chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Nausea
Clinical narrative: dizziness; felt yucky; vomiting/threw up; extremely nauseation; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FEELING ABNORMAL (felt yucky), VOMITING (vomiting/threw up), NAUSEA (extremely nauseation) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diverticulitis and Acid reflux (esophageal). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), METRONIDAZOLE BENZOATE (METROZOLE [METRONIDAZOLE BENZOATE]) and LETROZOLE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (dizziness), FEELING ABNORMAL (felt yucky), VOMITING (vomiting/threw up), NAUSEA (extremely nauseation), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 16-Mar-2021, DIZZINESS (dizziness) outcome was unknown, VOMITING (vomiting/threw up) and HEADACHE (headache) had resolved. At the time of the report, FEELING ABNORMAL (felt yucky), NAUSEA (extremely nauseation) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: dizziness; felt yucky; vomiting/threw up; extremely nauseation; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FEELING ABNORMAL (felt yucky), VOMITING (vomiting/threw up), NAUSEA (extremely nauseation) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diverticulitis and Acid reflux (esophageal). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), METRONIDAZOLE BENZOATE (METROZOLE [METRONIDAZOLE BENZOATE]) and LETROZOLE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (dizziness), FEELING ABNORMAL (felt yucky), VOMITING (vomiting/threw up), NAUSEA (extremely nauseation), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 16-Mar-2021, DIZZINESS (dizziness) outcome was unknown, VOMITING (vomiting/threw up) and HEADACHE (headache) had resolved. At the time of the report, FEELING ABNORMAL (felt yucky), NAUSEA (extremely nauseation) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Body temperature, Chills, Headache, Heart rate
Clinical narrative: asthma attack without reason; coughing up phlegm; muscle weakness; nauseous; lethargy; chills; could not sleep; soreness at the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy), ASTHMA (asthma attack without reason), PRODUCTIVE COUGH (coughing up phlegm), INSOMNIA (could not sleep) and MUSCULAR WEAKNESS (muscle weakness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site) and HEADACHE (headache). On 13-Mar-2021, the patient experienced INSOMNIA (could not sleep) and CHILLS (chills). On 15-Mar-2021, the patient experienced LETHARGY (lethargy). On 16-Mar-2021, the patient experienced ASTHMA (asthma attack without reason), PRODUCTIVE COUGH (coughing up phlegm), MUSCULAR WEAKNESS (muscle weakness) and NAUSEA (nauseous). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date for Headache, at a dose of 1 dosage form and SALBUTAMOL (ALBUTEROL HFA) ongoing since an unknown date at a dose of 1 dosage form twice a day. On 13-Mar-2021, VACCINATION SITE PAIN (soreness at the injection site) and HEADACHE (headache) had resolved. On 15-Mar-2021, LETHARGY (lethargy) and CHILLS (chills) had resolved. On 16-Mar-2021, ASTHMA (asthma attack without reason) had resolved. At the time of the report, PRODUCTIVE COUGH (coughing up phlegm), INSOMNIA (could not sleep), MUSCULAR WEAKNESS (muscle weakness) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: elevated (Inconclusive) temperature was slightly elevated.. In March 2021, Heart rate: increased (Inconclusive) rapid HR.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lethargy, Muscular weakness, Nausea, Productive cough
Clinical narrative: asthma attack without reason; coughing up phlegm; muscle weakness; nauseous; lethargy; chills; could not sleep; soreness at the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy), ASTHMA (asthma attack without reason), PRODUCTIVE COUGH (coughing up phlegm), INSOMNIA (could not sleep) and MUSCULAR WEAKNESS (muscle weakness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site) and HEADACHE (headache). On 13-Mar-2021, the patient experienced INSOMNIA (could not sleep) and CHILLS (chills). On 15-Mar-2021, the patient experienced LETHARGY (lethargy). On 16-Mar-2021, the patient experienced ASTHMA (asthma attack without reason), PRODUCTIVE COUGH (coughing up phlegm), MUSCULAR WEAKNESS (muscle weakness) and NAUSEA (nauseous). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date for Headache, at a dose of 1 dosage form and SALBUTAMOL (ALBUTEROL HFA) ongoing since an unknown date at a dose of 1 dosage form twice a day. On 13-Mar-2021, VACCINATION SITE PAIN (soreness at the injection site) and HEADACHE (headache) had resolved. On 15-Mar-2021, LETHARGY (lethargy) and CHILLS (chills) had resolved. On 16-Mar-2021, ASTHMA (asthma attack without reason) had resolved. At the time of the report, PRODUCTIVE COUGH (coughing up phlegm), INSOMNIA (could not sleep), MUSCULAR WEAKNESS (muscle weakness) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: elevated (Inconclusive) temperature was slightly elevated.. In March 2021, Heart rate: increased (Inconclusive) rapid HR.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: asthma attack without reason; coughing up phlegm; muscle weakness; nauseous; lethargy; chills; could not sleep; soreness at the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy), ASTHMA (asthma attack without reason), PRODUCTIVE COUGH (coughing up phlegm), INSOMNIA (could not sleep) and MUSCULAR WEAKNESS (muscle weakness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site) and HEADACHE (headache). On 13-Mar-2021, the patient experienced INSOMNIA (could not sleep) and CHILLS (chills). On 15-Mar-2021, the patient experienced LETHARGY (lethargy). On 16-Mar-2021, the patient experienced ASTHMA (asthma attack without reason), PRODUCTIVE COUGH (coughing up phlegm), MUSCULAR WEAKNESS (muscle weakness) and NAUSEA (nauseous). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date for Headache, at a dose of 1 dosage form and SALBUTAMOL (ALBUTEROL HFA) ongoing since an unknown date at a dose of 1 dosage form twice a day. On 13-Mar-2021, VACCINATION SITE PAIN (soreness at the injection site) and HEADACHE (headache) had resolved. On 15-Mar-2021, LETHARGY (lethargy) and CHILLS (chills) had resolved. On 16-Mar-2021, ASTHMA (asthma attack without reason) had resolved. At the time of the report, PRODUCTIVE COUGH (coughing up phlegm), INSOMNIA (could not sleep), MUSCULAR WEAKNESS (muscle weakness) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: elevated (Inconclusive) temperature was slightly elevated.. In March 2021, Heart rate: increased (Inconclusive) rapid HR.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Heart rate
Clinical narrative: Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL for an unknown indication.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 112/72 mmHg (Low) Unknown. On 16-Mar-2021, Heart rate: 115 (High) Normally between 77 and 80 (74 when resting)..         Treatment information was not provided  Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Nausea, Pain, Palpitations
Clinical narrative: Heart palpitation; Nausea; She was very tired; Aches; She slept for many hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), HYPERSOMNIA (She slept for many hours), PALPITATIONS (Heart palpitation), NAUSEA (Nausea) and FATIGUE (She was very tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety.    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 PAIN (Aches), HYPERSOMNIA (She slept for many hours), NAUSEA (Nausea) and FATIGUE (She was very tired). On 10-Mar-2021, the patient experienced PALPITATIONS (Heart palpitation). At the time of the report, PAIN (Aches), HYPERSOMNIA (She slept for many hours), PALPITATIONS (Heart palpitation), NAUSEA (Nausea) and FATIGUE (She was very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Fatigue, Vaccination site swelling
Clinical narrative: Tired; Weak; Minor swelling at injection site; Whole body felt like it was on fire; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Whole body felt like it was on fire), ASTHENIA (Weak), VACCINATION SITE SWELLING (Minor swelling at injection site) and FATIGUE (Tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced BURNING SENSATION (Whole body felt like it was on fire) and VACCINATION SITE SWELLING (Minor swelling at injection site). On 12-Mar-2021, the patient experienced ASTHENIA (Weak). On 13-Mar-2021, the patient experienced FATIGUE (Tired). At the time of the report, BURNING SENSATION (Whole body felt like it was on fire) was resolving and ASTHENIA (Weak), VACCINATION SITE SWELLING (Minor swelling at injection site) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment using ice pack was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Heart rate, Throat tightness, Vaccination site pain
Clinical narrative: Transient throat tightening; 1 dime sized hive on injection arm; Injection arm tenderness; Feeling tired; This spontaneous case was reported by a nurse and describes the occurrence of THROAT TIGHTNESS (Transient throat tightening), VACCINATION SITE URTICARIA (1 dime sized hive on injection arm), VACCINATION SITE PAIN (Injection arm tenderness) and FATIGUE (Feeling tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included LEVOTHYROXINE, CLONAZEPAM (KLONOPIN) and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced THROAT TIGHTNESS (Transient throat tightening), VACCINATION SITE URTICARIA (1 dime sized hive on injection arm), VACCINATION SITE PAIN (Injection arm tenderness) and FATIGUE (Feeling tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) 04-Mar-2021 for Prophylactic, at an unspecified dose and frequency. On 05-Mar-2021, THROAT TIGHTNESS (Transient throat tightening) had resolved. At the time of the report, VACCINATION SITE URTICARIA (1 dime sized hive on injection arm), VACCINATION SITE PAIN (Injection arm tenderness) and FATIGUE (Feeling tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood pressure measurement: 132/80 (High) Elevated Blood pressure (132/80) 2-5 minutes after vaccine. On 05-Mar-2021, Heart rate: 140 (High) Elevated heart rate (140s) 2-5 minutes after vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant product  include Bioidentical hormone cream.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received- Event outcome provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Transient throat tightening; 1 dime sized hive on injection arm; Injection arm tenderness; Feeling tired; This spontaneous case was reported by a nurse and describes the occurrence of THROAT TIGHTNESS (Transient throat tightening), VACCINATION SITE URTICARIA (1 dime sized hive on injection arm), VACCINATION SITE PAIN (Injection arm tenderness) and FATIGUE (Feeling tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included LEVOTHYROXINE, CLONAZEPAM (KLONOPIN) and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced THROAT TIGHTNESS (Transient throat tightening), VACCINATION SITE URTICARIA (1 dime sized hive on injection arm), VACCINATION SITE PAIN (Injection arm tenderness) and FATIGUE (Feeling tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) 04-Mar-2021 for Prophylactic, at an unspecified dose and frequency. On 05-Mar-2021, THROAT TIGHTNESS (Transient throat tightening) had resolved. At the time of the report, VACCINATION SITE URTICARIA (1 dime sized hive on injection arm), VACCINATION SITE PAIN (Injection arm tenderness) and FATIGUE (Feeling tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood pressure measurement: 132/80 (High) Elevated Blood pressure (132/80) 2-5 minutes after vaccine. On 05-Mar-2021, Heart rate: 140 (High) Elevated heart rate (140s) 2-5 minutes after vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant product  include Bioidentical hormone cream.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received- Event outcome provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Lymphadenopathy, Myalgia
Clinical narrative: Flu like symptoms; smelled smoke/ smelling smoke (campfire not cigarette); Swollen lymph node; Fever; chills; body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAROSMIA (smelled smoke/ smelling smoke (campfire not cigarette)), LYMPHADENOPATHY (Swollen lymph node), PYREXIA (Fever) and CHILLS (chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The patient was covid-19 positive on November 2020 and January 2021.) in November 2020. Concurrent medical conditions included Drug allergy (Allergy to  Codeine) and Drug allergy (Allergy to Levaquin).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAROSMIA (smelled smoke/ smelling smoke (campfire not cigarette)), LYMPHADENOPATHY (Swollen lymph node), PYREXIA (Fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headaches). On 07-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), LYMPHADENOPATHY (Swollen lymph node), PYREXIA (Fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headaches) had resolved. On 19-Feb-2021, PAROSMIA (smelled smoke/ smelling smoke (campfire not cigarette)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: postive (Positive) COVID-19 Positive on 2020 November.. In January 2021, SARS-CoV-2 test: postive (Positive) COVID-19 Positive on 2021 January..    This case was linked to Dose 2 case (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Follow-up was received on 05-apr-2021. New event (Flu-like symptoms) was added. Patient demographics (height, weight, race) were added.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Flu like symptoms; smelled smoke/ smelling smoke (campfire not cigarette); Swollen lymph node; Fever; chills; body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAROSMIA (smelled smoke/ smelling smoke (campfire not cigarette)), LYMPHADENOPATHY (Swollen lymph node), PYREXIA (Fever) and CHILLS (chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The patient was covid-19 positive on November 2020 and January 2021.) in November 2020. Concurrent medical conditions included Drug allergy (Allergy to  Codeine) and Drug allergy (Allergy to Levaquin).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAROSMIA (smelled smoke/ smelling smoke (campfire not cigarette)), LYMPHADENOPATHY (Swollen lymph node), PYREXIA (Fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headaches). On 07-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), LYMPHADENOPATHY (Swollen lymph node), PYREXIA (Fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headaches) had resolved. On 19-Feb-2021, PAROSMIA (smelled smoke/ smelling smoke (campfire not cigarette)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: postive (Positive) COVID-19 Positive on 2020 November.. In January 2021, SARS-CoV-2 test: postive (Positive) COVID-19 Positive on 2021 January..    This case was linked to Dose 2 case (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Follow-up was received on 05-apr-2021. New event (Flu-like symptoms) was added. Patient demographics (height, weight, race) were added.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dysgeusia, Erythema, Feeling hot, Pain in extremity
Clinical narrative: Swollen arm; red arm; arm hot to the touch; Metal taste; Bruise arm; sore arm; knot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metal taste), CONTUSION (Bruise arm), PAIN IN EXTREMITY (sore arm), VACCINATION SITE NODULE (knot at the injection site) and PERIPHERAL SWELLING (Swollen arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE, ATENOLOL, LEVOTHYROXINE, METFORMIN and ESTRADIOL for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSGEUSIA (Metal taste), CONTUSION (Bruise arm), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE NODULE (knot at the injection site). On 16-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red arm) and FEELING HOT (arm hot to the touch). On 08-Mar-2021, DYSGEUSIA (Metal taste), CONTUSION (Bruise arm), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE NODULE (knot at the injection site) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red arm) and FEELING HOT (arm hot to the touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site nodule
Clinical narrative: Swollen arm; red arm; arm hot to the touch; Metal taste; Bruise arm; sore arm; knot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metal taste), CONTUSION (Bruise arm), PAIN IN EXTREMITY (sore arm), VACCINATION SITE NODULE (knot at the injection site) and PERIPHERAL SWELLING (Swollen arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE, ATENOLOL, LEVOTHYROXINE, METFORMIN and ESTRADIOL for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSGEUSIA (Metal taste), CONTUSION (Bruise arm), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE NODULE (knot at the injection site). On 16-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red arm) and FEELING HOT (arm hot to the touch). On 08-Mar-2021, DYSGEUSIA (Metal taste), CONTUSION (Bruise arm), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE NODULE (knot at the injection site) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red arm) and FEELING HOT (arm hot to the touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Panic attack
Clinical narrative: painic attack; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (painic attack) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PANIC ATTACK (painic attack). The patient was treated with ALPRAZOLAM at a dose of UNK dosage form. At the time of the report, PANIC ATTACK (painic attack) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Heart rate: increased (Inconclusive) Heart beat raising.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications include alprazolam. After 3 hours patient  heart was started raising. She had a panic attack..
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Neck pain after 1st dose; Neck swelling after 1st dose/Armpit swelling after 1st dose; Armpit pain; Mild pain in areas where lymph nodes were swollen; Soreness; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain after 1st dose), SWELLING (Neck swelling after 1st dose/Armpit swelling after 1st dose), AXILLARY PAIN (Armpit pain), PAIN IN EXTREMITY (Mild pain in areas where lymph nodes were swollen) and LYMPHADENOPATHY (Swollen lymph nodes) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00ZB21A and 031X21H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Drug allergy (Allergy to codeine-Sick to Stomach/Vomitting.) since 04-Apr-1992, Drug allergy (Allergy to Artificial sweeteners-Sick to stomach/Vomitting) since 03-Mar-1993, Celiac disease (Autoimmune Reactions) since 16-Mar-2002 and Hypothyroidism since 13-Mar-2021. Concomitant products included PANTOPRAZOLE from 30-Mar-2003 to an unknown date for Acid reflux (esophageal), LEVOTHYROXINE SODIUM (SYNTHROID) from 13-Mar-1997 to an unknown date for Hypothyroidism, MULTIVITAMIN [VITAMINS NOS] from 30-Mar-2003 to an unknown date for Vitamin supplementation.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). On an unknown date, the patient experienced NECK PAIN (Neck pain after 1st dose), SWELLING (Neck swelling after 1st dose/Armpit swelling after 1st dose), AXILLARY PAIN (Armpit pain), PAIN IN EXTREMITY (Mild pain in areas where lymph nodes were swollen) and MYALGIA (Soreness). On 16-Mar-2021, LYMPHADENOPATHY (Swollen lymph nodes) had resolved. At the time of the report, NECK PAIN (Neck pain after 1st dose), SWELLING (Neck swelling after 1st dose/Armpit swelling after 1st dose), AXILLARY PAIN (Armpit pain), PAIN IN EXTREMITY (Mild pain in areas where lymph nodes were swollen) and MYALGIA (Soreness) had resolved.            Treatment information was not provided by the reporter..   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant Follow up-Updated Reporter's address, Updated patient details and Allergies and Other relevant history, Updated suspect product dose1 batch number and dose 2 details. Updated Concomitant medications and start dates, Updated New Events and Outcome of the Events as resolved.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Neck pain after 1st dose; Neck swelling after 1st dose/Armpit swelling after 1st dose; Armpit pain; Mild pain in areas where lymph nodes were swollen; Soreness; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain after 1st dose), SWELLING (Neck swelling after 1st dose/Armpit swelling after 1st dose), AXILLARY PAIN (Armpit pain), PAIN IN EXTREMITY (Mild pain in areas where lymph nodes were swollen) and LYMPHADENOPATHY (Swollen lymph nodes) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00ZB21A and 031X21H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Drug allergy (Allergy to codeine-Sick to Stomach/Vomitting.) since 04-Apr-1992, Drug allergy (Allergy to Artificial sweeteners-Sick to stomach/Vomitting) since 03-Mar-1993, Celiac disease (Autoimmune Reactions) since 16-Mar-2002 and Hypothyroidism since 13-Mar-2021. Concomitant products included PANTOPRAZOLE from 30-Mar-2003 to an unknown date for Acid reflux (esophageal), LEVOTHYROXINE SODIUM (SYNTHROID) from 13-Mar-1997 to an unknown date for Hypothyroidism, MULTIVITAMIN [VITAMINS NOS] from 30-Mar-2003 to an unknown date for Vitamin supplementation.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). On an unknown date, the patient experienced NECK PAIN (Neck pain after 1st dose), SWELLING (Neck swelling after 1st dose/Armpit swelling after 1st dose), AXILLARY PAIN (Armpit pain), PAIN IN EXTREMITY (Mild pain in areas where lymph nodes were swollen) and MYALGIA (Soreness). On 16-Mar-2021, LYMPHADENOPATHY (Swollen lymph nodes) had resolved. At the time of the report, NECK PAIN (Neck pain after 1st dose), SWELLING (Neck swelling after 1st dose/Armpit swelling after 1st dose), AXILLARY PAIN (Armpit pain), PAIN IN EXTREMITY (Mild pain in areas where lymph nodes were swollen) and MYALGIA (Soreness) had resolved.            Treatment information was not provided by the reporter..   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant Follow up-Updated Reporter's address, Updated patient details and Allergies and Other relevant history, Updated suspect product dose1 batch number and dose 2 details. Updated Concomitant medications and start dates, Updated New Events and Outcome of the Events as resolved.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site exfoliation, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Little warm,almost like a bee sting, around the injection site/warm around the injection site; itchiness around the injection site; Broke out in a rash, looks like welt, three inches wide/rash around the injection site; peeled like a sunburn; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Little warm,almost like a bee sting, around the injection site/warm around the injection site), VACCINATION SITE EXFOLIATION (peeled like a sunburn), VACCINATION SITE PRURITUS (itchiness around the injection site) and VACCINATION SITE RASH (Broke out in a rash, looks like welt, three inches wide/rash around the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Hives. Concurrent medical conditions included Penicillin allergy.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Little warm,almost like a bee sting, around the injection site/warm around the injection site), VACCINATION SITE PRURITUS (itchiness around the injection site) and VACCINATION SITE RASH (Broke out in a rash, looks like welt, three inches wide/rash around the injection site). In March 2021, the patient experienced VACCINATION SITE EXFOLIATION (peeled like a sunburn). At the time of the report, VACCINATION SITE WARMTH (Little warm,almost like a bee sting, around the injection site/warm around the injection site), VACCINATION SITE EXFOLIATION (peeled like a sunburn), VACCINATION SITE PRURITUS (itchiness around the injection site) and VACCINATION SITE RASH (Broke out in a rash, looks like welt, three inches wide/rash around the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE WARMTH (Little warm,almost like a bee sting, around the injection site/warm around the injection site), VACCINATION SITE EXFOLIATION (peeled like a sunburn), VACCINATION SITE PRURITUS (itchiness around the injection site) and VACCINATION SITE RASH (Broke out in a rash, looks like welt, three inches wide/rash around the injection site) to be possibly related.    The patient takes concomitant medications for a HGC diet.  No treatment information was provided by the patient.   This case was linked to MOD-2021-246857 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received: Medical history updated, action taken and  event outcomes were updated; new additional event of peeled like a sunburn was reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Pain in extremity
Clinical narrative: soreness in the arm; taste of metal in their mouth; pain in the arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), DYSGEUSIA (taste of metal in their mouth) and PAIN IN EXTREMITY (pain in the arm) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm), DYSGEUSIA (taste of metal in their mouth) and PAIN IN EXTREMITY (pain in the arm). On 13-Mar-2021, PAIN IN EXTREMITY (soreness in the arm), DYSGEUSIA (taste of metal in their mouth) and PAIN IN EXTREMITY (pain in the arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Non significant follow up received on 12-APR-2021, no new information.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: at 56 days since she got the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (at 56 days since she got the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (at 56 days since she got the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (at 56 days since she got the first dose) had resolved.        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.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pain in extremity, Respiration abnormal, Stress
Clinical narrative: stressed; breathing heavy; Sore left arm; This spontaneous case was reported by a patient and describes the occurrence of STRESS (stressed), RESPIRATION ABNORMAL (breathing heavy) and PAIN IN EXTREMITY (Sore left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified since January 2021, Emphysema since January 2021 and RA since January 2021.    On 15-Mar-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 STRESS (stressed), RESPIRATION ABNORMAL (breathing heavy) and PAIN IN EXTREMITY (Sore left arm). At the time of the report, STRESS (stressed), RESPIRATION ABNORMAL (breathing heavy) and PAIN IN EXTREMITY (Sore left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 90 (Low) oxygen level 90%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Feeling hot, Vaccination site pain, Vaccination site pruritus
Clinical narrative: feeling red; a burning sensation, radiating to her elbow and shoulder; feeling hot; burning and itching at the injection site; burning and itching at the injection site; soreness around the injection site; little spot size of a quarter; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (feeling red), BURNING SENSATION (a burning sensation, radiating to her elbow and shoulder), FEELING HOT (feeling hot), VACCINATION SITE PRURITUS (burning and itching at the injection site) and VACCINATION SITE RASH (little spot size of a quarter) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included GLIPIZIDE, METFORMIN, LISINOPRIL, HYDROCHLOROTHIAZIDE and ROSUVASTATIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE RASH (little spot size of a quarter) and VACCINATION SITE PAIN (soreness around the injection site). On 15-Mar-2021, the patient experienced ERYTHEMA (feeling red), BURNING SENSATION (a burning sensation, radiating to her elbow and shoulder), FEELING HOT (feeling hot), VACCINATION SITE PRURITUS (burning and itching at the injection site) and VACCINATION SITE PAIN (burning and itching at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 11-Mar-2021, VACCINATION SITE RASH (little spot size of a quarter) and VACCINATION SITE PAIN (soreness around the injection site) had resolved. At the time of the report, ERYTHEMA (feeling red), BURNING SENSATION (a burning sensation, radiating to her elbow and shoulder), FEELING HOT (feeling hot), VACCINATION SITE PRURITUS (burning and itching at the injection site) and VACCINATION SITE PAIN (burning and itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included ice pack. The patient reported raised area, 2.5 - 3.0 inches In diameter at injection site.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: feeling red; a burning sensation, radiating to her elbow and shoulder; feeling hot; burning and itching at the injection site; burning and itching at the injection site; soreness around the injection site; little spot size of a quarter; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (feeling red), BURNING SENSATION (a burning sensation, radiating to her elbow and shoulder), FEELING HOT (feeling hot), VACCINATION SITE PRURITUS (burning and itching at the injection site) and VACCINATION SITE RASH (little spot size of a quarter) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included GLIPIZIDE, METFORMIN, LISINOPRIL, HYDROCHLOROTHIAZIDE and ROSUVASTATIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE RASH (little spot size of a quarter) and VACCINATION SITE PAIN (soreness around the injection site). On 15-Mar-2021, the patient experienced ERYTHEMA (feeling red), BURNING SENSATION (a burning sensation, radiating to her elbow and shoulder), FEELING HOT (feeling hot), VACCINATION SITE PRURITUS (burning and itching at the injection site) and VACCINATION SITE PAIN (burning and itching at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 11-Mar-2021, VACCINATION SITE RASH (little spot size of a quarter) and VACCINATION SITE PAIN (soreness around the injection site) had resolved. At the time of the report, ERYTHEMA (feeling red), BURNING SENSATION (a burning sensation, radiating to her elbow and shoulder), FEELING HOT (feeling hot), VACCINATION SITE PRURITUS (burning and itching at the injection site) and VACCINATION SITE PAIN (burning and itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included ice pack. The patient reported raised area, 2.5 - 3.0 inches In diameter at injection site.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Glucose tolerance test, Pregnancy test, Ultrasound scan
Clinical narrative: She is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (She is pregnant) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 29-Aug-2020 and the estimated date of delivery was 06-Jun-2021. On 20-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (She is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 20-Feb-2021, EXPOSURE DURING PREGNANCY (She is pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Glucose tolerance test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Estimated date of conception was reported on 14-Sep-2020.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Tremor, Vomiting
Clinical narrative: Shaking like a leaf; Chills; Vomited; Diarrhea, it was so bad,; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea, it was so bad,), TREMOR (Shaking like a leaf), VOMITING (Vomited) and CHILLS (Chills) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia (had pneumonia several years ago), Memory impairment (medication for memory), Torticollis (torticollis medicine.) and Blood disorder (blood thinner medicine). Concurrent medical conditions included Hypertension (Blood pressure medicine,).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DIARRHOEA (Diarrhea, it was so bad,). On 20-Feb-2021, the patient experienced VOMITING (Vomited). On an unknown date, the patient experienced TREMOR (Shaking like a leaf) and CHILLS (Chills). At the time of the report, DIARRHOEA (Diarrhea, it was so bad,), TREMOR (Shaking like a leaf), VOMITING (Vomited) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines included medcines for  blood pressure, blood thinner, memory and torticollis. No treatment information reported.