chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first vaccine 1/7/21, hard time finding the 2nd dose; A spontaneous report was received from a consumer concerning a patient of unspecified age and gender, who received Moderna COVID-19 vaccine (mRNA-1273) and reported had first vaccine, hard time finding the second dose missing dose/product dose omission issue .  The patient's medical history is unknown. Concomitant medication were not reported.  On 07 Jan 2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (Batch no: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, it was reported that, hard time finding the second dose. No Laboratory details provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was considered as recovered.; Reporter's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Pain in extremity, Vaccination site pain
Clinical narrative: Pain and tenderness in forearm; Stomach Upset; chills; Typical vaccination soreness; Woozy/wobbly; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Woozy/wobbly), PAIN IN EXTREMITY (Pain and tenderness in forearm), ABDOMINAL DISCOMFORT (Stomach Upset), CHILLS (chills) and VACCINATION SITE PAIN (Typical vaccination soreness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced DIZZINESS (Woozy/wobbly). On 20-Jan-2021, the patient experienced CHILLS (chills) and VACCINATION SITE PAIN (Typical vaccination soreness). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain and tenderness in forearm) and ABDOMINAL DISCOMFORT (Stomach Upset). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Woozy/wobbly), PAIN IN EXTREMITY (Pain and tenderness in forearm), ABDOMINAL DISCOMFORT (Stomach Upset), CHILLS (chills) and VACCINATION SITE PAIN (Typical vaccination soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Cramp in leg,have cramps in my back; pain in her hip and joints her leg, thigh pain; tightness thigh; pain in her hip and joints her leg; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramp in leg,have cramps in my back), PAIN IN EXTREMITY (pain in her hip and joints her leg, thigh pain), MUSCULOSKELETAL STIFFNESS (tightness thigh) and ARTHRALGIA (pain in her hip and joints her leg) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M80A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MUSCLE SPASMS (Cramp in leg,have cramps in my back), PAIN IN EXTREMITY (pain in her hip and joints her leg, thigh pain), MUSCULOSKELETAL STIFFNESS (tightness thigh) and ARTHRALGIA (pain in her hip and joints her leg). At the time of the report, MUSCLE SPASMS (Cramp in leg,have cramps in my back), PAIN IN EXTREMITY (pain in her hip and joints her leg, thigh pain), MUSCULOSKELETAL STIFFNESS (tightness thigh) and ARTHRALGIA (pain in her hip and joints her leg) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.  Treatment information not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: injection site still hot; injection site still red; Soreness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site still hot), VACCINATION SITE ERYTHEMA (injection site still red) and VACCINATION SITE PAIN (Soreness in the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M2OT) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 26-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 VACCINATION SITE WARMTH (injection site still hot), VACCINATION SITE ERYTHEMA (injection site still red) and VACCINATION SITE PAIN (Soreness in the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (injection site still hot), VACCINATION SITE ERYTHEMA (injection site still red) and VACCINATION SITE PAIN (Soreness in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included unspecified blood pressure medication.  Treatment medication included Tylenol.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (COVID arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 06-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 TYPE IV HYPERSENSITIVITY REACTION (COVID arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for Itching, at an unspecified dose and frequency. On 20-Feb-2021, TYPE IV HYPERSENSITIVITY REACTION (COVID arm) 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.   Concomitant products included high blood pressure medications.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: have been itching constantly all over; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (have been itching constantly all over) in a female 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (have been itching constantly all over). At the time of the report, PRURITUS (have been itching constantly all over) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Fatigue, Headache
Clinical narrative: stomach cramps; diarrhea; weak; lethargic; horrible headache; has no energy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), ASTHENIA (weak), LETHARGY (lethargic) and HEADACHE (horrible headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), ASTHENIA (weak), LETHARGY (lethargic), HEADACHE (horrible headache) and FATIGUE (has no energy). The patient was treated with PARACETAMOL (TYLENOL) for COVID-19 vaccination, at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps) was resolving and DIARRHOEA (diarrhea), ASTHENIA (weak), LETHARGY (lethargic), HEADACHE (horrible headache) and FATIGUE (has no energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication reported
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: stomach cramps; diarrhea; weak; lethargic; horrible headache; has no energy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), ASTHENIA (weak), LETHARGY (lethargic) and HEADACHE (horrible headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), ASTHENIA (weak), LETHARGY (lethargic), HEADACHE (horrible headache) and FATIGUE (has no energy). The patient was treated with PARACETAMOL (TYLENOL) for COVID-19 vaccination, at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps) was resolving and DIARRHOEA (diarrhea), ASTHENIA (weak), LETHARGY (lethargic), HEADACHE (horrible headache) and FATIGUE (has no energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication reported
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: arm was super sore; had a fever; was real tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was super sore), PYREXIA (had a fever) and FATIGUE (was real tired) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was super sore), PYREXIA (had a fever) and FATIGUE (was real tired). On 23-Jan-2021, PAIN IN EXTREMITY (arm was super sore), PYREXIA (had a fever) and FATIGUE (was real tired) 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. No concomitant medication information was reported.   This case was linked to MOD-2021-226959 (Patient Link).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cyanosis, Dizziness, Fall, Nausea
Clinical narrative: Chest thightness; Lightheadedness; He became cyanotic; Nausea; Patient fell over; This spontaneous case was reported by a nurse and describes the occurrence of CHEST DISCOMFORT (Chest thightness), DIZZINESS (Lightheadedness), CYANOSIS (He became cyanotic), NAUSEA (Nausea) and FALL (Patient fell over) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014N20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The parent's past medical history included Epilepsy and Allergy.    MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced CHEST DISCOMFORT (Chest thightness), DIZZINESS (Lightheadedness), CYANOSIS (He became cyanotic), NAUSEA (Nausea) and FALL (Patient fell over). The patient was treated with NORMAL SALINE at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Chest thightness), DIZZINESS (Lightheadedness), CYANOSIS (He became cyanotic), NAUSEA (Nausea) and FALL (Patient fell over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: Follow up information was received on 10-Mar-2021Report contains no new information, however listedness added, outcome added which was missed in previous version, seriousness criteria removed as it is not given in the document
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: diarrhea; nauseous; joint pain; fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), NAUSEA (nauseous), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bleeding (brain bleed before the vaccine which lead to brain surgery and a long recovery) and Surgery (Brain surgery).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (diarrhea), NAUSEA (nauseous), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (Headache). On 06-Mar-2021, DIARRHOEA (diarrhea), NAUSEA (nauseous), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first 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 COMPLICATION (Adverse reaction). At the time of the report, VACCINATION COMPLICATION (Adverse reaction) outcome was unknown. Not Provided          The patient took the second dose of the mRNA-1273, hence action taken with the vaccine in response to the events was not applicable.   No concomitant medication was reported.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Product administration interrupted
Clinical narrative: hasn't received a phone call or notification for 2nd dose; started over and received Pfizer instead; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (hasn't received a phone call or notification for 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (started over and received Pfizer instead) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (hasn't received a phone call or notification for 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (started over and received Pfizer instead). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (hasn't received a phone call or notification for 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (started over and received Pfizer instead) 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.   Concomitant product use was not provided by the reporter. Patient took Pfizer as second dose vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Event added (interchange of vaccine products)
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Arm was sore; Rash is on both arms, sides and back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and RASH (Rash is on both arms, sides and back) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) 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) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced RASH (Rash is on both arms, sides and back). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and RASH (Rash is on both arms, sides and back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. Patient had not used anything to treat his symptoms.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: very sick; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick) and VOMITING (throwing up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were provided.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ILLNESS (very sick) and VOMITING (throwing up). At the time of the report, ILLNESS (very sick) and VOMITING (throwing up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were provided. No treatment drug was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pain, Pruritus, Sleep deficit
Clinical narrative: A bright red patch/spread to about inch in diameter and still has a red ring around it; Swollen; Burning; Little sleep; it began itching; Throbbing; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it began itching), PAIN (Throbbing), ERYTHEMA (A bright red patch/spread to about inch in diameter and still has a red ring around it), SWELLING (Swollen) and BURNING SENSATION (Burning) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 05-Mar-2021, the patient experienced PRURITUS (it began itching), PAIN (Throbbing), BURNING SENSATION (Burning) and SLEEP DEFICIT (Little sleep). On 06-Mar-2021, the patient experienced ERYTHEMA (A bright red patch/spread to about inch in diameter and still has a red ring around it) and SWELLING (Swollen). At the time of the report, PRURITUS (it began itching), PAIN (Throbbing), SWELLING (Swollen), BURNING SENSATION (Burning) and SLEEP DEFICIT (Little sleep) outcome was unknown and ERYTHEMA (A bright red patch/spread to about inch in diameter and still has a red ring around it) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: A bright red patch/spread to about inch in diameter and still has a red ring around it; Swollen; Burning; Little sleep; it began itching; Throbbing; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it began itching), PAIN (Throbbing), ERYTHEMA (A bright red patch/spread to about inch in diameter and still has a red ring around it), SWELLING (Swollen) and BURNING SENSATION (Burning) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 05-Mar-2021, the patient experienced PRURITUS (it began itching), PAIN (Throbbing), BURNING SENSATION (Burning) and SLEEP DEFICIT (Little sleep). On 06-Mar-2021, the patient experienced ERYTHEMA (A bright red patch/spread to about inch in diameter and still has a red ring around it) and SWELLING (Swollen). At the time of the report, PRURITUS (it began itching), PAIN (Throbbing), SWELLING (Swollen), BURNING SENSATION (Burning) and SLEEP DEFICIT (Little sleep) outcome was unknown and ERYTHEMA (A bright red patch/spread to about inch in diameter and still has a red ring around it) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelids pruritus, Periorbital swelling, Swelling of eyelid
Clinical narrative: itching on left eyelid; swelling on left eyelid; puffed up left eyelid; This spontaneous case was reported by a consumer and describes the occurrence of EYELIDS PRURITUS (itching on left eyelid), SWELLING OF EYELID (swelling on left eyelid) and PERIORBITAL SWELLING (puffed up left eyelid) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced EYELIDS PRURITUS (itching on left eyelid), SWELLING OF EYELID (swelling on left eyelid) and PERIORBITAL SWELLING (puffed up left eyelid). On 10-Mar-2021, SWELLING OF EYELID (swelling on left eyelid) had resolved. At the time of the report, EYELIDS PRURITUS (itching on left eyelid) had resolved and PERIORBITAL SWELLING (puffed up left eyelid) had not 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.   No concomitant medications were provided by the reporter.   Patient reporting using cold compresses, hot compresses, and taking Benadryl to treat the events.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: nose felt blocked off; runny nose and eyes; sudden high fever; headache; whole right arm painful including fingers and palm; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (nose felt blocked off), PAIN IN EXTREMITY (whole right arm painful including fingers and palm), RHINORRHOEA (runny nose and eyes), HEADACHE (headache) and PYREXIA (sudden high fever) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, Arthritis (arthritis in her right thumb) and Shoulder discomfort (has a shoulder problem in her right arm).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (whole right arm painful including fingers and palm) and HEADACHE (headache). On 10-Mar-2021, the patient experienced NASAL CONGESTION (nose felt blocked off), RHINORRHOEA (runny nose and eyes) and PYREXIA (sudden high fever). On 08-Mar-2021, HEADACHE (headache) had resolved. On 09-Mar-2021, PAIN IN EXTREMITY (whole right arm painful including fingers and palm) had resolved. At the time of the report, NASAL CONGESTION (nose felt blocked off) and PYREXIA (sudden high fever) outcome was unknown and RHINORRHOEA (runny nose and eyes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication heat applied to sore arm. No concomitant medication details was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash, Vaccination site rash
Clinical narrative: rash inside and lower than where the injection was given; small rash 1.5 at the site of the injection; fatigue; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash inside and lower than where the injection was given), VACCINATION SITE RASH (small rash 1.5 at the site of the injection) and FATIGUE (fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Mood disorder. Concurrent medical conditions included Asthma and Allergy (respiratory allergies).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash inside and lower than where the injection was given), VACCINATION SITE RASH (small rash 1.5 at the site of the injection) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (rash inside and lower than where the injection was given), VACCINATION SITE RASH (small rash 1.5 at the site of the injection) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dyspnoea, Headache, Pain
Clinical narrative: Severe chest pain; Crazy head ache; Breathing issues; fever; 103°F fever; very weak; sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever), ASTHENIA (very weak), PAIN (sore), PYREXIA (103°F fever) and CHEST PAIN (Severe chest pain) in a 68-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Mar-2021, the patient experienced ASTHENIA (very weak) and PAIN (sore). On 10-Mar-2021, the patient experienced PYREXIA (103°F fever). On 11-Mar-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced CHEST PAIN (Severe chest pain), HEADACHE (Crazy head ache) and DYSPNOEA (Breathing issues). On 10-Mar-2021, PYREXIA (103°F fever) had resolved. At the time of the report, PYREXIA (fever), ASTHENIA (very weak), PAIN (sore), CHEST PAIN (Severe chest pain), HEADACHE (Crazy head ache) and DYSPNOEA (Breathing issues) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe chest pain; Crazy head ache; Breathing issues; fever; 103°F fever; very weak; sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever), ASTHENIA (very weak), PAIN (sore), PYREXIA (103°F fever) and CHEST PAIN (Severe chest pain) in a 68-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Mar-2021, the patient experienced ASTHENIA (very weak) and PAIN (sore). On 10-Mar-2021, the patient experienced PYREXIA (103°F fever). On 11-Mar-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced CHEST PAIN (Severe chest pain), HEADACHE (Crazy head ache) and DYSPNOEA (Breathing issues). On 10-Mar-2021, PYREXIA (103°F fever) had resolved. At the time of the report, PYREXIA (fever), ASTHENIA (very weak), PAIN (sore), CHEST PAIN (Severe chest pain), HEADACHE (Crazy head ache) and DYSPNOEA (Breathing issues) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: wasn't up to doing anything; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (wasn't up to doing anything) 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, 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 ASTHENIA (wasn't up to doing anything). At the time of the report, ASTHENIA (wasn't up to doing anything) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable
Sex: M
Vaccine: COVID19
Symptoms: Dose calculation error, Syringe issue, Underdose
Clinical narrative: Patient received a different dose; Syringe issue; Underdose; A spontaneous report was received from a pharmacist concerning a unspecified age of male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced patient received a different dose, syringe was disconnected from the needle/ syringe Issue and lost half a dose approx/ Under dose.  The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.  On 11 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number:032M20A) unknown route of administration in the unknown site for prophylaxis of COVID-19 infection.   On the same day, prior to receiving mRNA-1273, the syringe was disconnected from the needle and lost half a dose approx. Therefore patient received a different dose. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, syringe was disconnected from the needle and the patient received half a dose approx. were considered resolved on 11 Mar 2021.; Reporter's Comments: This report refers to a case of underdose and syringe issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Light body aches; tired; chills; Pain near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Light body aches), FATIGUE (tired), CHILLS (chills) and VACCINATION SITE PAIN (Pain near the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient's medical history included No Adverse event.  Concomitant products included LOSARTAN and AMLODIPINE for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (Light body aches), FATIGUE (tired), CHILLS (chills) and VACCINATION SITE PAIN (Pain near the injection site). On 11-Mar-2021, PAIN (Light body aches) and CHILLS (chills) had resolved. At the time of the report, FATIGUE (tired) and VACCINATION SITE PAIN (Pain near the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2020, SARS-CoV-2 test: positive (Positive) positive.     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 information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Injection site redness; Injection site tenderness; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Injection site tenderness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Injection site tenderness). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Injection site tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: small rash itchy around the injection site (R arm); small rash itchy around the injection site (R arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (small rash itchy around the injection site (R arm)) and VACCINATION SITE PRURITUS (small rash itchy around the injection site (R arm)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-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 VACCINATION SITE RASH (small rash itchy around the injection site (R arm)) and VACCINATION SITE PRURITUS (small rash itchy around the injection site (R arm)). At the time of the report, VACCINATION SITE RASH (small rash itchy around the injection site (R arm)) and VACCINATION SITE PRURITUS (small rash itchy around the injection site (R arm)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pruritus
Clinical narrative: A lot of itching/ Itching at the injection site; Rash/ Rash on arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (A lot of itching/ Itching at the injection site) and RASH (Rash/ Rash on arm after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (A lot of itching/ Itching at the injection site) and RASH (Rash/ Rash on arm after first dose). The patient was treated with CORTISONE for Rash and Vaccination site pruritus, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (A lot of itching/ Itching at the injection site) and RASH (Rash/ Rash on arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.   This case was linked to US-MODERNATX, INC.- (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received on 23-APR-2021 contains significant information. Vaccine dose number was updated. On 24-Jun-2021: Follow up received on 24-JUN-2021 contains no new information.; Sender's Comments:  US-MODERNATX, INC.-:crosslinked
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 100 Degrees F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Injection site pain, Pyrexia
Clinical narrative: fever of 101°F; Sore at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore at injection site) and PYREXIA (fever of 101°F) in a female 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 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced INJECTION SITE PAIN (Sore at injection site). On 07-Mar-2021, the patient experienced PYREXIA (fever of 101°F). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Sore at injection site) and PYREXIA (fever of 101°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Body temperature:. On 11-Mar-2021, Body temperature:.         Treatment included acetaminophen.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: itching at the injection site; swelling at the injection site; rash at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE RASH (rash at the injection site) 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-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.Consumer stated that his wife got the 1st shot on 24Feb2021 and developed itching, swelling, and rash at the injection site.   This case was linked to MOD-2021-108935 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Medical report contains information on Dose 2 and its events
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: small rash on neck and face; This spontaneous case was reported by a consumer and describes the occurrence of RASH (small rash on neck and face) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included Seasonal allergy and Shellfish allergy. Concomitant products included TAMOXIFEN and BETAHISTINE HYDROCHLORIDE (VERTEX [BETAHISTINE HYDROCHLORIDE]) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced RASH (small rash on neck and face). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL ALLERGY & SINUS) at an unspecified dose and frequency. At the time of the report, RASH (small rash on neck and face) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-026437, MOD-2021-026437 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Blood pressure measurement, Body temperature, Confusional state
Clinical narrative: Weak; She cannot get up; Confusion; Shortness of breath; Loss of appetite; Lethargic; Temperature of 99'F; Could not taste anything during dinner; This spontaneous case was reported by a patient family member or friend and describes the occurrence of AGEUSIA (Could not taste anything during dinner), ASTHENIA (Weak), DYSSTASIA (She cannot get up), CONFUSIONAL STATE (Confusion) and DYSPNOEA (Shortness of breath) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperthyroidism. Concomitant products included METHIMAZOLE for Hyperthyroidism, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced AGEUSIA (Could not taste anything during dinner). On 11-Mar-2021, the patient experienced ASTHENIA (Weak), DYSSTASIA (She cannot get up), CONFUSIONAL STATE (Confusion), DYSPNOEA (Shortness of breath), DECREASED APPETITE (Loss of appetite), LETHARGY (Lethargic) and PYREXIA (Temperature of 99'F). At the time of the report, AGEUSIA (Could not taste anything during dinner) had resolved and ASTHENIA (Weak), DYSSTASIA (She cannot get up), CONFUSIONAL STATE (Confusion), DYSPNOEA (Shortness of breath), DECREASED APPETITE (Loss of appetite), LETHARGY (Lethargic) and PYREXIA (Temperature of 99'F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement: 106/69 mmHg (Low) 106/69. On 11-Mar-2021, Body temperature: 99°f (High) 99°F. On 11-Mar-2021, Heart rate: 126 (High) 126 beats per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.