chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Malaise, Nausea, Vertigo
Clinical narrative: Feeling very sickly; Vertigo; Diarrhea; Nausea; Vomitting; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling very sickly), VERTIGO (Vertigo), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomitting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced MALAISE (Feeling very sickly), VERTIGO (Vertigo), DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (Vomitting) and HEADACHE (Headaches). At the time of the report, MALAISE (Feeling very sickly), VERTIGO (Vertigo), DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (Vomitting) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; 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: Vomiting
Clinical narrative: Feeling very sickly; Vertigo; Diarrhea; Nausea; Vomitting; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling very sickly), VERTIGO (Vertigo), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomitting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced MALAISE (Feeling very sickly), VERTIGO (Vertigo), DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (Vomitting) and HEADACHE (Headaches). At the time of the report, MALAISE (Feeling very sickly), VERTIGO (Vertigo), DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (Vomitting) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: itching at the site; huge red area extended about 6 inches from injection site; injection site feels a little warm; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itching at the site that is getting worse, huge red area extended about 6 inches from injection site and area feels a little warm.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On unknown date, the patient experienced itching at the site that is getting worse.Today woke up with huge red area extended about 6 inches from injection site, no fever but area feels a little warm. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, itching at the site that is getting worse, huge red area extended about 6 inches from injection site and area feels a little warm, were unknown.; Reporter's Comments: This case concerns a 74-year-old female who experienced nonserious expected events of vaccination site erythema, vaccination site warmth, vaccination site pruritus. Event onset with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Fatigue, Migraine
Clinical narrative: Migraine headache; Red and blotchy on the injection site; Sore throat; Lost his sense of smell and taste; Lost his sense of smell and taste; Fatigue; Arm is sore; Chills; A spontaneous report was received from a consumer who was a male patient who received Moderna's COVID-19 Vaccine, and who experienced chills, arm was sore, fatigue, lost his sense of smell and taste, sore throat, red and blotchy on the injection site and migraine headache.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 28-Dec-2020, approximately one day prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 (LOT 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The next day, on 29-Dec-2020, he began to have chills and his arm was sore.  Two days later, on 01-Jan-2021, he felt fatigued.  On 04-Jan-2020, he reported losing his sense of smell and sense of taste.  He reported a sore throat one day later on 05-Jan-2021 and stated that on 06-Jan-2021, his injection site was red and blotchy.  Finally, on 07-Jan-2021, patient said that he experienced a migraine headache.   He reported that for the migraine headache, he took six tablets of paracetamol which did not help.  He stated that he then took three, 81 mg tablets of baby aspirin which did provide some relief.    Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events were not provided.; 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. However, events loss of smell and taste is unlikely related to mRNA-1273. Further information is requested.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Vaccination site erythema, Vaccination site pain
Clinical narrative: Migraine headache; Red and blotchy on the injection site; Sore throat; Lost his sense of smell and taste; Lost his sense of smell and taste; Fatigue; Arm is sore; Chills; A spontaneous report was received from a consumer who was a male patient who received Moderna's COVID-19 Vaccine, and who experienced chills, arm was sore, fatigue, lost his sense of smell and taste, sore throat, red and blotchy on the injection site and migraine headache.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 28-Dec-2020, approximately one day prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 (LOT 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The next day, on 29-Dec-2020, he began to have chills and his arm was sore.  Two days later, on 01-Jan-2021, he felt fatigued.  On 04-Jan-2020, he reported losing his sense of smell and sense of taste.  He reported a sore throat one day later on 05-Jan-2021 and stated that on 06-Jan-2021, his injection site was red and blotchy.  Finally, on 07-Jan-2021, patient said that he experienced a migraine headache.   He reported that for the migraine headache, he took six tablets of paracetamol which did not help.  He stated that he then took three, 81 mg tablets of baby aspirin which did provide some relief.    Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events were not provided.; 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. However, events loss of smell and taste is unlikely related to mRNA-1273. Further information is requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: area is swollen; area is red; itchiness in injection site; soreness; This spontaneous case was reported by a dentist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itchiness in injection site), VACCINATION SITE PAIN (soreness), VACCINATION SITE SWELLING (area is swollen) and VACCINATION SITE ERYTHEMA (area is red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C2SJ20-2A or 02SJ20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (soreness). On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness in injection site). On 07-Jan-2021, the patient experienced VACCINATION SITE SWELLING (area is swollen) and VACCINATION SITE ERYTHEMA (area is red). On 01-Jan-2021, VACCINATION SITE PAIN (soreness) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchiness in injection site), VACCINATION SITE SWELLING (area is swollen) and VACCINATION SITE ERYTHEMA (area is red) 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.   Based on the established safety profile and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Vaccination site pruritus, vaccination site pain, vaccination site erythema, and vaccination site swelling are consistent with the known safety profile of the vaccine.; Reporter's Comments: Based on the established safety profile and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Vaccination site pruritus, vaccination site pain, vaccination site erythema, and vaccination site swelling are consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood glucose, Diarrhoea, Dizziness, Emotional distress
Clinical narrative: Hypoglycemic; shaking; feeling tired; stomach upset; Diarrhea; Feeling lightheadedness; A little emotional; feeling loopy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset), DIARRHOEA (Diarrhea), DIZZINESS (Feeling lightheadedness), EMOTIONAL DISTRESS (A little emotional) and HYPOGLYCAEMIA (Hypoglycemic) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GI upset and Vertigo. Concurrent medical conditions included Pre-diabetic. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and DILTIAZEM for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach upset), DIARRHOEA (Diarrhea), DIZZINESS (Feeling lightheadedness), EMOTIONAL DISTRESS (A little emotional) and FATIGUE (feeling tired). On 06-Jan-2021, the patient experienced HYPOGLYCAEMIA (Hypoglycemic) and TREMOR (shaking). On an unknown date, the patient experienced FEELING ABNORMAL (feeling loopy). On 06-Jan-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (stomach upset) had resolved and DIZZINESS (Feeling lightheadedness), EMOTIONAL DISTRESS (A little emotional), HYPOGLYCAEMIA (Hypoglycemic), TREMOR (shaking), FEELING ABNORMAL (feeling loopy) and FATIGUE (feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Blood glucose: 78 low. On 07-Jan-2021, Blood glucose: 74 low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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. However, very limited information regarding this event (hypoglycemia, tremor) has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, very limited information regarding this event (hypoglycemia, tremor) has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hypoglycaemia, Tremor
Clinical narrative: Hypoglycemic; shaking; feeling tired; stomach upset; Diarrhea; Feeling lightheadedness; A little emotional; feeling loopy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset), DIARRHOEA (Diarrhea), DIZZINESS (Feeling lightheadedness), EMOTIONAL DISTRESS (A little emotional) and HYPOGLYCAEMIA (Hypoglycemic) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GI upset and Vertigo. Concurrent medical conditions included Pre-diabetic. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and DILTIAZEM for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach upset), DIARRHOEA (Diarrhea), DIZZINESS (Feeling lightheadedness), EMOTIONAL DISTRESS (A little emotional) and FATIGUE (feeling tired). On 06-Jan-2021, the patient experienced HYPOGLYCAEMIA (Hypoglycemic) and TREMOR (shaking). On an unknown date, the patient experienced FEELING ABNORMAL (feeling loopy). On 06-Jan-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (stomach upset) had resolved and DIZZINESS (Feeling lightheadedness), EMOTIONAL DISTRESS (A little emotional), HYPOGLYCAEMIA (Hypoglycemic), TREMOR (shaking), FEELING ABNORMAL (feeling loopy) and FATIGUE (feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Blood glucose: 78 low. On 07-Jan-2021, Blood glucose: 74 low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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. However, very limited information regarding this event (hypoglycemia, tremor) has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, very limited information regarding this event (hypoglycemia, tremor) has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Discomfort, Headache, Pyrexia
Clinical narrative: Felt like someone beat her up; Headache; Temperature of 103F; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Felt like someone beat her up), HEADACHE (Headache) and PYREXIA (Temperature of 103F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced DISCOMFORT (Felt like someone beat her up), HEADACHE (Headache) and PYREXIA (Temperature of 103F). In January 2021, DISCOMFORT (Felt like someone beat her up), HEADACHE (Headache) and PYREXIA (Temperature of 103F) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Body temperature: 103F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. No treatment information was provided.  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.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Increasing headache; A spontaneous report was received from consumer concerning a female patient, of unknown age, who was administered Moderna COVID-19 vaccine and experienced increasing headache (headache).  The patient's medical history was not reported. No relevant concomitant medications were reported.  The patient received her first of two planned doses of mRNA-1273 (Batch number: 025L20A) through intramuscular route in her left arm for prophylaxis of COVID-19 infection on 07 Jan 2021. The patient experienced increasing headache on 08 Jan 2021.  The patient received pain reliever for headache.   The action taken for Moderna COVID-19 vaccine was unknown.   The outcome of the event which was increasing headache was unknown.; Reporter's Comments: Based on the established safety profile and a temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded.  The Headache is consistent with the known safety profile of the vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash is 7 inches, inflamed, hot, progressing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash is 7 inches, inflamed, hot, progressing) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced RASH (rash is 7 inches, inflamed, hot, progressing). At the time of the report, RASH (rash is 7 inches, inflamed, hot, progressing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant history of patient was not reported.  Treatment included diphenhydramine and cortisone.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027220A) for COVID-19 vaccination.     The patient's past medical history included Alcohol abuse (1 drink/month) in October 2020 and Marijuana abuse (one time 15 years ago). Family history included Cancer (Paternal family history of cancer (patient's grandmother and uncle passed away from cancer)) since an unknown date and High cholesterol (Maternal family history of high cholesterol) since an unknown date. Concurrent medical conditions included Drug allergy (Sulfa drugs (Minor reaction)) and Spotting menstrual (Spotting, but monitored by doctor and occurred in first pregnancy as well). Concomitant products included BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) and PARACETAMOL (TYLENOL) for Migraine.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 02-Dec-2020 and the estimated date of delivery was 08-Sep-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2020, Pregnancy test: positive (Positive) Positive. On 06-Jan-2021, Blood test: inconclusive mmHg (Inconclusive) (pre-vaccine) HCG 4717 at 5 weeks. On 06-Jan-2021, Ultrasound scan: inconclusive (Inconclusive) gestational sac was slightly irregularly shaped (unofficial finding).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Caffeinated tea.  No treatment information was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: 28 weeks pregnant at my first dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (28 weeks pregnant at my first dose) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included Live birth on 11-Oct-2018.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 21-Jun-2020 and the estimated date of delivery was 24-Mar-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (28 weeks pregnant at my first dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (28 weeks pregnant at my first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MATERNAL EXPOSURE DURING PREGNANCY (28 weeks pregnant at my first dose) to be not related.    No treatment related information has been reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Palpitations
Clinical narrative: palpitation; fast heart beat; little short of breath; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitation), HEART RATE INCREASED (fast heart beat), DYSPNOEA (little short of breath) and DIZZINESS (dizziness) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PALPITATIONS (palpitation), HEART RATE INCREASED (fast heart beat), DYSPNOEA (little short of breath) and DIZZINESS (dizziness). At the time of the report, PALPITATIONS (palpitation), HEART RATE INCREASED (fast heart beat), DYSPNOEA (little short of breath) and DIZZINESS (dizziness) 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.   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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling cold, Inappropriate schedule of product administration, Nasopharyngitis, Nausea
Clinical narrative: Very weak; cold; vomiting; nausea; feeling cold; 4 days (1/15/21) later they gave the 2nd dose of the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Very weak), NASOPHARYNGITIS (cold), VOMITING (vomiting), NAUSEA (nausea) and FEELING COLD (feeling cold) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (patient had surgery at end part of November last year) since an unknown date. Concomitant products included AMPHETAMINE, PROPRANOLOL HYDROCHLORIDE (PROPANOLOL LAM) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced ASTHENIA (Very weak), NASOPHARYNGITIS (cold), VOMITING (vomiting), NAUSEA (nausea), FEELING COLD (feeling cold) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 days (1/15/21) later they gave the 2nd dose of the vaccine). The patient was treated with PARACETAMOL (TYLENOL) (oral) at a dose of 1 dosage form. At the time of the report, ASTHENIA (Very weak), NASOPHARYNGITIS (cold), VOMITING (vomiting), NAUSEA (nausea) and FEELING COLD (feeling cold) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 days (1/15/21) later they gave the 2nd dose of the vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications included Tylenol and unknown medication for Nausea.; Sender's Comments: This report refers to a case of Product administration error for mRNA-1273, lot # 027L20A with associated AEs.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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Very weak; cold; vomiting; nausea; feeling cold; 4 days (1/15/21) later they gave the 2nd dose of the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Very weak), NASOPHARYNGITIS (cold), VOMITING (vomiting), NAUSEA (nausea) and FEELING COLD (feeling cold) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (patient had surgery at end part of November last year) since an unknown date. Concomitant products included AMPHETAMINE, PROPRANOLOL HYDROCHLORIDE (PROPANOLOL LAM) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced ASTHENIA (Very weak), NASOPHARYNGITIS (cold), VOMITING (vomiting), NAUSEA (nausea), FEELING COLD (feeling cold) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 days (1/15/21) later they gave the 2nd dose of the vaccine). The patient was treated with PARACETAMOL (TYLENOL) (oral) at a dose of 1 dosage form. At the time of the report, ASTHENIA (Very weak), NASOPHARYNGITIS (cold), VOMITING (vomiting), NAUSEA (nausea) and FEELING COLD (feeling cold) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 days (1/15/21) later they gave the 2nd dose of the vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications included Tylenol and unknown medication for Nausea.; Sender's Comments: This report refers to a case of Product administration error for mRNA-1273, lot # 027L20A with associated AEs.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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Nasal congestion, Nasal discomfort
Clinical narrative: head cold; lost her sensation of smell; exhausted; lost some of her tasting sensation; stuffy nose; Burning nose; Running nose; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost some of her tasting sensation), NASAL CONGESTION (stuffy nose), NASAL DISCOMFORT (Burning nose), RHINORRHOEA (Running nose) and NASOPHARYNGITIS (head cold) in a 43-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.     The patient's past medical history included Sore throat.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced AGEUSIA (lost some of her tasting sensation), NASAL CONGESTION (stuffy nose), NASAL DISCOMFORT (Burning nose) and RHINORRHOEA (Running nose). On 10-Jan-2021, the patient experienced NASOPHARYNGITIS (head cold), ANOSMIA (lost her sensation of smell) and FATIGUE (exhausted). At the time of the report, AGEUSIA (lost some of her tasting sensation) and ANOSMIA (lost her sensation of smell) outcome was unknown and NASAL CONGESTION (stuffy nose), NASAL DISCOMFORT (Burning nose), RHINORRHOEA (Running nose), NASOPHARYNGITIS (head cold) and FATIGUE (exhausted) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test: Negative.     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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: head cold; lost her sensation of smell; exhausted; lost some of her tasting sensation; stuffy nose; Burning nose; Running nose; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost some of her tasting sensation), NASAL CONGESTION (stuffy nose), NASAL DISCOMFORT (Burning nose), RHINORRHOEA (Running nose) and NASOPHARYNGITIS (head cold) in a 43-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.     The patient's past medical history included Sore throat.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced AGEUSIA (lost some of her tasting sensation), NASAL CONGESTION (stuffy nose), NASAL DISCOMFORT (Burning nose) and RHINORRHOEA (Running nose). On 10-Jan-2021, the patient experienced NASOPHARYNGITIS (head cold), ANOSMIA (lost her sensation of smell) and FATIGUE (exhausted). At the time of the report, AGEUSIA (lost some of her tasting sensation) and ANOSMIA (lost her sensation of smell) outcome was unknown and NASAL CONGESTION (stuffy nose), NASAL DISCOMFORT (Burning nose), RHINORRHOEA (Running nose), NASOPHARYNGITIS (head cold) and FATIGUE (exhausted) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test: Negative.     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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Throat tightness
Clinical narrative: 5 minutes after receiving the vaccine heartrate elevated for 1 or 2 minutes; 5 minutes after receiving the vaccine throat starting to close for 1 or 2 minutes; 15 minutes after receiving the vaccine arm feeling numb and in 5/7 minutes it went away; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (5 minutes after receiving the vaccine heartrate elevated for 1 or 2 minutes), THROAT TIGHTNESS (5 minutes after receiving the vaccine throat starting to close for 1 or 2 minutes) and HYPOAESTHESIA (15 minutes after receiving the vaccine arm feeling numb and in 5/7 minutes it went away) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced HEART RATE INCREASED (5 minutes after receiving the vaccine heartrate elevated for 1 or 2 minutes), THROAT TIGHTNESS (5 minutes after receiving the vaccine throat starting to close for 1 or 2 minutes) and HYPOAESTHESIA (15 minutes after receiving the vaccine arm feeling numb and in 5/7 minutes it went away). On 02-Jan-2021, HEART RATE INCREASED (5 minutes after receiving the vaccine heartrate elevated for 1 or 2 minutes), THROAT TIGHTNESS (5 minutes after receiving the vaccine throat starting to close for 1 or 2 minutes) and HYPOAESTHESIA (15 minutes after receiving the vaccine arm feeling numb and in 5/7 minutes it went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment for the events was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter'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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Pruritus, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: it was warm; it doesn't bother and can still see a ghost; large red lump/very small red lump to about 6 cm in diameter; injection site redness; injection site swelling; injection site pain; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (it was warm) and NIGHTMARE (it doesn't bother and can still see a ghost) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event (No medical history reported.).    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (it was warm) and NIGHTMARE (it doesn't bother and can still see a ghost). At the time of the report, VACCINATION SITE WARMTH (it was warm) and NIGHTMARE (it doesn't bother and can still see a ghost) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Follow up received on 22-Jan-2021 included patients date of Barth and patient experienced with some new 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: it was warm; it doesn't bother and can still see a ghost; large red lump/very small red lump to about 6 cm in diameter; injection site redness; injection site swelling; injection site pain; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (it was warm) and NIGHTMARE (it doesn't bother and can still see a ghost) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event (No medical history reported.).    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (it was warm) and NIGHTMARE (it doesn't bother and can still see a ghost). At the time of the report, VACCINATION SITE WARMTH (it was warm) and NIGHTMARE (it doesn't bother and can still see a ghost) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Follow up received on 22-Jan-2021 included patients date of Barth and patient experienced with some new 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.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Body temperature of 102.3deg F; Arm was sore; Injection site is warm; Bodyache; Chills; Headache; Tired; Injection site is red; A spontaneous report was received from a a 62-years old female patient concerning herself, who received two doses of Moderna's covid-19 vaccine (mRNA -1273) and experienced the events, sore arm(pain in extremity), chills(chills), body ache(myalgia), headache(headache), body temperature(pyrexia), injection site warmth(injection site warmth), red(injection site erythema) and feel tired(fatigue).  The patient's medical history was not provided. Concomitant medications were not reported.  On 08 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027120A) via unknown route for prophylaxis of COVID-19 infection.  On 08 Jan 2021 in the afternoon, the patient experienced the event sore arm, later in the night she had chills, body ache and headache. On 09 Jan 2021, the patient had a rise in body temperature and on 10 JAN 2021, the patient reported that injection site is warm and red, and she is tired. On 09 Jan 2021, the lab tests performed included body temperature 102.3. Treatment for the events included acetaminophen.  Action taken with mRNA-1273 in response to the events was unknown.  The events, sore arm, chills, body ache, headache and body temperature were resolved on 10 Jan 2021. At the time of this report, the outcome of the events, injection site warmth, red and feel tired were considered to be not resolved.; Reporter's Comments: This case concerns a 62-year-old female who experienced nonserious events of unexpected pain in extremity, injection site warmth and expected fever, chills, fatigue, myalgia, headache, and injection site erythema.  Event onset the same day as the first dose of mRNA-1273. Treatment with acetaminophen. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Body temperature of 102.3deg F; Arm was sore; Injection site is warm; Bodyache; Chills; Headache; Tired; Injection site is red; A spontaneous report was received from a a 62-years old female patient concerning herself, who received two doses of Moderna's covid-19 vaccine (mRNA -1273) and experienced the events, sore arm(pain in extremity), chills(chills), body ache(myalgia), headache(headache), body temperature(pyrexia), injection site warmth(injection site warmth), red(injection site erythema) and feel tired(fatigue).  The patient's medical history was not provided. Concomitant medications were not reported.  On 08 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027120A) via unknown route for prophylaxis of COVID-19 infection.  On 08 Jan 2021 in the afternoon, the patient experienced the event sore arm, later in the night she had chills, body ache and headache. On 09 Jan 2021, the patient had a rise in body temperature and on 10 JAN 2021, the patient reported that injection site is warm and red, and she is tired. On 09 Jan 2021, the lab tests performed included body temperature 102.3. Treatment for the events included acetaminophen.  Action taken with mRNA-1273 in response to the events was unknown.  The events, sore arm, chills, body ache, headache and body temperature were resolved on 10 Jan 2021. At the time of this report, the outcome of the events, injection site warmth, red and feel tired were considered to be not resolved.; Reporter's Comments: This case concerns a 62-year-old female who experienced nonserious events of unexpected pain in extremity, injection site warmth and expected fever, chills, fatigue, myalgia, headache, and injection site erythema.  Event onset the same day as the first dose of mRNA-1273. Treatment with acetaminophen. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Blood potassium increased
Clinical narrative: Alarming high potassium level; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD POTASSIUM INCREASED (Alarming high potassium level) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD POTASSIUM INCREASED (Alarming high potassium level). At the time of the report, BLOOD POTASSIUM INCREASED (Alarming high potassium level) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood potassium: (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were reported as a lot of medication for unknown indications. No treatment related information has been reported.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination site pain
Clinical narrative: Sore arm; 6 days after vaccine-tested Covid-19 positive; A Spontaneous report was received from a consumer concerning a 44-years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive with covid 19 and experienced sore arm.  The patient's medical history was not provided. Concomitant medications were not listed.  On 31 Dec 2021, the patient received her first dose of two planned doses mRNA-1273(Lot number:025L20A) for prophylaxis of COVID-19 infection.   On 6 Jan 2021 tested COVID-19 positive and also experienced Sore arm. Treatment details are not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, covid 19 infection and sore arm were unknown.; Reporter's Comments: Based on reporter's causality the event COVID -19 Positive is assessed as unlikely related to mRNA-1273. Further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Erythema, Peripheral swelling, Pruritus
Clinical narrative: PEG reaction; Arm is red, swollen, itchy; Arm  is red, swollen, itchy; Arm is red, swollen, itchy; A spontaneous report was received from a consumer, concerning herself, a 59-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced PEG reaction (Drug hypersensitivity), red (Pruritus), swollen (Erythema) and itchy arm (Peripheral swelling).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07-Jan-2021, after vaccination, the patient went to primary care physician and got a confirmation that she has PEG reaction, where her arm was red, swollen and itchy. However, patient was feeling well and did not get sick or nauseous or feverish. Treatment medications were not reported.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of the events PEG reaction, arm is red, swollen and itchy were not reported.; Reporter's Comments: This case concerns a 59-year-old female who experienced NS expected events of pruritus, erythema, and peripheral swelling. Event onset occurred 9 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.