chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LEPROSY (Patient said it looks like he has leprosy) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Psoriasis. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced BURNING SENSATION (burning), PSORIASIS (psoriasis/patient had flare up of psoriasis and rashes all over his scalp), HAEMORRHAGE (Bleeding), SCAB (extreme crust tightening on the scalp.), BLISTER (blister), RASH VESICULAR (blistering rash), PRURITUS (itching), RASH ERYTHEMATOUS (Red rash) and VACCINATION SITE PAIN (little sore arm). On an unknown date, the patient experienced LEPROSY (Patient said it looks like he has leprosy) (seriousness criterion medically significant), FEELING ABNORMAL (like someone was pulling on his head) and ERYTHEMA (red marks in the opposite side of the elbow where the hand bends). The patient was treated with HYDROCORTISONE at a dose of 2.5 mg; FLUOCINOLONE ACETONIDE (topical) at a dose of 0.01 %; TRIAMCINOLONE ACETONIDE at an unspecified dose and frequency and SELENIUM SULFIDE (SELSUN BLUE) at a dose of 1 dosage form. At the time of the report, LEPROSY (Patient said it looks like he has leprosy) and PSORIASIS (psoriasis/patient had flare up of psoriasis and rashes all over his scalp) outcome was unknown and BURNING SENSATION (burning), HAEMORRHAGE (Bleeding), SCAB (extreme crust tightening on the scalp.), BLISTER (blister), FEELING ABNORMAL (like someone was pulling on his head), RASH VESICULAR (blistering rash), ERYTHEMA (red marks in the opposite side of the elbow where the hand bends), PRURITUS (itching), RASH ERYTHEMATOUS (Red rash) and VACCINATION SITE PAIN (little sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. On 30-Jun-2021, the patient reported that the reaction had subsided with the use of steroidal creams and oils. On 09-Jul-2021, the patient reported that he had had flare up of psoriasis and rashes all over his scalp and mentioned that it looked like he had leprosy. This case was linked to MOD-2021-207737. Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up information received included treatment information and outcome of the event. On 09-Jul-2021: Additional information received included additional event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gastrointestinal disorder
Clinical narrative: feels tired; Today he is having intestine issues/ tummy issues; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (Today he is having intestine issues/ tummy issues) and FATIGUE (feels tired) 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 24-May-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 03-Jun-2021, the patient experienced GASTROINTESTINAL DISORDER (Today he is having intestine issues/ tummy issues). On an unknown date, the patient experienced FATIGUE (feels tired). At the time of the report, GASTROINTESTINAL DISORDER (Today he is having intestine issues/ tummy issues) and FATIGUE (feels tired) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Feel rundown; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feel rundown) and PYREXIA (Fever) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feel rundown) and PYREXIA (Fever). At the time of the report, MALAISE (Feel rundown) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided No treatment medication information was provided
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Feeling abnormal, Limb discomfort
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (felt little bad day after the second dose/feeling weird symptoms/just does not feel good/not the same/full of lead), limb discomfort (legs are not working), discomfort (body feels like it's heavy) and fatigue in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 040A21A and 016M20A) for COVID-19 immunization. No medical history reported. On Feb 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 24, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 25, 2021, patient experienced feeling abnormal (felt little bad day after the second dose/feeling weird symptoms/just does not feel good/not the same/full of lead). On Apr 25, 2021, patient experienced limb discomfort (legs are not working) and fatigue. On an unknown date, patient experienced discomfort (body feels like it's heavy). At the time of the report, feeling abnormal (felt little bad day after the second dose/feeling weird symptoms/just does not feel good/not the same/full of lead), limb discomfort (legs are not working), discomfort (body feels like it's heavy) and fatigue outcome: unknown. No concomitant medication or treatment information provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Hypoaesthesia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of severe chest pain radiating to the right arm, hypoesthesia (numb fingers) and arthralgia (severe joint pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 033B21A) for COVID-19 immunization. No medical history reported. On Jun 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 3, 2021, patient had severe chest pain radiating to the right arm), hypoesthesia (numb fingers) and arthralgia (severe joint pain). The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency; ibuprofen, at an unspecified dose and frequency; and Biofreeze (menthol), at an unspecified dose and frequency. At the time of the report, severe chest pain radiating to the right arm, hypoesthesia (numb fingers) and arthralgia (severe joint pain): unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: swelling of his left ankle and foot; red ankle and foot; very painful ankle and foot; swelling of his left ankle and foot; very painful ankle and foot; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling of his left ankle and foot), ERYTHEMA (red ankle and foot), PAIN IN EXTREMITY (very painful ankle and foot), PERIPHERAL SWELLING (swelling of his left ankle and foot) and ARTHRALGIA (very painful ankle and foot) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Gout.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced JOINT SWELLING (swelling of his left ankle and foot), ERYTHEMA (red ankle and foot), PAIN IN EXTREMITY (very painful ankle and foot), PERIPHERAL SWELLING (swelling of his left ankle and foot) and ARTHRALGIA (very painful ankle and foot). At the time of the report, JOINT SWELLING (swelling of his left ankle and foot), ERYTHEMA (red ankle and foot), PAIN IN EXTREMITY (very painful ankle and foot), PERIPHERAL SWELLING (swelling of his left ankle and foot) and ARTHRALGIA (very painful ankle and foot) outcome was unknown.            concomitant product use was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Hyperacusis, Neck pain, Oral pain, Tension headache
Clinical narrative: neck spasm; hyperacusis; pressure in upper mouth; Neck pain (with radiation); Tension headach; This spontaneous case was reported by a consumer and describes the occurrence of TENSION HEADACHE (Tension headach), NECK PAIN (neck spasm), HYPERACUSIS (hyperacusis), ORAL PAIN (pressure in upper mouth) and NECK PAIN (Neck pain (with radiation)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and ALPRAZOLAM (XANAX) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced TENSION HEADACHE (Tension headach). On 30-Apr-2021, the patient experienced NECK PAIN (neck spasm), HYPERACUSIS (hyperacusis), ORAL PAIN (pressure in upper mouth) and NECK PAIN (Neck pain (with radiation)). At the time of the report, TENSION HEADACHE (Tension headach), NECK PAIN (neck spasm), HYPERACUSIS (hyperacusis), ORAL PAIN (pressure in upper mouth) and NECK PAIN (Neck pain (with radiation)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Heart rate: 125 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient reported experiencing pressure headaches on 22-Mar-2021. On 30-Apr-2021 patina started that pulsating and pounding in the back of her head when she does workouts that get her heart rate to 125. No treatment information was reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Blood test, Computerised tomogram, Dysstasia
Clinical narrative: Pelvic pain; Stomach pain/ache; Pain is very bad, goes from 5 to 7 and 8, Pain getting worse everyday; Hard time standing on feet; Lower back pain; Will not get second dose of the Moderna COVID-19 vaccine; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PELVIC PAIN (Pelvic pain), ABDOMINAL PAIN UPPER (Stomach pain/ache), PAIN (Pain is very bad, goes from 5 to 7 and 8, Pain getting worse everyday), DYSSTASIA (Hard time standing on feet) and BACK PAIN (Lower back pain) in a 36-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 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced PELVIC PAIN (Pelvic pain), ABDOMINAL PAIN UPPER (Stomach pain/ache), PAIN (Pain is very bad, goes from 5 to 7 and 8, Pain getting worse everyday), DYSSTASIA (Hard time standing on feet), BACK PAIN (Lower back pain), PRODUCT DOSE OMISSION ISSUE (Will not get second dose of the Moderna COVID-19 vaccine) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN at a dose of 400 mg. On 30-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Will not get second dose of the Moderna COVID-19 vaccine) had resolved. At the time of the report, PELVIC PAIN (Pelvic pain), ABDOMINAL PAIN UPPER (Stomach pain/ache), DYSSTASIA (Hard time standing on feet), BACK PAIN (Lower back pain) and FATIGUE (Fatigue) outcome was unknown and PAIN (Pain is very bad, goes from 5 to 7 and 8, Pain getting worse everyday) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Blood test: normal (normal) normal. On 30-Apr-2021, Computerised tomogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pelvic pain, Product dose omission issue
Clinical narrative: Pelvic pain; Stomach pain/ache; Pain is very bad, goes from 5 to 7 and 8, Pain getting worse everyday; Hard time standing on feet; Lower back pain; Will not get second dose of the Moderna COVID-19 vaccine; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PELVIC PAIN (Pelvic pain), ABDOMINAL PAIN UPPER (Stomach pain/ache), PAIN (Pain is very bad, goes from 5 to 7 and 8, Pain getting worse everyday), DYSSTASIA (Hard time standing on feet) and BACK PAIN (Lower back pain) in a 36-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 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced PELVIC PAIN (Pelvic pain), ABDOMINAL PAIN UPPER (Stomach pain/ache), PAIN (Pain is very bad, goes from 5 to 7 and 8, Pain getting worse everyday), DYSSTASIA (Hard time standing on feet), BACK PAIN (Lower back pain), PRODUCT DOSE OMISSION ISSUE (Will not get second dose of the Moderna COVID-19 vaccine) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN at a dose of 400 mg. On 30-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Will not get second dose of the Moderna COVID-19 vaccine) had resolved. At the time of the report, PELVIC PAIN (Pelvic pain), ABDOMINAL PAIN UPPER (Stomach pain/ache), DYSSTASIA (Hard time standing on feet), BACK PAIN (Lower back pain) and FATIGUE (Fatigue) outcome was unknown and PAIN (Pain is very bad, goes from 5 to 7 and 8, Pain getting worse everyday) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Blood test: normal (normal) normal. On 30-Apr-2021, Computerised tomogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Fatigue, Headache, Myalgia
Clinical narrative: Sharp pain in head; Arm red big baseball size; Warm arm; Arm hurt to touch; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Sharp pain in head), ERYTHEMA (Arm red big baseball size), BURNING SENSATION (Warm arm), MYALGIA (Arm hurt to touch) and FATIGUE (Really tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 04B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Thyroid activity decreased, Acid reflux (oesophageal), Cholesterol, Allergy NOS, Neuropathy (in feet), Asthma and COPD. Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), LORATADINE and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, SALBUTAMOL (VENTOLIN [SALBUTAMOL]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT) for Asthma and COPD, ATENOLOL for Blood pressure management, ATORVASTATIN for Cholesterol, GABAPENTIN for Neuropathy peripheral, LEVOTHYROXINE for Thyroid activity decreased, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced HEADACHE (Sharp pain in head), ERYTHEMA (Arm red big baseball size), BURNING SENSATION (Warm arm), MYALGIA (Arm hurt to touch) and FATIGUE (Really tired). The patient was treated with IBUPROFEN for Head pain, at a dose of 800 mg three times a day. At the time of the report, HEADACHE (Sharp pain in head), ERYTHEMA (Arm red big baseball size), BURNING SENSATION (Warm arm), MYALGIA (Arm hurt to touch) and FATIGUE (Really tired) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Vaccination complication
Clinical narrative: not feeling well after receiving his 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (not feeling well after receiving his 1st dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 immunisation.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced VACCINATION COMPLICATION (not feeling well after receiving his 1st dose). On 27-May-2021, VACCINATION COMPLICATION (not feeling well after receiving his 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: inconclusive (Inconclusive) Inconclusive.     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.   Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: sleepiness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepiness) and FATIGUE (Tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced SOMNOLENCE (sleepiness) and FATIGUE (Tiredness). At the time of the report, SOMNOLENCE (sleepiness) and FATIGUE (Tiredness) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Additional information received on 04-JUN-2021 was updated the Patient DOB.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a patient of an unknown age and gender 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 DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication was not provided.  Treatment information was not provided.  Patient took second dose on an unspecified date.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission in error
Clinical narrative: Over due by a week for the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION IN ERROR (Over due by a week for the second dose) in a  patient of an unknown age and gender 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 PRODUCT DOSE OMISSION IN ERROR (Over due by a week for the second dose). At the time of the report, PRODUCT DOSE OMISSION IN ERROR (Over due by a week for the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product used was not provided by the reporter.  The patient missed her second dose due to being out of town.  Treatment information was not applicable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: Fever of 101F; Chills; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101F), CHILLS (Chills) and FATIGUE (Tiredness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and .048B21A.) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced PYREXIA (Fever of 101F), CHILLS (Chills) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 101F), CHILLS (Chills) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Body temperature: 101 f (High) 99 F.         Concomitant product use was unknown by the reporter.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a shot from a vial that had been left over in the refrigerator overnight; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a shot from a vial that had been left over in the refrigerator overnight) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) 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 EXPIRED PRODUCT ADMINISTERED (Patient received a shot from a vial that had been left over in the refrigerator overnight). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a shot from a vial that had been left over in the refrigerator overnight) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not reported  Treatment medication information were not reported
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Sore arm at the vaccination site; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the vaccination site) and FATIGUE (Tiredness) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the vaccination site) and FATIGUE (Tiredness). On 28-Mar-2021, VACCINATION SITE PAIN (Sore arm at the vaccination site) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided   This case was linked to MOD-2021-207780 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included HRT since 2000 and Thyroid disorder NOS since 2010. Concomitant products included PROGESTERONE for HRT.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.). On 28-May-2021, PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that NP- Thyroid 60mg  was used for thyroid and was given as concomitant medication. Treatment Information was not provided by the reporter.   This case was linked to MOD-2021-276129, MOD-2021-276128, MOD-2021-276130, MOD-2021-276103 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received on 28-Jul-2021 and contains NNI. Reporter stated there were no Adverse Events following this batch product's administration. On 03-Aug-2021: Significant follow-up received, patient demographics were added, dose numbers were added.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Insomnia, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the vaccination site), FATIGUE (Tiredness), CHILLS (chills), ARTHRALGIA (Severe shoulder pain/ joint pain in both shoulders) and INSOMNIA (It makes it hard for him to sleep) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the vaccination site) and FATIGUE (Tiredness). On 22-Apr-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced ARTHRALGIA (Severe shoulder pain/ joint pain in both shoulders) and INSOMNIA (It makes it hard for him to sleep). On 28-Mar-2021, VACCINATION SITE PAIN (Sore arm at the vaccination site) and FATIGUE (Tiredness) had resolved. On 25-Apr-2021, CHILLS (chills) had resolved. At the time of the report, ARTHRALGIA (Severe shoulder pain/ joint pain in both shoulders) and INSOMNIA (It makes it hard for him to sleep) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-207772.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hunger, Nausea
Clinical narrative: extremely hungry, wherein she was eating every 2 hours; Nauseous; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HUNGER (extremely hungry, wherein she was eating every 2 hours), NAUSEA (Nauseous) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HUNGER (extremely hungry, wherein she was eating every 2 hours), NAUSEA (Nauseous) and HEADACHE (Headache). At the time of the report, HUNGER (extremely hungry, wherein she was eating every 2 hours), NAUSEA (Nauseous) and HEADACHE (Headache) 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 and treatment medications were not provided.
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine given to 13 year old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 13 year old patient) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 13 year old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 13 year old patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Head discomfort, Hyperhidrosis, Memory impairment, Pyrexia
Clinical narrative: pressure on top of his cerebral cortex; Broke out in sweats; Some memory issues; Temperature of 102; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (pressure on top of his cerebral cortex), HYPERHIDROSIS (Broke out in sweats), MEMORY IMPAIRMENT (Some memory issues) and PYREXIA (Temperature of 102) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included OXYCODONE, DIAZEPAM, MULTIVITAMIN [VITAMINS NOS], FOLIC ACID and ZOLPIDEM for an unknown indication.   On 02-Jun-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 02-Jun-2021, the patient experienced HEAD DISCOMFORT (pressure on top of his cerebral cortex), HYPERHIDROSIS (Broke out in sweats), MEMORY IMPAIRMENT (Some memory issues) and PYREXIA (Temperature of 102). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (pressure on top of his cerebral cortex), HYPERHIDROSIS (Broke out in sweats), MEMORY IMPAIRMENT (Some memory issues) and PYREXIA (Temperature of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, Body temperature: 102 (High) 102.         Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Product dose omission issue, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), PAIN IN EXTREMITY (Pain in legs), FATIGUE (Fatigue) and PRODUCT DOSE OMISSION ISSUE (Refused to receive 2nd Moderna Vaccination/Now wants the 2nd Moderna Vaccination) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to allopathic drugs (allergy to codeine). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), PAIN IN EXTREMITY (Pain in legs) and FATIGUE (Fatigue). On 03-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Refused to receive 2nd Moderna Vaccination/Now wants the 2nd Moderna Vaccination). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), PAIN IN EXTREMITY (Pain in legs), FATIGUE (Fatigue) and PRODUCT DOSE OMISSION ISSUE (Refused to receive 2nd Moderna Vaccination/Now wants the 2nd Moderna Vaccination) 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. Treatment medications were not reported.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.    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 CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Concomitant and treatment medication was not provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Myalgia
Clinical narrative: Chillness; Achiness of the right arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Chillness) and MYALGIA (Achiness of the right arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced FEELING COLD (Chillness) and MYALGIA (Achiness of the right arm). At the time of the report, FEELING COLD (Chillness) and MYALGIA (Achiness of the right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: have sever pain my kidneys but not stones; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of RENAL PAIN (have sever pain my kidneys but not stones) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced RENAL PAIN (have sever pain my kidneys but not stones). At the time of the report, RENAL PAIN (have sever pain my kidneys but not stones) 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.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Med Info. AE reported. can this shoy make me have sever pain my kidneys but not stones.   Reporter did not allow further contact
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: My side effects were intense.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (My side effects were intense.) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    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 (My side effects were intense.). At the time of the report, VACCINATION COMPLICATION (My side effects were intense.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Sore arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) 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 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Swelling; Pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling) and PAIN (Pain) in a patient of an unknown age and gender 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 SWELLING (Swelling) and PAIN (Pain). At the time of the report, SWELLING (Swelling) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.  Patient stated that received vaccine on 26 May.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-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 an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: "Covid arm"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION ("Covid arm") in a patient of an unknown age and gender 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 REACTION ("Covid arm"). At the time of the report, VACCINATION SITE REACTION ("Covid arm") 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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-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 PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided by the reporter and no concomitant medication was reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; Lack of efficacy; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Apr-2021. The most recent information was received on 17-Apr-2021 and was forwarded to Moderna on an unknown date.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy). On 17-Apr-2021, DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown. At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant and treatment medications were reported.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related. The causality for the event of drug ineffective remains as possible.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Follow-up received on 4-06-2021 included no new information On 17-Apr-2021: Upon internal review on 14 Jul 2021, an event (lack of efficacy) was added at Moderna's request.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related. The causality for the event of drug ineffective remains as possible.