chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: diarrhea; heartburn; stool is liquid, had mucus and is yellow; fatigue; headache; nausea; pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DYSPEPSIA (heartburn), DIARRHOEA (stool is liquid, had mucus and is yellow), PAIN (pain) and FATIGUE (fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN (pain). On 02-Feb-2021, the patient experienced DIARRHOEA (diarrhea), DYSPEPSIA (heartburn), DIARRHOEA (stool is liquid, had mucus and is yellow), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, DIARRHOEA (diarrhea), DYSPEPSIA (heartburn), DIARRHOEA (stool is liquid, had mucus and is yellow), PAIN (pain), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Dyspnoea, Heart rate
Clinical narrative: delayed onset difficulty breathing; delayed onset dizziness; delayed onset weakness; confusion; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (delayed onset difficulty breathing), DIZZINESS (delayed onset dizziness), ASTHENIA (delayed onset weakness) and CONFUSIONAL STATE (confusion) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025220A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced DYSPNOEA (delayed onset difficulty breathing), DIZZINESS (delayed onset dizziness), ASTHENIA (delayed onset weakness) and CONFUSIONAL STATE (confusion). At the time of the report, DYSPNOEA (delayed onset difficulty breathing), DIZZINESS (delayed onset dizziness), ASTHENIA (delayed onset weakness) and CONFUSIONAL STATE (confusion) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Heart rate: (High) fast heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Flushing, Head discomfort, Rash, Throat irritation
Clinical narrative: facial flushing; increased blood pressure; scratchy throat; felt heavy; rash; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FLUSHING (facial flushing), BLOOD PRESSURE INCREASED (increased blood pressure), THROAT IRRITATION (scratchy throat), HEAD DISCOMFORT (felt heavy) and RASH (rash) 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.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced FLUSHING (facial flushing), BLOOD PRESSURE INCREASED (increased blood pressure), THROAT IRRITATION (scratchy throat), HEAD DISCOMFORT (felt heavy) and RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 mg. In January 2021, FLUSHING (facial flushing), BLOOD PRESSURE INCREASED (increased blood pressure), THROAT IRRITATION (scratchy throat), HEAD DISCOMFORT (felt heavy) and RASH (rash) 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.   She received her vaccine at a hospital and stayed about 1 hour after the vaccine was given due to her reaction. Relevant concomitant medication was not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red spot; A little itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot) and VACCINATION SITE PRURITUS (A little itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus and Blood pressure high.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot) and VACCINATION SITE PRURITUS (A little itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Red spot) and VACCINATION SITE PRURITUS (A little itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications reported were oral medication for diabetes and high blood pressure medication .; 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sinusitis
Clinical narrative: a sinus infection starting; mild fever; This spontaneous case was reported by a health care professional and describes the occurrence of SINUSITIS (a sinus infection starting) and PYREXIA (mild fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced SINUSITIS (a sinus infection starting) and PYREXIA (mild fever). On 02-Feb-2021, PYREXIA (mild fever) had resolved. At the time of the report, SINUSITIS (a sinus infection starting) 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.   Relevant concomitant medication was not reported. Treatment information was provided as Advil.  Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded, although it is possible the fever is associated with an unrelated sinus infection as the onset date of both is more than 3 weeks after vaccination.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded, although it is possible the fever is associated with an unrelated sinus infection as the onset date of both is more than 3 weeks after vaccination
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nodule, Pain in extremity, Rash, Skin lesion
Clinical narrative: lesions at the back of her hand; rash on both elbows/ rash on both hands; itchy nodules on both elbows; tiredness; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (itchy nodules on both elbows), SKIN LESION (lesions at the back of her hand), PAIN IN EXTREMITY (sore arm), RASH (rash on both elbows/ rash on both hands) and FATIGUE (tiredness) in a 76-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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness). On 01-Feb-2021, the patient experienced NODULE (itchy nodules on both elbows) and RASH (rash on both elbows/ rash on both hands). On 02-Feb-2021, the patient experienced SKIN LESION (lesions at the back of her hand). On 25-Jan-2021, PAIN IN EXTREMITY (sore arm) outcome was unknown, FATIGUE (tiredness) had resolved. At the time of the report, NODULE (itchy nodules on both elbows), SKIN LESION (lesions at the back of her hand) and RASH (rash on both elbows/ rash on both hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-254039 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up document was received. Reporter's contact information was updated. New event rash was included. It contains significant information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Feeling cold
Clinical narrative: Cold; Weak; Feeling really tired; Chills; Little bit nauseated, feels very queezy; Fever of 100.4; Arm is sore; Bright red at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING COLD (Cold), ASTHENIA (Weak), PAIN IN EXTREMITY (Arm is sore), VACCINATION SITE ERYTHEMA (Bright red at the injection site) and FATIGUE (Feeling really tired) in a 71-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.     Concomitant products included VERAPAMIL, AMITRIPTYLINE and VITAMINS NOS for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore) and VACCINATION SITE ERYTHEMA (Bright red at the injection site). On 03-Feb-2021, the patient experienced FEELING COLD (Cold), ASTHENIA (Weak), FATIGUE (Feeling really tired), CHILLS (Chills), NAUSEA (Little bit nauseated, feels very queezy) and PYREXIA (Fever of 100.4). At the time of the report, FEELING COLD (Cold), ASTHENIA (Weak), PAIN IN EXTREMITY (Arm is sore), VACCINATION SITE ERYTHEMA (Bright red at the injection site), FATIGUE (Feeling really tired), CHILLS (Chills), NAUSEA (Little bit nauseated, feels very queezy) and PYREXIA (Fever of 100.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 100.4 (Inconclusive) 100.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Vaccination site erythema
Clinical narrative: Cold; Weak; Feeling really tired; Chills; Little bit nauseated, feels very queezy; Fever of 100.4; Arm is sore; Bright red at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING COLD (Cold), ASTHENIA (Weak), PAIN IN EXTREMITY (Arm is sore), VACCINATION SITE ERYTHEMA (Bright red at the injection site) and FATIGUE (Feeling really tired) in a 71-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.     Concomitant products included VERAPAMIL, AMITRIPTYLINE and VITAMINS NOS for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore) and VACCINATION SITE ERYTHEMA (Bright red at the injection site). On 03-Feb-2021, the patient experienced FEELING COLD (Cold), ASTHENIA (Weak), FATIGUE (Feeling really tired), CHILLS (Chills), NAUSEA (Little bit nauseated, feels very queezy) and PYREXIA (Fever of 100.4). At the time of the report, FEELING COLD (Cold), ASTHENIA (Weak), PAIN IN EXTREMITY (Arm is sore), VACCINATION SITE ERYTHEMA (Bright red at the injection site), FATIGUE (Feeling really tired), CHILLS (Chills), NAUSEA (Little bit nauseated, feels very queezy) and PYREXIA (Fever of 100.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 100.4 (Inconclusive) 100.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; A spontaneous report was received from a Consumer concerning a 81-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot batch: 041LZ019) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced chills.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 3 Feb, the outcome of events, chills, was not reported.; Reporter'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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Headache, Pain, Swelling
Clinical narrative: Bruising at the injection site; Pain; Swelling; Tenderness in the left arm; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SWELLING (Swelling), TENDERNESS (Tenderness in the left arm), HEADACHE (Headache) and FATIGUE (Fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN (Pain), SWELLING (Swelling), TENDERNESS (Tenderness in the left arm), HEADACHE (Headache) and FATIGUE (Fatigue). On 01-Feb-2021, the patient experienced CONTUSION (Bruising at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Pain), SWELLING (Swelling), TENDERNESS (Tenderness in the left arm), HEADACHE (Headache), FATIGUE (Fatigue) and CONTUSION (Bruising at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Bruising at the injection site; Pain; Swelling; Tenderness in the left arm; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SWELLING (Swelling), TENDERNESS (Tenderness in the left arm), HEADACHE (Headache) and FATIGUE (Fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN (Pain), SWELLING (Swelling), TENDERNESS (Tenderness in the left arm), HEADACHE (Headache) and FATIGUE (Fatigue). On 01-Feb-2021, the patient experienced CONTUSION (Bruising at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Pain), SWELLING (Swelling), TENDERNESS (Tenderness in the left arm), HEADACHE (Headache), FATIGUE (Fatigue) and CONTUSION (Bruising at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Reporter did not allow further contact
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Peripheral swelling
Clinical narrative: Possible headache; Arm of injection swollen; Heartbeat; Fatigue; A spontaneous report was received from a consumer concerning a 42-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, peripheral swelling, heart rate increased, and fatigue.  The patient's medical history, was not provided. No Concomitant medications were reported .  On 20 Jan 2021,wednesday, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030620A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 27 Jan 2021 morning, patient experienced swelling on his left shoulder. Also patient reported that he experienced headache ,heartbeat and fatigue after the vaccination.  The treatment for the events was reported as Tylenol 2.  Action taken with mRNA-1273 in response to the events was unknown.  All the events were reported as resolving.; 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. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction to the Moderna vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to the Moderna vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to the Moderna vaccination). At the time of the report, VACCINATION COMPLICATION (Reaction to the Moderna vaccination) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a pharmacist and describes the occurrence of TINNITUS (Tinnitus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) 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.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Gait disturbance, Headache
Clinical narrative: Tenderness in the arm; sore arm; Weakness; Tiredness; Headache; chills; 24 hours later, I could not walk without assistance; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness in the arm), GAIT DISTURBANCE (24 hours later, I could not walk without assistance), PAIN IN EXTREMITY (sore arm), ASTHENIA (Weakness) and FATIGUE (Tiredness) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seizures since 1991 and Type 2 diabetes mellitus since 1995. Concomitant products included VALPROATE SEMISODIUM (DIVALPROEX) for Seizures, METFORMIN for Type 2 diabetes mellitus, PHENYTOIN (DILANTIN [PHENYTOIN]) and COLECALCIFEROL (VIT D3) for an unknown indication.   On 30-Dec-2020 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021 at 3:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced GAIT DISTURBANCE (24 hours later, I could not walk without assistance) and CHILLS (chills). On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ASTHENIA (Weakness), FATIGUE (Tiredness) and HEADACHE (Headache). On an unknown date, the patient experienced TENDERNESS (Tenderness in the arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Claritin at an unspecified dose and frequency. On 29-Jan-2021, TENDERNESS (Tenderness in the arm), GAIT DISTURBANCE (24 hours later, I could not walk without assistance), PAIN IN EXTREMITY (sore arm), ASTHENIA (Weakness), FATIGUE (Tiredness) and HEADACHE (Headache) had resolved. On 30-Jan-2021, CHILLS (chills) had resolved.            This case was linked to MOD-2021-004598 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Additional information was received and captured reporter details, medical history, patient details, concomitant medications and event.; 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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Tenderness in the arm; sore arm; Weakness; Tiredness; Headache; chills; 24 hours later, I could not walk without assistance; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness in the arm), GAIT DISTURBANCE (24 hours later, I could not walk without assistance), PAIN IN EXTREMITY (sore arm), ASTHENIA (Weakness) and FATIGUE (Tiredness) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seizures since 1991 and Type 2 diabetes mellitus since 1995. Concomitant products included VALPROATE SEMISODIUM (DIVALPROEX) for Seizures, METFORMIN for Type 2 diabetes mellitus, PHENYTOIN (DILANTIN [PHENYTOIN]) and COLECALCIFEROL (VIT D3) for an unknown indication.   On 30-Dec-2020 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021 at 3:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced GAIT DISTURBANCE (24 hours later, I could not walk without assistance) and CHILLS (chills). On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ASTHENIA (Weakness), FATIGUE (Tiredness) and HEADACHE (Headache). On an unknown date, the patient experienced TENDERNESS (Tenderness in the arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Claritin at an unspecified dose and frequency. On 29-Jan-2021, TENDERNESS (Tenderness in the arm), GAIT DISTURBANCE (24 hours later, I could not walk without assistance), PAIN IN EXTREMITY (sore arm), ASTHENIA (Weakness), FATIGUE (Tiredness) and HEADACHE (Headache) had resolved. On 30-Jan-2021, CHILLS (chills) had resolved.            This case was linked to MOD-2021-004598 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Additional information was received and captured reporter details, medical history, patient details, concomitant medications and event.; 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: M
Vaccine: COVID19
Symptoms: Swelling, Testicular pain
Clinical narrative: Painful  testicle; Swelling of testicle; A spontaneous report was received from a Consumer concerning of an unknown age, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events painful (Testicular pain) and swelling of the testicle (Testicular Swelling).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (Lot batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On the same day, the patient experienced the events painful and swelling of the testicle. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events,  painful, swelling of the testicle, was not reported.; 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate increased, Paraesthesia, Tachycardia
Clinical narrative: Heart rate increased; Flushing on face; Tingling from face to thighs; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart rate increased), FLUSHING (Flushing on face) and PARAESTHESIA (Tingling from face to thighs) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Heart rate increased), FLUSHING (Flushing on face) and PARAESTHESIA (Tingling from face to thighs). At the time of the report, TACHYCARDIA (Heart rate increased), FLUSHING (Flushing on face) and PARAESTHESIA (Tingling from face to thighs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Heart rate increased: increased High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient did not use any treatment medications.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-018077 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Rash at the injection site red circular thing; Arm itching; Soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in the arm), VACCINATION SITE RASH (Rash at the injection site red circular thing) and VACCINATION SITE PRURITUS (Arm itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness in the arm). On 02-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site red circular thing) and VACCINATION SITE PRURITUS (Arm itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Soreness in the arm) had resolved and VACCINATION SITE RASH (Rash at the injection site red circular thing) and VACCINATION SITE PRURITUS (Arm itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.   Treatment details included Benadryl.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site pain
Clinical narrative: arm was in pain; some areas of redness on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was in pain) and ERYTHEMA (some areas of redness on arm) in a 76-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 medical history reported.).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm was in pain) and ERYTHEMA (some areas of redness on arm). At the time of the report, VACCINATION SITE PAIN (arm was in pain) and ERYTHEMA (some areas of redness on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. vaccination site pain and vaccination site erythema are consistent with the product safety profile
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Limb injury, Lymphadenopathy
Clinical narrative: Arm hurt; Night sweats; Loss of appetite; Swollen lymph node on the left side of the neck; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (Arm hurt), NIGHT SWEATS (Night sweats), DECREASED APPETITE (Loss of appetite), LYMPHADENOPATHY (Swollen lymph node on the left side of the neck) and FATIGUE (Fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 medical history was reported.).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced LIMB INJURY (Arm hurt), NIGHT SWEATS (Night sweats), DECREASED APPETITE (Loss of appetite), LYMPHADENOPATHY (Swollen lymph node on the left side of the neck), FATIGUE (Fatigue) and HEADACHE (Headache). On 23-Jan-2021, LIMB INJURY (Arm hurt), NIGHT SWEATS (Night sweats), DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph node on the left side of the neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. Headache, fatigue and lymphadenopathy are consistent with the product safety profile.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Arm hurt; Night sweats; Loss of appetite; Swollen lymph node on the left side of the neck; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (Arm hurt), NIGHT SWEATS (Night sweats), DECREASED APPETITE (Loss of appetite), LYMPHADENOPATHY (Swollen lymph node on the left side of the neck) and FATIGUE (Fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 medical history was reported.).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced LIMB INJURY (Arm hurt), NIGHT SWEATS (Night sweats), DECREASED APPETITE (Loss of appetite), LYMPHADENOPATHY (Swollen lymph node on the left side of the neck), FATIGUE (Fatigue) and HEADACHE (Headache). On 23-Jan-2021, LIMB INJURY (Arm hurt), NIGHT SWEATS (Night sweats), DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph node on the left side of the neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. Headache, fatigue and lymphadenopathy are consistent with the product safety profile.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site extremely itchy; injection site red; injection site swollen (3-4.5in. diameter); sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), INJECTION SITE PRURITUS (injection site extremely itchy), INJECTION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site swollen (3-4.5in. diameter)) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 22-Jan-2021, the patient experienced INJECTION SITE PRURITUS (injection site extremely itchy), INJECTION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site swollen (3-4.5in. diameter)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 26-Jan-2021, INJECTION SITE PRURITUS (injection site extremely itchy), INJECTION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site swollen (3-4.5in. diameter)) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Influenza virus test, Myalgia
Clinical narrative: fever of 102 degrees Farenheit; sick by midnight; unable to lift left arm; left side of body hurt; really tired; bad chills; A spontaneous report was received from a consumer concerning a 33-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced being sick(illness), unable to lift left arm (vaccination site movement impairment), left side of body hurt (myalgia), bad chills(chills), really tired (fatigue) and fever (pyrexia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Patient reported that by midnight on 28-Jan-21, the day she received her vaccine, she was sick.  She stated that she could not lift her left arm, that her left side hurt, she had chills and felt really tired.  She reported going to the emergency room (ER) on what would have been 29-Jan-2021 where flu and covid-19 tests were administered; the Covid-19 test was positive.  No results were provided for the flu test. She reported again having chills on 29-Jan-2021 and a fever of 102 degrees Farenheit on 30-Jan-21.  She reported that the fever went down with paracetamol but then went up again.  On 31-Jan-2021, she returned to the ER. She stated that she had been home from work for 14 days.   Treatment included paracetamol, steroids and a Z-Pak.  Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events, sick (illness), unable to lift left arm (vaccination site movement impairment), left side of body hurt (myalgia), bad chills (chills), really tired (fatigue) and fever (pyrexia), were considered unknown.; Reporter'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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination site movement impairment
Clinical narrative: fever of 102 degrees Farenheit; sick by midnight; unable to lift left arm; left side of body hurt; really tired; bad chills; A spontaneous report was received from a consumer concerning a 33-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced being sick(illness), unable to lift left arm (vaccination site movement impairment), left side of body hurt (myalgia), bad chills(chills), really tired (fatigue) and fever (pyrexia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Patient reported that by midnight on 28-Jan-21, the day she received her vaccine, she was sick.  She stated that she could not lift her left arm, that her left side hurt, she had chills and felt really tired.  She reported going to the emergency room (ER) on what would have been 29-Jan-2021 where flu and covid-19 tests were administered; the Covid-19 test was positive.  No results were provided for the flu test. She reported again having chills on 29-Jan-2021 and a fever of 102 degrees Farenheit on 30-Jan-21.  She reported that the fever went down with paracetamol but then went up again.  On 31-Jan-2021, she returned to the ER. She stated that she had been home from work for 14 days.   Treatment included paracetamol, steroids and a Z-Pak.  Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events, sick (illness), unable to lift left arm (vaccination site movement impairment), left side of body hurt (myalgia), bad chills (chills), really tired (fatigue) and fever (pyrexia), were considered unknown.; Reporter'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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oral herpes, Parosmia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Congestion; Fever blister on her lip; Had more sensitivity to odors "like if her sinuses were wide open"; At the injection site a redness appeared that started to spread and that was also tender; At the injection site a redness appeared that started to spread and that was also tender; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion), ORAL HERPES (Fever blister on her lip), HYPERSENSITIVITY (Had more sensitivity to odors "like if her sinuses were wide open") and VACCINATION SITE ERYTHEMA (At the injection site a redness appeared that started to spread and that was also tender) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025l20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), CYANOCOBALAMIN (VIT B 12), ASCORBIC ACID (VIT C), CALCIUM and SIMVASTATIN for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (At the injection site a redness appeared that started to spread and that was also tender). On 20-Jan-2021, the patient experienced NASAL CONGESTION (Congestion), ORAL HERPES (Fever blister on her lip) and HYPERSENSITIVITY (Had more sensitivity to odors "like if her sinuses were wide open"). On 22-Jan-2021, ORAL HERPES (Fever blister on her lip) and VACCINATION SITE ERYTHEMA (At the injection site a redness appeared that started to spread and that was also tender) had resolved. On 25-Jan-2021, HYPERSENSITIVITY (Had more sensitivity to odors "like if her sinuses were wide open") had resolved. On 02-Feb-2021, NASAL CONGESTION (Congestion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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.; 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Arm pain; Very itchy; red spot for a week of the size of a cuarter and increased to a sober dollar; swollen and size of a baseball; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), VACCINATION SITE PRURITUS (Very itchy), VACCINATION SITE ERYTHEMA (red spot for a week of the size of a cuarter and increased to a sober dollar) and VACCINATION SITE SWELLING (swollen and size of a baseball) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, ATROPA BELLADONNA EXTRACT, HYOSCYAMUS NIGER DRY EXTRACT, PHENOBARBITAL (HYOPHEN [ATROPA BELLADONNA EXTRACT;HYOSCYAMUS NIGER DRY EXTRACT;PHENOBARBITAL]) and VITAMINS NOS for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), VACCINATION SITE PRURITUS (Very itchy), VACCINATION SITE ERYTHEMA (red spot for a week of the size of a cuarter and increased to a sober dollar) and VACCINATION SITE SWELLING (swollen and size of a baseball). On 28-Jan-2021, PAIN IN EXTREMITY (Arm pain) had resolved. On 01-Feb-2021, VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE SWELLING (swollen and size of a baseball) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red spot for a week of the size of a cuarter and increased to a sober dollar) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: No New information added On 22-Jun-2021: All event outcomes now recovered.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: no taste; no smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (no taste) and ANOSMIA (no smell) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included RANOLAZINE (RANEXA), LISINOPRIL, ATORVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced AGEUSIA (no taste) and ANOSMIA (no smell). At the time of the report, AGEUSIA (no taste) and ANOSMIA (no smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines not included  Concomitant medicines include Ranolazine, Lisinopril, Blood thinner, Atorvastatin, Baby aspirin Action taken with mRNA-1273 in response to the event was unknown; 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