chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: injection site was beet red; injection site was reallly hot; injection site was really hard; area around injection site itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site was beet red), VACCINATION SITE WARMTH (injection site was reallly hot), VACCINATION SITE INDURATION (injection site was really hard) and VACCINATION SITE PRURITUS (area around injection site itchy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site was beet red), VACCINATION SITE WARMTH (injection site was reallly hot), VACCINATION SITE INDURATION (injection site was really hard) and VACCINATION SITE PRURITUS (area around injection site itchy). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (injection site was beet red), VACCINATION SITE WARMTH (injection site was reallly hot), VACCINATION SITE INDURATION (injection site was really hard) and VACCINATION SITE PRURITUS (area around injection site itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Injection site pain, Myalgia, Pruritus
Clinical narrative: Itchiness; Redness; Swelling; Pain at injection site; Body Aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), ERYTHEMA (Redness), SWELLING (Swelling), INJECTION SITE PAIN (Pain at injection site) and MYALGIA (Body Aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 PRURITUS (Itchiness), ERYTHEMA (Redness), SWELLING (Swelling), INJECTION SITE PAIN (Pain at injection site), MYALGIA (Body Aches) and CHILLS (chills). At the time of the report, PRURITUS (Itchiness), ERYTHEMA (Redness), SWELLING (Swelling), INJECTION SITE PAIN (Pain at injection site), MYALGIA (Body Aches) and CHILLS (chills) outcome was unknown.            Benadryl used for treatment.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Itchiness; Redness; Swelling; Pain at injection site; Body Aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), ERYTHEMA (Redness), SWELLING (Swelling), INJECTION SITE PAIN (Pain at injection site) and MYALGIA (Body Aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 PRURITUS (Itchiness), ERYTHEMA (Redness), SWELLING (Swelling), INJECTION SITE PAIN (Pain at injection site), MYALGIA (Body Aches) and CHILLS (chills). At the time of the report, PRURITUS (Itchiness), ERYTHEMA (Redness), SWELLING (Swelling), INJECTION SITE PAIN (Pain at injection site), MYALGIA (Body Aches) and CHILLS (chills) outcome was unknown.            Benadryl used for treatment.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (pounding headache) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HEADACHE (pounding headache). At the time of the report, HEADACHE (pounding headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hot flush, Myalgia, Vomiting
Clinical narrative: vomiting; fatigue; muscle aches; chills; increased hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle aches), CHILLS (chills), HOT FLUSH (increased hot flashes) and VOMITING (vomiting) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included INFLIXIMAB (REMICADE), METHOTREXATE and TRAMADOL for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle aches), CHILLS (chills) and HOT FLUSH (increased hot flashes). On 01-Mar-2021, the patient experienced VOMITING (vomiting). At the time of the report, FATIGUE (fatigue), MYALGIA (muscle aches), CHILLS (chills), HOT FLUSH (increased hot flashes) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Borderline(Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN (Borderline bodyache) and HEADACHE (Borderline headache). The patient was treated with PARACETAMOL (TYLENOL) on 01-Mar-2021 for Headache and General body pain, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) on 02-Mar-2021 for Headache and General body pain, at a dose of 1 dosage form. At the time of the report, PAIN (Borderline bodyache) outcome was unknown and HEADACHE (Borderline headache) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heart rate, Pyrexia, Tachycardia
Clinical narrative: Increased Heart Rate - 90-100 BPM; Chills; Fever - Temperature of 101.5G; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Increased Heart Rate - 90-100 BPM), CHILLS (Chills) and PYREXIA (Fever - Temperature of 101.5G) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 030L20A) 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 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced TACHYCARDIA (Increased Heart Rate - 90-100 BPM), CHILLS (Chills) and PYREXIA (Fever - Temperature of 101.5G). At the time of the report, TACHYCARDIA (Increased Heart Rate - 90-100 BPM), CHILLS (Chills) and PYREXIA (Fever - Temperature of 101.5G) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: high (High) 101.5.. On 03-Mar-2021, Heart rate: high (High) 90-100 BPM..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided. List of concomitant medication were not given.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Wheezing
Clinical narrative: Sluggish; Feeling wheezy; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Feeling wheezy) and SLUGGISHNESS (Sluggish) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Light Asthma).   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced WHEEZING (Feeling wheezy). On 20-Feb-2021, the patient experienced SLUGGISHNESS (Sluggish). At the time of the report, WHEEZING (Feeling wheezy) and SLUGGISHNESS (Sluggish) had resolved.            No concomitant medications were provided. Treatment medication included inhaler.   This case was linked to US-MODERNATX, INC.-MOD-2021-034258 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-034258:Linked, Same reporter,case of daughter
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Lymphadenopathy
Clinical narrative: Mayor constipation; Swollen lymph node in his stomach area; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    A spontaneous report was received from a consumer concerning a 76-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Mayor constipation, swollen lymph node in his stomach area.  The patient's medical history was not provided. relevant concomitant products usage were not reported by the reporter.  On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unk) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 23 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unk) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, Mayor constipation, swollen lymph node in his stomach area.  No treatment information was provided.  The patient received both scheduled doses of mRNA 1273 before the events, therefore Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, Mayor constipation, swollen lymph node in his stomach area was unknown.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fall
Clinical narrative: Fell last night; Doesn't feel strength on his legs and arms; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell last night) and ASTHENIA (Doesn't feel strength on his legs and arms) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced FALL (Fell last night) and ASTHENIA (Doesn't feel strength on his legs and arms). At the time of the report, FALL (Fell last night) and ASTHENIA (Doesn't feel strength on his legs and arms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       After receiving vaccine, the patient fell down and doesn't have strength on his legs and arms. Now the patient is walking with the help of a walker.  Concomitant medications were not reported.  No treatment details were provided; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hot flush, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: redness; hot flushes 2 inches below site of injection; swelling in his arm; itching; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in his arm), PRURITUS (itching), PAIN IN EXTREMITY (arm hurt), ERYTHEMA (redness) and HOT FLUSH (hot flushes 2 inches below site of injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided.     On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling in his arm), PRURITUS (itching) and PAIN IN EXTREMITY (arm hurt). On 26-Feb-2021, the patient experienced ERYTHEMA (redness) and HOT FLUSH (hot flushes 2 inches below site of injection). At the time of the report, PERIPHERAL SWELLING (swelling in his arm), PRURITUS (itching), PAIN IN EXTREMITY (arm hurt), ERYTHEMA (redness) and HOT FLUSH (hot flushes 2 inches below site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicine No treatment medicine   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Non-significant-contact information updated, follow up appended
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Eye pain, Head discomfort, Headache, Urticaria
Clinical narrative: m blood pressure increased and went up very high to 146/106; hive on stomach for one day; headache; red blotch on arm; pressure on back of head; pain in back of eye; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (m blood pressure increased and went up very high to 146/106), URTICARIA (hive on stomach for one day), HEADACHE (headache), VACCINATION SITE RASH (red blotch on arm) and HEAD DISCOMFORT (pressure on back of head) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included CELECOXIB (CELEBREX), LISINOPRIL, WARFARIN, ALLOPURINOL, METOPROLOL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (m blood pressure increased and went up very high to 146/106), URTICARIA (hive on stomach for one day), HEADACHE (headache), VACCINATION SITE RASH (red blotch on arm), HEAD DISCOMFORT (pressure on back of head) and EYE PAIN (pain in back of eye). The patient was treated with SUMATRIPTAN SUCCINATE (IMITREX DF) at an unspecified dose and frequency. On 31-Jan-2021, URTICARIA (hive on stomach for one day) outcome was unknown. At the time of the report, BLOOD PRESSURE INCREASED (m blood pressure increased and went up very high to 146/106), HEADACHE (headache), VACCINATION SITE RASH (red blotch on arm), HEAD DISCOMFORT (pressure on back of head) and EYE PAIN (pain in back of eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: m blood pressure increased and went up very high to 146/106; hive on stomach for one day; headache; red blotch on arm; pressure on back of head; pain in back of eye; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (m blood pressure increased and went up very high to 146/106), URTICARIA (hive on stomach for one day), HEADACHE (headache), VACCINATION SITE RASH (red blotch on arm) and HEAD DISCOMFORT (pressure on back of head) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included CELECOXIB (CELEBREX), LISINOPRIL, WARFARIN, ALLOPURINOL, METOPROLOL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (m blood pressure increased and went up very high to 146/106), URTICARIA (hive on stomach for one day), HEADACHE (headache), VACCINATION SITE RASH (red blotch on arm), HEAD DISCOMFORT (pressure on back of head) and EYE PAIN (pain in back of eye). The patient was treated with SUMATRIPTAN SUCCINATE (IMITREX DF) at an unspecified dose and frequency. On 31-Jan-2021, URTICARIA (hive on stomach for one day) outcome was unknown. At the time of the report, BLOOD PRESSURE INCREASED (m blood pressure increased and went up very high to 146/106), HEADACHE (headache), VACCINATION SITE RASH (red blotch on arm), HEAD DISCOMFORT (pressure on back of head) and EYE PAIN (pain in back of eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; A spontaneous report was received from a 69-years-old  female patient concerning herself  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 2 Mar 2021, the patient experienced the event chills.  Treatment details included acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, chills was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) and HEADACHE (Headaches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches) and HEADACHE (Headaches). At the time of the report, PAIN (Body aches) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications taken by the patient were not provided. Treatment activities for event was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Feeling hot, Headache, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (fever, didn't checked it but feels really hot ), DECREASED APPETITE (Lost the appetite), PAIN (Body aches), PYREXIA (fever, didn't checked it but feels really hot) and CHILLS (Chills) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history 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 FEELING HOT (fever, didn't checked it but feels really hot ), PYREXIA (fever, didn't checked it but feels really hot) and HEADACHE (headaches). On 02-Mar-2021, the patient experienced DECREASED APPETITE (Lost the appetite) and NAUSEA (Nausea). In March 2021, the patient experienced PAIN (Body aches) and CHILLS (Chills). At the time of the report, FEELING HOT (fever, didn't checked it but feels really hot ), PAIN (Body aches), PYREXIA (fever, didn't checked it but feels really hot), CHILLS (Chills) and HEADACHE (headaches) outcome was unknown and DECREASED APPETITE (Lost the appetite) and NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD21-043005 (E2B Linked Report).; Sender's Comments:  MOD21-043005:same patient and reporter.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (fever, didn't checked it but feels really hot ), DECREASED APPETITE (Lost the appetite), PAIN (Body aches), PYREXIA (fever, didn't checked it but feels really hot) and CHILLS (Chills) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history 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 FEELING HOT (fever, didn't checked it but feels really hot ), PYREXIA (fever, didn't checked it but feels really hot) and HEADACHE (headaches). On 02-Mar-2021, the patient experienced DECREASED APPETITE (Lost the appetite) and NAUSEA (Nausea). In March 2021, the patient experienced PAIN (Body aches) and CHILLS (Chills). At the time of the report, FEELING HOT (fever, didn't checked it but feels really hot ), PAIN (Body aches), PYREXIA (fever, didn't checked it but feels really hot), CHILLS (Chills) and HEADACHE (headaches) outcome was unknown and DECREASED APPETITE (Lost the appetite) and NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD21-043005 (E2B Linked Report).; Sender's Comments:  MOD21-043005:same patient and reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain in extremity
Clinical narrative: My arm is still sore; Stomach cramps/very uncomfortable pain and felt like a menstrual cramps; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm is still sore) and ABDOMINAL PAIN UPPER (Stomach cramps/very uncomfortable pain and felt like a menstrual cramps) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (My arm is still sore) and ABDOMINAL PAIN UPPER (Stomach cramps/very uncomfortable pain and felt like a menstrual cramps). At the time of the report, PAIN IN EXTREMITY (My arm is still sore) and ABDOMINAL PAIN UPPER (Stomach cramps/very uncomfortable pain and felt like a menstrual cramps) had resolved. Not provided.      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.   This case was linked to MOD-2021-032185 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow up received on 16 JUL 2021 and event outcome updated.; Sender's Comments:  MOD-2021-032185:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Dizziness; fast heart beat; difficulty breathing; affecting me a lot already; muscle pain; headache; nausea; fatigue; Tendernesss in my right arm; A spontaneous report was received from a healthcare professional concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tenderness in right arm, dizziness, fast heart beat, difficulty breathing, muscle pain, fever, headache, nausea, fatigue, affecting lot already, lot of difficulty breathing.  The patient's medical history was not provided. Concomitant medications reported were Theophylline, Symbicort inhaler, salbutamol sulfate for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) tenderness in right arm, dizziness, fast heart beat, difficulty breathing, muscle pain, fever, headache, nausea, fatigue, affecting me a lot already, lot of difficulty breathing.  Treatment details included Aspirin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), tenderness in right arm, dizziness, fast heart beat, difficulty breathing, muscle pain, fever, headache, nausea, fatigue, affecting  lot already, lot of difficulty breathing was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia, Nausea, Tenderness
Clinical narrative: Dizziness; fast heart beat; difficulty breathing; affecting me a lot already; muscle pain; headache; nausea; fatigue; Tendernesss in my right arm; A spontaneous report was received from a healthcare professional concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tenderness in right arm, dizziness, fast heart beat, difficulty breathing, muscle pain, fever, headache, nausea, fatigue, affecting lot already, lot of difficulty breathing.  The patient's medical history was not provided. Concomitant medications reported were Theophylline, Symbicort inhaler, salbutamol sulfate for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) tenderness in right arm, dizziness, fast heart beat, difficulty breathing, muscle pain, fever, headache, nausea, fatigue, affecting me a lot already, lot of difficulty breathing.  Treatment details included Aspirin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), tenderness in right arm, dizziness, fast heart beat, difficulty breathing, muscle pain, fever, headache, nausea, fatigue, affecting  lot already, lot of difficulty breathing was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disorientation, Fatigue, Insomnia, Pain in extremity
Clinical narrative: chills; difficulty sleeping; pain in arm; fatigue; disoriented; fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), INSOMNIA (difficulty sleeping), PAIN IN EXTREMITY (pain in arm) and FATIGUE (fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (fever). On 27-Feb-2021, the patient experienced CHILLS (chills), INSOMNIA (difficulty sleeping), PAIN IN EXTREMITY (pain in arm), FATIGUE (fatigue) and DISORIENTATION (disoriented). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 28-Feb-2021, PYREXIA (fever), CHILLS (chills), INSOMNIA (difficulty sleeping), PAIN IN EXTREMITY (pain in arm), FATIGUE (fatigue) and DISORIENTATION (disoriented) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicine was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; difficulty sleeping; pain in arm; fatigue; disoriented; fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), INSOMNIA (difficulty sleeping), PAIN IN EXTREMITY (pain in arm) and FATIGUE (fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (fever). On 27-Feb-2021, the patient experienced CHILLS (chills), INSOMNIA (difficulty sleeping), PAIN IN EXTREMITY (pain in arm), FATIGUE (fatigue) and DISORIENTATION (disoriented). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 28-Feb-2021, PYREXIA (fever), CHILLS (chills), INSOMNIA (difficulty sleeping), PAIN IN EXTREMITY (pain in arm), FATIGUE (fatigue) and DISORIENTATION (disoriented) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicine was reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Mouth swelling
Clinical narrative: lips swelling; The tissue around the mouth and chin was swollen; A spontaneous report was received from a consumer (patient's caregiver) concerning a 85-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events lips swelling and the tissue around the mouth and chin was swollen.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly in right arm  for prophylaxis of COVID-19 infection.  On 26 Feb 2021, the patient experienced the event(s) lips swelling and the tissue around the mouth and chin was swollen.  Treatment details included antihistamine.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), lips swelling and the tissue around the mouth and chin was swollen was recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN (sore). At the time of the report, PAIN (sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site erythema, Vaccination site swelling
Clinical narrative: very, very dizzy; swelling at the area of the injection; redness at the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (very, very dizzy), VACCINATION SITE SWELLING (swelling at the area of the injection) and VACCINATION SITE ERYTHEMA (redness at the area of the injection) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) 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 VACCINATION SITE SWELLING (swelling at the area of the injection) and VACCINATION SITE ERYTHEMA (redness at the area of the injection). On 21-Feb-2021, the patient experienced DIZZINESS (very, very dizzy). On 21-Feb-2021, DIZZINESS (very, very dizzy) had resolved. On 22-Feb-2021, VACCINATION SITE SWELLING (swelling at the area of the injection) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (redness at the area of the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment details were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up received on 18th JUN 2021 contains no new information
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Oropharyngeal pain, Pain in extremity, Rash, Tongue eruption
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), DRY THROAT (dry throat), PAIN IN EXTREMITY (Sore arm), TONGUE ERUPTION (full body raised rash tongue and face) and RASH (full body raised rash tongue and face) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), DRY THROAT (dry throat), PAIN IN EXTREMITY (Sore arm), TONGUE ERUPTION (full body raised rash tongue and face) and RASH (full body raised rash tongue and face). At the time of the report, OROPHARYNGEAL PAIN (sore throat), DRY THROAT (dry throat), PAIN IN EXTREMITY (Sore arm), TONGUE ERUPTION (full body raised rash tongue and face) and RASH (full body raised rash tongue and face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: pregnancy patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy patient) in a 38-year-old female patient (gravida 4) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Gestational diabetes. Concomitant products included CITRANATAL HARMONY and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 02-Mar-2021 at 1:15 PM, 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. The patient's last menstrual period was on 23-Nov-2020 and the estimated date of delivery was 30-Aug-2021. On 02-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 02-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy patient) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Pregnancy test: positive (Positive) Positive.         Conception date of patient was on 05-Dec-2020. Number of fetus was found to be one.   On ??-Feb-2021, lab tests also included ultrasound scan and gluten tolerance, however the results were not provided.  Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: AstraZeneca as First Dose (clinical trial) and Moderna as Second dose; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (AstraZeneca as First Dose (clinical trial) and Moderna as Second dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced WRONG PRODUCT ADMINISTERED (AstraZeneca as First Dose (clinical trial) and Moderna as Second dose). On 13-Feb-2021, WRONG PRODUCT ADMINISTERED (AstraZeneca as First Dose (clinical trial) and Moderna as Second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13-JUL-2021 and contains no new significant information
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Very mild side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Very mild side effects) 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) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced ADVERSE REACTION (Very mild side effects). At the time of the report, ADVERSE REACTION (Very mild side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Dysgeusia, Fatigue, Headache
Clinical narrative: Taste the medication in her mouth; it was like a tinty taste or metal taste; Burning sensation on tongue; Pain at the injection site; Headache; Chills; Fatigue; Nausea; A spontaneous report was received from a consumer concerning herself of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced taste of the medication in her mouth; it was like a tinty taste or metal taste / dysgeusia, had burning sensation on the tongue / burning sensation, had pain at the injection site / vaccination site pain, headache, chills , fatigue and nausea.  The patient's medical history, as provided by the reporter, included cholesterol. Concomitant medications reported included cholesterol and estrogen medications.  On 26 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: 011M20A) via unknown route for prophylaxis of COVID-19 infection.   On 26 Feb 2021, the patient experienced event(s), felt the taste of the medication in her mouth; it was like a tinty taste or metal taste, had burning sensation on the tongue, had pain at the injection site, headache, chills , fatigue and nausea. The patient stated that she developed symptoms on the  way home from the hospital where she got the vaccine.   Treatment information included the use of acetaminophen.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) was not applicable.   The event felt the taste of medication in her mouth, it was like a tinty taste or metal taste, got resolved on 01 Mar 2021.  The outcome of event(s), had burning sensation on the tongue, had pain at the injection site, headache, chills, fatigue and nausea was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Taste the medication in her mouth; it was like a tinty taste or metal taste; Burning sensation on tongue; Pain at the injection site; Headache; Chills; Fatigue; Nausea; A spontaneous report was received from a consumer concerning herself of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced taste of the medication in her mouth; it was like a tinty taste or metal taste / dysgeusia, had burning sensation on the tongue / burning sensation, had pain at the injection site / vaccination site pain, headache, chills , fatigue and nausea.  The patient's medical history, as provided by the reporter, included cholesterol. Concomitant medications reported included cholesterol and estrogen medications.  On 26 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: 011M20A) via unknown route for prophylaxis of COVID-19 infection.   On 26 Feb 2021, the patient experienced event(s), felt the taste of the medication in her mouth; it was like a tinty taste or metal taste, had burning sensation on the tongue, had pain at the injection site, headache, chills , fatigue and nausea. The patient stated that she developed symptoms on the  way home from the hospital where she got the vaccine.   Treatment information included the use of acetaminophen.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) was not applicable.   The event felt the taste of medication in her mouth, it was like a tinty taste or metal taste, got resolved on 01 Mar 2021.  The outcome of event(s), had burning sensation on the tongue, had pain at the injection site, headache, chills, fatigue and nausea was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cluster headache, Feeling abnormal
Clinical narrative: Feels foggy/cloudy; Headaches every day since the 1st dose/headaches when coughs; A spontaneous report was received from a consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headaches every day since the 1st dose/headaches when coughs/cluster headache and feels foggy/cloudy/feeling abnormal.  The patient's medical history included allergies. Concomitant medications reported were fexofenadine hydrochloride, fluticasone propionate and eye drops.  On 05 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 010M20A) via unknown route for prophylaxis of COVID-19 infection.  On 05 Feb 2021 onwards, the patient is experiencing headaches every day. The patient also reported that, she had headaches when coughs and then felt foggy or cloudy.  Treatment details included Tylenol and naproxen.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event headache every day since the 1st dose was ongoing. The outcome of the events headaches when coughs and feels foggy/cloudy were unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Vaccination site pain
Clinical narrative: lost strings in her arm; sore arm had redness 8.5 in long and 3in wide and extend to back down her shoulder; minor sore on the day of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (minor sore on the day of injection), ERYTHEMA (sore arm had redness 8.5 in long and 3in wide and extend to back down her shoulder) and LIMB DISCOMFORT (lost strings in her arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (minor sore on the day of injection). On 08-Feb-2021, the patient experienced ERYTHEMA (sore arm had redness 8.5 in long and 3in wide and extend to back down her shoulder). On an unknown date, the patient experienced LIMB DISCOMFORT (lost strings in her arm). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (minor sore on the day of injection), ERYTHEMA (sore arm had redness 8.5 in long and 3in wide and extend to back down her shoulder) and LIMB DISCOMFORT (lost strings in her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over the body) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced RASH (Rash all over the body). At the time of the report, RASH (Rash all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Benadryl, Cortisone Cream.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: Minor headache; Gland swelling in his neck; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Minor headache) and LYMPHADENOPATHY (Gland swelling in his neck) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ALLOPURINOL for an unknown indication.    On 23-Feb-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 LYMPHADENOPATHY (Gland swelling in his neck). On an unknown date, the patient experienced HEADACHE (Minor headache). At the time of the report, HEADACHE (Minor headache) had resolved and LYMPHADENOPATHY (Gland swelling in his neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Treatment for the event headache was done with paracetamol.