chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Product storage error; No adverse event; Bivalent dose administered to 7 patient after temperature excursion.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to 7 patient after temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) 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)) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Oct-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to 7 patient after temperature excursion.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to 7 patient after temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to 7 patient after temperature excursion.) and PRODUCT STORAGE ERROR (Product storage error).    Storage condition at the time of the excursion was refrigerated. The vaccine was an individual vial. The size of the vial was 2.5mL. The highest temperature reached was 46.5 F. The excursion duration was 15 minutes. The vials were returned to the refrigerator. The vaccines appeared normal during visual inspection. The Lot numbers and Expiration Dates of the vaccines that underwent temperature excursion were 083B22A, 051D22A and 28Nov2022 and 19Nov2022 respectively.   This case was linked to US-MODERNATX, INC.-MOD-2022-664063, US-MODERNATX, INC.-MOD-2022-664049 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-664063: US-MODERNATX, INC.-MOD-2022-664049:Same reporter
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Children received first dose of the primary series with the Moderna bivalent vaccine booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Children received first dose of the primary series with the Moderna bivalent vaccine booster) and NO ADVERSE EVENT (No adverse event) in a 6-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Children received first dose of the primary series with the Moderna bivalent vaccine booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Children received first dose of the primary series with the Moderna bivalent vaccine booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Children received first dose of the primary series with the Moderna bivalent vaccine booster).    No concomitant medications were reported. No treatment details were reported. It was reported that total 3 Children's with age 6, 8 and 10 were involved who received Moderna bivalent booster dose instead of Primary series.   This case was linked to MOD-2022-664264, MOD-2022-664266 (E2B Linked Report).; Sender's Comments:  MOD-2022-664264:Patient 2 of 3 MOD-2022-664266:Patient 3 of 3
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: With first 3 doses patient only experienced a little pain in the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (With first 3 doses patient only experienced a little pain in the arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059F22A, 015M20A and 030L20A) for COVID-19 vaccination.     It was unknown whether patient had allergies and any history relating to mentioned adverse event. It was unknown whether patient had received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. It was unknown whether patient ever had COVID positive test or diagnosis.  Concurrent medical conditions included Cholesterol. Concomitant products included EZETIMIBE for Cholesterol, VITAMINS NOS for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (With first 3 doses patient only experienced a little pain in the arm). At the time of the report, PAIN IN EXTREMITY (With first 3 doses patient only experienced a little pain in the arm) had resolved.            It was reported that with first 3 doses and experienced a little pain in the arm which was lasted for 1 day.  No treatment medications were provided.   This case was linked to MOD-2022-664515 (Patient Link).
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Aug2019, 2nd August 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2019).   In August 2022, the patient received the 2nd dose of Shingrix. In August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.      Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's Comments: The pharmacist reported that the patient received second dose of Shingrix in August 2022. The reporter reported that two patients were relatives (reporter´s parents) who received Shingrix the same month. The reporter consented to follow up. Additional Supportive Information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. This case was one of the 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022149870:Same reporter
Age: 68.0
Sex: F
Vaccine: HEPAB
Symptoms: Incorrect dose administered, Product complaint, Syringe issue
Clinical narrative: liquid leaked out of the space between the needle and syringe; Product complaint; some of vaccine liquid leaked; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 68-year-old female patient who received HAB (Twinrix) (batch number J477Y, expiry date 20th May 2023) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 18th October 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the patient experienced syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered, syringe issue and pharmaceutical product complaint were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-Oct-2022 Reporter's comment:  The pharmacist reported that the patient was administered with Twinrix and some of vaccine liquid leaked out of the space between the needle and syringe.  The pharmacist believed that this may be related to a problem with the tip of the pre filled syringe (PQC). The reporter consented to follow up. Additional supportive information: The patient was administered with Twinrix and some of vaccine liquid leaked out of the space between the needle and syringe, which led to incomplete dose administered.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Immediate post-injection reaction, Incomplete course of vaccination, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Back pain under ribs, on the right side; pain is sometimes also on the left side and only occurs with activity; pain is severe enough to interfere with daily activities; first dose of Shingrix on 30-OCT-2019. He has not yet received his second dose; Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 30th October 2019, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced back pain, pain upon movement, activities of daily living impaired and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the back pain, pain upon movement and activities of daily living impaired were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain, back pain, pain upon movement and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-Oct-2022 Reporter's comment: The reporter was the patient.  The patient received Shingrix vaccine on an unknown arm. The patient had not yet received his second dose.  The patient had injection site pain at the time of the injection which was recovered.  Soon after the injection he experienced back pain under his ribs, on the right side which was not recovered.  The patient was not sure of the date for back pain when it was started.  The pain was sometimes also on the left side and had only occurred with activity.  The pain was severe enough to interfere with daily activities.  His doctor and physician's assistant told him they do not think the back pain was due to Shingrix.  He had a CT scan scheduled for today (on the day of reporting).  Nothing else was reported. The consent to follow-up was granted. The reporter may follow up with physician. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Back pain under ribs, on the right side; pain is sometimes also on the left side and only occurs with activity; pain is severe enough to interfere with daily activities; first dose of Shingrix on 30-OCT-2019. He has not yet received his second dose; Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 30th October 2019, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced back pain, pain upon movement, activities of daily living impaired and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the back pain, pain upon movement and activities of daily living impaired were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain, back pain, pain upon movement and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-Oct-2022 Reporter's comment: The reporter was the patient.  The patient received Shingrix vaccine on an unknown arm. The patient had not yet received his second dose.  The patient had injection site pain at the time of the injection which was recovered.  Soon after the injection he experienced back pain under his ribs, on the right side which was not recovered.  The patient was not sure of the date for back pain when it was started.  The pain was sometimes also on the left side and had only occurred with activity.  The pain was severe enough to interfere with daily activities.  His doctor and physician's assistant told him they do not think the back pain was due to Shingrix.  He had a CT scan scheduled for today (on the day of reporting).  Nothing else was reported. The consent to follow-up was granted. The reporter may follow up with physician. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Nausea, Vomiting
Clinical narrative: Pain ant + post ribs T4-T10; Nausea; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Pain ant + post ribs T4-T10), NAUSEA (Nausea) and VOMITING (Vomiting) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Sulpha).    On 26-Sep-2022 at 9:00 AM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 26-Sep-2022, the patient experienced MUSCULOSKELETAL CHEST PAIN (Pain ant + post ribs T4-T10), NAUSEA (Nausea) and VOMITING (Vomiting). On 01-Oct-2022, NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. At the time of the report, MUSCULOSKELETAL CHEST PAIN (Pain ant + post ribs T4-T10) had not resolved.            No concomitant medication was provided by the reporter. Patient did not had any reaction with other 4 Moderna vaccinations. Patient had symptoms within 15 minutes of injection and still having pain ant + post ribs T4-T10.  Patient not had any rash.  No treatment medication was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event; bivalent more than 12 hours after the initial vial puncture.vial was first punctured on 24OCT2022 and administration of vaccine on 25OCT2022; Vaccine administered more than 12 hours after the initial vial puncture.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent more than 12 hours after the initial vial puncture.vial was first punctured on 24OCT2022 and administration of vaccine on 25OCT2022), PRODUCT STORAGE ERROR (Vaccine administered more than 12 hours after the initial vial puncture.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 25-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent more than 12 hours after the initial vial puncture.vial was first punctured on 24OCT2022 and administration of vaccine on 25OCT2022), PRODUCT STORAGE ERROR (Vaccine administered more than 12 hours after the initial vial puncture.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent more than 12 hours after the initial vial puncture.vial was first punctured on 24OCT2022 and administration of vaccine on 25OCT2022), PRODUCT STORAGE ERROR (Vaccine administered more than 12 hours after the initial vial puncture.) 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 (bivalent more than 12 hours after the initial vial puncture.vial was first punctured on 24OCT2022 and administration of vaccine on 25OCT2022) and PRODUCT STORAGE ERROR (Vaccine administered more than 12 hours after the initial vial puncture.).    No concomitant medication details was reported. Individual vails was used and vail size was 2.5ml. On 21-OCT-2022 the vial was initially stored in the refrigerator. The vial was first punctured on 24-OCT-2022 8-9AM. Total amount of time the vial was exposed to room temperature range was 20 minutes approximately. The vial did not undergone any temperature excursions. No treatment medication details was reported.
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received the bivalent booster dose for their first dose of their primary series.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received the bivalent booster dose for their first dose of their primary series.) and NO ADVERSE EVENT (No adverse event) in a 23-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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient received the bivalent booster dose for their first dose of their primary series.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received the bivalent booster dose for their first dose of their primary series.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received the bivalent booster dose for their first dose of their primary series.).    No concomitant medications was reported. No treatment medications was reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Given bivalent booster dose as 1st dose of primary series; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Given bivalent booster dose as 1st dose of primary series) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-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 25-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Given bivalent booster dose as 1st dose of primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Given bivalent booster dose as 1st dose of primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Given bivalent booster dose as 1st dose of primary series).    The concomitant medication was not reported by reporter. Nurse reported that in one of their clinics, another nurse inadvertently gave the bivalent booster dose as a 1st does in the primary series today, 25-Oct-2022. This was given at 0.5 ml intramuscularly. The treatment medication was not reported by reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: terrible pain in the left side of the back , she was in so much pain.; terrible pain in the back of the shoulder; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (terrible pain in the left side of the back , she was in so much pain.) and ARTHRALGIA (terrible pain in the back of the shoulder) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 vaccination.     It was unknown if patient received any other vaccines within 1 month prior to Moderna COVID-19 vaccine. It was unknown if patient had ever tested or diagnosed for COVID-19. It was unknown if patient had allergy. It was unknown if patient had acute and Chronic illnesses at the time of vaccination.  Concurrent medical conditions included Blood cholesterol abnormal. Concomitant products included EZETIMIBE for Blood cholesterol abnormal, VITAMINS NOS for an unknown indication.    On 22-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 23-Oct-2022, the patient experienced BACK PAIN (terrible pain in the left side of the back , she was in so much pain.) and ARTHRALGIA (terrible pain in the back of the shoulder). At the time of the report, BACK PAIN (terrible pain in the left side of the back , she was in so much pain.) and ARTHRALGIA (terrible pain in the back of the shoulder) had not resolved.            Reported that patient received first dose of Moderna COVID-19 Vaccine on 21Jan2021, second dose on 18Feb2021, first booster on 8Aug2021, and last booster on 22Oct2022 with Lot number: 030L20A, 015M20A, 059F22A, 059F22A and Expiration date: unknown. It was unknown if AE cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). It was unknown if patient experienced a similar event in the past. It was unknown if any treatment was given for her symptoms.   This case was linked to MOD-2022-664514 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Received 0.25ml Bivalent booster instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Received 0.25ml Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 24-Oct-2022, the patient experienced UNDERDOSE (Received 0.25ml Bivalent booster instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25ml Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received 0.25ml Bivalent booster instead of 0.5 ml).    No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2022-664522 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date/administered a Moderna vaccine that was 3 days expired; vial was in the fridge for 3 days after the 30 day beyond use date; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/administered a Moderna vaccine that was 3 days expired), PRODUCT STORAGE ERROR (vial was in the fridge for 3 days after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/administered a Moderna vaccine that was 3 days expired), PRODUCT STORAGE ERROR (vial was in the fridge for 3 days after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/administered a Moderna vaccine that was 3 days expired), PRODUCT STORAGE ERROR (vial was in the fridge for 3 days after the 30 day beyond use date) 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 administered after 30-day Use By Date/administered a Moderna vaccine that was 3 days expired) and PRODUCT STORAGE ERROR (vial was in the fridge for 3 days after the 30 day beyond use date).    No concomitant medications was reported. No treatment medications was reported.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Illness, Mobility decreased, Musculoskeletal stiffness, Nausea
Clinical narrative: Was nauseated; I had stiffness in my legs; I have mobility issues anyway; I got violently ill/I don't know that I've ever been that sick before.; I was sort of dizzy; Vomiting for 4 hrs; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (I had stiffness in my legs), MOBILITY DECREASED (I have mobility issues anyway), ILLNESS (I got violently ill/I don't know that I've ever been that sick before.), DIZZINESS (I was sort of dizzy) and VOMITING (Vomiting for 4 hrs) in a 69-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. 059F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Oct-2022 at 2:30 AM, 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 25-Oct-2022, the patient experienced MUSCULOSKELETAL STIFFNESS (I had stiffness in my legs). 25-Oct-2022, the patient experienced MOBILITY DECREASED (I have mobility issues anyway), ILLNESS (I got violently ill/I don't know that I've ever been that sick before.), DIZZINESS (I was sort of dizzy) and VOMITING (Vomiting for 4 hrs). On 25-Oct-2022 at 10:30 AM, the patient experienced NAUSEA (Was nauseated). At the time of the report, MUSCULOSKELETAL STIFFNESS (I had stiffness in my legs), MOBILITY DECREASED (I have mobility issues anyway), ILLNESS (I got violently ill/I don't know that I've ever been that sick before.) and DIZZINESS (I was sort of dizzy) outcome was unknown and VOMITING (Vomiting for 4 hrs) and NAUSEA (Was nauseated) had resolved.            No concomitant medications were reported.  On 14-Mar-2021, patient received first dose of Moderna Covid-19 Vaccine, batch number reported as 032M20A.  On 11-Apr-2021, patient received first dose of Moderna Covid-19 Vaccine, batch number reported as 018B21A.  On 08-Nov-2021, patient received first booster of Moderna Covid-19 Vaccine, batch number reported as 004F21A.  No treatment details were reported.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Was nauseated; I had stiffness in my legs; I have mobility issues anyway; I got violently ill/I don't know that I've ever been that sick before.; I was sort of dizzy; Vomiting for 4 hrs; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (I had stiffness in my legs), MOBILITY DECREASED (I have mobility issues anyway), ILLNESS (I got violently ill/I don't know that I've ever been that sick before.), DIZZINESS (I was sort of dizzy) and VOMITING (Vomiting for 4 hrs) in a 69-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. 059F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Oct-2022 at 2:30 AM, 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 25-Oct-2022, the patient experienced MUSCULOSKELETAL STIFFNESS (I had stiffness in my legs). 25-Oct-2022, the patient experienced MOBILITY DECREASED (I have mobility issues anyway), ILLNESS (I got violently ill/I don't know that I've ever been that sick before.), DIZZINESS (I was sort of dizzy) and VOMITING (Vomiting for 4 hrs). On 25-Oct-2022 at 10:30 AM, the patient experienced NAUSEA (Was nauseated). At the time of the report, MUSCULOSKELETAL STIFFNESS (I had stiffness in my legs), MOBILITY DECREASED (I have mobility issues anyway), ILLNESS (I got violently ill/I don't know that I've ever been that sick before.) and DIZZINESS (I was sort of dizzy) outcome was unknown and VOMITING (Vomiting for 4 hrs) and NAUSEA (Was nauseated) had resolved.            No concomitant medications were reported.  On 14-Mar-2021, patient received first dose of Moderna Covid-19 Vaccine, batch number reported as 032M20A.  On 11-Apr-2021, patient received first dose of Moderna Covid-19 Vaccine, batch number reported as 018B21A.  On 08-Nov-2021, patient received first booster of Moderna Covid-19 Vaccine, batch number reported as 004F21A.  No treatment details were reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID 2 weeks ago, felt like had a bad cold and flu like symptoms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID 2 weeks ago, felt like had a bad cold and flu like symptoms) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Oct-2022, the patient experienced COVID-19 (Tested positive for COVID 2 weeks ago, felt like had a bad cold and flu like symptoms). At the time of the report, COVID-19 (Tested positive for COVID 2 weeks ago, felt like had a bad cold and flu like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Oct-2022, SARS-CoV-2 test: (Positive) Positive.  No concomitant medications were provided. Patient received all Moderna vaccines and tested positive for COVID 2 weeks ago, 10-Oct-2022, felt like he had a bad cold, flu like symptoms.  He did not take any medications. He inquired if he should take the Bivalent vaccine because he and his father will be traveling out of the country on 8-Nov-2022 for 3 months. This case was linked to US-MODERNATX, INC.-MOD-2022-664591 ( Linked Report).Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-664591:Father's case
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Muscle spasms, Nausea
Clinical narrative: chills; fever; nausea; headache; muscle cramps; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (24Oct2022), this case now contains all required information to be considered valid. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, Batch/Lot Number: EW0150), administration date: 31Mar2021, when the patient was 47-year-old, for COVID-19 immunization, reaction(s): "chills", "fever", "nausea", "headache", "muscle cramps"; BNT162b2 (DOSE 2, Batch/Lot Number: EW0170), administration date: 25Apr2021, when the patient was 47-year-old, for COVID-19 immunization, reaction(s): "chills", "fever", "nausea", "headache", "muscle cramps". The following information was reported: CHILLS (non-serious) with onset Nov2021, outcome "recovered" (Nov2021); PYREXIA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "fever"; HEADACHE (non-serious) with onset Nov2021, outcome "recovered" (Nov2021); MUSCLE SPASMS (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "muscle cramps"; NAUSEA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021). Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Reporter stated that with Pfizer Covid-19 Vaccines Dose 2, Dose 3 (1st booster) and Dose 4 Pfizer Bivalent (2nd booster) that she experienced similar events as she did with Dose 1.  Reporter mentioned some of the events she experienced are chills, fever (degrees Fahrenheit or Celsius was not provided), nausea, headache, muscle cramps and that every time she gets a Pfizer Covid-19 vaccine that she experiences multiple events and that she has already reported her adverse events to Pfizer. Reporter stated that for each of the 4 doses all events resolved within 36 hours. Reporter consented to follow-up via follow-up letter if additional information required.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; fever; nausea; headache; muscle cramps; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (24Oct2022), this case now contains all required information to be considered valid. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, Batch/Lot Number: EW0150), administration date: 31Mar2021, when the patient was 47-year-old, for COVID-19 immunization, reaction(s): "chills", "fever", "nausea", "headache", "muscle cramps"; BNT162b2 (DOSE 2, Batch/Lot Number: EW0170), administration date: 25Apr2021, when the patient was 47-year-old, for COVID-19 immunization, reaction(s): "chills", "fever", "nausea", "headache", "muscle cramps". The following information was reported: CHILLS (non-serious) with onset Nov2021, outcome "recovered" (Nov2021); PYREXIA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "fever"; HEADACHE (non-serious) with onset Nov2021, outcome "recovered" (Nov2021); MUSCLE SPASMS (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "muscle cramps"; NAUSEA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021). Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Reporter stated that with Pfizer Covid-19 Vaccines Dose 2, Dose 3 (1st booster) and Dose 4 Pfizer Bivalent (2nd booster) that she experienced similar events as she did with Dose 1.  Reporter mentioned some of the events she experienced are chills, fever (degrees Fahrenheit or Celsius was not provided), nausea, headache, muscle cramps and that every time she gets a Pfizer Covid-19 vaccine that she experiences multiple events and that she has already reported her adverse events to Pfizer. Reporter stated that for each of the 4 doses all events resolved within 36 hours. Reporter consented to follow-up via follow-up letter if additional information required.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 25May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Known allergies: Sulfa based drugs" (unspecified if ongoing), notes: Known allergies: Sulfa based drugs. Concomitant medication(s) included: OMEPRAZOLE, start date: 27May2022; DULOXETINE HCL, start date: 10Mar2022; ATORVASTATIN, start date: 26Sep2022, stop date: 16Oct2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2 weeks. Patient received PAXLOVID as treatment for Covid-19 start date was 17Oct2022 and stopped on 22Oct2022, Lot number 1918535A.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: rapid test positive; rapid test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 at 18:00 as dose 1, single (Lot number: EN6208), in left arm and on 06Apr2021 at 18:00 as dose 2, single (Lot number: EW015) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Nov2021 at 18:00 as dose 3 (booster), single (Lot number: 058F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Benign tremors" (unspecified if ongoing), notes: Benign tremors. Concomitant medication(s) included: PRIMIDONE; DICLOFENAC; ADVAIR; CBD OIL. Past drug history included: Tylenol, reaction(s): "Known allergies: Tylenol", notes: known allergies Tylenol. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Oct2022, outcome "not recovered" and all described as "rapid test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received the vaccine. Other medication received in 2 weeks included primadone, diclofenac, advair, CBD oil. Patient had rapid test positive 09Oct2022 and started treatment with Paxlovid 09Oct2022, stopped taking all meds except Advair during 5 day course.  Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 22 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "Peanuts" (unspecified if ongoing), notes: known allergies: Peanuts; "Tree nuts" (unspecified if ongoing), notes: known allergies: Tree nuts. Concomitant medication(s) included: WELLBUTRIN; ADVAIR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Negative, notes: During the week I tested negative; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received vaccine and other medication in 2 weeks (Welbutrin 450 mg and Advair Discus 250/50).   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Moderate soreness at injection site; tiredness; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GJ6742) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: NEXPLANON. Past drug history included: Morphine, reaction(s): "Known allergies morphine", notes: Known allergies morphine. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Oct2022 at 16:00, outcome "recovering", described as "Moderate soreness at injection site"; HEADACHE (non-serious) with onset 21Oct2022 at 16:00, outcome "recovering"; FATIGUE (non-serious) with onset 21Oct2022 at 16:00, outcome "recovering", described as "tiredness". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, headache.  Additional information: Facility type vaccine was workplace clinic. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph nodes were swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "other medical history: Heart palpitations (SVT)" (unspecified if ongoing); "other medical history: Heart palpitations (SVT)" (unspecified if ongoing); "known allergies:Shellfish" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL; NAPROXEN; AMBEREN; BIOTIN. Vaccination history included: BNT162b2 (Dose 1, single, lot number: EW0150, at left arm), administration date: 10Apr2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "For the first 2 shots the swollen lymph nodes lasted 3 weeks"; BNT162b2 (Dose 2, single, lot number: EW0170, at left arm), administration date: 02May2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "For the first 2 shots the swollen lymph nodes lasted 3 weeks". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lymph nodes were swollen".  Additional information: No other vaccine in four weeks. Facility type vaccine was pharmacy or drug Store. No covid prior vaccination and not tested for covid post vaccination. Swollen painful lymph nodes-both under-arms and neck, lower back pain, joint pain. For the first 2 shots the swollen lymph nodes lasted 3 weeks but almost all lymph nodes were swollen for the first few days, then only her neck and left underarm. The 3rd shot, the lymph nodes were swollen for less than a week.  Follow-up attempts are completed. No further information is expected.