chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19-2, UNK
Symptoms: COVID-19
Clinical narrative: experienced bitter taste/metallic taste every time / Had all covid shot but still contracted covid infection.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (experienced bitter taste/metallic taste every time / Had all covid shot but still contracted covid infection.) in a 74-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.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    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, dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form and NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 2 pill in morning, 2 pill in evening. On an unknown date, the patient experienced COVID-19 (experienced bitter taste/metallic taste every time / Had all covid shot but still contracted covid infection.). At the time of the report, COVID-19 (experienced bitter taste/metallic taste every time / Had all covid shot but still contracted covid infection.) outcome was unknown.     Concomitant medications were not reported.   Patient had experienced bitter taste/metallic taste every time.  Patient had received one dose of Pfizer covid vaccine and one from Moderna vaccine.It was also mentioned that he had all of his shots but he still contracted covid infection.   No treatment medication was reported
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine).    This case contains information for the 3rd of 5 patients described by the reporter.  Concomitant medication was not reported. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712703 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Feb-2023: No new information received. On 02-Mar-2023: Non significant information received. Reporter added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712703:1st patient case (Master case)
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19
Clinical narrative: Still contracted Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Still contracted Covid-19) in a 74-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.    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 dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (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 COVID-19 (Still contracted Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at a dose of Two doses in morning and two doses in evening. At the time of the report, COVID-19 (Still contracted Covid-19) outcome was unknown.            Concomitant medication was not reported.  Patient took all of his Covid-19 vaccinations. One dose was the Pfizer Covid-19 vaccine. The other doses were Moderna. Still contracted Covid-19 despite this. Patient took Paxlovid two pills in the morning and two pills in the evening. Experienced a bitter and metallic taste every time he took the medication.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 5 patients were administered with the an expired Moderna vaccine on 15Feb2023 (2 patients), 17Feb2023 (2 patients), and 20Feb2023 - 1 patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients were administered with the an expired Moderna vaccine on 15Feb2023 (2 patients), 17Feb2023 (2 patients), and 20Feb2023 - 1 patient) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 20-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients were administered with the an expired Moderna vaccine on 15Feb2023 (2 patients), 17Feb2023 (2 patients), and 20Feb2023 - 1 patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients were administered with the an expired Moderna vaccine on 15Feb2023 (2 patients), 17Feb2023 (2 patients), and 20Feb2023 - 1 patient) 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 EXPIRED PRODUCT ADMINISTERED (5 patients were administered with the an expired Moderna vaccine on 15Feb2023 (2 patients), 17Feb2023 (2 patients), and 20Feb2023 - 1 patient).    Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.  Reportedly, Pharmacist stated that 5 patients were administered with an expired Moderna vaccine on 15-Feb-2023 (2 patients), 17-Feb-2023 (2 patients), and 20-Feb-2023 (1 patient) with Lot number: AR9236B with published expiration date of 11-Feb-2023.   This case was linked to US-MODERNATX, INC.-MOD-2023-712703 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Feb-2023: Follow-up received includes no new information (NNI) On 02-Mar-2023: Follow-up document contains no additional information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712703:1st patient case (Master case)
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Administered with an expired Moderna vaccine on 15Feb2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with an expired Moderna vaccine on 15Feb2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 15-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with an expired Moderna vaccine on 15Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with an expired Moderna vaccine on 15Feb2023) 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 EXPIRED PRODUCT ADMINISTERED (Administered with an expired Moderna vaccine on 15Feb2023).    No concomitant medications were reported.  No treatment medications were reported.  Pharmacist stated that 5 patients were administered with an expired Moderna vaccine. This patient had received Moderna vaccine on 15-Feb-2023.   This case was linked to US-MODERNATX, INC.-MOD-2023-714107, US-MODERNATX, INC.-MOD-2023-714106, US-MODERNATX, INC.-MOD-2023-714105, US-MODERNATX, INC.-MOD-2023-714097.   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2023: Upon internal review on 08-Mar-2023, significant correction performed to update report type from invalid to spontaneous and updated inarrative. On 27-Feb-2023: Follow-up received includes no new information (NNI) On 02-Mar-2023: Follow-up document contains no additional information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714107:5th patient case US-MODERNATX, INC.-MOD-2023-714105:3rd patient case US-MODERNATX, INC.-MOD-2023-714097:2nd patient case US-MODERNATX, INC.-MOD-2023-714106:4th patient case
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Parkinson's disease
Clinical narrative: parkinson's disease; This spontaneous case was reported by a patient and describes the occurrence of PARKINSON'S DISEASE (parkinson's disease) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 045B21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19. Concurrent medical conditions included Diabetes and COPD.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2022, the patient experienced PARKINSON'S DISEASE (parkinson's disease) (seriousness criteria hospitalization and medically significant). At the time of the report, PARKINSON'S DISEASE (parkinson's disease) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: something was done with his arms,diagnosis of Parkinson's happened in MAY2022.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient had no allergies. No concomitant medication were reported.  The patient stated that for about a year, he has been suffering from Parkinson's disease. It started when patient was in rehabilitation towards the end of APR-2022. This prompted the healthcare provider at the rehab to check blood work and he mentioned that something was done with patient's arms. The diagnosis of Parkinson's happened in MAY2022. Patient saw a neurologist the day after he was discharged from the rehab. His neurologist didn't positively confirm the diagnosis but she was 99 percent sure that patient had Parkinson's. Patient was in detox for a couple of weeks when his hands started shaking real bad. From the blood work, they determined that patient had Parkinson's. Patient stated that, neurologist was doing some additional testing and trying to eliminate other diagnoses.  Company Comment:   This is a spontaneous case concerning a 56-year-old, male patient while in rehabilitation (probably for detox) experienced the unexpected serious (hospitalization and medically significant) event of Parkinson's disease. The symptoms began approximately one year after the administration of the second dose of mRNA-1273 vaccine (Patient also received a booster dose but it is unknown if it was before of after symptoms began). Patient stated he was diagnosed by a lab test, but no details have been shared. Investigations are being done. No further information was disclosed. Queries are being raised. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Bronchitis, COVID-19, Illness, Immune system disorder
Clinical narrative: She got very sick from it; her immune system was depleted; got COVID around 10-Jan-2023; 3-week bout of bronchitis; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (She got very sick from it), IMMUNE SYSTEM DISORDER (her immune system was depleted), BRONCHITIS (3-week bout of bronchitis) and COVID-19 (got COVID around 10-Jan-2023) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (ampicillin).    On 23-Sep-2022, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced COVID-19 (got COVID around 10-Jan-2023). On an unknown date, the patient experienced ILLNESS (She got very sick from it), IMMUNE SYSTEM DISORDER (her immune system was depleted) and BRONCHITIS (3-week bout of bronchitis). At the time of the report, ILLNESS (She got very sick from it) and IMMUNE SYSTEM DISORDER (her immune system was depleted) outcome was unknown and BRONCHITIS (3-week bout of bronchitis) and COVID-19 (got COVID around 10-Jan-2023) had resolved.        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.   Patient reported allergies and no other medical history.  No concomitant drug was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient received Moderna first dose on 1-FEB-2021, lot number: 037K20A, second Moderna dose on 03-Mar-2021, lot number: 043L20A, on 25-Oct-2021, patient received first Moderna booster, lot number : 026D21A, on 01-Mar-2022, patient received second Moderna booster (unknown lot number), on 5-Apr-2022, received third booster (lot number : 002M21A).  Patient wondering if she should be getting another booster because she would be traveling at the end of the month. She got COVID around 10-Jan2023, even after all those boosters. She got very sick from that. Patient had a 3-week bout of bronchitis right before that. The patient was told that her immune system was depleted, so she got COVID. That kicked her.   Patient was put on the drug that people get with COVID (drug name was unknown). It was an awful drug to take, but patient had to take that because she was really sick.   This case was linked to US-MODERNATX, INC.-MOD-2023-714077 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: She got very sick from it; her immune system was depleted; got COVID around 10-Jan-2023; 3-week bout of bronchitis; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (She got very sick from it), IMMUNE SYSTEM DISORDER (her immune system was depleted), BRONCHITIS (3-week bout of bronchitis) and COVID-19 (got COVID around 10-Jan-2023) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (ampicillin).    On 23-Sep-2022, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced COVID-19 (got COVID around 10-Jan-2023). On an unknown date, the patient experienced ILLNESS (She got very sick from it), IMMUNE SYSTEM DISORDER (her immune system was depleted) and BRONCHITIS (3-week bout of bronchitis). At the time of the report, ILLNESS (She got very sick from it) and IMMUNE SYSTEM DISORDER (her immune system was depleted) outcome was unknown and BRONCHITIS (3-week bout of bronchitis) and COVID-19 (got COVID around 10-Jan-2023) had resolved.        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.   Patient reported allergies and no other medical history.  No concomitant drug was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient received Moderna first dose on 1-FEB-2021, lot number: 037K20A, second Moderna dose on 03-Mar-2021, lot number: 043L20A, on 25-Oct-2021, patient received first Moderna booster, lot number : 026D21A, on 01-Mar-2022, patient received second Moderna booster (unknown lot number), on 5-Apr-2022, received third booster (lot number : 002M21A).  Patient wondering if she should be getting another booster because she would be traveling at the end of the month. She got COVID around 10-Jan2023, even after all those boosters. She got very sick from that. Patient had a 3-week bout of bronchitis right before that. The patient was told that her immune system was depleted, so she got COVID. That kicked her.   Patient was put on the drug that people get with COVID (drug name was unknown). It was an awful drug to take, but patient had to take that because she was really sick.   This case was linked to US-MODERNATX, INC.-MOD-2023-714077 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Bronchitis, COVID-19, Illness, Immune system disorder
Clinical narrative: No adverse event; Patient got 4 boosters; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient got 4 boosters) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 026D21A, 043L20A and 037K20A) for COVID-19 prophylaxis.     Patient had no other medical history.  Concurrent medical conditions included Penicillin allergy and Drug allergy (Ampicillin allergy).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-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 05-Apr-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXTRA DOSE ADMINISTERED (Patient got 4 boosters). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient got 4 boosters) 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 EXTRA DOSE ADMINISTERED (Patient got 4 boosters).    No concomitant information was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-713963 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713963:Bivalent Booster
Age: 66.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Patient got 4 boosters; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient got 4 boosters) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 026D21A, 043L20A and 037K20A) for COVID-19 prophylaxis.     Patient had no other medical history.  Concurrent medical conditions included Penicillin allergy and Drug allergy (Ampicillin allergy).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-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 05-Apr-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXTRA DOSE ADMINISTERED (Patient got 4 boosters). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient got 4 boosters) 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 EXTRA DOSE ADMINISTERED (Patient got 4 boosters).    No concomitant information was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-713963 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713963:Bivalent Booster
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 27-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Feb-2023, after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date).    No concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in his arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in his arm) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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, the patient experienced PAIN IN EXTREMITY (pain in his arm). At the time of the report, PAIN IN EXTREMITY (pain in his arm) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The caller reported an adverse reaction that his son experienced (AE-00016849/C-INT-0003181). While he was reporting that, he mentioned that he also received the Moderna vaccine and had also experienced pain in his arm for 3 days. He doesn't want to report anything more about this, he doesn't want to be contacted about this. He just wanted to report about his son. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-714200, US-MODERNATX, INC.-MOD-2023-714201 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714200:Mother-In-Law US-MODERNATX, INC.-MOD-2023-714201:Son
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received his 3rd primary dose as his 1st booster dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his 3rd primary dose as his 1st booster dose) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071B22A) for COVID-19 prophylaxis. No Medical History information was reported. 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, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his 3rd primary dose as his 1st booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his 3rd primary dose as his 1st booster dose) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his 3rd primary dose as his 1st booster dose). No concomitant medications were provided. At that time Moderna had not released Bivalent vaccine, as result patient received his 3rd primary dose as his 1st booster dose. HCP would like to know how to have Bivalent dose administered because patient was not immunocompromised. No treatment medication was provided.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoacusis
Clinical narrative: After he got the 2nd dose started hearing seashell like sound, noticed that after each succeeding booster dose; This spontaneous case was reported by a patient and describes the occurrence of HYPOACUSIS (After he got the 2nd dose started hearing seashell like sound, noticed that after each succeeding booster dose) in an elderly male 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 prophylaxis.     The patient's past medical history included Stapedectomy ((replacement of the stapes bone in the middle ear) on his left ear) in November 1998, Hearing loss, Tinnitus and Hearing disability (background noise he was hearing). Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) and VARICELLA ZOSTER VACCINE for an unknown indication.    On 29-Sep-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 an unknown date, the patient experienced HYPOACUSIS (After he got the 2nd dose started hearing seashell like sound, noticed that after each succeeding booster dose). At the time of the report, HYPOACUSIS (After he got the 2nd dose started hearing seashell like sound, noticed that after each succeeding booster dose) 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.   After the surgery, the symptoms disappeared and patient was good for about 22 to 24 years.  Patient received 1st dose of Moderna on 02-Mar-2021 (lot number 010A21A), 2nd dose on 30-Mar-2021 (lot number 008B21-2A0, 1st booster dose on 03-Nov-2021 (lot number - 058E21A) and 2nd booster dose on 14-Apr-2022 (lot number 046L21A).  Patient had flu shots every fall and updated Shingles vaccine (2 doses) within the last year but did not have the exact dates on record. Patient stated that he did not have any problems (related to the ear) before Mar2021. After patient got the 2nd dose of the Moderna Covid-19 vaccine (10-14 days approximately), he started hearing seashell-like sound which was different from the tinnitus which patient had before getting the operation. Patient went on to get 3 booster doses, the last one being the bivalent dose. Patient noticed that after each succeeding booster dose, the symptom only got worse. This symptom were present 24/7. Patient went to see the doctor who operated on him but since he was already semi-retired, referred the patient to another ear doctor. The patient was given 3 options, to get it operated again, to get a hearing air or do nothing.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-380937 (Patient Link).
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female 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 COVID-19 prophylaxis: Spikevax (Primary series dose 1) and Spikevax (Primary series dose 2). Past adverse reactions to the above products included No adverse event with Spikevax and Spikevax.    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. In December 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) 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 product reported by reporter.  It was reported that reporter's mother in law received her Moderna primary series vaccine and two Moderna booster doses and that his Mother-In-Law caught Covid-19 in December 2022.  No treatment medication reported by reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Drug ineffective, Suspected COVID-19
Clinical narrative: Her and her husband got COVID Oct2022; Her and her husband got COVID Oct2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6198, Expiration Date: 30Jun2021), on 21Mar2021 as dose 2, single (Lot number: EN6208) and on 30Aug2021 as dose 3 (booster), single (Lot number: EW0177) for covid-19 immunisation. The patient's relevant medical history included: "CLL" (ongoing), notes: 11 years now; has the slow kind; she had it at 60 when HCP found second cancer & diagnosed at 61; "first breast cancer" (unspecified if ongoing), notes: Got it following a second breast cancer, probably came from chemotherapy from 1st breast cancer at 45; "second breast cancer" (unspecified if ongoing), notes: Got it following a second breast cancer, probably came from chemotherapy from 1st breast cancer at 45; "Hot flashes" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA taken for hot flush (ongoing); VITAMIN D NOS taken for breast cancer, chronic lymphocytic leukaemia (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Her and her husband got COVID Oct2022". The patient underwent the following laboratory tests and procedures: Antibody test: (2020) No antibodies after shots, notes: had her antibodies tested after first two COVID shots and didn't have any antibodies. Clinical course: the patient tried to read and followed the rules and expected integrity from everyone else. Her husband and her did not get COVID because she was careful, and she was on Vitamin D everyday because of cancer and CLL and her antibodies tested after first two COVID vaccines and didn't had any antibodies. She took the and she assumed she not have any antibodies. She sees an oncologist twice a year for lab work and will probably take a pill someday. She got COVID this fall on Oct2022. It was similar to cold, was not as bad as the cold she got from her grandkids shortly after that.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Inappropriate schedule of product administration, Lethargy, Pyrexia
Clinical narrative: temperature; lethargic; didn't eat; Three months between shots. One before he had the first one in August. Not this year but probably 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 11-year-old male patient received BNT162b2 (BNT162B2), as dose 2 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: the year before he had got the shot. Not severe, had a cold, came home from school. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 Immunization, reaction(s): "Adverse reaction". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "temperature"; LETHARGY (non-serious), outcome "recovered", described as "lethargic"; DECREASED APPETITE (non-serious), outcome "recovered", described as "didn't eat"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Three months between shots. One before he had the first one in August. Not this year but probably 2021". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller was reporting on caller's daughter's oldest son. None of her daughter's family will take another one. Her daughter's oldest son had reactions to both the COVID shots. He had temperature, lethargic, and didn't eat. Was sure with his father he will never get another one either. Daughter's oldest son would have been 11 or 12 at the time. It was known that boys were having heart issues at that age. He was in the part where before guys sprout so a little chubby but not overweight. Reaction to the shot happened with both shots he took. Remembered he had one before he had a fever, lethargic, didn't eat, and that was pretty much it. Both times he had a reaction versus his brother who didn't. Doesn't know if age made a difference. Read something that teenage boys had an issue.  Doesn't know if he has had reactions to other shots that she was aware of. He recovered within 24 to 36 hours.  Dates: Whatever was normal. Three months between shots. One before he had the first one in August. Not this year but probably 2021. Both shots were Pfizer as at that time Pfizer was trusted the most. Dates: Unknown. Full product information for both shots unknown as she does not have her daughter's oldest son's vaccine information.  He was a good healthy kid. He did have COVID once, but she can't remember when. Clarified it was the year before he had got the shot. Not severe, had a cold, came home from school. At that time kids had to be tested to go to school even though it sounded like a cough he was positive and had to stay at home.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: temperature; lethargic; didn't eat; Three months between shots. One before he had the first one in August. Not this year but probably 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 11-year-old male patient received BNT162b2 (BNT162B2), as dose 2 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: the year before he had got the shot. Not severe, had a cold, came home from school. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 Immunization, reaction(s): "Adverse reaction". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "temperature"; LETHARGY (non-serious), outcome "recovered", described as "lethargic"; DECREASED APPETITE (non-serious), outcome "recovered", described as "didn't eat"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Three months between shots. One before he had the first one in August. Not this year but probably 2021". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller was reporting on caller's daughter's oldest son. None of her daughter's family will take another one. Her daughter's oldest son had reactions to both the COVID shots. He had temperature, lethargic, and didn't eat. Was sure with his father he will never get another one either. Daughter's oldest son would have been 11 or 12 at the time. It was known that boys were having heart issues at that age. He was in the part where before guys sprout so a little chubby but not overweight. Reaction to the shot happened with both shots he took. Remembered he had one before he had a fever, lethargic, didn't eat, and that was pretty much it. Both times he had a reaction versus his brother who didn't. Doesn't know if age made a difference. Read something that teenage boys had an issue.  Doesn't know if he has had reactions to other shots that she was aware of. He recovered within 24 to 36 hours.  Dates: Whatever was normal. Three months between shots. One before he had the first one in August. Not this year but probably 2021. Both shots were Pfizer as at that time Pfizer was trusted the most. Dates: Unknown. Full product information for both shots unknown as she does not have her daughter's oldest son's vaccine information.  He was a good healthy kid. He did have COVID once, but she can't remember when. Clarified it was the year before he had got the shot. Not severe, had a cold, came home from school. At that time kids had to be tested to go to school even though it sounded like a cough he was positive and had to stay at home.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Got COVID; Got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Got COVID".  Additional information: Patient got COVID this fall in Oct2022. He had no reactions to the COVID shots.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 51 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Certain antibiotics" (unspecified if ongoing). Concomitant medication included: ADVAIR, start date: 24Dec2010, stop date: 14Feb2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: COVID 19 treatment included Paxlovid from 14Feb2023 to 19Feb2023.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single at the age of 70 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (batch/lot number: unknown), as dose 2, single (batch/lot number: unknown) and as dose 3 (booster), single (batch/lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "allergies penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "treatment of COVID-19". The patient underwent the following laboratory tests and procedures: home test: (unspecified date) positive; (03Mar2023) repeat positive, notes: home test day 14 after original symptoms onset and day 10 after completing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 17Feb2023 to 21Feb2023.
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Drug ineffective, Suspected COVID-19
Clinical narrative: She has had 4 Pfizer COVID Vaccines for COVID and she has had COVID Twice; She has had 4 Pfizer COVID Vaccines for COVID and she has had COVID Twice; She has had 4 Pfizer COVID Vaccines for COVID and she has had COVID Twice; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (086396). The reporter is the patient.  An 85-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (ongoing); "Thyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "She has had 4 Pfizer COVID Vaccines for COVID and she has had COVID Twice".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with PF-07321332, ritonavir (PAXLOVID).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.