chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Vomiting
Clinical narrative: dehydration; throwing up starting 45 minutes after vaccine/can't keep anything down; Lightheaded/dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Lightheaded/dizzy), DEHYDRATION (dehydration) and VOMITING (throwing up starting 45 minutes after vaccine/can't keep anything down) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL, HYDROCHLOROTHIAZIDE, FLUOXETINE HYDROCHLORIDE (PROZAC) and OLANZAPINE (ZYPREXA) for an unknown indication.    On 30-Mar-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced DIZZINESS (Lightheaded/dizzy) and VOMITING (throwing up starting 45 minutes after vaccine/can't keep anything down). On 31-Mar-2021, the patient experienced DEHYDRATION (dehydration). At the time of the report, DIZZINESS (Lightheaded/dizzy), DEHYDRATION (dehydration) and VOMITING (throwing up starting 45 minutes after vaccine/can't keep anything down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications are lisinopril, hydrochlorothiazide, Prozac and Zyprexa.  Treatment reported as ER   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Email document received.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness on arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on arm) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness on arm). At the time of the report, PAIN IN EXTREMITY (soreness on arm) outcome was unknown.            This case was linked to MOD-2021-036287 (E2B Linked Report).; Sender's Comments:  MOD-2021-036287:dose 2
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Tire easily; Severe cramping for about 15 minutes/cramps for almost 2 weeks; Diarrhoea for about 15 minutes; Stomach ache; Headachecomes and goes; Body aches; Sick all day; Low grade fever; Chills; Ear ringing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhoea for about 15 minutes), ABDOMINAL PAIN UPPER (Stomach ache), TINNITUS (Ear ringing), MUSCLE SPASMS (Severe cramping for about 15 minutes/cramps for almost 2 weeks) and MALAISE (Sick all day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Chemical sensitivity, Sulfonamide allergy, Allergy to antibiotic and Allergy to antibiotic.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced TINNITUS (Ear ringing). On 05-Mar-2021, the patient experienced PYREXIA (Low grade fever) and CHILLS (Chills). On 06-Mar-2021, the patient experienced MALAISE (Sick all day), HEADACHE (Headachecomes and goes) and MYALGIA (Body aches). On 07-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea for about 15 minutes), ABDOMINAL PAIN UPPER (Stomach ache) and MUSCLE SPASMS (Severe cramping for about 15 minutes/cramps for almost 2 weeks). On an unknown date, the patient experienced FATIGUE (Tire easily). On 24-Mar-2021, DIARRHOEA (Diarrhoea for about 15 minutes), ABDOMINAL PAIN UPPER (Stomach ache), MUSCLE SPASMS (Severe cramping for about 15 minutes/cramps for almost 2 weeks), MALAISE (Sick all day), PYREXIA (Low grade fever), CHILLS (Chills) and MYALGIA (Body aches) had resolved. At the time of the report, TINNITUS (Ear ringing), HEADACHE (Headachecomes and goes) and FATIGUE (Tire easily) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment information was not provided by the reporter   The reporter assessed the events as possibly related to mRNA-1273
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscle spasms, Myalgia, Pyrexia, Tinnitus
Clinical narrative: Tire easily; Severe cramping for about 15 minutes/cramps for almost 2 weeks; Diarrhoea for about 15 minutes; Stomach ache; Headachecomes and goes; Body aches; Sick all day; Low grade fever; Chills; Ear ringing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhoea for about 15 minutes), ABDOMINAL PAIN UPPER (Stomach ache), TINNITUS (Ear ringing), MUSCLE SPASMS (Severe cramping for about 15 minutes/cramps for almost 2 weeks) and MALAISE (Sick all day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Chemical sensitivity, Sulfonamide allergy, Allergy to antibiotic and Allergy to antibiotic.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced TINNITUS (Ear ringing). On 05-Mar-2021, the patient experienced PYREXIA (Low grade fever) and CHILLS (Chills). On 06-Mar-2021, the patient experienced MALAISE (Sick all day), HEADACHE (Headachecomes and goes) and MYALGIA (Body aches). On 07-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea for about 15 minutes), ABDOMINAL PAIN UPPER (Stomach ache) and MUSCLE SPASMS (Severe cramping for about 15 minutes/cramps for almost 2 weeks). On an unknown date, the patient experienced FATIGUE (Tire easily). On 24-Mar-2021, DIARRHOEA (Diarrhoea for about 15 minutes), ABDOMINAL PAIN UPPER (Stomach ache), MUSCLE SPASMS (Severe cramping for about 15 minutes/cramps for almost 2 weeks), MALAISE (Sick all day), PYREXIA (Low grade fever), CHILLS (Chills) and MYALGIA (Body aches) had resolved. At the time of the report, TINNITUS (Ear ringing), HEADACHE (Headachecomes and goes) and FATIGUE (Tire easily) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment information was not provided by the reporter   The reporter assessed the events as possibly related to mRNA-1273
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Pain in extremity, Pyrexia
Clinical narrative: extra dose administered; Sore arm; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (extra dose administered), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 mg. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 mg. On 25-Feb-2021, the patient experienced ACCIDENTAL OVERDOSE (extra dose administered), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever). On 25-Feb-2021, ACCIDENTAL OVERDOSE (extra dose administered) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include blood pressure medication for blood pressure management. Patient was advised not to take a third dose. Patient has taken two Aleve and then went to bed.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of FATIGUE (fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included lisinopril, LEVOTHYROXINE SODIUM (SYNTHROID) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (fatigue). The patient was treated with AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) at an unspecified dose and frequency. On 14-Feb-2021, FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Adderall.   This case was linked to US-MODERNATX, INC.-MOD-2021-070500 (E2B Linked Report). This case was linked to MOD-2021-070500 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070500:Dose 1
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Received the 1st dose of the Moderna vaccine on the beginning of March, tested positive for Covid-19 on 10Mar2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Received the 1st dose of the Moderna vaccine on the beginning of March, tested positive for Covid-19 on 10Mar2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced COVID-19 (Received the 1st dose of the Moderna vaccine on the beginning of March, tested positive for Covid-19 on 10Mar2021). At the time of the report, COVID-19 (Received the 1st dose of the Moderna vaccine on the beginning of March, tested positive for Covid-19 on 10Mar2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication included.  No treatment medication included.  The patient tested covid-19 negative on 29th march 2021and is due for 2nd dose on 31st march 2021.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 0.2ml leaked out; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED (0.2ml leaked out) in a 73-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 No adverse event (No reported medical history.).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (0.2ml leaked out). On 29-Mar-2021, INCORRECT DOSE ADMINISTERED (0.2ml leaked out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  This report refers to a case of incorrect dose administered for mRNA-1273 with no associated AEs.; Sender's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 with no associated AEs.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Therapeutic response unexpected
Clinical narrative: Blood sugar sugar went up; Breathing got better; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar sugar went up) and THERAPEUTIC RESPONSE UNEXPECTED (Breathing got better) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     Concomitant products included INSULIN LISPRO (HUMALOG) for Blood sugar increased.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar sugar went up) and THERAPEUTIC RESPONSE UNEXPECTED (Breathing got better). The patient was treated with INSULIN LISPRO (HUMALOG) for Blood sugar increased, at an unspecified dose and frequency. On 29-Mar-2021, BLOOD GLUCOSE INCREASED (Blood sugar sugar went up) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Breathing got better) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: Blood sugar went up.     The patient received both scheduled doses of mRNA-1273 prior to the events. Therefore, action taken with the drug in response to the event is not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received contains no new information. On 18-May-2021: Follow-up information received contains no new information On 26-Jun-2021: No specific follow-up information recorded. On 28-Jun-2021: Nonsignificant follow up
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ear ringing; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ear ringing) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ear ringing). At the time of the report, TINNITUS (ear ringing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: hoarse voice; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (hoarse voice) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced DYSPHONIA (hoarse voice). The patient was treated with OMEPRAZOLE at an unspecified dose and frequency. At the time of the report, DYSPHONIA (hoarse voice) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: crackling sensation in right ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (crackling sensation in right ear) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, VALPROATE SEMISODIUM (DEPAKOTE), ATORVASTATIN, IRON, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), BIOTIN and MELATONIN for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced TINNITUS (crackling sensation in right ear). At the time of the report, TINNITUS (crackling sensation in right ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated about 30 minutes later she started to get crackling sensation in right ear.  Treatment information was not reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: fever; injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and VACCINATION SITE PAIN (injection arm soreness) in a 62-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 04-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (fever) and VACCINATION SITE PAIN (injection arm soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, PYREXIA (fever) and VACCINATION SITE PAIN (injection arm soreness) had resolved. Not Provided          Concomitant Product include:cholesterol medication,diabetes medications,high blood pressure medications. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts). At the time of the report, PAIN IN EXTREMITY (Arm hurts) outcome was unknown.            Treatment medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-Jun-2021 contain significant information about the second dose of moderna vaccine.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.25ml of dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received 0.25ml of dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milligram. On 25-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (patient received 0.25ml of dose). On 25-Mar-2021, INCORRECT DOSE ADMINISTERED (patient received 0.25ml of dose) had resolved.            No treatment medication was reported.  This report refers to a case of incorrect dose administered for mRNA-1273 with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 with no associated AEs.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: patient received 0.25ml of dose; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (patient received 0.25ml of dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) 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 UNDERDOSE (patient received 0.25ml of dose). On 25-Mar-2021, UNDERDOSE (patient received 0.25ml of dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: patient received 0.25ml of dose; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (patient received 0.25ml of dose) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) 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) .25 dosage form. On 25-Mar-2021, the patient experienced UNDERDOSE (patient received 0.25ml of dose). On 25-Mar-2021, UNDERDOSE (patient received 0.25ml of dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Headache, Lethargy, Pyrexia
Clinical narrative: stomachache; woke up several hour late and started to throw up(total of four times); developed a fever 99.3; headache; headache; lethargic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (lethargic), ABDOMINAL PAIN UPPER (stomachache), the first episode of HEADACHE (headache), VOMITING (woke up several hour late and started to throw up(total of four times)) and PYREXIA (developed a fever 99.3) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced LETHARGY (lethargic) and the first episode of HEADACHE (headache). On 31-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomachache), VOMITING (woke up several hour late and started to throw up(total of four times)), PYREXIA (developed a fever 99.3) and the second episode of HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) on 30-Mar-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargic), ABDOMINAL PAIN UPPER (stomachache), VOMITING (woke up several hour late and started to throw up(total of four times)), PYREXIA (developed a fever 99.3) and the last episode of HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: 99.3 (High) 99.3.         Concomitant medications were not provided. Other treatment medications included cold compresses and Pedialyte.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: stomachache; woke up several hour late and started to throw up(total of four times); developed a fever 99.3; headache; headache; lethargic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (lethargic), ABDOMINAL PAIN UPPER (stomachache), the first episode of HEADACHE (headache), VOMITING (woke up several hour late and started to throw up(total of four times)) and PYREXIA (developed a fever 99.3) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced LETHARGY (lethargic) and the first episode of HEADACHE (headache). On 31-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomachache), VOMITING (woke up several hour late and started to throw up(total of four times)), PYREXIA (developed a fever 99.3) and the second episode of HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) on 30-Mar-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargic), ABDOMINAL PAIN UPPER (stomachache), VOMITING (woke up several hour late and started to throw up(total of four times)), PYREXIA (developed a fever 99.3) and the last episode of HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: 99.3 (High) 99.3.         Concomitant medications were not provided. Other treatment medications included cold compresses and Pedialyte.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Administered 0.25ml doses; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Administered 0.25ml doses) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 dosage form. On 25-Mar-2021, the patient experienced UNDERDOSE (Administered 0.25ml doses). On 25-Mar-2021, UNDERDOSE (Administered 0.25ml doses) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  This report refers to a case of Underdose for mRNA-1273, lot #  017B21A, with no associated AEs.; Sender's Comments: This report refers to a case of Underdose for mRNA-1273, lot #  017B21A, with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Urticaria
Clinical narrative: broke out in hives; tightness in chest; severe headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke out in hives), CHEST DISCOMFORT (tightness in chest) and HEADACHE (severe headaches) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 URTICARIA (broke out in hives), CHEST DISCOMFORT (tightness in chest) and HEADACHE (severe headaches). At the time of the report, URTICARIA (broke out in hives), CHEST DISCOMFORT (tightness in chest) and HEADACHE (severe headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medications included 1 anti-inflammatory and 1 steroid medicine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: some left arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (some left arm pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 001B21A) for COVID-19 vaccination.     The patient's past medical history included Heart valve regurgitation and Dry eyes. Concurrent medical conditions included Depression, Anxiety, Narcolepsy (diagnosed 2000), Low blood pressure and COPD. Concomitant products included DILTIAZEM HYDROCHLORIDE (CARDIZEM CD), PHENELZINE SULFATE (NARDIL), CLONAZEPAM, GLYCEROL, PROPYLENE GLYCOL (SOOTHE [GLYCEROL;PROPYLENE GLYCOL]) and MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (some left arm pain). At the time of the report, PAIN IN EXTREMITY (some left arm pain) outcome was unknown.            Treatment details included acetaminophen. Event outcome details were not reported.   This case was linked to MOD-2021-047854 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of fatigue (very tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 024M20A) for COVID-19 vaccination. Concomitant products included lisinopril for hypertension. On Feb 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 15, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced fatigue (very tired). At the time of the report, fatigue (very tired) outcome: unknown. Action taken with mRNA-1273 in response to the event: not applicable. Treatment information not provided. This case linked to MOD-2021-049728, MOD-2021-049728 (patient link).
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered at less than 16 years of age; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered at less than 16 years of age) 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 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered at less than 16 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered at less than 16 years of age) 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 medication was not reported.  Treatment medication was not reported.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: Unknown) with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Pruritus, Rash
Clinical narrative: her feet get swollen; her feet get swollen and hot, a little bit painful, sometimes it goes up her legs; they're kind of itchy and red; they're kind of itchy and red; feet get swollen and hot; a rash on her arm for a week; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING (her feet get swollen), PAIN IN EXTREMITY (her feet get swollen and hot, a little bit painful, sometimes it goes up her legs), PRURITUS (they're kind of itchy and red), ERYTHEMA (they're kind of itchy and red) and FEELING HOT (feet get swollen and hot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and LISINOPRIL for an unknown indication.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RASH (a rash on her arm for a week). On an unknown date, the patient experienced SWELLING (her feet get swollen), PAIN IN EXTREMITY (her feet get swollen and hot, a little bit painful, sometimes it goes up her legs), PRURITUS (they're kind of itchy and red), ERYTHEMA (they're kind of itchy and red) and FEELING HOT (feet get swollen and hot). On 10-Mar-2021, RASH (a rash on her arm for a week) had resolved. At the time of the report, SWELLING (her feet get swollen), PAIN IN EXTREMITY (her feet get swollen and hot, a little bit painful, sometimes it goes up her legs), PRURITUS (they're kind of itchy and red), ERYTHEMA (they're kind of itchy and red) and FEELING HOT (feet get swollen and hot) outcome was unknown.            The patient had to keep them out of covers at night, they wake her up in the night and she has to be in the cold tile. The patient did not receive any treatment medications.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: her feet get swollen; her feet get swollen and hot, a little bit painful, sometimes it goes up her legs; they're kind of itchy and red; they're kind of itchy and red; feet get swollen and hot; a rash on her arm for a week; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING (her feet get swollen), PAIN IN EXTREMITY (her feet get swollen and hot, a little bit painful, sometimes it goes up her legs), PRURITUS (they're kind of itchy and red), ERYTHEMA (they're kind of itchy and red) and FEELING HOT (feet get swollen and hot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and LISINOPRIL for an unknown indication.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RASH (a rash on her arm for a week). On an unknown date, the patient experienced SWELLING (her feet get swollen), PAIN IN EXTREMITY (her feet get swollen and hot, a little bit painful, sometimes it goes up her legs), PRURITUS (they're kind of itchy and red), ERYTHEMA (they're kind of itchy and red) and FEELING HOT (feet get swollen and hot). On 10-Mar-2021, RASH (a rash on her arm for a week) had resolved. At the time of the report, SWELLING (her feet get swollen), PAIN IN EXTREMITY (her feet get swollen and hot, a little bit painful, sometimes it goes up her legs), PRURITUS (they're kind of itchy and red), ERYTHEMA (they're kind of itchy and red) and FEELING HOT (feet get swollen and hot) outcome was unknown.            The patient had to keep them out of covers at night, they wake her up in the night and she has to be in the cold tile. The patient did not receive any treatment medications.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced TENDERNESS (Tenderness). On 16-Feb-2021, TENDERNESS (Tenderness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided no treatment medication were provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Nausea, Vomiting
Clinical narrative: debilitating migraine; severe headache; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (debilitating migraine), HEADACHE (severe headache), NAUSEA (nausea) and VOMITING (vomiting) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-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 MIGRAINE (debilitating migraine), HEADACHE (severe headache), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, MIGRAINE (debilitating migraine), HEADACHE (severe headache), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication reported.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was told she needed to wait 90 days for second vaccine. Concomitant medications were not provided. Treatment medication included infusion.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick) 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 COVID-19 in November 2020.    On 02-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 MALAISE (feeling sick). At the time of the report, MALAISE (feeling sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported. .
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eye infection, Pain in extremity
Clinical narrative: pink eye/eye infection; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE INFECTION (pink eye/eye infection) and PAIN IN EXTREMITY (sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Mar-2021, the patient experienced EYE INFECTION (pink eye/eye infection). At the time of the report, EYE INFECTION (pink eye/eye infection) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had been to a doctor and was told that pink eye is a side effect of the vaccine. Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site left arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site left arm after 1st dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site left arm after 1st dose). On 02-Mar-2021, VACCINATION SITE PAIN (Pain at injection site left arm after 1st dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient did not receive any treatment medication.   This case was linked to MOD-2021-063821 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: cough; This spontaneous case was reported by a nurse and describes the occurrence of COUGH (cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0171B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced COUGH (cough). At the time of the report, COUGH (cough) outcome was unknown. 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 reported.   No corrective treatment was provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site bruising, Vaccination site erythema, Vaccination site induration
Clinical narrative: Dark red circular bruise; Swollen upper arm; Bruise became hard like rock the size of a silver dollar; In the center was a red dot where the patient got injected; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Dark red circular bruise), PERIPHERAL SWELLING (Swollen upper arm), VACCINATION SITE INDURATION (Bruise became hard like rock the size of a silver dollar) and VACCINATION SITE ERYTHEMA (In the center was a red dot where the patient got injected) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (Dark red circular bruise), PERIPHERAL SWELLING (Swollen upper arm), VACCINATION SITE INDURATION (Bruise became hard like rock the size of a silver dollar) and VACCINATION SITE ERYTHEMA (In the center was a red dot where the patient got injected). At the time of the report, VACCINATION SITE BRUISING (Dark red circular bruise), PERIPHERAL SWELLING (Swollen upper arm), VACCINATION SITE INDURATION (Bruise became hard like rock the size of a silver dollar) and VACCINATION SITE ERYTHEMA (In the center was a red dot where the patient got injected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Patient began rubbing and putting pressure on vaccination site believing that may help to resolve the issue.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up document included reporter contact details was updated.