chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Lethargy, Myalgia
Clinical narrative: Lethargy/extreme fatigue; Terrible headache; Nausea; Severe sick to stomach; Chills; Body aches; Left arm extremely red and huge egg shaped mark down to elbow; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Severe sick to stomach), LETHARGY (Lethargy/extreme fatigue), CHILLS (Chills), MYALGIA (Body aches) and VACCINATION SITE ERYTHEMA (Left arm extremely red and huge egg shaped mark down to elbow) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010AZ1A and 042C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history information was reported.  Concomitant products included ETANERCEPT (ENBREL) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Severe sick to stomach), CHILLS (Chills), MYALGIA (Body aches) and VACCINATION SITE ERYTHEMA (Left arm extremely red and huge egg shaped mark down to elbow). On 10-Mar-2021, the patient experienced LETHARGY (Lethargy/extreme fatigue), HEADACHE (Terrible headache) and NAUSEA (Nausea). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, ABDOMINAL PAIN UPPER (Severe sick to stomach), LETHARGY (Lethargy/extreme fatigue), CHILLS (Chills), MYALGIA (Body aches), VACCINATION SITE ERYTHEMA (Left arm extremely red and huge egg shaped mark down to elbow), HEADACHE (Terrible headache) and NAUSEA (Nausea) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments     Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received on 06-Jul-2021 contains no new information.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site erythema
Clinical narrative: Lethargy/extreme fatigue; Terrible headache; Nausea; Severe sick to stomach; Chills; Body aches; Left arm extremely red and huge egg shaped mark down to elbow; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Severe sick to stomach), LETHARGY (Lethargy/extreme fatigue), CHILLS (Chills), MYALGIA (Body aches) and VACCINATION SITE ERYTHEMA (Left arm extremely red and huge egg shaped mark down to elbow) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010AZ1A and 042C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history information was reported.  Concomitant products included ETANERCEPT (ENBREL) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Severe sick to stomach), CHILLS (Chills), MYALGIA (Body aches) and VACCINATION SITE ERYTHEMA (Left arm extremely red and huge egg shaped mark down to elbow). On 10-Mar-2021, the patient experienced LETHARGY (Lethargy/extreme fatigue), HEADACHE (Terrible headache) and NAUSEA (Nausea). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, ABDOMINAL PAIN UPPER (Severe sick to stomach), LETHARGY (Lethargy/extreme fatigue), CHILLS (Chills), MYALGIA (Body aches), VACCINATION SITE ERYTHEMA (Left arm extremely red and huge egg shaped mark down to elbow), HEADACHE (Terrible headache) and NAUSEA (Nausea) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments     Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received on 06-Jul-2021 contains no new information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Vaccination site erythema
Clinical narrative: it is hot,; My arm at the injection site swelled up; It was red, sore,and around 6 in.; It was red, sore,and around 6 in./painful.; Horrible headache; Vomiting; Nausea; Chills; Fever; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (it is hot,), VACCINATION SITE SWELLING (My arm at the injection site swelled up), VACCINATION SITE ERYTHEMA (It was red, sore,and around 6 in.), VACCINATION SITE PAIN (It was red, sore,and around 6 in./painful.) and HEADACHE (Horrible headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 026L22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history.  The patient's past medical history included No adverse event (no medical history.). Concomitant products included LOVASTATIN (LOVAX) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE SWELLING (My arm at the injection site swelled up), VACCINATION SITE ERYTHEMA (It was red, sore,and around 6 in.), VACCINATION SITE PAIN (It was red, sore,and around 6 in./painful.), HEADACHE (Horrible headache), VOMITING (Vomiting), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced VACCINATION SITE WARMTH (it is hot,). At the time of the report, VACCINATION SITE WARMTH (it is hot,), VACCINATION SITE SWELLING (My arm at the injection site swelled up), VACCINATION SITE ERYTHEMA (It was red, sore,and around 6 in.), VACCINATION SITE PAIN (It was red, sore,and around 6 in./painful.), HEADACHE (Horrible headache), VOMITING (Vomiting), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included Advil, Zyrtec and Benadryl.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth, Vomiting
Clinical narrative: it is hot,; My arm at the injection site swelled up; It was red, sore,and around 6 in.; It was red, sore,and around 6 in./painful.; Horrible headache; Vomiting; Nausea; Chills; Fever; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (it is hot,), VACCINATION SITE SWELLING (My arm at the injection site swelled up), VACCINATION SITE ERYTHEMA (It was red, sore,and around 6 in.), VACCINATION SITE PAIN (It was red, sore,and around 6 in./painful.) and HEADACHE (Horrible headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 026L22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history.  The patient's past medical history included No adverse event (no medical history.). Concomitant products included LOVASTATIN (LOVAX) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE SWELLING (My arm at the injection site swelled up), VACCINATION SITE ERYTHEMA (It was red, sore,and around 6 in.), VACCINATION SITE PAIN (It was red, sore,and around 6 in./painful.), HEADACHE (Horrible headache), VOMITING (Vomiting), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced VACCINATION SITE WARMTH (it is hot,). At the time of the report, VACCINATION SITE WARMTH (it is hot,), VACCINATION SITE SWELLING (My arm at the injection site swelled up), VACCINATION SITE ERYTHEMA (It was red, sore,and around 6 in.), VACCINATION SITE PAIN (It was red, sore,and around 6 in./painful.), HEADACHE (Horrible headache), VOMITING (Vomiting), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included Advil, Zyrtec and Benadryl.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Throat irritation; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Throat irritation) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 075A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced THROAT IRRITATION (Throat irritation). On 01-Mar-2021, THROAT IRRITATION (Throat irritation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were  reported No treatment medication were reported   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Report was received on 09 July 2021 and contains information on the event outcome getting updated from unknown to resolved and about receiving the second dose.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm; itching; swelling; redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) 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 05-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizzy; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and NAUSEA (Nauseous) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included INSULIN DETEMIR (LEVEMIR), INSULIN ASPART (NOVOLOG), LISINOPRIL, OMEPRAZOLE, AMLODIPINE and BUDESONIDE for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced DIZZINESS (Dizzy) and NAUSEA (Nauseous). On 14-Mar-2021, DIZZINESS (Dizzy) and NAUSEA (Nauseous) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment Medication was available.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Neck pain
Clinical narrative: severe neck pain leading to injection site; injection site pain; some shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (severe neck pain leading to injection site), INJECTION SITE PAIN (injection site pain) and ARTHRALGIA (some shoulder pain) in a 63-year-old female 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) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced NECK PAIN (severe neck pain leading to injection site), INJECTION SITE PAIN (injection site pain) and ARTHRALGIA (some shoulder pain). On 11-Mar-2021, INJECTION SITE PAIN (injection site pain) had resolved. At the time of the report, NECK PAIN (severe neck pain leading to injection site) and ARTHRALGIA (some shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (had a reaction) in a female 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (had a reaction). At the time of the report, ADVERSE EVENT (had a reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Eye infection, Eye pain, Eye swelling, Ocular hyperaemia
Clinical narrative: Swelling eye; Red eye; Sore on the eye; Fluid under eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swelling eye), OCULAR HYPERAEMIA (Red eye), EYE PAIN (Sore on the eye) and EYE INFECTION (Fluid under eye) 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 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced EYE SWELLING (Swelling eye), OCULAR HYPERAEMIA (Red eye), EYE PAIN (Sore on the eye) and EYE INFECTION (Fluid under eye). At the time of the report, EYE SWELLING (Swelling eye), OCULAR HYPERAEMIA (Red eye), EYE PAIN (Sore on the eye) and EYE INFECTION (Fluid under eye) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment taken was Antibiotic cream.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Fatigue, Limb discomfort
Clinical narrative: Diarrhoea; cold /Freezing; Severe stomach cramps; Feeling given very high on the arm; Tired /  feels that she is not 100%.; Muscle pain; Shoulder pain; Pain on to the bottom of the neck line; Awful pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain on to the bottom of the neck line), DIARRHOEA (Diarrhoea), NASOPHARYNGITIS (cold /Freezing), ABDOMINAL PAIN UPPER (Severe stomach cramps) and LIMB DISCOMFORT (Feeling given very high on the arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history.  The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (COZAAR) and METFORMIN for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (Awful pain). On 13-Mar-2021, the patient experienced NECK PAIN (Pain on to the bottom of the neck line), FATIGUE (Tired /  feels that she is not 100%.), MYALGIA (Muscle pain) and ARTHRALGIA (Shoulder pain). On 14-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), NASOPHARYNGITIS (cold /Freezing), ABDOMINAL PAIN UPPER (Severe stomach cramps) and LIMB DISCOMFORT (Feeling given very high on the arm). At the time of the report, NECK PAIN (Pain on to the bottom of the neck line), DIARRHOEA (Diarrhoea), NASOPHARYNGITIS (cold /Freezing), ABDOMINAL PAIN UPPER (Severe stomach cramps), LIMB DISCOMFORT (Feeling given very high on the arm), PAIN (Awful pain), FATIGUE (Tired /  feels that she is not 100%.), MYALGIA (Muscle pain) and ARTHRALGIA (Shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Neck pain, Pain
Clinical narrative: Diarrhoea; cold /Freezing; Severe stomach cramps; Feeling given very high on the arm; Tired /  feels that she is not 100%.; Muscle pain; Shoulder pain; Pain on to the bottom of the neck line; Awful pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain on to the bottom of the neck line), DIARRHOEA (Diarrhoea), NASOPHARYNGITIS (cold /Freezing), ABDOMINAL PAIN UPPER (Severe stomach cramps) and LIMB DISCOMFORT (Feeling given very high on the arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history.  The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (COZAAR) and METFORMIN for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (Awful pain). On 13-Mar-2021, the patient experienced NECK PAIN (Pain on to the bottom of the neck line), FATIGUE (Tired /  feels that she is not 100%.), MYALGIA (Muscle pain) and ARTHRALGIA (Shoulder pain). On 14-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), NASOPHARYNGITIS (cold /Freezing), ABDOMINAL PAIN UPPER (Severe stomach cramps) and LIMB DISCOMFORT (Feeling given very high on the arm). At the time of the report, NECK PAIN (Pain on to the bottom of the neck line), DIARRHOEA (Diarrhoea), NASOPHARYNGITIS (cold /Freezing), ABDOMINAL PAIN UPPER (Severe stomach cramps), LIMB DISCOMFORT (Feeling given very high on the arm), PAIN (Awful pain), FATIGUE (Tired /  feels that she is not 100%.), MYALGIA (Muscle pain) and ARTHRALGIA (Shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Vaccination site haemorrhage
Clinical narrative: bled a bit after getting the vaccine administered.; may not have received the full dose; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bled a bit after getting the vaccine administered.) and UNDERDOSE (may not have received the full dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-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 13-Mar-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bled a bit after getting the vaccine administered.) and UNDERDOSE (may not have received the full dose). On 13-Mar-2021, VACCINATION SITE HAEMORRHAGE (bled a bit after getting the vaccine administered.) and UNDERDOSE (may not have received the full dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient have event like  bled all the way through the entire bandage and the bandage was soaked with blood. Concomitant medication was not provided. Treatment information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Additional information received on 07 May 2021, No New Information was provided. On 07-Jul-2021: Follow-up received on 07 July 2021 and contains non significant information
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history.  The patient's past medical history included No adverse event. Concomitant products included VITAMINS NOS for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Heart pulse is racing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Heart pulse is racing) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced HEART RATE INCREASED (Heart pulse is racing). At the time of the report, HEART RATE INCREASED (Heart pulse is racing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid-19) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VITAMINS NOS for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Patient felt little headache for the whole entire day for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Patient felt little headache for the whole entire day for 3 days) in a 66-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 No adverse event. Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 11-Mar-2021, the patient experienced HEADACHE (Patient felt little headache for the whole entire day for 3 days). At the time of the report, HEADACHE (Patient felt little headache for the whole entire day for 3 days) had resolved.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis
Clinical narrative: having the shakes; cold; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (having the shakes) and NASOPHARYNGITIS (cold) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced CHILLS (having the shakes) and NASOPHARYNGITIS (cold). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (having the shakes) and NASOPHARYNGITIS (cold) outcome was unknown. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Eye colour change, Pain in extremity, Visual impairment
Clinical narrative: weak; arm hurt; Every time I move her eyes they follow me; there was brown sharpie lines in both eyes/right eye has halos or brown cobwebs; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), PAIN IN EXTREMITY (arm hurt), VISUAL IMPAIRMENT (Every time I move her eyes they follow me) and EYE COLOUR CHANGE (there was brown sharpie lines in both eyes/right eye has halos or brown cobwebs) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN, ELDERBERRY [SAMBUCUS NIGRA] and MAGNESIUM.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced EYE COLOUR CHANGE (there was brown sharpie lines in both eyes/right eye has halos or brown cobwebs). On 14-Mar-2021, the patient experienced ASTHENIA (weak), PAIN IN EXTREMITY (arm hurt) and VISUAL IMPAIRMENT (Every time I move her eyes they follow me). At the time of the report, ASTHENIA (weak), PAIN IN EXTREMITY (arm hurt), VISUAL IMPAIRMENT (Every time I move her eyes they follow me) and EYE COLOUR CHANGE (there was brown sharpie lines in both eyes/right eye has halos or brown cobwebs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm was sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm was sore at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A, 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (left arm was sore at injection site). At the time of the report, VACCINATION SITE PAIN (left arm was sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-053888, MOD-2021-044440 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: She experienced soreness of arm; She experienced rash on her feet; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She experienced soreness of arm) and RASH (She experienced rash on her feet) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (She experienced soreness of arm) and RASH (She experienced rash on her feet). On 09-Mar-2021, PAIN IN EXTREMITY (She experienced soreness of arm) had resolved. At the time of the report, RASH (She experienced rash on her feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Patient applied Benadryl cream on her rash.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness, Myalgia, Nausea
Clinical narrative: Flu like symptoms; Light headed; felt nauseous; Aches and body pains; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Light headed), NAUSEA (felt nauseous) and MYALGIA (Aches and body pains) in a 72-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Light headed), NAUSEA (felt nauseous) and MYALGIA (Aches and body pains). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Light headed), NAUSEA (felt nauseous) and MYALGIA (Aches and body pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications were reported. Treatment medications were not provided
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: Diarrhea; Nausea; Headache; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), HEADACHE (Headache), MYALGIA (Muscle aches) and NAUSEA (Nausea) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Muscle aches). On 15-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea), HEADACHE (Headache), MYALGIA (Muscle aches) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications reported by reporter. Treatment medication not reported.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Sore in the back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Sore 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced BACK PAIN (Sore in the back). At the time of the report, BACK PAIN (Sore in the back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. Treatment medication was not provided. Patient said that received the first dose a month ago and stated that this ache could not be due to the vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Hyperhidrosis, Throat irritation
Clinical narrative: Severe sweating; Itchy feeling in throat; Aching in bones; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Severe sweating), THROAT IRRITATION (Itchy feeling in throat), BONE PAIN (Aching in bones) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced HYPERHIDROSIS (Severe sweating), THROAT IRRITATION (Itchy feeling in throat), BONE PAIN (Aching in bones) and CHILLS (Chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Severe sweating), THROAT IRRITATION (Itchy feeling in throat), BONE PAIN (Aching in bones) and CHILLS (Chills) outcome was unknown.            No concomitant medications were provided.  For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Eating disorder symptom, Injection site pain, Myalgia, Nausea
Clinical narrative: Couldn't eat.; Back was sore; Nausea; Fever of 100.9F; Felt achy all over; sore arm at injection site for a day; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER SYMPTOM (Couldn't eat.), PAIN (Back was sore), INJECTION SITE PAIN (sore arm at injection site for a day), NAUSEA (Nausea) and PYREXIA (Fever of 100.9F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had mild form of Covid 19,not hospitalized.) in November 2020.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced INJECTION SITE PAIN (sore arm at injection site for a day). On 14-Mar-2021, the patient experienced EATING DISORDER SYMPTOM (Couldn't eat.), PAIN (Back was sore), NAUSEA (Nausea), PYREXIA (Fever of 100.9F) and MYALGIA (Felt achy all over). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Mar-2021, INJECTION SITE PAIN (sore arm at injection site for a day) had resolved. On 15-Mar-2021, EATING DISORDER SYMPTOM (Couldn't eat.), PAIN (Back was sore), NAUSEA (Nausea), PYREXIA (Fever of 100.9F) and MYALGIA (Felt achy all over) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: 100.9 (High) Fever at 100.9 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Couldn't eat.; Back was sore; Nausea; Fever of 100.9F; Felt achy all over; sore arm at injection site for a day; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER SYMPTOM (Couldn't eat.), PAIN (Back was sore), INJECTION SITE PAIN (sore arm at injection site for a day), NAUSEA (Nausea) and PYREXIA (Fever of 100.9F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had mild form of Covid 19,not hospitalized.) in November 2020.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced INJECTION SITE PAIN (sore arm at injection site for a day). On 14-Mar-2021, the patient experienced EATING DISORDER SYMPTOM (Couldn't eat.), PAIN (Back was sore), NAUSEA (Nausea), PYREXIA (Fever of 100.9F) and MYALGIA (Felt achy all over). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Mar-2021, INJECTION SITE PAIN (sore arm at injection site for a day) had resolved. On 15-Mar-2021, EATING DISORDER SYMPTOM (Couldn't eat.), PAIN (Back was sore), NAUSEA (Nausea), PYREXIA (Fever of 100.9F) and MYALGIA (Felt achy all over) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: 100.9 (High) Fever at 100.9 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a 78-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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was provided. Treatment medication was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm on arm of injection; itchy on arm of injection; rash on arm of injection; swollen on arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm on arm of injection), VACCINATION SITE PRURITUS (itchy on arm of injection), VACCINATION SITE RASH (rash on arm of injection) and VACCINATION SITE SWELLING (swollen on arm of injection) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FUROSEMIDE, METOPROLOL, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), GLIMEPIRIDE, METFORMIN, ESCITALOPRAM and ATORVASTATIN for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm on arm of injection), VACCINATION SITE PRURITUS (itchy on arm of injection), VACCINATION SITE RASH (rash on arm of injection) and VACCINATION SITE SWELLING (swollen on arm of injection). At the time of the report, VACCINATION SITE WARMTH (warm on arm of injection), VACCINATION SITE PRURITUS (itchy on arm of injection), VACCINATION SITE RASH (rash on arm of injection) and VACCINATION SITE SWELLING (swollen on arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspepsia, Dyspnoea, Peripheral swelling, Rash macular
Clinical narrative: Left Arm swollen, red , orange from inside; Red blotches on left arm with hurting of arm at injection site.; Burning in stomach; Red blotches on left arm with hurting of arm at injection site; Burning in chest; Difficulty in breathing; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left Arm swollen, red , orange from inside), RASH MACULAR (Red blotches on left arm with hurting of arm at injection site.), CHEST PAIN (Burning in chest), DYSPNOEA (Difficulty in breathing) and DYSPEPSIA (Burning in stomach) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 040AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced CHEST PAIN (Burning in chest) and DYSPNOEA (Difficulty in breathing). On 15-Mar-2021, the patient experienced PERIPHERAL SWELLING (Left Arm swollen, red , orange from inside), RASH MACULAR (Red blotches on left arm with hurting of arm at injection site.), DYSPEPSIA (Burning in stomach) and VACCINATION SITE PAIN (Red blotches on left arm with hurting of arm at injection site). At the time of the report, PERIPHERAL SWELLING (Left Arm swollen, red , orange from inside), RASH MACULAR (Red blotches on left arm with hurting of arm at injection site.), CHEST PAIN (Burning in chest), DYSPNOEA (Difficulty in breathing), DYSPEPSIA (Burning in stomach) and VACCINATION SITE PAIN (Red blotches on left arm with hurting of arm at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant products included CHOLESTEROL medication. Patient took Inhaler couple of times for burning in chest and difficulty in breathing.   This case was linked to MOD-2021-059394 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left Arm swollen, red , orange from inside; Red blotches on left arm with hurting of arm at injection site.; Burning in stomach; Red blotches on left arm with hurting of arm at injection site; Burning in chest; Difficulty in breathing; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left Arm swollen, red , orange from inside), RASH MACULAR (Red blotches on left arm with hurting of arm at injection site.), CHEST PAIN (Burning in chest), DYSPNOEA (Difficulty in breathing) and DYSPEPSIA (Burning in stomach) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 040AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced CHEST PAIN (Burning in chest) and DYSPNOEA (Difficulty in breathing). On 15-Mar-2021, the patient experienced PERIPHERAL SWELLING (Left Arm swollen, red , orange from inside), RASH MACULAR (Red blotches on left arm with hurting of arm at injection site.), DYSPEPSIA (Burning in stomach) and VACCINATION SITE PAIN (Red blotches on left arm with hurting of arm at injection site). At the time of the report, PERIPHERAL SWELLING (Left Arm swollen, red , orange from inside), RASH MACULAR (Red blotches on left arm with hurting of arm at injection site.), CHEST PAIN (Burning in chest), DYSPNOEA (Difficulty in breathing), DYSPEPSIA (Burning in stomach) and VACCINATION SITE PAIN (Red blotches on left arm with hurting of arm at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant products included CHOLESTEROL medication. Patient took Inhaler couple of times for burning in chest and difficulty in breathing.   This case was linked to MOD-2021-059394 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Headache, Pain
Clinical narrative: Felt like she had covid again; Body aches; Sore arm; Chills; Fever; Headaches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Felt like she had covid again), PAIN (Body aches), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020. Concomitant products included ROSUVASTATIN and VITAMINS NOS for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced COVID-19 (Felt like she had covid again), PAIN (Body aches), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headaches) and FATIGUE (Fatigue). At the time of the report, COVID-19 (Felt like she had covid again), PAIN (Body aches), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headaches) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Concomitant medications included  Seizure meds and Blood pressure meds.