chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Lethargy, Musculoskeletal stiffness, Vaccination site reaction
Clinical narrative: weak; lethargic; At injection site there is pink ring 3-4 inch in diameter; appetite has decreased; Arm was stiff; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm was stiff), ASTHENIA (weak), LETHARGY (lethargic), VACCINATION SITE REACTION (At injection site there is pink ring 3-4 inch in diameter) and DECREASED APPETITE (appetite has decreased) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Sulfa drug).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm was stiff). On 05-Mar-2021, the patient experienced ASTHENIA (weak), LETHARGY (lethargic), VACCINATION SITE REACTION (At injection site there is pink ring 3-4 inch in diameter) and DECREASED APPETITE (appetite has decreased). At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm was stiff), ASTHENIA (weak), LETHARGY (lethargic), VACCINATION SITE REACTION (At injection site there is pink ring 3-4 inch in diameter) and DECREASED APPETITE (appetite has decreased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medications were provided No Treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No specific follow-up information recorded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Has not been able to get the second dose yet; A spontaneous report was received from a consumer concerning a 73 years old female patient, who has not been able to get the second dose yet (Inappropriate schedule of product administration).  The patients medical history was not provided. Concomitant product use was not provided by the reporter.  On 01 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA for prophylaxis of COVID-19 infection.  It was reported that the patient has not been able to get the second dose of vaccine yet. The reason was not provided.  Treatment information was unknown.   Action taken with mRNA-1273 in response to the events was not reported.   The event, not been able to get the second dose yet (Inappropriate schedule of product administration) was considered as unknown.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot #: Unknown) with no associated AEs.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Aches; Chills; Severe tiredness; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), CHILLS (Chills), FATIGUE (Severe tiredness), HEADACHE (Headache) and PYREXIA (Fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN (Aches), CHILLS (Chills), FATIGUE (Severe tiredness), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, PAIN (Aches), CHILLS (Chills), FATIGUE (Severe tiredness), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment medications were not provided.   This case was linked to MOD-2021-022063 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Chills, Decreased appetite, Headache, Nausea
Clinical narrative: Had no taste; Coughing up phlegm; No appetite; Urinary tract infection/urinating frequently; Aches; Fever; Chills; Nauseous; Headache; A Spontaneous report was received from a 61-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection/urinating frequently, headache, coughing up phlegm, had no taste, aches, fever, chills, nauseous and no appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013A21A) in left arm for prophylaxis of COVID-19 infection.   On Saturday night 06 Mar 2021 or Sunday 07 Mar 2021, after receiving the vaccine patient developed fever, headache, chills, aches, no appetite, nauseous and he urinated frequently. The patient had been to his physician on 08-MAR-2021 and was prescribed antibiotics for urinary tract infection. On 08 Mar 2021, the patient started experiencing coughing up phlegm and he had no taste.  Action taken with mRNA-1273 in response to events was unknown.  The outcome of events urinary tract infection/urinating frequently, headache, coughing up phlegm, had no taste, aches, fever, chills, nauseous and no appetite was unknown.; Reporter'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.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Productive cough, Pyrexia, Urinary tract infection
Clinical narrative: Had no taste; Coughing up phlegm; No appetite; Urinary tract infection/urinating frequently; Aches; Fever; Chills; Nauseous; Headache; A Spontaneous report was received from a 61-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection/urinating frequently, headache, coughing up phlegm, had no taste, aches, fever, chills, nauseous and no appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013A21A) in left arm for prophylaxis of COVID-19 infection.   On Saturday night 06 Mar 2021 or Sunday 07 Mar 2021, after receiving the vaccine patient developed fever, headache, chills, aches, no appetite, nauseous and he urinated frequently. The patient had been to his physician on 08-MAR-2021 and was prescribed antibiotics for urinary tract infection. On 08 Mar 2021, the patient started experiencing coughing up phlegm and he had no taste.  Action taken with mRNA-1273 in response to events was unknown.  The outcome of events urinary tract infection/urinating frequently, headache, coughing up phlegm, had no taste, aches, fever, chills, nauseous and no appetite was unknown.; Reporter'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.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Sore arm of injection; Sore around shoulder blade; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm of injection) and ARTHRALGIA (Sore around shoulder blade) 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 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm of injection) and ARTHRALGIA (Sore around shoulder blade). At the time of the report, PAIN IN EXTREMITY (Sore arm of injection) and ARTHRALGIA (Sore around shoulder blade) outcome was unknown.            The concomitant medications were not provided. The treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Fever blisters appeared outside my upper lip; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Fever blisters appeared outside my upper lip) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced ORAL HERPES (Fever blisters appeared outside my upper lip). The patient was treated with CAMPHOR, EUCALYPTUS GLOBULUS OIL, MENTHOL, PHENOL, SYZYGIUM AROMATICUM OIL (NOXZEMA [CAMPHOR;EUCALYPTUS GLOBULUS OIL;MENTHOL;PHENOL;SYZYGIUM AROMATICUM OIL]) at an unspecified dose and frequency. At the time of the report, ORAL HERPES (Fever blisters appeared outside my upper lip) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: I can't wake up during the day; I have to lay down, I have to get a nap every 30 min; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (I can't wake up during the day) and SOMNOLENCE (I have to lay down, I have to get a nap every 30 min) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced SOMNOLENCE (I can't wake up during the day) and SOMNOLENCE (I have to lay down, I have to get a nap every 30 min). At the time of the report, SOMNOLENCE (I can't wake up during the day) and SOMNOLENCE (I have to lay down, I have to get a nap every 30 min) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient stated that she took other medication for other problems. Treatment medications were not 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling, Therapeutic response unexpected
Clinical narrative: improvement in her shoulder which was painful and troubling; soreness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), SWELLING (swelling) and THERAPEUTIC RESPONSE UNEXPECTED (improvement in her shoulder which was painful and troubling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (soreness) and SWELLING (swelling). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (improvement in her shoulder which was painful and troubling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, PAIN (soreness) and SWELLING (swelling) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (improvement in her shoulder which was painful and troubling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: fatigue; joint pain; temperature of 100.8; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue), ARTHRALGIA (joint pain) and PYREXIA (temperature of 100.8) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for an unknown indication.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced CHILLS (chills). On 09-Mar-2021, the patient experienced FATIGUE (fatigue), ARTHRALGIA (joint pain) and PYREXIA (temperature of 100.8). At the time of the report, CHILLS (chills), FATIGUE (fatigue), ARTHRALGIA (joint pain) and PYREXIA (temperature of 100.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8 (High) 100.8.         No treatment medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: chills; headache; nauseous; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (chills), HEADACHE (headache), NAUSEA (nauseous) and FATIGUE (fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-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 CHILLS (chills), HEADACHE (headache), NAUSEA (nauseous) and FATIGUE (fatigue). At the time of the report, CHILLS (chills), HEADACHE (headache), NAUSEA (nauseous) and FATIGUE (fatigue) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. No Concomitant medications were provided No Treatment information provided    This case was linked to MOD-2021-093117 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26APR2021, Added information about reporter details ( address, email), AE Contact Information Updated
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hypersensitivity, Illness, Pain in extremity
Clinical narrative: May be allergies; Dizzy; Arm hurt real bad; Very weak; weak/sick/I got really sick; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm hurt real bad), ASTHENIA (Very weak), ILLNESS (weak/sick/I got really sick) and HYPERSENSITIVITY (May be allergies) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031BZ1B and 011AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Diabetes, Lupus erythematosus, Latex allergy, Penicillin allergy, Allergy to antibiotic (Amoxicillin) and Fish allergy. Concomitant products included LOSARTAN, HYDROCHLOROTHIAZIDE, AMLODIPINE BESILATE (AMLODIPINE BESYLATE 10) and ATORVASTATIN for an unknown indication.   On 06-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm hurt real bad), ASTHENIA (Very weak) and ILLNESS (weak/sick/I got really sick). On 15-Apr-2021, the patient experienced HYPERSENSITIVITY (May be allergies). At the time of the report, DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm hurt real bad), ASTHENIA (Very weak), ILLNESS (weak/sick/I got really sick) and HYPERSENSITIVITY (May be allergies) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter.   This case was linked to MOD-2021-237235 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow-up 2: Patient allergies and relevant history added. Start time of Moderna vaccine updated. Event onset date updated. Event added.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Influenza like illness, Malaise
Clinical narrative: She did not feel good all week; Flu like symptoms; Lightheadedness a lot; Weak / no energy she was down; Injection site sore; Injection site puffy; Arm red about an inch or 2 around the injection site; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (She did not feel good all week), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Lightheadedness a lot), ASTHENIA (Weak / no energy she was down) and VACCINATION SITE PAIN (Injection site sore) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Muscle pain. Concomitant products included LORAZEPAM, FLUTICASONE, SODIUM PROPIONATE (PROPIONATE), VERAPAMIL, CELECOXIB (ACLEXA), ACETYLSALICYLIC ACID (ASPIRIN 81), ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]), FISH OIL, CETIRIZINE, MUPIROCIN and NAPROXEN SODIUM (ALEVE).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced MALAISE (She did not feel good all week), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Lightheadedness a lot), ASTHENIA (Weak / no energy she was down), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE SWELLING (Injection site puffy), VACCINATION SITE ERYTHEMA (Arm red about an inch or 2 around the injection site) and HEADACHE (Headaches). On 09-Mar-2021, MALAISE (She did not feel good all week), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Lightheadedness a lot), ASTHENIA (Weak / no energy she was down) and HEADACHE (Headaches) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE SWELLING (Injection site puffy) and VACCINATION SITE ERYTHEMA (Arm red about an inch or 2 around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included naproxen sodium  for headaches.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: She did not feel good all week; Flu like symptoms; Lightheadedness a lot; Weak / no energy she was down; Injection site sore; Injection site puffy; Arm red about an inch or 2 around the injection site; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (She did not feel good all week), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Lightheadedness a lot), ASTHENIA (Weak / no energy she was down) and VACCINATION SITE PAIN (Injection site sore) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Muscle pain. Concomitant products included LORAZEPAM, FLUTICASONE, SODIUM PROPIONATE (PROPIONATE), VERAPAMIL, CELECOXIB (ACLEXA), ACETYLSALICYLIC ACID (ASPIRIN 81), ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]), FISH OIL, CETIRIZINE, MUPIROCIN and NAPROXEN SODIUM (ALEVE).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced MALAISE (She did not feel good all week), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Lightheadedness a lot), ASTHENIA (Weak / no energy she was down), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE SWELLING (Injection site puffy), VACCINATION SITE ERYTHEMA (Arm red about an inch or 2 around the injection site) and HEADACHE (Headaches). On 09-Mar-2021, MALAISE (She did not feel good all week), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Lightheadedness a lot), ASTHENIA (Weak / no energy she was down) and HEADACHE (Headaches) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE SWELLING (Injection site puffy) and VACCINATION SITE ERYTHEMA (Arm red about an inch or 2 around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included naproxen sodium  for headaches.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Peripheral swelling
Clinical narrative: Arm is swollen; Chills; Under his arm in his armpit its swollen and painful.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is swollen), CHILLS (Chills) and AXILLARY PAIN (Under his arm in his armpit its swollen and painful.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PERIPHERAL SWELLING (Arm is swollen), CHILLS (Chills) and AXILLARY PAIN (Under his arm in his armpit its swollen and painful.). At the time of the report, PERIPHERAL SWELLING (Arm is swollen), CHILLS (Chills) and AXILLARY PAIN (Under his arm in his armpit its swollen and painful.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Food intolerance
Clinical narrative: cannot eat certain food; swallowing issues; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of DYSPHAGIA (swallowing issues) and FOOD INTOLERANCE (cannot eat certain food) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     Concomitant products included TOPIRAMATE for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced DYSPHAGIA (swallowing issues). On an unknown date, the patient experienced FOOD INTOLERANCE (cannot eat certain food). At the time of the report, DYSPHAGIA (swallowing issues) and FOOD INTOLERANCE (cannot eat certain food) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over midsection, arms, a little bit on legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over midsection, arms, a little bit on legs) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced RASH (Rash all over midsection, arms, a little bit on legs). At the time of the report, RASH (Rash all over midsection, arms, a little bit on legs) had not resolved.            Treatment information includes Benadryl and reported Symptoms are ongoing.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Confusional state, Dizziness, Hypertension
Clinical narrative: Feeling Confused; Feeling faint; Blood pressure rose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONFUSIONAL STATE (Feeling Confused), DIZZINESS (Feeling faint) and HYPERTENSION (Blood pressure rose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included FAMOTIDINE for an unknown indication.    On 02-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 CONFUSIONAL STATE (Feeling Confused), DIZZINESS (Feeling faint) and HYPERTENSION (Blood pressure rose). At the time of the report, CONFUSIONAL STATE (Feeling Confused), DIZZINESS (Feeling faint) and HYPERTENSION (Blood pressure rose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Blood pressure measurement: increased (High) increased.     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 also included blood pressure medication, antacids, and vitamins.  The MD increased the patients blood pressure medication up to 10mg.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: No new information was added.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Mild fatigue; Mild chills; Mild nausea; Muscle aches; Severe pain in the back; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Mild fatigue), CHILLS (Mild chills), NAUSEA (Mild nausea), MYALGIA (Muscle aches) and BACK PAIN (Severe pain in the back) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (Mild fatigue), CHILLS (Mild chills), NAUSEA (Mild nausea), MYALGIA (Muscle aches) and BACK PAIN (Severe pain in the back). At the time of the report, FATIGUE (Mild fatigue), CHILLS (Mild chills), NAUSEA (Mild nausea), MYALGIA (Muscle aches) and BACK PAIN (Severe pain in the back) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not reported.  No concomitant medication reported. No treatment was provided.    Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Restlessness, Somnolence, Vaccination complication, Vaccination site lymphadenopathy
Clinical narrative: She had reaction to any kind of medicine or vaccine; restless; felt sleepy; gland swollen; shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She had reaction to any kind of medicine or vaccine), RESTLESSNESS (restless), SOMNOLENCE (felt sleepy), VACCINATION SITE LYMPHADENOPATHY (gland swollen) and ARTHRALGIA (shoulder pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced RESTLESSNESS (restless), SOMNOLENCE (felt sleepy), VACCINATION SITE LYMPHADENOPATHY (gland swollen) and ARTHRALGIA (shoulder pain). On an unknown date, the patient experienced VACCINATION COMPLICATION (She had reaction to any kind of medicine or vaccine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (She had reaction to any kind of medicine or vaccine), RESTLESSNESS (restless), SOMNOLENCE (felt sleepy), VACCINATION SITE LYMPHADENOPATHY (gland swollen) and ARTHRALGIA (shoulder pain) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Exposed to COVID before first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Exposed to COVID before first dose of vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) 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 COVID-19 (Exposed to COVID before first dose of vaccine). At the time of the report, COVID-19 (Exposed to COVID before first dose of vaccine) outcome was unknown. Split for coding      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Patient stated that she is using Monocrobial Antibiotic Treatment for COVID-19
Sex: M
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and DIARRHOEA (Diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ONDANSETRON (ZOFRAN [ONDANSETRON]) for an unknown indication.    No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ONDANSETRON (ZOFRAN [ONDANSETRON]) (unknown route) 4 mg. On 04-Mar-2021, the patient experienced NAUSEA (Nausea) and DIARRHOEA (Diarrhea). At the time of the report, NAUSEA (Nausea) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Product dose omission issue
Clinical narrative: Second dose was due on 24Feb2021 but they had an emergency and could not attend; Missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of INCOMPLETE COURSE OF VACCINATION (Second dose was due on 24Feb2021 but they had an emergency and could not attend) and PRODUCT DOSE OMISSION ISSUE (Missed second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (Second dose was due on 24Feb2021 but they had an emergency and could not attend) and PRODUCT DOSE OMISSION ISSUE (Missed second dose). On 24-Feb-2021, INCOMPLETE COURSE OF VACCINATION (Second dose was due on 24Feb2021 but they had an emergency and could not attend) and PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.        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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Dizziness, Headache, Malaise, Palpitations
Clinical narrative: feverish 99.4 F.; Heart Racing; getting sick fast; light-headed; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish 99.4 F.), PALPITATIONS (Heart Racing), MALAISE (getting sick fast), DIZZINESS (light-headed) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus (No reported medical history).    On 06-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 PYREXIA (feverish 99.4 F.), PALPITATIONS (Heart Racing), MALAISE (getting sick fast), DIZZINESS (light-headed) and HEADACHE (headache). At the time of the report, PYREXIA (feverish 99.4 F.), PALPITATIONS (Heart Racing), MALAISE (getting sick fast), DIZZINESS (light-headed) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Blood glucose increased: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feverish 99.4 F.; Heart Racing; getting sick fast; light-headed; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish 99.4 F.), PALPITATIONS (Heart Racing), MALAISE (getting sick fast), DIZZINESS (light-headed) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus (No reported medical history).    On 06-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 PYREXIA (feverish 99.4 F.), PALPITATIONS (Heart Racing), MALAISE (getting sick fast), DIZZINESS (light-headed) and HEADACHE (headache). At the time of the report, PYREXIA (feverish 99.4 F.), PALPITATIONS (Heart Racing), MALAISE (getting sick fast), DIZZINESS (light-headed) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Blood glucose increased: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient got COVID after receiving vaccine; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Patient got COVID after receiving vaccine) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced COVID-19 (Patient got COVID after receiving vaccine). At the time of the report, COVID-19 (Patient got COVID after receiving vaccine) 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.   No concomitant medication reported. No treatment was provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Influenza like illness
Clinical narrative: flu-like symptoms; felt very cold; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING COLD (felt very cold) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING COLD (felt very cold) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING COLD (felt very cold) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD-2021-038496, MOD-2021-029671, MOD-2021-038923, MOD-2021-038934 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: No specific follow-up information recorded. This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021. The most recent information was received on 10-Mar-2021 and was forwarded to Moderna on 10-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING COLD (felt very cold) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING COLD (felt very cold) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING COLD (felt very cold) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD-2021-038496, MOD-2021-029671, MOD-2021-038923, MOD-2021-038934 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: No specific follow-up information recorded.; Sender's Comments:  MOD-2021-038496:Reporter's friend MOD-2021-029671:Reporter's first injection MOD-2021-038923:Reporter's second injection MOD-2021-038934:Reporter's husband
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Nausea
Clinical narrative: Sinus congestion; Feels terrible; Sore arm; Headache; Fever; Chills; Nausea; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID in may and was hospitalized for 19 days for the disease.) in May 2020. Concomitant products included ATORVASTATIN for Cholesterol.    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 NAUSEA (Nausea). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) with FEELING ABNORMAL (Feels terrible) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Mar-2021, NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No new information appended
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Sinus congestion
Clinical narrative: Sinus congestion; Feels terrible; Sore arm; Headache; Fever; Chills; Nausea; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID in may and was hospitalized for 19 days for the disease.) in May 2020. Concomitant products included ATORVASTATIN for Cholesterol.    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 NAUSEA (Nausea). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) with FEELING ABNORMAL (Feels terrible) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Mar-2021, NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No new information appended
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Pruritus
Clinical narrative: Foot is Itchy; Foot Numb; Foot Stinging; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Foot is Itchy), HYPOAESTHESIA (Foot Numb) and PAIN (Foot Stinging) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Guillain Barre syndrome.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PRURITUS (Foot is Itchy), HYPOAESTHESIA (Foot Numb) and PAIN (Foot Stinging). At the time of the report, PRURITUS (Foot is Itchy), HYPOAESTHESIA (Foot Numb) and PAIN (Foot Stinging) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Product use was not provided. Treatment information was not provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Malaise, Muscular weakness, Pyrexia
Clinical narrative: fever of 101 degrees Fahrenheit; she felt bad and exhausted; she felt bad and exhausted; she slept for 18 hours; her legs are really weak; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101 degrees Fahrenheit), MALAISE (she felt bad and exhausted), FATIGUE (she felt bad and exhausted), HYPERSOMNIA (she slept for 18 hours) and MUSCULAR WEAKNESS (her legs are really weak) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 antibody test positive (Treated with Remdesivir.) on 05-Feb-2021 and Weakness generalised.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PYREXIA (fever of 101 degrees Fahrenheit), MALAISE (she felt bad and exhausted), FATIGUE (she felt bad and exhausted), HYPERSOMNIA (she slept for 18 hours) and MUSCULAR WEAKNESS (her legs are really weak). The patient was treated with REMDESIVIR at an unspecified dose and frequency. At the time of the report, PYREXIA (fever of 101 degrees Fahrenheit), MALAISE (she felt bad and exhausted), FATIGUE (she felt bad and exhausted), HYPERSOMNIA (she slept for 18 hours) and MUSCULAR WEAKNESS (her legs are really weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were included.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: somewhat hard; redness; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (somewhat hard), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE INDURATION (somewhat hard) and VACCINATION SITE SWELLING (swollen). 18-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (somewhat hard), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swollen) outcome was unknown.            Concomitant products was not reported by the reporter.   This case was linked to MOD-2021-018417 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site pain
Clinical narrative: Second injection was given way up high, right behind the top of the shoulder.; Very sore arm, painful to lift the arm; A spontaneous report was received from a reporter (consumer) concerning a concerning  female patient of unspecified age , who received Moderna's COVID-19 vaccine (mRNA-1273) and for the patient, second injection was given way up high, right behind the top of the shoulder and very sore arm/painful to lift the arm.  The patient's medical history was not provided .Concomitant medications were not provided.  On an unspecified date, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot/batch: unknown) for prophylaxis of COVID-19 infection.   On an unspecified date, second injection was given way up high, right behind the top of the shoulder and patient experienced event very sore arm and painful to lift the arm .  Laboratory details was not provided . Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.    At the time of report, outcome of events incorrect route of product administration, vaccination site pain was resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with reported event of vaccination site pain.; Sender's Comments:  MOD-2021-038934:Reporter's Husband MOD-2021-038496:Reporter's Friend MOD-2021-038840:Reporter's Friend