chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feelings of worthlessness, Headache, Myalgia
Clinical narrative: Dizziness; Weakness; Chills; joint pain; muscle pain; Headache; overwhelming fatigue; brain fog; nonfunctional; debilitated; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (Headache), FATIGUE (overwhelming fatigue), FEELING ABNORMAL (brain fog), FEELINGS OF WORTHLESSNESS (nonfunctional) and ASTHENIA (debilitated). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (Headache), FATIGUE (overwhelming fatigue), FEELING ABNORMAL (brain fog), FEELINGS OF WORTHLESSNESS (nonfunctional) and ASTHENIA (debilitated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Feb-2021 and was forwarded to Moderna on 09-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (Headache), FATIGUE (overwhelming fatigue), FEELING ABNORMAL (brain fog), FEELINGS OF WORTHLESSNESS (nonfunctional) and ASTHENIA (debilitated). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (Headache), FATIGUE (overwhelming fatigue), FEELING ABNORMAL (brain fog), FEELINGS OF WORTHLESSNESS (nonfunctional) and ASTHENIA (debilitated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspepsia, Fatigue, Headache, Pain
Clinical narrative: Headache; So tired she could not sit-up; Heartburn (like her esophagus was burning); body pain; Fever(101.8); Shivering so bad she bit her tongue and could not control her jaw/ chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (So tired she could not sit-up), DYSPEPSIA (Heartburn (like her esophagus was burning)), PAIN (body pain) and PYREXIA (Fever(101.8)) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (In August-September, 2020).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (Headache), FATIGUE (So tired she could not sit-up), DYSPEPSIA (Heartburn (like her esophagus was burning)), PAIN (body pain), PYREXIA (Fever(101.8)) and CHILLS (Shivering so bad she bit her tongue and could not control her jaw/ chills). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and TYLENOL at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), FATIGUE (So tired she could not sit-up), DYSPEPSIA (Heartburn (like her esophagus was burning)), PAIN (body pain), PYREXIA (Fever(101.8)) and CHILLS (Shivering so bad she bit her tongue and could not control her jaw/ chills) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; So tired she could not sit-up; Heartburn (like her esophagus was burning); body pain; Fever(101.8); Shivering so bad she bit her tongue and could not control her jaw/ chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (So tired she could not sit-up), DYSPEPSIA (Heartburn (like her esophagus was burning)), PAIN (body pain) and PYREXIA (Fever(101.8)) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (In August-September, 2020).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (Headache), FATIGUE (So tired she could not sit-up), DYSPEPSIA (Heartburn (like her esophagus was burning)), PAIN (body pain), PYREXIA (Fever(101.8)) and CHILLS (Shivering so bad she bit her tongue and could not control her jaw/ chills). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and TYLENOL at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), FATIGUE (So tired she could not sit-up), DYSPEPSIA (Heartburn (like her esophagus was burning)), PAIN (body pain), PYREXIA (Fever(101.8)) and CHILLS (Shivering so bad she bit her tongue and could not control her jaw/ chills) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: body aches; muscle aches; chills; extreme fatigue; high less fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN (body aches), MYALGIA (muscle aches), CHILLS (chills), FATIGUE (extreme fatigue) and PYREXIA (high less fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced PAIN (body aches), MYALGIA (muscle aches), CHILLS (chills), FATIGUE (extreme fatigue) and PYREXIA (high less fever). On 14-Jan-2021, PAIN (body aches), MYALGIA (muscle aches), CHILLS (chills), FATIGUE (extreme fatigue) and PYREXIA (high less fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Head discomfort, Muscle spasms, Muscle twitching, Pruritus
Clinical narrative: slight tightness of throat; felt hot on left side of the body; knocking on left side of the head; started wheezing; itchy on my stomach; involuntary spasms; jaw went to one side and back again; toes were twitching; entire body had spasms; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (slight tightness of throat), FEELING HOT (felt hot on left side of the body), HEAD DISCOMFORT (knocking on left side of the head), WHEEZING (started wheezing) and PRURITUS (itchy on my stomach) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), SALBUTAMOL (ALBUTEROL HFA) and IBUPROFEN for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced THROAT TIGHTNESS (slight tightness of throat), FEELING HOT (felt hot on left side of the body), HEAD DISCOMFORT (knocking on left side of the head), WHEEZING (started wheezing), PRURITUS (itchy on my stomach), MUSCLE SPASMS (involuntary spasms), TRISMUS (jaw went to one side and back again), MUSCLE TWITCHING (toes were twitching) and MUSCLE SPASMS (entire body had spasms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 15-Jan-2021 for Adverse reaction, at an unspecified dose and frequency. On 16-Jan-2021, MUSCLE SPASMS (involuntary spasms), TRISMUS (jaw went to one side and back again), MUSCLE TWITCHING (toes were twitching) and MUSCLE SPASMS (entire body had spasms) had resolved. At the time of the report, THROAT TIGHTNESS (slight tightness of throat), FEELING HOT (felt hot on left side of the body), HEAD DISCOMFORT (knocking on left side of the head), WHEEZING (started wheezing) and PRURITUS (itchy on my stomach) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Trismus, Wheezing
Clinical narrative: slight tightness of throat; felt hot on left side of the body; knocking on left side of the head; started wheezing; itchy on my stomach; involuntary spasms; jaw went to one side and back again; toes were twitching; entire body had spasms; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (slight tightness of throat), FEELING HOT (felt hot on left side of the body), HEAD DISCOMFORT (knocking on left side of the head), WHEEZING (started wheezing) and PRURITUS (itchy on my stomach) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), SALBUTAMOL (ALBUTEROL HFA) and IBUPROFEN for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced THROAT TIGHTNESS (slight tightness of throat), FEELING HOT (felt hot on left side of the body), HEAD DISCOMFORT (knocking on left side of the head), WHEEZING (started wheezing), PRURITUS (itchy on my stomach), MUSCLE SPASMS (involuntary spasms), TRISMUS (jaw went to one side and back again), MUSCLE TWITCHING (toes were twitching) and MUSCLE SPASMS (entire body had spasms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 15-Jan-2021 for Adverse reaction, at an unspecified dose and frequency. On 16-Jan-2021, MUSCLE SPASMS (involuntary spasms), TRISMUS (jaw went to one side and back again), MUSCLE TWITCHING (toes were twitching) and MUSCLE SPASMS (entire body had spasms) had resolved. At the time of the report, THROAT TIGHTNESS (slight tightness of throat), FEELING HOT (felt hot on left side of the body), HEAD DISCOMFORT (knocking on left side of the head), WHEEZING (started wheezing) and PRURITUS (itchy on my stomach) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Flushing, Influenza like illness
Clinical narrative: discomfort in his arm; flu-like symptoms; fever of 101.1; weakness; chills; kind of tired; sore arm; flushing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FLUSHING (flushing), BODY TEMPERATURE FLUCTUATION (felt hot and cold), LIMB DISCOMFORT (discomfort in his arm) and CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE and ROSUVASTATIN for an unknown indication.   On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FLUSHING (flushing), BODY TEMPERATURE FLUCTUATION (felt hot and cold), CHILLS (chills) and FATIGUE (kind of tired). On an unknown date, the patient experienced LIMB DISCOMFORT (discomfort in his arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever of 101.1) and ASTHENIA (weakness). At the time of the report, PAIN IN EXTREMITY (sore arm), FLUSHING (flushing), BODY TEMPERATURE FLUCTUATION (felt hot and cold), LIMB DISCOMFORT (discomfort in his arm), CHILLS (chills), FATIGUE (kind of tired), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever of 101.1) and ASTHENIA (weakness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  Treatment medications included Tylenol and low dose Allegra.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-032046 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: No specific follow-up information recorded. On 10-May-2021: updated contact information
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Pyrexia
Clinical narrative: discomfort in his arm; flu-like symptoms; fever of 101.1; weakness; chills; kind of tired; sore arm; flushing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FLUSHING (flushing), BODY TEMPERATURE FLUCTUATION (felt hot and cold), LIMB DISCOMFORT (discomfort in his arm) and CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE and ROSUVASTATIN for an unknown indication.   On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FLUSHING (flushing), BODY TEMPERATURE FLUCTUATION (felt hot and cold), CHILLS (chills) and FATIGUE (kind of tired). On an unknown date, the patient experienced LIMB DISCOMFORT (discomfort in his arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever of 101.1) and ASTHENIA (weakness). At the time of the report, PAIN IN EXTREMITY (sore arm), FLUSHING (flushing), BODY TEMPERATURE FLUCTUATION (felt hot and cold), LIMB DISCOMFORT (discomfort in his arm), CHILLS (chills), FATIGUE (kind of tired), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever of 101.1) and ASTHENIA (weakness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  Treatment medications included Tylenol and low dose Allegra.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-032046 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: No specific follow-up information recorded. On 10-May-2021: updated contact information
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Herpes zoster, Rash
Clinical narrative: Shingles; Rash on back; Right shoulder pain; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), HERPES ZOSTER (Shingles), RASH (Rash on back) and ARTHRALGIA (Right shoulder pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D), BIOTIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced BACK PAIN (Back pain) and ARTHRALGIA (Right shoulder pain). On 02-Feb-2021, the patient experienced HERPES ZOSTER (Shingles) and RASH (Rash on back). The patient was treated with IBUPROFEN for Shingles, at a dose of 1 dosage form and ACYCLOVIR [ACICLOVIR] for Shingles, at a dose of 1 dosage form. At the time of the report, BACK PAIN (Back pain) and ARTHRALGIA (Right shoulder pain) outcome was unknown and HERPES ZOSTER (Shingles) and RASH (Rash on back) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on High blood pressure medication, Antihyperlipidemic and Aromatase Inhibitor.   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain in extremity
Clinical narrative: Arm pain; Fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 013C20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). At the time of the report, PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) 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. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: TCR information received on 28-JUN-2021 contains non-significant information.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (COVID arm). At the time of the report, RASH (COVID 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.   No concomitant medications reported.   No treatment medications were provided
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Chills; Fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 09-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea).   At the time of the report, CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided    Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Fatigue, Headache, Injection site pain
Clinical narrative: injection site was sore; red area below the injection site; raised area below the injection site; diarrhea; coughing; headache; nausea; vomiting; fever of 101°F; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), COUGH (coughing), HEADACHE (headache), NAUSEA (nausea) and VOMITING (vomiting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-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 15-Feb-2021, the patient experienced DIARRHOEA (diarrhea), COUGH (coughing), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever of 101°F) and FATIGUE (fatigue). On 17-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site was sore), VACCINATION SITE ERYTHEMA (red area below the injection site) and VACCINATION SITE SWELLING (raised area below the injection site). The patient was treated with CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PHENYLPROPANOLAMINE BITARTRATE (ALKA-SELTZER PLUS COLD & FLU MEDICINE) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL LOTION N) for Injection site swelling, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (diarrhea), COUGH (coughing), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever of 101°F) and FATIGUE (fatigue) had resolved and INJECTION SITE PAIN (injection site was sore), VACCINATION SITE ERYTHEMA (red area below the injection site) and VACCINATION SITE SWELLING (raised area below the injection site) outcome was unknown.            No concomitant medications were reported. No laboratory details were  provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site erythema, Vaccination site swelling, Vomiting
Clinical narrative: injection site was sore; red area below the injection site; raised area below the injection site; diarrhea; coughing; headache; nausea; vomiting; fever of 101°F; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), COUGH (coughing), HEADACHE (headache), NAUSEA (nausea) and VOMITING (vomiting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-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 15-Feb-2021, the patient experienced DIARRHOEA (diarrhea), COUGH (coughing), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever of 101°F) and FATIGUE (fatigue). On 17-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site was sore), VACCINATION SITE ERYTHEMA (red area below the injection site) and VACCINATION SITE SWELLING (raised area below the injection site). The patient was treated with CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PHENYLPROPANOLAMINE BITARTRATE (ALKA-SELTZER PLUS COLD & FLU MEDICINE) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL LOTION N) for Injection site swelling, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (diarrhea), COUGH (coughing), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever of 101°F) and FATIGUE (fatigue) had resolved and INJECTION SITE PAIN (injection site was sore), VACCINATION SITE ERYTHEMA (red area below the injection site) and VACCINATION SITE SWELLING (raised area below the injection site) outcome was unknown.            No concomitant medications were reported. No laboratory details were  provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort
Clinical narrative: slight chills in both arms; uncomfortable; A spontaneous report  was received from a healthcare professional concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events slight chills in both arms, uncomfortable.  The patient's medical history was not mentioned.  Concomitant medications reported were metoprolol tartrate 25mg 1 4 tablet daily, levothyroxine 25mcg daily, Propranolol 10mg ½ tablet daily, Vitamin C, Multivitamin for drug use for unknown indication.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 021M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unknown date patient experienced events as slight chills in both arms and uncomfortable.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event(s), slight chills in both arms, uncomfortable was UNKNOWN.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Illness
Clinical narrative: Sick; Weak; Really Tired; 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 really tired / fatigue, sick / illness and weak / asthenia.  The patient's medical history included diabetes. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the events, really tired, sick and weak.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, really tired, sick and weak was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ZOLEDRONIC ACID (RECLAST) and Advil                                                          for back painÍ¾ Daily for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was unknown   This case was linked to MOD-2021-108971.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Attached vaccine adverse event reporting form
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Cyst, Lymphadenopathy
Clinical narrative: Asked if it was cyst; Swollen lymph node; A spontaneous report was received from a consumer concerning a 62-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swollen lymph node, asked if it was cyst.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection. On 31 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Swollen lymph node, Asked if it was cyst.  No treatment information provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), swollen lymph node, asked if it was cyst was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Feeling signs of vertigo; Started to feel dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Started to feel dizzy) and VERTIGO (Feeling signs of vertigo) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history information was reported.     On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced DIZZINESS (Started to feel dizzy). On 08-Feb-2021, the patient experienced VERTIGO (Feeling signs of vertigo). At the time of the report, DIZZINESS (Started to feel dizzy) and VERTIGO (Feeling signs of vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact; 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.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypokinesia, Myalgia, Rash, Vaccination site pain
Clinical narrative: could hardly move; body aches; rash on the lower part of her right arm; chills; arm was sore at the injection site; A spontaneous report was received from a consumer concerning a 60-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash on the lower part of her right arm (rash), arm was sore at the injection site (vaccination site pain), body aches (Myalgia), chills, could hardly move (hypokinesia).  The patient's medical history was not provided. Concomitant product use was not reported.  On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, on the same day of receiving vaccine, the patient experienced rash on the lower part of her right arm, arm was sore at the injection site. She had body aches, chills and could hardly move on the morning of 13 Feb 2021. Treatment included acetaminophen and an anti-itch cream.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events, rash on the lower part of right arm, arm was sore at the injection site, body aches, chills, and could hardly move, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient experienced hives from below chest to knees. There were fewer spots from hips to knees
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site scar, Vaccination site warmth
Clinical narrative: Noticed a mark at injection site; It was warm and blotchy; Rash clear down her arm 6 inches long but is not bothersome; A spontaneous report was received from a consumer concerning a 90-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events noticed a mark at injection site, it was warm and blotchy, rash clear down her arm 6 inches long but is not bothersome.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 043L20A)  in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, noticed a mark at injection site, it was warm and blotchy, rash clear down her arm 6 inches long but is not bothersome.Consent to contact given.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, noticed a mark at injection site, it was warm and blotchy, rash clear down her arm 6 inches long but is not bothersome were  unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Rash macular, Vaccination site reaction
Clinical narrative: arm was sore for about 3-4 days; Rash got larger, redder, itchier; warm to the touch; itchy; rash; speckled red spots that were raised; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (speckled red spots that were raised), PAIN IN EXTREMITY (arm was sore for about 3-4 days), VACCINATION SITE REACTION (Rash got larger, redder, itchier), VACCINATION SITE WARMTH (warm to the touch) and PRURITUS (itchy) in a 71-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 04-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 RASH MACULAR (speckled red spots that were raised), PRURITUS (itchy) and RASH (rash). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore for about 3-4 days), VACCINATION SITE REACTION (Rash got larger, redder, itchier) and VACCINATION SITE WARMTH (warm to the touch). The patient was treated with HYDROCORTISONE for Itchy, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (speckled red spots that were raised), PAIN IN EXTREMITY (arm was sore for about 3-4 days), VACCINATION SITE REACTION (Rash got larger, redder, itchier), VACCINATION SITE WARMTH (warm to the touch), PRURITUS (itchy) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information also included anti-itch ointment.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up was received on 26 APR 2021 included reporter details was updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: arm was sore for about 3-4 days; Rash got larger, redder, itchier; warm to the touch; itchy; rash; speckled red spots that were raised; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (speckled red spots that were raised), PAIN IN EXTREMITY (arm was sore for about 3-4 days), VACCINATION SITE REACTION (Rash got larger, redder, itchier), VACCINATION SITE WARMTH (warm to the touch) and PRURITUS (itchy) in a 71-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 04-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 RASH MACULAR (speckled red spots that were raised), PRURITUS (itchy) and RASH (rash). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore for about 3-4 days), VACCINATION SITE REACTION (Rash got larger, redder, itchier) and VACCINATION SITE WARMTH (warm to the touch). The patient was treated with HYDROCORTISONE for Itchy, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (speckled red spots that were raised), PAIN IN EXTREMITY (arm was sore for about 3-4 days), VACCINATION SITE REACTION (Rash got larger, redder, itchier), VACCINATION SITE WARMTH (warm to the touch), PRURITUS (itchy) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information also included anti-itch ointment.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up was received on 26 APR 2021 included reporter details was updated.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Rash around the injection site; Injection site itches; A spontaneous report ) was received from a consumer concerning a 85-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash around the injection site, injection site itches.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced the event(s) rash around the injection site, injection site itches.  Treatment details included dexamethasone.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash around the injection site, injection site itches was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Nausea
Clinical narrative: lightheadedness; Diarrhea; Dizziness; Nauseous; Chills; A spontaneous report was received from a consumer concerning a 61-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nauseous, chills, diarrhea, dizziness, lightheadedness.  The patient's medical history was not provided. Concomitant medications reported were acetaminophen, levothyroxine, fluticasone proprionate, fluticasone proprionate and salmeterol xinafoate, multivitamin for drug use for unknown indication.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events nauseous, Chills, diarrhea, dizziness, lightheadedness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, nauseous, chills, diarrhea, dizziness, lightheadedness were  unknown.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: back was burning; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and BURNING SENSATION (back was burning) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Radioactive iodine in November 2020. Concomitant products included ALPRAZOLAM, APIXABAN (ELIQUIS), METOPROLOL, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), SIMVASTATIN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 10-Feb-2021, the patient experienced BURNING SENSATION (back was burning). On 30-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, BURNING SENSATION (back was burning) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Updated outcome of event back was burning from unknown to recovered and patient declined further follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Condition aggravated, Gait disturbance, Joint injury, Joint swelling
Clinical narrative: Achilles tendon was affected; his balance was affected; he was put him in a wheel chair; Cant move his ankle to any degree; worsened conditions after taking the Moderna vaccine; his right ankle and foot has swollen up; leg is swollen from the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of JOINT SWELLING (his right ankle and foot has swollen up), PERIPHERAL SWELLING (leg is swollen from the vaccine), TENDON INJURY (Achilles tendon was affected), BALANCE DISORDER (his balance was affected) and GAIT DISTURBANCE (he was put him in a wheel chair) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced JOINT SWELLING (his right ankle and foot has swollen up) and PERIPHERAL SWELLING (leg is swollen from the vaccine). On an unknown date, the patient experienced TENDON INJURY (Achilles tendon was affected), BALANCE DISORDER (his balance was affected), GAIT DISTURBANCE (he was put him in a wheel chair), JOINT INJURY (Cant move his ankle to any degree) and CONDITION AGGRAVATED (worsened conditions after taking the Moderna vaccine). At the time of the report, JOINT SWELLING (his right ankle and foot has swollen up), TENDON INJURY (Achilles tendon was affected), BALANCE DISORDER (his balance was affected), JOINT INJURY (Cant move his ankle to any degree) and CONDITION AGGRAVATED (worsened conditions after taking the Moderna vaccine) had not resolved and PERIPHERAL SWELLING (leg is swollen from the vaccine) and GAIT DISTURBANCE (he was put him in a wheel chair) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 13-Feb-2021: No specific follow-up information recorded. On 20-Apr-2021: Follow up received, Updated -  Events tab; Events added: Achilles tendon was affected (Tendon injury); his balance was affected (Balance disorder); put him in a wheelchair (Gait disturbance). Patient mentioned that his Achilles tendon was affected and put him in a wheelchair, and it has affected his balance. He believes that if he falls, he will die or will die from the escalation of swelling or blood clot. On 23-Apr-2021: Follow up received on: 23-Apr-2021Outcome for event "worsened conditions after taking the Moderna vaccine" updated to "Not Recovered/Not Resolved"