chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Migraine
Clinical narrative: fast heart beat; ears ringing; pain in neck; terrible migraine for 4 days; Sore arm; Pain in head; Chills; Fatigue; Muscle pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heart beat), TINNITUS (ears ringing), NECK PAIN (pain in neck), MIGRAINE (terrible migraine for 4 days) and PAIN IN EXTREMITY (Sore arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A, 013A21A and 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No patient medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced HEART RATE INCREASED (fast heart beat), TINNITUS (ears ringing), NECK PAIN (pain in neck), MIGRAINE (terrible migraine for 4 days), PAIN IN EXTREMITY (Sore arm), HEADACHE (Pain in head), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain ) and NAUSEA (nausea). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. In December 2021, HEART RATE INCREASED (fast heart beat), PAIN IN EXTREMITY (Sore arm), HEADACHE (Pain in head), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain ) and NAUSEA (nausea) had resolved. At the time of the report, TINNITUS (ears ringing), NECK PAIN (pain in neck) and MIGRAINE (terrible migraine for 4 days) had not resolved.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Neck pain, Pain in extremity, Tinnitus
Clinical narrative: fast heart beat; ears ringing; pain in neck; terrible migraine for 4 days; Sore arm; Pain in head; Chills; Fatigue; Muscle pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heart beat), TINNITUS (ears ringing), NECK PAIN (pain in neck), MIGRAINE (terrible migraine for 4 days) and PAIN IN EXTREMITY (Sore arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A, 013A21A and 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No patient medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced HEART RATE INCREASED (fast heart beat), TINNITUS (ears ringing), NECK PAIN (pain in neck), MIGRAINE (terrible migraine for 4 days), PAIN IN EXTREMITY (Sore arm), HEADACHE (Pain in head), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain ) and NAUSEA (nausea). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. In December 2021, HEART RATE INCREASED (fast heart beat), PAIN IN EXTREMITY (Sore arm), HEADACHE (Pain in head), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain ) and NAUSEA (nausea) had resolved. At the time of the report, TINNITUS (ears ringing), NECK PAIN (pain in neck) and MIGRAINE (terrible migraine for 4 days) had not resolved.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: day 3 of a fever/low grade fever/a fever more than 48 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (day 3 of a fever/low grade fever/a fever more than 48 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine (first two doses were pfizer). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (day 3 of a fever/low grade fever/a fever more than 48 hours). At the time of the report, PYREXIA (day 3 of a fever/low grade fever/a fever more than 48 hours) had not resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination complication
Clinical narrative: decent reaction; feeling miserable; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (decent reaction) and FEELING ABNORMAL (feeling miserable) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Blood pressure abnormal. Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.    On 05-May-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 VACCINATION COMPLICATION (decent reaction) and FEELING ABNORMAL (feeling miserable). At the time of the report, VACCINATION COMPLICATION (decent reaction) and FEELING ABNORMAL (feeling miserable) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications included blood pressure medication.   This case was linked to MOD-2021-410138, MOD-2021-410145 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: Mild Soreness at injection site after first shot; Drowsy after first shot; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsy after first shot) and VACCINATION SITE PAIN (Mild Soreness at injection site after first shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04120A) 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) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced SOMNOLENCE (Drowsy after first shot). On an unknown date, the patient experienced VACCINATION SITE PAIN (Mild Soreness at injection site after first shot). At the time of the report, SOMNOLENCE (Drowsy after first shot) and VACCINATION SITE PAIN (Mild Soreness at injection site after first shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient does not take concomitant medications.  No treatment details were reported.   This case was linked to MOD-2021-410130, MOD-2021-410132 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Headache, Vaccination site pain
Clinical narrative: Mild Soreness at injection site after 2nd shot; A little Headache after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild Soreness at injection site after 2nd shot) and HEADACHE (A little Headache after 2nd dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 04120A) 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) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (Mild Soreness at injection site after 2nd shot) and HEADACHE (A little Headache after 2nd dose). On 12-Feb-2021, VACCINATION SITE PAIN (Mild Soreness at injection site after 2nd shot) and HEADACHE (A little Headache after 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, Antibody test: 345 345.         Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-410126, MOD-2021-410132 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Vaccination site pain
Clinical narrative: Barely any soreness on the injection site after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Barely any soreness on the injection site after 3rd shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 04120A and 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for Product used for unknown indication: influenza (flu shot) on 14-Sep-2021. Past adverse reactions to the above products included No adverse event with influenza.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Barely any soreness on the injection site after 3rd shot). At the time of the report, VACCINATION SITE PAIN (Barely any soreness on the injection site after 3rd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Nov-2021, Antibody test: 186 (Inconclusive) 186 and 178 (Inconclusive) 178.         No concomitant medications provided. No treatment medications provided. She was going to have knee surgery soon so she wanted to be fully protected.   This case was linked to MOD-2021-410130, MOD-2021-410126 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: shaking violently; Slept almost all day/She doesn't sleep during the day and these days she slept around the clock; not feeling terribly well; could barely stand or move; could barely stand or move; mental fog; extremely tired; had a fever, under a 100; had chills from the inside; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking violently), SOMNOLENCE (Slept almost all day/She doesn't sleep during the day and these days she slept around the clock), MALAISE (not feeling terribly well), DYSSTASIA (could barely stand or move) and HYPOKINESIA (could barely stand or move) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 024M20A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disease, unspecified and Blood pressure. Concomitant products included LOSARTAN for Blood pressure, ASPIRIN [ACETYLSALICYLIC ACID] for Heart disease, unspecified, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced TREMOR (shaking violently), SOMNOLENCE (Slept almost all day/She doesn't sleep during the day and these days she slept around the clock), MALAISE (not feeling terribly well), DYSSTASIA (could barely stand or move), HYPOKINESIA (could barely stand or move), FEELING ABNORMAL (mental fog), FATIGUE (extremely tired), PYREXIA (had a fever, under a 100) and CHILLS (had chills from the inside). On 13-Dec-2021, TREMOR (shaking violently), SOMNOLENCE (Slept almost all day/She doesn't sleep during the day and these days she slept around the clock), MALAISE (not feeling terribly well), DYSSTASIA (could barely stand or move), HYPOKINESIA (could barely stand or move), FEELING ABNORMAL (mental fog), FATIGUE (extremely tired), PYREXIA (had a fever, under a 100) and CHILLS (had chills from the inside) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Dec-2021, Blood pressure measurement: good category (normal) blood pressure was in the good category. On 09-Dec-2021, Body temperature: under a 100 (Inconclusive) she had a fever, under a 100. On an unknown date, Body temperature: lower than 98.6 (normal) she usually runs lower than 98.6.         About 2 hours after receiving the booster, the patient was not feeling terribly well. The patient was feeling better on 13-Dec-2021. The patient had doctor visit on 14-Dec-2021 (not known if the patient visited to the doctor). While she was not feeling well, she was not taking her medication.  No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: a little bit of soreness; a little bit of rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN and RASH in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN and RASH. At the time of the report, PAIN and RASH had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Concomitant medication of the patient was not reported.   The patient had adverse events, on the day of vaccination only.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-410411 (Patient Link).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: First Moderna Covid-19 vaccine on 29 AUG 2021 and second dose on 26 OCT 2021; Injection site sore after the first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site sore after the first vaccination) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna Covid-19 vaccine on 29 AUG 2021 and second dose on 26 OCT 2021) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced VACCINATION SITE PAIN (Injection site sore after the first vaccination). On 26-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna Covid-19 vaccine on 29 AUG 2021 and second dose on 26 OCT 2021). On 26-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna Covid-19 vaccine on 29 AUG 2021 and second dose on 26 OCT 2021) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection site sore after the first vaccination) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received on 22Apr2021/Vaccine administered 38 days from 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 22Apr2021/Vaccine administered 38 days from 1st dose) 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 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 22Apr2021/Vaccine administered 38 days from 1st dose). On 22-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 22Apr2021/Vaccine administered 38 days from 1st dose) had resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient has not yet received the booster dose.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were given. No treatment information were provided.   This case was linked to MOD-2021-410313 (Patient Link).
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Dose administered to patient after temperature excursion; Temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 038B21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided by the reporter.  Reporter stated that storage condition at the time of the excursion was frozen storage. Temperature excursion where maximum temperature for freezer was 5.36 F and minimum was (-) 1.67 Fahrenheit. On 02-Dec-2021 the vial(s) moved from freezer to refrigerator. Visual inspection noted were: looked normal, no vaccine state change.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: they gave 1st doses of the Moderna Covid-19 Vaccine from 2 different lots to two adolescents; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE in an adolescent patient of an unknown 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Reporter stated that they gave 1st dose of the Moderna Covid-19 Vaccine from 2 different lots to two adolescents and they request any information on this situation.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 2 patients received doses that went up to 54 degrees Fahrenheit for 105 minutes; 2 patients received doses that went up to 54 degrees Fahrenheit for 105 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received doses that went up to 54 degrees Fahrenheit for 105 minutes) and PRODUCT STORAGE ERROR (2 patients received doses that went up to 54 degrees Fahrenheit for 105 minutes) 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 13-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received doses that went up to 54 degrees Fahrenheit for 105 minutes) and PRODUCT STORAGE ERROR (2 patients received doses that went up to 54 degrees Fahrenheit for 105 minutes). On 13-Dec-2021, EXPIRED PRODUCT ADMINISTERED (2 patients received doses that went up to 54 degrees Fahrenheit for 105 minutes) and PRODUCT STORAGE ERROR (2 patients received doses that went up to 54 degrees Fahrenheit for 105 minutes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: viral condition fully went away/Patient reported a condition they had for 13 years, went away after vaccination with COVID-19 Vaccine Moderna; viral condition got better; This spontaneous case was reported by a consumer and describes the occurrence of PRE-EXISTING CONDITION IMPROVED (viral condition fully went away/Patient reported a condition they had for 13 years, went away after vaccination with COVID-19 Vaccine Moderna) and THERAPEUTIC RESPONSE UNEXPECTED (viral condition got better) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Foot infection (a viral problem in the foot for 13 years.).    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 PRE-EXISTING CONDITION IMPROVED (viral condition fully went away/Patient reported a condition they had for 13 years, went away after vaccination with COVID-19 Vaccine Moderna) and THERAPEUTIC RESPONSE UNEXPECTED (viral condition got better). At the time of the report, PRE-EXISTING CONDITION IMPROVED (viral condition fully went away/Patient reported a condition they had for 13 years, went away after vaccination with COVID-19 Vaccine Moderna) and THERAPEUTIC RESPONSE UNEXPECTED (viral condition got better) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient reported a condition they had for 13 years and said that has been afflicted with a viral problem in the foot for 13 years and nothing would help it. After getting first dose of the vaccine, the condition got better.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-410453, MOD-2021-410454 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Lymphadenopathy, Myalgia, Swelling
Clinical narrative: Swollen lymph nodes near right elbow crease.; Sore, achy muscles; Light green urine; Swelled up/a little swelling; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (Light green urine), SWELLING (Swelled up/a little swelling), LYMPHADENOPATHY (Swollen lymph nodes near right elbow crease.) and MYALGIA (Sore, achy muscles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), OMEPRAZOLE, TOPIRAMATE, ALBUTEROL [SALBUTAMOL] and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced SWELLING (Swelled up/a little swelling). On 15-Apr-2021, the patient experienced CHROMATURIA (Light green urine). On 16-Apr-2021, the patient experienced MYALGIA (Sore, achy muscles). On 23-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes near right elbow crease.). On 17-Apr-2021, MYALGIA (Sore, achy muscles) had resolved. At the time of the report, CHROMATURIA (Light green urine) and SWELLING (Swelled up/a little swelling) had resolved and LYMPHADENOPATHY (Swollen lymph nodes near right elbow crease.) had not resolved.            No treatment details were reported.   This case was linked to MOD-2021-410354 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Fast Heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED 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 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced HEART RATE INCREASED. At the time of the report, HEART RATE INCREASED outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 26-Feb-2021, Heart rate increased to 100-105 (High). Patient had increased heart beat ranging 100-105.         No concomitant medications were reported  No treatment medications were reported
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on May-2021/second dose on 14-Dec-2021/patient received 2nd dose of Moderna COVID-19 vaccine 7 months after 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on May-2021/second dose on 14-Dec-2021/patient received 2nd dose of Moderna COVID-19 vaccine 7 months after 1st dose) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on May-2021/second dose on 14-Dec-2021/patient received 2nd dose of Moderna COVID-19 vaccine 7 months after 1st dose). On 14-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on May-2021/second dose on 14-Dec-2021/patient received 2nd dose of Moderna COVID-19 vaccine 7 months after 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: Patient reported a condition they had for 13 years, viral condition fully went away; viral condition fully went away; This spontaneous case was reported by a consumer and describes the occurrence of PRE-EXISTING CONDITION IMPROVED (Patient reported a condition they had for 13 years, viral condition fully went away) and THERAPEUTIC RESPONSE UNEXPECTED (viral condition fully went away) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Foot infection (Viral problem in the foot for 13 years) in 2008.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRE-EXISTING CONDITION IMPROVED (Patient reported a condition they had for 13 years, viral condition fully went away) and THERAPEUTIC RESPONSE UNEXPECTED (viral condition fully went away). At the time of the report, PRE-EXISTING CONDITION IMPROVED (Patient reported a condition they had for 13 years, viral condition fully went away) and THERAPEUTIC RESPONSE UNEXPECTED (viral condition fully went away) was resolving.            Symptoms: It was reported that the patient had pre-existed viral infection with his feet and nothing helped it cured, after taking Moderna COVID-19 vaccine, it started getting better, patient had no proof.  No concomitant medications were reported No treatment medications were reported   This case was linked to MOD-2021-410369 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: Viral condition fully went away/Patient reported a condition they had for 13 years, went away after vaccination with COVID-19 Vaccine Moderna; Viral condition fully went away; This spontaneous case was reported by a consumer and describes the occurrence of PRE-EXISTING CONDITION IMPROVED (Viral condition fully went away/Patient reported a condition they had for 13 years, went away after vaccination with COVID-19 Vaccine Moderna) and THERAPEUTIC RESPONSE UNEXPECTED (Viral condition fully went away) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Foot infection (viral problem in the foot for 13 years.).   On 17-Nov-2021, the patient received third 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 an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRE-EXISTING CONDITION IMPROVED (Viral condition fully went away/Patient reported a condition they had for 13 years, went away after vaccination with COVID-19 Vaccine Moderna) and THERAPEUTIC RESPONSE UNEXPECTED (Viral condition fully went away). At the time of the report, PRE-EXISTING CONDITION IMPROVED (Viral condition fully went away/Patient reported a condition they had for 13 years, went away after vaccination with COVID-19 Vaccine Moderna) and THERAPEUTIC RESPONSE UNEXPECTED (Viral condition fully went away) had resolved.            No Concomitant and Treatment medication were reported.   This case was linked to MOD-2021-410453 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination error
Clinical narrative: 2 vials used from the same lot to draw up 1 full dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION ERROR (2 vials used from the same lot to draw up 1 full dose) 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 10-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced VACCINATION ERROR (2 vials used from the same lot to draw up 1 full dose). On 10-Dec-2021, VACCINATION ERROR (2 vials used from the same lot to draw up 1 full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient got a third dose of 0.50 mL instead of a booster dose of 0.25 mL; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (Patient got a third dose of 0.50 mL instead of a booster dose of 0.25 mL) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In August 2021, the patient experienced ACCIDENTAL OVERDOSE (Patient got a third dose of 0.50 mL instead of a booster dose of 0.25 mL). In August 2021, ACCIDENTAL OVERDOSE (Patient got a third dose of 0.50 mL instead of a booster dose of 0.25 mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.   Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus in her right ear/fluttering type of noise like popcorn popping in the microwave; This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (tinnitus in her right ear/fluttering type of noise like popcorn popping in the microwave) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced TINNITUS (tinnitus in her right ear/fluttering type of noise like popcorn popping in the microwave). The patient was treated with PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; FLUOXETINE HYDROCHLORIDE (PROZAC) at an unspecified dose and frequency and Surgery (cut a tendon theysuspected was making that noise in ear) for Tinnitus. At the time of the report, TINNITUS (tinnitus in her right ear/fluttering type of noise like popcorn popping in the microwave) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  She had a surgery last week. She had a post surgical visit with her surgeon (contact 3) and is scheduled to receive a booster dose of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient got a booster dose from vial punctured more than 12 hours before; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose from vial punctured more than 12 hours before) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021 at 9:29 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Dec-2021 at 9:29 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose from vial punctured more than 12 hours before). On 09-Dec-2021 at 9:29 AM, EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose from vial punctured more than 12 hours before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications Included medications for Diabetes. No treatment Information was provided by the reporter.  Reporter stated that on 07-Dec-2021 the vial was initially stored in the refrigerator and on 08-Dec-2021 at 11:40 AM, the vial was first punctured and stored in refrigerator. The vial did not undergo any temperature excursions.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: lot of pain in the shoulder joints.,It feels like it is in her bones,t is radiating down her arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (lot of pain in the shoulder joints.,It feels like it is in her bones,t is radiating down her arm) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (lot of pain in the shoulder joints.,It feels like it is in her bones,t is radiating down her arm). At the time of the report, ARTHRALGIA (lot of pain in the shoulder joints.,It feels like it is in her bones,t is radiating down her arm) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Paraesthesia
Clinical narrative: pain in general in his joints & all over; tingling on the whole left side of his body; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain in general in his joints & all over), PARAESTHESIA (tingling on the whole left side of his body), HEADACHE (headache) and FATIGUE (tired) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Previously administered products included for COVID-19 vaccination: J&J COVID vaccine (J&J as his primary dose). Past adverse reactions to the above products included No adverse event with J&J COVID vaccine.    On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain in general in his joints & all over), PARAESTHESIA (tingling on the whole left side of his body), HEADACHE (headache) and FATIGUE (tired). At the time of the report, PAIN (pain in general in his joints & all over), PARAESTHESIA (tingling on the whole left side of his body), HEADACHE (headache) and FATIGUE (tired) outcome was unknown.            Concomitant medication of the patient was not reported.   No treatment information was provided by the reporter. The reporter wanted to know, if the patient can take Tylenol.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Knee deformity, Muscular weakness
Clinical narrative: patient's left knee gave out; Patient has had a very weak left arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Patient has had a very weak left arm) and KNEE DEFORMITY (patient's left knee gave out) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 062E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced MUSCULAR WEAKNESS (Patient has had a very weak left arm). On 12-Dec-2021, the patient experienced KNEE DEFORMITY (patient's left knee gave out). At the time of the report, MUSCULAR WEAKNESS (Patient has had a very weak left arm) and KNEE DEFORMITY (patient's left knee gave out) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2021-411705 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cellulitis, Vaccination site swelling
Clinical narrative: Cellulitis; feel weaker/weakness in wrist and shoulders; whole arm blew up; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis) in an 82-year-old male 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.     Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, PARACETAMOL (TYLENOL A) for an unknown indication.    On 11-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 CELLULITIS (Cellulitis) (seriousness criterion medically significant), ASTHENIA (feel weaker/weakness in wrist and shoulders) and VACCINATION SITE SWELLING (whole arm blew up). At the time of the report, CELLULITIS (Cellulitis) and VACCINATION SITE SWELLING (whole arm blew up) had resolved and ASTHENIA (feel weaker/weakness in wrist and shoulders) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Doctor gave antibiotics as treatment. Patient taken drug for blood pressure, cholesterol patient had an adverse effect. Cellulitis in left arm, the whole arm blew up. They told patient it was not related (the doctor at facility). doctor told him it probably was and gave him an antibiotic for a week. She said if it does not clear go the hospital. It cleared up.  Company comment: This is a spontaneous case concerning an 82-year-old male patient with no medical history reported who experienced the unexpected and serious event of cellulitis. The event occurred on an unknown day after a first dose of mRNA-1273 vaccine was administered. The rechallenge was not applicable since outcome of the event is not clear. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-404954, MOD-2021-404954 (Patient Link).; Sender's Comments: This is a spontaneous case concerning an 82-year-old male patient with no medical history reported who experienced the unexpected and serious event of cellulitis. The event occurred on an unknown day after a first dose of mRNA-1273 vaccine was administered. The rechallenge was not applicable since outcome of the event is not clear. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain, Pyrexia
Clinical narrative: fever; couldn't move my arms or legs; Pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "My body goes crazy", "I was very sick". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; HYPOKINESIA (non-serious), outcome "unknown", described as "couldn't move my arms or legs"; PAIN (non-serious), outcome "recovered", described as "Pain". Therapeutic measures were taken as a result of pain.  Additional information: It was reported that patient received Cosentyx prescription the pain was gone. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 31Jul2021 15:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient's daughter and the patient, both got the vaccine yesterday at 3 o'clock. The rest of the day they felt good, no symptoms at all. Last night, they started with fever.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.