chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Blood test normal, Cellulitis, Drug hypersensitivity
Clinical narrative: Two weeks after receiving my booster shot on 11/21/21, both my hips started hurting.  The pain has remained since then with no lessening.  On January 15, 2022 I got shingles.  On April 1, 2022 I got cellulitis.  On about May 20, 2022 I got a serious reaction to my reflux medicine (Omeprazole).  Reaction was painful and swollen tongue and throat.  Around May 15, 2022 I got severe fungus on my left big toe (not athlete's foot).  As of this date, severe pain in hips remains as well as toe fungus.  Changed reflux medication.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fungal foot infection, Glossodynia, Herpes zoster, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: Two weeks after receiving my booster shot on 11/21/21, both my hips started hurting.  The pain has remained since then with no lessening.  On January 15, 2022 I got shingles.  On April 1, 2022 I got cellulitis.  On about May 20, 2022 I got a serious reaction to my reflux medicine (Omeprazole).  Reaction was painful and swollen tongue and throat.  Around May 15, 2022 I got severe fungus on my left big toe (not athlete's foot).  As of this date, severe pain in hips remains as well as toe fungus.  Changed reflux medication.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Spondylitis, Swollen tongue, X-ray of pelvis and hip abnormal
Clinical narrative: Two weeks after receiving my booster shot on 11/21/21, both my hips started hurting.  The pain has remained since then with no lessening.  On January 15, 2022 I got shingles.  On April 1, 2022 I got cellulitis.  On about May 20, 2022 I got a serious reaction to my reflux medicine (Omeprazole).  Reaction was painful and swollen tongue and throat.  Around May 15, 2022 I got severe fungus on my left big toe (not athlete's foot).  As of this date, severe pain in hips remains as well as toe fungus.  Changed reflux medication.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test abnormal, Condition aggravated, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: muscle stiffness was getting worse; muscle stiffness was getting worse; had abnormal blood work; This case was reported by a consumer via call center representative and described the occurrence of muscle stiffness in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of musculoskeletal stiffness (1st dose received on 18th November 2021 and experienced muscle stiffness that affected his mobility (tight hamstrings), refer case US2022084079). Concurrent medical conditions included muscle stiffness.   On 18th April 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced muscle stiffness, condition aggravated and lab test abnormal. On an unknown date, the outcome of the muscle stiffness, condition aggravated and lab test abnormal were unknown.   It was unknown if the reporter considered the muscle stiffness, condition aggravated and lab test abnormal to be related to Shingrix.     Linked case(s) involving the same patient:  US2022084079   Additional Information: GSK Receipt Date: 25-May-2022 Reporter's comments: This case was reported by the patient. The patient received second dose of Shingrix and around that time the muscle stiffness was getting worse and even with doing the yoga it was not improving. The patient had abnormal blood work. The patient did not remember what specific lab value was abnormal or if that value was high or low. The reporter did not have the lot number for the Shingrix but he did provide his doctor's contact information as he received the shots at his doctor's office and they should have the lot numbers on file. The consent to follow up was given.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022084079:same reporter
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT STORAGE OF VACCINE; ADMINISTRATION OF VACCINE WHICH WAS STORED OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned an 18 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 04-AUG-2022) dose was not reported, administered on 05-MAR-2022 for prophylactic vaccination. Age at time of vaccination 18 years old. No concomitant medications were reported.  On 05-MAR-2022, the patient experienced administration of vaccine which was stored outside of recommended storage conditions. On an unspecified date, the patient experienced incorrect storage of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine which was stored outside of recommended storage conditions and incorrect storage of vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558343 and 20220558345.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT STORAGE OF VACCINE; ADMINISTRATION OF VACCINE WHICH WAS STORED OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 70 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 04-AUG-2022) dose was not reported, administered on 21-JAN-2022 for prophylactic vaccination. Age at time of vaccination 70 years old. No concomitant medications were reported.  On 21-JAN-2022, the patient experienced administration of vaccine which was stored outside of recommended storage conditions. On an unspecified date, the patient experienced incorrect storage of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine which was stored outside of recommended storage conditions and incorrect storage of vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558340, 20220558343 and 20220558451.
Sex: U
Vaccine: COVID19
Symptoms: Developmental hip dysplasia, Foetal exposure during pregnancy
Clinical narrative: Hip dysplasia; Fetal exposure during pregnancy; The mother of the infant of unknown ethnic origin and unknown gender was participating in Moderna mRNA-1273 Observational Pregnancy Outcome Study and patient developed DEVELOPMENTAL HIP DYSPLASIA (Hip dysplasia). Additionally, the patient had FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy).  The subject's mother medical history provided by the reporter includes Mother did not had COVID-19 infection which was confirmed by negative test. Concurrent medical conditions included Caffeine consumption (caffeinated beverages less than 3 per day) and Alcoholic (Alcoholic drinks 1 to 9 drinks per week).  No medical history was reported for the subject. Concomitant medications reported included ACETYLSALICYLIC ACID, DIPYRIDAMOLE, LEVOTHYROXINE, ASCORBIC ACID, CALCIUM, CHOLECALCIFEROL, CYANOCOBALAMIN, FERROUS FUMARATE, FOLIC ACID, NIACIN, RIBOFLAVIN, THIAMINE, VITAMIN A NOS, VITAMIN E NOS, ZINC OXIDE, DOCONEXENT, ICOSAPENT and POLYETHYLENE GLYCOL 3350 for an unknown indication.  The subject received the first dose of mRNA-1273 for COVID-19 vaccination on an unknown date. On an unknown date, the subject experienced DEVELOPMENTAL HIP DYSPLASIA (Hip dysplasia) (seriousness criteria medically significant and congenital anomaly). Additionally, the subject had FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy). The delivery occurred on 02-Feb-2022, which was reported as Abnormal Pregnancy Outcome. The outcome was reported as Term Birth with Cong Anomaly.  No treatment information was reported by the reporter.  The subject's last dose date prior to the event and the action taken with mRNA-1273 was unknown.  The outcome of the event DEVELOPMENTAL HIP DYSPLASIA (Hip dysplasia) was reported as unknown, and for the event FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy) it was reported as resolved.  The reporter did not provide the causality for event DEVELOPMENTAL HIP DYSPLASIA (Hip dysplasia) and FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy).; Sender's Comments: This Sponsored case concerning an infant patient of unknown gender, with no reported medical history and foetal exposure during pregnancy, who experienced the serious (due to medically important condition and congenital anomaly) unexpected, event of Developmental hip dysplasia, after the mRNA-1273 vaccine, dose number not provided, temporal association cannot be assessed due to lack of information on vaccination date. The outcome was reported as unknown. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: recurred Covid 19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (recurred Covid 19) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.  Concurrent medical conditions included Asthma. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 04-May-2022 to an unknown date and TERBINAFINE HYDROCHLORIDE (LAMISIL [TERBINAFINE HYDROCHLORIDE]) from 04-May-2022 to an unknown date for an unknown indication.  On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (recurred Covid 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 16-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (recurred Covid 19) had not resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, SARS-CoV-2 test: positive (Positive) Positive.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The patient received other unspecified medications/products within 2 weeks of starting COVID-19 treatment. After 4 days completing Paxlovid, symptoms of nasal congestion and generalized achiness recurred. Patient had been symptomatic for 3 days after developing Covid 19 on 11-May-2022. Symptoms were nasal congestion and achiness and diagnosis made by rapid Ag test. patient began Paxlovid on 13-May-2022 and was symptom free by 16-May-2022. The COVID-19 recurred again on 20-May-2022 at 17:30. The device date was 21-May-2022.   Company comment: This is a spontaneous case concerning a 71-year-old male patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19 (reported as recurred Covid 19), approximately 7 months after the third dose of mRNA-1273 vaccine. No details of previous doses were provided. As per source document, he received Paxlovid as treatment and 4 days after completed it, symptoms of nasal congestion and generalized achiness recurred. A positive SARS-CoV-2 was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 71-year-old male patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19 (reported as recurred Covid 19), approximately 7 months after the third dose of mRNA-1273 vaccine. No details of previous doses were provided. As per source document, he received Paxlovid as treatment and 4 days after completed it, symptoms of nasal congestion and generalized achiness recurred. A positive SARS-CoV-2 was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 9:28 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 9:28 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 71.48   Concomitant products were not provided.  On 11-Jan-2021, Excursion time were at 09:00 hours was 35,at 2.00 PM 35, total doses given for the day was 98 , condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on  05-Jan-2021 and 08-Jan-2021, vial was moved to clinic on 08-Jan-2021 and 11-Jan-2021. 2 and 9 vials was moved to clinic. Vaccine BUD date was 04-Feb-2021 and 07-Feb-2021.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree F.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Penicillin. Past adverse reactions to the above products included Allergy with Penicillin. Concomitant products included BUPRENORPHINE, ROPINIROLE and OMEPRAZOLE for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) on 15-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19) had not resolved.            Last date of administration of Pfizer covid-19 vaccine was 19-May-2021. Patient took other medications/products within 2 weeks of starting COVID-19 treatment.  Device Date was reported as 23-May-2022.  No treatment medication was provided.  Company Comment: This is a spontaneous case concerning a 46-year-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine. As reported, the patient was treated with Pfizer for COVID-19, the patient tested positive on Days 6 & 7 and on Day 9 the test was fully "strongly" positive again and had some cold symptoms. No further clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 46-year-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine. As reported, the patient was treated with Pfizer for COVID-19, the patient tested positive on Days 6 & 7 and on Day 9 the test was fully "strongly" positive again and had some cold symptoms. No further clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anger, Energy increased, Insomnia, Palpitations, Restlessness
Clinical narrative: Started with a PM dose on Day 1 Morning after the first dose Tons of energy/quick fuse/energized; restless; angry; Couldn't sleep after Day 2 AM and PM doses; Racing heart; Racing thoughts; This spontaneous case was reported by a consumer and describes the occurrence of ENERGY INCREASED (Started with a PM dose on Day 1 Morning after the first dose Tons of energy/quick fuse/energized), RESTLESSNESS (restless), ANGER (angry), INSOMNIA (Couldn't sleep after Day 2 AM and PM doses) and PALPITATIONS (Racing heart) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035c21a, 010a21a and 010a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Chemotherapy (I've taken steroids in the past as part of my chemotherapy treatments.). Concurrent medical conditions included Drug allergy (kna) and Breast cancer. Concomitant products included TAMOXIFEN from 07-Jun-2021 to an unknown date, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) from 17-May-2022 to an unknown date and GABAPENTIN from 28-Mar-2022 to an unknown date for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 21-May-2022, the patient experienced ENERGY INCREASED (Started with a PM dose on Day 1 Morning after the first dose Tons of energy/quick fuse/energized), RESTLESSNESS (restless), ANGER (angry), INSOMNIA (Couldn't sleep after Day 2 AM and PM doses), PALPITATIONS (Racing heart) and TACHYPHRENIA (Racing thoughts). At the time of the report, ENERGY INCREASED (Started with a PM dose on Day 1 Morning after the first dose Tons of energy/quick fuse/energized), RESTLESSNESS (restless), ANGER (angry), INSOMNIA (Couldn't sleep after Day 2 AM and PM doses), PALPITATIONS (Racing heart) and TACHYPHRENIA (Racing thoughts) outcome was unknown.            Patient was on Steroids. The patient hadn't taken any other medications/products within 2 weeks of starting COVID-19 treatment. Stopped taking Paxlovid after 4 doses. Device Date : 22May2022. Treatment information was not reported.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Tachyphrenia
Clinical narrative: Started with a PM dose on Day 1 Morning after the first dose Tons of energy/quick fuse/energized; restless; angry; Couldn't sleep after Day 2 AM and PM doses; Racing heart; Racing thoughts; This spontaneous case was reported by a consumer and describes the occurrence of ENERGY INCREASED (Started with a PM dose on Day 1 Morning after the first dose Tons of energy/quick fuse/energized), RESTLESSNESS (restless), ANGER (angry), INSOMNIA (Couldn't sleep after Day 2 AM and PM doses) and PALPITATIONS (Racing heart) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035c21a, 010a21a and 010a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Chemotherapy (I've taken steroids in the past as part of my chemotherapy treatments.). Concurrent medical conditions included Drug allergy (kna) and Breast cancer. Concomitant products included TAMOXIFEN from 07-Jun-2021 to an unknown date, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) from 17-May-2022 to an unknown date and GABAPENTIN from 28-Mar-2022 to an unknown date for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 21-May-2022, the patient experienced ENERGY INCREASED (Started with a PM dose on Day 1 Morning after the first dose Tons of energy/quick fuse/energized), RESTLESSNESS (restless), ANGER (angry), INSOMNIA (Couldn't sleep after Day 2 AM and PM doses), PALPITATIONS (Racing heart) and TACHYPHRENIA (Racing thoughts). At the time of the report, ENERGY INCREASED (Started with a PM dose on Day 1 Morning after the first dose Tons of energy/quick fuse/energized), RESTLESSNESS (restless), ANGER (angry), INSOMNIA (Couldn't sleep after Day 2 AM and PM doses), PALPITATIONS (Racing heart) and TACHYPHRENIA (Racing thoughts) outcome was unknown.            Patient was on Steroids. The patient hadn't taken any other medications/products within 2 weeks of starting COVID-19 treatment. Stopped taking Paxlovid after 4 doses. Device Date : 22May2022. Treatment information was not reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:53 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 68.11    Concomitant products were not provided.  On 15-Apr-2021, Excursion time were at 09 AM was 34, total doses given for the day was 188 , condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on  06-Apr-2021 , vial was moved to clinic on 15-Apr-2021. 18 vials was moved to clinic. Vaccine BUD date was 09-May-2021.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree F.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, SARS-CoV-2 test
Clinical narrative: Flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis.    No Medical History information was reported.   On 05-Mar-2020, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 04-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient experienced INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication were provided It was reported that patient still had a cough but much better took time to get through this. No treatment details were provided
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: the vial undergo any temperature excursions; Vaccine was placed in refrigerator on 20-Jan-2022, expired product date on 20-Jan-2022, administration date on 12-May-2022; 13 patients received  an expired vaccine for a booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose), PRODUCT TEMPERATURE EXCURSION ISSUE (the vial undergo any temperature excursions) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 20-Jan-2022, expired product date on 20-Jan-2022, administration date on 12-May-2022) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A and 038B21A) for COVID-19 vaccination.     Patient didn't had past medical history and allergy information reported as unknown. Patient ever had COVID + test or diagnosis reported as unknown. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (the vial undergo any temperature excursions) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 20-Jan-2022, expired product date on 20-Jan-2022, administration date on 12-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose), PRODUCT TEMPERATURE EXCURSION ISSUE (the vial undergo any temperature excursions) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 20-Jan-2022, expired product date on 20-Jan-2022, administration date on 12-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The temperature excursion details of vaccine reported as maximum or minimum temperatures reached 44.6°F and 38.8°F and excursion duration was 3 months.  The treatment information was not provided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Vial that expired on the 20Jan2022 were put in the freezer underwent excursion for 3 months; vial that expired on the 20Jan2022 were put in the freezer underwent excursion for 3 months; Patient received an expired vaccine for a booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine for a booster dose), PRODUCT STORAGE ERROR (Vial that expired on the 20Jan2022 were put in the freezer underwent excursion for 3 months) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial that expired on the 20Jan2022 were put in the freezer underwent excursion for 3 months) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     Patient had no allergies and no history relating to mentioned AE both Acute and Chronic illnesses at the time of vaccination. No other vaccine given within 1 month prior to Moderna COVID-19 vaccine. It was unknown if patient ever had COVID test or diagnosis.  Previously administered products included for Product used for unknown indication: Janssen (Jansen for primary series). Past adverse reactions to the above products included No adverse event with Janssen.    On 27-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine for a booster dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial that expired on the 20Jan2022 were put in the freezer underwent excursion for 3 months) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial that expired on the 20Jan2022 were put in the freezer underwent excursion for 3 months). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine for a booster dose), PRODUCT STORAGE ERROR (Vial that expired on the 20Jan2022 were put in the freezer underwent excursion for 3 months) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial that expired on the 20Jan2022 were put in the freezer underwent excursion for 3 months) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  It was reported that patient did not seek any medical attention. It was reported that the vial which expired was initially stored in refrigerator on 20-Jan-2022 and later were put in the freezer and from 23-Feb-2022 until the 12-May-2022 it was administered to 13 patients, all booster dosages, after the expiry. It was also reported that the vials underwent maximum 44.6 degree F and minimum 38.8 degree F of temperature excursion for 3 months. No visual inspection noting any vaccine state change as vials were in seal boxes. Number of vials/doses impacted: 660 doses, and they have now 520.   This case was linked to MOD-2022-572778 (Patient Link).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Vials were undergone temperature excursion by maximum 44.6 degree F and minimum by 38.8 degree F; Vaccine expired on the 20jan2022 were put in the freezer and from 23feb2022 until the12may2022 administerto patient; patient received  an expired vaccine for a booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received  an expired vaccine for a booster dose), PRODUCT TEMPERATURE EXCURSION ISSUE (Vials were undergone temperature excursion by maximum 44.6 degree F and minimum by 38.8 degree F) and PRODUCT STORAGE ERROR (Vaccine expired on the 20jan2022 were put in the freezer and from 23feb2022 until the12may2022 administerto patient) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No allergies to food and other products.     On 08-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received  an expired vaccine for a booster dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vials were undergone temperature excursion by maximum 44.6 degree F and minimum by 38.8 degree F) and PRODUCT STORAGE ERROR (Vaccine expired on the 20jan2022 were put in the freezer and from 23feb2022 until the12may2022 administerto patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received  an expired vaccine for a booster dose), PRODUCT TEMPERATURE EXCURSION ISSUE (Vials were undergone temperature excursion by maximum 44.6 degree F and minimum by 38.8 degree F) and PRODUCT STORAGE ERROR (Vaccine expired on the 20jan2022 were put in the freezer and from 23feb2022 until the12may2022 administerto patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Unknown whether the patient ever had COVID + test or diagnosis. On 20JAN2022, the vial was initially stored in the refrigerator.  The vial undergone temperature excursions. Excursion duration: 3 months. Patient did not seek medical care for the AE. Unkown if the patient symptoms improved or worsened. Treatment information was not provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Dosages expired on the 20Jan2022, initially stored in the refrigerator on 20Jan2022, The vial unerwent temperature excursions; Received dosages in January with the same lot number, 045L21A that expired on the 20Jan2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dosages in January with the same lot number, 045L21A that expired on the 20Jan2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dosages expired on the 20Jan2022, initially stored in the refrigerator on 20Jan2022, The vial unerwent temperature excursions) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 20-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dosages in January with the same lot number, 045L21A that expired on the 20Jan2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dosages expired on the 20Jan2022, initially stored in the refrigerator on 20Jan2022, The vial unerwent temperature excursions). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received dosages in January with the same lot number, 045L21A that expired on the 20Jan2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dosages expired on the 20Jan2022, initially stored in the refrigerator on 20Jan2022, The vial unerwent temperature excursions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no allergies. It was unknown if patient ever had COVID positive test or diagnosis. Patient had no Acute and Chronic illnesses at the time of vaccination. No concomitant drug was reported. The reporter stated that she received dosages in January with the same lot number, 045L21A that expired on the 20-Jan-2022 and they were put in the freezer and from 23-Feb-2022 until the 12-May-2022 they administered them to 13 patients, all booster dosages, after they expired. Date the vial was initially stored in the refrigerator: 20-Jan-2022. No treatment drug was reported.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness
Clinical narrative: sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sickness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease.    No Medical History information was reported.   On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In May 2022, the patient experienced ILLNESS (sickness). At the time of the report, ILLNESS (sickness) was resolving.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-576025 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient administered Dose 1 on 18-SEP-2021, Dose 2 on 11-NOV-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered Dose 1 on 18-SEP-2021, Dose 2 on 11-NOV-2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's.    No Medical History information was reported.   On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 11-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered Dose 1 on 18-SEP-2021, Dose 2 on 11-NOV-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered Dose 1 on 18-SEP-2021, Dose 2 on 11-NOV-2021) outcome was unknown.            Patient received 3rd MODERNA COVID-19 VACCINE on 11-MAY-2022. No concomitant medication information provided. No treatment medication information provided.   This case was linked to MOD-2022-576009 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms
Clinical narrative: tight leg cramps - both right and left thighs. started day 3 of treatment. has occurred 3 times. takes about 20 minutes to walk it off.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (tight leg cramps - both right and left thighs. started day 3 of treatment. has occurred 3 times. takes about 20 minutes to walk it off.) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 treatment.    The patient's past medical history included Cardiac arrhythmia. Concomitant products included ATENOLOL from 01-May-2022 to 23-May-2022 for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 22-May-2022 at 9:15 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCLE SPASMS (tight leg cramps - both right and left thighs. started day 3 of treatment. has occurred 3 times. takes about 20 minutes to walk it off.). At the time of the report, MUSCLE SPASMS (tight leg cramps - both right and left thighs. started day 3 of treatment. has occurred 3 times. takes about 20 minutes to walk it off.) outcome was unknown.            The patient had no known allergies.  The patient experienced tight leg cramps in both right and left thighs. It started day 3 of treatment and had occurred 3 times. It took about 20 minutes to walk it off.  The device date was reported as 23-May-2022.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well / Malaise; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (not feeling well / Malaise) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TREPROSTINIL for Pulmonary arterial hypertension and TREPROSTINIL DIOLAMIN (ORENITRAM) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 10-Feb-2022, the patient started TREPROSTINIL (Oral) at an unspecified dose. On 10-Feb-2022, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 3.125 milligram three times a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 2.5 milligram. On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to .25 milligram and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to .125 milligram. In May 2022, the patient experienced MALAISE (not feeling well / Malaise). At the time of the report, MALAISE (not feeling well / Malaise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MALAISE (not feeling well / Malaise) to be related.    No concomitant medication was reported. The reporter did not provide causality for the event of malaise with PO Orenitram. No treatment medication was reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Invalid dose administration/ patient administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Invalid dose administration/ patient administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Invalid dose administration/ patient administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Invalid dose administration/ patient administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. Dates of administration were 3MAY2022, 4MAY2022, 9MAY2022, 11MAY2022, 17MAY2022, and 20MAY2022.