chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Menveo administered to a 57 y/o; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 57-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMA749A, expiry date 30th November 2023) and (batch number AMXA749A, expiry date 31st March 2024) for prophylaxis.   On 29th September 2022, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 29th September 2022, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comments: The pharmacist asked for information about the administration of Menveo to a 57 years old patient. Since Menveo was approved for use in patients until 55 years old, she was asking how to proceed with this patient.  The reporter was consented to follow up. Additional Supportive Information: Menveo vaccine was administered to a 57 years old patient, which led Inappropriate age at vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Death, Malaise
Clinical narrative: FELL ILL; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; DIED; This spontaneous report received from a consumer via a company representative via social media (JNJ News) concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was perfectly healthy and was kept on a proper diet. The patient was previously received 2 doses of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin and batch number were not reported, expiry: UNKNOWN) dose was not reported, start therapy dates were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first two doses of covid-19 vaccine (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, after third vaccination patient fell ill and in AUG-2022, the patient died from unknown cause of death (Dose number in series 2). It was unknown whether autopsy was performed or not. It was reported as "Agreed, A good friend of mine was perfectly healthy, kept to a proper diet, had three vaccines and advised me to stay away from the unvaccinated. However, after the third vaccination, he fell ill and died in August" (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on AUG-2022, and the outcome of fell ill and revaccination with different covid-19 vaccine was not reported. This report was serious (Death). This case, from the same reporter is linked to 20221003368.; Sender's Comments: V0: 20221003166-COVID-19 VACCINE AD26.COV2.S- Died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: RARE STROKE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medication included birth control. On an unspecified date, the patient experienced rare stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rare stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20221005785 -covid-19 vaccine ad26.cov2.s - Rare stroke. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION (COVID REBOUND); REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age and sex. Initial information was processed along with additional information on 06-OCT-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy, and diuretic for acne. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 01 total, administered on left arm on 09-APR-2021 for covid-19 prophylaxis. Concomitant medications included spironolactone for diuretic for acne. On an unspecified date in SEP-2022, patient experienced Covid-19 symptoms which resulted to confirmed clinical vaccination failure (Dose number in series 1). The patient received additional dose of non-company suspect vaccine Moderna COVID-19 vaccine (elasomeran, Spikevax) (Dose number in series 2) (form of administration and route of administration were not reported, batch number: 017F21A, expiry: unknown) dose was not reported, administered on left arm on 03-NOV-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). On an unspecified date in SEP-2022 patient experienced Covid-19 symptoms (confirmed Covid-19 infection) (Dose number in series 2) and received non company suspect paxlovid (form of administration and route of administration were not reported, batch number: unknown and expiry: unknown) dose was not reported, administered from 13-SEP-2022 till 17-SEP-2022 for covid-19 treatment and symptoms were ended on 18-SEP-2022 after paxlovid treatment completion but again new symptoms started (covid rebound) on 24-SEP-2022 and patient tested positive on 24-SEP-2022 (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran was not applicable and with paxlovid was withdrawn on 17-SEP-2022. The patient had not recovered from confirmed covid-19 infection (covid rebound), and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported.  This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000254381.; Sender's Comments: V0: 20221008913.-covid-19 vaccine ad26.cov2.s- Confirmed Clinical Vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 29-Sep-2022, the patient experienced UNDERDOSE (Patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine).    No concomitant medication details was reported. It was reported that patient did not had any adverse events. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654894, US-MODERNATX, INC.-MOD-2022-654906, US-MODERNATX, INC.-MOD-2022-654905 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654906:Patient No. 3 US-MODERNATX, INC.-MOD-2022-654894:Patient No. 1 US-MODERNATX, INC.-MOD-2022-654905:Patient No. 2
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Monoplegia
Clinical narrative: My right leg was completely paralyzed; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (My right leg was completely paralyzed) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Primary progressive multiple sclerosis, Walking difficulty (Drop foot), Weakness in extremity (weak leg) and Foot drop. Concomitant products included OCRELIZUMAB (OCREVUS), DALFAMPRIDINE, GABAPENTIN (NEURONTIN) and CLOZAPINE for an unknown indication.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced MONOPLEGIA (My right leg was completely paralyzed) (seriousness criterion medically significant). At the time of the report, MONOPLEGIA (My right leg was completely paralyzed) had resolved.            In MAR-2021, patient started therapy with Moderna COVID-19 vaccine for unknown indication. In MAR-2021, after second COVID-19 vaccination patient's right leg was completely paralyzed.  No treatment information was provided.  Company comment: This spontaneous case concerns a 69 year old female patient with concurrent Primary progressive multiple sclerosis with drop foot, who experienced the unexpected serious (medically significant) event of Monoplegia, unknown days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient stated that her right leg was completely paralyzed after the vaccine. No information on detailed clinical course, relevant investigations, treatment of the event and details pertaining to the first dose was available in the report. The event resolved. Underlying Primary progressive multiple sclerosis with drop foot could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69 year old female patient with concurrent Primary progressive multiple sclerosis with drop foot, who experienced the unexpected serious (medically significant) event of Monoplegia, unknown days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient stated that her right leg was completely paralyzed after the vaccine. No information on detailed clinical course, relevant investigations, treatment of the event and details pertaining to the first dose was available in the report. The event resolved. Underlying Primary progressive multiple sclerosis with drop foot could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid/Covid the first two weeks/COVID infection was a fairly mild case; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid/Covid the first two weeks/COVID infection was a fairly mild case) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced COVID-19 (Covid/Covid the first two weeks/COVID infection was a fairly mild case). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in July 2022 for COVID-19, at a dose of 5 days. In July 2022, COVID-19 (Covid/Covid the first two weeks/COVID infection was a fairly mild case) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: (Positive) Positive and (Negative) Negative.         No concomitant medications were reported.  The patient had the original first two COVID vaccines and then two boosters and they were all Moderna.  It was reported that the last booster patient had was in early April of 2022. Patient did have COVID the first two weeks of July in 2022 and he heard on the news that after having COVID, it's best to wait 3 months or so before getting another booster.   The patient states his COVID infection was a fairly mild case. He took Paxlovid and got a rebound. He tested positive, then took Paxlovid for 5 days, then tested negative for a couple days, then tested positive for another 5-7 days. Patient had a little cough a little while after that, then everything was good.
Sex: M
Vaccine: COVID19
Symptoms: Leukaemia
Clinical narrative: Leukemia; This spontaneous case was reported by a consumer and describes the occurrence of LEUKAEMIA (Leukemia) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LEUKAEMIA (Leukemia) (seriousness criterion medically significant). At the time of the report, LEUKAEMIA (Leukemia) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. The patient experienced Leukemia month after 2nd Moderna.  Company comment-This spontaneous case concerns a male patient of unknown age  with no medical history reported, who experienced the unexpected serious (medically significant) event of Leukaemia on unknown date approximately one month after second dose of mRNA-1273 vaccination. No further information on risk factors, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a male patient of unknown age  with no medical history reported, who experienced the unexpected serious (medically significant) event of Leukaemia on unknown date approximately one month after second dose of mRNA-1273 vaccination. No further information on risk factors, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Patient had sore arm after vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Patient had sore arm after vaccination) 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 PAIN IN EXTREMITY (Patient had sore arm after vaccination). At the time of the report, PAIN IN EXTREMITY (Patient had sore arm after vaccination) outcome was unknown.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.  Concomitant product use was not provided by the reporter.  Reporter stated that her husband had sore arm after vaccination.   Treatment information was not provided.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: couple of days of not feeling well; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (couple of days of not feeling well) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 031A21A and 030M20A) for COVID-19 prophylaxis.     Patient had no any allergies to medications, food and other products.  The patient's past medical history included Angiogram coronary (4 years ago) and Stent placement (6 heart stents). Previously administered products included for Product used for unknown indication: INFLUENZA VACCIN (given within 1 month prior to Moderna COVID-19 vaccine) in September 2021. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCIN. Concurrent medical conditions included Hypertension, Endometrial cancer and Thyroid cancer. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), HYDROCHLOROTHIAZIDE, ATORVASTATIN, ISOSORBIDE and LEVOTHYROXINE SODIUM (UNITHROID) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (couple of days of not feeling well). At the time of the report, MALAISE (couple of days of not feeling well) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had problems with the thyroid medications.  It was reported that after the First, second and First booster patient  had a couple of days of not feeling well. Post first dose patient developed the event on 25-FEB-2021. Post second dose patient developed event on 25-MAR-2021.Post first booster patient developed event of 19-NOV-2021.  No treatment medications were reported.   This case was linked to MOD-2022-655145 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: patient experienced a pulmonary embolism Date of diagnosis: 4Aug2022; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (patient experienced a pulmonary embolism Date of diagnosis: 4Aug2022) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056m21a, 032f21a, 0391520a and 026l20a) for COVID-19 vaccination.     Concomitant products included METOPROLOL, AMLODIPINE, ALBUTEROL [SALBUTAMOL] and LORAZEPAM (ATIVAN) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY EMBOLISM (patient experienced a pulmonary embolism Date of diagnosis: 4Aug2022) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (patient experienced a pulmonary embolism Date of diagnosis: 4Aug2022) was resolving.            No treatment medications was reported. The patient did not have any COVID positive test or diagnosis.  Company Comment: This spontaneous case concerns a 48-year-old female patient with no medical history reported, who experienced the unexpected serious (hospitalization and medically significant) AESI of Pulmonary embolism which occurred 2 months 11 days after the fourth dose of mRNA-1273 vaccine in covid-19 vaccination series. No further information on clinical course, investigations and treatment received was available in the report. The outcome of the event was reported as resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to MOD-2021-005478 (Patient Link).; Sender's Comments: This spontaneous case concerns a 48-year-old female patient with no medical history reported, who experienced the unexpected serious (hospitalization and medically significant) AESI of Pulmonary embolism which occurred 2 months 11 days after the fourth dose of mRNA-1273 vaccine in covid-19 vaccination series. No further information on clinical course, investigations and treatment received was available in the report. The outcome of the event was reported as resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 0.5 ml of bivalent given as first dose of primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (0.5 ml of bivalent given as first dose of primary series) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 30-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (0.5 ml of bivalent given as first dose of primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (0.5 ml of bivalent given as first dose of primary series) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (0.5 ml of bivalent given as first dose of primary series).    No concomitant medication information provided.  The pharmacist states they had a vaccine error. They administered 0.5 ml of a Moderna bivalent vaccine to someone who had not yet received a primary dose yet on 30Sep2022. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product container issue
Clinical narrative: Received a booster dose of the Moderna Covid 19 vaccine bivalent from a vial that was punctured for 28 Hours.; Received a booster dose of the Moderna Covid 19 vaccine bivalent from a vial that was punctured for 28 Hours.; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received a booster dose of the Moderna Covid 19 vaccine bivalent from a vial that was punctured for 28 Hours.), PRODUCT CONTAINER ISSUE (Received a booster dose of the Moderna Covid 19 vaccine bivalent from a vial that was punctured for 28 Hours.) 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)) for COVID-19 vaccination.     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 POOR QUALITY PRODUCT ADMINISTERED (Received a booster dose of the Moderna Covid 19 vaccine bivalent from a vial that was punctured for 28 Hours.), PRODUCT CONTAINER ISSUE (Received a booster dose of the Moderna Covid 19 vaccine bivalent from a vial that was punctured for 28 Hours.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received a booster dose of the Moderna Covid 19 vaccine bivalent from a vial that was punctured for 28 Hours.), PRODUCT CONTAINER ISSUE (Received a booster dose of the Moderna Covid 19 vaccine bivalent from a vial that was punctured for 28 Hours.) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Received a booster dose of the Moderna Covid 19 vaccine bivalent from a vial that was punctured for 28 Hours.) and PRODUCT CONTAINER ISSUE (Received a booster dose of the Moderna Covid 19 vaccine bivalent from a vial that was punctured for 28 Hours.).    No concomitant medications was reported.  Patient was administered with Moderna Bivalent booster dose. Vial size was reported as 2.5ml  No treatment medications was reported.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Feeling abnormal, Pyrexia, SARS-CoV-2 test
Clinical narrative: Feeling yucky; Fever; When she asked the dosage amount that was given her husband and her heard 2.5 ml. She also stated that is possible that nurse could have said 0.25 or 0.50 ml; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (Feeling yucky), PYREXIA (Fever) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (When she asked the dosage amount that was given her husband and her heard 2.5 ml. She also stated that is possible that nurse could have said 0.25 or 0.50 ml) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B and AR9236B) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (not hospitalized, Treatment received: At home ibuprofen) on 10-Jul-2022. Previously administered products included for COVID-19: Ibuprofen in July 2022. Past adverse reactions to the above products included No adverse event with Ibuprofen.   On 07-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Oct-2022, 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 FEELING ABNORMAL (Feeling yucky), PYREXIA (Fever) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (When she asked the dosage amount that was given her husband and her heard 2.5 ml. She also stated that is possible that nurse could have said 0.25 or 0.50 ml). At the time of the report, FEELING ABNORMAL (Feeling yucky), PYREXIA (Fever) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (When she asked the dosage amount that was given her husband and her heard 2.5 ml. She also stated that is possible that nurse could have said 0.25 or 0.50 ml) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jul-2022, SARS-CoV-2 test: (Negative) Negative. On 11-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         The patient had no allergies. The patient had no acute and chronic illnesses at the time of vaccination.The patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: My lymph nodes are still swollen from the other shots; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (My lymph nodes are still swollen from the other shots) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Breast cancer. Concomitant products included INFLUENZA VACCINE for an unknown indication.   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, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (My lymph nodes are still swollen from the other shots). At the time of the report, LYMPHADENOPATHY (My lymph nodes are still swollen from the other shots) had not resolved.      No concomitant medication details reported. Patient got 4 Moderna Covid-19 vaccines and was ready to get the new one. But patient want to know if could get the injection in buttocks. Patient lymph nodes were still swollen from the other shots and just cannot get another one in arm. Patient did not have lymph nodes in arm, so got everything in the other arm. Patient just got flu shot in that arm. No treatment medication details were reported.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; got the Moderna Bivalent Booster yesterday instead of the first dose of the Moderna vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (got the Moderna Bivalent Booster yesterday instead of the first dose of the Moderna vaccine) and NO ADVERSE EVENT (no adverse event) in a 73-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.     No Medical History information was reported.   On 05-Oct-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. On 05-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (got the Moderna Bivalent Booster yesterday instead of the first dose of the Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (got the Moderna Bivalent Booster yesterday instead of the first dose of the Moderna vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      No relevant concomitant medications were reported.  Caller did not have vaccination card assessable at the time of call. Caller said first the vaccination provider told her she couldn't get another shot until 6 months passed. They also called the CDC and they gave 2 options to either get the first Moderna. Primary shot immediately or wait an get a second dose in 1 month.  Treatment medication was not provided by the reporter.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received the bivalent booster as their first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent booster as their first dose) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 06-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent booster as their first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent booster as their first dose) 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent booster as their first dose).    No concomitant medication information was provided. It was reported that patient received bivalent product for first dose instead of monovalent dose. No treatment medication were provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: diagnosis of COVID-19 from 9JUL2022-27JUL2022; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (diagnosis of COVID-19 from 9JUL2022-27JUL2022) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 008B21A and 013A21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine (had a similar reaction to flu vaccines in the past.). Past adverse reactions to the above products included Itching with Flu vaccine. Concurrent medical conditions included Allergy (Xyzal and Singulair for allergies). Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and MONTELUKAST SODIUM (SINGULAIR) for Allergy.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (diagnosis of COVID-19 from 9JUL2022-27JUL2022). On 27-Jul-2022, COVID-19 (diagnosis of COVID-19 from 9JUL2022-27JUL2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2022-655847 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 22-Aug-2022 and was administered on 04-Oct-2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-Aug-2022 and was administered on 04-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-Aug-2022 and was administered on 04-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-Aug-2022 and was administered on 04-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-Aug-2022 and was administered on 04-Oct-2022).    Concomitant drugs were not reported. It was reported that the monovalent vial of size 5.5ml with the beyond use date as 21-Sep-2022 was initially stored in refrigerator on 22-Aug-2022. The vial did not undergo any temperature excursion. Treatment medications were not provided. The case was reported for patient 1.   This case was linked to US-MODERNATX, INC.-MOD-2022-655876 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-655876:same reporter
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills
Clinical narrative: had chills; back was a little achy; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (back was a little achy) and CHILLS (had chills) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Oct-2022, the patient experienced BACK PAIN (back was a little achy). On 05-Oct-2022 at 4:00 AM, the patient experienced CHILLS (had chills). At the time of the report, BACK PAIN (back was a little achy) and CHILLS (had chills) outcome was unknown.            No concomitant medication were reported.             No treatment information was provided by the reporter.   This case was linked to MOD-2022-655857, MOD-2022-655858 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills
Clinical narrative: achy back; had chills; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (achy back) and CHILLS (had chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 033+21A and 003A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced BACK PAIN (achy back) and CHILLS (had chills). At the time of the report, BACK PAIN (achy back) and CHILLS (had chills) outcome was unknown.            Concomitant medication was not reported. After first dose and first booster and second booster patient had chills and achy back. Treatment information was not reported.   This case was linked to MOD-2022-655853, MOD-2022-655857 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 4 patients received 0.5 ml the Moderna booster as opposed to the bivalent; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (4 patients received 0.5 ml the Moderna booster as opposed to the bivalent) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (4 patients received 0.5 ml the Moderna booster as opposed to the bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (4 patients received 0.5 ml the Moderna booster as opposed to the bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (4 patients received 0.5 ml the Moderna booster as opposed to the bivalent).    No concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster; got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 IMMUNISATION (got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster), INTERCHANGE OF VACCINE PRODUCTS (got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster) and NO ADVERSE EVENT (No adverse event) 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.     Previously administered products included for Drug use for unknown indication: Pfizer (one dose of primary series of Pfizer). Past adverse reactions to the above products included No adverse event with Pfizer.    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 COVID-19 IMMUNISATION (got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster), INTERCHANGE OF VACCINE PRODUCTS (got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, COVID-19 IMMUNISATION (got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster), INTERCHANGE OF VACCINE PRODUCTS (got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for COVID-19 IMMUNISATION (got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster) and INTERCHANGE OF VACCINE PRODUCTS (got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster).    No Concomitant medications were provided. It was reported that patient got one dose of the primary series of Pfizer. The reporter mentioned that it was entered in the computer wrong and patient ended up getting the Moderna Bivalent booster.  No treatment medications were provided.