chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3-4 months out from the first dose and have not yet received the second dose.; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3-4 months out from the first dose and have not yet received the second dose.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history were reported.     On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3-4 months out from the first dose and have not yet received the second dose.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3-4 months out from the first dose and have not yet received the second dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment information not provided. No lab data has been provided by the reporter.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received first dose 23APR2021 and is now at the pharmacy to get the second dose (>35 days); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose 23APR2021 and is now at the pharmacy to get the second dose (>35 days)) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose 23APR2021 and is now at the pharmacy to get the second dose (>35 days)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose 23APR2021 and is now at the pharmacy to get the second dose (>35 days)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: first dosewas Moderna the second was Biontech; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (first dosewas Moderna the second was Biontech) 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 INTERCHANGE OF VACCINE PRODUCTS (first dosewas Moderna the second was Biontech). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (first dosewas Moderna the second was Biontech) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: answered yes to experiencing a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (answered yes to experiencing a side effect) 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 VACCINATION COMPLICATION (answered yes to experiencing a side effect). At the time of the report, VACCINATION COMPLICATION (answered yes to experiencing a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Vaccination site pain
Clinical narrative: it was worst than the 1st dose; she felt really bad,felt crappy all day long; she had a major headache that Tylenol wouldn't even make go away,super bad headache; body aches; the injection site ached for a few days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (it was worst than the 1st dose), FEELING ABNORMAL (she felt really bad,felt crappy all day long), HEADACHE (she had a major headache that Tylenol wouldn't even make go away,super bad headache), MYALGIA (body aches) and VACCINATION SITE PAIN (the injection site ached for a few days) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, LAMOTRIGINE for Antidepressant therapy, CLONAZEPAM for Anxiety, HYDROCHLOROTHIAZIDE for Blood pressure high, LISINOPRIL for Blood pressure management, TIZANIDINE for Muscle relaxant.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced FEELING ABNORMAL (it was worst than the 1st dose), FEELING ABNORMAL (she felt really bad,felt crappy all day long), HEADACHE (she had a major headache that Tylenol wouldn't even make go away,super bad headache), MYALGIA (body aches) and VACCINATION SITE PAIN (the injection site ached for a few days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Apr-2021, FEELING ABNORMAL (it was worst than the 1st dose), FEELING ABNORMAL (she felt really bad,felt crappy all day long), HEADACHE (she had a major headache that Tylenol wouldn't even make go away,super bad headache), MYALGIA (body aches) and VACCINATION SITE PAIN (the injection site ached for a few days) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable. No treatment medication provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Muscle twitching, Tremor
Clinical narrative: Muscle is contracting very hard at the site of the injections; Muscle is twitching; Muscle is shaking; Muscle is jumping and moving; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (Muscle is contracting very hard at the site of the injections), MUSCLE TWITCHING (Muscle is twitching), TREMOR (Muscle is shaking) and MUSCLE TWITCHING (Muscle is jumping and moving) 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 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE REACTION (Muscle is contracting very hard at the site of the injections), MUSCLE TWITCHING (Muscle is twitching), TREMOR (Muscle is shaking) and MUSCLE TWITCHING (Muscle is jumping and moving). At the time of the report, INJECTION SITE REACTION (Muscle is contracting very hard at the site of the injections), MUSCLE TWITCHING (Muscle is twitching), TREMOR (Muscle is shaking) and MUSCLE TWITCHING (Muscle is jumping and moving) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No concomitant medication was reported.  No treatment information was reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 007B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Hiatal hernia in July 2018. Concurrent medical conditions included Sinus infection. Concomitant products included CEFTRIAXONE SODIUM (ROCEPHIN) and AMOXICILLIN SODIUM (AMOXICILLIN [AMOXICILLIN SODIUM]) for Sinus infection.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced DIZZINESS (dizziness). The patient was treated with MECLIZINE [MECLOZINE] ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and MECLIZINE [MECLOZINE] for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has reported concomitant medications including unspecified blood pressure medication, unspecified cholesterol medication, unspecified allergy medication and unspecified acid reflux medication.   The patient reported experiencing dizziness within 20-30 minutes of receiving the first vaccine dose, which went away within 48 hours. The patient reported experiencing dizziness within 20-30 minutes of receiving the second vaccine dose, which has persisted. The patient reports that dizziness increases with reaching and bending, and that the prescribed Meclizine has been mildly effective.   This case was linked to MOD-2021-232615, MOD-2021-232615 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered vaccines which refroze; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccines which refroze) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) 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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccines which refroze). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccines which refroze) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No Treatment medications were provided. Healthcare provider, a clinic manager reports that they received 20 vials of the Moderna Covid-19 vaccine on 25May2021 from their local health department in frozen state. They used 10 vials in vaccination clinic. They were going to use the remaining 10 vials on 22Jun2021, in their vaccination clinic but they were informed by the health department that they do not transport the vaccines in frozen state, they always do in liquid state at 32 F.  The health department requested the clinic manager to call Moderna to know if these 10 vials were still viable.  The vials were still in the freezer  at -4F.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: I got very dizzy; im feling like my head is full and very painful; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I got very dizzy) and HEADACHE (im feling like my head is full and very painful) 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 DIZZINESS (I got very dizzy) and HEADACHE (im feling like my head is full and very painful). At the time of the report, DIZZINESS (I got very dizzy) and HEADACHE (im feling like my head is full and very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Muscle twitching, Vaccination complication, Vaccination site induration
Clinical narrative: muscle is twitching and shaking/muscle is jumping and moving; worse after second dose; muscle is contracting very hard at the site of the injections; side effect; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE TWITCHING (muscle is twitching and shaking/muscle is jumping and moving), VACCINATION COMPLICATION (worse after second dose), VACCINATION SITE INDURATION (muscle is contracting very hard at the site of the injections) and ADVERSE REACTION (side effect) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced MUSCLE TWITCHING (muscle is twitching and shaking/muscle is jumping and moving), VACCINATION COMPLICATION (worse after second dose), VACCINATION SITE INDURATION (muscle is contracting very hard at the site of the injections) and ADVERSE REACTION (side effect). At the time of the report, MUSCLE TWITCHING (muscle is twitching and shaking/muscle is jumping and moving), VACCINATION COMPLICATION (worse after second dose), VACCINATION SITE INDURATION (muscle is contracting very hard at the site of the injections) and ADVERSE REACTION (side effect) had not resolved.            No concomitant medications were provided by the Reporter. Patient has stated that he went to physical Therapist and confirmed it was just a muscle damage and not nerve damage and she massaged and suggested patient  to massage everyday to recover.   This case was linked to MOD-2021-233968 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Updated Reporter's E-mail and second name and Updated patient Identifiers and Updated onset of events and outcome as ongoing.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Suffering more intently with some of these; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Suffering more intently with some of these) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Suffering more intently with some of these). At the time of the report, VACCINATION COMPLICATION (Suffering more intently with some of these) had not resolved.            No concomitant medications were mentioned. No treatment details were reported. Action taken with mRNA-1273 Moderna COVID-19 Vaccine was not applicable
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: I got a call from the pharmacy saying 1st dose we got may have been expired.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I got a call from the pharmacy saying 1st dose we got may have been expired.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (I got a call from the pharmacy saying 1st dose we got may have been expired.). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (I got a call from the pharmacy saying 1st dose we got may have been expired.) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Patient states that she and her husband received both doses of the Moderna Covid-19 vaccine. Reports she received got a call from the pharmacy saying that their 1st dose may have come from an expired vaccine. She was asked to return for a 3rd dose and it would be treated like the1st dose. Patient don't know if it is right to get another dose. Concomitant product use was not provided by the reporter.   Treatment information was not provided   This case was linked to MOD-2021-232805 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2021: Follow-up received contains non-significant information
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Today there is a slight itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Today there is a slight itching) 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 20-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Today there is a slight itching). At the time of the report, PRURITUS (Today there is a slight itching) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Unspecific adverse event; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Unspecific adverse event) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Unspecific adverse event). At the time of the report, VACCINATION COMPLICATION (Unspecific adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment information not provided.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Eczema
Clinical narrative: worsening of eczema; This spontaneous case was reported by an other health care professional and describes the occurrence of ECZEMA (worsening of eczema) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and DUPILUMAB (DUPIXENT) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (worsening of eczema). At the time of the report, ECZEMA (worsening of eczema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was provided by the Reporter. No Treatment Information was provided by the Reporter.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Intentional dose omission, Nausea
Clinical narrative: dizzy; occasional and pain in the left arm; did not have a dose due to Moderna (COVID-19 vaccine,; tingling in her legs when she lay down at night that lasted couple of; nauseous; fever; chills; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jun-2021 and was forwarded to Moderna on 24-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), PAIN IN EXTREMITY (occasional and pain in the left arm), INTENTIONAL DOSE OMISSION (did not have a dose due to Moderna (COVID-19 vaccine,), PARAESTHESIA (tingling in her legs when she lay down at night that lasted couple of) and NAUSEA (nauseous) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy), PAIN IN EXTREMITY (occasional and pain in the left arm), INTENTIONAL DOSE OMISSION (did not have a dose due to Moderna (COVID-19 vaccine,), PARAESTHESIA (tingling in her legs when she lay down at night that lasted couple of), NAUSEA (nauseous), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, DIZZINESS (dizzy), PAIN IN EXTREMITY (occasional and pain in the left arm), INTENTIONAL DOSE OMISSION (did not have a dose due to Moderna (COVID-19 vaccine,), PARAESTHESIA (tingling in her legs when she lay down at night that lasted couple of), NAUSEA (nauseous), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: dizzy; occasional and pain in the left arm; did not have a dose due to Moderna (COVID-19 vaccine,; tingling in her legs when she lay down at night that lasted couple of; nauseous; fever; chills; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jun-2021 and was forwarded to Moderna on 24-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), PAIN IN EXTREMITY (occasional and pain in the left arm), INTENTIONAL DOSE OMISSION (did not have a dose due to Moderna (COVID-19 vaccine,), PARAESTHESIA (tingling in her legs when she lay down at night that lasted couple of) and NAUSEA (nauseous) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy), PAIN IN EXTREMITY (occasional and pain in the left arm), INTENTIONAL DOSE OMISSION (did not have a dose due to Moderna (COVID-19 vaccine,), PARAESTHESIA (tingling in her legs when she lay down at night that lasted couple of), NAUSEA (nauseous), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, DIZZINESS (dizzy), PAIN IN EXTREMITY (occasional and pain in the left arm), INTENTIONAL DOSE OMISSION (did not have a dose due to Moderna (COVID-19 vaccine,), PARAESTHESIA (tingling in her legs when she lay down at night that lasted couple of), NAUSEA (nauseous), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, COVID-19, Cough, Dyspnoea
Clinical narrative: COVID-19; Difficulty breathing; Cough; Wheezing; Feeling very weak; Headache; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DYSPNOEA (Difficulty breathing), COUGH (Cough), WHEEZING (Wheezing) and ASTHENIA (Feeling very weak) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes (Diagnosis: 1999, Insulin dependent) and Obesity (Most recent BMI, if known: 30-33).   On 13-Mar-2021 at 3:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19), DYSPNOEA (Difficulty breathing), COUGH (Cough), WHEEZING (Wheezing), ASTHENIA (Feeling very weak), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), DYSPNOEA (Difficulty breathing), COUGH (Cough), WHEEZING (Wheezing), ASTHENIA (Feeling very weak), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature (95.5-97.5): unknown (Inconclusive) unknown.   Patient stated that she took pocket mouth mask and an emergency use bag with the help of her husband for breathing difficulty patient stated that due to fear she did not went hospital. Patient had obesity with body mass index30 to 33 No Concomitant medication reported by the reporter Patient experienced COVID-19 March to April   This case was linked to MOD-2021-032045, MOD-2021-032045 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting, Wheezing
Clinical narrative: COVID-19; Difficulty breathing; Cough; Wheezing; Feeling very weak; Headache; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DYSPNOEA (Difficulty breathing), COUGH (Cough), WHEEZING (Wheezing) and ASTHENIA (Feeling very weak) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes (Diagnosis: 1999, Insulin dependent) and Obesity (Most recent BMI, if known: 30-33).   On 13-Mar-2021 at 3:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19), DYSPNOEA (Difficulty breathing), COUGH (Cough), WHEEZING (Wheezing), ASTHENIA (Feeling very weak), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), DYSPNOEA (Difficulty breathing), COUGH (Cough), WHEEZING (Wheezing), ASTHENIA (Feeling very weak), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature (95.5-97.5): unknown (Inconclusive) unknown.   Patient stated that she took pocket mouth mask and an emergency use bag with the help of her husband for breathing difficulty patient stated that due to fear she did not went hospital. Patient had obesity with body mass index30 to 33 No Concomitant medication reported by the reporter Patient experienced COVID-19 March to April   This case was linked to MOD-2021-032045, MOD-2021-032045 (Patient Link).
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination complication, Vaccination site discomfort, Vaccination site erythema, Vaccination site pain
Clinical narrative: overall body stiffness; tightness on the injection arm; discomfort the injection arm; tingling on the injection arm; itchiness on the injection arm; redness on the injection arm; tenderness on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (overall body stiffness), VACCINATION COMPLICATION (tightness on the injection arm), VACCINATION SITE DISCOMFORT (discomfort the injection arm), VACCINATION SITE PARAESTHESIA (tingling on the injection arm) and VACCINATION SITE PRURITUS (itchiness on the injection arm) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (overall body stiffness), VACCINATION COMPLICATION (tightness on the injection arm), VACCINATION SITE DISCOMFORT (discomfort the injection arm), VACCINATION SITE PARAESTHESIA (tingling on the injection arm), VACCINATION SITE PRURITUS (itchiness on the injection arm), VACCINATION SITE ERYTHEMA (redness on the injection arm) and VACCINATION SITE PAIN (tenderness on the injection arm). At the time of the report, MUSCULOSKELETAL STIFFNESS (overall body stiffness), VACCINATION COMPLICATION (tightness on the injection arm), VACCINATION SITE DISCOMFORT (discomfort the injection arm), VACCINATION SITE PARAESTHESIA (tingling on the injection arm), VACCINATION SITE PRURITUS (itchiness on the injection arm), VACCINATION SITE ERYTHEMA (redness on the injection arm) and VACCINATION SITE PAIN (tenderness on the injection arm) outcome was unknown.            This case was linked to MOD-2021-031381 (Patient Link).
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site paraesthesia, Vaccination site pruritus
Clinical narrative: overall body stiffness; tightness on the injection arm; discomfort the injection arm; tingling on the injection arm; itchiness on the injection arm; redness on the injection arm; tenderness on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (overall body stiffness), VACCINATION COMPLICATION (tightness on the injection arm), VACCINATION SITE DISCOMFORT (discomfort the injection arm), VACCINATION SITE PARAESTHESIA (tingling on the injection arm) and VACCINATION SITE PRURITUS (itchiness on the injection arm) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (overall body stiffness), VACCINATION COMPLICATION (tightness on the injection arm), VACCINATION SITE DISCOMFORT (discomfort the injection arm), VACCINATION SITE PARAESTHESIA (tingling on the injection arm), VACCINATION SITE PRURITUS (itchiness on the injection arm), VACCINATION SITE ERYTHEMA (redness on the injection arm) and VACCINATION SITE PAIN (tenderness on the injection arm). At the time of the report, MUSCULOSKELETAL STIFFNESS (overall body stiffness), VACCINATION COMPLICATION (tightness on the injection arm), VACCINATION SITE DISCOMFORT (discomfort the injection arm), VACCINATION SITE PARAESTHESIA (tingling on the injection arm), VACCINATION SITE PRURITUS (itchiness on the injection arm), VACCINATION SITE ERYTHEMA (redness on the injection arm) and VACCINATION SITE PAIN (tenderness on the injection arm) outcome was unknown.            This case was linked to MOD-2021-031381 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Pruritus, Rash
Clinical narrative: ITCH; SWELLING AROUND THE RASH.; Chest tightness; rash; chills; cough; This spontaneous case was reported by a nurse and describes the occurrence of RASH (rash), CHILLS (chills), PRURITUS (ITCH), COUGH (cough) and SWELLING (SWELLING AROUND THE RASH.) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 07-Jan-2021 to 21-Jan-2021. Concurrent medical conditions included Allergy to antibiotic, Ragweed allergy, Drug allergy, Diabetes in 2006, Venous ulcer NOS in 2018, Blood pressure high in 1998 and Venous insufficiency (Venous insufficiency both feet) in 2019. Concomitant products included VITAMIN B12 NOS for Anemia, ASPIRIN [ACETYLSALICYLIC ACID] for Anticoagulant therapy, ATENOLOL and HYDROCHLOROTHIAZIDE, SPIRONOLACTONE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) for Blood pressure management, INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN 70/30) for Diabetes, VITAMIN D NOS and FERROUS FUMARATE, VITAMINS NOS (ONE A DAY PLUS IRON) for an unknown indication.    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 CHILLS (chills) and COUGH (cough). On 05-Mar-2021, the patient experienced RASH (rash). On an unknown date, the patient experienced PRURITUS (ITCH), SWELLING (SWELLING AROUND THE RASH.) and CHEST DISCOMFORT (Chest tightness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 04-Mar-2021 to 14-Mar-2021 for Adverse event, at a dose of 25 milligram once a day and TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE [TRIAMCINOLONE ACETONIDE]) (topical) from 04-Mar-2021 to 14-Mar-2021 for Adverse event, at a dose of .1%. On 12-Mar-2021, CHEST DISCOMFORT (Chest tightness) had resolved. On 14-Mar-2021, RASH (rash), CHILLS (chills) and COUGH (cough) had resolved. At the time of the report, PRURITUS (ITCH) and SWELLING (SWELLING AROUND THE RASH.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-026758 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received 30-Jun-21:  Added relevant medical history, updated concomitant medications, added treatment medications, added date recovered.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: ITCH; SWELLING AROUND THE RASH.; Chest tightness; rash; chills; cough; This spontaneous case was reported by a nurse and describes the occurrence of RASH (rash), CHILLS (chills), PRURITUS (ITCH), COUGH (cough) and SWELLING (SWELLING AROUND THE RASH.) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 07-Jan-2021 to 21-Jan-2021. Concurrent medical conditions included Allergy to antibiotic, Ragweed allergy, Drug allergy, Diabetes in 2006, Venous ulcer NOS in 2018, Blood pressure high in 1998 and Venous insufficiency (Venous insufficiency both feet) in 2019. Concomitant products included VITAMIN B12 NOS for Anemia, ASPIRIN [ACETYLSALICYLIC ACID] for Anticoagulant therapy, ATENOLOL and HYDROCHLOROTHIAZIDE, SPIRONOLACTONE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) for Blood pressure management, INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN 70/30) for Diabetes, VITAMIN D NOS and FERROUS FUMARATE, VITAMINS NOS (ONE A DAY PLUS IRON) for an unknown indication.    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 CHILLS (chills) and COUGH (cough). On 05-Mar-2021, the patient experienced RASH (rash). On an unknown date, the patient experienced PRURITUS (ITCH), SWELLING (SWELLING AROUND THE RASH.) and CHEST DISCOMFORT (Chest tightness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 04-Mar-2021 to 14-Mar-2021 for Adverse event, at a dose of 25 milligram once a day and TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE [TRIAMCINOLONE ACETONIDE]) (topical) from 04-Mar-2021 to 14-Mar-2021 for Adverse event, at a dose of .1%. On 12-Mar-2021, CHEST DISCOMFORT (Chest tightness) had resolved. On 14-Mar-2021, RASH (rash), CHILLS (chills) and COUGH (cough) had resolved. At the time of the report, PRURITUS (ITCH) and SWELLING (SWELLING AROUND THE RASH.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-026758 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received 30-Jun-21:  Added relevant medical history, updated concomitant medications, added treatment medications, added date recovered.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: is it safe to get 2nd Moderna shot after 6 weeks?; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (is it safe to get 2nd Moderna shot after 6 weeks?) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (is it safe to get 2nd Moderna shot after 6 weeks?). On 23-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (is it safe to get 2nd Moderna shot after 6 weeks?) had resolved.            No concomitant medication was reported. No treatment drug details was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Illness, Myalgia, Pain, Vomiting, Weight decreased
Clinical narrative: I got so sick; Pain; Weight has dropped from 239 down to 178; my body is aching; Vomiting has been non stop; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I got so sick), PAIN (Pain), WEIGHT DECREASED (Weight has dropped from 239 down to 178), MYALGIA (my body is aching) and VOMITING (Vomiting has been non stop) 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 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got so sick), PAIN (Pain), WEIGHT DECREASED (Weight has dropped from 239 down to 178), MYALGIA (my body is aching) and VOMITING (Vomiting has been non stop). At the time of the report, ILLNESS (I got so sick), PAIN (Pain), WEIGHT DECREASED (Weight has dropped from 239 down to 178), MYALGIA (my body is aching) and VOMITING (Vomiting has been non stop) had not resolved.            Concomitant information was not reported. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Drowsiness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsiness) 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 SOMNOLENCE (Drowsiness). At the time of the report, SOMNOLENCE (Drowsiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report side effect) 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 VACCINATION COMPLICATION (Report side effect). At the time of the report, VACCINATION COMPLICATION (Report side effect) 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 assessment. treatment medications were not reported no concomitant medications were reported     This case was linked to MOD21-086996 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arachnoid web, Feeling abnormal, Pyrexia, Spondylitis
Clinical narrative: Arthritis in lower back; Arachnoid web of spine; Felt like hit by truck/slept; Fever; This spontaneous case was reported by a physician and describes the occurrence of SPONDYLITIS (Arthritis in lower back), ARACHNOID WEB (Arachnoid web of spine), FEELING ABNORMAL (Felt like hit by truck/slept) and PYREXIA (Fever) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection, solution for Hidradenitis suppurativa.    No relevant medical history was provided.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced ARACHNOID WEB (Arachnoid web of spine), FEELING ABNORMAL (Felt like hit by truck/slept) and PYREXIA (Fever). On an unknown date, the patient experienced SPONDYLITIS (Arthritis in lower back). The patient was treated with HYDROCORTISONE (CORTIZONE [HYDROCORTISONE]) for Adverse event, at a dose of 2 dosage form. In 2021, FEELING ABNORMAL (Felt like hit by truck/slept) and PYREXIA (Fever) had resolved. At the time of the report, SPONDYLITIS (Arthritis in lower back) had not resolved and ARACHNOID WEB (Arachnoid web of spine) 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.   This report was received via another manufacture which had received an solicited adverse event report from a consumer enrolled in clinical study, unknown type.  Concomitant medication information was not provided.  Additional treatment medication included a nerve block, unknown location.    The patient also reported that he slept.  Case is getting automatically downgraded as the SD states the case is other medically important condition and events were not IME listed.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain, Feeding disorder
Clinical narrative: not able to eat; belly hurts/abdominal pain/pain in stomach; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jun-2021 and was forwarded to Moderna on 24-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of FEEDING DISORDER (not able to eat) and ABDOMINAL PAIN (belly hurts/abdominal pain/pain in stomach) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.    Co-suspect product included non-company product PANCREATIN (CREON) for Chronic pancreatitis.    The patient's past medical history included Pancreas disorder (Hospitalized because of problems with pancreas). Previously administered products included for an unreported indication: AMOXICILLIN and macrodantin. Concurrent medical conditions included Allergy to antibiotic (Macrodantin  manifested by rash) and Allergy (Amoxicillin manifested by bad rash).   In October 2020, the patient started PANCREATIN (CREON) (unknown route) 3 capsules with meals 1 capsule with snacks. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced FEEDING DISORDER (not able to eat) and ABDOMINAL PAIN (belly hurts/abdominal pain/pain in stomach). At the time of the report, FEEDING DISORDER (not able to eat) and ABDOMINAL PAIN (belly hurts/abdominal pain/pain in stomach) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had been out of CREON for one and half days and could not find the CREON because of the shipment from her pharmacy was late. Patient was unable to eat  since june 10 as she needs CREON tablets to digest the food. No treatment information was provided by the reporter. No concomitant medication was provided by the reporter.