chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breathe around 10Jan2021; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breathe around 10Jan2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VALSARTAN (DIOVAN), HYDROXYCHLOROQUINE, MONTELUKAST and PRAVASTATIN for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breathe around 10Jan2021). At the time of the report, DYSPNOEA (Shortness of breathe around 10Jan2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-030436 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: intense dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (intense dizziness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE and PRAVASTATIN for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DIZZINESS (intense dizziness). On 26-Feb-2021, DIZZINESS (intense dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       the patient was taking blood pressure medicine
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Chills; Felt hot on outside; Pain at injection site; Feels like can't think straight; Tenderness at injection site; Swelling at injection site; A spontaneous report () was received from a consumer concerning a 71-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, felt hot on outside, felt cold on outside, pain at injection site, tenderness at injection site, swelling at injection site, feels like can't think straight.  The patient's medical history was not provided. Concomitant medications reported were Shot of vitamin d 12 for drug use for unknown indication.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 010a21a) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the event(s) chills, felt hot on outside, felt cold on outside, pain at injection site, tenderness at injection site, swelling at injection site, feels like can't think straight.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), chills, felt hot on outside, felt cold on outside, pain at injection site, tenderness at injection site, swelling at injection site, feels like can't think straight was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Thinking abnormal
Clinical narrative: Chills; Felt hot on outside; Pain at injection site; Feels like can't think straight; Tenderness at injection site; Swelling at injection site; A spontaneous report () was received from a consumer concerning a 71-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, felt hot on outside, felt cold on outside, pain at injection site, tenderness at injection site, swelling at injection site, feels like can't think straight.  The patient's medical history was not provided. Concomitant medications reported were Shot of vitamin d 12 for drug use for unknown indication.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 010a21a) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the event(s) chills, felt hot on outside, felt cold on outside, pain at injection site, tenderness at injection site, swelling at injection site, feels like can't think straight.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), chills, felt hot on outside, felt cold on outside, pain at injection site, tenderness at injection site, swelling at injection site, feels like can't think straight was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Vomiting
Clinical narrative: chills; fever; fatigue; headache; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache) and VOMITING (vomiting) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021 at 1:00 AM, the patient experienced CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache) and VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 dosage form. On 28-Feb-2021 at 4:00 PM, CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Awful headaches; Nausea; Chills; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Awful headaches), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Extremely tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (Awful headaches), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Extremely tired). At the time of the report, HEADACHE (Awful headaches), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: sweating; very dizzy; nauseous; vomited a little bit; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), DIZZINESS (very dizzy), NAUSEA (nauseous) and VOMITING (vomited a little bit) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Don't have it) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced HYPERHIDROSIS (sweating), DIZZINESS (very dizzy), NAUSEA (nauseous) and VOMITING (vomited a little bit). At the time of the report, HYPERHIDROSIS (sweating), DIZZINESS (very dizzy), NAUSEA (nauseous) and VOMITING (vomited a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the concomitant was not reported . the patient taken mecklasyn for the dizziness
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Felt a bit sore at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Felt a bit sore at the injection site) 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 22-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) at an unspecified dose. On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (Felt a bit sore at the injection site). At the time of the report, VACCINATION SITE PAIN (Felt a bit sore at the injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information and concomitant medications reported.  Action taken with mRNA-123 is not applicable.   This case was linked to MOD-2021-030354 (Linked Report).; Sender's Comments:  MOD-2021-030354:crosslinked by reporter
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: supposed to get the second dose on 17 Feb 2021, but were not able due to climate conditions/received second dose on 01 Mar 2021; A spontaneous report was received from consumer, who was also a 76-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was supposed to get the second dose on 17 Feb 2021, but were not able due to climate conditions/received second dose on 01 Mar 2021 (inappropriate schedule of product administration).  The patient's medical history was not provided. Concomitant product use was not provided.   On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  The patient reported that he was supposed to get the second dose on 17 Feb 2021, but was not able due to climate conditions.     On 01 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Feeling abnormal, Migraine, Myalgia
Clinical narrative: body hurt so bad; head to toe rash that is red blotches, it does not itch or burn; felt like she had COVID all over again; symptoms put her in bed; throwing up; developed diarrhea; body aches; severe headache that felt almost like a migraine; A spontaneous report was received from a consumer concerning a 57-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt like she had covid all over again, symptoms put her in bed, body hurt so bad, throwing up, head to toe rash that is red blotches, it does not itch or burn, developed diarrhea, body aches, severe headache that felt almost like a migraine.  The patient's medical history was not provided. Concomitant medications reported were Cecalafram, Eliquis, Hydroxychloroquine, prednisone, flimorsimite, omethrazal, pramitexole, metoparal, rovestatin, womens daily vitamin, C,B,D vitamins for drug use for unknown indication.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 022M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the event(s) felt like she had covid all over again, symptoms put her in bed. On an unknown date, the patient experienced the event(s) body hurt so bad, throwing up, head to toe rash that is red blotches, it does not itch or burn, developed diarrhea, body aches, severe headache that felt almost like a migraine.  Treatment details included liquid tylenol.  Action taken with mRNA-1273 in response to the events was not reported.  On 28 Feb 2021 the outcome of event(s), symptoms put her in bed, throwing up was resolved. The outcome of event(s), felt like she had covid all over again, body hurt so bad, head to toe rash that is red blotches, it does not itch or burn, developed diarrhea, body aches, severe headache that felt almost like a migraine was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash macular, Vomiting
Clinical narrative: body hurt so bad; head to toe rash that is red blotches, it does not itch or burn; felt like she had COVID all over again; symptoms put her in bed; throwing up; developed diarrhea; body aches; severe headache that felt almost like a migraine; A spontaneous report was received from a consumer concerning a 57-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt like she had covid all over again, symptoms put her in bed, body hurt so bad, throwing up, head to toe rash that is red blotches, it does not itch or burn, developed diarrhea, body aches, severe headache that felt almost like a migraine.  The patient's medical history was not provided. Concomitant medications reported were Cecalafram, Eliquis, Hydroxychloroquine, prednisone, flimorsimite, omethrazal, pramitexole, metoparal, rovestatin, womens daily vitamin, C,B,D vitamins for drug use for unknown indication.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 022M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the event(s) felt like she had covid all over again, symptoms put her in bed. On an unknown date, the patient experienced the event(s) body hurt so bad, throwing up, head to toe rash that is red blotches, it does not itch or burn, developed diarrhea, body aches, severe headache that felt almost like a migraine.  Treatment details included liquid tylenol.  Action taken with mRNA-1273 in response to the events was not reported.  On 28 Feb 2021 the outcome of event(s), symptoms put her in bed, throwing up was resolved. The outcome of event(s), felt like she had covid all over again, body hurt so bad, head to toe rash that is red blotches, it does not itch or burn, developed diarrhea, body aches, severe headache that felt almost like a migraine was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Bump came back after a week and was bigger; Bump came back after a week and was bigger, and hotter as well as more pronounced; Reaction that was red, warm to the touch and itchy; Reaction that was red, warm to the touch and itchy/ reaction was red and hot; Reaction that was red, warm to the touch and itchy/ reaction was red and hot; Developed a bump; Sore for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Developed a bump), PAIN IN EXTREMITY (Sore for a couple of days), VACCINATION SITE MASS (Bump came back after a week and was bigger), VACCINATION SITE WARMTH (Bump came back after a week and was bigger, and hotter as well as more pronounced) and VACCINATION SITE PRURITUS (Reaction that was red, warm to the touch and itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 03-Feb-2021, the patient experienced VACCINATION SITE MASS (Developed a bump), PAIN IN EXTREMITY (Sore for a couple of days), VACCINATION SITE PRURITUS (Reaction that was red, warm to the touch and itchy), VACCINATION SITE WARMTH (Reaction that was red, warm to the touch and itchy/ reaction was red and hot) and VACCINATION SITE ERYTHEMA (Reaction that was red, warm to the touch and itchy/ reaction was red and hot). On an unknown date, the patient experienced VACCINATION SITE MASS (Bump came back after a week and was bigger) and VACCINATION SITE WARMTH (Bump came back after a week and was bigger, and hotter as well as more pronounced). On 05-Feb-2021, VACCINATION SITE MASS (Developed a bump), PAIN IN EXTREMITY (Sore for a couple of days), VACCINATION SITE PRURITUS (Reaction that was red, warm to the touch and itchy), VACCINATION SITE WARMTH (Reaction that was red, warm to the touch and itchy/ reaction was red and hot) and VACCINATION SITE ERYTHEMA (Reaction that was red, warm to the touch and itchy/ reaction was red and hot) had resolved. At the time of the report, VACCINATION SITE MASS (Bump came back after a week and was bigger) and VACCINATION SITE WARMTH (Bump came back after a week and was bigger, and hotter as well as more pronounced) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment details were not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: tingling; numbness; slight ache; A spontaneous report was received from a consumer concerning a 82-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tingling, numbness, slight ache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012A21A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) tingling, numbness, slight ache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), tingling, numbness, slight ache was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site paraesthesia, Vaccination site pruritus, Vaccination site streaking, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Red streak in arm to elbow; Feels like bunch of little ant bites; Little bumps all over that itch; Welts; Arm swells up huge; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE STREAKING (Red streak in arm to elbow), VACCINATION SITE PARAESTHESIA (Feels like bunch of little ant bites), VACCINATION SITE PRURITUS (Little bumps all over that itch), VACCINATION SITE URTICARIA (Welts) and VACCINATION SITE SWELLING (Arm swells up huge) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE STREAKING (Red streak in arm to elbow), VACCINATION SITE PRURITUS (Little bumps all over that itch) and VACCINATION SITE URTICARIA (Welts). 03-Feb-2021, the patient experienced VACCINATION SITE PARAESTHESIA (Feels like bunch of little ant bites) and VACCINATION SITE SWELLING (Arm swells up huge). At the time of the report, VACCINATION SITE STREAKING (Red streak in arm to elbow), VACCINATION SITE PARAESTHESIA (Feels like bunch of little ant bites), VACCINATION SITE PRURITUS (Little bumps all over that itch), VACCINATION SITE URTICARIA (Welts) and VACCINATION SITE SWELLING (Arm swells up huge) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications was reported. treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Additional information was received on 22 -Apr-2021 no new information updated.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Headache, Vaccination site pain
Clinical narrative: shortness of breath; coughing; headache; chills; soreness in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), HEADACHE (headache), CHILLS (chills), VACCINATION SITE PAIN (soreness in injection arm) and DYSPNOEA (shortness of breath) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     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 27-Feb-2021, the patient experienced COUGH (coughing), HEADACHE (headache), CHILLS (chills) and VACCINATION SITE PAIN (soreness in injection arm). On 01-Mar-2021, the patient experienced DYSPNOEA (shortness of breath). On 28-Feb-2021, HEADACHE (headache) and CHILLS (chills) had resolved. At the time of the report, COUGH (coughing) had not resolved and VACCINATION SITE PAIN (soreness in injection arm) and DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient was taking treatment with tylenol, mucinex pm. Patient was taking high blood pressure medication and cholesterol medication concomitantly
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: warm; Hard; Itching; swelling; Redness; Tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (Redness) in a 73-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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Tender). At the time of the report, VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment details was not reported by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: warm; Hard; Itching; swelling; Redness; Tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (Redness) in a 73-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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Tender). At the time of the report, VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment details was not reported by the reporter.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: itchy; red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and ERYTHEMA (red) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 PRURITUS (itchy) and ERYTHEMA (red). At the time of the report, PRURITUS (itchy) and ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment information information was reported.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: site of injection is all red; little bit swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (site of injection is all red) and VACCINATION SITE SWELLING (little bit swollen) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 VACCINATION SITE ERYTHEMA (site of injection is all red) and VACCINATION SITE SWELLING (little bit swollen). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (site of injection is all red) and VACCINATION SITE SWELLING (little bit swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Reporter did not allow further contact
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: sore at the injection site; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore at the injection site) and CHILLS (chills) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore at the injection site) and CHILLS (chills). At the time of the report, VACCINATION SITE PAIN (sore at the injection site) and CHILLS (chills) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Illness
Clinical narrative: I am running a low temperature of 100; sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) and BODY TEMPERATURE ABNORMAL (I am running a low temperature of 100) 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 27-Feb-2021, the patient experienced ILLNESS (sick). On an unknown date, the patient experienced BODY TEMPERATURE ABNORMAL (I am running a low temperature of 100). On 28-Feb-2021, ILLNESS (sick) had resolved. At the time of the report, BODY TEMPERATURE ABNORMAL (I am running a low temperature of 100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (Low) running a low temperature of 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: big red large oval on arm it looks like a red band; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (big red large oval on arm it looks like a red band) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-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 ERYTHEMA (big red large oval on arm it looks like a red band). At the time of the report, ERYTHEMA (big red large oval on arm it looks like a red band) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non significant follow up received on 30-Apr-2021 included Email id.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Pain in extremity
Clinical narrative: pain in the arm; started losing hair, but now it is falling out in clumps; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) and ALOPECIA (started losing hair, but now it is falling out in clumps) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm) and ALOPECIA (started losing hair, but now it is falling out in clumps). On 12-Feb-2021, PAIN IN EXTREMITY (pain in the arm) had resolved. At the time of the report, ALOPECIA (started losing hair, but now it is falling out in clumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Vaccination site pain
Clinical narrative: Arm was tender, aching and sore  on 3Feb2021; shortness of breathe is ongoing,Shortness of breathe around 10Jan2021; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was tender, aching and sore  on 3Feb2021) and DYSPNOEA (shortness of breathe is ongoing,Shortness of breathe around 10Jan2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included VALSARTAN (DIOVAN), HYDROXYCHLOROQUINE, MONTELUKAST and PRAVASTATIN for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced DYSPNOEA (shortness of breathe is ongoing,Shortness of breathe around 10Jan2021). On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm was tender, aching and sore  on 3Feb2021). At the time of the report, VACCINATION SITE PAIN (Arm was tender, aching and sore  on 3Feb2021) and DYSPNOEA (shortness of breathe is ongoing,Shortness of breathe around 10Jan2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       He applied diclofenac sodium 1% gel applied to arm twice a day for soreness of injection site.   This case was linked to MOD-2021-030405 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness at the injection site). On 03-Feb-2021, INJECTION SITE PAIN (Soreness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: (between elbow and vaccination spot) spot; (between elbow and vaccination spot) red; (between elbow and vaccination spot) itchy; (between elbow and vaccination spot) swelled up; Slight fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.     This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever), VACCINATION SITE PAIN ((between elbow and vaccination spot) spot), VACCINATION SITE ERYTHEMA ((between elbow and vaccination spot) red), INJECTION SITE PRURITUS ((between elbow and vaccination spot) itchy) and VACCINATION SITE SWELLING ((between elbow and vaccination spot) swelled up) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Slight fever). On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN ((between elbow and vaccination spot) spot), VACCINATION SITE ERYTHEMA ((between elbow and vaccination spot) red), INJECTION SITE PRURITUS ((between elbow and vaccination spot) itchy) and VACCINATION SITE SWELLING ((between elbow and vaccination spot) swelled up). At the time of the report, PYREXIA (Slight fever), VACCINATION SITE PAIN ((between elbow and vaccination spot) spot), VACCINATION SITE ERYTHEMA ((between elbow and vaccination spot) red), INJECTION SITE PRURITUS ((between elbow and vaccination spot) itchy) and VACCINATION SITE SWELLING ((between elbow and vaccination spot) swelled up) outcome was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Muscle twitching
Clinical narrative: anxiety; twitching in lip; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety) and MUSCLE TWITCHING (twitching in lip) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) 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 an unknown date, the patient experienced ANXIETY (anxiety) and MUSCLE TWITCHING (twitching in lip). At the time of the report, ANXIETY (anxiety) and MUSCLE TWITCHING (twitching in lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Diarrhoea, Headache, Pain
Clinical narrative: Headache; Body aches; Stomach cramps; Dirrhea; Stomach still feels little irritated; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, body aches, stomach cramps, dirrhea, stomach still feels little irritated.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: D31M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the event(s) headache, body aches, stomach cramps, dirrhea, stomach still feels little irritated.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache, body aches, stomach cramps, dirrhea, stomach still feels little irritated was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: About 4 days ago, injection site started itching and progressed to red and hot; vaccination site erythema; muscle aches down legs, across back, shoulder blades; extreme tiredness; vaccination site pruritis; During 1st 36 hours after receiving 1st dose,Patient experienced minimum soreness at injection site, muscle aches down legs, across back, shoulder blades, extreme tiredness.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (About 4 days ago, injection site started itching and progressed to red and hot), VACCINATION SITE PRURITUS (vaccination site pruritis), VACCINATION SITE PAIN (During 1st 36 hours after receiving 1st dose,Patient experienced minimum soreness at injection site, muscle aches down legs, across back, shoulder blades, extreme tiredness.), VACCINATION SITE ERYTHEMA (vaccination site erythema) and MYALGIA (muscle aches down legs, across back, shoulder blades) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN, LEVOTHYROXINE, Furosamide, RIVAROXABAN (XARELTO), LISINOPRIL and CARVEDILOL for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (vaccination site pruritis), VACCINATION SITE PAIN (During 1st 36 hours after receiving 1st dose,Patient experienced minimum soreness at injection site, muscle aches down legs, across back, shoulder blades, extreme tiredness.), MYALGIA (muscle aches down legs, across back, shoulder blades) and FATIGUE (extreme tiredness). On 26-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (vaccination site erythema). On 01-Mar-2021, the patient experienced VACCINATION SITE WARMTH (About 4 days ago, injection site started itching and progressed to red and hot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (About 4 days ago, injection site started itching and progressed to red and hot), VACCINATION SITE PRURITUS (vaccination site pruritis), VACCINATION SITE PAIN (During 1st 36 hours after receiving 1st dose,Patient experienced minimum soreness at injection site, muscle aches down legs, across back, shoulder blades, extreme tiredness.), VACCINATION SITE ERYTHEMA (vaccination site erythema), MYALGIA (muscle aches down legs, across back, shoulder blades) and FATIGUE (extreme tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: About 4 days ago, injection site started itching and progressed to red and hot; vaccination site erythema; muscle aches down legs, across back, shoulder blades; extreme tiredness; vaccination site pruritis; During 1st 36 hours after receiving 1st dose,Patient experienced minimum soreness at injection site, muscle aches down legs, across back, shoulder blades, extreme tiredness.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (About 4 days ago, injection site started itching and progressed to red and hot), VACCINATION SITE PRURITUS (vaccination site pruritis), VACCINATION SITE PAIN (During 1st 36 hours after receiving 1st dose,Patient experienced minimum soreness at injection site, muscle aches down legs, across back, shoulder blades, extreme tiredness.), VACCINATION SITE ERYTHEMA (vaccination site erythema) and MYALGIA (muscle aches down legs, across back, shoulder blades) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN, LEVOTHYROXINE, Furosamide, RIVAROXABAN (XARELTO), LISINOPRIL and CARVEDILOL for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (vaccination site pruritis), VACCINATION SITE PAIN (During 1st 36 hours after receiving 1st dose,Patient experienced minimum soreness at injection site, muscle aches down legs, across back, shoulder blades, extreme tiredness.), MYALGIA (muscle aches down legs, across back, shoulder blades) and FATIGUE (extreme tiredness). On 26-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (vaccination site erythema). On 01-Mar-2021, the patient experienced VACCINATION SITE WARMTH (About 4 days ago, injection site started itching and progressed to red and hot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (About 4 days ago, injection site started itching and progressed to red and hot), VACCINATION SITE PRURITUS (vaccination site pruritis), VACCINATION SITE PAIN (During 1st 36 hours after receiving 1st dose,Patient experienced minimum soreness at injection site, muscle aches down legs, across back, shoulder blades, extreme tiredness.), VACCINATION SITE ERYTHEMA (vaccination site erythema), MYALGIA (muscle aches down legs, across back, shoulder blades) and FATIGUE (extreme tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: left shoulder swollen; left shoulder red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left shoulder swollen) and ERYTHEMA (left shoulder red) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LORAZEPAM for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (left shoulder swollen) and ERYTHEMA (left shoulder red). At the time of the report, PERIPHERAL SWELLING (left shoulder swollen) and ERYTHEMA (left shoulder red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       corrective treatment included ice pack, hydrogen peroxide.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pain in extremity
Clinical narrative: slight cough; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), COUGH (slight cough) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy and Leukemia since 2010.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced COUGH (slight cough) and HEADACHE (headache). On 03-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, COUGH (slight cough) outcome was unknown and HEADACHE (headache) had not resolved.            No concomitant and treatment drugs were reported.   This case was linked to MOD-2021-030579, MOD-2021-030579 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Added address of the reporter, second dose of the drug, patient demographics (height, weight, race, allergy, current condition). Added the events (cough, headache).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got first dose of the vaccine on 20Jan2021 and second on 01Mar2021; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose of the vaccine on 20Jan2021 and second on 01Mar2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose of the vaccine on 20Jan2021 and second on 01Mar2021). On 01-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose of the vaccine on 20Jan2021 and second on 01Mar2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-030370, MOD-2021-030416 (Patient Link).