chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on Jan-2021 and next dose 6 months later) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Sinus disorder (sinus sufferer for the last 25 years).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on Jan-2021 and next dose 6 months later). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on Jan-2021 and next dose 6 months later) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No information on concomitant medication was reported. No information on treatment medications was reported.   This case was linked to MOD-2022-562493 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Illness, Malaise, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on Jan-2021 and next dose 6 months later) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Sinus disorder (sinus sufferer for the last 25 years).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on Jan-2021 and next dose 6 months later). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on Jan-2021 and next dose 6 months later) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No information on concomitant medication was reported. No information on treatment medications was reported.   This case was linked to MOD-2022-562493 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: lower back pain; fatigue; swollen lymph nodes in left armpit which kept her up all night; low grade fever for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), FATIGUE (fatigue), LYMPHADENOPATHY (swollen lymph nodes in left armpit which kept her up all night) and PYREXIA (low grade fever for 3 days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.    On 04-Mar-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 BACK PAIN (lower back pain), FATIGUE (fatigue), LYMPHADENOPATHY (swollen lymph nodes in left armpit which kept her up all night) and PYREXIA (low grade fever for 3 days). At the time of the report, BACK PAIN (lower back pain), FATIGUE (fatigue) and LYMPHADENOPATHY (swollen lymph nodes in left armpit which kept her up all night) outcome was unknown and PYREXIA (low grade fever for 3 days) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medication was reported.     No treatment information was reported.   This case was linked to MOD-2022-563382, MOD-2022-563381 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Patient developed Tinnitus after receiving Moderna booster; This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (Patient developed Tinnitus after receiving Moderna booster) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Patient developed Tinnitus after receiving Moderna booster). At the time of the report, TINNITUS (Patient developed Tinnitus after receiving Moderna booster) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient age was reported as approximately 60 years. Concomitant product information was not provided. It was reported that patient received Moderna booster dose. Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received dose from a vial greater than 12hrs at room temperature/ Moderna vaccine that has been sitting at room temperature greater than 12 hours; Patient received dose from a vial greater than 12hrs at room temperature; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial greater than 12hrs at room temperature) and PRODUCT STORAGE ERROR (Patient received dose from a vial greater than 12hrs at room temperature/ Moderna vaccine that has been sitting at room temperature greater than 12 hours) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial greater than 12hrs at room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial greater than 12hrs at room temperature/ Moderna vaccine that has been sitting at room temperature greater than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial greater than 12hrs at room temperature) and PRODUCT STORAGE ERROR (Patient received dose from a vial greater than 12hrs at room temperature/ Moderna vaccine that has been sitting at room temperature greater than 12 hours) 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 patient received her Moderna booster dose and previous vaccination history was unavailable. The vial was initially stored in the refrigerator on 14-Apr-2022. On 06-May-2022 around 9:30 AM the vial was first punctured. The vial stored at room temperature post puncture. 4 doses were given on 07-May-2022 at 11:20 AM, 11:49 AM, 12:05 PM and 12:30 PM. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was reported as 29 hours. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Follow up received contains non significant information.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patinet received doses from a vials greater than 12hrs at room temperature; patients received doses from a vial greater than 12hrs at room temperature; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (patinet received doses from a vials greater than 12hrs at room temperature) and EXPIRED PRODUCT ADMINISTERED (patients received doses from a vial greater than 12hrs at room temperature) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 07-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received doses from a vial greater than 12hrs at room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patinet received doses from a vials greater than 12hrs at room temperature). At the time of the report, PRODUCT STORAGE ERROR (patinet received doses from a vials greater than 12hrs at room temperature) and EXPIRED PRODUCT ADMINISTERED (patients received doses from a vial greater than 12hrs at room temperature) 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 vial was initially stored in refrigerator on 14-Apr-2022. It was reported that patient received dose from vial which was at rom temperature for more than 12 hours.The vial was first punctured on 06-May-2022 around 9:30 AM and date of administration of vaccine was 07-May-2022 at 11:20 AM, 11:49 AM, 12:05 PM, and 12:30 PM. Post puncture vial was stored in room temperature.  Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius which is equal to 46 degree to 77 degree Fahrenheit) was 29 hours.  No treatment medication information was given.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Follow up received contains no new information
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error
Clinical narrative: Patient received dose from a vial kept more than 12hrs at room temperature post first puncture; Patient received dose from a vial kept more than 12hrs at room temperature post first puncture; second dose was adminstered after 4 month; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture), EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was adminstered after 4 month) in a 39-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was adminstered after 4 month). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture). At the time of the report, PRODUCT STORAGE ERROR (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture), EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was adminstered after 4 month) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. It was reported that, the vial was initially stored in the refrigerator on 14-Apr-2022. On 06-May-2022 at around 09.30 am, the vial was first punctured. Pots punctured the vial was stored at room temperature for 29 hours in temperature range (8 to 25 Degree Celsius 46 to 77 Degree Fahrenheit). Later on, 07-May-2022, 4 doses were administered to the patient at 11:20 AM, 11:49 AM, 12:05 PM and 12:30 PM. The vial was exposed to room temperature range from 8 degree to 25 degree Celsius that 46 to 77 Fahrenheit for 29 hours. The vial did not undergo the temperature excursion. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Follow-up received: patient demographics and dosage information was added.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received dose from a vial kept more than 12hrs at room temperature post first puncture; Patient received dose from a vial kept more than 12hrs at room temperature post first puncture; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture) and EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 07-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture). At the time of the report, PRODUCT STORAGE ERROR (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture) and EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture) 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, the vial was initially stored in the refrigerator on 14-Apr-2022 On 06-May-2022 at around 09.30 am, the vial was first punctured. Pots punctured; the vial was stored at room temperature for 29 hours in temperature range (8 to 25 Degree Celsius = 46 to 77 Degree Fahrenheit). Later on, 07-May-2022, 4 doses were administered to the patient at 11:20 AM, 11:49 AM, 12:05 PM and 12:30 PM.  The vial did not undergo the temperature excursion.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Live Follow-up information received includes patient demographics, and vaccine details were updated.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Inappropriate schedule of product administration, Lymphadenopathy, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), LYMPHADENOPATHY (swollen lymph nodes in left armpit which kept her up all night), FATIGUE (Fatigue), PYREXIA (low grade fever for 3 days) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 04-Mar-2021 and 2nd dose on 13-Apr-2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 04-Mar-2021 and 2nd dose on 13-Apr-2021). On an unknown date, the patient experienced BACK PAIN (lower back pain), LYMPHADENOPATHY (swollen lymph nodes in left armpit which kept her up all night), FATIGUE (Fatigue) and PYREXIA (low grade fever for 3 days). At the time of the report, BACK PAIN (lower back pain), LYMPHADENOPATHY (swollen lymph nodes in left armpit which kept her up all night), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 04-Mar-2021 and 2nd dose on 13-Apr-2021) outcome was unknown and PYREXIA (low grade fever for 3 days) had resolved. No Concomitant product use was reported. The patient reported that after receiving the second dose, the patient experienced low grade fever for 3 days, swollen lymph nodes in their left armpit which kept them up all night, fatigue, and lower back pain. No treatment information was provided. This case was linked to MOD-2022-562865, MOD-2022-563382 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: Lower back pain; Swollen lymph nodes in left armpit which kept her up all night; Fatigue; low grade fever for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain), LYMPHADENOPATHY (Swollen lymph nodes in left armpit which kept her up all night), FATIGUE (Fatigue) and PYREXIA (low grade fever for 3 days) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-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 BACK PAIN (Lower back pain), LYMPHADENOPATHY (Swollen lymph nodes in left armpit which kept her up all night), FATIGUE (Fatigue) and PYREXIA (low grade fever for 3 days). At the time of the report, BACK PAIN (Lower back pain), LYMPHADENOPATHY (Swollen lymph nodes in left armpit which kept her up all night) and FATIGUE (Fatigue) outcome was unknown and PYREXIA (low grade fever for 3 days) had resolved.      No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2022-562865, MOD-2022-563381 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: He had hardly any side effects for the 1st 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses). At the time of the report, IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant product use was reported.  No treatment information was reported.   This case was linked to MOD-2022-562710, MOD-2022-563454 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Inappropriate schedule of product administration
Clinical narrative: The patient received 1st dose on 04-MAR-2021 and 2nd dose on 13-APR-2021; He had hardly any side effects for the 1st 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received 1st dose on 04-MAR-2021 and 2nd dose on 13-APR-2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received 1st dose on 04-MAR-2021 and 2nd dose on 13-APR-2021). In 2021, the patient experienced IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses). At the time of the report, IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received 1st dose on 04-MAR-2021 and 2nd dose on 13-APR-2021) outcome was unknown.            No concomitant product use was reported.  No treatment information was reported.   This case was linked to MOD-2022-563451, MOD-2022-563456 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: He had hardly any side effects for the 1st 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 003A21A and 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-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 IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses). At the time of the report, IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Muscular weakness
Clinical narrative: A feeling of insecurity when walking due to muscle weakness; Today, I woke up with quite annoying dizziness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (A feeling of insecurity when walking due to muscle weakness) and DIZZINESS (Today, I woke up with quite annoying dizziness) 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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient experienced MUSCULAR WEAKNESS (A feeling of insecurity when walking due to muscle weakness) and DIZZINESS (Today, I woke up with quite annoying dizziness). At the time of the report, MUSCULAR WEAKNESS (A feeling of insecurity when walking due to muscle weakness) and DIZZINESS (Today, I woke up with quite annoying dizziness) outcome was unknown.     No concomitant medication was reported.   It was reported that five days ago patient received the fourth dose, a booster dose.  The treatment information was not reported.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received a booster at 17 years of age; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received a booster at 17 years of age) in a 17-year-old patient of an unknown 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received a booster at 17 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received a booster at 17 years of age) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  Reporter queried that if a 16 years old patient received Moderna dose 1 and 2, properly spaced and then received a booster at 17 years of age, does this individual need to repeat any of the doses.   This case was linked to MOD-2022-563487 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Live follow-up document received: Reporter's contact number was reported.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on back of neck or upper back region; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (rash on back of neck or upper back region) 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 RASH (rash on back of neck or upper back region). At the time of the report, RASH (rash on back of neck or upper back region) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Pharmacist stated the symptom exacerbated after patient received Moderna booster dose. No concomitant medications information was reported. No treatment medications were provided.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Nasopharyngitis, Pain
Clinical narrative: cold; pain; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), PAIN (pain), CHILLS (chills) and HEADACHE (headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve replacement and Artificial cardiac pacemaker user. Concurrent medical conditions included Heart disease, unspecified since 2008. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, FUROSEMIDE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced NASOPHARYNGITIS (cold), PAIN (pain), CHILLS (chills) and HEADACHE (headache). On 15-Feb-2021, NASOPHARYNGITIS (cold), PAIN (pain), CHILLS (chills) and HEADACHE (headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient's height was reported as 5'2. It was reported that the patient was very sensitive to vaccines, always had adverse reactions.  No treatment details were reported.   This case was linked to MOD-2022-563515, MOD-2022-563534, MOD-2022-563517, MOD-2022-563534 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nasopharyngitis
Clinical narrative: cold without fever; Ache all over the body; headache; chills; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold without fever), MYALGIA (Ache all over the body), HEADACHE (headache), CHILLS (chills) and FATIGUE (felt tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 071F21A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve replacement and Artificial cardiac pacemaker user. Concurrent medical conditions included Heart disease, unspecified (she had a mitral valve replacement and a pacemaker) since 2008. Concomitant products included APIXABAN (ELIQUIS) and FUROSEMIDE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022, the patient experienced NASOPHARYNGITIS (cold without fever), MYALGIA (Ache all over the body), HEADACHE (headache), CHILLS (chills) and FATIGUE (felt tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold without fever), MYALGIA (Ache all over the body), HEADACHE (headache), CHILLS (chills) and FATIGUE (felt tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Patient had no Allergies to medications, food and other products Patient stated that no Other vaccines given within 1 month prior to Moderna COVID-19 vaccine Patient didn't seek medical care & was very sensitive to vaccines in general & patient always have adverse reactions, but not as longer as this time Patient had no change in status such as improvement or worsening   This case was linked to MOD-2022-563515 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: cold without fever; Ache all over the body; headache; chills; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold without fever), MYALGIA (Ache all over the body), HEADACHE (headache), CHILLS (chills) and FATIGUE (felt tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 071F21A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve replacement and Artificial cardiac pacemaker user. Concurrent medical conditions included Heart disease, unspecified (she had a mitral valve replacement and a pacemaker) since 2008. Concomitant products included APIXABAN (ELIQUIS) and FUROSEMIDE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022, the patient experienced NASOPHARYNGITIS (cold without fever), MYALGIA (Ache all over the body), HEADACHE (headache), CHILLS (chills) and FATIGUE (felt tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold without fever), MYALGIA (Ache all over the body), HEADACHE (headache), CHILLS (chills) and FATIGUE (felt tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Patient had no Allergies to medications, food and other products Patient stated that no Other vaccines given within 1 month prior to Moderna COVID-19 vaccine Patient didn't seek medical care & was very sensitive to vaccines in general & patient always have adverse reactions, but not as longer as this time Patient had no change in status such as improvement or worsening   This case was linked to MOD-2022-563515 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: More than 35 days for 2nd moderna dose; Patient given 0.25 mL for second dose, instead of 0.5 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days for 2nd moderna dose) and ACCIDENTAL UNDERDOSE (Patient given 0.25 mL for second dose, instead of 0.5 mL) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days for 2nd moderna dose) and ACCIDENTAL UNDERDOSE (Patient given 0.25 mL for second dose, instead of 0.5 mL). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days for 2nd moderna dose) and ACCIDENTAL UNDERDOSE (Patient given 0.25 mL for second dose, instead of 0.5 mL) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  The patient visited pharmacy for 2nd dose sometime last week from date of this report.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Pyrexia
Clinical narrative: one of the impacted individuals who declined to be re-boosted reported fever following the dose from the expired lot; Moderna Covid-19 vaccine vial with a beyond use date of 03 May 2022 that had been inadvertently used to withdraw six booster doses and administered to six college students on 5 May 2022/ Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (one of the impacted individuals who declined to be re-boosted reported fever following the dose from the expired lot) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine vial with a beyond use date of 03 May 2022 that had been inadvertently used to withdraw six booster doses and administered to six college students on 5 May 2022/ Expired vaccine used) 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 05-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine vial with a beyond use date of 03 May 2022 that had been inadvertently used to withdraw six booster doses and administered to six college students on 5 May 2022/ Expired vaccine used). On an unknown date, the patient experienced PYREXIA (one of the impacted individuals who declined to be re-boosted reported fever following the dose from the expired lot). At the time of the report, PYREXIA (one of the impacted individuals who declined to be re-boosted reported fever following the dose from the expired lot) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine vial with a beyond use date of 03 May 2022 that had been inadvertently used to withdraw six booster doses and administered to six college students on 5 May 2022/ Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided Treatment medication was not provided by the reporter  It was reported that patient had conveyed to the nurse that given the reaction he was experiencing that he felt an effective dose had been administered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: after the first vaccine like a little bit more itchy; it hurt little bit more when I got it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8734) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing), notes: Acid reflux Consumer stated, "I have acid reflux but I don't take anything for it. Concomitant medication(s) included: LEXAPRO. The following information was reported: PRURITUS (non-serious), outcome "not recovered", described as "after the first vaccine like a little bit more itchy"; PAIN (non-serious), outcome "not recovered", described as "it hurt little bit more when I got it". The events "after the first vaccine like a little bit more itchy" and "it hurt little bit more when i got it" required physician office visit. Therapeutic measures were not taken as a result of pruritus, pain.
Age: 12.0
Sex: M
Vaccine: COVID19, HPVX
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Vomiting
Clinical narrative: vomiting; diarrhea; stomach cramps; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old male patient received BNT162b2 (BNT162B2), on 02May2022 at 16:00 as dose 3 (booster), single (Lot number: FK9895) at the age of 12 years, in left arm for covid-19 immunisation; hpv vaccine (HPV VACCINE), on 02May2022 as dose 2, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history included: "Exercise induced Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; FLONASE [FLUTICASONE PROPIONATE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: BNT162b2 ([{prev_dose_product=COVID 19,, prev_dose_brand=Pfizer,, prev_dose_brand_unknown=False,, prev_dose_lot_number=FK5618,, prev_dose_lot_unknown=False,, prev_dose_administration_date=01Dec2021, prev_dose_dose_number=2,, prev_dose_vaccine_location=Right, arm},), administration date: 01Dec2021, when the patient was 11-year-old, for Covid-19 Immunization; BNT162b2 ({prev_dose_product=COVID 19,, prev_dose_brand=Pfizer,, prev_dose_brand_unknown=False,, prev_dose_lot_number=FK5127,, prev_dose_lot_unknown=False,, prev_dose_administration_date=10N, ov2021, prev_dose_dose_number=1,, prev_dose_vaccine_location=Right, arm}]), administration date: 10Nov2021, when the patient was 11-year-old, for Covid-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 03May2022 at 02:00, outcome "recovered" (03May2022 at 20:00), described as "diarrhea"; HEADACHE (non-serious) with onset 03May2022 at 02:00, outcome "recovered" (03May2022 at 20:00); ABDOMINAL PAIN UPPER (non-serious) with onset 03May2022 at 02:00, outcome "recovered" (03May2022 at 20:00), described as "stomach cramps"; VOMITING (non-serious) with onset 03May2022 at 02:00, outcome "recovered" (03May2022 at 20:00). Therapeutic measures were not taken as a result of vomiting, diarrhoea, abdominal pain upper, headache.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Therapeutic response unexpected
Clinical narrative: I woke up and felt good there was no post nasal drip or congestion, do not know if the vaccine is helping my allergies; dose 1, 04May2022; dose 2, 04May2022; dose 3, 04May2022;; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2022 at 10:45 as dose 4 (booster), single (Lot number: FL3197) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "congestion" (unspecified if ongoing), notes: congestion; "Postnasal drip" (unspecified if ongoing), notes: post nasal drip; "Penicillin allergy" (unspecified if ongoing), notes: allergies Penicillin; "allergies" (unspecified if ongoing), notes: was having post nasal drip and congestion prior to my vaccine due to allergies. Concomitant medication(s) included: METFORMIN; LISINOPRIL; CRESTOR; BENADRYL; AZELASTINE. Vaccination history included: Bnt162b2 (other vaccine same date product: Pfizer,, other vaccine same date lot number: EL3247,, other vaccine same date vaccine date: 04May2022,, other vaccine same date dose number: 1,, other vaccine same date vaccine location: Left arm), for Covid-19 Immunization; Bnt162b2 (other vaccine same date product: Pfizer,, other vaccine same date lot number: EL3247,, other vaccine same date vaccine date: 04May2022,, other vaccine same date dose number: 2,, other vaccine same date vaccine location: Left arm,), for Covid-19 immunization; Bnt162b2 (other vaccine same date product: Pfizer,, other vaccine same date lot number: EW0217,, other vaccine same date vaccine date: 04May2022,, other vaccine same date dose number: 3,, other vaccine same date vaccine location: Left arm,), for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04May2022, outcome "unknown", described as "dose 1, 04May2022; dose 2, 04May2022; dose 3, 04May2022;"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 05May2022 at 06:30, outcome "unknown", described as "I woke up and felt good there was no post nasal drip or congestion, do not know if the vaccine is helping my allergies". Therapeutic measures were not taken as a result of therapeutic response unexpected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pulmonary pain
Clinical narrative: 1 dose: tightness of chest and pain in lungs for 28 hours; 1 dose: tightness of chest and pain in lungs for 28 hours; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Lot number: FK4175) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: seafood" (unspecified if ongoing), notes: known allergies Seafood, shellfish, pineapple; "known allergies: shellfish" (unspecified if ongoing), notes: known allergies Seafood, shellfish, pineapple; "Known allergies: pineapple" (unspecified if ongoing), notes: known allergies Seafood, shellfish, pineapple. The patient's concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious), PULMONARY PAIN (non-serious), outcome "unknown" and all described as "1 dose: tightness of chest and pain in lungs for 28 hours".  Additional information: No covid prior vaccination. Patient did not tested post vaccination for covid. Patient did not receive any other vaccine within four weeks. Patient did not receive other medications in two weeks. Patient did not received treatment for adverse events.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Batch/Lot number: unknown), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for Covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies. The patient was not pregnant at time of vaccination. Other medical history was reported as no. Other medication in 2 weeks was reported as no. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of Covid-19. Anti-viral details: Product: COVID-19 Treatment, Brand: Paxlovid, Treatment start date: 03May2022, Lot number: FY5656, Indication: Treatment of COVID-19. The device timestamp was on 05May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162b2  cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Known allergies: Sulfa antibiotics" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; negative. Therapeutic measures were taken as a result of covid-19.  Clinical information: All symptoms recovered by day 6 and tested negative on antigen test. Another antigen test done on day 8 which was negative.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.