chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Ageusia, Asthenia, Chills, Diarrhoea
Clinical narrative: weakness; I was so cold; the top of my head hurt so bad, it was like pounding; lost my taste buds; My skin burnt like a 2nd or 3rd degree burn; My teeth were chattering; Diarrhea; Gastro pain; Stomach pain; I am sleeping 12+ hs a day; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), GASTROINTESTINAL PAIN (Gastro pain), ABDOMINAL PAIN UPPER (Stomach pain), HEADACHE (the top of my head hurt so bad, it was like pounding) and AGEUSIA (lost my taste buds) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Diabetic, Blood pressure high and Fibromyalgia. Concomitant products included GOLIMUMAB (SIMPONI) for Autoimmune disorder, HYDROCHLOROTHIAZIDE for Blood pressure high, ALBUTEROL [SALBUTAMOL] for COPD, METFORMIN for Diabetic, OXYCODONE for Pain, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HYPERSOMNIA (I am sleeping 12+ hs a day). On 17-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), GASTROINTESTINAL PAIN (Gastro pain) and ABDOMINAL PAIN UPPER (Stomach pain). On 18-Mar-2021, the patient experienced HEADACHE (the top of my head hurt so bad, it was like pounding), AGEUSIA (lost my taste buds), THERMAL BURN (My skin burnt like a 2nd or 3rd degree burn), CHILLS (My teeth were chattering) and FEELING COLD (I was so cold). On an unknown date, the patient experienced ASTHENIA (weakness). At the time of the report, DIARRHOEA (Diarrhea), GASTROINTESTINAL PAIN (Gastro pain), ABDOMINAL PAIN UPPER (Stomach pain), HEADACHE (the top of my head hurt so bad, it was like pounding), AGEUSIA (lost my taste buds), THERMAL BURN (My skin burnt like a 2nd or 3rd degree burn), CHILLS (My teeth were chattering), HYPERSOMNIA (I am sleeping 12+ hs a day), ASTHENIA (weakness) and FEELING COLD (I was so cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment information not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Gastrointestinal pain, Headache, Hypersomnia, Thermal burn
Clinical narrative: weakness; I was so cold; the top of my head hurt so bad, it was like pounding; lost my taste buds; My skin burnt like a 2nd or 3rd degree burn; My teeth were chattering; Diarrhea; Gastro pain; Stomach pain; I am sleeping 12+ hs a day; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), GASTROINTESTINAL PAIN (Gastro pain), ABDOMINAL PAIN UPPER (Stomach pain), HEADACHE (the top of my head hurt so bad, it was like pounding) and AGEUSIA (lost my taste buds) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Diabetic, Blood pressure high and Fibromyalgia. Concomitant products included GOLIMUMAB (SIMPONI) for Autoimmune disorder, HYDROCHLOROTHIAZIDE for Blood pressure high, ALBUTEROL [SALBUTAMOL] for COPD, METFORMIN for Diabetic, OXYCODONE for Pain, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HYPERSOMNIA (I am sleeping 12+ hs a day). On 17-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), GASTROINTESTINAL PAIN (Gastro pain) and ABDOMINAL PAIN UPPER (Stomach pain). On 18-Mar-2021, the patient experienced HEADACHE (the top of my head hurt so bad, it was like pounding), AGEUSIA (lost my taste buds), THERMAL BURN (My skin burnt like a 2nd or 3rd degree burn), CHILLS (My teeth were chattering) and FEELING COLD (I was so cold). On an unknown date, the patient experienced ASTHENIA (weakness). At the time of the report, DIARRHOEA (Diarrhea), GASTROINTESTINAL PAIN (Gastro pain), ABDOMINAL PAIN UPPER (Stomach pain), HEADACHE (the top of my head hurt so bad, it was like pounding), AGEUSIA (lost my taste buds), THERMAL BURN (My skin burnt like a 2nd or 3rd degree burn), CHILLS (My teeth were chattering), HYPERSOMNIA (I am sleeping 12+ hs a day), ASTHENIA (weakness) and FEELING COLD (I was so cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment information not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Sinusitis
Clinical narrative: Massive sinus issues; the muscle in arm of injection hurts; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Massive sinus issues) and MYALGIA (the muscle in arm of injection hurts) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MYALGIA (the muscle in arm of injection hurts). On an unknown date, the patient experienced SINUSITIS (Massive sinus issues). At the time of the report, SINUSITIS (Massive sinus issues) and MYALGIA (the muscle in arm of injection hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Since the weather changed, she has been having a massive sinus issues and allergies. She has sinus infection but she does not think any of her sinus issue is related to the vaccine. She is taking over the counter sinus medication for her sinus issues.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Incorrect dose administered, Pain
Clinical narrative: Body ache; Received an Invalid dose; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (Body ache), INCORRECT DOSE ADMINISTERED (Received an Invalid dose) and HEADACHE (Headache) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported ).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (Body ache), INCORRECT DOSE ADMINISTERED (Received an Invalid dose) and HEADACHE (Headache). On 08-Apr-2021, INCORRECT DOSE ADMINISTERED (Received an Invalid dose) had resolved. At the time of the report, PAIN (Body ache) and HEADACHE (Headache) 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 was not provided by the reporter.  No treatment information was reported.     This case was linked to MOD21-075956 (E2B Linked Report).; Sender's Comments:  MOD21-075956:crosslink
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoacusis
Clinical narrative: having trouble hearing; fatigue; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS ("I am having trouble hearing" Patient says her daughter asked "do you need hearing aids"), FATIGUE (fatigue) and HEADACHE (slight headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cellulitis of leg and Sleep disorder NOS. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Sleep disorder NOS, AMLODIPINE, METOPROLOL, APIXABAN (ELIQUIS), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), FUROSEMIDE and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced FATIGUE (fatigue) and HEADACHE (slight headache). On 13-Apr-2021, the patient experienced HYPOACUSIS ("I am having trouble hearing" Patient says her daughter asked "do you need hearing aids"). On 12-Apr-2021, HEADACHE (slight headache) had resolved. On 13-Apr-2021, FATIGUE (fatigue) had resolved. At the time of the report, HYPOACUSIS ("I am having trouble hearing" Patient says her daughter asked "do you need hearing aids") had not resolved.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant medications included Tropivite supplement and unspecified antibiotic that is 500mg four times a day for cellulitis of leg.  Treatment medication included Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2021-077592 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077592:First dose
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: difficult to lift the arm because of soreness; had little soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had little soreness in the arm) and MOBILITY DECREASED (difficult to lift the arm because of soreness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN), LOVASTATIN, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), OMEPRAZOLE, MULTIVITAMIN [VITAMINS NOS] and IRON for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (had little soreness in the arm). On 14-Feb-2021, the patient experienced MOBILITY DECREASED (difficult to lift the arm because of soreness). At the time of the report, PAIN IN EXTREMITY (had little soreness in the arm) and MOBILITY DECREASED (difficult to lift the arm because of soreness) outcome was unknown.         Action taken with mRNA-1273 in response to the event was not applicable.  For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   This case was linked to MOD-2021-010258 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lip blister, Oral mucosal blistering
Clinical narrative: Blisters on the lips; Blisters inside the mouth; This spontaneous case was reported by a consumer and describes the occurrence of LIP BLISTER (Blisters on the lips) and ORAL MUCOSAL BLISTERING (Blisters inside the mouth) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CELECOXIB, PANTOPRAZOLE, AMLODIPINE, CITALOPRAM, MAGNESIUM and CYANOCOBALAMIN (VIT B 12) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced LIP BLISTER (Blisters on the lips) and ORAL MUCOSAL BLISTERING (Blisters inside the mouth). At the time of the report, LIP BLISTER (Blisters on the lips) and ORAL MUCOSAL BLISTERING (Blisters inside the mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medication included vitamin B3, arthritis pain killer and Pro-Air Inhaler sos for an unknown indication.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Pain in extremity
Clinical narrative: soreness in arm; hurts when she lifts; a little bit of chills; heart beating was kind of fast; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart beating was kind of fast), PAIN IN EXTREMITY (soreness in arm; hurts when she lifts) and CHILLS (a little bit of chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0310411952) for COVID-19 vaccination.     Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) and OMEPRAZOLE for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced HEART RATE INCREASED (heart beating was kind of fast). On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in arm; hurts when she lifts) and CHILLS (a little bit of chills). At the time of the report, HEART RATE INCREASED (heart beating was kind of fast), PAIN IN EXTREMITY (soreness in arm; hurts when she lifts) and CHILLS (a little bit of chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure increased, Heart rate irregular, Lymph node pain, Lymphadenopathy
Clinical narrative: average increase in blood pressure and heart rate by 10-15%; swelling in lymph nodes; irregular heart beat; irregular blood pressure/blood pressure rising and dropping; pain in lymph node in left arm pit/stabbing feeling around lymph node in left arm; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (irregular heart beat), BLOOD PRESSURE ABNORMAL (irregular blood pressure/blood pressure rising and dropping), LYMPH NODE PAIN (pain in lymph node in left arm pit/stabbing feeling around lymph node in left arm), BLOOD PRESSURE INCREASED (average increase in blood pressure and heart rate by 10-15%) and LYMPHADENOPATHY (swelling in lymph nodes) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced HEART RATE IRREGULAR (irregular heart beat), BLOOD PRESSURE ABNORMAL (irregular blood pressure/blood pressure rising and dropping) and LYMPH NODE PAIN (pain in lymph node in left arm pit/stabbing feeling around lymph node in left arm). On 03-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (average increase in blood pressure and heart rate by 10-15%) and LYMPHADENOPATHY (swelling in lymph nodes). At the time of the report, HEART RATE IRREGULAR (irregular heart beat), BLOOD PRESSURE ABNORMAL (irregular blood pressure/blood pressure rising and dropping), LYMPH NODE PAIN (pain in lymph node in left arm pit/stabbing feeling around lymph node in left arm) and BLOOD PRESSURE INCREASED (average increase in blood pressure and heart rate by 10-15%) had not resolved and LYMPHADENOPATHY (swelling in lymph nodes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was checked out by the clinic again on 12APR2021 and is still presenting with an irregular heart beat, blood pressure, and pain in the lymph gland of his left arm-pit.   No concomitant medications were reported.   Patient was suggested to see the infectious diseases department because doctors are not sure what is causing the symptoms, however, infectious diseases refused to see him as they believed that they were side effects from the COVID-19 vaccine.Patient sated that his blood pressure history has been around 134/79 and his highest heart rate was around 74 bpm. After receiving the vaccine, patient states that his average has increased 10-15% minimum. Patient reports that at the last clinic he went to the health care providers noticed swelling in the lymph nodes   No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Vaccination site discomfort
Clinical narrative: pain; discomfort at the injection site; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), VACCINATION SITE DISCOMFORT (discomfort at the injection site) and CHILLS (chills) 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 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (pain), VACCINATION SITE DISCOMFORT (discomfort at the injection site) and CHILLS (chills). At the time of the report, PAIN (pain), VACCINATION SITE DISCOMFORT (discomfort at the injection site) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Cramping/Muscle cramp/cramping in legs, feet and fingers; fingers would get in odd positions and couldn't straighten out; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramping/Muscle cramp/cramping in legs, feet and fingers) and MUSCULOSKELETAL STIFFNESS (fingers would get in odd positions and couldn't straighten out) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 221B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Cramping/Muscle cramp/cramping in legs, feet and fingers) and MUSCULOSKELETAL STIFFNESS (fingers would get in odd positions and couldn't straighten out). At the time of the report, MUSCLE SPASMS (Cramping/Muscle cramp/cramping in legs, feet and fingers) and MUSCULOSKELETAL STIFFNESS (fingers would get in odd positions and couldn't straighten out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Lacrimation increased, Myalgia
Clinical narrative: chills that then got more severe; watery eyes; sneezing; runny nose; no appetite; fever; body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), LACRIMATION INCREASED (watery eyes), SNEEZING (sneezing), DECREASED APPETITE (no appetite) and CHILLS (chills that then got more severe) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not reported ).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced DECREASED APPETITE (no appetite), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headaches). On 08-Apr-2021 at 4:00 PM, the patient experienced RHINORRHOEA (runny nose), LACRIMATION INCREASED (watery eyes) and SNEEZING (sneezing). On 08-Apr-2021 at 6:00 PM, the patient experienced CHILLS (chills that then got more severe). On 10-Apr-2021, RHINORRHOEA (runny nose), LACRIMATION INCREASED (watery eyes), SNEEZING (sneezing), DECREASED APPETITE (no appetite), CHILLS (chills that then got more severe), PYREXIA (fever) and MYALGIA (body aches) had resolved. At the time of the report, HEADACHE (headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments.  Concomitant product use was not provided by the reporter.  No treatment information was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: chills that then got more severe; watery eyes; sneezing; runny nose; no appetite; fever; body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), LACRIMATION INCREASED (watery eyes), SNEEZING (sneezing), DECREASED APPETITE (no appetite) and CHILLS (chills that then got more severe) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not reported ).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced DECREASED APPETITE (no appetite), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headaches). On 08-Apr-2021 at 4:00 PM, the patient experienced RHINORRHOEA (runny nose), LACRIMATION INCREASED (watery eyes) and SNEEZING (sneezing). On 08-Apr-2021 at 6:00 PM, the patient experienced CHILLS (chills that then got more severe). On 10-Apr-2021, RHINORRHOEA (runny nose), LACRIMATION INCREASED (watery eyes), SNEEZING (sneezing), DECREASED APPETITE (no appetite), CHILLS (chills that then got more severe), PYREXIA (fever) and MYALGIA (body aches) had resolved. At the time of the report, HEADACHE (headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments.  Concomitant product use was not provided by the reporter.  No treatment information was reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Eye swelling, Fatigue, Feeling hot, Hair colour changes
Clinical narrative: She feels a little warm; Constipated; She woke up and all her face is swollen; She feels tired; The injection site was in pain; Felt tired; She was completely swollen and inflamed her eyes; Her eyebrows were red; The injection site was hot; The injection site was inflamed; A swelling around her eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (A swelling around her eyes), EYE SWELLING (She was completely swollen and inflamed her eyes), HAIR COLOUR CHANGES (Her eyebrows were red), FEELING HOT (She feels a little warm) and CONSTIPATION (Constipated) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046AB21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Backache (She had been taking Meloxicam/ Metocarbamol previously for backache).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced EYE SWELLING (A swelling around her eyes). On 13-Apr-2021, the patient experienced EYE SWELLING (She was completely swollen and inflamed her eyes), HAIR COLOUR CHANGES (Her eyebrows were red), VACCINATION SITE WARMTH (The injection site was hot), VACCINATION SITE INFLAMMATION (The injection site was inflamed), FATIGUE (Felt tired) and VACCINATION SITE PAIN (The injection site was in pain). On 14-Apr-2021, the patient experienced FEELING HOT (She feels a little warm), CONSTIPATION (Constipated), SWELLING FACE (She woke up and all her face is swollen) and FATIGUE (She feels tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Pain, at a dose of UNK dosage form. At the time of the report, EYE SWELLING (A swelling around her eyes), EYE SWELLING (She was completely swollen and inflamed her eyes), HAIR COLOUR CHANGES (Her eyebrows were red), FEELING HOT (She feels a little warm), CONSTIPATION (Constipated), VACCINATION SITE WARMTH (The injection site was hot), VACCINATION SITE INFLAMMATION (The injection site was inflamed), SWELLING FACE (She woke up and all her face is swollen), FATIGUE (Felt tired), FATIGUE (She feels tired) and VACCINATION SITE PAIN (The injection site was in pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Advil was taken for treatment. Patient had been taking Meloxicam/Metocarbamol previously for backache.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vaccination site inflammation, Vaccination site pain, Vaccination site warmth
Clinical narrative: She feels a little warm; Constipated; She woke up and all her face is swollen; She feels tired; The injection site was in pain; Felt tired; She was completely swollen and inflamed her eyes; Her eyebrows were red; The injection site was hot; The injection site was inflamed; A swelling around her eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (A swelling around her eyes), EYE SWELLING (She was completely swollen and inflamed her eyes), HAIR COLOUR CHANGES (Her eyebrows were red), FEELING HOT (She feels a little warm) and CONSTIPATION (Constipated) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046AB21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Backache (She had been taking Meloxicam/ Metocarbamol previously for backache).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced EYE SWELLING (A swelling around her eyes). On 13-Apr-2021, the patient experienced EYE SWELLING (She was completely swollen and inflamed her eyes), HAIR COLOUR CHANGES (Her eyebrows were red), VACCINATION SITE WARMTH (The injection site was hot), VACCINATION SITE INFLAMMATION (The injection site was inflamed), FATIGUE (Felt tired) and VACCINATION SITE PAIN (The injection site was in pain). On 14-Apr-2021, the patient experienced FEELING HOT (She feels a little warm), CONSTIPATION (Constipated), SWELLING FACE (She woke up and all her face is swollen) and FATIGUE (She feels tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Pain, at a dose of UNK dosage form. At the time of the report, EYE SWELLING (A swelling around her eyes), EYE SWELLING (She was completely swollen and inflamed her eyes), HAIR COLOUR CHANGES (Her eyebrows were red), FEELING HOT (She feels a little warm), CONSTIPATION (Constipated), VACCINATION SITE WARMTH (The injection site was hot), VACCINATION SITE INFLAMMATION (The injection site was inflamed), SWELLING FACE (She woke up and all her face is swollen), FATIGUE (Felt tired), FATIGUE (She feels tired) and VACCINATION SITE PAIN (The injection site was in pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Advil was taken for treatment. Patient had been taking Meloxicam/Metocarbamol previously for backache.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine
Clinical narrative: Migraine After the First Shot; Tired After the First Shot; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine After the First Shot) and FATIGUE (Tired After the First Shot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04A21A and 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced MIGRAINE (Migraine After the First Shot) and FATIGUE (Tired After the First Shot). On 07-Mar-2021, MIGRAINE (Migraine After the First Shot) and FATIGUE (Tired After the First Shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to , INC.-MOD-2021-076824 (E2B Linked Report).; Sender's Comments:  .-MOD-2021-076824:Same patient - second doose
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pain in extremity
Clinical narrative: nausea; aches; pains; arm sore to the touch; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), PAIN (pains), CHILLS (chills), PAIN IN EXTREMITY (arm sore to the touch) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included IBUPROFEN and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN (aches), PAIN (pains), CHILLS (chills) and PAIN IN EXTREMITY (arm sore to the touch). On 14-Apr-2021, the patient experienced NAUSEA (nausea). At the time of the report, PAIN (aches), PAIN (pains), CHILLS (chills), PAIN IN EXTREMITY (arm sore to the touch) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Treatment products included Ibuprofen.   Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Skin mass, Swelling face, Tenderness
Clinical narrative: lump (swollen bump) underneath his jaw; noticed knot (swelling) on his forehead that traveled up to the side of his ear then up to the; tender from the eyebrow all the way down to his ear and jaw; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (lump (swollen bump) underneath his jaw), SKIN MASS (noticed knot (swelling) on his forehead that traveled up to the side of his ear then up to the) and TENDERNESS (tender from the eyebrow all the way down to his ear and jaw) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced SWELLING FACE (lump (swollen bump) underneath his jaw), SKIN MASS (noticed knot (swelling) on his forehead that traveled up to the side of his ear then up to the) and TENDERNESS (tender from the eyebrow all the way down to his ear and jaw). At the time of the report, SWELLING FACE (lump (swollen bump) underneath his jaw), SKIN MASS (noticed knot (swelling) on his forehead that traveled up to the side of his ear then up to the) and TENDERNESS (tender from the eyebrow all the way down to his ear and jaw) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include cholesterol medications.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old patient got the first dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old patient got the first dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old patient got the first dose). On 17-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old patient got the first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product used was provided by the reporter. Treatment information was not provided
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Rash
Clinical narrative: Pain from the elbow to the shoulder; Rash on back and stomach; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain from the elbow to the shoulder) and RASH (Rash on back and stomach) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced ARTHRALGIA (Pain from the elbow to the shoulder) and RASH (Rash on back and stomach). At the time of the report, ARTHRALGIA (Pain from the elbow to the shoulder) and RASH (Rash on back and stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment included Tylenol.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: feels crappy; fatigue; nausea; pain at the injection site; headache; fever of 102; slept 18 hours; light-headed; arm swelling,swelling on arm bigger than silver dollar; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept 18 hours), DIZZINESS (light-headed), PERIPHERAL SWELLING (arm swelling,swelling on arm bigger than silver dollar), FEELING ABNORMAL (feels crappy) and PYREXIA (fever of 102) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Lymphoma.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SOMNOLENCE (slept 18 hours), DIZZINESS (light-headed), PERIPHERAL SWELLING (arm swelling,swelling on arm bigger than silver dollar), PYREXIA (fever of 102), NAUSEA (nausea), VACCINATION SITE PAIN (pain at the injection site) and HEADACHE (headache). On an unknown date, the patient experienced FEELING ABNORMAL (feels crappy) and FATIGUE (fatigue). At the time of the report, SOMNOLENCE (slept 18 hours), DIZZINESS (light-headed), PERIPHERAL SWELLING (arm swelling,swelling on arm bigger than silver dollar), FEELING ABNORMAL (feels crappy), PYREXIA (fever of 102), FATIGUE (fatigue), NAUSEA (nausea), VACCINATION SITE PAIN (pain at the injection site) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient states that she is on a lot of psychological medicines. Treatment information was not provided.   This case was linked to MOD21-075908 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-075908:follow up
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Somnolence, Vaccination site pain
Clinical narrative: feels crappy; fatigue; nausea; pain at the injection site; headache; fever of 102; slept 18 hours; light-headed; arm swelling,swelling on arm bigger than silver dollar; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept 18 hours), DIZZINESS (light-headed), PERIPHERAL SWELLING (arm swelling,swelling on arm bigger than silver dollar), FEELING ABNORMAL (feels crappy) and PYREXIA (fever of 102) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Lymphoma.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SOMNOLENCE (slept 18 hours), DIZZINESS (light-headed), PERIPHERAL SWELLING (arm swelling,swelling on arm bigger than silver dollar), PYREXIA (fever of 102), NAUSEA (nausea), VACCINATION SITE PAIN (pain at the injection site) and HEADACHE (headache). On an unknown date, the patient experienced FEELING ABNORMAL (feels crappy) and FATIGUE (fatigue). At the time of the report, SOMNOLENCE (slept 18 hours), DIZZINESS (light-headed), PERIPHERAL SWELLING (arm swelling,swelling on arm bigger than silver dollar), FEELING ABNORMAL (feels crappy), PYREXIA (fever of 102), FATIGUE (fatigue), NAUSEA (nausea), VACCINATION SITE PAIN (pain at the injection site) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient states that she is on a lot of psychological medicines. Treatment information was not provided.   This case was linked to MOD21-075908 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-075908:follow up
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Impaired driving ability, Loss of personal independence in daily activities, Tremor
Clinical narrative: severe trembles; losing all his dependency and needs other to care for him; not able to drive; headache; teeth chatters; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (severe trembles), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (losing all his dependency and needs other to care for him), IMPAIRED DRIVING ABILITY (not able to drive), HEADACHE (headache) and CHILLS (teeth chatters) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TREMOR (severe trembles), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (losing all his dependency and needs other to care for him), IMPAIRED DRIVING ABILITY (not able to drive), HEADACHE (headache) and CHILLS (teeth chatters). At the time of the report, TREMOR (severe trembles), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (losing all his dependency and needs other to care for him), IMPAIRED DRIVING ABILITY (not able to drive), HEADACHE (headache) and CHILLS (teeth chatters) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm soreness) in a 43-year-old male 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) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (left arm soreness). At the time of the report, VACCINATION SITE PAIN (left arm soreness) 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 products included Triglyceride medications, Diabetic medications. Treatment products included Advil.   This case was linked to US-MODERNATX, INC.-MOD-2021-076713 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076713:case for dose 2
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: infected with covid within 10 days of 1st Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (infected with covid within 10 days of 1st Moderna vaccine) in a 76-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (infected with covid within 10 days of 1st Moderna vaccine). At the time of the report, COVID-19 (infected with covid within 10 days of 1st Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Feeling abnormal, Flatulence, Headache
Clinical narrative: Feeling bad; Stomach is hurting; Alot of air in the stomach; Fatigue; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad), ABDOMINAL PAIN UPPER (Stomach is hurting), FLATULENCE (Alot of air in the stomach), FATIGUE (Fatigue) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 131L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Apr-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 14-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling bad), ABDOMINAL PAIN UPPER (Stomach is hurting), FLATULENCE (Alot of air in the stomach), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Muscle pain). At the time of the report, FEELING ABNORMAL (Feeling bad), ABDOMINAL PAIN UPPER (Stomach is hurting), FLATULENCE (Alot of air in the stomach), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Muscle pain) outcome was unknown.            Concomitant medications were not reported. Treatment details not provided Action taken with mRNA-1273 in response to the events was  not applicable Patient agreed to follow-up with Safety. Preferred contact method is phone.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Feeling bad; Stomach is hurting; Alot of air in the stomach; Fatigue; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad), ABDOMINAL PAIN UPPER (Stomach is hurting), FLATULENCE (Alot of air in the stomach), FATIGUE (Fatigue) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 131L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Apr-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 14-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling bad), ABDOMINAL PAIN UPPER (Stomach is hurting), FLATULENCE (Alot of air in the stomach), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Muscle pain). At the time of the report, FEELING ABNORMAL (Feeling bad), ABDOMINAL PAIN UPPER (Stomach is hurting), FLATULENCE (Alot of air in the stomach), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Muscle pain) outcome was unknown.            Concomitant medications were not reported. Treatment details not provided Action taken with mRNA-1273 in response to the events was  not applicable Patient agreed to follow-up with Safety. Preferred contact method is phone.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Intentional dose omission
Clinical narrative: soreness in left elbow joint; He was denied his second dose on 14APR2021 due to this side; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL DOSE OMISSION (He was denied his second dose on 14APR2021 due to this side) and ARTHRALGIA (soreness in left elbow joint) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced INTENTIONAL DOSE OMISSION (He was denied his second dose on 14APR2021 due to this side). On an unknown date, the patient experienced ARTHRALGIA (soreness in left elbow joint). On 14-Apr-2021, INTENTIONAL DOSE OMISSION (He was denied his second dose on 14APR2021 due to this side) had resolved. At the time of the report, ARTHRALGIA (soreness in left elbow joint) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.