chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Patient received monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine for 6-11 years old administered instead of bivalent vaccine).    No concomitant medications were reported. Patient received 0.5ml of the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657547, US-MODERNATX, INC.-MOD-2022-657560 Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657560:Same reporter US-MODERNATX, INC.-MOD-2022-657547:
Age: 84.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in an 84-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine).    No concomitant medication details was reported. It was reported that the patient received 0.5 ml of the dark blue cap vaccine for 6 to 11 years old instead of the new bivalent vaccine. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657547, US-MODERNATX, INC.-MOD-2022-657560 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657560:Same reporter US-MODERNATX, INC.-MOD-2022-657547:
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine).    No concomitant medications were provided.  Patient received 0.5 ml of the dark blue cap vaccine for 6-11 years old instead of the new bivalent vaccine.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-657547, US-MODERNATX, INC.-MOD-2022-657552, US-MODERNATX, INC.-MOD-2022-657555, US-MODERNATX, INC.-MOD-2022-657558, US-MODERNATX, INC.-MOD-2022-657560, US-MODERNATX, INC.-MOD-2022-657564, US-MODERNATX, INC.-MOD-2022-657565, US-MODERNATX, INC.-MOD-2022-657567, US-MODERNATX, INC.-MOD-2022-657621, US-MODERNATX, INC.-MOD-2022-657622, US-MODERNATX, INC.-MOD-2022-657629 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657547:Same reporter US-MODERNATX, INC.-MOD-2022-657552:Same reporter US-MODERNATX, INC.-MOD-2022-657555:Same reporter US-MODERNATX, INC.-MOD-2022-657558:Same reporter US-MODERNATX, INC.-MOD-2022-657560:Same reporter US-MODERNATX, INC.-MOD-2022-657564:Same reporter US-MODERNATX, INC.-MOD-2022-657565:Same reporter US-MODERNATX, INC.-MOD-2022-657567:Same reporter US-MODERNATX, INC.-MOD-2022-657621:Same reporter US-MODERNATX, INC.-MOD-2022-657622:Same reporter US-MODERNATX, INC.-MOD-2022-657629:Same reporter
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine).    Concomitant medication details was not reported.  The patient received 0.5ml of the dark blue cap vial vaccine that was intended for use in 6-11 years old age patient, instead of the new bivalent vaccine.  Treatment details was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657506 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657506:Master case (Crosslink case with same reporter)
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; monovalent vaccine for 6 to 11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6 to 11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6 to 11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6 to 11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6 to 11 years old administered instead of bivalent vaccine).    Concomitant medications details were not reported by the reporter.  Patient age was 48 years 5 months.  It was reported that patient received 0.5ml of the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine.  Treatment details were not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-657547, US-MODERNATX, INC.-MOD-2022-657560 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657560:Same reporter US-MODERNATX, INC.-MOD-2022-657547:
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Received 0.5 milliliter of the dark blue cap vaccine for 6-11 years old instead of the new bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received 0.5 milliliter of the dark blue cap vaccine for 6-11 years old instead of the new bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received 0.5 milliliter of the dark blue cap vaccine for 6-11 years old instead of the new bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received 0.5 milliliter of the dark blue cap vaccine for 6-11 years old instead of the new bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received 0.5 milliliter of the dark blue cap vaccine for 6-11 years old instead of the new bivalent vaccine).    No concomitant medications were reported.   It was reported that 15 patients received 0.5ml of the dark blue cap vaccine(Monovalent) for 6-11 years old instead of the new Bivalent vaccine on 08-Oct-2022.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657547, US-MODERNATX, INC.-MOD-2022-657560; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657560:Same reporter US-MODERNATX, INC.-MOD-2022-657547:
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle soreness; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Muscle soreness) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 014M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy (Penicillin).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021 at 2:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Muscle soreness). At the time of the report, MYALGIA (Muscle soreness) had resolved.     No concomitant medication information was provided. It was reported that, patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination were Levothyroxine 125MCG, losartan 50MG, Atorvastatin. The patient was not diagnosed with COVID-19 Since the vaccination, had not been tested for COVID-19. Administration Time of dose to was 01:15 PM. The device date was given as 08-Oct-2022. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2022: Follow up received contains significant information: Suspect details updated.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.       No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be related.    No concomitant and treatment medications were reported.  Company comment: This literature non study case concerns an adult patient of unknown gender, with no reported medical history, who experienced the expected, serious (medically significant) AESI of Myocarditis, unknown days after receiving an unspecified dose of mRNA-1273 vaccine. No information on risk factors, detailed clinical course, investigations, treatment of the event, outcome and details pertaining to vaccination schedule was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-657553; Sender's Comments: This literature non study case concerns an adult patient of unknown gender, with no reported medical history, who experienced the expected, serious (medically significant) AESI of Myocarditis, unknown days after receiving an unspecified dose of mRNA-1273 vaccine. No information on risk factors, detailed clinical course, investigations, treatment of the event, outcome and details pertaining to vaccination schedule was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-657553:Same Article Patient 1
Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Death
Clinical narrative: Unknown cause of death; Breakthrough COVID-19; This case was reported in a article and describes the occurrence of DEATH (Unknown cause of death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.  REFERENCE: Increased mortality among persons with symptomatic coronavirus disease 2019 (COVID-19) during the period of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) B.1.617.2 (Delta Variant).    No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Unknown cause of death) (seriousness criterion death) and BREAKTHROUGH COVID-19 (Breakthrough COVID-19). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, BREAKTHROUGH COVID-19 (Breakthrough COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEATH (Unknown cause of death) and BREAKTHROUGH COVID-19 (Breakthrough COVID-19) to be related.    Concomitant and treatment medications were not provided. Reported that delta period was associated with 2.43 fold higher odds of death.  Company comment: This study case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected fatal event of Death (reported as Unknown cause of death), unknown days after receiving an unspecified dose of mRNA-1273 vaccine. It was reported that the patient had a breakthrough COVID-19 infection on an unknown date. The cause of death was not known. No information on risk factors, detailed clinical course, autopsy findings and details pertaining to vaccination schedule was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked. Sender's Comments: This case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected fatal event of Death (reported as Unknown cause of death), unknown days after receiving an unspecified dose of mRNA-1273 vaccine. It was reported that the patient had a breakthrough COVID-19 infection on an unknown date. The cause of death was not known. No information on risk factors, detailed clinical course, autopsy findings and details pertaining to vaccination schedule was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-657781:This case refers cluster of 999 pts (breakthrough infections); Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID infection; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (COVID infection) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.        Concurrent medical conditions included Cirrhosis liver.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (COVID infection) (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed. Related        For mRNA-1273 (Spikevax) (Unknown), the reporter considered COVID-19 (COVID infection) to be related.    Concomitant and treatment medications were not reported. Study was carried between July 18, 2021 and February 11, 2022, when B.1.617.2 (Delta) and B.1.1.529 (Omicron) were the predominant variants.  Author stated that the findings support the third dose of mRNA vaccine among patients with cirrhosis.  Company Comment: This is a literature non-study case concerning an adult patient of unknown gender with medical history of liver cirrhosis, who had fatal outcome with unexpected, serious event of COVID-19, 207 days after receiving the second dose of mRNA-1273 vaccine. The patient had compensated cirrhosis and was treated with remdesivir and dexamethasone at the time of infection but died following critical COVID-19. It is unknown if an autopsy was performed. Medical history of liver cirrhosis could be contributory factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a literature non-study case concerning an adult patient of unknown gender with medical history of liver cirrhosis, who had fatal outcome with unexpected, serious event of COVID-19, 207 days after receiving the second dose of mRNA-1273 vaccine. The patient had compensated cirrhosis and was treated with remdesivir and dexamethasone at the time of infection but died following critical COVID-19. It is unknown if an autopsy was performed. Medical history of liver cirrhosis could be contributory factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of Death
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Arm Pain; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain) and ARTHRALGIA (Shoulder pain) in an 87-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 Ulcerative colitis.    The patient's past medical history included Urticaria, Formication and Dyspepsia. Previously administered products included for Drug use for unknown indication: KEFLEX [CEFALEXIN] (Urticaria with Keflex), CODEINE (Urticaria with Codeine), DOXYCYCLINE (Urticaria with Doxycycline), Flagyl (Dyspepsia with Flagyl), CORTISONE (Urticaria with Cortisone), CALCORT (Urticaria with Calcort), Prednisone (Formication with Prednisone) and Amoxiclav (Urticaria with Amoxiclav). Past adverse reactions to the above products included Dyspepsia with Flagyl; Formication with Prednisone; and Urticaria with Amoxiclav, CALCORT, CODEINE, CORTISONE, DOXYCYCLINE and KEFLEX [CEFALEXIN]. Concurrent medical conditions included Cigarette smoker (Tobacco Use/Five to six packs of cigarette a day) since 2012, Transient ischaemic attack since 2015, Sulfonamide allergy (Sulfa drug allergy manifested by Hives), Allergic urticaria, Pain, Anxiety and Ulcerative colitis. Concomitant products included LORAZEPAM for Anxiety, PARACETAMOL (TYLENOL) for Pain, VITAMIN D3 for Supplementation therapy.   In 2017, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain) and ARTHRALGIA (Shoulder pain). At the time of the report, PAIN IN EXTREMITY (Arm Pain) and ARTHRALGIA (Shoulder pain) had not resolved.            It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  Patient stated that Humira was working for her initially but now medication was not working.  Treatment information was not provided.  The reporter's causality for the events of Arm Pain and Shoulder pain with Adalimumab Solution for Injection was No Reasonable Possibility.   This case was linked to MOD-2022-658030 (Patient Link).
Age: 87.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Inappropriate schedule of product administration, Malaise
Clinical narrative: not feeling to well; stomach does not feel good; Recevied 2 Bivalent Boosters 1 day apart; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (not feeling to well), ABDOMINAL DISCOMFORT (stomach does not feel good) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Recevied 2 Bivalent Boosters 1 day apart) in an 87-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     The patient had no allergies to medications, food and other products.  The patient's past medical history included Dialysis. Concurrent medical conditions included Cognitive disorder.    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 MALAISE (not feeling to well), ABDOMINAL DISCOMFORT (stomach does not feel good) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Recevied 2 Bivalent Boosters 1 day apart). At the time of the report, MALAISE (not feeling to well), ABDOMINAL DISCOMFORT (stomach does not feel good) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Recevied 2 Bivalent Boosters 1 day apart) outcome was unknown.            No relevant concomitant medications were reported.  Patient received a Moderna Bivalent Booster vaccine. Due to his cognitive problems he did not remember receiving it, and while getting his dialysis, the facility gave him another Bivalent Booster vaccine on the very next day. He was not feeling to well and that his stomach does not feel good.  Patient was not diagnosed with or tested positive for COVID.  No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test, Somnolence
Clinical narrative: Fever; feeling very sleepy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Fever) and SOMNOLENCE (feeling very sleepy) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Two weeks after the first shot she had Covid) in January 2021. Previously administered products included for Product used for unknown indication: Flu shot (given within 1 month prior to Moderna vaccine). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Allergy to antibiotic (Erythromycin) and Drug allergy (Codeine). Concomitant products included ALPRAZOLAM, AMLODIPINE, ATORVASTATIN and ESOMEPRAZOLE for an unknown indication.    On 11-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 12-Oct-2022, the patient experienced PYREXIA (Fever) and SOMNOLENCE (feeling very sleepy). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) and SOMNOLENCE (feeling very sleepy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Positive.         The patient received fist dose of Moderna vaccine with lot number 042L20A on 15-Jan-2021 in deltoid (shoulder) muscle via intramuscular route.  The patient received second dose of Moderna vaccine on 24-Apr-2021 in in deltoid (shoulder) muscle via intramuscular route.  The patient received first booster dose of Moderna vaccine on 08-Nov-2021 with lot number 071F21A in deltoid (shoulder) muscle via intramuscular route.  On 11-Oct-2022, the patient received second booster dose of Moderna COVID-19 bivalent vaccine.  The patient received a couple of Tylenol. The reporter wanted to know if it was normal to have fever after receiving the vaccine. The patient was taking other medication and the healthcare provider was aware of the side effects.   This case was linked to MOD-2022-658050, MOD-2022-658051 (Patient Link).
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID/ Had COVID after two week sof first dose/ Again COVID on April-2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID/ Had COVID after two week sof first dose/ Again COVID on April-2022) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A and 042L20A) for COVID-19 vaccination.     The patient had no allergy.  The patient's past medical history included Balance difficulty. Previously administered products included for Product used for unknown indication: Flu shot (Other vaccine given within 1 month to COVID-19 vaccination). Past adverse reactions to the above products included No adverse event with Flu shot.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced COVID-19 (Tested positive for COVID/ Had COVID after two week sof first dose/ Again COVID on April-2022). At the time of the report, COVID-19 (Tested positive for COVID/ Had COVID after two week sof first dose/ Again COVID on April-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Positive. In April 2022, SARS-CoV-2 test: (Positive) Positive.         The height was 176.7 cm (5feet 8 inch). The concomitant medication was not provided. The anatomical location was deltoid shoulder. The patient was COVID-19 positive again on Apr-2022. Treatment medication was not reported.   This case was linked to MOD-2022-658053, MOD-2022-658052 (Patient Link).
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID/ Had COVID after two week sof first dose/ Again COVID on April-2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID/ Had COVID after two week sof first dose/ Again COVID on April-2022) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A and 042L20A) for COVID-19 vaccination.     The patient had no allergy.  The patient's past medical history included Balance difficulty. Previously administered products included for Product used for unknown indication: Flu shot (Other vaccine given within 1 month to COVID-19 vaccination). Past adverse reactions to the above products included No adverse event with Flu shot.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced COVID-19 (Tested positive for COVID/ Had COVID after two week sof first dose/ Again COVID on April-2022). At the time of the report, COVID-19 (Tested positive for COVID/ Had COVID after two week sof first dose/ Again COVID on April-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Positive. In April 2022, SARS-CoV-2 test: (Positive) Positive.         The height was 176.7 cm (5feet 8 inch). The concomitant medication was not provided. The anatomical location was deltoid shoulder. The patient was COVID-19 positive again on Apr-2022. Treatment medication was not reported.   This case was linked to MOD-2022-658053, MOD-2022-658052 (Patient Link).
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: No Adverse event; Patient received the 1st dose on 15-Jan-2021 and 2nd dose on 24-Apr-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose on 15-Jan-2021 and 2nd dose on 24-Apr-2021) and NO ADVERSE EVENT (No Adverse event) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (two weeks after the first dose of Moderna COVID-19 vaccine) in January 2021 and Balance difficulty. Previously administered products included for Drug use for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose on 15-Jan-2021 and 2nd dose on 24-Apr-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose on 15-Jan-2021 and 2nd dose on 24-Apr-2021) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Positive. In April 2022, SARS-CoV-2 test: (Positive) Positive.         The patient had no allergies. No concomitant medications were reported.  The patient received the 1st dose and 2nd dose of Moderna COVID-19 vaccine in Deltoid (Shoulder) muscle.  No treatment medications were reported.   This case was linked to MOD-2022-658053, MOD-2022-658049 (Patient Link).
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, SARS-CoV-2 test
Clinical narrative: No Adverse event; Patient received the 1st dose on 15-Jan-2021 and 2nd dose on 24-Apr-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose on 15-Jan-2021 and 2nd dose on 24-Apr-2021) and NO ADVERSE EVENT (No Adverse event) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (two weeks after the first dose of Moderna COVID-19 vaccine) in January 2021 and Balance difficulty. Previously administered products included for Drug use for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose on 15-Jan-2021 and 2nd dose on 24-Apr-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose on 15-Jan-2021 and 2nd dose on 24-Apr-2021) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Positive. In April 2022, SARS-CoV-2 test: (Positive) Positive.         The patient had no allergies. No concomitant medications were reported.  The patient received the 1st dose and 2nd dose of Moderna COVID-19 vaccine in Deltoid (Shoulder) muscle.  No treatment medications were reported.   This case was linked to MOD-2022-658053, MOD-2022-658049 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID/Two weeks after the first shot she had Covid in January; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Tested positive for COVID/Two weeks after the first shot she had Covid in January) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (Flu shot was given within one month prior to Moderna vaccine.). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Allergy to antibiotic (Erythromycin) and Drug allergy (Codeine). Concomitant products included ALPRAZOLAM, AMLODIPINE, ATORVASTATIN and ESOMEPRAZOLE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced COVID-19 (Tested positive for COVID/Two weeks after the first shot she had Covid in January). At the time of the report, COVID-19 (Tested positive for COVID/Two weeks after the first shot she had Covid in January) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient received first dose on her deltoid (shoulder). Patient had no medical history relating to mentioned AE and there was no both acute and chronic illnesses at the time of vaccination. Treatment information was not provided.   This case was linked to MOD-2022-658051, MOD-2022-658038 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, SARS-CoV-2 test
Clinical narrative: No adverse event; Patient received first dose of Moderna vaccine on 15-Jan-2021 and second dose on 24-Apr-2021; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 15-Jan-2021 and second dose on 24-Apr-2021) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No acute and chronic illnesses were present at the time of vaccination.  The patient's past medical history included COVID-19 (Two weeks after the first shot, the patient had Covid) in January 2021. Previously administered products included for Drug use for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Allergy to antibiotic (Erythromycin) and Drug allergy (Codeine). Concomitant products included ALPRAZOLAM, AMLODIPINE, ATORVASTATIN and ESOMEPRAZOLE for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 15-Jan-2021 and second dose on 24-Apr-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 15-Jan-2021 and second dose on 24-Apr-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Positive.         The patient received the both the first and second doses on her deltoid (shoulder) muscle.  The patient was taking Alprazolam dose as needed.  No treatment medications were reported.   This case was linked to MOD-2022-658050, MOD-2022-658038 (Patient Link).
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue
Clinical narrative: feeling fatigue today; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (feeling fatigue today) in an 86-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in January 2021 and COVID-19 in April 2021. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Balance disorder.    On 11-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 12-Oct-2022, the patient experienced FATIGUE (feeling fatigue today). At the time of the report, FATIGUE (feeling fatigue today) outcome was unknown.            No concomitant medications were reported.  Patient received 1st dose of Moderna with Lot number: 042L20A on 15Jan2021 in Deltoid (Shoulder) IM in the Vaccination Location: Contact 3  Patient received 2nd dose of Moderna on 24Apr2021 in Deltoid (Shoulder) IM in the Vaccination Location: Contact 4  Patient received 1st booster  dose of Moderna on 08Nov2021 in Deltoid (Shoulder) IM in the Vaccination Location: Contact 5  with Lot number: 071F21A  Patient received 2nd booster  dose of Moderna on 057F22A in Deltoid (Shoulder) IM in the Vaccination Location: Contact 6  with Lot number: 057F22A  No treatment details were reported   This case was linked to MOD-2022-658052, MOD-2022-658049 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received a regular Moderna COVID19 vaccine instead of receiving a second booster; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received a regular Moderna COVID19 vaccine instead of receiving a second booster) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013b22a) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID19 vaccine (Dose 1) and Pfizer COVID19 vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer COVID19 vaccine and Pfizer COVID19 vaccine.    On 11-Oct-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received a regular Moderna COVID19 vaccine instead of receiving a second booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received a regular Moderna COVID19 vaccine instead of receiving a second booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received a regular Moderna COVID19 vaccine instead of receiving a second booster).    No concomitant medication were reported.  Patient's first booster was from Moderna. Patient received a regular Moderna COVID19 vaccine instead of receiving a second booster.   No treatment information was provided by the reporter.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: had sore arms; minor body aches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (had sore arms) and MYALGIA (minor body aches) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy and Blood cholesterol abnormal. Concomitant products included ROSUVASTATIN for Hypercholesteraemia.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In 2021, the patient experienced PAIN IN EXTREMITY (had sore arms) and MYALGIA (minor body aches). The patient was treated with IBUPROFEN at an unspecified dose and frequency. In 2021, PAIN IN EXTREMITY (had sore arms) and MYALGIA (minor body aches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient height was reported as 6 feet and 4 inches.  Patient received dose 1, dose 2, dose 3 and dose 4 of Moderna vaccine. Patient was healthy and active. Patient did not seek medical care for AE cause. Patient did not experienced a similar event in the past.   This case was linked to MOD-2022-658064, MOD-2022-658071, MOD-2022-658065 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: With vaccines 2-5 we had considerable body aches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYALGIA (With vaccines 2-5 we had considerable body aches) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A and 009C21A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy and Cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In 2021, the patient experienced MYALGIA (With vaccines 2-5 we had considerable body aches). The patient was treated with IBUPROFEN at an unspecified dose and frequency. In 2021, MYALGIA (With vaccines 2-5 we had considerable body aches) had resolved. re      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient height was reported as 6 feet and 4 inches.  It was reported that patient received two primary and 3 booster vaccines, all Moderna vaccines.   From vaccine 2 and 3 patient had considerable body aches with onset about 12 hours after the injections. Patient body aches lasted for 2 days.  Patient was healthy and active.  Patient did not seek medical care for AE cause. Patient did not experienced a similar event in the past.   This case was linked to MOD-2022-658061, MOD-2022-658071, MOD-2022-658065 (Patient Link).