chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Influenza like illness, Psoriasis, Stress
Clinical narrative: STRESSED/STRESS ISSUES; PSORIASIS FLARE UP ON OUTSIDE OF LEGS; Flu like symptoms; Fatigue; Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), STRESS (STRESSED/STRESS ISSUES), PSORIASIS (PSORIASIS FLARE UP ON OUTSIDE OF LEGS), INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced COUGH (Cough), INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue). In May 2022, the patient experienced PSORIASIS (PSORIASIS FLARE UP ON OUTSIDE OF LEGS). On an unknown date, the patient experienced STRESS (STRESSED/STRESS ISSUES). At the time of the report, COUGH (Cough), INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) outcome was unknown and STRESS (STRESSED/STRESS ISSUES) and PSORIASIS (PSORIASIS FLARE UP ON OUTSIDE OF LEGS) had resolved.            Concomitant product use was not provided by the reporter. On an unknown date, the patient was stressed/stress issues. In Dec-2021, the patient experienced that booster dose caused flu like symptoms, cough and fatigue. In May-2022, the patient experienced psoriasis flares up on outside of legs. He had stress issues due to family issues and experienced flare ups. He took cream and that helped a lot. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623063, MOD-2022-631087 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2022: Live Follow Up received and updated events outcome.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: First dose was administered on 01-Apr-21 and second dose was administered on 20-May-21; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 01-Apr-21 and second dose was administered on 20-May-21) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 01-Apr-21 and second dose was administered on 20-May-21) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 01-Apr-21 and second dose was administered on 20-May-21) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  It was reported that the primary reporter did not have the lot number information, because the packaging was discarded.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623369 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM WITH ALL THREE COVID VACCINES; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (SORE ARM WITH ALL THREE COVID VACCINES) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for Chronic lymphocytic leukaemia.    Previously administered products included for Drug use for unknown indication: PENICILIN, SIMVASTATIN and LIVALO. Past adverse reactions to the above products included Allergy with LIVALO, PENICILIN and SIMVASTATIN. Concurrent medical conditions included Chronic lymphocytic leukaemia. Concomitant products included ACETAMINOPHEN, ATORVASTATIN, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ), OMEPRAZOLE, ALLOPURINOL, TRAMADOL and VITAMINS NOS (MULTIVITAMINUM) for an unknown indication.   On 06-Aug-2021, the patient started VENETOCLAX (VENCLEXTA) (Oral) 100 milligram. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (SORE ARM WITH ALL THREE COVID VACCINES). At the time of the report, PAIN IN EXTREMITY (SORE ARM WITH ALL THREE COVID VACCINES) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporters causality for VENCLEXTA of the event of SORE ARM WITH ALL THREE COVID VACCINES was not provided.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-622062 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Inappropriate schedule of product administration, Vaccination site bruising
Clinical narrative: 30-DEC-2020-Dose 1,Dose 02-Jan-2021; Injection site bruising; Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Injection site bruising), IMMUNISATION REACTION (Vaccination adverse reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (30-DEC-2020-Dose 1,Dose 02-Jan-2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for Psoriatic arthritis.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2020, the patient experienced VACCINATION SITE BRUISING (Injection site bruising) and IMMUNISATION REACTION (Vaccination adverse reaction). On 02-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (30-DEC-2020-Dose 1,Dose 02-Jan-2021). At the time of the report, VACCINATION SITE BRUISING (Injection site bruising), IMMUNISATION REACTION (Vaccination adverse reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (30-DEC-2020-Dose 1,Dose 02-Jan-2021) outcome was unknown.            In December 2020, the patient experienced ill effects on the left side of body since getting covid vaccines and bruises a lot more often when injecting Humira in left thigh.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623778 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Illness, Rhinorrhoea
Clinical narrative: she was sick/ Sick; Running nose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she was sick/ Sick) and RHINORRHOEA (Running nose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and dose of INFLUENZA VACCINE (unknown route) at an unspecified dose. In January 2022, the patient experienced ILLNESS (she was sick/ Sick) and RHINORRHOEA (Running nose). In 2022, ILLNESS (she was sick/ Sick) had resolved. At the time of the report, RHINORRHOEA (Running nose) had not resolved.            Relevant concomitant medications were not reported.  In Jan-2022, she was sick with a running nose and it got resolved in 2022.  Treatment medication was not provided.  Company's opinion was that the causality with HUMIRA and the event of sick is not assessable.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-620239 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Malaise, Pain, Pyrexia
Clinical narrative: PAIN; 02-APR-2021-Dose 1,11-MAY-2021-Dose 2; Not feeling good; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling good), PYREXIA (Fever), PAIN (PAIN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (02-APR-2021-Dose 1,11-MAY-2021-Dose 2) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 11-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (02-APR-2021-Dose 1,11-MAY-2021-Dose 2). In May 2021, the patient experienced MALAISE (Not feeling good) and PYREXIA (Fever). On an unknown date, the patient experienced PAIN (PAIN). At the time of the report, MALAISE (Not feeling good), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (02-APR-2021-Dose 1,11-MAY-2021-Dose 2) outcome was unknown and PAIN (PAIN) was resolving.            No concomitant and treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial Reporter causality was not reported for events with Humira. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2022-621494 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adeverse Event; 03-FEB-2021-Dose 1, 21-MAR-2021-Dose 2; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (03-FEB-2021-Dose 1, 21-MAR-2021-Dose 2) and NO ADVERSE EVENT (No adeverse Event) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Lymphocytic lymphoma and Waldenstrom's macroglobulinaemia.    Concurrent medical conditions included Lymphocytic lymphoma and Waldenstrom's macroglobulinaemia.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On 21-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (03-FEB-2021-Dose 1, 21-MAR-2021-Dose 2). On an unknown date, the patient experienced NO ADVERSE EVENT (No adeverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (03-FEB-2021-Dose 1, 21-MAR-2021-Dose 2) and NO ADVERSE EVENT (No adeverse Event) outcome was unknown.            No concomitant and treatment medication were provided It was unknown if the patient was enrolled in COVID-19 vaccine trial This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2021-618975 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: Tooth infection; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Tooth infection) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Rheumatoid arthritis.    No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2022, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced TOOTH INFECTION (Tooth infection). In 2022, TOOTH INFECTION (Tooth infection) had resolved.            The concomitant medication was not reported by reporter. In Feb 2022, the patient was off of Skyrizi for a little while because she had an infected tooth and was on antibiotic. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623737 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu) in a 63-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On 16-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In March 2022, the patient experienced INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: One spot on lower leg; New spot /wondered if booster covid caused the spot on lower left leg; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (One spot on lower leg) and SKIN DISORDER (New spot /wondered if booster covid caused the spot on lower left leg) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced SKIN DISORDER (New spot /wondered if booster covid caused the spot on lower left leg). On an unknown date, the patient experienced SKIN DISORDER (One spot on lower leg). At the time of the report, SKIN DISORDER (One spot on lower leg) had resolved and SKIN DISORDER (New spot /wondered if booster covid caused the spot on lower left leg) had not resolved. Not Provided    No concomitant medications were reported. Patient had one spot on his lower left leg that had come back within the last 6 weeks.Patient did not knew this but would like to know the answer of whether the COVID booster caused the spot to come back. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Feeling abnormal, Pneumonia, Pyrexia
Clinical narrative: felt like I had pneumonia 24/7; no energy; I had diarrhea; I was feverish really bad; felt a little off; This spontaneous case was reported by an other health care professional and describes the occurrence of PNEUMONIA (felt like I had pneumonia 24/7) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced FEELING ABNORMAL (felt a little off) and PYREXIA (I was feverish really bad). On 16-May-2021, the patient experienced PNEUMONIA (felt like I had pneumonia 24/7) (seriousness criterion medically significant), ASTHENIA (no energy) and DIARRHOEA (I had diarrhea). At the time of the report, PNEUMONIA (felt like I had pneumonia 24/7), ASTHENIA (no energy) and PYREXIA (I was feverish really bad) had not resolved and FEELING ABNORMAL (felt a little off) and DIARRHOEA (I had diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that pneumonia, asthenia, pyrexia and illness were worsened. Events pneumonia and illness caused patient to seek medical care. Patient was sick for about a month.  Treatment information was not provided.  Company comment: This spontaneous case concerns a 49-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of pneumonia 2 days after the first dose of mRNA-1273. The patient describes that she had to pause and take a breath during daily activities (such as taking a shower), and that she had influenza like symptoms. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as not resolved.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-646291 (Patient Link).; Sender's Comments: This spontaneous case concerns a 49-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of pneumonia 2 days after the first dose of mRNA-1273. The patient describes that she had to pause and take a breath during daily activities (such as taking a shower), and that she had influenza like symptoms. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as not resolved.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 mild symptoms; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19 mild symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 030L20A and 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety and Regurgitation. Concomitant products included CLONAZEPAM (KLONOPIN) for Anxiety, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Regurgitation.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (COVID-19 mild symptoms). At the time of the report, COVID-19 (COVID-19 mild symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received first booster dose on 29-Oct-2021.  No treatment medication were provided.  Company Comment : This spontaneous case concerns a 63-year old female patient with no relevant medical history reported, who experienced  a non-serious unexpected AESI of COVID-19 approximately 1 year 3  months after receiving the second dose and approximately 6 months after the booster dose of mRNA vaccine. There is no information about the symptoms, the test reports and treatment details provided.  Current pandemic is considered a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-647508 (Patient Link).; Sender's Comments: This spontaneous case concerns a 63-year old female patient with no relevant medical history reported, who experienced  a non-serious unexpected AESI of COVID-19 approximately 1 year 3  months after receiving the second dose and approximately 6 months after the booster dose of mRNA vaccine. There is no information about the symptoms, the test reports and treatment details provided.  Current pandemic is considered a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: patient had a grand mal seizure 3 hours after receiving the bivalent Moderna; This spontaneous case was reported by a nurse and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (patient had a grand mal seizure 3 hours after receiving the bivalent Moderna) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Epilepsy.    On 12-Sep-2022, 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 12-Sep-2022, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (patient had a grand mal seizure 3 hours after receiving the bivalent Moderna) (seriousness criterion medically significant). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (patient had a grand mal seizure 3 hours after receiving the bivalent Moderna) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Moderna COVID-19 vaccines previously received are  1st Dose: Administered on 30-JAN-2021, Lot number- 037K20A, Expiration date - 22-JUN-2021 2nd Dose: Administered on - 27-FEB-2021, Lot number - 024M20A, Expiration date - 3-AUG-2021 3rd Dose: Administered on 27-OCT-2021, Lot number - 036C21A, Expiration date - 1-NOV-2021, Dosage administered was 100 mcg. It was reported that patient experienced seizure in her vehicle. No treatment drug details was reported. Company comment- This is a spontaneous case concerning a 51-year-old patient, with concurrent condition of epilepsy and immunocompromised, who experienced the unexpected and serious (medically significant) AESI generalised tonic-clonic seizure 3 hours after a dose of mRNA-1273.222 vaccine, given as a fourth dose of COVID vaccine schedule, was administered. It was reported patient experienced the seizure in her vehicle. Concurrent condition of epilepsy remains as a confounder. The benefit-risk relationship of the mRNA-1273.222 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 51-year-old patient, with concurrent condition of epilepsy and immunocompromised, who experienced the unexpected and serious (medically significant) AESI generalised tonic-clonic seizure 3 hours after a dose of mRNA-1273.222 vaccine, given as a fourth dose of COVID vaccine schedule, was administered. It was reported patient experienced the seizure in her vehicle. Concurrent condition of epilepsy remains as a confounder. The benefit-risk relationship of the mRNA-1273.222 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I've had slight side effects; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (I've had slight side effects) 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 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 (I've had slight side effects). At the time of the report, IMMUNISATION REACTION (I've had slight side effects) had resolved.            Other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Concomitant medications were not reported. Unknown whether patient seek medical care for AE and experienced a similar event in the past. The symptoms were improved. No treatment information was provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Polymers allergy
Clinical narrative: believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine; reports being tired for 2 days.; This spontaneous case was reported by a patient and describes the occurrence of POLYMERS ALLERGY (believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine) and FATIGUE (reports being tired for 2 days.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 prophylaxis.  Concurrent medical conditions included Hypothyroidism and Hypertension. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROCHLOROTHIAZIDE for an unknown indication. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced FATIGUE (reports being tired for 2 days.). On an unknown date, the patient experienced POLYMERS ALLERGY (believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine). In January 2021, FATIGUE (reports being tired for 2 days.) had resolved. At the time of the report, POLYMERS ALLERGY (believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine) outcome was unknown.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.    No treatment medications were provided by the reporter.   This case was linked to MOD-2022-648279, MOD-2022-648281 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Polymers allergy, Vaccination site erythema
Clinical narrative: believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine; reports being tired for 2 days.; This spontaneous case was reported by a patient and describes the occurrence of POLYMERS ALLERGY (believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine) and FATIGUE (reports being tired for 2 days.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 prophylaxis.  Concurrent medical conditions included Hypothyroidism and Hypertension. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROCHLOROTHIAZIDE for an unknown indication. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced FATIGUE (reports being tired for 2 days.). On an unknown date, the patient experienced POLYMERS ALLERGY (believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine). In January 2021, FATIGUE (reports being tired for 2 days.) had resolved. At the time of the report, POLYMERS ALLERGY (believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine) outcome was unknown.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.    No treatment medications were provided by the reporter.   This case was linked to MOD-2022-648279, MOD-2022-648281 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Polymers allergy
Clinical narrative: an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine.; large red circle from the injection site about the size of a Softball. The redness extended down her arm from the shoulder to her elbow; This spontaneous case was reported by a patient and describes the occurrence of POLYMERS ALLERGY (an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine.) and VACCINATION SITE ERYTHEMA (large red circle from the injection site about the size of a Softball. The redness extended down her arm from the shoulder to her elbow) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 006M20A and 028L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypothyroidism and Hypertension. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE ERYTHEMA (large red circle from the injection site about the size of a Softball. The redness extended down her arm from the shoulder to her elbow). On an unknown date, the patient experienced POLYMERS ALLERGY (an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine.). At the time of the report, POLYMERS ALLERGY (an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine.) and VACCINATION SITE ERYTHEMA (large red circle from the injection site about the size of a Softball. The redness extended down her arm from the shoulder to her elbow) outcome was unknown.            No treatment medication was provided by reporter.   This case was linked to MOD-2022-648146.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Polymers allergy, Vaccination site erythema
Clinical narrative: an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine.; large red circle from the injection site about the size of a Softball. The redness extended down her arm from the shoulder to her elbow; This spontaneous case was reported by a patient and describes the occurrence of POLYMERS ALLERGY (an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine.) and VACCINATION SITE ERYTHEMA (large red circle from the injection site about the size of a Softball. The redness extended down her arm from the shoulder to her elbow) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 006M20A and 028L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypothyroidism and Hypertension. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE ERYTHEMA (large red circle from the injection site about the size of a Softball. The redness extended down her arm from the shoulder to her elbow). On an unknown date, the patient experienced POLYMERS ALLERGY (an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine.). At the time of the report, POLYMERS ALLERGY (an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine.) and VACCINATION SITE ERYTHEMA (large red circle from the injection site about the size of a Softball. The redness extended down her arm from the shoulder to her elbow) outcome was unknown.            No treatment medication was provided by reporter.   This case was linked to MOD-2022-648146.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Headache, Interchange of vaccine products
Clinical narrative: Terrible headache; had a combination of both Pfizer and Moderna; had a combination of both Pfizer and Moderna; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Terrible headache), COVID-19 IMMUNISATION (had a combination of both Pfizer and Moderna) and INTERCHANGE OF VACCINE PRODUCTS (had a combination of both Pfizer and Moderna) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Occipital neuralgia.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Terrible headache), COVID-19 IMMUNISATION (had a combination of both Pfizer and Moderna) and INTERCHANGE OF VACCINE PRODUCTS (had a combination of both Pfizer and Moderna). At the time of the report, HEADACHE (Terrible headache) had resolved and COVID-19 IMMUNISATION (had a combination of both Pfizer and Moderna) and INTERCHANGE OF VACCINE PRODUCTS (had a combination of both Pfizer and Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Patient had a mixture of both Pfizer and Moderna. Patient reported that the occipital neuralgia was a worsening and noting it started days after the vaccine. This last time it started 5 days but before that with each vaccine patient had occipital neuralgia patient did not got it from the vaccine.  Patient reported that after getting each dose patient got a terrible headache, the first one lasted for few days and after the second one had a terrible headache for 2 weeks.  No treatment information was provided.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products
Clinical narrative: Revaccination with different COVID-19 vaccine; Interchange of vaccine products; Contracted COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Contracted COVID-19), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Contracted COVID-19). On an unknown date, the patient experienced 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 (Contracted COVID-19), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            No concomitant and treatment medications were reported. No further information and no additional adverse events reported.  Company comment: This is a spontaneous case regarding a female patient of an unknown age, with no reported medical history, who completed a two-dose primary series of mRNA-1273 vaccine and experienced non serious event of COVID-19 (AESI). Vaccination dates were not provided, latency cannot be assessed. Patient received Tozinameran vaccine as the booster dose of the COVID-19 vaccination schedule. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-648378, US-MODERNATX, INC.-MOD-2022-648363 (E2B Linked Report).; Sender's Comments: This is a spontaneous case regarding a female patient of an unknown age, with no reported medical history, who completed a two-dose primary series of mRNA-1273 vaccine and experienced non serious event of COVID-19 (AESI). Vaccination dates were not provided, latency cannot be assessed. Patient received Tozinameran vaccine as the booster dose of the COVID-19 vaccination schedule. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-648378:Father's case US-MODERNATX, INC.-MOD-2022-648363:Reporter's case
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Pain
Clinical narrative: Patient received Moderna as a 1st booster and experienced side effects; got achy for 24 hrs; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient received Moderna as a 1st booster and experienced side effects) and PAIN (got achy for 24 hrs) 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.    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 (Patient received Moderna as a 1st booster and experienced side effects) and PAIN (got achy for 24 hrs). At the time of the report, IMMUNISATION REACTION (Patient received Moderna as a 1st booster and experienced side effects) outcome was unknown and PAIN (got achy for 24 hrs) had resolved.            Patient birth year was reported as .  No concomitant medication was reported.  Reportedly, patient had 4 shots, 2 shots and 2 boosters. Patient would be going for fifth shot when available. Patient had no side effects from Pfizer.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Mouth swelling
Clinical narrative: allergic reaction 1 week after 1st dose; swelling in the mouth; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (allergic reaction 1 week after 1st dose) and MOUTH SWELLING (swelling in the mouth) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction 1 week after 1st dose) and MOUTH SWELLING (swelling in the mouth). At the time of the report, HYPERSENSITIVITY (allergic reaction 1 week after 1st dose) and MOUTH SWELLING (swelling in the mouth) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  It  was reported that a patient received his 1st and 2nd dose of the primary series from Moderna COVID-19 Vaccine, and 2 booster shots of J&J vaccine. Patient reported an allergic reaction (swelling in his mouth) 1 week after his 1st dose of the primary series was given, but no AEs after the 2nd dose of the Moderna vaccine. HCP mentioned that patient previously reported his case to Moderna, but HCP did not have a case number, and did not want to provide additional details on the case.  No treatment information was provided.   Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: side effect with moderna; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (side effect with moderna) 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)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    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 (side effect with moderna). At the time of the report, IMMUNISATION REACTION (side effect with moderna) outcome was unknown.            No concomitant medications were provided by the reporter.  Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event, Wrong technique in device usage process
Clinical narrative: no adverse event; when withdrawing the needle some came out and; when withdrawing the needle some came out and patient said it was a lot; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (when withdrawing the needle some came out and), ACCIDENTAL UNDERDOSE (when withdrawing the needle some came out and patient said it was a lot) and NO ADVERSE EVENT (no adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2022, 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 21-Sep-2022, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (when withdrawing the needle some came out and) and ACCIDENTAL UNDERDOSE (when withdrawing the needle some came out and patient said it was a lot). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (when withdrawing the needle some came out and), ACCIDENTAL UNDERDOSE (when withdrawing the needle some came out and patient said it was a lot) 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 WRONG TECHNIQUE IN DEVICE USAGE PROCESS (when withdrawing the needle some came out and) and ACCIDENTAL UNDERDOSE (when withdrawing the needle some came out and patient said it was a lot).    No concomitant medications were reported. Pharmacist seeking guidance because after administering the Moderna Bivalent vaccine, when withdrawing the needle some came out and patient said it was a lot, so there is no way of knowing how much the patient received.  No treatment medications were reported.