chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Neck pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (hurts to look at things), CHEST PAIN (onstant burning continuously in her chest,chest pains), HYPERHIDROSIS (perspiration), DYSPEPSIA (horrendous heartburn) and EAR PAIN (could feel pain in ears) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047a21a and 001c21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL), ACETYLSALICYLIC ACID, CAFFEINE (BC [ACETYLSALICYLIC ACID;CAFFEINE]), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), FAMOTIDINE (PEPCID [FAMOTIDINE]), CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 28-Apr-2021, the patient experienced EYE PAIN (hurts to look at things), HYPERHIDROSIS (perspiration), CHILLS (chills), MYALGIA (arm was sore,pain in her calves) and HEADACHE (intense headache,feels headache in her face,massive sudden headaches that are worse through out the night). On 29-Apr-2021, the patient experienced CHEST PAIN (onstant burning continuously in her chest,chest pains), DYSPEPSIA (horrendous heartburn), EAR PAIN (could feel pain in ears), NECK PAIN (could feel pain in neck), GASTRITIS (gastritis,stomach lining was extremely inflamed), ABDOMINAL PAIN UPPER (could feel pain in stomach) and BLOOD DISORDER (factor in the bloodwork made the doctor concerned about a blood clot.). On an unknown date, the patient experienced NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 29-Apr-2021, HYPERHIDROSIS (perspiration) and CHILLS (chills) had resolved. At the time of the report, EYE PAIN (hurts to look at things), CHEST PAIN (onstant burning continuously in her chest,chest pains), DYSPEPSIA (horrendous heartburn), EAR PAIN (could feel pain in ears), NECK PAIN (could feel pain in neck), GASTRITIS (gastritis,stomach lining was extremely inflamed), ABDOMINAL PAIN UPPER (could feel pain in stomach), BLOOD DISORDER (factor in the bloodwork made the doctor concerned about a blood clot.), NAUSEA (nauseous), MYALGIA (arm was sore,pain in her calves) and HEADACHE (intense headache,feels headache in her face,massive sudden headaches that are worse through out the night) outcome was unknown. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-106919.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error, Vaccination site pain
Clinical narrative: Inappropriate refrigeration of vaccine; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Inappropriate refrigeration of vaccine) and VACCINATION SITE PAIN (Pain at the injection site) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Inappropriate refrigeration of vaccine). On 01-Apr-2021, VACCINATION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Inappropriate refrigeration of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided  Treatment medication was not provided
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Pain, Paraesthesia, Pruritus
Clinical narrative: Numbness in right heel; pins and needles feeling extending to hands and feet; Itching; burning; Occasional pain following numbness in right heell; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in right heel), PARAESTHESIA (pins and needles feeling extending to hands and feet), PRURITUS (Itching), BURNING SENSATION (burning) and PAIN (Occasional pain following numbness in right heell) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) and SIMVASTATIN for an unknown indication.   On 28-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) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced HYPOAESTHESIA (Numbness in right heel), PARAESTHESIA (pins and needles feeling extending to hands and feet), PRURITUS (Itching), BURNING SENSATION (burning) and PAIN (Occasional pain following numbness in right heell). At the time of the report, HYPOAESTHESIA (Numbness in right heel), PARAESTHESIA (pins and needles feeling extending to hands and feet), PRURITUS (Itching), BURNING SENSATION (burning) and PAIN (Occasional pain following numbness in right heell) outcome was unknown. Not Provided          Treatment medications were not reported, but it was reported that movement relieves symptoms. Action taken with the product mRNA-1273 was not Applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-076261 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076261:
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Dysstasia, Myalgia, Pain
Clinical narrative: very strong pain in his lower parts (in the testicles); pain as strong as if he had been hit /  20 minutes without being able to get up because of the pain; could not breathe; he could not stand; changed the color of the skin on his face (half white and purple from the pain); dizziness; pain in his arm after the first injection; high fever; This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR PAIN (very strong pain in his lower parts (in the testicles)), PAIN (pain as strong as if he had been hit /  20 minutes without being able to get up because of the pain), DYSPNOEA (could not breathe), DYSSTASIA (he could not stand) and SKIN DISCOLOURATION (changed the color of the skin on his face (half white and purple from the pain)) in a male patient of an unknown age 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 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 TESTICULAR PAIN (very strong pain in his lower parts (in the testicles)), PAIN (pain as strong as if he had been hit /  20 minutes without being able to get up because of the pain), DYSPNOEA (could not breathe), DYSSTASIA (he could not stand), SKIN DISCOLOURATION (changed the color of the skin on his face (half white and purple from the pain)), DIZZINESS (dizziness), MYALGIA (pain in his arm after the first injection) and PYREXIA (high fever). At the time of the report, TESTICULAR PAIN (very strong pain in his lower parts (in the testicles)), PAIN (pain as strong as if he had been hit /  20 minutes without being able to get up because of the pain), DYSPNOEA (could not breathe), DYSSTASIA (he could not stand), SKIN DISCOLOURATION (changed the color of the skin on his face (half white and purple from the pain)), DIZZINESS (dizziness), MYALGIA (pain in his arm after the first injection) and PYREXIA (high fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-107332 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Skin discolouration, Testicular pain
Clinical narrative: very strong pain in his lower parts (in the testicles); pain as strong as if he had been hit /  20 minutes without being able to get up because of the pain; could not breathe; he could not stand; changed the color of the skin on his face (half white and purple from the pain); dizziness; pain in his arm after the first injection; high fever; This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR PAIN (very strong pain in his lower parts (in the testicles)), PAIN (pain as strong as if he had been hit /  20 minutes without being able to get up because of the pain), DYSPNOEA (could not breathe), DYSSTASIA (he could not stand) and SKIN DISCOLOURATION (changed the color of the skin on his face (half white and purple from the pain)) in a male patient of an unknown age 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 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 TESTICULAR PAIN (very strong pain in his lower parts (in the testicles)), PAIN (pain as strong as if he had been hit /  20 minutes without being able to get up because of the pain), DYSPNOEA (could not breathe), DYSSTASIA (he could not stand), SKIN DISCOLOURATION (changed the color of the skin on his face (half white and purple from the pain)), DIZZINESS (dizziness), MYALGIA (pain in his arm after the first injection) and PYREXIA (high fever). At the time of the report, TESTICULAR PAIN (very strong pain in his lower parts (in the testicles)), PAIN (pain as strong as if he had been hit /  20 minutes without being able to get up because of the pain), DYSPNOEA (could not breathe), DYSSTASIA (he could not stand), SKIN DISCOLOURATION (changed the color of the skin on his face (half white and purple from the pain)), DIZZINESS (dizziness), MYALGIA (pain in his arm after the first injection) and PYREXIA (high fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-107332 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Feeling of body temperature change, Insomnia, Myalgia
Clinical narrative: I was hot one minute & cold the next; I'm just in a state of disarray; I can't sleep due to arm pain; body aches/arm still hurts all the time; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (I was hot one minute & cold the next), FEELING ABNORMAL (I'm just in a state of disarray), INSOMNIA (I can't sleep due to arm pain), MYALGIA (body aches/arm still hurts all the time) and CHILLS (chills) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. "087871A") for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (I was hot one minute & cold the next), FEELING ABNORMAL (I'm just in a state of disarray), INSOMNIA (I can't sleep due to arm pain), MYALGIA (body aches/arm still hurts all the time) and CHILLS (chills). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (I was hot one minute & cold the next), FEELING ABNORMAL (I'm just in a state of disarray), INSOMNIA (I can't sleep due to arm pain), MYALGIA (body aches/arm still hurts all the time) and CHILLS (chills) outcome was unknown.             No concomitant medications  No treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included GERD since an unknown date, Hypertension since an unknown date and Atrial fibrillation since an unknown date. Concurrent medical conditions included Drug allergy (Lisinopril). Concomitant products included ALLOPURINOL, PROCHLORPERAZINE MALEATE, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS), FLUTICASONE PROPIONATE, METOPROLOL TARTRATE, ONDANSETRON HCL, PAROXETINE HCL, ROSUVASTATIN CALCIUM, LANSOPRAZOLE and OBINUTUZUMAB (GAZYVA) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) 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.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Inner ear inflammation, Labyrinthitis, Vestibular neuronitis
Clinical narrative: Adverse reaction; extensive rash on my injection arm & on shins below each knee; Labyrinthitis; inflammation in the inner ear.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction), VESTIBULAR NEURONITIS (extensive rash on my injection arm & on shins below each knee), LABYRINTHITIS (Labyrinthitis) and INNER EAR INFLAMMATION (inflammation in the inner ear.) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction), VESTIBULAR NEURONITIS (extensive rash on my injection arm & on shins below each knee), LABYRINTHITIS (Labyrinthitis) and INNER EAR INFLAMMATION (inflammation in the inner ear.). The patient was treated with VITAMIN C [ASCORBIC ACID] at a dose of 6000 mg; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; MECLIZINE HCL ongoing since an unknown date for Vertigo, at a dose of 25 mg and LORAZEPAM (ATIVAN) for Anxiety, at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (Adverse reaction), VESTIBULAR NEURONITIS (extensive rash on my injection arm & on shins below each knee), LABYRINTHITIS (Labyrinthitis) and INNER EAR INFLAMMATION (inflammation in the inner ear.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Significant follow-up appended On 20-Jul-2021: Follow-up information received on 20-Jul-2021 contains no new information.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Lot of body pain; Fever; Very bad headche; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Lot of body pain), PYREXIA (Fever) and HEADACHE (Very bad headche) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Very bad headche). On 04-May-2021, the patient experienced PAIN (Lot of body pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Lot of body pain), PYREXIA (Fever) and HEADACHE (Very bad headche) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication provided by the reporter.  .
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Ear haemorrhage, Epistaxis
Clinical narrative: Bleeding has now commenced from the ear; Epistaxis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (Epistaxis) and EAR HAEMORRHAGE (Bleeding has now commenced from the ear) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Hazelnut) and Food allergy (Celery-severe anaphalaxis).   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EPISTAXIS (Epistaxis). On 01-May-2021, the patient experienced EAR HAEMORRHAGE (Bleeding has now commenced from the ear). At the time of the report, EPISTAXIS (Epistaxis) and EAR HAEMORRHAGE (Bleeding has now commenced from the ear) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment medication were not applicable.   This case was linked to MOD-2021-075579 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Vaccine casued more fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Vaccine casued more fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Vaccine casued more fatigue). At the time of the report, FATIGUE (Vaccine casued more fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment or concomitant medications reported. Patient started treatment on an unspecified date (reported as "recently," relative to 30-APR-2021) with Covid vaccine (Moderna).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Pain in extremity
Clinical narrative: Pain in arm; Glucose increased; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and BLOOD GLUCOSE INCREASED (Glucose increased) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included GLIPIZIDE for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) and BLOOD GLUCOSE INCREASED (Glucose increased). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and BLOOD GLUCOSE INCREASED (Glucose increased) 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 medications were not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm hurt; 104.8 fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt) and PYREXIA (104.8 fever) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt) and PYREXIA (104.8 fever). At the time of the report, PAIN IN EXTREMITY (Arm hurt) and PYREXIA (104.8 fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provded.  Reporter stated, "I got the Moderna my arm hurt, the second shot I had 104.8 fever. I ain't call anybody. It is just use the app they gave you, report it move on." Clarification about the type of reporter was unknown hence captured as consumer. Further probing could not be done as the consumer was unwilling to complete the report. Hence limited  information available over the call.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Headache
Clinical narrative: Diarrhoea; Breathing difficult; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-May-2021 and was forwarded to Moderna on 05-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), DYSPNOEA (Breathing difficult) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporte.  Concomitant products included DUPILUMAB (DUPIXENT) for an unknown indication.    On 22-Mar-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), DYSPNOEA (Breathing difficult) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Diarrhoea), DYSPNOEA (Breathing difficult) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       on 22 march patient was prescribed to took two week treatment of steroids and same was finished on 2nd april.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Ear canal erythema, Feeling abnormal, Sleep disorder, Tinnitus
Clinical narrative: ring in ears/ ringing worse in left ear; interrupts my sleep; some redness left ear; interrupts daily life; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (ring in ears/ ringing worse in left ear), SLEEP DISORDER (interrupts my sleep), EAR CANAL ERYTHEMA (some redness left ear) and FEELING ABNORMAL (interrupts daily life) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Blood pressure, COLECALCIFEROL (D3) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced TINNITUS (ring in ears/ ringing worse in left ear), SLEEP DISORDER (interrupts my sleep), EAR CANAL ERYTHEMA (some redness left ear) and FEELING ABNORMAL (interrupts daily life). The patient was treated with ASCORBIC ACID, CALCIUM CARBONATE, COLECALCIFEROL, COLLAGEN, GLUCOSAMINE SULFATE, SOYA ISOFLAVONES (HCP) at an unspecified dose and frequency; PREDNISONE at a dose of 20 mg and ENT [CETYLPYRIDINIUM CHLORIDE;EPHEDRINE HYDROCHLORIDE;EUCALYPTUS GLOBULUS OIL;LIDOCAINE HYDROCHLORIDE;MENTHOL;TYROTHRICIN] at a dose of 50 mg. At the time of the report, TINNITUS (ring in ears/ ringing worse in left ear), SLEEP DISORDER (interrupts my sleep), EAR CANAL ERYTHEMA (some redness left ear) and FEELING ABNORMAL (interrupts daily life) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoma (non-Hodgkin's) (Non Hodgkin's Lymphoma).    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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Injection site rash, Injection site swelling, Migraine
Clinical narrative: couldn't get out of bed; migraine; rash at injection site; injection site raised; 102 temperature; body ache; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (couldn't get out of bed), MIGRAINE (migraine), INJECTION SITE RASH (rash at injection site), INJECTION SITE SWELLING (injection site raised) and PYREXIA (102 temperature) in a 44-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 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 BEDRIDDEN (couldn't get out of bed), MIGRAINE (migraine), INJECTION SITE RASH (rash at injection site), INJECTION SITE SWELLING (injection site raised), PYREXIA (102 temperature) and MYALGIA (body ache). At the time of the report, BEDRIDDEN (couldn't get out of bed), MIGRAINE (migraine), INJECTION SITE RASH (rash at injection site), INJECTION SITE SWELLING (injection site raised), PYREXIA (102 temperature) and MYALGIA (body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-107712, MOD-2021-107712 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: couldn't get out of bed; migraine; rash at injection site; injection site raised; 102 temperature; body ache; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (couldn't get out of bed), MIGRAINE (migraine), INJECTION SITE RASH (rash at injection site), INJECTION SITE SWELLING (injection site raised) and PYREXIA (102 temperature) in a 44-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 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 BEDRIDDEN (couldn't get out of bed), MIGRAINE (migraine), INJECTION SITE RASH (rash at injection site), INJECTION SITE SWELLING (injection site raised), PYREXIA (102 temperature) and MYALGIA (body ache). At the time of the report, BEDRIDDEN (couldn't get out of bed), MIGRAINE (migraine), INJECTION SITE RASH (rash at injection site), INJECTION SITE SWELLING (injection site raised), PYREXIA (102 temperature) and MYALGIA (body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-107712, MOD-2021-107712 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site reaction
Clinical narrative: Moderna arm; can we chat about this Moderna arm its no joke super itchy; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE REACTION (Moderna arm) and VACCINATION SITE PRURITUS (can we chat about this Moderna arm its no joke super itchy) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Moderna arm) and VACCINATION SITE PRURITUS (can we chat about this Moderna arm its no joke super itchy). At the time of the report, VACCINATION SITE REACTION (Moderna arm) and VACCINATION SITE PRURITUS (can we chat about this Moderna arm its no joke super itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information for the event was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication and treatment information provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Myalgia, Pyrexia
Clinical narrative: The next day I awoke very weak; light-headed; slightly feverish; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (The next day I awoke very weak), DIZZINESS (light-headed), PYREXIA (slightly feverish), MYALGIA (body aches) and CHILLS (chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002b21a and 011m20a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (aspirin) and Food allergy (soy milk). Concomitant products included CALCIUM, COLECALCIFEROL (CALCIUM PLUS D3) for Bone density decreased, CENTRUM SILVER WOMEN 50+ and ASCORBIC ACID, CUPRIC OXIDE, DL-ALPHA TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (PRESERVISION AREDS 2) for Vitamin supplementation, ATORVASTATIN for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced ASTHENIA (The next day I awoke very weak), DIZZINESS (light-headed), PYREXIA (slightly feverish), MYALGIA (body aches) and CHILLS (chills). On 22-Mar-2021, ASTHENIA (The next day I awoke very weak), DIZZINESS (light-headed), PYREXIA (slightly feverish), MYALGIA (body aches) and CHILLS (chills) had resolved.            No treatment was reported.   This case was linked to MOD-2021-029890 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu symptoms). At the time of the report, INFLUENZA (flu symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine received below 18 years of age; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received below 18 years of age) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received below 18 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received below 18 years of age) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site rash, Injection site swelling, Migraine, Pyrexia
Clinical narrative: injection site raised; 102 temperature; migraine; rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), INJECTION SITE RASH (rash at injection site), INJECTION SITE SWELLING (injection site raised) and PYREXIA (102 temperature) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   In 2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraine), INJECTION SITE RASH (rash at injection site), INJECTION SITE SWELLING (injection site raised) and PYREXIA (102 temperature). At the time of the report, MIGRAINE (migraine), INJECTION SITE RASH (rash at injection site), INJECTION SITE SWELLING (injection site raised) and PYREXIA (102 temperature) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided.  Treatment medications were not provided.   This case was linked to MOD-2021-107576 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure decreased, Blood pressure measurement, COVID-19, Chills
Clinical narrative: rash covering my back and stomach area; tested positive for Covid; nausea; fever; chills; headache; muscle pain; joint pain; extreme dizziness/weakness to the point where I wasn't able to stand without fear of fainting; blood pressure of 98/68; resting pulse of 87; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid), DIZZINESS (extreme dizziness/weakness to the point where I wasn't able to stand without fear of fainting), BLOOD PRESSURE DECREASED (blood pressure of 98/68), HEART RATE INCREASED (resting pulse of 87) and RASH (rash covering my back and stomach area) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (extreme dizziness/weakness to the point where I wasn't able to stand without fear of fainting), BLOOD PRESSURE DECREASED (blood pressure of 98/68), HEART RATE INCREASED (resting pulse of 87), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On 18-Feb-2021, the patient experienced HEADACHE (headache). On 20-Feb-2021, the patient experienced NAUSEA (nausea), PYREXIA (fever) and CHILLS (chills). On 22-Feb-2021, the patient experienced COVID-19 (tested positive for Covid). On an unknown date, the patient experienced RASH (rash covering my back and stomach area). On 11-Feb-2021, DIZZINESS (extreme dizziness/weakness to the point where I wasn't able to stand without fear of fainting) had resolved. On 12-Mar-2021, BLOOD PRESSURE DECREASED (blood pressure of 98/68), HEART RATE INCREASED (resting pulse of 87), RASH (rash covering my back and stomach area), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and NAUSEA (nausea) had resolved. At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown and PYREXIA (fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Blood pressure measurement (80-120): 98/68 Low. On 11-Feb-2021, Heart rate: 87 High. On 22-Feb-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided by reporter.   This case was linked to MOD-2021-107804 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Heart rate, Heart rate increased, Myalgia
Clinical narrative: rash covering my back and stomach area; tested positive for Covid; nausea; fever; chills; headache; muscle pain; joint pain; extreme dizziness/weakness to the point where I wasn't able to stand without fear of fainting; blood pressure of 98/68; resting pulse of 87; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid), DIZZINESS (extreme dizziness/weakness to the point where I wasn't able to stand without fear of fainting), BLOOD PRESSURE DECREASED (blood pressure of 98/68), HEART RATE INCREASED (resting pulse of 87) and RASH (rash covering my back and stomach area) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (extreme dizziness/weakness to the point where I wasn't able to stand without fear of fainting), BLOOD PRESSURE DECREASED (blood pressure of 98/68), HEART RATE INCREASED (resting pulse of 87), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On 18-Feb-2021, the patient experienced HEADACHE (headache). On 20-Feb-2021, the patient experienced NAUSEA (nausea), PYREXIA (fever) and CHILLS (chills). On 22-Feb-2021, the patient experienced COVID-19 (tested positive for Covid). On an unknown date, the patient experienced RASH (rash covering my back and stomach area). On 11-Feb-2021, DIZZINESS (extreme dizziness/weakness to the point where I wasn't able to stand without fear of fainting) had resolved. On 12-Mar-2021, BLOOD PRESSURE DECREASED (blood pressure of 98/68), HEART RATE INCREASED (resting pulse of 87), RASH (rash covering my back and stomach area), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and NAUSEA (nausea) had resolved. At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown and PYREXIA (fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Blood pressure measurement (80-120): 98/68 Low. On 11-Feb-2021, Heart rate: 87 High. On 22-Feb-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided by reporter.   This case was linked to MOD-2021-107804 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: rash covering my back and stomach area; tested positive for Covid; nausea; fever; chills; headache; muscle pain; joint pain; extreme dizziness/weakness to the point where I wasn't able to stand without fear of fainting; blood pressure of 98/68; resting pulse of 87; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid), DIZZINESS (extreme dizziness/weakness to the point where I wasn't able to stand without fear of fainting), BLOOD PRESSURE DECREASED (blood pressure of 98/68), HEART RATE INCREASED (resting pulse of 87) and RASH (rash covering my back and stomach area) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (extreme dizziness/weakness to the point where I wasn't able to stand without fear of fainting), BLOOD PRESSURE DECREASED (blood pressure of 98/68), HEART RATE INCREASED (resting pulse of 87), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On 18-Feb-2021, the patient experienced HEADACHE (headache). On 20-Feb-2021, the patient experienced NAUSEA (nausea), PYREXIA (fever) and CHILLS (chills). On 22-Feb-2021, the patient experienced COVID-19 (tested positive for Covid). On an unknown date, the patient experienced RASH (rash covering my back and stomach area). On 11-Feb-2021, DIZZINESS (extreme dizziness/weakness to the point where I wasn't able to stand without fear of fainting) had resolved. On 12-Mar-2021, BLOOD PRESSURE DECREASED (blood pressure of 98/68), HEART RATE INCREASED (resting pulse of 87), RASH (rash covering my back and stomach area), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and NAUSEA (nausea) had resolved. At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown and PYREXIA (fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Blood pressure measurement (80-120): 98/68 Low. On 11-Feb-2021, Heart rate: 87 High. On 22-Feb-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided by reporter.   This case was linked to MOD-2021-107804 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Vaccination site erythema, Vaccination site urticaria
Clinical narrative: Injection site redness; injection site urticaria; Injection site warmth; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE WARMTH (Injection site warmth), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE URTICARIA (injection site urticaria) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Previously administered products included for Product used for unknown indication: TRAMADOL, METHOCARBAMOL, uceris and Heparin. Past adverse reactions to the above products included No adverse event with Heparin, METHOCARBAMOL, TRAMADOL and uceris. Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs allergy), Allergic to cats, Cockroach allergy (Dust mite reaction allergy is manifestated by watery eyes, sneezing and coughing.), Drug allergy (Non-steroidal anti-inflammatory drugs allergy), Drug allergy (Metrocarbamol allergy), Drug allergy (Heparin allergy), Drug allergy (Tramadol allergy), Drug allergy (Uceris allergy ) and Topical adhesive allergy (Bandage adhesives allergy manifestated by broke out rash). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 06-Jan-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced INJECTION SITE WARMTH (Injection site warmth). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE URTICARIA (injection site urticaria). At the time of the report, INJECTION SITE WARMTH (Injection site warmth), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE URTICARIA (injection site urticaria) had not resolved.            No treatment medication information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MEDICATION ERROR (Some liquid (Moderna vaccine) fell on bare skin) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced MEDICATION ERROR (Some liquid (Moderna vaccine) fell on bare skin). At the time of the report, MEDICATION ERROR (Some liquid (Moderna vaccine) fell on bare skin) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. Treatment information was not provided. This case was linked to US-MODERNATX, INC.-MOD-2021-107844 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-107844:For Reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.