chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Swelling glands in my neck more pronounced in my left side; Itchy; Hives around the upper body (shoulders, back, neck); Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchy), URTICARIA (Hives around the upper body (shoulders, back, neck)) and LYMPHADENOPATHY (Swelling glands in my neck more pronounced in my left side) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (45 allergens) and Seafood allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, METHIMAZOLE for Asthma, OMEPRAZOLE for GERD, TRAZODONE for Insomnia, GABAPENTIN and ALPRAZOLAM (XANAX) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 28-Feb-2021, the patient experienced PRURITUS (Itchy) and URTICARIA (Hives around the upper body (shoulders, back, neck)). On 03-Mar-2021, the patient experienced LYMPHADENOPATHY (Swelling glands in my neck more pronounced in my left side). On 28-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 05-Mar-2021, LYMPHADENOPATHY (Swelling glands in my neck more pronounced in my left side) had resolved. On 10-Mar-2021, PRURITUS (Itchy) and URTICARIA (Hives around the upper body (shoulders, back, neck)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information included asthma inhaler. Gabapentin was indicated to used as Mood Stabilizer. Treatment Medication includes: Counter allergy meds (Zyrtek).   This case was linked to MOD-2021-105816 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI from Email Follow up. On 05-May-2021: Follow up received: Added Event outcome, Concomitant Medication along with Indications, Medical History.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Product dose omission issue, Rash
Clinical narrative: Schedule the second dose and its passed 40 days; Rash (on face, neck, arms, chest and back); Queasy feeling (felt sick but never got sick); Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Schedule the second dose and its passed 40 days), RASH (Rash (on face, neck, arms, chest and back)), NAUSEA (Queasy feeling (felt sick but never got sick)) and FATIGUE (Fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced RASH (Rash (on face, neck, arms, chest and back)), NAUSEA (Queasy feeling (felt sick but never got sick)) and FATIGUE (Fatigue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Schedule the second dose and its passed 40 days). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 14-Feb-2021, RASH (Rash (on face, neck, arms, chest and back)) and FATIGUE (Fatigue) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Schedule the second dose and its passed 40 days) outcome was unknown and NAUSEA (Queasy feeling (felt sick but never got sick)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: No specific follow-up information recorded.; 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: soreness in elbow of the arm where injection was given; soreness in muscle of the arm where injection was given; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness in muscle of the arm where injection was given) and PAIN IN EXTREMITY (soreness in elbow of the arm where injection was given) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (soreness in muscle of the arm where injection was given) and PAIN IN EXTREMITY (soreness in elbow of the arm where injection was given). At the time of the report, MYALGIA (soreness in muscle of the arm where injection was given) and PAIN IN EXTREMITY (soreness in elbow of the arm where injection was given) outcome was unknown.            No Concomitant medications were provided. No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise
Clinical narrative: Did not feel well; sweating; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well) and HYPERHIDROSIS (sweating) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Did not feel well) and HYPERHIDROSIS (sweating). At the time of the report, MALAISE (Did not feel well) and HYPERHIDROSIS (sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided Treatment information was not provided   This case was linked to MOD21-046551 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Vaccination site movement impairment
Clinical narrative: couldn't lift arm; headache; nausea; pain in hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in hand), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift arm), HEADACHE (headache) and NAUSEA (nausea) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in hand), HEADACHE (headache) and NAUSEA (nausea). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift arm). At the time of the report, PAIN IN EXTREMITY (pain in hand), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift arm), HEADACHE (headache) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: TCR document attached
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: 2nd dose after 43 days from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (2nd dose after 43 days from the first dose) 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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced OFF LABEL USE (2nd dose after 43 days from the first dose). On 26-Feb-2021, OFF LABEL USE (2nd dose after 43 days from the first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided  Treatment information was not provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Interchange of vaccine products
Clinical narrative: Got the Moderna vaccine before she unblinded herself from the clinical trial. When they called to unblind from the trial, they found out she got the Novavax vaccine, not the placebo; A spontaneous report was received from a consumer concerning his mother, a 71-years-old female patient, who received Moderna's covid-19 vaccine (mRNA -1273) first dose of Moderna vaccine received before finding out she received Novavax vaccine from clinical trial.   The patient's medical history, as provided by the reporter included Novavax vaccine. Concomitant medications were not reported.   On 02-MAR-2021, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.     On 02-MAR-2021, the patient received the mRNA-1273 vaccine before she unblinded herself from the clinical trial and when they called to unblind from the trial, they found out she got the Novavax vaccine, not the placebo. On an unknown date in 2021, the lab test performed included antibody test which was negative. Treatment details were not provided.   Action taken with mRNA-1273 in response to the events was not applicable   The outcome of the event first dose of Moderna vaccine received before finding out she received Novavax vaccine from clinical trial was considered resolved.; Reporter's Comments: This report refers to a case of Interchange of vaccine products for mRNA-1273 (lot # unknown) with no associated AEs reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Mild body aches in both arms and both legs; Mild headache; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (Mild body aches in both arms and both legs) and HEADACHE (Mild headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 026L20A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (Mild body aches in both arms and both legs) and HEADACHE (Mild headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache and Ache, at a dose of 1 dosage form. At the time of the report, PAIN (Mild body aches in both arms and both legs) and HEADACHE (Mild headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased
Clinical narrative: Has to use more insulin since receiving the COVID-19 vaccine; 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 BLOOD GLUCOSE DECREASED (Has to use more insulin since receiving the COVID-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diabetes.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE DECREASED (Has to use more insulin since receiving the COVID-19 vaccine). At the time of the report, BLOOD GLUCOSE DECREASED (Has to use more insulin since receiving the COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-035936 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body ache; Fever; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events body ache, fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Feb 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 4 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Unknown)  for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events body ache, fever.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, body ache, fever was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Symptom recurrence, Vaccination site reaction
Clinical narrative: The ring went away and reappeared; Ring about 3 inches around injection site; A spontaneous report  was received from a healthcare professional concerning a 38-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events ring about 3 inches around injection site/ vaccination site reaction, the ring went away and reappeared/ symptom recurrence.  The patient's medical history was not provided. Concomitant medications reported were Multivitamin and Supplement.  On 22 Feb 2021, one day prior to the onset of the events the patient received their dose of mRNA-1273 (lot/batch: 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the event ring about 3 inches around injection site. On 3 mar 2021, the patient experienced the event the ring went away and reappeared  Treatment details included hydrocortisone cream to the skin to treat her symptom.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date, the outcome of event, ring about 3 inches around injection site was resolved. The outcome of the event ring went away and reappeared was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Rash erythematous
Clinical narrative: Red rash on scalp; Scalp is itching; Scalp hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on scalp), PRURITUS (Scalp is itching) and FEELING HOT (Scalp hot to the touch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) 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) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on scalp), PRURITUS (Scalp is itching) and FEELING HOT (Scalp hot to the touch). At the time of the report, RASH ERYTHEMATOUS (Red rash on scalp), PRURITUS (Scalp is itching) and FEELING HOT (Scalp hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Type IV hypersensitivity reaction
Clinical narrative: COVID arm; Biggest ball in her arm, the size of a baseball; itchy; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (COVID arm), PERIPHERAL SWELLING (Biggest ball in her arm, the size of a baseball) and PRURITUS (itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (COVID arm), PERIPHERAL SWELLING (Biggest ball in her arm, the size of a baseball) and PRURITUS (itchy). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (COVID arm), PERIPHERAL SWELLING (Biggest ball in her arm, the size of a baseball) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.   This case was linked to MOD-2021-035978 (E2B Linked Report).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose 68 days after the first one; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and the second dose of the vaccine was received 68 days after the first dose.  The patient's medical history, was not provided by the reporter. No Concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   After 68 days, the second dose of the Moderna COVID-19 vaccine was administered to the patient.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event the second dose of the vaccine was received 68 days after the first dose was unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site warmth
Clinical narrative: Arm had big round circle that was hard and hot; Arm had big round circle that was hard and hot; A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm had big round circle that was hard/ vaccination site induration, and hot/ vaccination site warmth  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 first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 25 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 an unknown date, the patient experienced the events arm had big round circle that was hard and hot. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events Arm had big round circle that was hard and hot was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Coming down with shingles on their faces; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (Coming down with shingles on their faces) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Coming down with shingles on their faces). At the time of the report, HERPES ZOSTER (Coming down with shingles on their faces) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-036048, MOD-2021-036048 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: A red, tender, swollen lymph node under the right arpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (A red, tender, swollen lymph node under the right arpit) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter. Concurrent medical conditions included Hypertension and Drug allergy (Patient is allergic to HCTZ).  On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter.   On 04-Mar-2021, the patient experienced LYMPHADENOPATHY (A red, tender, swollen lymph node under the right arpit). At the time of the report, LYMPHADENOPATHY (A red, tender, swollen lymph node under the right arpit) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   The patient reported that she takes a lot of medications but declined to list them. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Event outcome updated.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site movement impairment
Clinical narrative: Cannot Pick Anything with her Left Arm; Left Bicep pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot Pick Anything with her Left Arm) and INJECTION SITE PAIN (Left Bicep pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TEMAZEPAM, DOXYCYCLINE, THYROID (ARMOUR THYROID), FLECAINIDE, METOPROLOL, APIXABAN (ELIQUIS) and DENOSUMAB (PROLIA) for an unknown indication.    On 08-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 VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot Pick Anything with her Left Arm) and INJECTION SITE PAIN (Left Bicep pain). The patient was treated with PARACETAMOL (TYLENOL) for Injection site pain, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot Pick Anything with her Left Arm) and INJECTION SITE PAIN (Left Bicep pain) 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 01-May-2021: No new information received On 04-May-2021: No new information received
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: body ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced MYALGIA (body ache). At the time of the report, MYALGIA (body ache) outcome was unknown.            Concomitant medication was not provided by the reporter.  The treatment information was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Nausea, Pyrexia
Clinical narrative: high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), VOMITING (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), CHILLS (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), DECREASED APPETITE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.) and HEADACHE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), VOMITING (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), CHILLS (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), DECREASED APPETITE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), HEADACHE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.) and NAUSEA (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), VOMITING (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), CHILLS (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), DECREASED APPETITE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), HEADACHE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.) and NAUSEA (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.) outcome was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), VOMITING (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), CHILLS (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), DECREASED APPETITE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.) and HEADACHE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), VOMITING (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), CHILLS (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), DECREASED APPETITE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), HEADACHE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.) and NAUSEA (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), VOMITING (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), CHILLS (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), DECREASED APPETITE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), HEADACHE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.) and NAUSEA (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.) outcome was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; 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 event diarrhea.  The patient's medical history included Crohn's disease. Concomitant medications reported were vedolizumab, hyoscyamine for Crohn's disease.  On 27 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030M20A)  in the left arm for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the event diarrhea.  Treatment details included imodium, hyoscyamine.  Action taken with mRNA-1273 in response to the events was not reported.   On 5 Mar 2021 the outcome of event diarrhea was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Arm on the injection site became red; Swollen/ getting bigger; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Arm on the injection site became red) and INJECTION SITE SWELLING (Swollen/ getting bigger) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), ALPRAZOLAM (XANAX), SECUKINUMAB (COSENTYX), MULTIVITAMIN [VITAMINS NOS] and VITAMIN D NOS for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Arm on the injection site became red) and INJECTION SITE SWELLING (Swollen/ getting bigger). At the time of the report, INJECTION SITE ERYTHEMA (Arm on the injection site became red) and INJECTION SITE SWELLING (Swollen/ getting bigger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information provided was patient took diphenhydramine.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzied; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzied) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 03-Mar-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) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizzied). At the time of the report, DIZZINESS (Dizzied) outcome was unknown.            Patient's concomitant medication included blood pressure medication.  No corrective treatment was provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Tooth extraction
Clinical narrative: Tooth extraction; Racing heart, heart rate was in the 130s; This spontaneous case was reported by an other health care professional and describes the occurrence of TOOTH EXTRACTION (Tooth extraction) and PALPITATIONS (Racing heart, heart rate was in the 130s) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chronic lymphocytic leukaemia, Heart rate abnormal in 2019, Dizziness in 2019, White blood cell count decreased in 2019, Laziness in 2019, Heart rate high (for about 3-4 min) in 2020, Glare in 2020 and Difficulty focusing eyes in 2020. Concomitant products included METOPROLOL SUCCINATE, IBRUTINIB (IMBRUVICA) from 29-Aug-2019 to an unknown date and IBRUTINIB for an unknown indication.    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 TOOTH EXTRACTION (Tooth extraction) and PALPITATIONS (Racing heart, heart rate was in the 130s). At the time of the report, TOOTH EXTRACTION (Tooth extraction) and PALPITATIONS (Racing heart, heart rate was in the 130s) 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.   Treatment medication include Baby Aspirin.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pruritus
Clinical narrative: A lot of itchiness all over their body; Itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A lot of itchiness all over their body) and VACCINATION SITE PRURITUS (Itchiness at injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.   Concurrent medical conditions included Acid reflux (esophageal) and Irritable bowel syndrome.  On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site). On 08-Mar-2021, the patient experienced PRURITUS (A lot of itchiness all over their body). On 08-Mar-2021, VACCINATION SITE PRURITUS (Itchiness at injection site) had resolved. At the time of the report, PRURITUS (A lot of itchiness all over their body) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  The concomitant medications included acid reflux medication, antidepressant medication, irritable bowel syndrome medication, and probiotic used for an unknown indications.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site rash, Myalgia, Nausea, Pyrexia
Clinical narrative: Body aches; Headache; Fever of 100.6; Nauseated; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), HEADACHE (Headache), PYREXIA (Fever of 100.6), NAUSEA (Nauseated) and INJECTION SITE RASH (Rash at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hyperlipidemia.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MYALGIA (Body aches), HEADACHE (Headache), PYREXIA (Fever of 100.6), NAUSEA (Nauseated) and INJECTION SITE RASH (Rash at injection site). On 05-Mar-2021, MYALGIA (Body aches), HEADACHE (Headache), PYREXIA (Fever of 100.6), NAUSEA (Nauseated) and INJECTION SITE RASH (Rash at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Pyrexia: 100.6 (abnormal) fever of 100.6.         No concomitant medications or treatment details reported.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin reaction, Urticaria
Clinical narrative: She woke up with a nod in a different spot in the same arm; A welt; Arm sore for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore for 5 days), SKIN REACTION (She woke up with a nod in a different spot in the same arm) and URTICARIA (A welt) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included Omeprozale, ACETYLSALICYLIC ACID (BABY ASPIRIN), MONTELUKAST SODIUM (SINGULAIR) and ALPRAZOLAM (XANAX) for an unknown indication.    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 (Arm sore for 5 days). On 22-Feb-2021, the patient experienced SKIN REACTION (She woke up with a nod in a different spot in the same arm) and URTICARIA (A welt). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 19-Feb-2021, PAIN IN EXTREMITY (Arm sore for 5 days) had resolved. At the time of the report, SKIN REACTION (She woke up with a nod in a different spot in the same arm) and URTICARIA (A welt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Productive cough
Clinical narrative: Cough; Phlegm; Hoarse voice; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PRODUCTIVE COUGH (Phlegm) and DYSPHONIA (Hoarse voice) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine allergy) and Iodine allergy.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced COUGH (Cough), PRODUCTIVE COUGH (Phlegm) and DYSPHONIA (Hoarse voice). At the time of the report, COUGH (Cough), PRODUCTIVE COUGH (Phlegm) and DYSPHONIA (Hoarse voice) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Received TCR form: Outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced HEADACHE (Headache). On 03-Feb-2021, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications reported.    Reporter did not allow further contact
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Tenderness, Vaccination site pain, Vaccination site warmth
Clinical narrative: 101 temp at injection site; Tender arm to touch; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (101 temp at injection site), TENDERNESS (Tender arm to touch) and VACCINATION SITE PAIN (Pain at injection site) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE WARMTH (101 temp at injection site), TENDERNESS (Tender arm to touch) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE WARMTH (101 temp at injection site), TENDERNESS (Tender arm to touch) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 101f (High) He put a themometer on the area and it read 101..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash macular, Rash morbilliform, Taste disorder, Urticaria
Clinical narrative: Something that looked like measles; Red dots; Welts; Big red blobs; Sharp taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of RASH MORBILLIFORM (Something that looked like measles), TASTE DISORDER (Sharp taste in mouth), RASH ERYTHEMATOUS (Red dots), URTICARIA (Welts) and RASH MACULAR (Big red blobs) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Propranolol) and Allergy to insect sting (Yellow jacket).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced TASTE DISORDER (Sharp taste in mouth). On 05-Mar-2021, the patient experienced RASH MORBILLIFORM (Something that looked like measles), RASH ERYTHEMATOUS (Red dots), URTICARIA (Welts) and RASH MACULAR (Big red blobs). At the time of the report, RASH MORBILLIFORM (Something that looked like measles), TASTE DISORDER (Sharp taste in mouth), RASH ERYTHEMATOUS (Red dots), URTICARIA (Welts) and RASH MACULAR (Big red blobs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MORBILLIFORM (Something that looked like measles), TASTE DISORDER (Sharp taste in mouth), RASH ERYTHEMATOUS (Red dots), URTICARIA (Welts) and RASH MACULAR (Big red blobs) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Propranolol) and Allergy to insect sting (Yellow jacket).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced TASTE DISORDER (Sharp taste in mouth). On 05-Mar-2021, the patient experienced RASH MORBILLIFORM (Something that looked like measles), RASH ERYTHEMATOUS (Red dots), URTICARIA (Welts) and RASH MACULAR (Big red blobs). At the time of the report, RASH MORBILLIFORM (Something that looked like measles), TASTE DISORDER (Sharp taste in mouth), RASH ERYTHEMATOUS (Red dots), URTICARIA (Welts) and RASH MACULAR (Big red blobs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Oral pain
Clinical narrative: Broke up in shingles on the left side of their face; A lot of pain, mostly in their mouth; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Broke up in shingles on the left side of their face) and ORAL PAIN (A lot of pain, mostly in their mouth) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concomitant products included BIFIDOBACTERIUM INFANTIS (ALIGN) for Supplementation therapy, ROSUVASTATIN CALCIUM (CRESTOR) and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Broke up in shingles on the left side of their face) and ORAL PAIN (A lot of pain, mostly in their mouth). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; VALACICLOVIR HYDROCHLORIDE (VALTREX) at a dose of 1 gram three times a day; LIDOCAINE at an unspecified dose and frequency; MUPIROCIN at an unspecified dose and frequency and METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Broke up in shingles on the left side of their face) and ORAL PAIN (A lot of pain, mostly in their mouth) 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.   This case was linked to MOD-2021-036002, MOD-2021-036002 (Patient Link).