chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Arm is still very inflammed; arm was red; arm was hot, still warm; arm was sore; Headache; Low grade fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is still very inflammed), ERYTHEMA (arm was red), VACCINATION SITE WARMTH (arm was hot, still warm), PAIN IN EXTREMITY (arm was sore) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The illness lasted for 2 weeks and she did not have any major symptoms from it) in November 2020 and Appendectomy (Emergency appendectomy) on 20-Jun-2021. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 23-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 PERIPHERAL SWELLING (Arm is still very inflammed), ERYTHEMA (arm was red), VACCINATION SITE WARMTH (arm was hot, still warm), PAIN IN EXTREMITY (arm was sore), HEADACHE (Headache), PYREXIA (Low grade fever) and FATIGUE (Fatigue). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm is still very inflammed), ERYTHEMA (arm was red) and VACCINATION SITE WARMTH (arm was hot, still warm) had not resolved and PAIN IN EXTREMITY (arm was sore), HEADACHE (Headache), PYREXIA (Low grade fever) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included  blood pressure medications and hormone replacement therapy.  Treatment information provided included application of ice on arm.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up received and added surgical procedure (emergency appendectomy) and updated reporter's contact information.; Sender's Comments: Based on the current available information which shows a strong temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded.  Headache, low grade fever and fatigue are consistent with the known safety profile of the mRNA-1273.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site warmth
Clinical narrative: Arm is still very inflammed; arm was red; arm was hot, still warm; arm was sore; Headache; Low grade fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is still very inflammed), ERYTHEMA (arm was red), VACCINATION SITE WARMTH (arm was hot, still warm), PAIN IN EXTREMITY (arm was sore) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The illness lasted for 2 weeks and she did not have any major symptoms from it) in November 2020 and Appendectomy (Emergency appendectomy) on 20-Jun-2021. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 23-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 PERIPHERAL SWELLING (Arm is still very inflammed), ERYTHEMA (arm was red), VACCINATION SITE WARMTH (arm was hot, still warm), PAIN IN EXTREMITY (arm was sore), HEADACHE (Headache), PYREXIA (Low grade fever) and FATIGUE (Fatigue). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm is still very inflammed), ERYTHEMA (arm was red) and VACCINATION SITE WARMTH (arm was hot, still warm) had not resolved and PAIN IN EXTREMITY (arm was sore), HEADACHE (Headache), PYREXIA (Low grade fever) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included  blood pressure medications and hormone replacement therapy.  Treatment information provided included application of ice on arm.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up received and added surgical procedure (emergency appendectomy) and updated reporter's contact information.; Sender's Comments: Based on the current available information which shows a strong temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded.  Headache, low grade fever and fatigue are consistent with the known safety profile of the mRNA-1273.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Myalgia, Pruritus, Throat irritation, Tongue pruritus
Clinical narrative: Itchy Sensation of Arm; Itchy Sensation of Throat; Itchy Sensation of Tongue; Wheezing; Rash - Near Injection Site; Aches; pains; A spontaneous report was received from a consumer concerning a 49-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itchy sensation of arm, itchy sensation of throat, itchy sensation of tongue, body aches, body pain, wheezing, rash - near injection site.  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 their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the events itchy sensation of arm. itchy sensation of throat, itchy sensation of tongue, body aches, body pain, wheezing, rash - near injection site. The patient sought professional guidance from her pharmacist.   Treatment included  diphenhydramine hydrochloride.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events include itchy sensation of arm, itchy sensation of throat, itchy sensation of tongue, body aches, body pain, wheezing, rash - near injection site was unknown/not reported.; Reporter's Comments: This case concerns a 49-year-old female who experienced NS unexpected events of pruritus, throat irritation, tongue pruritus, wheezing and NS expected events of injection site rash, myalgia.  The events occurred the same day as the first dose of mRNA-1273. Treatment included diphenhydramine. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Itchy Sensation of Arm; Itchy Sensation of Throat; Itchy Sensation of Tongue; Wheezing; Rash - Near Injection Site; Aches; pains; A spontaneous report was received from a consumer concerning a 49-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itchy sensation of arm, itchy sensation of throat, itchy sensation of tongue, body aches, body pain, wheezing, rash - near injection site.  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 their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the events itchy sensation of arm. itchy sensation of throat, itchy sensation of tongue, body aches, body pain, wheezing, rash - near injection site. The patient sought professional guidance from her pharmacist.   Treatment included  diphenhydramine hydrochloride.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events include itchy sensation of arm, itchy sensation of throat, itchy sensation of tongue, body aches, body pain, wheezing, rash - near injection site was unknown/not reported.; Reporter's Comments: This case concerns a 49-year-old female who experienced NS unexpected events of pruritus, throat irritation, tongue pruritus, wheezing and NS expected events of injection site rash, myalgia.  The events occurred the same day as the first dose of mRNA-1273. Treatment included diphenhydramine. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Back pain, Chills, Decreased appetite, Fatigue
Clinical narrative: injection site pain; nasty headache now; body pain; Nausea; fever; shakes; fatigue; her upper right arm started hurting bad; sore legs; no smell; back pain; sore throat; she has no appetite; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her upper right arm started hurting bad), PAIN IN EXTREMITY (sore legs), ANOSMIA (no smell), BACK PAIN (back pain) and OROPHARYNGEAL PAIN (sore throat) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She had COVID on 18 Dec 2020 and recovered in 3 weeks.) on 18-Dec-2020. Concurrent medical conditions included Asthma on 01-Nov-2007 and Allergies (Iodine,  Shellfish).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (her upper right arm started hurting bad), PAIN IN EXTREMITY (sore legs), ANOSMIA (no smell), BACK PAIN (back pain), OROPHARYNGEAL PAIN (sore throat), DECREASED APPETITE (she has no appetite), NAUSEA (Nausea), PYREXIA (fever), CHILLS (shakes) and FATIGUE (fatigue). On 27-Jan-2021 at 8:30 AM, the patient experienced PAIN (body pain). On 28-Jan-2021, the patient experienced HEADACHE (nasty headache now). On 29-Jan-2021 at 5:30 AM, the patient experienced INJECTION SITE PAIN (injection site pain). At the time of the report, PAIN IN EXTREMITY (her upper right arm started hurting bad), PAIN IN EXTREMITY (sore legs), ANOSMIA (no smell), BACK PAIN (back pain), OROPHARYNGEAL PAIN (sore throat), DECREASED APPETITE (she has no appetite), PAIN (body pain), NAUSEA (Nausea), PYREXIA (fever), CHILLS (shakes), FATIGUE (fatigue), HEADACHE (nasty headache now) and INJECTION SITE PAIN (injection site pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Pyrexia: 100.9 °F (High) ranged from 100.9F - 101.3 F. On 29-Jan-2021, Pyrexia: 99 °F High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications include Tylenol with codeine and 1 tablet Flexeril muscle relaxant and hydration.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Nausea, Oropharyngeal pain, Pain
Clinical narrative: injection site pain; nasty headache now; body pain; Nausea; fever; shakes; fatigue; her upper right arm started hurting bad; sore legs; no smell; back pain; sore throat; she has no appetite; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her upper right arm started hurting bad), PAIN IN EXTREMITY (sore legs), ANOSMIA (no smell), BACK PAIN (back pain) and OROPHARYNGEAL PAIN (sore throat) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She had COVID on 18 Dec 2020 and recovered in 3 weeks.) on 18-Dec-2020. Concurrent medical conditions included Asthma on 01-Nov-2007 and Allergies (Iodine,  Shellfish).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (her upper right arm started hurting bad), PAIN IN EXTREMITY (sore legs), ANOSMIA (no smell), BACK PAIN (back pain), OROPHARYNGEAL PAIN (sore throat), DECREASED APPETITE (she has no appetite), NAUSEA (Nausea), PYREXIA (fever), CHILLS (shakes) and FATIGUE (fatigue). On 27-Jan-2021 at 8:30 AM, the patient experienced PAIN (body pain). On 28-Jan-2021, the patient experienced HEADACHE (nasty headache now). On 29-Jan-2021 at 5:30 AM, the patient experienced INJECTION SITE PAIN (injection site pain). At the time of the report, PAIN IN EXTREMITY (her upper right arm started hurting bad), PAIN IN EXTREMITY (sore legs), ANOSMIA (no smell), BACK PAIN (back pain), OROPHARYNGEAL PAIN (sore throat), DECREASED APPETITE (she has no appetite), PAIN (body pain), NAUSEA (Nausea), PYREXIA (fever), CHILLS (shakes), FATIGUE (fatigue), HEADACHE (nasty headache now) and INJECTION SITE PAIN (injection site pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Pyrexia: 100.9 °F (High) ranged from 100.9F - 101.3 F. On 29-Jan-2021, Pyrexia: 99 °F High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications include Tylenol with codeine and 1 tablet Flexeril muscle relaxant and hydration.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: injection site pain; nasty headache now; body pain; Nausea; fever; shakes; fatigue; her upper right arm started hurting bad; sore legs; no smell; back pain; sore throat; she has no appetite; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her upper right arm started hurting bad), PAIN IN EXTREMITY (sore legs), ANOSMIA (no smell), BACK PAIN (back pain) and OROPHARYNGEAL PAIN (sore throat) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She had COVID on 18 Dec 2020 and recovered in 3 weeks.) on 18-Dec-2020. Concurrent medical conditions included Asthma on 01-Nov-2007 and Allergies (Iodine,  Shellfish).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (her upper right arm started hurting bad), PAIN IN EXTREMITY (sore legs), ANOSMIA (no smell), BACK PAIN (back pain), OROPHARYNGEAL PAIN (sore throat), DECREASED APPETITE (she has no appetite), NAUSEA (Nausea), PYREXIA (fever), CHILLS (shakes) and FATIGUE (fatigue). On 27-Jan-2021 at 8:30 AM, the patient experienced PAIN (body pain). On 28-Jan-2021, the patient experienced HEADACHE (nasty headache now). On 29-Jan-2021 at 5:30 AM, the patient experienced INJECTION SITE PAIN (injection site pain). At the time of the report, PAIN IN EXTREMITY (her upper right arm started hurting bad), PAIN IN EXTREMITY (sore legs), ANOSMIA (no smell), BACK PAIN (back pain), OROPHARYNGEAL PAIN (sore throat), DECREASED APPETITE (she has no appetite), PAIN (body pain), NAUSEA (Nausea), PYREXIA (fever), CHILLS (shakes), FATIGUE (fatigue), HEADACHE (nasty headache now) and INJECTION SITE PAIN (injection site pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Pyrexia: 100.9 °F (High) ranged from 100.9F - 101.3 F. On 29-Jan-2021, Pyrexia: 99 °F High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications include Tylenol with codeine and 1 tablet Flexeril muscle relaxant and hydration.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Eating disorder, Hypokinesia, Nasal discomfort
Clinical narrative: vomiting; sore ears; overnight chills; nose burning; difficulty getting out of bed; difficulty eating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VOMITING (vomiting), EAR PAIN (sore ears), CHILLS (overnight chills), NASAL DISCOMFORT (nose burning) and HYPOKINESIA (difficulty getting out of bed) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting), EAR PAIN (sore ears), CHILLS (overnight chills), NASAL DISCOMFORT (nose burning), HYPOKINESIA (difficulty getting out of bed) and EATING DISORDER (difficulty eating). At the time of the report, VOMITING (vomiting), EAR PAIN (sore ears), CHILLS (overnight chills), NASAL DISCOMFORT (nose burning), HYPOKINESIA (difficulty getting out of bed) and EATING DISORDER (difficulty eating) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-MAY-2021 and contains NNI.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; sore ears; overnight chills; nose burning; difficulty getting out of bed; difficulty eating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VOMITING (vomiting), EAR PAIN (sore ears), CHILLS (overnight chills), NASAL DISCOMFORT (nose burning) and HYPOKINESIA (difficulty getting out of bed) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting), EAR PAIN (sore ears), CHILLS (overnight chills), NASAL DISCOMFORT (nose burning), HYPOKINESIA (difficulty getting out of bed) and EATING DISORDER (difficulty eating). At the time of the report, VOMITING (vomiting), EAR PAIN (sore ears), CHILLS (overnight chills), NASAL DISCOMFORT (nose burning), HYPOKINESIA (difficulty getting out of bed) and EATING DISORDER (difficulty eating) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-MAY-2021 and contains NNI.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: had a terrible headache; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (had a terrible headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (had a terrible headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown and IBUPROFEN (MOTRIN IB) at an unspecified dose and frequency. At the time of the report, HEADACHE (had a terrible headache) 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.   The patient had no reaction from the first, and had a terrible headache after the second dose.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Eating disorder, Fatigue, Peripheral swelling
Clinical narrative: A little off with his food; A little arm puffiness; Fatigue/more tired; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (A little off with his food), PERIPHERAL SWELLING (A little arm puffiness) and FATIGUE (Fatigue/more tired) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced EATING DISORDER (A little off with his food), PERIPHERAL SWELLING (A little arm puffiness) and FATIGUE (Fatigue/more tired). At the time of the report, EATING DISORDER (A little off with his food), PERIPHERAL SWELLING (A little arm puffiness) and FATIGUE (Fatigue/more tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Fatigue, Feeling hot
Clinical narrative: Sinus drainage; Cough; Warm; A little weak; Fatigue; Chilled; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Sinus drainage), COUGH (Cough), FEELING HOT (Warm), ASTHENIA (A little weak) and FATIGUE (Fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinusitis.    On 16-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 RHINORRHOEA (Sinus drainage), COUGH (Cough), FEELING HOT (Warm), ASTHENIA (A little weak), FATIGUE (Fatigue) and CHILLS (Chilled). At the time of the report, RHINORRHOEA (Sinus drainage), COUGH (Cough), FEELING HOT (Warm), ASTHENIA (A little weak), FATIGUE (Fatigue) and CHILLS (Chilled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Sinus drainage; Cough; Warm; A little weak; Fatigue; Chilled; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Sinus drainage), COUGH (Cough), FEELING HOT (Warm), ASTHENIA (A little weak) and FATIGUE (Fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinusitis.    On 16-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 RHINORRHOEA (Sinus drainage), COUGH (Cough), FEELING HOT (Warm), ASTHENIA (A little weak), FATIGUE (Fatigue) and CHILLS (Chilled). At the time of the report, RHINORRHOEA (Sinus drainage), COUGH (Cough), FEELING HOT (Warm), ASTHENIA (A little weak), FATIGUE (Fatigue) and CHILLS (Chilled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vaccination site erythema, Vaccination site induration
Clinical narrative: Hot to Touch Sensation - Near Injection Site; Swelling (hardness) - Near Injection Site; Fever; Chills; Arm Pain - Near Injection Site; Body Aches; Arm Pain - Near Injection Site; Redness - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Aches), VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE INDURATION (Swelling (hardness) - Near Injection Site), the first episode of VACCINATION SITE PAIN (Arm Pain - Near Injection Site) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Herpes NOS. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Herpes NOS, HYDROCHLOROTHIAZIDE and LOSARTAN for Hypertension, VITAMIN B COMPLEX (SUPER B COMPLEX [VITAMIN B COMPLEX]) for Vitamin B complex supplementation, VITAMIN D [VITAMIN D NOS] for Vitamin D supplementation.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN (Body Aches), the first episode of VACCINATION SITE PAIN (Arm Pain - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE INDURATION (Swelling (hardness) - Near Injection Site), PYREXIA (Fever), CHILLS (Chills) and the second episode of VACCINATION SITE PAIN (Arm Pain - Near Injection Site). The patient was treated with NAPROXEN at an unspecified dose and frequency. On 30-Jan-2021, PAIN (Body Aches), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE INDURATION (Swelling (hardness) - Near Injection Site), PYREXIA (Fever), CHILLS (Chills) and the last episode of VACCINATION SITE PAIN (Arm Pain - Near Injection Site) 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.  No treatment information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to Touch Sensation - Near Injection Site; Swelling (hardness) - Near Injection Site; Fever; Chills; Arm Pain - Near Injection Site; Body Aches; Arm Pain - Near Injection Site; Redness - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Aches), VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE INDURATION (Swelling (hardness) - Near Injection Site), the first episode of VACCINATION SITE PAIN (Arm Pain - Near Injection Site) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Herpes NOS. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Herpes NOS, HYDROCHLOROTHIAZIDE and LOSARTAN for Hypertension, VITAMIN B COMPLEX (SUPER B COMPLEX [VITAMIN B COMPLEX]) for Vitamin B complex supplementation, VITAMIN D [VITAMIN D NOS] for Vitamin D supplementation.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN (Body Aches), the first episode of VACCINATION SITE PAIN (Arm Pain - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE INDURATION (Swelling (hardness) - Near Injection Site), PYREXIA (Fever), CHILLS (Chills) and the second episode of VACCINATION SITE PAIN (Arm Pain - Near Injection Site). The patient was treated with NAPROXEN at an unspecified dose and frequency. On 30-Jan-2021, PAIN (Body Aches), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE INDURATION (Swelling (hardness) - Near Injection Site), PYREXIA (Fever), CHILLS (Chills) and the last episode of VACCINATION SITE PAIN (Arm Pain - Near Injection Site) 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.  No treatment information was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Glossitis, Vaccination site erythema, Vaccination site pain
Clinical narrative: Hot Tongue; Redness (Injection Site); Sore Arm; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm/vaccination site pain, redness (injection site)/injection site erythema, hot tongue/glossitis.  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: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced the event sore arm.  On 6 Feb 2021, the patient experienced the events, redness (injection site) and hot tongue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, sore arm, redness (injection site), hot tongue 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash pruritic
Clinical narrative: a rash on their upper arm, not exactly on the site of the injection, of around 2x3 inches, and it is a little itchy; arm was sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm was sore) and RASH PRURITIC (a rash on their upper arm, not exactly on the site of the injection, of around 2x3 inches, and it is a little itchy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 04-Feb-2021, the patient experienced RASH PRURITIC (a rash on their upper arm, not exactly on the site of the injection, of around 2x3 inches, and it is a little itchy). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown and RASH PRURITIC (a rash on their upper arm, not exactly on the site of the injection, of around 2x3 inches, and it is a little itchy) had not resolved.        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: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash 3 days later on his torso; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Itchy rash 3 days later on his torso) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced RASH PRURITIC (Itchy rash 3 days later on his torso). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Itchy rash 3 days later on his torso) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported. Patient took cortizone cream 1%.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Erythema around vaccination site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Erythema around vaccination site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Erythema around vaccination site). At the time of the report, VACCINATION SITE ERYTHEMA (Erythema around vaccination site) 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.   No concomitant medications provided. No Treatment medications provided. The reporter does not recall any further information regarding the events.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Patient and event details updated
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Injection Site Pain; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection Site Pain) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection Site Pain) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Injection Site Pain) and HEADACHE (Headache) outcome was unknown.            Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysgeusia, Fatigue, Headache, Heart rate increased
Clinical narrative: Tingling sensation in lips and tongue; Burning sensation in tongue; Could not sleep that night; She felt sick; Did not go for second dose; Headache; Fatigue; Low grade fever; Diarrhea; Elevated heart rate; Metallic taste; Burning sensation on lips; This spontaneous case was reported by a patient and describes the occurrence of ORAL DISCOMFORT (Burning sensation on lips), DIARRHOEA (Diarrhea), HEART RATE INCREASED (Elevated heart rate), DYSGEUSIA (Metallic taste) and PARAESTHESIA ORAL (Tingling sensation in lips and tongue) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-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 ORAL DISCOMFORT (Burning sensation on lips), HEART RATE INCREASED (Elevated heart rate) and DYSGEUSIA (Metallic taste). On 27-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Low grade fever). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling sensation in lips and tongue), TONGUE DISCOMFORT (Burning sensation in tongue), INSOMNIA (Could not sleep that night), ILLNESS (She felt sick) and PRODUCT DOSE OMISSION ISSUE (Did not go for second dose). On 28-Jan-2021, HEART RATE INCREASED (Elevated heart rate) had resolved. At the time of the report, ORAL DISCOMFORT (Burning sensation on lips), DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste), PARAESTHESIA ORAL (Tingling sensation in lips and tongue), TONGUE DISCOMFORT (Burning sensation in tongue), INSOMNIA (Could not sleep that night), ILLNESS (She felt sick), PRODUCT DOSE OMISSION ISSUE (Did not go for second dose), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Start date for mRNA-1273 was updated to 25-Jan-2021 and Anatomical Location updated to left arm. New events, tingling sensation in lips and tongue, burning sensation in tongue, could not sleep that night, felt sick and did not go for second dose were added.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded. Headache, fever and fatigue are consistent with the known safety profile of the mRNA-1273 vaccine
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Insomnia, Oral discomfort, Paraesthesia oral, Product dose omission issue
Clinical narrative: Tingling sensation in lips and tongue; Burning sensation in tongue; Could not sleep that night; She felt sick; Did not go for second dose; Headache; Fatigue; Low grade fever; Diarrhea; Elevated heart rate; Metallic taste; Burning sensation on lips; This spontaneous case was reported by a patient and describes the occurrence of ORAL DISCOMFORT (Burning sensation on lips), DIARRHOEA (Diarrhea), HEART RATE INCREASED (Elevated heart rate), DYSGEUSIA (Metallic taste) and PARAESTHESIA ORAL (Tingling sensation in lips and tongue) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-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 ORAL DISCOMFORT (Burning sensation on lips), HEART RATE INCREASED (Elevated heart rate) and DYSGEUSIA (Metallic taste). On 27-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Low grade fever). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling sensation in lips and tongue), TONGUE DISCOMFORT (Burning sensation in tongue), INSOMNIA (Could not sleep that night), ILLNESS (She felt sick) and PRODUCT DOSE OMISSION ISSUE (Did not go for second dose). On 28-Jan-2021, HEART RATE INCREASED (Elevated heart rate) had resolved. At the time of the report, ORAL DISCOMFORT (Burning sensation on lips), DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste), PARAESTHESIA ORAL (Tingling sensation in lips and tongue), TONGUE DISCOMFORT (Burning sensation in tongue), INSOMNIA (Could not sleep that night), ILLNESS (She felt sick), PRODUCT DOSE OMISSION ISSUE (Did not go for second dose), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Start date for mRNA-1273 was updated to 25-Jan-2021 and Anatomical Location updated to left arm. New events, tingling sensation in lips and tongue, burning sensation in tongue, could not sleep that night, felt sick and did not go for second dose were added.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded. Headache, fever and fatigue are consistent with the known safety profile of the mRNA-1273 vaccine
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tongue discomfort
Clinical narrative: Tingling sensation in lips and tongue; Burning sensation in tongue; Could not sleep that night; She felt sick; Did not go for second dose; Headache; Fatigue; Low grade fever; Diarrhea; Elevated heart rate; Metallic taste; Burning sensation on lips; This spontaneous case was reported by a patient and describes the occurrence of ORAL DISCOMFORT (Burning sensation on lips), DIARRHOEA (Diarrhea), HEART RATE INCREASED (Elevated heart rate), DYSGEUSIA (Metallic taste) and PARAESTHESIA ORAL (Tingling sensation in lips and tongue) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-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 ORAL DISCOMFORT (Burning sensation on lips), HEART RATE INCREASED (Elevated heart rate) and DYSGEUSIA (Metallic taste). On 27-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Low grade fever). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling sensation in lips and tongue), TONGUE DISCOMFORT (Burning sensation in tongue), INSOMNIA (Could not sleep that night), ILLNESS (She felt sick) and PRODUCT DOSE OMISSION ISSUE (Did not go for second dose). On 28-Jan-2021, HEART RATE INCREASED (Elevated heart rate) had resolved. At the time of the report, ORAL DISCOMFORT (Burning sensation on lips), DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste), PARAESTHESIA ORAL (Tingling sensation in lips and tongue), TONGUE DISCOMFORT (Burning sensation in tongue), INSOMNIA (Could not sleep that night), ILLNESS (She felt sick), PRODUCT DOSE OMISSION ISSUE (Did not go for second dose), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Start date for mRNA-1273 was updated to 25-Jan-2021 and Anatomical Location updated to left arm. New events, tingling sensation in lips and tongue, burning sensation in tongue, could not sleep that night, felt sick and did not go for second dose were added.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded. Headache, fever and fatigue are consistent with the known safety profile of the mRNA-1273 vaccine
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Vaccination site cellulitis, Vaccination site erythema, Vaccination site swelling
Clinical narrative: cellulitis; redness from shoulder to elbow- left arm; redness at the injection site - left arm; swollen at the injection site - left arm; A spontaneous report was received from a consumer (patient's wife) and concerning a 72-year old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, redness at the injection site - left arm, redness from shoulder to elbow- left arm, swollen at the injection site - left arm.  The patient's medical history includes lung disease. No concomitant medications were reported.  On 14-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through unknown route in the left arm for prophylaxis of COVID-19 infection.   On 21-Jan-2021, that is a week later after receiving first dose of vaccination patient experienced a redness at the injection site, which kept traveling, and now is past his elbow. It ranges from shoulder to elbow. She reports it was swollen in the beginning and the redness is now fading. He used topical hydrocortisone cream as advised by a pharmacist. The reporter had called the patient's doctor and the nurse told her that it is likely cellulitis that he picked up during injection. The adverse event of cellulitis was assessed as medically significant.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event cellulitis, swollen at the injection site - left arm was unknown. The outcome of the event redness at the injection site - left arm, redness from shoulder to elbow- left arm was recovering.; 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:  US-MODERNATX, INC.-MOD-2021-024815:Case for patient