chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of insomnia (can't sleep at night) and myalgia (left arm is still extremely sore) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced insomnia (can't sleep at night) and myalgia (left arm is still extremely sore). At the time of the report, insomnia (can't sleep at night) and myalgia (left arm is still extremely sore) outcome: unknown. No concomitant medication or treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 20 expired doses administered to 20 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 expired doses administered to 20 patients) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 expired doses administered to 20 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 expired doses administered to 20 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Wrong product administered
Clinical narrative: patient received the Pfizer vaccine already,received moderna vaccine; non-Moderna COVID19 Vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (non-Moderna COVID19 Vaccine administered) and OVERDOSE (patient received the Pfizer vaccine already,received moderna vaccine) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced WRONG PRODUCT ADMINISTERED (non-Moderna COVID19 Vaccine administered). On an unknown date, the patient experienced OVERDOSE (patient received the Pfizer vaccine already,received moderna vaccine). On 27-Jan-2021, WRONG PRODUCT ADMINISTERED (non-Moderna COVID19 Vaccine administered) had resolved. At the time of the report, OVERDOSE (patient received the Pfizer vaccine already,received moderna vaccine) 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.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after the expiry time allowed in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose from a vial that was expired/vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired/vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired/vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature). On 22-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired/vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature) had resolved.        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 relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-114680 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia
Clinical narrative: Spanish speaking caller received the 1st dose of the Moderna vaccine on 10Apr2021 and hasn't received the 2nd dose; He had fever for 2 or 3 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Spanish speaking caller received the 1st dose of the Moderna vaccine on 10Apr2021 and hasn't received the 2nd dose) and PYREXIA (He had fever for 2 or 3 days after the 1st dose) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (He had fever for 2 or 3 days after the 1st dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Spanish speaking caller received the 1st dose of the Moderna vaccine on 10Apr2021 and hasn't received the 2nd dose). The patient was treated with IBUPROFEN (ADVEL) for Fever, at an unspecified dose and frequency. On 13-Apr-2021, PYREXIA (He had fever for 2 or 3 days after the 1st dose) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Spanish speaking caller received the 1st dose of the Moderna vaccine on 10Apr2021 and hasn't received the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Nausea
Clinical narrative: Decreased appetite; Tiredness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Decreased appetite), FATIGUE (Tiredness) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was COVID positive.) in January 2021.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DECREASED APPETITE (Decreased appetite), FATIGUE (Tiredness) and NAUSEA (Nausea). In March 2021, DECREASED APPETITE (Decreased appetite), FATIGUE (Tiredness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.   This case was linked to MOD-2021-233495 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after the expiry time allowed in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge) 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.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature increased, Decreased appetite, Headache, Myalgia
Clinical narrative: Loss of appetite; Body aches all over; Loss of taste; Headache which doesn't go away; Fever; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite), HEADACHE (Headache which doesn't go away), PYREXIA (Fever) and MYALGIA (Body aches all over) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B214 (or 9) and C41C21A) for COVID-19 vaccination.     No historical condition was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced AGEUSIA (Loss of taste), HEADACHE (Headache which doesn't go away) and PYREXIA (Fever). On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite) and MYALGIA (Body aches all over). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at a dose of 500 mg and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 200 mg. At the time of the report, AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite), HEADACHE (Headache which doesn't go away), PYREXIA (Fever) and MYALGIA (Body aches all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Body temperature increased: 99.3 (High) High and 103.5 (High) High.         No relevant concomitant medication was reported
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Loss of appetite; Body aches all over; Loss of taste; Headache which doesn't go away; Fever; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite), HEADACHE (Headache which doesn't go away), PYREXIA (Fever) and MYALGIA (Body aches all over) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B214 (or 9) and C41C21A) for COVID-19 vaccination.     No historical condition was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced AGEUSIA (Loss of taste), HEADACHE (Headache which doesn't go away) and PYREXIA (Fever). On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite) and MYALGIA (Body aches all over). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at a dose of 500 mg and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 200 mg. At the time of the report, AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite), HEADACHE (Headache which doesn't go away), PYREXIA (Fever) and MYALGIA (Body aches all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Body temperature increased: 99.3 (High) High and 103.5 (High) High.         No relevant concomitant medication was reported
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: small swelling 12 hours after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (small swelling 12 hours after the first shot) 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 SWELLING (small swelling 12 hours after the first shot). At the time of the report, SWELLING (small swelling 12 hours after the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported by reporter. No treatment medication reported by reporter.   Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache
Clinical narrative: It's becoming debilitating; horrible head aches/ headaches come and go; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (It's becoming debilitating) and HEADACHE (horrible head aches/ headaches come and go) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (It's becoming debilitating) and HEADACHE (horrible head aches/ headaches come and go). At the time of the report, ASTHENIA (It's becoming debilitating) outcome was unknown and HEADACHE (horrible head aches/ headaches come and go) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter. The patient reported that his headaches were getting a little bit better. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up received on 05-AUG-2021 and contains no new information. On 05-Aug-2021: follow up received included information about the outcome of the event (Headache) and was updated to recovering/resolving.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Paraesthesia
Clinical narrative: metallic taste in my mouth; got very light headed; tingly; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in my mouth), DIZZINESS (got very light headed) and PARAESTHESIA (tingly) 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 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced DYSGEUSIA (metallic taste in my mouth), DIZZINESS (got very light headed) and PARAESTHESIA (tingly). At the time of the report, DYSGEUSIA (metallic taste in my mouth), DIZZINESS (got very light headed) and PARAESTHESIA (tingly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Arm swollen around the vaccine injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm swollen around the vaccine injection) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Arm swollen around the vaccine injection). At the time of the report, VACCINATION SITE SWELLING (Arm swollen around the vaccine injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore achy arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore achy arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy, Sulfonamide allergy, Latex allergy and Dust allergy. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore achy arm). At the time of the report, PAIN IN EXTREMITY (sore achy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Description of Event or Problem:Patient has been taking a blood thinner Xarelto to prevent blood clots.  No treatment information was reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchiness arm, back,side and leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchiness arm, back,side and leg) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     Concomitant products included METHYLPREDNISOLONE for Itching.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced PRURITUS (itchiness arm, back,side and leg). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and LORATADINE (24 HOUR ALLERGY REMEDY) at a dose of 5 ml twice a day. At the time of the report, PRURITUS (itchiness arm, back,side and leg) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included Blood Pressure medication. Patient reported that on prior to receiving the vaccine he experience itching on his arm, back, side and legs that could have come from poison ivy or oak which his health care provider prescribed Methylprednisolone which he took 21 pills during a 5 days. After the 5 days on the Methylprednisolone and receiving the vaccine the patient reported still experiencing the itchiness. Patient reported that his health care provider was going to be prescribing him "hydroxine" tablet soon.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: COVID arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (COVID arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002537) for COVID-19 vaccination.     Concomitant products included MIRTAZAPINE (REMERON) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION COMPLICATION (COVID arm). At the time of the report, VACCINATION COMPLICATION (COVID arm) outcome was unknown. 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.   No treatment was received for the event experienced by the patient.  Patient stated that the reaction lasted up until the second dose of vaccine.   This case was linked to MOD-2021-231049 (Patient Link).
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: couldn't receive my 2nd dose 1 month apart as recommended; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jun-2021 and was forwarded to Moderna on 23-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (couldn't receive my 2nd dose 1 month apart as recommended) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-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 PRODUCT DOSE OMISSION ISSUE (couldn't receive my 2nd dose 1 month apart as recommended). At the time of the report, PRODUCT DOSE OMISSION ISSUE (couldn't receive my 2nd dose 1 month apart as recommended) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment medication were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination complication
Clinical narrative: I did not feel very well after neither of the vaccine; A rash appeared all over, itchy. It started after the vaccine was given and progressed day after day; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (A rash appeared all over, itchy. It started after the vaccine was given and progressed day after day) and VACCINATION COMPLICATION (I did not feel very well after neither of the vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 017c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced RASH PRURITIC (A rash appeared all over, itchy. It started after the vaccine was given and progressed day after day). On an unknown date, the patient experienced VACCINATION COMPLICATION (I did not feel very well after neither of the vaccine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (A rash appeared all over, itchy. It started after the vaccine was given and progressed day after day) and VACCINATION COMPLICATION (I did not feel very well after neither of the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) not applicable.    This case was linked to MOD-2021-234333, MOD-2021-234333 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Philadelphia chromosome positive, Platelet count, Platelet count increased, Therapeutic response unexpected, White blood cell count
Clinical narrative: Fiscally noticed that a rash that was caused by the medicine went away; White blood cell count increased; Platelet count increased; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Fiscally noticed that a rash that was caused by the medicine went away), WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased) and PLATELET COUNT INCREASED (Platelet count increased) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic myeloid leukemia since 20-Jun-2000 and Rash. Concomitant products included IMATINIB for Leukaemia, ACETYLSALICYLIC ACID (BABY ASPIRIN), LOSARTAN, TORSEMIDE, ATORVASTATIN and ALLOPURINOL for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-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 experienced THERAPEUTIC RESPONSE UNEXPECTED (Fiscally noticed that a rash that was caused by the medicine went away), WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased) and PLATELET COUNT INCREASED (Platelet count increased). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Fiscally noticed that a rash that was caused by the medicine went away) had resolved and WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased) and PLATELET COUNT INCREASED (Platelet count increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Philadelphia chromosome positive: inconclusive (Inconclusive) measures bad white cells. On an unknown date, Platelet count: high (High) High. On an unknown date, White blood cell count: increased (High) Increased white cells by 20% after two weeks from second dose.         Patient had event after increasing dose of imatinib  from 300 mg to 400 mg. Increase was on 01 June. Patient had another blood test and complete BCR-ABL to check defective blood cells and result by 20 July.  Action taken with mRNA-1273 in response to the event was not applicable  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-233328 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-JUL-2021 and does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: Fiscally noticed that a rash that was caused by the medicine went away; White blood cell count increased; Platelet count increased; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Fiscally noticed that a rash that was caused by the medicine went away), WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased) and PLATELET COUNT INCREASED (Platelet count increased) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic myeloid leukemia since 20-Jun-2000 and Rash. Concomitant products included IMATINIB for Leukaemia, ACETYLSALICYLIC ACID (BABY ASPIRIN), LOSARTAN, TORSEMIDE, ATORVASTATIN and ALLOPURINOL for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-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 experienced THERAPEUTIC RESPONSE UNEXPECTED (Fiscally noticed that a rash that was caused by the medicine went away), WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased) and PLATELET COUNT INCREASED (Platelet count increased). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Fiscally noticed that a rash that was caused by the medicine went away) had resolved and WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased) and PLATELET COUNT INCREASED (Platelet count increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Philadelphia chromosome positive: inconclusive (Inconclusive) measures bad white cells. On an unknown date, Platelet count: high (High) High. On an unknown date, White blood cell count: increased (High) Increased white cells by 20% after two weeks from second dose.         Patient had event after increasing dose of imatinib  from 300 mg to 400 mg. Increase was on 01 June. Patient had another blood test and complete BCR-ABL to check defective blood cells and result by 20 July.  Action taken with mRNA-1273 in response to the event was not applicable  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-233328 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-JUL-2021 and does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of gait disturbance (he couldn't walk after the vaccine) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. March 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced gait disturbance (he couldn't walk after the vaccine). At the time of the report, gait disturbance (he couldn't walk after the vaccine) outcome:  unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-233364 (patient link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after the expiry time allowed in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No medical history were reported. .    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist is unaware if patient is taking other medications. HCP is unaware patient received vaccine after the expiry time allow in the fridge. Safety consent to follow up with the pharmacist received. No concomitants medication were provided. No treatment medication were provided. No lab data has been provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Oral discomfort, Pharyngeal erythema, Tongue disorder
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of oral discomfort (feeling of a scalded mouth), tongue disorder (raised taste buds) and pharyngeal erythema (very red patchy throat) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced oral discomfort (feeling of a scalded mouth), tongue disorder (raised taste buds) and pharyngeal erythema (very red patchy throat). At the time of the report, oral discomfort (feeling of a scalded mouth), tongue disorder (raised taste buds) and pharyngeal erythema (very red patchy throat) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Feeling hot, Headache, Intentional product use issue, Parosmia
Clinical narrative: Hives; Itching; Feeling hot; cough; runny nose; heightened sense of smell; phlegm; skin rash; Headache; still have not got my second shot because I still have Symptoms; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PRURITUS (Itching), FEELING HOT (Feeling hot), COUGH (cough) and RHINORRHOEA (runny nose) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy since 1996.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), PRURITUS (Itching), FEELING HOT (Feeling hot), COUGH (cough), RHINORRHOEA (runny nose), PAROSMIA (heightened sense of smell), PRODUCTIVE COUGH (phlegm), RASH (skin rash), HEADACHE (Headache) and INTENTIONAL PRODUCT USE ISSUE (still have not got my second shot because I still have Symptoms). At the time of the report, URTICARIA (Hives), PRURITUS (Itching), FEELING HOT (Feeling hot), COUGH (cough), RHINORRHOEA (runny nose), PAROSMIA (heightened sense of smell), PRODUCTIVE COUGH (phlegm), RASH (skin rash) and HEADACHE (Headache) had not resolved and INTENTIONAL PRODUCT USE ISSUE (still have not got my second shot because I still have Symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  information about concomitant and treatment medication was provided by reporter   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received contains information that patient has not received second shot yet because he still has symptoms of first dose, added event - Intentional deviation from dosage regimen, allergic to penicillin.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Pruritus, Rash, Rhinorrhoea, Urticaria
Clinical narrative: Hives; Itching; Feeling hot; cough; runny nose; heightened sense of smell; phlegm; skin rash; Headache; still have not got my second shot because I still have Symptoms; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PRURITUS (Itching), FEELING HOT (Feeling hot), COUGH (cough) and RHINORRHOEA (runny nose) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy since 1996.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), PRURITUS (Itching), FEELING HOT (Feeling hot), COUGH (cough), RHINORRHOEA (runny nose), PAROSMIA (heightened sense of smell), PRODUCTIVE COUGH (phlegm), RASH (skin rash), HEADACHE (Headache) and INTENTIONAL PRODUCT USE ISSUE (still have not got my second shot because I still have Symptoms). At the time of the report, URTICARIA (Hives), PRURITUS (Itching), FEELING HOT (Feeling hot), COUGH (cough), RHINORRHOEA (runny nose), PAROSMIA (heightened sense of smell), PRODUCTIVE COUGH (phlegm), RASH (skin rash) and HEADACHE (Headache) had not resolved and INTENTIONAL PRODUCT USE ISSUE (still have not got my second shot because I still have Symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  information about concomitant and treatment medication was provided by reporter   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received contains information that patient has not received second shot yet because he still has symptoms of first dose, added event - Intentional deviation from dosage regimen, allergic to penicillin.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
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 PRODUCT DOSE OMISSION ISSUE (3-4 months out from the first dose and have not yet received the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PRODUCT DOSE OMISSION ISSUE (3-4 months out from the first dose and have not yet received the second dose). On 31-Mar-2021, PRODUCT DOSE OMISSION ISSUE (3-4 months out from the first dose and have not yet received the second dose) had resolved.        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 provided.   This case was linked to MOD-2021-233418 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hot flush
Clinical narrative: Hot Flashes; Feeling Tired; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot Flashes) and FATIGUE (Feeling Tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032D21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included LAVANDULA ANGUSTIFOLIA ESSENTIAL OIL (LAVELA WS 1265) for Anxiety.(homeopathic)   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced FATIGUE (Feeling Tired). On an unknown date, the patient experienced HOT FLUSH (Hot Flashes). On 14-Apr-2021, FATIGUE (Feeling Tired) had resolved. At the time of the report, HOT FLUSH (Hot Flashes) outcome was unknown.            The patient did not take any medication to help with the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received on 21 Jul 2021. contains non significant information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and FATIGUE (fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 021A20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jun-2021, the patient experienced PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2021, SARS-CoV-2 test: (Positive) positive.         No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter. Patient states that  she was grateful that she receive the vaccine and she would like to be part of a documentary to show how people with vaccine are not affected by Covid-19.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (received an expired dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 049C21A) for COVID-19 vaccination. No medical history reported. On May 25, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 22, 2021, patient administered expired product (received an expired dose). At the time of the report, administered expired product (received an expired dose) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medication, treatment information or lab data.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose from a vial that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired) 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a dose from a vial that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial that was expired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial that was expired). On 22-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial that was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose from a vial that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired) had resolved.        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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after the expiry time allowed in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist stated she is on Medication but no concomitant medications were mentioned. No treatment details were reported.