMA (her lips , around and under her nose is really red). At the time of the report, PAIN IN EXTREMITY (right upper arm sore), RHINORRHOEA (runny nose), BURNING SENSATION (She stated her face from under her eyes, around and under her nose, and her lips feel like they are sunburned), OCULAR HYPERAEMIA (under eyes really red), EYE SWELLING (under eyes swollen/puffy), EYE PRURITUS (under eyes really itchy), SWELLING (her lips, around and under nose swollen/puffy), PRURITUS (lips and around and under nose really itchy) and ERYTHEMA (her lips , around and under her nose is really red) had not resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No Concomitant medications were reported. Treatment include Topical Hydrocortisone cream Blistex Ointment Vasoline Vicks vapoRub OKeeffes Lip Repair
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rhinorrhoea, Swelling
Clinical narrative: right upper arm sore; runny nose; She stated her face from under her eyes, around and under her nose, and her lips feel like they are sunburned; under eyes really red; under eyes swollen/puffy; under eyes really itchy; her lips, around and under nose swollen/puffy; lips and around and under nose really itchy; her lips , around and under her nose is really red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right upper arm sore), RHINORRHOEA (runny nose), BURNING SENSATION (She stated her face from under her eyes, around and under her nose, and her lips feel like they are sunburned), OCULAR HYPERAEMIA (under eyes really red) and EYE SWELLING (under eyes swollen/puffy) in a 53-year-old female patient who received mRNA-1273 (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rosacea. Concurrent medical conditions included Drug allergy (Patient is allergic to sulfa and codeine.) and Drug allergy (codeine.). Concomitant products included VITAMINS NOS (DAILY MULTIVITAMIN) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (right upper arm sore), RHINORRHOEA (runny nose), BURNING SENSATION (She stated her face from under her eyes, around and under her nose, and her lips feel like they are sunburned), OCULAR HYPERAEMIA (under eyes really red), EYE SWELLING (under eyes swollen/puffy), EYE PRURITUS (under eyes really itchy), SWELLING (her lips, around and under nose swollen/puffy), PRURITUS (lips and around and under nose really itchy) and ERYTHEMA (her lips , around and under her nose is really red). At the time of the report, PAIN IN EXTREMITY (right upper arm sore), RHINORRHOEA (runny nose), BURNING SENSATION (She stated her face from under her eyes, around and under her nose, and her lips feel like they are sunburned), OCULAR HYPERAEMIA (under eyes really red), EYE SWELLING (under eyes swollen/puffy), EYE PRURITUS (under eyes really itchy), SWELLING (her lips, around and under nose swollen/puffy), PRURITUS (lips and around and under nose really itchy) and ERYTHEMA (her lips , around and under her nose is really red) had not resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No Concomitant medications were reported. Treatment include Topical Hydrocortisone cream Blistex Ointment Vasoline Vicks vapoRub OKeeffes Lip Repair
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Pruritus; Diffuse body rash; 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 PRURITUS (Pruritus) and RASH (Diffuse body rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Pruritus) and RASH (Diffuse body rash). At the time of the report, PRURITUS (Pruritus) and RASH (Diffuse body rash) 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.   No concomitant medication was reported.  No treatment information was reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Pain in the area of shot.; Nausea; Body Aches; Headache; Asthma got worse; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the area of shot.), NAUSEA (Nausea), MYALGIA (Body Aches), HEADACHE (Headache) and ASTHMA (Asthma got worse) in a 29-year-old male patient who received mRNA-1273 (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SALBUTAMOL (ALBUTEROL HFA), FLUTICASONE and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA HANDIHALER) for Asthma.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain in the area of shot.), NAUSEA (Nausea), MYALGIA (Body Aches), HEADACHE (Headache), ASTHMA (Asthma got worse) and PYREXIA (Fever). On 29-Apr-2021, PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain in the area of shot.), NAUSEA (Nausea), MYALGIA (Body Aches), HEADACHE (Headache) and ASTHMA (Asthma got worse) outcome was unknown.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the area of shot.; Nausea; Body Aches; Headache; Asthma got worse; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the area of shot.), NAUSEA (Nausea), MYALGIA (Body Aches), HEADACHE (Headache) and ASTHMA (Asthma got worse) in a 29-year-old male patient who received mRNA-1273 (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SALBUTAMOL (ALBUTEROL HFA), FLUTICASONE and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA HANDIHALER) for Asthma.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain in the area of shot.), NAUSEA (Nausea), MYALGIA (Body Aches), HEADACHE (Headache), ASTHMA (Asthma got worse) and PYREXIA (Fever). On 29-Apr-2021, PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain in the area of shot.), NAUSEA (Nausea), MYALGIA (Body Aches), HEADACHE (Headache) and ASTHMA (Asthma got worse) outcome was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Malaise
Clinical narrative: Feelings of hot and cold; overall feels terrible; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Feelings of hot and cold), MALAISE (overall feels terrible) and CHILLS (Chills) in a 57-year-old male patient who received mRNA-1273 (batch nos. 004321A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feelings of hot and cold), MALAISE (overall feels terrible) and CHILLS (Chills). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Feelings of hot and cold), MALAISE (overall feels terrible) and CHILLS (Chills) had resolved.            No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Event outcome updated. No need to any further FU on this.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: low grade fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) and MYALGIA (Body ache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], FISH OIL, Claritin for allergies, labetalol for blood pressure, metformin diabetes and insulin for diabetes for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced PYREXIA (low grade fever) and MYALGIA (Body ache). On 05-May-2021, PYREXIA (low grade fever) and MYALGIA (Body ache) 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.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Migraine, Mobility decreased, Pain, Pyrexia
Clinical narrative: migraine; Couldnt get out of bed; Injection site raised; Body ache; Non serious rash at injection site; 102 temperature; This spontaneous case was reported by a physician and describes the occurrence of MIGRAINE (migraine), MOBILITY DECREASED (Couldnt get out of bed), VACCINATION SITE PAPULE (Injection site raised), PAIN (Body ache) and VACCINATION SITE RASH (Non serious rash at injection site) in a 42-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    The patient's past medical history included Tobacco user (Half of pack of cigarette per day) from 1993 to 2013, Bone fistula in 2011, Bone spur in 2011 and Meniscus tear in 2011. Concurrent medical conditions included Alcohol use in 1999, Osteoarthritis in 2011 and Allergy to allopathic drugs (Sulfa allergy manifested by ill/nauseous/dizzy).   In 2018, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 milligram per millilitre. In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. In March 2021, the patient experienced MIGRAINE (migraine), MOBILITY DECREASED (Couldnt get out of bed), VACCINATION SITE PAPULE (Injection site raised), PAIN (Body ache), VACCINATION SITE RASH (Non serious rash at injection site) and PYREXIA (102 temperature). In March 2021, MIGRAINE (migraine), MOBILITY DECREASED (Couldnt get out of bed), VACCINATION SITE PAPULE (Injection site raised), PAIN (Body ache), VACCINATION SITE RASH (Non serious rash at injection site) and PYREXIA (102 temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature (97-99): 102f (High) 102F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment medications include Singulair and Tylenol.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site papule, Vaccination site rash
Clinical narrative: migraine; Couldnt get out of bed; Injection site raised; Body ache; Non serious rash at injection site; 102 temperature; This spontaneous case was reported by a physician and describes the occurrence of MIGRAINE (migraine), MOBILITY DECREASED (Couldnt get out of bed), VACCINATION SITE PAPULE (Injection site raised), PAIN (Body ache) and VACCINATION SITE RASH (Non serious rash at injection site) in a 42-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    The patient's past medical history included Tobacco user (Half of pack of cigarette per day) from 1993 to 2013, Bone fistula in 2011, Bone spur in 2011 and Meniscus tear in 2011. Concurrent medical conditions included Alcohol use in 1999, Osteoarthritis in 2011 and Allergy to allopathic drugs (Sulfa allergy manifested by ill/nauseous/dizzy).   In 2018, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 milligram per millilitre. In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. In March 2021, the patient experienced MIGRAINE (migraine), MOBILITY DECREASED (Couldnt get out of bed), VACCINATION SITE PAPULE (Injection site raised), PAIN (Body ache), VACCINATION SITE RASH (Non serious rash at injection site) and PYREXIA (102 temperature). In March 2021, MIGRAINE (migraine), MOBILITY DECREASED (Couldnt get out of bed), VACCINATION SITE PAPULE (Injection site raised), PAIN (Body ache), VACCINATION SITE RASH (Non serious rash at injection site) and PYREXIA (102 temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature (97-99): 102f (High) 102F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment medications include Singulair and Tylenol.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Feeling abnormal, Influenza like illness, Vaccination site pain
Clinical narrative: feelings of impending doom (similar to someone having a heart attack); Anxiety, feelings of impending doom (similar to someone having a heart attack); flu like symptoms; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety, feelings of impending doom (similar to someone having a heart attack)), FEELING ABNORMAL (feelings of impending doom (similar to someone having a heart attack)), VACCINATION SITE PAIN (vaccination site pain) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 08-Apr-2021, the patient experienced ANXIETY (Anxiety, feelings of impending doom (similar to someone having a heart attack)) and INFLUENZA LIKE ILLNESS (flu like symptoms). On an unknown date, the patient experienced FEELING ABNORMAL (feelings of impending doom (similar to someone having a heart attack)). At the time of the report, ANXIETY (Anxiety, feelings of impending doom (similar to someone having a heart attack)), FEELING ABNORMAL (feelings of impending doom (similar to someone having a heart attack)), VACCINATION SITE PAIN (vaccination site pain) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, COVID-19
Clinical narrative: tested positive for COVID; showing symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (showing symptoms) and COVID-19 (tested positive for COVID) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced ADVERSE REACTION (showing symptoms). On 06-May-2021, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, ADVERSE REACTION (showing symptoms) outcome was unknown. 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.