chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Dry mouth; Diarrhea; Sleepy; Joint aches and pain; Headache; joint aches and pain; A spontaneous report (United States) was received from a consumer concerning a 44-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dry mouth, diarrhea, sleepy, joint aches and pain, headache.  The patient's medical history was not provided. Concomitant medications reported were laxatives for drug use for unknown indication.  On 13 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the events dry mouth,diarrhea, sleepy, joint aches and pain, headache. Consent given to follow up No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 16 Feb 2021 the outcome of events, joint aches and pain was resolved. The outcome of events, dry mouth, diarrhea, sleepy, headache were unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on her arm; This spontaneous case was reported by a nurse and describes the occurrence of RASH (Rash on her arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced RASH (Rash on her arm). At the time of the report, RASH (Rash on her arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Updated the outcome of event Rash(from not recovered to recovered).Declined further followup.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Diarrhoea, Dizziness, Headache, Hypertension
Clinical narrative: Diarrhea; Dizziness; High blood pressure; Headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), HYPERTENSION (High blood pressure) and HEADACHE (Headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Kidney disorder. Concomitant products included CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), HYPERTENSION (High blood pressure) and HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), HYPERTENSION (High blood pressure) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Blood pressure measurement: 119/117 (Inconclusive) Hypertension (high blood pressure).     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 medications also included: Blood pressure medication.  Treatment information also included: Blood pressure medication.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional information received: Patient had declined further follow-up.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: Felt flu-ish but no fever; General malaise / Felt crappy for the first 24 hours; A spontaneous report was received from a consumer concerning a 74-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, felt flu-ish but no fever / influenza like illness, general malaise and felt crappy for the first 24 hours / malaise.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 17 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the events, felt crappy for the first 24 hours, felt flu-ish but no fever and general malaise.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 18 Feb 2021, the outcome of events, felt crappy for the first 24 hours, felt flu-ish but no fever and general malaise was resolved.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Injection site pain, Lymphadenopathy
Clinical narrative: Swelling in Lymph Nodes; Pain at Injection Site; Dry mouth sensation; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth sensation), DIZZINESS (Dizzy), LYMPHADENOPATHY (Swelling in Lymph Nodes) and INJECTION SITE PAIN (Pain at Injection Site) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Immune disorder (NOS).   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced DRY MOUTH (Dry mouth sensation), DIZZINESS (Dizzy) and INJECTION SITE PAIN (Pain at Injection Site). On 17-Feb-2021, the patient experienced LYMPHADENOPATHY (Swelling in Lymph Nodes). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, DRY MOUTH (Dry mouth sensation), DIZZINESS (Dizzy), LYMPHADENOPATHY (Swelling in Lymph Nodes) and INJECTION SITE PAIN (Pain at Injection Site) outcome was unknown.            No concomitant medications were provided by the reporter.   Patient also used ice pack to treat the events.   This case was linked to MOD-2021-015805 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchiness at the injection site; Redness that is increasing at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness that is increasing at the injection site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness that is increasing at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness that is increasing at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included Vaseline.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Nausea, Pain
Clinical narrative: No appetite; Achy body; Nausea; chills; little headache; Fever; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (No appetite), PAIN (Achy body), NAUSEA (Nausea) and CHILLS (chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Achy body), NAUSEA (Nausea), CHILLS (chills), HEADACHE (little headache) and PYREXIA (Fever). On 15-Feb-2021, the patient experienced DECREASED APPETITE (No appetite). On 16-Feb-2021, PAIN IN EXTREMITY (Sore arm), PAIN (Achy body), NAUSEA (Nausea), CHILLS (chills), HEADACHE (little headache) and PYREXIA (Fever) had resolved and DECREASED APPETITE (No appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Patient took an unspecified migraine medication for the treatment of the events.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Reporter e-mail added.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: No appetite; Achy body; Nausea; chills; little headache; Fever; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (No appetite), PAIN (Achy body), NAUSEA (Nausea) and CHILLS (chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Achy body), NAUSEA (Nausea), CHILLS (chills), HEADACHE (little headache) and PYREXIA (Fever). On 15-Feb-2021, the patient experienced DECREASED APPETITE (No appetite). On 16-Feb-2021, PAIN IN EXTREMITY (Sore arm), PAIN (Achy body), NAUSEA (Nausea), CHILLS (chills), HEADACHE (little headache) and PYREXIA (Fever) had resolved and DECREASED APPETITE (No appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Patient took an unspecified migraine medication for the treatment of the events.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Reporter e-mail added.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 36-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 27-Jun-2018.    On 18-Feb-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 an unknown date and the estimated date of delivery was 09-Oct-2021. On 18-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On 18-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: Internal review on 19JUL2021 resulted in updates to pregnancy details.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Peripheral swelling, Pyrexia
Clinical narrative: left arm is swollen; low grade fever of 101.2F; A spontaneous report was received from a consumer concerning a 71-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left arm is swollen, low grade fever of 101.2f.  The patient's medical history was not provided. Concomitant medications reported were high cholesterol meds, hypertension meds, sickle cell disease meds for drug use for unknown indication.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the event(s) left arm is swollen, low grade fever of 101.2f. Safety to follow up given.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, left arm is swollen, low grade fever of 101, 2f was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm on injection site; swollen on injection site; Area is the size of a mosquito bite; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm on injection site), VACCINATION SITE SWELLING (swollen on injection site) and SWELLING (Area is the size of a mosquito bite) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm on injection site), VACCINATION SITE SWELLING (swollen on injection site) and SWELLING (Area is the size of a mosquito bite). At the time of the report, VACCINATION SITE WARMTH (Warm on injection site), VACCINATION SITE SWELLING (swollen on injection site) and SWELLING (Area is the size of a mosquito bite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Tremor
Clinical narrative: severe shaking; chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (severe shaking), CHILLS (chills) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced CHILLS (chills) and HEADACHE (Headache). On 17-Feb-2021, the patient experienced TREMOR (severe shaking). At the time of the report, TREMOR (severe shaking), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details included lorazepam, acetaminophen and dexamethasone.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Pain, Pruritus
Clinical narrative: Pretty strong itching from my waist down; Body aches; Tingling where I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Pretty strong itching from my waist down), INJECTION SITE PARAESTHESIA (Tingling where I got the shot) and PAIN (Body aches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Dry skin.    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 INJECTION SITE PARAESTHESIA (Tingling where I got the shot). On 03-Feb-2021, the patient experienced PAIN (Body aches). On 05-Feb-2021, the patient experienced PRURITUS (Pretty strong itching from my waist down). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for General body pain, at a dose of UNK dosage form. On 04-Feb-2021, PAIN (Body aches) had resolved. On 08-Feb-2021, PRURITUS (Pretty strong itching from my waist down) had resolved. At the time of the report, INJECTION SITE PARAESTHESIA (Tingling where I got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Patient used an unspecified lotion to treat itching.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Night sweats
Clinical narrative: night sweats; Light headache; dizziness; loss of appetite; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Light headache), DIZZINESS (dizziness), DECREASED APPETITE (loss of appetite), FATIGUE (tiredness) and NIGHT SWEATS (night sweats) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (Light headache), DIZZINESS (dizziness), DECREASED APPETITE (loss of appetite) and FATIGUE (tiredness). On 15-Feb-2021, the patient experienced NIGHT SWEATS (night sweats). On 17-Feb-2021, NIGHT SWEATS (night sweats) had resolved. At the time of the report, HEADACHE (Light headache), DIZZINESS (dizziness), DECREASED APPETITE (loss of appetite) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.    Treatment for the event included Tylenol.    This case was linked to US-MODERNATX, INC.-MOD-2021-016096 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-016096:same reporter, different patient
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Hyperglycaemia
Clinical narrative: Elevated glucose numbers around 210; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERGLYCAEMIA (Elevated glucose numbers around 210) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced HYPERGLYCAEMIA (Elevated glucose numbers around 210). At the time of the report, HYPERGLYCAEMIA (Elevated glucose numbers around 210) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Blood glucose increased: 210 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nasopharyngitis, Pruritus
Clinical narrative: Itchy in her head; chills; Fatigue; Cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (Cold), PRURITUS (Itchy in her head), CHILLS (chills) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Psoriasis. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, OMEPRAZOLE and CLONAZEPAM for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold), CHILLS (chills) and FATIGUE (Fatigue). On an unknown date, the patient experienced PRURITUS (Itchy in her head). At the time of the report, NASOPHARYNGITIS (Cold), PRURITUS (Itchy in her head), CHILLS (chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was include acetaminophen and her doctor prescribed Benadryl for the itch (she has not used it yet).   Reporter did not allow further contact
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Chills; 100F Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (100F Fever) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023m20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced CHILLS (Chills) and PYREXIA (100F Fever). On 18-Feb-2021, CHILLS (Chills) had resolved. At the time of the report, PYREXIA (100F Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 100 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue, Headache
Clinical narrative: Bad headache; Washed out; Temperature of 99 degrees; A spontaneous report was received from a consumer, concerning a 82-years-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced bad headache, temperature of 99 degrees and washed out.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 17 Feb 2021, the patient received first of two planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection in left arm.  On 17 Feb 2021, after vaccination, the patient experienced symptoms of bad headache, temperature of 99 degrees and patient was washed out.  Action taken with mRNA-1273 in response to the events were unknown.   The outcome of the event's bad headache, temperature of 99 degrees and washed out were considered unknown at the time of this report.; 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.; Sender's Comments: 24 Feb 2021 (Pallavi Parab): The event body temperature increased was kept as listed since the temperature reached to 99 degree Celsius (kindly reassess).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Vaccination site rash
Clinical narrative: red dots around the injection site, and on the 15th it; arm pain; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), NECK PAIN (Neck pain) and VACCINATION SITE RASH (red dots around the injection site, and on the 15th it) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m201a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event).    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and NECK PAIN (Neck pain). On 13-Feb-2021, the patient experienced VACCINATION SITE RASH (red dots around the injection site, and on the 15th it). At the time of the report, PAIN IN EXTREMITY (arm pain), NECK PAIN (Neck pain) and VACCINATION SITE RASH (red dots around the injection site, and on the 15th it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history  and relevant concomitant medications weren't reported.  Treatment information was not provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: headache of all headache; Chills; Fever; A spontaneous report was received concerning a 84 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced head ache, chills and fever.  The patient's medical history included Covid-19. No relevant concomitant medications were reported.   On 15 Feb 2021, around 3pm, the patient received their first of two planned doses of mRNA-1273 (Lot: number:031M20A) intramuscularly on the left arm for prophylaxis of COVID-19 infection.  .  On 16 Feb 2021, the next day, the patient woke up with a "headache of all headaches", chills and fever. The patient took paracetamol in the morning. Five to six hours later he took ibuprofen and waited until 6pm to take more paracetamol and ibuprofen. He stated that his headache was so bad he was unable to do anything.   On 17 Feb 2021, the patient stated that the "head was better".   The outcome of the event headache was resolved.  The outcome of the events, chills and fever, were 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: More swollen today at injection site; Warm to the touch at injection site; Slightly swollen at injection site; Arm hard; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Arm hard), PAIN IN EXTREMITY (Sore arm), INJECTION SITE WARMTH (Warm to the touch at injection site), INJECTION SITE SWELLING (Slightly swollen at injection site) and INJECTION SITE SWELLING (More swollen today at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN, CHOLESTEROL and VITAMIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INDURATION (Arm hard) and PAIN IN EXTREMITY (Sore arm). On 11-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch at injection site) and INJECTION SITE SWELLING (Slightly swollen at injection site). On 18-Feb-2021, the patient experienced INJECTION SITE SWELLING (More swollen today at injection site). At the time of the report, INDURATION (Arm hard), PAIN IN EXTREMITY (Sore arm), INJECTION SITE WARMTH (Warm to the touch at injection site), INJECTION SITE SWELLING (Slightly swollen at injection site) and INJECTION SITE SWELLING (More swollen today at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Myalgia, Paraesthesia, Pruritus
Clinical narrative: Burning feeling in the hands and feet; itchy but no rash; full body itch; Pins and needles; joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pins and needles), PRURITUS (itchy but no rash; full body itch), BURNING SENSATION (Burning feeling in the hands and feet), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anaphylactic reaction to venom (Patient has anaphylactic reaction to venom or anything that stings.).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 30-Jan-2021, the patient experienced PARAESTHESIA (Pins and needles). On 02-Feb-2021, the patient experienced PRURITUS (itchy but no rash; full body itch). On 05-Feb-2021, the patient experienced BURNING SENSATION (Burning feeling in the hands and feet). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PARAESTHESIA (Pins and needles), PRURITUS (itchy but no rash; full body itch), BURNING SENSATION (Burning feeling in the hands and feet), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) 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 reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Arthralgia and myalgia are consistent with the product safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Pain in extremity
Clinical narrative: Arm a little sore; Rash at the injection site; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm a little sore), INJECTION SITE RASH (Rash at the injection site) and INJECTION SITE PAIN (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042LWA and 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE PAIN (sore arm). On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm a little sore) and INJECTION SITE RASH (Rash at the injection site). On 23-Jan-2021, INJECTION SITE PAIN (sore arm) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm a little sore) and INJECTION SITE RASH (Rash at the injection site) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Infection, Rash
Clinical narrative: infection; Red Rash on the upper chest; This spontaneous case was reported by a pharmacist and describes the occurrence of INFECTION (infection) and RASH (Red Rash on the upper chest) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced INFECTION (infection) and RASH (Red Rash on the upper chest). At the time of the report, INFECTION (infection) and RASH (Red Rash on the upper chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications are not provided by the reporter. No treatment drugs are not provided by reporter.; Sender's Comments: There is not enough information to assess the event of infection as the specific infection was not reported.  However, based on the known profile for mRNA1273, a causal relationship with infection is unlikely.  The event of rash is consistent with the product safety profile., however, causality cannot be established as treatment and onset dates are lacking.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Concomitant medications were not provided. The Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue and headache are consistent with the product safety profile.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Feeling cold
Clinical narrative: feeling cold; Weakness; Tired out; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold), ASTHENIA (Weakness), PYREXIA (Fever ), CHILLS ( Chills) and FATIGUE (Tired out) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (Fever ) and CHILLS ( Chills). On 19-Feb-2021, the patient experienced FEELING COLD (feeling cold), ASTHENIA (Weakness) and FATIGUE (Tired out). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at a dose of 1 dosage form. At the time of the report, FEELING COLD (feeling cold), ASTHENIA (Weakness) and FATIGUE (Tired out) outcome was unknown and PYREXIA (Fever ) and CHILLS ( Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 102 (Inconclusive) 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fever chills and fatigue are consistent with the product safety profile.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feeling cold; Weakness; Tired out; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold), ASTHENIA (Weakness), PYREXIA (Fever ), CHILLS ( Chills) and FATIGUE (Tired out) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (Fever ) and CHILLS ( Chills). On 19-Feb-2021, the patient experienced FEELING COLD (feeling cold), ASTHENIA (Weakness) and FATIGUE (Tired out). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at a dose of 1 dosage form. At the time of the report, FEELING COLD (feeling cold), ASTHENIA (Weakness) and FATIGUE (Tired out) outcome was unknown and PYREXIA (Fever ) and CHILLS ( Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 102 (Inconclusive) 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fever chills and fatigue are consistent with the product safety profile.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Exposure during pregnancy, Full blood count, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 32-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Asthma (well-managed, occasional rescue inhaler (1-2x/year)) in October 2004. Concurrent medical conditions included Depression (well-managed) since March 2014. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN SR) for Depression, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, CALCIUM for an unknown indication.   On 08-Jan-2021 at 5:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021 at 8:54 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 23-May-2020 and the estimated date of delivery was 27-Feb-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy. The delivery occurred  on 07-Mar-2021, which was reported as Full-term. For neonate 1, the birth weight was 3060 grams (6lbs 12oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Term Birth w/o Complications. At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jun-2020, Pregnancy test: posiitive (Positive) posiitive. On 13-Jul-2020, Full blood count: normal (normal) normal. On 07-Dec-2020, Blood glucose: normal (normal) normal and normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reports prior use of alcohol from 2006 to Jun-2020.   Lab data included Sequential Screen Aug 18 2020 and Sep 17 2020 - both normal  Anatomy Scan oct 12th 2020 - Normal  V struct test - Feb 04 2021 - Normal. GBS, PCR, Step B - 4-Feb-2021 - Normal   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Added patient's demographics, medical history, concomitant medications. Pregnancy outcome information was added. On 27-May-2021: Follow-up information received on 27-May-2021 contains non-significant information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Malaise, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Felt bad/felt lousy), PAIN IN EXTREMITY (Arm was killing me/Whole arm hurt), CONTUSION (Blue and bright red bruises on left arm), PERIPHERAL SWELLING (Really swollen) and MUSCULOSKELETAL STIFFNESS (Unable to turn neck on left side) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced MALAISE (Felt bad/felt lousy), PAIN IN EXTREMITY (Arm was killing me/Whole arm hurt), CONTUSION (Blue and bright red bruises on left arm), PERIPHERAL SWELLING (Really swollen), MUSCULOSKELETAL STIFFNESS (Unable to turn neck on left side) and HEADACHE (Back part of the head hurt). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (Felt bad/felt lousy), PAIN IN EXTREMITY (Arm was killing me/Whole arm hurt), CONTUSION (Blue and bright red bruises on left arm), PERIPHERAL SWELLING (Really swollen), MUSCULOSKELETAL STIFFNESS (Unable to turn neck on left side) and HEADACHE (Back part of the head hurt) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache is consistent with the product safety profile.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Felt bad/felt lousy), PAIN IN EXTREMITY (Arm was killing me/Whole arm hurt), CONTUSION (Blue and bright red bruises on left arm), PERIPHERAL SWELLING (Really swollen) and MUSCULOSKELETAL STIFFNESS (Unable to turn neck on left side) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced MALAISE (Felt bad/felt lousy), PAIN IN EXTREMITY (Arm was killing me/Whole arm hurt), CONTUSION (Blue and bright red bruises on left arm), PERIPHERAL SWELLING (Really swollen), MUSCULOSKELETAL STIFFNESS (Unable to turn neck on left side) and HEADACHE (Back part of the head hurt). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (Felt bad/felt lousy), PAIN IN EXTREMITY (Arm was killing me/Whole arm hurt), CONTUSION (Blue and bright red bruises on left arm), PERIPHERAL SWELLING (Really swollen), MUSCULOSKELETAL STIFFNESS (Unable to turn neck on left side) and HEADACHE (Back part of the head hurt) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache is consistent with the product safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Myalgia
Clinical narrative: dizziness; weakness; headache; muscle pain; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), HEADACHE (headache), MYALGIA (muscle pain) and CHILLS (chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Diabetes.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       N treatment and concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: dizziness; weakness; headache; muscle pain; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), HEADACHE (headache), MYALGIA (muscle pain) and CHILLS (chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Diabetes.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       N treatment and concomitant medications were reported.