chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Mastitis, Pyrexia, Urticaria
Clinical narrative: 2 weeks later she developed shingles caused by the booster; developed an "infection deep inside my breast."; had a high fever of 102.5 for two days; Two weeks later she developed hives for 2 weeks.; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (2 weeks later she developed shingles caused by the booster), MASTITIS (developed an "infection deep inside my breast."), PYREXIA (had a high fever of 102.5 for two days) and URTICARIA (Two weeks later she developed hives for 2 weeks.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2022, the patient experienced PYREXIA (had a high fever of 102.5 for two days). In June 2022, the patient experienced URTICARIA (Two weeks later she developed hives for 2 weeks.). On an unknown date, the patient experienced HERPES ZOSTER (2 weeks later she developed shingles caused by the booster) and MASTITIS (developed an "infection deep inside my breast."). The patient was treated with CELECOXIB (CELEBREX) at an unspecified dose and frequency. On 07-Jun-2022, PYREXIA (had a high fever of 102.5 for two days) had resolved. At the time of the report, HERPES ZOSTER (2 weeks later she developed shingles caused by the booster), MASTITIS (developed an "infection deep inside my breast.") and URTICARIA (Two weeks later she developed hives for 2 weeks.) had resolved.            No concomitant medication was provided by reporter.  Patient treatment reported that, rinsed mouth out with salt water. The Lot number reported as, 058422-2A or 058A22-2A (illegible).   This case was linked to MOD-2022-682179, MOD-2021-168219 (Patient Link).
Age: 88.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: given vaccine which was beyond the 30 day use by date; No adverse event; given vaccine which was beyond the 30 day use by date; given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Sep-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion). On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (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 (given vaccine which underwent temperture excursion), PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date) and EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date).    No relevant concomitant medications were reported. Patient had gotten vaccine which underwent temperature excursion on 15-17Aug 2022. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681465, US-MODERNATX, INC.-MOD-2022-682086 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681465:MOD22-030301, MOD22-030312 US-MODERNATX, INC.-MOD-2022-682086:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Received Expired Monovalent vaccine after 30-day Use By Date; 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 (Received Expired Monovalent vaccine after 30-day Use By Date) 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 13-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-May-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 (Received Expired Monovalent vaccine after 30-day Use By Date) 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 (Received Expired Monovalent vaccine after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (Received Expired Monovalent vaccine after 30-day Use By Date).    No concomitant medication was reported.  HCP reported that some adult patients received expired doses of both Mono and Bivalent vials of Moderna COVID-19 vaccine after 30-day Use By Date. Vials were mix of individual vials or unbroken cartons of size 5.5 ml red cap and 2.5 ml bivalent. Reporter asked if the vials were viable and was there a need to revaccinate.  On 02-Mar-2022, the monovalent vial (lot- 046L21A) was shipped and thawed in a cooler while being transported.  The vial did not undergo any temperature excursions.  Reporter did not notice the vaccine was expired, some of these patients received another Monovalent dose after the expired dose within recommended time.  This case is about patient 2 out of 2 adult patients who received monovalent shots on 13-May-2022 from vial shipped in 02-Mar-2022.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-682174, US-MODERNATX, INC.-MOD-2022-682176 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682174:Monovalent (Same reporter) US-MODERNATX, INC.-MOD-2022-682176:Monovalent (Same reporter)
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, FLUX
Symptoms: Chills, Feeling abnormal, Pain
Clinical narrative: bodyache; feeling bad/It was hitting him pretty hard; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PAIN (bodyache) and FEELING ABNORMAL (feeling bad/It was hitting him pretty hard) in a 21-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Atopic dermatitis, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 20-Sep-2022, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram. On 27-Oct-2022, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PAIN (bodyache) and FEELING ABNORMAL (feeling bad/It was hitting him pretty hard). At the time of the report, CHILLS (Chills), PAIN (bodyache) and FEELING ABNORMAL (feeling bad/It was hitting him pretty hard) had not resolved. Not Provided      The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The patient received the Bivalent covid Vaccine and Flu Vaccine on 26 Oct 2022and 27 Oct 2022. He was experiencing. Chills and body aches and feeling bad. It was hitting him pretty hard. He felt like it was a reaction to one of the vaccines, but not sure which one.  The MPID number for Moderna COVID-19 vaccine is 4782591. The MPID number for Pfizer BioNTech COVID-19 vaccine is 4782534.  No Concomitant medication was reported. No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Acne, Body temperature, Headache, Malaise
Clinical narrative: upset stomach in the middle of the night; didn't feel well; started getting a pimple on her face, and said realized it was inside my mouth in my cheek, a giant pimple, 3/8 inches wide, round, non ulcerative, but deep in the mucosa tissue; Mouth Ulcers; really bad headache; fever of 101.5 for two days; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach in the middle of the night), MALAISE (didn't feel well), ACNE (started getting a pimple on her face, and said realized it was inside my mouth in my cheek, a giant pimple, 3/8 inches wide, round, non ulcerative, but deep in the mucosa tissue), MOUTH ULCERATION (Mouth Ulcers) and HEADACHE (really bad headache) 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. 014H22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach in the middle of the night), MALAISE (didn't feel well), ACNE (started getting a pimple on her face, and said realized it was inside my mouth in my cheek, a giant pimple, 3/8 inches wide, round, non ulcerative, but deep in the mucosa tissue), MOUTH ULCERATION (Mouth Ulcers), HEADACHE (really bad headache) and PYREXIA (fever of 101.5 for two days). The patient was treated with CELECOXIB (CELEBREX) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (upset stomach in the middle of the night), MALAISE (didn't feel well), ACNE (started getting a pimple on her face, and said realized it was inside my mouth in my cheek, a giant pimple, 3/8 inches wide, round, non ulcerative, but deep in the mucosa tissue), MOUTH ULCERATION (Mouth Ulcers) and HEADACHE (really bad headache) outcome was unknown and PYREXIA (fever of 101.5 for two days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5.         No concomitant medication was reported.  The patient had fear that mouth ulcer would spread, patient stated took Celebrex and rinsed mouth out with salt water.   This case was linked to MOD-2022-682167, MOD-2021-168219 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration, Pyrexia
Clinical narrative: upset stomach in the middle of the night; didn't feel well; started getting a pimple on her face, and said realized it was inside my mouth in my cheek, a giant pimple, 3/8 inches wide, round, non ulcerative, but deep in the mucosa tissue; Mouth Ulcers; really bad headache; fever of 101.5 for two days; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach in the middle of the night), MALAISE (didn't feel well), ACNE (started getting a pimple on her face, and said realized it was inside my mouth in my cheek, a giant pimple, 3/8 inches wide, round, non ulcerative, but deep in the mucosa tissue), MOUTH ULCERATION (Mouth Ulcers) and HEADACHE (really bad headache) 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. 014H22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach in the middle of the night), MALAISE (didn't feel well), ACNE (started getting a pimple on her face, and said realized it was inside my mouth in my cheek, a giant pimple, 3/8 inches wide, round, non ulcerative, but deep in the mucosa tissue), MOUTH ULCERATION (Mouth Ulcers), HEADACHE (really bad headache) and PYREXIA (fever of 101.5 for two days). The patient was treated with CELECOXIB (CELEBREX) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (upset stomach in the middle of the night), MALAISE (didn't feel well), ACNE (started getting a pimple on her face, and said realized it was inside my mouth in my cheek, a giant pimple, 3/8 inches wide, round, non ulcerative, but deep in the mucosa tissue), MOUTH ULCERATION (Mouth Ulcers) and HEADACHE (really bad headache) outcome was unknown and PYREXIA (fever of 101.5 for two days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5.         No concomitant medication was reported.  The patient had fear that mouth ulcer would spread, patient stated took Celebrex and rinsed mouth out with salt water.   This case was linked to MOD-2022-682167, MOD-2021-168219 (Patient Link).
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: given vaccine which underwent temperature excursion; No Adverse Event; given vaccine which was beyond the 30 day use by date; given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), PRODUCT STORAGE ERROR (given vaccine which underwent temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion). On 24-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given vaccine which underwent temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), PRODUCT STORAGE ERROR (given vaccine which underwent temperature excursion) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion) and PRODUCT STORAGE ERROR (given vaccine which underwent temperature excursion).    No concomitant products reported. It was reported that the lot number underwent temperature excursion on 15 to 17-Aug-2022 and was administered to the patient post temperature excursion.  No treatment products reported.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: given vaccine which was beyond the 30 day use by date; No adverse event; given vaccine which was beyond the 30 day use by date; given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion). On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (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 (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date) and PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date).    No relevant concomitant medications were reported.  Patient had gotten vaccine which underwent temperature excursion on 15-17Aug 2022.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681465, US-MODERNATX, INC.-MOD-2022-682168 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681465: US-MODERNATX, INC.-MOD-2022-682168:
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date; Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date), POOR QUALITY PRODUCT ADMINISTERED (Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date). On 24-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date), POOR QUALITY PRODUCT ADMINISTERED (Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (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 (Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date) and POOR QUALITY PRODUCT ADMINISTERED (Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date).    Concomitant medication was not reported.  Patient received vaccine which was beyond the 30 day use by date and underwent temperature excursion between 15-Aug-2022 and 17-Aug-2022.   Treatment medication was not reported.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: underwent temperature excursion on 15-17Aug2022; NO ADVERSE EVENT; underwent temperature excursion on 15-17Aug2022 and was administered to 16 patients post temperature excursion.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (underwent temperature excursion on 15-17Aug2022 and was administered to 16 patients post temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (underwent temperature excursion on 15-17Aug2022) and NO ADVERSE EVENT (NO ADVERSE EVENT) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (underwent temperature excursion on 15-17Aug2022 and was administered to 16 patients post temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (underwent temperature excursion on 15-17Aug2022) and NO ADVERSE EVENT (NO ADVERSE EVENT). At the time of the report, EXPIRED PRODUCT ADMINISTERED (underwent temperature excursion on 15-17Aug2022 and was administered to 16 patients post temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (underwent temperature excursion on 15-17Aug2022) and NO ADVERSE EVENT (NO ADVERSE EVENT) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (NO ADVERSE EVENT) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (underwent temperature excursion on 15-17Aug2022 and was administered to 16 patients post temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (underwent temperature excursion on 15-17Aug2022).    No concomitant products reported.  It was reported that the lot number underwent temperature excursion on 15 to 17 Aug 2022 and was administered to 16 patients post temperature excursion.   No treatment products reported.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator on 22-Aug-2022, vaccine was administered on 26-Sep-2022; No adverse event; Expiry beyond use date 22-Sep-2022, vaccine was administered on 26-Sep2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expiry beyond use date 22-Sep-2022, vaccine was administered on 26-Sep2022), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22-Aug-2022, vaccine was administered on 26-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B and AR9237B) for COVID-19 prophylaxis.     Patient had no acute illness at the time of vaccination and up to one month before. It was unknown if patient had any covid-19 test or diagnosed with covid-19 or not.    On 22-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expiry beyond use date 22-Sep-2022, vaccine was administered on 26-Sep2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22-Aug-2022, vaccine was administered on 26-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expiry beyond use date 22-Sep-2022, vaccine was administered on 26-Sep2022), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22-Aug-2022, vaccine was administered on 26-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expiry beyond use date 22-Sep-2022, vaccine was administered on 26-Sep2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22-Aug-2022, vaccine was administered on 26-Sep-2022).    Concomitant product use was not provided by the reporter.  It was reported that vial did not gone under temperature excursion.  Treatment information was not provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested pos for covid 14Nov22. 15Nov tested pos lab. Started Paxlovid 15Nov - 19Nov. Tested neg 20Nov  - 22Nov. 23Nov tested positive again!!! Rebound!. Wish I hadn't taken it !!! Suck time all us; Tested pos for covid 14Nov22. 15Nov tested pos lab. Started Paxlovid 15Nov - 19Nov. Tested neg 20Nov  - 22Nov. 23Nov tested positive again!!! Rebound!. Wish I hadn't taken it !!! Suck time all us; Interchange of vaccine products; 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 70-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: El1284), on 11Feb2021 as dose 2, single (Lot number: En6201), on 11Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, on 22Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) and on 01May2022 as dose 5 (booster), single (Lot number: Fm9992) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 09Sep2022 as dose 6 (booster), single (Lot number: As7144b), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Nov2022, outcome "not recovered" and all described as "Tested pos for covid 14Nov22. 15Nov tested pos lab. Started Paxlovid 15Nov - 19Nov. Tested neg 20Nov - 22Nov. 23Nov tested positive again!!! Rebound!. Wish I hadn't taken it !!! Suck time all us". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Nov2022) Positive; (15Nov2022) Positive; (20Nov2022) Negative; (22Nov2022) Negative; (23Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was not received other medication in 2 weeks. Anti viral details: Patient was treated with Paxlovid. Treatment start date:15Nov2022, Treatment stop date: 19Nov2022. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Anaphylaxis or anaphylactic shock (7 days).  Skin rash invaded my back, front, upper tights between legs. Later went to arms, neck, hands and feet. Now it radiates thru the body, sometimes is all upper, sometimes is all lower body areas. Lips are engorded. Left eye is affected. Pelvic area is also very red and itches. The hives are big.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Anaphylactic shock, Erythema, Eye disorder, Lip swelling
Clinical narrative: Anaphylaxis or anaphylactic shock (7 days).  Skin rash invaded my back, front, upper tights between legs. Later went to arms, neck, hands and feet. Now it radiates thru the body, sometimes is all upper, sometimes is all lower body areas. Lips are engorded. Left eye is affected. Pelvic area is also very red and itches. The hives are big.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Anaphylaxis or anaphylactic shock (7 days).  Skin rash invaded my back, front, upper tights between legs. Later went to arms, neck, hands and feet. Now it radiates thru the body, sometimes is all upper, sometimes is all lower body areas. Lips are engorded. Left eye is affected. Pelvic area is also very red and itches. The hives are big.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pruritus, Rash
Clinical narrative: APPROXIMATELY TWO WEEKS AFTER MY SHOT I BEGAN TO BECOME ITCHY ON THE BACK OF MY HEAD AND NECK, THEN AFTER A FEW MORE DAYS I STARTED TO GET BUMPS AND ITCHYNESS ON THE BACK OF MY ELBOWS , KNEES, AND AROUND MY WAISTLINE AREA.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: The vaccine administered box expiration was 11/25/2022 and the vaccine was used on 12/01/22-- pt has not experienced any adverse effects
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test, Cardiac failure, Chest X-ray, Computerised tomogram
Clinical narrative: I had Cervical spine surgery on 11-9-22 and was being released to go home when I went into A-Fib and was rushed from Hospital to Medical center.  After x-ray, blood test, ct scan, echocardiogram I was admitted for heart failure.  Cardio Dr. Said he could not find anything wrong with my heart but wants to see me to put a monitor on and see what my heart is doing.  He is an Electro cardio Dr. And My PCP wants me to see a Cardiologist which I can?t get into until February.  My PCP is having to work with me as the hospital took me off the Blood pressure medication I was on, and after being released on 11-13-22 and I came home, my blood pressure was at a very high number.  He now has me back on the Losartan and the new heart pill Metoprolol 50 mg, twice a day.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Hypertension, Spinal operation
Clinical narrative: I had Cervical spine surgery on 11-9-22 and was being released to go home when I went into A-Fib and was rushed from Hospital to Medical center.  After x-ray, blood test, ct scan, echocardiogram I was admitted for heart failure.  Cardio Dr. Said he could not find anything wrong with my heart but wants to see me to put a monitor on and see what my heart is doing.  He is an Electro cardio Dr. And My PCP wants me to see a Cardiologist which I can?t get into until February.  My PCP is having to work with me as the hospital took me off the Blood pressure medication I was on, and after being released on 11-13-22 and I came home, my blood pressure was at a very high number.  He now has me back on the Losartan and the new heart pill Metoprolol 50 mg, twice a day.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered expired on 11/25/2022 per box and vaccine administered on 12/01
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Back pain, Computerised tomogram abdomen, Differential white blood cell count, Full blood count
Clinical narrative: Started with pain in lower left groin area with severe itching (no rash); then paralysis - unable to: raise my body up, roll to either side, move legs up. Excruciating pain in my left groin area with really bad pain in my buttocks, thighs, back.  Later pain in right groin area and same type itching on lower left leg ankle area with no rash.  When I could finally move, unable to lift up legs to climb stairs, extreme difficulty getting in and out of tub, showering and putting on clothes. Unable to lift arms up over head to comb hair or reach for objects.  Extreme pain in upper arm (left and right) with hard "knots" in deltoids both arms.  When able to move, had to use a cane to assist with mobility.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Groin pain, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Started with pain in lower left groin area with severe itching (no rash); then paralysis - unable to: raise my body up, roll to either side, move legs up. Excruciating pain in my left groin area with really bad pain in my buttocks, thighs, back.  Later pain in right groin area and same type itching on lower left leg ankle area with no rash.  When I could finally move, unable to lift up legs to climb stairs, extreme difficulty getting in and out of tub, showering and putting on clothes. Unable to lift arms up over head to comb hair or reach for objects.  Extreme pain in upper arm (left and right) with hard "knots" in deltoids both arms.  When able to move, had to use a cane to assist with mobility.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Mobility decreased, Musculoskeletal pain, Nodule, Pain in extremity
Clinical narrative: Started with pain in lower left groin area with severe itching (no rash); then paralysis - unable to: raise my body up, roll to either side, move legs up. Excruciating pain in my left groin area with really bad pain in my buttocks, thighs, back.  Later pain in right groin area and same type itching on lower left leg ankle area with no rash.  When I could finally move, unable to lift up legs to climb stairs, extreme difficulty getting in and out of tub, showering and putting on clothes. Unable to lift arms up over head to comb hair or reach for objects.  Extreme pain in upper arm (left and right) with hard "knots" in deltoids both arms.  When able to move, had to use a cane to assist with mobility.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paralysis, Pruritus, Red blood cell sedimentation rate, Scan with contrast, Spinal X-ray
Clinical narrative: Started with pain in lower left groin area with severe itching (no rash); then paralysis - unable to: raise my body up, roll to either side, move legs up. Excruciating pain in my left groin area with really bad pain in my buttocks, thighs, back.  Later pain in right groin area and same type itching on lower left leg ankle area with no rash.  When I could finally move, unable to lift up legs to climb stairs, extreme difficulty getting in and out of tub, showering and putting on clothes. Unable to lift arms up over head to comb hair or reach for objects.  Extreme pain in upper arm (left and right) with hard "knots" in deltoids both arms.  When able to move, had to use a cane to assist with mobility.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Walking aid user, X-ray of pelvis and hip
Clinical narrative: Started with pain in lower left groin area with severe itching (no rash); then paralysis - unable to: raise my body up, roll to either side, move legs up. Excruciating pain in my left groin area with really bad pain in my buttocks, thighs, back.  Later pain in right groin area and same type itching on lower left leg ankle area with no rash.  When I could finally move, unable to lift up legs to climb stairs, extreme difficulty getting in and out of tub, showering and putting on clothes. Unable to lift arms up over head to comb hair or reach for objects.  Extreme pain in upper arm (left and right) with hard "knots" in deltoids both arms.  When able to move, had to use a cane to assist with mobility.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test, Computerised tomogram, Gait inability, Groin pain
Clinical narrative: Started with pain in lower left groin area with severe itching (no rash); then paralysis - unable to: raise my body up, roll to either side, move legs up. Excruciating pain in my left groin area with really bad pain in my buttocks, thighs, back.  Later pain in right groin area and same type itching on lower left leg ankle area with no rash.  When I could finally move, unable to lift up legs to climb stairs, extreme difficulty getting in and out of tub, showering and putting on clothes. Unable to lift arms up over head to comb hair or reach for objects.  Extreme pain in upper arm (left and right) with hard "knots" in deltoids both arms.  When able to move, had to use a cane to assist with mobility.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Investigation, Loss of personal independence in daily activities, Magnetic resonance imaging, Monoplegia, Movement disorder
Clinical narrative: Started with pain in lower left groin area with severe itching (no rash); then paralysis - unable to: raise my body up, roll to either side, move legs up. Excruciating pain in my left groin area with really bad pain in my buttocks, thighs, back.  Later pain in right groin area and same type itching on lower left leg ankle area with no rash.  When I could finally move, unable to lift up legs to climb stairs, extreme difficulty getting in and out of tub, showering and putting on clothes. Unable to lift arms up over head to comb hair or reach for objects.  Extreme pain in upper arm (left and right) with hard "knots" in deltoids both arms.  When able to move, had to use a cane to assist with mobility.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal pain, Nodule, Pain in extremity, Paralysis, Pruritus
Clinical narrative: Started with pain in lower left groin area with severe itching (no rash); then paralysis - unable to: raise my body up, roll to either side, move legs up. Excruciating pain in my left groin area with really bad pain in my buttocks, thighs, back.  Later pain in right groin area and same type itching on lower left leg ankle area with no rash.  When I could finally move, unable to lift up legs to climb stairs, extreme difficulty getting in and out of tub, showering and putting on clothes. Unable to lift arms up over head to comb hair or reach for objects.  Extreme pain in upper arm (left and right) with hard "knots" in deltoids both arms.  When able to move, had to use a cane to assist with mobility.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, X-ray
Clinical narrative: Started with pain in lower left groin area with severe itching (no rash); then paralysis - unable to: raise my body up, roll to either side, move legs up. Excruciating pain in my left groin area with really bad pain in my buttocks, thighs, back.  Later pain in right groin area and same type itching on lower left leg ankle area with no rash.  When I could finally move, unable to lift up legs to climb stairs, extreme difficulty getting in and out of tub, showering and putting on clothes. Unable to lift arms up over head to comb hair or reach for objects.  Extreme pain in upper arm (left and right) with hard "knots" in deltoids both arms.  When able to move, had to use a cane to assist with mobility.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested strongly positive for Covid; tested strongly positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 12Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 19Oct2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 70 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "discectomy" (unspecified if ongoing); "fusion of a neck vertebrae" (unspecified if ongoing); "herniating disc" (unspecified if ongoing); "severe shoulder pain symptoms" (unspecified if ongoing); "Arm pain symptoms" (unspecified if ongoing); "upper back pain symptoms" (unspecified if ongoing); "newhand surgery to correct the injury" (unspecified if ongoing); "a tendon transplant" (unspecified if ongoing); "Mild arthritis, hands/wrist (Mainly on the right)" (ongoing); "hereditary condition diagnosed a few years ago" (unspecified if ongoing); "Left shoulder pain/Persistent shoulder pain" (ongoing); "Loss of range of motion" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, in Nov2021 as dose number unknown, single; CELEBREX taken for arthritis (ongoing). Vaccination history included: I've had flu shots before this. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested strongly positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test (normal high range 13.0): (unspecified date) 600.0 AU/mL, notes: Reference: Neg less than 13.0; SARS-CoV-2 antibody test: (unspecified date) Positive; SARS-CoV-2 test: (2021) Strongly positive; (unspecified date) Unknown results.In mid-Jul (unknown year), patient developed headcold symptoms and tested strongly positive for Covid. Patient's case was also very mild, no fever or sore throat, just sinus issues. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200101818 same patient, different vaccine dose/event;
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Ear pain, Headache, Oropharyngeal pain, Oxygen saturation decreased
Clinical narrative: Cardiac Arrythmias/Heart issues; Accelerated Palpitations/ Heart issues; Lack Of Oxygen; Throat Pain; Ear Pain; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Nov2022 at 12:30 as dose 4 (booster), single (Lot number: GL2042) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination; "Caffeine allergy" (unspecified if ongoing); "Antihistamines allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: PALPITATIONS (non-serious) with onset 22Nov2022 at 04:30, outcome "not recovered", described as "Accelerated Palpitations/ Heart issues"; ARRHYTHMIA (medically significant) with onset 22Nov2022 at 04:30, outcome "not recovered", described as "Cardiac Arrythmias/Heart issues"; EAR PAIN (non-serious) with onset 22Nov2022 at 04:30, outcome "not recovered"; HEADACHE (non-serious) with onset 22Nov2022 at 04:30, outcome "not recovered"; OXYGEN SATURATION DECREASED (non-serious) with onset 22Nov2022 at 04:30, outcome "not recovered", described as "Lack Of Oxygen"; OROPHARYNGEAL PAIN (non-serious) with onset 22Nov2022 at 04:30, outcome "not recovered", described as "Throat Pain". The events "cardiac arrythmias/heart issues", "accelerated palpitations/ heart issues", "lack of oxygen", "throat pain", "ear pain" and "headache" required physician office visit. Therapeutic measures were taken as a result of arrhythmia, palpitations which included Nebivolol. Since the vaccination, the patient has not been tested for COVID-19.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Cardiac Arrythmias/Heart issues; Accelerated Palpitations/ Heart issues; Lack Of Oxygen; Throat Pain; Ear Pain; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Nov2022 at 12:30 as dose 4 (booster), single (Lot number: GL2042) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination; "Caffeine allergy" (unspecified if ongoing); "Antihistamines allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: PALPITATIONS (non-serious) with onset 22Nov2022 at 04:30, outcome "not recovered", described as "Accelerated Palpitations/ Heart issues"; ARRHYTHMIA (medically significant) with onset 22Nov2022 at 04:30, outcome "not recovered", described as "Cardiac Arrythmias/Heart issues"; EAR PAIN (non-serious) with onset 22Nov2022 at 04:30, outcome "not recovered"; HEADACHE (non-serious) with onset 22Nov2022 at 04:30, outcome "not recovered"; OXYGEN SATURATION DECREASED (non-serious) with onset 22Nov2022 at 04:30, outcome "not recovered", described as "Lack Of Oxygen"; OROPHARYNGEAL PAIN (non-serious) with onset 22Nov2022 at 04:30, outcome "not recovered", described as "Throat Pain". The events "cardiac arrythmias/heart issues", "accelerated palpitations/ heart issues", "lack of oxygen", "throat pain", "ear pain" and "headache" required physician office visit. Therapeutic measures were taken as a result of arrhythmia, palpitations which included Nebivolol. Since the vaccination, the patient has not been tested for COVID-19.