chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Weight decreased
Clinical narrative: She was a little tired (fatigue) after the shot; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (She was a little tired (fatigue) after the shot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TREPROSTINIL SODIUM (REMODULIN) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension and Seasonal allergy (seasonal allergy were bad at the time of report.).   On 21-May-2021, the patient started TREPROSTINIL SODIUM (REMODULIN) (Intravenous) .042 microgram/kilogram. On 21-May-2021, TREPROSTINIL SODIUM (REMODULIN) (Intravenous) dosage was changed to concentration 1.0 mg/ml. On 06-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2022, the patient experienced FATIGUE (She was a little tired (fatigue) after the shot). At the time of the report, FATIGUE (She was a little tired (fatigue) after the shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Weight decreased: 97.4 97.4 lbs and. In June 2022, Weight decreased 97 97 lbs.         The weight of the patient in May-2022 was reported as 96.6 lbs.  Concomitant medications were not reported.  The patient had took second booster dose.  The patient began therapy with Remodulin (treprostinil sodium, concentration 1.0 mg/ml) on 21-May-2021 for primary pulmonary arterial hypertension. On an unreported date, the patient experienced event of weight loss (weight decreased). Action taken with IV Remodulin was not reported for the event of weight decreased. At the time of reporting, the outcome of weight decreased was unknown. Patient reported that a new central line was placed, and sutures were little irritated (suture related complication). At the time of reporting, the outcome of suture related complication was unknown. The reporter did not provide causality for the event of suture related complication. It was reported that patient had the line replaced in April. Patient had an embedded suture that was irritating the site, which was red and sore (injection site irritation, injection site erythema, injection site pain and suture related complication, previously reported). The physician advised that there were no infections. Action taken with IV Remodulin was not reported for the events of injection site irritation, injection site erythema, injection site pain, seasonal allergy, and fatigue. At the time of reporting, the outcome of injection site irritation, injection site erythema, injection site pain, seasonal allergy and fatigue was unknown.  Treatment information was not reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder, Urticaria
Clinical narrative: about a week and a half after the second booster, patient had to go off his medication because it lowers his immunity; develop hives; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (about a week and a half after the second booster, patient had to go off his medication because it lowers his immunity) and URTICARIA (develop hives) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A22B, 025L21B, 031M220A and 029L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Food allergy (Corn products), Immunocompromised, Rheumatoid arthritis and Heart disorder (heart issue). Concomitant products included LOVASTATIN, FLUOXETINE HYDROCHLORIDE (PROZAC), BUPROPION HYDROCHLORIDE (WELLBUTRIN) and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced IMMUNE SYSTEM DISORDER (about a week and a half after the second booster, patient had to go off his medication because it lowers his immunity) and URTICARIA (develop hives). At the time of the report, IMMUNE SYSTEM DISORDER (about a week and a half after the second booster, patient had to go off his medication because it lowers his immunity) and URTICARIA (develop hives) had not resolved.            It was reported that the patient did not experience any COVID or was tested positive.  No treatment medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: On of my friends had side effects after receiving the second booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (On of my friends had side effects after receiving the second booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (On of my friends had side effects after receiving the second booster). At the time of the report, IMMUNISATION REACTION (On of my friends had side effects after receiving the second booster) outcome was unknown.            No concomitant medications were reported.   No treatment details were reported.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dermatitis allergic
Clinical narrative: Allergic rash; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (Allergic rash) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe).   On 17-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Nov-2021, received 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) at an unspecified dose. On an unknown date, the patient experienced DERMATITIS ALLERGIC (Allergic rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DERMATITIS ALLERGIC (Allergic rash) had resolved with sequelae.            Concomitant medication of the patient was not reported.  Formulation of Humira (adalimumab) was reported as solution for injection in pre-filled pen.  Causality for Humira (adalimumab): The reporter's causality for the event of allergic rash with Humira (adalimumab) was a reasonable possibility (probable).  It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: The first temperature excursion lasted for 9 hours 45 minutes/The total amount of the excursion is 29 hours 30 minutes.; Administered vaccine after having two excursion for a total of 29 hours and 30 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine after having two excursion for a total of 29 hours and 30 minutes) and PRODUCT TEMPERATURE EXCURSION ISSUE (The first temperature excursion lasted for 9 hours 45 minutes/The total amount of the excursion is 29 hours 30 minutes.) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine after having two excursion for a total of 29 hours and 30 minutes). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The first temperature excursion lasted for 9 hours 45 minutes/The total amount of the excursion is 29 hours 30 minutes.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine after having two excursion for a total of 29 hours and 30 minutes) and PRODUCT TEMPERATURE EXCURSION ISSUE (The first temperature excursion lasted for 9 hours 45 minutes/The total amount of the excursion is 29 hours 30 minutes.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was first punctured on 04-Mar-2022. The vial were not exposed to room temperature. The vial was stored only in freezer. The vial did undergo temperature excursion. The maximum 10.8 degree Fahrenheit and minimum 5.5 degree Fahrenheit were reached. The vial was not moved from freezer to refrigerator. The vial was found to be refrozen in the visual inspection. At least 1 vial was impacted. No previous excursions were seen.   This case was linked to MOD-2022-592557 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pruritus
Clinical narrative: Itching; Pain burning; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), PAIN (Pain burning) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis, Rheumatoid arthritis and Plaque psoriasis.    There was no reported medical history.    On 01-Apr-2022, the patient received 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 mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PRURITUS (Itching), PAIN (Pain burning) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, PRURITUS (Itching) had not resolved and PAIN (Pain burning) and INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.            It was unknown if patient was enrolled in COVID-19 vaccine trial. Concomitant medications were not reported. On an unknown date HUMIRA was discontinued Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2022: Significant follow-up received contains suspect drug details added and reporter causality updated.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypersensitivity, Myalgia
Clinical narrative: Allergies; Body ache; Eveny joint in body hurt; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergies), MYALGIA (Body ache) and ARTHRALGIA (Eveny joint in body hurt) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Concomitant products included CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) and CINNAMOMUM CASSIA (CINNAMON [CINNAMOMUM CASSIA]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergies), MYALGIA (Body ache) and ARTHRALGIA (Eveny joint in body hurt). The patient was treated with DICLOFENAC ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergies) had not resolved and MYALGIA (Body ache) and ARTHRALGIA (Eveny joint in body hurt) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was linked to MOD-2022-592712 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Fatigue, Headache, Hyperacusis, Illness
Clinical narrative: I became seriously ill; bizarre nerve vibrations in my head, neck, body; sensitivity to light and sound; sensitivity to light and sound; devier exercise intolerance; muscle spasms; severe insomnia; debilitating headaches; chronic fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (I became seriously ill), NEURALGIA (bizarre nerve vibrations in my head, neck, body), PHOTOPHOBIA (sensitivity to light and sound), HYPERACUSIS (sensitivity to light and sound) and EXERCISE TOLERANCE DECREASED (devier exercise intolerance) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I became seriously ill), NEURALGIA (bizarre nerve vibrations in my head, neck, body), PHOTOPHOBIA (sensitivity to light and sound), HYPERACUSIS (sensitivity to light and sound), EXERCISE TOLERANCE DECREASED (devier exercise intolerance), MUSCLE SPASMS (muscle spasms), INSOMNIA (severe insomnia), HEADACHE (debilitating headaches) and FATIGUE (chronic fatigue). At the time of the report, ILLNESS (I became seriously ill), NEURALGIA (bizarre nerve vibrations in my head, neck, body), PHOTOPHOBIA (sensitivity to light and sound), HYPERACUSIS (sensitivity to light and sound), EXERCISE TOLERANCE DECREASED (devier exercise intolerance), MUSCLE SPASMS (muscle spasms), INSOMNIA (severe insomnia), HEADACHE (debilitating headaches) and FATIGUE (chronic fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the reporter did not remember much in January and February of this year. No treatment medication was reported.   This case was linked to MOD-2022-592428 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Muscle spasms, Neuralgia, Photophobia
Clinical narrative: I became seriously ill; bizarre nerve vibrations in my head, neck, body; sensitivity to light and sound; sensitivity to light and sound; devier exercise intolerance; muscle spasms; severe insomnia; debilitating headaches; chronic fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (I became seriously ill), NEURALGIA (bizarre nerve vibrations in my head, neck, body), PHOTOPHOBIA (sensitivity to light and sound), HYPERACUSIS (sensitivity to light and sound) and EXERCISE TOLERANCE DECREASED (devier exercise intolerance) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I became seriously ill), NEURALGIA (bizarre nerve vibrations in my head, neck, body), PHOTOPHOBIA (sensitivity to light and sound), HYPERACUSIS (sensitivity to light and sound), EXERCISE TOLERANCE DECREASED (devier exercise intolerance), MUSCLE SPASMS (muscle spasms), INSOMNIA (severe insomnia), HEADACHE (debilitating headaches) and FATIGUE (chronic fatigue). At the time of the report, ILLNESS (I became seriously ill), NEURALGIA (bizarre nerve vibrations in my head, neck, body), PHOTOPHOBIA (sensitivity to light and sound), HYPERACUSIS (sensitivity to light and sound), EXERCISE TOLERANCE DECREASED (devier exercise intolerance), MUSCLE SPASMS (muscle spasms), INSOMNIA (severe insomnia), HEADACHE (debilitating headaches) and FATIGUE (chronic fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the reporter did not remember much in January and February of this year. No treatment medication was reported.   This case was linked to MOD-2022-592428 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Sciatic nerve neuropathy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SCIATIC NERVE NEUROPATHY (Sciatic nerve problems) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis. No Medical History information was reported. In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2022, received fourth 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) at an unspecified dose. On an unknown date, the patient experienced SCIATIC NERVE NEUROPATHY (Sciatic nerve problems). At the time of the report, SCIATIC NERVE NEUROPATHY (Sciatic nerve problems) outcome was unknown. No concomitant medications were reported. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. The reporter causality for an event of sciatic nerve problems with adalimumab (Humira, solution for injection in prefilled pen) was provided as no reasonable possibility. No treatment medications were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). On 26-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  HCP reported that the facility where she works, there had been temperature excursions with freezer. It had been happening for weeks since April 2022.  The storage condition at the time of the excursion was reported as frozen storage.  The affected batch lot numbers were reported as 065K21A and 045L21A.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9(-18.9) Fahrenheit degrees.  The vaccines suffered 2 temperature excursions since April, both of which lasted less than 1 minute.  The vials were stored frozen.  Visual inspection did not note any vaccine state change.  Treatment information was not provided.   This case was linked to MOD-2022-591989 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Eye disorder, Injection site rash, Nasal congestion
Clinical narrative: Eye disorder; Injection site rash; Nasal stuffiness; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal stuffiness), EYE DISORDER (Eye disorder) and INJECTION SITE RASH (Injection site rash) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form. and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. In November 2021, the patient experienced NASAL CONGESTION (Nasal stuffiness). On an unknown date, the patient experienced EYE DISORDER (Eye disorder) and INJECTION SITE RASH (Injection site rash). At the time of the report, NASAL CONGESTION (Nasal stuffiness) and INJECTION SITE RASH (Injection site rash) had not resolved and EYE DISORDER (Eye disorder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: live follow up received suspect drug Humira drug details updated and new event Injection site rash added On 21-Jun-2022: live follow up received new event eye disorder added
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Reporter informed about temperature excursions with freezer in the facility, where she works. It had been happening for weeks since April 2022. The storage condition at the time of the excursion was reported as frozen storage. The affected batch lot numbers were reported as 065K21A and 045L21A. The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees. The vaccines suffered 2 temperature excursions since April, both of which lasted less than 1 minute. The vials were stored frozen. Visual inspection did not noted any vaccine state change. No treatment medication were provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The vials were stored at frozen storage at the time of the excursion. The Lot number which were expired are 065K21A and 045L21A. The vials reached a maximum temperature of 30 Fahrenheit Degrees and minimum of -18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April 2022, both lasted less than 1 minute,  they were now stored in frozen condition and no vaccine state change was observed.  No treatment drug details was reported.   This case was linked to MOD-2022-591989 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna COVID 19 vaccine after temperature excursion; Patients received the Moderna COVID 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID 19 vaccine after temperature excursion) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  HCP reported about temperature excursions with freezer in the facility. It had been happening for weeks since April 2022.  The batch numbers were reported as 065K21A and 045L21A.  The storage condition at the time of the excursion was reported as frozen storage.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute.   The vails were stored in Frozen state.   No treatment information was provided
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). On 26-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and they were stored in frozen condition and no vaccine state change was observed through visual inspection.  No treatment medications were reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter stated that the facility where she worked, there had been temperature excursions with freezer. It had been happening for weeks since April 2022. The batch numbers were reported as 065K21A and 045L21A. The storage condition at the time of the excursion was reported as frozen storage. The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus 18.9 Fahrenheit degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute. The vails were stored in frozen state. The visual inspection noting any vaccine state change was reported as no.  No treatment information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: arm is very swollen; arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is very swollen) and PAIN IN EXTREMITY (arm is sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm is very swollen) and PAIN IN EXTREMITY (arm is sore). At the time of the report, PERIPHERAL SWELLING (arm is very swollen) and PAIN IN EXTREMITY (arm is sore) outcome was unknown.            Height was reported as 5.5. No relevant concomitant medications were reported. Patient received her second booster dose. Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). On 28-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  Vaccine was frozen at the time of the excursion. The temperatures were reported as Maximum 30 Fahrenheit Degrees and Minimum -18.9 Fahrenheit Degrees The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute Lot numbers were reported as 065K21A and 045L21A.   This case was linked to MOD-2022-591989 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received the Moderna Covid 19 vaccine after temperature excursion; Patient received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). On 21-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  HCP reported about temperature excursions with freezer in the facility. It had happened for weeks since April 2022.The batch numbers were reported as 065K21A and 045L21A.The storage condition at the time of the excursion was reported as frozen storage.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees. The vaccines suffered two temperature excursions since April, both lasted less than 1 minute.   The vails were stored back in frozen state.  No visual inspection noted any vaccine state change.  Date the vials moved from freezer to refrigerator was unknown.  No proposed desired Use by Date.  No treatment information was provided.   This case was linked to MOD-2022-591989 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Reporter informed about temperature excursions with freezer in the facility, where she works. It had been happening for weeks since April 2022. The storage condition at the time of the excursion was reported as frozen storage. The affected batch lot numbers were reported as 065K21A and 045L21A. The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees. The vaccines suffered 2 temperature excursions since April, both of which lasted less than 1 minute. The vials were stored frozen. Visual inspection did not noted any vaccine state change. No treatment medication were provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine administered to patients post temperature excursion) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003M21A) for COVID-19 prophylaxis. No Medical History information was reported. On 10-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine administered to patients post temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine administered to patients post temperature excursion) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Vaccine was stored at the refrigerated storage condition. Minimum temperature was 26 degree F and average temperature was 28 degree F was reached. Excursion duration was 15 minutes at minimum temperature and total duration was 5 hours. All the vaccine which was stored was used up. No changes was noticed in vaccine state change. Pertinent details included vials were administered to patients with no previous temperature excursions. It was unknown if patient was diagnosed or tested positive for COVID-19. It was unknown if patient was having chronic or long standing health condition. It was reported events did not cause patient to seek medical care. It was reported that the patient did not report any adverse effects. It was reported that the patient had received the vaccine after it had undergone freezing in refrigerator the day before for about a five hour period. No treatment information were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). On 27-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The storage condition at the time of the excursion was reported as frozen storage. The affected batch lot numbers were reported as 065K21A and 045L21A. The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees. The vaccines suffered 2 temperature excursions since April, both of which lasted less than 1 minute. The vials were stored frozen. Visual inspection did not noted any vaccine state change. No treatment medication were provided.