chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery. Concurrent medical conditions included Blood pressure. Concomitant products included CARVEDILOL and VITAMINS NOS for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) had not resolved.            Treatment drug Tylenol when going to bed (did not specify the frequency)
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dysstasia, Fatigue, Hypoaesthesia, Pyrexia
Clinical narrative: Hard to get up; Numbness of lower extremities; Sneezing; Fever 99.9F; Fatigue; Pain and tenderness on the injection site; swelling (hardness) injection site; Redness on the injection site; swelling (hardness) injection site; A spontaneous report was received from a consumer concerning a 65-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hard to get up, numbness of lower extremities, sneezing, fatigue, pain and tenderness on injection site, vaccination site swelling, redness on the injection site and fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16-Feb -2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of Covid-19 infection.   The patient reported that she had pain, tenderness, swelling (hardness), redness on the injection site, severe fatigue, hard to get up, sneezing, fever 99.9F, and her lower extremities were numb. No further information was provided. Treatment information was unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, hard to get up, numbness of lower extremities, sneezing, fatigue, pain and tenderness on injection site, swelling injection site, redness on the injection site, and pyrexia were considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Hard to get up; Numbness of lower extremities; Sneezing; Fever 99.9F; Fatigue; Pain and tenderness on the injection site; swelling (hardness) injection site; Redness on the injection site; swelling (hardness) injection site; A spontaneous report was received from a consumer concerning a 65-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hard to get up, numbness of lower extremities, sneezing, fatigue, pain and tenderness on injection site, vaccination site swelling, redness on the injection site and fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16-Feb -2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of Covid-19 infection.   The patient reported that she had pain, tenderness, swelling (hardness), redness on the injection site, severe fatigue, hard to get up, sneezing, fever 99.9F, and her lower extremities were numb. No further information was provided. Treatment information was unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, hard to get up, numbness of lower extremities, sneezing, fatigue, pain and tenderness on injection site, swelling injection site, redness on the injection site, and pyrexia were considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tachycardia
Clinical narrative: Felt dizzy; Increased Heart Rate; Felt dizzy; Increased Heart Rate; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of DIZZINESS (Felt dizzy), the first episode of TACHYCARDIA (Increased Heart Rate), the second episode of DIZZINESS (Felt dizzy) and the second episode of TACHYCARDIA (Increased Heart Rate) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Blood disorder NOS (Blood Thinner).    On 12-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 the first episode of DIZZINESS (Felt dizzy) and the first episode of TACHYCARDIA (Increased Heart Rate). On 16-Feb-2021, the patient experienced the second episode of DIZZINESS (Felt dizzy) and the second episode of TACHYCARDIA (Increased Heart Rate). At the time of the report, last episode of DIZZINESS (Felt dizzy) and the last episode of TACHYCARDIA (Increased Heart Rate) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included unspecified blood pressure medication and blood thinners.  No treatment medications provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: started getting headaches everyday; the injection site was hurting; Injection site swollen, about 3 inches long on the arm; Injection site red; Injection site warm; Injection site Itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site Itchy), HEADACHE (started getting headaches everyday), VACCINATION SITE PAIN (the injection site was hurting) and VACCINATION SITE SWELLING (Injection site swollen, about 3 inches long on the arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE PAIN (the injection site was hurting), VACCINATION SITE SWELLING (Injection site swollen, about 3 inches long on the arm) and VACCINATION SITE ERYTHEMA (Injection site red). On an unknown date, the patient experienced HEADACHE (started getting headaches everyday). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE PAIN (the injection site was hurting) and VACCINATION SITE ERYTHEMA (Injection site red) had not resolved and HEADACHE (started getting headaches everyday) and VACCINATION SITE SWELLING (Injection site swollen, about 3 inches long on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included Tylenol about 3 times a day. The patient put ice and warm compress on the injection site.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: follow up received on 28-Apr-2021 included No new information was received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: started getting headaches everyday; the injection site was hurting; Injection site swollen, about 3 inches long on the arm; Injection site red; Injection site warm; Injection site Itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site Itchy), HEADACHE (started getting headaches everyday), VACCINATION SITE PAIN (the injection site was hurting) and VACCINATION SITE SWELLING (Injection site swollen, about 3 inches long on the arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE PAIN (the injection site was hurting), VACCINATION SITE SWELLING (Injection site swollen, about 3 inches long on the arm) and VACCINATION SITE ERYTHEMA (Injection site red). On an unknown date, the patient experienced HEADACHE (started getting headaches everyday). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE PAIN (the injection site was hurting) and VACCINATION SITE ERYTHEMA (Injection site red) had not resolved and HEADACHE (started getting headaches everyday) and VACCINATION SITE SWELLING (Injection site swollen, about 3 inches long on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included Tylenol about 3 times a day. The patient put ice and warm compress on the injection site.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: follow up received on 28-Apr-2021 included No new information was received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Headache; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and INJECTION SITE PAIN (Pain at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEADACHE (Headache) and INJECTION SITE PAIN (Pain at the injection site). At the time of the report, HEADACHE (Headache) and INJECTION SITE PAIN (Pain at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash got worse; rash covering her arm to her elbow and part of her shoulder; still itchy; rash at the injection site; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PRURITUS (itchy), RASH (rash got worse), RASH (rash covering her arm to her elbow and part of her shoulder) and PRURITUS (still itchy) in an 82-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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE PRURITUS (itchy). On 13-Feb-2021, the patient experienced RASH (rash got worse), RASH (rash covering her arm to her elbow and part of her shoulder) and PRURITUS (still itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PRURITUS (itchy), RASH (rash got worse), RASH (rash covering her arm to her elbow and part of her shoulder) and PRURITUS (still itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications included unspecified medications for blood pressure and cholesterol.  On 12-Feb-2021 she experienced a rash at the injection site that was itchy and on 13-Feb-2021 got worse, covering her arm to her elbow and part of her shoulder. It had been getting better every day and now is just a little pink but still itchy.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Muscle fatigue, Peripheral swelling
Clinical narrative: looks like an apple under my skin / Redness of the arm; Hotness; Covid arm with swelling; Swelling of arm; Soreness at injection site; Chills; Tired; low grade fever; Muscle fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (Muscle fatigue), ERYTHEMA (looks like an apple under my skin / Redness of the arm), VACCINATION SITE WARMTH (Hotness), PERIPHERAL SWELLING (Covid arm with swelling) and VACCINATION SITE SWELLING (Swelling of arm) in a 53-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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced MUSCLE FATIGUE (Muscle fatigue), VACCINATION SITE PAIN (Soreness at injection site), CHILLS (Chills), FATIGUE (Tired) and PYREXIA (low grade fever). On 16-Feb-2021, the patient experienced ERYTHEMA (looks like an apple under my skin / Redness of the arm), VACCINATION SITE WARMTH (Hotness), PERIPHERAL SWELLING (Covid arm with swelling) and VACCINATION SITE SWELLING (Swelling of arm). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. On 14-Feb-2021, PYREXIA (low grade fever) had resolved. At the time of the report, MUSCLE FATIGUE (Muscle fatigue), VACCINATION SITE PAIN (Soreness at injection site), CHILLS (Chills) and FATIGUE (Tired) had resolved and ERYTHEMA (looks like an apple under my skin / Redness of the arm), VACCINATION SITE WARMTH (Hotness), PERIPHERAL SWELLING (Covid arm with swelling) and VACCINATION SITE SWELLING (Swelling of arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: Follow-up information received on 17-Feb-2021 contains no new information.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: looks like an apple under my skin / Redness of the arm; Hotness; Covid arm with swelling; Swelling of arm; Soreness at injection site; Chills; Tired; low grade fever; Muscle fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (Muscle fatigue), ERYTHEMA (looks like an apple under my skin / Redness of the arm), VACCINATION SITE WARMTH (Hotness), PERIPHERAL SWELLING (Covid arm with swelling) and VACCINATION SITE SWELLING (Swelling of arm) in a 53-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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced MUSCLE FATIGUE (Muscle fatigue), VACCINATION SITE PAIN (Soreness at injection site), CHILLS (Chills), FATIGUE (Tired) and PYREXIA (low grade fever). On 16-Feb-2021, the patient experienced ERYTHEMA (looks like an apple under my skin / Redness of the arm), VACCINATION SITE WARMTH (Hotness), PERIPHERAL SWELLING (Covid arm with swelling) and VACCINATION SITE SWELLING (Swelling of arm). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. On 14-Feb-2021, PYREXIA (low grade fever) had resolved. At the time of the report, MUSCLE FATIGUE (Muscle fatigue), VACCINATION SITE PAIN (Soreness at injection site), CHILLS (Chills) and FATIGUE (Tired) had resolved and ERYTHEMA (looks like an apple under my skin / Redness of the arm), VACCINATION SITE WARMTH (Hotness), PERIPHERAL SWELLING (Covid arm with swelling) and VACCINATION SITE SWELLING (Swelling of arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: Follow-up information received on 17-Feb-2021 contains no new information.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: A rash at the injection; Swelling at the injection site; Severe itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (A rash at the injection), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PRURITUS (Severe itching at the injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D NOS, CALCIUM and MAGNESIUM for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE RASH (A rash at the injection), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PRURITUS (Severe itching at the injection site). The patient was treated with FLUOCINONIDE at a dose of UNK dosage form. On 31-Jan-2021, VACCINATION SITE RASH (A rash at the injection), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PRURITUS (Severe itching at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: top of both her arms had little red blisters and they were rough and slightly itchy; top of both her arms had little red blisters and they were rough and slightly itchy; top of both her arms had little red blisters and they were rough and slightly itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (top of both her arms had little red blisters and they were rough and slightly itchy), PRURITUS (top of both her arms had little red blisters and they were rough and slightly itchy) and BLISTER (top of both her arms had little red blisters and they were rough and slightly itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ERYTHEMA (top of both her arms had little red blisters and they were rough and slightly itchy), PRURITUS (top of both her arms had little red blisters and they were rough and slightly itchy) and BLISTER (top of both her arms had little red blisters and they were rough and slightly itchy). At the time of the report, ERYTHEMA (top of both her arms had little red blisters and they were rough and slightly itchy), PRURITUS (top of both her arms had little red blisters and they were rough and slightly itchy) and BLISTER (top of both her arms had little red blisters and they were rough and slightly itchy) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Treatment for asthma before and after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Treatment for asthma before and after getting the vaccine) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHMA (Treatment for asthma before and after getting the vaccine). The patient was treated with PREDNISONE ongoing since an unknown date for Asthma, at an unspecified dose and frequency; CORTISONE ongoing since an unknown date for Asthma, at an unspecified dose and frequency and MEPOLIZUMAB (NUCALA) ongoing since an unknown date for Asthma, at an unspecified dose and frequency. At the time of the report, ASTHMA (Treatment for asthma before and after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reporter by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Slight redness down his arm and most of his shoulder muscle; Still itches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Slight redness down his arm and most of his shoulder muscle) and PRURITUS (Still itches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) 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 02-Feb-2021, the patient experienced ERYTHEMA (Slight redness down his arm and most of his shoulder muscle) and PRURITUS (Still itches). At the time of the report, ERYTHEMA (Slight redness down his arm and most of his shoulder muscle) and PRURITUS (Still itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph Node on Neck not on the side of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph Node on Neck not on the side of the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph Node on Neck not on the side of the injection site). At the time of the report, LYMPHADENOPATHY (Lymph Node on Neck not on the side of the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and NAUSEA (nausea). At the time of the report, CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow-up was received on 25-MAY-2021,Email was updated
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient tested positive covid-19 next day the vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient tested positive covid-19 next day the vaccination) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced COVID-19 (Patient tested positive covid-19 next day the vaccination). At the time of the report, COVID-19 (Patient tested positive covid-19 next day the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site reaction, Injection site swelling, Pain in extremity
Clinical narrative: swollen area; redness; area of the injection was much lower than the first shot; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), INJECTION SITE SWELLING (swollen area), ERYTHEMA (redness) and INJECTION SITE REACTION (area of the injection was much lower than the first shot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE and METOPROLOL for blood pressure and thyroid. On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm sore). On 11-Feb-2021, the patient experienced INJECTION SITE SWELLING (swollen area), ERYTHEMA (redness) and INJECTION SITE REACTION (area of the injection was much lower than the first shot). At the time of the report, PAIN IN EXTREMITY (arm sore), INJECTION SITE SWELLING (swollen area), ERYTHEMA (redness) and INJECTION SITE REACTION (area of the injection was much lower than the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: symptoms after second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (symptoms after second dose) 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 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (symptoms after second dose). At the time of the report, VACCINATION COMPLICATION (symptoms after second dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination site movement impairment
Clinical narrative: Can hardly raise right arm; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can hardly raise right arm), HEADACHE (Headache) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to allopathic drugs (Allergic to Ibuprofen and Tylenol).    On 09-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021 at 8:00 PM, the patient experienced HEADACHE (Headache) and CHILLS (Chills). On 10-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can hardly raise right arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can hardly raise right arm), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reporter by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: soreness in left deltoid; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness in left deltoid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced MYALGIA (soreness in left deltoid). At the time of the report, MYALGIA (soreness in left deltoid) outcome was unknown.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-029003 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-029003:
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: "Much illness" from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("Much illness" from the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS ("Much illness" from the first dose). At the time of the report, ILLNESS ("Much illness" from the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood calcium decreased, Blood potassium decreased, Blood sodium decreased, C-reactive protein increased
Clinical narrative: weakness in legs; sudden onset of shivering and chills; diffuse muscle aches and joint aches; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (weakness in legs), CHILLS (sudden onset of shivering and chills) and MYALGIA (diffuse muscle aches and joint aches) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 24-Jan-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 ASTHENIA (weakness in legs), CHILLS (sudden onset of shivering and chills) and MYALGIA (diffuse muscle aches and joint aches). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness in legs), CHILLS (sudden onset of shivering and chills) and MYALGIA (diffuse muscle aches and joint aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Blood calcium decreased: (Inconclusive) Decreased. On 05-Feb-2021, Blood potassium decreased: (Inconclusive) Decreased. On 05-Feb-2021, Blood sodium decreased: (Inconclusive) Decreased. On an unknown date, C-reactive protein increased: 6.2 (Inconclusive) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: weakness in legs; sudden onset of shivering and chills; diffuse muscle aches and joint aches; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (weakness in legs), CHILLS (sudden onset of shivering and chills) and MYALGIA (diffuse muscle aches and joint aches) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 24-Jan-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 ASTHENIA (weakness in legs), CHILLS (sudden onset of shivering and chills) and MYALGIA (diffuse muscle aches and joint aches). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness in legs), CHILLS (sudden onset of shivering and chills) and MYALGIA (diffuse muscle aches and joint aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Blood calcium decreased: (Inconclusive) Decreased. On 05-Feb-2021, Blood potassium decreased: (Inconclusive) Decreased. On 05-Feb-2021, Blood sodium decreased: (Inconclusive) Decreased. On an unknown date, C-reactive protein increased: 6.2 (Inconclusive) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itchiness; Redness; Swollen Lymph Node; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE ERYTHEMA (Redness) and LYMPHADENOPATHY (Swollen Lymph Node) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included AMITRIPTYLINE, PANTOPRAZOLE, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), MONTELUKAST, CYCLOBENZAPRINE, VITAMINS NOS (DAILY VITAMINS), CENTRUM SILVER +50 and CALCIUM for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE ERYTHEMA (Redness) and LYMPHADENOPATHY (Swollen Lymph Node). At the time of the report, PAIN IN EXTREMITY (pain in arm), VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE ERYTHEMA (Redness) and LYMPHADENOPATHY (Swollen Lymph Node) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included ice.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Myalgia, Pain in extremity, Pruritus
Clinical narrative: eczema on arms; arms are itchy; left arm was sore; it was like being punched in the arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (left arm was sore), PAIN IN EXTREMITY (it was like being punched in the arm), ECZEMA (eczema on arms) and PRURITUS (arms are itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Mitral valve prolapse and Osteoporosis. Concurrent medical conditions included Eczema (Eczema(since birth)) and Bronchitis asthmatic (since 2019). Concomitant products included IRON for Anemia, MONTELUKAST for Asthma, COLECALCIFEROL, MENAQUINONE (D3 +K2) for Calcium supplementation, CALCIUM for Osteoporosis, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), LORATADINE, MAGNESIUM and ALLIUM SATIVUM for an unknown indication, MULTIVITAMIN [VITAMINS NOS].   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced MYALGIA (left arm was sore) and PAIN IN EXTREMITY (it was like being punched in the arm). On 10-Feb-2021, the patient experienced ECZEMA (eczema on arms) and PRURITUS (arms are itchy). At the time of the report, MYALGIA (left arm was sore), PAIN IN EXTREMITY (it was like being punched in the arm), ECZEMA (eczema on arms) and PRURITUS (arms are itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included hydrocortisone lotion.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Follow up received on 01-MAY-2021 included patient  concomitant medicationswas added second dose events added
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Vaccination site erythema; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0U1L2014) 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 05-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, VACCINATION SITE ERYTHEMA (Vaccination site erythema) 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 treatment information was provided.  No concomitant medication was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: She ended up on the ER, where they stated that it must have been an allergic reaction to; Very painful hives that went from the back, up to her neck and head; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Very painful hives that went from the back, up to her neck and head) and HYPERSENSITIVITY (She ended up on the ER, where they stated that it must have been an allergic reaction to) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and PROBIOTICS NOS for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced URTICARIA (Very painful hives that went from the back, up to her neck and head). On 07-Feb-2021, the patient experienced HYPERSENSITIVITY (She ended up on the ER, where they stated that it must have been an allergic reaction to). At the time of the report, URTICARIA (Very painful hives that went from the back, up to her neck and head) and HYPERSENSITIVITY (She ended up on the ER, where they stated that it must have been an allergic reaction to) outcome was unknown. Related      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.   Other concomitant medications include high blood pressure medication Patient was administered a steroid injection and an antihistamine.    This case was linked to MOD-2021-248302 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up received on 06-JUL-2021 and contains significant information and deleted the events which were related to dose 2 and reporter contact details were updated.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Kind of allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Kind of allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Kind of allergic reaction). At the time of the report, HYPERSENSITIVITY (Kind of allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gout, Headache, Vaccination site pain
Clinical narrative: light headache; Chills; Sore arm at the injection site; joints sore; Gout flared up/realized the gout was going to attack; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout flared up/realized the gout was going to attack), CHILLS (Chills), VACCINATION SITE PAIN (Sore arm at the injection site) and ARTHRALGIA (joints sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis. Concomitant products included METOPROLOL SUCCINATE (METOPROLOL SUCC CT), FUROSEMIDE (LASIX [FUROSEMIDE]), PRAVASTATIN, VITAMIN D [VITAMIN D NOS], ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and FISH OIL for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced GOUT (Gout flared up/realized the gout was going to attack). On 16-Jan-2021, the patient experienced CHILLS (Chills), VACCINATION SITE PAIN (Sore arm at the injection site) and ARTHRALGIA (joints sore). At the time of the report, GOUT (Gout flared up/realized the gout was going to attack), CHILLS (Chills), VACCINATION SITE PAIN (Sore arm at the injection site) and ARTHRALGIA (joints sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient reported, I do believe that a person, as myself, who has a history of high inflammation could possibly be susceptible to the problems I have experienced. No treatment information was provided.   This case was linked to MOD-2021-084810 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: The follow up was received- New event was added in the follow up. patient reported she never felt light headed, she felt light headache. patients assessment of causality was added.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Arm sore; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore) and NAUSEA (nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030NE0A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer and Shoulder prosthesis user.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm sore) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (Arm sore) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.