chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Ill-defined disorder, Pain in extremity, Pruritus
Clinical narrative: Covid arm/slight soreness in the arm; really really badly itching; it had a harder look; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Covid arm/slight soreness in the arm), PRURITUS (really really badly itching) and ILL-DEFINED DISORDER (it had a harder look) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Covid arm/slight soreness in the arm), PRURITUS (really really badly itching) and ILL-DEFINED DISORDER (it had a harder look). At the time of the report, PAIN IN EXTREMITY (Covid arm/slight soreness in the arm), PRURITUS (really really badly itching) and ILL-DEFINED DISORDER (it had a harder look) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   This case was linked to MOD-2021-037201 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling abnormal, Nausea, Pyrexia, Vomiting
Clinical narrative: nauseous/felt like throwing up again; slight temperature which was about 100degF; not feeling good; threw up everything; still felt sick in my stomach; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (threw up everything), ABDOMINAL DISCOMFORT (still felt sick in my stomach), NAUSEA (nauseous/felt like throwing up again), PYREXIA (slight temperature which was about 100degF) and FEELING ABNORMAL (not feeling good) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VOMITING (threw up everything), ABDOMINAL DISCOMFORT (still felt sick in my stomach), PYREXIA (slight temperature which was about 100degF) and FEELING ABNORMAL (not feeling good). On 07-Mar-2021, the patient experienced NAUSEA (nauseous/felt like throwing up again). At the time of the report, VOMITING (threw up everything) outcome was unknown and ABDOMINAL DISCOMFORT (still felt sick in my stomach), NAUSEA (nauseous/felt like throwing up again), PYREXIA (slight temperature which was about 100degF) and FEELING ABNORMAL (not feeling good) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.  Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-037195 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Balance disorder, Feeling drunk
Clinical narrative: Balance was off; Was feeling really loopy; felt drunk; lost balance over half a dozen times; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Balance was off), ABNORMAL BEHAVIOUR (Was feeling really loopy), FEELING DRUNK (felt drunk) and BALANCE DISORDER (lost balance over half a dozen times) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced BALANCE DISORDER (Balance was off), ABNORMAL BEHAVIOUR (Was feeling really loopy), FEELING DRUNK (felt drunk) and BALANCE DISORDER (lost balance over half a dozen times). At the time of the report, BALANCE DISORDER (Balance was off), ABNORMAL BEHAVIOUR (Was feeling really loopy), FEELING DRUNK (felt drunk) and BALANCE DISORDER (lost balance over half a dozen times) 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.   Concomitant medication include clonazepam for anxiety & PTSD.  No treatment information was provided   This case was linked to MOD-2021-102218 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Headache, Injection site erythema
Clinical narrative: diarrhea; Cough; redness at injection site; body aches; chills; Fever of 101.6 for 2 days; Headache; swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), COUGH (Cough), INJECTION SITE ERYTHEMA (redness at injection site), MYALGIA (body aches) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, AMLODIPINE and ROSUVASTATIN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (diarrhea), COUGH (Cough), INJECTION SITE ERYTHEMA (redness at injection site), MYALGIA (body aches), CHILLS (chills), PYREXIA (Fever of 101.6 for 2 days), HEADACHE (Headache) and INJECTION SITE SWELLING (swollen at injection site). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 06-Mar-2021, DIARRHOEA (diarrhea), INJECTION SITE ERYTHEMA (redness at injection site), MYALGIA (body aches), CHILLS (chills), PYREXIA (Fever of 101.6 for 2 days) and INJECTION SITE SWELLING (swollen at injection site) had resolved. At the time of the report, COUGH (Cough) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Pyrexia: 101.6 (High) 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.
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: diarrhea; Cough; redness at injection site; body aches; chills; Fever of 101.6 for 2 days; Headache; swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), COUGH (Cough), INJECTION SITE ERYTHEMA (redness at injection site), MYALGIA (body aches) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, AMLODIPINE and ROSUVASTATIN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (diarrhea), COUGH (Cough), INJECTION SITE ERYTHEMA (redness at injection site), MYALGIA (body aches), CHILLS (chills), PYREXIA (Fever of 101.6 for 2 days), HEADACHE (Headache) and INJECTION SITE SWELLING (swollen at injection site). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 06-Mar-2021, DIARRHOEA (diarrhea), INJECTION SITE ERYTHEMA (redness at injection site), MYALGIA (body aches), CHILLS (chills), PYREXIA (Fever of 101.6 for 2 days) and INJECTION SITE SWELLING (swollen at injection site) had resolved. At the time of the report, COUGH (Cough) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Pyrexia: 101.6 (High) 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.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Pain in arm; Headache; Nausea; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Low grade fever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary fibrosis, Emphysema and COPD.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Low grade fever). At the time of the report, PAIN IN EXTREMITY (Pain in arm), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Low grade fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications with H/O pulmonary fibrosis, emphysema, and  COPD. Treatment details included None.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Herpes virus infection, Migraine, Pain, Pruritus
Clinical narrative: pain; Severe migraine; Herpes flare up; itchy; swelling; burned; blister; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Severe migraine), HERPES VIRUS INFECTION (Herpes flare up), PRURITUS (itchy), SWELLING (swelling) and SKIN BURNING SENSATION (burned) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced MIGRAINE (Severe migraine), HERPES VIRUS INFECTION (Herpes flare up), PRURITUS (itchy), SWELLING (swelling), SKIN BURNING SENSATION (burned) and BLISTER (blister). On an unknown date, the patient experienced PAIN (pain). On 27-Feb-2021, MIGRAINE (Severe migraine) had resolved. At the time of the report, HERPES VIRUS INFECTION (Herpes flare up), PRURITUS (itchy), SWELLING (swelling), SKIN BURNING SENSATION (burned) and BLISTER (blister) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment details included Patient was prescribed phenazopyridine 200mg, acyclovir 400mg TID, and a third 'antibiotic' that, he could not recall. Patient attempted to self medicate with an anti-itch topical spray but found no, relief..
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Skin burning sensation, Swelling
Clinical narrative: pain; Severe migraine; Herpes flare up; itchy; swelling; burned; blister; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Severe migraine), HERPES VIRUS INFECTION (Herpes flare up), PRURITUS (itchy), SWELLING (swelling) and SKIN BURNING SENSATION (burned) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced MIGRAINE (Severe migraine), HERPES VIRUS INFECTION (Herpes flare up), PRURITUS (itchy), SWELLING (swelling), SKIN BURNING SENSATION (burned) and BLISTER (blister). On an unknown date, the patient experienced PAIN (pain). On 27-Feb-2021, MIGRAINE (Severe migraine) had resolved. At the time of the report, HERPES VIRUS INFECTION (Herpes flare up), PRURITUS (itchy), SWELLING (swelling), SKIN BURNING SENSATION (burned) and BLISTER (blister) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment details included Patient was prescribed phenazopyridine 200mg, acyclovir 400mg TID, and a third 'antibiotic' that, he could not recall. Patient attempted to self medicate with an anti-itch topical spray but found no, relief..
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Myalgia
Clinical narrative: she often needs a cane to walk; slight headache; muscle pain; A SPOTANOUS report was received concerning a 92 Years old, Female patient who received Moderna's COVID-19 vaccine (mRNA-1273) SECOND dose on 16-feb-2021, batch no:016M20A intramuscular route     The patient's medical history was not provided     Event of Problem : Patient stated that she received her 2nd dose of the Moderna COVID 19 vaccine on 16FEB2021 at pharmacy. About a week ago (unsure of the exact date), she started having slight headache and muscle pain. The muscle pain usually starts in the evening and she often times need a cane to walk. She takes Aspin to alleviate the symptoms. She has not called her doctor because she does not think it is necessary.    Treatment information was ASPIRIN  Action taken with mRNA-1273 in response to the events was not provided.     The outcome of the events were UNKNOWN
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Injection site mass, Limb discomfort, Pruritus
Clinical narrative: Patient says her arm hurts when she lifts it; (node)Swollen; (node)itchy; (node)red; (node)hard; (node) tender to touch; felt a nodeabout a size of a baseball at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (felt a nodeabout a size of a baseball at injection site), LIMB DISCOMFORT (Patient says her arm hurts when she lifts it), SWELLING ((node)Swollen), PRURITUS ((node)itchy) and ERYTHEMA ((node)red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SEMAGLUTIDE (OZEMPIC) and PARACETAMOL (TYLENOL) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Mar-2021, the patient experienced INJECTION SITE MASS (felt a nodeabout a size of a baseball at injection site), SWELLING ((node)Swollen), PRURITUS ((node)itchy), ERYTHEMA ((node)red), INDURATION ((node)hard) and TENDERNESS ((node) tender to touch). On 09-Mar-2021, the patient experienced LIMB DISCOMFORT (Patient says her arm hurts when she lifts it). At the time of the report, INJECTION SITE MASS (felt a nodeabout a size of a baseball at injection site), LIMB DISCOMFORT (Patient says her arm hurts when she lifts it), SWELLING ((node)Swollen), PRURITUS ((node)itchy), ERYTHEMA ((node)red), INDURATION ((node)hard) and TENDERNESS ((node) tender to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes Blood pressure tablets, Cholesterol tablets and stomach tablets. Treatment includes Tylenol.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tenderness
Clinical narrative: Patient says her arm hurts when she lifts it; (node)Swollen; (node)itchy; (node)red; (node)hard; (node) tender to touch; felt a nodeabout a size of a baseball at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (felt a nodeabout a size of a baseball at injection site), LIMB DISCOMFORT (Patient says her arm hurts when she lifts it), SWELLING ((node)Swollen), PRURITUS ((node)itchy) and ERYTHEMA ((node)red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SEMAGLUTIDE (OZEMPIC) and PARACETAMOL (TYLENOL) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Mar-2021, the patient experienced INJECTION SITE MASS (felt a nodeabout a size of a baseball at injection site), SWELLING ((node)Swollen), PRURITUS ((node)itchy), ERYTHEMA ((node)red), INDURATION ((node)hard) and TENDERNESS ((node) tender to touch). On 09-Mar-2021, the patient experienced LIMB DISCOMFORT (Patient says her arm hurts when she lifts it). At the time of the report, INJECTION SITE MASS (felt a nodeabout a size of a baseball at injection site), LIMB DISCOMFORT (Patient says her arm hurts when she lifts it), SWELLING ((node)Swollen), PRURITUS ((node)itchy), ERYTHEMA ((node)red), INDURATION ((node)hard) and TENDERNESS ((node) tender to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes Blood pressure tablets, Cholesterol tablets and stomach tablets. Treatment includes Tylenol.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Body temperature, Faeces pale, Flatulence, Headache
Clinical narrative: Light colored "poop"; Stomach issues progressively increase/has a lot of gas; Severe bloating of abdomen; Got sick; Severe body aches; Felt like head was going to explode; Fever 101.9F; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick), ABDOMINAL DISTENSION (Severe bloating of abdomen), FAECES PALE (Light colored "poop"), FLATULENCE (Stomach issues progressively increase/has a lot of gas) and MYALGIA (Severe body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Abdominal disorder (Issues with abdomen), Hiatal hernia, Narrowing of esophagus, Breast cancer, Surgery (32 surgeries for hiatal hernia,), Spinal fusion (Lumbar fusion and neck fusion), Cholecystectomy (Gall bladder removed) and Surgery (Component separation surgery (abdomen)). Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs allergy), Drug allergy (allergic to Levaquin.), Blood pressure high and Drug allergy (allergic to cipro.).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced ILLNESS (Got sick). 04-Mar-2021, the patient experienced MYALGIA (Severe body aches), HEADACHE (Felt like head was going to explode) and PYREXIA (Fever 101.9F). On 08-Mar-2021, the patient experienced ABDOMINAL DISTENSION (Severe bloating of abdomen). On an unknown date, the patient experienced FAECES PALE (Light colored "poop") and FLATULENCE (Stomach issues progressively increase/has a lot of gas). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (Got sick), ABDOMINAL DISTENSION (Severe bloating of abdomen), FAECES PALE (Light colored "poop"), FLATULENCE (Stomach issues progressively increase/has a lot of gas), MYALGIA (Severe body aches), HEADACHE (Felt like head was going to explode) and PYREXIA (Fever 101.9F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature increased: 101.9 (High) 101.9 F.         No relevant concomitant medications were reported.  .
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Myalgia, Pyrexia
Clinical narrative: Light colored "poop"; Stomach issues progressively increase/has a lot of gas; Severe bloating of abdomen; Got sick; Severe body aches; Felt like head was going to explode; Fever 101.9F; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick), ABDOMINAL DISTENSION (Severe bloating of abdomen), FAECES PALE (Light colored "poop"), FLATULENCE (Stomach issues progressively increase/has a lot of gas) and MYALGIA (Severe body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Abdominal disorder (Issues with abdomen), Hiatal hernia, Narrowing of esophagus, Breast cancer, Surgery (32 surgeries for hiatal hernia,), Spinal fusion (Lumbar fusion and neck fusion), Cholecystectomy (Gall bladder removed) and Surgery (Component separation surgery (abdomen)). Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs allergy), Drug allergy (allergic to Levaquin.), Blood pressure high and Drug allergy (allergic to cipro.).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced ILLNESS (Got sick). 04-Mar-2021, the patient experienced MYALGIA (Severe body aches), HEADACHE (Felt like head was going to explode) and PYREXIA (Fever 101.9F). On 08-Mar-2021, the patient experienced ABDOMINAL DISTENSION (Severe bloating of abdomen). On an unknown date, the patient experienced FAECES PALE (Light colored "poop") and FLATULENCE (Stomach issues progressively increase/has a lot of gas). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (Got sick), ABDOMINAL DISTENSION (Severe bloating of abdomen), FAECES PALE (Light colored "poop"), FLATULENCE (Stomach issues progressively increase/has a lot of gas), MYALGIA (Severe body aches), HEADACHE (Felt like head was going to explode) and PYREXIA (Fever 101.9F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature increased: 101.9 (High) 101.9 F.         No relevant concomitant medications were reported.  .
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Flushing, Headache, Heart rate increased
Clinical narrative: Bad diarrhea; Fast heartbeat; wobly; flushed; Shaking inside body; dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flushed), NERVOUSNESS (Shaking inside body), DIZZINESS (dizziness), HEADACHE (Headache) and HEART RATE INCREASED (Fast heartbeat) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DILTIAZEM, ALPRAZOLAM, HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE), LOSARTAN, DULOXETINE and ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]) for an unknown indication.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) mRNA-1273. On 25-Feb-2021, the patient experienced FLUSHING (flushed), NERVOUSNESS (Shaking inside body), DIZZINESS (dizziness), HEADACHE (Headache) and TREMOR (wobly). On 26-Feb-2021, the patient experienced HEART RATE INCREASED (Fast heartbeat). On 27-Feb-2021, the patient experienced DIARRHOEA (Bad diarrhea). On 01-Mar-2021, FLUSHING (flushed), NERVOUSNESS (Shaking inside body), DIZZINESS (dizziness), HEADACHE (Headache) and DIARRHOEA (Bad diarrhea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. Tylenol was provided as a corrective treatment for the symptoms No treatment medication were provided. Symptoms subsided on day 5 and she felt fine. Consent obtained for safety follow up   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Tremor
Clinical narrative: Bad diarrhea; Fast heartbeat; wobly; flushed; Shaking inside body; dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flushed), NERVOUSNESS (Shaking inside body), DIZZINESS (dizziness), HEADACHE (Headache) and HEART RATE INCREASED (Fast heartbeat) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DILTIAZEM, ALPRAZOLAM, HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE), LOSARTAN, DULOXETINE and ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]) for an unknown indication.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) mRNA-1273. On 25-Feb-2021, the patient experienced FLUSHING (flushed), NERVOUSNESS (Shaking inside body), DIZZINESS (dizziness), HEADACHE (Headache) and TREMOR (wobly). On 26-Feb-2021, the patient experienced HEART RATE INCREASED (Fast heartbeat). On 27-Feb-2021, the patient experienced DIARRHOEA (Bad diarrhea). On 01-Mar-2021, FLUSHING (flushed), NERVOUSNESS (Shaking inside body), DIZZINESS (dizziness), HEADACHE (Headache) and DIARRHOEA (Bad diarrhea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. Tylenol was provided as a corrective treatment for the symptoms No treatment medication were provided. Symptoms subsided on day 5 and she felt fine. Consent obtained for safety follow up   Reporter did not allow further contact
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Headache; Little bit of fever; On and off chills; Felt very fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Little bit of fever), CHILLS (On and off chills) and FATIGUE (Felt very fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HEADACHE (Headache), PYREXIA (Little bit of fever), CHILLS (On and off chills) and FATIGUE (Felt very fatigue). At the time of the report, HEADACHE (Headache), PYREXIA (Little bit of fever), CHILLS (On and off chills) and FATIGUE (Felt very fatigue) 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.   No concomitant medications or treatment details provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Pruritus
Clinical narrative: fatigue; chills; Sore; Soreness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness) and PRURITUS (Itchiness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness) and PRURITUS (Itchiness). On 08-Feb-2021, PAIN IN EXTREMITY (Soreness) and PRURITUS (Itchiness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   This case was linked to MOD-2021-079358 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering
Clinical narrative: "blurry" blisters in her mouth; This spontaneous case was reported by a health care professional and describes the occurrence of ORAL MUCOSAL BLISTERING ("blurry" blisters in her mouth) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A2A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ), VITAMIN D3, LORATADINE, METFORMIN and WARFARIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ORAL MUCOSAL BLISTERING ("blurry" blisters in her mouth). At the time of the report, ORAL MUCOSAL BLISTERING ("blurry" blisters in her mouth) 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 information included hot water and salt.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: No new information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Headache, Myalgia
Clinical narrative: lost their smell; muscle pain; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain), HEADACHE (headaches) and ANOSMIA (lost their smell) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced MYALGIA (muscle pain) and HEADACHE (headaches). On 09-Mar-2021, the patient experienced ANOSMIA (lost their smell). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, MYALGIA (muscle pain), HEADACHE (headaches) and ANOSMIA (lost their smell) 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.   No concomitant medications reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: pain in the body; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in the body), PYREXIA (fever) and CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MYALGIA (pain in the body), PYREXIA (fever) and CHILLS (chills). At the time of the report, MYALGIA (pain in the body), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Dizziness, Headache, Nausea, Oesophageal discomfort
Clinical narrative: Esophageal problems; Esophageal problems/ruptured esophagus; Severe headache; Nausea; Bedridden; Dry Heaving; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETCHING (Dry Heaving), OESOPHAGEAL DISCOMFORT (Esophageal problems), DIZZINESS (Esophageal problems/ruptured esophagus), BEDRIDDEN (Bedridden) and HEADACHE (Severe headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced RETCHING (Dry Heaving) and BEDRIDDEN (Bedridden). On 04-Mar-2021, the patient experienced DIZZINESS (Esophageal problems/ruptured esophagus), HEADACHE (Severe headache) and NAUSEA (Nausea). On 21-Apr-2021, the patient experienced OESOPHAGEAL DISCOMFORT (Esophageal problems). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) for Adverse event, at a dose of UNK dosage form. On 27-Mar-2021, RETCHING (Dry Heaving), BEDRIDDEN (Bedridden), HEADACHE (Severe headache) and NAUSEA (Nausea) had resolved. At the time of the report, OESOPHAGEAL DISCOMFORT (Esophageal problems) had not resolved and DIZZINESS (Esophageal problems/ruptured esophagus) 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.   Concomitant product use included a pain killer for an unknown indication.  Treatment medication included IV Benadryl for headache and nausea medicine that did not work five days after onset of symptoms.  The patient was advised not to take the second dose of the Moderna COVID-19 Vaccine.  The patient reported to have an appointment with a gastroenterologist for the ongoing esophageal symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Additional information added to include updated reporter information and event outcomes.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: Esophageal problems; Esophageal problems/ruptured esophagus; Severe headache; Nausea; Bedridden; Dry Heaving; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETCHING (Dry Heaving), OESOPHAGEAL DISCOMFORT (Esophageal problems), DIZZINESS (Esophageal problems/ruptured esophagus), BEDRIDDEN (Bedridden) and HEADACHE (Severe headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced RETCHING (Dry Heaving) and BEDRIDDEN (Bedridden). On 04-Mar-2021, the patient experienced DIZZINESS (Esophageal problems/ruptured esophagus), HEADACHE (Severe headache) and NAUSEA (Nausea). On 21-Apr-2021, the patient experienced OESOPHAGEAL DISCOMFORT (Esophageal problems). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) for Adverse event, at a dose of UNK dosage form. On 27-Mar-2021, RETCHING (Dry Heaving), BEDRIDDEN (Bedridden), HEADACHE (Severe headache) and NAUSEA (Nausea) had resolved. At the time of the report, OESOPHAGEAL DISCOMFORT (Esophageal problems) had not resolved and DIZZINESS (Esophageal problems/ruptured esophagus) 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.   Concomitant product use included a pain killer for an unknown indication.  Treatment medication included IV Benadryl for headache and nausea medicine that did not work five days after onset of symptoms.  The patient was advised not to take the second dose of the Moderna COVID-19 Vaccine.  The patient reported to have an appointment with a gastroenterologist for the ongoing esophageal symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Additional information added to include updated reporter information and event outcomes.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: It didn't look like it has 0.5ml in it; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (It didn't look like it has 0.5ml in it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (It didn't look like it has 0.5ml in it). At the time of the report, INCORRECT DOSE ADMINISTERED (It didn't look like it has 0.5ml in it) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  Company Comment:  This report refers to a case of incorrect dose administered for mRNA-1273,  with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-05-2021 contains non-significant information. On 25-Jun-2021: Follow up information was received from initial reporter: The reporter declined for further follow up; Sender's Comments: This report refers to a case of incorrect dose administered for mRNA-1273,  with no associated AEs.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive Covid-19 Test; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive Covid-19 Test) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Positive Covid-19 Test). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive Covid-19 Test) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Red rash itchy with around 8 bumps; Red rash itchy with around 8 bumps; Red rash itchy with around 8 bumps; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red rash itchy with around 8 bumps), RASH (Red rash itchy with around 8 bumps), SWELLING (Red rash itchy with around 8 bumps) and PRURITUS (Itchy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Dust allergy and Pollen allergy. Concomitant products included CARVEDILOL, ATORVASTATIN, HYDROCHLOROTHIAZIDE and RIVAROXABAN (XARELTO) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red rash itchy with around 8 bumps), RASH (Red rash itchy with around 8 bumps), SWELLING (Red rash itchy with around 8 bumps) and PRURITUS (Itchy). The patient was treated with ACRIVASTINE (BENADRYL [ACRIVASTINE]) at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at a dose of 1 dosage form and TRIAMCINOLONE at a dose of 1 dosage form. At the time of the report, ERYTHEMA (Red rash itchy with around 8 bumps), RASH (Red rash itchy with around 8 bumps), SWELLING (Red rash itchy with around 8 bumps) and PRURITUS (Itchy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-229894 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Significant follow up updated on 21-Jun-2021
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; COVID; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of COVID-19 (COVID) and the second episode of COVID-19 (COVID) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced the first episode of COVID-19 (COVID). On 08-Mar-2021, the patient experienced the second episode of COVID-19 (COVID). On 09-Mar-2021, last episode of COVID-19 (COVID) 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.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Fever; Nausea; Really, really bad headache/ Feels like whole head is in a vice grip; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Really, really bad headache/ Feels like whole head is in a vice grip) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00105736) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Really, really bad headache/ Feels like whole head is in a vice grip). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Really, really bad headache/ Feels like whole head is in a vice grip) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: injection site it is very red; injection site hurts when she touches it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site it is very red) and VACCINATION SITE PAIN (injection site hurts when she touches it) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site it is very red) and VACCINATION SITE PAIN (injection site hurts when she touches it). At the time of the report, VACCINATION SITE ERYTHEMA (injection site it is very red) and VACCINATION SITE PAIN (injection site hurts when she touches it) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Significant tinnitus in right ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Significant tinnitus in right ear) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced TINNITUS (Significant tinnitus in right ear). At the time of the report, TINNITUS (Significant tinnitus in right ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No specific follow-up information recorded. On 05-May-2021: Translated doc added On 18-May-2021: Translated document - moderna dosage anatomical location was specified , vaccine details was added .