chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lichen planus, Mass, Psoriasis, Rash
Clinical narrative: Covered with red bumps that have a crust in the middle/got the bump/creeping up to the chest; Psoriasis; Lichen plantus; Covered with red bumps that have a crust in the middle; Rash/Couple of spots on the leg; This spontaneous case was reported by a patient and describes the occurrence of MASS (Covered with red bumps that have a crust in the middle/got the bump/creeping up to the chest), PSORIASIS (Psoriasis), LICHEN PLANUS (Lichen plantus), ERYTHEMA (Covered with red bumps that have a crust in the middle) and RASH (Rash/Couple of spots on the leg) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053022A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Osteoarthritis, Type 2 diabetes mellitus and Hypercholesterolemia.    On 06-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Oct-2022, the patient experienced RASH (Rash/Couple of spots on the leg). On an unknown date, the patient experienced MASS (Covered with red bumps that have a crust in the middle/got the bump/creeping up to the chest), PSORIASIS (Psoriasis), LICHEN PLANUS (Lichen plantus) and ERYTHEMA (Covered with red bumps that have a crust in the middle). The patient was treated with FLUOCINONIDE at a dose of 0.05 percent ointment twice a day. At the time of the report, MASS (Covered with red bumps that have a crust in the middle/got the bump/creeping up to the chest), PSORIASIS (Psoriasis), LICHEN PLANUS (Lichen plantus), ERYTHEMA (Covered with red bumps that have a crust in the middle) and RASH (Rash/Couple of spots on the leg) had not resolved.            No concomitant medications were reported. On 25-Mar-2021, the patient received first dose of Moderna COVID-19 vaccine of batch number 026A21A. On 24-Apr-2021, the patient received second dose of Moderna COVID-19 vaccine of batch number 008B212A. On 28-Oct-2021, the patient received first booster dose (dose 3) of Moderna COVID-19 vaccine of batch number 011A21A. Patient did not had COVID positive test or diagnosis Treatment information included patient was instructed to use ointment for two weeks, stop for a week, and start it again. It was reported that patient was only using ointment because doctors had prescribed it but it was not doing anything.   This case was linked to MOD-2022-681960 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Accidentally received Moderna Bivalent booster instead of first primary dose; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Accidentally received Moderna Bivalent booster instead of first primary dose) and NO ADVERSE EVENT (No adverse event) in a 25-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Seafood allergy and Penicillin allergy.    On 30-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Accidentally received Moderna Bivalent booster instead of first primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Accidentally received Moderna Bivalent booster instead of first primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medications were not reported.                                        No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Non-significant Live Follow Up information received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion; No adverse event; The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 49-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.     No Medical History information was reported.    On 30-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion).    No concomitant medications were reported.  It was reported that Proposed desired Use by Date was 05-Dec-2022. Two unbroken cartons of Bivalent vaccine was stored in frozen condition at the time of excursion. The vial had reached 11.5 degrees Fahrenheit for 1 hour 18 minutes. There was a little bit of frost on the brim or neck of all of the vaccine vials. Now the vials were quarantined in the freezer and labeled not for patient use. No other adverse events reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681480, US-MODERNATX, INC.-MOD-2022-681490 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681480:patient 2 (Bivalent case) US-MODERNATX, INC.-MOD-2022-681490:Monovalent case
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; given an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given an expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given an expired vaccine) 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 (given an expired vaccine).    The patient was accidently administered an expired dose of the monovalent vaccine.  The vial was initially stored in the refrigerator on 30-Nov-2022 at 07:00 hours. The vial was administered on 30-Nov-2022 at 11.30 hours.  The vial had not undergone any temperature excursions.  No concomitant medication was reported. No treatment medication was reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 25-Oct-2022 and administered on 01-Dec-2022; No adverse event; Moderna Bivalent dose was administered to patient after the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent dose was administered to patient after the 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Oct-2022 and administered on 01-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a 46-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent dose was administered to patient after the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Oct-2022 and administered on 01-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent dose was administered to patient after the 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Oct-2022 and administered on 01-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent dose was administered to patient after the 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Oct-2022 and administered on 01-Dec-2022).    No concomitant information was reported. The injection site was deltoid. The size of the individual vial in carton was 2.5ml. The vial did not underwent any temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-681957, US-MODERNATX, INC.-MOD-2022-681956 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681957:patient 03 US-MODERNATX, INC.-MOD-2022-681956:patient 02
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 25-Oct-2022 and was administered on 01-Dec-2022; No adverse event; dose administered after the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after the 30-day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 25-Oct-2022 and was administered on 01-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 25-Oct-2022 and was administered on 01-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after the 30-day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 25-Oct-2022 and was administered on 01-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose administered after the 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 25-Oct-2022 and was administered on 01-Dec-2022).    Concomitant drugs were not reported. The injection site for patient was reported as deltoid. It was reported that the bivalent individual vial in carton of size 2.5ml did not underwent any temperature excursion. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-681955, US-MODERNATX, INC.-MOD-2022-681957, US-MODERNATX, INC.-MOD-2022-681955 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681955:same reporter US-MODERNATX, INC.-MOD-2022-681957:same reporter US-MODERNATX, INC.-MOD-2022-681955:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 25Oct2022 and administration of vaccine on 01Dec2022; No Adverse Event; 3 Moderna Bivalent doses were administered after the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 Moderna Bivalent doses were administered after the 30-day use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25Oct2022 and administration of vaccine on 01Dec2022) and NO ADVERSE EVENT (No Adverse Event) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 Moderna Bivalent doses were administered after the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25Oct2022 and administration of vaccine on 01Dec2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 Moderna Bivalent doses were administered after the 30-day use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25Oct2022 and administration of vaccine on 01Dec2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (3 Moderna Bivalent doses were administered after the 30-day use by date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25Oct2022 and administration of vaccine on 01Dec2022).    No concomitant medication were reported.  The injection site was Deltoid. Bivalent vaccine of individual vial in carton. The vial size was 2.5 mL.  The vial was initially stored in the refrigerator on 25-Oct-2022.  The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-681955, US-MODERNATX, INC.-MOD-2022-681956 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681956:same reporter US-MODERNATX, INC.-MOD-2022-681955:same reporter
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Got a cold with the other three shots; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Got a cold with the other three shots) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 008B212A and 011A21A) for COVID-19 vaccination.     Patient did not have allergies. Patient did not have ever had COVID positive test or diagnosis.  Concurrent medical conditions included Blood pressure high, Osteoarthritis, High cholesterol and Type II diabetes mellitus.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NASOPHARYNGITIS (Got a cold with the other three shots). At the time of the report, NASOPHARYNGITIS (Got a cold with the other three shots) outcome was unknown.      The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to MOD-2022-681468 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID). At the time of the report, COVID-19 (got COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. It was reported that patient received monoclonal infusion on Sep. Patient received 4 doses of the COVID19 vaccines in total. No treatment medications were provided.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, SARS-CoV-2 test
Clinical narrative: mild reactions (unspecified) after all 4 Moderna shots during 48 hours; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (mild reactions (unspecified) after all 4 Moderna shots during 48 hours) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included High density lipoprotein increased (taking Praluent for HDL cholesterol adjustments). Concomitant products included ALIROCUMAB (PRALUENT) for High density lipoprotein increased.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (mild reactions (unspecified) after all 4 Moderna shots during 48 hours). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (mild reactions (unspecified) after all 4 Moderna shots during 48 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: Positive.   The reporter stated that he did not remember if his wife (patient) started taking Praluent before or after any Moderna COVID-19 vaccination. The reporter did not remember the dates for the previous vaccinations but stated that her wife had already received 4 Moderna shots (included first and second booster doses).  The patient experienced mild reactions (unspecified) after each injection but it was resolved within 48 hours and the patient might have took Tylenol, Ibuprofen or Advil to treat symptoms.   This case was linked to MOD-2022-681969 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site reaction
Clinical narrative: After receiving the first dose of the vaccine she had an injection site reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (After receiving the first dose of the vaccine she had an injection site reaction) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE REACTION (After receiving the first dose of the vaccine she had an injection site reaction). At the time of the report, VACCINATION SITE REACTION (After receiving the first dose of the vaccine she had an injection site reaction) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  After receiving the first dose of the vaccine she had an injection site reaction and the pharmacist required her to stay at the vaccination facility for an hour for monitoring. They would not give her another dose of the vaccine without first talking to her physician. The physician recommended that the patient should receive an additional dose.  No treatment medication information was provided.   This case was linked to MOD-2022-681977 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Fatigue, Head discomfort, Lethargy
Clinical narrative: After receiving the first dose of the vaccine she had an injection site reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (After receiving the first dose of the vaccine she had an injection site reaction) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE REACTION (After receiving the first dose of the vaccine she had an injection site reaction). At the time of the report, VACCINATION SITE REACTION (After receiving the first dose of the vaccine she had an injection site reaction) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  After receiving the first dose of the vaccine she had an injection site reaction and the pharmacist required her to stay at the vaccination facility for an hour for monitoring. They would not give her another dose of the vaccine without first talking to her physician. The physician recommended that the patient should receive an additional dose.  No treatment medication information was provided.   This case was linked to MOD-2022-681977 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: After receiving the first dose of the vaccine she had an injection site reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (After receiving the first dose of the vaccine she had an injection site reaction) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE REACTION (After receiving the first dose of the vaccine she had an injection site reaction). At the time of the report, VACCINATION SITE REACTION (After receiving the first dose of the vaccine she had an injection site reaction) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  After receiving the first dose of the vaccine she had an injection site reaction and the pharmacist required her to stay at the vaccination facility for an hour for monitoring. They would not give her another dose of the vaccine without first talking to her physician. The physician recommended that the patient should receive an additional dose.  No treatment medication information was provided.   This case was linked to MOD-2022-681977 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site reaction
Clinical narrative: lethargy; head was going to explode like a watermellon; fever up 6 degrees; nausea; Tiredness; She received a covid-19 test there which was positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (She received a covid-19 test there which was positive), LETHARGY (lethargy), HEAD DISCOMFORT (head was going to explode like a watermellon), PYREXIA (fever up 6 degrees) and NAUSEA (nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 010A21A and 018B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Sep-2022, the patient experienced COVID-19 (She received a covid-19 test there which was positive). On an unknown date, the patient experienced LETHARGY (lethargy), HEAD DISCOMFORT (head was going to explode like a watermellon), PYREXIA (fever up 6 degrees), NAUSEA (nausea) and FATIGUE (Tiredness). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency and VITAMIN D [VITAMIN D NOS] at an unspecified dose and frequency. At the time of the report, COVID-19 (She received a covid-19 test there which was positive), LETHARGY (lethargy), HEAD DISCOMFORT (head was going to explode like a watermellon), PYREXIA (fever up 6 degrees), NAUSEA (nausea) and FATIGUE (Tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2022, SARS-CoV-2 test: Positive. On an unknown date, Body temperature: up 6 degrees.         No concomitant medications were reported.  The patient had not any side effects with the other two dose of vaccine.  On 10-Sep-2022 she went to the hospital with symptoms.  The patient was given Paxlovid, took one dose and vomited. The patient did not finish the remainder of Paxlovid treatment.   This case was linked to MOD-2022-681993 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Fatigue, Head discomfort, Lethargy
Clinical narrative: lethargy; head was going to explode like a watermellon; fever up 6 degrees; nausea; Tiredness; She received a covid-19 test there which was positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (She received a covid-19 test there which was positive), LETHARGY (lethargy), HEAD DISCOMFORT (head was going to explode like a watermellon), PYREXIA (fever up 6 degrees) and NAUSEA (nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 010A21A and 018B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Sep-2022, the patient experienced COVID-19 (She received a covid-19 test there which was positive). On an unknown date, the patient experienced LETHARGY (lethargy), HEAD DISCOMFORT (head was going to explode like a watermellon), PYREXIA (fever up 6 degrees), NAUSEA (nausea) and FATIGUE (Tiredness). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency and VITAMIN D [VITAMIN D NOS] at an unspecified dose and frequency. At the time of the report, COVID-19 (She received a covid-19 test there which was positive), LETHARGY (lethargy), HEAD DISCOMFORT (head was going to explode like a watermellon), PYREXIA (fever up 6 degrees), NAUSEA (nausea) and FATIGUE (Tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2022, SARS-CoV-2 test: Positive. On an unknown date, Body temperature: up 6 degrees.         No concomitant medications were reported.  The patient had not any side effects with the other two dose of vaccine.  On 10-Sep-2022 she went to the hospital with symptoms.  The patient was given Paxlovid, took one dose and vomited. The patient did not finish the remainder of Paxlovid treatment.   This case was linked to MOD-2022-681993 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: lethargy; head was going to explode like a watermellon; fever up 6 degrees; nausea; Tiredness; She received a covid-19 test there which was positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (She received a covid-19 test there which was positive), LETHARGY (lethargy), HEAD DISCOMFORT (head was going to explode like a watermellon), PYREXIA (fever up 6 degrees) and NAUSEA (nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 010A21A and 018B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Sep-2022, the patient experienced COVID-19 (She received a covid-19 test there which was positive). On an unknown date, the patient experienced LETHARGY (lethargy), HEAD DISCOMFORT (head was going to explode like a watermellon), PYREXIA (fever up 6 degrees), NAUSEA (nausea) and FATIGUE (Tiredness). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency and VITAMIN D [VITAMIN D NOS] at an unspecified dose and frequency. At the time of the report, COVID-19 (She received a covid-19 test there which was positive), LETHARGY (lethargy), HEAD DISCOMFORT (head was going to explode like a watermellon), PYREXIA (fever up 6 degrees), NAUSEA (nausea) and FATIGUE (Tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2022, SARS-CoV-2 test: Positive. On an unknown date, Body temperature: up 6 degrees.         No concomitant medications were reported.  The patient had not any side effects with the other two dose of vaccine.  On 10-Sep-2022 she went to the hospital with symptoms.  The patient was given Paxlovid, took one dose and vomited. The patient did not finish the remainder of Paxlovid treatment.   This case was linked to MOD-2022-681993 (Patient Link).
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 12-OCT-2022 and dose was administered on 17-NOV-2022; No adverse event; Dose was given beyond the 30 day refrigeration date (BUD); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given beyond the 30 day refrigeration date (BUD)), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-OCT-2022 and dose was administered on 17-NOV-2022) and NO ADVERSE EVENT (No adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given beyond the 30 day refrigeration date (BUD)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-OCT-2022 and dose was administered on 17-NOV-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given beyond the 30 day refrigeration date (BUD)), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-OCT-2022 and dose was administered on 17-NOV-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose was given beyond the 30 day refrigeration date (BUD)) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-OCT-2022 and dose was administered on 17-NOV-2022).    No concomitant medications were reported.  The vial size was reported as 2.5 mL.  The vial was initially stored in the refrigerator on 12-Oct-2022.  The vial did not undergo any temperature excursions.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-682153, US-MODERNATX, INC.-MOD-2022-682156 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682153:MOD22-030328, same reporter US-MODERNATX, INC.-MOD-2022-682156:MOD22-030331, same reporter
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 02-Mar-2022; No adverse event; Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 02-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 02-Mar-2022), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 02-Mar-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 025L21B) for COVID-19 immunisation.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 02-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 02-Mar-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 02-Mar-2022), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 02-Mar-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 02-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 02-Mar-2022).    Concomitant product use was not provided by the reporter.  It was reported the vials were shipped on 13-Jan-2022 and thawed in a cooler while being transported. Vial size was 5.5 ml red cap. Vials did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-682174, US-MODERNATX, INC.-MOD-2022-682176 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Live follow up added included updated reporter and narrative information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682174:Monovalent (Same reporter) US-MODERNATX, INC.-MOD-2022-682176:Monovalent (Same reporter)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 09-Mar-2022; No adverse event; Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 09-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 09-Mar-2022), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 09-Mar-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 09-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 09-Mar-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 09-Mar-2022), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 09-Mar-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 09-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 09-Mar-2022).    Concomitant product use was not provided by the reporter.  It was reported the vials were shipped on 13-Jan-2022 and thawed in a cooler while being transported. Vial size was 5.5 ml red cap. Vials did not undergo any temperature excursions.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Live follow-up received reporter added, 30 days use by date and vaccine storage date were added and narrative was updated.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chalazion, Hordeolum
Clinical narrative: Styes and chalazions in the eye with no previous history of having any before.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy bumps / blisters form on hands, feet, thighs, and arms.  The bumps / blisters mirror both sides of body. The rash lasts for a week, and heals in about 2 weeks after initial rash begins.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ear pain
Clinical narrative: Earache
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Breast mass, Heart rate increased, Lymphadenopathy, Menstrual disorder
Clinical narrative: Red rash with first vaccine second vaccine lymph nodes in armpit swoll to the point where I had to call the doctor because I was so worried. Menstrual period is off .lower stomach pain feels like stabbing comes and goes however always is there just less Intense.  Vaginal wall tenderness .breast lumps
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan normal, Vulvovaginal pain, White blood cell count increased
Clinical narrative: Red rash with first vaccine second vaccine lymph nodes in armpit swoll to the point where I had to call the doctor because I was so worried. Menstrual period is off .lower stomach pain feels like stabbing comes and goes however always is there just less Intense.  Vaginal wall tenderness .breast lumps
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in the refrigerator on 02-Mar-2022, patient received Monovalent shots on 04-Apr-2022; No adverse event; Received Expired Monovalent vaccine after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 02-Mar-2022, patient received Monovalent shots on 04-Apr-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 02-Mar-2022, patient received Monovalent shots on 04-Apr-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 02-Mar-2022, patient received Monovalent shots on 04-Apr-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 02-Mar-2022, patient received Monovalent shots on 04-Apr-2022).    No concomitant medications were reported. The vial could be either from individual vials or unbroken cartons and was of the size of 2.5 ml. 1 Adult patient received Monovalent shots on 04-APR-2022 from vial shipped in 02-MAR-2022 thawed in a cooler while being transported. The vial did not undergo any temperature excursions. Treatment information was not provided. This case was for adult patient who received monovalent dose on 04-Apr-2022, as described by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Live Significant follow up received: Reporter added and narrative updated.