chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Pruritus
Clinical narrative: Sweaty; Itchy all over; Headache; This spontaneous case was reported by a physician and describes the occurrence of HYPERHIDROSIS (Sweaty), PRURITUS (Itchy all over) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, METFORMIN, LINAGLIPTIN (TRAJENTA), LOSARTAN, HYDROCHLOROTHIAZIDE, METOPROLOL, LEVOTHYROXINE SODIUM (SYNTHROID) and OMEPRAZOLE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HYPERHIDROSIS (Sweaty), PRURITUS (Itchy all over) and HEADACHE (Headache). On 27-Feb-2021, HYPERHIDROSIS (Sweaty), PRURITUS (Itchy all over) and HEADACHE (Headache) had 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.   No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (BAD REACTION) 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 VACCINATION COMPLICATION (BAD REACTION). At the time of the report, VACCINATION COMPLICATION (BAD REACTION) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was reported. Reporter did not allow further contact
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on her arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain on her arm). At the time of the report, PAIN IN EXTREMITY (Pain on her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on her arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain on her arm). At the time of the report, PAIN IN EXTREMITY (Pain on her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (hard time breathing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DYSPNOEA (hard time breathing). On 09-Feb-2021, DYSPNOEA (hard time breathing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Nausea, Presyncope
Clinical narrative: room started spinning; broke out into sweat; felt like passing out; dry heaving twice; dizziness; threw up once; nauseous; tired; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (room started spinning), HYPERHIDROSIS (broke out into sweat), PRESYNCOPE (felt like passing out), RETCHING (dry heaving twice) and DIZZINESS (dizziness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (Had 3.). Concurrent medical conditions included Diabetes.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VERTIGO (room started spinning), HYPERHIDROSIS (broke out into sweat), PRESYNCOPE (felt like passing out), RETCHING (dry heaving twice), DIZZINESS (dizziness), VOMITING (threw up once), NAUSEA (nauseous) and FATIGUE (tired). At the time of the report, VERTIGO (room started spinning), HYPERHIDROSIS (broke out into sweat), PRESYNCOPE (felt like passing out), RETCHING (dry heaving twice), DIZZINESS (dizziness), VOMITING (threw up once), NAUSEA (nauseous) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she did not take any medication for the symptoms and she also skipped her night time unknown medication. Patient reported that she did not take any medication other morning and put a wet rag on her head.  No specific concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Retching, Vertigo, Vomiting
Clinical narrative: room started spinning; broke out into sweat; felt like passing out; dry heaving twice; dizziness; threw up once; nauseous; tired; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (room started spinning), HYPERHIDROSIS (broke out into sweat), PRESYNCOPE (felt like passing out), RETCHING (dry heaving twice) and DIZZINESS (dizziness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (Had 3.). Concurrent medical conditions included Diabetes.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VERTIGO (room started spinning), HYPERHIDROSIS (broke out into sweat), PRESYNCOPE (felt like passing out), RETCHING (dry heaving twice), DIZZINESS (dizziness), VOMITING (threw up once), NAUSEA (nauseous) and FATIGUE (tired). At the time of the report, VERTIGO (room started spinning), HYPERHIDROSIS (broke out into sweat), PRESYNCOPE (felt like passing out), RETCHING (dry heaving twice), DIZZINESS (dizziness), VOMITING (threw up once), NAUSEA (nauseous) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she did not take any medication for the symptoms and she also skipped her night time unknown medication. Patient reported that she did not take any medication other morning and put a wet rag on her head.  No specific concomitant medications were reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough
Clinical narrative: very bad chills; dry cough; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (very bad chills) and COUGH (dry cough) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced CHILLS (very bad chills) and COUGH (dry cough). At the time of the report, CHILLS (very bad chills) and COUGH (dry cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (very bad chills) and COUGH (dry cough) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced CHILLS (very bad chills) and COUGH (dry cough). At the time of the report, CHILLS (very bad chills) and COUGH (dry cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: Approximately 1/2 dose dripped down arm; needle loose on syringe; Approximately 1/2 dose dripped down arm; A spontaneous report was received from an other healthcare professional concerning their patient, 77 years old, female patient who received approximately 1/2 dose dripped down arm/under dose, needle loose on syringe/syringe connection issue.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patient received the first of two planned doses of mRNA-1273 (Batch number: 012M20) on 28 Jan 2021 intramuscularly at left arm for prophylaxis of COVID-19 infection.   The patient received the second of two planned doses of mRNA-1273 (Batch number: 023M20A) on 25 Feb 2021 intramuscularly at left arm for prophylaxis of COVID-19 infection.    On 25 Feb 2021, the patient received approximately 1/2 dose dripped down arm and needle loose on syringe. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events approximately 1/2 dose dripped down arm and needle loose on syringe was considered recovered/resolved.; Reporter's Comments: This report refers to a case of vaccine underdose and syringe connection issues for mRNA-1273, lot # 023M20A with no associated AEs. Based on reporter's causality the event exposure via skin contact is assessed as unlikely related to mRNA-1273
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Lymphadenopathy
Clinical narrative: chills; Malaise; Achiness; Headache; Dizziness; Diarrhea; Lymph nodes under arm and groin; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache) and DIZZINESS (Dizziness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and LYMPHADENOPATHY (Lymph nodes under arm and groin). At the time of the report, CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and LYMPHADENOPATHY (Lymph nodes under arm and groin) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.    This case was linked to MOD21-028609 (E2B Linked Report). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache) and DIZZINESS (Dizziness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and LYMPHADENOPATHY (Lymph nodes under arm and groin). At the time of the report, CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and LYMPHADENOPATHY (Lymph nodes under arm and groin) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.    This case was linked to MOD21-028609 (E2B Linked Report).; Sender's Comments:  MOD21-028609:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: chills; Malaise; Achiness; Headache; Dizziness; Diarrhea; Lymph nodes under arm and groin; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache) and DIZZINESS (Dizziness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and LYMPHADENOPATHY (Lymph nodes under arm and groin). At the time of the report, CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and LYMPHADENOPATHY (Lymph nodes under arm and groin) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.    This case was linked to MOD21-028609 (E2B Linked Report). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache) and DIZZINESS (Dizziness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and LYMPHADENOPATHY (Lymph nodes under arm and groin). At the time of the report, CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and LYMPHADENOPATHY (Lymph nodes under arm and groin) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.    This case was linked to MOD21-028609 (E2B Linked Report).; Sender's Comments:  MOD21-028609:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: itching; redness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itching), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling). At the time of the report, INJECTION SITE PRURITUS (itching), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pain left arm but the vaccine was administered on the right arm; Felt like having fever/Having temperature now; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain left arm but the vaccine was administered on the right arm) and PYREXIA (Felt like having fever/Having temperature now) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain left arm but the vaccine was administered on the right arm) and PYREXIA (Felt like having fever/Having temperature now). At the time of the report, PAIN IN EXTREMITY (Pain left arm but the vaccine was administered on the right arm) and PYREXIA (Felt like having fever/Having temperature now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported  No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pruritus
Clinical narrative: itchy; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy) and MYALGIA (muscle soreness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy) and MYALGIA (muscle soreness). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itchy) and MYALGIA (muscle soreness) had resolved.            No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Outcome updated
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Severe cold chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Severe cold chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (Severe cold chills). On 03-Mar-2021, CHILLS (Severe cold chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: NNI TCR attached.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site pustule, Vaccination site swelling, Vaccination site warmth
Clinical narrative: puss at injection site; hot to touch at injection site; swelling at injection site; itchiness at injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PUSTULE (puss at injection site), VACCINATION SITE WARMTH (hot to touch at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PRURITUS (itchiness at injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 007M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included SIMVASTATIN (ZOCOR), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), APIXABAN (ELIQUIS), METFORMIN, ACETYLSALICYLIC ACID, ATORVASTATIN CALCIUM, RAMIPRIL (AVOPRIL AS), IRON, CALCIUM and VITAMIN D3 for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PUSTULE (puss at injection site), VACCINATION SITE WARMTH (hot to touch at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PRURITUS (itchiness at injection site). At the time of the report, VACCINATION SITE PUSTULE (puss at injection site), VACCINATION SITE WARMTH (hot to touch at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PRURITUS (itchiness at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Soreness in arm; Seems much heavier than what happened with a flu shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm) and LIMB DISCOMFORT (Seems much heavier than what happened with a flu shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (Flu Shot). Concurrent medical conditions included Migraine. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication, ACETYLSALICYLIC ACID (BABY ASPIRIN).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm) and LIMB DISCOMFORT (Seems much heavier than what happened with a flu shot). At the time of the report, PAIN IN EXTREMITY (Soreness in arm) and LIMB DISCOMFORT (Seems much heavier than what happened with a flu shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient uses baby aspirin for silent migraines. Patient also takes Several Supplements and Vitamins
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Tenderness, Testicular pain, Testicular swelling
Clinical narrative: Swollen lymph node; Pain arm (L); Swollen testicle (R test); Tenderness testicle; Lot a pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain arm (L)), TESTICULAR SWELLING (Swollen testicle (R test)), TENDERNESS (Tenderness testicle), TESTICULAR PAIN (Lot a pain) and LYMPHADENOPATHY (Swollen lymph node) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain arm (L)), TESTICULAR SWELLING (Swollen testicle (R test)), TENDERNESS (Tenderness testicle), TESTICULAR PAIN (Lot a pain) and LYMPHADENOPATHY (Swollen lymph node). At the time of the report, PAIN IN EXTREMITY (Pain arm (L)), TESTICULAR SWELLING (Swollen testicle (R test)), TENDERNESS (Tenderness testicle), TESTICULAR PAIN (Lot a pain) and LYMPHADENOPATHY (Swollen lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: got sick to their stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (got sick to their stomach) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (got sick to their stomach). At the time of the report, ABDOMINAL DISCOMFORT (got sick to their stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Redness on my face and ears; Rash on underside of arms; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on my face and ears) and RASH (Rash on underside of arms) 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 ERYTHEMA (Redness on my face and ears). an unknown date, the patient experienced RASH (Rash on underside of arms). At the time of the report, ERYTHEMA (Redness on my face and ears) and RASH (Rash on underside of arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: she was in bed for 3 days; she had chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (she was in bed for 3 days) and CHILLS (she had chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Asthma.    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 FATIGUE (she was in bed for 3 days) and CHILLS (she had chills). At the time of the report, FATIGUE (she was in bed for 3 days) and CHILLS (she had chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unknown medication for blood pressure and asthma inhaler.   No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got covid-19 after 1st vaccine injection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got covid-19 after 1st vaccine injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got covid-19 after 1st vaccine injection). At the time of the report, COVID-19 (got covid-19 after 1st vaccine injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: soreness; headache; fatigue; chills; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (FEVER) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (soreness), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (FEVER). At the time of the report, PAIN (soreness), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site induration, Vaccination site pain, Vaccination site rash
Clinical narrative: Headache; Hard Injection Site; Sore Right Arm; Rash (3.5" ) on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard Injection Site), VACCINATION SITE PAIN (Sore Right Arm), VACCINATION SITE RASH (Rash (3.5" ) on the Injection Site) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hard Injection Site), VACCINATION SITE PAIN (Sore Right Arm) and VACCINATION SITE RASH (Rash (3.5" ) on the Injection Site). On 24-Feb-2021, the patient experienced HEADACHE (Headache). On 26-Feb-2021, HEADACHE (Headache) had resolved. On 01-Mar-2021, VACCINATION SITE INDURATION (Hard Injection Site), VACCINATION SITE PAIN (Sore Right Arm) and VACCINATION SITE RASH (Rash (3.5" ) on the Injection Site) had 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: Fatigue, Myalgia
Clinical narrative: Muscle soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness) and FATIGUE (Fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     Concomitant products included BENAZEPRIL, AMLODIPINE and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced MYALGIA (Muscle soreness) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Muscle soreness) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Dizziness for 36 hours; Weakness for 36 hours; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness for 36 hours) and ASTHENIA (Weakness for 36 hours) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DIZZINESS (Dizziness for 36 hours) and ASTHENIA (Weakness for 36 hours). At the time of the report, DIZZINESS (Dizziness for 36 hours) and ASTHENIA (Weakness for 36 hours) was resolving.        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.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: rash below the injection site; warm to touch on arm below the injection site "COVID ARM; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash below the injection site) and INJECTION SITE ERYTHEMA (warm to touch on arm below the injection site "COVID ARM) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Lumpectomy (breast cancer) (removal of lymph nodes).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced INJECTION SITE RASH (rash below the injection site) and INJECTION SITE ERYTHEMA (warm to touch on arm below the injection site "COVID ARM). At the time of the report, INJECTION SITE RASH (rash below the injection site) and INJECTION SITE ERYTHEMA (warm to touch on arm below the injection site "COVID ARM) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided Treatment information included Ice pack, Benadryl, Tylenol.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Pyrexia, Tremor
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), TREMOR (shaking), CHILLS (chills), NAUSEA (nausea) and PYREXIA (low grade fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 043L20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (Dizziness). On 03-Mar-2021, the patient experienced TREMOR (shaking), CHILLS (chills) and NAUSEA (nausea). On an unknown date, the patient experienced PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), TREMOR (shaking), CHILLS (chills), NAUSEA (nausea) and PYREXIA (low grade fever) outcome was unknown. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: middle of the night woke up soaking wet; did not have a lot of energy; had some fever; some chills; fatigue did not go away; muscle pain in her arm; woke up with a headache; did not feel quite right; felt sleepy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel quite right), SOMNOLENCE (felt sleepy), HYPERHIDROSIS (middle of the night woke up soaking wet), DIZZINESS (did not have a lot of energy) and PYREXIA (had some fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GLUCOSAMINE, BICALUTAMIDE (APOTEX BICALUTAMID), SPIRONOLACTONE, METOPROLOL, LOSARTAN, WARFARIN, WARFARIN, FUROSEMIDE, FUROSEMIDE and METHOCARBAMOL, PARACETAMOL (EXTRA STRENGTH TYLENOL BACK PAIN) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced FEELING ABNORMAL (did not feel quite right), SOMNOLENCE (felt sleepy), PYREXIA (had some fever), CHILLS (some chills), FATIGUE (fatigue did not go away), MYALGIA (muscle pain in her arm) and HEADACHE (woke up with a headache). On 01-Mar-2021, the patient experienced HYPERHIDROSIS (middle of the night woke up soaking wet) and DIZZINESS (did not have a lot of energy). On 02-Mar-2021, HYPERHIDROSIS (middle of the night woke up soaking wet) had resolved. At the time of the report, FEELING ABNORMAL (did not feel quite right), SOMNOLENCE (felt sleepy), DIZZINESS (did not have a lot of energy), PYREXIA (had some fever), CHILLS (some chills), FATIGUE (fatigue did not go away), MYALGIA (muscle pain in her arm) and HEADACHE (woke up with a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information includes Non-aspirin and Tylenol.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Pyrexia, Somnolence
Clinical narrative: middle of the night woke up soaking wet; did not have a lot of energy; had some fever; some chills; fatigue did not go away; muscle pain in her arm; woke up with a headache; did not feel quite right; felt sleepy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel quite right), SOMNOLENCE (felt sleepy), HYPERHIDROSIS (middle of the night woke up soaking wet), DIZZINESS (did not have a lot of energy) and PYREXIA (had some fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GLUCOSAMINE, BICALUTAMIDE (APOTEX BICALUTAMID), SPIRONOLACTONE, METOPROLOL, LOSARTAN, WARFARIN, WARFARIN, FUROSEMIDE, FUROSEMIDE and METHOCARBAMOL, PARACETAMOL (EXTRA STRENGTH TYLENOL BACK PAIN) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced FEELING ABNORMAL (did not feel quite right), SOMNOLENCE (felt sleepy), PYREXIA (had some fever), CHILLS (some chills), FATIGUE (fatigue did not go away), MYALGIA (muscle pain in her arm) and HEADACHE (woke up with a headache). On 01-Mar-2021, the patient experienced HYPERHIDROSIS (middle of the night woke up soaking wet) and DIZZINESS (did not have a lot of energy). On 02-Mar-2021, HYPERHIDROSIS (middle of the night woke up soaking wet) had resolved. At the time of the report, FEELING ABNORMAL (did not feel quite right), SOMNOLENCE (felt sleepy), DIZZINESS (did not have a lot of energy), PYREXIA (had some fever), CHILLS (some chills), FATIGUE (fatigue did not go away), MYALGIA (muscle pain in her arm) and HEADACHE (woke up with a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information includes Non-aspirin and Tylenol.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received second dose on the 45th day; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose on the 45th day) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose on the 45th day). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose on the 45th day) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow up received on 07 Apr 2021.Updated second dosage details (patient took  second dose on the 45th day).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VOMITING (vomiting). At the time of the report, VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes
Clinical narrative: genital herpes sores; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL HERPES (genital herpes sores) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Genital herpes. Concomitant products included FAMOTIDINE, CITALOPRAM, LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced GENITAL HERPES (genital herpes sores). In January 2021, GENITAL HERPES (genital herpes sores) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included none.   This case was linked to MOD-2021-032016 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin burning sensation
Clinical narrative: itching; skin burning sensation all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and SKIN BURNING SENSATION (skin burning sensation all over body) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Penicillin allergy.    On 01-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced SKIN BURNING SENSATION (skin burning sensation all over body). On 02-Mar-2021 at 3:00 AM, the patient experienced PRURITUS (itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) at an unspecified dose and frequency. At the time of the report, PRURITUS (itching) and SKIN BURNING SENSATION (skin burning sensation all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Follow up was received on 01 may 2021 included no new information