chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Heart rate, Oxygen saturation, Pyrexia
Clinical narrative: fatigue; diarrhea; little of fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DIARRHOEA (diarrhea) and PYREXIA (little of fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.  Concurrent medical conditions included Kidney stone and Blood pressure increased.  On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced FATIGUE (fatigue), DIARRHOEA (diarrhea) and PYREXIA (little of fever). At the time of the report, FATIGUE (fatigue), DIARRHOEA (diarrhea) and PYREXIA (little of fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2022, Heart rate: 96 (normal) 96. On 18-Apr-2022, Oxygen saturation: 96 (normal) 96. No concomitant medication were provided. Patient reported no allergy. No treatment medication were provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient (Husband) received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient (Husband) received expired Moderna Covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient (Husband) received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient (Husband) received expired Moderna Covid-19 vaccine) outcome was unknown.            No concomitant information were reported by the reporter. No treatment information were reported by the reporter.   This case was linked to MOD-2022-543577, MOD-2022-543586 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: reaction to the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction to the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (reaction to the first dose). At the time of the report, VACCINATION SITE REACTION (reaction to the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-544281, MOD-2022-544280, MOD-2022-544280 (Patient Link).   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: 100 degree Fahrenheit temperature for 24 hours; tired feeling; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (100 degree Fahrenheit temperature for 24 hours) and FATIGUE (tired feeling) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A214 and 001A21A) for COVID-19 vaccination.     The patient had no allergies and had not been tested positive or diagnosed with COVID-19.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PYREXIA (100 degree Fahrenheit temperature for 24 hours) and FATIGUE (tired feeling). In 2021, PYREXIA (100 degree Fahrenheit temperature for 24 hours) had resolved. At the time of the report, FATIGUE (tired feeling) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100 degree fahrenheit (High) 100 degree Fahrenheit for 24 hours.         No concomitant medications were reported. No treatment information was provided.  The patient's husband described the adverse events as a reaction to the second dose of the vaccine.   This case was linked to MOD-2022-544448, MOD-2022-544443, MOD-2022-544267, MOD-2022-544281 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: 100°F temperature for 24 hours; tired feeling; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (100°F temperature for 24 hours) and FATIGUE (tired feeling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     It was reported that the Patient did not have any allergy. It was also reported that patient never had Covid-19 test.     On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (100°F temperature for 24 hours) and FATIGUE (tired feeling). At the time of the report, PYREXIA (100°F temperature for 24 hours) and FATIGUE (tired feeling) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 degree Fahrenheit temperature for 24 hours.         No concomitant and treatment drug was reported.   This case was linked to MOD-2022-544267, MOD-2022-544448, MOD-2022-544443, MOD-2022-544280 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Retching
Clinical narrative: Dry heaves; Chills; Body aches; Fever; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (Dry heaves), CHILLS (Chills), MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy. Concurrent medical conditions included Cancer (NOS) since 2021.    On 15-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2022, the patient experienced RETCHING (Dry heaves), CHILLS (Chills), MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headaches). On 17-Apr-2022, RETCHING (Dry heaves), CHILLS (Chills), MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headaches) had resolved.            Patient is currently on immunoglobulin treatments which he receives weekly or biweekly and these treatments were needed due to side effects from chemotherapy.  Patient did not experience any adverse evet to the first 3 shots.  Patient experienced the events from  15 Apr 2022 afternoon until 17 Apr 2022 morning- about 36 hours. On 17 Apr 2022 he felt a little out of it and was back to normal by Sunday evening around 6 pm.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: Dispensed dose of expired Moderna COVID-19 vaccine; Slightly sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Slightly sore arm) and EXPIRED PRODUCT ADMINISTERED (Dispensed dose of expired Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient did not have any allergies to medication, food and other products, and also patient did not have any acute illness at the time of vaccination and up to one month before. Patient did not have any chronic illness or long-standing health conditions.  Patient neither diagnosed with COVID-19 nor tested positive.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for Anticoagulant therapy.    On 06-Apr-2022 at 11:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dispensed dose of expired Moderna COVID-19 vaccine). In April 2022, the patient experienced PAIN IN EXTREMITY (Slightly sore arm). At the time of the report, PAIN IN EXTREMITY (Slightly sore arm) and EXPIRED PRODUCT ADMINISTERED (Dispensed dose of expired Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial did not undergo any temperature excursion and it was unknown when the vial initially stored in the refrigerator as transferred from another store.  It was reported that patient did not experience any adverse events besides a slightly sore arm similar to his previous Moderna doses.   Treatment medications were not reported.   This case was linked to MOD-2022-544635 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Incredible stiffness; Pain in hips, knees, calves, and feet; Lower extremity joint pain/joint pain that lingers; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Incredible stiffness), PAIN IN EXTREMITY (Pain in hips, knees, calves, and feet) and ARTHRALGIA (Lower extremity joint pain/joint pain that lingers) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]), ESCITALOPRAM and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Incredible stiffness), PAIN IN EXTREMITY (Pain in hips, knees, calves, and feet) and ARTHRALGIA (Lower extremity joint pain/joint pain that lingers). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Incredible stiffness), PAIN IN EXTREMITY (Pain in hips, knees, calves, and feet) and ARTHRALGIA (Lower extremity joint pain/joint pain that lingers) had resolved.            This case was linked to MOD-2022-544329, MOD-2022-544381, MOD-2022-544382 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Incredible stiffness; Lower extremity joint pain in the hips, knees, calves,and feet.; Joint pain that lingers; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Incredible stiffness), PAIN IN EXTREMITY (Lower extremity joint pain in the hips, knees, calves,and feet.) and ARTHRALGIA (Joint pain that lingers) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A, 032M20A and 016M20A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]), ESCITALOPRAM and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Incredible stiffness), PAIN IN EXTREMITY (Lower extremity joint pain in the hips, knees, calves,and feet.) and ARTHRALGIA (Joint pain that lingers). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Incredible stiffness), PAIN IN EXTREMITY (Lower extremity joint pain in the hips, knees, calves,and feet.) and ARTHRALGIA (Joint pain that lingers) had resolved.            Reported that the events started a week after vaccination and lasted for months.   This case was linked to MOD-2022-544380, MOD-2022-544329, MOD-2022-544382 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: incredible stiffness; pain in hips, knees, calves, and feet; lower extremity joint pain/joint pain that lingers; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (incredible stiffness), PAIN IN EXTREMITY (pain in hips, knees, calves, and feet) and ARTHRALGIA (lower extremity joint pain/joint pain that lingers) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 032M20A, 016M20A and 050C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]), ESCITALOPRAM and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (incredible stiffness), PAIN IN EXTREMITY (pain in hips, knees, calves, and feet) and ARTHRALGIA (lower extremity joint pain/joint pain that lingers). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (incredible stiffness), PAIN IN EXTREMITY (pain in hips, knees, calves, and feet) and ARTHRALGIA (lower extremity joint pain/joint pain that lingers) had resolved.            This case was linked to MOD-2022-544380, MOD-2022-544381, MOD-2022-544329 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Body aches after first shot; Tired after first shot/Fatigue after first shot; Chills after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches after first shot), FATIGUE (Tired after first shot/Fatigue after first shot) and CHILLS (Chills after first shot) in a 28-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced PAIN (Body aches after first shot), FATIGUE (Tiered after first shot/Fatigue after first shot) and CHILLS (Chills after first shot). At the time of the report, PAIN (Body aches after first shot), FATIGUE (Tiered after first shot/Fatigue after first shot) and CHILLS (Chills after first shot) outcome was unknown.    The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.  Concomitant mediation was not reported. Treatment information was not reported. Patient reported that 1 to 2 hours after vaccination, she felt tired, body aches, fatigue and chills.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine on 06-Apr-2022 which had an expiration date of 18-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 06-Apr-2022 which had an expiration date of 18-Mar-2022) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 06-Apr-2022 which had an expiration date of 18-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 06-Apr-2022 which had an expiration date of 18-Mar-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. There was no acute illness at the time of vaccination and up to one month before.  Patient had never diagnosed or tested positive for COVID-19. The patient reported no adverse events from the vaccine on 06-Apr-2022. The vial didn't undergo any temperature excursions.  The treatment information was not reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: tired feeling; 100 degree F temperature for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired feeling) and PYREXIA (100 degree F temperature for 24 hours) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 046A214 and 001A21A) for COVID-19 vaccination.     The patient did not have any allergies (medications, food and other products). The patient neither had COVID positive test nor had a diagnosis of COVID.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired feeling) and PYREXIA (100 degree F temperature for 24 hours). At the time of the report, FATIGUE (tired feeling) and PYREXIA (100 degree F temperature for 24 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 degree Fahrenheit.         Concomitant medication of the patient was not reported.  The patient did not have any reactions after the first dose.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-544443 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Pain; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Pain) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 100 microgram. On an unknown date, the patient experienced PAIN (Pain) and FATIGUE (Fatigue). At the time of the report, PAIN (Pain) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided.   This case was linked to MOD-2022-461991 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised Patient did not received 3 full primary series doses; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised Patient did not received 3 full primary series doses) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A, 036A21A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised Patient did not received 3 full primary series doses). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised Patient did not received 3 full primary series doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. Patient received first and second dose of Moderna in left arm shoulder deltoid muscle. Paitent had no adverse event after first and second dose of Moderna vaccine. Patient also reported no other adverse events to booster dose as well. The weight of the patient was unknown. No treatment details reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered
Clinical narrative: Vaccine was administered after it had been open for more than 12 hours; Vaccine was administered after it had been open for more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after it had been open for more than 12 hours) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after it had been open for more than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after it had been open for more than 12 hours) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after it had been open for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after it had been open for more than 12 hours) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after it had been open for more than 12 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Products were reported. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Vaccine information updated.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: At the time of vaccination it was approx 6 to 10 days past the 30 days window; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (At the time of vaccination it was approx 6 to 10 days past the 30 days window) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065k21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (At the time of vaccination it was approx 6 to 10 days past the 30 days window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (At the time of vaccination it was approx 6 to 10 days past the 30 days window) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter.  Patient allergic condition was unknown and patient was diagnosed with COVID-19 condition was unknown.  For patient acute illnesses condition at the time of vaccination and up to one month before was unknown.  Patient chronic or long lasting health condition was unknown.  Also for patient prescription over the counter medications ,dietary supplements or herbal remedies being taken at the time of vaccination or at the time of adverse event was unknown. For patient other vaccines given on the same day as Moderna Covid-19 vaccine as well as vaccines received within one moth  prior to any dose of Moderna COVID-19 vaccine was unknown. No patient have contacted  to reporter about any reaction. Treatment information was not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial of Moderna went  past 30 day at 2-8 degree Celsius; Covid-19 vaccine that were given beyond the 30 day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (Vial of Moderna went  past 30 day at 2-8 degree Celsius) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial of Moderna went  past 30 day at 2-8 degree Celsius). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (Vial of Moderna went  past 30 day at 2-8 degree Celsius) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. it was reported that the dose was 0.25 7 patients received 2nd booster dose of moderna which was approximately 6-10 days past the 30-day expiration window.  At the time of this report, no patient has contacted about any reactions. No treatment medication reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: At the time of administration the vial was approximately 6-10 days past the 30 days window; Covid-19 vaccine that were given beyond the 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (At the time of administration the vial was approximately 6-10 days past the 30 days window) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (At the time of administration the vial was approximately 6-10 days past the 30 days window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (At the time of administration the vial was approximately 6-10 days past the 30 days window) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  7 patients received 2nd booster dose of moderna which was approximately 6-10 days past the 30-day expiration window. At the time of this report, no patient has contacted about any reactions.  No treatment medications were reported.  It was reported that isolated all vaccines with reported lot number and pulled from over inventory rotation.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dispensed 28 doses of expired Moderna Covid-19 vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine.) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient was not diagnosed or tested positive for COVID-19. There was no diagnosed acute illness at the time of vaccination and up to one month before. There was no chronic or long-standing health conditions.     On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Vials did not undergone any temperature excursions. It was reported as expired vaccine was administered but results from the moderna stability study showed proper activity against COVID-19. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine) 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 patient don't have acute illness at the time of vaccination and up to one month before. Patient reports no adverse events from the vaccine that was took on 06-Apr-2022. The vial did not undergo any temperature excursions. On unknown date the vial was initially stored in the refrigerator. Patient had never been diagnosed with or tested positive for COVID-19. The result of stability study shows full activity against COVID-19.  No treatment medication was reported.   This case was linked to MOD-2022-541343 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1- 16-Jun-2021 Dose 2- 04-Aug-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1- 16-Jun-2021 Dose 2- 04-Aug-2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included MULTIVITAMIN IRON for an unknown indication.   On 16-Jun-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Aug-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1- 16-Jun-2021 Dose 2- 04-Aug-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1- 16-Jun-2021 Dose 2- 04-Aug-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was prescribed with some medications after third dose. Those are hydrochlorothiazide 25 mg tablet, hydrocodone 10 mg with acetaminophen 325 mg tablet, methocarbamol 750 mg tablet, naproxen 500 mg tablet. The patient had no known drug allergies. No treatment medications were reported.   This case was linked to MOD-2022-544255 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1- 16-Jun-2021 Dose 2- 04-Aug-2021; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1- 16-Jun-2021 Dose 2- 04-Aug-2021) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006821A and 047A21A) for COVID-19 vaccination.     Patient medical history included HLD. It was unknown that the patient was ever been diagnosed positive with COVID-19. Patient had no acute illnesses at the time of vaccination and up to one month before.  The patient's past medical history included Anemia (no recent changes in current condition). Concurrent medical conditions included Penicillin allergy, Hypertension (no recent changes in current condition), Diabetes mellitus (no recent changes in current condition) and Parkinson's disease (no recent changes in current condition). Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL SULFATE HFA), ALENDRONATE SODIUM (ALENDRONATE), AMLODIPINE, ASPIRIN [ACETYLSALICYLIC ACID], BRINZOLAMIDE (AZOPT), CALCITONIN, SALMON (CALCITONIN-SALMON), BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN), FUROSEMIDE, LATANOPROST, LOSARTAN, BIMATOPROST (LUMIGAN), METFORMIN, ROSUVASTATIN and TRAMADOL from 01-Apr-2022 to an unknown date for an unknown indication.   On 16-Jun-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Aug-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Aug-2021 at 1:30 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1- 16-Jun-2021 Dose 2- 04-Aug-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1- 16-Jun-2021 Dose 2- 04-Aug-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not receive dose.4. The formulation of the calcitonin(salmon) 200 unit was actuation  nasal spray No treatment medications were reported.   This case was linked to MOD-2022-544279 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered from vaccines that experienced a T excursion; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) in a 50-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided. Max Temperature reached was 64°F Excursion duration was approximately 7 hours Three was no changes in visual inspection.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered from vaccines that experienced a T excursion; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion). On 23-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that excursion duration was approximately 7 hours. The product was refrigerated at the time of excursion. Max Temperature reached was 64°F. There was no change in vaccine state on visual inspection. No treatment information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: three patient that received the second  booster to early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (three patient that received the second  booster to early) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L21A, 069H21A, 018B21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (three patient that received the second booster to early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (three patient that received the second booster to early) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter.      No Treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Live Follow-up received contains No new information
Sex: U
Vaccine: PNC20
Symptoms: Decreased appetite, Dizziness, Fatigue, Migraine, Nausea
Clinical narrative: I have had severe Sid_Ts effects to this vaccine pc20 and I can_Tt eat anything have constant migraines , dizziness and extreme nausea and fatigue is there anything to minimize this; MIGRAINE; DIZZINESS; NAUSEA; FATIGUE; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DECREASED APPETITE (non-serious), outcome "unknown", described as "I have had severe Sid_Ts effects to this vaccine pc20 and I can_Tt eat anything have constant migraines , dizziness and extreme nausea and fatigue is there anything to minimize this"; MIGRAINE (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Syringe issue
Clinical narrative: Prevnar 13 Vaccine syringe broke into two pieces when the needle was screwed onto the syringe; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 07Apr2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group,  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: EW2019, Expiration Date: 31Dec2023) for immunisation, Device Lot Number: EW2019, Device Expiration Date: 31Dec2023. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Prevnar 13 Vaccine syringe broke into two pieces when the needle was screwed onto the syringe". Additional information: It was reported that Prevnar 13 vaccine syringe broke into two pieces when the needle was screwed onto the syringe. The glass is still connected to the vaccine, which was further clarified that the piece where syringe is, caller doesn't know what the little piece is called, the area where the neck of the syringe screws into the vaccine is connected to the needle. It was also reported that the sample was available for return and it was confirmed that there was no patient involvement.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Hypersensitivity, Infection, Swelling
Clinical narrative: severe allergic reaction; swelling; developed infection; had a flare up due to eating something that had egg in it a week ago; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  An elderly female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (medically significant) with onset Apr2022, outcome "unknown", described as "had a flare up due to eating something that had egg in it a week ago"; HYPERSENSITIVITY (medically significant), outcome "unknown", described as "severe allergic reaction"; SWELLING (medically significant), outcome "unknown"; INFECTION (medically significant), outcome "unknown", described as "developed infection". The events "severe allergic reaction", "swelling" and "developed infection" required emergency room visit. Clinical Information: Description of event: Patient had a severe allergic reaction with swelling and developed infection and had to go to the emergency room for treatment. This was the patient's first time getting a pneumonia vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect drug cannot be denied for the reported events.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Feeling hot
Clinical narrative: arm is still a little red and warm to the touch; arm is still a little red and warm to the touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 06Apr2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset Apr2022, outcome "recovered" (Apr2022) and all described as "arm is still a little red and warm to the touch". Additional information: The patient reported that she had Prevnar 20 last Wednesday, 06Apr2022. Her arm is still a little red and warm to the touch, she looked on the internet and it said that this would last up to three days. The patient was wondering if there is any problem but did state that she felt ok and just wanted to ask.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.