chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypertension
Clinical narrative: Alien Arm Syndrome; feel off when it happens; I feel Dizzy/Light headedness; she felt tired; Blood Pressure went up really high/ blood pressure increased to >200/102 mmHg/ BP increases; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (Blood Pressure went up really high/ blood pressure increased to >200/102 mmHg/ BP increases), ALIEN LIMB SYNDROME (Alien Arm Syndrome), FEELING ABNORMAL (feel off when it happens), DIZZINESS (I feel Dizzy/Light headedness) and FATIGUE (she felt tired) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERTENSION (Blood Pressure went up really high/ blood pressure increased to >200/102 mmHg/ BP increases). On an unknown date, the patient experienced ALIEN LIMB SYNDROME (Alien Arm Syndrome), FEELING ABNORMAL (feel off when it happens), DIZZINESS (I feel Dizzy/Light headedness) and FATIGUE (she felt tired). At the time of the report, HYPERTENSION (Blood Pressure went up really high/ blood pressure increased to >200/102 mmHg/ BP increases) and DIZZINESS (I feel Dizzy/Light headedness) had not resolved and ALIEN LIMB SYNDROME (Alien Arm Syndrome), FEELING ABNORMAL (feel off when it happens) and FATIGUE (she felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2022, Blood pressure measurement: increased to >200/102 mmHg.. On 15-Mar-2022, Electrocardiogram: Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient reported that she received 3 doses of Moderna COVID-19 vaccine. After the first 2 vaccines she felt tired and she did not have any symptoms. After the 3rd shot her Blood Pressure went up really high and after that she started having symptoms every month right before her period. She went to the doctor and was diagnosed with Alien Arm Syndrome but that was not exactly what was happening. That was the closest diagnosis they could come up with. She stated, her symptoms restarted every month right before the period, Blood pressure increased, felt dizzy, light Headed, and felt off when it happened.  No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Caller declined providing medical history. Caller reports they tested positive before back in September 2022.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE and Influenza (at doctor's office). Past adverse reactions to the above products included No adverse event with Influenza and PFIZER BIONTECH COVID-19 VACCINE.    On 06-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 11-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, SARS-CoV-2 test: Positive. On 12-Jan-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was reported. Patient's all other vaccines were Pfizer. Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. On 11-Jan-2023, patient started having cold symptoms. On 12-Jan-2023, she experienced extreme body pain, fatigue and chills. She tested herself and was positive for COVID on 12-Jan-2023. No treatment information was reported.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Antibody test, COVID-19, COVID-19 immunisation, Interchange of vaccine products
Clinical narrative: Suspected COVID-19 infection/ got COVID-19; Revaccination with different covid-19 vaccine; Interchange of vaccine products; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Suspected COVID-19 infection/ got COVID-19), COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    The patient's past medical history included Kidney transplant.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Suspected COVID-19 infection/ got COVID-19), COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 (Suspected COVID-19 infection/ got COVID-19), COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Not developed any antibodies.         No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. The reporter stated "I got JJ first shot then the moderna, got tested for antibodies because I have had a kidney transplant found out I didn´t develop any antibodies. One week later I got COVID-19. Lucky it was a mild case so I was ok.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Type 2 diabetes mellitus
Clinical narrative: I have become type 2 diabetic since vaccinated; covid-19 infection; This spontaneous case was reported by a patient and describes the occurrence of TYPE 2 DIABETES MELLITUS (I have become type 2 diabetic since vaccinated) and COVID-19 (covid-19 infection) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Bipolar affective disorder and Fruit allergy (Apples pistachios).   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 09-Sep-2021, the patient experienced TYPE 2 DIABETES MELLITUS (I have become type 2 diabetic since vaccinated) (seriousness criteria hospitalization and medically significant) and COVID-19 (covid-19 infection) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to COVID-19 and TYPE 2 DIABETES MELLITUS. The patient was treated with INSULIN at an unspecified dose and frequency. At the time of the report, TYPE 2 DIABETES MELLITUS (I have become type 2 diabetic since vaccinated) and COVID-19 (covid-19 infection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: Positive. On 17-Nov-2022, SARS-CoV-2 test: (Negative) Nasal Swab.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was reported. Co- suspect was reported as Phizer sucrose Bivalent, dose 3 (left arm)  Company comment: This spontaneous case concerns a 37-years-old male patient, with no relevant reported medical history, who experienced the unexpected serious (hospitalization and medically significant) event of  Type 2 diabetes mellitus and unexpected serious (medically significant) event of COVID-19 with Positive SARS-CoV-2 test that occurred on unspecified days after receiving second dose of mRNA-1273 vaccine.The events outcome was reported as not recovered.The patient was treated with INSULIN  No information on risk factors, detailed clinical course, investigations, concomitant medication, and treatment received are available for review. The causality of the event COVID-19 was assessed as not applicable, due to lack of biologic plausibility. The event might be explained by current pandemic outbreak. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: It was reported the patient had a DVT; pulmonary embolism; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (It was reported the patient had a DVT) and PULMONARY EMBOLISM (pulmonary embolism) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced DEEP VEIN THROMBOSIS (It was reported the patient had a DVT) (seriousness criterion medically significant) and PULMONARY EMBOLISM (pulmonary embolism) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (It was reported the patient had a DVT) and PULMONARY EMBOLISM (pulmonary embolism) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided.  On an unspecified date of 2022, patient was administered with first booster dose of Moderna COVID-19 vaccine.  Company comment: This spontaneous case concerns a female patient of an unspecified age, with no medical history reported, who experienced the unexpected serious (medically significant) AESI of Deep vein thrombosis and Pulmonary embolism that occurred after receiving the mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. It was reported that patient had a Deep Vein Thrombosis and pulmonary embolism 8 weeks after the second Moderna booster. No further information regarding risk factors, clinical course, medical history, concurrent conditions, concomitant medication, additional vaccination details, investigations and treatment received were provided. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 Vaccine in not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Rheumatoid arthritis
Clinical narrative: He started developing rheumatoid arthritis symptoms. His blood work looked like RA; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RHEUMATOID ARTHRITIS (He started developing rheumatoid arthritis symptoms. His blood work looked like RA) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (He started developing rheumatoid arthritis symptoms. His blood work looked like RA) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (He started developing rheumatoid arthritis symptoms. His blood work looked like RA) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: blood work looks like RA.         No concomitant and treatment medications were reported. Patient had event after 6 weeks of vaccination.; Reporter's Comments: Company Comment This spontaneous case concerns an unknown-years-old male patient, with no medical history reported who experienced the unexpected seriousness criterion medically significant AESI  of   Rheumatoid arthritis unknown days after a  dose of  mRNA- 1273 bivalent vaccine. On an unknown date his blood work looks like RA. The benefit-risk relationship of mRNA-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: metals (coins, spoons, mobiles) are sticking all over his body; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (metals (coins, spoons, mobiles) are sticking all over his body) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (metals (coins, spoons, mobiles) are sticking all over his body). At the time of the report, IMMUNISATION REACTION (metals (coins, spoons, mobiles) are sticking all over his body) outcome was unknown.            Concomitant medication of the patient was not reported.   It was reported that the patient just got vaccine of Moderna for COVID-19 and for some reason metals (coins, spoons, mobiles) were sticking all over his body. He tried it prior to obtaining the shot.  No treatment information was provided by the reporter.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: developed covid symptoms ,sore muscles,cold symptoms,runny nose, a bit of coughing; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (developed covid symptoms ,sore muscles,cold symptoms,runny nose, a bit of coughing) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 20-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (developed covid symptoms ,sore muscles,cold symptoms,runny nose, a bit of coughing). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Cold symptoms, at an unspecified dose and frequency. At the time of the report, COVID-19 (developed covid symptoms ,sore muscles,cold symptoms,runny nose, a bit of coughing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2023, SARS-CoV-2 test: Positive.     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.   Concomitant medications were not reported.  The patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient reported that she received the first dose of Moderna Monovalent Primary series on 20Dec2022, and developed covid symptoms the night of 01jan2023.  For 3 days patient experienced sore muscles, cold symptoms such as runny nose, a bit of coughing, and had no fever.   Patient would like to know when she is eligible to receive 2nd primary dose because her symptoms had topped but continued to show positive on Antigen home test.  The patient did not seek medical attention and only took cold medicine for cold symptoms and asking how to make positive test go away faster.   Patient did not know the LOT number.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medication was provided by reporter.  It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medication information was reported. Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment medication information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: His wife had to go to the hospital and got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (His wife had to go to the hospital and got COVID) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (His wife had to go to the hospital and got COVID). At the time of the report, COVID-19 (His wife had to go to the hospital and got COVID) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Dosage text was reported as Additional Booster.  Unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Reporter stated that his wife received 2 primary series doses and 2 boosters, she was going to get another booster but in the meantime, she had to go to the hospital and got COVID there, she was told that she should wait 3 months to get a booster and she was receiving conflicting/different information about how long she should wait to receive a booster.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (Product storage error).    This case contains information for the 42nd out of 77 adult patients described by the reporter. No concomitant information was reported. It was reported that, approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion).    Concomitant product use was not provided by the reporter.  On an unknown date, the patient received Moderna bivalent booster dose that had undergone a temperature excursion. The dose was administered before it was known if the vaccine was ok.  Treatment information was not provided.  This case contains information for 43rd of 77 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Approximately 77 patients received Moderna bivalent; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Approximately 77 patients received Moderna bivalent), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Approximately 77 patients received Moderna bivalent), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Approximately 77 patients received Moderna bivalent), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Approximately 77 patients received Moderna bivalent) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medication was provided. Reportedly, the doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment information was provided. This case was related to patient number 44 out of 77 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    This case is for 45th patient out of 77 patients reported.  No concomitant medication information was provided.  It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    The case was reported for 46th patient out of 77 adult patients who had received the vaccine as reported by the reporter.  No concomitant medication was provided.  It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-69612.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    The case was reported for 47th patient out of 77 adult patients who had received the vaccine as reported by the reporter.  No concomitant medication was provided.  It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Transcription medication error
Clinical narrative: Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong; Circumstance or information capable of leading to medication error; The patients have not reported any adverse reactions; This spontaneous case was reported by a pharmacist and describes the occurrence of TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions). At the time of the report, TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (The patients have not reported any adverse reactions) to be not related. No further causality assessments were provided for TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    This case was patient number 2 out of 16 patients.  No concomitant medication information provided.  They administered Bivalent boosters from Bivalent Lot numbers of 061F22A and AS7170B. They wrote AS7170B on all 26 patient's vaccination cards.  No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696236.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696236:master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patient received Moderna bivalent booster doses that had undergone a temperature excursion; dose were administered before it was known if the vaccine was ok to use after the excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (dose were administered before it was known if the vaccine was ok to use after the excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (dose were administered before it was known if the vaccine was ok to use after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (dose were administered before it was known if the vaccine was ok to use after the excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose were administered before it was known if the vaccine was ok to use after the excursion).    This case was related to patient number 48 out of 77.  No concomitant medication information provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue).    The case was reported for 49th patient out of 77 adult patients who had received the vaccine as reported by the reporter.  No concomitant medication was provided.  It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue).    The case was reported for 50th patient out of 77 adult patients who had received the vaccine as reported by the reporter.  No concomitant medication was provided.  It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case