chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: watery stool diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (watery stool diarrhea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 DIARRHEA (watery stool diarrhea). At the time of the report, DIARRHEA (watery stool diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications were pro
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, White blood cell count
Clinical narrative: a little tired after both first and second doses; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (a little tired after both first and second doses) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported.).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (a little tired after both first and second doses). At the time of the report, FATIGUE (a little tired after both first and second doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: high (High) Higher than normal..         Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment for the event was not reported.   This case was linked to MOD-2021-072612 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Maternal exposure during breast feeding
Clinical narrative: tightness and heaviness in her upper chest; breastfeeding following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness and heaviness in her upper chest) and MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding following vaccination) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No significant historical event reported.). Concomitant products included LEVOTHYROXINE, ASCORBIC ACID (VITAMIN C ACID), PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], VITAMIN D3 and PROBIOTICS NOS for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding following vaccination). On 06-Apr-2021, the patient experienced CHEST DISCOMFORT (tightness and heaviness in her upper chest). On 02-Apr-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding following vaccination) had resolved. At the time of the report, CHEST DISCOMFORT (tightness and heaviness in her upper chest) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment taken with Advil, the day after the shot.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash were the Moderna vaccine was given; BUMPS all over the arm at the spot (Injection Site); Itching Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (BUMPS all over the arm at the spot (Injection Site)), VACCINATION SITE PRURITUS (Itching Injection Site) and VACCINATION SITE RASH (rash were the Moderna vaccine was given) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE MASS (BUMPS all over the arm at the spot (Injection Site)) and VACCINATION SITE PRURITUS (Itching Injection Site). On 12-Apr-2021, the patient experienced VACCINATION SITE RASH (rash were the Moderna vaccine was given). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (BUMPS all over the arm at the spot (Injection Site)), VACCINATION SITE PRURITUS (Itching Injection Site) and VACCINATION SITE RASH (rash were the Moderna vaccine was given) outcome was unknown.            No relevant concomitant medication was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: new evet added (Vaccination site rash).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever spike 101 F; Fever spike 101 F; Fever spike 100 F; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever spike 100 F), the second episode of PYREXIA (Fever spike 101 F), HEADACHE (Headache) and the first episode of PYREXIA (Fever spike 101 F) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced PYREXIA (Fever spike 100 F) and HEADACHE (Headache). On 07-Apr-2021, the patient experienced the first episode of PYREXIA (Fever spike 101 F). On 09-Apr-2021, the patient experienced the second episode of PYREXIA (Fever spike 101 F). On 04-Apr-2021, PYREXIA (Fever spike 100 F) had resolved. On 09-Apr-2021, last episode of PYREXIA (Fever spike 101 F) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100 Farad (High) fever on Sun (100F), 101 Farad (High) Wed spike of 101 and 101 Farad (High) Friday spike of 101.         Concomitant product use was not provided by the reporter. Treatment information included tylenol for headache.; 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: Discomfort, Erythema, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: still very tender; extremely tired; next morning even redder and started spreading; discomfort as if it was shingles; not itching and it hurts; it felt like it was just sitting there in my arm; several hours later, arm started getting sore; felt my arm, it was real hot; felt swollen/5-inch diameter circle; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (it felt like it was just sitting there in my arm), PAIN IN EXTREMITY (several hours later, arm started getting sore), FEELING HOT (felt my arm, it was real hot), PERIPHERAL SWELLING (felt swollen/5-inch diameter circle) and ERYTHEMA (next morning even redder and started spreading) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Appendectomy (2 years ago). Concurrent medical conditions included Cholesterol, Blood pressure and Allergy (cocktail with two allergy).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced FEELING ABNORMAL (it felt like it was just sitting there in my arm), PAIN IN EXTREMITY (several hours later, arm started getting sore), FEELING HOT (felt my arm, it was real hot) and PERIPHERAL SWELLING (felt swollen/5-inch diameter circle). On 08-Apr-2021, the patient experienced ERYTHEMA (next morning even redder and started spreading), DISCOMFORT (discomfort as if it was shingles) and PAIN (not itching and it hurts). On 09-Apr-2021, the patient experienced TENDERNESS (still very tender) and FATIGUE (extremely tired). At the time of the report, FEELING ABNORMAL (it felt like it was just sitting there in my arm), PAIN IN EXTREMITY (several hours later, arm started getting sore), FEELING HOT (felt my arm, it was real hot), PERIPHERAL SWELLING (felt swollen/5-inch diameter circle), DISCOMFORT (discomfort as if it was shingles), PAIN (not itching and it hurts), TENDERNESS (still very tender) and FATIGUE (extremely tired) outcome was unknown and ERYTHEMA (next morning even redder and started spreading) had not resolved.            Concomitant products included two cholesterol medications and blood pressure medication.Treatment included Tylenol every four hours.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: still very tender; extremely tired; next morning even redder and started spreading; discomfort as if it was shingles; not itching and it hurts; it felt like it was just sitting there in my arm; several hours later, arm started getting sore; felt my arm, it was real hot; felt swollen/5-inch diameter circle; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (it felt like it was just sitting there in my arm), PAIN IN EXTREMITY (several hours later, arm started getting sore), FEELING HOT (felt my arm, it was real hot), PERIPHERAL SWELLING (felt swollen/5-inch diameter circle) and ERYTHEMA (next morning even redder and started spreading) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Appendectomy (2 years ago). Concurrent medical conditions included Cholesterol, Blood pressure and Allergy (cocktail with two allergy).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced FEELING ABNORMAL (it felt like it was just sitting there in my arm), PAIN IN EXTREMITY (several hours later, arm started getting sore), FEELING HOT (felt my arm, it was real hot) and PERIPHERAL SWELLING (felt swollen/5-inch diameter circle). On 08-Apr-2021, the patient experienced ERYTHEMA (next morning even redder and started spreading), DISCOMFORT (discomfort as if it was shingles) and PAIN (not itching and it hurts). On 09-Apr-2021, the patient experienced TENDERNESS (still very tender) and FATIGUE (extremely tired). At the time of the report, FEELING ABNORMAL (it felt like it was just sitting there in my arm), PAIN IN EXTREMITY (several hours later, arm started getting sore), FEELING HOT (felt my arm, it was real hot), PERIPHERAL SWELLING (felt swollen/5-inch diameter circle), DISCOMFORT (discomfort as if it was shingles), PAIN (not itching and it hurts), TENDERNESS (still very tender) and FATIGUE (extremely tired) outcome was unknown and ERYTHEMA (next morning even redder and started spreading) had not resolved.            Concomitant products included two cholesterol medications and blood pressure medication.Treatment included Tylenol every four hours.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pruritus, Pyrexia, Vaccination site warmth
Clinical narrative: In bed for 3 days; Low grade fevers; Arm was hot; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was hot), PRURITUS (Itching), MALAISE (In bed for 3 days) and PYREXIA (Low grade fevers) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Arm was hot), PRURITUS (Itching) and PYREXIA (Low grade fevers). On an unknown date, the patient experienced MALAISE (In bed for 3 days). At the time of the report, VACCINATION SITE WARMTH (Arm was hot), PRURITUS (Itching), MALAISE (In bed for 3 days) and PYREXIA (Low grade fevers) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-Jun-2021: Outcome of the event updated.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and FATIGUE (Fatigue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA), METOPROLOL, FINASTERIDE, LISINOPRIL and TAMSULOSIN for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and FATIGUE (Fatigue). On 20-Mar-2021, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported by the patient   This case was linked to MOD-2021-072747, MOD-2021-072609 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up received on 08-JUL-2021 : Updated email address.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site rash, Vaccination site swelling
Clinical narrative: big swelling at the injection site; pretty large rash; feeling exhausted/ very tired nothing at all; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling exhausted/ very tired nothing at all), VACCINATION SITE SWELLING (big swelling at the injection site) and VACCINATION SITE RASH (pretty large rash) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Relevant medical history not reported.).    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced FATIGUE (feeling exhausted/ very tired nothing at all). On 05-Apr-2021, the patient experienced VACCINATION SITE SWELLING (big swelling at the injection site) and VACCINATION SITE RASH (pretty large rash). At the time of the report, FATIGUE (feeling exhausted/ very tired nothing at all), VACCINATION SITE SWELLING (big swelling at the injection site) and VACCINATION SITE RASH (pretty large rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use by the patient included an unspecified birth control.   Per patient and source, no treatment was taken for the events.  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.   Reporter did not allow further contact; 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen) and PAIN IN EXTREMITY (arm is sore/ARM HURTS) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The patient's past medical history included Asthma, GERD, Overactive bladder, Hypothyroidism, Constipation and Mitral regurgitation. Concurrent medical conditions included Pain, Allergic reaction to drug, Allergy to chemicals and COPD. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 04-Nov-2014 to an unknown date for Allergy, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) from 25-Feb-2021 to an unknown date for GERD, LEVOTHYROXINE from 05-May-2008 to an unknown date for Hypothyroidism, OXYBUTYNINE [OXYBUTYNIN] from 02-Mar-2008 to an unknown date for Overactive bladder, TRAZODONE and oxybutazone. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm is swollen) and PAIN IN EXTREMITY (arm is sore/ARM HURTS). On 08-May-2021, PERIPHERAL SWELLING (arm is swollen) had resolved. At the time of the report, PAIN IN EXTREMITY (arm is sore/ARM HURTS) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product included pain medication. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: added patient details. relevant medical history. concomitant medication.2nd dose details.; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: joint pain in arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (joint pain in arm) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PROPRANOLOL, LISINOPRIL, VITAMIN D3, CALCIUM and THYROID T3 for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (joint pain in arm) and HEADACHE (headache). On 09-Apr-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (joint pain in arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: sore arm; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and COLLAGEN for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, 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 experienced PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and HEADACHE (Headache) had resolved.            Treatment included unspecified antibiotic.   This case was linked to US-MODERNATX, INC.-MOD-2021-226811 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-226811:Same reporter, reporters case
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder
Clinical narrative: could not controlled body; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (could not controlled body) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOVEMENT DISORDER (could not controlled body). At the time of the report, MOVEMENT DISORDER (could not controlled body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and treatment medications were reported.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Stabbing Pain on her back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Stabbing Pain on her back) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced BACK PAIN (Stabbing Pain on her back). At the time of the report, BACK PAIN (Stabbing Pain on her back) outcome was unknown.            No Concomitant and treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Arm sore; Fever; headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), PYREXIA (Fever), HEADACHE (headache) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm sore), PYREXIA (Fever), HEADACHE (headache) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Arm sore), PYREXIA (Fever), HEADACHE (headache) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and treatment medications were reported.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, White blood cell count, White blood cell count increased
Clinical narrative: A little tired after second dose; White blood cell count high; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (White blood cell count high) and FATIGUE (A little tired after second dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced WHITE BLOOD CELL COUNT INCREASED (White blood cell count high). On 08-Apr-2021, the patient experienced FATIGUE (A little tired after second dose). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (White blood cell count high) and FATIGUE (A little tired after second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, White blood cell count: high (High) above normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment.   This case was linked to MOD-2021-072595.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia oral, Taste disorder
Clinical narrative: numbness in her tongue; weird taste in her mouth; on and off chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL, TASTE DISORDER, and CHILLS in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001V21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced HYPOAESTHESIA ORAL, TASTE DISORDER, and CHILLS. At the time of the report, HYPOAESTHESIA ORAL, TASTE DISORDER, and CHILLS had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nasopharyngitis, Pyrexia, Rhinorrhoea
Clinical narrative: runny nose; cold; fever; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHEA (runny nose), NASOPHARYNGITIS (cold), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00ZAZIA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test negative.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced RHINORRHEA (runny nose), NASOPHARYNGITIS (cold), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication include vitamin C and patient thinks the event experienced is not due to the vaccine because in Dec2020 it happened the same to her. There is no relevant Treatment medication provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: rash was on neck and torso; rash at the site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash was on neck and torso) and VACCINATION SITE RASH (rash at the site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (rash at the site of injection). On 04-Apr-2021, the patient experienced RASH (rash was on neck and torso). On 05-Apr-2021, RASH (rash was on neck and torso) and VACCINATION SITE RASH (rash at the site of injection) had resolved.            The doctor recommended Benadryl for rash. The action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MODERNATX, INC.-MOD-2021-072620 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2021-072620:1st dose
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: hand pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (hand pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (hand pain). At the time of the report, PAIN IN EXTREMITY (hand pain) 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. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue
Clinical narrative: Nurse dropped open needle on the floor; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (Nurse dropped open needle on the floor) 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 DEVICE CONNECTION ISSUE (Nurse dropped open needle on the floor). At the time of the report, DEVICE CONNECTION ISSUE (Nurse dropped open needle on the floor) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 040B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DILTIAZEM, HYDROCHLOROTHIAZIDE and LOSARTAN for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PRURITUS (Itching). At the time of the report, PRURITUS (Itching) outcome was unknown.            Caller stated she took Aspirin earlier and was currently itching so wanted to know if she could take Benadryl.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pruritus, Vaccination site rash
Clinical narrative: Shingles Rash on left side of body by Rib- cage and Itching; Itching on left side of body by Rib Cage; Small Rash on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles Rash on left side of body by Rib- cage and Itching), PRURITUS (Itching on left side of body by Rib Cage) and VACCINATION SITE RASH (Small Rash on the Injection Site) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included INSULIN for an unknown indication.   On 02-Apr-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 08-Apr-2021, the patient experienced HERPES ZOSTER (Shingles Rash on left side of body by Rib- cage and Itching), PRURITUS (Itching on left side of body by Rib Cage) and VACCINATION SITE RASH (Small Rash on the Injection Site). At the time of the report, HERPES ZOSTER (Shingles Rash on left side of body by Rib- cage and Itching), PRURITUS (Itching on left side of body by Rib Cage) and VACCINATION SITE RASH (Small Rash on the Injection Site) outcome was unknown.            Treatment included as Tylenol per oral.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-072615 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072615:2st dose
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Sensation of foreign body, Taste disorder
Clinical narrative: funky feeling on throat; funky taste on mouth; odd taste but not in the sinus; feeling like something was stuck on her throat, like swallowing a pill; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (funky feeling on throat), TASTE DISORDER (funky taste on mouth), TASTE DISORDER (odd taste but not in the sinus) and SENSATION OF FOREIGN BODY (feeling like something was stuck on her throat, like swallowing a pill) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included OLMESARTAN for Blood pressure.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (funky feeling on throat), TASTE DISORDER (funky taste on mouth), TASTE DISORDER (odd taste but not in the sinus) and SENSATION OF FOREIGN BODY (feeling like something was stuck on her throat, like swallowing a pill). At the time of the report, OROPHARYNGEAL DISCOMFORT (funky feeling on throat), TASTE DISORDER (funky taste on mouth), TASTE DISORDER (odd taste but not in the sinus) and SENSATION OF FOREIGN BODY (feeling like something was stuck on her throat, like swallowing a pill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain in extremity
Clinical narrative: soft tissue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (soft tissue) and PAIN IN EXTREMITY (sore arm) 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 24-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 INCORRECT ROUTE OF PRODUCT ADMINISTRATION (soft tissue) and PAIN IN EXTREMITY (sore arm). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (soft tissue) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-MAY-2021 Contains no new information.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: sharp shooting and piercing pain in her right breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (sharp shooting and piercing pain in her right breast) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), TRAZODONE HYDROCHLORIDE (DESYREL), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), AMLODIPINE BESILATE (NORVASC), BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), VORTIOXETINE HYDROBROMIDE (TRINTELLIX) and CLONAZEPAM for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced BREAST PAIN (sharp shooting and piercing pain in her right breast). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 06-Apr-2021, BREAST PAIN (sharp shooting and piercing pain in her right breast) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported felt something on top of her right arm. She had taken Benadryl for unknown indication.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Treatment medication added.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: Hypertension; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION  in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood cholesterol increased. Concomitant products included ATORVASTATIN for Cholesterol blood increased.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced HYPERTENSION. The patient was treated with AMLODIPINE for Hypertension, at an unspecified dose and frequency. At the time of the report, HYPERTENSION outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Blood pressure measurement: 200 mmHg (High).         Patient went to Emergency Room and stayed for 2 nights after his BP normalized.    Reporter did not allow further contact.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus
Clinical narrative: Generalized itching after receiving the second dose; Losing sleep because of the itching; Severe itching - mostly on her arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Losing sleep because of the itching), PRURITUS (Severe itching - mostly on her arms and legs) and PRURITUS (Generalized itching after receiving the second dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015B20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Drug allergy (Sulfamethoxazole). Concomitant products included AZELASTINE, BUDESONIDE, LATANOPROST, ALBUTEROL [SALBUTAMOL], MESALAMINE, FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), BUSPIRONE, MELOXICAM (MELOXICAN), ENALAPRIL and DICLOFENAC (VOLTAREN [DICLOFENAC]) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2012,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Severe itching - mostly on her arms and legs). On 17-Mar-2021, the patient experienced INSOMNIA (Losing sleep because of the itching). On an unknown date, the patient experienced PRURITUS (Generalized itching after receiving the second dose). At the time of the report, INSOMNIA (Losing sleep because of the itching), PRURITUS (Severe itching - mostly on her arms and legs) and PRURITUS (Generalized itching after receiving the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment: Antihistamine Drugs   This case was linked to MOD-2021-072689 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Events, product information updated On 11-May-2021:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Rash, Vaccination site warmth
Clinical narrative: Arm is hot; Rash; Arm was sore; Couldn't lift her arm for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), LIMB DISCOMFORT (Couldn't lift her arm for 2 days), VACCINATION SITE WARMTH (Arm is hot) and RASH (Rash) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and LIMB DISCOMFORT (Couldn't lift her arm for 2 days). On 09-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Arm is hot) and RASH (Rash). On 02-Apr-2021, PAIN IN EXTREMITY (Arm was sore) and LIMB DISCOMFORT (Couldn't lift her arm for 2 days) had resolved. At the time of the report, VACCINATION SITE WARMTH (Arm is hot) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.  Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Telephone Contact Report (TCR) received on 20-Jun-2021, contains no new information and patient declined further follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Glucose tolerance test, Maternal exposure during pregnancy, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 26-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Nov-2021. On 05-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 05-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Blood test: normal (normal) normal. On 07-Apr-2021, Glucose tolerance test: normal (normal) normal. On 07-Apr-2021, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication is provided. Treatment information was not provided.  The patient's estimated date of conception was 20-Feb-2021.